Notice2021-15236
Movement of Organisms Modified or Produced Through Genetic Engineering; Notice of Exemptions
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Published
July 19, 2021
Issuing agencies
Agriculture DepartmentAnimal and Plant Health Inspection Service
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 135 (Monday, July 19, 2021)</title>
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[Federal Register Volume 86, Number 135 (Monday, July 19, 2021)]
[Notices]
[Pages 37988-37989]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
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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:
<bullet> Federal eRulemaking Portal: Go to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Enter APHIS-2020-0072 in the Search field. Select the Documents tab,
then select the Comment button in the list of documents.
<bullet> 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 <a href="http://www.regulations.gov">www.regulations.gov</a> 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.
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\1\ To view the final rule and supporting documents, go to
<a href="https://www.regulations.gov">https://www.regulations.gov</a>, and enter APHIS-2018-0034 in the Search
field.
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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):
<bullet> 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
<bullet> The genetic modification is a targeted single base pair
substitution; or
<bullet> 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
<a href="https://www.aphis.usda.gov/aphis/ourfocus/biotechnology">https://www.aphis.usda.gov/aphis/ourfocus/biotechnology</a>.
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.
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\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.
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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
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