Rule2024-24831
Glufosinate-P; 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
October 29, 2024
Effective
October 29, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of glufosinate-P in or on multiple commodities, which are identified and discussed later in this document. BASF Corporation and MITSUI Chemicals Crop & Life Solutions, INC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 89 Issue 209 (Tuesday, October 29, 2024)</title>
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[Federal Register Volume 89, Number 209 (Tuesday, October 29, 2024)]
[Rules and Regulations]
[Pages 85859-85867]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-24831]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0250; EPA-HQ-OPP-2020-0533; FRL-12339-01-OCSPP]
Glufosinate-P; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
glufosinate-P in or on multiple commodities, which are identified and
discussed later in this document. BASF Corporation and MITSUI Chemicals
Crop & Life
[[Page 85860]]
Solutions, INC requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective October 29, 2024. Objections and
requests for hearings must be received on or before December 30, 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-2020-0250 and EPA-HQ-OPP-2020-
0533 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 Public Reading Room and the OPP Docket 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, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number: 202-566-2427; email address: <a href="/cdn-cgi/l/email-protection#5a081e1c0814352e33393f291a3f2a3b743d352c"><span class="__cf_email__" data-cfemail="32607674607c5d465b515741725742531c555d44">[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 Federal Register
Office'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 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-2020-0250 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
December 30, 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-2020-0250, 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. Summary of Petitioned-For Tolerance
In the Federal Register of March 24, 2023 (88 FR 17778) (FRL-10579-
02-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
2F9021) by BASF Corporation Agricultural Solutions, 26 Davis Drive,
P.O. Box 13528, Research Triangle Park, NC 27709. The petition
requested that 40 CFR 180.473 be amended by modifying the tolerances
for residues of glufosinate to include residues of L-glufosinate
ammonium, glufosinate-P-ammonium [(2S)-2-amino- 4-
(hydroxymethylphosphinyl) butanoic acid -monoammonium salt] as measured
by the sum of glufosinate (2-amino-4-(hydroxymethylphosphinyl)butanoic
acid) and its metabolites, 2-(acetylamino)-4-(hydroxymethyl phosphinyl)
butanoic acid, and 3-(hydroxymethylphosphinyl) propanoic acid,
expressed as 2-amino-4-(hydroxy methylphosphinyl)butanoic acid
equivalents in or on canola, meal at 1.1 parts per million (ppm);
cattle, fat at 0.40 ppm; cattle, meat at 0.15 ppm; cattle, meat
byproducts at 6.0 ppm; corn, field, forage at 4.0 ppm; corn, field,
grain at 0.20 ppm; corn, field, stover at 6.0 ppm; corn, sweet, forage
at 1.5 ppm; corn, sweet, kernels plus cob with husks removed at 0.30
ppm; corn, sweet, stover at 6.0 ppm; cotton, gin byproducts at 30 ppm;
cotton, seed, subgroup 20C at 15.00 ppm; egg at 0.15 ppm; goat, fat at
0.40 ppm; goat, meat at 0.15 ppm; goat, meat byproducts at 6.0 ppm;
grain aspirated fractions at 25.00 ppm; hog, fat at 0.40 ppm; hog, meat
at 0.15 ppm; hog, meat byproducts at 6.0 ppm; horse, fat at 0.40 ppm;
horse, meat at 0.15 ppm; horse, meat byproducts at 6.0 ppm; milk at
0.15 ppm; poultry, fat at 0.15 ppm; poultry, meat at .15 ppm; poultry,
meat byproducts at 0.60 ppm; rapeseed, subgroup 20A at 0.4 ppm; sheep,
fat at 0.40 ppm; sheep, meat at 0.15 ppm; sheep, meat byproducts at 6.0
ppm; soybean at 2.0 ppm; soybean, hulls at 10.0 ppm and tolerances for
indirect or inadvertent residues on barley, hay at 0.4 ppm; barley,
straw at 0.4 ppm; buckwheat, fodder at 0.4 ppm; buckwheat, forage at
0.4 ppm; oat, forage at 0.4 ppm; oat, hay at 0.4 ppm; oat, straw at 0.4
ppm; rye, forage at 0.4 ppm; rye, straw at 0.4 ppm; teosinte at 0.4
ppm; triticale at 0.4 ppm; wheat, forage at 0.4 ppm; wheat, hay at 0.4
ppm; and wheat, straw at 0.4 ppm.
Also, in the Federal Register of December 21, 2020 (85 FR 82998)
(FRL-10016-93), 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 0F8842) by Meiji Seika Pharma Co., Ltd, c/o Landis
International, Inc., 3185 Madison Highway, P.O. Box 5126, Valdosta, GA
31603-5126. The petition requested to establish tolerance for residues
of L-
[[Page 85861]]
glufosinate free acid, (2S)-2-amino-4-
[hydroxy(methyl)phosphinoyl]butyric acid, including its metabolites and
degradates, 2-(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid
(NAG), and 3-(hydroxymethylphosphinyl) propanoic acid (MPP), expressed
as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents in or
on apple at 0.05 ppm; beet, sugar, molasses at 5.0 ppm; beet, sugar,
roots at 0.9 ppm; beet, sugar, tops (leaves) at 1.5 ppm; bushberry
subgroup 13B at 0.15 ppm; canola, meal at 1.1 ppm; canola, seed at 0.40
ppm; cattle, fat at 0.40 ppm; cattle, meat at 0.15 ppm; cattle, meat
byproducts at 6.0 ppm; corn, field, forage at 4.0 ppm; corn, field,
grain at 0.20 ppm; corn, field, stover at 6.0 ppm; corn, sweet, forage
at 1.5 ppm; corn, sweet, kernels plus cob with husks removed at 0.30
ppm; corn, sweet, stover at 6.0 ppm; cotton, gin byproducts at 15 ppm;
cotton, undelinted seed at 4.0 ppm; egg at 0.15 ppm; fruit, citrus,
crop group 10-10 at .15 ppm; fruit, pome, crop group 11-10 at .25 ppm;
fruit, stone, crop group 12-12 at 0.30 ppm; goat, fat at 0.40 ppm;
goat, meat at 0.15 ppm; goat, meat byproducts at 6.0 ppm; grape at 0.05
ppm; hog, fat at 0.40 ppm; hog, meat at 0.15 ppm; hog, meat byproducts
at 6.0 ppm; horse, fat at 0.40 ppm; horse, meat at 0.15 ppm; horse,
meat byproducts at 6.0 ppm; milk at 0.15 ppm; nut, tree, crop group 14-
12 at 0.50 ppm; olive at 0.50 ppm; potato at 0.80 ppm; potato, chips at
1.6 ppm; potato, granules/flakes at 2.0 ppm; poultry, fat at 0.15 ppm;
poultry, meat at .15 ppm; poultry, meat byproducts at 0.60 ppm; sheep,
fat at 0.40 ppm; sheep, meat at 0.15 ppm; sheep, meat byproducts at 6.0
ppm; soybean at 2.0 ppm; soybean, hulls at 10.0 ppm.
These documents referenced summaries of the petitions prepared by
BASF Corporation Agricultural Solutions and Meiji Seika Pharma Co.,
Ltd, (now known as MITSUI Chemicals Crop & Life Solutions), the
petitioners, which are available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. One comment was received on the notice of filing
for petition 0F8842. No comments were received on the notice of filing
for petition 2F9021. EPA's response to this comment is discussed in
Unit IV.C.
The tolerances EPA is establishing vary from what the petitioners
have requested in a few ways, which are explained in greater detail in
Unit IV.C. In sum, BASF Corporation Agricultural Solutions and MITSUI
Chemicals Crop & Life Solutions have deleted crops from their initial
request, the Agency will be establishing tolerances only on those crops
as mentioned in Unit V. Moreover, in order to align with the
International Organization for Standardization (ISO) recognized
nomenclature, EPA is establishing tolerances for glufosinate-P, which
is the current standard name for L-glufosinate free acid. Because
applications of glufosinate-P-ammonium (also known as L-glufosinate-
ammonium) result in residues of glufosinate-P on crops, EPA is setting
the tolerance for glufosinate-P residues, which will cover any residues
that remain on food from applications of pesticides with either form of
the pesticide.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for L-glufosinate, including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with L-glufosinate
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.
Glufosinate is racemic mixture comprised of D- and L-stereoisomers,
and the D/L form of glufosinate (also referred to as the racemic
glufosinate) is currently registered as a pesticide (herbicide) in the
United States. The L-isomer is the herbicidally active part of D/L-
glufosinate, and the D-isomer is herbicidally inactive. The L-isomer is
referred to as L-glufosinate in this document and the supporting risk
assessment documents and refers to the active moiety from both L-
glufosinate ammonium and L-glufosinate acid, which are two forms of the
L-isomer used in pesticide formulations. As mentioned above the Agency
has received applications for both L-glufosinate ammonium and L-
glufosinate acid. The International Organization for Standardization
(ISO) has designated L-glufosinate ammonium as glufosinate-P-ammonium
and L-glufosinate free acid as glufosinate-P, so EPA is establishing
tolerances using that nomenclature; however, for consistency with EPA's
supporting risk assessments, this document is using the terms L-
glufosinate ammonium and L-glufosinate acid.
The available in vivo and in vitro data for comparison across L-
glufosinate acid and L-glufosinate ammonium, and the in vitro and in
vivo DNT data for D/L-glufosinate ammonium indicate no significant
differences in oral toxicities for the most sensitive endpoint (i.e.,
neurotoxicity). As such, these databases are being considered together
when assessing toxicity and selecting endpoints for pertinent
exposures. Hence both L-glufosinate ammonium and L-glufosinate acid are
considered toxicologically equivalent for oral and dermal exposure
pathways. Also, L-glufosinate ammonium, when dissolved in water,
dissociates to L-glufosinate acid. Therefore, the Agency considers
glufosinate-P ammonium and glufosinate-P as functionally similar.
The targets identified following oral exposure to L-glufosinate
were the brain and peripheral nervous system (rats, mice, and dogs),
kidney (rats and mice), thyroid (rats only), and the adrenals (mice
only). Neurotoxicity was observed after acute, subchronic, and chronic
exposures. Adverse findings included clinical signs indicative of
neurotoxicity (i.e., tremors, clonic convulsions, inability to maintain
body posture, etc.), increased motor activity, alterations in brain
weight, and neuropathology of the brain, eye, and spinal cord. Kidney
toxicity manifested as increased kidney weights, alterations in
urinalysis parameters, and hypertrophy of the proximal tubular cells of
the pars recta. Slight thyroid c-cell hyperplasia was
[[Page 85862]]
observed in male rats, while in mice, microscopic findings of the
adrenal and increased adrenal weight were noted.
Increased quantitative susceptibility was observed in the L-
glufosinate rat prenatal developmental toxicity study, the L-
glufosinate range-finding developmental neurotoxicity (DNT) study, and
the D/L-glufosinate DNT study.
L-glufosinate is classified as ``Not Likely to be Carcinogenic to
Humans'' based on a lack of treatment-related tumor response in both
the L-glufosinate rat and mouse carcinogenicity studies. There is a low
concern for mutagenicity for L-glufosinate.
Specific information on the studies received and the nature of the
adverse effects caused by L-glufosinate 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 document ``L-Glufosinate. Human Health Risk
Assessment for New Active Ingredient Isomer'' at 21-34 in docket ID
number EPA-HQ-OPP-2020-0250.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which 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>.
For more detailed information on the toxicological endpoints for L-
glufosinate used for human risk assessment can be found in the L-
Glufosinate. Human Health Risk Assessment for New Active Ingredient
Isomer in docket ID number EPA-HQ-OPP-2020-0250.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to L-glufosinate, EPA considered exposure to L-glufosinate
under all tolerances established for racemic glufosinate as well as the
petitioned-for tolerances in this rulemaking. EPA assessed dietary
exposures from L-glufosinate 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 L-glufosinate. In conducting the
acute dietary exposure assessment, EPA used the Dietary Exposure
Evaluation Model software with the Food and Commodity Intake Database
(DEEM-FCID) Version 3.16. This software uses the 2003-2008 food
consumption data from the U.S. Department of Agriculture's (USDA's)
National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA). As to residue levels in food, EPA conducted an
unrefined acute dietary exposure assessment for L-glufosinate assuming
tolerance-level residues for L-glufosinate (scaled by 0.5X for
application rate adjustment) and 100% CT assumptions for all crops and
livestock commodities. The proposed uses of L-glufosinate exactly match
the established uses of D/L-glufosinate in terms of crops, number of
applications, retreatment intervals, and preharvest intervals; the only
difference being that the use rate for L-glufosinate is one-half that
of D/L-glufosinate, consistent with herbicidal activity residing
primarily in the L-isomer. Since the rate of L-glufosinate is one-half
that of D/L-glufosinate, the expected residues for L-glufosinate are
one-half those of D/L-glufosinate.
ii. Chronic exposure. The chronic dietary exposure assessment also
uses the DEEM-FCID Version 3.16 software with the 2003-2008 NHANES/
WWEIA data. As to residue levels in food, EPA conducted a partially
refined chronic dietary exposure assessment using anticipated residues
based on average field trial residue levels for plant commodities,
average calculated residues for livestock commodities, all foods scaled
by 0.5X for application rate adjustment, and 100% CT.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that L-glufosinate 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 the 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 these tolerances.
The Agency is not using percent crop treated estimates for
assessing acute and chronic exposures.
2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for L-glufosinate in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of L-glufosinate. 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>.
Determination of the residues of concern for human health in
drinking water included consideration of racemic glufosinate and the
degradate, 3-methylphosphinico-propionic acid (MPP). Although the
chronic EDWCs for MPP are approximately 2x higher than the EDWCs for
the racemic glufosinate, EPA has determined that using the EDWCs for
the racemic glufosinate will be protective of effects that might occur
from exposure to the degradate. This conclusion is based on a
comparison of the toxicity databases for glufosinate and MPP, which
indicate that glufosinate is more than twice as potent as MPP. Because
the toxic effects from glufosinate and MPP are significantly
[[Page 85863]]
different, an aggregate assessment of glufosinate and MPP is not
appropriate.
Based on the Pesticides in Water Calculator (PWC; version 1.52),
the estimated drinking water concentrations (EDWCs) of D/L-glufosinate
are estimated to be 201 parts per billion (ppb) for acute dietary
exposures and 24.4 ppb for chronic dietary exposures. Surface water
simulations resulted in the highest EDWCs.
These values reflect application of D/L-glufosinate and were scaled
by half to reflect the reduced application rate and expected
concentrations of L-glufosinate in water. The adjusted EDWCs were
incorporated in the Dietary Exposure Evaluation Model software with the
Food Commodity Intake Database (DEEM-FCID) into the food categories
``water, direct, all sources'' and ``water, indirect, all sources.''
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
L-glufosinate is not being proposed for residential uses. However,
there are residential exposures to L-glufosinate as a result of the
existing residential uses of the racemic glufosinate. These exposures
have been assessed for L-glufosinate and are included in a short-term
aggregate assessment for L-glufosinate. For this assessment, the
application rate was scaled by 0.5x to reflect residues of L-
glufosinate only, and the application rate was converted to acid
equivalents because the PODs are likewise expressed as acid
equivalents. For currently registered uses of racemic glufosinate,
residential handler and post-application dermal and inhalation risks
are not of concern for L-glufosinate. The scenarios that are
recommended to be considered for aggregate risk assessment are high-
contact lawn activities for adults and children 1 to <2 years old and
golfer activities for children 6 to <11 years old and children 11 to
<16 years old.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to L-glufosinate and any
other substances and L-glufosinate does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
action, therefore, EPA has not assumed that L-glufosinate has 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/pesticide-cumulative-risk-assessment-framework">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework</a>.
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. Increased quantitative
susceptibility was observed in the L-glufosinate rat prenatal
developmental toxicity study, the L-glufosinate range-finding DNT
study, and the D/L-glufosinate DNT study. Quantitative susceptibility
was observed in the developmental rat study in which decreased fetal
body weight in both sexes was observed at the highest dose tested;
however, no maternal toxicity was identified. Quantitative
susceptibility was observed in a L-glufosinate dose-range finding DNT
study in which maternal effects were not observed up to the highest
dose tested while offspring toxicity manifested as decreased pup body
weight and increased total and ambulatory motor activity counts in
males. The D/L-glufosinate DNT study observed alterations in brain
morphometrics (a decrease in the mean length of the ventral limb of the
dentate hilus), an increase in motor activity, and a decrease in body
weight for the offspring at a dose level that did not elicit maternal
toxicity.
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 for all exposure scenarios for glufosinate-
P. That decision is based on the following findings:
i. The toxicity database for L-glufosinate is complete, as a result
of bridging data between the racemic glufosinate, L-glufosinate, and L-
glufosinate ammonium databases.
ii. Evidence of neurotoxicity was observed in the L-glufosinate
database in both adults and early life stages. However, the concern is
low because all selected endpoints are based on, and protective of, the
most sensitive neurotoxic effects in the database, as indicated by the
following: (1) the 17% increase in motor activity observed in females
in the 28-day range-finding subchronic rat study occurred at a dose
level that is approximately 13x-80x higher than the selected PODs; (2)
the decreased brain weight and vacuolation of the cerebrum in the
chronic mouse study occurred at dose levels approximately 11x-67x
higher than the selected PODs; (3) the neuropathology observed in the
subchronic neurotoxicity study occurred at a dose level approximately
29x-174x higher than the selected PODs; (4) the increased total and
ambulatory motor activity counts in the range-finding DNT study
occurred at a dose level approximately 27x higher than the selected
PODs; and (5) the brain morphometric changes and increased motor
activity observed in the offspring in the D/L-glufosinate DNT occurred
at a dose level approximately 42x higher than the selected PODs for all
relevant exposure scenarios.
iii. As discussed in Unit III.D.2. above, increased quantitative
susceptibility was observed in the L-glufosinate rat prenatal
developmental toxicity study, the L-glufosinate range-finding DNT
study, and the D/L-glufosinate ammonium DNT study. However, the concern
for the increased susceptibility is low, as clear NOAELs have been
identified for those studies and all selected PODs are protective of
the effects seen in those studies.
iv. There are no residual uncertainties identified in the exposure
databases.
The dietary food exposure assessments were performed based on 100%
CT and conservative residue estimates. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to L-glufosinate in drinking water. These
assessments will not underestimate the exposure and risks posed by L-
glufosinate.
[[Page 85864]]
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
aggregate 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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure to L-glufosinate
from food and water will occupy 26% of the aPAD with the females 13 to
49 years old population subgroup. For all the other population
subgroups, the most highly exposed population subgroup is all infants
(<1 year old) at 4.7% of the aPAD.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
L-glufosinate from food and water will utilize 12% of the cPAD for
children (1-2 years old), the population group receiving the highest
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). Using the
exposure assumptions described in this unit for short-term exposures,
EPA has concluded the combined short-term food, water, and residential
exposures result in aggregate MOEs of 1,100 for adults, 2,600 for
children (11 to <16 years old), 1,700 for children (6 to <11 years old)
and 230 for children (1 to <2 years old), which are above the LOC (100)
and are 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, L-
glufosinate 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, no
further assessment of intermediate-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for L-glufosinate.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, L-glufosinate 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 L-glufosinate residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Two analytical methods have been validated by the Analytical
Chemistry Branch (ACB) for enforcement of the currently established
tolerances of D/L-glufosinate: (1) method HRAV-5A was validated by ACB
for the determination of glufosinate and MPP in/on apple, grape,
almond, soybean seed, corn grain, and corn forage and (2) method BK/01/
99 was validated by ACB for determination of glufosinate, N-acetyl-
glufosinate (NAG), and MPP in/on canola seed and sugar beet root.
Based on the results from the petition method validations (PMVs)
and the ability of the methods to detect both the D- and L- isomers of
glufosinate, EPA concludes that adequate enforcement methods are
available for L-glufosinate.
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#e0928593898495858d8594888f8493a0859081ce878f96"><span class="__cf_email__" data-cfemail="532136203a3726363e36273b3c3720133623327d343c25">[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 L-glufosinate.
C. Response to Comments
The Agency did receive one comment raising concerns that there are
studies indicating that L-glufosinate is harmful and toxic to health of
humans even in small doses. The commentor was also concerned over the
use of L-glufosinate on corn, cotton and soybean which are staples of
American diet. The commentor emphasized the role of EPA in reasonably
assessing its analysis of pesticide tolerances, safety, and awareness
of disproportionate effects of agricultural production, and its firm
commitment to environmental justice.
Although the Agency recognizes that some individuals believe that
pesticides should be banned on agricultural crops, the existing legal
framework provided by section 408 of the FFDCA 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 glufosinate-P tolerances are
safe. The commenter provided no information supporting a conclusion
that glufosinate-P is not safe, nor did the commenter provide any basis
for concluding that the tolerances would have a disproportionate effect
on any population.
D. Revisions to Petitioned-For Tolerances
The Agency is establishing a tolerance for residues of glufosinate-
P, including its metabolites and degradates, that result from
applications of glufosinate-P or glufosinate-P-ammonium, with
compliance to be determined by measuring the sum of glufosinate (2-
amino-4-(hydroxymethylphosphinyl)butanoic acid) and its metabolites, 2-
(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3-
(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents. BASF Corporation
had petitioned for expression of L-glufosinate-ammonium, glufosinate-P-
ammonium [(2S)-2-amino-4-(hydroxymethylphosphinyl) butanoic acid -
monoammonium salt] as measured by the sum of glufosinate (2-amino-4-
(hydroxymethylphosphinyl)butanoic acid) and its metabolites, 2-
(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3-
(hydroxymethylphosphinyl) propanoic
[[Page 85865]]
acid, expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid,
and MITSUI Chemicals Crop & Life Solutions, Inc. had petitioned for
expression of L-glufosinate free acid, (2S)-2-amino-4-
[hydroxy(methyl)phosphinoyl]butyric acid, including its metabolites and
degradates, 2-(acetylamino)-4-(hydroxymethylphosphinyl) butanoic acid
(NAG), and 3-(hydroxymethylphosphinyl) propanoic acid (MPP), expressed
as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents. As
discussed in Unit III.A, glufosinate-P-ammonium (also referred to as L-
glufosinate ammonium) is the ammonium salt of glufosinate-P (also
referred to as L-glufosinate acid). Since the glufosinate-P-ammonium
breaks down into residues of glufosinate-P, EPA is establishing the
tolerances for residues of glufosinate-P including its metabolites and
degradates, that may result from applications of either form of
glufosinate-P.
In addition, the petitioners have withdrawn their requests to
establish tolerances on the following crops, so EPA is not establishing
tolerances on those crops at this time: apple; beet, sugar, molasses;
beet, sugar, roots; beet, sugar, tops (leaves); bushberry subgroup 13-
07B; fruit, citrus, crop group 10-10; fruit, pome, crop group 11-10;
fruit, stone, crop group 12-12; grape; nut, tree, crop group 14-12;
olive; potato; potato, chips; and potato, granules/flakes.
Finally, EPA has applied its policy on OECD Rounding Classes to the
petitioned-for tolerances to establish tolerances without trailing
zeros after the decimal place.
V. Conclusion
Therefore, tolerances are established for residues of glufosinate-P
including its metabolites and degradates in or on canola, meal at 1.1
parts per million (ppm); cattle, fat at 0.4 ppm; cattle, meat at 0.15
ppm; cattle, meat byproducts at 6 ppm; corn, field, forage at 4 ppm;
corn, field, grain at 0.2 ppm; corn, field, stover at 6 ppm; corn,
sweet, forage at 1.5 ppm; corn, sweet, kernels plus cob with husks
removed at 0.3 ppm; corn, sweet, stover at 6 ppm; cotton, gin
byproducts at 30 ppm; cotton, seed, subgroup 20C at 15 ppm; egg at 0.15
ppm; goat, fat at 0.4 ppm; goat, meat at 0.15 ppm; goat, meat
byproducts at 6 ppm; grain aspirated fractions at 25 ppm; hog, fat at
0.4 ppm; hog, meat at 0.15 ppm; hog, meat byproducts at 6 ppm; horse,
fat at 0.4 ppm; horse, meat at 0.15 ppm; horse, meat byproducts at 6
ppm; milk at 0.15 ppm; poultry, fat at 0.15 ppm; poultry, meat at 0.15
ppm; poultry, meat byproducts at 0.6 ppm; rapeseed, subgroup 20A at 0.4
ppm; sheep, fat at 0.4 ppm; sheep, meat at 0.15 ppm; sheep, meat
byproducts at 6 ppm; soybean at 2 ppm; soybean, hulls at 10 ppm.
In addition, tolerances are established for indirect or inadvertent
residues of glufosinate-P including its metabolites and degradates in
or on barley, hay at 0.4 ppm; barley, straw at 0.4 ppm; buckwheat,
fodder at 0.4 ppm; buckwheat, forage at 0.4 ppm; oat, forage at 0.4
ppm; oat, hay at 0.4 ppm; oat, straw at 0.4 ppm; rye, forage at 0.4
ppm; rye, straw at 0.4 ppm; teosinte at 0.4 ppm; triticale at 0.4 ppm;
wheat, forage at 0.4 ppm; wheat, hay at 0.4ppm; and wheat, straw at 0.4
ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal governments, on the relationship between the national government
and the States or Tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: October 21, 2024.
Elizabeth Vizard,
Acting Director, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, 40 CFR chapter I
is amended 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. Revise and republish Sec. 180.473 to read as follows:
[[Page 85866]]
Sec. 180.473 Glufosinate; tolerances for residues.
(a) General. (1) Tolerances are established for residues of
glufosinate, including its metabolites and degradates, in or on the
commodities in table 1 to paragraph (a)(1). Compliance with the
tolerance levels specified in table 1 to paragraph (a)(1) is to be
determined by measuring the sum of glufosinate (2-amino-4-
(hydroxymethylphosphinyl)butanoic acid) and its metabolites, 2-
(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3-
(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents.
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond, hulls........................................... 0.50
Banana \1\.............................................. 0.30
Beet, sugar, molasses................................... 5.0
Beet, sugar, roots...................................... 0.9
Beet, sugar, tops (leaves).............................. 1.5
Bushberry subgroup 13-07B............................... 0.15
Canola, meal............................................ 1.1
Cattle, fat............................................. 0.40
Cattle, meat............................................ 0.15
Cattle, meat byproducts................................. 6.0
Corn, field forage...................................... 4.0
Corn, field, grain...................................... 0.20
Corn, field, stover..................................... 6.0
Corn, sweet, forage..................................... 1.5
Corn, sweet, kernels plus cob with husks removed........ 0.30
Corn, sweet, stover..................................... 6.0
Cotton, gin byproducts.................................. 30
Cottonseed subgroup 20C................................. 15
Egg..................................................... 0.15
Fig, dried.............................................. 0.15
Fruit, citrus, group 10-10.............................. 0.15
Fruit, pome, group 11-10................................ 0.25
Fruit, small, vine climbing, except fuzzy kiwifruit, 0.05
subgroup 13-07F........................................
Fruit, stone, group 12-12............................... 0.30
Goat, fat............................................... 0.40
Goat, meat.............................................. 0.15
Goat, meat byproducts................................... 6.0
Grain aspirated fractions............................... 25
Hog, fat................................................ 0.40
Hog, meat............................................... 0.15
Hog, meat byproducts.................................... 6.0
Hop, dried cones........................................ 0.9
Horse, fat.............................................. 0.40
Horse, meat............................................. 0.15
Horse, meat byproducts.................................. 6.0
Melon subgroup 9A....................................... 0.08
Milk.................................................... 0.15
Nut, tree, group 14-12.................................. 0.50
Pepper/eggplant subgroup 8-10B.......................... 0.15
Potato, chips........................................... 1.6
Potato granules/flakes.................................. 2.0
Poultry, fat............................................ 0.15
Poultry, meat........................................... 0.15
Poultry, meat byproducts................................ 0.60
Rapeseed subgroup 20A................................... 0.4
Rice, grain............................................. 1.0
Rice, hull.............................................. 2.0
Sheep, fat.............................................. 0.40
Sheep, meat............................................. 0.15
Sheep, meat byproducts.................................. 6.0
Soybean................................................. 2.0
Soybean, hulls.......................................... 10
Squash/cucumber subgroup 9B............................. 0.15
Tomato, paste........................................... 0.15
Tomato subgroup 8-10A................................... 0.1
Tropical and subtropical, medium to large fruit, edible 0.1
peel, subgroup 23B.....................................
Tropical and subtropical, medium to large fruit, smooth, 0.2
inedible peel, subgroup 24B............................
Tropical and subtropical, small fruit, edible peel, 0.5
subgroup 23A...........................................
Tropical and subtropical, small fruit, inedible peel, 0.1
subgroup 24A...........................................
Vegetable, tuberous and corm, subgroup 1C............... 0.8
------------------------------------------------------------------------
(2) Tolerances are established for residues of glufosinate-P,
including its metabolites and degradates, in or on the commodities in
table 2 to paragraph (a)(2), as a result of applications of
glufosinate-P or glufosinate-P-ammonium to those commodities.
Compliance with the tolerance levels specified in table 2 to paragraph
(a)(2) is to be determined by measuring the sum of glufosinate (2-
amino-4-(hydroxymethylphosphinyl) butanoic acid) and its metabolites,
2-(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3-
(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents.
Table 2 to Paragraph (a)(2)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Canola, meal............................................ 1.1
Cattle, fat............................................. 0.4
Cattle, meat............................................ 0.15
Cattle, meat byproducts................................. 6
Corn, field, forage..................................... 4
Corn, field, grain...................................... 0.2
Corn, field, stover..................................... 6
Corn, sweet, forage..................................... 1.5
Corn, sweet, kernels plus cob with husks removed........ 0.3
Corn, sweet, stover..................................... 6
Cotton, gin byproducts.................................. 30
Cottonseed, subgroup 20C................................ 15
Egg..................................................... 0.15
Goat, fat............................................... 0.4
Goat, meat.............................................. 0.15
Goat, meat byproducts................................... 6
Grain, aspirated fractions.............................. 25
Hog, fat................................................ 0.4
Hog, meat............................................... 0.15
Hog, meat byproducts.................................... 6
Horse, fat.............................................. 0.4
Horse, meat............................................. 0.15
Horse, meat byproducts.................................. 6
Milk.................................................... 0.15
Poultry, fat............................................ 0.15
Poultry, meat........................................... 0.15
Poultry, meat byproducts................................ 0.6
Rapeseed, subgroup 20A.................................. 0.4
Sheep, fat.............................................. 0.4
Sheep, meat............................................. 0.15
Sheep, meat byproducts.................................. 6
Soybean................................................. 2
Soybean, hulls.......................................... 10
------------------------------------------------------------------------
(b) [Reserved]
(c) Tolerances with regional registrations. Tolerances with
regional registrations are established for residues of glufosinate,
including its metabolites and degradates, in or on the commodities in
table 3 to paragraph (c). Compliance with the tolerance levels
specified in table 3 to paragraph (c) is to be determined by measuring
the sum of glufosinate, (2-amino-4-(hydroxymethylphosphinyl)butanoic
acid) and its metabolites, 2-(acetylamino)-4-(hydroxymethyl phosphinyl)
butanoic acid, and 3-(hydroxymethylphosphinyl) propanoic acid,
expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid
equivalents.
Table 3 to Paragraph (c)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Grass, forage........................................... 0.15
Grass, hay.............................................. 0.2
------------------------------------------------------------------------
(d) Indirect or inadvertent residues. (1) Tolerances are
established for indirect or inadvertent residues of glufosinate,
including its metabolites and degradates, in or on the commodities in
table 4 to paragraph (d)(1), as a result of the application of
glufosinate to crops listed in paragraph (a) of this section.
Compliance with the tolerance levels specified in table 4 to paragraph
(d)(1) is to be determined by measuring the sum of glufosinate (2-
amino-4-(hydroxymethylphosphinyl) butanoic acid) and its metabolite, 3-
(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents.
[[Page 85867]]
Table 4 to Paragraph (d)(1)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Barley, hay............................................. 0.40
Barley, straw........................................... 0.40
Buckwheat, fodder....................................... 0.40
Buckwheat, forage....................................... 0.40
Oat, forage............................................. 0.40
Oat, hay................................................ 0.40
Oat, straw.............................................. 0.40
Rye, forage............................................. 0.40
Rye, straw.............................................. 0.40
Teosinte................................................ 0.40
Triticale............................................... 0.40
Wheat, forage........................................... 0.40
Wheat, hay.............................................. 0.40
Wheat, straw............................................ 0.40
------------------------------------------------------------------------
(2) Tolerances are established for indirect or inadvertent residues
of glufosinate-P, including its metabolites and degradates, in or on
the commodities in table 5 to paragraph (d)(2), as a result of the
application of glufosinate-P or glufosinate-P-ammonium to crops listed
in paragraph (a)(2) of this section. Compliance with the tolerance
levels specified in table 5 to paragraph (d)(2) is to be determined by
measuring the sum of glufosinate (2-amino-4-(hydroxymethylphosphinyl)
butanoic acid) and its metabolite, 3-(hydroxymethylphosphinyl)
propanoic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents.''
Table 5 to Paragraph (d)(2)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Barley, hay............................................. 0.4
Barley, straw........................................... 0.4
Buckwheat, fodder....................................... 0.4
Buckwheat, forage....................................... 0.4
Oat, forage............................................. 0.4
Oat, hay................................................ 0.4
Oat, straw.............................................. 0.4
Rye, forage............................................. 0.4
Rye, straw.............................................. 0.4
Teosinte................................................ 0.4
Triticale............................................... 0.4
Wheat, forage........................................... 0.4
Wheat, hay.............................................. 0.4
Wheat, straw............................................ 0.4
------------------------------------------------------------------------
[FR Doc. 2024-24831 Filed 10-28-24; 8:45 am]
BILLING CODE 6560-50-P
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