[Federal Register Volume 77, Number 100 (Wednesday, May 23, 2012)]
[Rules and Regulations]
[Pages 30402-30407]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12410]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0674; FRL-9349-3]


Acibenzolar- S -methyl; Time-Limited Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes time-limited tolerances for 
residues of acibenzolar-S-methyl in or on grapefruit, apples and pears. 
Syngenta Crop Protection LLC. requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 23, 2012. Objections and 
requests for hearings must be received on or before July 23, 2012, 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2011-0674, is available either 
electronically through http://www.regulations.gov or in hard copy at 
the OPP Docket in the Environmental Protection Agency Docket Center 
(EPA/DC), located in EPA

[[Page 30403]]

West, Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. 
The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
Public Reading Room is (202) 566-1744, and the telephone number for the 
OPP Docket is (703) 305-5805. Please review the visitor instructions 
and additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Rose Kearns, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5611; email address: kearns.rosemary@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-2011-0674 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 
July 23, 2012. 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 part178, 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-2011-0674, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 7, 2011 (76 FR 55331) (FRL-
8886-7), 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 1G7889 
by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419-
8300. The petition requested that 40 CFR 180.561 be amended by 
establishing temporary tolerances for residues of the fungicide, 
acibenzolar-S-methyl, in or on apples, grapefruit and pears 0.05 parts 
per million (ppm) in conjunction with approval of an experimental use 
permit. That notice referenced a summary of the petition prepared by 
Syngenta Crop Protection, LLC, the registrant, which is available in 
the docket, http://www.regulations.gov. There were no comments received 
in response to the notice 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 acibenzolar-S-methyl 
including exposure resulting from the tolerances established by this 
action. EPA's assessment of exposures and risks associated with 
acibenzolar-S-methyl 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.
    General information on the toxicity of acibenzolar-S-methyl can be 
found in a recent tolerance rulemaking for this pesticide in the 
Federal Register of April 11, 2012 (77 FR 21670) (FRL-

[[Page 30404]]

9343-3). Specific information on the studies received and the nature of 
the adverse effects caused by acibenzolar-S-methyl 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 ``Acibenzolar-S-methyl Human Health 
Risk Assessment,'' on page 15 in docket ID number EPA-HQ-OPP-2011-0674.

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 
population-adjusted dose (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 Acibenzolar-S-Methyl 
used for human risk assessment is shown in the recent tolerance 
rulemaking document for acibenzolar-S-methyl in the Federal Register of 
April 11, 2012 (77 FR 21670).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to acibenzolar-S-methyl, EPA considered exposure under the 
petitioned-for tolerances as well as all existing acibenzolar-S-methyl 
tolerances in 40 CFR 180.561. EPA assessed dietary exposures from 
acibenzolar-S-methyl 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.
    Such effects were identified for acibenzolar-S-methyl. In 
estimating acute dietary exposure, EPA used food consumption 
information from the U.S. Department of Agriculture (USDA) 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, EPA assumed a distribution of 
residues based on field trial data and tolerance level residues for 
apple, grapefruit and pear. Empirical and Dietary Exposure Evaluation 
Model (DEEM) default processing factors were used to modify the field 
trial data. Maximum screening-level percent crop treated (PCT) 
estimates were used for commodities for which data were available. If 
no PCT data were available, 100 PCT was assumed.
    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 a conservative 
chronic dietary exposure analysis for the general U.S. population and 
various population subgroups. Tolerance level residues and 100 crop 
treated assumptions were used. DEEM default and empirical processing 
factors were used to modify the tolerance values.
    iii.  Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that acibenzolar-S-methyl does not pose a cancer risk to 
humans. Therefore, a dietary exposure assessment for the purpose of 
assessing cancer risk is unnecessary.
    iv.  Anticipated residue and PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if certain conditions are met. PCT data was not used for 
conducting the chronic dietary risk assessment.
    2. Dietary exposure from drinking water. The residues of concern 
for drinking water are acibenzolar-S-methyl benzo(1,2,3) thiadiazole-7-
carbothioic acid (-S-methyl ester, convertible to 
benzo(1,2,3)thiadiazole-7-carboxylic acid (CGA-210007) in drinking 
water. These simulation model take into account data on the physical, 
chemical, and fate/transport characteristics of acibenzolar-S-methyl. 
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 Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
acibenzolar-S-methyl for acute exposures are estimated to be 45 parts 
per billion (ppb) for surface water and 0.08 ppb for ground water, for 
chronic exposures for non-cancer assessments are estimated to be 19.1 
ppb for surface water and 0.08 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 45 ppb was used to assess 
the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of 
value 19.1 ppb was used to assess 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). Acibenzolar-S-methyl 
is currently registered for the following uses that could result in 
residential exposures: Turfgrass use on sodfarms, golf courses, 
collegiate athletic fields, and lawns around commercial and industrial 
buildings. Residential exposure was assessed for adult handlers and for 
adult and child post-application activities. Exposure for adult and 
child golfers were used to aggregate adult post-application dermal 
exposure with dietary and drinking water exposure. The aggregate 
exposure assessment for children combines dermal and

[[Page 30405]]

incidental oral post-application exposure with food and water exposure.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 acibenzolar-S-methyl to share a common mechanism 
of toxicity with any other substances, and acibenzolar-S-methyl does 
not appear to produce a toxic metabolite produced by other substances. 
For the purposes of this tolerance action, therefore, EPA has assumed 
that acibenzolar-S-methyl 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 Food Quality 
Protection Act Safety Factor (FQPA 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. The toxicology database for 
acibenzolar-S-methyl is complete and adequate for assessing increased 
susceptibility under FQPA. The pre- and postnatal toxicity database for 
acibenzolar-S-methyl includes developmental toxicity studies in rats 
and rabbits, a DNT study in rats, and a 2-generation reproduction 
toxicity study in rats. Based on the developmental toxicity in rats and 
the developmental neurotoxicity studies in rats, there is concern for 
increased qualitative and/or quantitative susceptibility following in 
utero exposure to acibenzolar-S-methyl. However, the degree of concern 
for the increased susceptibility seen in these studies is low as there 
are no residual uncertainties with regard to pre- and/or postnatal 
toxicity since NOAELs and LOAELs have been identified for all effects 
of concern, a clear dose response has been well defined, and the PODs 
selected for risk assessment are protective of the fetal/offspring 
effects. Additionally, the dietary and residential risk assessments are 
conservative and will not underestimate dietary exposure and there are 
no residual uncertainties in the exposure database.
    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 acibenzolar-S-methyl is complete.
    ii. There are no residual uncertainties identified in the exposure 
databases. The dietary risk assessment is conservative and will not 
underestimate dietary and/or non-dietary residential exposure to 
acibenzolar-S-methyl. The acute analysis assumed a distribution of 
residues based on field trial data, tolerance level residues for the 
Experimental Use Permit (EUP) uses and maximum PCT estimates were used 
for commodities for which data were available. The chronic dietary food 
exposure assessment was performed based on 100 PCT and tolerance-level 
residues. EPA made conservative (protective) assumptions in the ground 
water and surface water modeling used to assess exposure to 
acibenzolar-S-methyl in drinking water. EPA used similarly conservative 
assumptions to assess post-application exposure of children as well as 
incidental oral exposure of toddlers. These assessments will not 
underestimate the exposure and risks posed by acibenzolar-S-methyl.

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.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for acute exposure, the acute dietary exposure from food and water to 
acibenzolar-S-methyl will occupy 37% of the aPAD for children 3-5 years 
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
acibenzolar-S-methyl from food and water will utilize 12% of the cPAD 
for children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for acibenzolar-S-methyl. Based 
on the explanation in Unit III.C.3., regarding residential use 
patterns, chronic residential exposure to residues of acibenzolar-S-
methyl is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Acibenzolar-S-methyl is currently registered for uses that could 
result in short-term residential exposure, and the Agency has 
determined that it is appropriate to aggregate chronic exposure through 
food and water with short-term residential exposures to acibenzolar-S-
methyl.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 700 for females 
13-49 years from handler activities, and, 1,600 for females 13-49 years 
old, and 800-1,000 for children 1-2 and 6-12 years old, respectively, 
from post-application exposure. Because EPA's level of concern for 
acibenzolar-S-methyl is a MOE of 100 or below, these short-term-
aggregate MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    An intermediate-term adverse effect was identified; however, 
acibenzolar-S-methyl is not registered for any use pattern that would 
result in intermediate-term residential exposure. Intermediate-term 
risk is assessed based on intermediate-term residential exposure plus 
chronic dietary exposure.

[[Page 30406]]

Because there is no intermediate-term residential exposure and chronic 
dietary exposure has already been assessed under the appropriately 
protective cPAD (which at least one protective as the POD used to 
assess intermediate-term risk), no further assessment of intermediate-
term risk is necessary, and EPA relies on the chronic dietary risk 
assessment for evaluating intermediate-term risk for acibenzolar-S-
methyl.
    Because no intermediate-term adverse effect was identified, 
acibenzolar-S-methyl is not expected to pose an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, acibenzolar-S-methyl is not expected to pose a cancer risk to 
humans.
    6. 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 acibenzolar-S-methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology high performance liquid 
chromatography using ultra-violet detection ((HPLC/UV) Method AG-617A) 
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; email 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.
    There are no established Codex, Mexican, or Canadian maximum 
residue limits for acibenzolar-S-methyl in/on any commodity. Therefore, 
international harmonization is not an issue for acibenzolar-S-methyl.

V. Conclusion

    Therefore, time-limited tolerances are established for residues of 
acibenzolar-S-methyl, in or on apple, grapefruit and pear at 0.05 ppm. 
A time limitation been imposed because these tolerances are being 
established in conjunction with approval of an EUP to use acibenzolar-
S-methyl on apple, pear and grapefruit. The EUP approval period and 
time-limited tolerances will expire 12/31/2015 which provides ample 
time for all treated crops to be harvested, stored, and out of channels 
of trade.

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 and pests, Reporting and 
recordkeeping requirements.

    Dated: May 14, 2012.
Lois Rossi,
Director, Registration Division, 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 180.561 is amended as follows:

[[Page 30407]]

0
a. Redesignate paragraph (a) as (a)(1); and
0
b. Add paragraph (a)(2).
    The amendments read as follows:


Sec.  180.561  Acibenzolar- S -methyl; tolerances for residues.

    (a) General.
    (1) * * *
    (2) Tolerances are established for residues of acibenzolar- S -
methyl, benzo(1,2,3)thiadiazole-7-carbothioic acid- S -methyl ester, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below 
is to be determined by measuring only those acibenzolar- S -methyl 
residues convertible to benzo(1,2,3)thiadiazole-7-carboxylic acid (CGA-
210007), expressed as the Stoichiometric equivalent of acibenzolar- S -
methyl, in or on the following raw agricultural commodities.

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
Apple.........................................         0.05   12/31/2015
Grapefruit....................................         0.05   12/31/2015
Pear..........................................         0.05   12/31/2015
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-12410 Filed 5-22-12; 8:45 am]
BILLING CODE 6560-50-P