84 FR 24983 - Pyriofenone; Pesticide Tolerances

This regulation establishes tolerances for residues of pyriofenone in or on fruiting vegetable, crop group 8-10. ISK Biosciences Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

[Federal Register Volume 84, Number 104 (Thursday, May 30, 2019)]
[Rules and Regulations]
[Pages 24983-24987]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2019-11261]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0677; FRL-9993-11]


Pyriofenone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
pyriofenone in or on fruiting vegetable, crop group 8-10. ISK 
Biosciences Corporation requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 30, 2019. Objections and 
requests for hearings must be received on or before July 29, 2019 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-2018-0677, 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 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: [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-2018-0677 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
July 29, 2019. 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-2018-0677, 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 21, 2018 (83 FR 65660) (FRL-
9985-67), 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 
7F8647) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, 
Concord, Ohio 44077. The petition requested that 40 CFR 180.660 be 
amended by establishing tolerances for residues of the fungicide 
pyriofenone, in or on fruiting vegetable, crop group 8-10 at 0.30 parts 
per million (ppm). That document referenced a summary of the petition 
prepared by ISK Biosciences Corporation, the registrant, which is 
available in the docket, http://www.regulations.gov. There were no

[[Page 24984]]

comments received in response to the notice of filing. Based upon 
review of the data supporting the petition and under its authority in 
FFDCA section 408(d)(4)(A)(i), EPA is establishing a tolerance that 
varies slightly from what the petitioner sought. The reason for this 
change is 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 pyriofenone including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with pyriofenone 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.
    The liver (dog, rat, and mouse), kidney (rat and mouse), and cecum 
(rat) were the primary organs affected in toxicity studies associated 
with the species identified above. Indications of liver toxicity 
included increased weight, dark color, histological abnormalities, and 
serum hepatic enzyme changes. Indications of kidney toxicity included 
increased weight, coarse surface, histological abnormalities, increased 
urinary ketones, and perigenital staining. Cecum effects included 
increased weight; and enlarged, distended, and inflamed conditions. 
There are no inhalation risks of concern, due to high margins of 
exposure via the inhalation route as well as very low toxicity observed 
in the acute inhalation toxicity study (Toxicity Category IV). Based on 
a weight of evidence approach, it was determined that a subchronic 
inhalation study was not required. No dermal toxicity was noted at the 
limit dose. No developmental toxicity was noted at the limit dose in 
rats; abortions were noted in rabbits at 300 mg/kg/day. The rabbit 
abortions were associated with decreased maternal body weight gain and 
food consumption. There was no reproductive toxicity observed at the 
highest dose tested in rats (334 mg/kg/day), no neurotoxicity observed 
in the database, and no quantitative or qualitative sensitivity was 
noted in offspring. Based on a battery of mutagenicity studies, there 
was no evidence of genotoxicity nor an increased incidence of tumors. 
There was no evidence that pyriofenone directly targets the immune 
system based on the results of the immunotoxicity study and the other 
studies in the toxicity database. Based on a lack of evidence of 
carcinogenicity in available studies conducted with mice and rats, 
pyriofenone is classified as ``Not Likely to Be Carcinogenic to 
Humans.''
    Specific information on the studies received and the nature of the 
adverse effects caused by pyriofenone 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 Pyriofenone. Human Health Risk 
Assessment for the Section 3 Registration on Fruiting Vegetables (Crop 
Group 8-10) on pages 29-37 in docket ID number EPA-HQ-OPP-2018-0677.

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 pyriofenone used for 
human risk assessment is shown in Table 1 of this unit.

[[Page 24985]]



   Table--Summary of Toxicological Doses and Endpoints for Pyriofenone for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (All populations)..       A dose and endpoint of concern attributable to a single dose was not
                                                                      observed.
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Chronic dietary (All populations)  NOAEL= 9.1 mg/kg/day  Chronic RfD = cPAD   Carcinogenicity in rat.
                                   UFA = 10x...........   = 0.091 mg/kg/day.  LOAEL = 46.5 mg/kg/day based on
                                   UFH = 10x...........                        chronic nephropathy in females.
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)           Classification: ``Not likely to be Carcinogenic to Humans''.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to pyriofenone, EPA considered exposure under the petitioned-
for tolerances as well as all existing pyriofenone tolerances in 40 CFR 
180.660. EPA assessed dietary exposures from pyriofenone 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 pyriofenone; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In estimating chronic dietary exposure, EPA 
used food consumption information from the United States Department of 
Agriculture's National Health and Nutrition Examination Survey, What We 
Eat in America, (NHANES/WWEIA) as incorporated in the Dietary Exposure 
and Evaluation Model with Food Commodity Intake Database (DEEM-FCID) 
Version 3.16. As to residue levels in food, EPA assumed 100 percent 
crop treated (PCT) and tolerance-level residues. Potential residues in 
drinking water were included in the DEEM-FCID categories ``water, all 
sources'' and ``water, indirect all sources''. All populations were 
evaluated for chronic dietary exposure and risk from food and drinking 
water.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that pyriofenone is not likely to be carcinogenic; therefore, 
a dietary exposure assessment for the purpose of assessing cancer risk 
is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for pyriofenone. Tolerance level residues and 100 
PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for pyriofenone in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of pyriofenone. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Tier I Cranberry Model and Pesticide Root Zone Model 
Ground Water (PRZM GW), the estimated drinking water concentrations 
(EDWCs) of pyriofenone for chronic exposures for non-cancer assessments 
are estimated to be 2.7 ppb for surface water and 3.9 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration value of 3.9 ppb was used to assess 
the contribution to drinking water.
    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). Pyriofenone is not 
registered for any specific use patterns that would result in 
residential exposure. Therefore, a residential exposure assessment is 
not required.
    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 
pyriofenone to share a common mechanism of toxicity with any other 
substances, and pyriofenone does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that pyriofenone 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 website at https://www.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

[[Page 24986]]

additional safety factor when reliable data available to EPA support 
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. Exposure to pyriofenone did 
not result in any developmental effects at the limit dose in rats, but 
abortions were noted in rabbits at 300 mg/kg/day. EPA is regulating 
pyriofenone at doses that are protective of this effect. The abortions 
were associated with decreased maternal body weight gain and food 
consumption. There were no reproductive effects observed in rats at the 
highest tested dose (334 mg/kg/day), nor was any quantitative or 
qualitative sensitivity noted in offspring.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for pyriofenone is complete.
    ii. There is no indication that pyriofenone is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional uncertainty factors (UFs) to account for neurotoxicity.
    iii. There is no evidence that pyriofenone results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The chronic dietary food exposure assessment was performed 
based on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to pyriofenone in drinking water. These assessments 
will not underestimate the exposure and risks posed by pyriofenone.

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, 
pyriofenone 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 
pyriofenone from food and water will utilize 6.9% of the cPAD for 
children 1-2 years old the population group receiving the greatest 
exposure. There are no residential uses for pyriofenone, therefore, the 
chronic aggregate risk is limited to the chronic dietary risk and is 
not of concern.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). There are no 
residential uses for pyriofenone; therefore, short-term aggregate risks 
are addressed by the chronic aggregate risk estimates and are not of 
concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). There are no residential uses for pyriofenone; therefore, 
intermediate-term aggregate risks are addressed by the chronic 
aggregate risk estimates and are not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, pyriofenone is not expected to pose a cancer risk to humans.
    6. 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 pyriofenone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography method with 
tandem mass spectrometric detection [LC-MS/MS]) is available to enforce 
the tolerance expression. The method was independently validated to a 
limit of quantitation (LOQ) of 0.01 ppm in grapes, wheat grain, and 
wheat straw.

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 pyriofenone.

C. Revisions to Petitioned-For Tolerances

    Under FFDCA section 408(d)(4)(A)(i), EPA may establish tolerances 
that vary from those sought by the petition. EPA has modified the 
commodity definition to be consistent with Agency nomenclature. 
Additionally, the tolerance level has been modified to be consistent 
with the Agency's rounding class practice.

V. Conclusion

    Therefore, tolerances are established for residues of pyriofenone, 
including its metabolites and degradates in or on fruiting vegetable, 
crop group 8-10 at 0.3 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), nor is it a regulatory action 
under Executive Order 13771, entitled ``Reducing Regulations and 
Controlling Regulatory Costs'' (82 FR 9339, February 3, 2017). This 
action does not contain any information collections subject to OMB 
approval under the Paperwork Reduction Act

[[Page 24987]]

(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special 
considerations under Executive Order 12898, entitled ``Federal Actions 
to Address Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: May 22, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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



0
2. In Sec.  180.660, add alphabetically ``Vegetable, fruiting, group 8-
10'' to the table in paragraph (a) to read as follows:


Sec.  180.660  Pyriofenone; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Vegetable, fruiting, group 8-10.............................         0.3
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-11261 Filed 5-29-19; 8:45 am]
BILLING CODE 6560-50-P