This section of the FEDERAL REGISTER

contains documents other than rules or

proposed rules that are applicable to the

public. Notices of hearings and investigations,

committee meetings, agency decisions and

rulings, delegations of authority, filing of

petitions and applications and agency

statements of organization and functions are

examples of documents appearing in this

section.

Notices Federal Register

89569 

Vol. 89, No. 219 

Wednesday, November 13, 2024 

DEPARTMENT OF AGRICULTURE 

Submission for OMB Review; 

Comment Request 

The Department of Agriculture has 

submitted the following information 

collection requirement(s) to OMB for 

review and clearance under the 

Paperwork Reduction Act of 1995, 

Public Law 104–13. Comments are 

requested regarding: whether the 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; the accuracy of the 

agency’s estimate of burden including 

the validity of the methodology and 

assumptions used; ways to enhance the 

quality, utility and clarity of the 

information to be collected; and ways to 

minimize the burden of the collection of 

information on those who are to 

respond, including through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Comments regarding this information 

collection received by December 13, 

2024 will be considered. Written 

comments and recommendations for the 

proposed information collection should 

be submitted within 30 days of the 

publication of this notice on the 

following website www.reginfo.gov/ 

public/do/PRAMain. Find this 

particular information collection by 

selecting ‘‘Currently under 30-day 

Review—Open for Public Comments’’ or 

by using the search function. 

An agency may not conduct or 

sponsor a collection of information 

unless the collection of information 

displays a currently valid OMB control 

number and the agency informs 

potential persons who are to respond to 

the collection of information that such 

persons are not required to respond to 

the collection of information unless it 

displays a currently valid OMB control 

number. 

Economic Research Service 

Title: Corn and Soybean Grower 

Survey. 

OMB Control Number: 0536–NEW. 

Summary of Collection: 0536–NEW. 

The proposed data collection will use a 

survey of corn and soybean farmers in 

the Midwestern U.S. to study farmers’ 

preferences for participating in 

programs that support cover cropping 

and gather new information about 

current cover cropping practices. The 

survey will use questions on contract 

enrollment to examine how contract 

flexibility, ease of applying, payments, 

and other aspects of cover crop 

contracts affect farmers’ willingness to 

enroll their corn and soybean fields in 

cover crop programs. Results will be 

compared between farmers with no 

history of cover cropping in Federal 

programs and those who have cover 

cropped in Federal Programs. 

Need and Use of the Information: 

USDA agencies are interested in 

supporting the long-run adoption of 

climate smart conservation practices 

such as cover crops. There are multiple 

Federal, state, and private programs that 

support planting cover crops. This study 

will provide information about current 

use of cover crops as well as what 

influences participation on programs for 

cover crops. Data will be used for 

research purposes and only reported in 

the aggregate. The information provided 

by this study will benefit farmers, nongovernmental organizations, and 

industry stakeholders as well as 

policymakers and program managers at 

the local, State, Tribal, and National 

levels. 

Description of Respondents: 

Individuals. 

Number of Respondents: 2,500. 

Frequency of Responses: One time. 

Total Burden Hours: 2,411 hours. 

Levi S. Harrell, 

Departmental Information Collection 

Clearance Officer. 

[FR Doc. 2024–26252 Filed 11–12–24; 8:45 am] 

BILLING CODE 3410–18–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2023–0022] 

Movement of Organisms Modified or 

Produced Through Genetic 

Engineering; Notice of Additional 

Modifications Exempt Plants Can 

Contain 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are adding modifications 

a plant may contain and qualify for 

exemption from regulations governing 

movement of organisms modified or 

produced using genetic engineering 

because the modifications are 

achievable through conventional 

breeding. An earlier notice proposed 

five types of modifications. Based on a 

review of public comments, we have 

been able to streamline and simplify our 

description of these modifications and 

are now finalizing two additional 

modifications a plant can contain and 

qualify for exemption. This action 

updates and clarifies the types of 

modifications that can be made to plants 

that qualify for exemption to reflect 

advances in science and technology, 

and what is achievable through 

conventional breeding methods to 

facilitate the application of 

biotechnology for the development of 

new crops. 

DATES: The APHIS website will be 

updated with these additional 

modifications on November 13, 2024. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Neil Hoffman, Science Advisor, 

Biotechnology Regulatory Services, 

APHIS, 4700 River Road, Unit 78, 

Riverdale, MD 20737–1238; 

Neil.E.Hoffman@usda.gov; (301) 851– 

3877. 

SUPPLEMENTARY INFORMATION: The 

regulations in 7 CFR part 340 govern the 

movement (importation, interstate 

movement, or release into the 

environment) of certain organisms 

modified or produced through genetic 

engineering. The U.S. Department of 


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1To view the final rule and supporting 

documents, go to https://www.regulations.gov/ 

docket/APHIS-2018-0034. 

Agriculture’s (USDA’s) Animal and 

Plant Health Inspection Service (APHIS) 

first issued these regulations in 1987 

under the authority of the Federal Plant 

Pest Act of 1957 and the Plant 

Quarantine Act of 1912, two acts that 

were subsumed into the Plant Protection 

Act (PPA, 7 U.S.C. 7701 et seq.) in 2000, 

along with other provisions. Since 1987, 

APHIS has amended the regulations 

seven times, in 1988, 1990, 1993, 1994, 

1997, 2005, and 2020. 

On May 18, 2020, we published in the 

Federal Register (85 FR 29790–29838, 

Docket No. APHIS–2018–0034) a final 

rule 1 that marked the first 

comprehensive revision of the 

regulations since they were established 

in 1987. The final rule provided a clear, 

predictable, and efficient regulatory 

pathway for innovators, facilitating the 

development of organisms modified or 

produced using genetic engineering 

(modified organisms) that are unlikely 

to pose plant pest risks. 

The May 2020 final rule described the 

scope or applicability of regulations and 

stated that the regulations do not apply 

to plants with modifications that are 

achievable through conventional 

breeding (85 FR 29790–29796). To 

ensure the regulations do not apply to 

plants that are equivalent to those that 

could be developed through 

conventional breeding, the May 2020 

final rule established a regulatory 

exemption to initially identify and 

continuously update modifications that 

are achievable through conventional 

breeding and, thus, exempt from 

regulation (85 FR 29791–29796; 

§ 340.1(b)). 

Initially, APHIS identified three 

commonly known modifications 

achievable through conventional 

breeding methods, including small 

insertions/deletions at a single locus of 

a plant’s genome (85 FR 29792; 

§ 340.1(b)(1) through (3)). Specifically, 

§ 340.1(b) exempted plants that contain 

a single modification of one of the 

following types, specified in 

§ 340.1(b)(1) through (3): 

• The genetic modification is a 

change resulting from cellular repair of 

a targeted DNA break in the absence of 

an externally provided repair template; 

or 

• The genetic modification is a 

targeted single base pair substitution; or 

• The genetic modification introduces 

a gene known to occur in the plant’s 

gene pool or makes changes in a 

targeted sequence to correspond to a 

known allele of such a gene or to a 

known structural variation present in 

the gene pool. 

Knowing that it is impracticable to 

identify and list the universe of 

modifications that are achievable 

through conventional breeding at any 

given time because of advances in 

knowledge, technology and 

conventional breeding methods, the 

May 2020 final rule also established a 

process for listing additional 

modifications that plants can contain 

while still being exempted from the 

regulations (85 FR 29793–29795; 

§ 340.1(b)(4)). Thus, § 340.1(b)(4) 

provides that the Administrator may 

propose to exempt plants with 

additional modifications, based on what 

could be achieved through conventional 

breeding. Such proposals may either be 

APHIS-initiated or may be initiated via 

a request that is accompanied by 

adequate supporting information and 

submitted by another party. In either 

case, APHIS will publish a notice in the 

Federal Register of the proposal, along 

with the supporting documentation, and 

will request public comments. After 

reviewing the comments, APHIS will 

publish a subsequent notice in the 

Federal Register announcing its final 

determination. A list specifying 

modifications a plant can contain and 

be exempt pursuant to § 340.1(b)(4) is 

available on the APHIS website at 

https://www.aphis.usda/gov/biotechexemptions. 

On November 15, 2023, we published 

a notice in the Federal Register (88 FR 

78285–78291, Docket No. APHIS–2023– 

0022) proposing the five modifications 

that plants could contain and be eligible 

for exemption: 

First, we proposed that a diploid or 

autopolyploid plant with any 

combination of complete loss of 

function modifications in one to all 

alleles of a single genetic locus, or an 

allopolyploid plant with any 

combination of complete loss of 

function modifications in one or both 

alleles of a single genetic locus on up to 

four pairs of homoeologous 

chromosomes, without the insertion of 

exogenous DNA, would qualify for 

exemption (proposed 340.1(b)(4)(vi) 

(Additional Modification 1 (AM1)). 

APHIS explained that this category was 

intended to apply to scenarios involving 

targeted DNA breaks—through 

insertions, deletions, and other types of 

modifications (such as a nick)—created 

using different techniques that might 

not be expressly outlined in the initial 

modifications APHIS described in the 

May 2020 final rule (namely, paragraphs 

(b)(1) and (2) of § 340.1), but 

functionally would achieve the same 

end result—loss of function. In addition, 

it proposed to extend loss of function 

mutations without the insertion of 

exogenous DNA to polyploid plants. 

Second, we proposed that any diploid 

or autopolyploid plant in which the 

genetic modification is a single 

contiguous deletion of any size, 

resulting from cellular repair of one or 

two targeted DNA breaks on a single 

chromosome or at the same location(s) 

on two or more homologous 

chromosomes, without insertion of 

DNA, or with insertion of DNA in the 

absence of a repair template, would 

qualify for exemption (proposed 

340.1(b)(4)(vi)(AM2)). As proposed, 

allopolyploid plants with additional 

modifications to homoeologous loci of 

homoeologous chromosomes would not 

have qualified for exemption. 

Third, we proposed to allow the 

modifications described at § 340.1(b)(2) 

and (3) to be made to all alleles of a 

genetic locus on the homologous 

chromosomes of autopolyploids 

(proposed 340.1(b)(4)(vi)(AM3)). As 

proposed, allopolyploid plants with 

additional modifications to 

homoeologous loci of homoeologous 

chromosomes would not have qualified 

for exemption. 

Fourth, we proposed that plants with 

up to four modifications, made 

simultaneously or sequentially, of types 

that already qualify such plants for 

exemption when made individually, 

and provided each modification is at a 

different genetic locus, would be 

exempt from regulation because such 

modifications are achievable through 

conventional breeding methods 

(proposed 340.1(b)(4)(vi)(AM4)). It 

proposed that allopolyploid plants 

could contain up to four of the proposed 

complete loss of function modifications 

described or four modifications 

described under § 340.1(b)(2) and (3) or 

a combination thereof, provided each 

modification is introduced into just one 

allele; however, allopolyploid plants 

would not be exempt if they contain a 

modification that is allowable only in 

diploid and autopolyploid plants. 

Fifth, we proposed that plants that 

have previously completed voluntary 

reviews confirming the plants’ exempt 

status as described in § 340.1(e), which 

provides the process by which 

developers can request such a 

confirmation of exempt status, and that 

have been produced, grown, and 

observed consistent with conventional 

breeding methods appropriate for the 

plant species, could be successively 

modified in accordance with any of the 

modifications listed under paragraph 

340.1(b) of the regulations (proposed 

340.1(b)(4)(vi)(AM5)). 


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We initially took comments on the 

notice through December 15, 2023. In a 

notice published in the Federal Register 

on December 27, 2023 (88 FR 89362, 

Docket No. APHIS–2023–0022), we 

reopened the comment period, and 

extended it until January 19, 2024. 

We received 6,477 comments by the 

end of the reopened comment period. 

The comments were diverse and from 

interest groups, industry 

representatives, industry trade 

organizations, private individuals, 

scientists, plant breeders, and crop 

specialists. 

Based on a review of public 

comments, we have made several 

revisions to the five proposed 

modifications, simplifying and 

consolidating them into two 

modification categories, AM1 and AM2. 

To achieve this, APHIS consolidated the 

first and second proposed modifications 

to create the AM1 described in this final 

notice. The intent of the first and second 

proposed modifications was to provide 

developers with greater flexibility in 

how they could generate targeted breaks 

in a plant’s DNA like those that occur 

through conventional breeding methods. 

AM1, as finalized, carries through this 

intent by building on the existing 

modification described at § 340.1(b)(1), 

which currently allows a single targeted 

break in DNA and self-repair (i.e., a nontemplated insertion, deletion, or a 

combination of insertion and deletion 

(indel) to rejoin the DNA). AM1 now 

allows more than one cut to make the 

targeted break and the use of external 

templates in some circumstances. The 

finalized AM1 also carries through the 

original intent of the proposal by 

allowing developers to use a deletion of 

any size resulting from a targeted break, 

thereby recovering the functionality 

APHIS originally included in the 2019 

proposed rule (84 FR 26514–26541, 

Docket No. APHIS–2018–0034) but did 

not expressly articulate in the May 2020 

final rule, and which APHIS proposed 

as additional modifications in the 

November 2023 notice (88 FR 78286, 88 

FR 78288, Docket No. APHIS–2023– 

0022). Collectively, as described in this 

final notice, AM1 allows plants with 

modifications involving an insertion or 

deletion (indel), or contiguous deletion 

of any size, made at a targeted location, 

with or without insertion of DNA if 

generated without using a repair 

template, or without insertion of DNA if 

generated using a repair template, to 

qualify for exemption. 

Similarly, APHIS consolidated the 

third and fourth proposed modifications 

to create the AM2 described in this final 

notice. The intent of the third and 

fourth proposed modifications was to 

make modifications that are already 

listed in the regulations (§ 340.1(b)(2) 

and (3)) available for use in polyploid 

plants and to increase the number of 

modifications that can be made 

simultaneously or sequentially to 

plants. AM2 carries through this intent 

by exempting plants with up to 12 

modifications, made simultaneously or 

sequentially, if each modification occurs 

in a different gene and is of a type listed 

under § 340.1(b). By increasing the 

number of modifications that can be 

made to a plant, AM2 also effectively 

allows all modifications listed in 

§ 340.1(b) to be made in all polyploids. 

Finally, the fifth proposed 

modification would have required 

developers to complete a confirmation 

process to verify a plant’s exempt status 

before making sequential modifications 

and outlined conditions to ensure that 

simultaneous or sequential 

modifications were made in plants that 

had been produced, grown, and 

observed, consistent with conventional 

breeding practices. APHIS has not 

finalized a modification associated with 

this proposal. Instead, to stay true to the 

voluntary nature of APHIS’ 

confirmation request process and ensure 

that plants are developed consistent 

with conventional breeding practices, 

APHIS will only accept voluntary 

requests to confirm a plant’s exempt 

status for plants that have been 

produced. This means APHIS will no 

longer accept confirmation requests 

involving plants with hypothetical 

modifications because, if produced, the 

plants may not be viable, may not have 

the intended phenotype, or have a 

different genotype than originally 

requested. 

We wish to highlight additional 

distinctions between AM1 and AM2 

described in this final notice, and the 

modifications we initially proposed. 

First, we are no longer restricting AM1 

to loss of function modifications if the 

gain of function (GOF) modification 

results from natural DNA repair in the 

absence of a repair template. We 

received comments and supporting 

literature during the comment period 

that such GOF modifications can be 

accomplished through conventional 

breeding techniques. Second, we are no 

longer making distinctions between 

allopolyploids and autopolyploids 

when describing the modifications. We 

received comments during the comment 

period indicating the distinction 

between allopolyploids and 

autopolyploids was not necessary, with 

documentation demonstrating that 

similar modifications can be made in 

the two ploidy types by conventional 

breeding. Eliminating this distinction 

was a key factor that enabled us to 

consolidate the modifications from five 

to two and simplify our description of 

the modifications overall. Third, we are 

increasing the number of simultaneous 

or sequential modifications from 4 (as 

proposed) to 12 (as described in this 

final notice). In the proposal we 

published in November 2023, we noted 

that we welcomed comments from the 

public on the number of individual 

modifications that are achievable 

simultaneously or sequentially in plants 

based on conventional breeding 

methods, and comments on the reasons 

for or against allowing for simultaneous 

or sequential modifications in all plants. 

We received comments during the 

comment period requesting an increase 

in the number of simultaneous or 

sequential modifications covered by the 

exemption and documentation that 

more than four modifications are 

possible by conventional breeding. In 

our discussion below, we further 

describe these comments and the 

literature references we received that 

show 12 simultaneous or sequential 

modifications are achievable through 

conventional breeding. Fourth, we are 

no longer considering hypothetical 

plants for confirmation requests based 

on comments we received on AM5 

suggesting the exclusion of hypothetical 

plants from the scope of exemption 

would simplify the exemption. We are 

also clarifying that any plant not subject 

to part 340 (because it is not modified, 

meets the criteria for a regulatory 

exemption, or has completed the 

regulatory status review process) may be 

modified in accordance with the 

exemption. 

Below, we first discuss the specific 

comments that resulted in the changes 

to the modifications we proposed in the 

November 2023 notice. We then discuss 

the other comments received on the 

notice. 

Comment: Many commenters felt that 

we should not make a distinction 

between Loss of Function (LOF) and 

GOF mutations in AM1. They noted that 

the distinction greatly increases the 

complexity of the modification 

descriptions. 

Response: Proposed AM1 described 

LOF modifications in all alleles of a 

single genetic locus in diploids and 

autopolyploids and on up to four pairs 

of homoeologous chromosomes in 

allopolyploids. Our proposal limited the 

modification to LOF mutations because 

GOF modifications are statistically less 

common than LOF mutations, and we 

thought the same GOF mutation would 

not be expected to occur across multiple 

alleles in allopolyploids by 

conventional breeding. Based on 


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comments we received demonstrating 

proof of concept that GOF mutations 

can occur across all subgenomes in 

allopolyploids (e.g., (Ostlie, et al., 

2015)), we are revising AM1 to allow 

GOF modifications that result from the 

generation of insertions and deletions 

(indels) that occur through DNA break 

and repair. 

Because we are dispensing with 

distinctions between LOF and GOF and 

allopolyploids and autopolyploids, we 

no longer consider it useful to have a 

separate modification that allows for a 

deletion of any size (proposed AM2). 

Instead, we have introduced this 

functionality into the final AM1. Indels 

are typically modifications that are 

under 50 base pairs (bp) whereas 

deletions of any size are a type of 

structural variant (Mahmoud, et al., 

2019). 

As noted previously, we are revising 

AM1 to: ‘‘An indel or contiguous 

deletion of any size, made at a targeted 

location, with or without insertion of 

DNA if generated without using a repair 

template, or without insertion of DNA if 

generated using a repair template.’’ 

We wish to emphasize that AM1 is 

not prescriptive in how indel 

modifications or contiguous deletions 

are made. It is based on the outcome 

rather than any specific techniques 

used. We also wish to resolve confusion 

around our use of the phrase ‘‘without 

the insertion of exogenous DNA.’’ Our 

intent is to ensure exempt plants are 

free of foreign DNA in the final product, 

but not to prohibit foreign DNA used to 

make the final product. For example, 

CRISPR-Cas9, a foreign DNA, could be 

used to make a modification and plants 

with the modification and lacking 

CRISPR-Cas9 would still qualify for the 

exemption. To be clear, to qualify for 

AM1, the final plant must not retain 

foreign DNA. Lastly, although we 

initially defined GOF and LOF based on 

gene activity, commenters noted they 

were confused, because LOF of a gene 

can result in a GOF in phenotype and 

vice versa. Also, by our proposed 

definition, promoter deletions that led 

to either increases or decreases in the 

expression of a downstream gene could 

be GOF or LOF, respectively. AM1, as 

described in this final notice, no longer 

makes a distinction between LOF and 

GOF, thereby resolving this confusion 

and incongruence and mooting these 

comments. 

Comment: The language of the 

proposed modifications is complex and 

can be simplified by not making a 

distinction between autopolyploids and 

allopolyploids and loss of function and 

gain of function modifications. 

Response: After reading information 

provided in the comments describing 

the types of modifications that can be 

made in allopolyploids, APHIS agrees 

that our descriptions of modifications 

that plants can contain and qualify for 

exemption can be simplified to 

eliminate the distinction between 

autopolyploid and allopolyploids and 

allow gain of function indels. More 

detail is provided in responses below. 

Comment: Many commenters felt the 

modifications should not make a 

distinction between autopolyploids and 

allopolyploids and noted that regulatory 

authorities in no other countries make 

this distinction. 

Response: Although APHIS initially 

made a distinction between 

allopolyploids (such as wheat) and 

autopolyploids (such as potato) in the 

proposed modifications, based on our 

review of the comments and cited 

literature, we agree that such distinction 

is not necessary. 

For example, we originally proposed 

that AM4 would have allowed multiple 

modifications involving single base pair 

substitutions and insertions described 

in § 340.1(b)(2) and (3), for 

autopolyploids as homozygous 

modifications and for allopolyploids 

only as heterozygous modifications. In 

the comments, we learned of two 

reasons to change our view on this 

distinction. First, in some 

allopolyploids, such as wheat, that are 

largely self-pollinating, homozygous 

modifications routinely accumulate, and 

heterozygous alleles are less common 

(Rutkoski, et al., 2022). Second, doubled 

haploids are commonly used in 

breeding to generate homozygous alleles 

in a single generation in over 250 

species (Maluszynski, et al., 2003). 

Commenters provided 4 examples of 4- 

to-8 homozygous mutations pyramided 

in wheat and rapeseed (Tyagi, et al., 

2014; Zhang, et al., 2019; Zheng, et al., 

2020; Luo, et al., 2021; Wang, et al., 

2023b). Given this new information, we 

have removed the distinction between 

allopolyploids and autopolyploids in 

AM2 as described in this final notice. 

Similarly, as originally proposed, 

AM1, would have limited the number of 

knockouts of a single genetic locus in 

allopolyploids to four pairs of 

homoeologous chromosomes, consistent 

with the limit of four modifications in 

proposed AM4, but counting 

modifications differently in 

autopolyploids and allopolyploids. As 

described in more detail below in our 

discussion of final AM2, which allows 

multiple modifications, we will now 

count modifications in the same way in 

autopolyploids and allopolyploids. 

Along these lines, as originally 

proposed, AM3 would have allowed 

single nucleotide substitutions (also 

known as base pair substitutions) to all 

alleles of a single genetic locus in 

autopolyploids, but not allopolyploids. 

In response to this proposal, 

commenters provided references to 

published scientific data to demonstrate 

the use of conventional breeding to 

produce an identical homozygous single 

nucleotide substitution across all three 

subgenomes of wheat (Ostlie, et al., 

2015). This modification, a cytosine to 

thymine (C/T) transition that converted 

valine at amino acid 2004 to an alanine, 

created resistance to ACCase type 

inhibitors (Ostlie, et al., 2015) and the 

researchers enhanced their chances of 

finding the desired modification by 

using selection with ACCase inhibitors. 

To evaluate whether the single 

nucleotide substitution across all three 

subgenomes could be found without 

selection, we examined the EMS 

generated mutant collection (Krasileva, 

et al., 2017) that is publicly available 

through the EnsemblPlants database 

(https://plants.ensembl.org/index.html). 

The technology created by (Krasileva, et 

al., 2017) makes it possible to identify 

mutations across multiple genomes. 

Plants with the desired mutations can 

then be crossed to generate plants with 

the identified mutations across three 

genomes. Using this source, we 

identified 11 cases where wheat lines 

had C/T mutations that resulted in 

identical mutations in ACCase in all 3 

subgenomes (D53N; G55D; V212M; 

A321T; G543D; G655E; S708N; G1377D; 

A1848T; G1984E; E2203K) and 2 cases 

where wheat lines had G/A mutations 

that resulted in the identical ACCase 

mutation in all three subgenomes 

(P647S and L1003F). This finding 

demonstrated to us that the Krasileva 

mutagenesis library could be used to 

identify plants with the identical single 

nucleotide substitution across all three 

subgenomes even in the absence of 

selection. This is a proof of concept that 

single nucleotide substitutions across 

subgenomes can be isolated using 

ordered mutant libraries prepared from 

allopolyploids. 

Mutagenized lines tend to create 

specific types of DNA modifications. 

For example, ethyl methanesulfonate 

(EMS) mutagenesis preferentially 

converts the base guanine (G) to adenine 

(A) and the base cytosine (C) to thymine 

(T) (Leitao, 2012). A similar mutagen, 

methyl methanesulfonate (MMS) 

preferentially converts A to T, T to A, 

A to G, and T to C (Leitao, 2012). 

Radiation mutagenesis by gamma 

radiation or fast neutron bombardment 


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preferentially results in deletions 

(Wyant, et al., 2022). Historically, 

breeders have created collections of 

lines based on naturally occurring 

variation to be used for their breeding 

pool. Naturally occurring mutations 

have been shown to occur at comparable 

frequencies for all 12 combinations of 

nucleotide substitutions (Weng, et al., 

2018). A recent trend is to characterize 

the collection by whole genome 

sequencing (genotyping by sequencing) 

to facilitate identification of specific 

mutations. Sequenced collections of 

diversity panels are available in 

Arabidopsis (The 1001 Genomes 

Consortium, 2016), maize (Bukowski, et 

al., 2018), rice (Zhao, et al., 2021), 

soybean (Torkamaneh, et al., 2021), 

cotton (He, et al., 2021), canola 

(Hurgobin, et al., 2018), tobacco 

(Thimmegowda, et al., 2018), strawberry 

(Qiao, et al., 2021), alfalfa (Shen, et al., 

2020), sorghum (Jensen, et al., 2020), 

and wheat (Brinton, et al., 2020), to 

name a few. In some cases, second 

releases are available with more 

sequenced lines covering greater 

variation than the original. We can 

expect these community resources to 

include more species and details over 

time. Genotyping by sequencing is 

generally applicable to any species. 

Given the new information about the 

availability, for breeding purposes, of 

naturally occurring and mutagenized 

collections genotyped through 

sequencing, APHIS concludes that it is 

possible to identify and introduce single 

nucleotide substitutions and deletions 

across the subgenomes of allopolyploids 

by conventional breeding. 

As originally proposed, AM3 would 

have also allowed a modification that 

introduces a gene known to occur in the 

plant’s gene pool or makes changes in 

a targeted sequence to correspond to a 

known allele of such a gene or to a 

known structural variation present in 

the gene pool for autopolyploids, but 

not for allopolyploids. In the comments, 

we were made aware of an example 

where homozygous copies of a cellulose 

synthase-like F6 gene were introduced 

into all three subgenomes of wheat 

(Danilova, et al., 2019). This new 

information demonstrates that 

sequences from the gene pool can be 

introduced into all subgenomes of 

allopolyploids by conventional 

breeding. 

Based on the comments and 

information we collectively received 

related to the proposed modification 

described as AM3, and as discussed in 

the above paragraphs, we are removing 

the proposed limitation to 

autopolyploids. The modifications 

described in § 340.1(b)(2) and (3) apply 

to a single modification. As a result, 

they were effectively limited to a single 

pair of homologous chromosomes in 

polyploids species. As discussed more 

fully below, based on the comments and 

literature in this final notice, we will 

allow up to 12 such modifications in 

plants (now AM2). This means 

modifications can now be made across 

subgenomes of polyploids and the 

plants can qualify for exemption from 

regulation, further removing 

distinctions involving ploidy plants. 

As originally proposed, AM2 would 

have allowed a modification consisting 

of a single contiguous deletion of any 

size in diploids and autopolyploids. 

Given the proof of concept for using an 

ordered mutant collection to identify 

single nucleotide substitutions across 

subgenomes of allopolyploids, we 

considered whether a similar approach 

could be used to identify similar 

deletions across subgenomes such that 

allopolyploids would also qualify for 

proposed AM2. (Krasileva, et al., 2017) 

identified just 1268 deletions in their 

mutant collection, which is not 

surprising based on observations that 

EMS primarily creates point mutations 

(Gilchrist and Haughn, 2010). Fast 

neutron or gamma radiation 

mutagenesis, however, predominantly 

creates deletions (Gilchrist and Haughn, 

2010; Kumawat, et al., 2019) and mutant 

population resources using these 

techniques have been reported (Anai, 

2012; Du, et al., 2021). It is likely that 

ordered mutant collections prepared by 

fast neutron bombardment or gamma 

radiation mutagenesis can be used to 

isolate similar, but not identical, 

deletions across subgenomes. Given 

this, and for simplicity, the 

functionality described in the 

modification proposed AM2, is now 

included in the modification described 

as AM1 in this final notice. 

Comment: Many commenters felt that 

proposed AM4 was overly limiting 

because breeders routinely combine 

many more favorable genes, alleles, or 

quantitative trait loci (QTL) than four 

during a breeding project. One 

commenter suggested there should be 

no upper limit following the lead of 

other countries such as Canada. Another 

noted that a complex trait such as 

flowering time may require the 

combination of 50 to 100 QTLs. 

Response: In the May 2020 final rule, 

when USDA first adopted the 

exemption for plants with modifications 

achievable through conventional 

breeding, APHIS explained: 

‘‘There are many biological and 

practical factors that affect a plant 

breeder’s ability to develop a new crop 

variety by introducing genetic variation 

and intentionally selecting for desired 

traits. These include the number of 

targeted loci and type of desired genetic 

changes, the genetic distance between 

the desired changes, generation time, 

breeding system (sexual or asexual), 

ploidy type and level and genomic 

complexity, resource availability (time, 

money, labor, and genomic resources), 

extent of domestication, and other 

factors. These factors, and thus the 

extent of intentionally selected genetic 

variation that can be introduced, vary 

widely among plant species. Moreover, 

new plant breeding techniques can 

make possible more complex 

combinations of genetic modifications 

than can practically be achieved 

through conventional breeding methods. 

Initially, the exemptions will apply 

only to plants containing a single 

targeted modification in one of the 

categories listed. APHIS anticipates 

scientific information and/or experience 

may, over time, allow APHIS to list 

additional modifications that plants can 

contain and still be exempted from the 

regulations so that the regulatory system 

stays up to date and keeps pace with 

advances in scientific knowledge, 

evidence, and experience. This may 

include multiple simultaneous genomic 

changes.’’ (U.S. Department of 

Agriculture Animal and Plant Health 

Inspection Service, 2020c). 

Since APHIS initially adopted its 

exemption 4 years ago, there has been 

steady introgression of desired genes, 

alleles, and QTLs in several crops 

through modern conventional breeding 

methods. Genomic assisted breeding, 

genetic mapping and studies, high 

through-put genotyping, speed breeding, 

multi-parent advance generation intercrosses, and pyramid breeding 

strategies, to name a few, have advanced 

quickly and are now affordable for many 

crop types. New methods, like 

OutcrossSeq (Chen, et al., 2021), are 

consistently emerging to improve and 

accelerate breeding methods for difficult 

to breed crops, like those for which no 

inbred lines are available for genetic 

study and breeding because they are 

self-incompatible, clonally propagated, 

or have a long generation time, making 

the identification or integration of 

agronomically important genes difficult, 

particularly in crops with a complex 

autopolyploid genome or with 

predominant asexual reproduction. 

We also considered the progress made 

in breeding potato, a clonally 

propagated crop. Clonally propagated 

crops are thought to be difficult to breed 

because, as a result of not requiring seed 

production, they accumulate genetic 

alterations that are detrimental to 

breeding and hence require 


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heterozygosity for vigorous growth 

(Brown, et al., 2017; Kardile, et al., 

2022). Recently much progress has been 

made in breeding inbred diploid potato 

lines by overcoming self-incompatibility 

(Kardile, et al., 2022) and purging 

deleterious alleles causing inbreeding 

depression in homozygous lines (Zhang, 

et al., 2021). These developments have 

led to the first potato elite inbred lines 

established through selfing that were 

crossed to successfully exploit heterosis 

in the F1 generation (Zhang, et al., 

2021). 

Similarly, in banana, another clonally 

propagated crop, low fertility and seed 

viability, abnormal meiosis, and 

inbreeding depression have been 

breeding challenges, but some progress 

has been made in overcoming fertility 

problems and seed viability by 

screening for fertile plants and using 

embryo rescue to improve seed 

germination ((Brown, et al., 2017; Batte, 

et al., 2019)). The insight gained in 

overcoming inbreeding depression in 

potato will likely be used in other clonal 

crops such as banana. We are witnessing 

conventional breeding advancements 

that were once used nearly exclusively 

to improve easy to breed crops, now 

being actively used in breeding 

programs for difficult to breed crops. 

Some crops that play key roles in 

nutrition security, sustainable 

agriculture, biodiversity, and cultural 

traditions, have been overlooked in 

agricultural crop development because 

they represent a small percentage of 

total tonnage and acreage of production 

or belong to resource poor nations. 

These crops may be difficult to breed 

because genetic tools have yet to be 

developed. However, this situation 

could change as advanced breeding 

tools become more affordable, due to the 

steep decline in sequencing costs, and 

therefore more widely deployed in all 

crops. 

Commenters provided APHIS with 

examples demonstrating that many 

more than four favorable alleles or QTL 

can be pyramided. In some cases, 

modifications are made to more than 

one gene to create the desired trait. In 

one example, (Ye, et al., 2008) noted 

that, in theory, with marker assisted 

selection coupled with gene pyramiding 

and double haploid practices, ‘‘a plant 

having as many as twenty target markers 

can be obtained at an almost perfect 

certainty in about three rounds of 

selection.’’ APHIS found several 

examples in rice where 10 to 11 

favorable alleles or QTLs were 

successfully pyramided (Das, et al., 

2018; Dixit, et al., 2020; Sandhu, et al., 

2021; Yadav, et al., 2021). In one of the 

cases, the group initially pyramided 15 

alleles and QTLs, with at least some in 

a heterozygous (non-fixed) condition 

but lost some in later generations that 

they might have retained had they 

chosen to use double haploid 

technology to fix the alleles and QTLs 

of interest. We found cases for 

pyramiding eight alleles or QTLs in 

tomato (Hanson, et al., 2016), eight and 

perhaps more in wheat (Tyagi, et al., 

2014; Rahman, et al., 2020), seven in 

canola (Wang, et al., 2023b), six in 

potato (Rogozina, et al., 2021), five in 

apple (Baumgartner, et al., 2015), five in 

tobacco (Lewis, et al., 2020), five in 

soybean (Diers, et al., 2023), five in 

grape (Ha ́dlı ́k, et al., 2024), four in 

coffee (de Almeida, et al., 2021; 

Saavedra, et al., 2023), and three in 

poplar (Lv, et al., 2021). In many cases, 

these pyramids were fixed in the 

homozygous state, while in other 

species that are typically vegetatively 

propagated, some were present in the 

heterozygous state. For the potato and 

grape examples, the papers describe 

cases where breeder collections were 

screened with markers for resistance 

genes and individuals in the collection, 

representing historical crosses, were 

found to have pyramids of resistance 

genes. The other examples represent 

cases where the pyramids were 

specifically bred de novo to combine 

target genes in the population. 

Given the breeding advances that 

have been made in many crops, the 

number of modifications that can be 

made in any crop is not static. Periodic 

updates to the modifications plants can 

contain and qualify for exemption, like 

this one, will remain necessary moving 

forward. In general, the greater the 

number of favorable alleles or QTLs to 

be pyramided in a crop, the greater the 

number of plants that need to be 

screened to obtain the desired plant. 

Various techniques, such as second 

filial (F2) enrichment, are used to 

reduce the numbers of plants required, 

but the numbers of plants required 

nonetheless rise exponentially with the 

number of alleles or QTLs to be 

pyramided (Bonnett, et al., 2005; Wang, 

et al., 2023a). The extent of pyramiding 

that is possible also depends on whether 

the alleles or QTLs are all present in 

elite lines, such that little or no 

backcrossing may be required to remove 

deleterious alleles, or whether the 

alleles and QTLs are being introgressed 

from multiple different non-elite lines 

and wild relatives, requiring extensive 

backcrossing. Taking these factors and 

the noted differences between species 

into consideration, in the final notice 

we are establishing the number of 

allowable modifications based on a 

number that is readily achievable in 

crops with advanced breeding systems 

and extending this number to all crops 

as we see evidence of breeding advances 

being widely deployed. As we described 

earlier, for rice at least 10 modifications 

have already been achieved multiple 

times (Das, et al., 2018; Dixit, et al., 

2020; Rahman, et al., 2020; Sandhu, et 

al., 2021; Yadav, et al., 2021). Given the 

rapid advances in plant breeding this 

number of modifications will quickly, if 

not already, become out of date. 

Therefore, in this final notice, AM2 will 

allow up to 12 modifications made 

simultaneously or sequentially. Setting 

the limit at 12 modifications also 

enables an even number of 

modifications in diploids, triploids, 

tetraploids, hexaploids, and octaploids. 

In terms of counting modifications, both 

a modification to a single allele and a 

pair of functionally equivalent 

modifications to a pair of alleles on 

homologous chromosomes will count as 

one modification. Thus, where all 

alleles of a given locus are modified, the 

maximum number of modified loci is 12 

in diploids, 6 in tetraploids, 4 in 

hexaploids, and 3 in octoploids. 

Triploids and pentaploid modifications 

will be counted as tetraploids and 

hexaploids, respectively. In polyploids, 

if only one allele is modified in the case 

of a dominant mutation, the loci 

modified can exceed 6, 4, and 3 in 

tetraploids, hexaploids, and octoploids, 

respectively. In terms of counting, there 

are at least three cases where multiple 

DNA breaks or edits can be made and 

‘‘counted’’ as a single modification: 

1. When two guide RNAs are used to 

cut out a single contiguous portion of a 

gene or to otherwise make a single 

deletion of any size. 

2. When multiple indels are created 

near the target site or at any other 

unintended sites with near homology to 

the target site with one indel being 

functional while the other indels have 

no additional effect. 

3. A gene in the gene pool is inserted 

into the genome or an existing gene is 

edited several times to correspond to a 

gene in the gene pool. 

As noted previously, in this final 

notice, the proposed AM4 is 

renumbered as AM2 and is revised as 

follows: ‘‘Plants with up to 12 

modifications, made simultaneously or 

sequentially, are exempt from regulation 

if each modification individually 

qualifies the plant for exemption and 

occurs in a different gene.’’ 

With respect to this final version of 

AM2, we wish to clarify that the phrase 

‘‘individually qualifies the plant for 

exemption’’ refers to the modifications 

described at § 340.1(b) that qualify 


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2May 29, 1992 (57 FR 22984–23005; Docket No. 

92N–0139). 

plants for exemption and does not 

include the exemptions described in 

§ 340.1(c). We also wish to note that 

when AM2 is used in combination with 

AM1, we are restricting the use of repair 

templates to create modifications across 

subgenomes. As noted above, we expect 

that ordered mutant libraries could be 

used to identify similar but not identical 

deletions across subgenomes in 

allopolyploid species. We have not yet 

identified any literature demonstrating 

that identical indel or deletion 

modifications can be achieved across 

subgenomes using conventional 

breeding methods. For this reason, we 

are restricting the application of AM2 in 

combination with AM1, when a repair 

template is used, to allow modification 

to one pair of homologous 

chromosomes. If new literature emerges 

demonstrating an identical indel or 

deletion modification can be achieved 

across subgenomes using conventional 

breeding methods, we will reconsider 

this restriction. 

Comment: Several commenters asked 

APHIS to clarify whether AM5 applies 

to plants that have been cleared through 

the regulatory status review or petition 

process. Another concern raised was 

that AM5 would change a voluntary 

consultation process into a mandatory 

process with the requirement that the 

exemption only applied to plants that 

are ‘‘produced, grown, and observed 

consistent with conventional breeding 

methods.’’ Another commenter 

suggested removing the requirement for 

a plant to be produced, grown, and 

observed consistent with conventional 

breeding methods because it is not clear 

what APHIS meant. Some commenters 

noted that APHIS could restrict 

hypothetical, successively modified 

plants from AM5 by stating in 

associated guidance that plants that are 

merely hypothetical in nature would not 

be eligible for subsequent hypothetical 

modifications because they have not yet 

been produced, grown, and observed 

consistent with conventional breeding 

methods for the appropriate plant 

species. 

Response: APHIS acknowledges that 

plants that are not subject to part 340, 

because they have undergone the 

petition process, the regulatory status 

review process, or meet the criteria for 

regulatory exemption, may be modified 

in accordance with the exemption. 

Therefore, it is no longer necessary to 

use proposed AM5 to describe this 

allowance. APHIS wishes to clarify that 

an exempt plant can only contain a 

single modification to a particular gene. 

For example, this means that once a 

modification has been made to a 

particular gene and that plant is not 

subject to part 340, plants with 

successive modifications to the same 

gene will not qualify for exemption 

because such modifications are not 

achievable through conventional 

breeding. 

APHIS agrees with the commenters 

who suggested that APHIS should no 

longer consider hypothetical 

modifications for confirmation requests. 

APHIS is concerned that allowing large 

numbers of hypothetical modifications 

will overburden APHIS with 

confirmation requests for plants that 

have little or no value because the 

plants may not be viable, may not have 

the intended phenotype, or have a 

different genotype than originally 

requested. 

Response to General Comments on the 

Proposed Modifications 

Comment: Pay special attention to the 

massive lawsuits resulting from the 

human health impacts of glyphosate, 

which would not have happened if 

glyphosate-resistant genetically 

modified organisms (GMOs) had not 

been released into the environment. 

Response: While it is true that 

glyphosate has been the subject of 

litigation, APHIS does not agree with 

the commenter that glyphosate use on 

glyphosate resistant (GR) crops has been 

the primary subject of the litigation. 

Glyphosate is widely used in the 

residential lawn and garden market 

business segment. When glyphosate is 

used in the lawn and garden markets, 

glyphosate is not sprayed on GR crops. 

According to Werner Baumann, CEO of 

Bayer AG, more than 90 percent of the 

Roundup litigation claims Bayer has 

faced in recent years have come from 

the U.S. residential lawn and garden 

market business segment that do not 

involve the application of glyphosate 

onto GR crops (Brooks, 2021). 

Comment: Absent case-specific 

government oversight, testing, and 

approval of individual GMO products, 

how would ‘‘voluntary’’ testing by 

manufacturers protect Americans from 

potentially negative health effects of 

consuming products engineered under 

such broad exemptions? 

Response: The modifications (AM1 

and AM2) described in this final notice 

pertain to products that otherwise could 

be produced by conventional breeding. 

Although conventional breeding is not 

risk free, the risks associated with it are 

manageable by accepted standards 

(National Research Council, 1989). The 

health effects of products that qualify 

for exemption are not expected to be 

different than the risks posed by 

conventionally bred crops and likewise 

manageable by accepted standards. 

Comment: What level of 

documentation and data transparency 

would be required of GMO producers 

who might exploit the proposed 

exemptions? 

Response: The developers of crops 

that qualify for exemption have no 

requirements to submit documentation 

to APHIS. If they wish confirmation 

from APHIS that their particular crop 

meets the criteria for exemption, the 

developer can request a confirmation 

request. Information needed for a 

confirmation request is detailed in a 

guide found on APHIS’ Biotechnology 

Regulatory Services website (https://

www.aphis.usda.gov/sites/default/files/ 

requesting-confirmation-ofexemption.pdf). Again, however, we 

wish to reiterate that this final notice 

describes modifications pertaining to 

products that could otherwise have been 

developed through conventional 

breeding. This limitation on the scope of 

the modifications that plants can 

contain and qualify for exemption 

precludes the sort of abuse envisioned 

by the commenters. 

Comment: Would third-party testing 

be required before releasing food 

products produced using the proposed 

modifications and exempt from 

regulation? 

Response: Oversight of all food 

products including those produced 

using plants that qualify for exemption 

is conducted by the U.S. Food and Drug 

Administration (FDA). FDA recently 

released guidance for industry on foods 

derived from plants produced using 

genome editing (U.S. Food and Drug 

Administration, 2024). FDA explained 

in the New Plant Variety (NPV) policy 

that the regulatory status of a food, 

irrespective of the method by which it 

is developed, is dependent upon 

objective characteristics of the food and 

the intended use of the food (or its 

components) (57 FR 22984 at 22984).2

Please see the FDA’s guidance for more 

information (U.S. Food and Drug 

Administration, 2024). 

Comment: One commenter suggested 

that USDA conduct public trials to 

establish the modifications are safe 

before finalizing the exemptions. 

Response: We disagree. The 

modifications described in this final 

notice only pertain to plants with 

modifications that could otherwise be 

achieved through conventional 

breeding. Conventionally bred crops 

have a history of safe use. Public field 

trials of crops with modifications 

eligible for exemption would not be 

expected to reveal otherwise because 


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the use of genetic engineering, in and of 

itself, does not present an increased 

plant pest risk (National Research 

Council, 1987; National Research 

Council, 1989; National Academies of 

Sciences Engineering and Medicine, 

2016). 

Comment: The proposed 

modifications sidestep National 

Environmental Protection Act (NEPA) 

review, transparency, and public 

participation. 

Response: We disagree with this 

comment. The exemption at § 340.1(b) 

excludes from the scope of regulation at 

part 340, modified plants that could 

have been created through conventional 

breeding to ensure that plants with 

similar characteristics are treated 

similarly from a regulatory perspective. 

APHIS assessed this exemption in the 

Programmatic Environmental Impact 

Statement (PEIS) prepared to support 

the 2020 revisions to part 340, which 

included a thorough, detailed, and 

transparent review, and invited public 

comment on, the description of why 

modified plants described at § 340.1(b) 

fall outside of APHIS’s authority under 

the regulations. APHIS explained that 

modified plants that qualify for 

exemption under § 340.1(b), are no 

different, as a class, and in terms of 

plant pest risk, from comparable plants 

that are made through conventional 

breeding, which, likewise, do not come 

before APHIS. In May 2020, when 

APHIS adopted the revised part 340, 

APHIS expressly stated in the final rule 

that it would continue to update the 

modifications that plants can contain 

and qualify for exemption to further 

clarify the types of modified plants that 

do not fall within the scope of 

regulation. As described in the PEIS, 

where, as here, modified plants are not 

within APHIS’s scope of regulation or 

jurisdictional authority, a NEPA 

analysis is not required. It is also worth 

noting that the modifications described 

in this final notice would have also 

fallen outside the scope of the legacy 

regulations previously codified at part 

340, because plants with such 

modifications would not have met the 

definition of a ‘‘regulated article.’’ 

§§ 340.0, 340.1 (2019). Many developers 

provide transparency by voluntarily 

submitting confirmation requests to 

APHIS. When APHIS confirms a 

modified plant meets the criteria for 

exemption from regulation, APHIS posts 

on its website the incoming submission 

and our response, redacted to protect 

Confidential Business Information, as 

appropriate. 

Comment: The modifications may 

increase the amount of genome edited 

crops in the food supply and lead to an 

increase in commingling of genome 

edited crops with crops that are not 

produced with genetic engineering or 

genome editing including organic crops. 

Crops created using genome editing may 

not be disclosed as bioengineered. For 

these two reasons, consumers wishing 

to purchase food made without this 

technology may have more limited 

consumer choice. 

Response: Again, it is worth noting 

that the modifications described in this 

final notice would have also fallen 

outside the scope of the legacy 

regulations previously codified at 7 CFR 

part 340, because plants with such 

modifications would not have meet 

definition of a ‘‘regulated article.’’ 

§§ 340.0, 340.1 (2019). With that said, 

genome edited crops that meet the 

criteria for exemption from part 340 are 

currently not permitted to be used in 

organic production (National Organic 

Standards Board, 2019). Inadvertent 

commingling of crops exempted from 

part 340 would not result in loss of 

organic certification to the organic 

producer, however. Although 

commingling is possible, if it were to 

occur, we expect it to occur at a low 

frequency. 

As we noted in the PEIS associated 

with the 2020 revisions to part 340, on 

average 1 to 3 percent of non-GE farmers 

have reported commodity rejection by 

suppliers due to the presence of GE crop 

material, and the number of organic 

farms reporting economic losses from 

the presence of GE material was 0.7 

percent in 2010 (U.S. Department of 

Agriculture Animal and Plant Health 

Inspection Service, 2020a). In the PEIS, 

we also noted that we expected 

innovation in the agricultural 

biotechnology to increase under revised 

part 340, and there could be seen a 

wider variety of modified crop plants in 

commercial production. If development 

and adoption by growers of new 

varieties of modified crop plants does 

occur, there may be an increase in the 

potential for incidents of unintended 

presence of modified crop material in 

non-modified crops or crop products. 

This would primarily be due to the 

possibility that there would be more 

modified crop varieties in production 

and therefore more non-modified crop 

types that could potentially have 

commingling issues with the 

corresponding GE crops. An increase in 

development and adoption of new 

varieties of modified crops would entail 

maintaining segregation of modified 

crop products from a wider variety of 

non-modified and identity-preserved 

cropping systems along supply chains. 

Though the likelihood of 

commingling could increase, there are 

incentives to keep it low. Identity 

preserved systems are in place to guard 

against commingled products entering 

the marketplace and non-modified 

producers have economic incentives to 

keep it low. Furthermore, most modified 

plants exempt from § 340.1(b) are not 

immediately commercialized as they 

may still be subject to regulation by 

FDA and U.S. Environmental Protection 

Agency (EPA), as appropriate. From our 

experience with the Am I Regulated 

Program (AIR) under the legacy 

regulations, there were roughly 80 cases 

of plants that completed the AIR 

process, but only three of the modified 

plants were or are being grown in the 

United States for commercial purposes 

(High Oleic Acid soybean, waxy corn, 

and a reduced pungency mustard 

green). Additionally, it has been our 

experience that many developers whose 

products meet the criteria for exemption 

nonetheless ask for confirmation letters 

because the letters help them market 

their products domestically and 

overseas. These letters are posted on the 

APHIS website and are available to the 

public. Organic and other growers of 

non-modified crops have this resource 

to become aware of new genome edited 

crops. Conversations between neighbors 

and other voluntary interactions are 

another way for an organic grower to 

learn whether their neighbors are 

growing GE crops, and if so, to take 

steps to minimize commingling. 

Comment: Some commenters 

expressed concern about off target and 

unintended effects. 

Response: APHIS considers some offtarget and unintended effects. For 

example, APHIS considers the 

unintended retention of exogenous DNA 

inserted as part of the modification 

process to be an unintended 

modification (e.g., DNA encoding 

genome modification machinery such as 

the Cas9 protein). APHIS also considers 

modifications to DNA sequences that 

are highly similar to the target sequence 

as unintended modifications (e.g., 

sequences found in multigene families 

that have the same or highly similar 

sequences as the intended target, 

pseudogenes, or other conserved 

sequences), as those sequences would 

likely be modified at frequencies 

exceeding low-similarity promiscuous 

binding. Except for § 340.1(b)(3) and 

AM2 involving § 340.1(b)(3) type 

modifications (i.e., modifications that 

allow for the insertion of a gene from a 

plant’s gene pool), the modified plant 

must be free of any DNA that was 

deliberately inserted as part of the 

modification process, including vector 

sequences, and requests to confirm a 

plant’s exempt status should include 


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scientific methodology describing the 

design or verification steps taken to 

anticipate, reduce, and monitor for offtarget modifications to highly similar 

sequences. For § 340.1(b)(3) and AM2 

involving § 340.1(b)(3) type 

modifications, only DNA from within 

the gene pool may be retained in the 

plant. 

APHIS does not consider 

modifications occurring at sites without 

similarity to the target region, as these 

are associated with spontaneous or 

other types of background mutation that 

occur naturally in plants and do not 

raise plant pest risk concerns in 

conventional breeding programs. APHIS 

does not believe it is necessary to 

regulate such modifications of genome 

editing in plants because (1) the 

mutation rate from genome editing at 

sites without similarity to the target 

region is low relative to the background 

mutation rate that occurs in 

conventional breeding, and (2) whatever 

changes do occur are likely to be 

segregated away from the target 

mutation during the breeding process. 

Comprehensive CRISPR/Cas off-target 

analysis on a genome-wide scale has 

been performed in rice, maize, tomato, 

and Arabidopsis (Feng, et al., 2014; 

Peterson, et al., 2016; Nekrasov, et al., 

2017; Feng, et al., 2018; Tang, et al., 

2018; Lee, et al., 2019). In these cases 

where the frequency of mutation at sites 

without similarity to the target region 

was measured in CRISPR/Cas 

expressing lines and their progeny, the 

authors concluded that the rate of 

mutation was below the level of 

background mutation induced during 

seed multiplication or tissue culture 

(Hahn and Nekrasov, 2019). Although 

there can be variation in mutation rates 

due to the nature of the technique used 

and the biological system to which it is 

applied, the mutation rates in such 

conventional breeding techniques as 

chemical and irradiation-based 

mutagenesis dwarf the rate associated 

with genome editing methods. 

Due to the nature of plant breeding— 

in which populations are created and 

evaluated, and individual plants are 

selected for the intended 

modifications—untargeted 

modifications (or untargeted mutations) 

are likely to be lost unless they are 

genetically linked to the targeted 

modification that is introduced. For 

these reasons, APHIS does not consider 

untargeted modifications (untargeted 

mutations) when determining eligibility 

for an exemption. This is also consistent 

with APHIS’ approach regarding 

conventional breeding techniques. 

APHIS believes that similar products 

should have similar regulatory 

requirements. Crops made by 

conventional breeding are not reviewed 

for spontaneous and/or background 

mutations. 

Comment: There should be no 

exemptions. There needs to be 

comprehensive safety testing and longterm environmental monitoring for all 

GE crops. 

Response: This comment is outside 

the scope of this notice, and, for reasons 

discussed in the final rule (U.S. 

Department of Agriculture Animal and 

Plant Health Inspection Service, 2020c), 

we disagree with the commenter. 

Comment: USDA does not and cannot 

demonstrate that GE plants thus 

exempted would not pose increased 

plant pest or noxious weed risks. Plants 

that are exempt are more disease 

susceptible, e.g. Nicotiana attenuata, 

low lignin plants. 

Response: Consistent with the 

provisions in § 340.1(b)(4), the 

modifications that APHIS has described 

are not based on plant pest risk per se 

but, instead, are based on whether the 

modified plant could have been 

achieved through conventional 

breeding. Plants produced through 

conventional breeding are not risk free; 

rather, their risks are at an acceptable 

level that has historically not merited 

regulation. Plants with additional 

modifications listed in this final notice 

are not expected to have any greater risk 

than those having a history of safe use. 

Comment: USDA has placed 

limitations on the modifications and 

these limitations are not based on plant 

pest risk. 

Response: As described in the 

regulations, the modifications described 

in this final notice are based on 

modifications that could be achieved 

through conventional breeding. For each 

modification, APHIS has identified 

literature and publicly available 

information indicating proof of concept 

that the additional modifications are 

achievable through conventional 

breeding. 

Comment: Modifications should be 

inclusive of the current state of 

scientific knowledge and not just the 

literature record because the literature 

does not capture the full range of 

modifications that are achievable 

through conventional breeding. 

Response: Consistent with the 

provision at § 340.1(b)(4), APHIS has 

developed the modifications based on 

available literature and public 

information (including the comments 

we received in response to the proposal) 

describing modifications achievable 

through conventional breeding. 

Comment: The modifications should 

broaden the origin boundaries for 

insertions to include any sequences in 

the kingdom Plantae versus sexual 

compatibility. 

Response: We acknowledge that 

examples of horizontal gene transfer 

have occurred in plants on an 

evolutionary time scale. Our review of 

the literature indicates these types of 

insertions do not routinely occur during 

the conventional plant breeding process. 

At this time, we will not broaden the 

modifications to allow insertions from 

any species within the kingdom Plantae. 

Comment: USDA should broadly 

exempt all gene edited products. 

Response: The exemption at § 340.1(b) 

is for DNA modifications that could be 

achieved through conventional plant 

breeding. Based on the available 

literature and public information, some 

types of gene editing can accomplish 

modifications beyond what can 

currently be achieved through 

conventional breeding. Although 

products with these types of edits are 

not currently exempt from regulation, 

most non-exempt plants have a pathway 

for commercialization through the 

regulatory status review process to 

evaluate the plant pest risk of those 

products. 

Comment: A commenter advised 

APHIS to conduct regular and frequent 

review of regulations to stay relevant in 

light of new scientific developments. 

Response: APHIS agrees and in fact 

does so. APHIS also reminds 

stakeholders that under § 340.1(b)(4), 

they can help APHIS ensure the 

regulations are current by informing 

APHIS of new scientific developments 

that demonstrate that additional 

modifications are possible through 

conventional breeding. 

Response To Specific Comments on the 

Proposed Modifications 

Comment: APHIS should also 

consider the de-regulation of cis 

genetically engineered crops, made by 

targeted insertion or CRISPR 

transposition systems (emerging tools to 

be utilized in crops). 

Response: Plants with targeted 

insertions qualify for the exemption 

listed at § 340.1(b)(3) if the inserted 

sequence is found within the plant’s 

gene pool. CRISPR transposition 

systems can be used to make cisgenic 

modifications to plants that qualify for 

exemption provided the CRISPR tools 

(or any foreign DNA) are segregated 

away from the final product. 

Comment: APHIS should provide 

guidance for when a plant contains a 

modification meets more than one of the 

criteria for exemption. 

Response: The commenter has 

presented an example where two cuts 


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4 Genetic Technology (Precision Breeding) Act 

2023 (legislation.gov.uk). 

are made to a single locus, a deletion 

that would qualify under AM1 and a 

targeted insertion that would qualify 

under § 340.1(b)(3). In cases where a 

plant has been edited in a manner that 

meets the description of more than one 

of the modifications listed under 

§ 340.1(b), developers can claim either 

type of modification as the basis for 

their confirmation request. 

With the new AM2, there will be 

cases where a plant may have 

modifications of multiple types listed 

under paragraph 340.1(b). For example, 

a developer might make an indel 

modification to one gene and a single 

nucleotide substitution to a second 

gene. In that case the developer should 

claim AM2 for the multiple 

modifications and specify the type of 

each modification made in the plant. 

APHIS will provide additional examples 

on its website for greater clarity. It will 

be fact specific based on the specific 

nature of the plant. We invite 

developers to consult with us to 

determine the appropriate path. 

Comment: Commenters raised the 

point that the notice did not address 

triploid crops such as watermelon, 

banana, and plantain and aneuploids 

such as peppermint and complex auto/ 

allopolyploids such as sweet potato. A 

commenter also pointed out that for 

many species the distinction between 

auto and allopolyploids is not always 

straightforward. For example, 

homologous recombination, one of the 

distinguishing characteristics of 

autopolyploid is thought to occur to 

varying degrees in allopolyploids. 

Response: As we are no longer making 

a distinction between autopolyploids 

and allopolyploids in the modifications 

described in this final notice, these 

points are now moot. 

Comment: A comment was made that 

the term ‘‘loci’’ is not precise when 

applied to allopolyploids because it 

implies a positional relationship 

remains intact in evolution and 

positional relationships between 

homoeologs could have changed during 

speciation prior to polyploidization. 

Response: We agree with the 

commenter. It can be difficult to tell 

whether a gene in one subgenome 

directly corresponds to a similar gene 

on another subgenome. Confusion can 

result because gene families may have 

arisen due to gene duplication prior to 

the hybridization event that resulted in 

the speciation, and after speciation 

genetic rearrangements may have 

altered positional information (Adams 

and Wendel, 2005; Soltis, et al., 2014). 

Furthermore, after speciation gene 

inactivation may have reduced the 

number of gene family members on one 

subgenome relative to another further 

confounding the evolutionary 

relationships between genes (Adams 

and Wendel, 2005; Soltis, et al., 2014). 

We wish to clarify that our meaning for 

genetic locus in allopolyploids pertains 

to a single pair of alleles in each 

subgenome at a fixed location and need 

not reflect positional relationships 

across other subgenomes. 

Comment: Commenters requested 

clarification as to when an external 

template may be used. 

Response: An external repair template 

may be used to generate a modification 

and the plant will qualify for an 

exemption when creating: 

1. An indel without insertion of DNA 

or a single contiguous deletion of any 

size provided the final product does not 

retain foreign DNA (AM1). When 

combined with AM2, application of 

AM1/AM2 is restricted in creating exact 

modifications across subgenomes. For 

indels or deletions that require exact 

modifications for the desired outcome, 

the exemption allows modification to 

one pair of homologous chromosomes. If 

an external template is used to make an 

indel or deletion that need not be 

specific, such as for gene inactivation, 

the restriction of AM1/AM2 to one pair 

of homologous chromosomes does not 

apply; 

2. A single base pair (nucleotide) 

substitution (§ 340.1(b)(2)); and 

3. Insertion based on sequences 

within the gene pool (§ 340.1(b)(3)). 

When an external repair template is 

used to make a targeted insertion 

representing a sequence outside the 

gene pool, the plant would not qualify 

for exemption. 

Comment: The proposed 

modifications are at odds with 

international regulations especially on 

the number of edits allowed and with 

respect to ploidy. The USDA should 

consider evaluations undertaken by 

expert agencies in other geographies 

such as Argentina, Brazil, Canada, and 

the European Union. 

Response: In response to these 

comments, APHIS has reviewed the 

frameworks for other international and 

domestic regulatory agencies that 

oversee products of biotechnology. 

Globally, regulatory frameworks for 

biotechnology leverage different 

authorities and definitions, and 

subsequently have different approaches 

to regulation. One approach uses the 

definition of a ‘‘living modified 

organism’’ from the Cartagena Protocol 

on Biosafety (Secretariat of the 

Convention on Biological Diversity, 

2000) to determine what biotechnology 

products fall under a regulatory scope. 

This approach is now used by many 

countries, including Argentina. 

Beginning in 2015, and continuing with 

updates through 2021, Argentina has 

maintained a regulatory framework 3 for 

new breeding technologies, including 

genome editing (Lema, 2020). In 

Argentina, all modified plants require 

evaluation to determine whether or not 

they are considered a GMO under 

Argentina law. Under the ‘‘Argentina 

Model,’’ products developed using 

genome editing are not considered 

genetically modified organisms unless 

they contain a ‘‘new combination of 

genetic material,’’ which it defines as 

‘‘change produced in the genome of the 

organism by the incorporation, in a 

stable and joint manner, of ONE (1) or 

more genes or nucleic acid sequences 

that are part of a defined genetic 

construction.’’ Regardless of the 

outcome of this analysis, Argentina may 

impose monitoring requirements on any 

plant product based on its 

characteristics and/or novelty. Countries 

that have adopted approaches that are 

similar to the Argentina Model, include 

Chile, Brazil, Paraguay, Uruguay, 

Colombia, Guatemala, Honduras, Japan, 

the Philippines, and Israel. 

Other countries have also recently 

considered how to regulate the products 

of genome editing within their existing 

regulatory frameworks. For example, in 

2023, the Canadian Food Inspection 

Agency updated their guidance to 

clarify that genome edited crops do not 

present novel risks and, like certain 

other crops grown in Canada, do not 

require review unless the crop has an 

herbicide resistance trait or has both a 

novel trait and a potential to have 

significant environmental impacts 

(Government of Canada, 2023b; 

Government of Canada, 2023a). The 

United Kingdom also finalized a 

‘‘Genetic Technology Act’’ 4 in 2023 to 

establish new regulatory and marketing 

standards for plants and animals that 

are ‘‘precision bred’’ and remove such 

products from regulation as genetically 

modified organisms. Under this law, a 

modified plant is ‘‘precision bred’’ if 

‘‘(a) any feature of its genome results 

from the application of modern 

biotechnology, (b) every feature of its 

genome that results from the application 

of modern biotechnology is stable, (c) 

every feature of its genome that results 

from the application of modern 

biotechnology could have resulted from 

traditional processes, whether or not in 

conjunction with selection techniques, 

alone, and (d) its genome does not 


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contain any feature that results from the 

application of any artificial modification 

technique other than modern 

biotechnology produced through 

precision breeding techniques, so long 

as they could have resulted from 

traditional processes.’’ (emphasis 

added). 

In February 2024, the European 

Parliament voted in favor of proposed 

legislation 5 that would consider plants 

produced through ‘‘New Genomic 

Techniques’’ (NGT) (like genome 

editing) as conventional equivalents if 

such plants could also occur naturally 

or be produced by conventional 

breeding. Under the proposal, an NGT 

plant ‘‘is considered equivalent to 

conventional plants when it differs from 

the recipient/parental plant by no more 

than 20 genetic modifications’’ of 

various types (European Commission, 

2023b). These include targeted 

modifications are similar to those 

APHIS has identified in § 340.1(b)(1) 

through (3) and in AM1 and AM2 (small 

insertions, deletions of any length, 

nucleotide substitutions, and insertions 

or substitutions of DNA present in the 

gene pool of the plant). The proposal, 

which has not yet reached consensus 

agreement among EU members, includes 

a mandatory verification that a plant 

meets the NGT criteria. Most recently, 

on July 11, 2024, the European Food 

Safety Authority (EFSA) published an 

opinion (European Food Safety 

Authority Panel on Genetically 

Modified Organisms, et al., 2024) on the 

definitions and scientific justification of 

the NGT proposal in response to an 

analysis by the French Agency for Food, 

Environmental and Occupational Health 

& Safety. EFSA concluded that ‘‘it is 

scientifically justified to consider 

[certain NGT plants identified in the 

proposal] as equivalent to 

conventionally bred plants.’’ As a next 

step, the Council of the European Union 

will begin negotiations with member 

states about the specifics of the 

legislation—that is to say, this law is not 

yet final. 

Changes in regulatory approaches 

involving products of genome editing 

are also being made in southeast Asia. 

Most recently, in July of 2024, Thailand 

revised its regulations to allow for the 

certification and subsequent release into 

the environment of ‘‘organisms 

developed from gene editing 

technology,’’ defined as ‘‘organisms that 

have been genetically improved in a 

manner similar to mutation or 

hybridization, where the final product 

contains genetic material from donor 

organisms that can naturally crossbreed 

with the recipient organisms.’’ In 

August 2024, the Singapore Food 

Agency (SFA) published its framework 

for genome edited crops (Singapore 

Food Agency, 2024). SFA will regulate 

crops that contain foreign DNA, which 

includes crops with DNA that could not 

have been inserted naturally or been 

introduced into the crop using 

conventional breeding techniques. In 

cases where the developer determines 

their crop contains foreign DNA, SFA 

requires the crop to undergo a premarket safety assessment. For crops 

with modifications made through 

genome editing that do not involve the 

retention of foreign DNA, developers are 

encouraged (but not required) to notify 

SFA in cases where they determine their 

crop does not contain foreign DNA. 

Within the United States, in May 

2023, the EPA issued a final rule 

exempting a class of plant-incorporated 

protectants (PIPs) created using genetic 

engineering from registration 

requirements under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA), and from the food or feed 

residue tolerance requirements under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA) (U.S. Environmental 

Protection Agency, 2023). The final rule 

exempts PIPs from FIFRA registration 

and FFDCA tolerance requirements in 

cases where they both pose no greater 

risk than PIPs that EPA has already 

concluded meet safety requirements, 

and when they could have otherwise 

been created through conventional 

breeding, as follows: PIPs in which 

genetic engineering has been used to 

insert or modify a gene to match a gene 

found in a sexually compatible plant; 

and, loss-of-function PIPs in which the 

genetically engineered modification 

reduces or eliminates the activity of a 

gene, which then helps make the plant 

resistant to pests. EPA’s PIP exemption 

does not limit the number of 

modifications developers can make 

using genetic engineering provided the 

resulting PIPs meet the criteria for 

exemption. More recently, on February 

22, 2024, FDA issued updated guidance 

related to the handling of NPV to affirm 

that ‘‘the regulatory status of foods 

derived from plant varieties produced 

using genome editing will, like that of 

food from other plant varieties, be based 

on the objective characteristics of the 

food and the intended use of the food 

(or its components)’’ (U.S. Food and 

Drug Administration, 2024). 

Although there are some differences 

in specific details, in general, we see 

countries around the world adopting a 

similar approach as we have for the 

movement of plants developed using 

new genome editing techniques: If a 

modified plant could have been 

developed using conventional breeding, 

the level of regulatory oversight will 

more closely align with a 

conventionally developed product. In 

2020, when APHIS first adopted the 

exemption for plants with modifications 

achievable through conventional 

breeding, APHIS explained: 

‘‘There are many biological and 

practical factors that affect a plant 

breeder’s ability to develop a new crop 

variety by introducing genetic variation 

and intentionally selecting for desired 

traits. These include the number of 

targeted loci and type of desired genetic 

changes, the genetic distance between 

the desired changes, generation time, 

breeding system (sexual or asexual), 

ploidy type and level and genomic 

complexity, resource availability (time, 

money, labor, and genomic resources), 

extent of domestication, and other 

factors. These factors, and thus the 

extent of intentionally selected genetic 

variation that can be introduced, vary 

widely among plant species. Moreover, 

new plant breeding techniques can 

make possible more complex 

combinations of genetic modifications 

than can practically be achieved 

through conventional breeding methods. 

Initially, the exemptions will apply 

only to plants containing a single 

targeted modification in one of the 

categories listed. APHIS anticipates 

scientific information and/or experience 

may, over time, allow APHIS to list 

additional modifications that plants can 

contain and still be exempted from the 

regulations so that the regulatory system 

stays up to date and keeps pace with 

advances in scientific knowledge, 

evidence, and experience. This may 

include multiple simultaneous genomic 

changes.’’ (U.S. Department of 

Agriculture Animal and Plant Health 

Inspection Service, 2020c). 

As discussed above, APHIS has 

received numerous comments and 

supporting literature and has conducted 

our own extensive literature review 

indicating that 12 modifications are 

within the scope of conventional 

breeding for diploids and polyploids. 

Based on this new information, we have 

eliminated most restrictions on the 

modification of allopolyploids, 

eliminated the restrictions with regard 

to GOF modifications, and increased to 

12 the number of modifications that can 

be made simultaneously or sequentially 

in plants that qualify for exemption. As 

such, the modifications described in 

this final notice bring APHIS’ treatment 

of plants with modifications that are 


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6National Family Farm Coalition, et al. v Vilsack, 

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achievable through conventional 

breeding into greater alignment with 

other countries that have adopted 

regulatory approaches that consider 

most genome edited plants as 

conventional equivalents, including 

those that allow multiple modifications 

and modifications in ploidy plants. 

Comment: A commenter noted that 

several modifications might be made to 

the same genetic locus if successive 

rounds of mutagenesis were used. Thus, 

it seems unnecessary to limit targeted 

base pair substitutions to one base pair 

in § 340.1(b)(2). 

Response: APHIS is not aware, and 

the commenter did not provide an 

example of this type of modification 

made by conventional breeding. Until 

we have more concrete proof of concept, 

APHIS will limit targeted modifications 

to a single modification per gene. This 

limitation applies to successive 

modifications made to a plant that 

qualifies for exemption under § 340.1(b). 

Comment: A commenter noted that a 

certain number of nucleotides can 

always be present in a plant’s genome 

simply by chance. In the European 

Union’s proposal for the regulation of 

NGT, insertions or substitutions of up to 

twenty nucleotides are considered to be 

exempted from the GMO regulations, 

irrespective if they result in GOF or 

LOF. A similar sentiment was expressed 

in the comment that sequences of 

smaller sizes from outside the breeder’s 

gene pool should be exempted. 

Response: As noted above, the 

European Union proposal is not yet 

final and remains under negotiation 

within the European Union. As part of 

considering this proposal, the European 

Commission has made available a 

document entitled, ‘‘Potential criteria to 

determine whether a plant obtained by 

targeted mutagenesis or cisgenesis could 

also occur naturally or be produced by 

conventional breeding techniques,’’ 

which includes a disclaimer indicating 

this ‘‘draft has not been adopted or 

endorsed by the European Commission 

(European Commission, 2023a). Any 

views expressed are the preliminary 

views of the Commission services and 

may not in any circumstances be 

regarded as stating an official position of 

the Commission.’’ Although we are not 

revising the modifications to 

incorporate this suggestion at this time, 

we will continue to follow 

developments in the European Union as 

they are finalized. With that said, we 

wish to note that within this final 

notice, in AM1, we allow insertions that 

occur in the absence of a repair 

template. This repair could result in a 

sequence not within the gene pool and 

there is no restriction on the size of the 

repair (insertion). 

Comment: One commenter asked for 

clarification as to whether, in proposed 

AM4 and AM5, heterozygosity refers to 

genomic rather than allelic. 

Response: In the proposed 

modifications, the heterozygosity 

referred to allelic. However, the 

modifications described in this final 

notice no longer make distinctions 

between allopolyploids and 

autopolyploids, so this point in now 

moot. 

Comment: One commenter noted that 

the observation mandate in AM5 

unfairly penalizes crops with 

excessively long breeding cycles such as 

trees or berries, and research groups 

with limited access to field trials such 

as small universities. 

Response: Moving forward, we will 

only consider confirmation requests for 

actual plants with up to 12 

modifications. Our standard for the 

exemption is based on a conventional 

breeding standard and crops with long 

breeding cycles are also at a similar 

disadvantage compared to short cycle 

crops under conventional breeding. The 

regulatory status review process 

provides another pathway to 

commercialization that may be more 

advantageous for long cycle crops that 

require more than 12 simultaneous 

modifications. 

Comment: There is ongoing litigation 

on the revisions to 7 CFR part 340. New 

modifications should not be finalized 

prior to judicial ruling on the ongoing 

litigation. 

Response: We disagree with this 

comment. 

In May 2020, when APHIS issued the 

final rule outlining the updates to 7 CFR 

part 340, APHIS anticipated scientific 

information and/or experience would, 

over time, allow APHIS to list 

additional modifications that plants can 

contain and be exempted from the 

regulations so that the regulatory system 

stays up to date and keeps pace with 

advances in scientific knowledge, 

evidence, and experience. To ensure the 

regulations do not apply to plants that 

are equivalent to those that could be 

developed through conventional 

breeding, the May 2020 final rule 

established a regulatory process for 

continuously identifying and updating 

modifications that are achievable 

through conventional breeding and, 

thus, exempt from regulation (85 FR 

29791–29796; § 340.1(b)). To this end, 

§ 340.1(b)(4) provides that the 

Administrator may propose to exempt 

plants with additional modifications, 

based on what could be achieved 

through conventional breeding through 

a notice published in the Federal 

Register. 

As of August 2, 2024, APHIS has 

issued 96 responses confirming the 

exempt status of modified plants, 

reviewed 70 other modified plants 

through the regulatory status review 

process, and continued to gather 

information and literature about what 

can be achieved through conventional 

breeding methods. For example, as 

discussed more fully above, since 

APHIS initially adopted its exemption 4 

years ago, advances in conventional 

breeding methods have enabled the 

steady introgression of desired genes, 

alleles, and QTLs in several crops 

(Krishna, et al., 2023; Abdul Aziz and 

Masmoudi, 2024). Genomic assisted 

breeding, genetic mapping and studies, 

high through-put genotyping, speed 

breeding, multi-parent advance 

generation inter-crosses, and pyramid 

breeding strategies have advanced 

quickly and are now affordable for many 

crop types (Krishna, et al., 2023; Abdul 

Aziz and Masmoudi, 2024), and new 

methods are consistently emerging to 

improve and accelerate breeding 

methods for difficult to breed crops, 

particularly in crops with a complex 

autopolyploid genome or with 

predominant asexual reproduction 

(Chen, et al., 2021). It is important that 

APHIS update its list of modifications 

plants can contain and qualify for 

exemption from regulations to ensure its 

regulations reflect these advances in 

science and technology and remain 

rooted in the best science. 

Indeed, since July 2021, APHIS has 

followed the established regulatory 

processes to identify modifications that 

plants can contain without being subject 

to part 340 (86 FR 37988 (July 19, 2021); 

88 FR 78285). In late July 2021, 

plaintiffs filed a lawsuit in the United 

States District Court for the Northern 

District of California to challenge 

APHIS’ May 2020 final rule.6 During the 

pendency of this litigation, countries 

around the globe have updated their 

biotechnology policies and regulations 

related to new plant breeding 

techniques (or plants with modifications 

achievable through conventional 

breeding). As described in greater detail 

above, many of these countries, 

including the United Kingdom, the 

Philippines, Singapore, and Thailand, 

treat genome edited plants (including 

polyploid plants) that are free of 

exogenous DNA as conventional plants 

irrespective of the number of 

modifications made to the plants. In 

contrast, because APHIS was an early 


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leader in establishing a regulatory 

exemption for plants with modifications 

that are achievable through 

conventional breeding, APHIS initially 

limited developers to a single 

modification of the type described in 

§ 340.1(b)(1) through (3)—a narrower 

standard for conventional equivalence 

compared to both international 

regulatory frameworks and scientific 

literature describing what can be 

accomplished today through 

conventional breeding methods. To 

ensure the United States maintains its 

position as a global leader in 

agricultural biotechnology regulation 

and that its regulatory system and list of 

modifications exempt plants can 

contain is current and accurately 

reflects what can be achieved through 

conventional breeding methods, it is 

essential that APHIS issue this final 

notice updating the types of 

modifications plants can contain and 

qualify for exemption from regulation. 

Issuing this notice is also important to 

avoid differential treatment for products 

produced through genetic engineering 

that are otherwise equivalent to 

conventionally bred and/or developed 

products. As discussed above, plants 

with modifications that are achievable 

through conventional breeding that 

qualify for exemption, are no different, 

as a class, and in terms of plant pest 

risk, from comparable plants that are 

made through conventional breeding, 

which, likewise, do not come before 

APHIS. Updating the list of 

modifications that plants can contain 

and qualify for exemption will ensure 

that APHIS’ regulations do not impose 

unnecessary costs on modified plants 

that are equivalent to those developed 

through conventional breeding, 

including expenses associated with 

obtaining a permit, complying with 

permitting conditions, and preparing 

submissions for regulatory status review 

(i.e., the case-by-case method for 

determining whether a modified plant is 

subject to part 340, described in 

§ 340.5). 

To put these costs in perspective, 

developers with modified plants that do 

not meet the criteria for regulatory 

exemption have the option for obtaining 

a permit that authorizes the use of the 

modified plant under conditions or 

submitting a regulatory status review 

request that seeks a determination that 

the plant is not subject to part 340, 

because it is unlikely to present an 

increased plant pest risk compared to 

the non-modified version of the plant. 

To date, roughly 45 percent of APHIS’ 

regulatory status review submissions 

have involved plants with modifications 

that would likely meet the criteria for 

exemption described in this final notice. 

On average, APHIS has taken roughly 

234 days to complete its evaluation of 

these modified plants and determine 

they are not subject to regulation under 

part 340. Until now, developers have 

incurred costs associated with 

regulatory uncertainty, obtaining a 

permit and complying with associated 

conditions if they wish to engage in 

regulated activities (which, could range 

in cost from $13,000–$671,000, 

depending on a variety of factors) (U.S. 

Department of Agriculture Animal and 

Plant Health Inspection Service, 2020b), 

and preparing regulatory status review 

submissions for modified plants that 

were intended to be exempt from 

regulation, while APHIS has expended 

staff resources evaluating modified 

plants that were not intended to fall 

within the scope of part 340, which has 

increased workloads, and, in turn, 

drawn criticism for increased regulatory 

processing times and calls for 

improvement (Bass and Kovak, 2024; 

Kovak and Bass, 2024; US Congress 

Committee on Appropriations, 2024). 

Beyond this, if APHIS were to continue 

imposing unnecessary regulatory costs 

on plants with modifications achievable 

through conventional breeding, the 

United States could face the risk of U.S. 

investors going to countries with 

regulatory frameworks that already treat 

such modifications as conventional 

equivalents, including global 

agricultural competitors (Clayton 

Yeutter Institute Round Table 

Discussion, 2023), at a time when the 

United States seeks to advance the U.S. 

bioeconomy and biotechnology. 

Along these lines, in September 2022, 

the President issued Executive Order 

14081, entitled ‘‘Advancing 

Biotechnology and Biomanufacturing 

Innovation for a Sustainable, Safe, and 

Secure Bioeconomy,’’ which directs 

regulatory agencies to improve the 

efficiency of biotechnology regulations 

(Executive Office of the President, 

2022). Issuing this notice directly 

supports Section 8 of this Executive 

Order, will aid the United States in 

maintaining its position as a global 

leader in agricultural biotechnology, 

and will help keep U.S. developers 

working in the United States on 

products that help U.S. producers tackle 

climate, resource, and food security 

challenges. 

Lastly, it is important to note that the 

modified plants that are described in 

this final notice and that are eligible for 

exemption under § 340.1(b) have never 

been subject to regulation under part 

340—these modified plants were not 

intended to be within the scope of the 

revised regulations (part 340 (2020)) and 

were not within the scope of the legacy 

regulations (part 340 (2019)), and their 

conventionally bred counterparts have 

not been subject to regulation. In fact, if 

the May 2020 final rule that established 

the exemption for plants with 

modifications achievable through 

conventional breeding were to be set 

aside, it would mean that all the plants 

containing the modifications described 

in this notice—and more—would still 

be outside the scope of regulation. 

The following table summarizes the 

modifications and their applicability to 

polyploids: 

TABLE 1—SUMMARY OF MODIFICATIONS AND APPLICABILITY TO POLYPLOIDS

Notes Designation Modification 

1 pair of homologous chromosomes ....................... § 340.1(b)(1) ............... The genetic modification is a change resulting from cellular repair 

of a targeted DNA break in the absence of an externally provided repair template. 

1 pair of homologous chromosomes ....................... § 340.1(b)(2) ............... The genetic modification is a targeted single base pair substitution. 

1 pair of homologous chromosomes ....................... § 340.1(b)(3) ............... The genetic modification introduces a gene known to occur in the 

plant’s gene pool or makes changes in a targeted sequence to 

correspond to a known allele of such a gene or to a known 

structural variation present in the gene pool. 

1 pair of homologous chromosomes across 

subgenomes without repair template and one 

pair of homologous chromosomes with repair 

template.

340.1(b)(4)(vi)(AM1) .. An indel or contiguous deletion of any size, made at a targeted location, with or without insertion of DNA if generated without 

using a repair template, or without insertion of DNA if generated 

using a repair template. 


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89582 Federal Register / Vol. 89, No. 219 / Wednesday, November 13, 2024 / Notices 

TABLE 1—SUMMARY OF MODIFICATIONS AND APPLICABILITY TO POLYPLOIDS—Continued 

Notes Designation Modification 

Allows up to 12 simultaneous (multiplex) or sequential modifications.340.1(b)(4)(vi)(AM2) .. Plants with up to 12 modifications, made simultaneously or sequentially, are exempt from regulation if each modification individually qualifies the plant for exemption and occurs in a different gene. Modifications to either a single allele or pair of 

alleles on homologous chromosomes will count as one modification. See website for information on counting modifications. 

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00854-2. 

Accordingly, pursuant to the process 

established under § 340.1(b)(4), we are 

adopting the two additional 

modifications articulated in this notice 

for the reasons set forth in our initial 

notice and in this final notice. 

Authority: 7 U.S.C. 7701–7772 and 

7781–7786; 31 U.S.C. 9701; 7 CFR 2.22, 

2.80, and 371.3. 

Done in Washington, DC, this 6th day of 

November 2024. 

Michael Watson, 

Administrator, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2024–26232 Filed 11–12–24; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Natural Resources Conservation 

Service 

Environmental Impact Statement; 

Coon Creek Watershed 

AGENCY: Natural Resources 

Conservation Service, USDA. 

ACTION: Notice of availability; record of 

decision. 

SUMMARY: This notice of availability 

presents the Record of Decision (ROD) 

on a Watershed Project Plan— 

Programmatic Environmental Impact 

Statement (Plan-PEIS) for the Coon 

Creek Watershed prepared in 

partnership with La Crosse, Monroe, 

and Vernon Counties, Wisconsin 

(Sponsors). This notice announces the 

plan to proceed with the 

implementation of Alternative 2— 

Proposed Action—Decommission Dams, 

identified in the Plan-PEIS. Alternative 

2 proposes to decommission all 14 dams 

by excavating a notch to pass the 100- 

year flood without impounding water. 

This action will avoid environmental 

impacts to the extent possible and 

mitigate impacts that are unavoidable. 

ADDRESSES: You may request a copy of 

the ROD from: Steve Becker, NRCS State 

Conservation Engineer, 8030 Excelsior 

Drive, Suite 200, Madison, WI 53717. 

FOR FURTHER INFORMATION CONTACT: 

Steve Becker; telephone: (608) 400– 

6176; or email: steve.becker@usda.gov. 

Individuals who require alternative 

means for communication should 

contact the U.S. Department of 

Agriculture (USDA) Target Center at 

(202) 720–2600 (voice and text 

telephone (TTY)) or dial 711 for 

Telecommunications Relay service (both 

voice and text telephone users can 

initiate this call from any telephone). 

SUPPLEMENTARY INFORMATION: 

Decision 

Natural Resources Conservation 

Service (NRCS) has prepared a ROD 

following completion of the Plan-PEIS. 

The Plan-PEIS provides a retrospective 

analysis of the existing flood control 

project and then evaluates alternatives 

for the final disposition of 14 flood 

control dams. The purpose of the PlanPEIS is to ensure agencies consider the 

environmental impacts of their action in 

decision making. NRCS involvement is 

through Public Law 83–566, Watershed 

Protection and Flood Prevention Act, as 

amended. The ROD is available for 

viewing at the following link: https://

www.wfkandccwatersheds.com/2023. 

NRCS has decided to assist the 

Sponsors with implementing 

Alternative 2 which proposes to 

decommission all 14 dams in the 

watershed. 

Background 

The Coon Creek Watershed has an 

area of 90,601 acres (141.6 square miles) 

to the confluence with the Mississippi 

River. The focused planning area for the 

Plan-PEIS is 68,762 acres (107.4 square 

miles). The Plan-PEIS is follows an 

original Watershed Work Plan 

developed in 1958 to reduce flood 

damages in the Coon Creek valley under 

the Watershed Protection and Flood 

Prevention Act of 1954, as amended. 

The major problems in the watershed 

in 1958 were floodwater damages to: 

crops and pasture, fences, farmsteads, 

machinery, buildings, livestock, county 

and township roads and bridges, and 

urban areas of Coon Valley and 

Chaseburg. Project measures 

implemented under the original 

Watershed Work Plan included 14 flood 

control dams installed between 1961 

and 1964 with a total capacity of 1,160 

acre-feet to regulate flood flows from 21 

square miles, or 27 percent of the 

watershed above the village of Coon 

Valley. Project measures also included a 

multitude of land treatment practices to 

reduce erosion and sedimentation 

behind the dams. The dams have now 

completed their Federal interest or 

original economic evaluation period of 

50 years. 

On the night of August 27, 2018, 

seven watershed dams over-topped and 

three dams failed including the 

Luckasson Dam (CC 21); Blihovde Dam 

(CC23); Korn Dam (CC 29). Rainfall 

amounts up to 11 inches were reported 

on the night of August 27 and early 

morning of August 28. Additional 

rainfall amounts up to 7 inches were 

reported in the afternoon of August 28 

after the dam failures. 

The dams failed (breached) along the 

interface between the earthfill and 

highly jointed sandstone abutments. 

Each breach extended full depth to the 

valley floor. No one was injured or 

killed. Large debris fields were observed 

downstream of the dams for about 2 

miles. Barns and outbuildings were 

destroyed. An unoccupied house was 

moved off its foundation. Agricultural 

lands and road crossings were damaged. 

Engineering investigations concluded 

that flow through the jointed sandstone 

during high pool stage caused internal 

erosion and piping of the earthfill dam 

and contributed to the failures. The 

Sponsors and NRCS are concerned that 

a similar vulnerability exists in the 

remaining 11 dams. 

Environmental Review 

The ROD summarizes the findings of 

the Plan-PEIS and provides the basis for 

a decision to decommission 14 flood 

control dams in the Coon Creek 

watershed. The watershed project plan 

and the environmental document were 

combined in the single Plan-PEIS 

document. NRCS is the lead Federal 

agency responsible for the content and 

quality of the Plan-EIS for the purposes 


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