[Federal Register Volume 89, Number 213 (Monday, November 4, 2024)]
[Rules and Regulations]
[Pages 87509-87512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25564]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2023-0397; FRL-12201-01-OCSPP]


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 Palm, oil. Syngenta Crop Protection, LLC requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective November 4, 2024. Objections and 
requests for hearings must be received on or before January 3, 2025, 
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-2023-0397, 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 and for the OPP Docket is (202) 566-1744. Please review 
the visitor instructions and additional information about the docket 
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Registration Division 
(7505T), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (202) 566-1030; email address: <a href="/cdn-cgi/l/email-protection#297b6d6f7b67465d404a4c5a694c5948074e465f"><span class="__cf_email__" data-cfemail="12405654405c7d667b717761527762733c757d64">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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, 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-2023-0397 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 3, 2025. 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-2023-0397, by one of 
the following methods:
    <bullet> Federal eRulemaking Portal: https://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.
    <bullet> Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
    <bullet> Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    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 September 12, 2023 (88 FR 62499) (FRL-
10579-07-OCSPP), 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 3E9048) by Syngenta Crop Protection, LLC, P.O. Box 18300, 
Greensboro, NC 27419. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the fungicide 
mefenoxam, in or on palm oil at 0.02 parts per million (ppm). That 
document referenced a summary of the petition

[[Page 87510]]

prepared by Syngenta Crop Protection, LLC., the registrant, which is 
available in the docket, https://www.regulations.gov. Comments were 
received on the notice of filing. EPA's response to these comments is 
discussed 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 mefenoxam including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with mefenoxam follows.
    In an effort to streamline its publications in the Federal 
Register, EPA is not reprinting sections of the rule that repeat what 
has been previously published in tolerance rulemakings for the same 
pesticide chemical. Where scientific information concerning a 
particular chemical remains unchanged, the content of those sections 
would not vary between tolerance rulemakings, and EPA considers 
referral back to those sections as sufficient to provide an explanation 
of the information EPA considered in making its safety determination 
for the new rulemaking.
    EPA has previously published a tolerance rulemaking for mefenoxam 
in which EPA concluded, based on the available information, that there 
is a reasonable certainty that no harm would result from aggregate 
exposure to mefenoxam and established tolerances for residues of that 
chemical. EPA is incorporating previously published sections from that 
rulemaking as described further in this rule, as they remain unchanged.

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.
    Mefenoxam (metalaxyl-m) is a systemic phenylamine fungicide which 
inhibits protein synthesis in fungi. Mefenoxam is an R-isomer enriched 
formulation. Metalaxyl is the racemic R/S isomer formulation. The 
Agency compared the available chemistry and toxicity data for mefenoxam 
and metalaxyl and concluded that metalaxyl data may be used in support 
of mefenoxam regulatory actions because the two chemicals have similar 
toxicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by mefenoxam as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies are discussed in Unit III.A. of the 
final rule published in the Federal Register of December 21, 2018 (83 
FR 65541) (FRL-9985-52).

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 the NOAEL and 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 mefenoxam used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of December 21, 2018 (83 FR 65541) 
(FRL-9985-52).

C. Exposure Assessment

    Much of the exposure assessment remains the same although updates 
have occurred to accommodate exposures from petitioned-for tolerances. 
These updates are discussed in this section; for a description of the 
rest of the EPA approach to and assumptions for the exposure 
assessment, please reference Unit III.C. of the December 2018, 
rulemaking.
    1. Dietary exposure from food and feed uses. EPA's dietary exposure 
assessments have been updated to include the additional exposure from 
the petitioned-for tolerances of mefenoxam on the crops requested in 
this action. In evaluating dietary exposure to mefenoxam, EPA 
considered exposure under the petitioned-for tolerances as well as all 
existing mefenoxam and metalaxyl tolerances in 40 CFR 180.546 and 
180.408, respectively.
    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. The acute dietary assessment 
is based on tolerance levels adjusted to account for all of the 
residues of concern and assumes 100 percent crop treated (PCT). The 
assessment was conducted using the Dietary Exposure Evaluation Model 
software with the Food Commodity Intake Database (DEEM-FCID) Version 
4.02, EPA with 2005-2010 food consumption information from the United 
States Department of Agriculture's (USDA's) National Health and 
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). 
Empirical processing factors were included where available. Otherwise, 
DEEM-FCID default processing factors were used.
    ii. Chronic exposure. There is no increase in hazard from repeat 
exposures to mefenoxam. Therefore, a chronic dietary POD was not 
selected. The acute endpoint and acute dietary

[[Page 87511]]

exposure assessment are protective of potential effects from chronic 
duration dietary exposures.
    iii. Cancer. EPA has concluded that mefenoxam does not pose a 
cancer risk to humans based on no evidence of carcinogenicity observed 
in the relevant studies. Therefore, a dietary exposure assessment for 
the purpose of assessing cancer risk is unnecessary.
    2. Dietary exposure from drinking water. Drinking water exposure 
modeling for mefenoxam is not necessary because exposure estimates for 
metalaxyl are expected to exceed those for mefenoxam and are therefore 
protective. Maximum annual application rates for metalaxyl, up to 12.3 
lb ai/A, were modeled. These rates are approximately twice those of 
mefenoxam. The maximum estimated drinking water concentrations (EDWCs) 
based on metalaxyl are 350 [mu]g/L for acute exposure (which is based 
on surface water sources) and 135 [micro]g/L for chronic exposure 
(which is based on groundwater sources).
    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). There are no 
residential uses for mefenoxam being proposed as part of this action or 
that have been added since the most recent risk assessment that would 
impact the residential (non-occupational) or residential post-
application exposure and risk estimates found in the most recent risk 
assessment of mefenoxam; therefore, EPA relied on the previously 
assessed residential exposure for assessing aggregate risk.
    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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to mefenoxam and metalaxyl 
with any other substances and mefenoxam and metalaxyl do not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this action, therefore, EPA has not assumed that mefenoxam 
and metalaxyl 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 Food Quality 
Protection Act (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.
    EPA continues to conclude that there are reliable data to support 
the reduction of the (FQPA) (SF) to 1X. See Unit III.D. of the December 
2018, rulemaking for a discussion of the Agency's rationale for that 
determination.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing dietary exposure estimates to the acute 
PAD (aPAD) and chronic PAD (cPAD). Short-, intermediate-, and chronic-
term aggregate risks are evaluated by comparing the estimated total 
food, water, and residential exposure to the appropriate PODs to ensure 
that an adequate MOE exists.
    1. Acute risk. The acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for acute exposure, the acute dietary exposure from food and water is 
27% of the acute population-adjusted dose (aPAD) for the general U.S. 
population, and 55% of the aPAD for the highest exposed population 
group, all infants. Because there are no acute residential exposures 
from mefenoxam, the acute aggregate exposure and risk is equal to the 
acute dietary exposure and risk. As these levels are below the Agency's 
level of concern (LOC) of 100% of the aPAD, the Agency concludes that 
aggregate exposure to mefenoxam will not pose an acute risk.
    2. Chronic risk. No hazard endpoint was selected for chronic 
dietary exposure for mefenoxam; therefore, a chronic dietary analysis 
was not warranted. However, chronic dietary exposure was estimated for 
inclusion in the short-term aggregate analysis.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus average chronic exposure 
to food and water (considered to be a background exposure level). 
Mefenoxam is currently registered for uses that could result in short-
term residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to mefenoxam.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 270 for children 
1 to 2 years old, the most highly exposed group. Because EPA's level of 
concern for mefenoxam is 100, which means any MOE below 100 may 
indicate risks of concern, this MOE is not of concern.
    4. Intermediate-term risk. There are no intermediate-term 
residential exposures for mefenoxam, and therefore an intermediate-term 
aggregate exposure assessment was not warranted.
    5. Aggregate cancer risk for U.S. population. Mefenoxam is 
classified as ``not likely to be carcinogenic to humans'', therefore, 
EPA concludes that exposure to mefenoxam will not pose an aggregate 
cancer risk.
    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 mefenoxam residues.
    More detailed information on this action can be found in the 
document titled ``Metalaxyl-M (Mefenoxam)''. Human Health Risk 
Assessment for Establishment of a Tolerance without U.S. Registration 
for use on Palm Oil.'' in docket ID number EPA-HQ-OPP-2023-0397.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available enforcement analytical methods, 
see Unit IV.A. of the December 21, 2018, rulemaking.

[[Page 87512]]

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. Tolerances/maximum 
residue limits (MRLs) to support uses of mefenoxam in Canada are 
established for residues of metalaxyl, including metabolites that can 
be converted to the 2,6-DMA moiety, each expressed as metalaxyl 
equivalents. However, no MRLs are established for palm fruit in Codex 
and Canada; thus, harmonization is not an issue for this commodity.

C. Response to Comments

    Three comments were received in response to the notice of filing. 
One comment was received from an anonymous commenter applauding the 
government's process to petition for new uses. The other two comments 
were criticizing chemicals that are not relevant to this action.

V. Conclusion

    Therefore, tolerances are established for residues of mefenoxam 
[methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-D-alaninate], in or on 
palm, oil at 0.02 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 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 23, 2024.
Charles Smith,
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 table 1 to paragraph (a) by adding, in 
alphabetical order, an entry for ``Palm, oil'' to read as follows:


Sec.  180.546  Mefenoxam; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Palm, oil \1\...............................................        0.02
 
                                * * * * *
------------------------------------------------------------------------
\1\ There is no U.S. registration as of November 4, 2024.

* * * * *
[FR Doc. 2024-25564 Filed 11-1-24; 8:45 am]
BILLING CODE 6560-50-P


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