37988 Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices 

1To view the final rule and supporting 

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

enter APHIS–2018–0034 in the Search field. 

have issued a permit for the release of 

Ramularia crupinae for the biological 

control of common crupina (Crupina 

vulgaris) in the contiguous United 

States. 

The EA and FONSI may be viewed on 

the Regulations.gov website (see 

footnote 1). Copies of the EA and FONSI 

are also available for public inspection 

at 1620 of the USDA South Building, 

14th Street and Independence Avenue 

SW, Washington, DC. Normal reading 

room hours are 8 a.m. to 4:30 p.m., 

Monday through Friday, except 

holidays. Persons wishing to inspect 

copies are requested to call ahead on 

(202) 799–7039 to facilitate entry into 

the reading room. In addition, copies 

may be obtained by calling or writing to 

the individual listed under FOR FURTHER

INFORMATION CONTACT. 

The EA and FONSI have been 

prepared in accordance with: (1) The 

National Environmental Policy Act of 

1969 (NEPA), as amended (42 U.S.C. 

4321 et seq.); (2) regulations of the 

Council on Environmental Quality for 

implementing the procedural provisions 

of NEPA (40 CFR parts 1500–1508); (3) 

USDA regulations implementing NEPA 

(7 CFR part 1b); and (4) APHIS’ NEPA 

Implementing Procedures (7 CFR part 

372). 

Done in Washington, DC, this 28th day of 

June 2021. 

Mark Davidson, 

Administrator, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2021–15176 Filed 7–16–21; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2020–0072] 

Movement of Organisms Modified or 

Produced Through Genetic 

Engineering; Notice of Exemptions 

AGENCY: Animal and Plant Health 

Inspection Service, Agriculture (USDA). 

ACTION: Notice. 

SUMMARY: We are advising the public 

that we are proposing to exempt plants 

with additional modifications that could 

otherwise be achieved through 

conventional breeding from the 

regulations that govern the introduction 

(importation, interstate movement, or 

release into the environment) of certain 

organisms modified or produced 

through genetic engineering. The 

exempt plants would have distinct 

modifications on the paternal and 

maternal alleles of a single gene 

resulting from repair of a targeted DNA 

break; deletions generated using an 

externally provided repair template; or 

deletions resulting from repair of two 

targeted double strand breaks on a 

chromosome. This action would reduce 

the regulatory burden for developers of 

certain plants modified or produced 

through genetic engineering that are 

unlikely to pose plant pest risks while 

enabling the Animal and Plant Health 

Inspection Service to focus its 

regulatory resources on risk analyses of 

unfamiliar products and those more 

likely to pose a plant pest risk. 

DATES: We will consider all comments 

that we receive on or before August 18, 

2021. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

www.regulations.gov. Enter APHIS– 

2020–0072 in the Search field. Select 

the Documents tab, then select the 

Comment button in the list of 

documents. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2020–0072, Regulatory Analysis 

and Development, PPD, APHIS, Station 

3A–03.8, 4700 River Road Unit 118, 

Riverdale, MD 20737–1238. 

Supporting documents and any 

comments we receive on this docket 

may be viewed at www.regulations.gov 

or in our reading room, which is located 

in Room 1620 of the USDA South 

Building, 14th Street and Independence 

Avenue SW, Washington, DC. Normal 

reading room hours are 8 a.m. to 4:30 

p.m., Monday through Friday, except 

holidays. To be sure someone is there to 

help you, please call (202) 799–7039 

before coming. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Neil Hoffman, Science Advisor, 

Biotechnology Regulatory Services, 

APHIS, 4700 River Road Unit 98, 

Riverdale, MD 20737–1238; (301) 851– 

3947. 

SUPPLEMENTARY INFORMATION: The 

regulations in 7 CFR part 340 govern the 

introduction (importation, interstate 

movement, or release into the 

environment) of certain organisms 

modified or produced through genetic 

engineering. The 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 developed 

using genetic engineering that are 

unlikely to pose plant pest risks. 

The May 2020 final rule included 

regulatory exemptions for certain 

categories of plants that have been 

modified. 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. 

In addition to the modifications listed 

above, § 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 paragraph (b)(4) 

is available on the APHIS website at 

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

ourfocus/biotechnology. 

In this document, we are proposing to 

add three modifications that plants can 

contain and be exempt from regulation 

pursuant to § 340.1. These modifications 

are similar and functionally equivalent 

to modifications that commonly occur 

within conventional breeding and to the 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices 37989 

2Naito, K., M. Kusaba, N. Shikazono, T. Takano, 

A. Tanaka, T. Tanisaka, and M. Nishimura (2005). 

Transmissible and nontransmissible mutations 

induced by irradiating Arabidopsis thaliana pollen 

with gamma-rays and carbon ions. Genetics, 169, 

881–889. 3 Kazama, Y., K. Ishii, T. Hirano, T. Wakana, M. 

Yamada, S. Ohbu, and T. Abe (2017). Different 

mutational function of low- and high-linear energy 

transfer heavy-ion irradiation demonstrated by 

whole-genome resequencing of Arabidopsis 

mutants. Plant J. 92, 1020–1030. 4Men, A.E., T.S. Laniya, I.R. Searle, I. IturbeOrmaetxe, I. Gresshoff, Q. Jiang, B.J. Carroll, and 

P.M. Gresshoff (2002). Fast Neutron Mutagenesis of 

Soybean (Glycine soja L.) Produces a 

Supernodulating Mutant Containing a Large 

Deletion in Linkage Group H. Genome Letters 3: 

147–155. 

5Sears, E.A. (1977). An induced mutant with 

homoeologous pairing in common wheat. Canadian 

J of Genetics and Cytology 19: 585–593. 

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

but enable a developer to more 

efficiently obtain a complete loss of 

function of a targeted gene. We are also 

making available for public review 

scientific literature that we consulted 

prior to initiating the proposal. The 

literature supports exempting plants 

with these additional modifications. 

Under the first additional genetic 

modification proposed, plants would 

not be subject to the regulations when 

cellular repair of a targeted DNA break 

in the same location on two homologous 

chromosomes, in the absence of a repair 

template, results in homozygous or 

heterozygous biallelic mutations, each 

of which is a loss of function mutation. 

A double strand break followed by 

cellular repair often occurs in both 

paternal and maternal alleles (biallelic) 

during genome editing. As a range of 

DNA indels frequently occur after a 

double strand break, the mutation in the 

paternal allele often differs from the 

mutation in the maternal allele. Biallelic 

knockout mutations are easily obtained 

in conventional breeding through selffertilizing or backcrossing and selection. 

In this case, the biallelic mutation is 

usually homozygous. However, in cases 

where the deletions are not identical but 

both deletions lead to a loss of function 

of the allele, the phenotype will be the 

same as the homozygous biallelic 

mutation obtained through conventional 

breeding. If both alleles are modified by 

indels such that neither allele is 

functional, the size, position, and 

sequence of the indels within the gene 

need not be identical to qualify for the 

exemption. 

The second additional genetic 

modification proposed is a contiguous 

deletion of any size resulting from 

cellular repair of a targeted DNA break 

in the presence of an externally 

supplied repair template. The deletion 

can occur on one or two homologous 

chromosomes. This modification is 

similar to the one described in 

§ 340.1(b)(1), except that it allows an 

externally supplied repair template to 

be used. When genome editing is used 

to create a single DNA break, a range of 

indels result from the cellular repair 

mechanism. To limit the range of 

mutations recovered and, therefore, to 

more efficiently obtain a complete loss 

of function of the targeted gene(s), some 

developers also add a template to guide 

the repair process. To limit this 

proposed additional modification to 

what is achievable through conventional 

breeding, it would only apply to 

deletions created by the double strand 

break and externally supplied repair 

template. 

The third additional genetic 

modification proposed is for a change 

resulting from cellular repair of two 

targeted DNA breaks on a single 

chromosome or at the same location on 

two homologous chromosomes, when 

the repair results in a contiguous 

deletion of any size in the presence or 

absence of a repair template, or in a 

contiguous deletion of any size 

combined with an insertion of DNA in 

the absence of a repair template. The 

insertion cannot result from the 

insertion of exogenous construct DNA. 

The modifications on two homologous 

chromosomes can be heterozygous as 

long as each results in a loss of function 

of the targeted gene(s). To qualify for the 

exemption, the plant must have 

mutations that are restricted to a pair of 

homologous chromosomes in diploids 

and allopolyploids or any two 

homologous chromosomes in 

autopolyploids. Radiation mutagenesis, 

which is commonly used in 

conventional breeding, can create any 

size deletion. As mutations are typically 

detrimental to the organism, what is 

achievable in practice is limited by the 

viability and fertility of the organism. 

Large mutations can be maintained in a 

heterozygous state but do not tend to 

undergo homozygous inheritance 

(Naito, 2005).2 For example, in 

Arabidopsis, which has a genome size of 

135 Mb (Arabidopsis Genome Initiative, 

2000), a radiation-induced deletion of 

3.1 Mb was obtained that disrupted 852 

genes and was maintainable only as a 

heterozygote, presumably because genes 

essential for survival are present in the 

deleted region (Kazama, et al., 2017).3

Polyploid plants and those with large 

genomes are better able to accommodate 

even larger deletions (Men et al., 2002).4

For example, in hexaploid wheat, X-ray 

mutagenesis was used to create a 

mutant, ph1, widely used in breeding 

programs, that has a 70 Mb deletion 

(Sears, 1977).5 To put the size of this 

wheat deletion in perspective, it is 

larger than half of the entire genome of 

Arabidopsis. Based on the use of plants 

with large deletion mutations in 

conventional breeding programs, any 

size contiguous deletion created by two 

double strand breaks should be 

exempted because it falls well within 

what could be achieved through 

conventional breeding. 

After reviewing any comments we 

receive, we will announce our decision 

regarding the three new modifications 

that plants could contain and qualify for 

exemption in a subsequent 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 14th day of 

July, 2021. 

Michael Watson, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2021–15236 Filed 7–16–21; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2021–0032] 

Notice of Request for Revision to and 

Extension of Approval of an 

Information Collection; National 

Poultry Improvement Plan 

AGENCY: Animal and Plant Health 

Inspection Service, Agriculture (USDA). 

ACTION: Revision to and extension of 

approval of an information collection; 

comment request. 

SUMMARY: In accordance with the 

Paperwork Reduction Act of 1995, this 

notice announces the Animal and Plant 

Health Inspection Service’s intention to 

request a revision to and extension of 

approval of an information collection 

associated with the National Poultry 

Improvement Plan. 

DATES: We will consider all comments 

that we receive on or before September 

17, 2021. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

www.regulations.gov. Enter APHIS– 

2021–0032 in the Search field. Select 

the Documents tab, then select the 

Comment button in the list of 

documents. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2021–0032, Regulatory Analysis 

and Development, PPD, APHIS, Station 

3A–03.8, 4700 River Road, Unit 118, 

Riverdale, MD 20737–1238. 


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