[Federal Register: July 25, 2007 (Volume 72, Number 142)]
[Rules and Regulations]
[Page 40759-40763]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jy07-11]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0076; FRL-8137-7]
Penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-
dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for combined residues
or residues of penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-
dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide) in or on fish; fish, shellfish,
mollusc; and fish, shellfish, crustacean. Dow AgroSciences LLC
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective July 25, 2007. Objections and
requests for hearings must be received on or before September 24, 2007,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0076. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Philip V. Errico, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6663; e-mail address:
errico.philip@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, any person may file an objection
to any aspect of this regulation and may also request a hearing on
those objections. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2006-0076 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before September 24, 2007.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2006-0076, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of April 14, 2006 (72 FR Page 19507) (FRL-
8063-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5F7012) by Dow AgroSciences LLC, Dow AgroSciences
[[Page 40760]]
LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054. The petition
requested that 40 CFR 180.605 be amended by establishing an exemption
from tolerance for residues of the herbicide penoxsulam (2-(2,2-
difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-
6-(trifluoromethyl)benzenesulfonamide, in or on fish and shellfish
resulting from its use as an aquatic herbicide. That notice referenced
a summary of the petition prepared by Dow AgroSciences, LLC, the
registrant, which is available to the public in the docket, http://www.regulations.gov.
Comments were received on the notice of filing.
EPA's response to these comments is discussed in Unit IV. below.
The Registrant modified their submission and requested tolerances
be established. The reason for these changes is explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.'' These provisions were added to the FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
Consistent with section 408(b)(2)(D), of the FFDCA and the factors
specified in section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for the petitioned-for tolerance
for residues of penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-
dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide) on fish, shellfish, mollusc; fish;
and shellfish, crustacean at 0.02, 0.01, and 0.01 ppm. EPA's assessment
of exposures and risks associated with establishing the tolerance
follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by penoxsulam (2-(2,2-difluoroethoxy)-N-
(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide) as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule
published in the Federal Register of September 24, 2004 (EPA-HQ-OPP-
2004-0286), (FRL-7678-6).
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UF) are
used in conjunction with the LOC to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (aPAD) and chronic population adjusted dose
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all
applicable uncertainty/safety factors. Short-, intermediate, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the margin of exposure (MOE) called for by the product of
all applicable uncertainty/safety factors is not exceeded.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.
A summary of the toxicological endpoints for penoxsulam (2-(2,2-
difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-
6-(trifluoromethyl)benzenesulfonamide) used for human risk assessment
can be found at http://www.regulations.gov in document ``Penoxsulam. Human
Health Risk Assessment for Proposed Uses on Fish and Shellfish. PC
Code: 119031, Petition No: 5F7012, DP Num: 325461.'' at page 42 in
Docket ID EPA-HQ-OPP-2006-0076.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-
dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide, EPA considered exposure under the
petitioned-for tolerances as well as all existing penoxsulam (2-(2,2-
difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-
6-(trifluoromethyl)benzenesulfonamide) tolerances in (40 CFR 180.605).
EPA assessed dietary exposures from penoxsulam (2-(2,2-difluoroethoxy)-
N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide) in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
No such effects were identified in the toxicological studies for
penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-
c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998; Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). As to
[[Page 40761]]
residue levels in food, EPA assumed all foods for which there are
tolerances were treated and contain tolerance-level residues.
iii. Cancer. Penoxsulam was classified as ``Suggestive Evidence of
Carcinogenic Potential.'' There is some cancer concern, but the data
are judged not sufficient for a stronger conclusion or a quantitative
cancer risk assessment (see Unit III.E.5).
iv. Anticipated residue and percent crop treated (PCT) information.
EPA assumed tolerance level residues and 100% of the crop is treated.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for penoxsulam (2-(2,2-difluoroethoxy)-N-
(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide) in drinking water. Because the
Agency does not have comprehensive monitoring data, drinking water
concentration estimates are made by reliance on simulation or modeling
taking into account data on the environmental fate characteristics of
penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-
c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide). Further
information regarding EPA drinking water models used in pesticide
exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm
.
Based on the FQPA Index Reservoir Screening Tool and Screening
Concentrations in Groundwater models, the estimated environmental
concentrations (EECs) of penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-
dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide) for acute exposures are estimated
to be 150 parts per billion (ppb) for surface water and 150 ppb for
ground water. The EECs for chronic exposures are estimated to be 150
ppb for surface water and 150 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 150 ppb was used to access
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration value of 150 ppb was used to access
the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-
dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide) is currently registered for the
following residential non-dietary sites: Turf/lawn. EPA assessed
residential exposure using the following assumptions:
1,000 ft2 per day by low pressure hand wand or
back pack sprayer for spot treatment of lawns
0.5 acres per day by push-type granular spreader for
broadcast treatment of lawns
0.06 lb active ingredient (ai) per acre for broadcast
treatment
0.0014 to 0.0016 lbs per 1,000 ft2 for spot
treatment
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to penoxsulam (2-(2,2-
difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-
6-(trifluoromethyl)benzenesulfonamide) and any other substances and
penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-
c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has not assumed
that penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-
dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide) has a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's website at
http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (``10X'') tenfold margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the data base on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor. In applying this provision, EPA either retains the default
value of 10X when reliable data do not support the choice of a
different factor, or, if reliable data are available, EPA uses a
different additional FQPA safety factor value based on the use of
traditional uncertainty/safety factors and/or special FQPA safety
factors, as appropriate.
2. Prenatal and postnatal sensitivity. Based on the results of the
submitted toxicology studies, EPA concluded that no FQPA safety factor
is needed (i.e. 1X) since there are no residual uncertainties for
prenatal and/or postnatal toxicity.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
i. There was no toxicologically significant evidence observed of
neurotoxicity in either the acute or chronic neurotoxicity study.
ii. No definitive quantitative or qualitative susceptibility was
observed in either of the developmental rat or rabbit studies.
iii. Significant dose-related effects in the 2-generation
reproduction study were limited to the delay in preputial separation.
No other endpoints of reproductive toxicity or offspring growth and
survival were affected by treatment.
iv. The chronic dietary food exposure assessment utilizes proposed
tolerance level residues and 100% crop treated for all commodities. By
using these conservative assessments, actual and chronic exposures/
risks will not be underestimated.
v. The dietary drinking water assessment (Tier 1 estimates)
utilizes values generated by model and associated modeling parameters
which are designed to provide conservative, health protective, high-end
estimates of water concentrations.
E. Aggregate Risks and Determination of Safety
Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable uncertainty/
safety factors.
[[Page 40762]]
For linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-, intermediate, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the MOE called for by the product of all applicable
uncertainty/safety factors is not exceeded.
1. Acute risk. There were no treatment-related effects observed in
any of the available toxicity studies on penoxsulam that could be
considered to have resulted from a single dose of penoxsulam. Therefore
no acute exposure is expected.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-
c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) for the most
highly exposed population subgroup from food and water, which utilizes
7% of the cPAD is all infants (< 1 year old).
3. Short-term risk and intermediate term risk. For this aquatic use
pattern, short- and intermediate-term aggregate exposure takes into
account residential exposure, exposure while swimming, plus chronic
exposure to food and water (considered being a background exposure
level). There is a potential for post application exposure from oral
and dermal routes of exposure while swimming in aquatic sites and/or
from turf (lawns, golf courses, sports fields, and sod farms) sites
treated with penoxsulam.
EPA used the SWIMODEL from the Residential Standard Operating
Procedures (SOPs) to assess dermal and oral exposure to recreational
swimmers. Parameters used in calculating exposure and risk are based on
information for competitive swimmers both adult and children (6 years
old) in swimming pools which includes an exposure duration of 5 hours.
It is anticipated that recreational swimmers in weed infested areas
would be less likely to swim with their heads immersed than
recreational swimmers in weed-free swimming pools. Since there were no
short-term dermal, systemic, neuro or developmental toxicity concerns,
the short-term post application assessment addresses only the oral
exposure, which results in the same estimated dose for intermediate-
term exposure. Thus a short-term aggregate exposure was not required,
and the intermediate-term post application exposure assessment combined
both oral and dermal exposures, and is also protective for short-term
exposure. Short- and intermediate-term postapplication exposures
resulted in MOEs> 100 and are therefore not a concern to the Agency.
The Agency considers the swimmer dermal and oral MOEs to be over
estimates of the actual risk, and therefore swimming exposure
assessment was not used in assessing the short- and intermediate-term
aggregate risk, and only the exposure resulting from the turf use was
assessed.
The short-term aggregate risk assessment estimates include both
oral and inhalation exposures appropriate to the population of concern.
Short-term dermal exposure was not aggregated because no toxicological
endpoint was selected. For adults, short-term exposure to penoxsulam
can occur as a result of the residential use on turf. Because oral
exposure from the residential use as a handler is not expected in
adults and no short-term dermal endpoint was selected, only the short-
term residential exposure by inhalation is expected in adults. The
worst-case MOE residential exposure estimate was aggregated with the
chronic dietary (food + water) to provide a worst-case estimate of
short-term aggregate risk for U.S. population. As the aggregate MOE is
greater than 100, the short-term aggregate risk to adults does exceed
EPA's level of concern.
For children/toddlers, short-term exposure to penoxsulam can occur
as a result of the residential use on turf. Because post-application
inhalation exposure is negligible and no short-term dermal endpoint was
selected, only short-term residential exposure from oral exposure was
included with food and drinking water in the short-term aggregate risk
assessment for children/toddlers. The worst-case MOE residential
exposure estimate for children was aggregated with the chronic dietary
(food + water) to provide a worst-case estimate of short-term aggregate
risk for all infants (< 1 year old), the child population subgroup with
the highest estimated chronic dietary food exposure. As the aggregate
MOE is greater than 100, the short-term aggregate risks to children do
not exceed EPA's level of concern.
Because the amount of residues on turf after 30 days will be
negligible, both inhalation and dermal exposure is negligible, and
therefore no intermediate-term aggregate exposure assessment from this
turf use is required.
4. Aggregate cancer risk for U.S. population. The cancer potential
for penoxsulam is classified as ``Suggestive Evidence of Carcinogenic
Potential.'' The classification is based on an increase in large
granular lymphocyte leukemia (also called mononuclear cell leukemia
(MNCL)) in male Fischer 344 rats. There were increased tumors at all
dose levels which exceeded the laboratory historical control data.
There is considerable controversy as to the significance and relevance
of the tumors for humans, but they cannot be discounted in the overall
weight of the evidence. While there is some cancer concern, the data
are judged not sufficient for a stronger conclusion or a quantitative
cancer risk assessment.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-
dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide) residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology, using high performance liquid
chromatograph with tandem mass spectroscopy-mass spectroscopy detector
(LC/MS/MS), and is available to enforce the tolerance expression. The
method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no CODEX maximum residue limits (MRLs) for fish; fish,
shellfish, mollusc; and fish, shellfish, crustacean.
C. Response to Comments
Comments were received from a private citizen objecting to this
product being used in the world, and that the product is too dangerous
to be allowed use. A print-out of what appears to be EPA's summary of
the toxicological effects and tolerances for rice were included. No
other information was provided. EPA has found that there is a
reasonable certainty of no harm to humans after considering all
pertinent toxicology studies and the exposure levels of humans to
penoxsulam.
V. Conclusion
Therefore, the tolerance is established for residues of penoxsulam
(2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-
c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide,
[[Page 40763]]
in or on fish, shellfish, mollusc; fish; and shellfish, crustacean at
0.02, 0.01, and 0.01 ppm. The registrant initially requested exemptions
from tolerances for fish and shellfish. Based upon review of the data
supporting the petition by EPA and subsequent to completion of this
risk assessment, the registrant revised their submission and requested
tolerances for finfish at 0.01 ppm; shellfish, crustacean at 0.01 ppm;
and shellfish, mollusc at 0.02 ppm. For consistency the commodity terms
are revised to fish at 0.01 ppm; fish, shellfish, crustacean at 0.01
ppm; and fish, shellfish, mollusc at 0.02 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers and food retailers, not States or tribes, nor does this action
alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of section
408(n)(4) of FFDCA. As such, the Agency has determined that this action
will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, the Agency has determined
that Executive Order 13132, entitled Federalism (64 FR 43255, August
10, 1999) and Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000) do not apply to this rule. In addition, This rule does not impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 13, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--AMENDED
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.605 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:
Sec. 180.605 Penoxsulam; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Fish....................................................... 0.01
Fish, shellfish, crustacean................................ 0.01
Fish, shellfish, mollusc................................... 0.02
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E7-14335 Filed 7-24-07; 8:45 am]
BILLING CODE 6560-50-S