Public Health Impact

The California Court of Appeal, Third Appellate District (Sacramento), has upheld the listing of bisphenol A (BPA) as a reproductive toxicant under Proposition 65 (Prop 65). Prop 65 a right-to-know law that requires individuals to receive a clear and reasonable warning before being exposed to certain chemicals that California deems to be carcinogens or reproductive toxicants.

NTP Information Cited
By way of background, the National Toxicology Program – Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR) published a monograph in 2008, titled, “Monograph on the Potential Human Reproductive and Developmental Effects of [BPA].” The monograph, which primarily addressed studies in laboratory animals, stated that it is possible that BPA can affect human development or reproduction. Based on NTP-CERHR’s finding that BPA can affect human development or reproduction, the National Resources Defense Council (NRDC) petitioned California’s Office of Environmental Health Hazard Assessment (OEHHA) requesting that BPA be listed under Prop 65 as a chemical known to cause reproductive toxicity.

After reviewing the NTP-CERHR monograph, the Developmental and Reproductive Toxicant Identification Committee (DART-IC)—an OEHHA committee of qualified scientific experts—voted not to list BPA as a reproductive toxicant based on the state’s qualified experts listing mechanism in 2009. DART-IC members expressed skepticism as to whether the conclusions from the animal studies could be extrapolated to humans.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Blood Lead Surveillance System (BLSS)'' (OMB Control No. 0920-0931, Exp. Date 05/31/2021). The National Center for Environmental Health (NCEH) is leading a three-year extension information collection request (ICR) for two CDC information collections, one for childhood blood lead surveillance by NCEH and another for adult blood lead surveillance by the National Institute for Occupational Safety and Health (NIOSH).

NTP Information Cited

The Office of Environmental Health Hazard Assessment (OEHHA) is adopting new cancer inhalation unit risk (IUR) and slope factors for Cobalt and Cobalt Compounds for use in the Air Toxics Hot Spots Program. IURs are used to estimate lifetime cancer risks associated with inhalation exposure to a carcinogen. OEHHA is required to develop guidelines for conducting health risk assessments under the Air Toxics Hot Spots Program (Health and Safety Code Section 44360(b)(2)). In implementing this requirement, OEHHA develops new IURs and revises existing IURs for many air pollutants. The IURs for cobalt and insoluble and soluble cobalt compounds were developed using the most recent guidance, “Air Toxics Hot Spots Program Technical Support Document for Cancer Potency Factors,” finalized by OEHHA in 2009.

NTP Information Cited
NTP (1996). Toxicology and Carcinogenesis Studies of Nickel Subsulfide (CAS No. 12035-72-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). NTP TR 453. Research Triangle Park, NC.

NTP (1998a). NTP Technical Report on the Toxicology and Carcinogenesis Studies of Cobalt Sulfate Heptahydrate (CAS No. 10026-24-1) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). NTP TR 471. Research Triangle Park, NC.

NTP (1998b). TR-471: Cobalt sulfate heptahydrate (10026-24-1). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC (USA): National Toxicology Program (NTP). Accessed November 2017. https://manticore.niehs.nih.gov/cebssearch/publication/TR-47.

NTP (2014a). NTP Technical Report on the Toxicology Studies of Cobalt Metal (CAS No. 7440-48-4) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Cobalt Metal in F344/NTac Rats and B6C3F1/N Mice (Inhalation Studies). NTP TR 581. Research Triangle Park, NC.

NTP (2014b). TR-581: Cobalt (7440-48-4). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC (USA): National Toxicology Program (NTP). Accessed November, 2017. https://manticore.niehs.nih.gov/cebssearch/publication/TR- 581.

NTP (2016). National Toxicology Program. Cobalt and Cobalt Compounds That Release Cobalt Ions In Vivo, CAS No. 7440-48-4 (Cobalt metal). Report on Carcinogens, Fourteenth Edition. 8 p.

This bill would, commencing January 1, 2025, prohibit a person or entity from manufacturing, selling, delivering, holding, or offering for sale, in commerce any cosmetic product that contains any of several specified intentionally added ingredients, except under specified circumstances.

NTP Information Cited
Eberle CE, Sandler DP, Taylor KW, White AJ. Hair dye and chemical straightener use and breast cancer risk in a large US population of black and white women. Int J Cancer. 2020 Jul 15;147(2):383-391. doi: 10.1002/ijc.32738. Epub 2019 Dec 3.

This bill would, commencing January 1, 2025, prohibit a person or entity from manufacturing, selling, delivering, holding, or offering for sale, in commerce any cosmetic product that contains any of several specified intentionally added ingredients, except under specified circumstances.

NTP Information Cited
Eberle CE, Sandler DP, Taylor KW, White AJ. Hair dye and chemical straightener use and breast cancer risk in a large US population of black and white women. Int J Cancer. 2020 Jul 15;147(2):383-391. doi: 10.1002/ijc.32738. Epub 2019 Dec 3.

The Environmental Protection Agency (EPA) is finalizing changes to existing regulations to protect the public from lead in plumbing materials used in public water systems or residential or nonresidential facilities providing water for human consumption. The changes in this rule codify aspects of the Reduction of Lead in Drinking Water Act of 2011 (RLDWA) and the Community Fire Safety Act of 2013 (CFSA).

NTP Information Cited
National Toxicity Program, 2012. Monograph on Health Effects of Low-level Lead. U.S. Department of Health and Human Services. June 2012. Available on the internet at: https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf

The Office of Environmental Health Hazard Assessment (OEHHA) is adopting new Reference Exposure Levels (RELs) for Toluene for use in the Air Toxics Hot Spots Program. RELs are airborne concentrations of a chemical that are not anticipated to result in adverse noncancer health effects for specified exposure durations in the general population, including sensitive subpopulations. The adopted RELs cover different types of exposure to toluene in air: infrequent 1-hour exposures, repeated 8-hour exposures, and continuous long-term exposures. OEHHA is required to develop guidelines for conducting health risk assessments under the Air Toxics Hot Spots Program (Health and Safety Code Section 44360(b)(2)). In response to this statutory requirement, OEHHA develops RELs for many air pollutants, including Toluene. The Toluene RELs were developed using the most recent “Air Toxics Hot Spots Program Technical Support Document for the Derivation of Noncancer Reference Exposure Levels” (OEHHA, 2008). Toluene has been demonstrated to have neurotoxic effects. This chemical will also be added to the list of Toxic Air Contaminants that may disproportionately impact children, pursuant to Health and Safety Code Section 39669.5(b)(1).

NTP Information Cited

National Toxicology Program (NTP) (1990). Toxicology and carcinogenesis studies of toluene in F344/N rats and B6C3F1 mice (inhalation studies). http://ntp.niehs.nih.gov/ntp/htdocs/LT_rpts/tr371.pdf.

The Office of Environmental Health Hazard Assessment (OEHHA) is adopting a new cancer inhalation unit risk (IUR) and slope factor for p-Chloro-a,a,a-Trifluorotoluene for use in the Air Toxics Hot Spots Program. IURs are used to estimate lifetime cancer risks associated with inhalation exposure to a carcinogen. OEHHA is required to develop guidelines for conducting health risk assessments under the Air Toxics Hot Spots Program (Health and Safety Code Section 44360(b)(2)). In implementing this requirement, OEHHA develops new IURs and revises existing IURs for many air pollutants. The IUR for PCBTF was developed using the most recent “Air Toxics Hot Spots Program Technical Support Document for Cancer Potency Factors,” finalized by OEHHA in 2009.

NTP Information Cited

NTP (1992). Toxicity studies of p-chloro-a,a,a-trifluorotoluene (CAS No. 98-56-6) administered in corn oil and a-cyclodextrin to F344/N rats and B6C3F1 mice in 14- day comparative gavage studies. Toxicity Report Series. Technical Report No. 14. National Toxicology Program, Research Triangle Park, NC.

NTP (2009). Chemical Information Profile for 1-Chloro-4-(trifluoromethyl)-benzene (CAS No. 98-56-6); Supporting Nomination for Toxicological Evaluation by the National Toxicology Program. National Toxicology Program, National Institute of Environmental Health Sciences, June 2009.

NTP (2018). NTP Technical Report: Toxicology and Carcinogenesis Studies of p-Chloro-a,a,a-trifluorotoluene (CAS No. 98-56-6) in Sprague Dawley Rats (Hsd:Sprague Dawley SD) and B6C3F1/N Mice (Inhalation Studies), TR 594. Research Triangle Park, NC, June 2018.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is announcing the publication of the updated Public Health Goal (PHG) for 1,2-dibromo-3-chloropropane (DBCP). A PHG is the level of a drinking water contaminant at which adverse health effects are not expected to occur from a lifetime of exposure. The updated Public Health Goal of 0.003 parts per billion (ppb) is based on carcinogenicity and is set at a level of risk of one additional cancer case per one million persons exposed over a 70-year lifetime.

NTP Information Cited

NTP (1982). Carcinogenesis bioassay of 1,2-dibromo-3-chloropropane in F344 rats and B6C3F1 mice (inhalation study). National Toxicology Program Technical Report Series No. 206, National Toxicology Program, Bethesda, MD.

Reducing childhood lead exposure is a priority for EPA. As part of EPA's efforts to reduce childhood lead exposure, backed by the President's Task Force on Environmental Health Risks and Safety Risks to Children, EPA evaluated the current dust-lead clearance levels (DLCL). Clearance levels are currently defined as the maximum amount of lead permitted in dust on a surface following completion of an abatement activity. Surface dust is collected via dust wipe samples that are sent to a laboratory for analysis. The post-abatement dust- lead levels must be below the clearance levels. The DLCL have not changed since they were issued in 2001. EPA is now proposing to lower the DLCL from 40 micrograms of per square feet (µg/feet squared) and 250 µg/feet squared to 10 µg/feet squared and 100 µg/feet squared for floors and window sills, respectively.

NTP Information Cited
HHS, National Toxicology Program. NTP Monograph on Health Effects of Low-Level Lead. National Institute of Environmental Health Sciences, Research Triangle Park, NC. NIH Pub. No. 12–5996. ISSN 2330–1279. June 13, 2012. https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf

The U.S. Environmental Protection Agency (EPA) is granting petitions to add n-propyl bromide (nPB) (Chemical Abstract Service (CAS) No. 106-94-5) to the list of hazardous air pollutants (HAP) contained in the Clean Air Act (CAA). The EPA is taking final action to grant these petitions based on the petitioners having met the requirements contained in CAA section 112(b)(3), which allows any person to petition the Administrator to add a substance to the list of HAP. The term 1-bromopropane (1-BP), which is used throughout this document, is the common name for nPB. This is the first occasion on which the EPA is granting petitions to add a substance to the list of HAP that Congress created in 1990. Following this action, the EPA will take a separate regulatory action to add 1-BP to the list of HAP under CAA section 112(b)(1).

NTP Information Cited
Not all carcinogens operate via a mutagenic mode of action (MOA). In fact, many of the National Toxicology Program (NTP) substances categorized as ‘‘Known to be a human carcinogen’’ are carcinogenic via non-mutagenic mechanisms. There is mixed evidence of mutations in bacterial and mammalian cells and limited data on DNA damage in 1–BP-exposed workers. However, there is clear evidence for the carcinogenicity of 1–BP in multiple tissues in two rodent species from a 2- year cancer bioassay by the NTP. The NTP’s Report on Carcinogens, 14th Edition finds 1–BP is ‘‘reasonably anticipated to be a human carcinogen’’ based on sufficient evidence of carcinogenicity from studies in experimental animals.

Office of Environmental Health Hazard Assessment (OEHHA) proposes to adopt a Proposition 65 No Significant Risk Level (NSRL) of 9.9 micrograms per day for trichloroacetic acid, by amending Title 27, California Code of Regulations, section 25705(b).

NTP Information Cited

National Toxicology Program (NTP 2015). Toxicology Studies of Bromodichloroacetic Acid (CAS No. 71133-14-7) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Bromodichloroacetic Acid in F344/NTac Rats and B6C3F1/N Mice (Drinking Water Studies). NTP Technical Report Series No. 583. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

Office of Environmental Health Hazard Assessment (OEHHA) proposes to adopt a Proposition 65 No Significant Risk Level (NSRL) of 2.8 micrograms per day for dibromoacetic acid, by amending Title 27, California Code of Regulations, section 25705(b).

NTP Information Cited

Office of Environmental Health Hazard Assessment (OEHHA) proposes to adopt a Proposition 65 No Significant Risk Level (NSRL) of 17 micrograms per day for dichloroacetic acid, by amending Title 27, California Code of Regulations, section 25705(b).

NTP Information Cited

National Toxicology Program (NTP 2015). Toxicology Studies of Bromodichloroacetic Acid (CAS No. 71133-14-7) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Bromodichloroacetic Acid in F344/NTac Rats and B6C3F1/N Mice (Drinking Water Studies). NTP Technical Report Series No. 583. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

The Environmental Protection Agency and the National Highway Traffic Safety Administration, on behalf of the Department of Transportation, are issuing final rules to amend and establish carbon dioxide and fuel economy standards. Specifically, EPA is amending carbon dioxide standards for model years 2021 and later, and NHTSA is amending fuel economy standards for model year 2021 and setting new fuel economy standards for model years 2022-2026. The standards set by this action apply to passenger cars and light trucks, and will continue our nation's progress toward energy independence and carbon dioxide reduction, while recognizing the realities of the marketplace and consumers' interest in purchasing vehicles that meet all of their diverse needs. These final rules represent the second part of the Administration's action related to the August 24, 2018 proposed Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule. These final rules follow the agencies' actions, taken September 19, 2019, to ensure One National Program for automobile fuel economy and carbon dioxide emissions standards, by finalizing regulatory text related to preemption under the Energy Policy and Conservation Act and withdrawing a waiver previously provided to California under the Clean Air Act.

NTP Information Cited
NTP (National Toxicology Program). 2016. Report on Carcinogens, Fourteenth Edition.; Research Triangle Park NC: U.S. Department of Health and Human Services Public Health Service. Available at https://ntp.niehs.nih.gov/go/roc14.

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency for the implementation of the Safe Drinking Water and Toxic Enforcement Act of 1986. OEHHA received a request for a Safe Use Determination (SUD) for exposures to bisphenol A (BPA) from certain polycarbonate eyewear products manufactured, distributed, or sold by The Vision Council (TVC) member companies. Based on OEHHA’s screening-level analysis of the information and data provided by TVC, the upper-end estimate of dermal exposure to BPA for users of certain polycarbonate eyewear products (prescription glasses and sunglasses, OTC reading glasses, non-prescription sunglasses, and safety glasses) manufactured, distributed, or sold by TVC member companies, with acetonitrile extractable concentrations of BPA as specified above, is 0.53 µg/day. This exposure estimate falls below the "Maximum Allowable Dose Level (MADL)” for BPA (dermal exposure from solid materials) of 3 µg per day. The MADL is defined as the level of exposure that corresponds to the “no observed effect level” divided by 1000. Thus, exposures to BPA from use of such eyewear products, under the conditions described in OEHHA’s assessment, would not require a Proposition 65 warning.

NTP Information Cited

CERHR (2008). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A. Research Triangle Park, NC, National Toxicology Program: 395.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is announcing the publication of Public Health Goals (PHGs) for four trihalomethanes (THMs) found in drinking water as a result of disinfection methods: chloroform, bromodichloromethane (BDCM), dibromochloromethane (DBCM), and bromoform. A PHG is the level of a drinking water contaminant at which adverse health effects are not expected to occur from a lifetime of exposure.

NTP Information Cited
NTP (1985). Toxicology and carcinogenesis studies of chlorodibromomethane (CAS No. 124- 48-1) in F344/N rats and B6C3F1 mice (gavage studies). NTP Technical Report Series No. 282, National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC.

NTP (1987). Toxicology and carcinogenesis studies of bromodichloromethane (CAS No. 75-27- 4) in F344/N rats and B6C3F1 mice (gavage studies). NTP Technical Report Series No. 321, National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC. 182 pp.

NTP (1988). Chloroform reproduction and fertility assessment in CD-1 mice when administered by gavage. Report by Environmental Health Research and Testing, Inc., Lexington, Kentucky, to National Toxicology Program, NTP-89-018. NTIS PB89-148639. National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC.

NTP (1989a). Toxicology and carcinogenesis studies of tribromomethane (bromoform) (CAS No. 75-25-2) in F344/N rats and B6C3F1 mice (gavage studies). NTP Technical Report Series No. 350, National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC.

NTP (1989b). Bromoform: reproduction and fertility assessment in Swiss CD-1 mice when administered by gavage. Report no. NTP-89-068. National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC.

NTP (1994). Comparative toxicology studies of corn oil, safflower oil, and tricaprylin (CAS Nos. 8001-30-7, 8001-23-8, and 538-23-8) in male F344/N rats as vehicles for gavage. NTP Technical Report Series No. 426, National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC.

NTP (1996). Final report on the short term reproductive and developmental toxicity of chlorodibromomethane (CAS No. 124-48-1) administered in drinking water to Sprague-Dawley rats. Report by R.O.W. Sciences, Inc., Gaithersburg, MD. Pub No. NTIS/PB97-111728. National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC.

NTP (1998). Final Report on the short-term reproductive and developmental toxicity of bromodichloromethane (CAS No. 75-27-4) administered in drinking water to Sprague-Dawley rats. Pub no. NTIS/PB99-111262. National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC.

NTP (2006). Toxicology and carcinogenesis studies of bromodichloromethane (CAS No. 75-27- 4) in male F344/N rats and female B6C3F1 mice (Drinking Water Studies). National Toxicol Program Tech Rep Ser 532:1-248.

NTP (2007). Toxicology studies of bromodichloromethane (CAS No. 75-27-4) in genetically modified (FVB Tg.AC Hemizygous) mice (dermal, drinking water, and gavage studies) and carcinogenicity studies of bromodichloromethane in genetically modified [B6.129-Trp53(tm1Brd) (N5) haploinsufficient] mice (drinking water and gavage studies). NTP Genet Modif Model Rep 5:1-227.

NTP (2016a). Chloroform. In: Report on Carcinogens, Fourteenth Edition. National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC. Accessed at: https://ntp.niehs.nih.gov/pubhealth/roc/index-1.html.

NTP (2016b). Bromodichloromethane. In: Report on Carcinogens, Fourteenth Edition. National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC. Accessed at: https://ntp.niehs.nih.gov/pubhealth/roc/index-1.html.  

The Office of Environmental Health Hazard Assessment (OEHHA) is releasing a draft document summarizing the carcinogenicity and derivation of a cancer inhalation unit risk factor (IUR) for p‑Chloro-α,α,α-trifluorotoluene (p-chlorobenzotrifluoride, PCBTF). IURs are used to estimate lifetime cancer risks associated with inhalation exposure to a carcinogen.

NTP Information Cited

NTP (1992). Toxicity studies of p-chloro-a,a,a-trifluorotoluene (CAS No. 98-56-6) administered in corn oil and α-cyclodextrin to F344/N rats and B6C3F1 mice in 14-day comparative gavage studies. Toxicity Report Series. Technical Report No. 14. National Toxicology Program, Research Triangle Park, NC.

NTP (2009). Chemical Information Profile for 1-Chloro-4-(trifluoromethyl)-benzene [CAS No. 98-56-6]; Supporting Nomination for Toxicological Evaluation by the National Toxicology Program. National Toxicology Program, National Institute of Environmental Health Sciences, June 2009.

Effective January 3, 2020, the Office of Environmental Health Hazard Assessment is adding cannabis (marijuana) smoke and Δ9-tetrahydrocannabinol (Δ9-THC) to the list of chemicals known to the state to cause reproductive toxicity (developmental endpoint) for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65)

NTP Information Cited
NTP. 1996. Toxicology and carcinogenesis studies of 1-trans-delta(9)- tetrahydrocannabinol (CAS No. 1972-08-3) in f344 rats and B6C3F1 mice (gavage studies). Natl Toxicol Program Tech Rep Ser 446:1-317

In this advance notice of proposed rulemaking (ANPRM), EPA is soliciting information from the public as EPA considers proposing a future rule on adding certain per- and polyfluoroalkyl substances (PFAS) to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) and section 6607 of the Pollution Prevention Act (PPA). In this ANPRM, EPA outlines what PFAS are, why the Agency is considering adding certain PFAS to EPCRA section 313, what listing actions are being considered, who may be required to report, the current understanding of hazard concerns for PFAS, EPA’s hazard assessments on PFAS, and other information available on these chemicals. In considering a chemical for addition to the EPCRA section 313 list, EPA bases its listing decision on the chemical’s hazard (i.e., toxicity), not the risk (i.e., toxicity plus potential exposures) related to that chemical. EPA is requesting comment on which, if any, PFAS should be evaluated for listing, how to list them, and what would be appropriate reporting thresholds given their persistence and bioaccumulation potential. Lastly, EPA asks for any additional data to inform the Agency’s evaluation and determination of which PFAS may meet the EPCRA section 313 listing criteria.

NTP Information Cited

EPA is collaborating with National Toxicology Program (NTP) to study individual PFAS and PFAS as a chemical class. Specifically, NTP has conducted toxicology studies to evaluate and identify the adverse effects of certain PFAS chemicals including PFBS, PFHxS, PFOS, PFHxA, PFOA, PFNA, and PFDA. NTP continues to assess the potential health effects of PFAS through a large multi-faceted research effort (https://ntp.niehs.nih.gov/whatwestudy/topics/pfas/index.html).

EPA is proposing corrections to existing regulatory language for the Toxics Release Inventory (TRI) Program. EPA is proposing corrections that will update identifiers, formulas, and names for certain TRI-listed chemicals and updates to the text that identifies which chemicals the 0.1 percent de minimis concentration applies to in order to remedy a cross-reference to a no-longer-accurate Occupational Safety and Health Administration (OSHA) regulatory citation. These proposed corrections maintain previous regulatory actions and do not alter existing reporting requirements or impact compliance burdens or costs.

NTP Information Cited
National Toxicology Program (NTP), Annual Report on Carcinogens (latest edition)

The Environmental Protection Agency (EPA) proposes regulatory revisions to the National Primary Drinking Water Regulation (NPDWR) for lead and copper under the authority of the Safe Drinking Water Act (SDWA). This proposed rule provides more effective protection of public health by reducing exposure to lead and copper in drinking water. This proposed rule also strengthens procedures and requirements related to health protection and the implementation of the existing Lead and Copper Rule (LCR) in the following areas: Lead tap sampling; corrosion control treatment; lead service line replacement; consumer awareness; and public education. This proposal does not include revisions to the copper requirements of the existing LCR. In addition, this proposal includes new requirements for community water systems to conduct lead in drinking water testing and public education in schools and child care facilities.

NTP Information Cited
National Toxicology Program. NTP Monograph on Health Effects of LowLevel Lead. National Institute of Environmental Health Sciences, Research Triangle Park, NC. NIH Pub. No. 12–5996. ISSN 2330–1279. June 13, 2012. https://ntp.niehs.nih.gov/ntp/ohat/ lead/final/monographhealtheffects lowlevellead_newissn_508.pdf.

On Oct. 18, 2019, the Office of Environmental Health Hazard Assessment (OEHHA) proposes to adopt a Proposition 65 No Significant Risk Level (NSRL) of 23 micrograms per day for p-chloro-α,α,α-trifluorotoluene (PCBTF), by amending Title 27, California Code of Regulations, section 25705(b). https://oehha.ca.gov/proposition-65/crnr/notice-proposed-rulemaking-title-27-california-code-regulations-amendment-13

NTP Information Cited
NTP Technical Report on the Toxicology and Carcinogenesis Studies of p-Chloro-α,α,α-Trifluorotoluene (CASRN 98-56-6) in Sprague Dawley Rats (Hsd:Sprague Dawley SD) and B6C3F1/N Mice (Inhalation Studies). Research Triangle Park (NC): National Toxicology Program. Natl Toxicol Program Res Rep Ser. 2018 June;(TR-594): 1-199. https://ntp.niehs.nih.gov/go/tr594

On April 23, 2019, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 023) to add "endometrial cancer'' to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add the major site uterine cancer, including its subtype, endometrial cancer, to the List. The Administrator also finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.

NTP Information Cited
The Program reviewed the NTP Report on Carcinogens and found that twelve 9/11 agents are known to be human carcinogens and twenty-seven 9/11 agents are reasonably anticipated to be human carcinogens. However, IARC has not determined that any of these thirty-nine 9/11 agents demonstrate sufficient or limited evidence of a causal association with uterine or endometrial cancer in humans.

National Toxicology Program, HHS [2016], Report on Carcinogens, 14th Edition (Research Triangle Park, NC). https://ntp.niehs.nih.gov/go/roc14.

The Office of Environmental Health Hazard Assessment (OEHHA) is releasing a draft document summarizing the carcinogenicity and derivation of cancer inhalation unit risk factors (IURs) for cobalt and cobalt compounds. IURs are used to estimate lifetime cancer risks associated with inhalation exposure to a carcinogen. This document will be reviewed and discussed by the Scientific Review Panel on Toxic Air Contaminants (SRP) at its meeting on October 4, 2019 in Sacramento, CA.

NTP Information Cited

NTP (1996). Toxicology and Carcinogenesis Studies of Nickel Subsulfide (CAS No. 12035-72-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). NTP TR 453. Research Triangle Park, NC. 2050

NTP (1998a). NTP Technical Report on the Toxicology and Carcinogenesis Studies of Cobalt Sulfate Heptahydrate (CAS No. 10026-24-1) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). NTP TR 471. Research Triangle Park, NC.

NTP (1998b). TR-471: Cobalt sulfate heptahydrate (10026-24-1). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC (USA): National Toxicology Program (NTP). Accessed November 2017. https://manticore.niehs.nih.gov/cebssearch/publication/TR-471.

NTP (2014a). NTP Technical Report on the Toxicology Studies of Cobalt Metal (CAS No. 7440-48-4) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Cobalt Metal in F344/NTac Rats and B6C3F1/N Mice (Inhalation Studies). NTP TR 581. Research Triangle Park, NC.

NTP (2014b). TR-581: Cobalt (7440-48-4). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC (USA): National Toxicology Program (NTP). Accessed November, 2017. https://manticore.niehs.nih.gov/cebssearch/publication/TR-581.

NTP (2016). National Toxicology Program. Cobalt and Cobalt Compounds That Release Cobalt Ions In Vivo, CAS No. 7440-48-4 (Cobalt metal). Report on Carcinogens, Fourteenth Edition. 8 p.

This document presents final notification level (NL) recommendations by the Office of Environmental Health Hazard Assessment (OEHHA) for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) in drinking water. This supersedes the underlying scientific analysis (OEHHA, 2018) that supported the interim NLs that were adopted in 2018.

NTP Information Cited

NTP (2016). NTP Monograph Immunotoxicity Associated with Exposure to Perfluorooctanoic Acid or Perfluorooctane Sulfonate. National Toxicology Program, Research Triangle Park, NC.

NTP (2018a). Tox-96: Perfluorinated Compounds: Sulfonates - Pathology Tables, Survival and Growth Curves from NTP Short-Term Studies. National Toxicology Program, Research Triangle Park, NC. https://tools.niehs.nih.gov/cebs3/views/?action=main.dataReview&bin_id=3874 (last accessed March 20, 2019).

NTP (2018b). Tox-97: Perfluorinated Compounds: Carboxylates - Pathology Tables, Survival and Growth Curves from NTP Short-Term Studies. National Toxicology Program, Research Triangle Park, NC. https://tools.niehs.nih.gov/cebs3/views/?action=main.dataReview&bin_id=3875 (last accessed March 20, 2019).

NTP (2018c). TR-598: Technical Report Pathology Tables and Curves - PFOA. National Toxicology Program, Research Triangle Park, NC. https://tools.niehs.nih.gov/cebs3/views/?action=main.dataReview&bin_id=13658 (last accessed March 20, 2019).

Addressing childhood lead exposure is a priority for EPA. As part of EPA's efforts to reduce childhood lead exposure, EPA evaluated the current dust-lead hazard standards (DLHS) and the definition of lead-based paint (LBP). Based on this evaluation, this final rule revises the DLHS from 40 [micro]g/ft\2\ and 250 [micro]g/ft\2\ to 10 [micro]g/ft\2\ and 100 [micro]g/ft\2\ on floors and window sills, respectively. EPA is also finalizing its proposal to make no change to the definition of LBP because insufficient information exists to support such a change at this time.

NTP Information Cited
National Toxicology Program. NTP Monograph on Health Effects of LowLevel Lead. National Institute of Environmental Health Sciences, Research Triangle Park, NC. NIH Pub. No. 12–5996. ISSN 2330–1279. June 13, 2012. https://ntp.niehs.nih.gov/ntp/ohat/ lead/final/monographhealtheffects lowlevellead_newissn_508.pdf.

Under the Toxic Substances Control Act (TSCA), EPA is promulgating a rule to ensure that any discontinued uses of asbestos cannot re-enter the marketplace without EPA review, closing a loophole in the regulatory regime for asbestos.

NTP Information Cited
National Toxicology Program. (NTP, 2016). Report on Carcinogens, Fourteenth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. Retrieved from https://ntp.niehs.nih.gov/ntp/roc/content/profiles/asbestos.pdf.

National Toxicology Program. (NTP, 1980). First Annual Report on Carcinogens. Retrieved from https://ntrl.ntis.gov/NTRL/dashboard/searchResults/titleDetail/PB84122852.xhtml. 

Safe harbor levels, which include No Significant Risk Levels (NSRLs) for cancer-causing chemicals and Maximum Allowable Dose Levels (MADLs) for chemicals causing reproductive toxicity, have been established for many of the chemicals listed under Proposition 65. Exposure levels and discharges to drinking water sources that are below the safe harbor levels are exempt from the requirements of Proposition 65. In some instances, enforcement actions may have resulted in negotiated exposure levels relative to specific settlement agreements. Please visit the Attorney General's Proposition 65 web site at http://ag.ca.gov/prop65 (link is external) for further information about specific enforcement actions.

NTP Information Cited

National Cancer Institute (NCI, 1980). Bioassay of4,4'-0xydianilinefor Possible Carcinogenicity. Carcinogenesis Technical Report Series No. 205. NIH Publication No. 80-1761. US Department of Health and Human Services, NCI Carcinogenesis Testing Program, and National Toxicology Program.

National Toxicology Program (NTP, 1982). Toxicology and Carcinogenesis Studies of D & C Red 9 in F344/N Rats and B6C3F1 Mice (Feed Study). NTP Technical Report Series No. 225. NIH Publication No. 82-1781. US Department of Health and Human Services, NTP, Research Triangle Park, NC. 

National Toxicology Program (NTP, 1983). Toxicology and Carcinogenesis Studies of 4,4'-Methylenedianiline Dihydrochloride in F344/N Rats and B6CJF1 Mice (Drinking Water Studies). NTP Technical Report Series No. 248. NTIS Publication No. PB 83238824. US Department of Health and Human Services, NTP, Research Triangle Park, NC. 

National Toxicology Program (NTP, 1985). Toxicology and Carcinogenesis Studies of Chlorodibromomerhane in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 282. NIH Publication No. 85-2538. US Department of Health and Human Services, NTP, Research Triangle Park, NC. 

National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies· of Chlo1intJled Paraffins (Cl2. 60% Chlorine) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 308. US Department of Health and Human Services, NTP, Research Triangle Park, NC. 

National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies of 3-Chloro-2-methy/propene in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 300. NIH Publication No. 86-2556. US Department of Health and Human Services, NTP, Research Triangle Park, NC. 

National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies of C.l. Basic Red 9 Monohydrochloride in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 196. NlH Publication No. 86-2541. US Department of Health and Human Services, NTP, Research Triangle Park, NC. 

National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies of Diglycidyl Resorcinol Ether in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 257. NIH Publication No. 87-2513. US Department of Health and Human Services, NTP, Research Triangle Park, NC. 

National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies of Dimethylvinyl Chloride (1-chloro-2-methyl-propene) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 316. NIH Publication No. 86­ 2572. US Department of Health and Human Services, NTP, Research Triangle Park, NC. 

National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies of Disperse Blue 1 (a commercial dye containing approximately 50% 1,4,5,8-tetra amino anthraquinone, 30% other compounds structurally related to 1,4,5,8-tetra amino anthraquinone and 20% water in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 299. NIH Publication No. 86-2555. US Department of Health and Human Services, NTP, Research Triangle Park, NC. 

National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies of HC Blue 1 in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series; No. 271. NTIS Publication No. PB 86-114683. US Department of Health and Human Services, NTP, Research Triangle Park, NC. 

National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies of Toluene Diisocyanate in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 251. NTIS Publication No. 87115176. US Department of Health and Human Services, NTP, Research Triangle Park, NC. 

National Toxicology Program (NTP, 1987). Toxicology and Carcinogenesis Studies of Chlorendic Acid in F344 Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 304. N1H Publication No. 87-2560, US Department of Health and Human Services (DHEW), NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1989). Toxicology and Carcinogenesis Studies of Hexachloroethane in F344/N Rats (Gavage Studies). NTP Technical Report Series No. 361. NTIS Publication No. 89-2816. US Department of Health and Human Services, NTP, Research Triangle Park, NC. 

National Toxicology Program (NTP, 1991). Chemical Status Report. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. This proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. It is being published as part of the ongoing review of OTC drug products conducted by FDA. It is also being published to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Sunscreen Innovation Act (SIA).

NTP Information Cited

1. NTP Technical Report 518, ‘‘Toxicology and Carcinogenesis Studies of Triethanolamine in B6C3F1 Mice (Dermal Study),’’ May 2004, (available at https://ntp.niehs.nih.gov/ntp/htdocs/lt_ rpts/tr518.pdf), accessed March 27, 2018. 
   
   Technical Report 449, ‘‘Toxicology and Carcinogenesis Studies of Triethanolamine in F344/N Rats and B6C3F1 Mice (Dermal Studies),’’ November 1999, (available at https:// ntp.niehs.nih.gov/ntp/htdocs/lt_rpts/ tr449.pdf), accessed March 27, 2018. 
   
    French, J.E., ‘‘NTP Technical Report on the Toxicity Studies of 2-Hydroxy-4- Methoxybenzophenone (Cas No. 131–57–7) Adminstered Topically and in Dosed Feed to F344/N Rats and B6c3f1 Mice,’’ Toxicity Rep
   
    ‘‘Testing Status of 2-Hydroxy-4- methoxybenzophenone 10260–S’’ (available at https://ntp.niehs.nih.gov/ testing/status/agents/ts-10260-s.html), accessed March 27, 2018.

On February 5, 2019, the Office of Administrative Law approved the amendment of Title 27, California Code of Regulations, section 25705, to add a No Significant Risk Level for the chemical bromodichloroacetic acid. The regulation will be effective on April 1, 2019. This regulation establishes a No Significant Risk Level of 0.95 micrograms per day for bromodichloroacetic acid for purposes of Proposition 65.

NTP Information Cited
National Toxicology Program (NTP, 2015). Toxicology Studies of Bromodichloroacetic Acid (CAS No. 71133-14-7) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Bromodichloroacetic Acid in F344/NTac Rats and B6C3F1/N Mice (Drinking Water Studies). NTP Technical Report Series No. 583.  

On February 5, 2019, the Office of Administrative Law approved the amendment of Title 27, California Code of Regulations, section 25705, to add a No Significant Risk Level for the chemical bromochloroacetic acid. The regulation will be effective on April 1, 2019. This regulation establishes a No Significant Risk Level of 0.70 micrograms per day for bromochloroacetic acid for purposes of Proposition 65.

NTP Information Cited
National Toxicology Program (NTP, 2009). Toxicology and Carcinogenesis Studies of Bromochloroacetic Acid (CAS No. 5589-96-8) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). NTP Technical Report Series No. 549. NIH Publication No. 09-5890.

This regulation establishes an exemption from the requirement of a tolerance for residues of chlorate in or on cantaloupe and tomato under the Federal Food, Drug, and Cosmetic Act (FFDCA).

NTP Information Cited
Risk Assessment of Tomato and Cantaloupe Fumigation with Sodium Chlorite 3.2% (chlorine dioxide gas) and Inorganic Chlorates Human Health Assessment Scoping Document in Support of Registration Review (Docket ID No. EPA–HQ–OPP–2016–0080–0008) both of which can be found in the docket for this action at http:// www.regulations.gov

Revised Inorganic Chlorates. HED Chapter of the Reregistration Eligibility Decision Document (RED) (Docket ID No. EPA–HQ–OPP–2005–0507–0004

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list p-chloro-α,α,α-trifluorotoluene (also known as para-chlorobenzotrifluoride, or PCBTF) as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986[1]. This action is being proposed under the authoritative bodies listing mechanism.

NTP Information Cited

National Toxicology Program (NTP, 2018). Toxicology and Carcinogenesis Studies of p-Chloro-α,α,α-Trifluorotoluene in Sprague Dawley Rats (Hsd:Sprague Dawley SD) and B6C3F1/N Mice (Inhalation Studies). Technical Report Series No. 594. US Department of Health and Human Services, NTP, Research Triangle Park, NC.  Available at https://ntp.niehs.nih.gov/ntp/htdocs/lt_rpts/tr594_508.pdf

The Food and Drug Administration (FDA, the Agency, or we) is partially granting a petition submitted by the Breast Cancer Fund (now known as the Breast Cancer Prevention Partners), Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Consumers Union, Environmental Defense Fund, Environmental Working Group, Improving Kids’ Environment, Natural Resources Defense Council, WE ACT for Environmental Justice, and Mr. James Huff, by amending the food additive regulations to no longer authorize the use of benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine as synthetic flavoring substances for use in food. We are taking this action because, despite FDA’s scientific analysis and determination that these substances do not pose a risk to public health under the conditions of their intended use, the petitioners provided data demonstrating that these additives induce cancer in laboratory animals, and, as a result of this finding in animals, FDA cannot as a matter of law maintain the listing of these synthetic flavoring substances in the food additive regulations. Because of evidence that benzophenone causes cancer in animals, FDA also is amending the food additive regulations to no longer provide for the use of benzophenone as a plasticizer in rubber articles intended for repeated use in contact with food. FDA is denying as moot the portions of the petition proposing that the food additive regulations be amended to no longer authorize the use of styrene as a synthetic flavoring substance because this use has been permanently and completely abandoned. In addition, FDA is declining to act on the petitioners’ request to issue a regulation to prohibit the use of these synthetic flavoring substances in food because that issue is not the proper subject of a food additive petition.

NTP Information Cited

FDA reviewed data from 2 NTP-sponsored 103-week carcinogenic bioassays on ethyl acrylate in F344/N rats and B6C3F1 mice.

FDA reviewed data from 2 NTP-sponsored 105-week carcinogenic bioassays on benzophenone in F344/N rats and B6C3F1 mice.

FDA reviewed data from 2 NTP-sponsored 2-year carcinogenicity bioassays on methyl eugenol in F344/N rats and B6C3F1 mice.

FDA reviewed data from 2 NTP-sponsored carcinogenicity bioassays on myrcene (b-myrcene) in F344/N rats and B6C3F1 mice.

FDA reviewed data from 2 NTP-sponsored 2-year carcinogenicity bioassays on pulegone in F344/N rats and B6C3F1 mice.

FDA reviewed data from 3 NTP-sponsored 2-year carcinogenicity bioassays on pyridine in F344/N rats, Wistar rats, and B6C3F1 mice.

The National Highway Traffic Safety Administration (NHTSA) and the Environmental Protection Agency (EPA) are proposing the “Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule for Model Years 2021-2026 Passenger Cars and Light Trucks” (SAFE Vehicles Rule). The SAFE Vehicles Rule, if finalized, would amend certain existing Corporate Average Fuel Economy (CAFE) and tailpipe carbon dioxide emissions standards for passenger cars and light trucks and establish new standards, all covering model years 2021 through 2026. More specifically, NHTSA is proposing new CAFE standards for model years 2022 through 2026 and amending its 2021 model year CAFE standards because they are no longer maximum feasible standards, and EPA is proposing to amend its carbon dioxide emissions standards for model years 2021 through 2025 because they are no longer appropriate and reasonable in addition to establishing new standards for model year 2026. The preferred alternative is to retain the model year 2020 standards (specifically, the footprint target curves for passenger cars and light trucks) for both programs through model year 2026, but comment is sought on a range of alternatives discussed throughout this document. Compared to maintaining the post-2020 standards set forth in 2012, current estimates indicate that the proposed SAFE Vehicles Rule would save over 500 billion dollars in societal costs and reduce highway fatalities by 12,700 lives (over the lifetimes of vehicles through MY 2029). U.S. fuel consumption would increase by about half a million barrels per day (2-3 percent of total daily consumption, according to the Energy Information Administration) and would impact the global climate by 3/1000th of one degree Celsius by 2100, also when compared to the standards set forth in 2012.

NTP Information Cited

NTP. (2014). 13th Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program.

Addressing childhood lead exposure is a priority for EPA. As part of EPA's efforts to reduce childhood lead exposure, EPA evaluated the current dust-lead hazard standards (DLHS) and the definition of lead-based paint (LBP). Based on this evaluation, EPA is proposing to lower the DLHS from 40 μg/ft2 and 250 μg/ft2 to 10 μg/ft2 and 100 μg/ft2 on floors and window sills, respectively. EPA is proposing no changes to the current definition of LBP due to insufficient information to support such a change.

NTP Information Cited

HHS, National Toxicology Program. NTP Monograph: Health Effects of Low-Level Lead. 2012.

Status of chemicals considered by OEHHA for addition to the Proposition 65 list under the authoritative bodies mechanism.

NTP Information Cited

Toxicology Studies of Cobalt Metal (CAS No. 7440-48-4) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Cobalt Metal in F344/NTac Rats and B6C3F1/N Mice (Inhalation Studies) NTP (2014)

NTP Technical Report on the Toxicology and Carcinogenesis Studies of Trim VX in Wistar HAN [Crl:WI (Han)] Rats and B6C3F1/N Mice (Inhalation Studies) NTP (2016)

Under the Toxic Substances Control Act (TSCA), EPA is proposing a significant new use rule (SNUR) for asbestos as defined under the Asbestos Hazard Emergency Response Act. The proposed significant new use of asbestos (including as part of an article) in manufacturing (including importing) or processing for certain uses identified by EPA as no longer ongoing. The Agency has found no information indicating that the following uses are ongoing, and therefore, the following uses are subject to this proposed SNUR: Adhesives, sealants, and roof and non-roof coatings; arc chutes; beater-add gaskets; extruded sealant tape and other tape; filler for acetylene cylinders; high-grade electrical paper; millboard; missile liner; pipeline wrap; reinforced plastics; roofing felt; separators in fuel cells and batteries; vinyl-asbestos floor tile; and any other building material (other than cement).

NTP Information Cited

National Toxicology Program. (NTP, 2016). Report on Carcinogens, Fourteenth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.

The Office of Environmental Health Hazard Assessment (OEHHA) announces the availability of the [1]revised draft technical support document for the proposed updates of the public health goals (PHGs) for cis- and trans-1,2-dichloroethylene in drinking water. OEHHA revised the document based on public and peer review comments. OEHHA is soliciting [2]comments on this second public review draft during the next 30 days.

NTP Information Cited

NTP (National Toxicology Program). (2002) NTP technical report on the toxicity studies of trans-1,2-dichloroethylene (CAS No. 156-60-5) administered in microcapsules in feed to F344/N rats and B6C3F1 mice. Public Health Service, U.S. Department of Health and Human Services; NTP TR 55. Available from the National Institute of Environmental Health Sciences, Research Triangle Park, NC.

Effective May 25, 2018, the Office of Environmental Health Hazard Assessment (OEHHA) is adding TRIM® VX to the list of chemicals known to the State of California to cause cancer for purposes of Proposition 65. The listing of TRIM® VX is based on formal identification by the National Toxicology Program (NTP), an authoritative body, that the chemical causes cancer. The criteria used by OEHHA for the listing of chemicals under the “authoritative bodies” mechanism can be found in Title 27, Cal. Code of Regs., section 25306. The documentation supporting OEHHA’s determination that the criteria for administrative listing have been satisfied for TRIM® VX is included in the “Notice of Intent to List: TRIM® VX” posted on OEHHA’s website and published in the January 26, 2018 issue of the California Regulatory Notice Register (Register 2018, No. 4-Z). The publication of the notice initiated a public comment period that closed on February 26, 2018. OEHHA received two public comments on TRIM® VX. The comments and OEHHA’s responses are posted with the Notice of Intent to List.

NTP Information Cited

The listing of TRIM® VX is based on formal identification by the National Toxicology Program (NTP), an authoritative body, that the chemical causes cancer. The criteria used by OEHHA for the listing of chemicals under the “authoritative bodies” mechanism can be found in Title 27, Cal. Code of Regs., section 25306.

National Toxicology Program (NTP, 2016). NTP Technical Report on the Toxicology and Carcinogenesis Studies of TRIM® VX in Wistar Han [Crl:WI (Han)] Rats and B6C3F1/N Mice (Inhalation Studies). Technical Report Series No. 591. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

Acrylamide is on the Proposition 65 list of chemicals known to the state to cause cancer or reproductive toxicity (such as birth defects and other reproductive harm). Acrylamide is formed in some baked, fried and roasted foods. It is also present in tobacco smoke. Smokers are exposed to particularly high levels of acrylamide. Acrylamide is a carcinogen. It was added to the Proposition 65 list in 1990 because studies showed it produced cancer in laboratory rats and mice. In February 2011, acrylamide was added to the Proposition 65 list as causing reproductive and developmental effects because, in studies of laboratory animals, acrylamide affected the growth of offspring exposed in the womb and caused genetic damage that resulted in the death of mouse and rat embryos. Plant-based foods that are rich in carbohydrates can form acrylamide when baked, fried or roasted – whether they are cooked at home, in restaurants or by commercial food processors and manufacturers. French fries, potato chips, other fried and baked snack foods, coffee, roasted grain-based coffee substitutes, roasted asparagus, canned sweet potatoes and pumpkin, canned black olives, roasted nuts, prune juice, breakfast cereals, crackers, cookies, breads, and toast all may contain varying amounts of acrylamide. Foods that have been boiled or steamed do not contain acrylamide. The U.S. Food and Drug Administration (FDA) and other health and scientific organizations continue to study the health effects of acrylamide in food. The FDA has not advised people at this time to stop eating products that contain acrylamide. The FDA does advise people to quit smoking.

NTP Information Cited

NTP (National Toxicology Program). 2016. Report on Carcinogens, Fourteenth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc14

National Toxicology Program. (NTP, 2018). Acrylamide.
https://www.niehs.nih.gov/health/topics/agents/acrylamide/index.cfm

National Toxicology Program. (NTP, 2013). Fact sheet on Acrylamide. https://www.niehs.nih.gov/health/assets/docs_a_e/acrylamide_508.pdf

On May 9, 2018, the Office of Administrative Law approved the amendment of Title 27, California Code of Regulations, section 25705, No Significant Risk Level (NSRL) for the chemical vinylidene chloride. The regulation will be effective on July 1, 2018. This regulation establishes a No Significant Risk Level of 0.88 micrograms per day for vinylidene chloride for purposes of Proposition 65.

NTP Information Cited

National Toxicology Program (NTP, 2015). Toxicology and Carcinogenesis Studies of Vinylidene chloride (CAS No. 75-35-4) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). NTP Technical Report Series No. 582. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 2015). Toxicology and Carcinogenesis Studies of Vinylidene chloride.

Safe harbor levels, which include No Significant Risk Levels (NSRLs) for cancer-causing chemicals and Maximum Allowable Dose Levels (MADLs) for chemicals causing reproductive toxicity, have been established for many of the chemicals listed under Proposition 65. Exposure levels and discharges to drinking water sources that are below the safe harbor levels are exempt from the requirements of Proposition 65. In some instances, enforcement actions may have resulted in negotiated exposure levels relative to specific settlement agreements.

NTP Information Cited

Gold L, Slone T, Backman G, Magaw R, DaCosta M, Ames B (1987). Second chronological supplement to the Carcinogenic Potency Database: Standardized results of animal bioassays published through December 1984 and by the National Toxicology Program through May 1986. Environmental Health Perspectives 74: 237-329.

Gold L, Slone T, Backman G, Eisenberg S, DaCosta M, Wong M, Manley N, and Ames B (1990). Third chronological supplement to the Carcinogenic Potency Database: Standardized results of animal bioassays published through December 1986 and by the National Toxicology Program through June 1987. Environmental Health Perspectives 84: 215-285.

National Toxicology Program (NTP, 1987). Toxicology and Carcinogenesis Studies of Chlorendic Acid in F344 Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 304. N1H Publication No. 87-2560, US Department of Health and Human Services (DHEW), NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1991). Chemical Status Report. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies of C.l. Basic Red 9 Monohydrochloride in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 196. Nlli Publication No. 86-2541. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1982). Toxicology and Carcinogenesis Studies of D & C Red 9 in F344/N Rats and B6C3F1 Mice (Feed Study). NTP Technical Report Series No. 225. NIH Publication No. 82-1781. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Cancer Institute (NCI, 1980). Bioassay of 4,4'-0xydianiline for Possible Carcinogenicity. Carcinogenesis Technical Report Series No. 205. NIH Publication No. 80-1761. US Department of Health and Human Services, NCI Carcinogenesis Testing Program, and National Toxicology Program.

National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies of Diglycidyl Resorcinol Ether in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 257. NIH Publication No. 87-2513. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP , 1986). Toxicology and Carcinogenesis Studies o f Dimethylvinyl Chloride (1-chloro-2-methyl-propene) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 316. NIH Publication No. 86­ 2572. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP , 1986). Toxicology and Carcinogenesis Studies o f HC Blue 1 in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series; No. 271. NTIS Publication No. PB 86-114683. US Department of Health and Human Services, NTP, Resean:h Triangle Park, NC.

National Toxicology Program (NTP, 1989). Toxicology and Carcinogenesis Studies of Hexachloroethane in F344/N Rats (Gavage Studies). NTP Technical Report Series No. 361. NTIS Publication No. 89-2816. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

On April 6, 2018, the Office of Administrative Law approved an amendment of Title 27, California Code of Regulations, section 25705, No Significant Risk Level (NSRL) for the chemical glyphosate. The regulation will be effective on July 1, 2018. This regulation establishes a NSRL of 1100 micrograms per day for glyphosate.

NTP Information Cited

National Toxicology Program (NTP, 2015). Handbook for Preparing Report on Carcinogens Monographs. Office of the Report on Carcinogens, Division of the NTP, National Institute of Environmental Health Sciences, US Department of Health and Human Services. 

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is announcing the availability of the revised draft technical support document for the proposed updates of the Public Health Goals (PHGs) for nitrate and nitrite in drinking water.

NTP Information Cited

NTP (2001). NTP Technical Report on the Toxicology and Carcinogenesis Studies of Sodium Nitrite (CAS No. 7632-00-0) in F344/N Rats and B6C3F1 Mice. National Toxicology Program, US Department of Health and Human Services, Research Triangle Park, NC.

NTP (2014). Report on Carcinogens, Thirteenth Edition. Research Triangle Park, NC: US Department of Health and Human Services, Public Health Service.

Notice is hereby given that the Office of Environmental Health Hazard Assessment (OEHHA) proposes to adopt a Proposition 65 No Significant Risk Level (NSRL) of 0.95 micrograms per day for bromodichloroacetic acid, by amending Title 27, California Code of Regulations, section 25705(b).

NTP Information Cited

National Toxicology Program (NTP, 2015). Toxicology Studies of Bromodichloroacetic Acid (CAS No. 71133-14-7) in F344/N Rats and B6C3F₁/N Mice and Toxicology and Carcinogenesis Studies of Bromodichloroacetic Acid in F344/NTac Rats and B6C3F₁/N Mice (Drinking Water Studies). NTP Technical Report Series No. 583. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list TRIM VX as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986. This action is being proposed under the authoritative bodies listing mechanism.

NTP Information Cited

National Toxicology Program (NTP, 2016).  NTP Technical Report on the Toxicology and Carcinogenesis Studies of TRIM VX in Wistar Han [Crl:WI (Han)] Rats and B6C3F1/N Mice (Inhalation Studies). Technical Report Series No. 591. US Department of Health and Human Services, NTP, Research Triangle Park, NC. 

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability for public comment on the drugs proposed for placement on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2018 (List), as well as the NIOSH Policy and Procedures for Developing the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.

NTP Information Cited
NTP (National Toxicology Program, DHHS) [2016]. 14th Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.

In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension with no revision of a currently approved information collection, Qualified Products Lists for Fire Chemicals for Wildland Fire Management.

NTP Information Cited

Review of the submitted information assures that the product does not contain ingredients meeting the criteria for Chemicals of Concern. Chemicals of Concern are defined as chemicals appearing on one or more of the following lists: Agency list of unacceptable ingredients; National Toxicology Program (NTP) Annual Report on Carcinogens;

The United States Consumer Product Safety Commission (Commission or CPSC) issues this final rule prohibiting children’s toys and child care articles that contain concentrations of more than 0.1 percent of diisononyl phthalate (DINP), diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexyl phthalate (DCHP). Section 108 of the Consumer Product Safety Improvement Act of 2008 (CPSIA) established permanent and interim prohibitions on the sale of certain consumer products containing specific phthalates. That provision also directed the CPSC to convene a Chronic Hazard Advisory Panel (CHAP) to study the effects on children’s health of all phthalates and phthalate alternatives as used in children’s toys and child care articles and to provide recommendations to the Commission regarding whether any phthalates or phthalate alternatives, other than those already permanently prohibited, should be prohibited. The CPSIA requires the Commission to promulgate a final rule after receiving the final CHAP report. This rule fulfills that requirement.

NTP Information Cited

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency for the implementation of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The Carcinogen Identification Committee (CIC) advises and assists OEHHA in compiling the list of chemicals known to the state to cause cancer as required by Health and Safety Code section 25249.8. The Committee serves as the state’s qualified experts for determining whether a chemical has been clearly shown through scientifically valid testing according to generally accepted principles to cause cancer.

NTP Information Cited

NTP (1993a). National Toxicology Program, U.S. Department of Heath and Human Services. Toxicology and carcinogenesis studies of coumarin (CAS No. 91-64-5) in F344/N rats and B6C3F1 mice (gavage studies). National Toxicology Program Technical Report Series No. 422.

NTP (1993b). National Toxicology Program, U.S. Department of Heath and Human Services. Toxicology and Carcinogenesis Studies of 3,4-Dihydrocoumarin (CAS No. 119-84-6) in F344/N Rats and B6C3F1 Mice (Gavage Studies). National Toxicology Program Technical Report Series No. 423.

NTP (1997). National Toxicology Program, U.S. Department of Heath and Human Services. Effect of Dietary Restriction on Toxicology and Carcinogenesis Studies in F344/N Rats and B6C3F1 Mice. National Toxicology Program Technical Report Series No. 460.

NTP (1999a). Rats: Fischer F344 (for study years 1984-1994). Historical Controls Database, National Toxicology Program, from https://ntp.niehs.nih.gov/go/historical_controls. 

NTP (1999b). Mice: B6C3F1 (for study years 1984-1994). Historical Controls Database, National Toxicology Program, from https://ntp.niehs.nih.gov/go/historical_controls.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is announcing the availability of the draft technical support document for the update of the Public Health Goals (PHGs) for cis-1,2-dichloroethylene (cis-1,2-DCE) and trans-1,2-dichloroethylene (trans-1,2-DCE) in drinking water. The document proposes an updated PHG of 13 parts per billion (ppb) for cis-1,2-DCE and 50 ppb for trans-1,2-DCE.

NTP Information Cited

NTP (National Toxicology Program). (2002) NTP technical report on the toxicity studies of trans-1,2-dichloroethylene (CAS No. 156-60-5) administered in microcapsules in feed to F344/N rats and B6C3F1 mice. Public Health Service, U.S. Department of Health and Human Services; NTP TR 55. Available from the National Institute of Environmental Health Sciences, Research Triangle Park, NC. 

Effective July 7, 2017, OEHHA is adding penta­bromo­di­phenyl ether mixture [DE-71 (technical grade)] to the list of chemicals known to the state to cause cancer for purposes of Proposition 65, under the "authoritative bodies" mechanism.

NTP Information Cited

The listing of penta­bromo­di­phenyl ether mixture [DE-71 (technical grade)] is based on formal identification by the National Toxicology Program (NTP), an authoritative body, that the chemical causes cancer.

On May 4, 2017, the Office of Administrative Law approved the amendment of Title 27, California Code of Regulations, section 25705, No Significant Risk Level (NSRL) for the chemical styrene.  The regulation will be effective on July 1, 2017.  This regulation establishes a No Significant Risk Level of 27 micrograms per day for styrene for purposes of Proposition 65.

NTP Information Cited
National Toxicology Program (NTP, 2011). Report on Carcinogens, Twelfth Edition, US Department of Health and Human Services, Public Health Service, NTP, Research Triangle Park, North Carolina, page 383-391.

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list pentabromodiphenyl ether mixture [DE-71 (technical grade)] as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986. This action is being proposed under the authoritative bodies listing mechanism.

NTP Information Cited
National Toxicology Program (NTP, 2016). Toxicology Studies of a Pentabromodiphenyl Ether Mixture [DE-71 (Technical Grade)] (CASRN 32534-81-9) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of a Pentabromodiphenyl Ether Mixture [DE-71 (Technical Grade)] in Wistar Han [Crl:WI(Han)] Rats and B6C3F1/N Mice (Gavage Studies). Technical Report Series No. 589. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on ``Childhood Blood Lead Surveillance (CBLS) and Adult Blood Lead Epidemiology and Surveillance (ABLES).'' The National Center for Environmental Health (NCEH) is leading a new three-year information collection request (ICR) that covers two CDC information collections, one for childhood blood lead surveillance by NCEH and another for adult blood lead surveillance by the National Institute for Occupational Safety and Health (NIOSH). CDC requests an annual time burden of 1,120 burden hours for both collections.

NTP Information Cited
In 2012, the National Toxicology Program (NTP) concluded that there is sufficient evidence that BLLs at less than 10 [micro]g/dL and at less than 5 [micro]g/dL are associated with adverse health effects in both children, less than 18 years, and in adults, 18 years and older.

On April 4, 2017, the Office of Administrative Law approved the amendment of Title 27, California Code of Regulations, section 25805, Maximum Allowable Dose Level (MADL) for the chemical ethylene glycol (ingested).  The regulation will be effective on July 1, 2017.  This regulation establishes a MADL of 8,700 (oral) micrograms per day for ethylene glycol (ingested).  

NTP Information Cited
National Toxicology Program. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Ethylene Glycol. NTP CERHR MON. 2004 Jan;(11):1-III36. PubMed PMID: 16015391.

This document provides the reasons for EPA's response to a petition it received under the Toxic Substances Control Act (TSCA). The TSCA section 21 petition was received from Earthjustice, Natural Resources Defense Council, Toxic-Free Future, Safer Chemicals, Healthy Families, BlueGreen Alliance, and Environmental Health Strategy Center on December 13, 2016. The petitioners requested that EPA issue an order under TSCA section 4, requiring that testing be conducted by manufacturers (which includes importers) and processors on tetra­bromo­bis­phenol A (``TBBPA'') (CAS No. 79-94-7). After careful consideration, EPA denied the TSCA section 21 petition for the reasons discussed in this document.

NTP Information Cited
NTP (National Toxicology Program) (n.d.). Modified One-Generation Studies. (retrieved in 2016).

This regulation establishes a time-limited tolerance for residues of oxytetracycline in or on fruit, citrus, group 10-10. This action is in response to EPA's granting of an emergency exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide in citrus production. This regulation establishes a maximum permissible level for residues of oxytetracycline in or on the commodities in this crop group. The time-limited tolerance expires on December 31, 2019.

NTP Information Cited
There was no evidence of carcinogenicity for male or female mice fed oxytetracycline at 1,875 mg/kg/day for two years. In the rat carcinogenicity study, there was equivocal evidence for carcinogenicity based upon increased incidences of pheochromocytomas of the adrenal gland at the highest doses tested for males of 2,500 and increased incidences of adenomas of the pituitary gland in females at 1,875 mg/kg/day; both doses are extremely high as compared to expected human exposure and above the limit dose. The mutagenicity assays were all negative except for the mouse lymphoma forward mutation assay which was positive only with metabolic activation. Based upon this information and the weight of the evidence as a whole, the EPA has classified oxytetracycline as a ``Group D'' carcinogen (``Not Classifiable as to Human Carcinogenicity''). A review of the same data by the National Toxicology Program's (NTP) Peer Review Committee was in agreement with this classification. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary and was not conducted.

This regulation establishes an exemption from the requirement of a tolerance for residues of isoamyl acetate (CAS Reg. No. 123-92-2) when used as an inert ingredient (buffering agent) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest. The Technology Sciences Group on behalf of the Jeneil Biosurfactant Company submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance.

NTP Information Cited
The National Toxicology Program reported dogs exposed to 5,000 parts per million (ppm) isoamyl acetate via inhalation for one hour showed drowsiness and nasal irritation. Cats exposed to 4,000 ppm isoamyl acetate for 20 minutes experienced eye and nose irritation.

This document announces the availability of EPA's response to a petition it received on November 23, 2016, under section 21 of the Toxic Substances Control Act (TSCA). The TSCA section 21 petition was received from the Fluoride Action Network, Food & Water Watch, Organic Consumers Association, the American Academy of Environmental Medicine, the International Academy of Oral Medicine and Toxicology, and other individual petitioners. The TSCA section 21 petition requested that EPA exercise its authority under TSCA section 6 to ``prohibit the purposeful addition of fluoridation chemicals to U.S. water supplies.'' After careful consideration, EPA has denied the TSCA section 21 petition for the reasons discussed in this document.

NTP Information Cited
National Toxicology Program (NTP). Systematic literature review on the effects of fluoride onlearning and memory in animal studies. NTP Research Report 1. Research Triangle Park, NC. 2016.

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) is adopting new Reference Exposure Levels (RELs) for carbonyl sulfide (COS) for use in the Air Toxics Hot Spots Program. RELs are airborne concentrations of a chemical that are not anticipated to result in adverse noncancer health effects for specified exposure durations in the general population, including sensitive subpopulations. The adopted RELs cover different types of exposure to COS in air: infrequent 1-hour exposures, repeated 8-hour exposures, and continuous long-term exposure.

NTP Information Cited
NTP (2010) Testing Status of Agents at NTP. Carbonyl sulfide. from https://ntp.niehs.nih.gov/go/GT

As required under section 6(b)(4) of the Toxic Substances Control Act (TSCA), EPA is proposing to establish a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. Risk evaluation is the second step, after Prioritization, in a new process of existing chemical substance review and management established under recent amendments to TSCA. This proposed rule identifies the steps of a risk evaluation process including scope, hazard assessment, exposure assessment, risk characterization, and finally a risk determination. EPA is proposing that this process be used for the first ten chemical substances to be evaluated from the 2014 update of the TSCA Work Plan for Chemical Assessments, chemical substances designated as High-Priority Substances during the prioritization process, and those chemical substances for which EPA has initiated a risk evaluation in response to manufacturer requests. The proposed rule also includes the required ‘‘form and criteria’’ applicable to such manufacturer requests.

NTP Information Cited
The National Toxicology Program of the National Institute of Environmental Health Sciences has developed a tool called ‘‘systematic review’’ to assist in WoE evaluations particularly for hazard identification.

As required under section 6(b)(4) of the Toxic Substances Control Act (TSCA), EPA is proposing to establish a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. Risk evaluation is the second step, after Prioritization, in a new process of existing chemical substance review and management established under recent amendments to TSCA. This proposed rule identifies the steps of a risk evaluation process including scope, hazard assessment, exposure assessment, risk characterization, and finally a risk determination. EPA is proposing that this process be used for the first ten chemical substances to be evaluated from the 2014 update of the TSCA Work Plan for Chemical Assessments, chemical substances designated as High- Priority Substances during the prioritization process, and those chemical substances for which EPA has initiated a risk evaluation in response to manufacturer requests. The proposed rule also includes the required "form and criteria'' applicable to such manufacturer requests.

NTP Information Cited
The National Toxicology Program of the National Institute of Environmental Health Sciences has developed a tool called "systematic review'' to assist in WoE evaluations particularly for hazard identification. This tool uses a defined set of processes to identify, select, critically assess, and synthesize evidence to arrive at a hazard conclusion for a chemical. It is designed to enhance transparency and informs scientific judgments. The evidence synthesis step involves considering factors that decrease confidence in the body of evidence for a particular health endpoint (e.g. risk of bias, inconsistencies across studies, imprecision) as well as factors that increase confidence (e.g. magnitude of the effect, residual confounding, consistency).

The Safe Drinking Water Act (SDWA) requires the U.S. Environmental Protection Agency (EPA) to conduct a review every six years of existing national primary drinking water regulations (NPDWRs) and determine which, if any, need to be revised. The purpose of the review, called the Six- Year Review, is to evaluate current information for regulated contaminants to determine if there is new information on health effects, treatment technologies, analytical methods, occurrence and exposure, implementation and/or other factors that provides a health or technical basis to support a regulatory revision that will improve or strengthen public health protection. EPA has completed a detailed review of 76 NPDWRs and at this time has determined that eight NPDWRs are candidates for regulatory revision. The eight NPDWRs are included in the Stage 1 and the Stage 2 Disinfectants and Disinfection Byproducts Rules, the Surface Water Treatment Rule, the Interim Enhanced Surface Water Treatment Rule and the Long Term 1 Enhanced Surface Water Treatment Rule. EPA requests comments on the eight NPDWRs identified as candidates for revision and will consider comments and data as it proceeds with determining whether further action is needed. In addition, as part of this Six-Year Review, EPA identified 12 other NPDWRs that were or continue to be addressed in recently completed, ongoing or pending regulatory actions. EPA thus excluded those 12 NPDWRs from detailed review. This document is not a final regulatory decision, but rather the initiation of a process that will involve more detailed analyses of factors relevant to deciding whether a rulemaking to revise an NPDWR should be initiated.

NTP Information Cited
National Toxicology Program (NTP). 2005. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Sodium Chlorate (CAS No. 7775–09–9) in F344/ N Rats and B6C3F1 Mice (Drinking Water Studies). NTP TR 517 NIH Publication No. 06–4457 National Institutes of Health, Public Health Service, U.S. Department of Health and Human Services. December 2005.

NTP. 2007. NTP technical report on the toxicology and carcinogenesis studies of dibromoacetic acid (CAS No. 631–64–1) in F344/N rats and B6C3F1 mice (drinking water studies). NTP Technical Report Series No. 537. NTP, National Institutes of Health, Public Health Service, U.S. Department of Health and Human Services.

NTP. 2009. Toxicology and carcinogenesis studies of bromochloroacetic acid (CAS No. 5589–96–8) in F344/N rats and B6C3F1 mice (drinking water studies). Technical Report Series No. 549. Research Triangle Park, NC: U.S. Department of Health and Human Services.

NTP. 2014. Toxicology studies of bromodichloroacetic acid (CAS No. 71133–14–7) in F344 rats and B6C3F1 mice and toxicology and carcinogenesis studies of bromodichloroacetic acid in F344/NTac rats and B6C3F1/N mice (drinking water studies). Peer Review Draft, scheduled peer review date; May 22, 2014. Technical Report Series No. 583. Research Triangle Park, NC: U.S. Department of Health and Human Services.

NTP. 2016. Systematic Review of the Effects of Fluoride on Learning and Memory in Animal Studies.

Trichloroethylene (TCE) is a volatile organic compound widely used in industrial and commercial processes and has some limited uses in consumer and commercial products. EPA identified significant health risks associated with TCE use in vapor degreasing and EPA’s proposed determination is that these risks are unreasonable risks. To address these unreasonable risks, EPA is proposing under section 6 of the Toxic Substances Control Act (TSCA) to prohibit the manufacture (including import), processing, and distribution in commerce of TCE for use in vapor degreasing; to prohibit commercial use of TCE in vapor degreasing; to require manufacturers, processors, and distributors, except for retailers of TCE for any use, to provide downstream notification of these prohibitions throughout the supply chain; and to require limited recordkeeping.

NTP Information Cited
National Toxicology Program. 12th Report on Carcinogens. 2011.

The Environmental Protection Agency (EPA) is publishing a draft notice of the rationale for granting petitions to add n-propyl bromide (nPB), also known as 1-bromopropane (1–BP), (Chemical Abstract Service No. 106–94–5) to the list of hazardous air pollutants (HAP) contained in section 112(b)(1) of the Clean Air Act (CAA). The Halogenated Solvents Industry Alliance (HSIA) and New York State Department of Environmental Conservation (NYSDEC) submitted petitions requesting that nPB be added to the list of HAP. In response to the EPA requests for additional data, HSIA subsequently supplemented its petition. Petitions to add a substance to the list of HAP are permitted under the CAA section 112(b)(3). Based on the EPA’s evaluation of the petitioners’ showing concerning potential hazards, emissions, and atmospheric dispersion modeling that provided estimates of ambient concentrations of nPB, the EPA has determined that there is adequate evidence to support a determination that emissions and ambient concentrations of nPB may reasonably be anticipated to cause adverse health effects.

NTP Information Cited
National Toxicology Program (NTP) Report on Carcinogens (RoC), 13th Edition, 2014 (NTP, 2014) in which the NTP classified nPB, identified as 1–BP, as being reasonably anticipated to be a human carcinogen.

Recent scientific and technological advances have the potential to improve assessment of public health risks posed by chemicals, yet questions remain how best to integrate the findings from the new tools and methods into risk assessment. A new National Academies of Sciences, Engineering, and Medicine report recommends approaches for using 21st century science to evaluate the many factors that lead to health risks and disease, laying the groundwork for a new direction in risk assessment that acknowledges the complexity of disease causation.

NTP Information Cited
NTP (National Toxicology Program). 2004. A National Toxicology Program for the 21st Century: A Roadmap for the Future [online].

Trichloroethylene (TCE) is a volatile organic compound widely used in industrial and commercial processes and has some limited uses in consumer and commercial products. EPA identified significant health risks associated with TCE use in aerosol degreasing and for spot cleaning in dry cleaning facilities. EPA has preliminarily determined that these risks are unreasonable risks. To address these unreasonable risks, EPA is proposing under section 6 of the Toxic Substances Control Act (TSCA) to prohibit the manufacture, processing, and distribution in commerce of TCE for use in aerosol degreasing and for use in spot cleaning in dry cleaning facilities; to prohibit commercial use of TCE for aerosol degreasing and for spot cleaning in dry cleaning facilities; to require manufacturers, processors, and distributors, except for retailers of TCE for any use, to provide downstream notification of these prohibitions throughout the supply chain; and to require limited record keeping.

NTP Information Cited

National Toxicology Program. 13th Report on Carcinogens. 2014.

Proposed update of the PHGs for nitrate and nitrite published in 1997. OEHHA is proposing to retain the original PHG values.

NTP Information Cited

NTP (2001). NTP Technical Report on the Toxicology and Carcinogenesis Studies of Sodium Nitrite (CAS No. 7632-00-0) in F344/N Rats and B6C3F1 Mice. National Toxicology Program, U.S. Department of Health and Human Services, Research Triangle Park, NC.

NTP (2014). Report on Carcinogens, Thirteenth Edition. Research Triangle Park, NC: US Department of Health and Human Services, Public Health Service.

EPA is issuing a final rule to implement the Formaldehyde Standards for Composite Wood Products Act, which added Title VI to the Toxic Substances Control Act (TSCA). The purpose of TSCA Title VI is to reduce formaldehyde emissions from composite wood products, which will reduce exposures to formaldehyde and result in benefits from avoided adverse health effects. This final rule includes formaldehyde emission standards applicable to hardwood plywood, medium-density fiberboard, and particleboard, and finished goods containing these products, that are sold, supplied, offered for sale, or manufactured (including imported) in the United States. This final rule includes provisions relating to, among other things, laminated products, products made with no-added formaldehyde resins or ultra low-emitting formaldehyde resins, testing requirements, product labeling, chain of custody documentation and other recordkeeping requirements, enforcement, import certification, and product inventory sell-through provisions, including a product stockpiling prohibition. This final rule also establishes a third-party certification program for hardwood plywood, medium-density fiberboard, and particleboard and includes procedures for the accreditation of third-party certifiers and general requirements for accreditation bodies and third-party certifiers.

NTP Information Cited

National Toxicology Program. Report on carcinogens. Thirteenth edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. 2014.

The Office of Environmental Health Hazard Assessment (OEHHA) is releasing a revised draft document summarizing the toxicity and derivation of RELs for Ethylene Glycol n-mono Butyl Ether (EGBE). These documents will be reviewed and discussed by the Scientific Review Panel on Toxic Air Contaminants (SRP) at its meeting on December 14, 2016 in Sacramento, CA. RELs are airborne concentrations of a chemical that are not anticipated to result in adverse non–cancer health effects for specified exposure durations in the general population, including sensitive subpopulations.

NTP Information Cited
NTP (2000). Toxicology and carcinogenesis studies 2-butoxyethanol (CAS NO. 111-76-2) in F344/N rats and B6C3F1 mice (inhalation studies).

The Office of Environmental Health Hazard Assessment (OEHHA) is releasing a revised draft document summarizing the carcinogenicity and derivation of an inhalation cancer unit risk factor (URF) for tertiary-Butyl Acetate (TBAc). Inhalation cancer unit risk factors are used to estimate lifetime cancer risks associated with inhalation exposure to a carcinogen. These documents will be reviewed and discussed by the Scientific Review Panel on Toxic Air Contaminants (SRP) at its meeting on December 14, 2016 in Sacramento, CA.

NTP Information Cited
National Toxicology Program (NTP). 1995. Toxicology and Carcinogenesis Studies of t-Butyl Alcohol (CAS No. 75-65-0) In F344/N Rats and B6C3F1 Mice (Drinking Water Studies). NTP TR436, NIH Publication No. 95-3167. National Institute of Environmental Health Sciences, Research Triangle Park, NC.

Effective October 21, 2016, the Office of Environmental Health Hazard Assessment (OEHHA) is adding pentachlorophenol and by-products of its synthesis (complex mixture) to the list of chemicals known to the state to cause cancer for purposes of Proposition 65.

NTP Information Cited
National Toxicology Program (NTP, 2014). Report on Carcinogens, Thirteenth Edition, US Department of Health and Human Services, Public Health Service, NTP, Research Triangle Park, North Carolina.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is announcing the publication of the updated Public Health Goal (PHG) for antimony in drinking water. A PHG is the level of a drinking water contaminant at which adverse health effects are not expected to occur from a lifetime of exposure. The California Safe Drinking Water Act of 1996 requires OEHHA to develop PHGs based exclusively on public health considerations. PHGs published by OEHHA are considered by the State Water Resources Control Board in setting drinking water standards (Maximum Contaminant Levels, or MCLs) for California.

NTP Information Cited
NTP (1989). Toxicology and carcinogenesis studies of hydroquinone in F344/N rats and B6C3F1 mice. National Toxicology Program, Research Triangle Park, NC.

NTP (1992). NTP report on the toxicity studies of antimony potassium tartrate in F344/N rats and B6C3F1 mice (drinking water and intraperitoneal injection studies). NTP Tox 11, NIH Publication No. 92-3130, March 1992. National Toxicology Program, Research Triangle Park, NC.

The Department of Veterans Affairs (VA) proposes to amend its adjudication regulations relating to presumptive service connection to add certain diseases associated with contaminants present in the base water supply at U.S. Marine Corps Base Camp Lejeune (Camp Lejeune), North Carolina, from August 1, 1953 to December 31, 1987. The chemical compounds involved have been associated by various scientific organizations with the development of certain diseases. This proposed rule would establish that veterans, former reservists, and former National Guard members, who served at Camp Lejeune for no less than 30 days (consecutive or nonconsecutive) during this period, and who have been diagnosed with any of eight associated diseases, are presumed to have a service-connected disability for purposes of entitlement to VA benefits. In addition, VA proposes to establish a presumption that these individuals were disabled during the relevant period of service, thus establishing active military service for benefit purposes. Under this proposed presumption, affected former reservists and National Guard members would have veteran status for purposes of entitlement to some VA benefits. This proposed amendment would implement a decision by the Secretary of Veterans Affairs that service connection on a presumptive basis is warranted for claimants who served at Camp Lejeune during the relevant period and for the requisite amount of time and later develop certain diseases. The Secretary’s decision is supported by the conclusions of internationally recognized scientific authorities that strong evidence exists establishing a relationship between exposure to certain volatile organic compounds (VOCs) that were in the water at Camp Lejeune and later development of certain disabilities.

NTP Information Cited
National Toxicology Program. 2014. Report on Carcinogens, Thirteenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.

National Toxicology Program. 2015. Report on Carcinogens, Monograph on Trichloroethylene. http://ntp.niehs.nih.gov/ntp/roc/monographs/finaltce_508.pdf

This proposed rule would amend HUD’s lead-based paint regulations on reducing blood lead levels in children under age 6 who reside in federally-owned or -assisted pre-1978 housing and formally adopt the revised definition of ‘‘elevated blood lead levels’’ in children under the age of 6 in accordance with guidance of the Centers for Disease Control and Prevention (CDC), and establish more comprehensive testing and evaluation procedures for the housing where such children reside. In 2012, the CDC issued guidance revising its definition of elevated blood lead level in children under age 6 to be a blood lead level based on the distribution of blood lead levels in the national population. Since CDC’s revision of its definition, HUD has applied the revised definition to funds awarded under its Lead-Based Paint Hazard Control grant program and its Lead Hazard Reduction Demonstration grant program, and has updated its Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing to reflect this definition. CDC is continuing to consider, with respect to evolution of scientific and medical understanding, how best to identify childhood blood lead levels for which environmental interventions are recommended. Through this rule, HUD formally adopts through regulation the CDC’s approach to the definition of ‘‘elevated blood lead levels’’ in children under the age of 6 and addresses the additional elements of the CDC guidance pertaining to assisted housing.

NTP Information Cited
HHS, National Institute of Environmental Health Sciences, National Toxicology Program. NTP Monograph on Health Effects of Low-Level Lead. NIH Publication No. 12–5996. June 13, 2012.

Effective August 5, 2016, the Office of Environmental Health Hazard Assessment (OEHHA) is adding 1-bromopropane (CAS No. 106-94-5) to the list of chemicals known to the state to cause cancer for purposes of Proposition 65.

NTP Information Cited
National Toxicology Program (NTP, 2011). National Toxicology Program. Toxicology and Carcinogenesis Studies of 1‑Bromopropane (CAS No. 106-94-5) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Technical Report Series No. 564. NIH Publication No. 11-5906. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.

Effective July 29, 2016, the Office of Environmental Health Hazard Assessment (OEHHA) is adding bromodichloroacetic acid (CAS No. 71133-14-7) to the list of chemicals known to the state to cause cancer for purposes of Proposition 65.

NTP Information Cited
National Toxicology Program (NTP, 2015). Toxicology Studies of Bromodichloroacetic Acid (CAS No. 71133-14-7) in F344/N Rats and B6C3F1 Mice and Toxicology and Carcinogenesis Studies of Bromodichloroacetic Acid in F344/NTac Rats and B6C3F1/N Mice (Drinking Water Studies). NTP Technical Report Series No. 583. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

The Department of Energy (DOE or the Department) is proposing to amend its current chronic beryllium disease prevention program regulation. The proposed amendments would improve and strengthen the current provisions and continue to be applicable to DOE Federal and contractor employees who are, were, or potentially were exposed to beryllium at DOE sites.

NTP Information Cited
National Toxicology Program. Thirteenth Report on Carcinogens. ‘‘Beryllium and Beryllium Compounds.’’ 2014. Accessed on 10/26/2015.

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list the chemical bromodichloroacetic acid as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986.

NTP Information Cited
National Toxicology Program (NTP, 2015). Toxicology Studies of Bromodichloroacetic Acid (CAS No. 71133-14-7) in F344/N Rats and B6C3F1 Mice and Toxicology and Carcinogenesis Studies of Bromodichloroacetic Acid in F344/NTac Rats and B6C3F1/N Mice (Drinking Water Studies). NTP Technical Report Series No. 583. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

Effective April 22, 2016, the Office of Environmental Health Hazard Assessment (OEHHA) is adding styrene (CAS No. 100-42-5) to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The listing of styrene is based on formal identification by the National Toxicology Program (NTP), an authoritative body, that the chemical causes cancer. The criteria used by OEHHA for the listing of chemicals under the “authoritative bodies” mechanism can be found in Title 27, Cal. Code of Regs., section 25306.

NTP Information Cited
 National Toxicology Program (NTP, 2011). Report on Carcinogens, Twelfth Edition, US Department of Health and Human Services, Public Health Service, NTP, Research Triangle Park, North Carolina, page 383-391.

The listing of styrene is based on formal identification by the National Toxicology Program (NTP), an authoritative body, that the chemical causes cancer. The criteria used by OEHHA for the listing of chemicals under the “authoritative bodies” mechanism can be found in Title 27, Cal. Code of Regs., section 25306.

NTP Information Cited
National Toxicology Program (NTP, 2011). Report on Carcinogens, Twelfth Edition, US Department of Health and Human Services, Public Health Service, NTP, Research Triangle Park, North Carolina, page 383-391.

OEHHA reviewed the studies identified in the NTP-CERHR Monograph that provide the basis for the listing, and conducted a literature search for any other relevant studies or reports published after the NTP-CERHR review was completed. Additional relevant studies were identified and reviewed by OEHHA. This is discussed in more detail in the initial statement of reasons for this proposed regulatory amendment.

NTP Information Cited
NTP-CERHR (2004). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Ethylene Glycol. Research Triangle Park, NC, National Toxicology Program, Center for the Evaluation of Risks to Human Reproduction: NIH Publication No. 04 – 4481.

On May 11, 2015, Bisphenol A (BPA) was added to the Proposition 65 list of chemicals known to the state to cause reproductive toxicity based on the female reproductive endpoint. Female reproductive toxicity occurs when a chemical damages any aspect of the female reproductive system. BPA is commonly used in certain linings of metal cans and lids of glass bottles containing food and beverages. Under Proposition 65, one year after the listing, beginning May 11, 2016, warnings are required for all exposures to BPA unless the person causing the exposure can show that the exposure when multiplied by 1,000 times has no observable effect.

NTP Information Cited
NTP-CERHR Expert Panel Report on the Reproductive and Developmental Toxicity of Bisphenol A; Report No. NTP-CERHR-BPA-07

National Toxicology Program, U.S. Department of Health and Human Services, Center for the Evaluation of Risks to Human Reproduction (2007) (Published Nov 26, 2007).

With this notice, EPA is announcing the availability of and opening the public comment period for the draft TSCA Work Plan Chemical risk assessment for 1-Bromopropane (1–BP). EPA develops TSCA Work Plan Chemical assessments using the best available information and approaches. These assessments focus on those TSCA uses of the chemical with significant potential for exposure to humans and/or the environment. EPA issues draft risk assessments for public review and comment, followed by independent peer review in accordance with Agency peer review guidelines. The Agency considers all public and peer review comments as it revises and finalizes the risk assessment. Based on the final TSCA risk assessment, the Agency may either initiate risk reduction actions that are necessary to address the potential risks identified, or may conclude its work on the chemical uses being assessed if no risks are found.

NTP Information Cited
National Toxicology Program - Center for the Evaluation of Risks to Human Reproduction (NTP), 2003. "NTP-CERHR Monograph on the potential Human Reproductive and Developmental Effects of 1-Bromopropane."

NTP (National Toxicology Program). (1989). Toxicology and Carcinogenesis Studies of Bromoethane in F344/N Rats and B6C3F1 Mice (Inhalation Studies). (Report No. 363).

NTP (National Toxicology Program). (2011). NTP Technical Report on the Toxicology and Carcinogenesis Studies of 1-Bromopropane (CAS No. 106-94-5) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). (NTP TR 564; NIH Publication No. 11-5906). Research Triangle Park, NC.

NTP (National Toxicology Program). (2013). Draft Report on Carcinogens. Monograph for 1-Bromopropane. In Office of the Report on Carcinogens. Research Triangle Park, NC.

NTP (National Toxicology Program). (2014). Report on Carcinogens. 13th Edition.

This regulation establishes tolerances for residues of diflubenzuron in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

NTP Information Cited
PCA, a plant metabolite of diflubenzuron, tested positive for splenic tumors in the male rats and hepatocellular adenomas/carcinomas in male mice in a National Toxicology Program (NTP) study.

This regulation establishes an exemption from the requirement of a tolerance for residues of benzyl acetate (CAS Reg. No. 140–11–4), when used as an inert ingredient (solvent) in pesticide formulations applied to growing crops only under 40 CFR 180.920. Technology Sciences Group, on behalf of the Huntsman Corporation, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of benzyl acetate.

NTP Information Cited
Because of the confounding effects of corn oil on the incidences of pancreatic neoplasm and because of the controversy over the use of the gavage route of administration, the National Toxicology Program (NTP) decided to re-study benzyl acetate using the dosed feed route of administration. In 1993, the NTP conducted a second set of carcinogenicity studies in rats and mice using the dose feed route of administration. 

The point of departure for benzyl acetate is 110 mg/kg/day from the NTP 2-year carcinogenicity study in mice (dietary study) based on decreased in body weights in both sexes at the LOAEL of 345/375 mg/kg/day. There was no evidence of carcinogenicity in mice and rats. 

The Office of Environmental Health Hazard Assessment (OEHHA) is releasing a Scientific Review Panel on Toxic Air Contaminants (SRP) review draft document summarizing the toxicity and derivation of RELs for Ethylene Glycol n-mono Butyl Ether (EGBE). These documents will be reviewed and discussed by the SRP at their meeting on March 4, 2016 in Sacramento, CA. RELs are airborne concentrations of a chemical that are not anticipated to result in adverse non–cancer health effects for specified exposure durations in the general population, including sensitive subpopulations.

NTP Information Cited
NTP (2000).  Toxicology and Carcinogenesis Studies of 2-Butoxyethanol (CAS 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies).  National Toxicology Program, Research Triangle Park, NC.

NTP (2015).  NTP Nonneoplastic Lesion Atlas: Nose, Epithelium - Accumulation, Hyaline Droplet.  Retrieved October 2015.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids’ Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff, proposing that the food additive regulations be amended to no longer authorize the use of seven listed synthetic flavoring food additives and to establish zero tolerances for the additives.

NTP Information Cited
The petitioners cite, as evidence, conclusions by the National Toxicology Program, the International Agency for Research on Cancer, and the California Environmental Protection Agency's Office of Environmental Health Hazard Assessment.  The petitioners also include results from an observational epidemiology study in humans exposed to styrene and a number of long-term, animal feeding studies conducted on each of the seven additives to support their request.

The Environmental Protection Agency (EPA) is adding 1-bromopropane to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and section 6607 of the Pollution Prevention Act (PPA) of 1990. 1-Bromopropane has been classified by the National Toxicology Program in their 13th Report on Carcinogens as ‘‘reasonably anticipated to be a human carcinogen.’’ The EPA has determined that 1-bromopropane meets the EPCRA section 313(d)(2)(B) criteria because it can reasonably be anticipated to cause cancer in humans.

NTP Information Cited
NTP, 2014. National Toxicology Program. Report on Carcinogens, Thirteenth Edition. Released October 2, 2015. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Research Triangle Park, NC 27709.

NTP, 2013. Report on Carcinogens Monograph on 1-Bromopropane.  Office of the Report on Carcinogens, Division of the National Toxicology Program, National Institute of Environmental Health Sciences, U.S. Department of Health and Human Services.  NIH Publication No. 13-5982, September 25, 2013

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list “pentachlorophenol and by-products of its synthesis (complex mixture)” as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986.

NTP Information Cited
“The combined incidence of benign and malignant liver tumors (hepatocellular adenoma and carcinoma) was significantly increased in mice of both sexes following dietary exposure to Dowicide EC-7⁴ and in males following exposure to technical-grade pentachlorophenol. In males exposed to either formulation, the separate incidence of malignant liver tumors also was significantly increased” (footnote not in original).

“The incidences of benign and malignant adrenal-gland tumors (pheochromocytoma) combined, benign adrenal-gland tumors, and preneoplastic adrenal-gland lesions (medullary hyperplasia) were significantly increased in mice of both sexes exposed to Dowicide EC-7.”

“The incidence of malignant tumors of the blood vessels (hemangiosarcoma) of the spleen and/or liver was significantly increased in female mice exposed to technical-grade pentachlorophenol or Dowicide EC-7.”

“In male F344 rats (Chhabra et al. 1999, NTP 1999), increased incidences of tumors were observed in the tunica vaginalis of the testes and in the nose. In a stop-exposure study, the incidence of malignant mesothelioma of the tunica vaginalis was significantly increased after dietary exposure to 99% pure pentachlorophenol for one year, followed by one year of observation. Although the increased incidence of squamous-cell carcinoma of the nose was not statistically significant, this is a rare tumor, and its incidence exceeded the range for historical controls.”

NTP (2014). Report on Carcinogens, Thirteenth Edition, U.S. Department of Health and Human Services, Public Health Service, NTP, Research Triangle Park, North Carolina. 

Environmental Protection Agency (EPA) is denying a petition to remove ethylene glycol monobutyl ether (EGBE) from the category Certain Glycol Ethers under the list of chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and section 6607 of the Pollution Prevention Act (PPA) of 1990. EPA has reviewed the available data on this chemical and has determined that EGBE does not meet the deletion criterion of EPCRA section 313(d)(3). Specifically, EPA is denying this petition because EPA’s review of the petition and available information resulted in the conclusion that EGBE meets the listing criterion of EPCRA section 313(d)(2)(B) due to its potential to cause serious or irreversible chronic health effects in humans, specifically, liver toxicity and concerns for hematological effects.

NTP Information Cited
NTP. 2000. NTP technical report on the toxicology and carcinogenesis studies of 2- butoxyethanol (CAS No. 111–76–2) in F344/N rats and B6C3F1 mice (inhalation studies). National Toxicology Program. Research Triangle Park, NC. NTP TR 484. https://ntp.niehs.nih.gov/results/pubs/longterm/reports/longterm/tr400499/abstracts/tr484/index.html.  

NTP. 1996. Toxicology and carcinogenesis studies of acetonitrile (CAS No 75–05–8) in F344/N rats and B6C3F1 mice (inhalation studies). National Toxicology Program. Research Triangle Park, NC. 

NTP. 1993. NTP technical report on toxicity studies of ethylene glycol ethers: 2-methoxyethanol, 2-ethoxyethanol, 2-butoxyethanol (CAS Nos. 109–86–4, 110–80–5, 111–76–2) administered in drinking water to F344/N rats and B6C3F1 mice. National Toxicology Program. Research Triangle Park, NC. 26; NIH Publication 93–3349.

This notice announces the beginning of a 45-day public comment period on the five chemicals listed below. These chemicals will be discussed at the November 9, 2015 meeting of the Proposition 65 Developmental and Reproductive Toxicant Identification Committee (DARTIC). The five chemicals are: • Nickel • Pentachlorophenol • Perfluorooctanoic acid (PFOA) • Perfluorooctane sulfonate (PFOS) • Tetrachloroethylene

NTP Information Cited
NTP, Report on Carcinogens

OEHHA is referring nitrapyrin and di­lamino­toluene (mixed) to the Carcinogen Identification Committee (CIC), the state’s qualified experts for carcinogenicity determinations under Proposition 65, for review.

NTP Information Cited
The NTP is mandated to provide to Congress an annual report on carcinogens. The last report was provided in October, 2014 (Exhibit). In this report 2,5-di­lamino­toluene was not listed as either a known human carcinogen, or a chemical suspected of being a human carcinogen.

Note that no stomach tumors were found in the 2-year NTP study in the same species.] may confirm the lack of genotoxic activity of toluene-2,5-diamine sulfate in vivo.

National Toxicology Program, NTP Technical Report on the Toxicology and Carcinogenesis Studies of Two Pentachlorophenol Technical-Grade Mixtures in B6C3Fl Mice, NTP TR 349, NIH Publication No. 89-2804,
March, 1989.

NTP provided historical control data (updated in 1999) for testicular tumors  (currently termed testicular adenoma) among 20 NCI/NTP dietary carcinogenicity studies in male Fischer 344 rats given the NIH-07 diet (the same diet used for the study of 2,5-di­lamino­toluene).

Ashby J and Tennant RW (1988). Chemical structure, Salmonella mutagenicity and extent of carcinogenicity as indicators of genotoxic carcinogenesis among 222 chemicals tested in rodents by the U.S. NCI/NTP. Mutat Res 204 (1): 17-115.

National Cancer Institute (1978) Bioassay of 2,5-Toluenediamine Sulfate for Possible Carcinogenicity (CAS No. 6369-59-1) NCI-GG-TR-126.

The Occupational Safety and Health Administration (OSHA) proposes to amend its existing exposure limits for occupational exposure in general industry to beryllium and beryllium compounds and promulgate a substance-specific standard for general industry regulating occupational exposure to beryllium and beryllium compounds. This document proposes a new permissible exposure limit (PEL), as well as ancillary provisions for employee protection such as methods for controlling exposure, respiratory protection, medical surveillance, hazard communication, and recordkeeping. In addition, OSHA seeks comment on a number of alternatives, including a lower PEL, that could affect construction and maritime, as well as general industry.

NTP Information Cited
In brief, IARC determined beryllium and its compounds to be carcinogenic to humans (Group 1 category), while EPA considers beryllium to be a probable human carcinogen (EPA, 1998), and the National Toxicology Program (NTP) has determined beryllium and its compounds to be known carcinogens (NTP, 2014).

Other scientific organizations, including the International Agency for Research on Cancer (IARC), the National Toxicology Program (NTP), the U.S. Environmental Protection Agency (EPA), the National Institute for Occupational Safety and Health (NIOSH), and the American Conference of Governmental Industrial Hygienists (ACGIH) have reached similar conclusions with respect to the carcinogenicity of beryllium

National Toxicology Program. (1993). Toxicology and Carcinogenesis Studies of Talc (CAS No. 14807–96–6)(NonAsbestiform) in F344/N Rats and B6C3F1 Mice (Inhalation Studies).

National Toxicology Program. (1999). Final Report on Carcinogens: Background Document for Beryllium and Beryllium Compounds. 

National Toxicology Program. (2002). Tenth report on carcinogens. U.S. Department of Health and Human Services, National Toxicology Program, Research Triangle Park, NC. 

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list furfuryl alcohol as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986

NTP Information Cited
NTP (National Toxicology Program).  1990.  NTP Technical Report on the Toxicology and Carcinogenesis Studies of Furfural (CAS No. 98-01-1) in F344/N rats and B6C3F1 mice (Gavage Studies). NTP-TR-382, MRID 46011016.

National Toxicology Program (NTP). 1999. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Furfuryl Alcohol (CASRN 98-00-0) in F344/N Rats and B6C3F1 Mice. NTP TR 482. NIH Publication No. National Toxicology Program, Research Triangle Park, NC.

Irwin, R. (1990). NTP Technical report on the toxicology and carcinogenesis studies of furfural in F344/N rats and B6C3F1 mice (gavage studies).  NIH publication number 90-2837, National Toxicology Program.

NJP (National Toxicology Program). 1993. NTP Technical Report on the Toxicology and Carcinogepesis Studies of Furan (CAS No. 110-00-9) in F344/N rats and B6C3F1 mice (Gavage Studies). NTP-TR-402.

Pursuant to California Government Code section 11340.6, petitioners Mateel Environmental Justice Foundation, Californians for Alternatives to Toxics, Ecological Rights Foundation and Center for Environmental Health petition the California Office of Environmental Health Hazard Assessment to amend CCR, title 27, section 27001(b) to add glyphosate, malathion, tetrachlorvinphos and parathion to the chemicals listed under that section as known to the State to cause cancer.

NTP Information Cited
National Toxicology Program.  Bioassay of parathion for possible carcinogenticity.  National Cancer Institute Carcinogenesis Technical Report Series 1979; 70: 1-123

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list 1-bromopropane as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986.

NTP Information Cited
National Toxicology Program (NTP, 2011). National Toxicology Program. Toxicology and Carcinogenesis Studies of 1‑Bromopropane (CAS No. 106-94-5) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Technical Report Series No. 564. NIH Publication No. 11-5906. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC. 

Effective June 19, 2015, the Office of Environmental Health Hazard Assessment (OEHHA) is adding ethylene glycol (ingested) (CAS No. 107-21-1) to the list of chemicals known to the state to cause reproductive toxicity for purposes of Proposition 65.

NTP Information Cited
NTP-CERHR (2004). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Ethylene Glycol. Research Triangle Park, NC, National Toxicology Program, Center for the Evaluation of Risks to Human Reproduction: NIH Publication No. 04 – 4481. 

Eight synthetic flavorings—which may be found in ice cream, baked goods, candy and beverages—are known to cause cancer in lab animals, and should be banned by the U.S. Food and Drug Administration, a coalition of leading health groups said in a petition filed with the agency today.

NTP Information Cited
NTP, Technical Report on the Toxicology and Carcinogenesis Studies of Benzophenone (CAS No 119-61-9) in F33/N Rats and B6C3F1 Mice, 2006. See http://ntp.niehs.nih.gov/results/pubs/longterm/reports/longterm/tr500580/listedreports/tr533/index.html

NTP, Final Report on Carcinogens Background Document for Methyleugenol, 2000. See http://ntp.niehs.nih.gov/pubhealth/roc/listings/m/methyleugenol/summary/index.html

NTP, Carcinogenesis Studies of Methyl Eugenol (CAS No. 93-15-2) in F344/N Rats and B6C3F1 Mice (Gavage Studies), 2000. http://ntp.niehs.nih.gov/results/pubs/longterm/reports/longterm/tr400499/abstracts/tr491/index.html

NTP, Toxicology and Carcinogenesis Studies of β-Myrcene (CAS No. 123-35-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies), 2010. http://ntp.niehs.nih.gov/results/pubs/longterm/reports/longterm/tr500580/listedreports/tr557/index.html

NTP, Toxicology and Carcinogenesis Studies of Pulegone (CAS No. 89-82-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies), 2011. http://ntp.niehs.nih.gov/results/pubs/longterm/reports/longterm/tr500580/listedreports/tr563/index.html

NTP, Toxicology and Carcinogenesis Studies of Pyridine (CAS No. 110-86-1) in F344/N Rats, Wistar Rats, and B6C3F1 Mice (Drinking Water Studies), 2000. http://ntp.niehs.nih.gov/results/pubs/longterm/reports/longterm/tr400499/abstracts/tr470/index.html

NTP, Report on Carcinogens, Thirteenth Edition, Styrene, 2014. See http://ntp.niehs.nih.gov/go/roc13

NTP, Final Report on Carcinogens Background Document for Styrene, 2008. See http://ntp.niehs.nih.gov/pubhealth/roc/listings/s/styrene/summary/index.html

NTP, Technical Report on the Toxicology and Carcinogenesis Studies of 2,4-Hexadienal (89% trans,trans isomer, CAS No. 142-83-6; 11% cis,trans isomer) in F344/N Rats and B6C3F1 Mice (Gavage Studies), 2003. See http://ntp.niehs.nih.gov/ntp/htdocs/lt_rpts/tr509.pdf

The Office of Environmental Health Hazard Assessment (OEHHA) is releasing a draft document for review by the State's Science Review Panel on Toxic Air Contaminants (SRP). The SRP review draft document summarizes the toxicity and derivation of Reference Exposure Levels (RELs) for Carbonyl Sulfide. This document is for review and comment by the Science Review Panel at their meeting on June 19, 2015. RELs are airborne concentrations of a chemical that are not anticipated to result in adverse non–cancer health effects for specified exposure durations in the general population, including sensitive subpopulations.

NTP Information Cited
The National Toxicology Program (NTP) studied 4 strains of mutant Salmonella (TA97,
TA98, TA100, and TA1535) in the Ames test and used from 0.58 to 2.89 µg COS per
test plate with and without induced liver extract from rats or hamsters. They reported a
weakly positive response based on positive results in one strain (TA97) (NTP, 1995).

NTP. (1995). Genetic Toxicology - Bacterial Mutagenicity. NTP Study ID: A35125.
CEBS Accession Number: 002-01834-0001-0000-9

The Food and Drug Administration (FDA) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, we are proposing to establish conditions under which OTC antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital are generally recognized as safe and effective. In the 1994 TFM, certain antiseptic active ingredients were proposed as being generally recognized as safe for use in health care settings based on safety data evaluated by FDA as part of its ongoing review of OTC antiseptic drug products. However, in light of more recent scientific developments, we are now proposing that additional safety data are necessary to support the safety of antiseptic active ingredients for these uses. We also are proposing that all health care antiseptic active ingredients have in vitro data characterizing the ingredient’s antimicrobial properties and in vivo clinical simulation studies showing that specified log reductions in the amount of certain bacteria are achieved using the ingredient.

NTP Information Cited
Dermal carcinogenicity data have been obtained from studies where alcohol was used as a vehicle control in 2-year studies. For example, a study performed by the National Toxicology Program (NTP) evaluated the carcinogenic potential of diethanolamine by the dermal route of administration in rats and mice (Ref.
130).

Another study performed by the NTP evaluated the carcinogenic potential of benzethonium chloride by the dermal route of administration in rats and mice (Ref. 131). Each species had a vehicle control group that was treated with 95 percent alcohol only. The rats and mice were treated for 5 days per week for 103 weeks. There was no evidence of an increased incidence of skin tumors in the alcohol-treated rats or mice.

National Toxicology Program, ‘‘TR 478: Toxicology and Carcinogenesis Studies of Diethanolamine in F344/N Rats and B6C3F1 Mice,’’ 1999.

National Toxicology Program, ‘‘NTP Toxicology and Carcinogenesis Studies of Benzethonium Chloride (CAS No. 121–54–0) in F344/N Rats and B6C3F1 Mice (Dermal Studies),’’ National Toxicology Program Technical Report Series, 438:1–220, 1995.

National Toxicology Program, ‘‘TR 510: Toxicology and Carcinogenesis Studies of Urethane, Ethanol, and Urethane/Ethanol in B6C3F1 Mice,’’ 2004.

National Toxicology Program, ‘‘NTP: Toxicology and Carcinogenesis Studies of 4-Hexylresorcinol in F3441N Rats and B6C3F1 Mice, Technical Report Series, No. 330,’’ 1988.

Bisphenol A (BPA) will be considered for listing at the next meeting of the Developmental and Reproductive Toxicant Identification Committee (DARTIC) scheduled for May 7, 2015 in Sacramento. At this meeting,, the DARTIC will consider whether BPA "has been clearly shown through scientifically valid testing according to generally accepted principles to cause female reproductive toxicity".

NTP Information Cited
NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A (2008) [Attachment to OEHHA, 2009]

National Toxicology Program - Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2008). "NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A." NTP, US Department of Health and Human Services, Research Triangle Park, NC, NIH Publication No. 08-5994.

The Office of Environmental Health Hazard Assessment (OEHHA) convened a meeting of the Proposition 65 Carcinogen Identification Committee (CIC) on November 19, 2014, at the California Environmental Protection Agency Headquarters Building in Sacramento, California. The Committee considered whether or not dibenzanthracenes (as a chemical group), dibenz[a,c]anthracene, dibenz[a,j]anthracene, and N-nitrosomethyl-n-alkylamines with alkyl chain lengths of 3 through 12 and 14 carbons should be listed under Proposition 65 as known to the state to cause cancer.

NTP Information Cited
DB [a,h]A: NTP (1981): “Reasonably anticipated to be a human carcinogen”

The Environmental Protection Agency (EPA) is proposing to add 1-bromopropane to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and section 6607 of the Pollution Prevention Act (PPA) of 1990. 1-Bromopropance has been classified by the National Toxicology Program in their 13th Report on Carcinogens as “reasonably anticipated to be human carcinogen.” EPA believes that 1-bromopropane meets the EPCRA section 313(d)(2)(B) criteria because it can reasonably be anticipated to cause cancer in humans. Based on a review of the available production and use information, 1-bromopropane is expected to be manufactured, processed, or otherwise used in quantities that would exceed the EPCRA section 313 reporting thresholds.

NTP Information Cited
NTP, 2014. National Toxicology Program. Report on Carcinogens, Thirteenth Edition. Released October 2, 2014. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Research Triangle Park, NC 27709.

NTP, 2014. National Toxicology Program. Report on Carcinogens, Thirteenth Edition, Introduction section. Released October 2, 2014. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Research Triangle Park, NC 27709.

NTP, 2014. National Toxicology Program. Report on Carcinogens, Thirteenth Edition, Process for Preparation of the Report on Carcinogens section. Released October 2, 2014. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Research Triangle Park, NC 27709.

NTP, 2013. Report on Carcinogens Monograph on 1-Bromopropane. Office of the Report on Carcinogens, Division of the National Toxicology Program, National Institute of Environmental Health Sciences, U.S. Department of Health and Human Services. NIH Publication No. 13–5982, September 25, 2013

NTP, 2014. National Toxicology Program. Report on Carcinogens, Thirteenth Edition, Profile for 1-Bromopropane. Released October 2, 2014. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program

Effective March 27, 2015,the Office of Environmental Health Hazard Assessment (OEHHA) is adding beta-myrcene(CAS No. 123-35-3)to the list of chemicals known to the state to cause cancer for purposes of Proposition 65

NTP Information Cited
In 2010, the NTP published a report on beta-myrcene (β‑myrcene), entitled Toxicology and Carcinogenesis Studies of β-Myrcene (CAS No. 123-35-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies), that concludes that the chemical causes cancer (NTP, 2010).  This report satisfies the formal identification and sufficiency of evidence criteria in the Proposition 65 regulations.

NTP (2010). Toxicology and Carcinogenesis Studies of β-Myrcene (CAS No. 123-35-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Technical Report Series No. 557, NIH Publication No. 10-5898. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list styrene as known to the State to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986.

NTP Information Cited
In 2011, NTP published the Twelfth Edition of the Report on Carcinogens (NTP, 2011). This report satisfies the formal identification and sufficiency of evidence criteria in the Proposition 65 regulations for styrene. NTP concluded that styrene is “reasonably anticipated to be a human carcinogen based on limited evidence of carcinogenicity from studies in humans, sufficient evidence of carcinogenicity from studies in experimental animals, and supporting data on mechanisms of carcinogenesis” (emphasis in original). OEHHA is relying on NTP’s discussion of data and conclusions in the report that styrene causes cancer.

National Toxicology Program (NTP, 2011). Report on Carcinogens, Twelfth Edition, U.S. Department of Health and Human Services, Public Health Service, NTP, Research Triangle Park, North Carolina, page 383-391.

EPA is announcing the availability of three draft test guidelines for public review and comment that are being added to its 890 Series, entitled “Endocrine Disruptor Screening Program Test Guidelines.” The draft guidelines relate to the following three non-mammalian species tests identified under Tier 2 of the Endocrine Disruptor Screen Program (EDSP): Japanese quail 2-generation reproduction test; Medaka extended 1-generation reproduction test; and Larval amphibian growth and development assay. These draft test guidelines are part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances. The test guidelines serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions. The test guidelines provide guidance for conducing the test, and are also used by EPA, the public, and companies that submit data to EPA.

NTP Information Cited
EPA followed the general validation principles of the Organization for Economic Co-Operation and Development (OECD) and the Intergovernmental Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) in the development of the four non-mammalian Tier 2 tests.

Under the Toxic Substance Control Act (TSCA), EPA is proposing significant new use rule (SNUR) for 2,4- toluene diisocyanate, 2,6-toluene diisocyanate, toluene diisocyanate unspecified isomers (these three chemical substances are hereafter referred to as toluene diisocyanates or TDI) and related compounds as identified in this proposed rule. The proposed significant new use is any use in a consumer product, with a proposed exception for use of certain chemical substances in coatings, elastomers, adhesives, binders, and sealants that results in less than or equal to 0.1 percent by weight of TDI in a consumer product. In addition, EPA is also proposing that the general SNUR article exemption for persons who import or process these chemical substances as part of an article would not apply." "Persons subject to the SNUR would be required to notify EPA at least 90 days before commencing any manufacturing or processing. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary based on the information available at that time, an opportunity to protect against potential unreasonable risks, if any, from that activity before it occurs."

NTP Information Cited
TDI has also been classified by the European Commission (EC) as Category 3 for carcinogenicity (‘‘causes concerns for humans owing to possible carcinogenic effects’’) (Ref. 16) and by the United States National Toxicology Program (NTP) as ‘‘reasonably anticipated to be a human carcinogen’’ (Ref. 17).

This regulation would establish the framework for a website operated by OEHHA that would provide supplemental information to the public about potential exposures to Proposition 65 listed chemicals.

NTP Information Cited
REFERENCES FOR SECTION 25602
US Department of Health and Human Services, National Toxicology Program. 13th Report on Carcinogens (October 2014).

Section 108 of the Consumer Product Safety Improvement Act of 2008 (CPSIA), requires the United States Consumer Product Safety Commission (Commission or CPSC) to convene a Chronic Hazard Advisory Panel (CHAP) to study the effects on children’s health of all phthalates and phthalate alternatives as used in children’s toys and child care articles and to provide recommendations to the Commission regarding whether any phthalates or phthalate alternatives other than those already permanently prohibited should be prohibited. The CPSIA requires the Commission to promulgate a final rule after receiving the final CHAP report. The Commission is proposing this rule pursuant to section 108(b) of the CPSIA. The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), § 104(i)(3),[42 U.S.C. 9604(i)(3)], directs the ATSDR administrator to prepare Toxicological Profiles of priority hazardous substances and, as necessary, to revise and publish each updated toxicological profile.

NTP Information Cited
‘‘Review all relevant data, including the most recent, best-available, peer reviewed, scientific studies of these phthalates and phthalate alternatives that employ objective data collection practices or employ other objective methods.’’ The CHAP reviewed all of the available data on phthalates, including publications in peer-reviewed scientific journals; reports submitted by manufacturers to the U.S. EPA; 10 and authoritative reviews from agencies such as the Agency for Toxic Substances and Disease Registry (ATSDR), the European Chemical Agency (ECHA), the International Agency for Research on Cancer (IARC), Center for the Evaluation of Research on Human Reproduction (CERHR), National Toxicology Program (NTP); and the National Research Council (NRC). (CHAP, 2014, p. 12). In addition, the CHAP invited scientific experts to present their latest research in areas such as biomonitoring, epidemiology, phthalate syndrome, toxicology of phthalates mixtures, phthalates mode of action, and species differences. The CHAP also invited a coauthor of an NRC report (NRC, 2009) to present the NRC panel’s perspective on risk assessment methodology, especially as applied to phthalates risk assessment. Furthermore, the CHAP heard testimony from federal agency scientists, as well as scientists representing manufacturers of phthalates alternatives.

This notice announces the availability of Set 26 Toxicological Profiles for review and comment. Comments can include additional information or reports on studies about the health effects of Set 26 substances. Although ATSDR considered key studies for each of these substances during the profile development process, this Federal Register notice solicits any relevant, additional studies, particularly unpublished data. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile. ATSDR remains committed to providing a public comment period for this document as a means to best serve public health and our clients. The Set 26 Toxicological Profiles are available online at http://www.atsdr.cdc.gov/toxprofiles/index.asp and http://www.regulations.gov/#!home, docket ATSDR–2014–0001. The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), § 104(i)(3),[42 U.S.C. 9604(i)(3)], directs the ATSDR administrator to prepare Toxicological Profiles of priority hazardous substances and, as necessary, to revise and publish each updated toxicological profile.

NTP Information Cited
Each profile will include an examination, a summary, and an interpretation of available toxicological information and epidemiological evaluations. This information and these data identify the levels of significant human exposure for the substance and for the associated health effects. The profiles must also include a determination of whether adequate information on the health effects of each substance is available (or in the process of development) in order to identify levels of significant human exposure. If adequate information is not available, ATSDR, in cooperation with the National Toxicology Program (NTP), is required to ensure the initiation of a program of research to provide such information. 

The Office of Environmental Health Hazard Assessment (OEHHA) has developed a PBPK (physiologically based pharmacokinetic) model describing the relationship between airborne lead and blood levels in workers and released it in October 2013. The model was developed at the request of the California Department of Public Health (CDPH) and is being used to understand workplace exposures.

NTP Information Cited
The chemical form of inhaled lead affects its solubility and therefore influences its absorption from the respiratory tract and gut. Some lead forms (e.g., lead acetate, lead chloride) are soluble in water; other forms (e.g., lead sulfide) are much less soluble (NTP 2011).

NTP (2011) ‘Lead and lead compounds Report on Carcinogens’, Twelfth Edition, National Toxicology program, department of health and human services http://ntp.niehs.nih.gov/go/roc12

This action supplements our proposed amendments to the national emission standards for hazardous air pollutants (NESHAP) for the Primary Aluminum Production source category published in the Federal Register on December 6, 2011. In that action, the Environmental Protection Agency (EPA) proposed amendments based on the initial residual risk and technology reviews (RTR) for this source category, and also proposed certain emission limits reflecting performance of Maximum Achievable Control Technology (MACT). Today’s action reflects a revised technology review and a revised residual risk analysis for the Primary Aluminum Production source category and proposes new and revised emission standards based on those analyses, newly obtained emissions test data, and comments we received in response to the 2011 proposal, including certain revisions to the technology-based standards reflecting performance of MACT. This action also proposes new compliance requirements to meet the revised standards. This action, if adopted, will provide improved environmental protection regarding potential emissions of hazardous air pollutant (HAP) emissions from primary aluminum production facilities.

NTP Information Cited
National Toxicology Program (NTP), 2011. Report on Carcinogens. 12th ed. Research Triangle Park, NC: US Department of Health and Human Services (DHHS), Public Health Service. Available online at http://ntp.niehs.nih.gov/ntp/roc/twelfth/roc12.pdf

Based on consistent views of major scientific bodies (i.e., National Toxicology Program (NTP) in their 12^th Report of the Carcinogens (ROC), 7 International Agency for Research on Cancer (IARC) 8 and other international agencies) 9 that consider all Ni compounds to be carcinogenic, we currently consider all Ni compounds to have the potential of being carcinogenic to humans. The 12th Report of the Carcinogens states that the ‘‘combined results of epidemiological studies, mechanistic studies, and carcinogenic studies in rodents support the concept that Ni compounds generate Ni ions in target cells at sites critical for carcinogenesis, thus allowing consideration and evaluation of these compounds as a single group.’’  Although the precise Ni compound (or compounds) responsible for the= carcinogenic effects in humans is not always clear, studies indicate that Ni sulfate and the combinations of Ni sulfides and oxides encountered in the Ni refining industries cause cancer in humans (these studies are summarized in a review by Grimsrud et al., 2010 10). The major scientific bodies mentioned above have also recognized that there are differences in toxicity and/or carcinogenic potential across the different Ni compounds.

In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension with no revision of a currently approved information collection, Qualified Products Lists for Fire Chemicals for Wild Land Fire Management.

NTP Information Cited

SUPPLEMENTARY INFORMATION:

Title: Qualified Products Lists for Fire Chemicals for Wild Land Fire Management. OMB Number: 0596–0182. Expiration Date of Approval: January 31, 2015. Type of Request: Extension with no revision.

• National Toxicology Program (NTP) ‘‘Annual Report on Carcinogens’’.

In order to clarify the scope of the listing, OEHHA is referring diaminotoluene (mixed) to the CIC for a determination as to whether the chemical should continue to be included on the list of chemicals known to the state to cause cancer pursuant to Title 27, Cal. Code of Regs., section 25306 (j).

NTP Information Cited

Under the Safe Drinking Water and Toxic Enforcement Act of 1986 [Health and Safety Code Section 25249.8(b)], one of the ways a chemical is known to the State to cause cancer or reproductive toxicity is if a body considered to be authoritative by the Scientific Advisory Panel has formally identified it as causing cancer or reproductive toxicity. The Health and Welfare Agency has adopted a regulation to guide this part of the implementation of the Act  (Title 22, California Code of Regulations, Section 12306).  The Panel has identified the U.S. Environmental Protection Agency (EPA), the International Agency for Research on Cancer (ARC), and the National Toxicology Program (NTP) as authoritative bodies, National Toxicology Program, NTP Technical Report on the Toxicology and Carcinogenesis Studies of Two Pentachlorophenol Technical-Grade Mixtures in B6C3Fl Mice, NTP TR 349, NIH Publication No. 89•2804,  March, 1989.

This action supplements our proposed amendments to the national emission standards for hazardous air pollutants (NESHAP) for the Ferroalloys Production source category published in the Federal Register on November 23, 2011. In that action, the Environmental Protection Agency (EPA) proposed amendments based on the initial technology and residual risk reviews for this source category. Today’s action presents a revised technology review and a revised residual risk review for the Ferroalloys Production source category and proposes revisions to the standards based on those reviews. This action also proposes new compliance requirements to meet the revised standards. This action would result in significant environmental improvements through the reduction of fugitive manganese emissions and through more stringent emission limits for several processes.

NTP Information Cited

Based on consistent views of major scientific bodies (i.e., National Toxicology Program (NTP) in their 12th Report of the Carcinogens (ROC) 11, International Agency for Research on Cancer (IARC) 12 and other international agencies) 13 that consider all nickel compounds to be carcinogenic, we currently consider all nickel compounds to have the potential of being carcinogenic to humans.

The Office of Environmental Health Hazard Assessment (OEHHA) is releasing for public review a draft document on the toxicity and derivation of Reference Exposure Levels (RELs) for Carbonyl Sulfide (COS).

NTP Information Cited
The National Toxicology Program (NTP) studied 4 strains of mutant Salmonella (TA97, TA98, TA100, and TA1535) in the Ames test and used from 0.58 to 2.89 µg COS per test plate with and without induced liver extract from rats or hamsters. They reported a weakly positive response based on positive results in one strain (TA97) (NTP, 1995).

NTP. (1995). Genetic Toxicology - Bacterial Mutagenicity. NTP Study ID: A35125.  CEBS Accession Number: 002-01834-0001-0000-9 from http://tools.niehs.nih.gov/cebs3/ntpViews/?studyNumber=A35125.

OSHA is reviewing its overall approach to managing chemical exposures in the workplace and seeks stakeholder input about more effective and efficient approaches that addresses challenges found with the current regulatory approach. This review involves considering issues related to updating permissible exposure limits (PELs), as well as examining other strategies that could be implemented to address workplace conditions where workers are exposed to chemicals. The notice details the role of past court decisions on the Agency’s current approach to chemical management for the purpose of informing stakeholders of the legal framework in which the Agency must operate. It then describes possible modifications of existing processes, along with potential new sources of data and alternative approaches the Agency may consider. The Agency is particularly interested in information about how it may take advantage of newer approaches, given its legal requirements. This RFI is concerned primarily with chemicals that cause adverse health effects from long-term occupational exposure, and is not related to activities being conducted under Executive Order 13650, Improving Chemical Facility Safety and Security.

NTP Information Cited

Question IV.A.3: OSHA is considering greater reliance on peer-reviewed toxicological evaluations by other Federal agencies, such as NIOSH, EPA, ATSDR, NIEHS and NTP for hazard identification and dose-response analysis in the observed range. What advantages and disadvantages would result from this approach and could it be used in support of the PEL update process?

4. Use of Systems Biology and Other Emerging Test Data in Risk Assessment Toxicity testing is undergoing transformation from an approach primarily based on pathological outcomes in experimental animal studies to a more predictive paradigm that characterizes critical molecular/cellular perturbations in toxicity pathways using in vitro test systems.  The paradigm shift is being largely driven by the technological advances in molecular systems biology such as the use of high throughput screening (HTS) assays, new computational methods to predict chemical properties, and computer models able to associate molecular events with a biological response. The vision, strategies, and frameworks for applying the new toxicity data to risk-based decision making are laid out in landmark reports by the National Research Council (NRC, 2009; Ex. #24, NRC, 2007; Ex. #25). A collaborative Federal initiative known as ‘‘Tox21’’ has been established between the National Toxicology Program (NTP), the EPA Office of Research and Development, the NIH

Chemical Genomics Center (NCGC), and the Food and Drug Administration (FDA) to collaborate on development, validation, and translation of innovative HTS methods to characterize key steps in toxicity pathways (NTP, 2013; Ex. #40). Tox21 has already screened over a 1000 compounds in more than 50 quantitative HTS assays that have been made available to the scientific community through publically accessible databases (e.g., EPA ACToR, NTP CEBS). EPA has launched a program, known as ‘‘NexGen’’, to implement the NRC vision and advance the next generation of risk assessment (EPA, 2013b; Ex. #41). NexGen is a partnership among EPA, NTP, NCGC, AND FDA, along with ATSDR and California’s EPA Office of Environmental Health Hazard Assessment. The objectives of NexGen are to pilot the new NRC risk assessment framework, refine existing bioinformatics systems, and develop specific prototype health risk assessments. These objectives are expected to be achieved through an iterative development process that includes discussion with scientists, risk managers, and stakeholders

#40: National Toxicology Program (NTP). (2013). High Throughput Screening

Initiative. Retrieved from: http://ntp.niehs.nih.gov/go/28213.

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by removing the general safety test (GST) requirements for biological products. FDA is proposing this action because the existing codified GST regulations are duplicative of requirements that are also specified in biologics licenses, or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation, in response to an Executive order.

NTP Information Cited
Furthermore, we anticipate that the proposal to eliminate the codified GST regulations would encourage the implementation of the principles of the ‘‘3Rs,’’ to reduce, refine, and replace animal use in testing, thus addressing the need to minimize the use of animals in such testing and promoting more humane, appropriate, and specific test methods for assuring the safety of biological products.

Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Authorization Act of 2000 (42 U.S.C. 2851–3). Additional information on the Federal Government’s implementation of the principles of the 3Rs may be found at the ICCVAM Web site at http://ntp.niehs.nih.gov/go/iccvam.

This document proposes to establishes an exemption from the requirement of a tolerance for residues of various fragrance component substances (when used as inert ingredients) in antimicrobial pesticide formulations for use on food contact surfaces in public eating places, dairy processing equipment, and food processing equipment and utensils

NTP Information Cited
The derivation of TTC human exposure threshold values for non-cancer endpoints is based on an extensive reference database compiled by Munro, (Ref. 1) which included data on chronic, subchronic, reproductive and developmental toxicity studies primarily derived from the reports of the US National Toxicology Program (NTP), the toxicological monographs of JECFA, the EPA Integrated Risk Information System (IRIS), and the Developmental and Reproductive Toxicology (DART) database compiled by the US National Library of Medicine. These sources were considered to contain well-validated toxicological data for well-defined chemical structures, covering pesticides, food additives, industrial and other types of chemicals. Only studies using the oral route of administration (gavage, diet, drinking water, or capsule) were included. In all, the reference database contained 2941 no-observed-adverse-effect levels (NOAELs) from studies conducted on 613 substances, and from these the most conservative (lowest) NOAEL for each substance was entered on the published database. The NOAELs in the reference database were those selected by the original authors of each study, apart from the studies in the IRIS database, for which the NOAELs were selected by the EPA. Munro commented that some authors were highly conservative in their selection of a NOAEL, but such NOAELs were still used for the database to maintain a conservative approach. Munro also stated that, in the calculation of the TTC values, NOAELs from subchronic studies were divided by a factor of 3 to approximate the NOAELs that are likely to be derived from a chronic study.

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list the chemical ethylene glycol (EG) as known to the state to cause reproductive toxicity (developmental endpoint) under the Safe Drinking Water and Toxic Enforcement Act of 1986. This action is being proposed under the authoritative bodies listing mechanism

NTP Information Cited
NTP-CERHR (2004). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Ethylene Glycol. Research Triangle Park, NC, National Toxicology Program, Center for the Evaluation of Risks to Human Reproduction: NIH Publication No. 04 – 4481.
107-21-1

The Office of Environmental Health Hazard Assessment (OEHHA) is adopting new and revised Reference Exposure Levels (RELs) for benzene.

NTP Information Cited
The National Toxicology Program (NTP, 1986) conducted a chronic (2 year) toxicity
“bioassay” in F344 rats and B6C3F1 mice of benzene by gavage in corn oil. Doses
were 0, 25, 50, and 100 mg/kg-day for females and 0, 50, 100, and 200 mg/kg-day for males. Dose-related lymphocytopenia and leukocytopenia were observed in both
species in all dosed groups. Mice exhibited lymphoid depletion of the thymus and
spleen and hyperplasia of the bone marrow.

Effective May 2, 2014, the Office of Environmental Health Hazard Assessment (OEHHA) is adding N,N-dimethyl-p-toluidine to the list of chemicals known to the State to cause cancer for purposes of Proposition 65.

NTP Information Cited
NTP (2012). National Toxicology Program. Toxicology and Carcinogenesis Studies of N,N-Dimethyl-p-Toluidine (CAS No. 99-97-8) in F344/N Rats and B6C3F1/N Mice (Gavage Studies). Technical Report Series No. 579. NIH Publication No. 12-5921. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.

This action establishes more stringent vehicle emissions standards and will reduce the sulfur content of gasoline beginning in 2017, as part of a systems approach to addressing the impacts of motor vehicles and fuels on air quality and public health. The gasoline sulfur standard will make emission control systems more effective for both existing and new vehicles, and will enable more stringent vehicle emissions standards. The vehicle standards will reduce both tailpipe and evaporative emissions from passenger cars, light-duty trucks, medium-duty passenger vehicles, and some heavy-duty vehicles. This will result in significant reductions in pollutants such as ozone, particulate matter, and air toxics across the country and help state and local agencies in their efforts to attain and maintain health-based National Ambient Air Quality Standards. Motor vehicles are an important source of exposure to air pollution both regionally and near roads. These vehicle standards are intended to harmonize with California's Low Emission Vehicle program, thus creating a federal vehicle emissions program that will allow automakers to sell the same vehicles in all 50 states. The vehicle standards will be implemented over the same timeframe as the greenhouse gas/fuel efficiency standards for light-duty vehicles (promulgated by EPA and the National Highway Safety Administration in 2012), as part of a comprehensive approach toward regulating emissions from motor vehicles.

NTP Information Cited
In the National Toxicology Program’s Report on Carcinogens (ROC), the following compounds have been listed as: a) known carcinogens to humans: benzene, 1,3-butadiene, formaldehyde; b) possibly carcinogenic to humans: acetaldehyde; or c) reasonably anticipated to be a human carcinogen: naphthalene.

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list the chemical ethylene glycol (EG) as known to the state to cause reproductive toxicity (developmental endpoint) under the Safe Drinking Water and Toxic Enforcement Act of 1986.1 This action is being proposed under the authoritative bodies listing mechanism.

NTP Information Cited
NTP-CERHR (2004). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Ethylene Glycol. Research Triangle Park, NC, National Toxicology Program, Center for the Evaluation of Risks to Human Reproduction: NIH Publication No. 04 – 4481.

This regulation establishes tolerances for residues of diflubenzuron (N-[[(4-chlorophenyl)amino]carbonyl]-2,6-difluorobenzimide) in or on fruit, citrus, group 10-10 and citrus, oil. Chemtura Corporation, requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

NTP Information Cited
para-chloroaniline hydrochloride (PCA), a plant metabolite of diflubenzuron, tested positive for splenic tumors in male rats and hepatocellular adenomas/carcinomas in male mice. TR-351, 1989).

The Food and Drug Administration (FDA) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, we are proposing to establish conditions under which OTC consumer antiseptic products intended for use with water (referred to throughout as consumer antiseptic washes) are generally recognized as safe and effective. In the 1994 TFM, certain antiseptic active ingredients were proposed as being safe for antiseptic handwash use by consumers based on safety data evaluated by FDA as part of our ongoing review of OTC antiseptic drug products. However, in light of more recent scientific developments and changes in the use patterns of these products we are now proposing that additional safety data are necessary to support the safety of antiseptic active ingredients for this use. We also are proposing that all consumer antiseptic wash active ingredients have data that demonstrate a clinical benefit from the use of these consumer antiseptic wash products compared to nonantibacterial soap and water.

NTP Information Cited
Toxicology and Carcinogenesis Studies of 4-Hexylresorcinol (CAS No. 136-77-6) in F344/N Rats and B6C3F1 Mice (Gavage Studies).  Under the conditions of these 2-year gavage studies, there was no evidence of carcinogenic activity of 4-hexylresorcinol for male or female F344/N rats.  There was equivocal evidence of carcinogenic activity of 4-hexylresorcinol for male B6C3F1 mice.  There was no evidence of carcinogenic activity for female B6C3F1 mice.  (TR-330, 1988).

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the expanded safe use of acacia (gum arabic) in foods. This action is in response to a petition filed by Nexira.

NTP Information Cited
Carcinogenesis Bioassay of Gum Arabic (CAS No. 9000-01-5) in F344 Rats and B6C3F1 Mice (Feed Study). Under the conditions of this bioassay, gum arabic was not carcinogenic for F344 rats or B6C3F1 mice of either sex.  (TR-227, 1982).

EPA is adding ortho-nitrotoluene (o-nitrotoluene) to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and section 6607 of the Pollution Prevention Act (PPA) of 1990. o-Nitrotoluene has been classified by the National Toxicology Program in its 12th Report on Carcinogens as “reasonably anticipated to be a human carcinogen.” EPA has determined that o-nitrotoluene meets the EPCRA section 313(d)(2)(B) criteria because it can reasonably be anticipated to cause cancer in humans.

NTP Information Cited
National Toxicology Program Report on Carcinogens (ROC):  ortho-nitrotoluene reasonably anticipated to be a human carcinogen.

On May 2, 2013, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 002) requesting the addition of prostate cancer to the List of WTC-Related Health Conditions (List) covered in the WTC Health Program. In this final rule, the Administrator adds malignant neoplasm of the prostate (prostate cancer) to the List in the WTC Health Program regulations.

NTP Information Cited
National Toxicology Program Report on Carcinogens (ROC).  Various methods of evaluation were established to determine if cancers or types of cancer are added to the World Trade Center-related health conditions.  One method is to evaluate findings of the 9/11 exposure with the National Toxicology Program’s categorization as a known or reasonably anticipated human carcinogen.

The Occupational Safety and Health Administration (OSHA) proposes to amend its existing standards for occupational exposure to respirable crystalline silica. The basis for issuance of this proposal is a preliminary determination by the Assistant Secretary of Labor for Occupational Safety and Health that employees exposed to respirable crystalline silica face a significant risk to their health at the current permissible exposure limits and that promulgating these proposed standards will substantially reduce that risk. This document proposes a new permissible exposure limit, calculated as an 8-hour time-weighted average, of 50 micrograms of respirable crystalline silica per cubic meter of air (50 μg/m3). OSHA also proposes other ancillary provisions for employee protection such as preferred methods for controlling exposure, respiratory protection, medical surveillance, hazard communication, and recordkeeping. OSHA is proposing two separate regulatory texts—one for general industry and maritime, and the other for construction—in order to tailor requirements to the circumstances found in these sectors.

NTP Information Cited
National Toxicology Program Report on Carcinogens (ROC):  Silica crystalline (respirable size) is known to be a human carcinogen.

On May 2, 2013, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 002) requesting the addition of prostate cancer to the List of WTC-Related Health Conditions (List) covered in the WTC Health Program. The Administrator has determined to publish a proposed rule adding malignant neoplasm of the prostate (prostate cancer) to the List in the WTC Health Program regulations.

NTP Information Cited
National Toxicology Program Report on Carcinogens (ROC):  arsenic and cadmium are known to be a human carcinogen.

EPA is proposing new requirements under the Formaldehyde Standards for Composite Wood Products Act, or Title VI of the Toxic Substances Control Act (TSCA). These proposed requirements are designed to implement the statutory formaldehyde emission standards for hardwood plywood, medium-density fiberboard, and particle board sold, supplied, offered for sale, or manufactured (including imported) in the United States. As directed by the statute, this proposal includes provisions relating to, among other things, laminated products, products made with no-added formaldehyde resins or ultra low-emitting formaldehyde resins, testing requirements, product labeling, chain of custody documentation and other recordkeeping requirements, enforcement, and product inventory sell-through provisions, including a product stockpiling prohibition. The composite wood product formaldehyde emission standards contained in TSCA Title VI are identical to the emission standards currently in place in California. This regulatory proposal implements these emissions standards and is designed to ensure compliance with the TSCA Title VI formaldehyde emission standards while aligning, where practical, with the regulatory requirements in California.

NTP Information Cited
National Toxicology Program Report on Carcinogens (ROC):  formaldehyde is known to be a human carcinogen.

The Formaldehyde Standards for Composite Wood Products Act (Title VI of the Toxic Substances Control Act (TSCA)) establishes formaldehyde emission standards for hardwood plywood, particle board, and medium-density fiberboard (composite wood products) and directs EPA to promulgate implementing regulations by January 1, 2013. Pursuant to the requirements of TSCA Title VI, EPA is proposing a framework for a TSCA Title VI Third-Party Certification Program for composite wood products. Under the framework, third-party certifiers (TPCs) would be accredited by EPA-recognized accreditation bodies (ABs) so that TPCs may certify composite wood product panel producers under TSCA Title VI. This proposed rule identifies the roles and responsibilities of the TPCs and ABs involved, as well as the criteria for participation in the TSCA Title VI Third-Party Certification Program. The Agency is proposing the TSCA Title VI Third-Party Certification Program framework prior to the rest of the TSCA Title VI implementing regulations in order to allow interested parties an opportunity to comment and to begin identifying the business practices and infrastructure that may need to be modified or developed in order to effectively participate in the program.

NTP Information Cited
National Toxicology Program Report on Carcinogens (ROC):  formaldehyde is known to be a human carcinogen.

This regulation establishes an exemption from the requirement of a tolerance for residues of guar hydroxy­propyl­tri­methyl­ammonium chloride (CAS Reg. No. 71329-50-5) when used as an inert ingredient (thickener/drift reduction agent) in pesticide formulations applied to growing crops. SciReg. Inc., on behalf of Rhodia Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of guar hydroxypropyltrimethylammonium chloride.

NTP Information Cited
The National Toxicology Program conducted carcinogenicity studies in mice and rats.  No adverse effects were observed at doses up to 3,570 mg/kg/day. (TR-229).

This action would establish more stringent vehicle emissions standards and reduce the sulfur content of gasoline beginning in 2017, as part of a systems approach to addressing the impacts of motor vehicles and fuels on air quality and public health. The proposed gasoline sulfur standard would make emission control systems more effective for both existing and new vehicles, and would enable more stringent vehicle emissions standards. The proposed vehicle standards would reduce both tailpipe and evaporative emissions from passenger cars, light-duty trucks, medium-duty passenger vehicles, and some heavy-duty vehicles. This would result in significant reductions in pollutants such as ozone, particulate matter, and air toxics across the country and help state and local agencies in their efforts to attain and maintain health-based National Ambient Air Quality Standards. Motor vehicles are an important source of exposure to air pollution both regionally and near roads. These proposed vehicle standards are intended to harmonize with California's Low Emission Vehicle program, thus creating a federal vehicle emissions program that would allow automakers to sell the same vehicles in all 50 states. The proposed vehicle standards would be implemented over the same timeframe as the greenhouse gas/fuel efficiency standards for light-duty vehicles, as part of a comprehensive approach toward regulating emissions from motor vehicles.

NTP Information Cited
National Toxicology Program Report on Carcinogens (ROC): acetaldehyde and naphthalene are reasonably anticipated to be human carcinogens; benzene, 1,3-butadiene and formaldehyde are known human carcinogens.

Effective April 19, 2013, the Office of Environmental Health Hazard Assessment (OEHHA) is removing bisphenol A (BPA) (CAS No. 80-05-7) from the list of chemicals known to the State to cause cancer or reproductive toxicity for purposes of Proposition 65.1 The chemical was added to the list on April 11, 2013 based on reproductive endpoints (developmental toxicity).

NTP Information Cited
NTP-CERHR (2008). NTP-CERHR Monograph on the Potential Human Reproductive And Developmental Effects of Bisphenol A. Research Triangle Park, NC, National Toxicology Program: NIH Publication No. 08 – 5994.

NTP (1985) Bisphenol A: reproduction and fertility assessment in CD-1 mice when administered in the feed. NTP-85-192. Re­search Triangle Park, NC.

On September 12, 2012, HHS published a final rule in the Federal Register adding certain types of cancer to the List of World Trade Center (WTC)-Related Health Conditions (List) established in the WTC Health Program regulation. Breast cancer was included on the List, although only individuals experiencing nighttime sleep disruption as a result of response and cleanup activities involving shiftwork are currently considered to have experienced exposure relevant for certification. A recent publication in The Lancet Oncology by the International Agency for Research on Cancer (IARC) concludes that there is limited evidence that polychlorinated biphenyls (PCBs) cause breast cancer in humans. As described below, the WTC Program Administrator (Administrator) has found that PCBs were present in WTC dust in the New York City disaster area and, accordingly, the Program will now certify breast cancer in eligible WTC responders and survivors who were exposed to either shiftwork/nighttime sleep disruption or PCBs as a result of the 9/11 attacks.

NTP Information Cited
National Toxicology Program Report on Carcinogens (ROC):  Polychlorinated biphenyls are reasonably anticipated to be a human carcinogen.

EPA is proposing to add ortho-nitrotoluene (o-nitrotoluene) to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and section 6607 of the Pollution Prevention Act (PPA) of 1990. o-Nitrotoluene has been classified by the National Toxicology Program in their 12th Report on Carcinogens as “reasonably anticipated to be a human carcinogen.” EPA believes that o-nitrotoluene meets the EPCRA section 313(d)(2)(B) criteria because it can reasonably be anticipated to cause cancer in humans. Based on a review of the available production and use information, o-nitrotoluene is expected to be manufactured, processed, or otherwise used in quantities that would exceed the EPCRA section 313 reporting thresholds.

NTP Information Cited

National Toxicology Program Report on Carcinogens (ROC): o-Nitrotoluene is reasonably anticipated to be a human carcinogen.

EPA and NHTSA, on behalf of the Department of Transportation, are issuing final rules to further reduce greenhouse gas emissions and improve fuel economy for light-duty vehicles for model years 2017 and beyond. On May 21, 2010, President Obama issued a Presidential Memorandum requesting that NHTSA and EPA develop through notice and comment rulemaking a coordinated National Program to improve fuel economy and reduce greenhouse gas emissions of light-duty vehicles for model years 2017-2025, building on the success of the first phase of the National Program for these vehicles for model years 2012-2016. This final rule, consistent with the President's request, responds to the country's critical need to address global climate change and to reduce oil consumption. NHTSA is finalizing Corporate Average Fuel Economy standards for model years 2017-2021 and issuing augural standards for model years 2022-2025 under the Energy Policy and Conservation Act, as amended by the Energy Independence and Security Act. NHTSA will set final standards for model years 2022-2025 in a future rulemaking. EPA is finalizing greenhouse gas emissions standards for model years 2017-2025 under the Clean Air Act. These standards apply to passenger cars, light-duty trucks, and medium-duty passenger vehicles, and represent the continuation of a harmonized and consistent National Program. Under the National Program automobile manufacturers will be able to continue building a single light-duty national fleet that satisfies all requirements under both programs while ensuring that consumers still have a full range of vehicle choices that are available today. EPA is also finalizing minor changes to the regulations applicable to model years 2012-2016, with respect to air conditioner performance, nitrous oxides measurement, off-cycle technology credits, and police and emergency vehicles.

NTP Information Cited
National Toxicology Program Report on Carcinogens (ROC): acetaldehyde and naphthalene are reasonably anticipated to be human carcinogens; benzene, 1,3-butadiene and formaldehyde are known human carcinogens.

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program. The WTC Health Program, which is administered by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), provides medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors of the New York City attacks. In accordance with WTC Health Program regulations, which establish procedures for adding a new condition to the list of covered health conditions, this final rule adds to the List of WTC-Related Health Conditions the types of cancer proposed for inclusion by the notice of proposed rulemaking.

NTP Information Cited
Five main sources, including the National Toxicology Program, were used to evaluate whether to add cancers to the WTC-Related Health Conditions list. One of several methods used to identify cancers employed the list of known human carcinogens and those agents reasonably anticipated to be carcinogenic in humans (ROC).

Effective July 24, 2012, the Office of Environmental Health Hazard Assessment (OEHHA) is adding two chemicals, isopyrazam (CAS No. 881685-58-1) and 3,3’,4,4’‑tetrachloroazobenzene (CAS No. 14047-09-7), to the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (commonly known as Proposition 651)

NTP Information Cited
NTP (2010). National Toxicology Program. Toxicology and Carcinogenesis Studies of 3,3',4,4'-Tetrachloroazobenzene (TCAB) (CAS No. 14047-09-7) in Harlan Sprague-Dawley Rats and B6C3F1 Mice (Gavage Studies).  Technical Report Series No. 558. NIH Publication No. 11-5899. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.

The Consumer Product Safety Commission (CPSC or Commission) proposes to codify its statement of policy on animal testing, as amended, which was previously published in the Federal Register. The amended statement of policy on animal testing is intended for manufacturers of products subject to the Federal Hazardous Substances Act (FHSA) to find alternatives to animal testing and reduce the number of animal tests under the FHSA.

NTP Information Cited
According to the ICCVAM Authorization Act, ICCVAM member agencies should promote and encourage the development and use of alternatives to animal test methods for regulatory purposes. Since the establishment of ICCVAM, the CPSC has approved, where applicable, recommendations made by ICCVAM to reduce and refine animal testing applicable to test methods under the FHSA. The CPSC is amending and updating regulations under the FHSA to make the ICCVAM recommendations and the CPSC animal testing policy more accessible and transparent to interested parties. CPSC will also create a page on its website regarding ICCVAM recommendations and new developments in test methods that further reduce or refine animal testing. (ICCVAM)

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program. The WTC Health Program, which is administered by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), provides medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors of the New York City attacks. In accordance with our regulations, which establish procedures for adding a new condition to the list of health conditions covered by the WTC Health Program, this proposed rule would add certain types of cancer to the List of WTC-Related Health Conditions.

NTP Information Cited
NTP’s Report on Carcinogens states arsenic and vinyl chloride as known carcinogens (ROC).

The Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) transmitted its 69th Report to the EPA Administrator on April 5, 2012. In the 69th ITC Report, which is included with this notice, the ITC is adding a category of cadmium compounds including any chemical that contains cadmium as part of that chemical's structure, 6 non-phthalate plasticizers, 25 phosphate ester flame retardants, 2 other flame retardants, 9 chemicals to which children living near hazardous waste sites may be exposed, and a category of 69 diisocyanates and related compounds (including 14 Action Plan chemicals and 55 related compounds) to the TSCA Priority Testing List. In addition, the ITC is removing 103 cadmium compounds and 14 High Production Volume (HPV) Challenge Program orphan chemicals from the Priority Testing List during this reporting period (June to November 2011). The ITC is adding the category of cadmium compounds and removing 103 cadmium compounds to provide a more comprehensive approach to assessing cadmium compounds' safety.

NTP Information Cited
NTP is testing (tris(chloropropyl)phosphate) (mixture of isomers).

The U.S. Environmental Protection Agency (EPA) is announcing the IRIS 2012 agenda and requesting scientific information on health effects that may result from exposure to the chemical substances on the agenda, including assessments that EPA is starting this year.

NTP Information Cited
(Draft Monograph on Health Effects of Low-Level Lead)

The Food and Drug Administration (FDA) is establishing a list of harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke (the established HPHC list) as required by the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

NTP Information Cited
For establishing the list of harmful and potentially harmful constituents in tobacco products and smoke, part of the criteria used were constituents identified by the National Toxicology Program as known or probable human carcinogens.

Under the Toxic Substances Control Act (TSCA), EPA is proposing: To add nine benzidine-based chemical substances to the Significant New Use Rule (SNUR) on benzidine-based chemical substances; a SNUR for di-n-pentyl phthalate (DnPP) (1,2-benzene­di­carboxylic acid, 1,2-dipentyl ester) (CAS No. 131-18-0); and a SNUR for alkanes, C12–13, chloro (CAS No. 71011-12-6). In the case of the benzidine-based chemical substances, EPA is also proposing to make inapplicable the exemption relating to persons that import or process substances as part of an article. If finalized, this rule would require persons who intend to manufacture, import, or process these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate activities associated with a significant new use and an opportunity to protect against potential unreasonable risks, if any, from exposure to the chemical substance.

NTP Information Cited
Benzidine-based dyes are metabolized to its parent molecule, which is a known carcinogen (ROC). Exposure to phthalates in animal studies caused a decreased development of the reproductive system. A study of Di-n-pentyl phthalate showed a decrease in the number of litters from fertile pairs, decreased number of live pups, and decreased fertility and reproduction

In this final rule, OSHA is modifying its Hazard Communication Standard (HCS) to conform to the United Nations' Globally Harmonized System of Classification and Labelling of Chemicals (GHS). OSHA has determined that the modifications will significantly reduce costs and burdens while also improving the quality and consistency of information provided to employers and employees regarding chemical hazards and associated protective measures. Consistent with the requirements of Executive Order 13563, which calls for assessment and, where appropriate, modification and improvement of existing rules, the Agency has concluded this improved information will enhance the effectiveness of the HCS in ensuring that employees are apprised of the chemical hazards to which they may be exposed, and in reducing the incidence of chemical-related occupational illnesses and injuries. The modifications to the standard include revised criteria for classification of chemical hazards; revised labeling provisions that include requirements for use of standardized signal words, pictograms, hazard statements, and precautionary statements; a specified format for safety data sheets; and related revisions to definitions of terms used in the standard, and requirements for employee training on labels and safety data sheets. OSHA is also modifying provisions of other standards, including standards for flammable and combustible liquids, process safety management, and most substance-specific health standards, to ensure consistency with the modified HCS requirements. The consequences of these modifications will be to improve safety, to facilitate global harmonization of standards, and to produce hundreds of millions of dollars in annual savings.

NTP Information Cited
Used the classification listing that NTP uses on Safety Data Sheets; based classification to determine carcinogenicity on the National Toxicology Program’s Report on Carcinogens (ROC).

The Food and Drug Administration (FDA) is announcing the availability of a final recommendation for the revision of the permitted daily exposure (PDE) for the solvent cumene according to the maintenance procedures for the guidance for industry entitled “Q3C Impurities: Residual Solvents.” The recommendation was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

NTP Information Cited
NTP Work Cited: NTP 2-year rodent bioassay of cumene showed clear evidence of carcinogenicity (TR-452).

On May 3, 2011, under authority of Clean Air Act (CAA) sections 111 and 112, the EPA proposed both national emission standards for hazardous air pollutants (NESHAP) from coal- and oil-fired electric utility steam generating units (EGUs) and standards of performance for fossil-fuel-fired electric utility, industrial-commercial-institutional, and small industrial-commercial-institutional steam generating units (76 FR 24976). After consideration of public comments, the EPA is finalizing these rules in this action.

NTP Information Cited
NTP 2-year rodent bioassay of Ni sulfate hexahydrate (water soluble) showed no evidence of carcinogenicity (TR-454); NTP 2-year rodent bioassay of Ni subsulfide showed clear evidence of carcinogenicity (TR-453); NTP’s Report on Carcinogens states considering Ni compounds to be carcinogenic as a group (ROC).

With the issuance of this final rule, the Administrator of the Drug Enforcement Administration (DEA) places the substance carisoprodol, including its salts, isomers, and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible, into Schedule IV of the Controlled Substances Act (CSA). This action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing.

NTP Information Cited
DEA used NTP’s Toxicity studies of carisoprodol in rats and mice to support its placement of carisoprodol into Schedule IV of the Controlled Substances Act.

EPA and NHTSA, on behalf of the Department of Transportation, are issuing this joint proposal to further reduce greenhouse gas emissions and improve fuel economy for light-duty vehicles for model years 2017-2025. This proposal extends the National Program beyond the greenhouse gas and corporate average fuel economy standards set for model years 2012-2016. On May 21, 2010, President Obama issued a Presidential Memorandum requesting that NHTSA and EPA develop through notice and comment rulemaking a coordinated National Program to reduce greenhouse gas emissions of light-duty vehicles for model years 2017-2025. This proposal, consistent with the President's request, responds to the country's critical need to address global climate change and to reduce oil consumption. NHTSA is proposing Corporate Average Fuel Economy standards under the Energy Policy and Conservation Act, as amended by the Energy Independence and Security Act, and EPA is proposing greenhouse gas emissions standards under the Clean Air Act. These standards apply to passenger cars, light-duty trucks, and medium-duty passenger vehicles, and represent a continued harmonized and consistent National Program. Under the National Program for model years 2017-2025, automobile manufacturers would be able to continue building a single light-duty national fleet that satisfies all requirements under both programs while ensuring that consumers still have a full range of vehicle choices. EPA is also proposing a minor change to the regulations applicable to MY 2012-2016, with respect to air conditioner performance and measurement of nitrous oxides.

NTP Information Cited
Components of greenhouse gas emissions of light-duty vehicles (benzene, 1,3-butadiene, acetaldehyde, and naphthalene) were cited in the National Toxicology Program’s Report on Carcinogens (ROC). The following compounds have been listed as: a) known carcinogens to humans: Benzene, 1,3-Butadiene; b) possibly carcinogenic to humans; acetaldehyde; or c) reasonably anticipated to be a human carcinogen: naphthalene.

The EPA is proposing amendments to the national emissions standards for hazardous air pollutants for Ferroalloys Production to address the results of the residual risk and technology review that the EPA is required to conduct under the Clean Air Act. These proposed amendments include revisions to particulate matter standards for electric arc furnaces, metal oxygen refining processes, and crushing and screening operations. The amendments also add emission limits for hydrochloric acid, mercury, polycyclic aromatic hydrocarbons, and formaldehyde from electric arc furnaces. Furthermore, the amendments expand and revise the requirements to control fugitive emissions from furnace operations and casting. Other proposed requirements related to testing, monitoring, notification, recordkeeping, and reporting are included. We are also proposing to revise provisions addressing periods of startup, shutdown, and malfunction to ensure that the rules are consistent with a recent court decision.

NTP Information Cited
NTP Work Cited: EPA cited the National Toxicology Program’s Report on Carcinogens (ROC), which states that nickel compounds are known human carcinogens.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS) announces a public meeting to review its approach to classifying carcinogens and establishing recommended exposure limits (RELs) for occupational exposures to hazards associated with cancer. NIOSH requested initial input on these issues (including answers to five questions listed below under SUPPLEMENTARY INFORMATION), to be submitted to NIOSH Docket number 240.

NTP Information Cited
In contrast to the current NIOSH Carcinogen Policy, the National Toxicology Program allows for a more differential classification.

EPA is promulgating this final rule under section 4(a)(1)(B) of the Toxic Substances Control Act (TSCA) to require manufacturers, importers, and processors to conduct testing to obtain screening level data for health and environmental effects and chemical fate for 15 high production volume (HPV) chemical substances listed in this final rule. This test data is needed in order to help EPA to determine whether these 15 HPV chemical substances pose a risk to human health and/or environmental safety. Based on comments received by EPA on the proposed rule for this final rule, EPA has determined that only 15 of the 29 HPV chemical substances proposed for testing meet the criteria for testing at this time.

NTP Information Cited
NTP Work Cited: National Toxicology Program’s Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) developed test method protocols for the uptake of neutral red as a test for cytotoxicity.

EPA is proposing to issue a test rule under Toxic Substances Control Act (TSCA) section 4(a)(1)(B) to require manufacturers and processors of 23 high production volume (HPV) chemical substances to develop screening-level health, environmental, and fate data based on the potential for substantial exposures of workers and consumers to these chemicals. EPA is also proposing to issue simultaneously a significant new use rule (SNUR) for another 22 HPV chemical substances under TSCA section 5(a)(2). The SNUR would require persons to file a significant new use notice (SNUN) with EPA prior to manufacturing, importing, or processing any of these chemical substances for use in a consumer product or for any use, or combination of uses, that is reasonably likely to expose 1,000 or more workers at a single corporate entity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. EPA is also soliciting comment on a number of issues with regard to both the test rule and the SNUR.

NTP Information Cited
NTP Work Cited: National Toxicology Program’s Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) developed test method protocols for the uptake of neutral red as a test for cytotoxicity. Standardized protocols are referenced.

In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension (without revision) of a currently approved information collection, Qualified Products List for Water Enhancers (Gels) for Wildland Firefighting.

NTP Information Cited
The Forest Service evaluates and approves commercial wildland firefighting chemicals. Products must not contain chemicals listed as a Chemical of Concern. To create their list, they include chemicals appearing in the National Toxicology Program’s Report on Carcinogens. (ROC)

In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension (with contact revision) of a currently approved information collection, Qualified Products List for Long-Term Retardant For Wildland Firefighting.

NTP Information Cited
The Forest Service evaluates and approves commercial wildland firefighting chemicals. Products must not contain chemicals listed as a Chemical of Concern. To create their list, they include chemicals appearing in the National Toxicology Program’s Report on Carcinogens. (ROC)

EPA and NHTSA, on behalf of the Department of Transportation, are each finalizing rules to establish a comprehensive Heavy-Duty National Program that will reduce greenhouse gas emissions and fuel consumption for on-road heavy-duty vehicles, responding to the President's directive on May 21, 2010, to take coordinated steps to produce a new generation of clean vehicles. NHTSA's final fuel consumption standards and EPA's final carbon dioxide (CO2) emissions standards are tailored to each of three regulatory categories of heavy-duty vehicles: Combination Tractors; Heavy-duty Pickup Trucks and Vans; and Vocational Vehicles. The rules include separate standards for the engines that power combination tractors and vocational vehicles. Certain rules are exclusive to the EPA program. These include EPA's final hydrofluorocarbon standards to control leakage from air conditioning systems in combination tractors, and pickup trucks and vans. These also include EPA's final nitrous oxide (N2O) and methane (CH4) emissions standards that apply to all heavy-duty engines, pickup trucks and vans. EPA's final greenhouse gas emission standards under the Clean Air Act will begin with model year 2014. NHTSA's final fuel consumption standards under the Energy Independence and Security Act of 2007 will be voluntary in model years 2014 and 2015, becoming mandatory with model year 2016 for most regulatory categories. Commercial trailers are not regulated in this phase of the Heavy-Duty National Program. The agencies estimate that the combined standards will reduce CO2 emissions by approximately 270 million metric tons and save 530 million barrels of oil over the life of vehicles sold during the 2014 through 2018 model years, providing over $7 billion in net societal benefits, and $49 billion in net societal benefits when private fuel savings are considered. EPA is also finalizing provisions allowing light-duty vehicle manufacturers to use CO2 credits to meet the light-duty vehicle N2O and CH4 standards, technical amendments to the fuel economy provisions for light-duty vehicles, and a technical amendment to the criteria pollutant emissions requirements for certain switch locomotives.

NTP Information Cited
In the National Toxicology Program’s Report on Carcinogens (ROC), the following compounds have been listed as: a) known carcinogens to humans: Benzene, 1,3-Butadiene; b) possibly carcinogenic to humans: acetaldehyde; or c) reasonably anticipated to be a human carcinogen: naphthalene.

EPA and NHTSA, on behalf of the Department of Transportation, are each finalizing rules to establish a comprehensive Heavy-Duty National Program that will reduce greenhouse gas emissions and fuel consumption for on-road heavy-duty vehicles, responding to the President's directive on May 21, 2010, to take coordinated steps to produce a new generation of clean vehicles. NHTSA's final fuel consumption standards and EPA's final carbon dioxide (CO2) emissions standards are tailored to each of three regulatory categories of heavy-duty vehicles: Combination Tractors; Heavy-duty Pickup Trucks and Vans; and Vocational Vehicles. The rules include separate standards for the engines that power combination tractors and vocational vehicles. Certain rules are exclusive to the EPA program. These include EPA's final hydrofluorocarbon standards to control leakage from air conditioning systems in combination tractors, and pickup trucks and vans. These also include EPA's final nitrous oxide (N2O) and methane (CH4) emissions standards that apply to all heavy-duty engines, pickup trucks and vans. EPA's final greenhouse gas emission standards under the Clean Air Act will begin with model year 2014. NHTSA's final fuel consumption standards under the Energy Independence and Security Act of 2007 will be voluntary in model years 2014 and 2015, becoming mandatory with model year 2016 for most regulatory categories. Commercial trailers are not regulated in this phase of the Heavy-Duty National Program. The agencies estimate that the combined standards will reduce CO2 emissions by approximately 270 million metric tons and save 530 million barrels of oil over the life of vehicles sold during the 2014 through 2018 model years, providing over $7 billion in net societal benefits, and $49 billion in net societal benefits when private fuel savings are considered. EPA is also finalizing provisions allowing light-duty vehicle manufacturers to use CO2 credits to meet the light-duty vehicle N2O and CH4 standards, technical amendments to the fuel economy provisions for light-duty vehicles, and a technical amendment to the criteria pollutant emissions requirements for certain switch locomotives.

NTP Information Cited
In the National Toxicology Program’s Report on Carcinogens (ROC), the following compounds have been listed as: a) known carcinogens to humans: Benzene, 1,3-Butadiene; b) possibly carcinogenic to humans: acetaldehyde; or c) reasonably anticipated to be a human carcinogen: naphthalene.

In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension (without revision) of a currently approved information collection, Qualified Products List for Class A Foams for Wildland Firefighting.

NTP Information Cited
The Forest Service evaluates and approves commercial wildland firefighting chemicals. Products must not contain chemicals listed as a Chemical of Concern. To create their list, they include chemicals appearing in the National Toxicology Program’s Report on Carcinogens. (ROC)

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) intends to review its approach to classifying carcinogens and establishing recommended exposure limits (RELs) for occupational exposures to hazards associated with cancer. As part of this effort, NIOSH is requesting initial input on these issues (including answers to the 5 questions in the following section), to be submitted to the NIOSH Docket number 240, for a comment period lasting through September 22, 2011. This information will be taken under consideration and used to inform NIOSH efforts to assess and document its carcinogen policy and REL policy regarding occupational hazards associated with cancer.

NTP Information Cited
The National Toxicology Program's carcinogen classification allows for a more differential categorization than NIOSH's definition.

The Food and Drug Administration (FDA) is requesting comments, including scientific and other information, concerning the harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke. This information will assist the Agency in establishing a list of HPHCs in tobacco products and tobacco smoke (the HPHC list).

NTP Information Cited
National Toxicology Program has identified constituents in tobacco products and tobacco smoke as human carcinogens or reasonably anticipated to be human carcinogens. (ROC)

This regulation establishes an exemption from the requirement of a tolerance for residues of carboxymethyl guar gum sodium salt (CAS Reg. No. 39346-76-4) and carboxy­methyl-hydroxy­propyl guar (CAS Reg. No. 68130-15-4); when used as an inert ingredient (thicker/drift reduction agent) in pesticide formulations applied to growing crops. SciReg Inc., on behalf of Rhodia Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of carboxymethyl guar gum sodium salt and carboxy­methyl-hydroxy­propyl guar.

NTP Information Cited
In carcinogenicity studies in mice and rats, no adverse effects were observed. (TR-229)

Bisphenol A (BPA) (Chemical Abstracts Service Registry Number (CASRN) 80-05-7), a high production volume (HPV) chemical, is a reproductive, developmental, and systemic toxicant in animal studies and is weakly estrogenic. EPA is providing this ANPRM to request comment on requiring toxicity testing to determine the potential for BPA to cause adverse effects, including endocrine-related effects, in environmental organisms at low concentrations. EPA is also seeking comment on requiring environmental testing consisting of sampling and monitoring for BPA in surface water, ground water, drinking water, soil, sediment, sludge, and landfill leachate in the vicinity of expected BPA releases to determine whether environmental organisms may currently be exposed to concentrations of BPA in the environment that are at or above levels of concern for adverse effects, including endocrine-related effects. This ANPRM is directed only toward the environmental presence and environmental effects of BPA. EPA is working with the Department of Health and Human Services (HHS) on potential human health issues, but is not considering any additional testing specifically in regard to human health issues at this time.

NTP Information Cited
BPA is a reproductive and developmental toxicant. Studies show reduced fetal or birth weight or growth early in life, effects on testis of male rats, possible decreased fertility in mice, altered estrous cycling in female rats, and reduced survival of fetuses. There are also reports of endocrine-related low-dose effects on puberty and neurological development. (Monograph on Bisphenol A)

PHMSA amends the Hazardous Materials Regulations by removing saccharin and its salts from the list of hazardous substances and reportable quantities. The Comprehensive Environmental Response, Compensation and Liability Act, requires PHMSA to list and regulate all hazardous substances designated by statute or by the U.S. Environmental Protection Agency (EPA). EPA recently removed saccharin and its salts from their list of hazardous substances through notice and comment rulemaking. This final rule simply harmonizes the lists to better enable shippers and carriers to identify the affected hazardous substances, comply with all applicable regulatory requirements, and make required notifications if the release of a hazardous substance occurs.

NTP Information Cited
Saccharin and its salts do not pose a present or potential risk of causing carcinogenic effects on humans. (ROC, Appendix B)

This regulation establishes an exemption from the requirement of a tolerance for residues of Diethylene Glycol MonoEthyl Ether (DEGEE) when used as an inert ingredient as a solvent, stabilizer and/or antifreeze within pesticide formulations/products, for preharvest use on growing crops and raw agricultural commodities, without limitation. Huntsman, Dow AgroSciences L.L.C., Nufarm Americas Inc., BASF, Stepan Company, Loveland Products Inc., and Rhodia Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of DEGEE on growing crops and raw agricultural commodities.

NTP Information Cited
Ethylene glycol, which is structurally similar to DEGEE, does not cause carcinogenicity in mice. (TR-413)

The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the-counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004).

NTP Information Cited
The Report on Carcinogens indicates that UVA and UVB radiation across the spectrum are known human carcinogens, but either UVA or UVB radiation alone is reasonably anticipated to be a human carcinogen. Cited in the National Toxicology Program’s Report on Carcinogens. (ROC)

This regulation establishes an exemption from the requirement of a tolerance for residues of ethylene glycol (CAS Reg. No. 107-21-1) when used as a pesticide inert ingredient as a solvent, stabilizer and/or antifreeze within pesticide formulations/products without limitation. Huntsman, et. al, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of ethylene glycol. Also, this regulation establishes an exemption from the requirement of a tolerance for residues of ethylene glycol (CAS Reg. No. 107-21-1) when used as an inert ingredient as an encapsulating agent for pesticides being applied post-harvest as residual, and crack and crevice sprays in and around food and nonfood areas of residential and nonresidential structures, including food handling establishments, with no limit. The Sumitomo Chemical Company submitted a petition to EPA under FFDCA, requesting an establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of ethylene glycol.

NTP Information Cited
Based on the lack of mutagenicity and lack of carcinogenicity in rodents, ethylene glycol is not expected to pose a carcinogenic risk in humans. (TR-26)

In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to make changes to and renew an existing approved collection. The ICR Supporting Statement, which is abstracted below, describes the nature of the information collection (including proposed minor form revisions) and its estimated burden and cost.

NTP Information Cited
Addition of National Toxicology Program Carcinogens rule is estimated to increase the number of reporting facilities by 74 and the number of Form Rs submitted by 186 with an associated burden increase of 6,641 hours.

DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement the requirements for minimizing the use of materials containing hexavalent chromium in items acquired by DoD (deliverables and construction materials hereafter referred to as deliverables). Hexavalent chromium is a chemical that has been used in numerous DoD weapons systems and platforms due to its corrosion protection properties. However, hexavalent chromium is a known carcinogen. This rule codifies a DoD policy for addressing the serious human health and environmental risks related to the use of hexavalent chromium. The rule prohibits the delivery of items containing more than 0.1 percent by weight hexavalent chromium in any homogeneous material under DoD contracts unless there is no acceptable alternative to the use of hexavalent chromium.

NTP Information Cited
The National Toxicology Program’s Report on Carcinogens lists hexavalent chromium compounds as known human carcinogens. (ROC)

The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding four chemicals -- androstenedione (CAS No. 63-05-8), dibromoacetonitrile (CAS No. 3252-43-5), hexachlorobutadiene (CAS No. 87-68-3), and malonaldehyde, sodium salt (CAS No. 24382-04-5) -- to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 ). The listing of the four chemicals is effective May 3, 2011.

NTP Information Cited
National Toxicology Program (NTP, 1988). Toxicology and Carcinogenesis Studies of Malonaldehyde, Sodium Salt (3-Hydroxy-2-propenal, Sodium Salt) (CAS No. 24382-04-5) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 331. NIH Publication No. 89-2587, U.S. Department of Health and Human Services, NTP Research Triangle Park, NC.

The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding four chemicals -- androstenedione (CAS No. 63-05-8), dibromoacetonitrile (CAS No. 3252-43-5), hexachlorobutadiene (CAS No. 87-68-3), and malonaldehyde, sodium salt (CAS No. 24382-04-5) -- to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 ). The listing of the four chemicals is effective May 3, 2011.

NTP Information Cited
National Toxicology Program (NTP, 2010). Toxicology and Carcinogenesis Studies of Androstenedione (CAS No. 63-05-8) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 560. NIH Publication No. 10-5901. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.

The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding four chemicals -- androstenedione (CAS No. 63-05-8), dibromoacetonitrile (CAS No. 3252-43-5), hexachlorobutadiene (CAS No. 87-68-3), and malonaldehyde, sodium salt (CAS No. 24382-04-5) -- to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 ). The listing of the four chemicals is effective May 3, 2011.

NTP Information Cited
National Toxicology Program (NTP, 2010). Toxicology and Carcinogenesis Studies of Dibromoacetonitrile (CAS No. 3252-43-5) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). NTP Technical Report Series No. 544. NIH Publication No. 10-5886. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.

The United States (U.S.) Environmental Protection Agency (EPA or Agency) is proposing national emission standards for hazardous air pollutants (NESHAP) from coal- and oil-fired electric utility steam generating units (EGUs) under Clean Air Act (CAA or the Act) section 112(d) and proposing revised new source performance standards (NSPS) for fossil-fuel-fired EGUs under CAA section 111(b). The proposed NESHAP would protect air quality and promote public health by reducing emissions of the hazardous air pollutants (HAP) listed in CAA section 112(b). In addition, these proposed amendments to the NSPS are in response to a voluntary remand of a final rule. We also are proposing several minor amendments, technical clarifications, and corrections to existing NSPS provisions for fossil-fuel-fired EGUs and large and small industrial-commercial-institutional steam generating units.

NTP Information Cited
Acetaldehyde is reasonably anticipated to be a human carcinogen. Benzene is characterized as a known human carcinogen. Both are cited in the National Toxicology Program’s Report on Carcinogens. (ROC)

EPA is announcing a 60-day public comment period and listening session for the external review draft human health assessment titled, ‘‘Toxicological Review of Methanol (Non-Cancer): In Support of Summary Information on the Integrated Risk Information System (IRIS)’’ (EPA/635/R–11/001). The draft assessment was prepared by the National Center for Environmental Assessment (NCEA) within the EPA Office of Research and Development (ORD). EPA is releasing this draft assessment solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. This draft assessment has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency policy or determination.

NTP Information Cited
A National Toxicology Program report recommended performing pathology reviews to resolve differences of opinion in the diagnoses of certain tumors reported in a Ramazzini Institute methanol research study. This study was cited and used to support some of the conclusions in the draft IRIS Methanol Toxicological Review. Following the report from the National Toxicology Program, EPA placed the external peer review of the draft IRIS Methanol Toxicological Review on hold. (IRIS)

This regulation establishes an exemption from the requirement of a tolerance for residues of sodium ferric ethylenediaminetetraacetate (EDTA) in or on all food commodities when applied as a molluscicide and used in accordance with good agricultural practices. W. Neudorff GmbH KG submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of sodium ferric EDTA under the FFDCA.

NTP Information Cited
National Toxicology Program (NTP); Technical Report Series No. 11. (TR-11)

The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding acrylamide (CAS No. 79-06-1) to the list of chemicals known to the state to cause reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The listing of acrylamide is effective February 25, 2011. Acrylamide is being listed as a chemical known to the State of California to cause developmental and male reproductive toxicity.

NTP Information Cited
NTP-CERHR. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Acrylamide. NIH Publication No. 05-4472. (2005)

In compliance with the Paperwork Reduction Act (PRA)(44 U.S.C. 3501 et seq.), EPA is planning to submit a request to renew an existing approved Information Collection Request (ICR) to the Office of Management and Budget (OMB). This ICR is scheduled to expire on July 31, 2011. The ICR Supporting Statement, which is summarized below and also posted in the docket, along with a technical document titled ‘‘Revising TRI Burden to Ratio-Based Methodology,’’ describes the nature of the information collection (including proposed form changes) and its estimated burden and cost. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection as described below.

NTP Information Cited
On November 26, 2010, the Addition of National Toxicology Program Carcinogens rule was published in the Federal Register.

The addition of National Toxicology Program Carcinogens rule, affects the EPA’s Information ColIection Request (ICR) by increasing the number of reporting facilities by 74 and the number of Form Rs submitted by 186 with an associated burden increase of 6,641 hours.

This regulation establishes an exemption from the requirement of a tolerance for residues of (S,S)-Ethylene­diamine Di­succinic Acid Tri­sodium Salt (CAS Reg. No. 178949–82–1) when used as an inert ingredient (sequestrant or chelating agent) in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest under EPA regulations. Innospec Limited submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of (S,S)-ethylenediamine disuccinic acid trisodium salt.

NTP Information Cited
NTP tested trisodium ethylenediaminetetraacetate trihydrate (EDTA)in mice and rats and it showed no carcinogenic potential. Since (S,S)-Ethylene­diamine Di­succinic Acid Tri­sodium Salt is similar to EDTA, (S,S)-EDDS is not likely to be carcinogenic to humans at low doses. (TR-11) (TS)

4-Methylimidazole meets the criteria for listing as known to the State to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code Section 25249.5 et seq.), more commonly known as Proposition 65, via the authoritative bodies mechanism. The regulatory requirements for listing by this mechanism are set forth in Title

NTP Information Cited
National Toxicology Program (NTP, 2007). Toxicology and Carcinogenesis Studies of 4-Methylimidazole (CAS No. 822-36-6) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 535. NIH Publication No. 07-4471. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the publication of the final technical support documents for the Public Health Goals (PHGs) for benzo(a)pyrene, methoxychlor, and TCDD (dioxin) in drinking water. The PHG for benzo(a)pyrene is established at 0.007 parts per billion (ppb), based on carcinogenic effects in rats and mice. The PHG for methoxychlor is established at 0.09 ppb, based on effects in male offspring of female mice treated with methoxychlor during pregnancy. The PHG for TCDD is established at 0.00005 parts per trillion (ppt), based on tumors in multiple sites in female rats.

NTP Information Cited
NTP (1982a). Bioassay of 2,3,7,8-tetrachlorodibenzo-p-dioxin for possible carcinogenicity (gavage study). TR 201. National Toxicology Program, U.S. DHHS, Public Health Service, Research Triangle Park, NC.

The Environmental Protection Agency (EPA or the Agency) is proposing to amend its regulations under the Resource Conservation and Recovery Act (RCRA) to remove saccharin and its salts from the lists of hazardous constituents and commercial chemical products, which are hazardous wastes when discarded or intended to be discarded. EPA is also proposing to amend the regulations under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) to remove saccharin and its salts from the list of hazardous substances. This proposed rule is in response to a petition submitted to EPA by the Calorie Control Council (CCC), to remove saccharin and its salts from the above lists. EPA is proposing to grant CCC's petition based on a review of the evaluations conducted by key public health agencies concerning the carcinogenic and other potential toxicological effects of saccharin and its salts, as well as EPA’s own assessment of the waste generation and management information for saccharin and its salts, which demonstrate that saccharin and its salts do not meet the criteria in the hazardous waste regulations for remaining on EPA's lists of hazardous constituents, hazardous wastes, and hazardous substances.

NTP Information Cited
EPA believes that saccharin and its salts, based on the results of the latest reviews of the available scientific information performed by NTP and IARC, do not pose a present or potential risk of causing toxic, carcinogenic, mutagenic or teratogenic effects on humans or other life forms. (ROC)

EPA is proposing to add sixteen (16) chemicals to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and section 6607 of the Pollution Prevention Act of 1990.

NTP Information Cited
These 16 chemicals have been classified by the NTP in their Report on Carcinogens (ROC) as "reasonably anticipated to be a human carcinogen."
1-Amino-2,4- Dibromoanthraquinone (CAS No. 81-49-2)
2,2-bis(Bromomethyl)-1,3- propanediol (CAS No. 3296-90-0)
Furan (CAS No. 110-00-9)
Glycidol (CAS No. 556-52-5)
Isoprene (CAS No. 78-79-5)
Methyleugenol (CAS No. 93-15-2)
1,6-Dinitropyrene (CAS No. 42397-64-8)
1,8-Dinitropyrene (CAS No. 42397-65-9)
6-Nitrochrysene (CAS No. 7496-02-8)
4-Nitropyrene (CAS No. 57835-92-4)
o-Nitroanisole (CAS No. 91-23-6)
Nitromethane (CAS No. 75-52-5)
Phenolphthalein (CAS No. 77-09-8)
Tetrafluoroethylene (CAS No. 116-14-3)
Tetranitromethane (CAS No. 509-14-8)
Vinyl Fluoride (CAS No. 75-02-5)

The Food and Drug Administration (FDA) announces the availability of five documents related to FDA’s continuing assessment of Bisphenol A (BPA) and solicits public comments on the four documents prepared by FDA’s Center for Food Safety and Applied Nutrition (CFSAN). These documents do not represent an agency opinion or position on BPA, on which an interim update was recently provided. (See http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm064437.htm). Rather, these documents provide perspectives and opinions that are being considered by FDA as it continues its safety assessment of BPA. This action will enable FDA to consider comments from the public in its assessment of BPA for food contact applications.

NTP Information Cited
National Toxicology Program, Center for the Evaluation of Risks to Human Reproduction. NTP–CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A. NIH Publication No. 08–5994. September 2008.

The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding Bromochloroacetic acid (CAS No. 5589-96-8), Cumene (CAS No. 98-82-8) and Diclofop-methyl (CAS No. 51338-27-3) to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 ). The listing of bromochloroacetic acid, cumene and diclofop-methyl is effective April 6, 2010.

NTP Information Cited
National Toxicology Program (NTP, 2009). Toxicology and Carcinogenesis Studies of Cumene (CAS No. 98-82-8) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). NTP Technical Report Series No. 542.

National Toxicology Program (NTP, 2009). Toxicology and Carcinogenesis Studies of Bromochloroacetic Acid (CAS No. 5589-96-8) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). NTP Technical Report Series No. 549.

EPA is proposing a test rule under section 4(a)(1)(B) of the Toxic Substances Control Act (TSCA) that would require manufacturers, importers, and processors of certain high production volume (HPV) chemicals to conduct testing to obtain screening level data for health and environmental effects and chemical fate.

NTP Information Cited

Acetaldehyde, benzene, 1,3-butadiene, alcoholic beverages, and naphthalene are reasonably anticipated to be a human carcinogen by the U.S. Department of Health and Human Services National Toxicology Program 12th Report on Carcinogens. (ROC)

The Food and Drug Administration (FDA) is announcing the reorganization of the Office of the Commissioner (OC). This reorganization includes the organizations and their substructure components as listed in this document. This notice was previously published in the Federal Register of August 18, 2009, but it contained several errors. For the convenience of the reader, the reorganization is published again in its entirety.

NTP Information Cited
Office of Science: Serves as principal authority and provides leadership for the Center’s participation in the National Toxicology Program (NTP).

In response to two petitions seeking disclosure of selected inert ingredients on pesticide labels, based on hazard, EPA is initiating rulemaking to increase public availability of the identities of the inert ingredients in pesticide products. This action would assist consumers and users of pesticides in making informed decisions and reduce the presence of potentially hazardous ingredients in pesticides.

NTP Information Cited
Suggested hazard criteria, which could be used to identify potential carcinogenic substances to be listed in the ingredient statement, include (1) known or presumed human carcinogens and those classified as Group 1 or Group 2 by the International Agency for Research on Cancer (IARC); (2) evidence of carcinogenic activity by the National Toxicology Program (NTP) and/or the Environmental Protection Agency (EPA); and/or (3) a Category I Potential Carcinogen by the Occupational Safety and Health Administration (OSHA).

In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that EPA is planning to submit a request for a new Information Collection Request (ICR) to the Office of Management and Budget (OMB). Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection as described below.

NTP Information Cited

NTP Work Cited: Phthalates are used in the manufacture of a wide range of industrial and household consumer products to prolong durability and increase the flexibility of plastics and as chemical stabilizers for other materials. Animal data suggest a broad spectrum of potential health outcomes including developmental toxicity, endocrine disruption, and carcinogenicity. However, the characterization of human exposure to phthalates is limited and the National Toxicology Program’s Center for the Evaluation of the Risks to Human Reproduction has concluded that more data regarding the potential for human exposure are needed. 

OHAT (formerly CERHR) Evaluations and Workshops, see phthalates. (OHAT)

EPA proposes several revisions to the Lead Renovation, Repair, and Painting Program (RRP) rule that published in the Federal Register on April 22, 2008. The rule establishes accreditation, training, certification, and recordkeeping requirements, as well as work practice standards on persons performing renovations for compensation in most pre-1978 housing and child-occupied facilities. In this document, EPA proposes eliminating the ‘‘opt-out’’ provision that currently exempts a renovation firm from the training and work practice requirements of the rule where the firm obtains a certification from the owner of a residence he or she occupies that no child under age 6 or pregnant women resides in the home and the home is not a child- occupied facility. EPA also proposes requiring renovation firms to provide a copy of the records demonstrating compliance with the training and work practice requirements of the RRP rule to the owner and, if different, the occupant of the building being renovated or the operator of the child-occupied facility.

NTP Information Cited
Lead exerts ‘‘a broad array of deleterious effects on multiple organ systems via widely diverse mechanisms of action’’. Health effects include impacts on heme biosynthesis and related functions, neurological development and function, reproduction and physical development, kidney function, cardiovascular function, and immune function. There is also some evidence of lead carcinogenicity, primarily from animal studies, together with limited human evidence of suggestive associations. (Lead)

This notice announces the final priority data needs for six priority hazardous substances as part of the continuing development and implementation of the ATSDR Substance-Specific Applied Research Program (SSARP). This notice also serves as a continuous call for voluntary research proposals. A Tri-Agency Superfund Applied Research Committee (TASARC), comprised of scientists from ATSDR, NTP, EPA, FDA, and NIOSH, will review all proposals.

NTP Information Cited
The priority data needs for six substances are included in the ATSDR Priority List of Hazardous Substances (73 FR 12178, March 6, 2008). ATSDR initially announced these priority data needs in the Federal Register on December 28, 2007 (72 FR 73828). EPA, the National Institute of Environmental Health Sciences (NIEHS)/National Toxicology Program (NTP), the National Institute for Occupational Safety and Health (NIOSH), and the U.S. Food and Drug Administration/National Center for Toxicological Research (FDA/NCTR) reviewed the six priority data needs and accompanying documents. The mechanisms described in the "Implementation of Substance-Specific Applied Research Program" section of this Federal Register Notice address these data needs.

OSHA proposes to modify its existing Hazard Communication Standard (HCS) to conform with the United Nations’ (UN) Globally Harmonized System of Classification and Labeling of Chemicals (GHS). OSHA has preliminarily determined that the proposed modifications will improve the quality and consistency of information provided to employers and employees regarding chemical hazards and associated protective measures. The Agency anticipates this improved information will enhance the effectiveness of the HCS in ensuring that employees are apprised of the chemical hazards to which they may be exposed, and in reducing the incidence of chemical-related occupational illnesses and injuries.

NTP Information Cited
Since carcinogenicity is the most controversial and difficult health effect to address, OSHA considers chemicals found to be carcinogenic in the National Toxicology Program’s Report on Carcinogens, or in monographs published by the International Agency for Research on Cancer, to be carcinogens in addition to those regulated by OSHA as carcinogens.  (ROC)

EPA and NHTSA are issuing this joint proposal to establish a National Program consisting of new standards for light-duty vehicles that will reduce greenhouse gas emissions and improve fuel economy. This joint proposed rulemaking is consistent with the National Fuel Efficiency Policy announced by President Obama on May 19, 2009, responding to the country’s critical need to address global climate change and to reduce oil consumption. EPA is proposing greenhouse gas emissions standards under the Clean Air Act, and NHTSA is proposing Corporate Average Fuel Economy standards under the Energy Policy and Conservation Act, as amended. These standards apply to passenger cars, light-duty trucks, and medium-duty passenger vehicles, covering model years 2012 through 2016, and represent a harmonized and consistent National Program. Under the National Program, automobile manufacturers would be able to build a single light-duty national fleet that satisfies all requirements under both programs while ensuring that consumers still have a full range of vehicle choices.

NTP Information Cited
The National Toxicology Program in its Report on Carcinogens has characterized many components of automobile and truck engines to be known or potential carcinogens. They are benzene, 1, 3-butadiene, acetaldehyde, and naphthalene. (ROC)

EPA and NHTSA are issuing this joint proposal to establish a National Program consisting of new standards for light-duty vehicles that will reduce greenhouse gas emissions and improve fuel economy. This joint proposed rulemaking is consistent with the National Fuel Efficiency Policy announced by President Obama on May 19, 2009, responding to the country’s critical need to address global climate change and to reduce oil consumption. EPA is proposing greenhouse gas emissions standards under the Clean Air Act, and NHTSA is proposing Corporate Average Fuel Economy standards under the Energy Policy and Conservation Act, as amended. These standards apply to passenger cars, light-duty trucks, and medium-duty passenger vehicles, covering model years 2012 through 2016, and represent a harmonized and consistent National Program. Under the National Program, automobile manufacturers would be able to build a single light-duty national fleet that satisfies all requirements under both programs while ensuring that consumers still have a full range of vehicle choices.

NTP Information Cited
The National Toxicology Program in its Report on Carcinogens has characterized many components of automobile and truck engines to be known or potential carcinogens. They are benzene, 1, 3-butadiene, acetaldehyde, and naphthalene.  (ROC)

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) intends to evaluate the scientific data on the brominated organic solvent, 1-Bromopropane (1–BP, CAS # 106–94–5, also known as n-propyl bromide), and develop appropriate communication documents, such as a Current Intelligence Bulletin, Criteria Document and/or other informational products, and establish a Recommended Exposure Limit (REL) for 1–BP. NIOSH is requesting information on the following: (1) published and unpublished reports and findings from in vitro and in vivo toxicity studies with 1–BP, (2) information on possible health effects observed in workers exposed to 1–BP, (3) information on workplaces and products in which 1–BP can be found, (4) description of work tasks and scenarios with a potential for exposure to 1–BP, (5) workplace exposure data, and (6) information on control measures (e.g., engineering controls, work practices, personal protective equipment) that are being used in workplaces where potential exposures to 1–BP occur.

NTP Information Cited
The National Toxicology Program (NTP) estimated that approximately 8.2 million pounds (lbs) of 1–BP were used in the United States (U.S.) in 2002. Estimates of the number of workers exposed to 1–BP are unavailable due to limited exposure data and its relatively recent introduction into domestic commerce.  (1-Bromopropane) 

The Food and Drug Administration (FDA) is requesting comments and scientific data and information on acrylamide in food. Acrylamide is a chemical that can form in some foods during certain types of high-temperature cooking. FDA is seeking information on practices that manufacturers have used to reduce acrylamide in food and the reductions they have been able to achieve in acrylamide levels. FDA is considering issuing guidance for industry on reduction of acrylamide levels in food products.

NTP Information Cited
Under the sponsorship of the National Toxicology Program, FDAs National Center for Toxicological Research (NCTR) embarked in 2002 on a series of new toxicology assays for acrylamide. These studies were designed to address deficiencies in earlier carcinogenicity studies and to provide more reliable data on potential carcinogenic risk of acrylamide and other potential effects of acrylamide exposure. The work at NCTR includes long-term carcinogenicity bioassays of acrylamide and its metabolite glycidamide in mice and rats, as well as toxicokinetic, bioavailability, mutagenicity, and neurodevelopmental studies. NCTRs work also includes the development of a physiologically based pharmacokinetic model for acrylamide and glycidamide. (Acrylamide) (Glycidamide )

Draft public health goal for hexavalent chromium in drinking water. This draft document is a new risk assessment, culminating an extensive evaluation of oral toxicity of this chemical. A PHG of 0.06 ug/L or 0.06 parts per billion (ppb) is proposed for hexavalent chromium in drinking water, based on tumor incidence data from rodent cancer bioassays.

NTP Information Cited
NTP (2008). NTP Technical Report on the Toxicology and Carcinogenesis Studies of Sodium Dichromate Dihydrate in F344/N Rats and B6C3F1 Mice. NTP TR 546. National Toxicology Program.

Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is announcing the availability of the final technical support document for the Public Health Goal (PHG) for the solvent 1,2,3-trichloropropane in drinking water. This document establishes a PHG for 1,2,3-trichloropropane of 0.0007 parts per billion, versus the current Notification Level of 0.005 ppb, set in 2005. The PHG is based on an updated cancer potency calculation.

NTP Information Cited
NTP (1982). Carcinogenesis bioassay of 1,2-dibromo-3-chloropropane (CAS No. 96-12-8) in F344/N rats and B6C3F1 mice (inhalation studies). Technical Report Series No 206. NIH publication No. 82-1762. 

This regulation establishes an exemption from the requirement of a tolerance for residues of amine salts of alkyl (C8-C24) benzenesulfonic acid (dimethylaminopropylamine, isopropylamine, mono-, di-, and triethanolamine) when used as an inert ingredient in pesticide formulations applied to growing crops and applied to animals. The Joint Inerts Task Force, Cluster Support Team Number 8, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of amine salts of alkyl (C8-C24) benzenesulfonic acid (dimethyl aminopropylamine, isopropylamine, mono-, di, and triethanolamine).

NTP Information Cited
Subchronic (13-week) oral toxicity study in rats (NTP, 1992). (Diethanolamine)

Public Health Goal (PHG) of 0.0007 mg/L or 0.7 parts per billion (ppb) is proposed for antimony in drinking water, based on data from use of antimonials in medical practice. In 1997, the Office of Environmental Health Hazard Assessment (OEHHA) developed a PHG for antimony of 20 ppb in drinking water, based on extrapolation from effect levels in rats.

NTP Information Cited
NTP (1992). Technical report on the toxicity studies of antimony potassium tartrate in F344/N rats and B6C3F1 mice (drinking water and intraperitoneal injection studies). NTP Tox 11.

This notice announces the availability of the draft toxicological profile for perfluoroalkyls, prepared by ATSDR, for review and comment.

NTP Information Cited
NTP in conjunction with ATSDR and EPA identified categories of possible data needs addressed in the draft profile. The NTP's carcinogenicity study of PFOA is mentioned in the section on ongoing studies. (PFOA)

OEHHA within the California Environmental Protection Agency is announcing the availability of the final technical support document for the Public Health Goal (PHG) for the solvent tri­chloro­ethyl­ene in drinking water. This document increases the PHG for tri­chloro­ethyl­ene to 1.7 parts per billion, versus 0.8 ppb in the original PHG published in 1999. The PHG is based on the same cancer endpoint with an updated potency calculation.

NTP Information Cited
NTP (1983). Technical report on the carcinogenesis studies of tri­chloro­ethyl­ene (without epichlorohydrin) (CAS No.79-01-6) in F344/N rats and B6C3Fl mice (gavage studies): Draft report. Publ. No. 83-1799. 

A proposed PHG health risk assessment for each of the four major trihalomethanes (THMs) found in drinking water as a consequence of the chlorination disinfection process, and proposes four individual Public Health Goals (PHGs). The four THMs are chloroform (CHCl3), bromoform (CHBr3), bromodichloromethane (CHBrCl2, or BDCM), and dibromochloromethane (CHBr2Cl, or DBCM). The proposed PHG for chloroform is 0.001 milligram per liter (mg/L) or 1 microgram per liter (μg/L) or 1 part per billion (ppb); for bromoform 5 μg/L; for BDCM 0.4 μg/L; and for DBCM 0.7 μg/L.

NTP Information Cited
NTP (1985). Toxicology and carcinogenesis studies of chlorodibromomethane (CAS No. 124-48-1) in F344/N rats and B6C3F1 mice (gavage studies). NTP Technical Report Series No. 282.

NTP (1987). Toxicology and carcinogenesis studies of bromodichloromethane (CAS No. 75-27-4) in F344/N rats and B6C3F1 mice (gavage studies). NTP Technical Report Series No. 321.

NTP (1988). Chloroform reproduction and fertility assessment in CD-1 mice when administered by gavage. Report by Environmental Health Research and Testing, Inc., Lexington, Kentucky, to National Toxicology Program, NTP-89-018. NTIS PB89-148639.

NTP (1989a). Toxicology and carcinogenesis studies of tribromomethane (bromoform) (CAS No. 75-25-2) in F344/N rats and B6C3F1 mice (gavage studies). NTP Technical Report Series No. 350.

NTP (1989b). Bromoform: reproduction and fertility assessment in Swiss CD-1 mice when administered by gavage. Report no. NTP-89-068.

NTP (1994). Comparative toxicology studies of corn oil, safflower oil, and tricaprylin (CAS Nos. 8001-30-7, 8001-23-8, and 538-23-8) in male F344/N rats as vehicles for gavage. NTP Technical Report Series No. 426.

NTP (1996). Final report on the short term reproductive and developmental toxicity of chlorodibromomethane (CAS No. 124-48-1) administered in drinking water to Sprague-Dawley rats. Report by R.O.W. Sciences, Inc., Gaithersburg, MD. Pub No. NTIS/PB97-111728.

NTP (1998). Final Report on the short-term reproductive and developmental toxicity of bromodichloromethane (CAS No. 75-27-4) administered in drinking water to Sprague-Dawley rats. Pub no. NTIS/PB99-111262.

NTP (2004). Bromodichloromethane and Chloroform. In: 11th Report on Carcinogens.

This regulation amends the exemption from the requirement of a tolerance for residues of silver (excludes silver salts) in or on all foods when applied or used in public eating places, dairy processing equipment, and food processing equipment. ETO H2O, Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act requesting to establish concentration limits for silver in end-use solutions eligible for tolerance exemption. The regulation being established will exempt all foods from the requirement of a tolerance for residues of silver resulting from contact with surfaces treated with solutions in which the end-use concentration of silver is not to exceed 50 parts per million (ppm).

NTP Information Cited
There are extensive data and analysis on silvers toxicity in the historical data/literature and the regulatory advisories established by other Federal Agencies, which do not indicate an increased susceptibility of children to the toxic effects of silver. A NTP developmental toxicity study concluded that the NOAEL recorded for developmental toxicity in rats receiving gavage doses of silver acetate was greater than 100 mg/ kg when the test material was administered on gestation days 6 through 19. No increase in susceptibility was apparent in this study.

Under the Clean Air Act, as amended by Sections 201, 202, and 210 of the Energy Independence and Security Act of 2007, the Environmental Protection Agency is required to promulgate regulations implementing changes to the Renewable Fuel Standard program.

NTP Information Cited
Acetaldehyde is reasonably anticipated to be a human carcinogen by the U.S. DHHS in the 11th Report on Carcinogens. (Acetaldehyde) The U.S. Department of Health and Human Services (DHHS) has characterized benzene as a known human carcinogen. (Benzene) The U.S. DHHS has characterized 1,3-butadiene as a known human carcinogen. (1,3-Butadiene) The U.S. DHHS in the 11th Report on Carcinogens identified alcoholic beverages as a known human carcinogen (they have not evaluated the cancer risks specifically from exposure to ethanol), with evidence for cancer of the mouth, pharynx, larynx, esophagus, liver and breast. (Ethanol) The National Toxicology Program listed naphthalene as reasonably anticipated to be a human carcinogen in 2004 on the basis of bioassays reporting clear evidence of carcinogenicity in rats and some evidence of carcinogenicity in mice. (Naphthalene ) (ROC)

A revised Public Health Goal (PHG) of 0.3 parts per billion (ppb) is hereby established for pentachlorophenol (PCP) in drinking water, based on carcinogenicity. The earlier PHG for PCP of 0.4 ppb, developed in 1997, is based on the same rodent carcinogenicity data and a cancer potency value identical to that used in this revised PHG.

NTP Information Cited
NTP (1989). Toxicology and carcinogenesis studies of two pentachlorophenol technical-grade mixtures in B6C3F1 mice. NTP TR 349, NIH No. 88-2804.

NTP (1999). Toxicology and carcinogenesis studies of pentachlorophenol in F344/N rats. NTP TR 483, NIH No. 99-3973.

The purpose of this document is to review and evaluate the new data since 1997 regarding the toxicity of lead that are relevant to the estimation of a public health-protective level in drinking water, and establish any necessary changes in the previous risk assessment based on the new findings. This document is centered on updating the earlier OEHHA assessments for drinking water (OEHHA, 1997a, 2007).

NTP Information Cited
NTP (2005). Report on carcinogens. 11th edition.

OSHA is requesting data, information, and comment on issues related to occupational exposure to diacetyl and food flavorings containing diacetyl, including current employee exposures to diacetyl; the relationship between exposure to diacetyl and the development of adverse health effects; exposure assessment and monitoring methods; exposure control methods; employee training; medical surveillance for adverse health effects related to diacetyl exposure; and other pertinent subjects. In this notice, OSHA intends the term diacetyl and food flavorings containing diacetyl to encompass other constituents of food flavorings containing diacetyl. In addition to information on diacetyl, OSHA seeks information on acetoin, acetaldehyde, acetic acid, furfural, and other compounds present in food flavorings that may cause or contribute to flavoring-related lung disease. The Agency is also interested in and seeks information about diacetyl present in substances other than food flavorings (e.g., naturally occurring diacetyl or diacetyl in fragrances) as well as substitutes used in place of diacetyl (e.g., diacetyl trimer). The information received in response to this document will assist the Agency in developing a proposed standard addressing occupational exposure to diacetyl and food flavorings containing diacetyl.

NTP Information Cited
The National Toxicology Program has approved the nomination of BFV, diacetyl, and acetoin for longer term inhalation testing.  (Artificial Butter Flavoring Mixture) (2,3-Butanedione (Diacetyl)) (Acetoin)

This notice announces the final priority data needs for two priority hazardous substances as part of the continuing development and implementation of the ATSDR Substance-Specific Applied Research Program (SSARP). The notice also serves as a continuous call for voluntary research proposals.

NTP Information Cited
A Tri-Agency Superfund Applied Research Committee (TASARC), comprised of scientists from ATSDR, the National Toxicology Program (NTP), and EPA will review all proposals.

This regulation establishes time-limited tolerances for combined residues of diflubenzuron and its metabolites p-chlorophenylurea and p-chloroaniline in or on alfalfa, forage and alfalfa, hay. This action is in response to EPAs granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on alfalfa and mixed grass/alfalfa fields. This regulation establishes a maximum permissible level for residues of diflubenzuron and its metabolites p-chlorophenylurea and p-chloroaniline, in these food commodities. The time-limited tolerances expire and are revoked on December 31, 2011.

NTP Information Cited
There are two metabolites of diflubenzuron; PCA and CPU. PCA tested positive for splenic tumors in male rats and hepatocellular adenomas/carcinomas in male mice in a National Toxicology Program (NTP) study. (TR-351)

This regulation establishes an exemption from the requirement of a tolerance for residues of (S,S)­Ethylene­di­amine­di­succinic Acid (CAS Reg. No. 20846-91-7) ((S,S)EDDS) when used as an inert ingredient sequestrant or chelating agent in pesticide formulations applied to growing crops only under 40 CFR 180.920. Associated Octel Company, Limited, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of (S,S)Ethylenediaminedisuccinic acid.

NTP Information Cited
No carcinogenicity studies are available on (S,S)EDDS, however, NTP tested trisodium EDTA in mice and rats showed no carcinogenic potential. Based on its similarity with EDTA and lack of mutagenicity, (S,S)EDDS is not likely to be carcinogenic to humans at low doses. (TR-011)

Based on its review of the air quality criteria and national ambient air quality standards (NAAQS) for lead (Pb), EPA is making revisions to the primary and secondary NAAQS for Pb to provide requisite protection of public health and welfare, respectively. With regard to the primary standard, EPA is revising the level to 0.15 μg/m3. EPA is retaining the current indicator of Pb in total suspended particles (Pb-TSP). EPA is revising the averaging time to a rolling 3-month period with a maximum (not-to-be-exceeded) form, evaluated over a 3-year period. EPA is revising the secondary standard to be identical in all respects to the revised primary standard.

NTP Information Cited

Lead has been classified as a probable human carcinogen by the International Agency for Research on Cancer (inorganic lead compounds), based mainly on sufficient animal evidence, and as reasonably anticipated to be a human carcinogen by the U.S. National Toxicology Program (lead and lead compounds). ROC

The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 104(i)(3) [42 U.S.C. 9604(i)(3)], directs the Administrator of ATSDR to prepare toxicological profiles of priority hazardous substances and to revise and publish each updated toxicological profile as necessary. This notice announces the availability of the 22nd set of toxicological profiles, which consists of four updated drafts prepared by ATSDR for review and comment. The toxicological profiles for formaldehyde and perfluoroalkyls are on a modified schedule pending additional review.

NTP Information Cited
The profiles must also include a determination of whether adequate information on the health effects of each substance is available or in the process of development. When adequate information is not available, ATSDR, in cooperation with the National Toxicology Program (NTP), is required to ensure the initiation of research to determine these health effects.

The Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) transmitted its 63rd Report to the Administrator of the EPA on October 7, 2008. In the 63rd ITC report, which is included with this notice, the ITC is revising the TSCA section 4(e) Priority Testing List by removing 1 tungsten compound and 1 High Production Volume (HPV) Challenge Program orphan chemical.

NTP Information Cited
At this time the ITC is removing tungstate (WO42-), disodium, dihydrate, (T-4)-, a.k.a. disodium tungstate (Na2WO4) dihydrate (CAS No. 10213-10-2) from the Priority Testing List because of the voluntary information provided by the International Tungsten Industry Association and their cooperation in a National Toxicology Program/National Institute for Occupational Safety and Health research program to address exposure and toxicity data needs.

We are setting emission standards for new non-road spark-ignition engines that will substantially reduce emissions from these engines. The exhaust emission standards apply starting in 2010 for new marine spark-ignition engines, including first-time EPA standards for stern-drive and inboard engines. The exhaust emission standards apply starting in 2011 and 2012 for different sizes of new land-based, spark-ignition engines at or below 19 kilowatts (kW). These small engines are used primarily in lawn and garden applications. We are also adopting evaporative emission standards for vessels and equipment using any of these engines. In addition, we are making other minor amendments to our regulations.

NTP Information Cited
The International Agency for Research on Carcinogens (IARC) has determined that benzene is a human carcinogen and the U.S. Department of Health and Human Services (DHHS) has characterized benzene as a known human carcinogen. (ROC)

In this order, EPA denies objections to, and requests for hearing on, a prior order denying a petition requesting that EPA revoke all pesticide tolerances for dichlorvos under section 408(d) of the Federal Food, Drug, and Cosmetic Act. The objections and hearing requests were filed on February 1, 2008, by the Natural Resources Defense Council (NRDC). The Original petition was also filed by NRDC.

NTP Information Cited
In the 1989 NTP cancer studies with rats and mice, male and female reproductive organs (prostate, testes, epididymis, ovaries, uterus) were examined and no changes attributable to DDVP were found. (TR-342)

EPA is adopting a comprehensive program to dramatically reduce pollution from locomotives and marine diesel engines. The controls will apply to all types of locomotives, including line-haul, switch, and passenger, and all types of marine diesel engines below 30 liters per cylinder displacement, including commercial and recreational, propulsion and auxiliary. The near-term emission standards for newly-built engines will phase in starting in 2009. The near-term program also includes new emission limits for existing locomotives and marine diesel engines that apply when they are remanufactured, and take effect as soon as certified remanufacture systems are available, as early as 2008. The long-term emissions standards for newly-built locomotives and marine diesel engines are based on the application of high-efficiency catalytic after-treatment technology. These standards begin to take effect in 2015 for locomotives and in 2014 for marine diesel engines. We estimate particulate matter (PM) reductions of 90 percent and nitrogen oxides (NOX) reductions of 80 percent from engines meeting these standards, compared to engines meeting the current standards.

NTP Information Cited
The National Toxicology Program listed naphthalene as "reasonably anticipated to be a human carcinogen" in 2004 on the basis of bioassays reporting clear evidence of carcinogenicity in rats and some evidence of carcinogenicity in mice. (ROC) 

The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding dibromoacetic acid (CAS No. 631-64-1) to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., commonly known as Proposition 65). The listing of dibromoacetic acid is effective June 17, 2008. Toxicological endpoints: Reproductive Toxicity and Cancer

NTP Information Cited
National Toxicology Program (NTP, 2007). Toxicology and Carcinogenesis Studies of Dibromoacetic Acid (CAS No. 631-64-1) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). NTP Technical Report Series No. 537. NIH Publication No. 07-4475

The Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) transmitted its sixty-second report to the Administrator of EPA on April 17, 2008. In the 62nd ITC Report, which is included with this notice, the ITC is revising the TSCA section 4(e) Priority Testing List by removing four tungsten compounds and four cresols.

NTP Information Cited
The ITC is removing tungsten oxide (WO3), a.k.a. tungsten trioxide because of the voluntary information provided by the International Tungsten Industry Association and their cooperation in a National Toxicology Program/National Institute for Occupational Safety and Health research program to address exposure and toxicity data needs. The ITC is retaining tungstate (WO42-), disodium, dihydrate, (T-4)-, a.k.a. sodium tungstate (Na2 (WO4)), dihydrate (CAS No. 10213-10-2), on the Priority Testing List because of ongoing discussions with the International Tungsten Industry Association.

The United States Consumer Product Safety Commission (Commission or CPSC) is proposing flammability standards for residential upholstered furniture under the Flammable Fabrics Act (FFA). The proposal would establish performance requirements and certification and labeling requirements for upholstered furniture. Manufacturers of upholstered furniture would choose one of two possible methods of compliance: They could use cover materials that are sufficiently smolder resistant to meet a cigarette ignition performance test; or they could place fire barriers that meet smoldering and open flame resistance tests between the cover fabric and interior filling materials. Manufacturers of upholstered furniture would be required to certify compliance with the standard and to comply with certain recordkeeping requirements as specified in the proposal.

NTP Information Cited
At the request of the staff, the National Toxicology Program (NTP) of the Department of Health and Human Services has undertaken a review of several FRs that could be used to meet CPSC flammability rules. The NTP review will be a relatively long-term project that contributes to the overall level of knowledge about FR chemicals among scientists and regulators.

This Public Health Goal (PHG) technical support document provides information on health effects from copper in drinking water. PHGs are developed for chemical contaminants based on the best available toxicological data in the scientific literature. These documents and the analyses contained in them provide estimates of the levels of contaminants in drinking water that would pose no significant health risk to individuals consuming the water on a daily basis over a lifetime.

NTP Information Cited
NTP (1993) Technical Report on Toxicity Studies of Cupric Sulfate (CAS No. 7758-99-8) Administered in Drinking Water and Feed to F344/N Rats and B6C3FX Mice. NIH Publication 93-3352; Research Triangle Park, NC 27709

This Public Health Goal (PHG) technical support document provides information on health effects from Water Soluble Polychlorinated Biphenyls Expected to be Found in Drinking Water. PHGs are developed for chemical contaminants based on the best available toxicological data in the scientific literature. These documents and the analyses contained in them provide estimates of the levels of contaminants in drinking water that would pose no significant health risk to individuals consuming the water on a daily basis over a lifetime.

NTP Information Cited
NTP (2000). Ninth Annual Report on Carcinogens.

The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding anthraquinone (CAS No. 84-65-1) to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., commonly known as Proposition 65). The listing of anthraquinone is effective September 28, 2007. Anthraquinone (CAS No. 84-65-1) is being listed as a chemical known to the State of California to cause cancer. The listing of this chemical is based on formal identification by an authoritative body (i.e., the National Toxicology Program (NTP)), that the chemical causes cancer. The criteria used by OEHHA for the listing of chemicals under the authoritative bodies mechanism can be found in Title 22, Cal. Code of Regs., section 12306. Toxicological endpoint: cancer

NTP Information Cited
National Toxicology Program (NTP, 2005). Toxicology and Carcinogenesis Studies of Anthraquinone (CAS No. 84-65-1) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 494. NIH Publication No. 05-3953. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, NTP, Research Triangle Park, NC. Also listed in the 11th Report on Carcinogens (2004) as reasonably anticipated to be a human carcinogen.

EPA is announcing that the Oak Ridge Institute of Science and Education (ORISE), under an Interagency agreement between the Department of Energy and EPA, will convene an independent panel of experts and organize and conduct an external peer-review workshop to review the external review draft document titled, "Toxicological Review of Tetrahydrofuran: In Support of Summary Information on the Integrated Risk Information System (IRIS" (NCEA-S-1620). The EPA also is announcing a public comment period for the draft document. EPA intends to consider comments and recommendations from the public and the expert panel meeting when EPA finalizes the draft document.

NTP Information Cited
The National Toxicology Program studies referenced in the Toxicological Review of Tetrahydrofuran are available by calling EPA's IRIS Hotline at 202-566-1676, by fax at 202-566-1749 or by e-mail at iris@epa.gov.

This notice announces the intent of ATSDR to develop two interaction profiles.

NTP Information Cited
Where such information is not available or under development, ATSDR shall, in cooperation with the National Toxicology Program, initiate a program of research to determine these health effects.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the publication of the final Public Health Goals (PHGs) for glyphosate, which is an update of the PHG published in 1997.

NTP Information Cited
NTP (1992). NTP Technical Report on Toxicity Studies of Glyphosate (CAS No. 1071-83-6) Administered In Dosed Feed To F344/N Rats And B6C3F₁ Mice. TOX-16.

EPA is announcing that the Oak Ridge Institute of Science and Education (ORISE), under an Interagency agreement between the Department of Energy and EPA, will convene an independent panel of experts and organize and conduct an external peer-review workshop to review the external review draft document titled, "Toxicological Review of Bromobenzene: In Support of Summary Information on the Integrated Risk Information System (IRIS" (NCEA-C-1497). The EPA also is announcing a public comment period for the draft document. EPA intends to consider comments and recommendations from the public and the expert panel meeting when EPA finalizes the draft document.

NTP Information Cited
If you are requesting a paper copy, please provide your name, mailing address, and the document title. Copies are not available from ORISE. The National Toxicology Program studies referenced in the Toxicological Review of Bromobenzene are available by calling EPA's IRIS Hotline at (202) 566-1676, by fax at (202) 566-1749 or by e-mail at iris@epa.gov.

The Environmental Protection Agency (EPA) determines that n-propyl bromide (nPB) is an acceptable substitute for methyl chloroform and chlorofluorocarbon (CFC)-113 in the solvent cleaning sector under the Significant New Alternatives Policy (SNAP) program under section 612 of the Clean Air Act. The SNAP program reviews alternatives to Class I and Class II ozone depleting substances and approves use of alternatives which do not present a substantially greater risk to public health and the environment than the substance they replace or than other available substitutes.

NTP Information Cited
These metabolic and subchronic inhalation studies conducted under the National Toxicology Program did not specifically examine for reproductive toxicity or nPB metabolism in target organs that control reproductive function. In summary, there is little available data about the metabolic activation or reactive metabolites responsible for reproductive toxicity in rodents. Similarly, for nPB, there is little information available about differences and similarities between rodents and humans.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding di-isodecyl phthalate (DIDP) (CAS No. 68515-49-1 and 26761-40-0) to the list of chemicals known to the state to cause reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., commonly known as Proposition 65). The listing of di-isodecyl phthalate (DIDP) is effective April 20, 2007.

NTP Information Cited

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the publication of the final Public Health Goals (PHGs) for N-nitrosodimethylamine and cadmium.

NTP Information Cited
NTP (2000). 9th Report on Carcinogens.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is removing isosafrole [CAS No. 120-58-1], 5-nitro-o-anisidine [CAS No. 99-59-2], and tris(aziridinyl)-p-benzoquinone (triaziquone) [CAS No. 68-76-8] from the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The delisting of the three chemicals is effective December 8, 2006. 5-Nitro-o-anisidine was removed from the NTP Sixth Annual Report on Carcinogens as a substance reasonably anticipated to be a human carcinogen in 1991, when NTP concluded there was insufficient evidence of carcinogenicity.

NTP Information Cited
Report on Carcinogens, Eleventh Edition (2004); Appendix B; National Toxicology Program, U.S. Department of Health and Human Services, Research Triangle Park, NC

This regulation establishes tolerances for combined residues of diflubenzuron and its metabolites 4-chlorophenylurea and 4-chloroaniline in or on brassica, leafy greens subgroup 5B, turnip greens, peanut, peanut hay, peanut oil, barley grain, barley hay, barley straw, oat grain, oat forage, oat hay, oat straw, wheat grain, wheat forage, wheat hay, wheat straw, aspirated grain fractions, and pummelo. The Interregional Research Project #4 requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

NTP Information Cited
The Agency has classified diflubenzuron as "Group E," evidence of non-carcinogenicity for humans, based on lack of evidence of carcinogenicity in rats and mice. There are also two metabolites of diflubenzuron; PCA and CPU. PCA tested positive for splenic tumors in male rats and hepatocellular adenomas/ carcinomas in male mice in a National Toxicology Program (NTP) study. (TR-351)

EPA is promulgating amendments to the Toxic Substances Control Act (TSCA) section 12(b) export notification regulations at subpart D of 40 CFR part 707. One amendment changes the current annual notification requirement to a one-time requirement for exporters of chemical substances or mixtures (hereinafter referred to as "chemicals") for which certain actions have been taken under TSCA. Relatedly, for the same TSCA actions, EPA is changing the current requirement that the Agency notify foreign governments annually after the Agency's receipt of export notifications from exporters to a requirement that the Agency notify foreign governments once after it receives the first export notification from an exporter. EPA is also promulgating de minimis concentration levels below which notification will not be required for the export of any chemical for which export notification under TSCA section 12(b) is otherwise required, promulgating other minor amendments (to update the EPA addresses to which export notifications must be sent, to indicate that a single export notification may refer to more than one section of TSCA where the exported chemical is the subject of multiple TSCA actions, and to correct an error in 40 CFR 799.19 that currently omits mentioning multi-chemical test rules as being among those final TSCA section 4 actions that trigger export notification), and clarifying exporters' and EPA's obligations where an export notification- triggering action is taken with respect to a chemical previously or currently subject to export notification due to the existence of a previous triggering action.

NTP Information Cited
EPA will consider the lists maintained by the World Health Organization, International Agency for Research on Cancer (IARC) and the US Department of Health and Human Services, Public Health Service, National Toxicology Program (NTP) as the definitive sources. The NTP Report on Carcinogens is mandated by section 301(b)(4) of the Public Health Service Act, as amended (42 U.S.C. 201 et seq.), which stipulates that the Secretary of the Department of Health and Human Services shall publish an annual report which contains a list of all substances: • Which either are known to be carcinogens in humans or may reasonably be anticipated to be human carcinogens • To which a significant number of persons residing in the United States are exposed. (ROC)

EPA is proposing to require testing for certain chemicals on the Agency for Toxic Substances and Disease Registry (ATSDR)/EPA Priority List of Hazardous Substances which is compiled under the Comprehensive Environmental Response Compensation and Liability Act (CERCLA), and is soliciting proposals for enforceable consent agreements (ECAs). EPA is proposing a test rule under section 4(a) of the Toxic Substances Control Act (TSCA) that would require manufacturers (including importers) and processors of four chemical substances (chloroethane, hydrogen cyanide, methylene chloride, and sodium cyanide) to conduct testing for certain health effects relating to the manufacture, distribution in commerce, processing, use, or disposal of these substances.

NTP Information Cited
The toxicological profiles are developed by ATSDR in collaboration with EPA and NTP, independent peer reviewers, and the public.

The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 104(i)(3) [42 U.S.C. 9604(i)(3)] directs the Administrator of ATSDR to prepare toxicological profiles of priority hazardous substances and to revise and publish each updated toxicological profile as necessary. This notice announces the availability of the 20th set of toxicological profiles, which consists of one new draft and six updated drafts, prepared by ATSDR for review and comment.

NTP Information Cited
The profiles must also include a determination of whether adequate information on the health effects of each substance is available or in the process of development. When adequate information is not available, ATSDR, in cooperation with the National Toxicology Program (NTP), is required to assure the initiation of research to determine these health effects.

The Environmental Protection Agency (EPA) is requesting nominations of chemical and microbial contaminants for possible inclusion in the third drinking water Contaminant Candidate List (CCL 3). EPA is also requesting information that shows the nominated contaminant may have an adverse health effect on people and the contaminant occurs or is likely to occur.

NTP Information Cited

This regulation establishes an exemption from the requirement of a tolerance for residues of eucalyptus oil on honey and honeycomb when applied at 2 g or less eucalyptus oil per hive to suppress varroa mites. Brushy Mountain Bee farm, c/o IR-4 Project submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of eucalyptus oil in honey and honeycomb.

NTP Information Cited
National Toxicology Program. 1982. Salmonella assay for genetic toxicity from exposure to 1,8 cineole. Study 246429.

National Toxicology Program. 1982. CHO cell cytogenetics; chromosome aberrations and sister chromatid exchanges from exposure to 1,8 cineole. Study 590755.

Request for public comments on the identification of priority data needs for two priority hazardous substances, and an ongoing call for voluntary research proposals.

NTP Information Cited
A Tri-Agency Superfund Applied Research Committee (TASARC) comprised of scientists from ATSDR, the National Toxicology Program (NTP), and EPA, will review all proposals.

The Food and Drug Administration is issuing a notice of proposed rulemaking that would establish that over-the-counter (OTC) skin bleaching drug products are not generally recognized as safe and effective (GRASE) and are misbranded. FDA is also withdrawing the previous proposed rule on skin bleaching drug products for OTC human use, which was issued in the form of a tentative final monograph (TFM). FDA is issuing this proposed rule after considering new data and information on the safety of hydroquinone, the only active ingredient that had been proposed for inclusion in a monograph for these products. This proposal is part of FDA's ongoing review of OTC drug products. Further, upon issuance of a final rule, FDA intends to consider all skin bleaching drug products, whether currently marketed on a prescription or OTC basis, to be new drugs requiring an approved new drug application (NDA) for continued marketing.

NTP Information Cited
Toxicology and carcinogenesis studies on orally administered hydroquinone conducted under the support of the National Toxicology Program (NTP) (Refs. 1 and 2) have indicated "some evidence" of carcinogenicity in male and female rats and in female mice. FDA's Center for Drug Evaluation and Research (CDER) Carcinogenicity Assessment Committee (CAC) has evaluated the design, results, and NTP interpretation of these studies, and concurs with the NTP's assessment. (TR-366)

This final rule revises the May 20, 2006 effective date of the diesel particulate matter (DPM) final concentration limit of 160 micrograms of total carbon (TC) per cubic meter of air (160TC ug/m3) promulgated in the 2001 final rule "Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners," and published in the Federal Register on January 19, 2001 (66 FR 5706) and amended on September 19, 2005 (70 FR 55019).

NTP Information Cited
In the 10th edition of its Report on Carcinogens, the National Toxicology Program (NTP) of the National Institutes of Health formally retained its designation of diesel exhaust particulates as "reasonably anticipated to be a human carcinogen." (U.S. Dept. of Health and Human Services, 2002). (ROC)

Although many commenters agreed that the adverse health effects associated with miners' exposure to DPM warranted an exposure limit, commenters from trade associations and industry continued to challenge the conclusions of the 2001 risk assessment. Discussions addressing this issue were summarized in the 2001 risk assessment and the 2005 update. As referenced in this section, the U.S. Environmental Protection Agency, World Health Organization, and the National Toxicology Program regard DPM exposure as adversely affecting human health.

This action finalizes our decision not to revise the Ethylene Oxide Emission Standards for Sterilization Facilities, originally promulgated on December 6, 1994. Within 8 years of promulgating these standards, the Clean Air Act directs us to assess the risk and to promulgate more stringent standards if necessary to protect public health with an ample margin of safety and to prevent adverse environmental effects. Also, within 8 years of promulgating the national emission standards, the Clean Air Act requires us to review and revise the standards as necessary, taking into account developments in practices, processes, and control technologies. Today¿s action reflects our findings that after conducting these risk and technology reviews, no additional control requirements are warranted.

NTP Information Cited
In 1994, the International Agency for Research on Cancer categorized ethylene oxide in their Group 1 (Carcinogenic to Humans). In 2000, the United States Department of Health and Human Services revised its listing for ethylene oxide to "known to be a human carcinogen" in the Ninth Report on Carcinogens.

DHHS. 2000. Report on Carcinogens, Eleventh Edition; United States Department of Health and Human Services, Public Health Service, National Toxicology Program.
(ROC)

EPA is promulgating a final rule under the Toxic Substances Control Act that requires manufacturers (including importers) and processors of 17 high production volume chemicals to conduct acute toxicity, repeat dose toxicity, developmental and reproductive toxicity, genetic toxicity (gene mutations and chromosomal aberrations), ecotoxicity (in fish, Daphnia, and algae), and environmental fate (including 5 tests for physical chemical properties and biodegradation) testing.

NTP Information Cited
With one exception, the "Class 1" chemical substances listed in Table 2 in § 799.5085(j) of the regulatory text (i.e., 12 of the 17 chemical substances included in this final rule) must be tested at a purity of at least 99%. The exception is 1,3-propanediol, 2,2-bis[(nitrooxy)methyl]-,dinitrate (ester) also known as pentaerythritol tetranitrate (PETN), which cannot be tested at 99% purity because of its explosive properties and must either be diluted in water or tested in a mixture with an appropriate stabilizing compound (e.g., D-lactose monohydrate is the stabilizer in PETN, NF which is a mixture that is 20% by weight PETN and 80% by weight Dlactose monohydrate). PETN, NF is the form of PETN which was tested by NTP in several toxicity studies.

U.S. Department of Health and Human Services. National Institutes of Health. NTP. Toxicology and carcinogenesis studies of pentaerythritol tetranitrate in F344/N rats and B6C3F1 mice (feed studies). (TR-365)

The Agency is proposing to establish 16 new and amend three existing exemptions from the requirement of a tolerance for residues of various ethylenediaminetetraacetic acid (EDTA) chemicals in or on raw agricultural commodities when used as inert ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). This regulation eliminates the need to establish a maximum permissible level for residues of these EDTA chemicals.

NTP Information Cited
The toxicological profile data considered in this assessment included information located by the Office of Pesticide Programs on the internet, studies conducted by the National Toxicology Program (NTP) and the National Cancer Institute (NCI), several work products produced by the Cosmetic Ingredient Review, several evaluations by the World Health Organization, and articles from open literature.

Based on the available toxicity data on ethylenediaminetetraacetic acid (EDTA) and its various salts, with particular emphasis on the comparison of the findings in the two developmental toxicity studies; the reviews and evaluations conducted by NTP, NCI, and WHO; the knowledge that trace metal supplementation occurs via the food and drinking water consumed by human beings; and considering the estimated exposures of the wide-spread existing uses of ethylenediaminetetraacetic acid (EDTA) and its various salts which are less than levels at which adverse effects were noted, EPA concludes that there is a reasonable certainty of no harm from aggregate exposure to residues of ethylenediaminetetraacetic acid (EDTA) and its various salts. (TR-11)

In accordance with Health and Safety Code Section 116293 (SB1822, Sher, Statutes of 2002), the Office of Environmental Health Hazard Assessment (OEHHA) hereby publishes the final Public Health Goal (PHG) for cis/trans-1,2-dichloroethylene, 1,1,1-trichloroethane, 1,1,2-trichloroethane, radium-226 and 228, strontium-90, and tritium in drinking water. OEHHA has completed technical support documents that provide the scientific basis for the PHGs.

NTP Information Cited
NTP (2002). Toxicity Studies of trans-1,2-Dichloroethylene (CAS No. 156-60-5) Administered in Microcapsules in Feed to F344/N Rats and B6C3F₁ Mice. TOX-55.

In accordance with Health and Safety Code Section 116293 (SB1822, Sher, Statutes of 2002), the Office of Environmental Health Hazard Assessment (OEHHA) hereby publishes the final Public Health Goal (PHG) for cis/trans-1,2-dichloroethylene, 1,1,1-trichloroethane, 1,1,2-trichloroethane, radium-226 and 228, strontium-90, and tritium in drinking water. OEHHA has completed technical support documents that provide the scientific basis for the PHGs.

NTP Information Cited
NTP (1988). Developmental toxicity evaluation of 1,1,1-trichloroethane (CAS No. 7l-55-6) administered to CD rats. Final report part 2. TO151 and TO179.

NTP (1996). Technical report on renal toxicity studies of selected halogenated ethanes administered by gavage to F344/N rats. Toxicity Report Series. TOX-45

The Occupational Safety and Health Administration (OSHA) is amending the existing standard which limits occupational exposure to hexavalent chromium (Cr(VI)). OSHA has determined based upon the best evidence currently available that at the current permissible exposure limit (PEL) for Cr(VI), workers face a significant risk to material impairment of their health.

NTP Information Cited
The National Toxicology Program (NTP) conducted an extensive multigenerational reproductive assessment by continuous breeding where the chromate was administered in the diet. The assessment yielded negative results. Animal inhalation studies were also negative. Thus, it cannot be concluded that Cr(VI) is a reproductive toxin for normal working situations. (Hexavalent chromium)

The Environmental Protection Agency (EPA) is promulgating today's final rule, the Stage 2 Disinfectants and Disinfection Byproducts Rule (DBPR), to provide for increased protection against the potential risks for cancer and reproductive and developmental health effects associated with disinfection byproducts (DBPs).

NTP Information Cited
Two-year bioassays by the National Toxicology Program (NTP) released in abstract form have recently been completed on BDCM and chlorate. The draft abstract on BDCM reported no evidence of carcinogenicity when BDCM was administered via drinking water (NTP 2005a). Another recent study, a modified two-year bioassay on BDCM in the drinking water, reported little evidence of carcinogenicity (George et al. 2002). In a previous NTP study, tumors were observed, including an increased incidence of kidney, liver, and colon tumors, when BDCM was administered at higher doses by gavage in corn oil (NTP 1987). EPA will examine new information on BDCM as it becomes available. In the chlorate draft abstract, NTP found some evidence that it may be a carcinogen (NTP 2004). Chlorate is a byproduct of hypochlorite and chlorine dioxide systems. A long-term, two-year bioassay NTP study on DBA is also complete but has not yet undergone peer review (NTP 2005b). (TR-321) (TR-532) (GMM-5) (TR-517) (TR-537)

EPA is proposing revised standards to limit emissions of perchloroethylene (PCE) from existing and new dry cleaning facilities.

NTP Information Cited
NTP technical report on the toxicology and carcinogenesis of tetrachloroethylene (perchloroethylene) (CAS No. 127-18-4) in F344/N rats and B6C3F1 mice (inhalation studies) National Toxicology Program, Research Triangle Park, NC. (TR-311), NIH Publication No. 86-2567. August 1986.

EPA is amending the list of hazardous air pollutants contained in section 112 of the Clean Air Act by removing the compound methyl ethyl ketone (MEK) (2-Butanone) (CAS No. 78-93-3). This action is being taken in response to a petition submitted by the Ketones Panel of the American Chemistry Council (formerly the Chemical Manufacturers Association) on behalf of MEK producers and consumers to delete MEK from the HAP list. Petitions to remove a substance from the HAP list are permitted under section 112 of the CAA.

NTP Information Cited
There is an absence of positive results in the majority of mutagenicity and genotoxicity tests which are designed to indicate the potential for carcinogenicity. Methyl ethyl ketone has been tested for activity in an extensive spectrum of in vitro and in vivo genotoxicity assays and has shown no evidence of genotoxicity in most conventional assays (National Toxicology Program, no date; World Health Organization 1992; Zeiger et al., 1992).

While developing the final rule, EPA learned that preliminary results of a recent cancer bioassay by the National Toxicology Program suggested that methyl isobutyl ketone (MIBK) appears to be a weak or marginally active carcinogen in rats and mice, possibly by a nongenotoxic mode of action. (TR-538)

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of n-octanol (n-octyl alcohol) produced by a new manufacturing process, the hydrodimerization of 1,3-butadiene. This action is in response to a petition filed by Kuraray International Corp.

NTP Information Cited
The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. "Toxicology and Carcinogenesis Studies of 1,3-Butadiene (CAS No. 106-99-0) in B6C3F1 Mice (Inhalation Studies)," National Toxicology Program. (TR-434)

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding butyl benzyl phthalate (BBP) (CAS No. 85 68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), and di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3) to the list of chemicals known to the state to cause reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., commonly known as Proposition 65). The listing of the three phthalates is effective December 2, 2005 Toxicological endpoint: cancer. Toxicological endpoints: Developmental toxicity, Female reproductive toxicity, and Male reproductive toxicity

NTP Information Cited
National Toxicology Program. Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2003b). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-n-Butyl Phthalate (DBP). NIH Publication No. 03-4486.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding butyl benzyl phthalate (BBP) (CAS No. 85 68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), and di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3) to the list of chemicals known to the state to cause reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., commonly known as Proposition 65). The listing of the three phthalates is effective December 2, 2005 Toxicological endpoint: cancer. Toxicological endpoints: female reproductive toxicity and male reproductive toxicity

NTP Information Cited
National Toxicology Program. Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2003c). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-n-Hexyl Phthalate (DnHP). NIH Publication No. 03-4489.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding butyl benzyl phthalate (BBP) (CAS No. 85 68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), and di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3) to the list of chemicals known to the state to cause reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., commonly known as Proposition 65). The listing of the three phthalates is effective December 2, 2005 Toxicological endpoint: cancer. Toxicological endpoints: Developmental toxicity

NTP Information Cited
National Toxicology Program. Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2003a). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Butyl Benzyl Phthalate (BBP). NIH Publication No. 03-4487.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding estrogens, steroidal to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5, Proposition 65). The listing of estrogens, steroidal is effective August 19, 2005.

NTP Information Cited
National Toxicology Program (NTP, 2002). Report on Carcinogens, Tenth Edition. Carcinogen Profiles. U.S. Department of Health and Human Services, Public Health Service. National Institute of Environmental Health Sciences, Research Triangle Park, NC.

MSHA is proposing to revise their existing health standards for asbestos exposure at metal and nonmetal mines, surface coal mines, and surface areas of underground coal mines. The proposed rule would reduce the full-shift permissible exposure limit and the excursion limit for airborne asbestos fibers, and make several nonsubstantive changes to add clarity to the standard. Exposure to asbestos has been associated with lung and other cancers, mesotheliomas, and asbestosis. This proposed rule would help assure that fewer miners who work in an environment where asbestos is present would suffer material impairment of health or functional capacity over their working lifetime.

NTP Information Cited
There have been increasing numbers of studies on asbestos and its hazards over the past 40 years. These efforts encompass government, industry, and academia on a local, national, and international scale. Government agencies and scientific groups in the United States, such as the National Institute for Occupational Safety and Health (NIOSH), the Agency for Toxic Substances and Disease Registry (ATSDR), the American Conference of Governmental Industrial Hygienists (ACGIH), and the National Toxicology Program (NTP), have addressed issues involving carcinogens, such as asbestos.

In this final rule: MSHA revises the existing standards addressing diesel particulate matter (DPM) exposure in underground metal and nonmetal (M/NM) mines; changes the interim concentration limit measured by total carbon to a comparable permissible exposure limit measured by elemental carbon, which renders a more accurate DPM exposure measurement; increases flexibility of compliance for mine operators by requiring longstanding hierarchy of controls for its other exposure-based health standards at M/NM mines, but retains the prohibition on rotation of miners for compliance; requires MSHA to consider economic as well as technological feasibility in determining if operators qualify for an extension of time in which to meet the final DPM limit; deletes the requirement for a control plan; and makes conforming changes to existing provisions concerning compliance determinations, environmental monitoring and recordkeeping.

NTP Information Cited
Moyer, et al. review of NTP data from 90-day and 2-yr exposures of particulates and use of mouse inhalation model and the NTP 10th edition of the Report on Carcinogens are cited in the MSHA revision of existing standards addressing diesel particulate matter (DPM) exposure in underground metal and nonmetal (M/NM) mines. (ROC)

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding 2-bromopropane (2-BP) (CAS No. 75-26-3)...to the list of chemicals known to the state to cause cancer or reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5, Proposition 65). The listing of... 2-bromopropane (2-BP) is effective May 31, 2005. Toxicological endpoint: Female reproductive and male reproductive toxicity

NTP Information Cited
National Toxicology Program - Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2003). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of 2-Bromopropane . NIH Publication No. 04-4480. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, NTP, Research Triangle Park, NC.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding cobalt sulfate (CAS No. 10124-43-3) and diazoaminobenzene (CAS No. 136-35-6) to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5, Proposition 65). The listing of cobalt sulfate and diazoaminobenzene is effective May 20, 2005. Toxicological Endpoint: cancer

NTP Information Cited
National Toxicology Program (NTP, 2004). Report on Carcinogens, Eleventh Edition. Carcinogen Profiles. U.S. Department of Health and Human Services, Public Health Service. National Institute of Environmental Health Sciences, Research Triangle Park, NC.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding cobalt sulfate (CAS No. 10124-43-3) and diazoaminobenzene (CAS No. 136-35-6) to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5, Proposition 65). The listing of cobalt sulfate and diazoaminobenzene is effective May 20, 2005. Toxicological Endpoint: cancer

NTP Information Cited
NTP concluded that diazoaminobenzene (DAAB) is reasonably anticipated to be a human carcinogen based on evidence from studies in animals and with human tissue demonstrating that DAAB is metabolized to benzene, a known human carcinogen, and on evidence that DAAB causes genetic damage. 

This regulation establishes exemptions from the requirement of a tolerance for residues of several alpha and/or beta-pinene polymers when used as inert ingredients in or on growing crops and when applied to raw agricultural commodities after harvest. Hercules, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of alpha and/or beta-pinene polymers.

NTP Information Cited
The data considered in this assessment included information submitted by the petitioner, and information located by OPP on the internet, primarily information prepared by the National Toxicology Program (NTP) and the robust summaries for bicyclic terpene hydrocarbons submitted in 2002 to EPA by the Terpene Consortium of the Flavor and Fragrance High Production Volume Consortia (FFHPVC).

This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities.

NTP Information Cited
In an oral gavage chronic toxicity/oncogenicity study conducted by the National Toxicology Program at dose levels of 0, 250 and 500 mg/kg/day in F344 rats and B6C3F1 mice, there was some evidence of carcinogenicity of isophorone in male rats (kidney tumors, preputial gland carcinomas). (TR-291)

The Occupational Safety and Health Administration (OSHA) has conducted a review of its Ethylene Oxide (EtO) Standard pursuant to section 610 of the Regulatory Flexibility Act and section 5 of Executive Order 12866 on Regulatory Planning and Review.

NTP Information Cited
There is a continued need for the rule. Workers exposed to EtO in a range of industries would continue to be at risk of cancer, genetic changes and other adverse health effects, without the standard. Since the standard was developed, the International Agency for Research on Cancer reclassified EtO as a known human carcinogen and the National Toxicology program reclassified EtO as a one "known to be a human carcinogen." (TR-326)(ROC)

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of acacia (gum arabic) as a thickener, emulsifier, or stabilizer in alcoholic beverages at a maximum use level of 20 percent. This action is in response to a petition filed by Kerry, Inc.

NTP Information Cited
FDA conducted literature searches that updated the information that had formed the basis of the Select Committee report. The agency reviewed toxicological data from a 1982 National Toxicology Program (NTP) report of 2-year carcinogenicity feeding studies on acacia in F344 rats and B6C3F1 mice. The agency evaluated the carcinogenicity of acacia and concluded that F344 rats and B6C3F1 mice consuming diets containing up to 5-percent acacia for 2 years showed no increased incidences of tumors at any site. (TR-227)

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding vanadium pentoxide (orthorhombic crystalline form) to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., Proposition 65). The listing of the chemical is effective February 11, 2005. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 2002). Toxicology and Carcinogensis Studies of Vanadium Pentoxide (CAS No. 1314-62-1) in F344/N Rats and B6C3F1 Mice (Inhalation). NTP Technical Report Series No. 507. NIH Publication No. 03-4441. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, NTP, Research Triangle Park, NC.

The Commission is proposing a flammability standard under the authority of the Flammable Fabrics Act that would address open flame ignition of mattresses and mattress and foundation sets ("mattresses/sets").

NTP Information Cited
Additional activities by EPA, The National Toxicology Program (NTP) of the Department of Health and Human Services (DHHS), and the Occupational Safety and Health Administration (OSHA) can provide information about any adverse health effects of FR chemicals and take actions to limit their use if necessary.

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled "Guidance for Industry: Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients." The guidance recommends content for a labeling statement for cosmetic products containing alpha hydroxy acids (AHAs) as ingredients.

NTP Information Cited
Publication of this guidance is an interim measure while FDA continues to review the data on the effects of AHA-containing products on skin sensitivity to UV radiation, including a photocarcinogenicity study by the National Toxicology Program's Center for Phototoxicology and recent studies published in peer-reviewed journals. FDA invites comments to continue to inform FDA of new studies when they become available. (TR-524)

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding 1-bromopropane (1-BP) to the list of chemicals known to the state to cause reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., Proposition 65). The listing of the chemical is effective December 7, 2004. Toxicological Endpoint: Developmental, female reproductive and male reproductive toxicity

NTP Information Cited
NTP Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR 2003). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of 1-Bromopropane (CAS No. 106-94-5). NIH Publication No. 04-4479

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding riddelliine to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5, Proposition 65). The listing of riddelliine is effective December 3, 2004. Toxicological Endpoint: Cancer

NTP Information Cited
Health and Safety Code section 25249.8(a) requires that certain substances identified by the International Agency for Research on Cancer (IARC) or the National Toxicology Program (NTP), as described in Labor Code sections 6382(b)(1) and (d), be included on the Proposition 65 list. 

The EPA is amending the list of hazardous air pollutants contained in section 112(b)(1) of the Clean Air Act by removing the compound ethylene glycol monobutyl ether (EGBE) (2-Butoxyethanol)(CAS No. 111-76-2) from the group of glycol ethers.

NTP Information Cited
In the preamble to the proposed rule, we stated that the Agency believes EGBE is not genotoxic and that two distinctly different nonlinear modes of action are principally responsible for the increased forestomach and liver tumors reported by NTP (TR-494).

OSHA proposes to amend its existing standard for employee exposure to hexavalent chromium (Cr(VI)). The basis for issuance of this proposal is a preliminary determination by the Assistant Secretary that employees exposed to Cr(VI) face a significant risk to their health at the current permissible exposure limit and that promulgating this proposed standard will substantially reduce that risk.

NTP Information Cited
The NTP's First Annual Report on Carcinogens identified calcium chromate, chromium
chromate, strontium chromate, and zinc chromate as carcinogens in 1980.

The NTP conducted an extensive multigenerational reproductive assessment by continuous breeding where the chromate was administered in the diet. The assessment yielded negative results.

The EPA is promulgating national emission standards for hazardous air pollutants for industrial, commercial, and institutional boilers and process heaters and has identified industrial, commercial, and institutional boilers and process heaters as major sources of hazardous air pollutants.

NTP Information Cited
A NTP study (TR-392) showed no evidence of carcinogenic activity in male rats or male and female mice, and equivocal evidence in female rats, from ingestion of chlorinated water. The EPA has not classified chlorine for potential carcinogenicity.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding aristolochic acids and herbal remedies containing plant species of the genus Aristolochia to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5, Proposition 65). The listing of "aristolochic acids and herbal remedies containing plant species of the genus Aristolochia is effective July 9, 2004. Toxicological Endpoint: Cancer

NTP Information Cited
Health and Safety Code section 25249.8(a) requires that certain substances identified by the International Agency for Research on Cancer (IARC) or the National Toxicology Program (NTP), as described in Labor Code sections 6382(b)(1) and (d), be included on the Proposition 65 list. 

The Department of the Treasury is removing the requirement for bottlers of wine, distilled spirits, and malt beverages to show a warning on products containing saccharin.

NTP Information Cited
Since 1981, saccharin had been listed in the Report on Carcinogens as reasonably anticipated to be a human carcinogen. However, it was delisted in the 9th Report on Carcinogens. The NTP determined that the rodent cancer data is insufficient to meet the current criteria to list the chemical as reasonably anticipated to be a human carcinogen. This is based on the perception that the observed bladder tumors in rats arise by mechanisms not relevant to humans and the lack of data in humans suggesting a carcinogenic hazard.

Amends the Alcohol and Tobacco Tax and Trade Bureau's labeling regulations to remove the requirement for bottlers of wine, distilled spirits, and malt beverages to show a warning on products containing saccharin. The regulatory amendments in this document reflect the National Toxicology Program's revised findings about saccharin and the removal of the statutory requirement for the warning.

NTP Information Cited
On May 15, 2000, the U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program published the 9th Report on Carcinogens. The report delisted saccharin, which had been listed in the Report as "reasonably anticipated to be a human carcinogen" since 1981. The Report explained that saccharin was removed from the list after a review of the carcinogenicity data for saccharin concluded that rodent cancer data are not sufficient to meet the current criteria to list this chemical as reasonably anticipated to be a human carcinogen based on the perception that the observed bladder tumors in rats arise by mechanisms not relevant to humans, and the lack of data in humans suggesting a carcinogenic hazard.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding 3,3'-dimethoxybenzidine-(DMOB)based dyes metabolized to 3,3'-dimethoxybenzidine, 3,3'-dimethylbenzidine- (DMB)based dyes metabolized to 3,3'-dimethylbenzidine, ethylbenzene, propylene glycol mono-t-butyl ether, and thiouracil to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., Proposition 65). The listing of these chemicals is effective June 11, 2004. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 2004). Toxicology and Carcinogenesis Studies of Propylene Glycol Mono-t-Butyl Ether (CAS No. 57018-52-7) In F344/N Rats and B6C3F1 Mice and a Toxicology Study of Propylene Glycol Mono-t-Butyl Ether In Male NBR Rats (Inhalation Studies). NTP Technical Report Series No. 515. NIH Publication No. 04-4449

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding 3,3'-dimethoxybenzidine-(DMOB)based dyes metabolized to 3,3'-dimethoxybenzidine, 3,3'-dimethylbenzidine- (DMB)based dyes metabolized to 3,3'-dimethylbenzidine, ethylbenzene, propylene glycol mono-t-butyl ether, and thiouracil to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., Proposition 65). The listing of these chemicals is effective June 11, 2004. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 2002). Tenth Report on Carcinogens. Carcinogen Profiles. U.S. Department of Health and Human Services, Public Health Service. National Institute of Environmental Health Sciences, Research Triangle Park, NC.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding 3,3'-dimethoxybenzidine-based dyes metabolized to 3,3'-dimethoxybenzidine, 3,3'-dimethylbenzidine-based dyes metabolized to 3,3'-dimethylbenzidine, ethylbenzene, propylene glycol mono-t-butyl ether, and thiouracil to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., Proposition 65). The listing of these chemicals is effective June 11, 2004. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 2002). Tenth Report on Carcinogens. Carcinogen Profiles. U.S. Department of Health and Human Services, Public Health Service. National Institute of Environmental Health Sciences, Research Triangle Park, NC.

The FDA is requesting the submission of data and information on furan, a heat treatment related byproduct that has been detected in certain thermally treated foods.

NTP Information Cited
Results from the NTP bioassay on furan (TR-402) showed clear evidence of carcinogenic activity in both rats and mice. Cytotoxic and carcinogenic effects were seen at all doses, and a no adverse effect level was not identified. The FDA would like to acquire data on the effects of furan doses lower than those used in the NTP study.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding nickel compounds to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5, Proposition 65). The listing of nickel compounds is effective May 7, 2004. Toxicological Endpoint: Cancer

NTP Information Cited
NTP released its Tenth Report on Carcinogens in 2002 in which it included nickel compounds on the list of substances as known to be human carcinogens. 

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the publication of the final Public Health Goal (PHG) for arsenic.

NTP Information Cited
NTP (1989). Toxicology and Carcinogenesis Studies of Roxarsone (CAS No. 121-19-7) in F344/N Rats and B6C3F₁ Mice (Feed Studies). TR-345.

The EPA proposes national emission standards for hazardous air pollutants (HAPs) for hazardous waste combustors (HWCs). These proposed standards will, when final, implement section 112(d) of the Clean Air Act by requiring HWCs to meet HAP emission standards reflecting the application of the maximum achievable control technology.

NTP Information Cited
Nickel has been identified as a HAP emitted from HWCs. The EPA used data from the NTP inhalation studies of Nickel (II) Oxide (TR 451) and Nickel Sulfate Hexahydrate (TR 454) in identifying risks associated with exposure to nickel. The 2001 DHHS National Toxicology Program 9th Report on Carcinogens classified 2,3,7,8-TCDD as a known human carcinogen.

This action proposes national emission standards for hazardous air pollutants for hazardous waste combustors including hazardous waste burning incinerators, cement kilns, lightweight aggregate kilns, industrial/commercial/ institutional boilers and process heaters, and hydrochloric acid production furnaces that EPA has identified as major sources of hazardous air pollutant emissions. Proposed standards will implement section 112(d) of the Clean Air Act (CAA) by requiring hazardous waste combustors to meet emission standards.

NTP Information Cited
In 2001 the DHHS National Toxicology Program classified 2,3,7,8-TCDD as a know human carcinogen in it's 9th Report on Carcinogens.

A pair of inhalation studies (TR-453 and TR-454) performed under the auspices of the National Toxicology Program (NTP) of the National Institutes of Health concluded that there was no evidence of carcinogenic activity of soluble nickel salts in rats or mice and that there was some evidence of carcinogenic activity of nickel oxide (TR-451) in male and female rats based on increased incidence of alveolar/bronchiolar adenoma or carcinoma and increased incidence of benign or malignant pheochromocytoma (a tumor of the adrenal gland) and equivocal evidence in mice based on marginally increased incidence of alveolar/bronchiolar adenoma or carcinoma in females and no evidence in males.

In December 2006, the Tenth Annual Report on Carcinogens classifies nickel compounds as "known to be human carcinogens".

Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk

NTP Information Cited
One comment objected that animal studies using ephedrine alkaloids to evaluate the safety of ephedrine alkaloids as dietary ingredients were not considered in the evaluation and cited the results of the National Toxicology Program's long term rodent studies on ephedrine (TR-307).

The Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) transmitted its Fifty-Third Report to the Administrator of the EPA on December 2, 2003 revising the Priority Testing List by adding 3 pyridinamines and 20 tungsten compounds requesting that EPA add the 3 pyridinamines and 20 tungsten compounds to the TSCA section 8(a) Preliminary Assessment Information Reporting (PAIR) rule and soliciting voluntary use, exposure, and effects information for 3 pyridinamines, 20 tungsten compounds, and 43 vanadium compounds through its Voluntary Information Submissions Innovative Online Network.

NTP Information Cited
Tungsten was nominated for toxicology and carcinogenicity studies to the National Toxicology Program by the Centers for Disease Control and Prevention's National Center for Environmental Health based on recent data showing elevated tungsten body burdens in residents of Fallon, NV, and the limited data available to assess the potential long-term adverse health effects of tungsten exposure. Further information is needed to more fully evaluate human and environmental exposures and health effects.

The EPA proposes to amend the list of hazardous air pollutants contained in section 112(b)(1) of the Clean Air Act by removing ethylene glycol monobutyl ether from the group of glycol ethers.

NTP Information Cited
The EPA used data from the NTP's 2-year inhalation study (TR-484) in considering the removal of EGBE from the list of hazardous air pollutants.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding fumonisin B1 to the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The listing of fumonisin B1 is effective November 14, 2003 Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 2001). Toxicology and Carcinogenesis Studies of Fumonisin B1 (CAS No. 116355-83-0) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 496, NIH Publication No. 01-3955

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the availability of the final technical support documents for a Public Health Goal (PHG) for each of the following eleven (11) chemicals in drinking water.

NTP Information Cited
NTP (1983). Lifetime carcinogenesis studies of amosite asbestos (CAS No. 12172-73-5) in Syrian golden hamsters (feed studies). Tech report series No. 249.

NTP (1985). Toxicology and carcinogenesis studies of chrysotile asbestos (CAS No. 12001-29-5) in F344/N rats (feed studies ). Tech report series No. 295.

NTP (1988). Toxicology and carcinogenesis studies of crocidolite asbestos (CAS No. 12001-28-4) in F344/N rats (feed studies). Tech report series No. 280.

NTP (1990a). Lifetime carcinogenesis studies of chrysotile asbestos (CAS No. 12001- 29-5) in Syrian golden hamsters (feed studies). Tech report series No. 246.

NTP (1990b). Toxicology and carcinogenesis series of amosite asbestos in F344/N rats. Tech report series No. 279.

NTP (1990c). Technical Report on the toxicology and carcinogenesis studies of tremolite (CAS No. 14567-73-8) in Fischer 344 rats (feed studies). Tech report series No. 277.

NTP (2000). Asbestos. CAS No. 1332-21-4. Ninth Report on Carcinogens

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the availability of the final technical support documents for a Public Health Goal (PHG) for each of the following eleven (11) chemicals in drinking water.

NTP Information Cited
NTP (1982). Carcinogenesis bioassay of di(2-ethylhexyl)adipate (CAS No. 103-23-1) in F344 Rats and B6C3F₁ Mice (Feed Study). Technical Report, Series No. 212.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the availability of the final technical support documents for a Public Health Goal (PHG) for each of the following eleven (11) chemicals in drinking water.

NTP Information Cited
NTP (1985). Technical Report on the Toxicology and Carcinogenesis Studies of Chlorobenzene (CAS No. 108-90-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP TR 261.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the availability of the final technical support documents for a Public Health Goal (PHG) for each of the following eleven (11) chemicals in drinking water.

NTP Information Cited
NTP (1982). Carcinogenesis bioassay of 1,2-dibromoethane in F344 rats and B6C3F1 mice (inhalation study). Technical report No. 210.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the availability of the final technical support documents for a Public Health Goal (PHG) for each of the following eleven (11) chemicals in drinking water. (barium)

NTP Information Cited
NTP (1994). Technical report on the toxicology and carcinogenesis studies of barium chloride dihydrate (CAS No. 10326-27-9) in F344/N rats and B6C3F1 mice. TR-432

The EPA is proposing maximum contaminant level goals (MCLGs) for chloroform, monochloroacetic acid and trichloroacetic acid;National Primary Drinking Water Regulations for total trihalomethanes and haloacetic acids; and revisions to the reduced monitoring requirements for bromates.

NTP Information Cited
The EPA used data from the NTP Toxicology and Carcinogenesis Studies of Bromodichloromethane (TR-321), Tribromomethane (TR-350), and Monochloroacetic Acid (TR-396) in determining the MCLGs for water disinfection byproducts.

The Department of Labor is proposing revising the existing diesel particulate matter (DPM) interim concentration limit.

NTP Information Cited
A published review of the particulate inhalation studies conducted by the NTP was used to update the toxicological effects of DPM exposure.

The FDA is proposing a rule that would establish conditions under which over-the-counter drug products for the reduction or prevention of dental plaque and gingivitis are generally recognized as safe and effective and not misbranded.

NTP Information Cited
The NTP 13-week Stannous Chloride studies were used to develop the existing safety factor for potential exposure to Stannous salts from use of a dentifrice containing stannous fluoride. (TR-231)

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding strong inorganic acid mists containing sulfuric acid to the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The listing of strong inorganic acid mists containing sulfuric acid is effective March 14, 2003. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 2000). Report on Carcinogens, Ninth Edition: Carcinogen Profiles. U.S. Department of Health and Human Services, Public Health Service, NTP, Research Triangle Park, NC.

The FDA is prohibiting the extralabel use of phenylbutazone animal and human drugs in female dairy cattle 20 months of age or older. The extralabel use presents a risk to the public health.

NTP Information Cited
The FDA has determined that the extralabel use of phenylbutazone presents a risk to the public health. The FDA's conclusion is based on available toxicology data including data from the NTP Toxicology and Carcinogenesis Studies of Phenylbutazone (TR-367) and the NTP genotoxicity tests.

The EPA has established an exemption from the tolerance requirements pursuant to FFDCA 408(c) and 9(d) for residues of certain Sucrose Octanoate Esters (SOEs) in or on all food commodities when applied/used in accordance with good agricultural practices.

NTP Information Cited
The EPA has determined, based on available toxicology data including data from an NTP genetic toxicology study, that no harm will result from aggregate exposure of residues of SOEs to the U.S. population.

The EPA is soliciting public comment on whether a preliminary determination that nine contaminants do not meet all three Safe Drinking Water Act requirements is appropriate, and thus no National Primary Drinking Water Regulations (NPDWR) should be considered for these contaminants.

NTP Information Cited
The EPA used data from the NTP Toxicity Studies of Hexachloro-1,3-butadiene, (TOX- 1) and Naphthalene (TR-410) & (TR-500) in determining that NPDWRs should not be considered for these contaminants.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding pyridine to the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The listing of pyridine is effective May 17, 2002. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 2000). Toxicology and Carcinogenesis Studies of Pyridine (CAS No. 110-86-1) in F344/N Rats, Wistar Rats and B6C3F1 Mice (Drinking Water Studies). NTP Technical Report Series No. 470. NIH Publication No. 97-3960.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding naphthalene to the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The listing of naphthalene is effective April 19, 2002. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 2000). Toxicology and Carcinogenesis Studies of Naphthalene (CAS No. 91-20-3) in F344/N Rats (Inhalation Studies). NTP Technical Report Series No. 500. NIH Publication No. 01-4434.

EPA intends to reclassify eight inert ingredients from List 2, Potentially Toxic Inerts/High Priority for Testing to List 1 Inerts of Toxicological Concern. One of the criteria for being considered a List 1 inert ingredient is to be characterized by the NTP as an animal carcinogen in at least one species and sex.

NTP Information Cited
The EPA used data from the NTP Toxicology and Carcinogenesis Studies of 2-Benzyl-4-chlorophenol (TR-424), 2-Butoxyethanol (TR-484), Butyl benzyl Phthalate (TRs 213 & 458), Diethanolamine (TR-478), Ethylbenzene (TR-466), 1,2-Epoxybutane (TR-329), 2-Mercaptobenzothiazole (TR-332), and Nitromethane (TR-461) to support its reclassification of these inert ingredients to List 1. (TR-444)

The EPA established tolerances for combined residues of the insecticide diflubenzuron and its metabolites 4-chlorophenylurea and 4-chloroaniline (PCA) in or on pear.

NTP Information Cited
Information from the NTP bioassay of p-Chloroaniline Hydrochloride, TR-351, was used to establish the tolerance of diflubenzuron and its metabolites 4-chlorophenylurea and 4-chloroaniline at .50 ppm in or on pears.

The EPA is proposing AEGLs for 8 chemicals to provide Federal, State, and local agencies with threshold short-term exposure to hazardous airborne chemicals.

NTP Information Cited
The EPA used data from the NTP Toxicology and Carcinogenesis Studies of Propylene Oxide (TR-267) in determining the proposed AEGL values for propylene oxide.

The Food and Drug Administration is announcing the availability of draft recommendations for the revision of the permitted daily exposures (PDE) for n-methylpyrrolidone and tetrahydrofuran.

NTP Information Cited
Based on data from NTP Carcinogenicity Studies of Tetrahydrofuran, (TR-475), the ICH Steering Committee recommended that tetrahydrofuran be moved from class 3 into class 2.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding the chemical methyleugenol to the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The chemical is listed effective November 16, 2001. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 2000a). Toxicology and Carcinogenesis Studies ofMethyleugenol (CAS No. 93-15-2) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 491 NIH Publication No. 00-3950.

The EPA is proposing AEGLs for 18 chemicals to provide Federal, State, and local agencies with threshold short-term exposure limits for the public to hazardous, airborne chemicals.

NTP Information Cited
The EPA used data from the NTP Toxicology and Carcinogenesis Studies of Tetrachloroethylene (TR-311) and Tetranitromethane (TR-386) in determining the proposed AEGL values for these two chemicals.

The California Environmental Protection Agency's Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency for the implementation of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). As the lead agency, OEHHA is removing saccharin from the list of chemicals known to the state to cause cancer, for purposes of Proposition 65. Saccharin [CAS No. 81-07-2] was originally added to the Proposition 65 list on October 1, 1989. This chemical was added to the Proposition 65 list as a result of the issuance of a judicial decision enforcing Labor Code Section 6382(b)(1) and (d) which are incorporated by reference as Proposition 65 listing provisions pursuant to Health and Safety Code Section 25249.8(b). Labor Code Section 6382(b)(1) requires inclusion of substances listed as human or animal carcinogens by the International Agency for Research on Cancer (IARC). Labor Code Section 6382(d) requires the inclusion of chemicals identified as carcinogens or potential carcinogens by IARC or the National Toxicology Program (NTP). Saccharin was identified by IARC and NTP as causing cancer.

NTP Information Cited
In 2000, NTP released its Ninth Report on Carcinogens in which it delisted saccharin [CAS No. 81 07-2] from the list of substances reasonably anticipated to be a human carcinogen. 

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding thirteen chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The chemicals are listed effective February 27, 2001. Ethoprop, indium phosphide, lynestrenol, norethynodrel, and propachlor are listed pursuant to an administrative listing mechanism provided under Proposition 65, based upon a formal identification by an authoritative body that the chemicals cause cancer.

NTP Information Cited
National Toxicology Program (NTP, 2000a). Toxicology and Carcinogenesis Studies of Indium Phosphide (CAS No. 22398-80-7) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Board Draft. NTP Technical Report Series No. 499. NTIS Publication No. 00-4433.

The Department of Labor is establishing new health standards for underground coal mines that use equipment powered by diesel engines. High concentrations of diesel particulate matter (DPM) increases the risk of serious health hazards in underground mines.

NTP Information Cited
The NTP is listed as one of many scientific organizations and governmental agencies that has reviewed the available epidemiologic and toxicological evidence for carcinogenicity and has identified dpm as a probable human carcinogen. (9th Report on Carcinogens)

The EPA is setting new diesel exhaust emission standards for heavy-duty highway engines to protect the public's health. Health studies indicate potential hazards that appear to be related to acute and chronic exposure.

NTP Information Cited
The EPA cited the NTP as an example of a governmental agency that has identified diesel exhaust particles as reasonably anticipated to be a human carcinogen.(Ninth Report on Carcinogens).

The EPA is lowering the reporting thresholds for lead and lead compounds which are subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act and section 6607 of the Pollution Prevention Act.

NTP Information Cited
Commenters contended that the Persistent Bioaccumulative Toxic Chemicals (PBT) rule framework was designed only for organic substances and is being incorrectly applied to metals. The EPA disagreed citing, as an example, the NTP's criteria for characterizing chemical carcinogens is the same for organic as well as inorganic substances to support its position that it is scientifically valid to establish generic criteria that are applicable to all substances. (8th Report on Carcinogens)

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding five chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The chemicals are listed effective December 22, 2000. Bromoethane and isoxaflutole are listed pursuant to an administrative listing mechanism provided under Proposition 65, based upon a formal identification by an authoritative body that the chemicals cause cancer.

NTP Information Cited
National Toxicology Program (NTP, 1989). Toxicology and Carcinogenesis Studies of Bromoethane (Ethyl Bromide) (CAS No. 74-96-4) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). NTP Technical Report Series No. 363 NTIS Publication No. 90-2818.

The FDA is amending the food additive regulations to provide for the safe use of hydrogenated butadiene/acrylonitrile copolymers intended for contact with food in repeated use applications. Although the additive itself has not been shown to cause cancer, it has been found to contain residual amounts of acrylonitrile and butadiene, carcinogenic impurities resulting from the manufacture of the additive.

NTP Information Cited
The FDA used data from the NTP Carcinogenicity Study of 1,3-Butadiene, (TR-434), to estimate the upper-bound limit of lifetime human risk from exposure resulting from the use of the additive. And based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to butadiene would result from the proposed use of the additive.

OSHA is promulgating new standards regulating exposure to MDA.

NTP Information Cited
The Committee determined that the tumors found in the NTP study did not result from exposure to MDA. (TR-248)

The EPA has established tolerances for combined residues of vinclozolin and its metabolites containing the 3,5-dichloroaniline moiety in or on specific raw agricultural commodities.

NTP Information Cited
The EPA used data from the NTP's p-Chloroaniline bioassay (TR-351) to help assess the carcinogenicity for structurally related chloroanilines.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding three chemicals to the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The chemicals are listed effective June 2, 2000 pursuant to an administrative listing mechanism provided under Proposition 65, based upon a formal identification by an authoritative body that the chemical causes cancer.

NTP Information Cited
National Toxicology Program (NTP, 1998a). Toxicology and Carcinogenesis Studies of Chloroprene (CAS No. 126-99-8) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Board Draft. NTP Technical Report Series No. 467 NTIS Publication No. 98-3957.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding three chemicals to the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The chemicals are listed effective June 2, 2000 pursuant to an administrative listing mechanism provided under Proposition 65, based upon a formal identification by an authoritative body that the chemical causes cancer.

NTP Information Cited
National Toxicology Program (NTP, 1996). Toxicology and Carcinogenesis Studies of Isobutyl Nitrite (CAS No.542-56-3) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). NTP Technical Report Series No. 448.

The EPA has received a pesticide petition for establishing a tolerance for residues of diflubenzuron in or on the raw agricultural commodity rangeland grass at 6.0 ppm. P-Chloroaniline (PCA) is a metabolite of diflubenzuron.

NTP Information Cited
Information from the NTP bioassay of p-Chloroaniline Hydrochloride, TR-351, was used to determine that the dietary risk from diflubenzuron-derived PCA is below EPA's level of concern.

OSHA notice providing index to Jan. 19, 1989 final rule and list of references relied upon for health effects evaluations in rule.

NTP Information Cited
NTP references cited include TR-306, TR-228, TR-263, TR-273, ;TR-311, TR-259, TR-251.

The FDA is amending the food additive regulations to provide for the safe use of ethylene-norbornene copolymers as articles or components of articles in contact with dry food. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of benzene, a carcinogenic impurity resulting from the manufacture of the additive.

NTP Information Cited
The FDA used data from the NTP Carcinogenicity Study of Benzene (TR-289), to estimate the upper-bound limit of lifetime human risk from exposure resulting from the use of the additive. And based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to benzene would result from the proposed use of the additive.

The EPA proposed to terminate the Special Review of 1,3-Dichloropropene (1,3-D). The EPA has determined that the benefits associated with the continued use of 1,3-D under the recently revised terms and conditions of 1,3-D's reregistration outweigh the risks.

NTP Information Cited
The EPA classified 1,3-D as a probable, human carcinogen based on the review of data from carcinogenicity studies including the NTP Toxicology and Carcinogenesis Studies of Telone II (TR-269).

The FDA is amending the food additive regulations to provide for the safe use of 4,5-dichloro-1,2-dithiol-3-one as a slimicide in the manufacture of food-contact paper and paperboard. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of tetrachloroethylene, a carcinogenic impurity resulting from the manufacture of the additive

NTP Information Cited
The FDA used data from the NTP Carcinogenicity Study of Tetrachloroethylene (TR-311), to estimate the upper-bound limit of lifetime human risk from exposure resulting from the use of the additive. And based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to tetrachloroethylene would result from the proposed use of the additive.

The EPA established tolerances for residues of the insecticide diflubenzuron and its metabolites 4-chlorophenylurea and 4-chloroaniline in/on rice grain at 0.02 ppm and rice straw at 0.8 ppm.

NTP Information Cited
The 4-chloroaniline (PCA) metabolite was classified as a Group B2 carcinogen (probable human carcinogen) based on the results of the NTP bioassay on PCA (TR-351). The NTP bioassay and the results of several NTP mutagenicity studies on PCA discussed in the bioassay report were part of the information used to estimate dietary risk assessments.

The EPA is denying a petition to remove acetonitrile from the list of chemicals subject to the reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA) and section 6607 of the Pollution Prevention Act of 1990 (PPA).

NTP Information Cited
EPA reviewed all of the available data, including the NTP Technical Report of the Toxicology and Carcinogenesis of Acetonitrile (TR-447), to conclude that acetonitrile can reasonably be anticipated to cause serious or irreversible chronic health effects in humans, including neurotoxicity and death.

The FDA is issuing a final rule establishing that the over-the-counter stimulant laxative ingredients danthron and phenolphthalein are not generally recognized as safe and effective and are misbranded.

NTP Information Cited
After reviewing all of the available data, including the NTP phenolphthalein studies, the FDA concluded that phenolphthalein caused chromosome aberrations, cell transformation, and mutagenicity in mammalian cells and is reasonably anticipated to have human carcinogenic potential. TR 465: Toxicology and Carcinogenesis Studies of Phenolphthalein in F344/N Rats and B6C3F1 Mice (Feed Studies) Dunnick JK et al.,; Phenolphthalein Induces Thymic Lymphomas Accompanied By Loss Of The P53 Wild Type Allele In Heterozygous P53-Deficient (+/-) Mice,; Toxicologic Pathology 1997, 25(6): 533-540.

This Notice provides the status of ATSDR's Superfund mandated Substance-Specific Applied Research Program (SSARP). To date, 188 priority data needs have been identified for the 50 priority hazardous substances frequently found at waste sites.

NTP Information Cited
The ATSDR maintains an interagency agreement (IAG) with NTP to conduct toxicologic testing of substances identified at National Priority List sites.  Under this agreement, the NTP filled the toxicity priority data need for the immunotoxicology study of carbon tetrachloride.  The NTP is currently addressing reproductive toxicity data needs for chlordane, endrin, and heptachor; the bioavailability of PCB's in soil; and dose-response data for di-n-butyl phthalate.

The FDA is amending the food additive regulations to provide for the safe use of 2,9-dichloro-5,12-dihydroquinone[2,3-b]acridine-7,14-dione (C.I. Pigment Red 202) as a colorant for polymers used in contact with food. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of para-chloroaniline, a carcinogenic impurity resulting from the manufacture of the additive.

NTP Information Cited
The FDA used data from the NTP carcinogenicity study of para-Chloroaniline Hydrochloride (TR-351) to estimate the upper-bound limit of lifetime human risk from exposure resulting from the proposed  use of the additive. And, based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to para-chloroaniline would result from the proposed use of the additive

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1996a). NTP Technical Report on Comparative Toxicity and Carcinogenicity Studies of o-Nitrotoluene and o-Toluidine Hydrochloride (CAS Nos. 88-72-2 and 636-21-5). Administered in Feed to Male F344/N Rats. NTP Toxicity Report Series No. 44. NTIS Publication Number 96-3936.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1994). Seventh Annual Report on Carcinogens: 1994. Volume 1: 357-362. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1981). Carcinogenesis Bioassay of Cytembena (CAS No. 21739-91-3). NTP Technical Report Series No. 207. NTIS Publication No. 81-1763.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1987). Toxicology and Carcinogenesis Studies of Methyl Carbamate (CAS No. 598-55-0) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 328. NTIS Publication No. 88-2584.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1996b). Toxicology and Carcinogenesis Studies of Phenolphthalein (CAS No. 77-09-8) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 465. NTIS Publication No. 97-3390.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1989a). Toxicology and Carcinogenesis Studies of para-Chloroaniline Hydrochloride (CAS No. 20265-96-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 351.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1989b). Toxicology and Carcinogenesis Studies of Nalidixic Acid (CAS No. 389-08-2) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 368. NTIS Publication No. 90-2823.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1982a). Carcinogenesis Bioassay of C.I. Solvent Yellow 14 (CAS No. 842-07-9) in F344/N Rats and B6C3F1 Mice (Feed Study). NTP Technical Report Series No. 226. NTIS Publication No. 82-1782.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1997). Toxicology and Carcinogenesis Studies of Salicylazosulfapyridine (CAS No. 599-79-1) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 457. NTIS Publication No. 97-3373.

This regulation establishes a temporary tolerance for residues of the insecticide diflubenzuron and metabolites convertible to p-chloroaniline (PCA) expressed as diflubenzuron on rice grain at 0.01 ppm.

NTP Information Cited
PCA was classified as a Group B2 carcinogen (probable human carcinogen). The classification for PCA was based on the results of the NTP bioassay on p-chloroaniline hydrochloride (TR-351). The results of several NTP mutagenicity studies on PCA discussed in the bioassay report were also cited.

EPA is adding tribromophenol and wastes generated from its production to its list of CERCLA hazardous substances. EPA used structure activity relationship (SAR) analysis information in support of its listing of tribromophenol.

NTP Information Cited
NTP mutagenicity studies are cited to show that a negative in Salmonella does not necessarily predict that 2,4,6-trichlorophenol is not a carcinogen. As part of its validation of the use of SAR analysis for identifying hazardous wastes, EPA cited a comparison of the NTP bioassay of 1,2-dibromoethane (TR-210) with the NCI bioassay of 1,2-dichloroethane (TR-55). The study results showed that carcinogenic activity was retained with the substitution of a chlorine by a bromine.

The Safe Drinking Water Act (SDWA) requires the EPA to publish a list of contaminants that are known or anticipated to occur in public water systems and which may require regulation under the SDWA. The EPA has reviewed and considered public comments of the draft CCL in creating the final CCL.

NTP Information Cited
As part of its evaluation of the risk associated with methyl bromide's contamination of drinking water, the EPA cited the results of the NTP 2-year inhalation study (TR-385).

As part of its ongoing review of OTC drug products, the FDA is proposing to amend the tentative final monograph for over-the-counter laxative drug products by reclassifying phenolphthalein from Category I (generally recognized as safe and effective) to Category II (not generally recognized as safe and effective).

NTP Information Cited
Based on the results of NTP studies, the FDA considers use of phenolphthalein a potential risk to humans. The NTP findings of rodent carcinogenicity and genotoxicity in several test systems indicate that chronic use of phenolphthalein could lead to damage to the human genome and could increase the risk of malignancy.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 18 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective August 26, 1997. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1992). Toxicology and Carcinogenesis Studies of C.I. Direct Blue 15 (CAS No. 2429-74-5) in F344/N Rats and B6C3F1 Mice (DrinkingWater Studies). NTP Technical Report Series No. 397. NTIS Publication No. 92-2852.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 18 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective August 26, 1997. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1994a). Toxicology and Carcinogenesis Studies of 1-amino-2,4-dibromoanthraquinone (CAS No. 81-49-2) in F344/N Rats and B6C3F1 Mice (Feed Studies). Board Draft. NTP Technical Report Series No. 383. NTIS Publication No. 94-2838.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 18 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective August 26, 1997. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1994b). Toxicology and Carcinogenesis Studies of C.I. Direct Blue 218 (CAS No. 28407-37-6) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 430. NTIS Publication No. 94-3161.

OSHA approves, subject to certain conditions, the California Hazard Communication Standard, including Proposition 65 -- the California Safe Drinking Water and Toxic Enforcement Act.

NTP Information Cited
In accordance with Proposition 65, California annually publishes a list of chemicals known to cause cancer or reproductive toxicity. This list includes chemicals identified as carcinogens by IARC and the NTP.

The EPA is proposing to add a chemical category that includes dioxin and 27 dioxin-like compounds to the list of toxic chemicals subject to the reporting requirements under EPCRA.

NTP Information Cited
As part of the basis for this proposed rule, the EPA noted that the NTP bioassays of 1,2,3,6,7,8- and 1,2,3,7,8,9-hexachlorodibenzo-p-dioxin (TR-198) showed that these compounds are carcinogenic. The EPA also noted that the NTP's Annual Report on Carcinogens listed PCBs as substances which may reasonably be anticipated to be human carcinogens.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added nine chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). These chemicals are listed effective May 1, 1997. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1995a). Toxicology and Carcinogenesis Studies of Nitromethane (CAS No. 72-52-5) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Board Draft. NTP Technical Report Series No. 461. NTIS Publication No. 95-3377.

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added nine chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). These chemicals are listed effective May 1, 1997. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1995b). Toxicology and Carcinogenesis Studies of Tetrafluoroethylene (CAS No. 116-14-3) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Board Draft. NTP Technical Report Series No. 450. NTIS Publication No. 95-3366.

Final Rule: The FDA is amending the food additive regulations to provide for the safe use of 2,2-ethylidenebis(4,6-di-tert-butylphenyl)fluorophosphonite as an antioxidant in adhesives and in the preparation of polymers intended for contact with food. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of methylene chloride, which is a carcinogenic impurity resulting from the manufacture of the additive.

NTP Information Cited
The FDA used data from the NTP Inhalation Bioassay on Methylene Chloride, TR-306, to estimate the upper-bound limit of lifetime human risk from exposure resulting from the proposed use of this additive. And, based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to methylene chloride would result from the proposed use of the additive.

EPA is denying a petition to remove the barium compounds category from the list of chemicals subject to reporting requirements under the Community Right-to-Know Act and the Pollution Prevention Act. The EPA concluded that barium ion can become available from the barium compounds subject to the reporting, and that barium ion can reasonably be anticipated to cause chronic toxicity.

NTP Information Cited
The EPA's toxicological evaluation of barium compounds included review of data from the NTP's Drinking Water Toxicity/Carcinogenicity Studies of Barium Chloride Dihydrate (TR-432).

Final Rule: The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of 1,2-benzisothiazolin-3-one as a biocide in rubber latex for use in the manufacture of rubber articles intended for repeated use in contact with food. In its evaluation of the safety of this additive, the FDA has reviewed the safety of the additive itself and that of polychlorinated dibenzo-p-dioxins (PCDD) and dibenzo-p-dioxins impurities resulting from the manufacturing process.

NTP Information Cited
An independent pathology review reanalyzed slides of the liver tumors observed in a bioassay of TCDD using the NTP's 1986 classification system for liver tumors. The FDA used this classification to estimate carcinogenic risk.

Notice: The EPA has made available the final Guidelines for Reproductive Toxicity Risk Assessment. The Guidelines include protocols designed to determine the potential of a test substance to produce reproductive toxicity in laboratory animals.

NTP Information Cited
NTP Work Cited: An NTP continuous breeding protocol, Fertility Assessment by Continuous Breeding, is cited as an example of alternative reproductive tests which the EPA considered in developing the Guidelines.

The EPA is promulgating a new use rule which requires persons to notify the EPA at least 90 days before commencing the manufacture, import, or processing of certain (22) benzidine-based chemical substances for significant new use as described in this rule.

NTP Information Cited
As part of the basis for this significant new use rule, EPA noted that NIOSH and NCI jointly recommended that three benzidine-based dyes, Direct Black 38, Direct Blue 6, and Direct Brown 95, be handled in the workplace as if they were human carcinogens. This recommendation was based on testing data including the NTP/NCI bioassay which confirmed that these dyes cause cancer in rodents. (TR-108)

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of a copolymer of ethyl acrylate, methyl methacrylate, and methacrylamide in combination with melamine-formaldehyde resin as a coating for polyethylene phthalate films intended for use in contact with food. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of unreacted ethyl acrylate, which is a carcinogenic impurity resulting from the manufacture of the additive.

NTP Information Cited
The FDA used the data from the NTP Bioassay on Ethyl Acrylate (TR-259) to estimate the upper-bound limit of lifetime human risk from exposure resulting from the proposed use of the additive. And, based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to ethyl acrylate would result from the proposed use of the additive.

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of phosphorylated tall oil fatty acids as pigment dispersants in polymeric films intended for use in contact with food. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of dimethyl hydrogen phosphite, which is a carcinogenic impurity resulting from the manufacture of the additive.

NTP Information Cited
The FDA used the data from the NTP Bioassay on Dimethyl Hydrogen Phosphite (TR-287) to estimate the upper-bound limit of lifetime human risk from exposure resulting from the proposed use of the additive.  And, based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to dimethyl hydrogen phosphite would result from the proposed use of the additive.

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of polyaryletherketone resins as a basic resin for use in food-contact materials. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of methylene chloride, which is a carcinogenic impurity resulting from the manufacture of the additive.

NTP Information Cited
The FDA used data from the NTP Bioassay on Methylene Chloride (TR-306) to estimate the upper-bound limit of lifetime human risk from exposure resulting from the proposed use of this additive. And, based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to methylene chloride would result from the proposed use of the additive.

EPA is proposing a test rule under section 4(a) of the Toxic Substances Control Act to require manufacturers and processors of 21 hazardous air pollutants (HAPs) to test these substances for certain health effects.

NTP Information Cited
As part of the process to select which study data were needed for these HAPs, EPA reviewed the NTP's database of ongoing testing to locate unpublished studies.

EPA proposes to establish a pesticide tolerance for residues of the insecticidal fluorine compounds cryolite and or synthetic cryolite. Fluoride has been identified as the residue of toxicological concern in cryolite and synthetic cryolite.

NTP Information Cited
The NTP chronic study of sodium fluoride (TR-393) was cited as an example of toxicological data considered in the support of the proposed tolerance and regulation.

The EPA announced the publication of the new "Proposed Guidelines for Carcinogen Risk Assessment" which replaces the 1986 guidelines.

NTP Information Cited
Default assumptions are recognized as necessary in risk assessment ( National Research Council report) and the EPA has incorporated into its risk assessment guidelines default assumptions in part using inferences based on general scientific knowledge. The studies and experience of the NTP are cited and referred to throughout this Federal Register notice as part of the scientific knowledge used by the EPA to develop their defaults and how they plan their assessment of evidence of toxicity.

EPA proposes to establish a tolerance for residues of the insecticide diflubenzuron in or on the raw agricultural commodity artichokes at 6.0 ppm. Para-chloroaniline (PCA) is a metabolite of diflubenzuron.

NTP Information Cited
The EPA's Health Effects Division Peer Review Committee classified PCA as a Group B2 carcinogen (probable human carcinogen) based on the results of the NTP chronic study of p-chloroaniline hydrochloride (TR-351).

Proposed Rule: OSHA reopened the record for proposed revisions of the 1,3-Butadiene (BD) standard to solicit public comment on a joint labor/industry agreement recommending that OSHA reduce the permissible exposure limits and expand on some provisions that should be included in the standard.

NTP Information Cited
Representatives of major unions and industry groups submitted a voluntary agreement based in part, on new NTP 1,3-Butadiene data (TR-434). The recommended regulatory requirements can lead to lower and less frequent exposures for employees who work with or near BD.

The FDA is amending the food additive regulations to provide for the safe use of sucrose esterified with medium and long chain fatty acids (olestra) as a replacement for fats and oils.

NTP Information Cited
The FDA used data from the NTP historical pathology database to support its rationale that there was no association between treatment with olestra and the incidence of leukemia developed by male rats during a 2-year carcinogenicity study.

The FDA is amending the food additive regulations to provide for the safe use of C.I. Pigment Yellow 138 as a colorant for all food-contact polymers. In its evaluation of the safety of this additive, the FDA has reviewed the safety of the additive itself and that of polychlorinated dibenzo-p-dioxins (PCDD) impurities resulting from the manufacturing process.

NTP Information Cited
An independent pathology review analyzed slides of the liver tumors observed in the bioassay of TCDD using the NTP's 1986 classification system for liver tumors. The FDA used this classification to estimate carcinogenic risk.

EPA's issued this Notice to inform the public that the Agency has, after reviewing additional study date, reassessed the potential adverse effects and the benefits associated with the use of pesticide products containing dichlorvos. The Agency has preliminarily determined that, unless the terms and conditions of registration are modified as proposed in this Notice, the risks from the use of dichlorvos outweigh the benefits of their continued use.

NTP Information Cited
As part of the relevant data, the EPA has classified dichlorvos as a Group C (possible human) carcinogen based on the results of the NTP bioassay (TR-342) and on the conclusions of a special NTP Panel of Experts convened April 1988 to further assess the incidence of pancreatic lesions observed in the 2-year rat studies.

EPA is proposing to delete diethyl phthalate (DEP) from the list of chemicals subject to reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 and section 6607 of the Pollution Prevention Act of 1990.

NTP Information Cited
As part of the relevant data, EPA used results of the NTP dermal bioassay to conclude that there is insufficient evidence to establish that DEP is likely to cause cancer. TR-429.

The EPA is proposing a significant new use rule under section 5(a)(2) of TSCA which would require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of benzidine-based chemical substances. The EPA believes that benzidine-based chemical substances may be hazardous to human health and that the proposed rule will protect against potentially adverse exposure.

NTP Information Cited
EPA supported, in part, their conclusion about the potential hazard of benzidine-based chemical substances on the results of three benzidine-based dye rodent studies reported by the NTP. TR-108.

The ITC is revising its Priority Testing List including the removal of butyraldehyde; sulfonyl bis(4-chlorobenzene); 2-propenoic acid,2-cyanoethyl ester; and dipropylene glycol from the List as a result of NTP testing.

NTP Information Cited
The NTP has sponsored a reproductive screening test of butyraldehyde; has developed most of the screening test data and will be conducting health effects testing for sulfonyl bis(4-chlorobenzene); is currently testing a dipropylene glycol mixture; and is evaluating the practical problems which may prevent effective health effects testing of ethyl cyanoacrylate.

Proposal to delist di-(2-ethylhexyl) adipate from the reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 and section 6607 of the Pollution Prevention Act of1990

NTP Information Cited
As part of the relevant data, EPA used results of the NTP bioassay to conclude that, overall, the evidence is too limited to establish that di-(2-ethylhexyl) adipate is likely to cause cancer. TR 212.

The EPA proposes to establish a tolerance for residues of the insecticide dimethoate in or on the raw agricultural commodities blueberries and asparagus (see Federal Register July 5, 1995, p. 34945)

NTP Information Cited
The NTP has concluded that dimethoate is a "mutagenic" compound based on its testing for gene mutation and chromosomal aberrations.

The EPA has taken final action on reportable quantities (RQs) for hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act. The person in charge of a facility or vessel from which a hazardous substance is released in excess of its RQs must notify appropriate authorities, who can then evaluate whether a response is needed.

NTP Information Cited
The Agency has promulgated a final RQ of 100 pounds (as proposed) based on chronic toxicity. Because no chronic toxicity studies have been reported for diethanolamine, both EPA and commenters used data from a NTP 13-week subchronic study (TOX-20) to develop their respective conclusions.

The EPA established tolerances for residues of the insecticide diflubenzuron in or on raw agricultural commodities. Para-chloroaniline (PCA) is a metabolite of diflubenzuron.

NTP Information Cited
Information from the NTP bioassay on PCA was used to help establish maximum permissible levels (TR-351).

EPA is denying a petition to delist monosodium methanearsonate and disodium methanearsonate from the reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986.

NTP Information Cited
The EPA and the NTP have classified inorganic arsenicals, including arsenate, as known human carcinogens. (NTP 7th Annual Report on Carcinogens)

The EPA is proposing to withdraw certain testing requirements for two chemical substances listed in the Office of Water chemicals test rule. This proposal includes the withdrawal of the 90-day subchronic testing requirements for 1,1,2,2-tetrachloroethane.

NTP Information Cited
The NTP's 90-day subchronic toxicity drinking water study of 1,1,2,2-tetrachloroethane meets the 90-day subchronic toxicity test required under the test rule and can be used to establish long-term Health Advisories for the Office of Water. (TOX-45)

The FDA is proposing to require the filing of a premarket approval application for a medical device. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced.

NTP Information Cited
The FDA used the NTP bioassay on 4,4-Methylenedianiline Dihydrochloride in their evaluation of potential risk of polyurethane elastomer materials which may be present in the devices and may degrade over time and release degradation products which are potential carcinogens in animals. (TR-248)

EPA proposes to establish food/feed additive regulations for residues of the insecticide d-limonene when used as an active ingredient in insect-repellent tablecloths and in insect repellent strips used in food/feed-handling establishments.

NTP Information Cited
Data on the oral toxicity of d-limonene was summarized in the NTP 2-year bioassay and comprehensive literature review. TR-347

EPA is proposing to revoke food additive regulations for five pesticides which EPA has determined "induce cancer" within the meaning of the Delaney clause of section 409 of the Federal Food, Drug and Cosmetic Act (FFDCA). After a full evaluation of all the data and supporting information regarding animal carcinogenicity, the EPA has concluded that exposure to triadimefon results in the induction of hepatocellular adenomas in NMRI mice. Hepatocellular adenomas are considered to be evidence of cancer because hepatocellular adenomas can progress to hepatocellular carcinomas.

NTP Information Cited
EPA supports its conclusion that hepatocellular adenomas can progress to hepatocellular carcinomas with NTP's rationale for combining tumor types for an overall analysis of carcinogenicity (in addition to analyzing them separately).

Methylene chloride is used as a solvent in the initial step in the manufacturing process of acesulfame potassium and may be present as an impurity in the additive. The FDA used risk assessment procedures to estimate the upper-bound limit of risk presented by methylene chloride.

NTP Information Cited
The FDA used data from the NTP bioassay on methylene chloride to calculate the potency, or unit risk, from exposure to this chemical. TR-306

EPA is taking this action pursuant to its authority to add to the list those chemicals and chemical categories that meet the EPCRA section 313(d)(2) criteria for addition to the list of toxic chemicals.

NTP Information Cited
Long-chain chlorinated paraffins have not been classified as "probable human carcinogens" by NTP or IARC and the NTP bioassay (TR-305) showed insufficient evidence. Therefore the EPA concludes that there is insufficient evidence to list long-chain chlorinated paraffins on the EPCRA section 313 list.

OSHA is proposing to modify its existing standards on respiratory protection so that employers will provide effective protection for employees who wear respirators. agents include saccharin and di-2-ethylhexyl phthalate (DEHP).

NTP Information Cited
One of the respiratory protection testing agents was di-2-ethylhexyl phthalate (DEHP). OSHA cites positive carcinogenic findings of DEHP in two rodent species by NTP as sufficient evidence to preclude its use in respirator quantitative fit testing. TR-217

The proposed rule would generally extend the coverage provided under the 1986 OSHA Asbestos Standard for Construction to State and local government employees who are not covered by OSHA- or EPA-approved State plans. It also proposes to extend coverage provided under the OSHA Asbestos Standard for General Industry for automotive brake and clutch repair.

NTP Information Cited
The EPA classifies asbestos as a Group A carcinogen as cited in the NTP's 7th Annual Report on Carcinogens. (TR-280) (TR-279) (TR-277) (TR-295)

Notification of publication of draft guideline "Notes for Guidance on Specific Aspects of Regulatory Genotoxicity Tests" to provide guidance on genotoxicity testing.

NTP Information Cited
The test battery approach is designed to reduce the risk of false negative results. However, genotoxicity test batteries as described will only detect carcinogens that act primarily via a mechanism involving direct genetic damage. According to results of the NTP (Haseman, et al, 1990), approximately 15 percent of carcinogens are not detected by the commonly used batteries of genotoxicity tests.

Includes establishment of maximum residual disinfectant level goals (MRDLGs) for chlorine, chloramines, and chlorine dioxide and maximum contaminant level goals (MCLGs) for bromodichloromethane, dibromochloromethane, and bromoform.

NTP Information Cited
Data from the NTP toxicology and carcinogenesis studies of bromodichloromethane (TR-321), chlorinated and chloraminated water (TR-392), bromoform (TR-350), and dibromochloromethane (TR-282) were used as part of the evaluation to set maximum residual disinfectant level goals for these substances.

Amendment of food additive regulations to provide for the safe use of cellulose triacetate as an immobilizing agent for lactase for use in reducing the lactose content of milk.

NTP Information Cited
Data from the NTP toxicology and carcinogenesis study of dichloromethane (TR-306) was used to calculate the risk from exposure to dichloromethane as an impurity in cellulose triacetate.

Receipt of report of the TSCA Interagency Testing Committee to the Administrator. The ITC revised the Priority Testing List including the removal of eight chemicals from the List.

NTP Information Cited
The negative results of the NTP toxicology and carcinogenesis study of the structurally-related N-phenyl-2-napththylamine (TR-333) was used by the ITC in developing its rationale for removing N-phenyl-1-napththylamine from the List.

Revocation of certain food additive regulations for several pesticides which EPA has determined "induce cancer" within the meaning of the Delaney Clause of section 409 of the Federal Food, Drug and Cosmetic Act.

NTP Information Cited
NTP toxicology and carcinogenesis study of ethylene oxide (TR-326) is cited as one of the studies used for conclusions that ethylene oxide induces cancer in animals.

Establishment of new requirements for the registration of designated fuels and fuel additives as authorized by sections of the Clean Air Act.

NTP Information Cited
NTP 13-week inhalation study of N-Hexane in B6C3F1 mice is cited as a reference for the neuropathology assessment. (TOX-02)

Revocation of the food additive tolerance for residues of the pesticide dicofol in or on dried tea.

NTP Information Cited
Data from the NTP toxicology and carcinogenesis study of dicofol (TR-90) showed a statistically significant increase of hepatocellular adenomas and combined hepatocellular adenomas and carcinomas in male mice (B6C3F1) at two doses tested.

Exemption from the requirement of a tolerance be established for residues of d-limonene when used as an inert ingredient in pesticide formulations applied to growing crops or raw agricultural commodities after harvest.

NTP Information Cited
The NTP toxicology and carcinogenesis study of d-Limonene showed no carcinogenic activity in female rats and mice and in male mice. Clear evidence of kidney-associated carcinogenic activity was noted in male rats. However, the NTP concluded that the male rat kidney carcinogenicity is not predictive of mammalian carcinogenicity. (TR-347)

Notification of proposed rulemaking in the form of a tentative final monograph that would establish conditions under which over-the-counter oral antiseptic drug products are generally recognized as safe and effective and not misbranded.

NTP Information Cited
The FDA noted that benzethonium chloride is currently being evaluated for carcinogenic potential by the NTP. The agency also nominated gentian violet for study by the NTP after reviewing the available data and deciding that a definitive conclusion regarding its carcinogenic activity could not be reached. (TR-438)

Requirement of employers to establish hazard communication programs to transmit information on the hazards of chemicals to their employees by means of labels on containers, material safety data sheets, and training programs.

NTP Information Cited
Annual Report on Carcinogens published by the NTP is used by OSHA in identifying toxic substances to be regulated.

Amendment to the food additive regulations to provide for the safe use of dimethyl dicarbonate as a yeast inhibitor in dealcoholized and low alcohol wines, Jan 26, 1993, and in ready-to-drink tea beverages.

NTP Information Cited
NTP toxicology and carcinogenesis study on methyl carbamate (TR-328) was used to estimate the human cancer risk from the potential exposure to methyl carbamate stemming from the proposed use of dimethyl dicarbonate as a yeast inhibitor in wine.

Establishment of conditions under which over-the-counter antihistamine drug products are generally recognized as safe and effective and not misbranded. Dec. 9, 1992. Amendment of final rule to include doxylamine succinate.

NTP Information Cited
Data from the NTP toxicology and carcinogenesis study on pyrilamine (TRs 408, 409) was used to determine that pyrilamine maleate is safe for OTC use. The results of an NCTR-toxicology and carcinogenesis study of doxylamine succinate conducted under the auspices of the NTP were used in developing a talk paper concerning the NCTR-findings in animals to inform consumers of these data and the uncertainty of their relevance to humans.

Amendment of food additive regulations to provide for the safe use of 3,5-di-tert-butyl-4-hydroxyhydrocinnamic acid triester with 1,3,5-tris(2-hydroxyethyl)-s-triazine-2,4,6-(1H,3H,5H)-trione as an antioxidant for polyester elastomers in contact with dry food and rubber articles intended for repeated use in contact with food.

NTP Information Cited
Because ethyl acrylate may be present in the additive, data from the NTP toxicology and carcinogenesis study on ethyl acrylate (TR-259) were used to estimate the upper-bound limit of lifetime human risk.

Addition of 313 chemicals and chemical categories to the list of toxic chemicals required to be reported on under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 and section 6607 of the Pollution Prevention Act of 1990.

NTP Information Cited
EPA considered chemicals designated as possible, probable, or known carcinogens in the Monographs of IARC and the 6th Annual Report on Carcinogens published by the NTP. Also, used results of the NTP toxicology and carcinogenesis studies of C.I. Acid Red 114 (TR-405), C.I. Direct Blue 218 (TR-430), Chlorendic acid (TR-304), 3-Chloro-2-methyl-1-propene (TR-300), Diglycidyl resorcinol ether, (TR-257), 3,3-Dimethoxybenzidine dihydrochloride (TR-372), 3,3-Dimethylbenzidine dihydrochloride (TR-390), and 5,5-Diphenylhydantoin (phenytoin) (TR-404).

Announcement of decision not to revise the maximum contaminant level goal (MCLG) for fluoride after consideration of recent reports concerning the health effects of fluoride.

NTP Information Cited
NTP toxicology and carcinogenesis study of fluoride (TR-393) cited. Study concluded that there was equivocal evidence in male F344/N rats, and no evidence in female F344/N rats or male or female mice.

Final Rule: Addition of 21 chemicals and 2 chemical categories to the list of toxic chemicals under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA).

NTP Information Cited
NTP toxicity study of formic acid (TOX-19) demonstrated sufficient evidence to establish that formic acid can reasonably be anticipated to cause in humans chronic health effects as described in EPCRA section 313(d)(2)(B).

Establishment of a tolerance for the combined residues of the herbicide dicamba and its 5-hydroxy metabolite.

NTP Information Cited
Negative results of NTP toxicology and carcinogenesis study of dichlorodibenzo-p-dioxin (TR-123) cited. The Agency has concluded that there is no potential carcinogenic risk to humans from a DCDD impurity in the dicamba to be used on cotton.

Proposed Rule: Proposed test rule under section 4(a) of the Toxic Substances Control Act (TSCA) that would require manufacturers and processors of five chemicals, acetophenone, phenol, n, n-dimethylaniline, ethyl acetate, and 2,6-dimethylphenol, to conduct testing for certain chemical fate, health and environmental effects.

NTP Information Cited
The proposed rule reflects EPA's current thinking in the area of mutagenicity testing, both as an endpoint and as it leads to oncogenicity testing. This new information is partially based on data from the NTP's study of the ability of short-term tests to predict carcinogenic potential. For phenol, no additional testing for developmental effects is being proposed because NTP studies are adequate for this endpoint. For N,N-dimethylaniline, the NTP toxicology and carcinogenesis study (TR-360) identified the rat as more sensitive than the mouse to the noncarcinogenic effects on erythrocytes and spleen.

Proposed a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act for all acrylate esters falling within the definition proposed in this rule (acrylate substances).

NTP Information Cited
The EPA has concluded certain acrylates may present a risk of cancer. This conclusion is based primarily upon data available for a subset of acrylates which have demonstrated positive results. The NTP toxicology and carcinogenesis study of ethyl acrylate (TR-259) used to support conclusion.

Revocation of the food additive regulation for residues of the pesticide dichlorvos in or on packaged or bagged non perishable processed food.

NTP Information Cited
Data from the NTP toxicology and carcinogenesis study of dichlorvos (TR-342) in F344 rats showing statistically significant increases in leukemia in males at 2 dose levels was used.

Establishment of a tolerance for residues of the insecticide dimethoate in or on raw Brussels sprouts.

NTP Information Cited
NTP concluded that dimethoate is a mutagenic compound based on its testing for gene mutation and chromosomal aberrations.

Revocation of certain food additive regulations for four pesticides, benomyl, mancozeb, phosmet, and trifluralin, which were included in a 1989 petition.

NTP Information Cited
Ethylene thiourea (ETU), a major contaminant, metabolite and breakdown product of mancozeb has been shown in the NTP toxicology and carcinogenesis study (TR-388) to induce cancer in animals.

Exemption from the requirement of a tolerance be established for residues of C.I. Pigment Violet #23, C.I. Pigment Blue #15, C.I. Pigment Green #7 and FD Red No. 40 when used as inert ingredients in pesticide formulations applied to growing crops only.

NTP Information Cited
NTP data used to support the proposed tolerance exemptions for C.I. Pigment Blue #15 and C.I. Pigment Green #7. The NTP decided not to perform toxicology and carcinogenesis studies of C.I. Pigment Green #7 and C.I. Pigment Blue #15 based on the lack of absorption or adverse effects in a 90-day feed study in rats and mice.

Tentative Final Rule: Tentative affirmation that gelatin is generally recognized as safe (GRAS) for use as a direct human food ingredient.

NTP Information Cited
Data from the NTP toxicology and carcinogenesis study on penta­chloro­phenol (TR-349) showing PCP induces carcinogenic neoplasms in mice was used in modifying the regulation to state that there shall be no detectable levels of PCP in gelatin when tested by the method referenced in this regulation.

Establishment of a 3-year time-limited tolerance for residues of cryolite and/or synthetic cryolite.

NTP Information Cited
Data from the NTP toxicology and carcinogenesis study of sodium fluoride (TR-393) was considered in support of the tolerances.

Announcement that revisions of the national ambient air quality standards for ozone are not appropriate at this time.

NTP Information Cited
Substantial new information has been published since the last criteria document. The NTP toxicology and carcinogenesis study on ozone (TR-440) to be peer-reviewed 11/93 was cited as an example of a study which may yield significant new information.

Issued guidelines specifying criteria for determining when any customary or reasonably foreseeable use of an art material can result in chronic hazard.

NTP Information Cited
NTP criteria for assessing the quality and adequacy of animal studies.

OSHA publishes a new standard for occupational exposure to cadmium.

NTP Information Cited
Clear evidence of carcinogenicity of cadmium in animals was based on NTP's definition of clear evidence of carcinogenicity from the Report of the NTP Ad Hoc Panel on Chemical Carcinogenesis Testing and Evaluation.

The EPA is partially granting a petition submitted by the Governor of New York to add 80 chemicals and 2 chemical categories to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-To-Know Act by proposing to add 68 chemicals and 2 chemical categories.

NTP Information Cited
The EPA used several NTP bioassays as sources of information. (TOX-18) (TR-403) (TR-314) (TR-237) (TR-039) (TR-00A)

The FDA is amending the food additive regulations to provide for the safe use of ethyl acrylate in the manufacture of paper and paperboard intended for use in contact with food.

NTP Information Cited
The FDA used data from TR-259 on ethyl acrylate to estimate the upper-bound limit of lifetime human risk from exposure.

EPA is promulgating maximum contaminant level goals and National Primary Drinking Water Regulations for 18 synthetic organic and 5 inorganic chemicals.

NTP Information Cited
The MCLG for Di(2-ethylhexyl)adipate was derived from the NTP 2-year dietary study, TR-212. The classification of DEHP as a Group B2 (probable human) carcinogen was based on the NTP 2-year study, (TR-217)

The Priority Testing List was revised by adding one chemical group, the siloxanes, and four chloralkyl phosphates.

NTP Information Cited
At the request of the NTP, TSCA Section 8(d) reports on health effects of bis-(4-chlorophenyl) sulfone were provided to facilitate NTP's evaluation of this chemical.