Document ID: EPA-HQ-OPP-2016-0392-0003
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fenpicoxamid
Posted Date: 2017-10-16T04:00Z

[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Rules and Regulations]
[Pages 47996-48000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22357]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0392; FRL-9966-73]

Fenpicoxamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
fenpicoxamid (XDE 777) in or on banana, rye, and wheat. Dow 
AgroSciences LLC requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 16, 2017. Objections and 
requests for hearings must be received on or before December 15, 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-2016-0392, 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, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2016-0392 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 
December 15, 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-2016-0392, 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 December 20, 2016 (81 FR 92758) (FRL-
9956-04), 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 
5E8440) by Dow AgroSciences LLC, 9330 Zionsville Rd, Indianapolis, IN 
46268. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the fungicide fenpicoxamid 
(XDE- 777) in or on banana at 0.1 parts per million (ppm), rye, grain 
and wheat, grain at 0.7 ppm; and residues of fenpicoxamid and its 
metabolite X12326349 expressed as fenpicoxamid

[[Page 47997]]

equivalents in or on meat and fat from cattle, goats, and sheep at 0.01 
ppm; and meat byproducts of cattle, goats, and sheep at 0.02 ppm. That 
document referenced a summary of the petition prepared by Dow 
AgroSciences 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. Based upon review of the data supporting the 
petition, EPA is establishing tolerances as follows: 0.15 ppm for 
banana and 0.60 ppm for rye, grain and wheat, grain. In addition, EPA 
has concluded that no tolerances are needed for livestock commodities 
at this time. The reason for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for fenpicoxamid including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with fenpicoxamid 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. Fenpicoxamid has no significant acute toxicity via oral, 
dermal or inhalation route of exposure. Moreover, it is not a skin 
irritant and does not cause skin sensitization.
    Liver effects were consistently observed in mice regardless of 
duration; however, the severity, magnitude, and diversity of the liver 
response progressed from adaptive in subchronic exposures to adverse in 
chronic exposures. Mice exposed to fenpicoxamid in the diet for 80 
weeks experienced liver weight increase accompanied by microscopic 
changes including very slight to moderate centrilobular/midzonal 
hepatocellular hypertrophy with altered tinctorial properties 
(increased cytoplasmic eosinophilia), vacuolization consistent with 
fatty change, and very slight hepatocyte necrosis. These liver effects 
also coincided with an increased incidence of microscopic calculi 
within the gallbladder in both sexes. A treatment-related increase in 
liver tumors were seen in male mice and is the basis for the Agency's 
classification of the chemical as ``Suggestive Evidence of Carcinogenic 
Potential''. The Agency determined that a non-linear approach 
adequately accounted for all chronic toxicity, including 
carcinogenicity, that could result from chronic exposure to 
fenpicoxamid and, therefore, quantification of carcinogenic potential 
was not required. This decision was based on the following 
considerations: (1) There was limited evidence of carcinogenicity in 
the fenpicoxamid toxicity database; (2) the concern for mutagenicity 
and genotoxicity is low; and (3) there was no evidence of 
carcinogenicity at doses at or below the chronic reference dose.
    Rats were likewise only adversely affected by treatment following 
chronic exposures. Chronic dietary exposure elicited treatment-related 
changes in the kidneys (increased severity of chronic progressive 
glomerulonephropathy) that were considered detrimental to the rat's 
health. However, unlike mice, chronic exposure did not elicit an 
increase in neoplasms in any tissue. Rabbits and dogs tolerated oral 
exposure up to doses of 495 and 1,115 milligrams/kilogram/day (mg/kg/
day), respectively, without any signs of deteriorating health. There 
was no evidence of fetal susceptibility in rats or rabbits, or 
offspring susceptibility in rats. None of the available studies 
produced evidence of treatment-induced immunotoxicity or neurotoxicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by fenpicoxamid 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 ``Fenpicoxamid (XDE-777): Human Health 
Risk Assessment to Establish Tolerances for Bananas, Wheat, and Rye 
Commodities Without U.S. Registration'' at pages 10 through 20 in 
docket ID number EPA-HQ-OPP-2016-0392.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for fenpicoxamid used for 
human risk assessment is shown in the Table of this unit.

[[Page 47998]]

  Table--Summary of Toxicological Doses and Endpoints for Fenpicoxamid for Use in Human Health Risk Assessments
----------------------------------------------------------------------------------------------------------------
                                                                        RfD, PAD, level
       Exposure/scenario              Point of       Uncertainty/FQPA    of concern for          Study and
                                     departure        safety factors    risk assessment    toxicological effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General           There were no effects in the toxicity database that could be attributed to a
 Population, including Infants    single dose; therefore, an acute POD was not identified.
 and Children).
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All             NOAEL = 40 mg/kg/  UFA = 10x UFH =    cRfD = 0.40 mg/kg/ Carcinogenicity study--
 Populations).                    day.               10x FQPA SF = 1x.  day cPAD = 0.40    mouse. MRID 49731126.
                                                                        mg/kg/day.         LOAEL = 156 and 388
                                                                                           mg/kg/day for males
                                                                                           and females,
                                                                                           respectively, based
                                                                                           on treatment-related
                                                                                           adverse liver effects
                                                                                           in males (increased
                                                                                           liver weight,
                                                                                           hypertrophy,
                                                                                           hepatocyte necrosis
                                                                                           and fatty change) and
                                                                                           females (increased
                                                                                           liver weight,
                                                                                           hypertrophy and fatty
                                                                                           change) and gall
                                                                                           bladder calculi.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal,            ``Suggestive Evidence of Carcinogenic Potential'' based on the presence of
 inhalation).                     liver tumors in male mice only. The cRfD is protective of carcinogenic
                                  effects.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
  PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fenpicoxamid, EPA assessed dietary exposures from 
fenpicoxamid 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. No such effects were 
identified in the toxicological studies for fenpicoxamid; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the food consumption data from the U.S. Department 
of Agriculture's (USDA's) 2003-2008 food consumption data from the 
USDA's National Health and Nutrition Examination Survey, What We Eat in 
America, (NHANES/WWEIA). As to residue levels in food, EPA used 
tolerance-level residues and 100% crop treated.
    iii. Cancer. As discussed in Unit III.A., EPA has concluded that a 
nonlinear RfD approach is appropriate for assessing cancer risk to 
fenpicoxamid.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residues and/or PCT information in the 
dietary assessment for fenpicoxamid. Tolerance-level residues and 100% 
CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. Because there are no 
domestic uses of fenpicoxamid registered in the United States, there 
will not be residues of fenpicoxamid in drinking water. Therefore, a 
drinking water assessment is not required.
    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). Fenpicoxamid is not 
registered for any specific use patterns that would result in 
residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found fenpicoxamid to share a common mechanism of 
toxicity with any other substances, and fenpicoxamid does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
fenpicoxamid does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. Developmental toxicity was 
not observed in the rat or rabbit developmental studies and, no 
reproductive or offspring effects were observed in the reproduction 
toxicity study. As a result, EPA concluded there is low concern for 
prenatal or postnatal sensitivity from fenpicoxamid exposure.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be

[[Page 47999]]

adequately protected if the FQPA SF were reduced to 1X for all exposure 
scenarios. That decision is based on the following findings:
    i. The toxicity database for fenpicoxamid is complete.
    ii. There is no indication that fenpicoxamid is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that fenpicoxamid results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
fenpicoxamid is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fenpicoxamid from food for the highest exposed population subgroup, 
children 1-2 years of age, is 0.002737 mg/kg/day or <1.0% of the cPAD. 
The chronic dietary exposure estimate for the general population is 
0.001022 mg/kg/day or <1.0% of the cPAD.
    3. Short-term and intermediate-term risk. Because fenpicoxamid is 
not registered for any uses that may result in residential exposure, 
fenpicoxamid is not expected to cause any short-term or intermediate-
term risk not already accounted for in the Agency's assessment of 
chronic risk.
    4. Aggregate cancer risk for U.S. population. Based on the Agency's 
assessment of chronic risk, the Agency concludes that fenpicoxamid is 
not expected to pose a cancer risk.
    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 fenpicoxamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid 
chromatography method with tandem mass spectrometry detection (LC/MS/
MS), Method No. 120615) is available to enforce the tolerance 
expression.

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.
    Codex has not established any MRLs for residues of fenpicoxamid.

C. Revisions to Petitioned-For Tolerances

    EPA is establishing tolerances for wheat, grain and rye, grain (at 
0.60 ppm) that differ from what the petition requested (0.7 ppm). The 
petitioner included only wheat grain residues for individual growing 
season/area combinations. Including all residues for wheat grain in the 
OECD MRL calculator in accordance with Agency policy results in a 
tolerance level of 0.60 ppm. Because the wheat grain data can be used 
to assess residues in rye grain, the Agency is establishing a tolerance 
at 0.60 ppm for rye grain as well. Finally, although the notice of 
filing and the petition summary indicate that the petitioner was 
seeking tolerances for wheat and rye, the section of the petition that 
listed actual requested tolerances more narrowly sought only ``wheat, 
grain'' and ``rye, grain'' tolerances because those are the forms in 
which the wheat and rye will be imported. Accordingly, EPA is 
establishing tolerances for the commodities ``wheat, grain'' and ``rye, 
grain''.
    EPA is establishing a different tolerance level for banana than 
what was requested based on available residue data and the OECD 
calculator, and in order to harmonize with Canada's MRL.
    EPA is not establishing any of the petitioned-for tolerances for 
livestock commodities. Based on the results of the livestock feeding 
studies, the residues of concern for livestock commodities 
(fenpicoxamid and X12326349) would be below the limit of quantification 
(LOQ) of the enforcement analytical method. Therefore, the Agency 
concludes, as indicated in 40 CFR 180.6(a)(3), that there is no 
reasonable expectation of finite residues and no tolerances are needed 
for livestock commodities at this time.

V. Conclusion

    Therefore, tolerances are established for residues of fenpicoxamid 
and its metabolites and degradates, in or on banana at 0.15 ppm, and 
rye and wheat grain at 0.60 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).

[[Page 48000]]

    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: September 6, 2017.
Richard P. Keigwin, Jr.,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  180.109 to subpart C to read as follows:

Sec.  [emsp14]180.109   Fenpicoxamid; Tolerances for residues.

    (a) General. Tolerances are established for residues of 
fenpicoxamid including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
for fenpicoxamid is to be determined by measuring only fenpicoxamid 
([[4-methoxy-2-[[[(3S,7R,8R,9S)-9-methyl-8-(2-methyl-1-oxopropoxy)-2,6-
dioxo-7-(phenylmethyl)-1,5-dioxonan-3-yl]amino]carbonyl]-3-
pyridinyl]oxy]methyl 2-methylpropanoate) in or on the commodity.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Banana*.................................................            0.15
Wheat, grain*...........................................            0.60
Rye, grain*.............................................            0.60
------------------------------------------------------------------------
*There are no U.S. registrations for use of fenpicoxamid on this
  commodity.

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

[FR Doc. 2017-22357 Filed 10-13-17; 8:45 am]
 BILLING CODE 6560-50-P