Rule2024-15067
Metamitron; Pesticide Tolerance for Emergency Exemptions
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
July 10, 2024
Effective
July 10, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes a time-limited tolerance for residues of metamitron in or on the raw agricultural commodity (RAC) beet, sugar, roots. This action is in response to EPA's granting of emergency exemptions under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on the crop, sugar beets. This regulation establishes a maximum permissible level for residues of metamitron in or on the RAC beet, sugar, roots. The time-limited tolerance expires on December 31, 2027.
Full Text
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<title>Federal Register, Volume 89 Issue 132 (Wednesday, July 10, 2024)</title>
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[Federal Register Volume 89, Number 132 (Wednesday, July 10, 2024)]
[Rules and Regulations]
[Pages 56669-56673]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-15067]
[[Page 56669]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2024-0221; FRL-12054-01-OCSPP]
Metamitron; Pesticide Tolerance for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
residues of metamitron in or on the raw agricultural commodity (RAC)
beet, sugar, roots. This action is in response to EPA's granting of
emergency exemptions under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) authorizing use of the pesticide on the crop,
sugar beets. This regulation establishes a maximum permissible level
for residues of metamitron in or on the RAC beet, sugar, roots. The
time-limited tolerance expires on December 31, 2027.
DATES: This regulation is effective July 10, 2024. Objections and
requests for hearings must be received on or before September 9, 2024
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-2024-0221, is available at
<a href="https://www.regulations.gov">https://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 Docket
Public Reading Room is (202) 566-1744. Please review the visitor
instructions and additional information about the docket available at
<a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, 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#35677173677b5a415c565046755045541b525a43"><span class="__cf_email__" data-cfemail="7e2c3a382c30110a171d1b0d3e1b0e1f50191108">[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 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
C. How can I file an objection or hearing request?
Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 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-
2024-0221 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 September 9, 2024. 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-2024-0221, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://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="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with FFDCA sections
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is
establishing a time-limited tolerance for combined residues of
metamitron, (4-amino-3-methyl-6-phenyl-1,2,4-triazin-5(4H)-one),
including its metabolites and degradates, in or on the RAC beet, sugar,
roots at 0.01 parts per million (ppm). This time-limited tolerance
expires on December 31, 2027.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under FIFRA
section 18. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
FIFRA section 18 related time-limited tolerances to set binding
precedents for the application of FFDCA section 408 and the safety
standard to other tolerances and exemptions. Section 408(e) of FFDCA
allows EPA to establish a tolerance or an exemption from the
requirement of a tolerance on its own initiative, i.e., without having
received any petition from an outside party.
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
[[Page 56670]]
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.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemptions for Metamitron on Sugar Beets and FFDCA
Tolerances
The Colorado and Nebraska Departments of Agriculture requested
emergency exemptions for use of metamitron on the crop sugar beets to
control problematic weed populations of Palmar amaranth, that are not
controlled by the available registered pesticides, stating that
significant economic losses would be suffered without adequate control
of this weed. After having reviewed the submissions, EPA determined
that emergency conditions exist for Colorado and Nebraska, and that the
criteria for approval of the emergency exemptions were met. EPA has
authorized specific exemptions under FIFRA section 18 for the use of
metamitron on sugar beets for control of Palmer amaranth in Colorado
and Nebraska.
As part of its evaluation of the emergency exemption applications,
EPA assessed the potential risks presented by residues of metamitron in
or on the RAC beet, sugar, roots. In doing so, EPA considered the
safety standard in FFDCA section 408(b)(2), and EPA decided that the
necessary tolerance under FFDCA section 408(l)(6) would be consistent
with the safety standard and with FIFRA section 18. Consistent with the
need to move quickly on the emergency exemptions in order to address an
urgent non-routine situation and to ensure that the resulting food is
safe and lawful, EPA is issuing this tolerance without notice and
opportunity for public comment as provided in FFDCA section 408(l)(6).
Although this time-limited tolerance expires on December 31, 2027,
under FFDCA section 408(l)(5), residues of the pesticide not in excess
of the amount specified in the tolerance remaining in or on beet,
sugar, roots after that date will not be unlawful, provided the
pesticide was applied in a manner that was lawful under FIFRA, and the
residues do not exceed a level that was authorized by this time-limited
tolerance at the time of that application. EPA will take action to
revoke this time-limited tolerance earlier if any experience with,
scientific data on, or other relevant information on this pesticide
indicate that the residues are not safe.
Because this time-limited tolerance is being approved under
emergency conditions, EPA has not made any decisions about whether
metamitron meets FIFRA's registration requirements for use on the crop
sugar beets or whether permanent tolerances for this use would be
appropriate. Under these circumstances, EPA does not believe that this
time-limited tolerance decision serves as a basis for registration of
metamitron by a State for special local needs under FIFRA section
24(c). Nor does this tolerance by itself serve as the authority for
persons in any State other than Colorado and Nebraska to use this
pesticide on the applicable crops under FIFRA section 18 absent the
issuance of an emergency exemption applicable within that State. For
additional information regarding the emergency exemptions for
metamitron, contact the Agency's Registration Division at the address
provided under FOR FURTHER INFORMATION CONTACT.
IV. 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 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 expected as a result of the emergency exemption requests and
the time-limited tolerance for residues of metamitron in or on the RAC
beet, sugar, roots at 0.01 ppm. EPA's assessment of exposures and risks
associated with establishing the time-limited tolerance follows.
A. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides</a>.
Specific information on the studies received and the nature of the
adverse effects caused by metamitron as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in the document ``Metamitron. Human Health Risk
Assessment for Section 18 Emergency Exemptions for Use on Sugar Beets
in Colorado and Nebraska'' hereinafter referred to as ``Metamitron
Human Health Risk Assessment'' in docket ID number EPA-HQ-OPP-2024-
0221. A summary of the toxicological endpoints for metamitron used for
human risk assessment can be found in this document on pages 22-24.
[[Page 56671]]
B. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to metamitron, EPA considered exposure under the time-limited
tolerance established by this action. EPA assessed dietary exposures
from metamitron 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.
Such effects were identified for metamitron. In estimating acute
dietary exposure, EPA used food consumption information from the 2005-
2010 U.S. Department of Agriculture's National Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA). As to
residue levels in food, EPA used the highest anticipated combined
residue levels in sugar beet roots from field trials (for metamitron
and its metabolite desamino-metamitron), a default processing factor of
1 for processing sugar beet roots into molasses and assumed 100 percent
crop treated (PCT). The EPA is concerned when dietary risk exceeds 100%
of the acute population adjustment dose (aPAD). The acute dietary (food
and drinking water) exposure and risk estimates were not of concern for
the general U.S. population and all population subgroups (i.e., all
risk estimates were <100% of the aPAD) at the 95th percentile. Risk
estimates for both the general U.S. population and the most highly
exposed population (all infants, <1 year old) are <=5.5% of the aPAD.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the 2005-2010 U.S.
Department of Agriculture's National Health and Nutrition Examination
Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in
food, EPA used the highest anticipated combined residue levels from
field trials (for metamitron and its metabolite desamino-metamitron), a
default processing factor of 1 for molasses, and assumed 100 percent
crop treated (PCT). For chronic assessments, the EPA is concerned when
dietary risk exceeds 100% of the chronic population adjustment dose
(cPAD). The resulting chronic (food and drinking water) risk estimates
are not of concern (<100% of the cPAD) for the general U.S. population
and all population subgroups. Risk estimates for both the general U.S.
population and the most highly exposed population subgroup (all
infants, <1 year old) are <=4.0% of the cPAD.
iii. Cancer. Based on the data found in the Metamitron Human Health
Risk Assessment, referenced in Unit IV.A., EPA has concluded that
metamitron does not pose a cancer risk to humans. Therefore, a dietary
exposure assessment for the purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of this tolerance.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for metamitron in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of metamitron. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment</a>.
Based on the Pesticide Water Calculator (PWC) model (ver. 2.001)
and updated drinking water scenarios, the estimated drinking water
concentrations (EDWCs) of metamitron are 91 ppb parts per billion (ppb)
for acute exposures, and 48 ppb for chronic exposures (non-cancer
assessments). Both EDWCs are based upon surface water modelling, which
resulted in higher EDWCs (worst case, more conservative) than those
from ground water models. The modeled EDWCs were directly entered into
the dietary exposure models used for estimating exposures from drinking
water (91 ppb for acute exposures and 48 ppb for chronic exposures).
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). Metamitron is not
registered for any specific use patterns that would result in
residential exposure.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at: <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide">https://www.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. 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.''
EPA has not found metamitron to share a common mechanism of
toxicity with any other substances, and metamitron does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
metamitron does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides</a>.
C. 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 SF when reliable data available to EPA support the choice of
a different factor.
2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility following in utero exposure to metamitron in
either the rat or rabbit developmental toxicity studies up to the
highest doses tested, and there is no evidence of increased
quantitative susceptibility following in utero and/or pre-/post-natal
exposure in the multi-
[[Page 56672]]
generation reproduction studies in rats. All offspring effects were
observed at the same or higher dose level than maternal toxicity.
Evidence of qualitative sensitivity was demonstrated in a
multigeneration reproductive toxicity study, as decreased offspring
survival was observed in the absence of comparable parental toxicity.
However, the concern is low as the sensitivity was observed at a higher
dose level than the established LOAEL/NOAEL for the parental
generation, a clear NOAEL/LOAEL has been established for the offspring
generation, and all selected endpoints are protective of the
qualitative sensitivity.
Reduction of the 10X FQPA SF to 1X is appropriate as the database
is complete, no quantitative susceptibility was observed, the concern
for qualitative sensitivity in a multigeneration reproductive toxicity
study is low as it was observed at a higher dose level than the
established parental NOAEL/LOAEL within the study, the current PODs are
protective of the sensitivity, and clear NOAELs/LOAELs have been
established across the database.
3. Conclusion. EPA has determined that reliable data show that the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for metamitron is complete and adequate
for hazard characterization, toxicity endpoint selection, and FQPA SF
consideration.
ii. Neurotoxicity (clinical signs and functional observational
battery (FOB) findings) was observed in two non-guideline studies
following an acute exposure (single dose) in both mice and rats. In a
metabolism study, reduced mobility and piloerection were observed after
a single oral dose, but the effects resolved within 24 hours post-
dosage. No additional potentially neurotoxic effects were observed
across the metamitron database, including the rat subchronic
neurotoxicity study (SCN), at the doses tested. The concern for
neurotoxicity is low, as all selected PODs are protective of the
adverse effects identified in the non-guideline studies and the
metabolism study. Therefore, there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that metamitron results in increased
quantitative susceptibility after in utero exposure to rats or rabbits
in the prenatal developmental studies. The concern for qualitative
sensitivity in the multigeneration reproduction study is low as it was
observed at a higher dose level than the established parental NOAEL/
LOAEL within the study, the current PODs are protective of the
sensitivity, and clear NOAELs/LOAELs have been established across the
database.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and anticipated residues based on crop field trials with all
residues below the limit of quantitation for metamitron. The limit of
detection was used, and standard processing factors applied to estimate
residues in molasses. EPA made conservative (protective) assumptions in
the ground and surface water modeling used to assess exposure to
metamitron in drinking water. These assessments will not underestimate
the exposure and risks posed by metamitron.
D. 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. Since there are no residential exposure scenarios,
aggregate exposure and risk are equivalent to the acute and chronic
dietary (food and drinking water) exposure and risk, which are not of
concern.
1. Acute risk. Using the exposure assumptions discussed in this
document for acute exposure, the acute dietary exposure from food and
water to metamitron will occupy 5.5% of the aPAD for all infants, the
population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
metamitron from food and water will utilize 4.0% of the cPAD for all
infants, the population group receiving the greatest exposure.
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). Metamitron is
not registered for uses that could result in short-term residential
exposure. Because there is no short-term residential exposure and
chronic dietary exposure has already been assessed under the
appropriately protective cPAD (which is at least as protective as the
POD used to assess short-term risk), no further assessment of short-
term risk is necessary, and EPA relies on the chronic dietary risk
assessment for evaluating short-term risk for metamitron.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term non-dietary, non-occupational
exposure plus chronic exposure to food and water (considered to be a
background exposure level). Metamitron is not registered for any use
patterns that would result in intermediate-term residential exposure.
Because there is no intermediate-term residential exposure and chronic
dietary exposure has already been assessed under the appropriately
protective cPAD (which is at least as protective as the POD used to
assess intermediate-term risk), no further assessment of intermediate-
term risk is necessary, and EPA relies on the chronic dietary risk
assessment for evaluating intermediate-term risk for metamitron.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in adequate rodent carcinogenicity studies
and the low concern for mutagenic potential, metamitron is not expected
to pose a cancer risk to humans.
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 metamitron residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high-performance liquid
chromatography method with tandem mass spectrometry detection (LC/MS/
MS), Method SGS-17-01-03), is available to enforce the tolerance
expression. 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#ff8d9a8c969b8a9a929a8b97909b8cbf9a8f9ed1989089"><span class="__cf_email__" data-cfemail="d6a4b3a5bfb2a3b3bbb3a2beb9b2a596b3a6b7f8b1b9a0">[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
[[Page 56673]]
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 metamitron, and therefore,
harmonization is not an issue at this time.
VI. Conclusion
Therefore, a time-limited tolerance is established for residues of
metamitron, (4-amino-3-methyl-6-phenyl-1,2,4-triazin-5(4H)-one), in or
on the RAC beet, sugar, roots at 0.01 ppm. This tolerance expires on
December 31, 2027.
VII. Statutory and Executive Order Reviews
This action establishes a tolerance under FFDCA sections 408(e) and
408(l)(6). 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 in accordance
with FFDCA sections 408(e) and 408(l)(6), 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).
VIII. 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: June 28, 2024.
Edward Messina,
Director, 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. Add Sec. 180.726 to subpart C to read as follows:
Sec. 180.726 Metamitron; tolerances for residues.
(a) [Reserved]
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the herbicide metamitron, including its
metabolites and degradates, in or on the specified agricultural
commodities to table 1 to this paragraph (b), resulting from use of the
pesticide pursuant to FIFRA section 18 emergency exemptions. Compliance
with the tolerance levels specified in table 1 to this paragraph (b) is
to be determined by measuring residues of metamitron (4-amino-3-methyl-
6-phenyl-1,2,4-triazin-5(4H)-one) in or on the listed commodities. The
tolerances expire on the dates specified in table 1 to this paragraph
(b).
Table 1 to Paragraph (b)
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
Beet, sugar, roots........................... 0.01 12/31/2027
------------------------------------------------------------------------
(c)-(d) [Reserved]
[FR Doc. 2024-15067 Filed 7-9-24; 8:45 am]
BILLING CODE 6560-50-P
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</html>Indexed from Federal Register on July 10, 2024.
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