[Federal Register Volume 85, Number 220 (Friday, November 13, 2020)]
[Rules and Regulations]
[Pages 72571-72574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23423]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0346; FRL-10012-87]


Mefenoxam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
mefenoxam in or on the tree nut, crop group 14-12 and almond, hulls. 
Syngenta Crop Protection requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

[[Page 72572]]


DATES: This regulation is effective November 13, 2020. Objections and 
requests for hearings must be received on or before January 12, 2021, 
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-2019-0346, 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.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and 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: 
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 
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-2019-0346 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 
January 12, 2021. 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-2019-0346, 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 June 24, 2020 (85 FR 37806) (FRL-10010-
82), 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 
9F8759) by Syngenta Crop Protection LLC, P.O. Box 18300, Greensboro, NC 
27419. The petition requested that 40 CFR 180.546 be amended by 
establishing a tolerance for residues of mefenoxam, (methyl N-(2,6-
dimethylphenyl)-N-(methoxyacetyl)-DL-alaninate) including its 
metabolites and degradate, in or on tree nuts crop group 14-12 at 0.3 
parts per million (ppm). Syngenta's petition was intended to cover 
residues of mefenoxam in or on nut commodities from domestic use of the 
pesticide, although EPA erroneously stated in the Notice of Filing that 
Syngenta had requested a tolerance to cover residues of mefenoxam on 
imported nut commodities. EPA hereby clarifies that error and has 
evaluated the request as submitted by the petition. The error did not 
substantially impact the way EPA evaluated the petition. In addition, 
although not mentioned in EPA's document, Syngenta's petition also 
requested that currently established tolerances for residues of 
metalaxyl in/on almond and walnut at 0.5 ppm be removed from 40 CFR 
180.408, under the premise these commodities would be adequately 
covered by the proposed tree nut, crop group 14-12 tolerance for 
mefenoxam, which is the single enantiomer of the racemic mixture 
metalaxyl. A summary document of the petition prepared by Syngenta Crop 
Protection, the registrant, is available in the docket, http://www.regulations.gov. One comment was received in response to the notice 
of filing, although it was not germane to the petition for mefenoxam 
tolerances.

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

[[Page 72573]]

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 mefenoxam including exposure 
resulting from the tolerance established by this action. EPA's 
assessment of exposures and risks associated with mefenoxam follows.
    On December 21, 2018, EPA published in the Federal Register a final 
rule establishing tolerances for residues of mefenoxam in or on several 
commodities based on the Agency's conclusion that aggregate exposure to 
mefenoxam is safe for the general population, including infants and 
children. See 83 FR 65541 (FRL-9985-52). Because the Agency's position 
concerning several sections of that document have not changed, EPA is 
incorporating them by reference here--the toxicological profile and 
points of departure, description of the assumptions for assessing 
exposure from residues in or on food, in drinking water, and 
residential exposures, the Agency's conclusion about cumulative risk, 
and Agency's determination regarding the children's safety factor. 
Further information about EPA's risk assessment and determination of 
safety supporting the tolerances established in the December 21, 2018 
Federal Register action, as well as the new mefenoxam tolerance can be 
found at http://www.regulations.gov in the document titled ``Mefenoxam 
(Metalaxyl-M). Human Health Risk Assessment for the Establishment of 
Permanent Tolerances and New Uses in/on Wasabi, Cacao, and Crop Group 
Expansion from Kiwifruit to Fruit, Small, Vine Climbing, Except Grape, 
Crop Subgroup 13-07E.'' dated June 5, 2018, in docket ID EPA-HQ-OPP-
2017-0562 and the document titled, ``Mefenoxam (Metalaxyl-M). Human 
Health Risk Assessment for the Proposed New Use in/on Tree Nuts, Crop 
Group 14-12 and the Establishment of a Permanent Tolerance.'' in docket 
ID number EPA-HQ-OPP-2019-0346.
    EPA's exposure assessments have been updated to include the 
additional exposure from use of mefenoxam on tree nut, crop group 14-
12. EPA's aggregate exposure assessment incorporated this additional 
dietary exposure, as well as exposures from drinking water and 
residential sources, although those latter exposures are not impacted 
by the new uses on the tree nut, crop group 14-12 and thus have not 
changed since the last assessment.
    Acute dietary risks are below the Agency's level of concern: 52% of 
the acute population adjusted dose (aPAD) for children 1 to 2 years 
old, the population group of concern. Due to the lack of a chronic 
endpoint, a chronic dietary risk is not expected. As required by the 
FFDCA, EPA considered aggregate exposures to mefenoxam, i.e., exposures 
from food, drinking water, and residential uses, in its risk 
assessment. There are no residential uses expected to result in acute, 
intermediate-term, or chronic exposures; therefore, aggregate risks for 
those exposure durations are equal to the dietary risks for those 
exposure durations and not of concern.
    Based on the absence of increased hazard from repeated exposures to 
mefenoxam, short-term aggregate risk assessments are protective of 
potential effects from longer-term exposures. Additionally, residential 
exposures are not expected to occur beyond the short-term time 
interval.
    Using the exposure assumptions described for short-term exposures, 
EPA has concluded the combined short-term food, water, and residential 
exposures result in aggregate margins of exposures above the level of 
concern of 100 for all scenarios assessed and are not of concern.
    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 mefenoxam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    There are adequate residue analytical methods for enforcing 
tolerances for mefenoxam residues of concern in/on the registered plant 
and livestock commodities. These several methods include gas 
chromatography equipped with an alkali flame ionization detector (GC/
AFID), gas chromatography equipped with a nitrogen/phosphorus detector 
(GC/NPD), the multiresidue method in PAM, Vol. I Section 302 (Protocol 
D) in the nitrogen-specific mode, and gas-liquid chromatography/mass 
spectrometry in the chemical ionization mode with selected ion 
monitoring (SIM) of the M+1 ion at m/z 268 for determining residues in/
on nut crops and livestock.
    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: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established an MRL for mefenoxam or metalaxyl in 
or on the tree nut, crop group 14-12.

C. Revisions to Petitioned-For Tolerances

    There are no revisions to the requested tolerance petition of 
mefenoxam. The petition requested that upon establishment of tolerances 
in or on tree nuts crop group 14-12 at 0.3 ppm, the currently 
established tolerances for residues of metalaxyl in or on almond and 
walnuts at 0.5 ppm be removed from 40 CFR 180.408, because residues in 
or on these commodities were anticipated to be adequately covered by 
the new tree nut crop group 14-12 tolerance. EPA has decided not to 
remove the existing tolerances for metalaxyl on almond and walnut. 
Existing registrations permit use of metalaxyl on almond and walnut, 
and those uses would result in residues of metalaxyl on those 
commodities that would not be covered by the new mefenoxam tolerances. 
Therefore, removal of such tolerances would result in adulterated 
commodities.
    Although a tolerance on almond hulls was not requested, available 
processing data demonstrates that residues from treated almonds 
concentrate on hulls during processing; therefore, a separate

[[Page 72574]]

tolerance is needed to cover those residues. Based on application rates 
for mefenoxam and extrapolating from the available data concerning 
concentration during processing for metalaxyl, EPA concludes a 
tolerance level of 5 ppm for residues of mefenoxam in or on almond 
hulls is appropriate. EPA is establishing that tolerance here. The 
FFDCA anticipates that residues of pesticides applied to raw 
agricultural commodities may pass through to processed commodities and 
allows tolerances on raw agricultural commodities to cover processed 
forms of those commodities as long as residues remain within tolerance 
levels. 21 U.S.C. 346a(a)(2). Where residues concentrate in the 
processed food, a separate tolerance is necessary. Given the potential 
to pass-through, EPA examines whether tolerances on the raw 
agricultural commodities will cover residues on the processed food, and 
if not, establishes them. EPA believes it is reasonable to expect that 
a tolerance may need to be established in processed forms of 
commodities for which tolerances on the raw agricultural commodities 
are requested.

V. Conclusion

    Therefore, tolerances are established for residues of mefenoxam, 
including its metabolites and degradates in or on the tree nut, crop 
group 14-12 at 0.3 ppm and almond hulls at 5 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 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: October 9, 2020.
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.  180.546 amend paragraph (a) by designating the table as 
Table 1 to paragraph (a) and adding in alphabetical order to newly 
designated Table 1 to paragraph (a) entries for ``Almond, hulls'' and 
``Tree nut, crop group 14-12'' to read as follows:


Sec.  180.546  Mefenoxam; tolerances for residues.

* * * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Almond hulls...............................................            5
 
                                * * * * *
Tree nut, crop group 14-12.................................          0.3
 
                                * * * * *
------------------------------------------------------------------------

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[FR Doc. 2020-23423 Filed 11-12-20; 8:45 am]
BILLING CODE 6560-50-P


