Federal Register, Volume 85 Issue 96 (Monday, May 18, 2020)

[Federal Register Volume 85, Number 96 (Monday, May 18, 2020)]
[Rules and Regulations]
[Pages 29790-29838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10638]

[[Page 29789]]

Vol. 85

Monday,

No. 96

May 18, 2020

Part II

Department of Agriculture

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Animal and Plant Health Inspection Service

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7 CFR Parts 330, 340 and 372

Movement of Certain Genetically Engineered Organisms; Final Rule

Federal Register / Vol. 85 , No. 96 / Monday, May 18, 2020 / Rules
and Regulations

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Parts 330, 340, and 372

[Docket No. APHIS-2018-0034]
RIN 0579-AE47

Movement of Certain Genetically Engineered Organisms

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the regulations regarding the movement
(importation, interstate movement, and environmental release) of
certain genetically engineered organisms in response to advances in
genetic engineering and our understanding of the plant pest risk posed
by genetically engineered organisms, thereby reducing the regulatory
burden for developers of organisms that are unlikely to pose plant pest
risks. This final rule, which marks the first comprehensive revision of
the regulations since they were established in 1987, provides a clear,
predictable, and efficient regulatory pathway for innovators,
facilitating the development of genetically engineered organisms that
are unlikely to pose plant pest risks.

DATES: Effective August 17, 2020. Sections 340.4 and 340.5 are
applicable beginning April 5, 2021.

FOR FURTHER INFORMATION CONTACT: Dr. Alan Pearson, Assistant Deputy
Administrator, Biotechnology Regulatory Services, APHIS, 4700 River
Road, Unit 98, Riverdale, MD 20737-1238; (301) 851-3944.

SUPPLEMENTARY INFORMATION:

Background

The Animal and Plant Health Inspection Service (APHIS) of the
United States Department of Agriculture (USDA) administers the
regulations in 7 CFR part 340, ``Introduction of Organisms and Products
Altered or Produced Through Genetic Engineering Which are Plant Pests
or Which There is Reason to Believe are Plant Pests'' (referred to
below as ``the regulations'').
These regulations govern the introduction (importation, interstate
movement, or release into the environment) of certain genetically
engineered (GE) organisms.
Along with the Environmental Protection Agency (EPA), and the Food
and Drug Administration (FDA), APHIS is responsible for the oversight
and review of GE organisms. In 1986, the Coordinated Framework for
Regulation of Biotechnology (Coordinated Framework) \1\ was published
by the Office of Science and Technology Policy. It describes the
comprehensive Federal regulatory policy for ensuring the safety of
biotechnology research and products and explains how Federal agencies
use existing Federal statutes to ensure public health and environmental
safety while maintaining regulatory flexibility to avoid impeding the
growth of the biotechnology industry. The Coordinated Framework
explains the regulatory roles and authorities for APHIS, EPA, and the
FDA. The Coordinated Framework was updated in 2017 in light of advances
that had occurred since 1986 in the field of biotechnology.
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\1\ To view the 1986 framework, go to https://www.aphis.usda.gov/brs/fedregister/coordinated_framework.pdf. To
view the 2017 revision to the framework, go to https://www.aphis.usda.gov/biotechnology/downloads/2017_coordinated_framework_update.pdf.
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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 six times, in 1988, 1990, 1993, 1994,
1997, and 2005, to institute exemptions from the requirement for
permits to conduct activities for certain microorganisms and
Arabidopsis, to institute the current notification process and petition
procedure, and to exclude plants engineered to produce industrial
compounds from the notification process.
While the regulations have been effective in ensuring the safe
introduction of GE organisms during the past 30 years, they do not
reflect the findings from APHIS' three decades of experience in
evaluating GE organisms for plant pest risk or account for developments
in genetic engineering over that period. APHIS' evaluations to date
have provided evidence that genetically engineering a plant with a
plant pest as a vector, vector agent, or donor does not result in a GE
plant that presents a plant pest risk. Further, genetic engineering
techniques have been developed that do not employ plant pests as donor
organisms, recipient organisms, vectors, or vector agents, yet may
result in organisms that do pose a plant pest risk. Given these
developments, as well as legal and policy issues discussed below, it
has become necessary, in our view, to update our regulations
accordingly.
On January 19, 2017, we published in the Federal Register (82 FR
7008-7039, Docket No. APHIS-2015-0057) a proposed rule \2\ intended to
revise our regulatory approach from ``regulate first before analyzing
risks'' to ``analyze plant pest and noxious weed risks of GE organisms
prior to imposing regulatory restrictions.''
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\2\ To view the 2017 proposed rule, the subsequent withdrawal,
all supporting documents, and comments APHIS received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0057.
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Under the January 2017 proposed rule, a stakeholder could request
that we conduct a risk assessment to determine whether a GE organism
would pose plant pest or noxious weed risks and thus need to be
regulated. Regulated GE organisms could be imported, moved interstate,
or released into the environment under a flexible, risk-based
permitting procedure.
APHIS received 203 comments on the proposal during the comment
period. Commenters expressed concerns about many provisions of the
proposed rule. Many stated that the proposed requirements would be too
burdensome and had the potential to stifle innovation.
After reviewing the comments, APHIS subsequently withdrew the
proposed rule. Following the withdrawal, APHIS conducted extensive
outreach. Our outreach efforts took place in all regions of the United
States and encompassed all sectors of the agriculture supply chain, as
well as academic researchers, growers of various crops, and advocacy
groups. Organizations ranged in size from small laboratories to larger
scale businesses. APHIS also took proactive steps to meet with
organizations both supportive and skeptical of agricultural
biotechnology. In total, APHIS met with more than 80 organizations,
including 17 universities, State departments of agriculture, and farmer
organizations.
Much of the feedback received during this process centered on the
need to focus regulatory efforts and oversight upon risk, rather than
the method used to develop GE organisms. Stakeholders also expressed a
desire for flexible and adaptable regulations so that future
innovations do not invalidate the regulations. We also received
feedback urging us to keep international trade objectives in mind when
proposing new regulations and ensuring that new regulatory requirements
are transparent and clearly articulated.
The feedback we received led us to update APHIS' regulatory
framework, in a manner that further focuses our regulatory efforts on
the properties of the GE organism itself rather than on the

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method used to produce it. We believed that this regulatory approach
would better reflect our current knowledge of the field of
biotechnology and would therefore enable us to evaluate GE organisms
for plant pest risk with greater precision than the existing framework
allowed. The regulatory framework was also intended to enable APHIS to
avoid conducting repetitive analyses, to utilize its staff time more
efficiently than before, and to provide better stewardship of taxpayer
dollars.
On June 6, 2019, we published in the Federal Register (84 FR 26514-
26541, Docket No. APHIS-2018-0034) a proposal \3\ to amend the
regulations in accordance with the Secretary of Agriculture's March 28,
2018, statement on plant breeding innovations. The Secretary's
statement and the accompanying explanatory details provided
clarification on the USDA's oversight over plants produced through
innovative, new breeding techniques, including genome editing
techniques. (The statement and further details are available at:
https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/brs-news-and-information/2018_brs_news/plant_breeding.)
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\3\ To view the proposed rule, the comments we received, and
supporting documents, go to http://www.regulations.gov/#!docketDetail;vD=APHIS-2018-0034. Additionally, please note that
within the body of this document, that rule and this final rule are
referred to at times as the Sustainable, Ecological, Consistent,
Uniform, Responsible, Efficient (SECURE) rule. The SECURE rule is
the nomenclature used by USDA to discuss the rule with stakeholders.
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We would note also that the June 2019 proposed rule and this final
rule are consistent with the President's ``Executive Order on
Modernizing the Regulatory Framework for Agricultural Biotechnology
Products'' (June 11, 2019, Executive Order 13874). Executive Order
13874 directs the Federal Government to adopt regulatory approaches for
the products of agricultural biotechnology that are proportionate to
the risks such products pose, and that avoid arbitrary or unjustifiable
distinctions across like products developed through different
technologies. Among other things, Executive Order 13874 states that
regulatory decisions should be science- and evidence-based, taking
economic factors into account as appropriate and consistent with
applicable law; that regulatory reviews should be conducted in a timely
and efficient manner; and that biotechnology regulations should be
transparent, predictable, and consistent.
We solicited comments on our proposed rule and its supporting
analyses until August 6, 2019. We received 6,150 comments by that date.
They were from developers of GE organisms; growers of GE plants for
food crops and other uses; trade associations representing both of
those groups and sellers of such commodities as corn, soybeans, and
grain; scientists representing academic institutions; organic farmers
and trade associations representing their interests; consumer and
public interest groups; and individuals. Most of the comments, while
not form letters, expressed a generalized, similarly themed opposition
to GE products. Of the comments that specifically addressed the
provisions of the rule, approximately 25 expressed some support for the
rule. The comments are discussed below by topic.

Applicability of the Regulations

Exemptions
The June 2019 proposed rule exempted from the regulations certain
categories of plants that have been modified. Specifically, Sec.
340.1(b)(1) through (4) proposed to exempt such plants if:
The genetic modification is solely a deletion of any size;
or
The genetic modification is a single base pair
substitution; or
The genetic modification is solely introducing nucleic
acid sequences from within the plant's natural gene pool or from
editing nucleic acid sequences in a plant to correspond to a sequence
known to occur in that plant's natural gene pool; or
The plant is an offspring of a GE plant and does not
retain the genetic modification in the GE plant parent.
In addition to above-listed categories, proposed Sec. 340.1(c)
stated that modified plants would not be subject to the regulations if
they have plant-trait-mechanism of action (MOA) combinations that are
the same as those of modified plants for which APHIS has conducted a
regulatory status review (RSR) and found not to be subject to the
regulations under part 340.
The above-listed exemptions elicited a broad spectrum of comments.
Some commenters welcomed the regulatory relief offered by the
exemptions as written, while others viewed them as too broad and still
others as excessively restrictive.
Among the commenters who viewed the exemptions as excessively
broad, several commenters stated that APHIS did not provide the
``necessary scientific justifications'' for the exemptions from
regulation listed in proposed Sec. 340.1(b)(1) through (3).
The exemptions in Sec. 340.1(b)(1) through (3) are based on the
principles listed below. (For reasons discussed later in this document,
we are removing from this final rule the exemption contained in Sec.
340.1(b)(4) of the proposed rule, which would have pertained to ``null
segregants,'' or the offspring of a GE plant that does not retain the
genetic modification in the GE plant parent; while there is still a
paragraph (b)(4) in this final rule, it serves a different purpose
which we discuss later in this document.)
1. Plants created through conventional breeding have a history of
safe use related to plant pest risk;
2. The types of plants that qualify for these exemptions can also
be created through conventional breeding; and
3. There is no evidence that use of recombinant deoxyribonucleic
acid (DNA) or genome editing techniques necessarily and in and of
itself introduces plant pest risk, irrespective of the technique
employed.
When a plant meets one of the above-listed exemptions, therefore,
it is not expected to pose plant pest risks greater than the plant pest
risks posed by plants modified by conventional breeding methods and
thus should rightly not be subjected to regulation under part 340. (The
term ``conventional breeding'' may generally be used interchangeably
with ``traditional breeding.'' In the June 2019 proposed rule, APHIS
used both terms, with ``traditional breeding'' appearing more
frequently in the text. Based in part on dialogue with other agencies
involved in regulating biotechnology, we have elected to use the term
``conventional breeding'' throughout this final rule and its supporting
documents, except when the need to quote directly indicates otherwise.
For purposes of this rule and its supporting documents, ``conventional
breeding'' has the meaning it is understood to have within the context
of part 340, based on the examples provided immediately below. Other
Federal or State regulations may use the term ``conventional breeding''
in the context of their regulations and attribute slightly different
meanings.)
We noted in the preamble to the June 2019 proposed rule that
conventionally bred crops have a long history of safe use with respect
to plant pest risk and that the long history of conventional plant
breeding gives us extensive experience in safely managing any
associated plant pest risks. Conventional breeding techniques generally
involve the deliberate selection of plants with desirable traits from
existing population genetic variation or from new genetic variation

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created through artificial hybridization or induced mutagenesis. As we
noted in the June 2019 proposed rule, such techniques include marker-
assisted breeding, tissue culture, protoplast, cell, or embryo fusion,
and chemical or radiation-based mutagenesis. Products generated solely
using such techniques have never been regulated under the part 340
regulations. Although conventional breeding is not risk free, the risks
associated with it are, according to a 1989 National Research Council
(NRC) report,\4\ ``manageable by accepted standards.'' In other words,
the types of traits that can be introduced through conventional
breeding have not led to plant pest risk concerns.
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\4\ National Research Council (NRC) 1989. Field Testing
Genetically Modified Organisms: Framework for Decisions. Washington
DC. National Academy Press. 185 pp. Retrieved from http://www.nap.edu/catalog/1431.html.
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The types of DNA modifications that occur through conventional
breeding by mutagenesis are well characterized (Oladosu, et al., 2016;
Kharkwal, et al., 2012). Among the common outcomes that result from
mutagenesis are deletions, insertions, inversions, or translocations of
DNA and base pair substitutions (Oladosu, et al., 2016) which often
result from double strand breaks in the DNA followed by natural DNA
repair. Base-pair substitution also results from chemical modification
of a base followed by natural DNA repair. These types of modifications
occur at a low rate from naturally occurring environmental exposure to
ionizing radiation, radical oxygen, chemical compounds, or biological
agents such as viruses, or at an elevated rate in response to radiation
and chemical-induced mutagenesis. In conventional breeding, these types
of DNA modifications are introduced randomly. Individual plants
possessing a mutation conferring a useful phenotype are isolated by
screening, and random mutations that are introduced and do not convey a
useful phenotype are addressed during backcrossing. New plant breeding
technologies, such as those used in genome editing, can be used to
create targeted double strand breaks in specific parts of the genome
that when repaired result in deletions and small insertions, just as
from natural environmental exposure or radiation mutagenesis (Chen, et
al., 2019). Likewise, new plant breeding technologies can also be used,
in a specific, targeted manner, to create base pair substitutions that
are similar to the modifications that can be created by random chemical
mutagenesis. In other words, the same types of DNA modifications that
occur in conventional breeding can also be constructed precisely using
new plant breeding technologies (Custers, et al., 2019). We are
exempting plants generated using plant breeding technologies that have
non-templated insertions and deletions and that have a single base pair
substitution, because they could otherwise be created by conventional
breeding and pose no increased plant pest risk relative to their
conventionally bred counterparts.
The exemption in proposed Sec. 340.1(b)(3) applies to the use of
new plant breeding technologies to recreate the introduction of a gene,
allele of a gene, or structural variation that could otherwise be
introduced by crosses. APHIS notes that conventional methods of plant
breeding and new plant breeding technologies often share the same goals
with similar results. Human selection of plants has been used for
thousands of years; and crossing has been used to introduce alleles
into breeding populations since at least the early 18th century
(Goulet, et al., 2017). More recently, plant breeders have expanded the
source of genetic material that can be used to introduce genetic
changes into breeding populations through wide crosses, embryo rescue,
and protoplast fusion (Bravo, et al., 2011; De Filippis, 2014; Singh,
1990), as well as the rate of introduction of genetic material through
marker-assisted and genomic selection; all of these approaches are
considered conventional breeding methods and are used to expand and
guide changes in the gene pool available within a population. Genetic
engineering can be used to introduce a genetic sequence from any donor
source into plants, which cannot be accomplished through conventional
breeding. To limit the exemption in paragraph (b)(3) to what is
possible in conventional breeding, the third exemption applies only to
the introduction of a gene, allele, or structural variant known to
occur from a donor source (1) in the same species as the recipient, or
(2) in a species compatible via wide crosses, embryo rescue, or
protoplast fusion with the recipient species.
The NRC has concluded in multiple studies \5\ that there was no
evidence of unique hazards inherent in the use of recombinant DNA
techniques with respect to plants, and that crops modified by molecular
and cellular methods should pose risks no different from those modified
by conventional breeding methods for similar traits. Moreover, new
molecular methods for editing genomes have been developed since the NRC
studies that can be more specific and precise than those evaluated by
the NRC studies, and plants modified by these new methods should also
pose plant pest risks that are no different from plants that are
modified for similar traits by conventional breeding methods. For all
of the foregoing reasons, we consider the exemptions to be based on the
best available science.
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\5\ National Academies of Sciences, Engineering, and Medicine
(NAS) 1987. Introduction of Recombinant DNA-engineered Organisms
into the Environment: Key Issues. Washington, DC National Academy
Press. 24 pp. Retrieved from https://www.nap.edu/read/18907/chapter/1.
National Research Council (NRC) 1989. Field Testing Genetically
Modified Organisms: Framework for Decisions. Washington DC. National
Academy Press. 185 pp. Retrieved from http://www.nap.edu/catalog/1431.html.
National Academies of Sciences, Engineering, and Medicine (NAS)
2016. Genetically Engineered Crops: Experiences and Prospects.
Washington, DC National Academy Press. 420 pp. doi:10.17226/23395.
Retrieved from http://www.nap.edu/23395.
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Some commenters stated that APHIS did not adequately consider risk
when developing the exemptions. It was stated that the proposed
exemptions do not consider potential pest risks or human,
environmental, or agricultural impacts on nontarget organisms. A
commenter claimed that APHIS regulates risks other than plant pest
risks, such as inadvertent introduction to the food supply and economic
impacts from gene flow, so there should be scientific evidence that
plants exempted from regulations do not pose any of the full range of
risks.
We do not agree with these comments. With regard to the commenters
who stated that the exemptions failed to consider impacts on non-target
organisms, APHIS considers impacts on non-target organisms that are
beneficial to plants to be indirect plant pest impacts. It is not
accurate to say that APHIS has previously regulated risks other than
plant pest risks. Under the current regulations prior to the effective
date of this final rule (referred to below as ``the current
regulations''), APHIS has imposed measures to limit gene flow from GE
plants that already met the definition of a regulated article. (Please
see the ``Implementation Table'' on Regulations.gov regarding the dates
when various provisions of this rule become applicable.) In these
cases, APHIS considered the GE plants to be regulated articles because
they had used a plant pest as the donor organism, recipient organism,
or vector or vector agent, and therefore could pose a plant pest risk.
As noted in the proposed rule, APHIS' evaluations to date have provided
evidence that genetically

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engineering a plant with a plant pest does not in and of itself result
in a plant that presents a plant pest risk, however. In cases where GE
crops were not subject to regulation, no ``other risks'' such as
inadvertent introduction to the food supply or economic impacts from
gene flow have been regulated by APHIS insofar as they were outside the
scope of the regulations.
A commenter opposed the exemptions listed in proposed Sec.
340.1(b)(1) through (3) on the basis that plants produced through most
methods that would be used for genome editing are regenerated from
single cells in tissue culture, resulting in somaclonal variation with
unpredictable consequences, and that off-target mutations caused by
genome editing are more likely than chemical and radiation mutagenesis
to be non-random. A second commenter asked that the exemptions be
limited so that they apply only to plants produced using techniques
that minimize off-target mutations. A third commenter asked whether
off-target mutations are considered when determining eligibility for an
exemption.
Somaclonal variation has been utilized extensively for breeding
purposes, and the resultant new plant variety is not subject to the
APHIS regulations in part 340 that we are replacing with this final
rule (Krishna, et al., 2016; Neelakandan and Wang, 2012). APHIS is not
aware of a reason to mandate government oversight over new plant
varieties resulting from somaclonal variation.
Background mutation occurs naturally in plants and does not raise
plant pest risk concerns in conventional breeding programs. APHIS does
not believe it is necessary to regulate off-target effects of genome
editing in plants because (1) the off-target mutation rate from genome
editing 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; Feng, et al., 2018; Peterson, et al., 2016; Nekrasov, et
al., 2017; Lee, et al., 2018; Tang, et al., 2018). In these cases where
the frequency of off-target mutation was measured in CRISPR/Cas
expressing lines and their progeny, the authors concluded that the rate
of off-target mutation was below the level of background mutation
induced during seed amplification or tissue culture (Hahn and Nekrasov,
2019). Although there can be variation in off-target 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 such methods.
Due to the nature of plant breeding--in which populations are
created and evaluated, and individual plants are selected for the
intended modifications--off-target changes are likely to be lost unless
they are genetically linked to the targeted modification that is
introduced. APHIS wishes to clarify that, for these reasons, off-target
mutations are not considered when determining eligibility for an
exemption. This is also consistent with APHIS' approach regarding
conventional breeding techniques. As noted above, these techniques
often have a high mutation rate, but have a history of safe use with
respect to plant pest risk. APHIS has modified the regulatory text in
Sec. 340.1(b) to indicate that we are considering only targeted
modifications when determining eligibility for an exemption.
Some commenters stated that the scope of the exemptions listed in
proposed Sec. 340.1(b)(1) through (3) should be broadened to encompass
the range of genetic modifications that are accessible to plant
breeders through conventional breeding methods, and proposed
alternative language that would allow an unlimited number of genetic
modifications to be made and exempt from the regulations.
The commenters appear to have interpreted our references in the
June 2019 proposed rule and its preamble to plants that could otherwise
have been developed through ``traditional breeding methods'' to mean
any type and extent of genetic change that is theoretically possible
through conventional breeding methods. 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,
self-compatibility), ploidy level and genomic complexity, resource
availability (time, money, labor, and genomic resources), 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 (Custers, et al., 2019;
Wolter, et al., 2019; Najera, et al., 2019). Currently, APHIS lacks
sufficient familiarity to develop a risk-based exemption for products
containing complex combinations that might be produced in the future.
APHIS is clarifying that the exemptions listed in Sec. 340.1(b)(1)
through (3) are based on types of modifications that are easily
recognizable to the developers of the organism and on genetic changes
that could be practically achieved by conventional breeding methods in
any plant species. However, over time, APHIS expects to gain more
familiarity with the products of these new plant breeding innovations.
Accordingly, we are revising Sec. 340.1(b) to establish a process for
listing additional modifications that plants can contain while still
being exempted from the regulations. This process is specified in
paragraph (b)(4) of Sec. 340.1 in this final rule.
Some commenters inquired how the exemptions in proposed Sec.
340.1(b)(1) through (3) pertain to combinations of genetic
modifications or to sequential edits. For example, would a deletion and
a single base substitution made at the same time in a plant qualify for
exemption? If a single change is made to a plant, when could another
change be made that qualified for an exemption? Some commenters argued
that there is no valid scientific reason that the exemptions should not
allow multiple simultaneous genomic changes to be made. Other
commenters asked us to reaffirm that the exemptions are limited to only
a single genome editing change, and that a plant containing multiple
changes made at the same or different times would not be exempt, or
that we delete the exemptions altogether, since genome edits could be
made sequentially such that each intermediate organisms would be
exempt, cumulatively resulting in a final organism with many targeted
changes that would also be exempt. Several commenters requested that
APHIS include a process for adding new categories of exemptions and
revising exemptions in order to ensure that the regulatory system stays
up to date and keeps pace with advances in scientific knowledge,
evidence, and experience.
APHIS seeks to clarify that exemptions listed in Sec. 340.1(b)(1)
through (3) apply to plants containing single targeted modifications.
The exemptions were formulated to apply to what could otherwise be
achieved through conventional plant breeding

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techniques in any species. As discussed above, the plants that are
eligible for exemption would have no increased plant pest risk than
conventionally bred plants. APHIS realizes that in some species, a
single targeted modification is often less than what could otherwise be
developed through conventional breeding. However, as noted above, the
extent of intentionally selected variation that could otherwise be
introduced through conventional breeding varies depending on the plant
species. To establish clear and unambiguous exemptions that could apply
to any plant species while enabling for variation in what can be
achieved through conventional breeding, APHIS has revised the
regulatory text in Sec. 340.1(b).
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. If the Administrator determines that it
is appropriate to list additional modifications, APHIS will notify the
public in the Federal Register and will take public comment. After
reviewing the comments, APHIS will issue a subsequent notice announcing
its determination. This process is provided in new paragraph (b)(4) in
Sec. 340.1.
One commenter requested that APHIS document examples of deletions
of any size that could be made by conventional breeding.
The first exemption allows a single deletion of any size because
radiation 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). 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). Polyploid plants and those with
large genomes are better able to accommodate even larger deletions (Men
et al., 2002). 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). To put the size of this deletion in
perspective, it is larger than half of the entire genome of
Arabidopsis.
Some commenters recommended that the exemption in Sec. 340.1(b)(1)
be broadened to allow for insertions that occur during the natural DNA
repair mechanism after double-strand break of the DNA. In the proposed
rule, the exemption in paragraph (b)(1) mentions only deletions.
APHIS agrees with the comment. Deletions, small insertions, and
combinations of deletions and insertions are all possible outcomes
resulting from the cellular mechanisms used to repair DNA breaks that
occur naturally or that are induced during conventional plant breeding,
and all have been used in conventional plant breeding (Manova and
Gruszka, 2015; Wang, et al., 2016). The exemption in Sec. 340.1(b)(1)
has been revised to reflect all of the possible outcomes of natural DNA
repair mechanisms that occur in the absence of a deliberately provided
repair template.
A commenter asked that APHIS eliminate the exemptions for deletions
and single base pair substitutions, arguing that any type of change in
a gene sequence can potentially cause phenotypic changes that have
significant consequences.
APHIS disagrees with this argument. Naturally occurring single base
pair substitutions and deletions are commonly induced and are widely
used to generate new crop varieties in conventional mutation breeding,
which includes both chemically induced and irradiation-based
mutagenesis (Oladosu, et al., 2016; Kharkwal, 2012; Ahloowalia and
Maluszynski, 2001). The targeted single base pair substitutions or
deletions covered by these exemptions are the same in kind as, and do
not pose any increased plant pest risks than, the substitutions or
deletions introduced through conventional breeding. Thus, they should
not be subject to the regulations.
Many commenters argued that limiting the exemption in proposed
Sec. 340.1(b)(1) to a single deletion and the exemption in Sec.
340.1(b)(2) to a single base pair substitution does not take into
account that multiple base pair substitutions and/or deletions are
routinely and safely introduced into plants using conventional breeding
methods, including mutagenesis.
The argument that multiple substitutions or deletions can occur
through conventional breeding methods, including mutagenesis, seems to
be conflating the specific targeted changes that can be made via genome
editing techniques with the multiple random changes that occur during
conventional breeding, only one or few of which might contribute to the
desired phenotype. In the case of random chemical or radiation
mutagenesis, thousands of mutations are introduced into the plant but
most are detrimental, or neutral at best. The fact that multiple
mutations exist in the plant is a negative feature that needs to be
overcome by laboriously self-fertilizing or backcrossing the mutated
plant for multiple generations. Even then, a developer may not find an
agronomically suitable phenotype. By applying selection, it is
possible, though at a very low frequency, to get two desirable
mutations in a single mutated line if the mutations are unlinked. It is
improbable to get two linked mutations in a single line, particularly
if the mutations are sought within the same gene. In contrast, genome
editing can easily introduce multiple beneficial changes in one
generation, leading to phenotypes that we have not seen by conventional
breeding.
The exemptions listed in Sec. 340.1(b) are based on measures that
are easily defined, are based on familiarity, and thus are meant to be
limited to genetic changes that could practically be achieved by
conventional breeding methods in any plant. It is not possible to
define a number of such changes greater than one which could
practically be achieved by conventional breeding methods in all plant
species. The number of changes that can practically be achieved through
conventional breeding methods can vary widely from one species to
another. For this reason, APHIS is retaining the limitation of a single
modification, as this approach ensures that we can identify those
plants that pose a plant pest risk. We anticipate that most plants that
are not eligible for the exemption and do not pose a plant pest risk
will pass through the RSR process quickly.
In addition, as noted above, we are revising Sec. 340.1(b) by
adding a new paragraph (b)(4) that establishes a process for listing
additional modifications that plants can contain while being exempted
from the regulations, based on what could be achieved through
conventional plant breeding. Thus, while the exemptions in Sec.
340.1(b)(1) through (3) will initially apply only to plants containing
a single modification in one of the categories listed, APHIS
anticipates that scientific information and/or experience will,

[[Page 29795]]

over time, allow multiple and sequential changes in some species after
public notice and comment.
The introductory text of 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 be APHIS-initiated, or in response to a
request.
Paragraph (b)(4)(i) sets forth the process for APHIS-initiated
proposals. APHIS will publish a notice in the Federal Register of the
proposal by the Administrator to exempt plants with additional
modifications. The notice will make available any supporting
documentation, and will request public comment. After reviewing the
comments, APHIS will publish a subsequent notice in the Federal
Register announcing its final determination and responding to the
comments received.
Under paragraph (b)(4)(ii), any person may request that APHIS
exempt plants developed with additional modifications that could be
achieved through conventional breeding. The request will have to
include the following supporting information, in writing:
A description of the modification(s);
The factual grounds demonstrating that the proposed
modification(s) could be achieved through conventional plant breeding;
Copies of scientific literature, unpublished studies, or
other data that support the request; and
Any information known to the requestor that would be
unfavorable to the request.
Paragraph (b)(4)(iii) provides the timeframe for Agency review of
such requests. It provides that, after APHIS receives all the
information required for a request, APHIS will complete its review of
the request and render a final determination within 12 months, except
in circumstances that could not reasonably have been anticipated.
Under paragraph (b)(4)(iv) if, after review of the request, APHIS
disagrees with the conclusions of the request or determines that there
is insufficient evidence that the modification could be achieved
through conventional breeding methods, APHIS will deny the request and
notify the requestor in writing regarding this denial.
Paragraph (b)(4)(v) provides for Agency actions when we agree with
a request. It states that, if APHIS initially determines that the
modification could be achieved through conventional breeding methods,
APHIS will publish a notice in the Federal Register in accordance with
the process set forth in Sec. 340.1(b)(4)(i).
Under paragraph (b)(4)(vi), a list specifying the additional
modifications allowed will be posted on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology. This list would
include both those additional modifications originally proposed by the
Administrator and those that originate with a request.
Some commenters suggested a change to the exemption in proposed
Sec. 340.1(b)(2) so that it would allow a limitless number of
synonymous base pair changes. Synonymous base pair changes, it was
stated, do not alter the amino acid composition of the encoded protein.
One commenter suggested changing the exemption to allow however many
specific and known base pair changes are needed to achieve the intended
MOA.
APHIS rejects the first suggestion because synonymous changes can
lead, and indeed have been made, to generate significant phenotypic
changes, e.g., by altering mRNA splice sites, promoters, and regulatory
RNAs. APHIS acknowledges that these types of phenotypic changes could,
in principle, also occur through a single deletion, insertion, or base
pair change in conventional breeding. However, these types of
phenotypic changes are unlikely to be possible in all or perhaps even
most genes through deletion or single base pair changes. Moreover,
multiple targeted changes within a single gene are generally not likely
to be achieved in conventional breeding. Therefore, the exemption will
not be broadened to include multiple synonymous base pair changes.
However, as discussed below under this same subheading of comment
responses, we have revised the exemption in Sec. 340.1(b)(3) to
clarify that if multiple sequence changes are needed to generate an
allele that will result in the intended phenotype and if those changes
are known to occur in the plant's gene pool, the GE plant would qualify
for the exemption.
One commenter stated that APHIS should eliminate the exemption in
paragraph (b)(3), regarding introducing variation known to occur in the
gene pool, because sequences found naturally in closely related,
sexually compatible organisms do not necessarily have acceptable risks
when introduced into other species. The commenter offered an example,
stating that ``the introduced nucleic acids can direct the synthesis of
toxins, change metabolism in harmful ways, turn on or off genes and
metabolic pathways in the genetically engineered host, and make the
genetically engineered organism more susceptible to pests and
pathogens, or more fit in the wild and more weedy.''
APHIS disagrees with the comment. The commenter is pointing out
harms that potentially could occur, and are no less likely to occur, in
conventional breeding programs. However, such harms have not
materialized in conventional breeding programs because they rarely
occur and are intentionally eliminated during the evaluation and
selection process (NRC, 1989).
One commenter wished to know whether the exemption in proposed
Sec. 340.1(b)(3) supersedes the exemption in Sec. 340.1(b)(1) and
(b)(2). Another commenter felt that the exemptions in paragraphs (b)(1)
and (b)(2) were too narrow because polymorphisms, insertions,
inversions, and multiple megabase deletions and translocations are
abundant in nature and frequently induced in breeding programs through
mutagenesis.
APHIS seeks to clarify that Sec. 340.1(b)(3) does supersede Sec.
340.1(b)(1) and (b)(2) in the number of changes that can be made under
the exemption. APHIS also seeks to clarify that paragraphs (b)(1) and
(b)(2) pertain to products of mutagenesis which have not been observed
in the gene pool, whereas paragraph (b)(3) applies only to variation
already known to occur in the gene pool. Therefore, the exemption in
paragraph (b)(3) allows the introduction of a gene, i.e., a functional
unit of DNA that encodes an RNA or protein, or of an allele (a variant
form of a gene or, for the purposes of this regulation, a genetic
sequence) containing multiple sequence changes as long as the allele is
known to occur in the gene pool of the plant. With regard to the
comment that the exemptions in paragraphs (b)(1) and (b)(2) are
unnecessarily restrictive because there are changes abundant in nature
not covered by these exemptions, APHIS wishes to clarify that the
duplications, inversions, translocations, and transpositions already
known to occur in the gene pool would qualify under the exemption in
paragraph (b)(3).
Some commenters suggested deleting ``natural'' from Sec.
340.1(b)(3) because the gene pool of a plant may include variation that
has been previously induced through chemical or radiation mutagenesis
or that could be introduced via human-assisted wide crosses. Further
comments on the exemption in paragraph (b)(3) recommended substituting
the phrase ``known to occur'' with some variation of

[[Page 29796]]

``otherwise accessible through traditional plant breeding methods.''
APHIS agrees with the first comment and disagrees with the second.
APHIS considers the known and accessible gene pool of a plant to
include not only genetic sequences that can be introduced to a plant
via crosses that can take place without human assistance, but also
genetic sequences that can be introduced to a plant via human-assisted
wide crosses between distantly related species. In systems for which
breeding techniques such as bridging and embryo rescue have been
developed to enable wide crosses, distantly related plants are also
considered part of the gene pool. However, these categories may not be
considered ``natural,'' so APHIS is in favor of deleting this term.
APHIS is retaining the phrase ``known to occur,'' however. As discussed
above, when we refer to GE plants that could otherwise have been
developed through conventional breeding methods, we do not mean any
genetic changes that are theoretically possible. Almost any genetic
change is theoretically possible, given enough time. APHIS' intention
in Sec. 340.1(b)(3) is to exempt from regulation a product that could
be practically expected to be pursued and achieved in a conventional
breeding program. To qualify for an exemption based on occurrence in
the gene pool, the genetic change must be known to occur. We do not
intend the exemption to apply to limitless possibilities that are
theoretically possible but not currently known to occur in the gene
pool. Consequently, the exemption in paragraph (b)(3) has been slightly
modified for accuracy and clarity.
Some commenters asked that the exemption in paragraph (b)(3) be
expanded to include plants in which an allele has been modified to
align with a similar known allele found in a close relative, or in a
more distant relative beyond the family level of taxonomy, or that we
exempt plants containing any sequence from a plant that is known not to
be a plant pest and is routinely used for food.
APHIS considers the known and accessible gene pool of a plant to
include not only genetic sequences that can be introduced to a plant
via crosses that can take place without human assistance, but also
human-assisted wide crosses between more distantly related species. In
systems for which breeding techniques such as bridging and embryo
rescue have been developed to enable wide crosses, more distantly
related plants are also considered part of the known gene pool. APHIS
agrees in principle that exchange of genetic information between
unrelated species is likely to be safe in most cases. However, APHIS
does not have the experience to definitively state that exempting all
exchange of DNA between plants will not lead to increased plant pest
risk. In cases where genetic material from a more distantly related
plant species is introduced into the plant, developers can request an
RSR.
A commenter stated that their understanding is that the exemption
in Sec. 340.1(b)(3) would include any insertion or other sequence
modification of less than 20 base pairs. APHIS disagrees and seeks to
clarify that even an insertion or sequence modification smaller than 20
base pairs that does not otherwise qualify for exemptions Sec.
340.1(b)(1) or (b)(2) still has to meet the criteria of paragraph
(b)(3) to qualify for exemption under paragraph (b)(3). The exemption
does not apply to what is theoretically possible. The genetic variation
must be known to occur in the plant's gene pool in order to qualify for
the exemption.
A commenter stated that the regulation could clarify that exemption
under paragraph (b)(3) covers the introduction of natural or chemically
synthesized copies of nucleic acid sequences from one plant species
into the same or a crossable plant species, including (a) the targeted
insertion or replacement of sequences exceeding 20 base pairs in length
(e.g., the insertion or replacement or a promoter, terminator, exon,
intron, or small open reading frame, excluding complete genes), (b) the
targeted replacement of a cisgenic allele (i.e., perfect allelic
replacement), (c) the targeted insertion of a cisgenic sequence at the
same or a different location in the genome of the recipient species,
and (d) the targeted insertion of a cisgene with a new combination of
genetic elements, as plants containing such changes could have occurred
naturally or could result from conventional breeding since they fall
under exemption under paragraph (b)(3). A second commenter stated that
some genetic engineering experiments will replace promoters, altering
gene expression patterns in ways that are not attainable by today's
breeders.
APHIS does not intend to modify the regulation text per the
commenter's suggestion. Exemption under paragraph (b)(3) will exempt
from regulation plants that have been modified to introduce a gene
known to occur in the plant's gene pool, or that make 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. Some of the
examples provided by the first commenter may thus not be eligible for
exemption under paragraph (b)(3). For instance, (b)(3) will not exempt
from regulation a plant containing an insertion of a gene that is known
to occur in the gene pool if the insertion results in the creation of a
gene not known to occur in the gene pool, e.g., a gene that results in
the production of a protein or RNA, or a loss or gain of function, that
is not known to be produced by plants within the gene pool. However, if
a specific modification can be demonstrated to be present in the
plant's gene pool, then it can be exempted under paragraph (b)(3). If a
developer has a question about whether its plant is exempt from the
regulation, the developer can contact APHIS for a consultation.
Some commenters asked how the deletion exemption in Sec.
340.1(b)(1) pertains to diploid and polyploid plants. For example, if a
deletion is made to both alleles of a diploid or all four or six
alleles in tetraploid and hexaploid plants, respectively, would those
plants qualify for the exemption?
APHIS seeks to clarify that exemptions in Sec. 340.1(b)(1) through
(3) apply to modifications made to one pair of homologous chromosomes.
It is very straightforward in conventional breeding to identify a
single allele in a diploid line and then convert the heterozygote to a
homozygote in the next generation. However, it is very difficult
through conventional breeding to create the same allele in all
homoeologous genomes in polyploid plants. Therefore, for polyploid
plants, the exemptions would initially apply only to modifications made
to one pair of homologous chromosomes. As an example, consider a change
to a gene in common wheat (bread wheat). Common wheat has three sets
(AA BB DD) of homoeologous chromosomes. A developer can qualify for the
exemption if modifying the A genome through a change that qualifies for
exemption (b)(1), (b)(2), or (b)(3). If the developer wanted to make
the same corresponding changes to the B and D genomes, the developer
would go through the RSR process (as described below). Once APHIS
determines that this A/B/D plant is unlikely to pose an increased plant
pest risk, it will go on the list of plant-trait-MOAs that do not
require regulation (i.e., the Sec. 340.1(c) exemption list). At that
point, this developer, and any others, would be able to make the same
plant-trait-MOA combination and be exempt from regulation under part
340.
Some commenters noted that the exemption in proposed Sec.
340.1(b)(4), i.e., the exemption of null segregants derived from GE
plants, is superfluous

[[Page 29797]]

because the definition of genetic engineering applies only to organisms
whose DNA sequence has been modified.
APHIS agrees with these commenters. According to our definition of
genetic engineering, the genome of null segregants has not been created
or modified. Therefore, null segregants do not need an exemption from
regulation, and APHIS is removing this exemption from the final rule.
Some commenters stated that the exemption in proposed Sec.
340.1(c) for a GE plant with a plant-trait-MOA combination that has
previously undergone an analysis in accordance with Sec. 340.4 and has
been found by the Administrator to be unlikely to pose a plant pest
risk should be eliminated. One commenter stated that the impact of
releasing new GE plants into the environment cannot be accurately
predicted or assessed without case-by-case analysis and controlled
field experiments. Another commenter stated that every transformation
event is unique, and thus potentially has a novel phenotype that must
be assessed to determine appropriate regulation. The commenter further
stated that the National Academy of Sciences (NAS) has also advocated
the use of genetic engineering [i.e., transformation] as ``both a
useful and scientifically justifiable regulatory trigger'' because
``there is no scientific basis'' on which to exclude GE organisms from
regulatory review prior to evaluation of data on the interactions
between ``trait, organism and environment.''
APHIS disagrees with these points. Based on the risk assessments we
have performed in accordance with the petition process over 30 years,
we have determined that, in many cases, we would have been able to
evaluate the plant pest risks associated with a GE organism without
field-test data. Rather, APHIS has discovered that the introduced trait
of the GE organism provides the most reliable indicator of the
organism's potential for deleterious effects on plants and plant
products. These observations are expected and are consistent with the
findings of reports of NAS (NRC, 1989; NAS, 2016). APHIS will seek
additional information, potentially including data from controlled
field experiments, in cases where APHIS identifies a plausible pathway
to increased plant pest risk.
The same NAS study (NRC, 2002) cited by the commenter stated the
following: ``Transgenic organisms have potential environmental risks,
but the committee expects that most of them will not produce
significant actual environmental risks. Consequently, the committee
also suggests that for environmental risk regulatory oversight should
be designed to winnow the potentially riskier transgenic crops from the
less risky ones before a substantial regulatory burden is imposed on
the less risky ones.'' APHIS has designed a system where organisms that
pose a plausible plant pest risk are rapidly distinguished from those
that do not, based on the RSR process described below under the
subheading ``Regulatory Status Review,'' focusing regulation on the
former. The exemption that we proposed in Sec. 340.1(c) will apply
only to those GE plants that have undergone a risk assessment in the
RSR process. The revised regulations are proportionate to risk and are
therefore consistent with the recommendation of NAS's study.
Several comments were received on the definition and application of
the term MOA as it relates to the exemption in Sec. 340.1(c). The
issues raised by the commenters are discussed in detail below.
Two commenters stated that the categories of trait (defined in the
June 2019 proposed rule as ``an observable (able to be seen or
otherwise identified) characteristic of an organism'') and MOA (defined
as ``the biochemical process(es) through which genetic material
determines a trait'') could be interpreted so broadly that new GE
plants that have a plant-trait-MOA combination similar to that of a
nonregulated plant, yet contain unique features with unknown impacts on
non-target organisms and the surrounding ecosystem, would not require
review by APHIS. They stated that, for example, the ``Cry \6\ protein
MOA'' could include dozens of possibilities with unknown effects, and
that it could even be the case that APHIS review would not be required
when any gene encoding a Cry protein that targets broad orders of
insect pests is inserted into a plant that had previously been
engineered with any other trait and had been found by APHIS not to pose
a plant pest risk.
---------------------------------------------------------------------------

\6\ A Cry protein is a crystalline protein toxic to certain
species of insects primarily produced by the bacterium Bacillus
thuringiensis (Bt). Genes for Cry proteins have been widely used to
confer resistance to insect pests in several types of crop plants.
---------------------------------------------------------------------------

APHIS disagrees with the suggestion that the proposed definition of
MOA is too broad. The suggestion is based on a misreading of the
definitions and the preamble of the June 2019 proposed rule. As
described in the preamble, the MOA refers to the specific manner by
which the genetic modification confers the intended trait on the plant.
We noted that the same trait can be obtained by different MOAs that
would thus be subject to distinct RSRs. In the example cited, the
preamble was clear that non-target impacts related to Cry proteins
depend on whether the non-target insect has the correct receptor in its
gut to bind the Cry protein; thus, for each new Cry protein it will be
important to evaluate the potential for non-target impacts. Similarly,
the preamble provided an example of RNA interference-based resistance,
where it would be important to consider the specific target RNA and its
corresponding protein in order to determine whether there could be non-
target effects. Moreover, the regulatory text and preamble were clear
that it is the specific plant-trait-MOA combination that is the subject
of the RSR and decision. Developers could not qualify for exemption
under Sec. 340.1(c) by inserting any cry gene that encodes a protein
targeting a broad order or orders of insects into a plant with any
other trait and MOA that was previously reviewed by APHIS.
Another commenter stated that reasonably broad MOA categories
should be established that would cover broad protein functional
classes, account for all normal polymorphisms found in nature at the
DNA and protein levels at the genus level, and account for the normal
wide variation in expression seen among transgenic events and
backgrounds. An additional commenter recommended that the definition of
MOA refer to the biochemical process(es) through which the gene, rather
than the genetic material, determines a trait, stating that it is a
gene product and not the genetic material that determines the resulting
biochemical process. Finally, a commenter requested that the final rule
clarify which products would qualify for the exemption in Sec.
340.1(c), noting that APHIS alternately used the terms ``same'' and
``similar'' to describe products that could qualify based on their use
of a crop-trait-MOA combination that has already been assessed by APHIS
and determined unlikely to pose a plant pest risk than the appropriate
comparator(s).
APHIS agrees that in most cases, the MOA could cover all normal
polymorphisms of a gene found in nature, even at levels broader than
the genus. For example, the outcome of an RSR would apply to genetic
material encoding an enzyme that catalyzes a specific biochemical
reaction regardless of whether the genetic material is sourced from a
plant or a microbe, as long as the enzyme catalyzes the same
biochemical reaction regardless of the organism from which the genetic
material encoding the enzyme is obtained, and does not catalyze any

[[Page 29798]]

additional biochemical reactions that differ among the source
organisms. APHIS does not agree that the MOA would be so broad as to
cover broad functional classes, since broad functional classes could
encompass many different proteins that have multiple differences in the
biochemical processes in which they participate. Typically, an RSR
would be conducted at the level of the MOA of individual genes. If
those genes when stacked produce a new phenotype, such as a new
biochemical pathway, APHIS will consider the interaction of the gene
products in the RSR. Regarding variation in expression, in most cases
APHIS anticipates that variation in expression should not affect the
outcome of an RSR. However, as we noted in the preamble to the June
2019 proposed rule, there may be cases where it is important to
consider where, when, or at what level the genetic material is
expressed in the plant. In those cases, APHIS will specify whether and
in what way variation in expression limits the outcome of the review.
APHIS will not revise the definition of MOA in response to these
additional comments, because some MOAs may not involve changes in gene
products but rather changes in genetic material that affect the
expression of gene products. As this discussion makes clear, a plant-
trait-MOA combination may qualify for the exemption only if the
combination is the same as a previously reviewed plant-trait-MOA
combination that has been found to be unlikely to pose a plant pest
risk. To be clear, a merely ``similar'' combination does not qualify as
a ``same'' combination, but a ``similar'' product may qualify for the
exemption if it has the same combination as a previously reviewed
combination.
One commenter urged that in addition to mutated products of genome
editing, the concept of exemptions due to familiarity should be
broadened to include plants with transgenic traits that are familiar in
type and inherently unlikely to give a significant advantage to wild
plants. Examples would be sterility traits, stature reduction traits,
and quality traits relevant to industrial processing (e.g., modified
lignin in alfalfa and trees). According to the commenter, another class
of strong candidates for plant kingdom-wide exemption are the widely
used marker genes, such as nptII for kanamycin resistance, T-DNA
borders, and widely used promoters such as 35S and NOS.
APHIS appreciates these comments. The commenter did not provide any
scientific evidence or explanation that would make the comments
actionable at this time, however.
Several commenters asked that APHIS clarify the regulation of
plants containing stacked traits. One commenter requested that APHIS
codify in the regulations that plants developed through conventional
breeding that are derived from products determined to not be regulated
(either because of an exemption or as a result of an RSR) would
themselves be unlikely to pose increased plant pest risk and therefore
would not be subject to regulation. Other commenters argued that APHIS
should assess the risks of stacked traits, particularly plants
containing multiple herbicide resistance traits, using the noxious weed
authority.
A discussion of our noxious weed authority in the context of these
regulations is presented later in this document.
APHIS notes that in accordance with Sec. 340.1(c), the regulations
under part 340 do not apply to a GE plant with a plant-trait-MOA
combination that has previously undergone an analysis in accordance
with Sec. 340.4 and is not subject to the regulations. APHIS notes
that the word ``combination'' used in the regulation text is
deliberately enumerated as singular and not plural in order to denote
that the exemption applies to a single plant-trait-MOA combination and
not a molecular stack of multiple plant-trait-MOA combinations. Plant-
trait-MOA combinations that have undergone an analysis in accordance
with Sec. 340.4 and are not subject to the regulations may be stacked
by conventional breeding methods and would still qualify for the
exemption. However, this is not the case for plant-trait-MOAs stacked
molecularly; today stacked traits typically have independent MOAs. In
the future, we anticipate seeing more interactions between or among the
products of genes in molecular stacks, potentially including new MOAs
that were not evident in the review of individual traits. For this
reason, APHIS anticipates that plants that are the genetically
engineered product of more than one previously evaluated combination
will be subject to evaluation under Sec. 340.4. In cases where there
is no interaction between trait-MOA combinations, we expect to be able
to use the results of previous reviews to quickly reach a regulatory
status determination.
Finally, several commenters requested clarity on the regulatory
status of plant-trait-MOA combinations that were previously deregulated
under part 340 or deemed to be not regulated under the ``Am I
Regulated'' (AIR) process.
To provide the clarity the commenters requested, we are amending
paragraph (c) to exempt from these regulations a GE plant that has a
plant-trait-MOA combination contained in a GE plant determined by APHIS
to be deregulated under a petition submitted prior to October 1, 2021
pursuant to Sec. 340.6 of the current regulations in part 340. We are
also adding a new paragraph (d) to Sec. 340.1, stating that all GE
plants determined not to require regulation pursuant to the AIR process
will retain their nonregulated status under these regulations.
As we have noted, APHIS will publish a list (referred to earlier in
this document as the Sec. 340.1(c) exemption list) of plant-trait-MOA
combinations that have been evaluated under our new RSR process and
found not to require regulation under part 340. That list may be used
by a developer to determine whether its novel GE plant would qualify
for exemption under Sec. 340.1(c). GE plants previously evaluated
under the petition process will be included on the Sec. 340.1(c)
exemption list because such plants will have effectively been evaluated
at the MOA level and determined not to pose a plant pest risk.
Plants that have been determined not to require regulation pursuant
to the previous AIR process will not be included on the Sec. 340.1(c)
exemption list because they will not have been evaluated at the MOA
level or by analogous criteria. Such plants will be identified at a
separate list, at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology. Because the plants to be identified on this separate AIR
list were not evaluated under the petition process or under the RSR
process, developers will not be able to use the AIR list in determining
whether new GE plants they develop should be subject to or exempt from
the regulations. At the same time, we have multiple reasons for
concluding that the specific plants on the AIR list should retain their
nonregulated status under these regulations. Not only do we lack a
basis for overturning our prior individualized determinations reached
pursuant to the AIR process, we also believe that it is appropriate for
us to take into account the importance of preventing potential market
disruptions, including potential trade disruptions, and providing
regulatory certainty for developers, third parties, and the general
public.
Self Determination
Under the June 2019 proposed rule, developers would have the option
to determine whether their plants belong to one of the categories
listed under Sec. 340.1(b) or (c) and are therefore

[[Page 29799]]

exempt from the regulations. As stated in the preamble to that proposed
rule, allowing for such ``self-determinations'' would provide
developers with regulatory relief and would open more efficient and
predictable pathways for innovators to get new modified plants that do
not require regulation to market, in turn supporting further
innovation. Eliminating the need for redundant evaluations of products
would allow APHIS to devote more attention to assessing and regulating
GE organisms that are likely to be associated with potential plant pest
risks.
While many commenters agreed with the rationale discussed above and
welcomed the regulatory relief that allowing for developer ``self-
determination'' would provide, others either opposed the concept
entirely or expressed reservations. Many in the latter category cited
what they believed to be potential risks that could result from
allowing developers to determine whether their products are eligible
for exemption from the regulations. Some industry commenters questioned
whether allowing developers to make such determinations would actually
relieve regulatory burden and incentivize innovation to the extent that
we anticipated. The comments are discussed in detail in the paragraphs
that follow.
Many commenters opposed ``self-determination'' on the ground that
allowing developers to regulate themselves could result in conflicts of
interest. It was stated that developers of GE products with a financial
stake in the outcome should not be allowed to determine which products
should be subject to regulatory review. According to these commenters,
such an approach would fatally undermine the integrity, rigor, and
credibility of what must be an independent regulatory process,
weakening Agency ability to protect the public interest, and furthering
mistrust in the U.S. Federal regulatory system in the public's eye and
among key trading partners. By avoiding the RSR or permitting process,
these commenters believed, the developer could get its new product to
market without its ever having undergone an objective, third-party
review. In allowing developers to determine whether their products are
eligible for exemption, according to these commenters, we are
effectively abdicating our regulatory authority and not carrying out
our mission to protect U.S. agriculture.
We do not agree with these comments. The revised regulations in
part 340 recognize that plant products that are the result of
modifications that coincide with conventional plant breeding do not
pose additional plant pest risk and should not be regulated under these
regulations. Products that do not fall within the regulatory scope of
part 340 have not been subject to compulsory regulation in the past,
and developers have always been able to act accordingly to determine
whether their products are subject to the regulations.
It was further argued that allowing developers to determine the
regulatory status of their products will result in less transparency
and greater risk of commingling with organic and other non-GE crops and
will damage consumer confidence. Allowing developers to determine the
regulatory status of their products, it was claimed, will result in an
overall loss of transparency in that the public would not have access
to the data used by developers to make their determinations. Organic
farmers would have less information about modified crops grown near
their fields than they do now, because the information that informed
developers' determinations would remain proprietary, and their ability
to take preventive measures would be hindered. Some commenters cited
the recent finding in Washington of unapproved GE glyphosate-resistant
wheat \7\ as an example of risks posed by allowing developers to
determine whether their products are eligible for exemption and by
reducing our regulatory oversight over GE products more broadly.
---------------------------------------------------------------------------

\7\ On June 7, 2019, APHIS confirmed the discovery of GE wheat
plants growing in an unplanted agricultural field in Washington
State. The GE wheat in question was resistant to glyphosate,
commonly referred to as Round Up. On July 12, 2019, APHIS announced
that the GE wheat plants in question were developed by Monsanto (now
owned by Bayer CropScience (BCS)) and referred to as MON 71300 and
MON 71800. APHIS also announced that there is no evidence that any
GE wheat entered commerce or is in the food supply. https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/brs-news-andinformation/2019_brs_news/wheat_update_jul2019.
---------------------------------------------------------------------------

We do not agree with these comments. With regard to transparency,
we anticipate that many developers whose products fall within an
exemption will request confirmation letters because the letters will
help them market their products domestically and overseas. Those
letters will be posted on the APHIS website and will be available to
the general public, including organic and other growers of non-GE
crops. Information from previous RSRs will also be available to the
public. We do not agree that self-determinations will limit organic
growers from learning whether their neighbors are growing GE crops.
This information principally comes from conversation with neighbors and
from other voluntary interactions and arrangements, and is not based on
USDA decisions on regulatory status. We also do not agree that the
finding of GE wheat in Washington fields is relevant to the regulatory
changes made in this final rule. Under the new regulations set forth in
this final rule, the GE wheat involved in the incident would not be
eligible for an exemption and would need to go through the RSR process.
The commenters are generally confusing a fact-specific compliance
issue, which could arise under any number of regulatory schemes, with
broader questions about the appropriate regulatory approach. If APHIS
were to find that a plant was unlikely to pose an increased plant pest
risk, APHIS would make information publicly available regarding the
plant, trait, and a general description of the MOA. In cases where GE
crops are not subject to regulation because they are unlikely to pose a
plant pest risk, no other risks are regulated by APHIS insofar as they
are outside the scope of the regulations.
In the preamble to the June 2019 proposed rule, we stated that a
developer who made a determination of regulatory status that APHIS
found not to be valid would be subject to remedial measures or
penalties in accordance with the compliance and enforcement provisions
contained in Sec. 340.6 of the June 2019 proposed rule.
Some commenters stated that there is a need for a plan for
detection and enforcement in cases where developers incorrectly
determine their products to be non-regulated, or where changes in
evidence may call a developer's determination into question. Without a
record of what plants are being released, according to these
commenters, it will be impossible to conduct any kind of periodic
surveillance or audit to ensure compliance. These commenters believe
that this difficulty may be partly addressed by having a compulsory
reporting mechanism whereby a responsible party fills out a form to
declare its modification and assert its exempt status. This would
create a searchable record. According to such commenters, a database
compiled from self-reported data would not offer complete protection
against bad actors, but when combined with penalties that are
proportional to the degree of harm done by a developer incorrectly
making a determination, such a database may aid in correcting incorrect
determinations by developers.
APHIS disagrees with the proposal for a mandatory process and the
data base proposals associated with it and has instead included
provisions in part 340 for a voluntary confirmation process for

[[Page 29800]]

products exempted from the regulation. Voluntary confirmation will be
public information, however, and interested parties could search for it
of their own volition.
Under APHIS's long-standing regulations, APHIS regulates articles
based only upon a narrow and limited plant pest mechanism. The products
that commenters are concerned will be ``missed'' or ``overlooked'' in
the ``future'' have no current regulatory trigger. Under this rule,
APHIS' focus will be on plant pest risk associated with the product,
consistent with our legal authority. Consistent with long-standing
practices, we will continue to offer voluntary confirmation of
regulatory status to those who seek it. APHIS agrees with comments
expressing concern that a mandatory process may trigger confusion among
both consumers and the international trading partners, by unnecessarily
hindering global acceptance of products of biotechnology. That said, if
the market demands confirmation of regulatory status, APHIS has created
a mechanism for developers to request such confirmation, and for us to
provide it.
APHIS also notes that a large number of commenters supported the
kind of voluntary confirmation process contained in this final rule for
regulatory exemptions, noting public access to the confirmation
letters. Those comments noted that a voluntary process would provide
domestic and international transparency, be beneficial for marketing of
new products, support deregulation processes in other countries,
facilitate exports, facilitate the development of new genome edited
plant varieties, encourage the continued domestic and global adoption
of new traits, and enhance harmonization of global trait approvals.
If a plant pest issue arises from a plant that is exempt from these
regulations, APHIS has mechanisms to address such risks subsequently
and has a wealth of experience in dealing with such instances. As under
the current regulations, a developer could knowingly or unknowingly
violate APHIS regulations by transporting, importing, or releasing into
the environment a regulated plant without APHIS authorization. The PPA
contains authority for the Administrator of APHIS at any point to place
such articles under regulation. If a determination made by a developer
should be found to be invalid, however, APHIS does have the authority
to enforce sanctions. As noted in the preamble to the June 2019
proposed rule, pursuant to sections 7714 and 7731 of the PPA, APHIS may
seize, quarantine, treat, destroy, or apply other remedial measures to
an organism covered under the regulations that is new to or not widely
prevalent or distributed in the United States to prevent dissemination
of the organism. Enforcement provisions are also included in Sec.
340.6 of this rule. APHIS has many years of experience in initiating
and coordinating enforcement action as appropriate, in cases where
compliance issues exist.
Even in cases where we would impose penalties for invalid
determinations by developers, some commenters expressed skepticism that
those penalties would be efficacious in remediating harm or preventing
further harm. In the view of these commenters, if the movement or
release of a GE product that had already reached the market based on a
faulty determination by a developer resulted in commingling with other
crops or the dissemination of plant pests, whatever penalties or
remedial actions APHIS would impose would likely neither prove adequate
to address injuries to innocent parties nor provide sufficient
disincentives to discourage bad actors from making invalid
determinations. Elaborating on the latter point, one commenter stated
that penalties imposed by APHIS after the fact may not even be legally
defensible if we have allowed a developer to determine whether its
product is eligible for exemption. Another commenter stated that APHIS,
lacking a post-commercialization monitoring program, has little
capacity to recall the products of invalid determinations by
developers.
We do not agree with these comments. In the event that APHIS
discovers that a developer makes an invalid determination, the specific
penalties and/or remedial action will be applied case by case, as
appropriate. Similarly, whether the discovery of an invalid
determination is too late will also be decided on a case-by-case basis.
In regard to legal defensibility, the PPA provides ample flexibility
and broad civil penalty authority to deter violations of the PPA. For
example, the PPA provides statutory maximum penalties of $1,000,000 per
violation for any person who willfully violates the PPA.
Other commenters feared that the penalties could be excessive. It
was stated that any such penalty applied to a developer must be based
on a demonstration of significant economic harm to another entity from
the error, and not on technical or minor errors in interpretation. The
commenters further stated that in such situations, the penalties must
be proportional to that harm.
We agree that penalties must be proportional to the severity of
violations and the harms that may result from them, and we will enforce
the regulations accordingly. Furthermore, the harms must fall within
the harms considered under the PPA. Congress has outlined the factors
for consideration in assessing penalties under the PPA. These factors
include ``the nature, circumstance, extent, and gravity of the
violation or violations,'' as well as the violator's ability to pay,
the effect of the penalties on the violator's ability to continue to do
business, and any history of prior violations. (See 7 U.S.C. 7734.)
In the preamble to the June 2019 proposed rule, we stated that one
of the benefits of ``self-determination'' is that it would enable APHIS
to focus its regulatory resources and risk analyses on unfamiliar
products and thereby to avoid conducting repetitive analyses on GE
products that are very similar to those that we have already evaluated
for regulatory status. APHIS would thus be able to utilize its staff
time more efficiently, and provide better stewardship of taxpayer
dollars than it could under the existing regulations.
One commenter viewed allowing developer-made determinations as
evading APHIS' regulatory responsibilities rather than enabling APHIS
to use its resources more efficiently. The commenter stated that if GE
developers are concerned about delays in getting their products to
market because, in their view, APHIS does not have sufficient resources
to conduct all reviews in a timely manner, then those developers should
lobby Congress to provide more funding to enable APHIS to perform its
duties in a more timely manner, as opposed to having APHIS reduce its
oversight role.
APHIS disagrees with this comment. The plants that qualify for
exemption under part 340 fall into three categories: (1) Those that
could otherwise have been developed through conventional breeding
methods and have a history of safe use related to plant pest risk that
does not require regulation (Sec. 340.1(b)(1) through (3)); (2) those
that have the same plant-trait-MOA combination as other plants that
have already been evaluated by APHIS and have been found to be not
subject to the regulations (Sec. 340.1(c)); or (3) those determined to
be not subject to the regulations under the AIR process. It should be
noted that plants that qualify for exemption under Sec. 340.1(c) are
very similar to plants that have been evaluated previously by APHIS.
APHIS can utilize its resources most efficiently

[[Page 29801]]

by evaluating GE plants that do not fall into these categories and
therefore may pose a level of plant pest risk that requires regulation.
Many other commenters expressed skepticism from an opposing
perspective about the efficacy of allowing developers to determine
whether their products are eligible for exemption. These commenters
doubted that such ``self-determination'' would provide the regulatory
relief that we claimed in the preamble to the June 2019 proposed rule.
One reason given was that most developers would seek certification or
confirmation from APHIS that their determinations were valid, given the
possible liabilities associated with making incorrect determinations.
Such certification would therefore become a de facto requirement. One
commenter expressed the concern that in order to receive such
confirmation, developers would need to provide the information
described in proposed Sec. 340.4, which contains information
requirements for RSRs. It was further suggested that while academics,
startups, and small developers could see some benefit from ``self-
determination,'' companies with existing portfolios of GE crops will be
in a better position to benefit.
We do not agree with these comments. If innovators choose to forgo
the regulatory relief provisions offered by our revision of the
regulations in part 340 for any reason, they are welcome to do so. In
this final rule, APHIS focuses on plant protection, while also easing
regulatory burdens. Accordingly, we also aim to be responsive to
repeated concerns raised by small businesses, academic-based
researchers, and other innovators who have reported past difficulty
successfully seeing products through to commercialization. The approach
APHIS has taken is fully consistent with the priorities and direction
provided by Executive Order 13874, which we have discussed earlier.
In Sec. 340.1(d) \8\ of the June 2019 proposed rule, we indicated
that developers may request confirmation from APHIS that the plant is
not within the scope of the regulations in part 340. A developer may
find a confirmation letter useful in marketing its products
domestically or overseas because the letter would serve as verification
to an importing country or other party that APHIS concurs with the
developer's determination. Confirmation is not required, however, and
for developers not seeking confirmation letters, no submission of
information to APHIS is required, nor is any response from APHIS.
Guidelines for the information that would need to be submitted to
enable APHIS to respond to a request for confirmation are discussed
below under this same subheading of comment responses.
---------------------------------------------------------------------------

\8\ Due to the addition of a new paragraph (d) in Sec. 340.1,
as described earlier, provisions related to confirmation letters are
contained in Sec. 340.1(e) of this final rule.
---------------------------------------------------------------------------

Some commenters expressed doubt that developers would even be able
to employ the ``self-determination'' option due to what they perceived
as a lack of clarity surrounding it. It was stated that decisions on a
product's regulatory status would be based on APHIS' assessment of
plant pest risk, but that because APHIS would define plant pest risk
and because APHIS did not provide a list of traits for identification
of a plant pest in the proposed rule, a developer would lack the
guidance to make a determination safely.
APHIS disagrees with this comment. This rule clearly outlines the
kinds of information needed to successfully navigate the APHIS
regulatory system, as well as the protection goals and criteria that
APHIS will consider as part of this process. Plants that meet the
exemptions listed under Sec. 340.1 will not require regulatory
oversight under the regulations in part 340. The exemptions in Sec.
340.1(b) are based not on the trait, but on whether the plant could
have otherwise been produced through conventional plant breeding
techniques. The exemption in Sec. 340.1(c) is based on whether the
plant-trait-MOA combination is the same as one that APHIS has
previously determined to be nonregulated. APHIS will publish a list of
such combinations, which developers may use in determining whether
their GE plants qualify for exemption under Sec. 340.1(c). As more GE
plants undergo RSRs to determine their regulatory status, that list
will grow. A list of traits for identification of a plant pest is not
needed in order for developers to determine whether their products meet
one of these exemptions in Sec. 340.1(b) or (c).
Several commenters recommended that we provide more certainty about
the process by issuing guidance documents to aid developers in making
their determinations. Such documents, it was stated, could include,
among other things, information requirements and timelines, including
timelines for APHIS responses to requests for confirmation. Many
commenters stated that, in general, defined timeframes for APHIS
regulatory actions are important to improve predictability and to
support the planning needed to conduct seasonally based field research,
and therefore should be included in the regulations. Most commenters
who provided specific timeframes for confirmation requests suggested
that APHIS should respond to such requests within 60 days. It was
further suggested that to provide developers with additional guidance
for making determinations, APHIS should maintain a database of products
that have undergone RSRs and been found not to be subject to the
regulations.
APHIS has had a longstanding practice of providing guidance to aid
the regulated community in complying with the regulations. APHIS will
provide guidance to developers regarding the confirmation process. We
will also maintain on our website requests for and results of RSRs.
That information will aid developers in making their determinations.
Regarding timeframes, in the preamble to the proposed rule, APHIS
noted that we anticipate a timely turnaround time in providing
confirmation letters. APHIS agrees that providing a more specific
timeframe for responses to confirmation requests would improve
predictability. Based on our experience with the current AIR process,
which is functionally similar to the confirmation process, APHIS has
amended Sec. 340.1(e) by adding a sentence indicating that, except in
unforeseen circumstances, written responses will be provided within 120
days of receiving a confirmation request containing sufficient detail
to determine whether the plant meets one of the exemptions in Sec.
340.1.
One commenter stated that the type of information provided to APHIS
by developers should be a description of the crop and the justification
for meeting the exclusion, which would be similar to the information
submitted for the ``Am I Regulated'' Process.
APHIS agrees with the sentiment expressed in this comment and is
therefore setting out guidelines for parties requesting confirmations
to submit to APHIS in support of their requests. The guidelines are
listed below and will also be posted on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology. In addition,
developers who have specific concerns may consult with APHIS.
In communications with APHIS requesting confirmation of exemption
from the regulations, requestors will be expected to submit the
following:
1. A description of the plant, trait(s), and modification(s).
2. A clear statement of which regulatory exemption the
biotechnology developer is claiming for the plant and

[[Page 29802]]

why the plant qualifies for that exemption.
3. Details about the scientific method used to validate that the
plant met the exemption criterion.
APHIS expects that the description of the plant will include both
the scientific and common names. The trait information should include a
description of the intended and any observed phenotype(s) of the plant.
Details about the modification(s) must provide APHIS with a clear
understanding of the genetic change in the plant. In the case of Sec.
340.1(c) exemptions, requestors must submit the MOA.
Many commenters advocated that we establish a mandatory process for
developers to notify APHIS of their determinations and for APHIS to
issue confirmations. (We would note here, however, that there was
considerable divergence of opinion on this issue, with 25 commenters
expressing support for maintaining a voluntary confirmation process.)
Some commenters requested that confirmation be mandatory for all
determinations made by developers, while others stated that
confirmation should be mandatory only for developer-made determinations
of products that will be commercialized. Many requested that the
process be streamlined and include information and self-reporting
requirements and timelines. It was recommended by some commenters that
developers be required to provide notice to APHIS 90 days before
putting a product on the market.
We will not be making any changes to this final rule in response to
these comments. The confirmation process laid out in the June 2019
proposed rule was voluntary, and switching over to a ``mandatory''
confirmation and/or notification process in this final rule would run
counter to the spirit of regulatory relief underlying our new
regulatory framework. A voluntary confirmation process allows the
market to drive the demand for new plants, avoids codifying a process
that may grow antiquated as technology develops, provides developers
with a method to obtain confirmation that their products are in fact
exempt from the regulations, and avoids differential treatment for
genome-edited products that are otherwise equivalent to conventionally
bred and/or developed products.
Commenters did not persuasively explain how developers of products
that are not subject to the regulations could be compelled to comply
with a requirement for mandatory participation in a confirmation
process. APHIS notes that even if the commenters had provided a
sufficient regulatory mechanism to impose such a requirement, a
mandatory process would likely trigger the emergence of trade concerns,
as products that are scientifically justified to be exempt would also
appear on lists of GE organisms-essentially creating a third category
of products that are required to be listed but are otherwise exempt
from regulation (in addition to two other categories: (1) Organisms
that were subject to RSR and determined not to be regulated by APHIS,
and (2) regulated organisms). APHIS further notes that a mandatory
process would likely disadvantage the very small-scale, mid-size, and
university researchers and innovators that the rule was intended to
aid. Lastly, APHIS notes that the proposal for a mandatory confirmation
provides no added benefit in plant protection.
Some of the commenters who favored a formal or mandatory
confirmation process did so because they questioned the utility of a
voluntary process. It was stated that an APHIS confirmation that a
determination made by a developer is valid, as provided for in the June
2019 proposed rule, will be a formulaic letter without an accompanying
risk assessment. Some trading partners may not view such confirmation
letters as sufficient to meet their own requirements for admission of
U.S. GE products. It was stated that to keep export markets running
smoothly, industry needs an official U.S. attestation that the new
traits do not pose a plant pest risk.
We do not agree with these comments. The confirmation letters will
state that the product in question meets a regulatory exemption or has
a plant-trait-MOA combination that has already been reviewed by APHIS.
APHIS currently works with, and is committed to continuing to work
with, international trading partners and exporters to resolve trade
concerns. International trade issues are discussed in greater detail
later in this document.
Some commenters addressed the issue of whether, or how much,
information pertaining to determinations made by developers and APHIS
confirmations should be made public. Some commenters, citing the need
for transparency and certainty, recommended that we post confirmation
inquiries and confirmation letters on our website. Others, however,
thought that such information should be treated as confidential
business information (CBI) and therefore not be made publicly
available. One commenter suggested that we use a process similar to
that of the existing ``Am I Regulated'' process, under which CBI
exemptions could be claimed in the request for confirmation submitted
to APHIS, and a non-CBI version of the submission could be made
publicly available.
In the interest of transparency, APHIS will post the confirmation
letters online. APHIS notes, however, that confirmation letters are
subject to claims of CBI and will proceed in implementation of such
posting in accordance with all applicable laws and procedures. In
accordance with USDA regulations, 7 CFR 1.8(a) through (c), a submitter
of confidential commercial information must use good-faith efforts to
designate, at the time of submission, any portion of its submission
that it considers to be protected from disclosure under Exemption 4 of
the Freedom of Information Act (FOIA) (5 U.S.C. 552). When making
discretionary releases of records, as is the case with the posting of
the confirmation letters online, APHIS follows the FOIA, USDA, and
APHIS implementing regulations (7 CFR subpart A and 7 CFR 370.5,
respectively), and guidance from the U.S. Department of Justice's
Office of Information Policy relating to the handling of confidential
business information.
Finally, there were a few comments on proposed Sec. 340.1 that did
not fall into any of the categories discussed above.
One commenter suggested that the exemptions should focus on plant
species, not variety, as well as the purpose and type of application of
genome editing. The commenter stated that genome editing can be used
both to produce or improve on a specific characteristic or phenotype,
such as by silencing a disease sensitive gene, and to improve existing
breeding processes themselves, such as by using gene editing to more
efficiently induce double haploids.
The ``purpose and type of application of genome editing'' is just
another way of describing the plant-trait-MOA combination. In the
example given above where genome editing is used to improve an existing
breeding process by more efficiently inducing double haploids, genomic
modifications will be made to a specific plant, with a specific trait,
having a specific MOA. Recently a widely used haploid inducer in corn
was identified to be a defective allele (matL) of the gene named
Matrilineal (Kelleher, 2017). A haploid induction trait was shown to
work in rice by genome editing the matL allele (Yao, 2018). APHIS
considers this new process to be an example of a plant (rice), trait
(haploid induction), MOA (defective pollen specific phospholipase)
combination. Upon

[[Page 29803]]

completion of an RSR for this plant trait MOA combination, the Sec.
340.1(c) exemption would apply to all varieties of rice, not just the
variety it was introduced into.
Another commenter thought that there was a possible conflict
between Sec. Sec. 340.1(c) and 340.2(a). The latter paragraph of the
proposed rule stated that a plant with a plant-trait-MOA combination
that has not been evaluated by APHIS for regulatory status in
accordance with Sec. 340.4 would have to move under permit. According
to the commenter, the conflict arises because products we would allow
to move without permits based on developers' determinations would not
have been evaluated by APHIS.
We do not see such a conflict. When a developer determines that a
GE plant falls under Sec. 340.1(c), it is not subject to the
regulations in part 340 and therefore does not require a permit for
movement. We are making an editorial change to Sec. 340.2(a), however,
to clarify that a GE plant will be subject to the regulations: (1) If
it has not undergone an RSR in accordance with Sec. 340.4; or (2) if
it has undergone an RSR and, as a result of the evaluation, is subject
to the regulations. Such GE plants will require permits for movement.
One commenter stated that by allowing developers to determine
whether their products are eligible for exemption, we would not be in
compliance with the requirement of the Cartagena Protocol on Biosafety
that countries list all GE organisms released into the environment in
the Biosafety Clearing House.
APHIS notes this comment, and wishes to clarify that the United
States is not a signatory to the Cartagena Protocol on Biosafety. APHIS
also notes that Article 3 of the Cartagena Protocol on Biosafety does
not reference ``GE organisms.'' Instead, Article 3 (g) states that
``living modified organism means any living organism that possesses a
novel combination of genetic material obtained through the use of
modern biotechnology.'' Many international efforts are underway to
align regulatory approaches and to seek compatibility for emerging
technologies that were not in existence when existing policies were
developed.
Two commenters requested that APHIS develop and issue guidance for
developers of non-plant GE organisms to give them an opportunity to
determine for themselves whether their products are subject to the
regulations and to apply to APHIS for confirmation of regulatory
status.
APHIS does not agree that such a new process needs to be developed.
Currently, the Agency responds to the developers' questions about
whether a specific GE organism, including a non-plant organism, is
subject to the regulations. APHIS will continue that practice after
this final rule becomes effective.

Scope of the Regulations

Section 340.2 of the June 2019 proposed rule delineated the scope
of the regulations. We proposed to regulate, i.e., require a permit for
the movement of, any GE organism that:
1. Is a plant that has a plant-trait-MOA combination that has not
been subject to RSR; or
2. Meets our proposed definition of a plant pest; or
3. Is not a plant but has received deoxyribonucleic acid (DNA) from
a plant pest, and the DNA from the donor organism either is capable of
producing an infectious agent that causes plant disease or encodes a
compound that is capable of causing plant disease; or
4. Is a microorganism used to control plant pests or an
invertebrate predator or parasite (parasitoid) used to control
invertebrate plant pests and could pose a plant pest risk.
As was the case with the proposed exemptions, commenters expressed
a wide range of views regarding the scope of the proposed regulations.
While some supported our overall approach, others expressed the view
that the proposed rule would either narrow or broaden our regulatory
oversight excessively.
Some commenters who favored a broader scope stated that a
regulatory approach that provides for regulations of only those GE
organisms that are plant pests or pose a plant pest risk is too narrow.
Such an approach, it was stated, isolates the GE organism from the
environment in which it is used and the process by which it is
developed, thereby impeding science-based risk assessment. According to
these commenters, other hazards potentially associated with GE
organisms and not accounted for in the June 2019 proposed rule need to
be addressed. Some concepts discussed in these submissions included the
increased potential for commingling with non-GE crops; the potential
for contributing to the creation of herbicide-resistant weeds;
pesticide overuse; habitat destruction; reductions in insect
populations; and increased herbicide use, which, according to the
commenters, has been associated with GE crops and may have additional
deleterious effects on the environment and on human health.
While we recognize commenters' interests in addressing these
concerns, many of these comments are outside the scope of this
rulemaking and APHIS's statutory authority under the PPA. Commingling
between GE and non-GE crops is generally a market issue unrelated to
plant pest risk. Herbicide use is regulated by EPA, not USDA, so is not
within the scope of this regulation. The basis for the commenter's
claim that GE crops result in habitat destruction is not clear;
however, we note that APHIS does not regulate farming practices. USDA's
National Resources Conservation Service does have incentive programs to
promote more sustainable farming. The current rule includes an RSR
process that considers, as appropriate, impacts (if any) of a GE crop
on populations of beneficial insects and other non-target organisms
beneficial to agriculture.
Some commenters questioned the scientific justifications for the
above listed categories of GE organisms that would fall under the
regulations. It was stated that APHIS needs to re-cast its entire
proposal and frame it around the identification of the characteristics
of the organism or phenotypes of concern for which a plausible case can
be made, based not on speculation but data and experience, that they
present an unreasonable risk to American agriculture. It was further
argued that there is no scientific justification for regulating by
plant-trait-MOA instead of phenotype associated with the trait.
In order for the regulations under part 340 to enable future
innovation while simultaneously protecting American agriculture from
potential risks to plant health, it is vital that the regulations be
prospective rather than retrospective, while being appropriately
tailored to risk. A regulation that enumerated specific phenotypes that
APHIS is concerned with would not only be impractical, since a
phenotype may be of concern in one plant species but not in another
(including depending on whether the plant has sexually compatible
relatives, an attribute important for considering the distribution of a
phenotype introduced into a plant), but would become immediately
obsolete upon issuance. As articulated clearly in numerous studies,
including those by the National Academy of Sciences, no entity has the
foresight to identify only those phenotypes that present concerns
decades into the future. Moreover, the MOA utilized by the developer
matters when determining if there is a plant pest risk. The same
intended phenotype can result from multiple different MOAs, but each
MOA may differ in other phenotypes and thus may differ in their ability
to present a plant pest risk and

[[Page 29804]]

in the types of plant pest risk they may present.
APHIS thus does not consider the approach of regulating solely by
phenotype to be feasible. Instead, APHIS has articulated a regulatory
approach that is adaptable to future innovation and continues to
protect against risk, even in cases where it is not possible to
envision the kinds of products being developed in the future. In
particular, we have developed the RSR process in order to determine,
based on scientific knowledge and information, if a GE plant contains a
plant-trait-MOA combination that could plausibly present an increased
plant pest risk than the appropriate comparator plant(s). We will
regulate a GE plant only when we identify and are unable to rule out a
plausible pathway to increased plant pest risk. In this way, when
sufficient data and experience are lacking to rule out a plausible risk
identified by APHIS, we have a mechanism to acquire more information to
test the specific plausible risk hypothesis before decision making.
The risk-based system APHIS has developed in part 340 appropriately
provides entrance for genetically engineered organisms into the
regulatory framework and provides appropriate off-ramps from regulation
for those products that do not pose plant pest risks. Conversely, a
narrowly focused characterization of an intended phenotype, regardless
of the plant species or MOA by which the phenotype is conferred, would
not provide a sound scientific basis for an entire regulatory program.
Many commenters expressed support for our scientific and risk-based
regulatory process that evaluates plants based on their plant-trait-MOA
combination.
A commenter stated that the restriction in Sec. 340.2(c) covering
a non-plant GE organism that has received DNA from a plant pest is
unclear and lacking in scientific justification. The commenter
questioned whether receiving DNA from a plant pest would likely make
the recipient into a plant pest.
The commenter misconstrues Sec. 340.2(c), which states that non-
plant GE organisms that receive DNA from a plant pest will be regulated
if that DNA is capable of producing an infectious agent that causes
plant disease or if the DNA encodes a compound that is capable of
causing plant disease. Such non-plant GE organisms could pose a plant
pest risk, justifying their regulation under part 340.
Some commenters stated that organisms and microorganisms used to
control plant pests should not require regulation if they are not plant
pests themselves or do not pose a plant pest risk. One commenter stated
that there appears to be a conflict between Sec. 340.2(d) and EPA's
regulatory authority under the Federal Insecticide, Fungicide, and
Rodenticide Act for microbial pesticides. The commenter further stated
that the intent of the PPA for biological control organisms is to
facilitate their development, but that APHIS is proposing to require
additional regulatory requirements without indicating a need for these
extra requirements in terms of protecting against plant pests.
We agree with the first comment (i.e., that organisms and
microorganisms used to control plant pests should not require
regulation if they are not plant pests themselves or do not pose a
plant pest risk), and this rulemaking does not provide for the
regulation of biological control organisms if they are not plant pests
themselves or do not pose a plant pest risk. As we noted in the
preamble to the June 2019 proposed rule, ``GE non-plant organisms that
do not pose a plant pest risk would not fall under the scope of the
regulations and therefore would not require permits for movement.'' We
disagree with the remaining comments. As we noted in the preamble to
the proposed rule, while biological control organisms are generally not
plant pests, some biological control organisms could be plant pests
because their potential effects on organisms beneficial to agriculture
could indirectly affect plant health. The PPA provides the authority to
regulate such biological control organisms used to control plant pests
to ensure that they do not pose a plant pest risk. As with non-GE
biological control organisms, the types of GE biological control
organisms that APHIS would regulate include organisms that could pose a
plant pest risk by lacking sufficient specificity for the target pest
and thereby harming beneficial non-target organisms, such as other
invertebrate predators or parasites (parasitoids), pollinators, or
microbes that promote plant health. Because biological control
organisms are almost always intended for eventual release into the
environment, it is not sufficient for us to consider only their use in
controlling their target plant pest. We must also take into
consideration the indirect plant pest risks that the organism may pose
due to harmful impacts on non-target organisms that are beneficial to
agriculture (e.g., harm to natural enemies of plant pests). If the GE
organism is known to have harmful impacts on beneficial non-target
organisms, it is consistent with APHIS' authority under the PPA to
prohibit or restrict its release. To the extent that we do not know
whether a GE biological control organism is sufficiently specific to
avoid harming beneficial non-target organisms, it is also prudent for
us to place regulatory controls on the movement and release of the GE
biological control organism until the impacts on beneficial non-target
organisms and any resulting direct or indirect plant pest effects are
better understood. In addition, we will exempt biological control
organism-containing microbial pesticide products that are currently
registered with EPA as microbial pesticide products that are not plant
pests.

Definitions

In this final rule, we have revised the definition of article to
provide greater clarity. The definition in the June 2019 proposed rule
was drawn from that provided in the PPA. However, while the PPA
indicates that an article may be an object that could harbor noxious
weeds, upon review of the provisions of the proposed rule, we have
determined that it is not appropriate to consider such an object an
article under these revised part 340 regulations. The proposed
definition could have been interpreted to suggest that APHIS intends to
regulate GE organisms, and require permits for their movement, under
the revised regulations based solely on their noxious weed potential.
As discussed elsewhere in this document, however, this is inconsistent
with APHIS' intent. The revised definition reads as follows: ``[a]ny
material or tangible object that could harbor plant pests.''
A commenter stated that we need to define environment, because
movement under permit includes release into the environment.
Environment was defined in the proposed rule, however, and we are
retaining that definition in this final rule.
In the June 2019 proposed rule, we defined environment as ``[a]ll
the land, air, and water; and all living organisms in association with
land, air, and water.'' We are retaining that proposed definition
without modification in this final rule.
Numerous commenters stated that the proposed definition of genetic
engineering requires greater clarity. Several commenters asked APHIS to
clarify that ``synthetic'' nucleic acids, for the purposes of this
regulation, are those that are non-naturally occurring. Some commenters
requested that APHIS clarify what is meant by both ``recombinant'' and
``synthetic'' nucleic

[[Page 29805]]

acids and cited the definitions and exemptions in the National
Institutes of Health (NIH) Guidelines for Research Involving
Recombinant or Synthetic Nucleic Acid Molecules'' (https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf). One commenter
stated that they understood the term ``synthetic nucleic acid'' to
refer to a sequence that was created ``new from scratch,'' and not to a
plant's nucleic acid sequence that was modified.
APHIS does not agree that the term ``recombinant'' requires further
definition in these regulations. After nearly half a century of
research and development involving recombinant nucleic acids, the term
``recombinant nucleic acids'' is well understood. The definition that
APHIS proposed was based on the definition of ``recombinant and
synthetic nucleic acids'' contained in Section I-B of the NIH
Guidelines. Accordingly, by ``synthetic'' nucleic acids we mean nucleic
acids that are chemically or by other means synthesized or amplified,
including those that are chemically or otherwise modified but can base
pair with naturally occurring nucleic acid molecules. Such nucleic
acids are not limited to those that are non-naturally occurring. They
could also include nucleic acids with sequences identical to those that
are naturally occurring, but which have been synthesized or amplified,
rather than constructed by joining nucleic acid molecules (nucleic
acids that have been so constructed are recombinant nucleic acids).
APHIS agrees that greater clarity regarding the term ``synthetic''
would provide developers and other stakeholders with a clearer picture
of the products that are included within the scope of the regulations.
Therefore, we are changing the definition of ``genetic engineering'' to
``techniques that use recombinant, synthesized, or amplified nucleic
acids to modify or create a genome.'' This change is consistent with
the objectives of the Coordinated Framework, in that it aligns our
usage of the term ``synthetic'' with that of the NIH.
One commenter believes that the definition for genetic engineering
should include changes to the epigenome.
APHIS does not agree. Epigenetic changes are caused by endogenous
regulatory processes, such as DNA methylation and histone modifications
through naturally occurring enzymes. Epigenetic changes are also caused
by small naturally occurring RNA molecules. Epigenetic changes reflect
an interaction of the genome with the environment that leads to changes
in gene expression without changing the sequence of DNA. Epigenetic
engineering differs from genetic engineering in that the former merely
adjusts the innate potential of the genome of an existing organism,
whereas genetic engineering has the potential to create organisms that
could not exist but for the technology.
Some commenters recommended that we add a definition of genetically
engineered organism to provide greater clarity relating to which
organisms would be regulated. The following language was a suggested
definition: ``An organism developed using genetic engineering,
excluding those offspring that do not retain the genetic modification
of the parent. For the purposes of this part, a plant will not be
considered a genetically engineered organism if it meets any of the
criteria outlined in Sec. 340.1(b)(1)(3).''
We do not agree with this comment. At the forefront, the SECURE
rule establishes clear exemptions for products that are not subject to
regulatory oversight under part 340, and, thereafter, sets forth
definitions for genetic engineering and for organism. Although we are
able to offer regulatory relief in part 340 by excluding those products
of biotechnology that mimic what can be achieved though plant breeding,
APHIS has not, in this rulemaking or prior rulemakings involving part
340, taken the position that genome editing does not constitute genetic
engineering. Taking such a position would be inconsistent with the
generally accepted scientific characterization of genome editing
technology (Knott and Doudna, 2018). While some commenters have asked
APHIS to revisit its proposed definition of ``genetically engineered
organism'' from the 2017 proposed rule involving part 340, even in that
rulemaking APHIS did not take the position that genome editing was
outside the scope of genetic engineering. Instead, APHIS explained it
was defining ``genetically engineered organism'' for the purpose of
establishing regulatory exemptions from part 340, including exemptions
for certain organisms created using techniques that fall within the
scope of genetic engineering, as follows: APHIS ``would also exclude,
from its definition of GE organism, certain organisms that are created
using techniques that fall within the scope of genetic engineering, but
that could otherwise have been produced using traditional breeding
techniques . . . .'' (82 FR pp.7008 and 7015, January 19, 2017). As
discussed above, the SECURE rule establishes regulatory exemptions at
the forefront, which promotes clarity regarding the scope of part 340,
and avoids adopting a confusing characterization of techniques of
biotechnology.
A couple of commenters stated that the proposed rule lacked a
definition of natural gene pool and a discussion of its relevance in
terms of safety.
The term was used in the regulatory text in Sec. 340.1(b)(3). As
discussed above, we have removed ``natural'' from that paragraph. We
discussed the relevance of exemption under paragraph (b)(3) to plant
pest risk above. We are, however, adding a definition of the term gene
pool to the regulations in this final rule in response to these
comments. Gene pool is defined as germplasm within which sexual
recombination is possible as a result of hybridization, including via
methods such as embryo culture or bridging crosses.
One commenter viewed our proposed definition of person as
potentially problematic in that it could open APHIS to legal
challenges. The commenter expressed concern that because the definition
includes not only individuals, business entities, and associations but
also any other ``organized group,'' the argument could be made that
APHIS falls under the definition. If so, according to the commenter,
there might be the possibility of a conflict if decisions under these
regulations are taken by the Administrator of APHIS. The commenter
requested clarification on this issue.
The definition of person would apply to individuals or entities
regulated by APHIS, including APHIS. Under the law, a company is an
entity that is recognized as a legal person that exists independently,
with rights and liabilities. APHIS has, in the past, issued itself
permits in conjunction with enforcement of the regulations so that
plant products could move legally across state lines. This practice is
not inconsistent with the PPA or with the prior or new regulations.
Therefore, regulation by APHIS under part 340 will not create conflict
or otherwise be adversely impacted.
A commenter stated that the proposed definition of plant pest is
too broad and could be construed to cover model organisms, such as
Drosophila melanogaster, that do not have significant negative effects
on agriculture. The commenter stated that an overly broad definition is
of concern to biomedical researchers because some invertebrates they
use could be classified as plant pests. Noting the lack of a mechanism
to acknowledge that an organism that consumes plant material is not
detrimental to agriculture, the commenter recommended that APHIS
establish a mechanism for classifying an

[[Page 29806]]

organism as ``agriculturally unimportant within the plant pest
category'' and that such a classification have influence on APHIS'
regulatory processes.
APHIS appreciates the comment, but does not believe that it is
necessary for APHIS to establish such a mechanism. The definition of
plant pest is based directly on, and does not exceed, the definition of
the term in the PPA. The proposed regulations contained an exemption
from the requirement for permit for interstate movement for Arabidopsis
thaliana. In this final rule, we are adding an exemption from some
permitting requirements for GE Drosophila melanogaster, which we will
discuss in more detail below, under the subheading ``Permits.''
Another commenter stated that by adopting a definition of plant
pest that aligns with the definition provided in the PPA, APHIS would
regulate a broad range of GE animals, including those used in medical
research, thereby imposing large, new, and unwarranted regulatory
burdens on researchers in medical research and other fields.
APHIS disagrees with the comment. As we stated in the preamble to
the proposed rule, while the PPA gives APHIS authority to regulate any
nonhuman animal as a plant pest, it is longstanding APHIS policy not to
regulate vertebrate animals as plant pests. In the absence of such a
policy, all herbivores and omnivores could be considered plant pests,
and thus subject to regulation, an untenable position since this would
require APHIS to consider livestock, such as cows, sheep, and horses,
as well as many laboratory research animals, to be plant pests.
In the June 2019 proposed rule, we defined plant pest risk as
``[t]he possibility of harm to plants resulting from introducing or
disseminating a plant pest or exacerbating the impact of a plant
pest.'' Many commenters viewed the proposed definition as vague and
potentially problematic due to the terminology we used.
Commenters expressed concern that the words ``possibility of'' in
the proposed definition are vague and uncharacteristic of standard risk
assessment terminology and methodology, which characterizes risk as
either a likely or probable adverse outcome. Some commenters requested
that the definition of plant pest risk be defined in terms of the
likelihood and magnitude of harm. Commenters also expressed concern
that the word ``harm'' in the proposed definition is inconsistent with
the PPA, and that the regulatory end-point should be risk of causing
injury to, damage to, or disease in any plant or plant product. It was
stated that the inconsistency and lack of precision in the terminology
used in the proposed definition could leave risk-based decisions made
by APHIS open to criticism or challenge for not addressing all
possibilities for harm, no matter how unlikely.
APHIS agrees with the commenters that greater clarity and
consistency in the definition of plant pest risk would be useful. APHIS
is revising the definition accordingly. We agree that the words
``possibility of'' could be construed in a manner that is
inappropriate. Numerous scenarios could be put forward as the basis for
events that represent the ``possibility'' of harm without any plausible
basis for concluding that such scenarios have any likelihood of
occurring. The glossary of the Society for Risk Analysis (SRA), which
is available at https://www.sra.org/sites/default/files/pdf/SRA_glossary_20150622.pdf, defines risk as, among other things, ``the
potential for realization of unwanted, negative consequences of an
event.'' The SRA glossary makes clear the distinction between the
qualitative definition of risk and the metrics that are used to measure
or characterize risk, which are framed in terms of likelihood and
magnitude of an adverse outcome. We view a qualitative definition as
more appropriate for defining risk, and use likelihood and consequence
to evaluate scientifically plausible risks identified in the RSR
process discussed below under the subheading ``Regulatory Status
Review.'' We also find the SRA terminology to be more useful than
``possibility of'' and are revising our definition of plant pest risk
accordingly. We are also revising the definition to refer to injury to,
damage to, or disease in any plant or plant product. Accordingly, this
final rule defines plant pest risk as ``[t]he potential for direct or
indirect injury to, damage to, or disease in any plant or plant product
resulting from introducing or disseminating a plant pest, or the
potential for exacerbating the impact of a plant pest.''
Importantly, while APHIS defines plant pest risk in this rule in
reference to the potential for direct or indirect injury, damage, or
disease, the RSR process itself is based on standard risk assessment
practices and uses a methodology that focuses on a likelihood and
magnitude assessment of plausible risks. Since the RSR process will
require that a plausible risk be identified in order to proceed with
further risk assessment, it will not be an open-ended evaluation of any
conceivably ``possible'' scenario that could be imagined.
One commenter stated that the term plant-trait-MOA is not defined
as a combination, though the individual terms are defined in the
proposed rule, and that if the combination has its own meaning, APHIS
should clarify that.
The term plant-trait-MOA refers to three individual terms/factors
for analyzing whether certain GE organisms may present a plausible
pathway to plant pest risk and by which we determine whether a product
actually poses a plant pest risk.
Under the definition of responsible person in the June 2019
proposed rule, responsibility for maintaining control over a GE
organism under permit during its movement and assuring compliance with
all permitting conditions could be given to an individual or an
institution. A commenter stated that individuals should not be included
under the definition. According to the commenter, responsibility should
reside only with the institution with which the signatory or any other
individual bearing such responsibility is affiliated. The commenter
pointed out that staff often move among jobs well before permit
conditions are fulfilled.
As discussed in the preamble to the June 2019 proposed rule,
attributing responsibility for a GE organism moved under permit to only
an institution may be problematic for enforcement of the regulations,
because such responsibility can be diffused, resulting in no
individual's being held responsible for compliance with the permit
conditions, the regulations in part 340, and the PPA. Our definition
ensures that for each permit, there is a single individual who is
responsible for ensuring an institution's compliance with permit
conditions, regulatory requirements, and the PPA. If this individual
moves to a different job or otherwise leaves an institution,
responsibility for any permits can be officially transferred, subject
to APHIS' approval, to another qualified individual, as described in
Sec. 340.5(i)(10) of this final rule (``permit conditions'').
A commenter stated that there is no justification for the
requirement, contained in the proposed definitions of both agent and
responsible person, that they be legal U.S. residents, and that there
is no means of verifying such a requirement.
We are retaining the requirement, as it would be a stronger
mechanism for ensuring accountability in the regulatory program than
the existing definition. We have learned through administration of the
program that the existing definition is not adequate, and has not
provided the necessary framework to hold noncompliant

[[Page 29807]]

developers responsible (e.g., academic researchers who returned to
their native countries without taking steps to destroy their GE-test
material prior to departure).
Finally, we have revised the definition of State to read as
follows: ``[a]ny of the several States of the United States, the
Commonwealth of the Northern Mariana Islands, the Commonwealth of
Puerto Rico, the District of Columbia, Guam, the Virgin Islands of the
United States, or any other territories or possessions of the United
States.'' This definition aligns with that contained in the PPA.
Regulatory Status Review
Section 340.4 of the June 2019 proposed rule set out the RSR
process, under which developers may request that APHIS evaluate their
novel plants and determine whether or not they fall within the scope of
the regulations, i.e., under one or more of the categories in Sec.
340.2. The section contained requirements for submitting requests for
reviews and re-reviews, including supporting information; listed the
factors that APHIS would consider in the course of its reviews;
described the review process; and provided for public notice of RSR
determinations. Commenters addressed all these topics.
As noted in the preamble to the June 2019 proposed rule, the RSR
process applies only to GE plants. APHIS specifically solicited
comments on whether the scope of the RSR should be expanded to include
non-plant GE organisms as well as GE plants, whether some equivalent
process for evaluating such organisms for regulatory status should be
developed instead, and, if so, what factors APHIS should consider in
its analyses.
Several commenters did request that APHIS develop a process to
evaluate the regulatory status of non-plant GE organisms, based on the
subject organism's potential plant pest risk; however, the commenters
did not provide specifics on what factors APHIS should consider in its
analyses. APHIS believes that further discussion and outreach with
impacted developers and other stakeholders on this issue is required
before pursuing rulemaking.
We received several comments pertaining to the re-review process.
Some commenters stressed the need to consider whether our requirements
adequately address the risk of requests for spurious reviews. Noting
that we proposed to require that any request for a re-review be
supported by ``new, scientifically valid evidence bearing on plant pest
risk,'' commenters urged us to clarify what we mean by ``scientifically
valid evidence'' in order to ensure that trivial evidence or
conjecture, or publications in non-credible online ``scientific''
journals, cannot form the basis of a request. Clarification was also
requested as to whether re-reviews can be initiated for all products
for which RSRs have been completed or only for those found after an
initial RSR to be subject to the part 340 regulations. One commenter
stated that in cases of re-reviews initiated by APHIS, APHIS needed to
provide for due process by allowing developers adequate time to
respond.
APHIS agrees that requests for re-review must be based on
``scientifically valid evidence'' that relates to plant pest risk.
APHIS has experience dealing with such requests and will conduct an
objective analysis of re-review requests to determine whether re-
reviews are warranted. A valid re-review request would apply only to
those GE plants or plant products that were previously found to be
subject to the regulations after an initial RSR was conducted.
In the June 2019 proposed rule, Sec. 340.4(a)(4) specified
information requirements for persons submitting a request for APHIS to
conduct an RSR of a GE plant and stated that additional guidance on how
to meet the requirements would be found on the APHIS website. A few
commenters requested that APHIS either (1) incorporate the additional
guidance into the regulations; (2) commit not to change the guidance
without public notice and comment procedures; or (3) make clear that
the additional guidance is non-binding because any changes made to it
would not otherwise be subject to formal notice and comment.
After reviewing these comments, APHIS has decided to pursue the
second of the three recommended options. When APHIS seeks to make a
substantive change to the information provided on our website, we will
indicate the proposed change, provide an explanation for it, and take
public comment on it. We will then review the comments and make a
determination as to whether to implement the change. In this final
rule, we are revising Sec. 340.4 to incorporate the notice-and-comment
process. The revised Sec. 340.4 also uses the term ``detailed
information'' rather than ``guidance,'' which was used in the proposed
rule. We are making this change, which we have placed in a new
paragraph (a)(4)(iv), to clarify that in order to satisfy the broad
requirements contained in the regulations for information on the
comparator plant(s), the genotype of the modified plant, and the new
trait(s) of the modified plant, the developer must provide the detailed
information indicated on the website. We anticipate that this change
will provide more consistency and predictability regarding information
requirements than would have been afforded by the June 2019 proposed
rule. Such predictability is important for ensuring that developers can
adequately comply with the regulations and can plan their product
development activities accordingly.
A number of commenters expressed concerns about specific details of
how to meet the detailed information requirements for the RSR process
that will be maintained on APHIS website. Some commenters were
concerned that the requirement for information on the genotype of the
modified plant was unclear and could be interpreted as requiring
sequence information comparing the entire genome of the modified plant
with that of the unmodified plant. Commenters stated that sequence
information should be limited to sequence information for the specific
genetic modification(s) in the plant. One commenter noted that some
gene-edited products could have had genetic material inserted during
development that was subsequently segregated away, and that we could
clarify that the whole genome sequence information is not required by
specifying that the required sequence information pertains to the
targeted modified sequence.
APHIS agrees with these comments. It was not our intent to request
whole genome sequence information. Rather, we are requesting sequence
information on the specific targeted genetic modification(s) in the
plant. We have revised the information that will be published on the
APHIS website to clarify the sequence information that must be
provided.
Some commenters stated that sequence information is not needed to
determine whether a GE plant poses a plant pest risk, as long as
developers provide the type of modification and describe the genotype
by providing information on the insertion, deletion, and/or expressed
gene product, and that if sequence information is required, it should
be limited only to sequences that confer the trait(s) and should
exclude vector sequences that are not in the final plant.
APHIS largely disagrees with these comments. The specified sequence
information is needed by APHIS in order to confirm the intended
trait(s) at the molecular/genetic level; to understand the MOA for
purposes of assessing the plant pest impact(s), if any, of the
modification(s); and to assess similarity with previously reviewed GE

[[Page 29808]]

plants. For inserted genetic material, APHIS requires the sequence of
the entire insert for molecular characterization. All genetic elements
integrated into the plant genome need to be described; therefore,
vector sequence information is not required if vector sequences are not
inserted. For genome editing, the sequence of the entire edited gene or
functional motif of a regulatory region (e.g., a transcription factor
binding site in a promoter region) is required to understand the
targeted sequence modification(s). The characteristics imparted by
inserted or edited regulatory sequences (such as expression levels,
patterns, and timing) are necessary to verify the full extent of the
engineered genetic changes as part of understanding the plant pest risk
associated with the modification(s).
Commenters raised concerns about how to meet the information
requirements concerning the MOA. One commenter stated that while there
may be information on a specific gene product, the precise mechanism of
action may not be elucidated.
APHIS recognizes that the MOA may not always be well characterized.
As we indicated in the preamble to the June 2019 proposed rule, we are
requiring information on the MOA to the extent that it is known. We
have revised the detailed information provided on the APHIS website to
clarify this point.
Other commenters stated that certain information categories appear
to exceed what APHIS has historically asked for when reviewing
petitions for nonregulated status under the current regulations, and
that RSR information requirements should align with the information
APHIS has required previously, should not increase a developer's data
submission burden, and should be sufficiently flexible to accommodate
the nature of the particular product being evaluated. A commenter
stated that gene expression data are unnecessary in many cases and that
APHIS should clarify when such data would be required, such as when the
intent is to change the expression pattern of a gene. Another commenter
stated that information on the production, creation, or enhancement of
a reservoir for a plant pest goes beyond the type of information
currently submitted by developers in support of petitions for
nonregulated status.
APHIS largely disagrees with these comments but recognizes that the
preamble to the June 2019 proposed rule lacked sufficient clarity
regarding information requirements that apply at various stages of the
RSR process. The information developers must submit, as specified in
Sec. 340.4(a) of this final rule and on the APHIS website, generally
aligns with information APHIS has been seeking previously, will reduce
rather than increase a developer's data submission burden, and is
intended to be sufficiently flexible to accommodate the nature of the
plant being evaluated. Under the petition process, developers have had
to submit data and information regarding a broad range of possible
harms for evaluation by APHIS, regardless of whether the plant could
plausibly pose a plant pest risk. The RSR process differs from the
petition process in that APHIS is requesting much less information for
the initial review, with no requirement for laboratory or field-test
data. If APHIS is unable to identify a plausible pathway by which the
GE plant could pose an increased plant pest risk in the initial review,
developers will not be required to submit any additional information to
APHIS. When there is a plausible pathway to plant pest risk identified,
developers will receive feedback about the type(s) of information that
APHIS would need to assess the identified plausible pathway and
complete a plant pest risk assessment. This information could include
field-test data, gene expression data, or other data relevant to
assessing whether the GE plant could have increased importance as a
host for plant pests. The preamble to the proposed rule discussed some
of the types of information that might be required in this situation,
but incorrectly made it appear as if this information would be required
for all initial reviews. We now clarify that such information could be
submitted during the initial review stage, but that any such submission
would be optional. To clarify that additional data would be requested
on the basis of identified plausible pathways to plant pest risk, APHIS
has added the following language to the existing text in Sec.
340.4(b)(3)(i): ``APHIS may request additional information as needed to
evaluate the factor(s) of concern.'' We are revising the detailed
information that will be published on the APHIS website to make this
distinction clear.
One commenter found it difficult to understand how plant-trait-MOA
could be adequately evaluated without field trials.
Data from field trials do not provide information about the plant-
trait-MOA. As we noted in the preamble to the proposed rule, APHIS'
experience in preparing risk assessments in accordance with the
petition process indicates that field trial data are generally not
necessary unless they address an identifiable plausible pathway to
plant pest risk. The introduced trait and MOA provide the most reliable
indicators of the organism's potential for plant pest risk. As we also
noted in the June 2019 preamble, our conclusions are consistent with
findings of reports of NAS.^{7 8}
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\7\ National Research Council (NRC) 1989. Field Testing
Genetically Modified Organisms: Framework for Decisions. Washington,
DC. National Academy Press. 185 pp. Retrieved from http://www.nap.edu/catalog/1431.html.
\8\ National Academies of Sciences, Engineering, and Medicine
(NAS) 2016. Genetically Engineered Crops: Experiences and Prospects.
Washington, DC: National Academy Press. 420 pp. doi: 10.17226/23395.
Retrieved from http://www.nap.edu/23395.
---------------------------------------------------------------------------

By having an understanding of the biology and any existing impacts
of the plant, the genetic trait to be inserted into the plant, and the
MOA, APHIS is able to conduct a review based upon a large body of
scientific publications, as well as APHIS' knowledge and experience.
Information from field tests would be unnecessary, in most cases, for a
determination of regulatory status under these regulations.
Accordingly, field test information would not be a generally applicable
requirement for the initial RSR and would be requested only as needed
when further analysis is required. This approach would not preclude
developers from providing information from field tests that they
consider pertinent to our analysis. For example, if a developer
requested a reevaluation of a GE plant that APHIS had previously
considered to be subject to regulation, field test information
demonstrating a lack of plant pest risk could be provided in support of
that request. Nor would the provisions preclude APHIS from asking for
field test information if APHIS considers it necessary in order to
conclude review of a particular request.
The revised detailed information requirements that will appear on
the APHIS website are listed below.
1. A description of the comparator plant(s), to include common
name(s), genus, species, and any relevant subspecies information that
would distinguish the plant.
2. The genotype of the modified plant, including a detailed
description of the differences in genotype between the modified and
unmodified plant, specifically:
a. If genetic material is inserted into the genome, provide
information on all inserted genetic material, including:
i. For genetic sequences, the name of the sequence, the donor
organism(s) or source, the function of the sequence, the nucleotide
sequence, and if applicable, the publicly available sequence
identification, protein accession

[[Page 29809]]

number, and enzyme commission number. If inserted genetic sequences
have been modified (e.g., codon usage efficiency, gene shuffling), a
statement regarding the nature and purpose of the modification, and
identification of the modifications by submitting an alignment of the
modified sequence with the unmodified sequence.
ii. For regulatory sequences, the function of each regulatory
sequence as it relates to the gene sequence and the donor organism(s)
or source of each regulatory sequence. Identify promoters as
constitutive, inducible, developmental, or tissue specific. If
developmental/tissue specific, describe the stage(s)/tissue(s) at/in
which the promotor is intended to be active.
b. If genetic material is not inserted into, or was inserted and is
no longer present in, the genome, and the genome is modified in a way
that does not fall under the exemptions in Sec. 340.1(b), provide:
i. The nature of the modification(s) and the gene(s) and
function(s) being modified;
ii. For substituted based pairs, the number of substitutions;
iii. The original unmodified sequence aligned to the targeted
modified sequence.
3. A detailed description of the new trait(s) of the modified
plant, including:
a. The purpose and intended phenotype of the new trait and
available information on the MOA by which the intended trait is
conferred;
b. Any expected changes in metabolism, physiology, and development
due to the trait/genetic modification, to the extent known;
c. Optional: Any additional experimental data, publications, and
other science-based assessments that may be helpful for APHIS'
evaluation of the potential of the plant to pose plant pest risks. Such
information could include, to the extent that it is known, information
about any new enzymes or other gene products produced; where, when, and
at what level the introduced or modified genetic material is expressed
in the plant; the biochemical action of the genetic material or its
product; and how the genetic material or its product participates in or
interacts with metabolic, physiological, or developmental processes in
the engineered plant or in other organisms. (APHIS does not intend to
require submitters to generate experimental data specifically for an
RSR. However, if a submitter is aware of information or experimental
data in the public domain that may support our assessment, the
submitter may include the data.)
The June 2019 proposed rule specified, in Sec. 340.4(b)(1)(i)
through (iii), the factors that APHIS would consider when conducting an
initial review of the plant pest risk posed by the GE plant and any
sexually compatible relatives that could acquire the engineered trait,
relative to that posed by their respective non-GE or other appropriate
comparator(s). To provide context for the discussion that follows, we
are listing those factors below, as they appeared in the proposed rule.
1. The biology of the comparator plant(s) and its sexually
compatible relatives;
2. The trait and mechanism-of-action of the modification(s); and
3. The effect of the trait and mechanism-of-action on:
a. The distribution, density, or development of the plant and its
sexually compatible relatives;
b. The production, creation, or enhancement of a plant pest or a
reservoir for a plant pest;
c. Harm to non-target organisms beneficial to agriculture; and
d. The weedy impacts of the plant and its sexually compatible
relatives.
Commenters had concerns and questions about some of the factors.
One commenter stated that APHIS should clarify that a comparator could
be a GE plant, even though Codex Food Safety Guidelines do not allow a
GE crop to be a comparator, because the majority of certain crops, such
as corn and soybean, are already GE.
APHIS agrees that in some circumstances a GE plant could be an
appropriate comparator for the purpose of evaluating plant pest risk,
and notes that the Codex Guidelines address food safety and do not
address plant pest risk. Typically, a comparator plant is the non-GE
plant from which the GE plant is derived. In some cases it may be
appropriate to use another GE variety of the plant as a comparator.
This could occur if, for example, a developer is using genetic
engineering to add a new trait to an existing GE plant. To date, APHIS
has not generally seen the use of a GE plant as a comparator, but this
could change in the future as products of genetic engineering become
more complex.
One commenter requested that APHIS define how it intends to
determine ``distribution, density, or development of the plant and its
sexually compatible relatives and weediness across plant types.''
Another suggested that we add a definition of weediness because it is
mentioned in the context of the RSR.
APHIS is making no changes to the rule in response to these
comments. The plant pest risk assessment framework document that
accompanied the proposed rule described how the distribution (including
density) of the GE plant and its sexually compatible relatives can be
predicted by the biological properties of the plant compared with the
known distribution and properties of the comparator(s), in the context
of the receiving environment. The development of the GE plant and its
sexually compatible relatives can similarly be predicted. Assessment of
these factors is important for determining whether the GE trait(s)
could increase the prevalence or alter the distribution of the plant or
its sexually compatible relative(s) in such a way that they could have
increased importance as hosts for plant pests. It is also important to
point out that consideration of weediness in this manner has long been
a part of the plant pest risk assessments conducted in response to
petitions for nonregulated status since the 1990s, under the
regulations that we are replacing in this final rule. This final rule
does not change this analysis, and does not expand the scope of APHIS'
consideration of weediness in evaluating plant pest risks as compared
with the scope of consideration that was present in APHIS' exercise of
its authority under the regulations that we are replacing.
Some commenters had concerns about the factor ``harm to non-target
organisms beneficial to agriculture,'' and asked us to shift our focus
to adverse effect on trophic functional groups beneficial to
agriculture and to articulate a scientific rationale as to how a plant,
whether GE or not, could pose a plant pest risk on the basis of its
potentially harming an insect predator or pollinator.
Beneficial organisms such as predators and pollinators fall
squarely under APHIS' authority because predators and pollinators are
essential to plant health, and harm to these organisms may result in
greater injury or damage to plants. APHIS analyses are based on whether
a GE trait introduced into a plant will had adverse impacts on non-
target organisms beneficial to agriculture. Non-target organisms
beneficial to agriculture encompass a broad range of organisms that
provide ecosystem services. Focusing on certain trophic guilds is not
adequate to address all aspects of plant pest risk to non-target
organisms beneficial to agriculture. For example, some GE traits may
have greater effects on closely related groups of insects, regardless
of the trophic guild of members of that group. Focusing on trophic
levels may also expand the scope to impacts

[[Page 29810]]

outside of agriculture. When there is a scientifically plausible link
to harm to non-target organisms beneficial to agriculture, the
information needed for a plant pest risk analysis would be determined
on a case-by-case basis, accounting for the particular biology of the
GE plant, the MOA of the GE trait, and the environment.
In addition to listing the factors discussed above, proposed Sec.
340.4(b) set out the components of the RSR process, including making
determinations and providing public notice of such determinations.
Proposed paragraph (b)(1) stated that when APHIS receives a request for
an RSR, APHIS will conduct an initial review of the potential plant
pest risk posed by the GE plant and any sexually compatible relatives
that could acquire the engineered trait, relative to the plant pest
risk posed by their respective non-GE or other appropriate
comparator(s), based on the factors discussed above. Proposed paragraph
(b)(2) stated that if APHIS is unable to identify potential plant pest
risks in the initial review, the GE plant will not be subject to the
regulations. Proposed paragraph (b)(3)(i) stated that if APHIS does
identify potential plant pest risks in the initial review, APHIS will
conduct an evaluation of the factor(s) of concern to determine the
likelihood and consequence of the potential plant pest risk posed by
the GE plant. Proposed paragraph (b)(3)(iii) stated that if the GE
plant is found unlikely to pose a plant pest risk and, therefore, not
to require regulation under part 340, then APHIS will post the finding
on its website. Proposed paragraph (b)(3)(iv) stated that if APHIS is
unable to find the GE plant unlikely to pose a pest risk, then the
plant will require regulation, and its movement will be allowed only
under permit in accordance with Sec. 340.5.
Commenters expressed numerous concerns about this process as we
described it in the proposed rule. Some thought that we provided
insufficient detail, especially concerning the distinction between the
initial review and the additional evaluation that some GE plants would
need to undergo. Others took issue with some of the terminology that we
used, stating that it lacked clarity and could lead to confusion about
our regulatory focus and decision making process. Numerous commenters
proposed alternative language, in some cases arguing that their
proposed alternatives were more consistent with standard risk
assessment terminology and the PPA than what we had proposed.
Commenters also stated that in order for regulation to be appropriately
calibrated with actual risk, our decision-making criteria should
incorporate the concept that the plant pest risk posed by the GE plant
should be greater than that posed by the plant from which it was
derived.
APHIS agrees with many of these comments. In this final rule, we
have amended Sec. 340.4(b) to provide additional detail and clarity
and to incorporate the concept that in order for regulation to be
appropriate, the plant pest risk posed by the GE plant or its sexually
compatible relatives must pose an increased plant pest risk relative to
the comparator(s).
Regarding terminology, we have revised Sec. 340.4(b) to indicate
that in the initial reviews, we will make determinations concerning
whether further review is necessary based on a finding of
``plausible,'' rather than ``potential,'' plant pest risks. We view the
former term as more precise and more in keeping with standard risk
assessment terminology. Further, since the RSR process will require
that a scientifically plausible risk be identified in order to proceed
with further risk assessment, the revision will ensure that the initial
review will not be an open-ended evaluation of any conceivably possible
scenario that could be imagined.
As noted earlier in this document, in connection with the
discussion on confirmation letters, some commenters saw a need for
timeframes for APHIS regulatory processes for purposes of
predictability and business planning. Commenters raised the issue in
connection with the RSR as well. We agree with the commenters on the
need for timeframes and are adding them to paragraphs (b)(2) and (3),
as discussed below.
Revised Sec. 340.4(b)(1) contains provisions related to the
initial review. The introductory text states that when APHIS receives a
request for an RSR of a GE plant, APHIS will conduct an initial review
to determine whether there is any plausible pathway by which the GE
plant, or any sexually compatible relatives that can acquire the
engineered trait from the GE plant, would pose an increased plant pest
risk relative to the plant pest risk posed by the respective non-GE or
other appropriate comparator(s), based on the factors listed in
paragraphs (b)(1)(i) through (iii) (also listed above), which remain
the same as those in the proposed rule.
Revised Sec. 340.4(b)(2) provides that except in unforeseen
circumstances, APHIS will complete the initial review within 180 days
of receiving a request that meets the requirements specified in this
section. If APHIS does not identify a plausible pathway by which the GE
plant or its sexually compatible relatives would pose an increased
plant pest risk relative to the comparator(s) in the initial review,
the GE plant will not be subject to the regulations. APHIS will post
information on the plant and trait and a general description of the MOA
on its website.
Regarding the timeframe, while the RSR process is new to APHIS, we
anticipate that in many cases the initial review may be completed
rapidly (that is, within 60 to 90 days). However, for plants that APHIS
has infrequently authorized in the past, we anticipate that additional
time may be required to compile information on the appropriate
comparator(s) needed to conduct the initial review. In addition, we
anticipate that additional time may be required to compile the
information on less familiar or more complex MOAs needed to conduct
initial reviews. Based on our experience, we anticipate that we will
generally be able to complete reviews of less familiar plants and MOAs
within 180 days, barring unforeseen circumstances.
Revised Sec. 340.4(b)(3)(i) states that if APHIS does identify a
plausible pathway by which the GE plant or its sexually compatible
relatives would pose an increased plant pest risk relative to the
comparator(s) in the initial review, the requestor may apply for a
permit and/or request that APHIS conduct an evaluation of the factor(s)
of concern to determine the likelihood and consequence of the increased
plant pest risk.
Revised paragraph (b)(3)(ii) states that for those GE plants for
which such an evaluation is conducted, APHIS will publish the results
of the evaluation in the Federal Register and will solicit and review
comments from the public. Soliciting public comments will allow APHIS
to collect information we might have missed and receive additional
comment. Except in circumstances that could not reasonably have been
anticipated, APHIS will complete these steps within 15 months of
receiving a request for an RSR that meets our requirements. This
evaluation will be similar to the current petition process, and will
include, in addition to public notice and comment, preparation of any
applicable National Environmental Policy Act (NEPA) analysis; hence,
the longer timeline.
Revised paragraph (b)(3)(iii) states that if APHIS finds that the
GE plant and its sexually compatible relatives are unlikely to pose an
increased plant pest risk relative to their comparator(s), the GE plant
is not subject to part 340 and APHIS will announce the final
determination in a subsequent Federal

[[Page 29811]]

Register notice and post the finding on its website. If APHIS does not
make such a finding, the GE plant will remain regulated, and its
movement will be allowed only under permit in accordance with Sec.
340.5.
Due to the changes made in Sec. 340.4(b)(2) and (b)(3)(iii), we
are not finalizing proposed paragraph (c), as it is no longer
necessary. (There is a paragraph (c) in Sec. 340.4 of this final rule,
but it discusses when the section becomes applicable, and is discussed
later in this document.) APHIS does not agree with other changes to the
regulatory text suggested by some commenters. Specifically, the
commenters recommended that we predicate our decisionmaking on whether
the GE plant poses an ``unacceptable plant pest risk'' or an
``unacceptable'' or ``unreasonable'' ``increase in plant pest risk.''
APHIS appreciates these comments and has given them full
consideration. APHIS does not find these terms to be necessary for
purposes of our decisionmaking, nor have we concluded that such terms
would provide the necessary precision to become the foundation for
regulatory analysis and decisionmaking. For example, these terms could
be interpreted to take into account considerations unrelated to plant
pest risk and, if used as a regulatory benchmark, could be used to
attempt to place APHIS risk assessors in the position of deemphasizing
scientific considerations. As such, APHIS does not make changes to the
regulatory text under in part 340 as suggested by the commenters.
A commenter stated that just as the MOA for achieving a phenotypic
trait in a GE organism should be taken into account, the MOA for
achieving the genotype changes used to achieve those phenotypic traits
should be taken into account as well. According to the commenter, the
reason why APHIS regulations have historically been ``event-specific''
\9\ is that genetic material is inserted into recipient plants in an
essentially random manner during the genetic engineering process which
can create mutations in recipients at rates of ~30-60 percent, and that
uncharacterized genetic material/DNA can unintentionally become
incorporated into recipients about 20 percent of the time.
---------------------------------------------------------------------------

\9\ Event-specific is used to distinguish the genome position of
the same DNA insertions after transformation. As noted by the
commenter, the same DNA introduced into a plant by transformation
will insert randomly in the genome. To distinguish the fact that the
position of the same inserted DNA varies between transformations,
each transformation is referred to as an event.
---------------------------------------------------------------------------

We do not agree with this comment. As noted above, we have not seen
evidence in the scientific literature that there are unique hazards
that arise solely from the use of recombinant DNA techniques, as
compared with more conventional plant breeding techniques.
One commenter stated that putting RSR results on the web would
encourage copycats rather than innovators.
We do not agree with this comment. As discussed later in this
document, certain sensitive RSR information will be eligible for CBI
exemptions and, therefore, protected.
Permits
Paragraphs (a) and (b) of proposed Sec. 340.5 contained,
respectively, permit issuing and application requirements. Proposed
Sec. 340.5(f) contained requirements for APHIS review of permit
applications.
In the June 2019 proposed rule, APHIS proposed to remove timeframes
for review of permit applications so as to ensure that APHIS has the
appropriate time to evaluate each permit application based upon the
plant pest risk posed by the GE organism and the complexity of the
application. Some commenters opposed the change and requested that we
retain those requirements in the regulations or otherwise incorporate
into this final rule ``reasonable'' timeframes to provide greater
certainty for developers about the length of the process. Commenters
had various suggestions as to the length of the timeframe(s). One
commenter, for example, recommended that APHIS be allowed 10 days to
review applications for permits for interstate movement and 30 days for
release permit applications. It was also recommended that we establish
timeframes for making determinations on permit amendments and for
review and comment by State and Tribal officials on permit
applications.
Although we recognize the need for certainty about the length of
the process, our experience has been that some permit and notification
applications take a minimal amount of time and others take longer, and
we anticipate this to continue. A review of our experience over the
last 2 years demonstrates that 45 days is currently sufficient to
authorize import and interstate movement permits, while up to 120 days
are often needed to authorize release permits. Therefore, APHIS is
adding a new Sec. 340.5(h)(5) \10\ containing timeframes for review of
permit applications. New paragraph (h)(5)(i) states that except in
circumstances that could not reasonably have been anticipated,
interstate movement and import permits will be approved or denied
within 45 days of receipt of a complete permit application. New
paragraph (h)(5)(ii) states that except in circumstances that could not
reasonably have been anticipated, release permits will be approved or
denied within 120 days of receipt of a complete permit application. New
paragraph (h)(5)(iii) states that in cases where an environmental
assessment or environmental impact statement is necessary to issue the
permit, the 120-day period will be extended.
---------------------------------------------------------------------------

\10\ As explained below, we are adding new paragraphs (e), (f)
and (g) to Sec. 340.5. As a result, except where otherwise
indicated by a specific reference to the proposed rule, for purposes
of this discussion, paragraphs will be referred to by their
designation in the regulatory text of this final rule.
---------------------------------------------------------------------------

Paragraph (h)(3) of Sec. 340.5 contains requirements for
inspections related to permitted activities. The paragraph states that
all premises associated with the permit are subject to inspection
before and after permit issuance, and that all materials associated
with the movement are subject to sampling after permit issuance. In
addition, the responsible person and agents must provide inspectors
access to premises, facilities, release locations, storage areas,
waypoints, materials, equipment, means of conveyance, documents, and
records related to the movement of organisms permitted under part 340.
A commenter stated that APHIS should define waypoint in a manner
that accounts for the fact that applicants for permits may not be able
to legally guarantee access to all waypoints, such as those that may be
the sole property of a third-party shipping company.
APHIS will work cooperatively with the permit holder if there is
need to gain access to a waypoint not under the permit holder's
control. A permit holder will not be held responsible for providing
access that is outside the permit holder's power to grant or deny.
In Sec. 340.5(h)(3), APHIS mandates that all materials associated
with activities conducted under permit would be subject to sampling.
One commenter questioned the need to include this requirement in the
regulations. According to the commenter, the PPA gives APHIS authority
to conduct investigations, including sampling, when required. The
commenter stated that sampling has never been done outside the scope of
an investigation,

[[Page 29812]]

and that practice should remain. The commenter said that if APHIS
decides to move forward with inclusion of a sampling requirement, it
should clearly describe how those samples will be handled, the level of
confidentiality that they will be subject to, and the specific uses for
which samples may be taken in order to protect confidential business
information. The commenter further stated that such samples are of
proprietary research materials and valuable enough to be targets of
misappropriation if not handled appropriately.
APHIS appreciates the comment and wants to reassure the regulated
community that sampling will be done only when necessary. APHIS accepts
that regulated material is proprietary property of the regulated entity
and will ensure the taking only of quantities of samples required for
diagnostic evaluation. The language in Sec. 340.5(h)(3) is consistent
with APHIS' authority under the PPA to conduct inspections. When
sampling is done, APHIS follows strict chain of custody protocols.
APHIS will protect all proprietary information and CBI associated with
sampling, and APHIS will share results only within USDA (marking
documents containing CBI to ensure protection of such information) and
with the regulated entity.
Paragraphs (c) and (d) of proposed Sec. 340.5 contained,
respectively, exemptions from permitting requirements for interstate
movement for GE Arabidopsis thaliana and Agrobacterium tumefaciens,
subject to certain conditions. Some commenters suggested that we
consider additional exemptions. One such commenter requested that in
addition to A. thaliana, APHIS should exempt specialty crops, in which
an allele has been edited to align with a similar, known allele in a
close relative. Another commenter pointed out that disarmed versions of
Agrobacterium rhizogenes have a record for transformation that is
equally useful and safe as the record for disarmed versions of A.
tumefaciens. The commenter requested that the exemption for ``disarmed
Agrobacterium tumefaciens'' be broadened to ``disarmed Agrobacterium
strains'' or ``disarmed members of the Rhizobiales'', such as
Ochrobactrum haywardense. Using the same reasons and arguments, the
commenter stated that APHIS should consider exempting Nicotiana
benthamiana. It was also suggested that because disarmed viruses are
commonly used in plant molecular biology studies, any pathogen with the
pathogenicity demonstrably removed could be exempted. Some commenters
favored even broader exemptions, stating that most types of transgenic
plants should also be exempted when shipments are small or in a form in
which persistence in the environment is very unlikely. The lack of such
exemptions, according to these commenters, impedes collaborative
research and breeding substantially.
We agree with these comments in part. Historically, A. thaliana and
A. tumefaciens have been exempted from permitting requirements for
interstate movement because interstate movement of the organisms has
not resulted in the dissemination of plant pests within the United
States. A. thaliana has been a research model plant species, and the
research community is very familiar with the biological and ecological
characteristics of the species. We have had extensive experience
assessing the plant pest risks associated with the interstate movement
of both organisms. In both cases, the plant pest risks are very low,
and safeguards exist that can adequately mitigate those risks. APHIS
agrees that other disarmed Agrobacterium species can be exempted from
the requirement of permits for importation or interstate movement and
has revised 340.5(d) accordingly. While some strains of disarmed
Agrobacterium species may cause mild plant disease symptoms in some
cases, importing them or moving them interstate presents very low plant
pest risk given their specific usage in transforming plants, their lack
of persistence in the newly transformed plants, and existing practices
for shipping Agrobacterium strains. We do not have sufficient
experience with the order Rhizobiales to further broaden this exemption
at this time. Other GE organisms, such as specialty crops, have not
been exempted before, and APHIS does not have extensive experience
assessing their plant pest risks. Therefore, APHIS does not think it is
appropriate to exempt such GE plants at this time in the same way as A.
thaliana and A. tumefaciens.
As noted earlier in the discussion of the definition of plant pest,
we are adding to this final rule an exemption from the requirement for
permits for import and interstate movement for GE Drosophila
melanogaster in response to public comments that this organism does not
have significant negative impacts on agriculture. This exemption is
contained in a new paragraph (e) of Sec. 340.5. This exemption
excludes strains that have been engineered to propagate through a
population by biasing the inheritance rate (e.g., gene drives), because
such strains could be designed to persist in the environment and we do
not have sufficient experience to conclude that such strains would not
pose a significant plant pest risk. We have also revised the exemption
text for Arabidopsis thaliana and Agrobacterium strains in Sec.
340.5(c) and (d), respectively, to conform with the revised definition
of genetic engineering, which is not limited to the insertion of
``cloned'' genetic material into an organism.
In response to comments about interagency coordination, which are
discussed in detail below under the subheading ``Statutory Authority,
Jurisdiction, and Interagency Coordination,'' we are adding a new
paragraph (f) to Sec. 340.5, which contains an exemption from
permitting requirements for any microbial pesticide that is currently
registered with the EPA as a microbial pesticide, so long as the
microorganism is not a plant pest as defined in Sec. 340.3. The
addition of this exemption ensures that these organisms will not be
subject to duplicative regulation.
Also in the interest of interagency coordination, as well as other
considerations discussed in detail later in this document in the
section pertaining to plant incorporated protectants (PIPs), we are
also adding a new paragraph (g) to Sec. 340.5 that exempts from the
permitting requirement for movement of any GE plant modified solely to
contain a PIP that is currently registered with EPA as a pesticide
product pursuant to the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA, 7 U.S.C. 136 et seq.) or that is currently exempted from
FIFRA pursuant to 40 CFR 174.21.
Numerous commenters expressed concerns about our proposed permit
conditions. Those issues are discussed individually in the paragraphs
that follow.
One commenter viewed the permit conditions in general as
excessively strict. The commenter stated that the conditions strive
toward zero risk, as opposed to the Coordinated Framework criterion of
unreasonable risk. It is important to maintain measures commensurate to
risk, according to the commenter.
We do not agree with this commenter's suggestion that our permit
conditions are too strict or are striving toward zero risk. Our permit
conditions are set to ensure containment and confinement of the
organism under permit. They are designed to be commensurate with the
risk posed by the GE organism. The commenter did not offer specific
guidance on how we should apply the ``unreasonable risk'' standard.

[[Page 29813]]

Some commenters requested that we clarify the distinction between
standard permit conditions that apply to all GE organisms and those
that apply only to GE plants or to GE microorganisms or insects.
We believe that the standard permit requirements, as listed in
Sec. 340.5(i)(1) through (10) of this final rule, make this
distinction clear. As written, all the standard conditions listed in
Sec. 340.5(i) of this final rule, except for paragraph (i)(6)(ii)
(which pertains specifically to GE plant volunteer monitoring), are
applicable to all GE organisms. Therefore, we are not making any
changes in response to these comments.
One commenter recommended that we adopt a hybrid permit system
under which performance standards are primarily used as the enforcement
mechanism. According to the commenter, specific permit conditions
should be added only when scientifically justified.
We will not be making any changes to the final rule as a result of
this comment. Some of the standard permit conditions in Sec. 340.5(i)
are, in fact, performance standards, consistent with the commenter's
recommendation. For example, paragraph (i)(1) states that ``[t]he
organism under permit must be maintained and disposed of in a manner so
as to prevent its unauthorized release, spread, dispersal, and/or
persistence in the environment.'' Under paragraph (i)(6), records
related to permit activity by the responsible person must ``be of
sufficient accuracy, quality, and completeness to demonstrate
compliance with all permit conditions and requirements under this
part.''
Nonetheless, we do not believe that a sole or primary regulatory
focus on performance standards would be desirable for the regulations
in part 340. As noted in the preamble to the June 2019 proposed rule,
Office of Inspector General (OIG) audits conducted in 2008 and 2015
recommended, among other things, that APHIS generally reduce its
reliance on performance-based standards in the regulations in part 340.
APHIS agrees with the OIG recommendations. While performance standards
offer the advantages of administrative streamlining for APHIS and
flexibility for regulated parties, there are also significant
disadvantages to a performance-standard-based regulatory approach. The
absence of specific measures that constitute compliance with the
regulations in performance-based standards introduces an element of
uncertainty into the process of determining whether a regulated party
is in compliance with the regulations. Enforcing the regulations, and
thereby protecting U.S. agriculture from plant pest risks, would thus
be made more difficult than it is when compliance measures are clearly
enumerated in specific permit conditions, as they always have been
under the regulations in part 340 and will continue to be as a result
of this rulemaking. Because permit conditions specify which actions
need to be taken by the responsible person to be in compliance with the
regulations and do not rely as much on subjective determinations (by
both the responsible person and APHIS personnel) as do performance
standards, the permitting system can provide more risk-appropriate
oversight, better regulatory enforcement, and transparency.
A commenter questioned the necessity of the requirement in Sec.
340.5(i)(6) for the submission of a report of no environmental release
for all authorized locations in which an environmental release of a GE
organism did not occur. It was stated that this provision is
inconsistent with the policy approach of the Coordinated Framework and
represents regulatory overreach that should be set aside. The commenter
saw no risk mitigation value in this requirement.
APHIS appreciates the commenter's concern but disagrees with the
commenter's arguments. A permit authorization often covers many sites,
and planting may never occur at some sites. Similar to the need for a
post-planting report (PPR) to indicate which sites are planted and
when, APHIS needs to know which sites were not planted, so as to
provide efficient and appropriately focused oversight. APHIS thinks
that the submission of a report of no release can help APHIS track the
status of all authorized test field locations in order to account for
and sufficiently monitor all such locations, thereby preventing the
accidental release of GE organisms into the environment. Additionally,
this requirement addresses recommendations issued by USDA's OIG,
following audits performed in 2015.
One commenter stated that developers may operate under multiple
permits for multiple plant-trait-MOA combinations at one time. The
commenter stated that plant lines within these multiple permits are
planted in proximity to one another to facilitate comparative science
and to utilize resources in the most efficient way possible, and that
if APHIS were to issue each permit with different conditions, of which
the developer may learn only weeks before planting, these materials may
have to be physically separated from each other or research would need
to be abandoned, inhibiting innovation and increasing the cost to
develop new products.
APHIS does not consider such scenarios to be likely. The permit
conditions for non-plant-made pharmaceutical and industrial (PMPI)-
producing plants are based on the reproductive ecology of each species
and the receiving environment. APHIS anticipates that such permit
conditions will generally be consistent across multiple permits for the
same species. The timeframes for the issuance of permits that have been
added to the regulations will enable developers to plan adequately to
meet the specified permit conditions.
One commenter stated that APHIS should specify in the regulations
timeframes for the submission by the responsible person of reports of
activities under permit that are required under Sec. 340.5(i)(6).
We do not agree with this comment. The types of reports to be
submitted and the timing of their submission will vary by species and,
therefore, will be included in each permit in the supplemental permit
conditions, rather than in the regulations.
One commenter recommended that we allow for changes in the
designation of a responsible person via a notification process.
We do not agree with this comment. In Sec. 340.3, we define
responsible person as the person responsible for maintaining control
over a GE organism under permit during its movement and for ensuring
compliance with all conditions contained in any applicable permit as
well as other requirements in part 340. In Sec. 340.5(i)(10), we state
that the responsible person for a permit remains responsible unless a
transfer of responsibility is approved by APHIS. The requirement for
APHIS approval is necessary to ensure that, in the event a transfer
becomes necessary, the new responsible person is aware, prepared, and
equipped to work with APHIS. That provision does not apply, however, to
an agent, a term defined in the June 2019 proposed rule as someone
designated by the responsible person to act on behalf of the permittee
to maintain control over an organism under permit during its movement
and to ensure compliance with permit conditions. A change in agent may
be effected through a notification.
One commenter requested that we not require Global Positioning
Satellite (GPS) coordinates in permit-related records, a requirement
that, according to the commenter, is effectively a permit condition,
though it is actually

[[Page 29814]]

contained in Sec. 340.6, the section covering recordkeeping. The
commenter stated that information on actual acreage shortly after
planting would suffice.
APHIS disagrees with this comment. GPS coordinates allow APHIS to
fully utilize Geographic Information System capabilities to oversee
what will be released within the defined authorized area. For example,
APHIS uses GPS coordinates information to determine whether a proposed
release site happens to be on Federal land or critical habitat.
Paragraph (j) of Sec. 340.5 addresses permit denials and
withdrawals. One commenter stated that APHIS must make it clear that
denial should occur only to prevent an unreasonable risk to U.S.
agriculture. The commenter further suggested that APHIS should include
assurances that a permit will be presumptively issued unless APHIS can
present a plausible argument that failure to comply with the permitting
conditions would result in such an unreasonable risk. Another commenter
suggested that the rule should be clarified to indicate that a permit
application may be withdrawn by the applicant as well as the
Administrator.
We will not be making any changes to the final rule as a result of
these comments. Under Sec. 340.5(j)(1), the Administrator may deny a
permit application if he or she concludes that the proposed actions
under permit may not prevent the unauthorized release, spread,
dispersal, and/or persistence in the environment of the GE organism; if
the responsible person or agent has materially failed to comply with
any provision of these regulations; or if the responsible person or
agent has failed to comply with any other regulations issued pursuant
to the PPA or the PPA itself. Permits will also be denied if the
responsible person or agent does not agree in writing to comply with
permit conditions or to allow inspection by APHIS. These conditions are
necessary to protect U.S. agriculture. Regarding withdrawal, the
existing regulations do not specify that a permit application may be
withdrawn by the applicant. Nonetheless, under current regulations,
applicants may request withdrawal of permit applications prior to the
issuance of the permit. This will continue to be the case when the
revised regulations become effective.
One commenter stated that developers may operate by covering
multiple plant-trait-MOA combinations under a single permit. According
to the commenter, permits may be requested by location, with many
experiments, containing multiple plant-trait-MOA combinations, planted
in the same location. The commenter submits that if a permit is
terminated due to a completed RSR, the termination should not apply to
the entire permit, but only to the individual plant-trait-MOA which was
reviewed.
APHIS responds that in such cases, the permit would not be
terminated, and that the specific plant-trait-MOA combination for which
the RSR was completed (resulting in a determination that the plant-
trait-MOA GE plant combination is not subject to part 340) would no
longer be regulated under that permit. APHIS would continue to provide
oversight for plant-trait-MOAs that are still under permit.
One commenter requested clarification on permit amendment
provisions, particularly as they applied to APHIS-initiated amendments
in Sec. 340.5(l)(2). The commenter expressed a concern that APHIS may
arbitrarily initiate modifications to an existing permit and stated
that APHIS should have no authority to initiate such amendments without
scientific evidence.
APHIS will not initiate a permit amendment process without
sufficient scientific justification. Under Sec. 340.5(l)(2), APHIS
will initiate a permit amendment process upon determining that such an
amendment is needed to address the plant pest risk posed by the GE
organism or the activities allowed under the permit. In such cases,
APHIS will provide notice to the responsible person of the amendment(s)
and the reasons for it.
Another commenter questioned whether we should include provisions
for amending permits in the regulations at all. It was stated that we
were reducing our flexibility by including such provisions.
Contrary to the commenter's assertion, we believe that the
provisions for permit amendments allow for greater regulatory
flexibility by enabling a rapid response to changing circumstances. We
have included these provisions to provide an opportunity for a
responsible person to request an amendment to permit conditions when
circumstances have changed, as opposed to our having to withdraw the
permit, which would necessitate that the responsible person then
reapply. Under the permit amendment provisions, APHIS would also have
the flexibility to amend a permit rather than revoking it if needed to
address new or previously unknown plant pest risks presented by the
organism.
Another commenter recommended that APHIS specify a timeframe for
review of permit amendments requested by a responsible person. The
commenter stated that furthermore, APHIS should notify the requestor if
the amendment request is deemed to be within or outside the scope of
the existing permit.
The timeframe for the review for the permit amendment will be the
same as for new permit applications and depends on the complexity of
the requested change. Consistent with past practice, APHIS will
continue to let requestors know if an amendment is outside the scope of
an existing permit.
Finally, we are making an editorial change to paragraph (l)(1) in
Sec. 340.5 to clarify the circumstances under which (1) APHIS will
approve an amendment request from a permit holder and (2) APHIS will
instead require a new permit application. Specifically, we are
providing examples of situations where each would apply. APHIS will
allow a permit to be amended if relatively minor changes are necessary.
Requests for more substantive changes will result in a denial of the
amendment request and necessitate a new permit application.
Paragraph (m) of Sec. 340.5 contains requirements for shipping
under permit. Paragraph (m)(1) contains a performance standard, stating
that all shipments of organisms under permit must be secure shipments.
Paragraphs (m)(2) and (3) contain, respectively, documentation and
labeling requirements, and paragraph (m)(4) contains provisions related
to treatment and disposal of shipping containers and packing materials.
One commenter stated that if APHIS' intent in paragraph (m)(1) is
to allow developers to make determinations regarding the types of
containers used during transport so long as they fit the above
stipulations, that represents an improvement. If this change, however,
is meant to be more restrictive, especially with the removal of a
variance option, then the responsible person or agent should be able to
make changes to shipping container options, if needed.
Paragraph (m)(1) is performance-based. It does not prescribe
specific container requirements. The change to the regulations is meant
to make the performance standard more explicit while at the same time
making the requirements less prescriptive. Based on the definition of
secure shipment (``Shipment in a container or a means of conveyance of
sufficient strength and integrity to withstand leakage of contents,
shocks, pressure changes, and other conditions incident to ordinary
handling in transportation''), APHIS does not anticipate that shipping
variances will be needed.
One commenter requested that we revise the language in Sec.
340.5(m)(4) to take into account reusable shipping containers. The
commenter

[[Page 29815]]

recommended that we replace the word ``treated'' with ``cleaned to
remove the organism before reuse.''
In response to this comment, we are revising the paragraph to read
as follows: ``Following the completion of the shipment, all packaging
material, shipping containers, and any other material accompanying the
organism will be devitalized consistent with supplemental permit
conditions, or disposed of to prevent unauthorized release.''
Other issues raised by commenters in relation to permits included
concerns about the rigor and integrity of the process, safety of
environmental releases under permit, field testing, implementation of
the permitting requirements, and the formatting of permits.
One commenter, noting that the definition of movement in Sec.
340.3 includes release into the environment, stated that there can be
no assurances beforehand of a safe outcome of such a release. The
commenter stated that all GE organisms that are to be released into the
environment should be subject to strict testing requirements.
APHIS acknowledges the commenter's concerns about safely releasing
GE organisms into the environment. For reasons discussed earlier in
this document, it is our view that categories of organisms that fall
under the exempted categories in Sec. 340.1(b) and (c), as well as GE
plants that have been subject to an RSR in accordance with Sec. 340.4
and for which APHIS has not identified a plausible pathway by which the
GE plant or its sexually compatible relatives could pose an increased
plant pest risk relative to the comparator(s), can be safely released
into the environment without the need for a permit. The movement,
including release into the environment, of all other GE organisms will
be allowed only under permit and subject to strict standards and, if
appropriate, supplementary permitting conditions to effectively
mitigate any risks that may be associated with such movement or
release.
A commenter stated that granting developers the option to move GE
plants under permit in lieu of an RSR raises concerns regarding the
integrity and robustness of the regulatory process.
Providing a developer the option to move a GE plant under permit
rather than requesting an RSR affords that developer the benefit of
maximum flexibility in the research and development of novel GE plants.
The provision does not, however, provide the developer a means of
evading regulatory scrutiny of new GE plants, as the commenter appears
to believe. Permits are a form of regulation, and movement of GE plants
under permit regularly occurs under our current regulations. An RSR
results in a determination, based on our evaluation of plant pest risk,
that a GE plant either is not subject to the regulations, and can be
moved with no further restriction under part 340, or is subject to the
regulations and may be moved only under permit. Whether a product
requires movement under permit as a result of an RSR, or because the
developer has chosen the permitting option in lieu of the RSR, the GE
plant will still be subject to a rigorous screening process. The
developer will have to submit a permit application, along with all
supporting information required under the regulations. APHIS will
carefully review the application and, if warranted, approve it. Prior
to issuance, the developer/responsible person will be required to agree
in writing that he or she understands and will comply with all the
standard and supplementary conditions listed on the permit. Compliance
is monitored after a permit has been issued. Our permitting process is
a longstanding and rigorous one that ensures that GE plants are moved
only under conditions that provide safeguards against the risk of
dissemination of plant pests.
Temporary Transition Provisions
One commenter recommended that the implementation of the new
permitting provisions and elimination of notifications should be phased
in so as not to disrupt seasonal field activities. Other commenters
stated that given the magnitude of the changes in regulatory
requirements that we proposed, we should phase in implementation so as
to allow regulated parties to adjust their operations to comply with
the new requirements. Some commenters recommended that we develop
timelines for compliance with each component of the proposed
regulation. Recommendations ranged from 30 days (30 days each for the
confirmation and RSR processes) to two years (for compliance with all
of the new processes). Commenters also requested that we provide
guidance on the new regulatory framework to aid them in making the
transition.
APHIS appreciates the commenters' concerns and supports a phased
approach to implementation. This final rule identifies a date when each
of the rule's sections becomes applicable. Implementation of this rule
will occur as follows.
Thirty days following the publication of this rule, APHIS will
discontinue receiving new AIR requests. This will allow developers
sufficient time to make such requests following publication, while also
ensuring that, to the best of the Agency's ability, all such requests
have been acted on by the time the rule becomes effective. The
exemptions identified in Sec. 340.1, and the confirmation letter
process described in that section, will become effective and will be
implemented 90 days after the publication date of this rule. (Please
note, however, that some of the exemptions in paragraph (c) of Sec.
340.1 are contingent on implementation of RSR, which will not occur
until April 5, 2021.) In the intervening 60-day period, developers can
self-determine regulated status according to the legacy definition of
regulated article; APHIS is available to respond to requests for
assistance in such determinations. Alternatively, developers may seek
permits or use the legacy notification process during that time period
in order to import regulated articles, move them interstate, or release
them into the environment.
The remaining provisions in this rule also will become effective
(that is, will appear in the CFR) 90 days after the publication of the
rule. However, they are applicable as follows: Beginning April 5, 2021,
APHIS will implement the permitting provisions in Sec. 340.5;
beginning April 5, 2021, APHIS will undertake a phased implementation
of the RSR process described in Sec. 340.4 by accepting requests for
reviews involving corn, soybean, cotton, potato, tomato, and alfalfa;
and beginning October 1, 2021, APHIS will accept requests for RSR
involving any genetically engineered plant. We have revised proposed
Sec. Sec. 340.4 and 340.5 to include these specific applicable dates.
Until RSR is available for a particular crop based on the schedule
set forth in the previous paragraph, APHIS will continue to receive
petitions for determination of nonregulated status for the crop in
accordance with the current regulations in Sec. 340.6. Accordingly,
developers may submit petitions for deregulation for any GE plants
through April 4, 2021; beginning April 5, 2021, APHIS will discontinue
receiving petitions for corn, soybean, cotton, potato, tomato, and
alfalfa, but will continue to receive petitions for all other GE plants
and organisms. As is currently the case, a developer may seek a permit
or use the notification process instead of, or in addition to,
submitting a petition. On October 1, 2021, APHIS will discontinue
receiving petitions altogether. Similarly, all currently issued
notifications and permits will remain valid until the expiration dates
specified in such authorizations, and

[[Page 29816]]

APHIS will continue to receive notifications and permit applications
pursuant to the processes in the current regulations in Sec. Sec.
340.3 and 340.4, as well as the operational practices associated with
those regulations, through April 4, 2021. Beginning April 5, 2021, the
notification process will be discontinued, and all applications for
permits must be submitted in accordance with the regulations identified
in this final rule.
This phased implementation mitigates potential disruption to
seasonal field activities and will provide developers with the
opportunity to review and adjust to the provisions in this final rule.
Commenters stated that APHIS must maintain oversight over field
trials, and that such trials should be allowed only under permits that
mandate stringent gene containment protocols with a management goal of
full containment. According to the commenters, safeguards and
monitoring must be required for the organism during field trials, and
monitoring should include tracking changes associated with ecosystem
harm, such as degradation of water quality, air pollution, climate
impacts, or loss of biological resources. It was also stated that APHIS
should publish the results of APHIS supervised field trials where they
will be publicly accessible, and that permit requirements should
include buffer zones for GE crop fields that adjoin organic and non-GE
crop fields to reduce GE trait and chemical drift.
APHIS has established and will continue to establish appropriate
oversight requirements for crops grown under permit, including
isolation requirements based on the reproductive ecology of the plant
species to prevent gene flow to plants not under the permit. APHIS does
not believe that ecosystem impacts, such as degradation of water
quality, air pollution, climate impacts, or loss of biological
resources unrelated to plant pest risk, require tracking or monitoring
under the part 340 regulations, and notes that growing non-GE plants
may give rise to similar impacts. Under this rulemaking, there is no
requirement that developers submit field-trial data to APHIS, although
they may do so if they choose to support an RSR or confirmation letter
request. As we noted in the preamble to the proposed rule, APHIS'
experience in preparing risk assessments in accordance with the
petition process indicates that field trial data are generally not
necessary unless they address an identifiable plausible pathway to
plant pest risk. The introduced trait and MOA provide the most reliable
indicators of the organism's potential for plant pest risk. If field
data are needed to address a plausible plant pest risk hypothesis,
those data bearing on whether an organism posed a plant pest risk would
be published in support of APHIS' decision making on the regulatory
status of that plant.
A commenter stated that APHIS should further clarify the length of
time after a permit expires during which access to materials and
premises must be allowed. The commenter was concerned that such access
could be misinterpreted to be in perpetuity, which is unnecessary.
We would require the responsible person to allow access to where
the organisms regulated under part 340 are located, including field
test sites after trials are harvested or terminated, throughout the
volunteer monitoring period described in the permit, which may continue
after permit expiration. Access to premises where regulated organisms
are maintained must be allowed throughout the volunteer monitoring
period even if the permit has expired, unless the product has been
devitalized or APHIS has conducted an RSR and determined it to be not
subject to part 340.
Two other recommendations by commenters were that we develop a
publicly available database listing all permits issued by APHIS and
their requirements, and that we provide for pre-approvals of
containment facilities for high-risk organisms, with permits tiered to
the approved facility number.
We thank the commenters for these suggestions. APHIS may explore
these ideas in the future as we develop more experience with permits
under the new regulations, though we do not believe that it is
necessary to implement (or to decide whether to implement) these ideas
immediately. For example, our ongoing experience with permits involving
containment facilities may lead us at some point to consider a specific
pre-approval process for certain facilities as suitable for higher-risk
organisms.
Finally, one commenter stated that each permit should contain
introductory text describing the unreasonable risk to U.S. agriculture
that the permit is designed to prevent. The commenter further stated
that if no such plausible description can be proffered, then APHIS
would have no reason for exercising oversight over, or requiring a
permit for, the movement of the GE organism for which APHIS intends to
issue the permit.
Under the new regulations, GE organisms will be required to move
under permit for one of three reasons: (1) Because APHIS has conducted
an RSR and has found a likely or indeterminate plant pest risk; (2)
because the developer has opted to go directly to seeking a permit
rather than requesting an RSR; or (3) because the GE plant or non-plant
organism fits under one of the regulated categories in Sec. 340.2. We
do not see the need for the introductory text that the commenter
recommends, which is likely to be duplicative or unnecessary in many if
not all cases.
In addition to the substantive changes discussed above, we are
making a couple of corrections to Sec. 340.5(b)(1) and (b)(2)(ii). In
the former paragraph, which contains general information requirements
for permit applications, we are adding ``the organism's genus, species
and any relevant subspecies and common name information.'' Under the
latter, which contains information requirements for permits for
interstate movement and listed, among other things, in the June 2019
proposed rule, ``a description of the method of shipment, and means of
ensuring the security of the shipment against unauthorized release of
the organism,'' we are including a requirement that the quantity of the
GE organism also be listed. In both cases, the requirements were in the
current regulations but were inadvertently omitted from the June 2019
proposed rule.
Record Retention, Compliance, and Enforcement
Numerous commenters identified concerns about the record retention
requirements described in proposed Sec. 340.6. Issues discussed
included overall clarity and scope, timeframes, and reporting
requirements.
Some commenters suggested that we needed to clarify our
recordkeeping and reporting requirements by adding more specific detail
about what information APHIS will require and when.
The reporting and recordkeeping requirements in Sec. 340.6 of the
June 2019 proposed rule did provide specific details regarding the
types of records that need to be kept and the timeframes for retention,
in paragraphs (a) and (b), respectively. At the same time, the
requirements that we proposed align with our historical approach, which
has provided flexibility based on variations in operations performed by
different entities and different subparts of a single entity. As
reflected in Sec. 340.6(a)(1), which refers the reader back to the
permit-related reporting and recordkeeping requirements in Sec. 340.5,
many of the recordkeeping and reporting requirements of this

[[Page 29817]]

rulemaking will depend on the nature of the GE organism and the
intended activity and will be included in the permit conditions.
It was suggested that some of the proposed information requirements
were duplicative. One commenter stated that APHIS requires information
about the location of a field release site to be included in the permit
application and then requests the same information again after
planting, resulting in duplicate or nearly duplicate records requests.
The commenter stated that APHIS also requests the identity of the
material being planted (the construct ID) on the application and then
requests the same information again on the planting report. According
to the commenter, during inspections this information is often
requested a third time. The commenter stated that this duplication
could be eliminated with no detrimental effects on compliance by having
applicants provide it on the permit application and then having APHIS
verify it during inspection.
These requirements are not duplicative, and it is not particularly
onerous to comply with them. Information submitted in a permit
application is used for specific release site analysis. Post-planting
reports provide APHIS with critical information related to the activity
that has been conducted under an APHIS-issued authorization. The
information submitted post-planting facilitates effective compliance
oversight. Planting does not occur for every genetic construct and
location that is approved in an authorization. APHIS needs
documentation (post-planting report) of which constructs are planted at
each specific field release site in order to perform effective
compliance oversight. Additionally, this requirement addresses
recommendations issued by USDA's OIG following audits performed in
2015.
A commenter recommended eliminating the requirement in Sec.
340.6(a)(2) that records be kept to identify all locations where
organisms under permit were stored. The commenter noted that while
APHIS regulates interstate movement, the proposed definition of move
does not include ``store.''
We do not agree with this comment. Under Sec. 340.5(b)(2)(i), all
permit applications must include, among other things, information on
the origin and destination of a GE organism moved under permit,
including information on addresses of all intermediate and final
destinations. Additionally, Sec. 340.5(b) states that within the
permit application, locations and destination(s) of regulated organisms
shall be included. A storage facility is considered by APHIS to be a
destination (premises). APHIS needs to know where the regulated GE
organism has been maintained in order to perform effective compliance
oversight.
We received comments that supported our proposed timeframes for
record maintenance and other comments that expressed concerns about the
timeframes.
One commenter raised concerns about APHIS's ability to respond to
incidents effectively if APHIS retained records associated with
regulatory activities for only 2 years.
The commenter may have misunderstood the recordkeeping requirement
in Sec. 340.6(b). The requirement that all records indicating that an
organism that was imported or moved interstate under permit reached its
intended destination be retained for 2 years applies to the responsible
person(s) rather than APHIS. APHIS did not propose any changes to the
duration or type of records that APHIS will retain. The proposed 2-year
retention requirement did represent an increase from the one in the
existing regulations, which was 1 year. APHIS believes that this 2-year
record retention requirement provides sufficient time to ensure that
regulated material has safely and securely reached the intended
destination, without imposing an undue burden on regulated parties.
One commenter viewed the requirement to retain records of permitted
activities for 5 years as burdensome for small entities and urged us to
ameliorate that burden by offering small entities an option to deposit
such records electronically with APHIS for retention.
We do not agree with this comment. APHIS does retain the records of
permitted activities that are submitted to APHIS, such as required
reports and other information needed to determine compliance. Large and
small regulated entities also generate and retain records that they may
not be required to submit to APHIS but are kept to demonstrate
compliance with permit conditions and for the entities' own stewardship
purposes. Should those types of records be submitted to APHIS for
retention, they would then be considered Federal records subject to the
Freedom of Information Act (FOIA), which, among other things, would
give rise to considerable administrative burdens for APHIS, which would
be obliged (for instance) to protect submitters' confidential business
information in maintaining such records and responding to FOIA
requests. Furthermore, adopting the commenter's recommendation could
raise concerns about disparate treatment. The comment did not include
size criteria or definitions or a description of a process that would
enable APHIS to make a fair determination of who could or could not
submit documents for APHIS to retain.
Finally, one commenter recommended that APHIS utilize the APHIS-
initiated amendment procedure for site-specific enforcement in
instances of noncompliance and amend Sec. 340.6(c)(i) to explicitly
allow the Administrator to deny an application or withdraw a permit
``in whole or part.'' The commenter contended that this would provide
APHIS the flexibility to apply site-specific, measured enforcement.
APHIS agrees with the intent of the comment but disagrees with the
suggestion that a regulatory text change is necessary, because the
permit-amendment provisions in Sec. 340.5(j)(2) already allow us
sufficient flexibility to respond to compliance issues in the manner
recommended by the commenter.
Confidential Business Information (CBI)
Commenters took divergent views on the issue of the proposed
Confidential Business Information (CBI) exemptions in the proposed
rule. Some thought the exemptions, as explained in the preamble to the
proposed rule, did not provide enough protection for submitters, while
others thought that the exemptions were too broad.
Several commenters stated that CBI protections should extend to
information pertaining to MOA and other information required to be
submitted for an RSR or needed by APHIS to confirm a determination by a
developer that its product is exempt from these regulations. Some
commenters also suggested that submitters may forgo seeking
confirmation or an RSR, and may opt to go under permits, if the MOA
will be made public after a product has come through the confirmation
or RSR process, because submitters want to protect that information.
As noted in the preamble to the proposed rule, APHIS intends to
release a general description of the plant, the trait, and the MOA of
GE plants that go through an RSR, but APHIS would do so without
revealing CBI. APHIS would similarly release a general description of
the plant, trait, and, as applicable, the MOA associated with
confirmation requests, again without revealing CBI. APHIS wants to
clarify that we are not requiring submitters to waive their

[[Page 29818]]

applicable CBI claims. Further, as we noted in the preamble, certain
technical information, such as data that could be used to re-create an
organism and that were not otherwise made publicly available by the
submitters, may be eligible for CBI designation. To the extent that CBI
claims exist, APHIS will review them, consistent with applicable laws
and statutory authorities, on a case-by-case basis. Submitters will be
given the opportunity to review and comment on a proposed general
description prior to public disclosure. Regardless of CBI
determination, developers will have the flexibility to select the
regulatory options, whether RSR or permit, that they deem best for
their business needs.
Other commenters expressed concern that extensive granting of CBI
designations could impede the ability of developers to determine
whether their products are eligible for exemption, and could impede
peer-reviewable risk assessment. These commenters favored posting
confirmation requests and responses and RSR determinations online. It
was suggested that if such data are not available, developers will lack
the necessary information to make reliable determinations for their GE
plants and may choose permitting instead. According to these
commenters, this would attenuate the regulatory relief that is one of
the objectives of this rulemaking.
APHIS will post confirmation requests and responses, as well as
determinations of nonregulated status pursuant to the outcomes of
initial RSRs, on the APHIS website, with CBI redacted. When additional
review is requested, as discussed earlier in this document, the
analysis, outcome, and supporting documents will be published in the
Federal Register and on the website, also with CBI redacted. We
recognize that, in some cases, information necessary for researchers
and developers to make determinations pursuant to Sec. 340.1(c) may
not be made public, due to CBI claims.
Commenters also expressed the view that mandatory field trial data
should not be eligible for CBI exemption.
Under this rulemaking, there is no requirement that developers
submit field-trial data to APHIS, though they may do so if they choose
to support an RSR or confirmation letter request. As noted above, APHIS
would allow only CBI exemptions that are consistent with applicable
case law and statutory authorities.
A commenter requested that we clarify how the process for
submitting CBI exemption requests and justifications for exemptions
differs from the process that occurs under the current regulations.
The process for submitting and justifying CBI claims will not
change under this rulemaking. Persons submitting any document to APHIS
in accordance with the regulations must identify those portions of the
document deemed to be CBI. Each page containing such information must
be marked ``CBI Copy.'' A second copy of the document must be submitted
with all such CBI deleted, and each page where the CBI was deleted must
be marked ``CBI Deleted.'' In addition, any person submitting a CBI
exemption request must justify the request by demonstrating how each
piece of information to which the request applies is a trade secret or
is commercial or financial information and is thereby privileged or
confidential.
Economic Analysis
Some comments directly addressed the economic analysis that
accompanied the June 2019 proposed rule. It was claimed that the
analysis was light on data characterizing the potential economic and
social impacts of the proposal. It was also stated that we did not
offer sufficient analysis of the challenges of assuring other countries
that imports of GE products from the United States are safe and meet
the importers' requirements.
In the analysis accompanying the June 2019 proposed rule, we did
request comments from the public on the potential economic impacts of
the rule on affected entities. Most of the commenters who addressed
potential economic impacts did so as part of a broader discussion of
other issues, such as the potential economic effects of commingling,
rather than addressing the economic analysis directly. Commenters did
not supply actual data that would have aided us in characterizing
potential social and economic impacts of the proposed rule. We do
discuss potential international trade issues at some length later in
this document.
Regulation of Plants That Produce Plant-Made Pharmaceuticals and
Industrials (PMPIs)
We stated in the June 2019 proposed rule that the likelihood
existed that most, if not all, GE PMPI-producing plants that are
currently under APHIS permits could be determined to be not regulated
if an RSR found them to be unlikely to pose a plant pest risk. We also
noted that our proposed rule envisioned that were this to occur, such
plants could be grown outdoors without the need for APHIS permits and
without APHIS oversight.
We received many comments on this issue. Some commenters expressed
concern that the proposed change to our regulatory approach to PMPI-
producing plants would weaken or eliminate APHIS' oversight of them.
Others favored less regulatory oversight of PMPI-producing plants than
that provided in the existing regulations. Still others requested that
we provide greater clarification of our regulatory approach to PMPI-
producing plants under this rulemaking and emphasized the need for
cooperation among regulatory agencies. These varying viewpoints are
discussed in greater detail below.
Some commenters stated that as a result of this rulemaking, APHIS
would abdicate its oversight role, leaving the planting of PMPI-
producing plants essentially unregulated. As a result, according to
these commenters, our agricultural food systems could be made
vulnerable to introduction of experimental GE crops, and environmental
quality and human health could be negatively affected based on the end
use of those crops for pharmaceutical or industrial purposes. One
commenter expressed concern that PMPI-producing plant developers would
be able to determine for themselves whether their products are eligible
for exemption. All of these commenters urged us to maintain our
existing level of regulatory oversight of PMPI-producing plants.
Some commenters favored still more stringent requirements. They
argued in favor of more restrictive oversight of PMPI-producing plants
than was provided for in either the proposed rule or the existing
regulations. They asserted that allowing PMPI-producing plants to be
grown outdoors without APHIS oversight does not comport with the OIG's
recommendations on regulating PMPI-producing plants to prevent
inadvertent release.
Finally, a few commenters stated that they did not consider PMPI-
producing plants to present inherent risks and argued that developers
of PMPI-producing plants should be able to sufficiently self-regulate
the planting of such plants. Some of these commenters took the view
that APHIS' regulatory oversight over PMPI-producing plants was, if
anything, already excessive and would remain excessive or become still
more so under the proposed rule. One commenter stated that developers
should be given the option to be regulated by the agency most relevant
to their GE products. Other commenters stressed the need for APHIS and
FDA to have a memorandum of understanding

[[Page 29819]]

(MOU) for the regulation of PMPI-producing plants.
After considering the comments received, we have decided to
continue to maintain regulatory oversight of PMPI-producing plants by
continuing to require permits for their movement. We are adding this
requirement to Sec. 340.2 of this final rule as paragraph (e), which
states that a permit is required for the movement of a plant that
encodes a product intended for pharmaceutical or industrial use.
Accordingly, PMPI-producing plants will not be eligible for the RSR
process. We also have determined that APHIS can continue to exercise
oversight of PMPIs pursuant to our existing statutory authority under
the PPA. We discuss how we arrived at this determination below.
The commenters who favored more stringent oversight of PMPI-
producing plants than under the current regulations often considered
them to present a significant inherent risk by virtue of being PMPI-
producing plants and/or considered our existing regulations in part 340
to contain inadequate safeguards.
We do not agree that more regulatory oversight of PMPI-producing
plants than under the current regulations is warranted, and we do not
consider our current regulatory framework to provide inadequate
safeguards. Since 1994 (58 FR 17047), we have required permits for the
movement of plants that produce pharmaceutical compounds. In 2003,
APHIS published an interim rule in the Federal Register (68 FR 46434-
46436, Docket No. 03-038-1) that extended this permitting requirement
to plants that produce industrial compounds; that same year, we
implemented additional safeguards for PMPI-producing plant field trials
that exceeded those previously in effect. These added safeguards, which
were implemented as permitting conditions, included requiring location
coordinates, authorizing release only in low-production geographies for
the particular crop at issue, requiring dedicated equipment, and
providing for frequent inspections of each trial site.
Since 2003, permits for field trials of PMPI-producing plants have
made up a small percentage of the overall permits that APHIS has issued
pursuant to the regulations in part 340. In the intervening 17 years,
we have not encountered any issues with field trials of PMPI-producing
plants that call into question the overall adequacy of our permitting
conditions for PMPI-producing plants. Furthermore, over time, APHIS has
regulated a large number of field trials of non-PMPI producing plants
under permit conditions for diverse plants, traits, MOAs, geographic
locations, and agroecological conditions. Regardless of whether the
plant is a PMPI-producing plant or not, these permit conditions have
been successful in ensuring that genetically engineered plants are
confined to the field trial location. Based on our experience in
permitting field trials of genetically engineered plants, we are
confident in our ability to devise appropriate permit conditions to
ensure confinement of all regulated plants, including PMPI-producing
plants as we have done for the past 17 years.
For this same reason, we do not consider it necessary to regulate
PMPI-producing plants as Federal noxious weeds in accordance with our
regulations in 7 CFR part 360, one of the options which we mentioned in
the proposed rule. We believe that doing so could suggest that APHIS
has identified unique risks associated with PMPI-producing plants based
on our data since 2003; this is not the case. Instead, we agree with
those commenters who have asked us to maintain our current level of
regulatory oversight based on the framework first elucidated in 2003.
The commenters who urged us to continue to exercise a similar or
greater level of regulatory oversight of PMPI-producing plants do raise
a salient point: PMPI-producing plants are not developed for food or
feed use and can encode compounds that are intended to have a
physiological effect in humans or animals. This is important for
several reasons.
First, in the 2003 interim rule that required permits for plants
that encode for industrials, we stated that APHIS' regulatory
experience and scientific familiarity lay primarily at the time with GE
plants produced for food or feed. This remains the case; while the
Agency certainly has more familiarity with PMPI-producing plants than
we possessed in 2003, PMPI-producing plants account for less than one
percent of the total number of GE plants for which we have issued
permits, and none have been designated nonregulated. Accordingly, the
Agency still has significantly more experience with GE plants that
produce food or feed than with those that produce PMPIs.
Second, as we set forth in the proposed rule, the intended use of
PMPIs makes them differently situated than other GE plants regulated by
APHIS, such that additional evaluation beyond RSR may be needed. We
therefore consider it appropriate to maintain the status quo and
continue to require permits for PMPI-producing plants.
In such instances when the risks associated with a plant or
organism are not fully understood, APHIS has interpreted its authority
under sections 7711 and 7712 of the Plant Protection Act and its
predecessor statutes to provide a basis for regulating the plant or
organism based on our best understanding of the risks presented (see 58
FR 17047; 68 FR 46434-46436).
Accordingly, APHIS will continue to exercise its authority under
the Plant Protection Act to maintain regulatory oversight of PMPI-
producing plants. FDA has authority under the Federal Food, Drug, and
Cosmetic Act (FFDCA, 21 U.S.C. 301 et seq.) to take action to have
foods withdrawn from the market if they contain PMPIs not approved for
use in food. FDA also regulates drugs and human biological products
under the FFDCA and therefore would have oversight over such products
from PMPI-producing plants. FDA has not traditionally overseen field
trials of PMPI-producing plants. APHIS will maintain the status quo by
continuing to require permits for movement and environmental release of
all PMPI-producing plants. It is not clear to us how an MOU between FDA
and APHIS would be beneficial in providing oversight.
One commenter recommended that we list categories of the types of
PMPI-producing plants that could generate food adulteration, should
they find their way into the food supply, and regulate only those types
of PMPI-producing plants.
Another commenter stated that we needed to clarify and possibly
refine our overall regulatory approach to PMPI-producing plants. The
commenter expressed a concern that a lack of clarity may result in
unnecessary costs and time delays in bringing new products to market,
thereby disproportionately impacting smaller developers and limiting
the availability of new opportunities for farmers. As an example of a
possible refinement to our regulatory approach, the same commenter
suggested that in regulating PMPI-producing plants, APHIS should
consider the likelihood that PMPI-producing plants will be produced in
niche crops, which can be readily segregated from commodity crops, thus
reducing the potential for their entering the food chain.
APHIS does not plan to develop a list of food adulterants or of
categories of the types of PMPI-producing plants that could generate
food adulteration. As noted above, the primary oversight authority in
matters concerning food

[[Page 29820]]

safety involving plants, such as whether the presence of a particular
substance in a food would make it adulterated, rests with FDA rather
than APHIS. With regard to the latter comment, in establishing
permitting requirements for PMPI-producing plant field trials, APHIS
does take into consideration the specific crop in which the PMPI is
produced.
Regulation of Plant-Incorporated Protectants (PIPs)
As noted in the preamble to the June 2019 proposed rule, certain
plants are genetically engineered to produce PIPs, meaning that they
produce pesticides. PIPs fall under the regulatory oversight of EPA.
However, because EPA generally only requires Experimental Use Permits
for field tests on 10 acres or more of land, only APHIS has
historically exercised regulatory oversight over plantings of PIP-
producing plants on 10 acres or less of land.
Under the provisions of the June 2019 proposed rule, there would be
a likelihood that many PIP-producing plants that are currently
regulated under APHIS permits or notifications could be determined not
to be covered by the regulations after RSRs, because such plants are
unlikely to pose greater plant pest risks by comparison with their
comparators. Such plants could therefore be grown outdoors without the
need for an APHIS permit and without undergoing APHIS oversight. Thus,
Federal oversight over small-scale (10 acres or less) outdoor field
test plantings of some PIPs would rest solely with EPA.
Commenters expressed a broad range of views regarding the scope of
our regulatory oversight over PIP-producing plants. Some commenters
expressed the view that APHIS should leave the regulation of PIPs
entirely to EPA. Others stated that APHIS should continue its oversight
over PIP-producing plants in coordination with EPA to ensure that PIPs
are regulated at all scales. Concerns were expressed by some commenters
about what they perceived as potentially a broadened regulatory scope.
It was stated that small releases of PIP-producing plants that are not
currently subject to APHIS regulations could be regulated under the
proposed rule.
After reviewing these comments, we have decided that the approach
presented in our June 2019 proposed rule remains appropriate. All PIPs,
as noted in that rule, are properly under the regulatory oversight of
EPA; to date, EPA has not seen a need to exercise oversight over PIP-
producing plants planted on 10 acres or less because APHIS has
exercised such oversight.
Accordingly, APHIS will continue to conduct oversight over PIP-
producing plants at all scales unless the PIP-producing plant were to
meet the conditions for an exemption from regulation in our revised
regulations, or were determined following RSR not to be covered by the
regulations. If APHIS determines that a PIP-producing plant is not
regulated under these regulations; EPA would still retain regulatory
authority and may decide to require an Experimental Use Permit and
provide oversight of field trials under 10 acres. APHIS has avenues for
cooperation with EPA, such as an agreement to provide oversight
assistance to EPA under the Economy Act, should EPA decide that
oversight of small PIP field trials is appropriate.
We have, however, decided to modify this final rule slightly to
clarify the nature of this interaction between APHIS and EPA regarding
PIPs. As noted above, we are adding a new Sec. 340.5(g) stating that a
permit is not required for the movement of any GE plant modified solely
to contain a PIP that is currently registered with EPA as a pesticide
product pursuant to the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA, 7 U.S.C. 136 et seq.), or that is currently exempted from
FIFRA pursuant to 40 CFR 174.21.
Under FIFRA, EPA is authorized to regulate pesticides. Pursuant to
FIFRA, EPA regulates certain PIPs as ``substances,'' and has
established a registration process for their use as pesticides. In
determining whether to grant a registration for a PIP with pesticidal
properties, EPA conducts ecological risk assessments to determine what
risks are posed by the PIP and whether changes to the use or proposed
use are necessary to protect the environment. The product is registered
under FIFRA and thereby eligible for sale on the market if the results
of the risk assessment indicate that the pesticide will not pose any
unreasonable risks to wildlife and the environment. Environmental
effects considered include effects on nontarget organisms. A PIP that
is currently registered will have undergone such a risk assessment and
will therefore have been determined not to pose unreasonable risks to
other plants. For that reason, we can exempt, and have decided to
exempt, such PIP-producing plants from our regulations.
We can also exempt, and have decided to exempt, modified PIP-
producing plants that EPA has exempted from FIFRA pursuant to 40 CFR
part 174.21. Section 25(b) of FIFRA allows EPA to promulgate
regulations to exempt from the requirements of FIFRA any pesticide
which the Administrator determines is ``of a character which is
unnecessary to be subject to [FIFRA] in order to carry out the purposes
of [FIFRA].'' Pursuant to this statutory authority, EPA's regulations
in 40 CFR part 174.21 set forth criteria used by EPA for exempting PIPs
from FIFRA requirements, including that the genetic material encoding
the PIP or leading to the production of the PIP is from a plant that is
sexually compatible with the recipient plant. These criteria currently
do not pertain to GE plants containing PIPs.
However, if EPA were to establish criteria for exemption from FIFRA
for certain additional plants containing PIPs, plants meeting those
criteria would, by statute, have been determined by EPA to be of a
character unnecessary to be subject to FIFRA in order to carry out the
purposes of FIFRA. Because EPA could not make such a broad
determination without consideration of the effects of such plants on
the environment, including risks to other plants, we are exempting such
plants from APHIS permitting requirements, as well.
Other commenters expressed concern that small releases of PIP-
producing plants that are not currently subject to APHIS regulations
could be regulated under this rule.
It is true that a GE PIP-producing plant that is not created using
a plant pest as a donor organism, recipient organism, or vector or
vector agent, was previously exempt from APHIS regulations under part
340 but could fall within the scope of these revised regulations if it
does not qualify for an exemption under Sec. 340.1 or under new Sec.
340.5(g). This is, in fact, true of all GE plants that are created
without the use of a plant pest donor organism, recipient organism, or
vector or vector agent. However, as we discuss at greater length in the
economic analysis that accompanies this final rule, we believe the
number of producers and products that may be newly regulated as a
result of this rule is extremely small. Moreover, we are not aware of
any GE
PIP-producing plant that has been produced to date without the use
of a plant pest as the donor organism, recipient organism, or vector or
vector agent.
Finally, one commenter stated that regulating PIPs more strictly
than regulating chemicals is not scientifically justifiable. The
commenter noted that EPA considers biological pesticides, including
PIPs, to ``generally pose less risk than most conventional
pesticides.''

[[Page 29821]]

This comment pertains to EPA's regulatory structure for PIPs. As
such, it is outside the scope of the current rulemaking.
International Trade Implications
A number of commenters expressed the concern that the regulatory
approach that underpins this rulemaking is out of step with that of key
international markets and governments. It was suggested that the rule
could result in greater asymmetry in regulatory approach between APHIS
and U.S. trading partners, thereby endangering U.S. export markets, and
that obtaining international acceptance of our new regulatory approach
should be a precondition for finalization. A commenter further stated
that we need to balance our regulation of GE organisms with the need
for industry to comply with international markets that are sensitive to
the unintended presence of GE organisms in non-GE products.
The fundamental APHIS protection goal under our regulations in part
340, which stem from and are delimited by our statutory authority to
regulate plant pests under the PPA, is to protect agriculture against
increased plant pest risks resulting from GE organisms. This regulatory
approach has always been different from that of other national systems,
which may not necessarily focus on plant pest risk and instead may be
technique-based. Nevertheless, our trading partners have historically
judged our approach to be acceptable, as it is transparent and science-
and risk-based. Trading partners that have understood and accepted our
regulatory system will not find our updated approach to meeting the
same objectives confusing. Thus, we do not see this revised system as
less compatible with those of our trading partners than in the past. As
we have in the past, we will continue to provide technical expertise,
information, and explanation to our trading partners regarding our
regulatory system and determinations of regulatory status.
It was further stated by commenters that a possible consequence of
the unwillingness of trading partners to accept our new regulatory
approach could be the undermining of the progress being made in the
Global Low-Level Presence Initiative (GLI), in which countries
(including the United States) are striving to achieve a science-based
and risk-based approach that would allow for a commercially achievable
tolerance for the presence of a biotechnology-enhanced trait that (1)
has been approved as safe by an exporting country based upon scientific
analysis and CODEX-adopted risk assessment principles, but (2) has not
yet been approved by an importing country. Additionally, the commenter
interpreted the U.S.-Mexico-Canada Agreement (USMCA) to expressly
commit all three countries to develop a low-level presence policy for
imports.
To maintain global acceptance for its regulatory approach, APHIS
needs to continue to maintain and enhance its credibility and its
leadership role in the field of biotechnology regulation. It was with
that goal in mind that we proposed these new regulations, which reflect
both the knowledge we have gained, over the more than 30 years since we
first promulgated our biotechnology regulations, and new developments
in the field.
While it is gratifying that the APHIS system of regulation is
perceived to provide protection against commingling or low level
presence of plant products that are unwanted or are unauthorized in
foreign (or even domestic) markets, the PPA, under which these
regulations are promulgated, does not authorize APHIS to use the
potential for low level presence as a basis for determining regulatory
status or for monitoring what has been commercialized. USDA recognizes
the focus of the Codex Guideline for the Conduct of Food Safety
Assessment of Foods Derived from Recombinant DNA Plants (2003) and the
associated annex addressing low level presence, an international
standard. However, we note that the subject of this guidance and its
agreed-upon annex is for food safety alone. USDA-APHIS reviews GE
plants for the potential for plant pest risk, not food safety.
Finally, we disagree with the commenter's interpretation of the
USMCA. We note that it instead stipulates that each Party shall adopt
or maintain policies or approaches designed to facilitate the
management of any LLP Occurrence. It does not mandate development of an
overarching policy.
Elaborating on the concerns discussed above, some commenters
emphasized the need for APHIS to develop and execute an international
engagement strategy with our trading partners that explains the
rationale for APHIS' pre-market regulatory approaches.
For 30 years, APHIS has consistently engaged and led in many
international contexts to provide knowledge of its regulatory policy,
science, and systems to encourage the safe development and trade of the
products of agricultural biotechnology. Most recently, APHIS has worked
to implement the Presidential Executive Order Modernizing the
Regulatory Framework for Agricultural Biotechnology Products (June 11,
2019, E.O. 13874) to ``provide leadership in international fora to
promote scientific competency, understanding of the U.S. regulatory
approach, and regulatory compatibility worldwide for biotechnology
products.'' \11\ For the past several years, APHIS has shared
rationales, experience, and information on potential regulatory changes
with U.S. trade agencies (e.g., the United States Trade Representative,
the Department of State, the USDA Foreign Agricultural Service), U.S.
trading partners, like-minded countries, and other countries in order
to garner understanding and support for this updated regulatory
approach. APHIS intends to continue such engagement.
---------------------------------------------------------------------------

\11\ National Strategy for Modernizing the Regulatory System for
Biotechnology Products. September, 2016.
---------------------------------------------------------------------------

Statutory Authority, Jurisdiction, and Interagency Coordination
We received many comments regarding our statutory authority, or
lack thereof, to implement our proposed regulations. Some commenters
claimed that we did not have such authority, while others expressed the
view that we were abdicating the authority we do possess and, in some
cases, failing to meet our statutory obligations. Some of these issues
have already been discussed elsewhere in this document in relation to
topics such as allowing developers to determine whether their products
are eligible for exemption.
As noted above, we base our determinations of regulatory status on
whether a GE plant or its sexually compatible relatives could pose an
increased plant pest risk relative to the comparator(s). One commenter
asserted that the PPA gives the Secretary the authority to develop
regulations for the movement of plant pests only, and not the authority
to develop regulations for the movement of organisms that pose a plant
pest risk.
We do not agree with this comment. In addition to the authority to
regulate the movement of plant pests under Sec. 7711 of the PPA,
including ``[a]ny article similar to or allied with any of the''
specific plant pests listed in Sec. 7702(14), as cited by the
commenter, we note that Sec. 7712 of the PPA specifically provides the
Secretary with broad authority to protect plants by regulating the
movement of, among other items, plants and articles in order to prevent
the introduction or dissemination of a plant pest within the United
States.

[[Page 29822]]

As noted many times in this document, for GE organisms that fall
under the regulations, permits are required for three activities:
Importation, interstate movement, and environmental release. One
commenter asserted that regulation of environmental releases done
within a State or territory is unconstitutional.
We do not agree with this comment. The impact of an unauthorized
environmental release may extend beyond the borders of the State in
which the GE organism was released. See Atay v. County of Maui, 842
F.3d at 701-02 (``Under the PPA, `movement' is defined broadly and
expressly includes a plant's `release into the environment,' [7 U.S.C.]
Sec. 7702(9)(E), such as open-air field testing of GE plants.
Experimental GE plants grown on test fields in Maui are without doubt
involved in interstate commerce. Setting aside the global market for GE
seed crops, seeds and other organisms carried afield by wind or other
vectors ``do not acknowledge State lines.'' 52 FR 22892, 22894 (June
16, 1987).'') (citation omitted); id. at 702 (``While the phrase
`movement in interstate commerce' within the meaning of the PPA's
preemption clause may be narrower than the full scope of Congress's
Commerce Clause power, we find that the phrase encompasses federally
regulated GE crops grown in Hawaii. [The plaintiff's] narrower
interpretation, which would limit the scope of the preemption clause to
local laws addressing plants that are in the act of traveling to or
through at least one other State, is less consistent with the statute's
larger context and purpose, which clearly envisions the dissemination
of plants and seeds from fields as implicating movement in interstate
commerce. See, e.g., 7 U.S.C. 7711(a). Indeed, Congress expressly
recognized in the PPA that `all plant pests, noxious weeds, plants,
plant products, articles capable of harboring plant pests or noxious
weeds regulated under this chapter are in or affect interstate
commerce.' Id. Sec. 7701(9).'') (citation omitted).
In contrast to the comments discussed above, which questioned the
reach of our authority to regulate, other comments faulted us for not
using our authority to regulate noxious weeds under the PPA. It was
stated that by not considering noxious weed potential as a criterion
for determining regulatory status of GE organisms, we restrict our
authority under the PPA. One commenter argued that APHIS is statutorily
obligated to integrate and apply the noxious weed authority to GE
crops.
APHIS recognizes that genetic engineering may be used to introduce
a trait that increases the distribution, density, or development of a
plant or the weedy impacts of the plant, factors that are considered
aspects of a plant's weediness. Accordingly, we would continue our
current practice of considering the weediness of the unmodified plant
and whether the new trait could in any way change the weediness. We
would also consider potential effects on the weediness of other plants
with which the engineered plant can interbreed, because it is relevant
to the assessment of the plant's plant pest risk. Plants and their
sexually compatible relatives could have increased importance as
reservoirs for plant pests if they are distributed differently, are
more prevalent, or are altered with respect to the time period during
which they serve as a host for plant pests due to the introduced trait.
As part of the RSR, APHIS would continue to consider whether the trait
might change plant pest interactions, establishment, and persistence
for both the plant engineered and any other plants with which it can
interbreed. If the plant had the potential to be a truly troublesome
and impactful weed, we would need to consider whether the plant with
the specific trait being evaluated should be considered for regulation
pursuant to our separate statutory authority to regulate noxious weeds
and the regulations issued under that authority. The proposed
regulation does not change this analysis.
APHIS disagrees with the proposition that APHIS is statutorily
obligated to integrate noxious weed authority into a revised part 340.
In the PPA, Congress identified plant pests and noxious weeds as
separate concerns, and delegated authority to the Secretary to
determine how to best use this authority. See, e.g., 7 U.S.C. 7711,
7712, 7754, 7758(c); see also Center for Food Safety v. Vilsack, 718
F.3d 829, 843 (9th Cir. 2013) (``Plant pests and noxious weeds are
regulated under separate regulatory frameworks. Regulations for plant
pests are contained in 7 CFR parts 330 and 340 while the regulations
governing noxious weeds are contained in 7 CFR part 360. The separate
regulatory frameworks for plant pests and noxious weeds are consistent
with standards of the statute treating plant pests and noxious weeds
separately. Indeed, the PPA kept in place the separate regulatory
frameworks for plant pests and noxious weeds that were originally
promulgated under the Federal Plant Pest Act and the Federal Noxious
Weed Act.'') (Citing 7 U.S.C. 7758(c)). We also do not perceive a basis
at this time for overhauling part 360 noxious weed regulations, which
we believe have functioned well over the years, or establishing
alternate regulations in title 7 governing noxious weeds.
Other commenters expressed the concern that by asserting our
statutory authority narrowly and emphasizing deregulation in this
rulemaking, we could be creating a regulatory vacuum. It was suggested
that States or localities may take advantage of that vacuum and assert
their own authorities, possibly intervening to disrupt necessary field
trials.
With regard to overall scope, the regulations proposed under part
340 are functionally equivalent to the rules under which APHIS has been
operating for essentially three decades. Under the existing
regulations, APHIS communicates with and cooperates with State and
local governments as appropriate and as circumstances warrant,
including for coordination of enforcement and permitting activities.
APHIS does not anticipate that the working relationship with State and
local governments will be changed in any significant way based upon
issuance of this rule. Federal courts have already considered the
applicability of preemption principles in this area, including by
applying the Plant Protection Act's express preemption provision, 7
U.S.C. 7756. See generally Atay v. County of Maui, 842 F.3d at 698-705.
Some commenters addressed issues of interagency and intra-agency
coordination in the regulation of GE products. A commenter suggested
that we needed to coordinate with EPA to improve the commercial
availability of herbicide resistant crops, concomitant with the
registration of herbicides for use on those crops. The commenter stated
that the asynchronous timing of USDA's deregulation of an herbicide-
resistant crop cultivar and of EPA's associated herbicide registration
has led to some scenarios in which growers are tempted to illegally
apply unregistered herbicide formulations. Another commenter stated
that duplicative regulations from oversight agencies, including FDA,
EPA, and APHIS, should be streamlined into a common regulatory
oversight regime depending on the product and its intended use.
The interagency working group which drafted the Coordinated
Framework sought to ensure regulation adequate to ensure health and
environmental safety while maintaining sufficient regulatory
flexibility to avoid impeding beneficial innovation. The former
commenter

[[Page 29823]]

believes that a delay in USDA regulatory decisions to better coordinate
with EPA registration decisions will curtail growers and applicators
from illegally applying unregistered herbicide formulations. However,
USDA needs to consider whether additional regulatory burden is
warranted or legally appropriate, given that the pesticide activity
noted is already considered to be illegal by existing regulation. We
note that one of the purposes of the Coordinated Framework is to ensure
that there is a standard mechanism for communication and, to the extent
possible, coordination among FDA, EPA, and APHIS as they perform their
respective regulatory functions. USDA and EPA are in communication over
the overarching purpose of coordination as it pertains to the pesticide
regulatory issues identified by the commenter. At the same time, this
rule does not impose delays on USDA decision making based on factors
within the regulatory jurisdiction of other agencies, nor do we think
that such delays would be appropriate.
With regard to the latter commenter, while FDA, EPA, and APHIS have
distinct areas of regulatory oversight relative to GE organisms, the
Agencies are committed to implementing Executive Order 13874, including
its requirements that EPA and USDA streamline regulations and guidance
documents within their purview and that these agencies ``use existing
statutory authority, as appropriate, to exempt low-risk products of
agricultural biotechnology from undue regulation.'' Where areas of
overlapping jurisdiction exist, the Agencies are seeking to avoid
redundant regulation. For example, FDA has jurisdiction over animals,
including insects, but does not regulate when another agency is
regulating, as APHIS is with GE moths and bollworm. With this rule,
APHIS is avoiding redundant regulation with regard to microbial
pesticides and plant incorporated protectants. As noted above, new
Sec. 340.5(f) states that a permit is not required for any GE
microorganism product that is currently registered with the EPA as a
microbial pesticide, so long as the microorganism is not a plant pest
as defined in Sec. 340.3. Similarly, Sec. 340.5(g) states that a
permit is not required for the movement of any plant modified solely to
contain a plant incorporated protectant that is currently registered
with the EPA or exempt from EPA regulations.
Finally, multiple commenters recommended that we provide greater
clarity regarding the regulatory jurisdiction of two agencies within
APHIS--Biotechnology Research Services (BRS) and Plant Protection and
Quarantine (PPQ)--that regulate, among other things, GE and non-GE
plants, respectively. The commenters expressed concern that some of the
revisions we proposed, in particular those in Sec. 340.2, may create
opportunities for duplicative regulation of products under part 340 by
BRS and under 7 CFR part 330 by PPQ.
The regulations in part 330 govern the movement of plant pests,
biological control organisms, and associated articles, such as soil.
Prior to a final rule \12\ published in the Federal Register on June
25, 2019 (84 FR 29938-29967, Docket No. APHIS-2008-0076), the
regulations in part 330 had specifically exempted from regulation under
that part any plant pests that had been genetically engineered, as that
term was defined in Sec. 340.1. In the June 25, 2019 final rule, that
specific exemption was removed from part 330. In its place, a
requirement, currently found in Sec. 330.200(a), was added. This new
requirement provided that plant pests, biological control organisms,
and associated articles that are not authorized for importation,
interstate movement, or environmental release in accordance with part
330, and are not explicitly exempted from regulation under part 330,
must be authorized for importation, interstate movement, or
environmental release under other regulations in title 7 of the Code of
Federal Regulations in order for that movement to be lawful.
---------------------------------------------------------------------------

\12\ To view the rule, its supporting documents, or the comments
that we received, go to https://www.regulations.gov/docket?D=APHIS-2008-0076.
---------------------------------------------------------------------------

The intent of this revision was to signal that there are multiple
parts in title 7 of the Code of Federal Regulations, not just part 330,
that contain requirements regarding the importation, interstate
movement, or environmental release of plant pests, biological control
organisms, or associated articles. However, we agree with the commenter
that one of the unintended effects was to cause confusion within this
rulemaking concerning the clear delineation between the requirements
for the movement of GE plant pests, which are found in part 340, and
the requirements for plant pests that had not been genetically
engineered, which are found in part 330.
Accordingly, we are revising Sec. 330.200 to indicate that GE
plant pests and biological organisms are exempted from regulation under
part 330, and are regulated under part 340.
A commenter expressed the concern that this rulemaking does not
further the Coordinated Framework established in the 1980s among USDA,
FDA, and EPA regarding federal biotechnology regulation. The commenter
states that the proposed rule amended part of this Coordinated
Framework without fully engaging EPA and FDA and did not reflect a
truly holistic approach, in the spirit of the Framework, to updating
the regulatory landscape for certain GE plants. The commenter strongly
believes that APHIS should follow the intent of the Coordinated
Framework.
APHIS has continued to coordinate with our Coordinated Framework
partners at FDA and EPA on an ongoing basis, and we are committed to
continuing this coordination with the implementation and
operationalization of this rule. In 2017, the three agencies
collaborated on an update to the Coordinated Framework. This update was
intended to:
Clarify which biotechnology product areas are within the
authority and responsibility of each agency;
Clarify the roles each agency plays in regulating
different product areas, particularly for those products that fall
within the scope of multiple agencies, and how those roles relate to
each other in the course of a regulatory assessment;
Provide a standard mechanism for communication and, as
appropriate, coordination among agencies while they perform their
respective regulatory functions, and identify agency designees
responsible for this coordination function; and
Specify the mechanisms and timelines for regularly
reviewing, and updating as appropriate, the Coordinated Framework to
minimize delays, support innovation, protect health and the environment
and promote public trust in the regulatory systems for biotechnology
products.
The updated Coordinated Framework is available at: https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/2017_coordinated_framework_update.pdf.
Additionally, as part of the rulemaking process, EPA and FDA have
had the opportunity to comment on this proposal and to provide
meaningful insight that informed this process.
Another commenter stated that language in the section of the
proposed rule describing regulation of PMPI-producing plants suggests
that the Coordinated Framework for regulating GE crops in the United
States is not nearly as ``coordinated'' as is necessary to ensure the
safety of our food supply. According to this commenter, a statute
should be enacted to create a new Federal agency that would have
explicit authority to provide oversight over all GE organisms (plants,
animals, and GE

[[Page 29824]]

microorganisms) for all possible risks, including plant pest and
noxious weed risks, environmental risks to beneficial organisms as well
as to ``neutral'' organisms like monarch butterflies, and human health
risks such as those associated with animal carcinogens and probable
human carcinogens like glyphosate.
Regulation of PMPI-producing GE plants is discussed above. The
remainder of this comment is outside the scope of the current
rulemaking and of APHIS' regulatory authority. We note, moreover, that
scientific evidence does not support the conclusion that GE organisms,
as a class, present risks that are different in degree or kind from the
risks that are presented by comparable non-GE organisms (NRC, 2010;
NAS, 2016b)
NEPA Implementing Regulations
As noted earlier, the June 2019 proposed rule proposed that the
notification and petition processes be removed from the regulations.
Concurrently, we proposed to remove language pertaining to
notifications and petitions from the NEPA implementing regulations in 7
CFR part 372. Specifically, we proposed to remove language pertaining
to notifications from Sec. 372.5(c)(3)(iii), and to remove language
pertaining to petitions from paragraphs (b)(7) and (c)(4) of Sec.
372.5. These changes were proposed to make the NEPA regulations
consistent with the proposed revised part 340.
Several commenters recommended that APHIS revise its NEPA
implementing regulations to ensure that individual actions taken under
the proposed rule are appropriately addressed and to describe the type
of environmental analysis and documentation that will generally be
developed. One commenter stated that APHIS should revise Sec. 372.5(b)
to include the proposed RSR as a type of action that normally requires
an environmental assessment but not necessarily an Environmental Impact
Statement. Another commenter recommended that APHIS clarify that
certain actions are not expected to have an impact on the environment
and therefore qualify for a categorical exclusion from the requirements
of NEPA.
APHIS disagrees with the suggestion that part 372 needs to be
further revised to more specifically describe the type of environmental
analysis that is necessary for individual actions under the final rule.
Actions will be accompanied by appropriate environmental analysis based
on the degree of environmental impact, consistent with the final
programmatic environmental impact statement (PEIS). In regard to the
new proposed RSR, APHIS stated in the final PEIS that RSRs will be
accompanied by an appropriate environmental analysis depending on the
degree of environmental impact.
APHIS seeks to further clarify APHIS' NEPA obligations under
various circumstances. When a modified plant qualifies for one of the
exemptions in Sec. 340.1(b), (c), or (d), the plant is not subject to
part 340 at all and APHIS renders no determination regarding its plant
pest risk. Therefore, APHIS will not complete a NEPA analysis for the
plant.
In the case of RSRs, whether conducted before or after a person
requests a permit, only some outcomes will require analysis pursuant to
NEPA. If, after initial review, APHIS finds a plausible pathway to
increased plant pest risk, APHIS will conduct a Plant Pest Risk
Assessment (PPRA) to evaluate the factor(s) of concern. In this
situation, APHIS will complete a NEPA analysis, as appropriate, for an
unconfined environmental release. Finally, when permits are issued for
confined environmental release, NEPA will apply as appropriate. Under
most circumstances, confined environmental releases are categorically
excluded in part 372 from the need to prepare an Environmental
Assessment or an Environmental Impact Statement.
List of Taxa
In the preamble to the June 2019 proposed rule, we noted that we
were proposing to remove the list of taxa containing plant pests from
the regulations. Instead, APHIS proposed to maintain a list of taxa
that contain plant pests on its website. We explained that the list on
the website would be more useful and reliable than a static list of
taxa, which becomes outdated. We solicited public comment on the
proposed change.
Commenters supported this change. One commenter, however, suggested
that it would be useful to maintain a version history on the website,
so that developers can be aware of the latest updates. The commenter
also recommended that whenever the website is updated, APHIS should
send an email notification to stakeholders. Another commenter requested
clarification on how the list would be maintained and modified.
APHIS agrees with the comment. Since taxonomic designations
sometimes change and new plant pests are continually being discovered,
APHIS will maintain a version history for the list of taxa that contain
plant pests and will provide an email notification to stakeholders when
the list is changed.
Oversight and Transparency
Some commenters expressed the concern that the regulatory framework
set forth in the June 2019 proposed rule would result in an overall
weakening of APHIS' regulatory oversight over GE products. Commenters
discussed a number of potential consequences of what they regarded as
diminishing APHIS' oversight role. As noted earlier in the discussion
pertaining to allowing developers to determine whether their products
are eligible for exemption, commenters were concerned that there could
be an increased risk of commingling of non-GE crops with GE crops. It
was also stated that because GE crops are already associated with
greater herbicide and pesticide use than non-GE crops, the rule could
result in the development of more herbicide- and pesticide-resistant
pests and weeds, leading to increased environmental and human health
risks. Some commenters stated that we needed to strengthen, rather than
loosen, our regulatory oversight.
We have addressed many of these issues earlier in this document and
the PEIS (Sec. Sec. 4.3.5 Agricultural Weeds and HR management; 4.6.2
Domestic Socioeconomic Environment; and 4.6.3 International Trade).
Additional discussion is presented below, under the heading ``General
Opposition to GE Products.'' As we have noted, however, these issues
are mostly outside the scope of the current regulations and of our
statutory authority under the PPA.
It was also suggested that the proposed new regulatory framework
could lead to a loss of transparency. Growers of non-GE crops, as noted
above, could lose access to information about neighboring GE crops.
According to some commenters, the public would also lose access to
important data. In particular, field-test data would no longer be
available to the public because the submission and publication of such
data would not always be required under the proposed rule.
One commenter recommended that in addition to providing the
information currently set forth in the proposed rule, APHIS should
establish on its website a single list of all GE organisms that are
being released into the environment. According to the commenter, that
list should include all plant-trait-MOA combinations, all RSRs, all
permitting, and all confirmations of developers' determinations of an
exemption. The commenter believes that with a complete and accurate
list of all GE organisms that have been released into

[[Page 29825]]

the environment, food industry stakeholders and the public will be able
to determine which GE plants have entered the food supply. Further,
according to the commenter, a transparent and comprehensive list will
provide helpful information if any food safety and environmental
threats materialize. In the commenter's view, this information will
also be important for international trade because it may prevent
unnecessary trade barriers from being constructed based on inaccurate
information about which GE plants may be entering a country without the
proper regulatory approval. Also, according to the commenter, it will
improve consumer confidence about GE plants because consumers will
realize that their existence is not being hidden from them. The
commenter recommended that to be as useful and as transparent as
possible, the list should include information about the plant, the type
of modifications or edits performed, the changed traits, a summary of
data about the benefits of the traits, and any testing for safety
concerns.
We do not agree with these comments. Under this rule, APHIS will
continue to make information available that is related to permits
issued under Sec. 340.5. APHIS will also make information available
concerning responses to confirmation requests under Sec. 340.1 and RSR
requests and results under Sec. 340.4. The information will be
available at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology.
As to organisms that are not regulated by APHIS, APHIS is not in the
best position to provide accurate and up-to-date information about such
organisms. In this regard, APHIS notes that pursuant to Executive Order
13874, USDA, EPA, and FDA recently released a unified website that
provides a one-stop-shop for information about the actions that the
Federal Government is taking to oversee the development of agricultural
biotechnology products. See https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/home. The
website provides links to relevant USDA, EPA, and FDA websites. See
https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/resources.
General Opposition to GE Products
Many individuals who commented opposed the rule because of their
concerns about GE products generally. An issue of particular concern,
raised by a large number of commenters, was the possibility of unsafe
GE products' getting into the food supply without consumers' knowledge.
Many of the commenters favored labeling of foods derived from GE
products. Commenters expressed the view that genetic engineering
techniques are not as safe as conventional breeding methods and that
all products developed using genetic engineering should be regulated,
with no exemptions allowed. Others stated that we should require long-
term testing of GE products prior to allowing commercialization. It was
further stated that in light of these considerations, our proposed
regulatory approach, with its focus on unfamiliar products developed
using genetic engineering, does not adequately evaluate products of
genetic engineering for potential long-term risk. Many commenters
argued that all GE organisms should be subject to assessments of their
long-term effects on the environment and human health and also
evaluated for indirect economic effects. Commenters also claimed that
the proposed rule, with its deregulatory emphasis, favored certain
economic interests at the expense of public health and safety and the
environment.
One commenter further stated that APHIS or a new GE organism-
specific agency should provide oversight over all GE organisms for all
possible risks, including any associated with the MOA used for gene
insertion, e.g. extra antibiotic-resistance genes, insertional
mutations, and unintended changes in the inserted genetic material.
According to this commenter, APHIS should require developers of GE
organisms to utilize the precision of the technology available to
identify the off-target effects of genetic engineering and to ensure
that associated risks are minimal.
The comments discussed above appear to be based on the premise that
the genetic engineering process itself is inherently risky. As we noted
in the preamble to the June 2019 proposed rule, and in this document,
available evidence, including reports from the National Academies of
Sciences, Engineering, and Medicine cited earlier in this document,
does not support this view. Moreover, the comments discussed above do
not reflect an accurate understanding of the limits of APHIS' statutory
authority, as explained elsewhere in this preamble.
In the reports we cited, issued in 1987 and 1989, respectively, by
the NRC,^{13 14} it was stated that there was no evidence for
unique hazards inherent in the use of recombinant DNA techniques and
that with respect to plants, crops modified by molecular and cellular
methods should pose risks no different from those modified by
conventional breeding methods for similar traits. A key conclusion from
these reports, taken together, is that it is not the process of genetic
engineering per se that imparts the risk, but the trait or traits that
it is used to introduce. A more recent NAS report, issued in 2016,
reaffirmed this conclusion.\15\
---------------------------------------------------------------------------

\13\ Introduction of Recombinant DNA-Engineered Organisms Into
the Environment: Key Issues. 1987. NRC. Washington, DC. National
Academies Press (US).
\14\ Field Testing Genetically Modified Organisms: Framework for
Decisions. 1989. NRC (US) Washington (DC). National Academies Press
(US).
\15\ NAS. 2016. Genetically Engineered Crops: Experiences and
Prospects. Washington, DC: The National Academies Press. doi:
10.17226/23395.
---------------------------------------------------------------------------

Several commenters took a position diametrically opposed to the
comments discussed above. The commenters stated that there is no
scientific rationale for the continued regulation of plant products
developed using genetic engineering techniques and legacy methods.
We do not agree with this comment. As discussed above,
responsibility for regulating GE and non-GE plants for plant pest risk
is divided between APHIS BRS and APHIS PPQ. In both cases, plants and
plant products are regulated or not regulated based on the risk of
introducing or disseminating plant pests that may be posed by their
movement or release into the environment. Because some (but not all) GE
and non-GE plants are associated with increased risk, it is necessary
for APHIS to regulate such plants in order to carry out its mission of
protecting U.S. agriculture.
Concerns were expressed by the organic farm industry regarding the
economic impact that the regulatory relief offered to developers in
this rulemaking would have on organic farmers, particularly as it
relates to the issue of GE crops commingling with organic crops. The
commenters stated that APHIS must consider how it will address the
needs of USDA-certified organic operations to prevent commingling with
GE organisms. Such considerations, it was stated, were not addressed in
the proposed rule. The commenters asserted that the USDA National
Organic Program regulations prohibit the use of genetic engineering in
the production of agricultural products marketed as organic in the
United States. According to these commenters, even inadvertent presence
of GE organisms can jeopardize the organic status of an otherwise
compliant organic product, and can lead to loss of markets and
significant industry disruption. Organic farms that reported crop loss
from the presence of GE organisms between 2011 and 2014

[[Page 29826]]

reported an average loss of $70,000 per farm (2014 USDA Organic
Survey).
APHIS has fully considered these factors from an economic
perspective and would refer the commenter to the economic analysis
accompanying this final rule. APHIS in that analysis expanded the
discussion of the various costs, including the costs associated with
buffer strips, spatial and temporal isolation, and the loss of premiums
associated with the risk to organic and non-GE growers from cross-
pollination or commingling. We note that organic crops and non-GE
products that are kept separate from their GE equivalents are treated
as value-added crops commanding premiums that vary according to
prevailing supply and demand conditions. Organic and other identity-
preserved crops generally receive a price premium, a premium adversely
impacted by the unintended presence of GE traits. The premiums
compensate farmers and traders for incremental costs they incur,
including those borne to maintain the segregation of non-GE and other
IP production from GE crops throughout the supply chain (through buffer
zones, spatial and temporal isolation, etc.). In the United States, the
coexistence of GE and non-GE production systems has been left to market
forces. Non-GE growers bear costs of coexistence and, in turn, pass
those costs on to purchasers of non-GE crops (Kalaitzandonakes and
Magnier, 2016).
One commenter stated that in addition to the threat of economic
harm from unintended presence of GE plant material, farmers who
unintentionally grow patented GE seeds or who harvest crops that are
cross-pollinated with GE traits could face costly lawsuits by
biotechnology companies for ``seed piracy.''
The issue raised by the commenter is outside the scope of the plant
pest authority delegated to APHIS under the PPA.
Some commenters argued that APHIS should conduct ongoing monitoring
and assessment of GE product impacts both in pre-market field trials
and following commercialization in order to protect the integrity of
conventional and organic seed and crops from prohibited substances and
excluded methods, including the methods of genetic engineering.
According to these commenters, safeguards and monitoring must be
required for the organism post-commercialization, and the FDA GRAS
(Generally Recognized as Safe) notification process is not enough for
such safeguards. In these commenters' view, monitoring should include
tracking changes associated with ecosystem harm, such as degradation of
water quality, air pollution, climate impacts, or loss of biological
resources. The commenters believe that this process must be rigorous,
transparent, and inclusive of APHIS's plant pest and noxious weed
authority under the PPA.
APHIS does not agree with these comments. Once APHIS determines
that a plant product does not pose a plant pest risk, APHIS has no
further authority to regulate it as such and to mandate requirements
for the submission of data unless there are new facts, such as a
compliance incident, that warrant such action. The FDA regulates human
and animal food from GE plants as FDA regulates all food within its
regulatory jurisdiction. The existing FDA safety requirements impose a
clear legal duty on everyone in the farm to table continuum to market
safe foods to consumers, regardless of the process by which such foods
are created. It is unlawful to produce, process, store, ship or sell to
consumers unsafe foods. Comments concerning FDA's process and
requirements should be directed to FDA.
One commenter discussed the need for compensating organic and other
growers of non-GE crops who could suffer harm as a result of this
rulemaking. It was argued that we need to establish a compensation
mechanism for those harmed by commingling, and that liability in cases
of commingling caused by GE crops should rest with the developers or
patent holders. One commenter also recommended that we establish a fair
compensation mechanism for losses caused by herbicides drifting from
fields planted with herbicide-resistant GE plants.
We thank the commenters for these recommendations; however, they
fall outside the scope of the regulations in part 340, which establish
the oversight and regulation of certain GE organisms. Regarding the
final comment, application protocols/practices for pesticides are
established and enumerated through EPA's labeling requirements. Once
APHIS determines that a plant product does not pose a plant pest risk,
it is not subject to our regulations in part 340 unless there are new
facts, such as a compliance incident, that warrant such action.
Additional Comments
Commenters offered a number of additional recommendations that are
beyond the scope of the current rulemaking. Some commenters recommended
that we invest in research to develop lower-cost rapid testing
technology. It was further suggested that we commit resources to
researching, tracking and analyzing incidences of unintended GE
presence and associated economic losses at all levels of the supply
chain. One commenter recommended that we coordinate with the USDA
Agricultural Marketing Service to establish contract protections for
organic and identity preservation grain growers to ensure that they
have fair access to testing data and recourse.
We thank the commenters for these recommendations. As noted above,
however, all of these recommended activities would fall outside the
scope of the regulations in part 340, which establish the oversight and
regulation of certain GE organisms.
One commenter stated that APHIS should consider protection goals
that align with making U.S. agriculture more sustainable, more
environmentally friendly, and less in need of future ``solutions'' to
genetic-engineering-produced noxious weed problems that involve
developing additional GE crops engineered to be tolerant of different,
more noxious herbicides.
This comment is outside the scope of these regulations. The PPA
provides for detection, control, eradication, suppression, prevention
or retardation of plant pests or noxious weeds.
Another commenter expressed concern over biodiversity and food
security in the context of accelerating climate change. The commenter
stated that genetic uniformity leads to disease susceptibility and that
biodiversity management systems need to be improved in terms of equity.
According to the commenter, we need systems that support keeping
diverse seeds in use, but genetic engineering has gone hand in hand
with large monoculture production.
This comment is outside the scope of these regulations. We note,
however, that the concerns identified by the commenter do not seem
specific to genetic engineering.
Other commenters expressed concerns about corporate concentration
and what they viewed as related feedback loops of seeds and chemical
use. Particular concern was expressed over the possible consolidation
of the seed industry that commenters thought could result from this
rulemaking. It was stated that legal and government systems favor the
largest companies, and that efforts to check the power of the largest
seed companies have been overridden or have fizzled out.
APHIS acknowledges the concern that the commenters have raised on
this topic. The regulations proposed under part 340 are intended to
streamline and offer additional regulatory relief to developers of all
sizes. We anticipate

[[Page 29827]]

that since smaller-scale business and academics have limited resources
and capacity to navigate regulatory systems, this rule will provide
especially acute benefits to smaller researchers and businesses. APHIS
has outlined and provided detailed descriptions of this dynamic in the
economic analysis accompanying this regulation.
Some commenters opposed the elimination of the notification and
petition procedures contained in the existing regulations. It was
stated that APHIS should not eliminate the petition process without
more clearly defining a streamlined, predictable path through which
responsible individuals can establish that their innovation no longer
needs to be reviewed by APHIS prior to release and commercialization.
Commenters opposed eliminating the notification procedure because they
were concerned that doing so would require many developers to go to
permitting, potentially disrupting business practices. Alternatives
suggested by these commenters included adding provisions for
streamlined permitting with standardized conditions for low-risk
organisms and returning to requiring individuals to provide information
on how they intend to meet performance standards.
In many ways, the APHIS evaluations for notifications under current
regulations are very similar to those done for permit applications, but
the notification procedure relies on applicants' agreeing to meet the
performance-based standards described in the regulations rather than
submitting an application for APHIS review describing the specific
measures that they will employ for the activity (as is the case for
permits). With permits, but not with notifications, APHIS can accept
the proposed measures or add to them, and the result is a set of
binding customized permit conditions.
We will not be making any changes in response to these comments. As
we noted in the preamble to the June 2019 proposed rule, the
notification procedure in the current regulations relies upon
performance-based standards. Since the specific measures that
constitute compliance with the regulations are not enumerated in the
performance standards, it can be difficult for APHIS inspectors to
determine whether a notification holder is in compliance. This
uncertainty can make enforcing the regulations, and thereby protecting
U.S. agriculture from plant pest risks, more difficult than it would be
if compliance measures were clearly enumerated as they are in specific
conditions under a permit. For this reason and to comply with OIG
recommendations with which we agreed, we proposed to eliminate the
notification procedure. We do not agree with the recommendation to
provide streamlined permit conditions for low-risk organisms. The
standard permitting conditions in Sec. 340.5(i) are needed to ensure
that activities conducted under permit for all GE organisms can be
performed with adequate mitigations for plant pest risk. Differences in
the level of risk associated with different organisms will be reflected
in the supplemental permitting conditions.
The current petition process for GE plants stems from the manner in
which regulated article is defined. As noted above, the current
regulations consider a GE organism to pose a plant pest risk and
therefore be a regulated article if the donor organism, recipient
organism, vector, or vector agent is a plant pest. Under the proposed
regulations, however, we would evaluate whether an organism would
require a permit for movement based on the characteristics of the
organism itself rather than on the method by which the organism is
genetically engineered. Based on the proposed change in approach, APHIS
believes that the petition process is no longer necessary and is
removing the petition process from the regulations. (As discussed
previously in this document, however, until RSR is available for a
particular crop, we will continue to receive petitions under the
process for that crop.)
Some commenters advocated that we retain the existing regulatory
framework rather than adopting the one we proposed. In the view of one
commenter, the proposed rule constituted a shift from a streamlined,
performance-based regulatory approach to a more prescriptive one. The
commenter saw that shift as a step backwards. Another commenter
expressed a preference for the process-based approach of the existing
regulations rather than the product-based one that we proposed. The
commenter stated that APHIS should regulate biotechnology products
based on the process by which they are created, using genetic
engineering as the trigger for regulatory review, to ensure that none
evade oversight entirely.
For reasons discussed at length in this document and in the June
2019 proposed rule, we do not agree with these comments.
One commenter viewed our overall regulatory approach as not
sufficiently flexible to take into account the relative risk levels
associated with different crops. The commenter recommended that we
consider such differences when making determinations about the
appropriate levels of regulation for different crops. We do not agree
with this comment. Our assessment of the risks associated with specific
GE crops will be reflected in our RSR determinations and in the permit
conditions we assign.
One commenter stated that our policy on low-level presence of
Regulated Genetically Engineered Plant Materials, discussed in the 2008
proposal, is absent from this one.
APHIS intends to continue its support of U.S. trade agencies to
address low level presence issues, as is further discussed above. This
approach is consistent with APHIS' statutory authority to regulate
plant pests, as further explained above.
One commenter stated that the June 2019 proposed rule lacked the
summary of commenters that is common to proposed rules from other
agencies. The commenter stated that APHIS should publish such a summary
in the final rule and should hold at least one public consultation with
stakeholders that do not have a direct or indirect financial interest
in the proposed regulations.
We do not agree with this comment. As we noted in the preamble to
the June 2019 proposed rule: ``Following the withdrawal of the January
2017 proposed rule, APHIS conducted extensive outreach to Land Grant
and public university researchers, as well as small-scale biotechnology
developers, agriculture innovators, and other interested stakeholders.
In total, APHIS met with more than 80 organizations, including 17
universities, State Departments of Agriculture, and farmer
organizations.'' In this final rule, we have further delineated the
nature of these discussions.
National Environmental Policy Act
To provide the public with documentation of APHIS' review and
analysis of any potential environmental impacts associated with the
processes in this final rule, we have prepared a final environmental
impact statement (EIS). The final EIS is based on a draft EIS, which we
drafted after soliciting public comment through a notice in the Federal
Register to help us delineate the scope of the issues and alternatives
to be analyzed. The final EIS responds to public comments, analyzes
each alternative and its environmental consequences, if any, and
provides APHIS' preferred alternative. The EIS was prepared in
accordance with: (1) NEPA, as amended (42 U.S.C. 4321 et seq.), (2)
regulations of the Council on Environmental Quality for implementing
the procedural provisions

[[Page 29828]]

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).
Copies of the final EIS are available on the Regulations.gov
website (see footnote 3 in this document for a link to Regulations.gov)
or by contacting the person listed under FOR FURTHER INFORMATION
CONTACT.
Executive Orders 12866, 13563, 13771 and Regulatory Flexibility Act
This final rule is an Executive Order 13771 deregulatory action.
Details on the estimated costs of this final rule can be found in the
rule's economic analysis.
This final rule has been determined to be significant for the
purposes of Executive Order 12866 and, therefore, has been reviewed by
the Office of Management and Budget.
We have prepared an economic analysis for this rule. The economic
analysis provides a cost-benefit analysis, as required by Executive
Orders 12866 and 13563, which direct agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health, and safety
effects, and equity considerations). Executive Order 13563 emphasizes
the importance of quantifying both costs and benefits, of reducing
costs, of harmonizing rules, and of promoting flexibility. The economic
analysis also provides a final regulatory flexibility analysis that
examines the potential economic effects of this rule on small entities,
as required by the Regulatory Flexibility Act. The economic analysis is
summarized below. Copies of the full analysis are available on the
Regulations.gov website (see footnote 1 in this document for a link to
Regulations.gov) or by contacting the person listed under FOR FURTHER
INFORMATION CONTACT.
The revisions to part 340 in this final rule create the framework
for more focused, risk-based regulation of the GE organisms that pose
plant pest risk. Under this rule, certain categories of plants are
exempted from the regulations in part 340. Developers are able to
determine, when appropriate, whether their products fit into one of the
exempted categories and are therefore not subject to APHIS'
regulations.
The rule also provides for a process to determine the regulatory
status of a plant under part 340. GE plants having the same plant-
trait-MOA combination as those previously found by APHIS to be not
subject to the regulations will not be regulated, nor will they be
required to undergo an RSR. GE plants found likely to pose a plant pest
risk and GE plants that are not eligible for an RSR will be allowed to
move only under permit. For plants that do not fall into any of the
exempted categories and are eligible for an RSR, developers have the
option of either requesting a review or requesting a permit for the
movement (including importation, interstate movement, or environmental
release) of their organism in lieu of an RSR. Developers of GE
organisms that are plant pests will continue to need permits to import,
move interstate, or environmentally release those organisms.
Shipping standards under this rule are less prescriptive and more
generally applicable, and the rule provides for the issuance of multi-
year permits. The provisions for record retention, compliance, and
enforcement have been altered to ensure that APHIS has sufficient
information to monitor compliance with its regulations and maintain
effective oversight of regulated GE organisms, in accordance with
provisions of the 2008 Farm Bill and recommendations of the 2015 USDA
OIG report on GE organisms. These changes improve the efficiency and
clarity of the regulations.
The amendments in this rule will benefit developers, producers, and
consumers of certain GE organisms; public and private research
entities; and APHIS. There will be no decrease in the level of
protection provided against plant pest risks. The regulatory framework,
including the RSR process used to determine regulatory status
established under this rule, will provide cost savings to some plant
developers and will allow for reallocation of APHIS resources to
Biotechnology Regulatory Services (BRS) priorities.
Under this rule, APHIS regulatory oversight (through permitting)
will not be required for plants that fall into one of the exempted
categories or have been assessed by means of an RSR and have been found
unlikely to pose an increased plant pest risk relative to its
comparator. Direct regulatory costs to some plant developers will be
reduced for the development of GE plants for which APHIS permits are no
longer necessary. Savings to the regulated community will result from a
reduced need to collect field data, fewer reporting requirements, and
lower management costs. Costs now associated with petitions for non-
regulated status will be reduced or eliminated where APHIS permits are
no longer necessary.
Cost savings for these entities are expected to more than offset
the new costs. APHIS estimated the cost savings for two regulatory
oversight scenarios where USDA either has sole regulatory authority or
shares oversight with EPA and/or FDA, based on a study of the costs
encountered by private biotechnology developers as they pursue
regulatory authorization of their innovations. When only APHIS has
regulatory oversight, compliance cost savings under the rule could
range from $1.6 million to $5.6 million ($3.6 million on average) for
the development of a given GE plant. If EPA and/or FDA also have an
oversight role in the development of a given GE plant, compliance cost
savings could range from $551,000 to $937,000 ($744,000 on average; see
Table A below and Table 5 of the RIA). From 1992 through September
2019, an average of just under 5 petitions were processed (granted non-
regulated status or the petition withdrawn) in a given year, with a
high of 14 in 1995. As the rule is expected to spur innovation, we
expect the number of new GE plants developed annually to increase over
time. In particular, the rule may provide impetus to the development of
new horticultural varieties, where the costs of acquiring non-regulated
status in the past may have been prohibitively high relative to the
potential market.
In the following estimate of impacts, we use the average cost
savings reported above per GE plant developed and assume the annual
number of new GE plants developed under the rule without APHIS permits
ranges from 5 (the current annual average number of processed
petitions) to 10 (twice this average). We further assume that about 20
percent of those new GE plants are solely within the purview of APHIS
oversight, and that the remaining 80 percent will also be under the
purview of FDA and/or EPA oversight. If five new GE plants are
developed annually without APHIS permits (all with no APHIS permit, but
four still with EPA and/or FDA evaluation), the annual savings would be
$6.5 million.\16\ If 10 new GE plants are developed annually without
APHIS permits (all with no APHIS permit, but 8 still with EPA and/or
FDA evaluation), the annual savings will be $13.1 million.\17\
---------------------------------------------------------------------------

\16\ 1 x $3,573,500 = $3,573,500. 4 x $744,000 = $2,976,000.
$3,573,000 + $2,976,000 = $6,549,500.
\17\ 2 x $3,573,500 = $7,147,000. 8 x $744,000 = $5,952,000.
$7,147,000 + $5,952,000 = $13,099,000.
---------------------------------------------------------------------------

New costs borne by regulated entities under the rule will include
rule familiarization and recordkeeping. Annual recordkeeping costs are
based

[[Page 29829]]

on information collection categories that were described in the
Paperwork Reduction Act section of the proposed rule, and are estimated
to total about $1,070,000. New maintenance and record retention
requirements in this rule should not significantly affect permit
holders. While some of the specific records required under this rule
were not explicitly included in the current regulations, they have been
required as part of the supplemental permit conditions that accompany
an issued permit. These records are integral to the activities under
the permit and should already be maintained by the permit holder as a
normal part of business operations and therefore readily be accessible.
About 1,250 distinct entities have applied for permits or notifications
under part 340. APHIS estimates that each of those entities will spend
a total of about 24 hours becoming familiar with the provisions of this
rule, at a total one-time cost of about $1.5 million.
Some plants that would not have been regulated under previous
regulations in part 340, because a plant pest was not used in their
development, would now be under the purview of APHIS oversight. APHIS
expects the number of plants in this category will be very small,
likely less than 1 per year based on historical activity. For those few
instances where an APHIS permit is required, developers could incur new
costs associated with permitting ranging from about $13,000 to
$671,000, depending on recordkeeping, reporting, stewardship, and
testing requirements.\18\
---------------------------------------------------------------------------

\18\ Additional recordkeeping and reporting costs could be about
$13,000 annually for a field trial that requires 25 reports per
year. Because few plants tested in the field are likely to
demonstrate commercial viability, we expect they would be tested on
a limited number of sites. Additional stewardship costs could range
from about $20,000 to $120,000. In the rare case in which a plant
demonstrates commercial viability and warrants further data
collection under the RSR process, the developer could incur
additional testing costs, which under current regulations are
estimated to range between about $152,000 and $538,000. Because the
data required under the RSR process will be more targeted than under
the current process, testing costs would likely be closer to the
lower bound.
---------------------------------------------------------------------------

In accordance with guidance on complying with Executive Order
13771, the primary estimate of the annual net private sector cost
savings for this rule is $8.3 million. This value is the mid-point
estimate of the net private cost savings annualized in perpetuity using
a 7 percent discount rate.
Current annual APHIS personnel costs for conducting genetic
engineering related activities that will be affected by this rule total
about $3.4 million. These include compliance activities, inspection
activities, `Am I Regulated' (AIR) process activities, notification
activities, permit activities, and petition activities. Under this
rule, APHIS' overall annual personnel costs of regulating GE plants are
not expected to change. While the volume of specific activities will
change, the overall volume of regulatory activities, the general nature
of those activities, and the level of skills necessary to perform those
activities will not change.
Costs to APHIS of implementing this rule include outreach
activities, developing guidance documents, training, and adjusting the
permit system. APHIS estimates that public outreach, guidance and
training will cost about $77,000. Requests for RSRs and response
letters under the rule will be handled in a manner similar to the
current AIR process, outside the electronic permitting system and
without incurring new costs.
Certain plants are genetically engineered in order to produce
PMPIs. To date, PMPI-producing GE plants regulated by APHIS have been
genetically engineered using a plant pest as the donor, vector, or
vector agent, and thus fall under the scope of regulated article in the
current regulations in part 340. In this rule, APHIS will maintain its
oversight of PMPI-producing plants. In this final rule, we are adding
this requirement to Sec. 340.2, as paragraph (e), which states that a
permit is required for the movement of a plant that encodes a product
intended for pharmaceutical or industrial use.
Certain plants are genetically engineered to produce PIPs, meaning
that they produce pesticides. APHIS has regulated those PIP-producing
plants that are captured by current regulations, i.e., when plant pests
or plant pest sequences are used. The PIPs also fall under the
regulatory oversight of EPA. However, because EPA generally requires
Experimental Use Permits (EUP) only for field tests on 10 acres or more
of land, APHIS has exercised regulatory oversight of PIP plantings on
fewer than 10 acres. Under this rule, GE PIP-producing plants that are
unlikely to pose an increased plant pest risk relative to their
comparators will not be regulated by APHIS following an RSR. Therefore,
under this rule Federal oversight of GE PIPs will rest solely with EPA.
EPA may decide to require EUPs for all, some, or none of the PIPs for
test plantings on fewer than 10 acres of land, and may conduct
inspections of all, some, or none of the PIPs that are under permit.
EPA may also exempt certain PIPs from requirements under the Federal
Insecticide Fungicide and Rodenticide Act (FIFRA). Current inspection
costs incurred by APHIS average roughly $800 per inspection.
A quicker APHIS evaluation process will mean a shorter period of
regulatory uncertainty that may facilitate developers' ability to raise
venture capital. Reduced regulatory requirements may also lead to
greater participation by public and private academic institutions in
genetic engineering research and product development. These indirect
benefits of the rule may spur genetic engineering innovations,
particularly in small acreage crops where genetic engineering has not
been widely utilized due to the expense of regulation.
In general, new plant varieties, including GE crop varieties, are
not required to be reviewed or approved for food safety by the FDA
before going to market. However, the developer is responsible for
ensuring product safety and developers of GE plant varieties have
routinely consulted with FDA prior to marketing new varieties to
resolve food safety or other questions about food within FDA's
jurisdiction.
APHIS expects that stewardship practices currently used to conduct
field trials of GE plant varieties will be maintained under the new
rule. It will be in a plant developer's best interest to supervise and
control the development process as at present, to prevent undesired
cross-pollination or commingling with non-GE crops. Developers have
various legal, quality control, and marketing motivations to maintain
rigorous voluntary stewardship measures. APHIS therefore believes that
developers will continue to utilize strict control measures for field
testing even in cases where APHIS does not require a permit.
Farmers who adopt GE crops may benefit from the rule. GE crop
adoption varies by crop and technology and can affect yields, net
returns, and pesticide use. Fernandez-Cornejo, et al. (2014) showed
that planting insect-resistant cotton and corn seed is associated with
higher net returns when pest pressure is high. The extent to which
adoption of herbicide tolerant (HT) traits affects net returns is mixed
and depends primarily on how much weed control costs are reduced and
seed costs are increased. HT soybean adoption is associated with an
increase in total household income because HT soybeans require less
management and enable farmers to generate income via off-farm
activities or by expanding their operations. Farmers may benefit by
having access to a wider variety of traits as well as a greater number
of new GE crop species,

[[Page 29830]]

affording them a broader selection of crops to suit their particular
management objectives. Among the types of innovations expected are
crops with greater resistance to disease and insect pests; greater
tolerance of stress conditions such as drought, high temperature, low
temperature, and salt; and more efficient use of fertilizer. These
types of traits can lower farmer input costs (water, fertilizer,
pesticide) and increase yields during times of adverse growing
conditions.
As mentioned, regulatory costs are expected to be lower under this
rule, thereby potentially spurring developer innovation, especially
among small companies and universities. Consumers will benefit from a
wider variety of available products, including ones with improved
taste, storage longevity, or nutritional content. In terms of the
potential benefits of GE crop plants, an emerging area of interest is
the nutritional modification of crop plants through the use of
biotechnology to provide human health benefits. Some of these types of
modifications are discussed in the EIS in section 4.4.1.4. They include
rice varieties developed to provide vitamin A and to address iron and
folate deficiency; wheat varieties with reduced levels of celiac-
disease-triggering gliadins and with increased levels of lysine and
zinc; and cyanide-free cassava. Innovations may also benefit consumers
through lower prices for existing products.
In addition to the compliance costs associated with regulation,
there are opportunity costs of delayed innovation if the approval
process for a plant is longer than necessary to ensure safety with
reasonable scientific certainty. Regulatory delays mean that the
benefits of innovation occur later than they would otherwise and most
likely at lower levels. The forgone benefits due to delayed innovation
can be substantial and developers, producers and consumers all lose
from regulatory delays. The forgone benefits stemming from even a
relatively brief delay in product release can overshadow both research
and regulatory costs.
It should be noted that while the rule will alter APHIS' evaluation
process for GE plants, it is not expected to affect the evaluation of
such plants by FDA or EPA or foreign regulatory agencies, the actions
of whom may affect the opportunity costs of regulatory delay. When FDA
and/or EPA also have a regulatory role, substantial time savings due to
the rule are most likely to be realized in those instances in which the
APHIS process takes the longest time. When APHIS is the only agency
with oversight (as with many new horticultural varieties such as
petunias or carnations modified to produce different flower color,
morphology, or longevity), there could be significant time savings over
the current petition process.
Some farmers (e.g., growers of identity-preserved crops, including
organic, other non-GE and other agricultural commodities segregated for
specific purity and quality tolerances) could be indirectly negatively
impacted by increased GE innovations. Identity preservation (IP) refers
to a process or system of maintaining the segregation and documenting
the identity of a product. Crops with unique product quality traits
such as low linolenic canola require IP to capture the added value.
Similarly, organic commodities must be produced according to specific
criteria and segregated in the marketplace in order to receive premium
prices. Some consumers choose not to purchase products derived from GE
crops and instead purchase commodities such as those labeled ``non-
GMO.'' In addition, the USDA organic standard does not allow for the
intentional use of GE seeds. In cases where crops intended for the non-
GE or other identity-preserved marketplaces contain unintended GE
products, their profitability may be diminished. Unintended GE presence
and diminished profitability may also occur for identity-preserved GE
crops with special attributes. Such crops are more likely to be
developed under the new rule.
Effects of this rule on the variety of GE crop species grown in the
United States and their wider adoption may increase the possibility of
cross-pollination or commingling. As commercial acreage of any given GE
crop increases and as a greater variety of crops are modified using
genetic engineering, the potential for more instances of unintended
presence of a GE organism increases. Costs incurred by growers of
organic and other identity-preserved varieties who seek to prevent such
unintended presence may increase.
Entities potentially affected by the rule fall under various
categories of the North American Industry Classification System.
Economic data are not available on business size for some entities.
Nonetheless, based on industry data obtained from the Economic Census
and the Census of Agriculture, we can assume that the majority of the
businesses affected by the rule will be small.
Table A provides a summary statement of the expected direct costs
and cost savings of the rule:

Table A--Expected Costs and Costs Savings of the Rule for the
Biotechnology Industry and for APHIS
[2016 dollars]
------------------------------------------------------------------------

------------------------------------------------------------------------
Biotechnology Industry
One-time industry-wide costs of $1,468,000.
rule familiarization.
------------------------------------------------------------------------
Annual industry-wide $1,070,000.
recordkeeping costs.
------------------------------------------------------------------------
Annual cost of permits for $13,000 to $671,000.
plants not previously regulated
\1\.
------------------------------------------------------------------------
Developer Savings per Trait \2\. Lower Bound Upper Bound
Estimate. Estimate.
APHIS sole regulatory oversight. $1,559,000........ $5,588,000.
APHIS oversight together with $551,000.......... $937,000.
FDA and/or EPA oversight.
------------------------------------------------------------------------
APHIS Biotechnology Regulatory
Services
Annual costs for public $77,000.
outreach, training, and e-
permitting \3\.
------------------------------------------------------------------------
\1\ The number of plants in this category is expected to be very small,
likely less than 1 per year based on historical activity. The range in
cost shown is for one permit. The actual cost will depend on
additional recordkeeping, reporting, stewardship, and testing
requirements.
\2\ These savings are shown on a per trait basis. On average, if five
new GE plants are developed annually without APHIS permits (all with
no APHIS permit, but four still with EPA and/or FDA evaluation), the
annual savings will be $6.5 million. If 10 new GE plants are developed
annually without APHIS permits (all with no APHIS permit, but 8 still
with EPA and/or FDA evaluation), the annual savings will be $13.1
million.
\3\ Requests for regulatory status and response letters under the rule
will be handled in a manner similar to the current `Am I Regulated'
process, outside the electronic permitting system and without
incurring new costs.

[[Page 29831]]

Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 2 CFR chapter IV.)
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Executive Order 13175
The USDA's Office of Tribal Relations (OTR) has assessed the impact
of this rule on Indian Tribes and determined that this rule has Tribal
implications; however, OTR has determined that Tribal consultation
under Executive Order 13175 is not required at this time.
If a Tribe requests consultation, APHIS will work with the OTR to
ensure meaningful consultation is provided where changes, additions,
and modifications identified herein are not expressly mandated by
Congress.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), some of the information collection
requirements included in this final rule have been approved under
Office of Management and Budget (OMB) control number 0579-0085 and some
of the information collection requirements were filed under OMB
comment-filed number 0579-0471, which has been submitted to OMB for
approval. When OMB notifies us of its decision, if approval is denied,
we will publish a document in the Federal Register providing notice of
what action we plan to take.
E-Government Act Compliance
The Animal and Plant Health Inspection Service is committed to
compliance with the E-Government Act to promote the use of the internet
and other information technologies, to provide increased opportunities
for citizen access to Government information and services, and for
other purposes. For information pertinent to E-Government Act
compliance related to this rule, please contact Mr. Joseph Moxey,
APHIS' Information Collection Coordinator, at (301) 851-2483.
Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the Office of Information and Regulatory Affairs has designated this
action as a rule that is not a major rule, as defined by 5 U.S.C.
804(2).

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(NRC), Washington, DC: National Academies Press. http://www.nap.edu/catalog/12804/impact-of-genetically-engineered-crops-on-farm-sustainability-in-the-united-states.
NAS (2016b). Genetically Engineered Crops: Experiences and
Prospects. Washington, DC: National Academies Press. http://www.nap.edu/catalog/23395/genetically-engineered-crops-experiences-and-prospects.
Peterson, B.A., DC Haak, M.T. Nishimura, et al. (2016). Genome-wide
assessment of efficiency and specificity in CRISPR/Cas9 mediated
multiple site targeting in Arabidopsis. PLoS One 11:e0162169.
Sears, E. A. (1977). An induced mutant with homoeologous pairing in
common wheat. Canadian J of Genetics and Cytology 19: 585-593.
Singh, B.D. (1990). Plant Breeding Principles and Methods, 4th ed.
Kalyani Publishers, New Delhi, pp.475-509.
Tang, X, G. Liu, J. Zhou, et al. (2018) A large-scale whole-genome
sequencing analysis reveals highly specific genome editing by both
Cas9 and Cpf1 (Cas12a) nucleases in rice. Genome Biol 19:84. https://genomebiology.biomedcentral.com/articles/10.1186/s13059-018-1458-5.
Wang, H., M. La Russa, and L.S. Qi (2016). Crispr/Cas9 in genome
editing and beyond. Annu Rev Biochem. 85:227-64.
Wolter, F., P. Schindele, and H. Puchta (2019). Plant breeding at
the speed of light: the power of CRISPR/Cas to generate directed
genetic diversity at multiple sites. BMC Plant Biol. 19: 176.

List of Subjects

7 CFR Part 330

Customs duties and inspection, Plant diseases and pests,
Quarantine, Reporting and recordkeeping requirements, Transportation.

7 CFR Part 340

Administrative practice and procedure, Packaging and containers,
Plant diseases and pests, Reporting and recordkeeping requirements,
Transportation.

7 CFR Part 372

Environmental impact statements.

Accordingly, we are amending 7 CFR parts 330, 340, and 372 as
follows:

PART 330--FEDERAL PLANT PEST REGULATIONS; GENERAL; PLANT PESTS,
BIOLOGICAL CONTROL ORGANISMS, AND ASSOCIATED ARTICLES; GARBAGE

0
1. The authority citation for part 330 continues to read as follows:

Authority: 7 U.S.C. 1633, 7701-7772, 7781-7786, and 8301-8317;
21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

0
2. In Sec. 330.200, paragraphs (b) and (d) are revised to read as
follows:

Sec. 330.200 Scope and general restrictions.

* * * * *
(b) Plant pests regulated by this subpart. For the purposes of this
subpart, and except for an organism that has undergone genetic
engineering as defined in Sec. 340.3 of this chapter, APHIS will
consider an organism to be a plant pest if the organism directly or
indirectly injures, causes damage to, or causes disease in a plant or
plant product, or if the organism is an unknown risk to plants or plant
products, but is similar to an organism known to directly or indirectly
injure, cause damage to, or cause disease in a plant or plant product.
Plant pests that have undergone genetic engineering, as defined in
Sec. 340.3 of this chapter, are subject to the regulations of part 340
of this chapter.
* * * * *
(d) Biological control organisms not regulated by this subpart.
Paragraph (c) of this section notwithstanding, biological control
organisms that have undergone genetic engineering, as defined in Sec.
340.3 of this chapter, as well as products that are currently under an
EPA experimental use permit, a Federal Insecticide Fungicide and
Rodenticide Act (FIFRA) section 18 emergency exemption, or products
that are currently registered with EPA as a microbial pesticide
product, are not regulated under this subpart. Additionally, biological
control organisms that are pesticides that are not registered with EPA,
but are being transferred, sold, or distributed in accordance with
EPA's regulations in 40 CFR 152.30, are not regulated under this
subpart for their interstate movement or importation. However, an
importer desiring to import a shipment of biological control organisms
subject to FIFRA must submit to the EPA Administrator a Notice of
Arrival of Pesticides and Devices as required by CBP regulations at 19
CFR 12.112. The Administrator will provide notification to the importer
indicating the disposition to be made of shipment upon its entry into
the customs territory of the United States.

0
3. Part 340 is revised to read as follows:

PART 340--MOVEMENT OF ORGANISMS MODIFIED OR PRODUCED THROUGH
GENETIC ENGINEERING

Sec.
340.1 Applicability of this part.
340.2 Scope of this part.
340.3 Definitions.
340.4 Regulatory status review.
340.5 Permits.
340.6 Record retention, compliance, and enforcement.
340.7 Confidential business information.
340.8 Costs and charges.

Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.3.

Sec. 340.1 Applicability of this part.

(a) The regulations in this part apply to those organisms described
in Sec. 340.2, but not to any organism that is exempt from this part
under paragraph (b), (c), or (d) of this section.
(b) The regulations in this part do not apply to plants that have
been modified such that they contain either a single modification of a
type listed in paragraphs (b)(1) through (3) of this section, or
additional modifications as determined by the Administrator, and
described in paragraph (b)(4) of this section.
(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; or
(2) The genetic modification is a targeted single base pair
substitution; or
(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

[[Page 29833]]

known structural variation present in the gene pool.
(4) The Administrator may propose to exempt plants with additional
modifications, based on what could be achieved through conventional
breeding. Such proposals may be Agency-initiated, and follow the
process in paragraph (b)(4)(i) of this section, or in response to a
request made in accordance with paragraph (b)(4)(ii) of this section.
(i) APHIS-initiated proposals for exemptions. APHIS will publish a
notice in the Federal Register of the proposal by the Administrator to
exempt plants with additional modifications. The notice will make
available any supporting documentation, and will request public
comment. After reviewing the comments, APHIS will publish a subsequent
notice in the Federal Register announcing its final determination.
(ii) Other parties' requests for exemptions. Any person may request
that the Administrator exempt plants developed with additional
modifications that could be achieved through conventional breeding. To
submit a request, the person must provide, in writing, information
supporting the modification(s). Supporting information must include the
following:
(A) A description of the modification(s);
(B) The factual grounds demonstrating that the proposed
modification(s) could be achieved through conventional plant breeding;
(C) Copies of scientific literature, unpublished studies, or other
data that support the request; and
(D) Any information known to the requestor that would be
unfavorable to the request.
(iii) Timeframe for Agency review of requests for additional
exemptions. After APHIS receives all information required under
paragraph (b)(4)(ii) of this section, APHIS will complete its review of
the request and render a determination within 12 months, except in
circumstances that could not reasonably have been anticipated.
(iv) Denial of requests. If APHIS disagrees with the conclusions of
the request or determines that there is insufficient evidence that the
modification could be achieved through conventional breeding methods,
APHIS will deny the request and notify the requestor in writing
regarding this denial.
(v) Agreement with requests. If APHIS initially determines that the
modification could be achieved through conventional breeding methods,
APHIS will publish a notice in the Federal Register and request public
comments in accordance with the process set forth in paragraph
(b)(4)(i) of this section. After reviewing the comments, APHIS will
publish a subsequent notice in the Federal Register announcing its
final determination.
(vi) website posting. A list specifying the additional
modifications will be posted on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology.
(c) The regulations in this part do not apply to a plant with:
(1) A plant-trait-mechanism of action combination that has
previously undergone an analysis by APHIS in accordance with Sec.
340.4 and has been determined by APHIS not to be regulated under this
part, or
(2) A plant-trait-mechanism of action combination found in a plant
that APHIS determined to be deregulated in response to a petition
submitted prior to October 1, 2021, pursuant to Sec. 340.6 as that
section was set forth prior to August 17, 2020. All plants determined
by APHIS to be deregulated pursuant to Sec. 340.6 as that section was
set forth prior to August 17, 2020 will retain their nonregulated
status under these regulations.
(d) The regulations in this part do not apply to plants determined
by APHIS not to require regulation under this part pursuant to the ``Am
I Regulated'' process. All plants determined by APHIS not to require
regulation under this part pursuant to the ``Am I Regulated'' process
will retain their nonregulated status under these regulations.
(e) Developers may request confirmation from APHIS that a plant is
not within the scope of this part. APHIS will provide a written
response (confirmation letter) within 120 days of receiving a
sufficiently detailed confirmation request, except in circumstances
that could not reasonably have been anticipated.

(Approved by the Office of Management and Budget under control number
0579-0471)

Sec. 340.2 Scope of this part.

Except under a permit issued by the Administrator in accordance
with Sec. 340.5, no person shall move any GE organism that:
(a) Is a plant that has a plant-trait-mechanism of action
combination that has not been evaluated by APHIS in accordance with
Sec. 340.4 or that, as a result of such evaluation, is subject to the
regulations; or
(b) Meets the definition of a plant pest in Sec. 340.3; or
(c) Is not a plant but has received deoxyribonucleic acid (DNA)
from a plant pest, as defined in Sec. 340.3, and the DNA from the
donor organism either is capable of producing an infectious agent that
causes plant disease or encodes a compound that is capable of causing
plant disease; or
(d) Is a microorganism used to control plant pests, or an
invertebrate predator or parasite (parasitoid) used to control
invertebrate plant pests, and could pose a plant pest risk; or
(e) Is a plant that encodes a product intended for pharmaceutical
or industrial use.

Sec. 340.3 Definitions.

Terms used in the singular form in this part shall be construed as
the plural, and vice versa, as the case may demand. The following
terms, when used in this part, shall be construed, respectively, to
mean:
Access. The ability during regular business hours to enter, or pass
to and from, a location, inspect, and/or obtain or make use or copies
of any records, data, or samples necessary to evaluate compliance with
this part and all conditions of a permit issued in accordance with
Sec. 340.5.
Administrator. The Administrator of the Animal and Plant Health
Inspection Service (APHIS) or any other employee of APHIS to whom
authority has been or may be delegated to act in the Administrator's
stead.
Agent. A person who is designated by the responsible person to act
in whole or in part on behalf of the permittee to maintain control over
an organism under permit during its movement and to ensure compliance
with all applicable permit conditions and the requirements in this
part. Multiple agents may be associated with a single responsible
person or permit. Agents may be, but are not limited to, brokers,
farmers, researchers, or site cooperators. An agent must be at least 18
years of age and be a legal resident of the United States.
Animal and Plant Health Inspection Service (APHIS). An agency of
the United States Department of Agriculture (USDA).
Article. Any material or tangible object that could harbor plant
pests.
Contained facility. A structure for the storage and/or propagation
of living organisms designed with physical barriers capable of
preventing the escape of the organisms. Examples include but are not
limited to laboratories, growth chambers,

[[Page 29834]]

fermenters, and containment greenhouses.
Donor organism. The organism from which genetic material is
obtained for transfer to the recipient organism.
Environment. All the land, air, and water; and all living organisms
in association with land, air, and water.
Gene pool. Germplasm within which sexual recombination is possible
as a result of hybridization, including via methods such as embryo
culture or bridging crosses.
Genetic engineering. Techniques that use recombinant, synthesized,
or amplified nucleic acids to modify or create a genome.
Import (importation). To move into, or the act of movement into,
the territorial limits of the United States.
Inspector. Any individual authorized by the Administrator or by the
Commissioner of Customs and Border Protection, Department of Homeland
Security, to enforce the regulations in this part.
Interstate. From one State into or through any other State or
within the District of Columbia, the Commonwealth of the Northern
Mariana Islands, the Commonwealth of Puerto Rico, Guam, the Virgin
Islands of the United States, or any other territory or possession of
the United States.
Mechanism of action (MOA). The biochemical process(es) through
which genetic material determines a trait.
Move (moving, movement). To carry, enter, import, mail, ship, or
transport; aid, abet, cause, or induce the carrying, entering,
importing, mailing, shipping, or transporting; to offer to carry,
enter, import, mail, ship, or transport; to receive to carry, enter,
import, mail, ship, or transport; to release into the environment; or
to allow any of the above activities to occur.
Organism. Any active, infective, or dormant stage of life form of
an entity characterized as living, including vertebrate and
invertebrate animals, plants, bacteria, fungi, mycoplasmas, mycoplasma-
like organisms, as well as entities such as viroids, viruses, or any
entity characterized as living, related to the foregoing.
Permit. A written authorization, including by electronic methods,
by the Administrator to move organisms regulated under this part and
associated articles under conditions prescribed by the Administrator.
Person. Any individual, partnership, corporation, company, society,
association, or other organized group.
Plant. Any plant (including any plant part) for or capable of
propagation, including a tree, a tissue culture, a plantlet culture,
pollen, a shrub, a vine, a cutting, a graft, a scion, a bud, a bulb, a
root, or a seed.
Plant pest. Any living stage of a protozoan, nonhuman animal,
parasitic plant, bacterium, fungus, virus or viroid, infectious agent
or other pathogen, or any article similar to or allied with any of the
foregoing, that can directly or indirectly injure, cause damage to, or
cause disease in any plant or plant product.
Plant pest risk. The potential for direct or indirect injury to,
damage to, or disease in any plant or plant product resulting from
introducing or disseminating a plant pest, or the potential for
exacerbating the impact of a plant pest.
Plant product. (1) Any flower, fruit, vegetable, root, bulb, seed,
or other plant part that is not included in the definition of plant; or
(2) Any manufactured or processed plant or plant part.
Recipient organism. The organism whose nucleic acid sequence will
be modified through the use of genetic engineering.
Release into the environment (environmental release). The use of an
organism outside the physical constraints of a contained facility.
Responsible person. The individual responsible for maintaining
control over a GE organism under permit during its movement and for
ensuring compliance with all conditions contained in any applicable
permit as well as with other requirements in this part and in the Plant
Protection Act (7 U.S.C. 7701 et seq.). This individual must sign the
permit application, and must be at least 18 years of age, and must be a
legal resident of the United States.
Secure shipment. Shipment in a container or a means of conveyance
of sufficient strength and integrity to withstand leakage of contents,
shocks, pressure changes, and other conditions incident to ordinary
handling in transportation.
State. Any of the several States of the United States, the
Commonwealth of the Northern Mariana Islands, the Commonwealth of
Puerto Rico, the District of Columbia, Guam, the Virgin Islands of the
United States, or any other territories or possessions of the United
States.
State or Tribal regulatory official. State or Tribal official with
responsibilities for plant health, or any other duly designated State
or Tribal official, in the State or on the Tribal lands where the
movement is to take place.
Trait. An observable (able to be seen or otherwise identified)
characteristic of an organism.
Unauthorized release. The intentional or accidental movement of an
organism under a permit issued pursuant to this part in a manner not
authorized by the permit; or the intentional or accidental movement
without a permit of an organism that is subject to the regulations in
this part.

Sec. 340.4 Regulatory status review.

(a)(1) Any person may submit a request to APHIS for a regulatory
status review, pursuant to paragraph (b)(3) of this section.
(2) Any person may request re-review of a GE plant previously found
to be subject to this part after an initial review was conducted,
provided that the request is supported by new, scientifically valid
evidence bearing on the plant pest risk associated with movement of the
plant.
(3) APHIS may also initiate a regulatory status review or re-review
of a GE plant to identify whether it is subject to regulation under
this part.
(4) Information submitted in support of a request for a regulatory
status review or re-review must meet the requirements listed in
paragraphs (a)(4)(i) through (iii) of this section.
(i) A description of the comparator plant(s), to include genus,
species, and any relevant subspecies information;
(ii) The genotype of the modified plant, including a detailed
description of the differences in genotype between the modified and
unmodified plant; and
(iii) A detailed description of the new trait(s) of the modified
plant.
(iv) Detailed information on how to meet the above-listed
requirements can be found on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology. If APHIS proposes
revisions to the detailed information on the APHIS website, APHIS will
make the proposed revisions available for notice and public comment
prior to implementation.
(b)(1) When APHIS receives a request for a regulatory status review
of a GE plant, APHIS will conduct an initial review to determine
whether there is a plausible pathway by which the GE plant, or any
sexually compatible relatives that can acquire the engineered trait
from the GE plant, would pose an increased plant pest risk relative to
the plant pest risk posed by the respective non-GE or other appropriate
comparator(s), based on the following factors:
(i) The biology of the comparator plant(s) and its sexually
compatible relatives;
(ii) The trait and mechanism-of-action of the modification(s); and

[[Page 29835]]

(iii) The effect of the trait and mechanism-of-action on:
(A) The distribution, density, or development of the plant and its
sexually compatible relatives;
(B) The production, creation, or enhancement of a plant pest or a
reservoir for a plant pest;
(C) Harm to non-target organisms beneficial to agriculture; and
(D) The weedy impacts of the plant and its sexually compatible
relatives.
(2) APHIS will complete the initial review within 180 days of
receiving a request for a regulatory status review that meets the
requirements specified in paragraph (a)(4) of this section, except in
circumstances that could not reasonably have been anticipated. If APHIS
does not identify a plausible pathway by which the GE plant or its
sexually compatible relatives would pose an increased plant pest risk
relative to the comparator(s) in the initial review, the GE plant is
not subject to the regulations in this part. APHIS will post the plant,
trait, and general description of the MOA on its website.
(b)(3)(i) If APHIS does identify a plausible pathway by which the
GE plant or its sexually compatible relatives would pose an increased
plant pest risk relative to the comparator(s) in the initial review,
the requestor may apply for a permit and/or request that APHIS conduct
an evaluation of the factor(s) of concern identified in the initial
review to determine the likelihood and consequence of the plausible
increased plant pest risk. APHIS may request additional information as
needed to evaluate the factor(s) of concern.
(ii) For those GE plants for which such an evaluation is conducted,
APHIS will publish the results of the evaluation in the Federal
Register and will solicit and review comments from the public. Except
in circumstances that could not reasonably have been anticipated, APHIS
will complete these steps within 15 months of receiving a request for a
regulatory status review that meets the requirements specified in
paragraph (a)(4) of this section.
(iii) If APHIS finds that the GE plant and its sexually compatible
relatives are unlikely to pose an increased plant pest risk relative to
their comparator(s), the GE plant is not subject to this part. APHIS
will publish its evaluation of the plant-trait-MOA combination in a
subsequent Federal Register document and will also post it on the APHIS
website. If APHIS does not make such a finding, the GE plant will
remain regulated under this part, and its movement will be allowed only
under permit in accordance with Sec. 340.5.
(c) This section is applicable beginning April 5, 2021 for GE corn,
soybean, cotton, potato, tomato, and alfalfa, and on October 1, 2021
for all GE plants.

(Approved by the Office of Management and Budget under control number
0579-0471)

Sec. 340.5 Permits.

(a) Permit requirement. A permit from APHIS is required for the
movement of all GE organisms subject to the regulations under this
part.
(b) Permit application requirements. All applications for permits
must be submitted in accordance with the requirements of this section.
The responsible person must apply for and obtain a permit through
APHIS' website. The application must also include the following
information:
(1) General information requirements for all permit applications.
All permit applications must include the name, title, and contact
information of the responsible person and agent (if any); the country
(or countries) and locality (or localities) where the organism was
collected, developed, manufactured, reared, cultivated, and cultured
(as applicable); the organism's genus, species and any relevant
subspecies and common name information; the intended activity (i.e.,
importation, interstate movement, or release into the environment of
the GE organism); and information on the intended trait and the
genotype of the intended trait. All permit applications must be signed
by the responsible person.
(2) Information requirements for permit applications for interstate
movement or importation. Applications for permits for interstate
movement or importation of GE organisms must include the following
additional information:
(i) The origin and destination of the GE organism, including
information on the addresses and contact details of the sender and
recipient, if different from the responsible person;
(ii) The quantity of the GE organism, the method of shipment, and
means of ensuring the security of the shipment against unauthorized
release of the organism; and
(iii) The manner in which packaging material, shipping containers,
and any other material accompanying the organism will be disposed of to
prevent unauthorized release.
(3) Information requirements for permit applications for release
into the environment. Applications for permits for release of GE
organisms into the environment must include information on all proposed
environmental release sites, including land area (size), Global
Positioning System coordinates, addresses, and land use history of the
site and adjacent areas; and the name and contact information of a
person at each environmental release site, if different from the
responsible person. In the event that additional release sites are
requested after the issuance of a permit, APHIS will evaluate and amend
permits as appropriate, in accordance with paragraph (l) of this
section.
(c) Exemption for GE Arabidopsis thaliana. A permit for interstate
movement is not required for GE Arabidopsis thaliana, provided that it
is moved as a secure shipment, the modified genetic material is stably
integrated into the plant genome, and the modified material does not
include the complete infectious genome of a plant pest.
(d) Exemption for GE disarmed Agrobacterium species. A permit for
importation or interstate movement is not required for any GE disarmed
Agrobacterium species, provided that it is moved as a secure shipment,
the modified genetic material is stably integrated into the genome, and
the modified material does not include the complete infectious genome
of a plant pest.
(e) Exemption for Drosophila melanogaster. A permit for importation
or interstate movement is not required for GE Drosophila melanogaster,
provided that it is moved as a secure shipment and that any introduced
genetic material is not designed to propagate through a population by
biasing the inheritance rate.
(f) Exemption for certain microbial pesticides. A permit is not
required for the movement of any GE microorganism product that is
currently registered with the Environmental Protection Agency (EPA) as
a microbial pesticide, so long as the microorganism is not a plant pest
as defined in Sec. 340.3.
(g) Exemption of certain plant-incorporated protectants. A permit
is not required for the movement of any GE plant modified solely to
contain a plant-incorporated protectant that is currently registered
with EPA as a pesticide product pursuant to the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq., FIFRA) or that is
currently exempted from FIFRA pursuant to 40 CFR 174.21.
(h) Administrative actions--(1) Review of permit applications.
APHIS will review the permit application to determine whether it is
complete. APHIS will notify the applicant orally or in writing if the
application is incomplete, and the applicant will be

[[Page 29836]]

provided the opportunity to revise the application. Once an application
is complete, APHIS will review it to determine whether to approve or
deny the application.
(2) APHIS assignment of permit conditions. If a permit application
is approved, the Administrator will issue a permit with conditions as
described in paragraph (i) of this section. Prior to issuance of a
permit, the responsible person must agree in writing, in a manner
prescribed by the Administrator, that the responsible person and all
agents of the responsible person are aware of, understand, and will
comply with the permit conditions. Failure to comply with this
provision will be grounds for the denial of a permit.
(3) Inspections. All premises associated with the permit are
subject to inspection before and after permit issuance, and all
materials associated with the movement are subject to sampling after
permit issuance. The responsible person and agents must provide
inspectors access to premises, facilities, release locations, storage
areas, waypoints, materials, equipment, means of conveyance, documents,
and records related to the movement of organisms permitted under this
part. Failure to provide access for inspection prior to the issuance of
a permit will be grounds for the denial of a permit. Failure to provide
access for inspection following permit issuance will be grounds for
withdrawal of the permit.
(4) State or Tribal review and comment. The Administrator will
submit for notification and review a copy of the permit application,
without confidential business information (CBI), and any permit
conditions to the appropriate State or Tribal regulatory official.
Timely comments received from the State or Tribal regulatory official
will be considered by the Administrator prior to permit issuance.
(5) Approval or denial of a permit. Except in circumstances that
could not reasonably have been anticipated, APHIS will approve or deny
the permit within:
(i) 45 days of receipt of a complete application for a permit for
interstate movement or for importation; or
(ii) 120 days of receipt of a complete application for a permit for
release into the environment.
(iii) The 120-day period may be extended if preparation of an
environmental assessment or environmental impact statement is
necessary.
(i) Permit conditions. The standard conditions listed in this
paragraph (i) will be assigned to all permits issued under this
section. The Administrator may assign supplemental permit conditions as
deemed necessary to ensure confinement of the GE organism. Prior to
issuance of a permit or an amended permit, the responsible person will
be required to agree in writing or electronically that he or she and
his or her agents will comply with the conditions of the permit, as
described in this paragraph (i). If the responsible person does not
agree to the conditions, the amendment will be denied.
(1) The organism under permit must be maintained and disposed of in
a manner so as to prevent its unauthorized release, spread, dispersal,
and/or persistence in the environment.
(2) The organism under permit must be kept separate from other
organisms, except as specifically allowed in the permit.
(3) The organism under permit must be maintained only in areas and
premises specified in the permit.
(4) The identity of the organism under permit must be maintained
and verifiable at all times.
(5) Authorized activities may be engaged in only while the permit
is valid; the duration for which the permit is valid will be listed on
the permit itself.
(6) Records related to activities carried out under the permit must
be maintained by the responsible person and must be of sufficient
accuracy, quality, and completeness to demonstrate compliance with all
permit conditions and requirements under this part. APHIS must be
allowed access to all records, to include visual inspection and
reproduction (e.g., photocopying, digital reproduction). The
responsible person must submit reports and notices to APHIS, containing
the information specified within the permit, at the times specified in
the permit. At a minimum:
(i) Following an environmental release, environmental release
reports must be submitted for all authorized release locations where
the release occurred. Environmental release reports must contain
details of sufficient accuracy, quality, and completeness to identify
the location, shape, and size of the release and the organism(s)
released into the environment. In the event no release occurs at an
authorized location, an environmental release report of no
environmental release must be submitted for all authorized locations
where an environmental release did not occur. Unauthorized releases
must be reported in accordance with paragraph (i)(9) of this section.
(ii) When the environmental release is of a plant, reports of
volunteer monitoring activities and findings must be submitted for all
authorized release locations where an environmental release occurred.
If no monitoring activities are conducted, a volunteer monitoring
report of no monitoring must be submitted indicating why no volunteer
monitoring was done.
(7) Inspectors must be allowed access, during regular business
hours, to all locations related to the permitted activities.
(8) The organism under permit must undergo the application of
measures determined by the Administrator to be necessary to prevent its
unauthorized release, spread, dispersal, and/or persistence in the
environment.
(9) In the event of a possible or actual unauthorized release, the
responsible person must contact APHIS as described in the permit within
24 hours of discovery and must subsequently supply a statement of facts
in writing no later than 5 business days after discovery.
(10) The responsible person for a permit remains the responsible
person for the permit unless a transfer of responsibility is approved
by APHIS. The responsible person must contact APHIS to initiate any
transfer. The new responsible person assumes all responsibilities for
ensuring compliance with the existing permit and permit conditions and
for meeting the requirements of this part.
(j) Denial or withdrawal of a permit. Permit applications may be
denied, or permits withdrawn, in accordance with this paragraph.
(1) Denial of permits. The Administrator may deny, either orally or
in writing, any application for a permit. If the denial is oral, the
Administrator will then communicate, as promptly as circumstances
allow, the denial, and the reasons for it, in writing. The
Administrator may deny a permit application if:
(i) The Administrator concludes that the proposed actions, e.g.,
movements under permit, may not prevent the unauthorized release,
spread, dispersal, and/or persistence in the environment of the
organism; or
(ii) The Administrator determines that the responsible person or
any agent of the responsible person has failed to comply with any
material provision of this part, any other regulations issued pursuant
to the Plant Protection Act (7 U.S.C. 7701 et seq.) or the Plant
Protection Act itself;
(iii) In addition, no permit will be issued if the responsible
person and his or her agents do not agree in writing, in accordance
with paragraph (h)(2) of this section, to comply with the permit
conditions or, in accordance with

[[Page 29837]]

paragraph (h)(3) of this section, to allow inspection by APHIS.
(2) Withdrawal of permits. The Administrator may withdraw, either
orally or in writing, any permit that has been issued. If the
withdrawal is oral, the Administrator will communicate, as promptly as
circumstances allow, the withdrawal, and the reasons for it, in
writing. The Administrator may withdraw a permit if:
(i) Following issuance of the permit, the Administrator receives
information that would have provided grounds for APHIS to deny the
original permit application;
(ii) The Administrator determines that actions taken under the
permit have resulted in the unauthorized release, spread, dispersal,
and/or persistence in the environment of the organism under permit; or
(iii) The Administrator determines that the responsible person or
any agent of the responsible person has failed to comply at any time
with any material provision of this part or with any other regulations
issued pursuant to the Plant Protection Act (7 U.S.C. 7701 et seq.).
This includes failure to comply with the conditions of any permit
issued.
(k) Appeal of denial or withdrawal of permit. Any person whose
permit application has been denied or whose permit has been withdrawn
may appeal the decision in writing to the Administrator.\1\ The
applicant must submit in writing an acknowledgment of the denial or
withdrawal, and a statement of intent to appeal, within 10 days after
receiving written notification of the denial or withdrawal. The
applicant may request additional time to prepare the appeal. The appeal
must state all of the facts and reasons upon which the person relies to
assert that the permit was wrongfully denied or withdrawn. The
Administrator will grant or deny the appeal in writing, stating the
reasons for the decision as promptly as circumstances allow. If there
is a conflict as to any material fact, a hearing shall be held to
resolve such conflict.
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\1\ The Office of the Administrator, as established in Sec.
371.2 of this chapter, will review appeals involving the denial or
withdrawal of a permit. Appeals may be sent to Office of the
Administrator, United States Department of Agriculture, Jamie L.
Whitten Building, Room 312-E, 1400 Independence Ave. SW, Washington,
DC 20250.
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(l) Amendment of permits--(1) Amendment at responsible person's
request. If the responsible person determines that circumstances have
changed since the permit was initially issued and wishes the permit to
be amended accordingly, the responsible person must request the
amendment by contacting APHIS directly. The responsible person will
have to provide supporting information justifying the amendment. APHIS
will review the amendment request, and will amend the permit if APHIS
determines that relatively minor changes are necessary. Requests for
more substantive changes will require a new permit application. Prior
to issuance of an amended permit, the responsible person will be
required to agree in writing or electronically that he or she and his
or her agents will comply with the conditions of the amended permit. If
the responsible person does not agree to the conditions, the amendment
will be denied.
(2) Amendment initiated by APHIS. APHIS may amend any permit and
its conditions at any time, upon determining that the amendment is
needed to address plant pest risks presented by the organism or the
activities allowed under the permit. APHIS will notify the responsible
person of the amendment to the permit and, as soon as circumstances
allow, the reason(s) for it. The responsible person may have to agree
in writing or electronically that he or she and his or her agents will
comply with the conditions of the amended permit before APHIS will
issue it. If APHIS requests such an agreement, and the responsible
person does not accept it, the existing permit will be withdrawn.
(m) Shipping under a permit. (1) All shipments of organisms under
permit must be secure shipments. Organisms under permit must be shipped
in accordance with the regulations in 49 CFR part 178.
(2) The container must be accompanied by a document that includes
the names and contact details for the sender and recipient.
(3) For any organism to be imported into the United States, the
outmost container must bear information regarding the nature and
quantity of the contents; the country (or countries) and locality
(localities) where collected, developed, manufactured, reared,
cultivated, and cultured (as applicable); the name and address of the
shipper, owner, or person shipping or forwarding the organism; the
name, address, and telephone number of the consignee; the identifying
shipper's mark and number; and the permit number authorizing the
importation. For organisms imported under permits by mail, the
container must also be addressed to a plant inspection station listed
in the USDA Plants for Planting Manual, which can be accessed at:
https://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/plants_for_planting.pdf. All imported containers of organisms
under permits must be accompanied by an invoice or packing list
indicating the contents of the shipment.
(4) Following the completion of the shipment, all packaging
material, shipping containers, and any other material accompanying the
organism will be devitalized consistent with supplemental permit
conditions, or disposed of to prevent unauthorized release.
(n) Applicability date: This section is applicable beginning April
5, 2021.

(Approved by the Office of Management and Budget under control number
0579-0471)

Sec. 340.6 Record retention, compliance, and enforcement.

(a) Recordkeeping. Responsible persons and their agents are
required to establish, keep, and make available to APHIS the following
records:
(1) Records and reports required under Sec. 340.5(i);
(2) Addresses and any other information (e.g., GPS coordinates,
maps) needed to identify all locations where the organism under permit
was stored or used, including all contained facilities and
environmental release locations;
(3) A copy of the APHIS permit authorizing the permitted activity;
and
(4) Legible copies of contracts (including amendments to contracts)
between the responsible person and agents that conduct activities
subject to this part for the responsible person, and copies of
documents relating to agreements made without a written contract.
(b) Record retention. Records indicating that an organism under
permit that was imported or moved interstate reached its intended
destination must be retained for at least 2 years. All other records
related to a permit must be retained for 5 years following the
expiration of the permit, unless a longer retention period is
determined to be needed by the Administrator and is documented in the
supplemental permit conditions.
(c) Compliance and enforcement. (1) Responsible persons and their
agents must comply with all of the requirements of this part. Failure
to comply with any of the requirements of this part may result in any
or all of the following:
(i) Denial of a permit application or withdrawal of a permit in
accordance with Sec. 340.5(j);
(ii) Application of remedial measures in accordance with the Plant
Protection Act (7 U.S.C. 7701 et seq.); and

[[Page 29838]]

(iii) Criminal and/or civil penalties in accordance with the Plant
Protection Act (7 U.S.C. 7701 et seq.).
(2) Prior to the issuance of a complaint seeking a civil penalty,
the Administrator may enter into a stipulation, in accordance with
Sec. 380.10 of this chapter.
(d) Liability for acts of an agent. For purposes of enforcing this
part, the act, omission, or failure of any agent for a responsible
person may be deemed also to be the act, omission, or failure of the
responsible person.

(Approved by the Office of Management and Budget under control number
0579-0471)

Sec. 340.7 Confidential business information.

Persons including confidential business information (CBI) in any
document submitted to APHIS under this part should do so in the
following manner. If there are portions of a document deemed to contain
confidential business information, those portions must be identified,
and each page containing such information must be marked ``CBI Copy.''
A second copy of the document must be submitted with all such CBI
deleted, and each page where the CBI was deleted must be marked ``CBI
Deleted.'' In addition, any person submitting CBI must justify how each
piece of information requested to be treated as CBI is a trade secret
or, if not a trade secret, is either commercial or financial
information that is privileged or confidential.

Sec. 340.8 Costs and charges.

The services of the inspector related to carrying out this part and
provided during regularly assigned hours of duty and at the usual
places of duty will be furnished by APHIS without cost to the
responsible person.\1\ The U.S. Department of Agriculture will not be
responsible for any costs or charges incidental to inspections or
compliance with the provisions of this part, other than for the
services of the inspector.
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\1\ The Department's provisions relating to overtime charges for
an inspector's services are set forth in part 354 of this chapter.
---------------------------------------------------------------------------

PART 372--NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES

0
4. The authority citation for part 372 continues to read as follows:

Authority: 42 U.S.C. 4321 et seq.; 40 CFR parts 1500-1508; 7 CFR
parts 1b, 2.22, 2.80, and 371.9.

Sec. 372.5 [Amended]

0
5. Section 372.5 is amended as follows:
0
a. By removing paragraph (b)(7);
0
b. In paragraph (c)(3)(iii), by removing the words ``, or
acknowledgment of notifications for,'' and adding the word ``for'' in
their place; and
0
c. By removing and reserving paragraph (c)(4).

Done in Washington, DC, this 13th day of May 2020.
Lorren Walker,
Acting Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2020-10638 Filed 5-15-20; 8:45 am]
BILLING CODE 3410-34-P