Glufosinate-P; Pesticide Tolerances, 85859-85867 [2024-24831]
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Federal Register / Vol. 89, No. 209 / Tuesday, October 29, 2024 / Rules and Regulations
achieving EJ for people of color, lowincome populations and Indigenous
peoples.
This action is subject to the
Congressional Review Act, and EPA will
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. This action
is not a ‘‘major rule’’ as defined by 5
U.S.C. 804(2).
Under section 307(b)(1) of the CAA,
petitions for judicial review of this
action must be filed in the United States
Court of Appeals for the appropriate
circuit by December 30, 2024. Filing a
petition for reconsideration by the
Administrator of this final rule does not
affect the finality of this action for the
purposes of judicial review nor does it
extend the time within which a petition
for judicial review may be filed, and
shall not postpone the effectiveness of
such rule or action. This action may not
be challenged later in proceedings to
enforce its requirements. (See section
307(b)(2).)
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Carbon monoxide,
Incorporation by reference,
Intergovernmental relations, Lead,
Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile
organic compounds.
Dated: October 23, 2024.
Debra Shore,
Regional Administrator, Region 5.
For the reasons stated in the
preamble, title 40 CFR part 52 is
amended as follows:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
2. Section 52.2570 is amended by
removing and reserving paragraphs (c)
(13), (c)(14), (c)(15), (c)(22), (c)(27),
(c)(28), (c)(30), (c)(32), (c)(33), (c)(34),
(c)(36), (c)(39), (c)(40), (c)(41), (c)(42),
(c)(43), (c)(45), (c)(49), (c)(72), (c)(78)
and (c)(91), and by adding paragraph
(c)(150) to read as follows:
■
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§ 52.2570
Identification of plan.
*
*
*
*
*
(c) * * *
(150) On October 27, 2023, WDNR
submitted a SIP revision request to align
provisions approved in the Wisconsin
SIP with current Wisconsin
administrative rules and statutes.
WDNR requested that certain provisions
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previously approved into the Wisconsin
SIP under now obsolete numbering
schemes be renumbered to ensure
citations in the Wisconsin SIP reflect
the current numbering systems of the
Wisconsin Administrative Code (WAC)
and the Wisconsin Statutes (Wis. Stats.).
WDNR also requested that EPA approve
rule and statute provisions that have
been revised since they were approved
into the Wisconsin SIP. Finally, WDNR
requested removal of rules and statutes
from the Wisconsin SIP that are no
longer in effect in Wisconsin. The rule
and statute provisions that have been
revised or removed were previously
approved in paragraphs (c) (13), (c)(14),
(c)(15), (c)(22), (c)(27), (c)(28), (c)(30),
(c)(32), (c)(33), (c)(34), (c)(36), (c)(39),
(c)(40), (c)(41), (c)(42), (c)(43), (c)(45),
(c)(49), (c)(72), (c)(78) and (c)(91) of this
section. Approval of these changes in
the Wisconsin SIP will not impact the
state’s air quality or ability to meet
Clean Air Act requirements.
(i) Incorporation by reference. (A)
Wisconsin Administrative Code, NR
400, except Note, 400.01, 400.02 (19m),
(27m), (107m), (123e), and (123s),
400.03(1)(a) through (cm) and (dm)
through (m), and 400.03(4)(jp) and (js),
as published in the Wisconsin Register,
July 2022 No. 799, effective August 1,
2022.
(B) Wisconsin Administrative Code,
NR 415, except 415.01, 415.02(3) and
(8), 415.075(1), (2)(a) intro, 1. through
4., 6. and 7., (b) and (c), (3)(a) through
(e), (4), (5), and (6), 415.076, and
415.09(2) and (3)(a) through (c), as
published in the Wisconsin Register,
April 2023 No. 808, effective May 1,
2023.
(C) Wisconsin Administrative Code,
NR 417, except Note, 417.01(2), 417.03,
417.05, and 417.07(2)(e) and (f), as
published in the Wisconsin Register,
November 1999 No. 526, effective
November 1, 1999.
(D) Wisconsin Administrative Code,
NR 431, only 431.03, 431.04 and 431.05,
as published in the Wisconsin Register,
November 2003 No. 574, effective
November 1, 2003.
(E) Wisconsin Administrative Code,
NR 436, except 436.01(2), 436.03(2), and
436.05(5), as published in the
Wisconsin Register, November 1999 No.
526, effective November 1, 1999.
(F) Wisconsin Administrative Code,
NR 445, only 445.16, as published in the
Wisconsin Register, March 2016 No.
723, effective April 1, 2016.
(G) Wisconsin Administrative Code,
NR 447, only 447.02 intro, (6), (7), (16),
(18) Note, and (31), 447.07 (3) intro, (a)
and (d), 447.12 (3)(b) Note, 447.16 (2),
and 447.18 intro and (1) Note, as
published in the Wisconsin Register,
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85859
June 2004 No. 582, effective July 1,
2004.
(H) Wisconsin Administrative Code,
NR 492, only 492.03, as published in the
Wisconsin Register, April 2013 No. 688,
effective May 1, 2013.
(I) Wisconsin Administrative Code,
NR 493, except Note and 493.01, as
published in the Wisconsin Register,
November 1999 No. 527.
(J) Wisconsin Administrative Code,
Chapter Trans 131, as published in the
Wisconsin Register, July 2023 No. 811,
effective August 1, 2023.
(K) Wisconsin Statutes, Chapter 15,
only 15.347(8), as revised by Updated
21–22 Wis. Stats., published October 4,
2023.
(L) Wisconsin Statutes, Chapter 110,
only 110.20, as revised by Updated 21–
22 Wis. Stats., published October 4,
2023.
(M) Wisconsin Statutes, Chapter 285,
285.01 except (17m), (21), (28), (33),
(35), (38), (39), (40); 285.11 except (12),
(13), (15), (16), (17), (18), (19); 285.13
except (7); 285.17 only (1); 285.19;
285.21 except (4); 285.23 except (6);
285.27 except (2)(d) and (3); 285.30;
285.31 only (5); 285.33 only (1); 285.35;
285.60 except (1)(b)2., (2g), (5m), (6)(b)
and (c), (8), (9), (10) and (11); 285.61
except (5)(a) and (b), (10) and (11);
285.62; 285.63 except (11); 285.65;
285.66; 285.68; 285.69 except (1)(c),
(1d), (2)(a), (c) intro, (c)2., (d) and (e),
(2e), (2m), (3), (5), (6), and (7); 285.79;
285.81 except (1m) and (4); 285.83
except (2); and 285.87 except (2), as
revised by Updated 21–22 Wis. Stats.,
published October 4, 2023.
(N) Wisconsin Statutes, Chapter 299,
only 299.95, as revised by Updated 21–
22 Wis. Stats., published October 4,
2023.
(ii) [Reserved]
[FR Doc. 2024–25032 Filed 10–28–24; 8:45 am]
BILLING CODE 6560–50–P
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
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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
SUMMARY:
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Federal Register / Vol. 89, No. 209 / Tuesday, October 29, 2024 / Rules and Regulations
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 https://www.regulations.gov or at the
Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the
Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room and the OPP
Docket is (202) 566–1744. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Charles Smith, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
202–566–2427; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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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 EPA’s tolerance
regulations at 40 CFR part 180 through
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the Federal Register Office’s e-CFR site
at https://www.ecfr.gov/current/title-40.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–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:
• 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-sendcomments-epa-dockets.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of 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
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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-
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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,
https://www.regulations.gov. 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.
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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 Lglufosinate free acid. Because
applications of glufosinate-Pammonium (also known as Lglufosinate-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.
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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 Lisomer 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 Lglufosinate ammonium and Lglufosinate acid. The International
Organization for Standardization (ISO)
has designated L-glufosinate ammonium
as glufosinate-P-ammonium and Lglufosinate 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 Lglufosinate ammonium and Lglufosinate 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/Lglufosinate 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, Lglufosinate 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
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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-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document ‘‘LGlufosinate. Human Health Risk
Assessment for New Active Ingredient
Isomer’’ at 21–34 in docket ID number
EPA–HQ–OPP–2020–0250.
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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 https://
www.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
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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 Lglufosinate. 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 Lglufosinate (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 Lglufosinate is one-half that of D/Lglufosinate, the expected residues for Lglufosinate are one-half those of D/Lglufosinate.
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
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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 Lglufosinate. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
pesticide-science-and-assessingpesticide-risks/models-pesticide-riskassessment.
Determination of the residues of
concern for human health in drinking
water included consideration of racemic
glufosinate and the degradate, 3methylphosphinico-propionic acid
(MPP). Although the chronic EDWCs for
MPP are approximately 2× 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
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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 nonoccupational, 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 Lglufosinate and are included in a shortterm aggregate assessment for Lglufosinate. For this assessment, the
application rate was scaled by 0.5× 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 highcontact 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
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mechanism of toxicity finding as to Lglufosinate 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 https://
www.epa.gov/pesticide-science-andassessing-pesticide-risks/pesticidecumulative-risk-assessment-framework.
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 (10×) 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 10×, 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 Lglufosinate 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
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adequately protected if the FQPA SF
were reduced to 1× for all exposure
scenarios for glufosinate-P. That
decision is based on the following
findings:
i. The toxicity database for Lglufosinate is complete, as a result of
bridging data between the racemic
glufosinate, L-glufosinate, and Lglufosinate 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 13×–80×
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 11×–67× higher than the
selected PODs; (3) the neuropathology
observed in the subchronic
neurotoxicity study occurred at a dose
level approximately 29×–174× 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 27× 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 42× 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 Lglufosinate rat prenatal developmental
toxicity study, the L-glufosinate rangefinding DNT study, and the D/Lglufosinate 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.
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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
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chronic dietary risk assessment for
evaluating intermediate-term risk for Lglufosinate.
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/Lglufosinate: (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-acetylglufosinate (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: residuemethods@
epa.gov.
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
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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 glufosinateP or glufosinate-P-ammonium, with
compliance to be determined by
measuring the sum of glufosinate (2amino-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. BASF Corporation had
petitioned for expression of Lglufosinate-ammonium, glufosinate-Pammonium [(2S)-2-amino-4-(hydroxy
methylphosphinyl) 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
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acid, expressed as 2-amino-4-(hydroxy
methylphosphinyl)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-(hydroxymethyl
phosphinyl) butanoic acid (NAG), and
3-(hydroxymethylphosphinyl)
propanoic acid (MPP), expressed as 2amino-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 Lglufosinate acid). Since the glufosinateP-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;
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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
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85865
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
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Revise and republish § 180.473 to
read as follows:
■
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§ 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-(hydroxy
methylphosphinyl)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)
khammond on DSKJM1Z7X2PROD with RULES
Commodity
Parts per
million
Almond, hulls ........................
Banana 1 ...............................
Beet, sugar, molasses ..........
Beet, sugar, roots .................
Beet, sugar, tops (leaves) ....
Bushberry subgroup 13–07B
Canola, meal ........................
Cattle, fat ..............................
Cattle, meat ..........................
Cattle, meat byproducts .......
Corn, field forage ..................
Corn, field, grain ...................
Corn, field, stover .................
Corn, sweet, forage ..............
Corn, sweet, kernels plus
cob with husks removed ...
Corn, sweet, stover ..............
Cotton, gin byproducts .........
Cottonseed subgroup 20C ...
Egg .......................................
Fig, dried ...............................
Fruit, citrus, group 10–10 .....
Fruit, pome, group 11–10 .....
Fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13–07F ....................
Fruit, stone, group 12–12 .....
Goat, fat ................................
Goat, meat ............................
Goat, meat byproducts .........
Grain aspirated fractions ......
Hog, fat .................................
Hog, meat .............................
Hog, meat byproducts ..........
Hop, dried cones ..................
Horse, fat ..............................
Horse, meat ..........................
Horse, meat byproducts .......
Melon subgroup 9A ..............
Milk .......................................
Nut, tree, group 14–12 .........
Pepper/eggplant subgroup
8–10B ................................
Potato, chips .........................
Potato granules/flakes ..........
Poultry, fat ............................
Poultry, meat ........................
Poultry, meat byproducts ......
Rapeseed subgroup 20A ......
Rice, grain ............................
VerDate Sep<11>2014
16:02 Oct 28, 2024
0.50
0.30
5.0
0.9
1.5
0.15
1.1
0.40
0.15
6.0
4.0
0.20
6.0
1.5
0.30
6.0
30
15
0.15
0.15
0.15
0.25
0.05
0.30
0.40
0.15
6.0
25
0.40
0.15
6.0
0.9
0.40
0.15
6.0
0.08
0.15
0.50
0.15
1.6
2.0
0.15
0.15
0.60
0.4
1.0
Jkt 265001
TABLE 1 TO PARAGRAPH (a)(1)—
Continued
TABLE 2 TO PARAGRAPH (a)(2)—
Continued
Parts per
million
Commodity
Rice, hull ...............................
Sheep, fat .............................
Sheep, meat .........................
Sheep, meat byproducts ......
Soybean ................................
Soybean, hulls ......................
Squash/cucumber subgroup
9B ......................................
Tomato, paste .......................
Tomato subgroup 8–10A ......
Tropical and subtropical, medium to large fruit, edible
peel, subgroup 23B ...........
Tropical and subtropical, medium to large fruit, smooth,
inedible peel, subgroup
24B ....................................
Tropical and subtropical,
small fruit, edible peel,
subgroup 23A ....................
Tropical and subtropical,
small fruit, inedible peel,
subgroup 24A ....................
Vegetable, tuberous and
corm, subgroup 1C ...........
2.0
0.40
0.15
6.0
2.0
10
0.15
0.15
0.1
0.1
0.2
Commodity
Hog, fat .................................
Hog, meat .............................
Hog, meat byproducts ..........
Horse, fat ..............................
Horse, meat ..........................
Horse, meat byproducts .......
Milk .......................................
Poultry, fat ............................
Poultry, meat ........................
Poultry, meat byproducts ......
Rapeseed, subgroup 20A .....
Sheep, fat .............................
Sheep, meat .........................
Sheep, meat byproducts ......
Soybean ................................
Soybean, hulls ......................
Parts per
million
0.4
0.15
6
0.4
0.15
6
0.15
0.15
0.15
0.6
0.4
0.4
0.15
6
2
10
0.5
(b) [Reserved]
(c) Tolerances with regional
0.1 registrations. Tolerances with regional
registrations are established for residues
0.8 of glufosinate, including its metabolites
and degradates, in or on the
(2) Tolerances are established for
commodities in table 3 to paragraph (c).
residues of glufosinate-P, including its
Compliance with the tolerance levels
metabolites and degradates, in or on the specified in table 3 to paragraph (c) is
commodities in table 2 to paragraph
to be determined by measuring the sum
(a)(2), as a result of applications of
of glufosinate, (2-amino-4-(hydroxy
glufosinate-P or glufosinate-Pmethylphosphinyl)butanoic acid) and
ammonium to those commodities.
its metabolites, 2-(acetylamino)-4Compliance with the tolerance levels
(hydroxymethyl phosphinyl) butanoic
specified in table 2 to paragraph (a)(2)
acid, and 3-(hydroxymethylphosphinyl)
is to be determined by measuring the
propanoic acid, expressed as 2-amino-4sum of glufosinate (2-amino-4-(hydroxy (hydroxymethylphosphinyl)butanoic
methylphosphinyl) butanoic acid) and
acid equivalents.
its metabolites, 2-(acetylamino)-4(hydroxymethyl phosphinyl) butanoic
TABLE 3 TO PARAGRAPH (c)
acid, and 3-(hydroxymethylphosphinyl)
propanoic acid, expressed as 2-amino-4Parts per
Commodity
(hydroxymethylphosphinyl)butanoic
million
acid equivalents.
Grass, forage ........................
Grass, hay ............................
TABLE 2 TO PARAGRAPH (a)(2)
Parts per
million
Commodity
Canola, meal ........................
Cattle, fat ..............................
Cattle, meat ..........................
Cattle, meat byproducts .......
Corn, field, forage .................
Corn, field, grain ...................
Corn, field, stover .................
Corn, sweet, forage ..............
Corn, sweet, kernels plus
cob with husks removed ...
Corn, sweet, stover ..............
Cotton, gin byproducts .........
Cottonseed, subgroup 20C ..
Egg .......................................
Goat, fat ................................
Goat, meat ............................
Goat, meat byproducts .........
Grain, aspirated fractions .....
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
1.1
0.4
0.15
6
4
0.2
6
1.5
0.3
6
30
15
0.15
0.4
0.15
6
25
0.15
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 (2amino-4-(hydroxymethylphosphinyl)
butanoic acid) and its metabolite, 3(hydroxymethylphosphinyl) propanoic
acid, expressed as 2-amino-4-(hydroxy
methylphosphinyl)butanoic acid
equivalents.
E:\FR\FM\29OCR1.SGM
29OCR1
Federal Register / Vol. 89, No. 209 / Tuesday, October 29, 2024 / Rules and Regulations
ACTION:
TABLE 4 TO PARAGRAPH (d)(1)
Commodity
Parts per
million
Barley, hay ............................
Barley, straw .........................
Buckwheat, fodder ................
Buckwheat, forage ................
Oat, forage ............................
Oat, hay ................................
Oat, straw .............................
Rye, forage ...........................
Rye, straw .............................
Teosinte ................................
Triticale .................................
Wheat, forage .......................
Wheat, hay ...........................
Wheat, straw .........................
0.40
0.40
0.40
0.40
0.40
0.40
0.40
0.40
0.40
0.40
0.40
0.40
0.40
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-Pammonium 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 (2amino-4-(hydroxymethylphosphinyl)
butanoic acid) and its metabolite, 3(hydroxymethylphosphinyl) propanoic
acid, expressed as 2-amino-4-(hydroxy
methylphosphinyl)butanoic acid
equivalents.’’
TABLE 5 TO PARAGRAPH (d)(2)
Commodity
Parts per
million
Barley, hay ............................
Barley, straw .........................
Buckwheat, fodder ................
Buckwheat, forage ................
Oat, forage ............................
Oat, hay ................................
Oat, straw .............................
Rye, forage ...........................
Rye, straw .............................
Teosinte ................................
Triticale .................................
Wheat, forage .......................
Wheat, hay ...........................
Wheat, straw .........................
0.4
0.4
0.4
0.4
0.4
0.4
0.4
0.4
0.4
0.4
0.4
0.4
0.4
0.4
[FR Doc. 2024–24831 Filed 10–28–24; 8:45 am]
BILLING CODE 6560–50–P
khammond on DSKJM1Z7X2PROD with RULES
CORPORATION FOR NATIONAL AND
COMMUNITY SERVICE
45 CFR Part 2584
RIN 3045–AA60
Protection of Human Subjects
Corporation for National and
Community Service.
AGENCY:
VerDate Sep<11>2014
16:02 Oct 28, 2024
Jkt 265001
Final rule.
The Corporation for National
and Community Service (operating as
AmeriCorps) is finalizing its adoption of
the Federal Policy for Protection of
Human Subjects (referred to as the
Common Rule). The Common Rule
outlines the basic ethical principles and
procedures that an agency will abide by
when conducting or sponsoring research
involving human subjects. Among the
procedures required by the Common
Rule are use of institutional review
boards (IRBs), obtaining informed
consent of research subjects, and
requiring submission of assurances of
compliance with the rule. AmeriCorps
is making the Common Rule applicable
to itself, meaning that all research
involving human subjects conducted,
supported, or otherwise subject to
regulation by AmeriCorps will be
subject to the Common Rule’s ethical
principles and procedures.
DATES: This rule is effective on
November 29, 2024.
FOR FURTHER INFORMATION CONTACT:
Mary Hyde, Ph.D., Director, AmeriCorps
Office of Research and Evaluation, at
(202) 606–6834 or mhyde@
americorps.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
I. Background
II. This Final Rule
III. Comments on and Finalization of the
Proposed Rule
IV. Regulatory Analyses
A. Executive Orders 12866 and 13563
B. Regulatory Flexibility Act
C. Unfunded Mandates Reform Act of 1995
D. Paperwork Reduction Act
E. Federalism (E.O. 13132)
F. Takings (E.O. 12630)
G. Civil Justice Reform (E.O. 12988)
H. Consultation With Indian Tribes (E.O.
13175)
I. Background
On June 18, 1991, the U.S.
Department of Health and Human
Services (HHS) issued a rule setting
forth the Common Rule requirements for
the protection of human subjects. (56 FR
28003). The HHS regulations are
codified at 45 CFR part 46. At that time,
15 other agencies joined HHS in
adopting a uniform set of rules for the
protection of human subjects, identical
to subpart A of 45 CFR part 46. The
basic provisions of the Common Rule
include, among other things,
requirements related to the review of
human subjects research by an IRB,
obtaining and documenting informed
consent of human subjects, and
submitting written assurance of
institutional compliance with the
Common Rule. On January 19, 2017 (82
PO 00000
Frm 00017
Fmt 4700
Sfmt 4700
85867
FR 7149), HHS issued a final rule
revising the Common Rule, which,
among other things, established new
requirements regarding the information
that must be given to prospective
research subjects as part of the informed
consent process.
At the time the Common Rule was
first adopted in 1991, AmeriCorps had
just been established as the Corporation
for National and Community Service
under the National and Community
Service Act of 1990. AmeriCorps was
not a participating agency in either that
1991 Common Rule rulemaking or in
the subsequent amendments to the
Common Rule; however, AmeriCorps
believes it is important to adopt this
standard framework for AmeriCorps
research professionals, prospective and
participating human subjects, and
consistency among Federal agencies, as
described above. This final rule
provides the incentives of a mandatory
procedural framework and provides
human research subjects the assurance
of protection offered by the Common
Rule.
II. Final Rule
AmeriCorps is codifying the text of
the revised Common Rule in its
regulations at 45 CFR part 2584 (the
proposed rule projected its placement at
45 CFR part 2558, but AmeriCorps has
since determined that part 2584 is more
appropriate given a planned
improvement of chapter 25’s
organization). This rule is substantively
identical to the HHS regulations in 45
CFR part 46, subpart A, ensuring
consistency across Federal agencies.
With this codification, AmeriCorps
would be subject to the same ethical
principles and procedures that other
agencies who have adopted the
Common Rule are subject to when
conducting or supporting research
involving human subjects. The rule
applies broadly; most relevant to
AmeriCorps, it covers instances when
an investigator conducting research
obtains information through interaction
with the individual and uses, studies, or
analyzes the information. The rule also
sets out certain research that is exempt
from the rule. For any non-exempt
research, under this rule AmeriCorps
would:
• Conduct or support non-exempt
research only if the institution engaged
in the research has provided an
assurance that it will comply with the
Common Rule, and
• Conduct or support non-exempt
research only if (when required by the
rule) the institution has certified to
AmeriCorps that the research has been
reviewed and approved by an IRB.
E:\FR\FM\29OCR1.SGM
29OCR1
Agencies
[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 [www.gpo.gov]
[FR Doc No: 2024-24831]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.regulations.gov or at the Office of
Pesticide Programs Regulatory Public Docket (OPP Docket) in the
Environmental Protection Agency Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW,
Washington, DC 20460-0001. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room and the OPP Docket is
(202) 566-1744. Please review the visitor instructions and additional
information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number: 202-566-2427; 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 EPA's
tolerance regulations at 40 CFR part 180 through the Federal Register
Office's e-CFR site at https://www.ecfr.gov/current/title-40.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-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:
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. 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, https://www.regulations.gov. 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 https://www.regulations.gov 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment.
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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework.
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:
[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 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