Federal Register / Vol. 89, No. 240 / Friday, December 13, 2024 / Rules and Regulations 100749 

List of Subjects in 40 CFR Part 174 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: December 4, 2024. 

Edward Messina, 

Director, Office of Pesticide Programs. 

Therefore, for the reasons stated in the 

preamble, EPA is amending 40 CFR 

chapter I as follows: 

PART 174—PROCEDURES AND 

REQUIREMENTS FOR PLANTINCORPORATED PROTECTANTS 

■ 1. The authority citation for part 174 

continues to read as follows: 

Authority: 7 U.S.C. 136–136y; 21 U.S.C. 

321(q), 346a and 371. 

■ 2. Add § 174.549 to subpart W to read 

as follows: 

§ 174.549 Bacillus thuringiensis Cry1Da2 

protein; exemption from the requirement of 

a tolerance. 

Residues of Bacillus thuringiensis 

Cry1Da2 protein in or on the food and 

feed commodities of corn, including 

corn, field; corn, sweet; and corn, pop, 

are exempt from the requirement of a 

tolerance when used as a plantincorporated protectant in corn. 

[FR Doc. 2024–29132 Filed 12–12–24; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 174 

[EPA–HQ–OPP–2022–0990; FRL–12381–01– 

OCSPP] 

Streptomyces Sviceus DGT–28 EPSPS 

(5-Enolpyruvylshikimate-3-Phosphate 

Synthase) Protein; Exemption From 

the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the 

Streptomyces sviceus DGT–28 EPSPS (5- 

enolpyruvylshikimate-3-phosphate 

synthase) protein (hereafter DGT–28 

EPSPS protein), in or on the food and 

feed commodities of corn: corn, field; 

corn, sweet; and corn, pop, when used 

as a plant-incorporated protectant (PIP) 

inert ingredient. Pioneer Hi-Bred 

International, Inc., (Pioneer) submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of DGT–28 EPSPS protein. 

DATES: This regulation is effective 

December 13, 2024. Objections and 

requests for hearings must be received 

on or before February 11, 2025, 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–2022–0990, 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 for 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: 

Madison Le, Biopesticides and Pollution 

Prevention Division (7511P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW, Washington, DC 20460–0001; 

main telephone number: (202) 564– 

5754; email address: BPPDFRNotices@

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 40 CFR part 174 

through the Office of the Federal 

Register’s e-CFR site at https://

www.ecfr.gov/current/title-40. 

C. How can I file an objection or hearing 

request? 

Under 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–2022–0990, 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 

February 11, 2025. 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– 

2022–0990, 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. Background and Statutory Findings 

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 an FFDCA petition (IN 11746) by 


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100750 Federal Register / Vol. 89, No. 240 / Friday, December 13, 2024 / Rules and Regulations 

Pioneer Hi-Bred International, Inc., 7100 

NW 62nd Avenue, P.O. Box 1000, 

Johnston, Iowa 50131. The petition 

requested that 40 CFR part 174 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of DGT–28 EPSPS protein 

derived from Streptomyces sviceus 

when used as an inert ingredient in a 

plant-incorporated protectant in or on 

maize. That document referenced a 

summary of the petition prepared by the 

petitioner Pioneer Hi-Bred International, 

Inc., which is available in the docket, 

https://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

III. Final Rule 

A. EPA’s Safety Determination 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(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. Pursuant to 

FFDCA section 408(c)(2)(B), in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in FFDCA section 

408(b)(2)(C), which require 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. . . . ’’ Additionally, 

FFDCA section 408(b)(2)(D) requires 

that the Agency consider ‘‘available 

information concerning the cumulative 

effects of a particular pesticide’s 

residues’’ and ‘‘other substances that 

have a common mechanism of toxicity.’’ 

EPA evaluated the available toxicity 

and exposure data on DGT–28 EPSPS 

protein and considered its validity, 

completeness, and reliability, as well as 

the relationship of this information 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. A 

summary of the data upon which EPA 

relied and its risk assessment based on 

those data can be found within the 

document entitled ‘‘Product 

Characterization Review and Human 

Health Risk Assessment of the 

Insecticidal Plant-Incorporated 

Protectant Active Ingredient, Bacillus 

thuringiensis Cry1Da2 and PlantIncorporated Inert Ingredient DGT–28 

EPSPS, and the Genetic Material 

Necessary (PHP88492) for their 

Production in Event DAS–1131–3 

Maize, and Establishment of a 

Permanent Tolerance Exemption for 

Residues of these Proteins when used as 

a Plant-incorporated protectant in 

corn.’’ (hereafter Human Health Risk 

Assessment). This document, as well as 

other relevant information, is available 

in the docket for this action EPA–HQ– 

OPP–2022–0990. 

The gene for the inert plantincorporated protectant protein DGT–28 

EPSPS was derived from the soil 

bacterium Streptomyces sviceus and is 

intended to confer tolerance to 

glyphosate herbicides. The Agency used 

a ‘‘weight of evidence’’ approach and 

determined that DGT–28 EPSPS protein 

is not expected to pose any risk of 

toxicity to humans and the likelihood of 

the protein to be a food allergen is 

minimal. Submitted data show that the 

DGT–28 EPSPS protein is not toxic via 

the oral route of exposure and 

bioinformatics analysis did not indicate 

any homology to known toxins. 

Likewise, the potential for allergenicity 

is low because: (1) A literature search 

for the bacterium source of DGT–28 

EPSPS protein, Streptomyces sviceus, 

did not yield any results that would 

indicate that S. sviceus is a known 

source of mammalian toxic or allergenic 

proteins; (2) DGT–28 EPSPS has been 

demonstrated to catalyze the same 

reaction as other EPSPS enzymes 

covered under current tolerance 

exemptions and have not been found to 

be associated with adverse health 

effects; (3) bioinformatic analysis 

indicates no biologically relevant 

similarity between DGT–28 EPSPS 

protein and known allergens; (4) DGT– 

28 EPSPS protein degrades rapidly 

when exposed to simulated gastric fluid 

and is completely digested in simulated 

intestinal fluid; DGT–28 EPSPS is heat 

labile at temperatures exceeding 50 °C, 

indicating that it will likely denature in 

the course of normal thermal treatment 

during food preparation; and (5) DGT– 

28 EPSPS protein is not glycosylated, 

which further reduces its allergenicity 

potential. Glycosylation is an enzymatic 

post-translational process in which 

carbohydrates (glycans) link to proteins, 

creating structures which could lead to 

an immune response in humans. 

The most likely exposure to the DGT– 

28 EPSPS protein is dietary through 

consumption of food products made 

from corn containing the protein. Oral 

exposure from ingestion of drinking 

water is unlikely because the DGT–28 

EPSPS protein is present at very low 

levels within the plant cells, and the 

amounts likely to enter the water 

column from leaves, pollen or plant 

detritus are low. Additionally, proteases 

and nucleases found in water and the 

environment would likely degrade the 

biological material containing the active 

ingredients and treatment process for 

municipal water plants are likely to 

remove DGT–28 EPSPS residues. While 

dietary exposure is expected to be 

limited, even if there is dietary exposure 

to residues of DGT–28 EPSPS protein, 

such exposure presents no concern for 

adverse effects due to the lack of 

toxicity or allergenicity. 

Non-dietary, non-occupational or 

residential exposure via pulmonary or 

ocular exposure is not likely since DGT– 

28 EPSPS protein is contained within 

plant cells, and corn pollen is not 

respirable. Exposure via the skin is 

somewhat more likely via the contact 

with corn products which might have 

been processed in a way that disrupts 

cellular structure. However, naturally 

occurring proteases are likely to degrade 

proteins in contact with the skin and, as 

described above, the DGT–28 EPSPS 

protein has little or no potential toxicity 

to mammals and minimal potential for 

allergenicity. Thus, adverse effects are 

not expected due to non-occupational 

and residential exposure to DGT 28– 

EPSPS protein. These findings are 

discussed in more detail in the Human 

Health Risk Assessment. 

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.’’ No risk of 

cumulative toxicity or effects from 

DGT–28 EPSPS protein has been 

identified as no toxicity or allergenicity 

has been shown for this protein in the 

submitted studies. Therefore, EPA has 

concluded that DGT–28 EPSPS protein 

does not have a common mechanism of 

toxicity with other substances. 

Although FFDCA section 408(b)(2)(C) 

provides for an additional tenfold 

margin of safety for infants and children 

in the case of threshold effects, EPA has 

determined that there are no such 

effects due to the lack of toxicity of 


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Federal Register / Vol. 89, No. 240 / Friday, December 13, 2024 / Rules and Regulations 100751 

DGT–28 EPSPS protein. As a result, an 

additional margin of safety for the 

protection of infants and children is 

unnecessary. 

Based upon its evaluation described 

above and in the Human Health Risk 

Assessment, EPA concludes that there is 

a reasonable certainty that no harm will 

result to the U.S. population, including 

infants and children, from aggregate 

exposure to residues of the DGT–28 

EPSPS protein. Therefore, an exemption 

from the requirement of a tolerance is 

established for residues of DGT–28 

EPSPS protein in or on the food and 

feed commodities of corn: corn, field; 

corn, sweet; and corn, pop when used 

as a plant-incorporated protectant inert 

ingredient in corn. 

B. Analytical Enforcement Methodology 

Validated enzyme linked 

immunosorbent assays (ELISAs) are 

available analytical methods for 

detection of DGT–28 EPSPS protein. 

These ELISAs have been demonstrated 

to reliably detect the levels of protein in 

the tissues of corn. 

C. Conclusion 

Therefore, an exemption from the 

requirement of a tolerance is established 

for residues of the Streptomyces sviceus 

DGT–28 EPSPS (5- 

enolpyruvylshikimate-3-phosphate 

synthase) protein in or on the food and 

feed commodities of corn: corn, field; 

corn, sweet; and corn, pop when used 

as an inert ingredient in a plantincorporated protectant (PIP) in corn. 

IV. Statutory and Executive Order 

Reviews 

This action establishes a tolerance 

exemption 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 tolerance exemption 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). 

V. 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 174 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: December 5, 2024. 

Edward Messina, 

Director, Office of Pesticide Programs. 

Therefore, for the reasons stated in the 

preamble, EPA is amending 40 CFR 

chapter I as follows: 

PART 174—PROCEDURES AND 

REQUIREMENTS FOR PLANT– 

INCORPORATED PROTECTANTS 

■ 1. The authority citation for part 174 

continues to read as follows: 

Authority: 7 U.S.C. 136–136y; 21 U.S.C. 

321(q), 346a and 371. 

■ 2. Add § 174.550 to subpart W to read 

as follows: 

§ 174.550 Streptomyces sviceus DGT–28 

EPSPS (5-enolpyruvylshikimate-3- 

phosphate synthase) protein; exemption 

from the requirement of a tolerance. 

Residues of Streptomyces sviceus 

DGT–28 EPSPS (5- 

enolpyruvylshikimate-3-phosphate 

synthase) protein in or on the food and 

feed commodities of corn; corn, field; 

corn, sweet; and corn, pop are exempt 

from the requirement of a tolerance 

when used as an inert ingredient in a 

plant-incorporated protectant in corn. 

[FR Doc. 2024–29362 Filed 12–12–24; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–OLEM–2024–0068; FRL–11724– 

02–OLEM] 

National Priorities List 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Comprehensive 

Environmental Response, 

Compensation, and Liability Act of 1980 

(‘‘CERCLA’’ or ‘‘the Act’’), as amended, 

requires that the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (‘‘NCP’’) include a list 

of national priorities among the known 

releases or threatened releases of 

hazardous substances, pollutants or 

contaminants throughout the United 

States. The National Priorities List 

(‘‘NPL’’) constitutes this list. The NPL is 

intended primarily to guide the 

Environmental Protection Agency (‘‘the 

EPA’’ or ‘‘the agency’’) in determining 

which sites warrant further 

investigation. These further 

investigations will allow the EPA to 

assess the nature and extent of public 

health and environmental risks 


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