[Federal Register Volume 81, Number 86 (Wednesday, May 4, 2016)]
[Rules and Regulations]
[Pages 26722-26727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10389]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0014; FRL-9944-82]


Mefenoxam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
mefenoxam in or on rapeseed subgroup 20A. Syngenta Crop Protection, 
LLC., requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective May 4, 2016. Objections and 
requests for hearings must be received on or before July 5, 2016, 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-2015-0014, 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: [email protected].

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.

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-2015-0014 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 5, 2016. 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-2015-0014, 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 April 6, 2015 (80 FR 18327) (FRL-9924-
00), 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 
4F8323) by Syngenta Crop Protection, LLC., 410 Swing Road, Greensboro, 
NC 27419. The petition requested that 40 CFR 180.546

[[Page 26723]]

be amended by establishing tolerances for residues of the fungicide 
mefenoxam, methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-DL-
alaninate, in or on rapeseed crop subgroup 20A at 0.05 parts per 
million (ppm). That document 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 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 mefenoxam including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with mefenoxam 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. Mefenoxam is the enriched R-enantiomer of metalaxyl which is 
a racemic mixture that contains approximately 50% each of the R- and S-
enantiomers. EPA conducted side-by-side comparison of the available 
toxicity data for mefenoxam and metalaxyl and concluded that mefenoxam 
has similar toxicity to that of metalaxyl. Therefore, the metalaxyl 
data may be used to support regulatory actions for mefenoxam.
    The Agency reassessed the toxicity databases for metalaxyl and 
mefenoxam in accordance with current policies and determined that many 
of the effects previously noted in several toxicological studies are no 
longer considered to be adverse (i.e. body weight gain without changes 
in absolute body weight; hepatocyte hypertrophy without necrosis; 
enzyme leakage to bloodstream or disruption of lipid homeostasis). In 
rat and dog repeat dose (i.e., subchronic and chronic) oral toxicity 
studies, there were no indications of adverse effects up to the highest 
dose tested (HDT).
    Adverse effects were only observed from acute exposure to rats. In 
the rat developmental toxicity study of metalaxyl, maternal toxicity 
consisted of dose-related increased incidence of convulsions that 
occurred shortly after dosing, as well as other clinical signs. In a 
range-finding acute neurotoxicity study of mefenoxam, females showed 
abnormal functional observation battery (FOB) findings at lower doses 
than males. However, there was no indication of toxicity up to the HDT 
in the mefenoxam subchronic neurotoxicity study, which confirms the 
lack of adverse effects observed in all other repeated-dose studies.
    There was no indication of developmental toxicity in studies of 
mefenoxam or metalaxyl. There was no indication of immunotoxicity in a 
mouse immunotoxicity study of mefenoxam. Metalaxyl and mefenoxam have 
been classified as ``not likely to be carcinogenic in humans'' based on 
the results for metalaxyl in the carcinogenicity study in mice and the 
combined chronic toxicity and carcinogenicity study in rats.
    Specific information on the studies received and the nature of the 
adverse effects caused by mefenoxam 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 ``Mefenoxam, Human Health Risk 
Assessment'' at pages 14-17 in docket ID number EPA-HQ-OPP-2015-0014.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for mefenoxam used for 
human risk assessment is shown in Table 1 of this unit.

[[Page 26724]]



   Table 1--Summary of Toxicological Doses and Endpoints for Mefenoxam for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/Scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  NOAEL = 50 mg/kg/day  Acute RfD = 0.5 mg/  Metalaxyl Prenatal Developmental
 including infants, children, and  UFA = 10x...........   kg/day.              Toxicity--Rat
 females 13-50 years of age.       UFH = 10x...........  aPAD = 0.5 mg/kg/    LOAEL = 250 mg/kg/day based on
                                   FQPA SF = 1x........   day.                 dose-related increases in
                                                                               clinical signs of toxicity (e.g.,
                                                                               post-dosing convulsions).
                                  ------------------------------------------------------------------------------
Chronic dietary (All populations)  No endpoint was identified. No systemic toxicity was observed in any toxicity
                                    study where the animals were administered metalaxyl or mefenoxam in the
                                    diet. Acute dietary assessment is protective of all other durations of
                                    exposure.
                                  ------------------------------------------------------------------------------
Incidental oral short-term (1 to   NOAEL = 50 mg/kg/day  LOC for MOE = 100..  Metalaxyl Prenatal Developmental
 30 days) and intermediate-term    UFA = 10x...........                        Toxicity--Rat
 (1 to 6 months).                  UFH = 10x...........                       LOAEL = 250 mg/kg/day based on
                                   FQPA SF = 1x........                        dose-related increases in
                                                                               clinical signs of toxicity (e.g.,
                                                                               post-dosing convulsions).
                                  ------------------------------------------------------------------------------
Dermal short-term (1 to 30 days)   No endpoint was identified. No systemic toxicity was observed at the limit
 and intermediate-term (1 to 6      dose (1,000 mg/kg/day) in rabbits treated with metalaxyl during a 21-day
 months).                           dermal toxicity study.
                                   For converting oral to dermal doses for risk assessment, the Dermal
                                    Absorption Factor (DAF) = 35%.
                                  ------------------------------------------------------------------------------
Inhalation short-term (1 to 30     NOAEL = 50 mg/kg/day  LOC for MOE = 100..  Metalaxyl Prenatal Developmental
 days) and intermediate-term (1    UFA = 10x...........                        Toxicity--Rat
 to 6 months).                     UFH = 10x...........                       LOAEL = 250 mg/kg/day based on
                                   FQPA SF = 1x........                        dose-related increases in
                                   Note: Toxicity via                          clinical signs of toxicity (e.g.,
                                    the inhalation and                         post-dosing convulsions).
                                    oral routes are
                                    assumed to be
                                    equivalent..
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``Not Likely to be Carcinogenic to Humans'' based on the
                                    absence of treatment-related increases in tumor incidence in adequately
                                    conducted carcinogenicity studies in rats and mice treated with metalaxyl.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to mefenoxam, EPA considered exposure under the petitioned-for 
tolerances as well as all existing mefenoxam tolerances in 40 CFR 
180.546 and metalaxyl tolerances 40 CFR 180.408. EPA assessed dietary 
exposures from mefenoxam/metalaxyl 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 mefenoxam. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) 2003-2008 National Health and 
Nutrition Examination Survey/What We Eat in America (NHANES/WWEIA). As 
to residue levels in food, EPA conducted a somewhat refined acute 
dietary exposure assessment for the proposed food use of mefenoxam on 
the rapeseed subgroup 20A and the existing uses of both metalaxyl and 
mefenoxam. Residues were assumed to be present at tolerance levels in 
plant commodities, with additional factors applied to certain plant 
commodities to include all residues of concern for risk assessment. 
Tolerance-level residues adjusted upward to account for metalaxyl/
mefenoxam residues of concern in livestock commodities were used and 
based on data from metabolism studies on goats and hens. DEEM default 
and empirical processing factors were used as available. It was assumed 
that 100% of the crops were treated (100% CT).
    ii. Chronic exposure. No such effects were identified in the 
toxicological studies for mefenoxam; therefore, a quantitative chronic 
dietary exposure assessment is unnecessary.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that mefenoxam 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 percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for mefenoxam. Tolerance-level residues and/or 100% 
CT were assumed for all food commodities
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for mefenoxam in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of mefenoxam. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www2.epa.gov/pesticide-science-

[[Page 26725]]

and-assessing-pesticide-risks/about-water-exposure-models-used-
pesticide.
    Based on the Surface Water Concentration Calculator (SWCC) and the 
Pesticide Root Zone Model-Ground Water (PRZM GW), the estimated 
drinking water concentrations (EDWCs) of mefenoxam for acute exposures 
are estimated to be 741 parts per billion (ppb) for surface water and 
3,700 ppb for ground water. These modeled estimates of drinking water 
concentrations were directly entered into the dietary exposure model.
    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).
    Mefenoxam is currently registered for the following uses that could 
result in residential exposures: Residential turf and ornamentals, 
including nonbearing citrus trees. EPA assessed residential exposure 
using the following assumptions: Residential handler exposure is 
expected to be short-term in duration. Intermediate-term exposures are 
not likely because of the intermittent nature of applications by 
homeowners. Residential post-application exposure was assessed based on 
short-term incidental oral risk estimates for children 1 < 2 years old. 
Dermal post-application risk assessments were not conducted because an 
adverse systemic dermal hazard was not identified for mefenoxam. 
Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 mefenoxam 
to share a common mechanism of toxicity with any other substances, and 
mefenoxam does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has assumed that mefenoxam 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence that 
mefenoxam results in increased susceptibility from in utero exposure to 
rats or rabbits in the prenatal developmental studies or exposure to 
young rats in the 2-generation reproduction 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 reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for metalaxyl and mefenoxam is complete.
    ii. In the rat prenatal developmental toxicity with metalaxyl, 
maternal animals exhibited clinical signs indicative of neurobehavioral 
effects as previously discussed.
    In the range-finding acute neurotoxicity study with mefenoxam, 
females exhibited abnormal functional observation battery (FOB) 
findings at doses lower than in males. In the subchronic neurotoxicity 
study with mefenoxam, there were no indications of neurotoxicity up to 
the HDT. In metalaxyl and mefenoxam treated adult animals, clinical 
signs and abnormal FOB findings were noted. However, a developmental 
neurotoxicity (DNT) study is not required for metalaxyl or mefenoxam 
because (1) there are no indications of increased susceptibility for 
infants or children; (2) the convulsions observed in the rat prenatal 
developmental toxicity study occurred in the maternal animals with no 
effects being observed in the young; (3) the convulsions occurred only 
after a bolus dose; (4) the available developmental and range-finding 
acute neurotoxicity studies provided clear NOAELs and LOAELs for 
evaluating effects; (5) the current POD is below the level at which any 
effects were seen in either study, and (6) there were no other 
indications of neurotoxicity in the mefenoxam or metalaxyl databases, 
which include a subchronic (adult rat) neurotoxicity study for 
mefenoxam. Therefore, there is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. In metalaxyl and mefenoxam treated animals, there was no 
evidence of increased susceptibility following pre-/postnatal exposure 
in the prenatal developmental toxicity studies or the reproduction and 
fertility effects study. There is no evidence that mefenoxam 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. The dietary food exposure assessments were performed based 
on 100% CT and tolerance levels or upper bound residue estimates. EPA 
made conservative (protective) assumptions in the ground and surface 
water modeling used to assess exposure to mefenoxam in drinking water. 
EPA used similarly conservative assumptions to assess postapplication 
exposure of children as well as incidental oral exposure of toddlers. 
These assessments will not underestimate the exposure and risks posed 
by mefenoxam.

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. The acute aggregate risk assessment considers 
exposure estimates from dietary consumption of mefenoxam (food and 
drinking water). Using the exposure assumptions discussed in this unit 
for acute exposure, the acute dietary exposure from food and water to 
mefenoxam will occupy 95% of the aPAD for children <1 years old, the 
population group

[[Page 26726]]

receiving the greatest exposure, but this is below the level of 
concern.
    2. Chronic risk. A chronic aggregate risk assessment takes into 
account chronic exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from repeated exposure was 
identified and no chronic dietary endpoint was selected. Therefore, 
mefenoxam is not expected to pose a chronic risk.
    3. Short-term and Intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account both short-term 
and intermediate-term residential exposure plus chronic exposure to 
food and water (considered to be a background exposure level). 
Mefenoxam is currently registered for uses that could result in short-
term and intermediate-term residential exposure, and the Agency has 
determined that it is appropriate to aggregate short-term and 
intermediate-term residential exposures to mefenoxam. Using the 
exposure assumptions described in this unit for short-term and 
intermediate-term exposures, EPA has concluded the combined short-term 
and intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 79,000 for adult; and 1,000 for children 1 < 2 years 
old. Because EPA's level of concern for mefenoxam is a MOE of 100 or 
below, these MOEs are not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, mefenoxam is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to mefenoxam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Several methods are available for enforcing tolerances: (1) A gas-
liquid chromatography procedure employing an alkali flame ionization 
detector (GLC/AFID); (2) a method using GLC/nitrogen phosphorus 
detection; and (3) a multi-residue method in PAM, Vol 1.
    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: 
[email protected].

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 not established a MRL for mefenoxam for the rapeseed 
crop subgroup 20A.

V. Conclusion

    Therefore, tolerances are established for residues of mefenoxam, 
methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-DL-alaninate, in or on 
rapeseed subgroup 20A at 0.05 ppm.

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.


[[Page 26727]]


    Dated: April 21, 2016.
Daniel J. Rosenblatt,
Acting 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. In Sec.  180.546, add alphabetically the entry for ``Rapeseed 
subgroup 20A'' to the table in paragraph (a) to read as follows:


Sec.  180.546  Mefenoxam; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Rapeseed subgroup 20A......................................        0.05
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-10389 Filed 5-3-16; 8:45 am]
 BILLING CODE 6560-50-P