[Federal Register Volume 81, Number 233 (Monday, December 5, 2016)]
[Rules and Regulations]
[Pages 87463-87467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29109]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0049; FRL-9954-69]


Oxathiapiprolin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
oxathiapiprolin in or on multiple commodities which are identified and 
discussed later in this document. In addition, this regulation amends 
the established tolerance for vegetable, tuberous and corm, subgroup 
1C; and removes existing tolerances for Brassica, head and stem, 
subgroup 5A, and leafy greens subgroup 4A that are superseded by this 
action. Interregional Research Project Number 4 (IR-4), E.I. du Pont de 
Nemours & Company (DuPont), and Syngenta Crop Protection, LLC 
(Syngenta) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective December 5, 2016. Objections and 
requests for hearings must be received on or before February 3, 2017, 
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-2016-0049, 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: Michael L. Goodis, Acting Director, 
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 
Publishing 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-2016-0049 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 
February 3, 2017. 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-2016-0049, 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 25, 2016 (81 FR 24044) (FRL-9944-
86) and May 19, 2016 (81 FR 31581) (FRL-9946-02), EPA issued documents 
pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing 
the filing of pesticide petitions (PPs) by DuPont (PP# 5F8435); 
Interregional Research Project Number 4 (PP# 5E8437) and Syngenta (PP# 
5F8441), respectively.
    The petition, 5F8437, requested that 40 CFR 180.685 be amended by 
establishing tolerances for residues of the fungicide oxathiapiprolin, 
1-[4-[4-[5-

[[Page 87464]]

(2,6-difluorophenyl)-4,5-dihydro-3-isoxazolyl]-2-thiazolyl]-1-
piperidinyl]-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]-ethanone, 
in or on basil, dried leaves at 80 parts per million (ppm); basil, 
fresh leaves at 10 ppm; Brassica head and stem vegetable group 5-14 at 
1.5 ppm; Brassica leafy greens subgroup 4-14B at 10 ppm; caneberry 
subgroup 13-07A at 0.5 ppm; leafy greens subgroup 4-14A at 15 ppm; and 
stalk and stem vegetable subgroup 22A at 2 ppm. The notice of filing 
for petition, PP# 5E8437, proposed a tolerance for individual crops 
included in designated crop group/subgroups under a proposed rule, 
``Tolerance Crop Grouping Program IV'' on November 14, 2014 (79 FR 
68153). This rule proposed certain revisions to EPA's pesticide 
tolerance crop grouping regulations. The final rule establishing 
tolerances for these crop groups/subgroups ``Pesticide Tolerance Crop 
Grouping Program Amendment IV'' published on May 3, 2016 (81 FR 26471).
    The Syngenta petition, 5F8441, requested that 40 CFR 180.685 be 
amended by establishing tolerances for residues of the fungicide 
oxathiapiprolin, 1-[4-[4-[5-(2,6-difluorophenyl)-4,5-dihydro-3-
isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2-[5-methyl-3-
(trifluoromethyl)-1H-pyrazol-1-yl]-ethanone, in or on: citrus oil at 
2.0 ppm; citrus, pulp at 0.09 ppm; fruit, citrus, group 10-10 at 0.06 
ppm; potato, wet peel at 0.07 ppm; and requested revising the existing 
0.01 ppm tolerance on vegetable, tuberous and corm, subgroup 1C to 0.04 
ppm.
    The Dupont petition, 5F8435, requested that 40 CFR 180.685 be 
amended by establishing tolerances for residues of the fungicide 
oxathiapiprolin, 1-[4-[4-[5-(2,6-difluorophenyl)-4,5-dihydro-3-
isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2-[5-methyl-3-
(trifluoromethyl)-1H-pyrazol-1-yl]-ethanone, in or on: soybean at 0.01 
ppm, and sunflower at 0.01 ppm.
    A summary of the petitions prepared by IR4 and the registrants, 
DuPont and Syngenta, are available in the docket, http://www.regulations.gov. One comment was received on the notice of filings. 
EPA's response to this comment is discussed in Unit IV.C.
    Based upon review of the data supporting the subject petitions, EPA 
has revised the proposed tolerance level for certain crops and 
corrected commodity definitions, as needed, to be consistent with 
current EPA policy. The reason for these changes are explained in Unit 
IV.D.

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 oxathiapiprolin including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with oxathiapiprolin 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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. In the toxicity studies for oxathiapiprolin, no treatment-
related effects were seen in any species at doses up to the limit dose 
(1,000 millgrams/kilogram (mg/kg)/day). No treatment-related effects 
were seen in subchronic or chronic oral toxicity (rats, mice, or dogs), 
dermal toxicity, neurotoxicity, or immunotoxicity studies. 
Additionally, there was no evidence of carcinogenicity in cancer 
studies with rats or mice. No treatment-related effects were seen in 
maternal or fetal animals in rat or rabbit developmental toxicity 
studies. Treatment-related effects were observed in offspring animals 
in rat reproduction studies (decreased body weight and delayed 
preputial separation); however, the effects were only observed at doses 
above the limit dose. Such high doses are not relevant for human health 
risk. The lack of observed treatment-related oxathiapiprolin toxicity 
effects is consistent with the low to moderate oral absorption and lack 
of bioaccumulation reported in the rat metabolism studies. In acute 
lethality studies, exposure to oxathiapiprolin resulted in low toxicity 
via the oral, dermal, and inhalation routes of exposure. 
Oxathiapiprolin was not a dermal or eye irritant, or a skin sensitizer.
    Specific information on the studies received and the nature of the 
adverse effects caused by oxathiapiprolin 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, ``Oxathiapiprolin--New Active 
Ingredient Human Health Risk Assessment of Uses on Turf, Ornamentals, 
and a Number of Crops'' dated June 25, 2015, in docket ID number EPA-
HQ-OPP-2014-0114.

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.

[[Page 87465]]

    The majority of the toxicity studies for oxathiapiprolin did not 
demonstrate treatment-related effects, with the exception of the 
reproduction study. The effects in the reproduction study were minimal 
and seen at doses (above the limit dose) not relevant for human 
exposure. There were no adverse acute or chronic effects identified for 
any population groups (including infants and children). Therefore, due 
to the limited toxicity in the oxathiapiprolin toxicological database, 
toxicity endpoints and points of departure were not selected for 
oxathiapiprolin exposure scenarios and a quantitative risk assessment 
was not conducted.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to oxathiapiprolin, EPA considered exposure under the 
petitioned-for tolerances as well as all existing oxathiapiprolin 
tolerances in 40 CFR 180.685. There is likely to be dietary exposure to 
oxathiapiprolin from its use as a pesticide on food. Should exposure 
occur, however, minimal to no risk is expected for the general 
population, including infants and children, due to the low toxicity of 
oxathiapiprolin.
    2. Dietary exposure from drinking water. Exposure to 
oxathiapiprolin via drinking water from the proposed uses is expected 
to be minimal due to rapid foliar uptake and limited quantities 
available in spray drift. No adverse effects were observed in the 
submitted toxicological studies for oxathiapiprolin regardless of the 
route of exposure.
    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).
    Oxathiapiprolin is not proposed or registered for any specific use 
pattern that would result in residential handler exposure. However, 
some of the uses could involve commercial application in areas where 
residential post-application activities could occur (i.e., individuals 
playing on treated golf courses, commercial landscapes or treated 
ornamentals purchased at a retail location). Since no adverse effects 
were observed for oxathiapiprolin in the submitted toxicological 
studies (regardless of the route of exposure), quantitative residential 
handler or post-application exposure assessments are not needed.
    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 
oxathiapiprolin to share a common mechanism of toxicity with any other 
substances, and oxathiapiprolin does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that oxathiapiprolin 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. No evidence of increased 
quantitative or qualitative susceptibility was seen in developmental 
toxicity studies in rats and rabbits. No treatment related effects were 
seen in maternal or fetal animals in the studies. However, there was 
evidence of increased quantitative susceptibility in reproduction 
studies in rats at doses above the limit dose. Decreased pup weight and 
delayed sexual maturation (preputial separation) were seen in the 
studies in the absence of maternal toxicity.
    3. Conclusion. EPA evaluated the available toxicity and exposure 
data on oxathiapiprolin and considered their validity, completeness, 
and reliability, as well as the relationship of this information to 
human risk. EPA considers the toxicity database to be complete and has 
identified no residual uncertainty with regard to prenatal and 
postnatal toxicity or exposure. No hazard was identified based on the 
available studies; therefore, EPA concludes that there are no threshold 
effects of concern to infants, children, or adults from 
oxathiapiprolin. As a result, EPA concludes that no additional margin 
of exposure (safety) is necessary.

E. Aggregate Risks and Determination of Safety

    Taking into account the available data for oxathiapiprolin, EPA has 
concluded that given the lack of toxicity of this substance, no risks 
of concern are expected. Therefore, 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 
oxathiapiprolin.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Method 30422 (Supplement No. 1) was developed for plant 
commodities, and Method 31138 was developed for livestock commodities. 
Residues of oxathiapiprolin and associated metabolites are extracted 
from crop or livestock commodity samples using a solution of formic 
acid, water and acetonitrile, and diluted with acetonitrile and water. 
Both methods use liquid chromotography with tandem mass spectrometry 
(LC/MS/MS), specifically reverse-phase liquid chromatography (LC), and 
detection by electrospray tandem mass spectrometry (MS/MS).
    The FDA multi-residue methods are not suitable for detection and 
enforcement of oxathiapiprolin residues or associated metabolites. 
However, the European Multiresidue Method (DFG Method S19) and the 
QuEChERS Multiresidue Method have shown success in some matrices.
    Adequate enforcement methodology (LC/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: [email protected].

[[Page 87466]]

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 maximum residue limits (MRLs) for 
oxathiapiprolin.

C. Response to Comments

    A comment was received from an anonymous commenter objecting to EPA 
``approving additional uses of oxathiapiprolin that add to the 
thousands of existing toxic chemical residues as well as the 
undetermined synergistic effects these toxicants pose to America's 
population.'' The existing legal framework provided by section 408 of 
the Federal Food, Drug, and Cosmetic Act (FFDCA) states that tolerances 
may be set when the pesticide meets the safety standard imposed by that 
statute. As required by that statute, EPA conducted a comprehensive 
assessment of oxathiapiprolin, including its potential for 
carcinogenicity. Based on its assessment of the available data, the 
Agency believes that given the observed lack of toxicity of this 
chemical, no risks of concern are expected. Therefore, 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 oxathiapiprolin.

D. Revisions to Petitioned-For Tolerances

    In the notice of filing for petition 5E8437, the titles of the 
designated new commodity group and subgroups are as listed in the 
``Tolerance Crop Grouping Program IV'' proposal of November 14, 2014 
(79 FR 68153). In the final rule which published on May 3, 2016, 
``Pesticide Tolerances Crop Grouping Program Amendment IV,'' EPA 
revised the crop group/subgroup titles by roughly retaining the same 
name and number as the pre-existing group/subgroup, except the number 
is followed by a hyphen and the final digits of the year established. 
Hence, the title of the requested ``Brassica leafy greens subgroup 4-
14B'' (due to the May 3, 2016 final rule as noted above) becomes 
``Brassica leafy greens subgroup 4-16B.'' Likewise, the requested 
``Leafy greens subgroup 4-14A'' becomes ``Leafy greens subgroup 4-
16A;'' and the title of the requested ``Brassica head and stem 
vegetable group 5-14'' was revised to ``Vegetable, Brassica head and 
stem, group 5-16.''
    To be consistent with current EPA policy, the commodity definitions 
were corrected for the following crops: vegetable, stalk and stem, 
subgroup 22A to stalk and stem vegetable subgroup 22A; citrus fruit, 
crop group 10 10 to fruit, citrus, group 10-10; citrus oil to citrus, 
oil; citrus pulp to citrus, dried pulp; soybean to soybean, seed; and 
sunflower to sunflower, seed.
    For certain proposed crop tolerances, the Agency corrected the 
proposed tolerance levels. For caneberry subgroup 13-07A, the corrected 
tolerance level includes an additional significant figure (0.50 ppm 
rather than the proposed 0.5 ppm). This is to avoid the situation where 
rounding of an observed residue to the level of precision of the 
tolerance expression would be considered non-violative (such as 0.54 
ppm being rounded to 0.5 ppm). For the same reason, the corrected 
tolerance for stalk and stem vegetable subgroup 22A is 2.0 ppm instead 
of the proposed 2 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of the fungicide 
oxathiapiprolin, 1-[4-[4-[5-(2,6-difluorophenyl)-4,5-dihydro-3-
isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2-[5-methyl-3-
(trifluoromethyl)-1H-pyrazol-1-yl]-ethanone, in or on basil, dried 
leaves at 80 ppm; basil, fresh leaves at 10 ppm; Brassica leafy greens 
subgroup 4-16B at 10 ppm; caneberry subgroup 13-07A at 0.50 ppm; leafy 
greens subgroup 4-16A at 15 ppm; citrus, dried pulp at 0.09 ppm; 
citrus, oil at 2.0 ppm; fruit, citrus, group 10-10 at 0.06 ppm; potato, 
wet peel at 0.07 ppm; soybean, seed at 0.01 ppm; stalk and stem 
vegetable subgroup 22A at 2.0 ppm; sunflower, seed at 0.01 ppm and 
vegetable, Brassica, head and stem, group 5-16 at 1.5 ppm. The existing 
0.01 ppm tolerance on vegetable, tuberous and corm, subgroup 1C is 
revised to 0.04 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

[[Page 87467]]

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: November 10, 2016.
Michael Goodis,
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. Amend the table in Sec.  180.685(a)(1) as follows:
0
 a. Remove the entries for ``Brassica, head and stem, subgroup 5A''; 
and ``Leafy greens subgroup 4A'';
0
b. Revise the entry for ``Vegetable, tuberous and corm, subgroup 1C''; 
and
0
 c. Add alphabetically the entries for ``Basil, dried leaves''; 
``Basil, fresh leaves''; ``Brassica leafy greens subgroup 4-16B''; 
``Caneberry subgroup 13-07A''; ``Citrus, dried pulp''; ``Citrus, oil''; 
``Fruit, citrus, group 10-10''; ``Leafy greens subgroup 4-16A''; 
``Potato, wet peel''; ``Soybean, seed''; ``Stalk and stem vegetable 
subgroup 22A''; ``Sunflower, seed'' and ``Vegetable, Brassica head and 
stem, group 5-16''.
    The revisions and additions read as follows:


Sec.  180.685  Oxathiapiprolin; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Basil, dried leaves.....................................              80
Basil, fresh leaves.....................................              10
Brassica leafy greens subgroup 4-16B....................              10
Caneberry subgroup 13-07A...............................            0.50
Citrus, dried pulp......................................            0.09
Citrus, oil.............................................             2.0
Fruit, citrus, group 10-10..............................            0.06
 
                              * * * * * * *
Leafy greens subgroup 4-16A.............................              15
 
                              * * * * * * *
Potato, wet peel........................................            0.07
Soybean, seed...........................................            0.01
Stalk and stem vegetable subgroup 22A...................             2.0
Sunflower, seed.........................................            0.01
 
                              * * * * * * *
Vegetable, Brassica head and stem, group 5-16...........             1.5
 
                              * * * * * * *
Vegetable, tuberous and corm, subgroup 1C...............            0.04
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* * * * *
[FR Doc. 2016-29109 Filed 12-2-16; 8:45 am]
 BILLING CODE 6560-50-P