Oxathiapiprolin; Pesticide Tolerances, 53469-53473 [2015-21917]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 80, Number 172 (Friday, September 4, 2015)]
[Rules and Regulations]
[Pages 53469-53473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21917]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0114; FRL-9931-18]


Oxathiapiprolin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
oxathiapiprolin in or on multiple commodities that are identified and 
discussed later in this document. E.I. du Pont de Nemours and Company 
(``Dupont'') requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 4, 2015. Objections and 
requests for hearings must be received on or before November 3, 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).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2014-0114, is available at https://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 https://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 https://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-2014-0114 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
November 3, 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

[[Page 53470]]

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-2014-0114, by one of the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of May 23, 2014 (79 FR 29729) (FRL-9910-
29), 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 
3F8220) by Dupont, 1007 Market Street, Wilmington, DE 19898. The 
petition requested that 40 CFR part 180 be amended by establishing 
tolerances for residues of the fungicide oxathiapiprolin, 1-(4-{4-
[(5RS)-5-(2,6-difluorophenyl)-4,5-dihydro-1,2-oxazol-3-yl]-1,3-thiazol-
2-yl{time} -1-piperidyl)-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-
yl] ethanone, in or on the following commodities: Brassica (cole) leafy 
vegetables, head and stem brassica crop subgroup 5A at 1.5 ppm; bulb 
vegetables, onion, bulb, crop subgroup 3-07A at 0.04 ppm; bulb 
vegetables, onion, green crop subgroup 3-07B at 2 ppm; cucurbit 
vegetables, crop group 9 at 0.2 ppm; fruiting vegetables crop group 8-
10 at 0.2 ppm; grape (import tolerance) at 0.9 ppm; ginseng root at 0.4 
ppm; leafy greens crop subgroup 4A at 15 ppm; peas, edible podded at 1 
ppm; peas, succulent, shelled at 0.05 ppm; and vegetable, root and 
tuber vegetables, tuberous corm vegetable crop subgroup 1C at 0.01 ppm. 
One comment was received on the notice of filing. EPA's response to 
this comment is discussed in Unit IV.C.
    Additionally, in the Federal Register of July 17, 2015 (80 FR 
42462) (FRL-9923-13), EPA issued a document pursuant to FFDCA section 
408(d)(3), 21 U.S.C. 346a(d)(3), announcing a correction to the filing 
of a pesticide petition (PP 3F8220) by Dupont. This document corrects 
the petition announced in the May 23, 2014 Federal Register by adding 
the omitted entry for dried fruit vegetable at 0.9 ppm. No FFDCA-
related comments were received on this notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the tolerance levels of some commodities and corrected several 
commodity definitions. The reasons 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 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.
    In the toxicity studies for oxathiapiprolin, no treatment-related 
effects were seen at doses up to the limit dose. 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 (1,227 milligram/kilogram/day (mg/kg/day)). Such 
high doses are not relevant for human health risk. No other treatment-
related effects were observed in oral or dermal studies with 
oxathiapiprolin. The lack of observed toxicity 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 https://www.regulations.gov in document, ``Oxathiapiprolin--New Active 
Ingredient Human Health Risk Assessment of Uses on Turf, Ornamentals, 
and a Number of Crops'' 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

[[Page 53471]]

dose at which the NOAEL and the LOAEL are identified. 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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    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. 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.
    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 https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. 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. As part of its qualitative assessment, EPA evaluated 
the available toxicity and exposure data on oxathiapiprolin and 
considered its 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.

[[Page 53472]]

    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: 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 not established a MRL for oxathiapiprolin.

C. Response to Comments

    One comment was received in response to the notice of filing of 
Dupont's application. The commenter objected to the increase of 
chemical residues generally and expressed concerns about the 
carcinogenic effects of chemicals on humans, particularly children. The 
Agency understands the commenter's concerns regarding toxic chemicals, 
their potential effects on humans, and population subgroups such as 
children. Pursuant to its authority under the FFDCA, and as discussed 
further in this preamble, EPA conducted a comprehensive assessment of 
oxathiapiprolin, including its potential for carcinogenicity. Based on 
its assessment of the available data, the Agency has concluded that 
there is a reasonable certainty that no harm will result from aggregate 
exposure to residues of oxathiapiprolin.

D. Revisions to Petitioned-for Tolerances

    For grape, green onion, cucurbit vegetables, and edible podded pea, 
EPA has added an additional significant figure (such as 1.0 ppm rather 
than 1 ppm) to conform to EPA's convention for establishing enforceable 
tolerances. Thus, the tolerance for grape was revised to 0.70, for 
green onion to 2.0, for cucurbit vegetables to 0.20, and for edible-
podded pea to 1.0. This is in order to avoid the situation where 
rounding of a residue result to the level of precision of the tolerance 
expression would be considered non-violative (such as 1.4 ppm being 
rounded to 1 ppm).
    In the case of crop group 8-10, Fruiting Vegetables, the 
petitioned-for-tolerance was based on the exclusion of a tomato field 
trial from the tolerance calculation. If this trial is excluded, all 
representative commodities (bell pepper, non-bell pepper, and tomato) 
support a crop group tolerance of 0.20 ppm. However, EPA has concluded 
that this trial cannot be excluded from the tolerance derivation 
because there were insufficient data to support this trial as an 
outlier. Including those data in the tolerance calculation for crop 
group 8-10, EPA is establishing a tolerance for crop group 8-10 at 0.50 
ppm and a tolerance for dried tomatoes at 3.0 ppm. EPA is not issuing a 
crop group 8-10 tolerance for dried versions of all commodities in that 
crop group, as EPA's current regulations do not permit the Agency to 
establish crop group processed commodity tolerances. Moreover, the 
available data do not support establishing separate individual 
tolerances for dried versions of the other commodities in crop group 8-
10.
    In the case of ginseng, Dupont submitted four field trials at the 
good agricultural practice (GAP) proposed use rate and two field trials 
at approximately two times the GAP. Based on a review of the data and 
consultation with the global partners, EPA has concluded that using the 
1x data is more appropriate for setting the tolerance, and is 
establishing a tolerance at 0.15 ppm based on that data.
    The Agency also corrected the commodity definitions for the 
following commodities: Bulb vegetables, onion, bulb, crop subgroup 3-
07A, to onion, bulb, subgroup 3-07A; bulb vegetables, onion, green crop 
subgroup 3-07B to onion, green, subgroup 3-07B; brassica (cole) leafy 
vegetables, head and stem brassica crop subgroup 5A to brassica, head 
and stem, subgroup 5A; cucurbit vegetables, crop group 9 to vegetable, 
cucurbit, group 9; fruiting vegetables crop group 8-10 to vegetable, 
fruiting, group 8-10; ginseng root to ginseng; leafy vegetables (except 
brassica vegetables), leafy greens crop subgroup 4A to leafy greens, 
subgroup 4A; peas, edible podded to pea, edible-podded; peas, 
succulent, shelled to pea, succulent shelled; and vegetable, root and 
tuber vegetables, tuberous corm vegetable crop subgroup 1C, to 
vegetable, tuberous and corm, subgroup 1C.
    The registrant did not petition for rotational crop tolerances. 
However, EPA has concluded that for future MRL harmonization purposes, 
it is appropriate to set a value of 0.10 ppm for inadvertent residues 
in all other food commodities/feed commodities (other than those 
covered by a tolerance as a result of use on growing crops).

V. Conclusion

    Therefore, tolerances are established for residues of 
oxathiapiprolin, 1-(4-{4-[(5RS)-5-(2,6-difluorophenyl)-4,5-dihydro-1,2-
oxazol-3-yl]-1,3-thiazol-2-yl{time} -1-piperidyl)-2-[5-methyl-3-
(trifluoromethyl)-1H-pyrazol-1-yl] ethanone, in or on the following 
commodities: Brassica, head and stem, subgroup 5A at 1.5 ppm; ginseng 
at 0.15 ppm; grape at 0.70 ppm; leafy greens subgroup 4A at 15 ppm; 
onion, bulb, crop subgroup 3-07A at 0.04 ppm; onion, green, crop 
subgroup 3-07B at 2.0 ppm; peas, edible podded at 1.0 ppm; peas, 
succulent, shelled at 0.05 ppm; tomato, dried at 3.0 ppm; vegetable, 
cucurbit, crop group 9 at 0.20 ppm; vegetables, fruiting, crop group 8-
10 at 0.50 ppm; and vegetable, tuberous and corm, crop subgroup 1C at 
0.01 ppm.
    In addition, inadvertent tolerances are established residues of 
oxathiapiprolin on all other food commodities/feed commodities (other 
than those covered by a tolerance as a result of use on growing crops) 
at 0.10 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

[[Page 53473]]

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 tolerances 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: August 27, 2015.
Jack E. Housenger,
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.  180.685 to subpart C to read as follows:


Sec.  [emsp14]180.685  Oxathiapiprolin; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fungicide oxathiapiprolin, 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 
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 the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A........................        1.5
Ginseng.....................................................        0.15
Grape \1\...................................................        0.70
Leafy greens subgroup 4A....................................       15
Onion, bulb, subgroup 3-07A.................................        0.04
Onion, green, subgroup 3-07B................................        2.0
Pea, edible-podded..........................................        1.0
Pea, succulent shelled......................................        0.05
Tomato, dried...............................................        3.0
Vegetable, cucurbit, group 9................................        0.20
Vegetable, fruiting, group 8-10.............................        0.50
Vegetable, tuberous and corm, subgroup 1C...................        0.01
------------------------------------------------------------------------
\1\ There is no associated U.S. registration as of September 4, 2015.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established 
for residues of the fungicide oxathiapiprolin, 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 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 the 
commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
All other food commodities/feed commodities (other than those       0.10
 covered by a tolerance as a result of use on growing crops).
------------------------------------------------------------------------

[FR Doc. 2015-21917 Filed 9-3-15; 8:45 am]
 BILLING CODE 6560-50-P