Movement of Organisms Modified or Produced Through Genetic Engineering; Notice of Exemptions, 37988-37989 [2021-15236]

Download as PDF 37988 Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices 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 Animal and Plant Health Inspection Service, Agriculture (USDA). ACTION: Notice. AGENCY: 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 lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:23 Jul 16, 2021 Jkt 253001 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. PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 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 1 To view the final rule and supporting documents, go to https://www.regulations.gov, and enter APHIS–2018–0034 in the Search field. E:\FR\FM\19JYN1.SGM 19JYN1 lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices 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. VerDate Sep<11>2014 18:23 Jul 16, 2021 Jkt 253001 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 2 Naito, 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. 4 Men, 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. 5 Sears, E.A. (1977). An induced mutant with homoeologous pairing in common wheat. Canadian J of Genetics and Cytology 19: 585–593. PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 37989 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 Animal and Plant Health Inspection Service, Agriculture (USDA). ACTION: Revision to and extension of approval of an information collection; comment request. AGENCY: 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. SUMMARY: E:\FR\FM\19JYN1.SGM 19JYN1

Agencies

[Federal Register Volume 86, Number 135 (Monday, July 19, 2021)]
[Notices]
[Pages 37988-37989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15236]


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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.
---------------------------------------------------------------------------

    \1\ To view the final rule and supporting documents, go to 
https://www.regulations.gov, and enter APHIS-2018-0034 in the Search 
field.
---------------------------------------------------------------------------

    The May 2020 final rule included regulatory exemptions for certain 
categories of plants that have been modified. Specifically, Sec.  
340.1(b) exempted plants that contain a single modification of one of 
the following types, specified in Sec.  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, Sec.  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 Sec.  
340.1. These modifications are similar and functionally equivalent to 
modifications that commonly occur within conventional breeding and to 
the

[[Page 37989]]

modification described in Sec.  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 self-fertilizing 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 Sec.  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.
---------------------------------------------------------------------------

    \2\ Naito, 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.
    \4\ Men, A.E., T.S. Laniya, I.R. Searle, I. Iturbe-Ormaetxe, 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.
    \5\ Sears, E.A. (1977). An induced mutant with homoeologous 
pairing in common wheat. Canadian J of Genetics and Cytology 19: 
585-593.
---------------------------------------------------------------------------

    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