[Federal Register Volume 76, Number 188 (Wednesday, September 28, 2011)]
[Rules and Regulations]
[Pages 59909-59914]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24685]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0186; FRL-8885-3]
Amisulbrom; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
amisulbrom in or on grapes and tomatoes. Nissan Chemical Industries,
Inc., c/o Lewis & Harrison requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective September 28, 2011. Objections and
requests for hearings must be received on or before November 28, 2011,
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-2010-0186. All documents in the
docket are listed in the docket index available at http://www.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: Olga Odiott, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington,
[[Page 59910]]
DC 20460-0001; telephone number: (703) 308-9369; e-mail address:
odiott.olga@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).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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 get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2010-0186 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
November 28, 2011. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
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. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0186, 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 Facility'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. Summary of Petitioned-for Tolerance
In the Federal Register of May 19, 2010 (75 FR 28009) (FRL-8823-2)
and the Federal Register of February 25, 2011 (76 FR 10584) (FRL-8863-
3), EPA issued notices pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
9E7650 and PP 0E7790) by Nissan Chemical Industries, Inc., c/o Lewis &
Harrison, 122 C St., NW., Suite 740, Washington, DC 20001. The
petitions requested that 40 CFR part 180 be amended by establishing
tolerances for residues of the fungicide amisulbrom, 3-[(3-bromo-6-
fluoro-2-methyl-1H-indole-1-yl) sulfonyl]-N,N-dimethyl-1H-1,2,4-
triazole-1-sulfonamide, in or on grapes at 0.4 parts per million (ppm),
raisins at 1.0 ppm (PP 9E7650), tomato at 0.5 ppm, and tomato paste at
1.2 ppm (PP 0E7790). The notices referenced summaries of the petitions
prepared by Nissan Chemical Industries, Inc., the registrant, which are
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notices of filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of 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 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 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. * *
*''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 amisulbrom including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with amisulbrom
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.
Amisulbrom is of low acute toxicity by the oral, dermal and
inhalation routes and is not irritating to the eyes and skin. Rat,
mouse, and rabbit studies indicate that amisulbrom systemic toxicity is
primarily characterized by decreases in body weight and body weight
gain, and reduced food consumption and/or efficiency. Based on the
results of the acute and subchronic oral neurotoxicity studies in rats,
as well as other subchronic and chronic studies, a developmental
neurotoxicity (DNT) study is not needed for amisulbrom. None of these
studies indicated specific neurotoxicity responses to amisulbrom. The
T-cell dependent antibody response (TDAR) assay showed no evidence of
treatment-related effects in rat and mouse immunotoxicity studies. The
rat
[[Page 59911]]
developmental toxicity study demonstrated cleft palate and other
malformations only at the highest doses. There were no effects in the
fetuses in the rabbit developmental toxicity study at the highest dose
tested.
In accordance with the EPA's Final Guidelines for Carcinogen Risk
Assessment (March 2005), amisulbrom is classified as ``Suggestive
Evidence of Carcinogenic Potential''. This classification is based on:
Liver tumors in male mice at both an adequate and excessive dose; liver
tumors in both sexes of rats only at an excessive dose; and forestomach
tumors in female rats also only at an excessive dose.
In the case of amisulbrom, a cancer risk from dietary exposure is
of low concern based on the following considerations:
The liver tumors seen in male mice only were benign with
no progression to malignancy;
The liver tumors in rats seen only at excessive doses
(i.e., greater than the Limit Dose of 1,000 milligrams/kilogram/day
(mg/kg/day)) were also benign with no progression to malignancy;
The forestomach tumors seen only in female rats occurred
only at an excessive dose which was greater than the Limit-Dose;
None of these tumors resulted in reduced latency; and
There is no concern for mutagenicity/genotoxicity.
In sum, the only evidence showing any concern for carcinogenicity
is the occurrence of benign liver tumors in one sex and one species
(i.e., male mice). Given the marginal evidence relating to potential
carcinogenicity, the Agency has determined that the chronic population
adjusted dose (PAD) will adequately account for all chronic effects,
including carcinogenicity, likely to result from exposure to
amisulbrom.
Specific information on the studies received and the nature of the
adverse effects caused by amisulbrom as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Amisulbrom. Human-Health Risk
Assessment for the Establishment of Tolerances for Amisulbrom Fungicide
in/on Imported Grape and Tomato'' at page 23 in docket ID number EPA-
HQ-OPP-2010-0186.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
PAD or a reference dose (RfD)--and a safe margin of exposure (MOE). For
non-threshold risks, the Agency assumes that any amount of exposure
will lead to some degree of risk. Thus, the Agency estimates risk in
terms of the probability of an occurrence of the adverse effect
expected in a lifetime. 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/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for amisulbrom used for
human risk assessment is shown in the following Table 1.
Table 1--Summary of Toxicological Doses and Endpoints for Amisulbrom for Use in Human Health Risk Assessment
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Point of departure and RfD, PAD, for risk Study and toxicological
Exposure/scenario uncertainty/safety factors assessment effects
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Acute dietary (General NOAEL = 200 mg/kg/day Acute RfD = 2 mg/kg/day Rat acute neurotoxicity
population including UFA = 10x aPAD = 2 mg/kg/day screen study.
infants and children) UFH = 10x LOAEL = 2,000 mg/kg/day based
FQPA SF = 1x on 7% decrease in brain
weight.
Chronic dietary (All NOAEL = 54 mg/kg/day Chronic RfD = 0.54 mg/kg/ Multiple studies: Combined
populations) UFA = 10x day chronic toxicity/
UFH = 10x cPAD = 0.54 mg/kg/day carcinogenicity study in
FQPA SF = 1x rats, multigenerational
reproduction study in rats,
mouse carcinogenicity, and
subchronic and chronic dog
studies. NOAEL = 54 mg/kg/
day from the
multigenerational study
(parental systemic NOAEL).
The LOAEL of 96 mg/kg/day is
from the combined chronic
toxicity/carcinogenicity
study in rats and is based
on decreased body weight,
body weight gains in both
sexes, and indications of
hepatotoxicity and
nephrotoxicity. The mouse
(98 mg/kg/day) and dog (100
mg/kg/day) LOAELs are
similar.
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Cancer (Oral, dermal, ``Suggestive Evidence of Carcinogenic Potential''. This classification is based on
inhalation) liver tumors in male mice at adequate and excessive doses and liver and stomach
tumors in male and/or female rats at excessive doses. The chronic RfD is protective
against potential carcinogenic effects.
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UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
adjusted dose (a = acute, c = chronic). RfD = reference dose.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to amisulbrom, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from amisulbrom in food
as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments
[[Page 59912]]
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. Such effects were identified for
amisulbrom. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII). As to residue levels in food, EPA
used tolerance level residues, default processing factors, and 100%
crop treated assumptions to characterize the acute dietary exposure
assessment.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA used tolerance level
residues, default processing factors, and 100% crop treated assumptions
to characterize the chronic dietary exposure assessment.
iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or non-linear approach is used and a cancer RfD is
calculated based on an earlier non-cancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. Based on the data summarized in Unit
III.A., EPA has concluded that a nonlinear RfD approach will be
protective of any cancer risk posed by amisulbrom. Cancer risk was
assessed using the same exposure estimates as discussed in Unit
III.C.1.ii., chronic exposure.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for amisulbrom. Tolerance level residues and/or 100%
CT were assumed for all food commodities.
2. Dietary exposure from drinking water. Pesticide residues in
drinking water are not expected. These tolerances are for residues of
amisulbrom in/on imported grapes and tomatoes and there are no
pesticide registrations in the United States associated with the
tolerances. Therefore, the presence of amisulbrom in drinking water in
this country resulting from the treatment of crops is not expected.
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).
Amisulbrom is not registered for use in the United States;
therefore, residential exposures are not expected.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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.''
EPA has not found amisulbrom to share a common mechanism of
toxicity with any other substances, and amisulbrom does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
amisulbrom does not have 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 Web site at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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 database 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 (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. There was an apparent
indication of prenatal sensitivity in the rat developmental toxicity
study. There were no effects in the dams at the highest dose tested
(1,000 mg/kg/day). However, several of the rat fetuses in two litters
were noted to have malformations and alterations including cleft
palate, bent scapula, humerus ulna and/or radius, constricted spinal
cord in the cervical region, cervical kyphosis, and medially thickened/
kinked ribs with distorted ribcage. The NOAEL for the offspring in the
rat developmental study was 300 mg/kg/day. There were no indications of
increased postnatal offspring sensitivity in the rat reproduction study
where the NOAEL (~54 mg/kg/day) and LOAEL (~274 mg/kg/day) for the pups
was the same as for the parents. There were no effects in the rabbit
developmental toxicity study at the highest dose tested (300 mg/kg/
day). Since effects in the rat pups in the developmental toxicity study
occur at a dose (1,000 mg/kg/day) well above the NOAELs used for risk
assessment (54 and 200 mg/kg/day), no additional UF for sensitivity/
susceptibility in the developing animal is needed because the
application of the lower NOAEL will be protective against possible
developmental effects in the offspring. Based on the available data and
the selection of risk assessment endpoints that are protective of
developmental effects, there are no residual uncertainties with regard
to prenatal and/or postnatal toxicity.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for amisulbrom is complete.
ii. Neither the rat subchronic neurotoxicity screen studies or the
rat multigenerational reproduction study or other subchronic or chronic
studies indicated specific neurotoxicity responses to amisulbrom.
Although the acute neurotoxicity study observed decreased brain weight,
this effect occurred only at the very high limit dose for acute
neurotoxicity testing, in only one sex, and a NOAEL was identified.
Therefore, there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
iii. Based on the developmental and reproductive toxicity studies
discussed in Unit III.D.2., there are no residual uncertainties with
regard to prenatal and/or postnatal toxicity.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. Since there are no currently
registered or proposed uses of amisulbrom in the United States and
adequate food residue data are available, these assessments will not
underestimate the exposure and risks posed by amisulbrom.
[[Page 59913]]
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists. Since the subject tolerances are for residues of
amisulbrom in/on imported commodities a risk assessment was conducted
for exposure to amisulbrom from food only, as there are no drinking
water or residential exposures associated with imported grapes and
tomatoes. The acute and the chronic dietary risk estimates from food
are not of concern for the general population or any other population
subgroup. Exposures were equivalent to < 1% aPAD and < 1% cPAD for all
population subgroups. As discussed in Unit III.C.1.iii, EPA concluded
that regulation based on the chronic reference dose will be protective
for both chronic and carcinogenic risks. As noted in this unit there
are no chronic risks of concern.
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 amisulbrom
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
A Liquid Chromatography-Mass Spectrometer/Mass Spectrometer (LC-MS/
MS) method (NAS 490/042294) is available as an enforcement method for
the determination of amisulbrom in plant commodities. The limit of
quantitation (LOQ) of the method was 0.01 ppm for amisulbrom. This
method was adequately validated for data collection purposes and a
successful independent laboratory validation study was conducted.
Additionally, amisulbrom is amenable to analysis using FDA multi-
residue methods C and E, which are also suitable confirmatory and/or
enforcement methods.
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
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established a MRL for amisulbrom.
V. Conclusion
Therefore, tolerances are established for residues of amisulbrom,
3-[(3-bromo-6-fluoro-2-methyl-1H-indole-1-yl)sulfonyl]-N,N-dimethyl-1H-
1,2,4-triazole-1-sulfonamide, in or on grape at 0.40 ppm; grape, raisin
at 1.0 ppm; tomato at 0.50 ppm; and tomato, paste at 1.2 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances 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 final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled 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 9, 2000) do not apply to this final rule. In addition,
this final 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) (Pub. L. 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
[[Page 59914]]
and pests, Reporting and recordkeeping requirements.
Dated: September 16, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.
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 180.656 is added to read as follows:
Sec. 180.656 Amisulbrom; tolerances for residues.
(a) General. Tolerances are established for residues of the
fungicide amisulbrom, including its metabolites and degradates, in or
on the commodities listed below. Compliance with the tolerance levels
is to be determined by measuring only amisulbrom, 3-[(3-bromo-6-fluoro-
2-methyl-1H-indole-1-yl) sulfonyl]-N, N-dimethyl-1H-1, 2, 4-triazole-1-
sulfonamide].
------------------------------------------------------------------------
Parts per
Commodity \1\ million
------------------------------------------------------------------------
Grape...................................................... 0.40
Grape, raisin.............................................. 1.0
Tomato..................................................... 0.50
Tomato, paste.............................................. 1.2
------------------------------------------------------------------------
\1\ There is no U.S. registration for use of amisulbrom on grape or
tomato.
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2011-24685 Filed 9-27-11; 8:45 am]
BILLING CODE 6560-50-P