[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Rules and Regulations]
[Pages 12516-12520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06334]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0616; FRL-9987-14]


Metrafenone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
metrafenone in or on mushroom. BASF Corporation requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 2, 2019. Objections and 
requests for hearings must be received on or before June 3, 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-2017-0616, 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-2017-0616 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 
June 3, 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

[[Page 12517]]

(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-2017-0616, 
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 February 27, 2018 (83 FR 8408) (FRL-
9972-17), 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 
7F8624) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research 
Triangle Park, NC 27709-3528. The petition requested that 40 CFR 
180.624 be amended by establishing a tolerance for residues of the 
fungicide metrafenone, (3-bromo-6-methoxy-2-methylphenyl) (2,3,4-
trimethoxy-6-methylphenyl)methanone, in or on mushroom at 0.5 parts per 
million (ppm). That document referenced a summary of the petition 
prepared by BASF Corporation, the registrant, which is available in the 
docket, http://www.regulations.gov. Comments were received on the 
notice of filing. EPA's response to these comments is discussed in Unit 
IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing the tolerance for residues of metrafenone at 0.50 ppm to 
be consistent with EPA rounding class practices. Additionally, the 
tolerance is established for the commodity ``White button mushroom'' to 
reflect the mushroom variety tested in the supporting crop field trial 
studies.

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 metrafenone including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with metrafenone 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 is the primary target organ for metrafenone in mice, 
rabbits and rats. Effects on the liver were seen in multiple studies 
throughout the database, including subchronic rat studies, the rabbit 
developmental toxicity study, and chronic studies in mice and rats. 
Liver effects observed in subchronic studies included increased liver 
weights, periportal cytoplasmic vacuolation, increased cholesterol, and 
hepatocellular hypertrophy. Liver effects observed in chronic studies 
included those from the subchronic studies as well as increased serum 
gamma glutamyl transferase, eosinophilic alterations, necrosis, 
polyploid hepatocytes, bile duct hyperplasia, liver masses, and 
hepatocellular adenomas. The additional effects in the chronic studies 
indicate a progression of toxicity with time. The effects on the liver 
are consistent with the results of the absorption, distribution, 
metabolism, and excretion (ADME) studies indicating that the highest 
tissue concentrations of metrafenone were found in the liver and 
gastrointestinal tract and that bile is the primary route of excretion.
    Additionally, nephrotoxicity was observed following chronic 
exposure to metrafenone in mice and rats. The kidney effects observed 
in the chronic studies included subacute/chronic interstitial 
inflammation and chronic/progressive nephropathy, cysts, brown pigment 
in renal cells, increased urinary volume, and increased urinary 
protein.
    In a 28-day dermal toxicity study in rats, there were no dermal or 
systemic effects observed up to the highest dose tested of 1,000 mg/kg/
day, the limit dose. In a 28-day immunotoxicity study in female rats, 
no effect on the immune system was observed up to the highest dose 
tested of 1,000 mg/kg/day, the limit dose. This is consistent with the 
rest of the database where no effects on the immune system were 
observed in any study.
    There was no evidence of qualitative or quantitative susceptibility 
in the developmental and reproduction toxicity studies. In the 
developmental rat study, no effects were observed in dams or fetuses up 
to the limit dose of 1,000 mg/kg/day. In the rabbit study, liver 
toxicity (increased liver weights, hypertrophy, and hepatocyte 
vacuolation) was observed in the dams but no developmental effects were 
observed up to the limit dose of 1,000 mg/kg/day.
    In the rat reproduction toxicity study, there was no evidence of 
reproductive toxicity. Effects in the offspring (decreased pup weight) 
occurred at doses similar to those that cause toxicity in the parental 
animals (decreased body weight).
    The required battery of mutagenicity studies was submitted, 
including bacterial reverse mutation assay, mammalian cell mutation 
(CHO cells), in vitro chromosome aberration (CHO cells), micronucleus 
assay and unscheduled DNA synthesis in mammalian cells in culture. 
There is no evidence that metrafenone is genotoxic.
    In the mouse carcinogenicity study, liver tumors (increased 
incidence of hepatocellular adenomas and adenomas plus carcinomas) were 
observed in male

[[Page 12518]]

mice at the highest dose of 1,109 mg/kg/day. In the rat chronic/
carcinogenicity study, there was an increased incidence in 
hepatocellular adenomas in females at the high dose of 1,419 mg/kg/day. 
However, the tumors in the rat females were not considered in the 
weight-of-evidence finding because they were associated with excessive 
toxicity to the females, leading to a reduction of the dose during the 
study. The registrant submitted mechanistic studies to support a mode 
of action (MOA) for the liver tumors, but the studies were conducted in 
rats. Although the MOA was considered plausible, the Agency concluded 
the data on rats could not be used to support a MOA finding in mice. 
The Agency concluded that quantification of cancer risk using a non-
linear approach would adequately account for all chronic toxicity 
(including carcinogenicity) that could result from exposure to 
metrafenone. The use of the chronic point of departure is protective 
based on the following reasons:
     A treatment-related increase in benign liver tumors was 
seen only in male CD-1 mice at doses that were adequate to assess the 
carcinogenicity.
     The liver tumors were observed at doses significantly 
higher (44x) than those currently used for risk assessment.
     No treatment-related tumors were seen in female mice.
     No treatment-related tumors were seen in male rats and 
liver tumors in female rats were seen only at the Limit Dose which was 
excessively toxic to females; no tumors were seen at the next dose of 
5,000 ppm, which was considered adequate to assess carcinogenicity.
     There is no mutagenicity concern for metrafenone.
    Specific information on the studies received and the nature of the 
adverse effects caused by metrafenone 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 ``Metrafenone. Human Health Risk 
Assessment for the Section 3 Registration for Use on Mushrooms'' at 
pages 26-36 in docket ID number EPA-HQ-OPP-2017-0616.

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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for metrafenone used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of October 22, 2014 (79 FR 63047) 
(FRL-9917-56).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to metrafenone, EPA considered exposure under the petitioned-
for tolerance as well as all existing metrafenone tolerances in 40 CFR 
180.624. EPA assessed dietary exposures from metrafenone 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 
metrafenone; 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 USDA National 
Health and Nutrition Examination Survey, What We Eat in America, 
(NHANES/WWEIA; 2003-2008). As to residue levels in food, EPA assumed 
100 percent crop treated (PCT), tolerance-level residues (using a 2X 
metabolism adjustment factor), and EPA's 2018 default processing 
factors (with the exception of chemical-specific processing factors 
where available).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that the use of the chronic point of departure is appropriate 
for assessing cancer risk to metrafenone. Therefore, a separate dietary 
exposure assessment for the purpose of assessing cancer risk is 
unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for metrafenone. Tolerance level residues (using a 2X metabolism 
adjustment factor), default processing factors (with the exception of 
chemical-specific processing factors where available), 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 metrafenone in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of metrafenone. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM 
GW), the estimated drinking water concentrations (EDWCs) of metrafenone 
total toxic residues for chronic exposures are estimated to be 14.52 
ppb for surface water and 12.3 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 of value 14.52 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). Metrafenone 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

[[Page 12519]]

``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 metrafenone to share a common mechanism of 
toxicity with any other substances, and metrafenone does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
metrafenone 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/guidance-identifying-pesticide-chemicals-and-other.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
qualitative or quantitative susceptibility in the developmental and 
reproduction toxicity studies. In the developmental rat study, no 
effects were observed in dams or fetuses up to the limit dose of 1,000 
mg/kg/day. In the rabbit study, liver toxicity (increased liver 
weights, hypertrophy, and hepatocyte vacuolation) was observed in the 
dams but no developmental effects were observed up to the limit dose of 
1,000 mg/kg/day. In the rat reproduction toxicity study, there was no 
evidence of reproductive toxicity. Effects in the offspring (decreased 
pup weight) occurred at doses similar to those which cause toxicity in 
the parental animals (decreased body weight).
    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 metrafenone is complete.
    ii. There is no indication that metrafenone 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 metrafenone results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT, tolerance-level residues (using a 2X metabolism adjustment 
factor), and EPA's 2017 default processing factors (with the exception 
of chemical-specific processing factors where available). EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to metrafenone in drinking water. 
These assessments will not underestimate the exposure and risks posed 
by metrafenone.

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, 
metrafenone 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 
metrafenone from food and water will utilize 16% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for metrafenone.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    A short- and intermediate-term adverse effect was identified; 
however, metrafenone is not registered for any use patterns that would 
result in short- and/or intermediate-term residential exposure. Short- 
and intermediate-term risk is assessed based on short-term residential 
exposure plus chronic dietary exposure. Because there is no short- and/
or intermediate-term residential exposure and chronic dietary exposure 
has already been assessed under the appropriately protective cPAD 
(which is at least as protective as the POD used to assess short-term 
risk), no further assessment of short-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating short- and 
intermediate-term risk for metrafenone.
    4. Aggregate cancer risk for U.S. population. EPA considers the 
chronic aggregate risk assessment to be protective of any aggregate 
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 metrafenone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology ((Method FAMS 105-01)) is 
available to enforce the tolerance expression. Additionally, BASF has 
proposed the QuEChERS LC-MS/MS method as a new enforcement method for 
metrafenone.
    The method for Method FAMS 105-01 may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email 
address: [email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture

[[Page 12520]]

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 established an MRL for metrafenone in or on mushrooms 
at 0.5 ppm. The Codex MRL is for ``Mushrooms'' defined as VF 0450 to 
include button mushroom, Rodman's agaricus mushroom and Hime-Matsutake, 
edible fungi. This MRL matches the tolerance established for 
metrafenone in or on white button mushroom in the United States, with 
the exception of the number of significant digits.

C. Response to Comments

    Two comments were received in response to the Notice of Filing 
associated with this action, requesting that the Agency deny approval 
of the product due to impacts on the environment. Because the Agency's 
role is to assess the safety of the tolerance, these comments are 
outside the scope of this rulemaking.

V. Conclusion

    Therefore, tolerances are established for residues of metrafenone, 
(3-bromo-6-methoxy-2-methylphenyl) (2,3,4-trimethoxy-6-methylphenyl) 
methanone, in or on white button mushroom at 0.50 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance 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 considered 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 (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: March 15, 2019.
Donna Davis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. In Sec.  180.624, add alphabetically the entry ``White button 
mushroom'' to the table in paragraph (a) to read as follows:


Sec.  180.624  Metrafenone; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
White button mushroom...................................            0.50
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-06334 Filed 4-1-19; 8:45 am]
 BILLING CODE 6560-50-P


