101938 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 

in table 1: zinc, 3-methyl-4- 

chlorophenol. 

(iv) Freshwater and saltwater aquatic 

life criteria. Freshwater and saltwater 

aquatic life criteria apply as specified in 

paragraph (c)(3) of this section. 

* * * * * 

(c) * * * 

(3) * * * 

(ii) For waters in which the salinity is 

equal to or greater than 10 parts per 

thousand 95% or more of the time, the 

applicable criteria are the saltwater 

criteria in column C, except for 

selenium in waters of the San Francisco 

Bay upstream to and including Suisun 

Bay and the Sacramento-San Joaquin 

Delta where the applicable criteria are 

the freshwater criteria in column B of 

the National Toxic Rule (‘‘NTR’’) at 

§ 131.36. 

(iii) For waters in which the salinity 

is between 1 and 10 parts per thousand 

as defined in paragraphs (c)(3)(i) and (ii) 

of this section, the applicable criteria 

are the more stringent of the freshwater 

or saltwater criteria, except for selenium 

in waters of the San Francisco Bay 

upstream to and including Suisun Bay 

and the Sacramento-San Joaquin Delta 

where the applicable criteria are the 

freshwater criteria in column B of the 

NTR. However, the Regional 

Administrator may approve the use of 

the alternative freshwater or saltwater 

criteria if scientifically defensible 

information and data demonstrate that 

on a site-specific basis the biology of the 

water body is dominated by freshwater 

aquatic life and that freshwater criteria 

are more appropriate; or conversely, the 

biology of the water body is dominated 

by saltwater aquatic life and that 

saltwater criteria are more appropriate. 

Before approving any change, the EPA 

will publish for public comment a 

document proposing the change. 

* * * * * 

[FR Doc. 2024–29483 Filed 12–16–24; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 174 

[EPA–HQ–OPP–2022–0231; FRL–12399–01– 

OCSPP] 

Brevibacillus Laterosporus 

Mpp75Aa1.1 and Bacillus 

Thuringiensis Vpb4Da2 Proteins; 

Exemptions From the Requirement of 

a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

exemptions from the requirement of a 

tolerance for residues of the 

Brevibacillus laterosporus Mpp75Aa1.1 

and Bacillus thuringiensis Vpb4Da2 

proteins (hereafter Mpp75Aa1.1 and 

Vpb4Da2 proteins) in or on the food and 

feed commodities of corn: corn, field; 

corn, sweet, and corn, pop when used 

as plant-incorporated protectants (PIP) 

in corn. Bayer CropScience LP., 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting these exemptions. 

These regulations eliminate the need to 

establish maximum permissible levels 

for residues of Mpp75Aa1.1 and 

Vpb4Da2 proteins. 

DATES: This regulation is effective 

December 17, 2024. Objections and 

requests for hearings must be received 

on or before February 18, 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–2022–0231, is 

available at https://

www.regulations.gov. 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 (7511M), 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/chapter-I/ 

subchapter-E/part-174. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a(g), 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–2022–0231, 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 18, 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– 

2022–0231, 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. 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 101939 

II. Background and Statutory Findings 

In the Federal Register of December 

19, 2023 (88 FR 87733) (FRL–10579–11– 

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 tolerance petition (PP 

3F9076) by Bayer CropScience LP, 800 

N. Lindbergh Blvd., St. Louis, Missouri 

63167. The petition requested that 40 

CFR part 174 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of the plant-incorporated protectants 

(PIPs) Brevibacillus laterosporus 

Mpp75Aa1.1 and Bacillus thuringienisis 

Vpb4Da2 in or on corn. That document 

referenced a summary of the petition 

prepared by the petitioner Bayer Crop 

Science LP, which is available in the 

docket at https://www.regulations.gov. 

There was one comment 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 it 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 Mpp75Aa1.1 and 

Vpb4Da2 proteins and considered their 

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 

‘‘Review of the Application for an 

Experimental Use Permit to Test MON 

95275 Corn (OECD Unique Identifier 

MON–95275–7) Expressing Transgenic 

Plant-Incorporated Protectants 

Mpp75Aa1.1, Vpb4Da2, and Double 

Stranded RNA DvSnf7.1 and the Genetic 

Material Necessary for their Production 

(Vector PV–ZMIR525664)’’ (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– 

0231. 

Mpp75Aa1.1 is a modified protein 

derived from the bacterium 

Brevibacillus laterosporus and is active 

against certain coleopteran pests of 

corn. Available data demonstrated that, 

with regard to humans, the Mpp75Aa1.1 

protein does not pose a toxic or 

allergenic risk. An acute oral toxicity 

study using purified Mpp75Aa1.1 

protein shows that the protein is not 

toxic to mammals via the oral route of 

exposure at levels well above those that 

are reasonably anticipated through 

normal dietary consumption of the crop. 

In addition, a bioinformatics analysis of 

the primary protein sequence did not 

identify any significant homologies of 

the Mpp75Aa1.1 protein to known 

mammalian toxins. Likewise, the 

potential for allergenicity is low 

because: (1) the bacterial source of the 

Mpp75Aa1.1 protein, Brevibacillus 

laterosporus, is ubiquitous in the 

environment, which implies widespread 

human and animal exposure, and a 

scientific literature search of the 

bacterium did not indicate any 

allergenic history; (2) bioinformatic 

analyses indicate no biologically 

relevant similarity between the 

Mpp75Aa1.1 protein and any known 

allergens; (3) the Mpp75Aa1.1 protein 

degrades rapidly when exposed to 

digestive enzymes (gastric proteases) 

present in the human gastrointestinal 

tract; (4) the Mpp75Aa1.1 protein shows 

loss of function under high 

temperatures (≥75 °C), indicating that it 

is heat labile and will likely denature in 

the course of normal thermal treatment 

during food preparation; and (5) the 

Mpp75Aa1.1 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 route of exposure to 

this plant-incorporated protectant is 

dietary, via products produced from 

corn expressing the Mpp75Aa1.1 

protein. Oral exposure from ingestion of 

drinking water is unlikely because the 

Mpp75Aa1.1 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. Further, if Mpp75Aa1.1 

protein were to enter the water column, 

it is expected to break down rapidly 

through natural processes (e.g., 

microbial or UV degradation) or normal 

communal water-treatment procedures. 

Even if there may be dietary exposure to 

residues of the Mpp75Aa1.1 protein, 

such exposure presents no concern for 

adverse effects based on the available 

toxicity and allergenicity analysis 

mentioned above. 

Non-dietary non-occupational 

exposure via dermal or ocular routes is 

not likely since the Mpp75Aa1.1 protein 

is contained within plant cells. The 

most likely non-dietary route of 

exposure to the Mpp75Aa1.1 protein 

may be through inhalation of corn 

pollen. However, exposure to the 

Mpp75Aa1.1 protein through this route 

of exposure is expected to be negligible 

for several reasons: (1) its presence in 

pollen was demonstrated to be very low 

(below the limit of quantification), and 

(2) corn pollen is not respirable, as it 

consists of spherical particles ranging in 

size from 80 to 125 mm, in contrast with 

respirable particles that are less than 10 

mm. Even if inhalation of dust-like 

particles were to occur, the Mpp75Aa1.1 

protein is contained within plant cells, 

which essentially eliminates pulmonary 

exposure to the proteins. Further, as 

described above, such exposure would 

not be expected to present any risk due 

to the lack of toxicity or allergenicity 

observed for the Mpp75Aa1.1 protein. 

These findings are discussed in more 

detail in the Human Health Risk 

Assessment. 

Vpb4Da2 is derived from the 

bacterium Bacillus thuringiensis (Bt) 

and is active against certain coleopteran 

pests of corn. Available data 

demonstrated that, with regard to 

humans, the Vpb4Da2 protein does not 

pose a toxic or allergenic risk. An acute 

oral toxicity study using purified 

Vpb4Da2 protein shows that the protein 

is not toxic to mammals via the oral 

route of exposure at levels well above 

those that are reasonably anticipated 

through normal dietary consumption of 

the crop. In addition, a bioinformatics 

analysis of the primary protein sequence 


ddrumheller on DSK120RN23PROD with RULES1
101940 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 

did not identify any significant 

homologies of the Vpb4Da2 protein to 

known mammalian toxins. Likewise, the 

potential for allergenicity is low 

because: (1) the bacterial source of the 

Vpb4Da2 protein, Bacillus thuringiensis, 

has a long history of safe use, including 

use as a pesticide, and is not considered 

to be a source of allergenic proteins; (2) 

bioinformatic analyses indicate no 

biologically relevant similarity between 

the Vpb4Da2 protein and any known 

allergens; (3) the Vpb4Da2 protein 

degrades rapidly when exposed to 

digestive enzymes (gastric proteases) 

present in the human gastrointestinal 

tract; (4) the Vpb4Da2 protein shows 

loss of function under high 

temperatures (≥55 °C), indicating that it 

is heat labile and will likely denature in 

the course of normal thermal treatment 

during food preparation; and (5) the 

Vpb4Da2 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 route of exposure to 

this plant-incorporated protectant is 

dietary, via products produced from 

corn expressing the protein. Oral 

exposure from ingestion of drinking 

water is unlikely because the Vpb4Da2 

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. 

Further, if protein were to enter the 

water column, it is expected to break 

down rapidly through natural processes 

(e.g., microbial or UV degradation) or 

normal communal water-treatment 

procedures. Even if there may be dietary 

exposure to residues of the Vpb4Da2 

protein, such exposure presents no 

concern for adverse effects based on the 

toxicity and allergenicity discussion 

above. 

Non-dietary non-occupational 

exposure via dermal or ocular routes is 

not likely since the Vpb4Da2 protein is 

contained within plant cells. The most 

likely non-dietary route of exposure to 

the Vpb4Da2 protein may be through 

inhalation of corn pollen. However, 

exposure to the Vpb4Da2 protein 

through this route of exposure is 

expected to be negligible for several 

reasons: (1) its presence in pollen was 

demonstrated to be very low (below the 

limit of quantification), and (2) corn 

pollen is not respirable, as it consists of 

spherical particles ranging in size from 

80 to 125 mm, in contrast with respirable 

particles that are less than 10 mm. Even 

if inhalation of dust-like particles were 

to occur, the Vpb4Da2 protein is 

contained within plant cells, which 

essentially eliminates pulmonary 

exposure to the proteins. Further, as 

described above, such exposure would 

not be expected to present any risk due 

to the lack of toxicity or allergenicity 

observed for the Vpb4Da2 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 the 

Mpp75Aa1.1 protein has been identified 

as no toxicity or allergenicity has been 

shown for this protein in the submitted 

studies. Therefore, EPA has concluded 

that the Mpp75Aa1.1 protein does not 

have a common mechanism of toxicity 

with other substances. Similarly, no risk 

of cumulative toxicity or effects from 

the Vpb4Da2 protein has been identified 

as no toxicity or allergenicity has been 

shown for this protein in the submitted 

studies. Therefore, EPA has concluded 

that the Vpb4Da2 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 the 

Mpp75Aa1.1 protein. As a result, an 

additional margin of safety for the 

protection of infants and children is 

unnecessary. Similarly, EPA has 

determined that there are no such 

effects due to the lack of toxicity of the 

Vpb4Da2 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 Mpp75Aa1.1 

protein derived from the bacterium 

Brevibacillus laterosporus. Therefore, an 

exemption from the requirement of a 

tolerance is established for residues of 

the Mpp75Aa1.1 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 in corn. 

Similarly, 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 Vpb4Da2 protein derived 

from the bacterium Bacillus 

thuringiensis (Bt). Therefore, an 

exemption from the requirement of a 

tolerance is established for residues of 

the Vpb4Da2 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 

in corn. 

B. Analytical Enforcement Methodology 

EPA has determined that validated 

Enzyme-Linked Immunosorbent Assays 

(ELISA) are available for the detection of 

Mpp75Aa1.1 and Vpb4Da2 proteins. 

These assays have been demonstrated to 

reliably detect the levels of the 

Mpp75Aa1.1 and Vpb4Da2 proteins in 

the tissues of corn. 

C. Response to Comment 

One comment was received during 

the public comment period for the 

notice of filing. The commentor 

provided general objections to EPA 

establishing exemptions from tolerances 

for pesticides but did not provide any 

specific or substantive objections to the 

petition to exempt the Mpp75Aa1.1 and 

Vpb4Da2 proteins when used as plantincorporated protectants. Based on its 

review of the data and other information 

submitted in support of the tolerance 

exemption petition (as described above 

in Unit III.A), EPA has determined that 

a tolerance exemption for Mpp75Aa1.1 

and Vpb4Da2 proteins, when used as 

plant-incorporated protectants, is safe 

under the FFDCA. Therefore, EPA is 

establishing an exemption from the 

requirement of a tolerance for residues 

of Mpp75Aa1.1 and Vpb4Da2 proteins 

in or on the food and feed commodities 

of corn. 

IV. Statutory and Executive Order 

Reviews 

This action establishes exemptions 

from the requirement of a tolerance 

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 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Rules and Regulations 101941 

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 exemptions from the requirement of 

a tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or Tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or Tribal governments, on the 

relationship between the National 

Government and the States or Tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999), and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000), do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

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 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 §§ 174.551 and 174.552 to 

subpart W to read as follows: 

Subpart W—Tolerances and Tolerance 

Exemptions 

* * * * * 

§ 174.551 Brevibacillus laterosporus 

Mpp75Aa1.1 protein; exemption from the 

requirement of a tolerance. 

Residues of Brevibacillus laterosporus 

Mpp75Aa1.1 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 a plantincorporated protectant in corn. 

§ 174.552 Bacillus thuringiensis Vpb4Da2 

protein; exemption from the requirement of 

a tolerance. 

Residues of Bacillus thuringiensis 

Vpb4Da2 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 a plant-incorporated 

protectant in corn. 

[FR Doc. 2024–29133 Filed 12–16–24; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 73 

[Docket No. CDC–2020–0024] 

RIN 0920–AA71 

Possession, Use, and Transfer of 

Select Agents and Toxins; Biennial 

Review of the List of Select Agents and 

Toxins 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Final rule. 

SUMMARY: This rule finalizes updates to 

the HHS list of select agents and toxins 

that could pose a severe threat to public 

health and safety. These updates were 

proposed along with other changes to 

the select agent and toxin regulations, 

which will be addressed in a separate 

regulatory action. In a companion 

document published in this issue of the 

Federal Register, the U.S. Department of 

Agriculture (USDA) is making parallel 

regulatory changes. 

DATES: This final rule is effective 

January 16, 2025. 

FOR FURTHER INFORMATION CONTACT: 

Daniel A. Singer, MD, Acting Director, 

Division of Regulatory Science and 

Compliance, Centers for Disease Control 

and Prevention, 1600 Clifton Road NE, 

Mailstop H21–4, Atlanta, Georgia 30329. 

Telephone: (404) 553–8266. 

SUPPLEMENTARY INFORMATION: The final 

rule is organized as follows: 

I. Background 

A. Legal Authority 

B. 2024 Proposed Rule 

II. Responses to Comments and Provisions of 

the Proposed Rule 

A. Removal of Brucella abortus, Brucella 

melitensis, and Brucella suis 

B. Nomenclature and Other Changes in the 

Select Agent and Toxin List 

C. Additional Comments Received 

D. Retaining Tier 1 Designation of 

Botulinum Neurotoxin Producing 

Species of Clostridium 

E. No Addition of Hantaviruses 

F. Toxin Review: Changes to Exclusion 

Limits for Short, Paralytic Alpha 

Conotoxins 

G. Designation of Nipah Virus as a Tier 1 

Select Agent 

H. Addition of a Footnote to the HHS 

Select Agent and Overlap Select Agent 

List 

I. Summary of Final Rule Provisions 

III. Alternatives Considered 

IV. Required Regulatory Analyses 

A. Executive Orders 12866, 13563, and 

14094 

B. The Regulatory Flexibility Act (RFA), as 

Amended by the Small Business 

Regulatory Enforcement Fairness Act 

(SBREFA) 


ddrumheller on DSK120RN23PROD with RULES1