[Federal Register Volume 86, Number 238 (Wednesday, December 15, 2021)]
[Rules and Regulations]
[Pages 71155-71158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27093]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0538; FRL-9194-01-OSCPP]


Mefentrifluconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective December 15, 2021. Objections and 
requests for hearings must be received on or before February 14, 2022 
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-2020-0538, is available at 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805.
    Due to the public health concerns relating to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide customer service via 
email, phone, and webform. For the latest status information on EPA/DC 
services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, 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 Office of the 
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2020-0538 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing and must be received by the Hearing Clerk on or before 
February 14, 2022. 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-2020-0538, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting

[[Page 71156]]

comments. Do not submit electronically any information you consider to 
be CBI or other information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of December 21, 2020 (85 FR 82998) (FRL-
10016-93), 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 
0E8849) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research 
Triangle Park, NC 22709-3528. The petition requested that 40 CFR part 
180 be amended by establishing tolerances for residues of 
mefentrifluconazole in or on banana at 1.5 parts per million (ppm) and 
coffee at 0.4 ppm. That document referenced a summary of the petition 
prepared by BASF Corporation, the petitioner, which is available in the 
docket for this action, docket ID number EPA-HQ-OPP-2020-0538 at, 
https://www.regulations.gov. One comment from an anonymous citizen was 
received in response to the notice of filing (NOF). The Agency response 
is listed in Unit IV.C.
    With respect to the subject action, the proposed tolerance levels 
were not altered, but the commodity definition for coffee was revised. 
The reason for this change is explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

A. Statutory Background

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

B. Aggregate Risk Assessment

    In an effort to streamline Federal Register publications, EPA is 
directing readers to certain sections of Federal Register notices for 
previous tolerance rulemakings for the same pesticide that contain 
information that has not changed in the current risk assessment. To 
that end, on June 28, 2019, EPA published in the Federal Register a 
final rule establishing a tolerance for residues of mefentrifluconazole 
in or on many livestock, corn, fruit, grain, nut and vegetable 
commodities based on the Agency's conclusion that aggregate exposure to 
mefentrifluconazole is safe for the general population, including 
infants and children. See 84 FR 30939 (FRL-9994-51). Please refer to 
the following sections of the aforementioned tolerance rulemaking that 
contain information that has remained the same under the current risk 
assessment for this rulemaking: Units III.A (Toxicological Profile); 
III.B (Toxicological Points of Departure/Levels of Concern); III.C 
(Exposure Assessment), except as explained in the next paragraph; and 
III.D (Safety Factor for Infants and Children).
    Updates to exposure assessment. The Agency conducted an updated 
risk assessment to evaluate exposure to residues of mefentrifluconazole 
on banana and coffee. EPA's acute and chronic dietary (food and 
drinking water) exposure assessments have been updated to include the 
additional exposure from use of mefentrifluconazole on banana and 
coffee. As to residue levels in food, a partially refined chronic 
dietary exposure and risk assessment was conducted assuming 100 percent 
crop treated (PCT) and using average field-trial residues for some 
commodities and tolerance-level residues for other commodities (banana 
and coffee). There will be no U.S. registrations for use of 
mefentrifluconazole on banana and coffee, and there is no proposed new 
residential use. Therefore, EPA's assessments of dietary exposure from 
drinking water and non-dietary (i.e., residential) exposure, as well as 
cancer classification and cumulative effects from substances with a 
common mechanism of toxicity, have not changed and are described in the 
June 2019 tolerance rulemaking.
    Assessment of aggregate risks. Acute aggregate risk estimates are 
equal to acute dietary (food and drinking water) risk estimates, which 
are below the Agency's level of concern of 100% of the acute population 
adjusted dose (aPAD): The exposure estimate is 5.6% of the aPAD at the 
95th percentile of exposure for females 13 to 49 years old, which is 
the population subgroup with the highest exposure estimate. Chronic 
aggregate risk estimates are equal to chronic dietary (food and 
drinking water) risk estimates, which are below the Agency's level of 
concern of 100% of the chronic population adjusted does (cPAD): The 
exposure estimate is 82% of the cPAD for children 1 to 2 years old, 
which is the population subgroup with the highest exposure estimate. 
Short-term aggregate risk estimates are equal to the total short-term 
residential post-application dermal exposure estimates plus average 
dietary exposure estimates. For adults, the most conservative 
residential exposure estimate is from post-application dermal exposure 
from golfing activities after applications to golf courses, with a 
margin of exposure (MOE) above the Agency's level of concern of 100 
(MOE = 2600). For children 6 to less than 11 years old, the most highly 
exposed child subgroup for residential exposure, the most conservative 
residential exposure estimate is from post-application dermal exposure 
from golfing activities after applications to golf courses. The dietary 
exposure for children 6 to 12 years old was used to calculate aggregate 
exposure as this subgroup is similar to the subgroup children 6 to less 
than 11 years old. The MOE is above the Agency's level of concern of 
100 (MOE = 1900). Children 1 to <2 years old were the highest exposed 
child subgroup for dietary exposures, which does not match the most 
highly exposed child subgroup for residential exposure (children 6 to 
<11 years old). However, the selected residential exposure scenarios 
for aggregation, adults and children (6 to <11 years old), represent

[[Page 71157]]

the worst-case risk estimates and are protective of all other life 
stages and exposure scenarios. Considering both the total short-term 
residential post-application dermal exposures and average dietary 
exposures for both adults and children, EPA has concluded the short-
term aggregate MOEs are 790 and 620 for adults and children 6 to less 
than 11 years old, respectively, which are above the level of concern 
of 100 and therefore are not of concern. Intermediate-term residential 
exposures are not expected from the residential use of 
mefentrifluconazole; therefore, intermediate-term aggregate risk is not 
a concern and quantitative estimates were not calculated. 
Mefentrifluconazole is classified as ``not likely to be carcinogenic to 
humans''; therefore, a quantitative cancer assessment was not 
conducted.

C. Determination of Safety

    Therefore, based on the risk assessments and information described 
above, EPA concludes there is a reasonable certainty that no harm will 
result to the general population, or to infants and children, from 
aggregate exposure to mefentrifluconazole residues. More detailed 
information on the subject action to establish a tolerance in or on 
banana and coffee can be found in the document entitled, 
``Mefentrifluconazole. Human Health Risk Assessment for Petition for 
the Establishment of Permanent Tolerances for Use on Banana and Coffee 
without U.S. Registration.'' dated 10/20/2021 at https://www.regulations.gov, under docket ID number EPA-HQ-OPP-2020-0538.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The analytical enforcement methodologies found in Unit IV.A. of the 
final rule published in the Federal Register on June 28, 2019, 
establishing tolerances for residues of mefentrifluconazole in or on 
multiple commodities are adequate for banana and coffee. See 84 FR 
30939 (FRL-9994-51). The methods 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). Codex 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.
    There are currently no Codex or Canadian MRLs established for 
residues of mefentrifluconazole in banana or coffee; therefore, there 
are no issues with harmonization.

C. Response to Comments

    One anonymous comment to the NOF was submitted insisting that no 
residues of fluoride, which is a different chemical, should be 
permitted for bananas and coffee. Even so, no additional information 
was provided that would support a conclusion that the tolerances 
requested for mefentrifluconazole are not safe. Although some 
individuals do not want pesticides to be used on food, the FFDCA 
authorizes EPA to establish tolerances that permit certain levels of 
pesticide residues in or on food when the Agency can determine that 
such residues are safe. EPA has made that determination for the 
tolerances subject to this action, and the commenter provided no 
information to support a determination that the tolerance is not safe.

D. Revisions to Petitioned-For Tolerances

    EPA is establishing a tolerance on ``coffee, green bean'' rather 
than the requested tolerance on ``coffee'' to be consistent with the 
terminology the Agency uses for that commodity.

V. Conclusion

    Therefore, tolerances are established for residues of 
mefentrifluconazole in or on banana at 1.5 ppm and coffee, green bean, 
at 0.4 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal Governments, on the relationship between the National Government 
and the States or Tribal Governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian Tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology

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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: December 9, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

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.  180.705, amend table 1 to paragraph (a) by adding in 
alphabetical order the entries ``Banana'' and ``Coffee, green bean'' to 
read as follows:


Sec.  180.705  Mefentrifluconazole; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Banana \1\..................................................         1.5
 
                                * * * * *
Coffee, green bean \1\......................................         0.4
 
                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of December 15, 2021.

* * * * *
[FR Doc. 2021-27093 Filed 12-14-21; 8:45 am]
BILLING CODE 6560-50-P


