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Call for public comments on 10 proposed nominations for RoC 11
[Federal Register: January 22, 2003 (Vol. 68, No. 14)]
[Notices]
[Pages 3033 - 3036]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Toxicology Program, Call for Public Comments on 10 Nominations, Proposed for Listing in the Report on Carcinogens, Eleventh Edition
Background
The National Toxicology Program (NTP) solicits final public comments on the nominations reviewed in 2002 for listing in the Report on Carcinogens, Eleventh Edition ("the Report"). This Report (previously known as the Annual Report on Carcinogens) is a Congressionally mandated listing of known human carcinogens and reasonably anticipated human carcinogens and its preparation is delegated to the National Toxicology Program by the Secretary, Department of Health and Human Services (DHHS). Section 301 (b) (4) of the Public Health Service Act, as amended, provides that the Secretary, (DHHS), shall publish a biennial report which contains a list of all substances (1) which either are known to be human carcinogens or may reasonably be anticipated to be human carcinogens; and (2) to which a significant number of persons residing in the United States (US) are exposed. The law also states that the reports should provide available information on the nature of exposures, the estimated number of persons exposed and the extent to which the implementation of Federal regulations decreases the risk to public health from exposure to these chemicals.
In 2002, ten nominations were reviewed for listing in the Eleventh Report. This review included two Federal and one non-government, scientific peer reviews and public comment and review. The three scientific review committees evaluated all available data relevant to the criteria for inclusion of candidate nominations in the Report. The criteria used in the review process and a detailed description of the review procedures, including the steps in the current formal review process, can be obtained from the NTP home page website at http://ntp.niehs.nih.gov/ntp/ or by contacting: Dr. C. W. Jameson, National Toxicology Program, Report on Carcinogens, MD EC-14, P.O. Box 12233, Research Triangle Park, NC 27709; phone: (919) 541-4096, fax: (919) 541-0144, email: jameson@niehs.nih.gov.
Public Comment Requested
The nominations reviewed in 2002 are provided in the following table with their Chemical Abstracts Services (CAS) Registry numbers (where available) and the recommendations from the three scientific peer reviews. The NTP will be making a final recommendation for these ten nominations for listing in, or changing the current listing from reasonably anticipated to be a human carcinogen to the known to be a human carcinogen category in the Eleventh Report.
Background documents provided to the review committees and the public are available on the Internet in PDF-format at the address above. Hard copies of these documents are also available upon request from Dr. Jameson (contact information above). The NTP will review the recommendations from each of the review committees and consider the public comments received throughout the process in making decisions regarding the NTP recommendations to the Secretary, DHHS, for listing of the nominated substances in the Report on Carcinogens, Eleventh Edition. The NTP solicits final public comment to supplement any previously submitted comments or to provide comments for the first time on any substance in the following table. Comments will be accepted for 60 days from the publication date of this announcement and should be directed to Dr. C. W. Jameson at the address provided above. Individuals submitting public comments are asked to include relevant contact information [name, affiliation (if any), address, telephone, fax, e-mail, and sponsoring organization (if any)].
Attachment
Dated: January 10, 2003
Kenneth Olden, Ph. D.
Director
National Toxicology Program
Summary of RG11, RG22 and NTP Board Subcommittee3 Recommendations
for the Nominations Reviewed
in 2002 for Listing in the Report on Carcinogens4, 11th Edition
NOMINATION/ |
PRIMARY USES OR EXPOSURES |
RG1 ACTION |
RG2 ACTION |
NTP BOARD |
|---|---|---|---|---|
1-Amino-2,4-dibromoanthraquinone/ (81-49-2) |
An anthraquinone-derived vat dye that is used in the textile industry. |
Motion to list 1-amino-2,4-dibromoanthraquinone as reasonably anticipated to be a human carcinogen passed by unanimous vote (8/0). |
Motion to list 1-amino-2,4-dibromoanthraquinone as reasonably anticipated to be a human carcinogen passed by unanimous vote (8/0). |
Motion to list 1-amino-2,4-dibromoanthraquinone as reasonably anticipated to be a human carcinogen passed by unanimous vote (9/0). |
Selected Heterocyclic Amines (three nominations): |
MeIQ, MeIQx, and PhIP are heterocyclic amines that are formed during heating or cooking and are found in cooked meat and fish. |
Motion to list MeIQ as reasonably anticipated to be a human carcinogen passed by unanimous vote (6/0). Motion to list MeIQx as reasonably anticipated to be a human carcinogen passed by a vote of 5 yes to 1 no. Negative vote cast because member felt data meet criteria to list as known human carcinogen. Motion to list PhIP as reasonably anticipated to be a human carcinogen passed by a vote of 5 yes to 1 no. Negative vote cast because member felt data meet criteria to list as known human carcinogen. |
Motion to list MeIQ as reasonably anticipated to be human carcinogen passed by unanimous vote (8/0). Motion to list MeIQx as reasonably anticipated to be human carcinogen passed by unanimous vote (8/0). Motion to list PhIP as reasonably anticipated to be human carcinogen passed by unanimous vote (8/0). |
Motion to list MeIQ as reasonably anticipated to be a human carcinogen passed by a vote of 8 yes, 0 no and 1 abstention. Abstention because member felt insufficient data for human exposure to list in the RoC. Motion to list MeIQx as reasonably anticipated to be a human carcinogen passed by a unanimous vote (9/0). Motion to list PhIP as reasonably anticipated to be a human carcinogen passed by unanimous vote (9/0). |
Cobalt Sulfate / (10026-2401) | Cobalt sulfate is used in electroplating and electrochemical industries. It is also used as a coloring agent for ceramics, a drying agent in inks, paints, varnishes and linoleum, and has been added to animal feed as a mineral supplement. |
Motion to list cobalt sulfate as reasonably anticipated to be a human carcinogen passed by unanimous vote (9/0). |
Motion to list cobalt sulfate as reasonably anticipated to be human carcinogen passed by a vote of 8 yes to 1 no. Negative vote cast because member felt exposure data in background document needed to be more specific for cobalt sulfate. |
Motion to list cobalt sulfate as reasonably anticipated to be a human carcinogen passed by a vote of 8 yes to 1 no. Negative vote cast because member felt human exposure data not specific for cobalt sulfate. |
Diethanolamine (DEA) / (111-42-2) | DEA is used in the preparation of surfactants used in liquid laundry, dishwashing detergents, cosmetics, shampoos, and hair conditioners; as a surface-active agent and corrosion inhibitor in metalworking fluids and as a dispersant in agricultural chemical formulations. |
Motion not to list DEA in the RoC passed by a vote of 7 yes to 2 no. Negative votes cast because members felt data sufficient to list as reasonably anticipated to be a human carcinogen. | Motion not to list DEA in the RoC passed by unanimous vote (9/0). |
Motion not to list DEA in the RoC passed by a vote of 8 yes to 1 no. Negative vote cast because member felt data sufficient to list as reasonably anticipated to be a human carcinogen. |
Naphthalene (91-20-3) |
Naphthalene is used as an intermediate in the synthesis of many industrial chemicals, and has been used as an ingredient in some moth repellants and toilet bowl deodorants, and to control lice on livestock and poultry. |
Motion to list naphthalene as reasonably anticipated to be human carcinogen passed by a vote of 6 yes to 1 no. Negative vote cast because member felt data not sufficient to list in the RoC. |
The RG2 could not make a majority recommendation for either listing or not listing naphthalene in the RoC. |
Motion to list naphthalene as reasonably anticipated to be a human carcinogen passed by unanimous vote (9/0). |
Nitrobenzene (98-95-3) |
Nitrobenzene is used mainly in the production of aniline, itself a major chemical intermediate in the production of dyes. |
Motion to list nitrobenzene as reasonably anticipated to be human carcinogen passed by unanimous vote (7/0). |
Motion to list nitrobenzene as reasonably anticipated to be human carcinogen passed by unanimous vote (7/0) |
Motion to list nitrobenzene as reasonably anticipated to be a human carcinogen passed by unanimous vote (9/0). |
Nitromethane (75-52-5) |
Nitromethane is used in specialized fuels, in explosives and in the synthesis of nitromethane derivatives, pharmaceuticals, agricultural soil fumigants and industrial antimicrobials. |
Motion to list nitromethane as reasonably anticipated to be human carcinogen passed by unanimous vote (8/0). |
Motion to list nitromethane as reasonably anticipated to be human carcinogen passed by unanimous vote (9/0). |
Motion to list nitromethane as reasonably anticipated to be a human carcinogen passed by unanimous vote (9/0). |
4,4'-Thiodianiline (139-65-1) |
4,4'-Thiodianiline has been produced commercially since the early 1940's as an intermediate of several diazo dyes. |
Motion to list 4,4'-thiodianiline as reasonably anticipated to be human carcinogen passed by a vote of 6 yes to 2 no. Negative votes cast because members felt there was not sufficient exposure to list in the RoC. |
Motion to list 4,4'-thiodianiline as reasonably anticipated to be human carcinogen passed by a vote of 6 yes to 3 no. Negative votes cast because members felt there was not sufficient exposure to list in the RoC. |
Motion to list 4,4'-thiodianiline as reasonably anticipated to be a human carcinogen passed by a vote of 5 yes to 2 no with 2 abstentions. Negative votes and abstentions cast because members felt there was not sufficient exposure to list in the RoC. |
1-The NIEHS Review Committee for the Report on Carcinogens (RG1)
2 - The NTP Executive Committee* Interagency Working Group for the Report on Carcinogens (RG2) *Agencies from the NTP Executive Committee represented on RG2 include: Agency for Toxic Substances and Disease Registry (ATSDR), Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), National Center for Environmental Health of the Centers for Disease Control and Prevention (NCEH/CDC), National Center for Toxicological Research of the Food and Drug Administration (NCTR/FDA), National Institute for Occupational Safety and Health/CDC (NIOSH/CDC), Occupational Safety and Health Administration (OSHA), National Cancer Institute of the National Institutes of Health (NCI/NIH), and National Institute of Environmental Health Sciences/NIH(NIEHS/NIH)
3- The NTP Board of Scientific Counselors Report on Carcinogens Subcommittee (the External Peer Review Group)
4 - RoC - Report on Carcinogens
[Billing Code 4140-01-P]
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