Federal Register / Vol. 89, No. 209 / Tuesday, October 29, 2024 / Rules and Regulations 85859 

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: 

§ 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 

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, 

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 

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 


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85860 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 

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-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 

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 LVerDate Sep<11>2014 16:02 Oct 28, 2024 Jkt 265001 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\29OCR1.SGM 29OCR1

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Federal Register / Vol. 89, No. 209 / Tuesday, October 29, 2024 / Rules and Regulations 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 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. 

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. 

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. 

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 

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, 3- 

methylphosphinico-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 

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 

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 

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 

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 (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. 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 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 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; 

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 

■ 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) 

Commodity Parts per 

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, subgroup 13–07F .................... 0.05 

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 

TABLE 1 TO PARAGRAPH (a)(1)— 

Continued 

Commodity Parts per 

million 

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 

peel, subgroup 23B ........... 0.1 

Tropical and subtropical, medium to large fruit, smooth, 

inedible peel, subgroup 

24B .................................... 0.2 

Tropical and subtropical, 

small fruit, edible peel, 

subgroup 23A .................... 0.5 

Tropical and subtropical, 

small fruit, inedible peel, 

subgroup 24A .................... 0.1 

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-Pammonium 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-(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 2 TO PARAGRAPH (a)(2) 

Commodity Parts per 

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 

TABLE 2 TO PARAGRAPH (a)(2)— 

Continued 

Commodity Parts per 

million 

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-(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 3 TO PARAGRAPH (c) 

Commodity Parts per 

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-(hydroxy

methylphosphinyl)butanoic acid 

equivalents. 


khammond on DSKJM1Z7X2PROD with RULES
Federal Register / Vol. 89, No. 209 / Tuesday, October 29, 2024 / Rules and Regulations 85867 

TABLE 4 TO PARAGRAPH (d)(1) 

Commodity Parts per 

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-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 (2- 

amino-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 ............................ 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 

CORPORATION FOR NATIONAL AND 

COMMUNITY SERVICE 

45 CFR Part 2584 

RIN 3045–AA60 

Protection of Human Subjects 

AGENCY: Corporation for National and 

Community Service. 

ACTION: Final rule. 

SUMMARY: 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. 

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 

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. 


khammond on DSKJM1Z7X2PROD with RULES