[Federal Register Volume 76, Number 188 (Wednesday, September 28, 2011)]
[Rules and Regulations]
[Pages 59909-59914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-24685]



40 CFR Part 180

[EPA-HQ-OPP-2010-0186; FRL-8885-3]

Amisulbrom; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


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) 

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: 


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 

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 

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 
    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 

[[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 
    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 
    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-

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
                              Point of departure and        RfD, PAD, for risk        Study and toxicological
     Exposure/scenario      uncertainty/safety factors          assessment                    effects
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
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
                                                                                    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
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.
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 

[[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 
    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 
    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 
    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 

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: 

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, 
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 

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:


1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

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-

                                                              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

    (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]