Metamitron; Pesticide Tolerance for Emergency Exemptions, 56669-56673 [2024-15067]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[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 [www.gpo.gov]
[FR Doc No: 2024-15067]



[[Page 56669]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 
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 Docket 
Public Reading Room 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, 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: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 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 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:
     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.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/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. 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    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 https://www.regulations.gov 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment.
    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: https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food

[[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