Rule2021-20743
Metalaxyl; Pesticide Tolerances
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 24, 2021
Effective
September 24, 2021
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of metalaxyl in or on black pepper. American Spice Trade Association requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 86 Issue 183 (Friday, September 24, 2021)</title>
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[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Rules and Regulations]
[Pages 53004-53009]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-20743]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0009; FRL-8785-01-OCSPP]
Metalaxyl; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
metalaxyl in or on black pepper. American Spice Trade Association
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective September 24, 2021. Objections and
requests for hearings must be received on or before November 23, 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-2020-0009, is available at <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#23716765716d4c574a404650634653420d444c55"><span class="__cf_email__" data-cfemail="3b697f7d6975544f52585e487b5e4b5a155c544d">[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 Government
Publishing Office's e-CFR site at <a href="http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl">http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl</a>.
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-2020-0009 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
November 23, 2021. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b), although at this
time, EPA strongly encourages those interested in submitting objections
or a hearing request, to submit objections and hearing requests
electronically. See Order Urging Electronic Service and Filing (April
10, 2020), <a href="https://www.epa.gov/sites/production/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf">https://www.epa.gov/sites/production/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf</a>.
At this time, because of the COVID-19 pandemic, the judges and staff of
the Office of Administrative Law Judges are working remotely and not
able to accept filings or correspondence by courier, personal deliver,
or commercial delivery, and the ability to receive filings or
correspondence by U.S. Mail is similarly limited. When submitting
documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a
person should utilize the OALJ e-filing system, at <a href="https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf">https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf</a>.
Although EPA's regulations require submission via U.S. Mail or hand
deliver, EPA intends to treat submissions filed via electronic means as
properly filed submissions during this time that the Agency continues
to maximize telework due to the pandemic; therefore, EPA believes the
preference for submission via electronic means will not be prejudicial.
If it is impossible for a person to submit documents electronically or
receive service electronically, e.g., the person does not have any
access to a computer, the person shall so advise OALJ by contacting the
Hearing Clerk at (202) 564-6281. If a person is without access to a
computer and must file documents by U.S. Mail, the person shall notify
the Hearing Clerk every time it files a document in such a manner. The
address for mailing documents is U.S. Environmental Protection Agency,
Office of Administrative Law Judges,
[[Page 53005]]
Mail Code 1900R, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
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-2020-0009, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
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 <a href="http://www.epa.gov/dockets/contacts.html">http://www.epa.gov/dockets/contacts.html</a>. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at <a href="http://www.epa.gov/dockets">http://www.epa.gov/dockets</a>.
II. Summary of Petitioned-For Tolerance
In the Federal Register of May 29, 2020 (85 FR 32338) (FRL-10009-
84), 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
9E8811) by American Spice Trade Association, 1101 17th Street NW, Suite
700, Washington, DC 20036. The petition requested that 40 CFR 180.408
be amended by establishing tolerances for residues of the fungicide
metalaxyl, methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-DL-
alaninate, in or on pepper, black at 1 part per million (ppm). That
document referenced a summary of the petition prepared by American
Spice Trade Association, the registrant, which is available in the
docket, <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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 has
modified the tolerance levels on black pepper. The reason for these
changes is explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
FFDCA section 408(b)(2)(A)(i) 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 metalaxyl including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with metalaxyl 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. EPA conducted a human health risk assessment to evaluate the
safety of the requested tolerances and the assessment ``Metalaxyl Human
Health Risk Assessment for the Proposed Tolerances in/on White and
Black Pepper without a U.S. Registration'' is found in docket ID number
EPA-HQ-OPP-2020-0009 at <a href="http://www.regulations.gov">www.regulations.gov</a>. In that document, EPA
evaluated the available hazard and exposure data to conduct dietary,
residential, and aggregate assessment to determine risk to human health
and refers back to the full discussions of the hazard profile, residue
chemistry database, and residential exposures contained in the previous
human health risk assessment conducted for the registration review of
metalaxyl/mefenoxam. The human health risk assessment ``Metalaxyl,
Mefenoxam (metalaxyl-m) Human Health Draft Risk Assessment for
Registration Review'' is located in docket EPA-HQ-OPP-2009-0863-0023.
The Draft Risk Assessment reflects both mefenoxam and metalaxyl.
The Agency compared the available chemistry and toxicity data for
mefenoxam and metalaxyl and concluded that the toxicity studies for
both chemicals can be combined for hazard characterization and dose-
response assessment because the two chemicals have similar toxicity and
identical chemical structures.
In rat and dog repeat dose (i.e., subchronic and chronic) oral
toxicity studies, there were no indications of adverse effects up to
the highest dose tested (HDT). Adverse effects (i.e., convulsions that
occurred minutes after dosing) were only observed from acute exposure
to rats.
There was no evidence of increased susceptibility following pre- or
post-natal exposure in the prenatal developmental toxicity studies or
the reproduction and fertility effects study in the animals treated
with metalaxyl. In the rat developmental toxicity study of metalaxyl,
maternal toxicity consisted of dose-related increased incidence of
convulsions that occurred shortly after dosing, as well as other
clinical signs. In a range-finding acute neurotoxicity study of
mefenoxam, females showed abnormal functional observation battery
findings at doses lower than males, but higher than in the rat
developmental study. However, there was no indication of toxicity up to
the HDT in the mefenoxam subchronic neurotoxicity study, which confirms
the lack of adverse effects observed in all other repeat-dose studies.
There was no indication of immunotoxicity in a mouse immunotoxicity
study of mefenoxam.
Metalaxyl is classified as ``Not Likely to be Carcinogenic to
Humans'' based on the lack of evidence of carcinogenicity in the
metalaxyl carcinogenicity study in mice and the combined chronic
toxicity and carcinogenicity study in rats.
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
[[Page 53006]]
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 <a href="http://www.epa.gov/pesticides/factsheets/riskassess.htm">http://www.epa.gov/pesticides/factsheets/riskassess.htm</a>.
A summary of the toxicological endpoints for metalaxyl used for the
human health risk assessment is shown in the Metalaxyl Human Health
Risk Assessment for the Proposed Tolerances in/on White and Black
Pepper without a U.S. Registration, and further explanation can be
found in ``Metalaxyl, Mefenoxam (metalaxyl-m) Human Health Draft Risk
Assessment for Registration Review''.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to metalaxyl, EPA considered exposure under the existing
tolerances for mefenoxam and the existing and petitioned-for tolerances
for metalaxyl. EPA assessed dietary exposures 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.
In conducting acute dietary exposure assessment, EPA used the 2003-
2008 food consumption data from the U.S. Department of Agriculture's
National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA). A partially refined acute dietary exposure
assessment was conducted for metalaxyl. The refinement was based on a
tolerance level adjustment to account for all residues of concern and
anticipated residues were used for livestock commodities. The analysis
used tolerance-level residues, adjusted to include additional residues
of concern, and 100 percent crop treated (PCT).
ii. Chronic exposure. Because no chronic dietary endpoint was
selected, a chronic dietary exposure assessment was not conducted.
Nevertheless, for purposes of assessing short-term aggregate risk, EPA
calculated average dietary exposures. In conducting the chronic dietary
exposure assessment, EPA used tolerance level values adjusted for
additional residues of concern and 100 PCT.
iii. Cancer. Metalaxyl is classified as ``Not Likely to Be
Carcinogenic to Humans'' therefore, a cancer assessment is not needed.
2. Dietary exposure from drinking water. Drinking water exposures
are not impacted by the import tolerances on black pepper; therefore,
the assessment for this tolerance action relied on the second
refinement for the drinking water exposure assessment (DWA) for
metalaxyl and mefenoxam, in support of the Agency human health
assessment for Registration Review for the estimated drinking water
concentrations (EDWCs). See ``Metalaxyl/Mefenoxam: Second Refinement
Addendum to Drinking Water Exposure Assessment in Support of
Registration Review'', which is located at <a href="https://www.regulations.gov">https://www.regulations.gov</a>
in docket ID number EPA-HQ-OPP-2009-0863.
That assessment modeled drinking water exposures using the
Pesticide Root Zone Model (PRZM, v5, November 15, 2006) and the
Variable Volume Water Body Model (VVWM, March 6, 2014) for surface
water and the PRZM-GW for groundwater. Using those models, EPA
calculated the following EDWCs for use in exposure assessment: 350 ppb
for acute exposure assessment and 135 ppb for chronic exposure
assessment.
3. 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).
Mefenoxam and metalaxyl are currently registered for the following
uses that could result in residential exposures: Lawns, ornamentals,
gardens, and trees. EPA assessed residential exposure using the
following assumptions: For residential handlers, all registered
metalaxyl and mefenoxam product labels with residential use sites
(lawns, ornamentals and garden and trees) require that handlers wear
specific clothing (e.g., long-sleeve shirt/long pants) and chemical-
resistant gloves. Therefore, EPA has made the assumption that these
products are not for homeowner use and has not conducted a quantitative
residential handler assessment.
There is potential for residential post-application exposures to
metalaxyl. Since no dermal endpoints were identified, only incidental
oral post-application exposures to small children ages 1 to <2 have
been assessed. Metalaxyl and mefenoxam are registered for use on home
lawns; therefore, there is the potential for incidental oral exposure
(hand-to-mouth, object-to-mouth, soil ingestion and granular
ingestion).
The recommended residential exposure for use in the children 1 to
<2 years old aggregate assessment reflects hand-to-mouth incidental
oral exposures from treated turf using a liquid formulation. Ingestion
of granules is considered an episodic event and not a routine behavior.
Because the Agency does not believe that this would occur on a regular
basis, the concern for human health is related to acute poisoning
rather than short-term residue exposure. Therefore, an acute dietary
dose is used to estimate exposure and risk resulting from episodic
ingestion of granules. For these same reasons, the episodic ingestion
scenario was not included in the aggregate assessment.
A summary of the residential exposures for metalaxyl used for the
human health risk assessment can be found in ``Metalaxyl, Mefenoxam
(metalaxyl-m) Human Health Draft Risk Assessment for Registration
Review'' docket ID number EPA-HQ-OPP-2009-0863-0023.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at <a href="http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide">http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide</a>.
4. Cumulative effects from substances with a common mechanism of
toxicity. FFDCA section 408(b)(2)(D)(v) 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 any other
substances and mefenoxam does not appear to produce a toxic metabolite
produced by
[[Page 53007]]
other substances. For the purposes of this action, therefore, EPA has
not assumed that mefenoxam has a common mechanism of toxicity with
other substances.
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
increased susceptibility in offspring in the prenatal developmental or
the 2-generation reproductive toxicity studies. In adult rats treated
with metalaxyl or mefenoxam, clinical signs and abnormal functional
observation battery (FOB) findings were noted after a bolus gavage dose
but not in repeated dose studies.
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 databases for metalaxyl and mefenoxam are adequate
to assess the potential for prenatal and postnatal toxicity for infants
and children.
ii. In the rat prenatal developmental toxicity with metalaxyl,
maternal animals exhibited clinical signs indicative of neurobehavioral
effects as previously discussed. In the range-finding acute
neurotoxicity study with mefenoxam, females exhibited abnormal FOB
findings at doses lower than in males. In the subchronic neurotoxicity
study with mefenoxam, there were no indications of neurotoxicity up to
the HDT. In metalaxyl and mefenoxam treated adult animals, clinical
signs and abnormal FOB findings were noted. However, a developmental
neurotoxicity (DNT) study is not required for metalaxyl or mefenoxam
because (1) there are no indications of increased susceptibility for
infants or children; (2) the convulsions observed in the rat prenatal
developmental toxicity study occurred in the maternal animals with no
effects being observed in the young; (3) the convulsions occurred only
after a bolus dose; (4) the available developmental and range-finding
acute neurotoxicity studies provided clear NOAELs and LOAELs for
evaluating effects; (5) the current POD is below the level at which any
effects were seen in either study, and (6) there were no other
indications of neurotoxicity in the mefenoxam or metalaxyl databases,
which include a subchronic (adult rat) neurotoxicity study for
mefenoxam. Therefore, there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity. See
``Metalaxyl, Mefenoxam (metalaxyl-m) Human Health Draft Risk Assessment
for Registration Review'' docket ID number EPA-HQ-OPP-2009-0863-0023.
iii. As discussed above in Unit III.D.2., there is no evidence that
metalaxyl results in increased susceptibility in the developmental or
reproductive toxicity studies; and
iv. There are no residual uncertainties in the exposure database.
Dietary exposure analysis was performed incorporating all existing and
proposed uses using tolerance level values to estimate residues in food
commodities and anticipated residues in livestock commodities. Drinking
water estimates were generated based upon conservative inputs and
modeling. Similarly, potential residential post application exposures
are based upon conservative, default assumptions. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to metalaxyl in drinking water. EPA used similarly
conservative assumptions to assess post-application exposure of
children as well as incidental oral exposure of toddlers. These
assessments are not expected to underestimate the exposure to
metalaxyl.
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. Using the exposure assumptions described in this unit
for acute exposure, EPA has concluded that acute exposure to metalaxyl
from food and water will utilize 52% of the aPAD for children 1 to 2
years old, the population subgroup with the highest exposure estimate.
2. Chronic risk. There is no increase in hazard from repeat
exposures to metalaxyl/mefenoxam; therefore, a chronic dietary POD was
not selected. Due to the lack of a chronic endpoint, a chronic dietary
risk is not expected. The acute endpoint and dietary exposure
assessment are protective of potential effects from chronic duration
dietary exposures.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Mefenoxam and
metalaxyl are 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 and metalaxyl. 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 an aggregate MOE of 270 for children. Because EPA's
level of concern for mefenoxam is a MOE of 100 or below, this MOE is
not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
metalaxyl and mefenoxam are not registered for any use patterns that
would result in intermediate-term residential exposure.
5. Aggregate cancer risk for U.S. population. Metalaxyl is
classified as ``Not Likely to Be Carcinogenic to Humans''; therefore,
EPA does not expect metalaxyl exposures to 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 metalaxyl residues.
[[Page 53008]]
IV. Other Considerations
A. Analytical Enforcement Methodology
There are adequate residue analytical methods for enforcing
tolerances for metalaxyl 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 black pepper and livestock.
The method 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:
<a href="/cdn-cgi/l/email-protection#2e5c4b5d474a5b4b434b5a46414a5d6e4b5e4f00494158"><span class="__cf_email__" data-cfemail="9deff8eef4f9e8f8f0f8e9f5f2f9eeddf8edfcb3faf2eb">[email protected]</span></a>.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established a MRL for metalaxyl in or on black pepper.
C. Response to Comments
Two comments were received in response to the notice of filing. One
of the comments was not germane to the petition for metalaxyl
tolerances.
The second comment argued against the use metalaxyl on black pepper
and expressed concern about the overall toxicity of pesticides.
Although the Agency recognizes that some individuals believe that
pesticides should be banned on agricultural crops, the existing legal
framework provided by FFDCA section 408 authorizes EPA to establish
tolerances when it determines that the tolerance is safe. Upon
consideration of the validity, completeness, and reliability of the
available data as well as other factors the FFDCA requires EPA to
consider, EPA has determined that these metalaxyl tolerances are safe.
The commenter has provided no information supporting a contrary
conclusion.
D. Revisions to Petitioned-For Tolerances
EPA is establishing the tolerance at 0.3 ppm rather than at the
petitioned-for tolerance level of 1.0 ppm. EPA's analysis of the
monitoring data that was submitted to support the tolerance level
concludes that 0.3 ppm is sufficient to cover residues in imported
black pepper.
V. Conclusion
Therefore, tolerances are established for residues of metalaxyl,
methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-DL-alaninate, in or on
pepper, black at 0.3 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). 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 (CRA)
Pursuant to the CRA (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: September 3, 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:
[[Page 53009]]
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. 180.408, amend the table in paragraph (a) by:
0
i. Designating the table as Table 1 to Paragraph (a).
0
ii. Adding in alphabetical order an entry for ``Pepper, black''.
0
iii. Add footnote 1.
The additions read as follows:
Sec. 180.408 Metalaxyl; tolerances for residues.
* * * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Pepper, black \1\.......................................... 0.3
* * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations for use of this pesticide on this
commodity as of September 24, 2021.
* * * * *
[FR Doc. 2021-20743 Filed 9-23-21; 8:45 am]
BILLING CODE 6560-50-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.