Document ID: EPA-HQ-OPP-2013-0714-0009
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Benalaxyl-M
Posted Date: 2015-07-30T04:00Z

[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Rules and Regulations]
[Pages 45443-45448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18741]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0714; FRL-9927-63]

Benalaxyl-M; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
benalaxyl-M in or on grape and tomato. Since there are currently no 
U.S. registrations of benalaxyl-M for use on grape and tomato, this 
tolerance will allow the import of grape and tomato containing residues 
of benalaxyl-M. Technology Sciences Group, on behalf of Isagro S.p.A, 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective July 30, 2015. Objections and 
requests for hearings must be received on or before September 28, 2015, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

[[Page 45444]]

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2013-0714, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 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: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

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-2013-0714 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 
September 28, 2015. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2013-0714, 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 CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (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.html.
    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 February 21, 2014 (79 FR 9870) (FRL-
9904-98), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
3E8162) by Technology Sciences Group on behalf of Isagro S.p.A., 1150 
18th Street NW., Suite 1000, Washington, DC 20036. The petition 
requested that 40 CFR part 180 be amended by establishing import 
tolerances for residues of the fungicide benalaxyl-M in or on grape at 
1.1 parts per million (ppm); grape juice at 1.1 ppm; grape wine at 1.1 
ppm; grape raisin at 2.2 ppm; tomato at 0.25 ppm; and tomato processed 
at 0.25 ppm. That document referenced a summary of the petition 
prepared by Technology Sciences Group on behalf of Isagro S.p.A., the 
registrant, which is available in the docket, http://www.regulations.gov. No tolerance-related comments were submitted.
    Based upon review of the data supporting the petition, EPA is 
establishing tolerances as follows: 3.0 ppm for grapes and 0.20 ppm for 
tomato. The reasons for these changes are explained in Unit IV.C.

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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for benalaxyl-M including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with benalaxyl-M 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

[[Page 45445]]

concerning the variability of the sensitivities of major identifiable 
subgroups of consumers, including infants and children.
    Benalaxyl-M has no significant acute toxicity via oral, dermal or 
inhalation route of exposure. It is not a skin irritant and does not 
cause skin sensitization.
    The liver and thyroid are the primary target organs for benalaxyl-
M. In rats, increased liver weights, clinical chemistry changes 
indicative of liver toxicity, hepatocellular hypertrophy, and thyroid 
follicular cell hypertrophy were seen following subchronic and chronic 
exposure. In mice, increased liver weight and microscopic lesions in 
the liver (hepatocellular hypertrophy, necrosis, eosinophilic foci) 
were observed following subchronic and chronic exposure. Additionally, 
chronic exposure in rats and mice led to increases in the incidence of 
liver (rat, mouse) and thyroid (rat) tumors. In dogs, increased liver 
weight, changes in clinical chemistry indicative of liver toxicity, and 
hepatocellular hypertrophy were observed following subchronic exposure 
via the diet, whereas clinical chemistry changes indicative of liver 
toxicity, fat vacuolation in the liver, and thyroid follicular cell 
hypertrophy were observed following chronic exposure via capsules.
    No evidence of increased quantitative or qualitative susceptibility 
was seen in the benalaxyl-M hazard database following in utero exposure 
with rats or rabbits in the prenatal developmental studies or in young 
rats in the 2-generation reproduction study. No evidence of maternal 
toxicity or developmental effects was observed in the developmental 
toxicity studies in rabbits or rats. There is no reproductive concern. 
No neurotoxic effects were observed in the acute and subchronic 
neurotoxicity studies in rats, and no immunotoxic effects were observed 
in the immunotoxicity study in rats.
    Benalaxyl-M was classified as ``Likely to be Carcinogenic to 
Humans''. This determination was based on the treatment-related liver 
tumors observed in male mice, liver tumors observed in male and female 
rats; and thyroid follicular cell tumors observed in female rats. No 
treatment-related tumors were observed in female mice. A linear low-
dose extrapolation model (Q*1) was used to estimate cancer 
risk, based on the male mouse liver tumor rates. There is no 
mutagenicity concern from the in vivo or in vitro genetic toxicity 
assays.
    Specific information on the studies received and the nature of the 
adverse effects caused by benalaxyl-M 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 ``Benalaxyl-M. Human-Health Risk 
Assessment for Tolerances in/on Imported Grape and Tomato'' on pages 10 
through 20 in docket ID number EPA-HQ-OPP-2013-0714.

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 benalaxyl-M used for 
human risk assessment is shown in the Table of this unit.
Table--Summary of Toxicological Doses and Endpoints for Benalaxyl-M for 
Use in Human Health Risk Assessment

 Table 4.5.4.--Summary of Toxicological Doses and Endpoints for Benalaxyl-M for Use in Dietary Human Health Risk
                                                   Assessments
----------------------------------------------------------------------------------------------------------------
                                                  Uncertainty/   RfD, PAD, Level
      Exposure/Scenario            Point of       FQPA safety     of concern for      Study and toxicological
                                  departure         factors      risk assessment              effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General         No appropriate
 Population, including          acute endpoint
 Infants, Children, and         was identified.
 females 13+).
Chronic Dietary..............  NOAEL= 20 mg/kg/ UFA= 10x.......  Chronic RfD =..  Chronic Toxicity/
(All Popyulations)...........   day.            UFH= 10x.......  cPAD = 0.02 mg/   Carcinogenicity Study--rat
                                                FQPA UFDB = 10x   kg/day.          (49040634)
                                                                                  LOAEL = 135 mg/kg/day based on
                                                                                   based on an increase in
                                                                                   [gamma]-glutamyl transferase
                                                                                   (GGT) in males, slight
                                                                                   increases liver weight in
                                                                                   both sexes, increased
                                                                                   incidence of hepatocellular
                                                                                   hypertrophy in both sexes,
                                                                                   increased incidence of
                                                                                   thyroid follicular cell
                                                                                   hypertrophy in both sexes,
                                                                                   increased incidence of
                                                                                   thyroid cell hyperplasia in
                                                                                   females, increased incidence
                                                                                   of thyroid follicular ectasia
                                                                                   in females, and an increased
                                                                                   incidence of ovarian stromal
                                                                                   cell hyperplasia in females.

[[Page 45446]]

 
Cancer (oral)................  Classification:
                                ``Likely to be
                                Carcinogenic
                                to Humans''.
                                Based on male
                                mouse liver
                                tumors, Q1*=
                                5.90 x 10\-3\
                                (mg/kg/day)\-
                                1\.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). UFDB = to account for the
  absence of a comparative thyroid study. FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (c =
  chronic). RfD = reference dose.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to benalaxyl-M, EPA assessed dietary exposures from benalaxyl-
M in food as follows:
    i. Acute exposure. No such effects were identified in the 
toxicological studies for benalaxyl-M; therefore, a quantitative acute 
dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
CSFII. As to residue levels in food, EPA used tolerance-level residues 
and 100% crop treated.
    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. 
If quantitative cancer risk assessment is appropriate, cancer risk may 
be quantified using a linear or nonlinear approach. If sufficient 
information on the carcinogenic mode of action is available, a 
threshold or nonlinear approach is used and a cancer RfD is calculated 
based on an earlier noncancer 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 benalaxyl-M should be classified as ``Likely to be 
Carcinogenic to Humans'' and a linear approach has been used to 
quantify cancer risk. Cancer risk was quantified using the same 
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 benalaxyl-M. Tolerance level residues and/or 
100% CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. An assessment of residues 
in drinking water is not required for this assessment because there is 
no drinking water exposure in the U.S. associated with the 
establishment of an import tolerance.
    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). Benalaxyl-M is not 
registered for any specific use patterns that would result in 
residential exposure.
    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 benalaxyl-M to share a common mechanism of 
toxicity with any other substances, and benalaxyl-M does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
benalaxyl-M 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. No evidence of increased 
quantitative or qualitative susceptibility was seen following in utero 
exposure to benalaxyl-M with rats or rabbits in the prenatal 
developmental toxicity studies or in young rats in the 2-generation 
reproduction study. The 2-generation reproduction study resulted in no 
effects on reproductive function or fertility. The offspring effects 
occurred at the same dose that caused parental effects. No evidence of 
developmental delay or developmental toxicity was observed in 
developmental toxicity studies in rabbits or in rats.
    The rabbit was tested at the limit dose (1000 mg/kg/day), and no 
maternal or developmental toxicity was observed. No significant 
developmental or maternal toxicity occurred at the highest dose level 
tested in the rat study, but the

[[Page 45447]]

limit dose was not tested. It is not necessary to require the 
submission of an additional rat study since a study at higher dose 
levels would not result in a lower NOAEL and the point of departure is 
already 10-fold lower than the NOAEL in the rat study.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were retained at 10x. That decision is based on the following 
findings:
    i. The toxicity database for benalaxyl-M is complete for purposes 
of assessing the exposures from the use of benalaxyl-M on imported 
grapes and tomatoes. However, there remains some uncertainty regarding 
the potential for benalaxyl-M effects on thyroid. Thyroid toxicity was 
seen following subchronic and chronic exposures to adult rats. There 
are, however, no data regarding the potential effects of benalaxyl-M on 
thyroid homeostasis in the young animals. This lack of characterization 
creates uncertainty with regards to potential life stage sensitivities 
due to exposure to benalaxyl-M. For future uses with higher exposure 
potential, the Agency will require a comparative thyroid assay in rats 
to assess the potential impact of benalaxyl-M exposure on thyroid 
function in the young given the pivotal role of thyroid hormones in 
brain development.
    ii. There is no indication that benalaxyl-M is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that benalaxyl-M results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases.

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. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
benalaxyl-M is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
benalaxyl-M from food will utilize 1.4% of the cPAD for the general 
U.S. population and all population sub-groups. The most highly exposed 
population subgroup was children 1-2 years old with an estimated risk 
of 7.1% cPAD.
    3. Aggregate cancer risk for U.S. population. The cancer dietary 
assessment made use of the same input assumptions as the chronic 
analysis. Benalaxyl-M has been classified as ``Likely to be 
Carcinogenic to Humans''. A linear low-dose extrapolation model 
(Q1*) was used to estimate cancer risk, with a 
Q1* = 5.90 x 10-3 (mg/kg/day) -1. The 
cancer risk estimate to the U.S. population is 1.7 x 10-6. 
EPA generally considers cancer risks in the range of 10-6 or 
less to be negligible. The precision which can be assumed for cancer 
risk estimates is best described by rounding to the nearest integral 
order of magnitude on the log scale; for example, risks falling between 
3 x 10-7 and 3 x 10-6 are expressed as risks in 
the range of 10-6. Considering the precision with which 
cancer hazard can be estimated, the conservativeness of low-dose linear 
extrapolation, and the rounding procedure described above in this unit, 
cancer risk should generally not be assumed to exceed the benchmark 
level of concern of the range of 10-6 until the calculated 
risk exceeds approximately 3 x 10-6. This is particularly 
the case where some conservatism is maintained in the exposure 
assessment.
    4. Determination of safety. There are no existing or proposed US 
registrations of benalaxyl-M and the only route of exposure is via 
dietary ingestion from imported grape and tomato commodities. 
Therefore, aggregate exposure and risk estimates are equivalent to the 
dietary exposures and risk estimates. 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 benalaxyl-M residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (RA.09.01, a high-performance 
liquid chromatography method with tandem mass spectrometry detection 
(HPLC/MS/MS) 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 United Nations 
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 established MRLs for benalaxyl-M at 0.3 and 0.2 ppm 
in or on grape and tomato, respectively. As a result, the EPA 
recommendations will result in harmonization of the U.S. tolerance with 
the Codex MRL for tomato, but not for grape since benalaxyl-M residues 
from the grape trials in Argentina were significantly higher than the 
Codex MRL.

C. Revisions to Petitioned-for Tolerances

    The requested tolerance levels differ from those being established 
by EPA. The petitioner used the NAFTA calculator to propose tolerance 
levels while EPA used OECD MRL calculation procedures. Additionally, 
for determination of the grape and tomato tolerance levels, the 
petitioner included the results from all trials. In contrast, EPA 
included only those data that matched the critical Good Agricultural 
Practice (cGAP). The tolerance for grape, raisin was not recommended 
because it is covered by the grape tolerance. No separate tolerances 
are needed for grape juice, grape wine, or processed tomato products as 
processing studies showed that residues of benalaxyl-M do not 
concentrate in these processed commodities.

[[Page 45448]]

V. Conclusion

    Therefore, tolerances are established for residues of benalaxyl-M, 
in or on grape and tomato at 3.0 and 0.20 ppm, respectively.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) 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 action has been 
exempted from review under Executive Order 12866, this action 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 action 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 FFDCA section 408(d), 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 action 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 FFDCA section 408(n)(4). 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    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 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: July 24, 2015.
Marty Monell,
Acting 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. Add Sec.  180.684 to subpart C to read as follows:

Sec.  180.684  Benalaxyl-M; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide benalaxyl-M, 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 benalaxyl 
[methyl N-(2,6-dimethylphenyl)-N-(phenylacetyl)-DL-alaninate] in or on 
the commodity.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Grape \1\...............................................            3.0
Tomato \1\..............................................            0.20
------------------------------------------------------------------------
\1\ There is no U.S. registration for use on this commodity as of July
  30, 2015.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2015-18741 Filed 7-29-15; 8:45 am]
 BILLING CODE 6560-50-P