[Federal Register Volume 84, Number 109 (Thursday, June 6, 2019)]
[Proposed Rules]
[Pages 26514-26541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11704]



[[Page 26513]]

Vol. 84

Thursday,

No. 109

June 6, 2019

Part II





Department of Agriculture





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Animal and Plant Health Inspection Service





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7 CFR Parts 340 and 372





 Movement of Certain Genetically Engineered Organisms; Proposed Rules

  Federal Register / Vol. 84 , No. 109 / Thursday, June 6, 2019 / 
Proposed Rules  

[[Page 26514]]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Parts 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: Proposed rule.

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SUMMARY: We are proposing to revise our 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 them, thereby reducing regulatory burden for developers of organisms 
that are unlikely to pose plant pest risks. This proposed rule, which 
would mark the first comprehensive revision of the regulations since 
they were established in 1987, would provide a clear, predictable, and 
efficient regulatory pathway for innovators, facilitating the 
development of new and novel genetically engineered organisms that are 
unlikely to pose plant pest risks.

DATES: We will consider all comments that we receive on or before 
August 5, 2019.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0034.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2018-0034, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2018-
0034 or in our reading room, which is located in Room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW, Washington, DC. 
Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. 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.
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    \1\ To view the framework, go to https://www.aphis.usda.gov/brs/fedregister/coordinated_framework.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. Under APHIS' current 
regulations, a GE organism is considered to be a regulated article if 
the donor organism, recipient organism, vector, or vector agent \2\ is 
a plant pest or if the Administrator has reason to believe the GE 
organism is a plant pest. A plant pest is defined in current Sec.  
340.1 as ``Any living stage (including active and dormant forms) of 
insects, mites, nematodes, slugs, snails, protozoa, or other 
invertebrate animals, bacteria, fungi, other parasitic plants or 
reproductive parts thereof; viruses; or any organisms similar to or 
allied with any of the foregoing; or any infectious agents or 
substances, which can directly or indirectly injure or cause disease or 
damage in or to any plants or parts thereof, or any processed, 
manufactured, or other products of plants.'' For a GE organism that is 
a regulated article to be introduced, a permit authorizing the 
introduction must be issued by APHIS, or the introduction must occur 
under a notification acknowledged by APHIS, a procedure that is 
discussed in detail below. If the introduction entails movement of the 
organism, it must be moved in a container that meets the requirements 
of current Sec.  340.8, and the container must be marked in accordance 
with the requirements listed under Sec.  340.7.
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    \2\ These terms are defined in the current Sec.  340.1 of the 
regulations.
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    A permit may authorize the introduction of regulated articles if 
developers follow the permit conditions specified by the Administrator 
to be necessary for each activity to prevent the dissemination and 
establishment of the GE organism. Such conditions include, but are not 
limited to, maintenance of the regulated article's identity through 
labeling, retention of records related to the article's specified use, 
segregation of the regulated article from other organisms, inspection 
of a site or facility where regulated articles are to undergo 
environmental release or will be contained after their interstate 
movement or importation, and the maintenance and disposal of the 
regulated article and all packing material, shipping containers, and 
any other material accompanying the regulated article to prevent the 
dissemination and establishment of plant pests. If a permit holder does 
not comply with any of the permit conditions, the permit may be 
canceled, and if so, further movement or environmental release of GE 
organisms under that permit will be prohibited.
    For authorizations under the notification process, the regulations 
contain performance-based standards applicable to shipping, 
environmental release, and field trials of GE organisms. These 
standards are aimed at preventing

[[Page 26515]]

the unwanted dissemination of such organisms during transit or as a 
result of an environmental release and the persistence of the organisms 
in the environment. APHIS conducts inspections of authorized facilities 
or environmental release sites to evaluate compliance with the 
regulations.
    In addition to issuing permits and acknowledging notifications, 
APHIS responds to petitions requesting nonregulated status under these 
regulations. Under the petition procedure, which is currently described 
in Sec.  340.6, any person may submit a petition to APHIS seeking a 
determination as to whether or not an article is regulated under part 
340. Paragraphs (b) and (c) of Sec.  340.6 describe the form that a 
petition for a determination of nonregulated status must take and the 
detailed information and scientific data supporting the petition. As of 
December 2018, of 162 petitions submitted for APHIS review since July 
1992, APHIS has granted 130 determinations of nonregulated status. 
Thirty-two petitions have been withdrawn. All of these determinations 
have been for GE plants. More information about these determinations is 
posted at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status. Many of 
these plants are grown for agricultural production in the United 
States. APHIS' determinations of nonregulated status apply to the GE 
plants as well as their progeny, meaning the nonregulated GE plant can 
be used in plant breeding programs and in agriculture without further 
oversight from APHIS.
    Although, as discussed above, the current regulations have various 
functions, their primary function to date has been as a means for APHIS 
to regulate the introduction of certain GE organisms via the permit and 
notification procedures referred to above. Permits and notifications 
are collectively known as ``authorizations.'' As of July 2018, APHIS 
has issued more than 19,500 authorizations for the environmental 
release of GE organisms in multiple sites, primarily for research and 
development of crop varieties for agriculture. Additionally, APHIS has 
issued nearly 14,000 authorizations for the importation of GE 
organisms, and more than 12,000 authorizations for the interstate 
movement of GE organisms. APHIS has denied slightly more than 1,600 
requests for authorizations, many of which were denied because APHIS 
ultimately decided the requests lacked sufficient information on which 
to base an Agency decision. Some of these were resubmitted with the 
additional necessary information.
    While the current regulations have been effective in ensuring the 
safe introduction of GE organisms during the past 30 years, advances in 
genetic engineering have occurred since they were promulgated. APHIS 
has now accumulated three decades of experience in evaluating GE 
organisms for plant pest risk. The Agency's evaluations to date have 
provided evidence that genetically engineering a plant with a plant 
pest as a vector, vector agent, or donor does not in and of itself 
result in a GE plant that presents a plant pest risk. Additionally, GE 
techniques have been developed that do not employ plant pests as donor 
organisms, recipient organisms, vectors, or vector agents yet may 
result in GE organisms that 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.

OIG Audits and 2008 Farm Bill

    Audits conducted by USDA's Office of Inspector General (OIG) have 
provided another impetus for updating our regulations. In 2005, OIG 
conducted an audit of APHIS' regulatory program for GE organisms. OIG 
found that the use of performance-based standards in APHIS' 
notification process allowed for a broad spectrum of methods to meet 
the standards, particularly regarding how the release would be confined 
to its test field, but Agency practices did not require responsible 
persons to provide written protocols detailing the exact methods that 
would be used to meet the standards. OIG suggested that APHIS revise 
the regulations to ``minimize the risk of inadvertent release'' of 
regulated articles ``into the environment.'' Among other things, OIG 
recommended that we include in the regulations a provision that would 
``require developers to provide written protocols prior to approval of 
the field trial.'' Other recommendations regarding reporting have been 
met by the issuance of policies, procedures, and guidelines, but OIG 
indicated that these recommendations should ultimately be made 
permanent in regulation.
    In 2015, OIG issued another audit, urging APHIS to implement the 
recommendations from the 2005 audit that APHIS had not yet implemented, 
including that APHIS ``revise its regulations to consolidate all 
requirements for conducting field tests of regulated materials.''
    In addition, in 2008, The Food, Conservation, and Energy Act of 
2008 (Farm Bill) was enacted. Section 10204 of the Farm Bill requires 
the Secretary of Agriculture to take action on each issue identified in 
the APHIS document entitled ``Lessons Learned and Revisions under 
Consideration for APHIS' Biotechnology Framework,'' \3\ and, where 
appropriate, promulgate regulations. Like the 2005 and 2015 OIG audits, 
the lessons learned document suggested revising the regulations to 
provide for greater regulatory oversight of field tests of regulated 
articles.
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    \3\ https://www.aphis.usda.gov/biotechnology/downloads/supportingdocs/LessonsLearned10-2007.pdf.
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    On October 9, 2008, APHIS published a proposal \4\ in the Federal 
Register (73 FR 60007-60048, Docket No. APHIS-2008-0023) to amend the 
regulations to address advances in genetic engineering, to make 
explicit our criteria for evaluation of GE organisms for noxious weed 
potential, and to respond to the remaining recommendations of the 2005 
OIG audit and the provisions of the Farm Bill.
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    \4\ To view the 2008 proposed rule, the subsequent withdrawal, 
all supporting documents, and comments APHIS received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0023.
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    APHIS sought public comment on the proposal from October 9, 2008, 
to June 29, 2009. APHIS received more than 88,300 comments during the 
comment period. Many commenters expressed concerns regarding the lack 
of details surrounding a proposed risk-based system that would 
determine which organisms would fall under APHIS oversight, as well as 
concerns about a proposed multi-tiered permit system. Commenters also 
expressed concern about what they perceived to be a significant 
expansion of Agency regulatory authority.
    Based on the breadth and nature of the comments received, we 
subsequently withdrew that proposed rule and began a fresh stakeholder 
engagement process aimed at exploring a variety of regulatory 
approaches.
    On January 19, 2017, we published in the Federal Register (82 FR 
7008-7039, Docket No. APHIS-2015-0057) a second proposed rule.\5\ In 
that document, we proposed 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.'' Under the January 2017 proposed rule, a stakeholder 
could request that we conduct a risk assessment to determine whether a 
GE

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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. Over time, APHIS would build up a library 
of such assessments and their results and post the information on its 
website. For a GE organism with the same organism-trait combination 
(traits are discussed in detail below) as another GE organism that we 
had already concluded did not require regulation, neither the request 
nor the risk assessment would be necessary. Additionally, APHIS 
proposed to exclude from regulation some GE organisms that could have 
been produced using traditional breeding methods. These provisions were 
intended to provide regulatory relief to developers.
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    \5\ 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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    APHIS sought public comment on the proposal from January 19, 2017, 
until June 19, 2017. APHIS received 203 comments during the comment 
period.
    Commenters expressed concerns about many provisions of the proposed 
rule. Many thought that the proposed requirements would be too 
burdensome and had the potential to stifle innovation.
    After reviewing the comments, APHIS published a document in the 
Federal Register on November 7, 2017 (82 FR 51582-51583, Docket No. 
APHIS-2015-0057), withdrawing the proposal to allow APHIS to reengage 
with stakeholders and deliberate further on how best to revise the 
regulations in part 340.
    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. 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.

Overview of the New APHIS Regulatory Framework

    Based on the feedback we received from stakeholders and on our 
internal Agency deliberations, we are proposing to revise the 
regulations in accordance with a new regulatory framework. The new 
framework will provide a clear, predictable, and efficient regulatory 
pathway for innovators while facilitating the development of new and 
novel GE plants that are unlikely to pose a plant pest risk. It will 
protect the health and value of America's agriculture and natural 
resources and help foster safe and predictable agricultural trade 
worldwide. We anticipate that adopting the new framework will result in 
significant savings for developers of GE organisms.
    The revised regulatory framework would reflect the Secretary of 
Agriculture's March 28, 2018, statement that provided clarification on 
the USDA's oversight of plants produced through plant breeding 
innovations. 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.
    The proposed framework is also consistent with the OIG 
recommendations, the 2008 Farm Bill requirements, as outlined above, 
and with the guiding principle of the Coordinated Framework that, 
``[i]n order to ensure that limited Federal oversight resources are 
applied where they will accomplish the greatest net beneficial 
protection of public health and the environment, oversight will be 
exercised only where the risk posed by the introduction is 
unreasonable.''
    APHIS' new regulatory approach is intended to prepare the Agency 
for future advances in the genetic modification of plants. (APHIS' 
approach to the regulation of non-plant GE organisms is discussed 
below.) For convenience, in this document we sometimes refer to plant 
varieties produced with innovative techniques that could otherwise have 
been achieved using methods of traditional plant breeding as plant 
breeding innovations. Where genetic modifications are similar in kind 
to those modifications made through traditional breeding, the plant 
pest risks should also be similar. These types of plants are equivalent 
to those that have a history of safe use and would be exempted from our 
proposed regulation. On the other hand, genetic modifications made in 
the future may result in increasingly complex products which, in turn, 
may pose new types of risks with which the Agency has less familiarity. 
This latter category of engineered plants would be subject to review 
under our new regulations. Once products are reviewed by the Agency and 
found unlikely to pose a plant pest risk, similar products would be 
exempt from further review.
    Our approach for GE organisms is consistent with the 2017 National 
Academy of Sciences Future Products of Biotechnology report, which 
stated that regulation should take into account familiarity. The 
report, which is available at https://www.nap.edu/catalog/24605/preparing-for-future-products-of-biotechnology, noted that unfamiliar 
products, and those that may be developed in the future, may have few 
or no comparators with existing products within the regulatory system. 
Such products, therefore, would require more regulatory oversight than 
familiar products until enough is known about the new products to 
enable us to assess accurately the plant pest risks associated with 
them. By focusing regulatory resources and risk analyses on unfamiliar 
products, APHIS will be able to avoid conducting repetitive analyses, 
utilize its staff time more efficiently, and provide better stewardship 
of taxpayer dollars.

Key Features of the Proposed Rule

    The approach we are proposing would differ from the current 
regulatory framework in that regulatory efforts would focus on the 
properties of the GE organism itself rather than on the method used to 
produce it. We believe that this new approach, which reflects our 
current knowledge of the field of biotechnology, would enable us to 
evaluate GE organisms for plant pest risk with greater precision than 
the current approach allows. GE organisms that pose a plant pest risk 
would fall within the scope of the proposed regulations and require 
permits for movement. As discussed in more detail later in this 
document, we would define plant pest risk in this proposed rule as 
``[t]he possibility of harm resulting from introducing, disseminating, 
or exacerbating the impact of a plant pest.''
    APHIS will continue to regulate GE organisms that are, in and of 
themselves, plant pests, as well as other GE non-plant organisms that 
pose plant pest risks. Such organisms would require permits for 
movement. Other 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.

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    Under the current system, when making decisions regarding 
regulatory oversight of GE plants, APHIS assesses each transformation 
event (also sometimes referred to as the individual transformed line, 
transgenic line, or GE line) separately, even though the inserted 
genetic material may be identical or very similar to transformation 
events already assessed. This has sometimes been referred to as an 
``event-by-event'' approach.
    Under the proposed rule, developers would have the option of 
requesting a permit or a regulatory status review of a GE plant that 
has not been previously reviewed and determined to be nonregulated. 
Decisions on regulatory status would be based on our assessment of 
plant pest risk. If movement of a GE plant, by which we mean its 
importation, interstate movement, or environmental release (throughout 
the discussion that follows, the terms move and movement are used to 
refer to all of those activities, except where otherwise indicated) is 
found to be unlikely to pose a plant pest risk, APHIS would not have 
authority under the PPA to regulate the plant in accordance with part 
340. If we were unable to reach such a finding, APHIS would regulate 
the subject plant, which would be allowed to move only under permit.
    Under Sec.  340.1(b) of the proposed rule, certain categories of 
modified plants would be exempted from the regulations in part 340 
because they could be produced through traditional breeding techniques 
and thus are unlikely to pose a greater plant pest risk than 
traditionally bred crops, which APHIS has historically not regulated. 
These products of biotechnology are likely to pose no greater plant 
pest risk than their traditionally bred comparators. These exemptions 
are restricted to plants because the long history of plant breeding 
gives us extensive experience in safely managing associated plant pest 
risks. The categories of plants that would be exempted under Sec.  
340.1(b) are discussed further below.
    Proposed Sec.  340.1(c) would exempt GE plants with plant-trait-
mechanism of action (MOA) combinations that we have already evaluated 
by conducting a regulatory status review and found to be unlikely to 
pose a plant pest risk. As discussed in further detail later in this 
document, MOA refers to the biochemical basis for the new trait. The 
results of all completed regulatory status reviews would be publicly 
accessible on the APHIS website. The regulatory status review process 
is discussed in detail below.
    Under our proposed new regulatory framework, a developer would have 
the option to make a self-determination as to whether his or her GE 
plant belongs to one of the categories listed under Sec.  340.1(b) or 
(c) and is therefore exempt from the regulations. A developer who 
determines that his or her GE plant belongs to an exempted category 
would have the option under proposed Sec.  340.1(d), to request written 
confirmation from APHIS that the self-determination is valid. These 
confirmation letters, which would provide a clear and succinct 
statement about the regulatory applicability of the GE plant and the 
nexus to plant health, may be useful to developers wishing to market 
their products domestically or overseas by allowing them to provide 
verification to an importing country or other party that APHIS concurs 
with their self-determinations. APHIS anticipates a timely turnaround 
time in developing and providing these confirmation letters to 
developers. Allowing for self-determinations would provide developers 
with regulatory relief and open more efficient and predictable pathways 
for innovators to get new modified plants that are unlikely to pose a 
plant pest risk to market, in turn supporting further innovation. APHIS 
anticipates that benefits will accrue to developers of all sizes, 
including small and mid-sized ones, as well as academic institutions. 
At the same time, APHIS would be able to allocate its resources more 
efficiently than under the current regulations. Because we would no 
longer have to perform the redundant task of assessing GE plants with 
plant-trait-MOA combinations that we have already determined are not 
subject to these regulations, we would be able to devote more attention 
to assessing and regulating those GE organisms that are likely to be 
associated with potential plant pest risks.
    We would note here that a developer making a self-determination 
that APHIS determines not to be valid may be subject to remedial 
measures or penalties in accordance with the compliance and enforcement 
provisions, which are discussed below, in proposed Sec.  340.6(c) if 
the organism is moved without proper authorization under part 340. In 
addition, penalties and remedial measures (including but not limited 
to, quarantine, seizure and/or destruction) under the authority of the 
PPA may be exercised.
    Under Sec.  340.4 of the proposed rule, the process by which we 
would evaluate GE plants for plant pest risk would be called a 
regulatory status review. When evaluating the plant pest risk posed by 
a newly developed GE plant, APHIS would consider three fundamental 
elements in combination and individually: (1) The basic biology of the 
plant prior to modification; (2) the trait that resulted from the 
genetic modification; and (3) the MOA. Since any one or any combination 
of these three elements may affect plant pest risk, APHIS would 
determine the need for regulatory oversight by appraising the risk 
posed by the plant's unique combination of the three elements.
    This proposed rule would define trait as an observable (able to be 
seen or otherwise identified) characteristic of an organism. We would 
define mechanism of action as the ``biochemical process(es) through 
which genetic material determines a trait.'' For example, a plant may 
be modified to confer the trait of male sterility by either of two MOAs 
in pollen: Expression of a protein that is toxic to the pollen grain 
(barnase system) or expression of a protein which changes 
deoxyribonucleic acids (DNA) in pollen-producing tissues (DNA adenine 
methylase system) in a disruptive way that ultimately results in death 
of those tissues.
    For reasons described in greater detail below, the regulatory 
status review process would apply only to plants and not to genetically 
engineered plant pests or other genetically engineered non-plant 
organisms that fall within the scope of the regulations. We are 
requesting comments from the public, however, on whether the scope of 
the regulatory status review 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 the Agency should consider in its 
analyses.
    Information pertaining to the results of all completed regulatory 
status reviews would be publicly accessible on the APHIS website. This 
information would include a comprehensive list of GE plant-trait-MOA 
combinations that we have evaluated for plant pest risk via the 
regulatory status review process under proposed Sec.  340.4. The list 
would also include GE plants for which we have made determinations of 
nonregulated status under the petition process. Developers could use 
the list to aid them in making their self-determinations. For example, 
if a developer were to find that his or her newly developed GE plant 
had the same plant-trait-MOA combination as a GE plant previously found 
by APHIS to be not subject to the Agency's regulations, the developer 
would know immediately

[[Page 26518]]

that the newly developed plant would not be subject to APHIS 
regulation. We anticipate that should this rule be implemented, this 
list would grow as new regulatory status reviews are completed.
    For GE plants that do not fall into one of the exempted categories 
and have not previously been assessed through the regulatory status 
review process, developers would have the option of either requesting 
an immediate regulatory status review or requesting a permit for the 
movement of their GE plant in lieu of a regulatory status review. (A 
developer who initially requests a permit would also have the option of 
following up with a request for a regulatory status review.) Providing 
these options would allow for maximum flexibility in the research and 
development of novel GE plants for all types of developers (multi-
national companies, small companies, and public sector researchers). 
Developers of GE organisms that are plant pests would continue to need 
permits to move those organisms.

Regulation of Plants That Produce Plant-Made Industrials and 
Pharmaceuticals

    APHIS recognizes that certain plants are genetically engineered in 
order to produce pharmaceutical and industrial compounds, also known as 
plant-made pharmaceuticals and industrials (PMPIs). Federal oversight 
of outdoor plantings of PMPI-producing plants could be necessary to 
prevent the unlawful introduction into the human or animal food supply 
of pharmaceutical or industrial PMPI products, even when the principal 
purpose of the plants is not for human or animal food use. In addition 
to potential adulteration issues (such as the potential of an 
unapproved food additive and other food safety risks) posed by such 
plants should they enter the food supply, a gap in Federal oversight 
could generate concerns from the general public regarding the safety 
and wholesomeness of the human or animal food supply, which could 
adversely impact agricultural interests. Establishing growing and 
handling conditions to confine such plants, and inspecting to ensure 
such conditions are followed, may enable corrective actions before 
material from the plants is inadvertently released and causes public 
health or economic impacts.
    Under the current regulations, APHIS requires permits for the 
environmental release of all GE plants that meet the definition of a 
regulated article and produce PMPIs. APHIS exercises oversight of all 
outdoor plantings of these regulated PMPI-producing plants. This 
oversight includes establishment of appropriate environmental release 
conditions, inspections, and monitoring. PMPI-producing plants and the 
products obtained from them may also be regulated by FDA (authority 
over food and drugs) or EPA (chemical substances as defined by the 
Toxic Substances Control Act (TSCA)), depending on their use or 
intended use. If a PMPI-producing plant or plant product were 
potentially to be used for human or animal food, food additive approval 
might be required under the Federal Food, Drug, and Cosmetic Act.
    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. However, under the provisions of this proposed 
rule, a GE plant that is developed using a plant pest as a vector, 
vector agent, or donor of genetic materials would not necessarily be 
regulated. Rather, the GE plant would be regulated only if it had a 
plant-trait-MOA combination that the Agency has not yet evaluated for 
plant pest risk or if it was evaluated and found to pose a potential 
plant pest risk. Additionally, APHIS' evaluations of GE plants for 
plant pest risk would generally not require data from outdoor 
plantings. Even if the plant represents a new plant-trait-MOA 
combination not previously reviewed, there is a likelihood that most, 
if not all, GE PMPI-producing plants that are currently under APHIS 
permits could be determined to be not regulated under the provisions of 
the proposed regulations after a regulatory status review because they 
are unlikely to pose a plant pest risk. Thus, such plants could be 
grown outdoors without the need for APHIS permits and without APHIS 
oversight.
    One of the reasons APHIS' oversight of such crops has been an 
important part of the coordinated framework for oversight of GE plants 
is that companies are not necessarily required to notify FDA or EPA 
when the developer plants PMPI-producing plants. For example, for PMPI-
producing plants whose products are subject to FDA oversight, FDA has 
no regulations governing planting of such crops. For crops genetically 
engineered to produce human drugs, companies only have to go to FDA 
when they have reached the point that they are ready to begin clinical 
trials with the pharmaceutical derived from the plant. This could be 
years after they first started growing the pharmaceutical-producing 
plant in the field.
    Under TSCA, EPA has requirements for new chemical substances, 
including industrial compounds produced in genetically engineered 
plants. However, given existing APHIS oversight, EPA does not currently 
have an oversight program nor regulations for genetically engineered 
plants that produce industrial compounds.
    APHIS has identified two options that have the potential for 
adequate Federal oversight of outdoor plantings of plants engineered to 
produce PMPIs. Under one option, APHIS would use other authorities 
(e.g., 7 CFR part 360) to regulate outdoor planting of plants 
engineered to produce PMPIs. Under a second option, a statute would be 
enacted, or existing statutory authority amended, to grant one or more 
Federal agencies explicit authority to provide oversight of outdoor 
plantings of all GE PMPI-producing plants and to evaluate GE PMPI-
producing plants for all possible risks, beyond plant pest and noxious 
weed risks. APHIS does not prefer one of these options over the other, 
nor does the Agency consider the two options necessarily to be 
exhaustive. Rather, we put them forward to indicate that the Agency is 
aware of the implications of this rule with regard to PMPIs, and to 
request specific public comment regarding the best manner to address 
this issue.

Plant-Incorporated Protectant Small-Scale Field Testing

    Certain plants are genetically engineered to produce plant-
incorporated protectants (PIPs), meaning that they produce pesticides. 
PIPs fall under the regulatory oversight of EPA. However, currently 
only APHIS exercises regulatory oversight of PIP plantings on 10 acres 
or less of land. Under the current regulations, APHIS requires permits 
or notifications for the environmental release of all GE plants that 
meet the definition of a regulated article and produce PIPs. APHIS 
exercises oversight of all outdoor plantings of these regulated PIP-
producing plants. This oversight includes the establishment of 
appropriate environmental release conditions, inspections, and 
monitoring.
    To date, PIP-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. However, under the provisions of this 
proposed rule, a GE plant that is developed using a plant pest as a 
vector, vector agent, or donor

[[Page 26519]]

of genetic materials would not necessarily be regulated. Rather, the GE 
plant would be regulated only if it had a plant-trait-MOA combination 
that the Agency has not yet evaluated for plant pest risk or if it was 
evaluated and found to pose a potential plant pest risk. Additionally, 
APHIS' evaluations of GE plants for plant pest risk would generally not 
require data from outdoor plantings. Even if the plant represents a new 
plant-trait-MOA combination not previously reviewed, there is a 
likelihood that many GE PIP-producing plants that are currently 
regulated under APHIS permits or notifications could be determined not 
regulated under the provisions of the proposed regulations after a 
regulatory status review because they are unlikely to pose plant pest 
risks. Thus, such plants could be grown outdoors without the need for 
an APHIS permit and without undergoing APHIS oversight.
    APHIS understands that this proposal would shift Federal oversight 
of small-scale (10 acres or less) outdoor plantings of some PIPs to 
EPA. EPA may decide to require experimental use permits for all, some, 
or none of such PIPs, and may conduct inspections of all, some, or none 
of those PIPs under permit. APHIS is fully committed to coordinating 
with EPA on these issues.
    APHIS understands that an MOU and services agreement may be 
necessary to provide personnel and other resources to assist EPA during 
the interim period while EPA implements its own program for the 
oversight of outdoor planting of PIPs 10 acres or less.
    APHIS recognizes that there are challenges associated with such a 
transition that would also require EPA to incur the costs associated 
with setting up a revised regulatory program. Further, such a 
transition would require policies, procedures, and guidance regarding 
APHIS' interaction with EPA. APHIS does not consider the approach 
listed above necessarily to be exhaustive. Rather, APHIS puts it 
forward to indicate that the Agency is aware of the implications of 
this rule with regard to small-scale testing of PIPs and to request 
specific public comment regarding the best manner to address this 
issue.
    Specific provisions of the proposed rule are discussed in detail 
below.

Applicability of the Regulations

    Proposed Sec.  340.1(a) would refer the reader to Sec.  340.2 for 
information on what GE organisms would be subject to the proposed 
regulations.
    Under proposed Sec.  340.1(b)(1) through (4), modified GE plants 
would not be regulated or subject to a regulatory status review in 
accordance with Sec.  340.4, 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.
    As noted above, non-plant GE organisms that are plant pests or pose 
a plant pest risk would require permits for movement under the proposed 
regulations; these proposed exemptions would apply only to GE plants.
    The exemptions reflect the Secretary of Agriculture's March 28, 
2018, statement that USDA does not plan to regulate plants that could 
otherwise have been developed through traditional breeding techniques. 
Such products of biotechnology are likely to pose no greater plant pest 
risk than their traditionally bred comparators, which APHIS does not 
regulate. All four categories of plants listed in the exemptions above 
could otherwise have been produced by traditional breeding methods. 
Traditional breeding techniques generally involve deliberate selection 
of those plants with desirable traits either from existing population 
genetic variations or from new genetic variations created through 
artificial hybridization or induced mutations, and have been used since 
the advent of sedentary agriculture. Every domesticated crop has been 
subjected to extensive traditional breeding. Genetic engineering relies 
on a newer toolset that may be used in addition to traditional breeding 
practices, including chemical or radiation-based mutagenesis, in order 
to expedite development of a plant with a desired genotype and/or 
traits.
    In two reports, issued in 1987 and 1989, respectively, by the 
National Research Council of the National Academies of 
Science,6 7 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 classical 
genetic 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 which are 
introduced. A recent National Academies of Sciences, Engineering, and 
Medicine report, issued in 2016, reaffirmed this conclusion.\8\
---------------------------------------------------------------------------

    \6\ Introduction of Recombinant DNA-Engineered Organisms Into 
the Environment: Key Issues. 1987. National Research Council. 
Washington, DC. National Academies Press (US).
    \7\ Field Testing Genetically Modified Organisms: Framework for 
Decisions. 1989. National Research Council (US) Washington (DC). 
National Academies Press (US).
    \8\ National Academies of Sciences, Engineering, and Medicine. 
2016. Genetically Engineered Crops: Experiences and Prospects. 
Washington, DC: The National Academies Press. doi: 10.17226/23395.
---------------------------------------------------------------------------

    The 1989 report elaborated on the safety of traditionally bred 
crops, stating that ``plants modified by classical genetic methods are 
judged safe for field testing on the basis of experience with hundreds 
of millions of genotypes field tested over decades.'' This does not 
mean there are no conceivable risks, but rather that those risks are, 
in the words of the committee, ``manageable by accepted standards.'' 
Thus, given the accepted safety of traditionally bred crops, and the 
principle that the use of recombinant DNA does not itself introduce 
unique risks, it is logical and appropriate to exempt from our 
regulation plants produced by any method if they also could have been 
produced by traditional breeding.
    APHIS recognizes that there is no universally applicable, sharp 
delineation between what is and what is not possible to achieve with 
traditional breeding methods in an agriculturally relevant timeframe. 
There are many biological and practical factors that affect the 
likelihood of success in a breeding program. 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. There is such variation in these factors 
among plant species that the probability of a plant breeding program 
being able to achieve specific, desired changes in a given species will 
differ on a case-by-case basis. Developing a standard for all species 
based on what is possible to achieve with traditional breeding methods 
in any given species is not a practical measure. Furthermore, plants 
that qualify for an exemption would not be reviewed by APHIS. For these 
reasons, the exemptions are based on measures that are easily 
recognizable and on genetic changes that could be achieved by 
traditional plant breeding

[[Page 26520]]

in any system. A single deletion or a single base pair change is a 
conservative estimate of what could be achieved in any system through 
traditional breeding. Changes beyond those in the exemptions would be 
assessed on a case-by-case basis for plant pest risk. We acknowledge 
there will be examples of plants created that do not qualify for the 
exemptions that pose little plant pest risk. We believe these examples 
will be promptly handled through the process of regulatory status 
review. In this way we believe we can offer both regulatory relief and 
appropriate regulation as needed.
    In general, the natural gene pool of a plant is determined by those 
plants with which the plant is sexually compatible. This is most 
typically considered to be restricted to crosses that can take place 
without human management. However, a number of traditional breeding 
techniques have been developed to enable wide crosses between distantly 
related species or plants that would not encounter each other in 
nature. Where such techniques have been developed for a given plant, 
distantly related plants are also considered part of the natural gene 
pool.
    In some cases, a GE parent plant will contain inserted donor 
nucleic acid, but after some number of breeding steps, there are 
progeny that are produced which contain neither the inserted donor 
nucleic acid nor any modifications made directly by the inserted 
nucleic acid. APHIS does not consider the progeny to be associated with 
a greater plant pest risk. Therefore, such progeny would not be subject 
to regulation under the fourth exemption.
    APHIS requests comment from the public regarding the categories of 
plants listed under proposed Sec.  340.1 as not subject to the 
regulations, including their breadth, whether we need to provide 
greater specificity in the exemptions, and whether additional 
categories should also be considered for exemption from the 
requirements of part 340.
    In addition to the categories listed in proposed paragraph (b), 
under proposed Sec.  340.1(c), GE plants that would not be subject to 
these proposed regulations if they have plant-trait-MOA combinations 
that are the same as those of GE plants that APHIS has found, after 
conducting a regulatory status review in accordance with proposed Sec.  
340.4, not to be subject to the regulations under part 340. We would 
list such GE plant-trait-MOA combinations on our website, as noted 
above, and developers could use this information to aid them in making 
their self-determinations.
    As noted earlier, we would also list GE plants for which we have 
made determinations of nonregulated status under the petition 
process,\9\ which is described in further detail below. Though the 
proposed regulatory status review would represent a change in our 
regulatory approach, GE plants for which determinations of nonregulated 
status have been made under the current system have been evaluated for 
the same plant pest risk factors which will be used under the proposed 
rule. Specifically, both reviews analyze the biology of the GE plant 
and its non-GE comparator, potential changes in plant pest impacts, 
impacts on nontarget organisms, and the propensity for increased 
weediness of the GE plant and any sexually compatible relatives. The 
initial list of plant-trait-MOA combinations that are not subject to 
the regulations is available on Regulations.gov as a separate document 
to this proposed rule. The list will include identification of the MOA 
of nonregulated plants reviewed under the petition process, which can 
be used for comparisons of future GE plants to determine regulatory 
status.
---------------------------------------------------------------------------

    \9\ Information about determinations of nonregulated status 
pursuant to the petition process currently in part 340 is available 
at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status.
---------------------------------------------------------------------------

    Plants produced using biotechnology which were reviewed in response 
to an ``Am I Regulated?'' (AIR) \10\ inquiry were not reviewed using 
all the plant pest risk factors listed above, but rather were reviewed 
for regulatory status based on whether the modified plant conformed to 
the definition of a ``regulated article'' in the current regulations 
and in a some instances on one or more of the factors, but not all. We 
know of no plant pest issues raised during the review of the AIR 
inquiry, and none have arisen from use of any of these plants. GE 
plants determined not to require regulation pursuant to the current AIR 
process would retain their nonregulated status under the new 
regulations to prevent potential market disruptions and provide 
regulatory certainty for developers. These plants would be listed 
separately from those evaluated at the MOA level, and this list would 
not be used for determining regulatory status based on MOA.
---------------------------------------------------------------------------

    \10\ Information about decisions made pursuant to the AIR 
process is available at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/am-i-regulated/regulated_article_letters_of_inquiry/regulated_article_letters_of_inquiry.
---------------------------------------------------------------------------

    We would note again that plants that are not subject to these 
regulations could still be subject to other APHIS or USDA regulations 
or to the regulations of the other Federal Agencies functioning within 
the Coordinated Framework.

Scope of the Regulations

    Proposed Sec.  340.2 would set forth general restrictions regarding 
the movement of GE organisms that would be subject to these 
regulations. The following categories of GE organisms would be allowed 
to move only under permit:
     The GE organism is a plant that has a plant-trait-MOA 
combination that has not been subjected to a regulatory status review 
in accordance with Sec.  340.4; or
     The GE organism meets the definition of plant pest in 
Sec.  340.3; or
     The GE organism is not a plant but has received 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
     The GE organism 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.
    GE plants that have not yet been evaluated for plant pest risk by 
means of a regulatory status review would be subject to permitting 
under Sec.  340.2(a). While APHIS has found that most plants evaluated 
to date do not pose plant pest risks, it is conceivable that some of 
those produced in the future may. For example, certain modifications 
may change the relationship of the plant to plant pests. In most cases, 
this would not be of concern, as APHIS understands that resistance to 
disease and insects varies widely among varieties. Still, if as a 
result of the modification, the plant became a reservoir for pests or 
diseases in such a way that plant pest issues were exacerbated not just 
for those who used the new variety, but for others in the surrounding 
area, APHIS might find it appropriate to take regulatory action. For 
instance, plants and their wild relatives could have increased 
importance as reservoirs for plant pests if the introduced trait 
resulted in an increase in their prevalence and/or caused a change in 
their distribution. For these reasons, APHIS believes it is appropriate 
to examine novel plant-trait-MOA combinations for plant pest risk. 
Regulatory oversight is needed for such plants until the level of plant 
pest risk associated with their movement is known.
    As noted earlier, under the current criteria, a GE organism is 
considered a

[[Page 26521]]

regulated article not only if the recipient organism itself is a plant 
pest, but also if the donor, vector, or vector agent used in the 
engineering process is a plant pest. This reflects the concern in the 
1980s that if an organism was modified using genetic material taken 
from a plant pest, or a plant pest was used as a vector or vector agent 
to carry genetic material into an organism, the resulting GE organism 
could also be a plant pest.
    Based on APHIS' experience evaluating field trial data from 
thousands of authorized environmental releases of regulated organisms, 
as well as the 130 determinations of nonregulated status for GE plants, 
this generally stated concern has not proven to be valid. Although a 
plant pest may contribute or vector genes to a GE organism, the mere 
presence of plant pest sequences has not been shown in APHIS' 
evaluation of data to cause a GE organism, particularly if it is a 
plant, to become a plant pest. Indeed, experience has shown that the 
use of genes from donor organisms which are plant pests, as well as the 
use of vectors which are from plant pests, has not to date resulted in 
plant pest risks of any sort in recipient organisms that are not 
already plant pests.
    The most common use of plant pest components in genetic engineering 
involve either the use of a disarmed version of the plant pathogenic 
bacterium Agrobacterium tumefaciens to vector genes into a plant or use 
of genetic material from plant pest donors which function as regulatory 
sequences in the plant. Currently, methods that use Agrobacterium 
tumefaciens as a vector of genetic material do not leave viable 
bacteria behind in the recipient organism and do not cause disease. 
Likewise, regulatory sequences such as the 35S promoter from 
Cauliflower Mosaic Virus and the nopaline synthase (nos) terminator 
from A. tumefaciens are themselves unable to be expressed and do not 
confer plant pest traits, though they do facilitate the expression of 
other genes in the GE organism. The use of plant pests in these ways 
either as donors of regulatory sequences or for vectoring genetic 
material into a recipient organism has a long history and has not 
resulted in disease or injury to the recipient organism or to other 
organisms.
    These advances in our knowledge of biotechnology notwithstanding, 
under Sec.  340.2(b), we would continue to regulate GE organisms in 
those cases where the organism which is engineered is itself a plant 
pest as defined in the PPA.
    Our approach to regulating such organisms, however, would differ 
from that of the existing regulations. In current Sec.  [thinsp]340.2, 
there is a list of taxa that contain plant pests. Under our proposed 
regulatory framework, however, we would not use taxonomic 
classification of donor organisms to determine if a GE organism is 
regulated. We would, therefore, remove the list from the regulations, 
along with the procedures described in current Sec.  340.5 for amending 
this list.
    Instead, when determining whether a GE non-plant organism is 
subject to the regulations, APHIS will assess whether a recipient 
organism is likely to be a plant pest, based on the most up-to-date 
pest information maintained by APHIS. This information is more specific 
than the information in the list of plant pest taxa in the current 
regulations, and should be more useful and reliable than static lists 
of taxa, which become outdated. APHIS will maintain a list of taxa that 
contain plant pests on its website and would be available for 
consultation by developers to help them determine whether or not their 
GE non-plant organism is or is not a plant pest. APHIS welcomes public 
comment on this proposed change.
    Under proposed Sec.  340.2(c), we would also regulate GE organisms 
that are not plants but have received DNA from a plant pest if the DNA 
from the donor organism is sufficient to produce an infectious entity 
or encodes a pathogenesis-related compound that is expected to cause 
plant disease symptoms. DNA from a donor organism that is a plant pest 
could, when inserted into an organism which is not a plant pest, result 
in a GE organism that is a plant pest if: (1) The DNA sequence that is 
encoded in the organism is able to be expressed as a functioning 
infectious entity capable of causing plant disease; or (2) if the 
inserted DNA enables the organism to produce pathogenesis-related 
compounds, that is, compounds that are typically produced by pathogens 
and involved in producing disease symptoms. Examples of such compounds 
would include plant degrading enzymes, plant growth regulators, 
phytotoxins, or compounds that can clog plant vascular systems.
    APHIS intends this criterion to be specific to GE organisms other 
than plants, such as nonpathogenic soil bacteria that through genetic 
engineering may become capable of producing plant disease symptoms in 
plants. This contrasts with the current regulations, under which we 
regulate GE organisms based merely on the presence of DNA from a plant 
pest.
    In addition, under Sec.  340.2(d), we would regulate GE organisms 
that are microbial pathogens used to control plant pests, microbial 
parasites used to control plant pathogens, or invertebrate predators or 
parasites (parasitoids) used to control plant pests if they could pose 
a plant pest risk. These organisms are generally not plant pests but 
their potential effects on organisms beneficial to agriculture 
(referred to below as ``beneficial'') could indirectly affect plant 
health. The PPA provides the authority to regulate such biological 
control organisms used to control plant pests to ensure they do not 
pose a plant pest risk. As with non-GE biological control organisms, 
the types of GE biological control organisms APHIS would regulate 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 only to consider 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.
    APHIS requests comment from the public regarding the categories of 
GE organisms listed under proposed Sec.  340.2 as subject to the 
regulations and whether additional categories, such as pollinators, 
should also be considered.

Definitions

    Definitions would be listed in proposed Sec.  340.3. APHIS proposes 
to retain certain definitions currently found in Sec.  340.1 of the 
regulations, to change other definitions, to add some new definitions, 
and to remove definitions that no longer need to appear in the 
regulations.
    APHIS is proposing to retain the following definitions from the 
current regulations, without change:

[[Page 26522]]

Administrator, Animal and Plant Health Inspection Service (APHIS), 
donor organism, environment, organism, and person.
    APHIS is proposing to revise the definitions of the following terms 
from those in the current regulations:
    We would define genetic engineering (GE) as techniques that use 
recombinant or synthetic nucleic acids to modify or create a genome. 
This proposed definition is clearer than the existing one, which refers 
to modification using ``recombinant DNA techniques,'' a term that is 
not defined in the regulations. The current definition could also be 
construed, contrary to our intentions, to exclude the use of synthetic 
DNA, in vivo DNA manipulation, and genome editing. The proposed 
definition of genetic engineering would not cover traditional breeding 
techniques, such as marker-assisted breeding, as well as tissue culture 
and protoplast, cell, or embryo fusion, or chemical or radiation-based 
mutagenesis. APHIS has never considered such techniques to constitute 
genetic engineering. Accordingly, organisms created through such 
techniques are currently excluded from the definition under part 340, 
and would continue to be so.
    We would define inspector as any individual authorized by the 
Administrator or the Commissioner of Customs and Border Protection, 
Department of Homeland Security, to enforce the regulations in part 
340. The current definition predates the establishment of the 
Department of Homeland Security, as well as the transfer of certain 
inspection responsibilities for imported organisms from APHIS to U.S. 
Customs and Border Protection.
    The definition of interstate would be from one State into or 
through any other State or within the District of Columbia, Guam, the 
Virgin Islands of the United States, or any other territory or 
possession of the United States. This proposed revision aligns the 
definition of interstate in part 340 with the definition used in the 
PPA.
    Move (moving, movement) would be defined as 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. This 
proposed revision aligns the definition of move in part 340 with the 
definition of move used in the PPA.
    The definition of permit would be a written authorization, 
including by electronic methods, by the Administrator to move organisms 
regulated under part 340 and associated articles under conditions 
prescribed by the Administrator. This proposed revision would generally 
align the definition of permit in part 340 with the definition of 
permit used in the PPA. However, whereas the definition in the PPA 
mentions that a permit may authorize the movement of plants, plant 
products, and biological control organisms, plant pests, noxious weeds, 
and associated articles, our proposed definition would pertain to the 
movement of organisms regulated under part 340 and associated articles. 
This change reflects the scope of the proposed regulations.
    Additionally, while the PPA allows for the issuance of oral 
permits, APHIS would not under these regulations. Oral permits do not 
provide adequate documentation that a responsible person was aware of 
and understood permitting conditions at the time the permit was issued.
    Plant would be defined as 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. This revision is necessary because 
the current definition of plant used in the regulations precedes the 
issuance of the PPA, and is broader than the PPA definition. The 
proposed definition would align with the definition used in the PPA. A 
result of this alignment would be that APHIS would no longer consider 
``cellular components,'' such as ribosomes, to be plants. Cellular 
components are not capable of propagating to cause plant pest risks.
    Plant pest would be defined as 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. This 
proposed definition would generally align the definition of plant pest 
in part 340 with that used in the PPA. However, 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, to be plant pests.
    Recipient organism would be defined as the organism whose nucleic 
acid sequence will be modified through the use of genetic engineering. 
In contrast, the current definition is ``the organism which receives 
genetic material from a donor organism.'' This change would differ from 
the current definition by distinguishing an organism with modified 
traits from the same organism prior to transformation; in some cases 
the recipient organism's nucleic acid sequence may be modified using 
genetic material from the same species.
    We propose to define release into the environment (environmental 
release) as the use of a GE organism outside the physical constraints 
of a contained facility. The existing definition of release into the 
environment refers to the release of a regulated article; however, in 
this proposed rule we are no longer using the latter term. Our proposed 
definition of release into the environment (environmental release), 
would also clarify that release into the environment and environmental 
release are synonymous terms.
    Responsible person would be defined as the person responsible for 
maintaining control over a GE organism under permit during its movement 
and ensuring compliance with all conditions contained in any applicable 
permit as well as other requirements of part 340. The proposed 
definition would further state that the responsible person may be, but 
would not be limited to, the signatory of a permit or the institution 
that the signatory represented at the time of the application. The 
responsible person must be at least 18 years of age and be a legal 
resident of the United States.
    The current regulations define responsible person as the person (at 
least 18 years of age and a U.S. resident) who has control and will 
maintain control over the introduction of the regulated article and 
assure that all conditions contained in the permit and requirements in 
part 340 are complied with. We are proposing to replace it with the new 
definition to clarify that the term refers to both individuals and 
institutions. That dual responsibility is implied in the existing 
definition, because we define the term person to include institutions, 
but it is not stated explicitly, potentially resulting in confusion 
over who ultimately is the responsible party. Attributing 
responsibility for a regulated organism only to an institution may be 
problematic for enforcement of the regulations, because such 
responsibility can be diffused, resulting in no individual being held 
accountable for violations. Attributing it only to an

[[Page 26523]]

individual may be similarly problematic because the signatory of the 
permit may change his or her institutional affiliation and location. 
The proposed definition would ensure that some individual or party 
would be held accountable for violating permit conditions and/or 
regulatory requirements.
    State would be defined as 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, the Virgin 
Islands of the United States, or other Territories or possessions of 
the United States. This change aligns the definition of State in part 
340 with that used in the PPA.
    We currently define State regulatory official as the State official 
with responsibilities for plant health, or any other duly designated 
State official, in the State where the introduction is to take place. 
We would change the term to State or Tribal regulatory official. We 
would define the State or Tribal regulatory official as the 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. Under the proposed 
definition, the official's responsibilities would not change. The 
proposed change from the former definition is to acknowledge Tribal 
authority on Tribal lands.
    APHIS proposes to add definitions of the following new terms:
    We would define access as 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 part 340 and all conditions of a permit issued 
in accordance with Sec.  340.5. This proposed definition is in line 
with APHIS' authority under the PPA to conduct inspections and, where 
necessary, sampling activities to verify that premises associated with 
permits meet our requirements.
    Because the responsible person, as defined above, may have an agent 
acting on his or her behalf, it is necessary to add to the regulations 
a definition of the latter term. Agent would be defined as ``[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 ensure compliance with all conditions 
contained in any applicable permit and the requirements in part 340. 
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.'' This proposed 
definition would codify the responsibilities of a designated agent 
acting on behalf of the responsible person.
    We would define article as any material or tangible object that 
could harbor plant pests or noxious weeds. This proposed definition is 
needed to clarify the meaning of the term as used throughout these 
proposed regulations and also aligns with the PPA definition of the 
term.
    Contained facility would be defined as a structure for the storage 
and/or propagation of living organisms designed with physical barriers 
capable of preventing the escape of the organisms, and that examples 
include laboratories, growth chambers, fermenters, and containment 
greenhouses. While the current regulations use the term contained 
facility, the term is not currently defined. APHIS proposes to add this 
definition to clarify what constitutes a contained facility.
    Import (importation) would be defined as to move into, or the act 
of movement into, the territorial limits of the United States. This is 
the definition used in the PPA.
    We would define mechanism of action, as discussed earlier in this 
document, as the biochemical process(es) through which genetic material 
determines a trait. We would add this definition because it is an 
element that we would consider, along with organism and trait, when 
evaluating a GE organism for plant pest risk.
    As discussed earlier, we would define plant pest risk as the 
possibility of harm to plants resulting from introducing or 
disseminating a plant pest or exacerbating the impact of a plant pest. 
It is necessary to add this definition because our regulatory status 
review process, described below, hinges on our evaluation of the plant 
pest risk posed by a GE plant.
    Parasitic plants can pose plant pest risks directly by injuring 
plants themselves, while other types of plants pose plant pest risks 
indirectly, either by serving as reservoirs, which can increase the 
numbers or distribution of plant pests, or by serving as hosts in which 
new plant pests can be created.
    Non-plant GE organisms may also pose both direct and indirect plant 
pest risks. Direct plant pests risks are limited to GE organisms which 
are themselves plant pests, i.e., capable of causing injury of, damage 
to or disease in plants or plant products. Indirect plant pest risks 
involve interactions of a GE organism with other organisms or the 
environment in such a way that injury of, damage to, or disease in 
plants or plant products by plant pests occurs or is increased. As with 
GE plants, an important mechanism by which a non-plant GE organism 
could have an indirect plant pest impact would be the suppression of 
populations of a beneficial organism which, in turn, suppresses plant 
pests. With decreased levels of the beneficial organism, injury, 
damage, or disease from the plant pest it suppresses might be 
increased.
    Plant product would be defined as any flower, fruit, vegetable, 
root, bulb, seed, or other plant part that is not included in the 
definition of plant or any manufactured or processed plant or plant 
part. This matches the definition of plant products found in the PPA. 
This definition is more precise than the current definition of product 
in part 340, which this definition would replace. For example, the 
current definition of product includes ``anything made by or from, or 
derived from an organism, living or dead.'' APHIS does not plan to 
regulate dead organisms as APHIS has found that they do not present a 
plant pest risk.
    Secure shipment would be defined as 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. This definition would 
be used to clarify the container requirements in the proposed rule.
    We would define trait, as discussed earlier in this document, to 
mean an observable (able to be seen or otherwise identified) 
characteristic of an organism. This proposed definition would provide 
clarity regarding the relationship between trait and MOA.
    Unauthorized release would be defined as the intentional or 
accidental movement of an organism under a permit issued pursuant to 
part 340 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 part 340. We would add this definition to ensure 
that the Administrator would have the ability to enforce regulatory 
requirements that are accidentally or intentionally violated and 
maintain effective compliance oversight.
    APHIS proposes to remove the following definitions from the 
regulations: Antecedent organism, courtesy permit, expression vector, 
introduce or introduction, product, regulated article, Secretary, 
stably

[[Page 26524]]

integrated, United States, vector or vector agent, and well-
characterized and contains only non-coding regulatory regions.
    These definitions would be removed because the terms would no 
longer be used in the regulations.
    APHIS proposes to remove the definition for introduce or 
introduction. APHIS currently uses the term in part 340 to denote 
certain kinds of activities that fall within the scope of the 
regulations, namely importation, interstate movement, and release into 
the environment. The PPA, however, does not specifically define the 
term introduction. Therefore, to avoid confusion, instead of using the 
term introduction to define the different types of regulated 
activities, APHIS would refer to these activities in the regulations as 
movement in accordance with the definition of move in the PPA. 
Additionally, as mentioned above, the regulations will specify and 
define as necessary the types of movements to which the regulations 
would apply, namely, importation, interstate movement, and release into 
the environment.
    APHIS proposes to remove the definition of regulated article. APHIS 
currently uses the term in part 340 to refer to which organisms fall 
within the scope of the regulations. A GE organism is considered to be 
a regulated article under the current definition if the donor, vector, 
or vector agent is a plant pest. However, GE techniques, such as genome 
editing and synthetic genomics, have recently been developed that need 
not employ plant pests as donor organisms, recipient organisms, 
vectors, or vector agents but that may pose plant pest risks. APHIS 
proposes to identify the categories of organisms that are subject to 
the regulations in Sec.  340.2 instead of through the definition of 
regulated article.
    Finally, based on the terms that APHIS is proposing to add or 
remove from the regulations, as well as the revised scope of the 
regulations, the Agency would revise the heading of part 340 to 
``Movement of Organisms Modified or Produced Through Genetic 
Engineering.''

Regulatory Status Review

    Under the existing regulations, APHIS deems GE organisms 
``regulated articles'' based upon the use of a plant pest in the 
genetic engineering process. APHIS receives requests from developers 
who wish to ascertain, prior to conducting a potentially regulated 
activity, whether a specific organism that they have developed meets 
our definition of regulated article and is therefore subject to the 
regulations. APHIS has been responding to such inquiries from 
developers since the late 1990's. In 2011, APHIS implemented a formal 
``Am I Regulated'' (AIR) process, providing a web page that instructs 
developers on how to submit an AIR inquiry. We developed the AIR 
process because we saw an increasing number of such requests. The 
process was intended to guide developers to provide consistent and 
predictable information that would enable the Agency to respond to 
inquiries in a timely manner so as to not inhibit innovation. This 
process is not codified in the existing regulations, however.
    The primary analysis conducted under this process is to determine 
whether or not the organism described in the AIR inquiry is a regulated 
article as defined in part 340. The organisms in question have ranged 
from clearly regulated (e.g., GE plants that DNA that was inserted by 
the plant pest Agrobacterium tumefaciens) to clearly not regulated 
ones, such as GE organisms that are genetically engineered without the 
use of a plant pest. Products of new genome editing techniques, such as 
TALENs and CRISPR, have presented intermediate scenarios that have been 
evaluated over the past few years. Additional considerations by APHIS 
under this process include weediness potential. If the organism in 
question is weedy or has weedy wild relatives, these concerns are also 
addressed in APHIS' response.
    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. Published APHIS 
decisions made under the current regulations in Sec.  340.6 have used 
different ways to express the basic standard ``unlikely to pose a plant 
pest risk'' in determining whether to grant nonregulated status to a 
specific GE organism. Alternative characterizations that have been used 
include ``poses no more of a plant pest risk than its non-GE 
counterpart,'' ``will not pose a plant pest risk,'' ``no plant pest 
risk,'' and ``no direct or indirect plant pest effects.'' Regardless of 
the phrases used, APHIS has applied the same basic evaluation criteria, 
specified in current Sec.  340.6(c)(4), to each determination to 
conclude that the GE organism is unlikely to pose a plant pest risk and 
therefore is not subject to the part 340 regulations. Those criteria 
include, conclusions on the potential of the GE organism to create pest 
or disease problems, the potential for nontarget effects that might 
affect organisms beneficial to agriculture, changes in agricultural 
practices that might exacerbate pest or disease problems, the potential 
for a GE organism to become a weed or increase its weediness or that of 
sexually compatible species, and the potential of the GE organism to 
transmit the introduced trait to organisms with which it does not 
interbreed.
    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, the Agency believes the petition process is no 
longer necessary and is proposing to remove the petition process from 
the regulations.
    In this document, APHIS is proposing to provide developers of novel 
GE plants that have not been previously evaluated by APHIS the option 
of either requesting a regulatory status review by the Agency to 
determine regulatory status or applying for a permit for movement under 
the regulations. Developers choosing to apply for a permit would, upon 
approval of the permit application, be able to immediately import, move 
interstate, or field test their plant under APHIS-imposed conditions 
and oversight. If they choose to request a regulatory status review, 
and the Agency finds that the plant-trait-MOA combination is not likely 
to pose a plant pest risk and therefore is not subject to the 
regulations, the developer could proceed with product development and 
marketing activities free from regulation under part 340.
    The current petition process contained in the regulations is only 
applicable to GE plants; likewise, the proposed regulatory status 
review described in proposed Sec.  340.4 would apply only to plants and 
not to GE plant pests or other GE non-plant organisms. The latter two 
categories would fall within the scope of the proposed regulations in 
Sec.  340.2 and therefore require permits for movement. Unlike most 
plants, other organisms described in Sec.  340.2(b), (c), and (d) are 
either known to be plant pests, engineered in such a way that they are 
likely to be plant pests, or will be used to control plant pests and 
therefore need to be regulated for direct or indirect plant pest risks. 
As noted earlier, we are requesting public comment on whether the 
regulatory status review process or some equivalent process should 
apply

[[Page 26525]]

to non-plant GE organisms and, if so, what factors should be analyzed.
    Proposed Sec.  340.4(a) describes the process for submitting a 
request for a regulatory status review. Since APHIS may also initiate a 
regulatory status review, that process is described as well.
    Under proposed Sec.  340.4(a)(1), any person could submit a request 
to APHIS for a regulatory status review of a GE plant that has not 
previously been reviewed for plant pest risk based on its plant-trait-
MOA combination. Proposed paragraph (a)(2) would allow any person to 
request a re-review of a GE plant listed as subject to part 340, 
provided that the person making the request can provide new, 
scientifically valid evidence bearing on the plant pest risk associated 
with movement of the plant.
    Proposed paragraph (a)(3) would state that APHIS could also 
initiate a regulatory status review or re-review of a GE plant. This 
provision would provide another means of enabling us to respond quickly 
to scientific developments when making decisions on whether or not GE 
plants are subject to the regulations. APHIS could initiate a re-review 
of a GE plant, regardless of the initial finding, if new information 
warrants such a reevaluation.
    Proposed paragraph Sec.  340.4(a)(4), would state that information 
submitted in support of a request for a regulatory status review would 
have to meet the requirements listed in paragraphs (a)(4)(i) through 
(iii), which are as follows:
     A description of the comparator plant, to include genus, 
species, and any relevant subspecies information;
     The genotype of the modified plant, including a detailed 
description of the differences in genotype between the modified and 
unmodified plant; and
     A detailed description of the new trait(s) of the modified 
plant.
    Additional guidance on how to meet these requirements will be 
available on the APHIS website and is included below:
    I. A description of the comparator plant to include:
    a. Common name(s);
    b. Genus, species, and any relevant subspecies information (e.g., 
variety) that would distinguish the plant; and
    II. The genotype of the modified plant, including a detailed 
description of the differences in genotype between the modified and 
unmodified plant.
    a. If genetic material is inserted into the genome, the following 
information shall be provided:
    i. For gene sequences, the name of the sequence, the donor 
organism(s) or source, the function of sequence, the nucleotide 
sequence, and if applicable, the publicly available sequence 
identification, protein accession number, and enzyme commission number. 
If genes have been modified (e.g., codon usage efficiency, gene 
shuffling, etc.), a statement regarding the nature of the modification 
and its purpose would be needed. The developer would also have to 
identify and highlight 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 source of each 
regulatory sequence would need to be described. Promoters must be 
identified as constitutive, inducible, developmental, or tissue 
specific. If inducible, known inducers must be described (e.g., 
chemical, temperature, light, stress, wounding, etc.). If 
developmental/tissue specific, the stage(s)/tissue at/in which the 
promoter is intended to be active must be described.
    b. If genetic material is not inserted into the genome, and the 
genome is modified in a way that does not fall under the exemptions in 
Sec.  340.1(b), the following must be provided:
    i. The nature of the modification(s) and the gene(s) and 
function(s) being modified.
    ii. For substituted base pairs, the number of substitutions.
    iii. The original unmodified sequence aligned to the modified 
sequence.
    III. A detailed description of the new trait(s) of the modified 
plant, including:
    a. The purpose of the new trait and the expected MOA by which the 
intended trait is conferred;
    b. Any expected changes in metabolism, physiology, and development 
due to the trait/genetic modification;
    c. If available, any additional experimental data, publications, 
and other science-based assessments that are relevant to APHIS' 
evaluation of the potential of the plant to pose plant pest risks. 
(APHIS does not intend for submitters to generate experimental data 
specifically for a regulatory status review. However, if a submitter is 
aware of information or experimental data in the public domain that may 
support our assessment, they may include it.)
    APHIS considers the categories of information specified above to be 
sufficient for assessing a GE plant and identifying the plant pest 
risks, if any, associated with it. That being said, the Agency solicits 
public comment on the adequacy of the requested information, and 
whether additional or alternate information requirements would be more 
appropriate. Specifically, APHIS is interested in whether commenters 
think the above information requirements may be insufficient to 
identify whether the plant poses a plant pest risk.
    To that end, APHIS wishes to highlight some of the differences 
between the above information requirements and the information 
currently required for either a petition for nonregulated status of a 
GE plant or an AIR inquiry. With regard to the genotype of the GE 
organism, APHIS would add specific information requirements for gene 
sequences, regulatory sequences, and genome modifications. The current 
regulations in Sec.  340.6 require the petitioner to supply a detailed 
description of the genotype of the GE organism, but do not specify that 
a description of the gene sequences, regulatory sequences, or genome 
editing of the organism is required. Operationally, however, APHIS 
considers this information to be necessary. APHIS anticipates using the 
information to confirm the intended trait(s) of the GE plant and to 
assess similarity with previously reviewed plants, which will assist 
the Agency in understanding the impacts the modification(s) will have 
on characteristics of the plant.
    The current regulations specify that a petition must contain field 
test reports for all trials conducted under permit or notification 
procedures involving the regulated organism, including the APHIS 
reference number, methods of observation, resulting data, and analysis 
regarding all deleterious effects on plants, non-target organisms, or 
the environment. A petition is typically requested after lengthy field 
testing. Currently, most of the field data submitted are intended to 
demonstrate that there have not been unintended deleterious effects on 
plants, non-target organisms, or the environment.
    To date, APHIS has authorized more than 100,000 field trials--a 
single permit or notification may authorize multiple trials--and APHIS 
has not received a report of unintended deleterious effects on plants, 
non-target organisms, or the environment. 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, the Agency 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.

[[Page 26526]]

These observations are expected and are consistent with findings of 
reports of the National Academies of Science, Engineering, and 
Medicine.11 12
---------------------------------------------------------------------------

    \11\ See: NRC (National Research Council). 1989. Field Testing 
Genetically Modified Organisms: Framework for Decisions. Washington, 
DC: National Academy Press.
    \12\ National Academies of Sciences, Engineering, and Medicine. 
2016. Genetically Engineered Crops: Experiences and Prospects. 
Washington, DC: The National Academies Press. doi: 10.17226/23395.
---------------------------------------------------------------------------

    Accordingly, field test information would not be a generally 
applicable requirement for the initial regulatory status review and 
would only be requested on an as-needed basis when further analysis is 
needed. APHIS considers information from field tests to be unnecessary, 
in most cases, for a determination of regulatory status under the 
proposed regulations. The approach APHIS is proposing focuses primarily 
on evaluating the genetics and characteristics of the GE plant-trait-
MOA combination and the likelihood that, based on these genetics and 
characteristics, the plant will pose a plant pest risk if it is 
released into the environment for the uses intended by the developer.
    This approach would not preclude a developer from providing 
information from field tests, if he or she considered it to be 
pertinent to our analysis. For example, if a developer wished for APHIS 
to reevaluate the status a GE plant that the Agency had previously 
considered to be subject to the regulations, field-test information 
demonstrating a lack of direct or indirect adverse effects on plants 
and plant products 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.
    APHIS would also remove a current regulatory requirement that 
requires the petition to state the country and locality of the donor 
organism from which a GE organism has received genetic material in 
order for APHIS to evaluate the genotype of the GE organism. In the 
Agency's experience, this information has not proven germane to 
evaluating risk associated with modifying the genome of the GE 
organism, since it does not provide information regarding the modified 
genome of the GE organism, or the manner in which the genome was 
modified.
    Information pertaining to the MOA may include, to the extent that 
it is or could be 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. This information is useful to us because these factors 
may affect the level of plant pest risk associated with the GE plant.
    The above information is needed to allow APHIS to evaluate the 
plant pest risk posed by the GE plant. The general description of the 
plant-trait-MOA combination will not be eligible for CBI designation. 
Making this information available would facilitate APHIS' transparent 
regulatory approach and thereby increase public understanding of what 
combinations the Agency has already assessed and the regulatory status 
of those combinations, aiding developers in making self-determinations 
as to whether their products would be exempt from the regulations in 
accordance with Sec.  340.1. Certain technical information that could 
be used to re-create an organism, however, may be eligible for CBI 
designation under existing statutory authorities.
    Proposed Sec.  340.4(b) would set out the regulatory review 
process. Under proposed Sec.  340.4(b)(1), upon receiving a request for 
a regulatory status review of a GE plant, APHIS would 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, based on following factors:
    I. The biology of the comparator plant and its sexually compatible 
relatives;
    II. The trait and mechanism-of-action of the modification(s); and
    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.
    APHIS uses existing knowledge and information on the biology of the 
comparator plant and its sexually compatible relatives, including their 
spatial and temporal distribution in the absence of intentional human 
assistance and their interactions with or impacts on other organisms 
and the environment, as the foundation for considering whether 
alterations in the GE plant are likely to pose plant pest risks.
    As noted earlier, the MOA is the specific manner by which the 
genetic modification of the GE plant confers the intended trait on the 
plant. It is necessary for a regulatory status review to evaluate both 
trait and MOA because the same trait may be obtained by different MOAs, 
which may pose greater or lesser plant pest risks. For example, the 
trait of coleopteran resistance can result from either of at least two 
MOAs: Expression of a Cry protein, or expression of a silencing complex 
targeting ribonucleic acids (RNA) in the coleopteran pest. Plants with 
insect-resistant traits can potentially cause plant pest risks through 
harms to organisms beneficial to agriculture, such as predator insects 
that can suppress pest populations. Though the two MOAs in the example 
both produce a coleopteran resistant trait, they would need to be 
evaluated separately for nontarget impacts to beneficial insects. 
Nontarget impacts related to Cry proteins depend on whether the 
nontarget insect has the correct protein in its gut to bind the Cry 
protein. Ribonucleic acid interference (RNAi)-based resistance could, 
on the other hand, be designed to target RNA encoding for any number of 
essential proteins in the target insect. The sequence could be very 
specific to the target insect or widely preserved across varying taxa. 
Only through extensive testing or bioinformatics analysis could risks 
to nontarget insects be determined. In summary, because these two MOAs 
are different, one would not expect the analysis of risks to nontarget 
organisms for one MOA to be informative in evaluating the risks to 
nontarget organisms of the other. The important principle is that it is 
not just the trait, but also the MOA, which is critical for 
differentiating GE plants in order to determine whether new reviews of 
plant pest risk are needed.
    As in plant pest risk assessments (PPRAs) prepared in response to 
petitions for nonregulated status under the current regulations, APHIS 
would evaluate whether planting or release of the GE plant could result 
in direct or indirect harm to non-target organisms that are beneficial 
to agriculture, such as pollinators and predators of plant pests. We 
would also evaluate the potential of the plant to displace native/
established organisms or otherwise alter community composition or 
structure in a manner that harms beneficial non-target organisms.
    APHIS recognizes that genetic engineering may be used to introduce 
a trait that increases the distribution,

[[Page 26527]]

density, or development of a plant or the weedy impacts of the plant, 
factors that are considered aspects of a plant's weediness. As such, we 
would continue the 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 in the timing during which they serve as 
a host for plant pests due to the introduced trait. As part of the 
regulatory status review, 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. Second, 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 and listing as a Federal noxious weed under the 
regulations in part 360. The proposed regulation does not change this 
analysis.
    Because the initial review is objective, rapid, and based on 
transparent predetermined criteria, it has functional similarity to the 
current AIR process. In both processes, the outcome is merely a finding 
of whether a GE organism is subject to the regulations in part 340. 
APHIS will maintain on our website a list of all GE plant-trait-MOA 
combinations which have been evaluated. The list will include the 
inquiry, and the Agency finding. In cases where no potential plant pest 
risks are identified, APHIS will conclude that the plant-trait-MOA 
combination is not likely to pose a plant pest risk, and, therefore, 
the agency will have no discretion to regulate. As such, and consistent 
with our current process for AIR inquiries, there will be no comment 
period or need for publication in the Federal Register.
    Proposed Sec.  340.4(b)(2) states that if we do not identify 
potential plant pest risk in the initial review, the GE plant would not 
be subject to the regulations in part 340, and APHIS would post the 
finding on its website.
    Under proposed Sec.  340.4(b)(3), in cases where the Agency 
identifies potential plant pest risks, APHIS would conduct a PPRA, a 
more robust analysis than the initial review, to evaluate the factor(s) 
of concern and to determine the likelihood and consequences of the 
potential plant pest risks identified in the initial review. In some 
cases, the Agency may be able to reach a finding that the plant-trait-
MOA combination is not subject to the regulations based on the outcome 
of the PPRA. In other cases, the Agency may determine that additional 
information is needed to evaluate the potential plant pest risks and 
field trials or greenhouse studies may be necessary to collect 
additional information to inform the risk assessment.
    Proposed Sec.  340.4(b)(3) also states that APHIS would make 
available information on the results of both the initial review and the 
subsequent PPRA conducted pursuant to this paragraph in a notice in the 
Federal Register and take public comments. After reviewing the 
comments, we would make a final determination of regulatory status and 
notify the public via a subsequent notice in the Federal Register. If 
the GE plant were found unlikely to pose a plant pest risk and 
therefore not to require regulation under part 340, APHIS would post 
the finding on its website. If the Agency could not reach such a 
finding, movement of the GE plant would be allowed only under permit.
    Along with this proposed rule, we are publishing a document 
entitled ``Framework for USDA APHIS' Plant Pest Risk Assessment (PPRA) 
for Genetically Engineered Plants.'' The framework will provide more 
detailed information on the PPRA process than is contained in this 
document. We welcome public comment on the framework.
    Proposed Sec.  340.4(c) states that APHIS would maintain on its 
website information on all requests for and results of regulatory 
status reviews. We would protect CBI associated with individual 
regulatory status reviews on the website, except that, as noted 
earlier, plant, trait, and MOA would not be eligible for consideration 
as CBI.

Permits

    The current regulations in Sec.  340.3 provide criteria for a 
notification procedure whereby certain GE plants may be authorized for 
introduction in lieu of a permit. Rather than using customized 
requirements, like the permitting conditions used for the permitting 
procedure, the notification procedure relies on performance-based 
standards that are described in the regulations themselves. The use of 
the performance-based standards that do not vary from one notification 
to the next facilitates rapid administrative turnaround on 
notifications. However, in some ways, the term ``notification'' has 
been misleading to the public, since sending a notification does not 
mean automatic authorization by APHIS.
    In many ways, the APHIS evaluations for notifications 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 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.
    Because the notification procedure uses only the performance-based 
standards in the regulations, it is more administratively streamlined 
and provides the responsible person with flexibility in how the 
standard is met, e.g., by allowing for appropriate changes in protocols 
used during the growing season. There are, however, some disadvantages 
to this approach. 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 if 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.
    The permitting procedure avoids this disadvantage, because the 
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. Because of this, APHIS has determined that 
it would have more risk-appropriate oversight, better regulatory 
enforcement, and improved transparency if all regulated movements are 
authorized under the permitting procedure. Therefore, APHIS is 
proposing to remove current notification provisions from the 
regulations and require that movement of all GE organisms subject to 
part 340 be conducted under permit.
    The use of the permitting procedure in lieu of notifications is 
also necessary for APHIS to address a number of the recommendations 
from the OIG audits and the 2008 Farm Bill. In both the OIG audits and 
the 2008 Farm Bill, concern was expressed regarding the use of 
performance-based standards to regulate field tests of regulated 
articles. It was

[[Page 26528]]

recommended that APHIS amend the regulations to exercise greater 
oversight and enforcement of such field tests and to require more 
extensive reporting and record retention regarding such tests. These 
requirements can be added to a permit as permitting conditions, but do 
not lend themselves to performance-based standards. Some permit 
conditions, however, are and have always been performance-based. APHIS 
acknowledges that there is more than one way to manage risk and works 
with the permit applicant to find a mutually acceptable way to do so. 
In some instances, permit conditions may allow for the flexibility 
inherent in performance standards, while ensuring a specific 
requirement is addressed, something not possible with the notification 
procedure.
    In short, if APHIS were to retain the notification procedure, in 
order to be responsive to the risk factors that may be associated with 
certain field trials but not others, to make it easier to assess 
compliance, and to be responsive to both the OIG audits and the 2008 
Farm Bill, APHIS would need to revise the procedure to substantially 
reduce its reliance on performance-based standards. However, doing so 
would eliminate the primary benefit of the current notification 
procedure, which is that it is more administratively streamlined than 
the permitting procedure. Indeed, a revised procedure which took into 
consideration all risk factors that may be associated with specific 
field trials would be overly burdensome. For these reasons, APHIS is 
proposing to eliminate the notification procedure, rather than revise 
it.
    The permitting procedure found in Sec.  340.4 of the current 
regulations describes types of permits, information required for permit 
applications, standard permit conditions, and administrative 
information (e.g., time frames, appeal procedure, etc.). Permits 
contain specific conditions that must be followed by the permit holder. 
Standard permit conditions, or ``general conditions,'' are listed in 
the current regulations, and APHIS supplements these with additional 
conditions as necessary. The current regulations specify the amount of 
time that APHIS is allotted for review of complete permit applications: 
60 days for permits for importation and interstate movement, 120 days 
for environmental release. The current regulations also outline 
requirements for protecting CBI when submitting a permit application.
    APHIS is proposing certain changes concerning permit application 
information requirements, permit conditions, records, and reports. We 
are proposing to remove the specified timeframes for APHIS review of 
permit applications to ensure the Agency has the appropriate time to 
evaluate each permit application based upon the risk the GE organism 
poses and the complexity of the permit application. Currently, some 
permit and notification applications take a minimal amount of time and 
others take longer, APHIS anticipates this to continue. We are also 
proposing to reorganize the regulations to improve the clarity of the 
permit application and evaluation procedures.
    As noted earlier, under proposed Sec.  340.2, GE plants that have 
not undergone a regulatory status review and those that have and were 
not found to be unlikely to pose a plant pest risk would both be 
subject to the regulations and could be moved only under permit. In 
some cases, a developer may opt to move a GE plant under permit 
initially while also requesting a regulatory status review. If a GE 
plant is subject to a regulatory status review during the time the 
permit is in effect, depending on the results, APHIS could amend the 
permit, or, if the plant is found not to require regulation, terminate 
the permit and communicate this termination to the permittee.
    Paragraph (a) of proposed Sec.  340.5 would state that movement of 
any GE organism subject to the regulations in part 340 would require a 
permit issued by APHIS.
    Paragraph (b) of proposed Sec.  340.5 would state that the 
responsible person would have to submit a permit application using a 
method listed on our website. The permit application would have to 
contain all the categories of information listed below.
    Proposed paragraph (b)(1) would list general information 
requirements for all types of permit applications. All applications 
would have to include the name, title, and contact information of the 
responsible person and agent; the country and locality where the 
organism was collected, developed, manufactured, reared, cultivated, or 
cultured; the intended activity (i.e., importation, interstate 
movement, or release into the environment of the GE organism); and 
information on the intended trait and genotype of the intended trait. 
These information requirements would be very similar to those for 
current permits.
    Under proposed paragraph (b)(2), applications for permits for 
interstate movement or importation would, in addition to meeting the 
requirements of paragraph (b)(1), have to include 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; the method of shipment, and means of ensuring the 
security of the shipment against unauthorized release of the organism; 
and the manner in which packaging material, shipping containers, and 
any other material accompanying the organism will be disposed of to 
prevent unauthorized release.
    Under proposed paragraph (b)(3), permit applications for release 
into the environment would have to address the general information 
requirements in paragraph (b)(1) and provide the following additional 
information: The location and size of all proposed environmental 
release sites, including area, geographic coordinates, addresses, 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 would 
continue the practice of evaluating and amending permits to add new 
release sites.
    Finally, proposed paragraph (b)(4) would state that APHIS would 
request additional information as needed. Based on APHIS' extensive 
experience with the current permitting process, there are additional 
pieces of information that APHIS proposes to routinely request, such as 
multiple GPS coordinates for requested acreage, as well as multiple GPS 
coordinates for actual release acreage to appropriately describe the 
approved area. This information would allow APHIS to fully utilize GIS 
capabilities to oversee what was released within an authorized area. 
Additional documentation or notices may be required commensurate with 
risk of persistence in the environment.
    APHIS currently has to follow up with applicants for this 
information; under this proposed rule, we would obtain it up front, as 
it would be required to support the permit application.
    The categories of information above also align with the 
recommendations of the 2005 and 2015 OIG audits, and the provisions of 
the 2008 Farm Bill. For example, the OIG recommendations are reflected 
in the provisions that would enable APHIS to require geographic 
coordinates for the locations of environmental releases.
    Proposed paragraph (c) of Sec.  340.5 would continue to exempt 
Arabidopsis thaliana from permitting requirements for interstate 
movement, provided that it is moved in a secure shipment and the cloned 
genetic material is stably

[[Page 26529]]

integrated into the plant genome and does not include the complete 
infectious genome of a plant pest. This exemption is based on that 
organism's historically exempt status, which exists because interstate 
movement of the organism has not resulted in the dissemination of plant 
pests within the United States. A. thaliana has desirable traits 
(including small size, short generation times, high seed set, and ease 
of growth) that lend themselves to use in scientific studies. A. 
thaliana's small genome size, lack of repetitive DNA, and ease of 
genetic modification using Agrobacterium tumefaciens make it especially 
useful for molecular genetic analysis. Though GE A. thaliana often 
needs to be moved interstate between laboratories and other containment 
facilities as part of scientific studies, safeguards exist which can 
adequately mitigate the plant pest risk.
    Proposed paragraph (d) of Sec.  340.5 would exempt disarmed 
Agrobacterium tumefaciens from permitting requirements for interstate 
movement, subject to the same conditions as A. thaliana. This exemption 
is granted because, like A. thaliana, disarmed GE A. tumefaciens often 
needs to be moved interstate between laboratories and other containment 
facilities as part of scientific studies, and safeguards exist which 
can adequately mitigate the plant pest risk. In addition, while some 
strains of disarmed Agrobacterium may cause mild plant disease symptoms 
in some cases, our extensive experience has shown that given its 
specific usage in transforming plants and its lack of persistence in 
the newly transformed plants, there is a very low plant pest risk.
    Proposed paragraph (e) of Sec.  340.5 would exempt biological 
control organism-containing microbial pesticide products that are 
currently registered with EPA as a microbial pesticide product and that 
are not plant pests.
    Under the authority of the Federal Insecticide, Fungicide and 
Rodenticide Act (FIFRA, 7 U.S.C. 136 et seq.), EPA regulates certain 
biological control organisms (including eukaryotic microorganisms, 
prokaryotic microorganisms, and parasitically replicating microscopic 
elements, including, but not limited to, viruses) as ``pesticides,'' 
(see 40 CFR 152.20(a)(3)) and has established a regulatory process for 
their use as microbial pesticides.
    Proposed paragraph (f) of Sec.  340.5 would contain specifics 
regarding APHIS' review of permit applications. Under proposed (f)(1), 
APHIS would review permit applications to determine completeness. As 
under the current regulations, if the application is incomplete, APHIS 
would notify the applicant orally or in writing, and the applicant 
would be provided a sufficient opportunity to revise the application. 
Once an application is complete, APHIS would review it to determine 
whether to approve or deny the permit application.
    Paragraph (f)(2) of Sec.  340.5 would contain provisions regarding 
APHIS' assignment of permit conditions. If a permit application is 
approved, permit conditions would be assigned to each permit 
commensurate with the risk of the organism under permit and activity. 
Under the current regulations, the permitting procedure does not 
require a formal acknowledgement from the applicant prior to permit 
issuance that they are aware of and consent to the permit conditions, 
though it has been our practice to request such acknowledgment. APHIS 
considers such an acknowledgement to be necessary in order to verify 
that applicants are aware of and willing to abide by the conditions. 
Accordingly, we are proposing to codify our current practice by adding 
to the regulations a requirement that, prior to permit issuance, 
applicants must agree, in writing and in a manner prescribed by the 
Administrator, that they are aware of, understand, and will comply with 
all permit conditions. If an applicant fails to comply with this 
provision, their application would be denied.
    Under paragraph (f)(3) of Sec.  340.5, all premises associated with 
the permit would be subject to inspection before and after permit 
issuance, and all materials associated with activities conducted under 
permit would be subject to sampling. APHIS would require that the 
responsible person provide inspectors with access, as defined under 
proposed Sec.  340.3, to inspect any relevant premises, facility, 
location, storage area, waypoint, materials, equipment, means of 
conveyance, records, and other articles related to the movement of 
organisms regulated under part 340. While this requirement is 
functionally the same as the current one, it clarifies what locations 
and articles may be subject to inspection. Failure to allow the 
inspection of premises prior to the issuance of a permit would be 
grounds for the denial of a permit application. Failure to allow an 
inspection after permit issuance would be grounds for withdrawal of the 
permit.
    While the current regulations provide for review of permit 
applications by State regulatory officials, they do not provide for 
review by Tribal officials. Recognizing that Tribal officials may 
exercise oversight on Tribal lands equivalent to that of State 
officials within States, APHIS proposes in Sec.  340.5(f)(4) to submit 
copies of permit applications to appropriate State and Tribal officials 
for review. Timely comments received from the State or Tribal 
regulatory official would be considered by the Administrator prior to 
permit issuance.
    General permit conditions, which APHIS is proposing to list in 
paragraph (g) of Sec.  340.5, would be assigned to all permits. As 
under the current regulations, additional or expanded permit conditions 
may also be assigned if determined by the Administrator to be necessary 
to ensure confinement of the GE organism. Examples of such supplemental 
requirements may include, but are not limited to, specific requirements 
for reproductive, cultural, spatial, and temporal controls; monitoring; 
post-termination land use; site security or access restrictions; 
management practices such as training of personnel involved in the 
movement; and practices to prevent articles associated with the 
movement of an organism under permit from spreading the organism.
    The use of permits and permit conditions gives APHIS and the 
responsible person an understanding as to what actions must be taken 
for the permit holder to comply with the regulations. In the current 
regulations, APHIS also provides a list of general permitting 
conditions that are assigned to all permits in order to provide as much 
transparency and predictability as possible about permit conditions. To 
that end, as mentioned above, APHIS would continue to maintain a list 
of general conditions that APHIS would assign to all permits issued 
under the regulations within the regulations themselves. Paragraph (g) 
of Sec.  340.5 would contain these general conditions. APHIS would 
require that:
    I. 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.
    II. The organism under permit must be kept separate from other 
organisms, except as specifically allowed in the permit.
    III. The organism under permit must be maintained only in areas and 
premises specified in the permit.
    IV. The organism under permit's identity must be maintained and 
verifiable at all times.
    V. Authorized activities may only be done while the permit is 
valid; the duration for which the permit is valid will be listed on the 
permit itself.

[[Page 26530]]

    VI. The responsible person would have to maintain records related 
to activities performed under permit of sufficient accuracy, quality, 
and completeness to demonstrate compliance with all permit conditions 
and requirements under the regulations. APHIS would be allowed access 
to all records, to include visual inspection and reproduction 
(photocopying, digital reproduction, etc.). The responsible person 
would have to submit reports and notices regarding the status of the 
organism under permit and actions and activities associated with the 
organism to APHIS at the times specified on the permit and containing 
the specified information. These reports would include, at a minimum:
    a. Environmental release reports:
    i. Following an environmental release, environmental release 
reports would have to be submitted for all authorized release locations 
where an environmental release occurred. Environmental release reports 
would have to contain details of sufficient accuracy, quality, and 
completeness to identify the location, shape, and size of the release 
and the organisms released into the environment.
    ii. In the event no release occurs at an authorized location, an 
environmental release report of no environmental release would have to 
be submitted for all authorized locations where an environmental 
release did not occur.
    iii. When the environmental release is that of a plant, reports of 
volunteer monitoring activities and findings would have to 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 would have to be submitted 
indicating why no volunteer monitoring was done.
    VII. Inspectors would have to be allowed access, during regular 
business hours, to all locations where the organism under permit is or 
has been located and any equipment used with the organism under permit.
    VIII. The organism under permit would have to undergo the 
application of remedial measures determined by the Administrator to be 
necessary to prevent its unauthorized release, spread, dispersal, and/
or persistence in the environment.
    IX. In the event of a possible or actual unauthorized release, the 
responsible person would have to contact APHIS, as described in the 
permit, within 24 hours of discovery, and subsequently supply a 
statement of facts in writing or electronically no later than 5 
business days after discovery.
    X. The responsible person for a permit remains the responsible 
person for the duration of 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 part 
340.
    Most of the conditions listed above are drawn from the current 
regulations, although APHIS has added some details to clarify their 
meaning. For example, while the existing regulations provide that APHIS 
inspectors shall be allowed access to records related to the permit, 
they do not specify what ``access to records'' means. APHIS would 
clarify that this includes visual inspection and reproduction 
(photocopying, digital reproduction, etc.) of all records required to 
be maintained under the proposed regulations or under the conditions of 
the permit. APHIS believes that these additional details will better 
communicate to applicants what the general permitting conditions are 
and will better support administration of the permitting program, 
including compliance and enforcement.
    The conditions related to permit duration are new. Under the 
current regulations, notifications for environmental releases and 
interstate movement are valid for 1 year. Interstate movement permits 
are only valid for 1 year from the date of issuance, and a new import 
permit must be obtained for each imported shipment. These permits are 
referred to as ``limited permits.'' The duration period for a permit 
issued solely for an environmental release is not currently specified.
    APHIS has found that it often takes considerably longer than 1 year 
for activities authorized under a permit to be completed. For example, 
with a perennial plant such as a tree, it may take much longer than 1 
year to gather relevant data about the plant for the purpose of 
determining risk. Additionally, monitoring activities may be required 
for several years after a field test is complete. In other cases, 
multiyear research projects may require multiple shipments of GE 
organisms under permit for analysis. APHIS is therefore proposing to 
eliminate the current limits in the regulations on the duration of 
permits for interstate movement and importation. APHIS also would 
continue not to specify in the regulations the duration for which an 
environmental release permit is valid. The duration for which a permit 
is valid would instead be specified on the permit itself, although as 
is currently true, some reporting requirements may extend beyond the 
expiration of the permit. APHIS would work with the developer to ensure 
that the duration would be appropriate, so that APHIS would have the 
flexibility to issue these permits with suitable durations to meet 
individual circumstances.
    APHIS is also proposing to make regular reporting regarding any 
activities associated with environmental release of a GE organism under 
permit a general permitting condition. As mentioned previously in this 
document, the 2005 and 2015 OIG audits suggested that APHIS exercise 
greater and more coordinated oversight over field tests of GE 
organisms. APHIS identified regular reporting regarding actual release 
site coordinates and details of the release as a key means of 
exercising such oversight. Adding this reporting requirement as a 
general permitting condition will ensure that it is communicated to all 
responsible persons.
    Similarly, to respond to the recommendations of the 2015 OIG audit, 
APHIS would add a requirement as a general permitting condition that 
the responsible person must notify the Agency in writing if any 
activity associated with environmental release under permit will not be 
conducted. OIG recommended that APHIS implement improvements to track 
the status of all authorized test field locations in order to account 
for and sufficiently monitor all such locations and thereby prevent the 
inadvertent release of GE organisms into the environment. Thus, APHIS 
is proposing to require the submission of reports so APHIS knows the 
status and location of authorized field trials. Specifically, APHIS is 
proposing to require the submission of a report of no release to 
account for all approved test fields under an authorization. For 
example, APHIS may approve 50 test fields within various locations in 
the United States, but test field releases only occur in 30 of the 50 
approved locations. Thus, a report of no release would allow APHIS to 
account for the 20 other test fields. This will lead to efficient 
compliance oversight of the 30 test fields that have permitted 
releases. This general condition would work in tandem with the 
reporting requirement mentioned above, and help APHIS resolve what 
could otherwise be considered inconsistencies between the permit 
conditions and the regular reports.
    APHIS recognizes that some of these general permitting conditions 
pertain only to activities associated with

[[Page 26531]]

environmental release under permit of a GE organism. APHIS also 
recognizes that it is possible that certain permit applications may not 
include a request to release the organism into the environment. Where 
conditions apply to a specific activity, e.g., movement into the United 
States, movement interstate, or release into the environment, the 
appropriate condition will be acknowledged. However, the permit issued 
would still contain these general conditions to communicate to the 
responsible person APHIS' general requirements regarding environmental 
release of GE organisms under permit. This will ensure that, consistent 
with the recommendations of the OIG audits, all responsible persons are 
aware of those requirements. The conditions would also prove useful, 
should the responsible person subsequently request amendments to the 
permit to authorize environmental release.
    While the general permitting conditions that are currently in the 
regulations contain a condition that pertains to packing material used 
to transport the organism under permit, APHIS would not retain this as 
a general permitting condition. Instead, as discussed below, 
requirements for shipping under permit would be contained in paragraph 
(k) of Sec.  340.5.
    Conditions for denial of a permit application or withdrawal of an 
existing permit are contained in current Sec.  340.4(g). We are 
proposing to amend these conditions to make them clearer and provide 
additional protection against plant pest risks.
    Proposed Sec.  340.5(h)(1) lists circumstances under which a permit 
application may be denied. An application could be denied either orally 
or in writing. If the denial is oral, the Administrator will then 
communicate the denial and the reasons for it in writing as promptly as 
circumstances allow. A denial may occur when the Administrator 
concludes that, based on the application or additional information, the 
proposed actions, i.e., movements under permit, may result in the 
unauthorized release, spread, dispersal, and/or persistence of a GE 
organism in the environment. Such a situation would arise if we 
determined that the possibility of the unauthorized release would exist 
regardless of any permit conditions we could assign. A second cause for 
denial would be the failure of the responsible person or any agent of 
the responsible person to comply at any time with part 340 or any APHIS 
regulation pursuant to the PPA or with the conditions of any permit 
that has previously been issued in accordance with the regulations. A 
previous record of noncompliance would call into question the 
applicant's ability or willingness to abide by our permitting 
conditions. Finally, if all other application requirements are met, we 
would still decline to issue the permit if the applicant does not agree 
in writing to comply with the permit conditions we assign for movement 
of the organism or does not allow inspection, in accordance with the 
regulations, of the premises associated with the permit.
    Conditions for the withdrawal of permits would be contained in 
Sec.  340.5(h)(2). A permit could be withdrawn if, following issuance 
of the permit, the Administrator receives information that would 
otherwise have provided grounds for APHIS to deny the permit 
application; if the Administrator determines that actions taken under 
the permit have resulted in the unauthorized release, spread, 
dispersal, and/or persistence in the environment of a GE organism; or 
if the Administrator determines that the responsible person or any 
agent of the responsible person has failed to comply at any time with 
the regulations in part 340, any other regulations pursuant to the PPA, 
or any permit conditions. The first two of these proposed conditions 
are new. They would provide additional protections against plant pest 
risks that may be associated with the movement of GE organisms under 
permit. Failure to comply with permit conditions is grounds for 
withdrawal under the current regulations, but we would provide 
additional protection against plant pest risks by broadening the 
provision to include failure to comply with any APHIS regulation as 
well.
    Under proposed Sec.  340.5(h), the Administrator would communicate 
the denial or withdrawal and the reasons for it in writing as soon as 
circumstances allow.
    Proposed Sec.  340.5(i) would retain the current procedures for 
appealing the denial of a permit application or withdrawal of a permit, 
with one modification. Any person whose permit application has been 
denied or whose permit has been withdrawn could appeal the decision in 
writing or electronically to the Administrator. Under the current 
regulations, the appeal must be submitted within 10 days after the 
applicant receives the written notification of the denial or withdrawal 
and must state all of the facts and reasons that, in the view of the 
applicant, demonstrate that the permit was wrongfully denied or 
withdrawn. The Administrator grants or denies 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 is 
held to resolve the conflict. Under this proposed rule, we would 
require an acknowledgment by the applicant of the denial or withdrawal 
within 10 days after receiving the written notification, along with a 
statement of the applicant's intent to appeal. The proposed change is 
intended to allow the applicant adequate time to gather the necessary 
information and prepare the appeal.
    APHIS is also proposing to clarify in Sec.  340.5(j) of the 
regulations the procedure to be used when amendment of existing permit 
conditions is sought by the responsible person or required by APHIS. In 
the current regulations, the administrative practices that APHIS uses 
to amend permits are not stated explicitly. Adding them to the 
regulations would provide increased transparency and efficiency.
    Proposed paragraph (j)(1) would state that if a responsible person 
determines that circumstances have changed since the permit was issued, 
he or she may contact APHIS directly and request an amendment or 
amendments. Supporting information may need to be submitted to justify 
the request. APHIS may amend the permit if only minor changes are 
needed. Requests for more substantive changes may require a new permit 
application. Prior to issuance of an amended permit, the responsible 
person or his or her agent(s) will be required to agree in writing to 
comply with the conditions of amended permit. If the responsible person 
does not agree to the conditions, the amendment will be denied.
    APHIS may also initiate amendments to permits and permit conditions 
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 would provide notice to the responsible 
person of the amendment(s) and, as soon as circumstances allow, the 
reasons for it. The responsible person and his or her agents would have 
to agree in writing to comply with the new conditions before APHIS 
would issue the amended permit. Failure to provide such an agreement 
may result in the withdrawal of an existing permit.
    Section 340.8 of the current regulations lists container 
requirements for the shipping of regulated articles, i.e., shipping 
under permit. These requirements are very prescriptive. While they do 
allow a responsible person to request variances from the requirements, 
this request process, by its nature, results in a case-by-case 
determination of whether other types of

[[Page 26532]]

containers are acceptable for the transportation of the organism. The 
current regulations also do not clearly reflect the performance-based 
standard that APHIS used to develop the requirements, which was that 
the container should be sufficient to prevent dissemination of a GE 
organism during movement under permit.
    Proposed paragraph (k) of Sec.  340.5 would update the requirements 
for shipping under permit to resolve the issues discussed above.
    Paragraph (k)(1) would state that shipping containers or means of 
conveyance would have to meet the standards listed under our proposed 
definition of secure shipment, i.e., would have to be of sufficient 
strength and integrity to withstand leakage of contents, shocks, 
pressure changes, and other conditions incident to ordinary handling in 
transportation. These requirements would make the performance standard 
referred to above more explicit in the regulations than it is now, 
while at the same time making the requirements less prescriptive, thus 
eliminating the need for a request process for variances.
    In that paragraph, we would also retain a provision from the 
current regulations, currently a footnote to Sec.  340.8, that 
specifies that all organisms shipped under permit must be shipped in 
accordance with the regulations in 49 CFR part 178. Those regulations, 
which are administered by the Department of Transportation (DOT), 
provide packaging requirements for materials, including organisms that 
DOT has designated as hazardous materials.
    Paragraph (k)(2) would state that the container would have to be 
accompanied by a document that included the names and contact details 
for both the sender and the recipient. These details are essential for 
purposes of enforcement.
    Paragraph (k)(3) would list container-labeling and documentation 
requirements for GE organisms imported under permit into the United 
States. These requirements are currently found in Sec.  340.7 and would 
not be changed.
    Finally, paragraph (k)(4) would state that following the completion 
of the shipment, all packing material, shipping containers, and any 
other material accompanying the organism would have to be treated or 
disposed of in such a manner so as to prevent the unauthorized 
dissemination and establishment of the organism. This requirement is 
currently a general permitting condition, but could more accurately be 
described as a shipping requirement.
    APHIS currently authorizes a small number of permits for commercial 
production. APHIS has occasionally received inquiries from stakeholders 
regarding whether a permit could authorize the commercial distribution 
of an organism subject to the regulations. Currently, most developers 
of GE organisms do not commercialize their products until after those 
products are granted a determination of nonregulated status. However, 
APHIS does not prohibit commercializing GE organisms that have not been 
granted a determination of nonregulated status.
    Under the proposed regulations, there may be some GE organisms that 
an entity wishes to commercialize or grow on a large scale, under 
permit. As it does currently, APHIS would evaluate these permit 
applications on a case-by-case basis to determine whether permitting 
conditions can be developed that adequately address the risk associated 
with the organism.
    The current regulations in Sec.  340.4(h) provide APHIS with the 
ability to issue courtesy permits in order to facilitate the movement 
of GE organisms that are not subject to the regulations in part 340 but 
whose movement might otherwise be hindered because of their similarity 
to organisms or articles that are regulated by other APHIS programs. 
APHIS commits significant resources to the issuance of these courtesy 
permits.
    Courtesy permits have been part of the regulations since their 
inception in 1987, and have been useful to inform shippers and State 
and Federal inspectors not yet fully familiar with requirements for GE 
organisms that the shipments in question were not regulated. However, 
their continued use has led to the widespread misunderstanding by some 
researchers that courtesy permits are actually required for the 
movement of certain organisms or that issuance of a courtesy permit 
removes the requirement for applicants to follow other applicable 
regulations, such as the plant pest regulations found in 7 CFR part 
330. This confusion partially stems from the similarities between the 
application form for courtesy permits and those for other types of 
permits, as well as between the courtesy permit itself and other 
permits. Therefore, in an effort to alleviate confusion and to better 
focus and allocate APHIS resources, APHIS would no longer issue 
courtesy permits. It has been common APHIS practice to facilitate the 
importation of nonregulated articles through the use of letters 
indicating that no permit is required; under the proposed regulations, 
APHIS would move to this approach. APHIS would continue to work with 
researchers and relevant government regulatory officials to facilitate 
the transition.

Record Retention, Compliance, and Enforcement

    APHIS is proposing to consolidate all record retention, compliance, 
and enforcement requirements in part 340 into a new Sec.  340.6. APHIS 
is also proposing to strengthen these provisions in order to manage 
compliance with the regulations more efficiently, to augment the 
approaches used to prevent or remediate plant pest risks, and to 
utilize appropriate enforcement strategies. These proposed regulatory 
changes also reflect certain provisions of the 2008 Farm Bill and align 
with recommendations of the 2005 and 2015 OIG audits.
    The current regulations require a responsible person to retain for 
1 year records demonstrating that an organism that was imported or 
moved interstate under a permit arrived at its intended destination but 
contain no record-retention requirements related to environmental 
release of an organism under permit. While APHIS has frequently added 
this record retention requirement as a permitting condition, both the 
2005 and 2015 OIG audits and the 2008 Farm Bill recommended that the 
Agency specify the retention requirement in the regulations themselves. 
These recommendations have been corroborated by the Agency's own 
experience administering the regulations.
    Proposed Sec.  340.6(a) would require that a responsible person and 
his or her agent(s) would have to establish and keep the following 
records and reports:
     All records and reports required as a condition of a 
permit;
     Addresses and any other information, e.g., GPS coordinates 
and maps, needed to identify all locations where the organism under 
permit was stored or used, including all contained facilities and 
environmental release locations;
     A copy of the APHIS permit authorizing the permitted 
activity; and
     Legible copies of contracts between the responsible person 
and all agents that conduct activities subject to the regulations for 
the responsible person and copies and documents relating to agreements 
made without a written contract.
    We are proposing these requirements for compliance assurance, 
evaluation, and enforcement purposes, including fact findings and 
investigations into the possible unauthorized environmental release of 
a GE organism subject to permitting or its escape from a

[[Page 26533]]

containment facility. A thorough record of activities taken under the 
permit is necessary in order for APHIS to assess compliance and 
determine whether enforcement actions are needed.
    Proposed paragraph (b) of Sec.  340.6 lists requirements for record 
retention. Records indicating that an organism that was imported or 
moved interstate under permit reached its intended destination would 
have to be retained for at least 2 years. The current requirement is 1 
year. In the event that there is uncertainty regarding whether the 
organism arrived at this location, it may take APHIS more than 1 year 
to investigate the matter.
    All other records related to the permit would have to be retained 
for 5 years following permit expiration, unless the Administrator 
determines that a longer time period is appropriate and documents that 
determination in the supplemental conditions of the permit.
    APHIS recognizes that, in practice, our proposed requirements would 
require most records associated with activities conducted under permit 
to be retained for 5 years (or longer), and that this is a significant 
duration to retain a potentially substantial number of records 
pertaining to permit activities, especially for a researcher or small 
company. However, retaining documents for less than 5 years may impede 
fact findings and investigations into possible compliance infractions. 
In conducting such investigations, APHIS has found it necessary to 
obtain information from field trials conducted up to 5 years prior to 
an investigation. In instances in which the information was not 
available, APHIS' ability to do an expeditious and thorough 
investigation was adversely impacted.
    The Agency requests specific public comment regarding whether a 
shorter duration is warranted for certain records pertaining to permit 
activities and which activities these may be. Additionally, APHIS 
requests comment on any alternate means that stakeholders may identify 
for the Agency to obtain necessary information from developers in the 
event of a fact finding or an investigation of possible regulatory 
noncompliance.
    Proposed paragraph (c) of Sec.  340.6 would state that responsible 
persons and their agents must comply with the proposed regulations. 
Failure to comply with the regulations could result in any or all of 
the following: Denial of a permit application or withdrawal of a 
permit, application of remedial measures in accordance with the PPA, 
and criminal or civil penalties in accordance with the PPA.
    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. APHIS typically issues an Emergency Action 
Notification or administrative order to the owner of the organism to 
specify these remedial measures.
    If APHIS intends to issue a civil penalty, the Agency may enter 
into a stipulation prior to issuance of the complaint seeking the 
penalty. Our regulations regarding such stipulations are located in 7 
CFR 380.10.
    Proposed paragraph (d) of Sec.  340.6 would specify that for 
purposes of enforcing the regulations, 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. We would note, however, 
that in enforcing the regulations, we will take the least drastic 
action that is commensurate with the mitigating factors of the 
noncompliance. It is expected, therefore, that major and/or repeated 
infractions would be dealt with more harshly than minor ones.

Confidential Business Information

    The current regulations contain requirements pertaining to CBI in 
various sections. APHIS is proposing to consolidate these requirements 
for protecting CBI into a single section, Sec.  340.7, thereby making 
it easier for interested persons to find the necessary information. 
Under proposed Sec.  340.7, 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 CBI must 
justify how each piece of information requested to be treated as CBI is 
a trade secret or is commercial or financial information and is 
privileged or confidential. As noted earlier, in order to facilitate 
APHIS' transparent regulatory approach, a general description of the 
plant-trait-MOA combination will not be eligible for CBI designation. 
Certain technical information, however, such as GPS location data, or 
data that could be used to recreate an organism, may be deemed as CBI 
under existing statutory authorities.

Costs and Charges

    Proposed Sec.  340.8 would contain APHIS' requirements regarding 
costs and charges for the services of inspector, which are found in the 
current regulations in Sec.  340.9. Currently, the section provides 
that the services of an inspector during regularly assigned hours of 
duty are provided free of charge, but that APHIS will not be 
responsible for any other costs or charges incident to inspections or 
compliance, apart from the services of this inspector. These provisions 
would remain unchanged in this proposed rule.

Miscellaneous

    Because, as described above, we are proposing to eliminate the 
notification procedure from these regulations, we would also remove 
language pertaining to notifications from 7 CFR 372.5(c)(3)(iii). 
Because we are proposing to eliminate petitions for determinations of 
nonregulated status, we are also removing language pertaining to that 
process in paragraphs (b)(7) and (c)(4) of Sec.  372.5. These changes 
would make those regulations consistent with the proposed ones 
contained in this document.

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with the 
revision of our regulations regarding the movement of certain GE 
organisms, APHIS has prepared a programmatic environmental impact 
statement (PEIS). The PEIS was prepared in accordance with: (1) The 
National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 
4321 et seq.), (2) regulations of the Council on Environmental Quality 
for implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) 
APHIS' NEPA Implementing Procedures (7 CFR part 372). The PEIS may be 
viewed on the Regulations.gov website or in our reading room. (A link 
to Regulations.gov and information on the location and hours of the 
reading room are provided under the heading ADDRESSES at the beginning 
of this proposed rule.) In addition, copies may be obtained by calling 
or writing to the individual listed under FOR FURTHER INFORMATION 
CONTACT.

Executive Orders 12866, 13563, and 13771 and Regulatory Flexibility Act

    This proposed rule has been determined to be significant for the 
purposes of Executive Order 12866 and,

[[Page 26534]]

therefore, has been reviewed by the Office of Management and Budget. 
This proposed rule, if finalized as proposed, is expected to be an 
Executive Order 13771 deregulatory action. Details on the estimated 
cost savings of this proposed rule can be found in the rule's economic 
analysis.
    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). 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 an initial 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 by 
contacting the person listed under FOR FURTHER INFORMATION CONTACT or 
on the Regulations.gov website (see ADDRESSES above for instructions 
for accessing Regulations.gov).
    We are proposing to revise our regulations regarding the movement 
of certain genetically engineered organisms in response to advances in 
genetic engineering and our understanding of the plant pest risk posed 
by them, thereby reducing regulatory burden for developers of organisms 
that are unlikely to pose plant pest risks. The proposed rule would 
provide a clear, predictable, and efficient regulatory pathway for 
innovators, facilitating the development of new and novel genetically 
engineered organisms that are unlikely to pose plant pest risks.
    The proposed regulations would benefit developers, producers, and 
consumers of certain GE organisms, public and private research 
entities, and the Agency. There would not be any decrease in the level 
of protection provided against plant pest risks. The regulatory 
framework, including the regulatory status review process used to 
determine regulatory status of GE plants, established under the 
proposed rule would provide cost savings to the biotechnology industry 
and allow APHIS to allocate its resources more effectively than it can 
under the present regulations.
    Under the proposed rule, APHIS regulatory oversight (through 
permitting) would not be required for GE plants that fall into an 
exempted category or have been assessed by means of a regulatory status 
review and found unlikely to pose plant pest risks. Direct regulatory 
costs to GE plant developers would be reduced for the development of GE 
plants for which permits are no longer necessary. Savings to the 
regulated community would 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 would be reduced 
or eliminated where 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, 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 proposed rule could range 
from $1.5 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 $538,000 to $924,000 ($730,600 on average). 
From 1993 through 2017, 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 12 in 1995. As the rule is expected to spur 
innovation, we expect the number of new organisms developed annually to 
increase over time. In particular, the proposed rule may provide 
impetus to the development of new horticultural varieties, where the 
costs of acquiring non-regulated status may have been high in the past 
relative to the potential market.
    In the following estimate of impacts, we use average cost savings 
per GE plant developed and assume the annual number of new GE organisms 
developed under the proposed rule without APHIS permits would range 
from 5 (the current annual average of processed petitions) to 10 (twice 
this average). We further assume that about 20 percent of those new GE 
organisms would have required only APHIS oversight, and the remaining 
would still require FDA and/or EPA oversight. If 5 new GE plants are 
developed annually without APHIS permits (all with no APHIS permit, but 
4 still with EPA and/or FDA evaluation), the annual savings would be 
$6.5 million.\13\ 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 would be $13.0 million.\14\
---------------------------------------------------------------------------

    \13\ One x $3,560,245 = $3,560,245. Four x $730,600 = 
$2,922,400. $3,560,245 + $2,922,400 = $6,482,645.
    \14\ Two x $3,560,245 = $7,120,490. Eight x $730,600 = 
$5,844,800. $7,120,490 + $5,844,800 = $12,965,290.
---------------------------------------------------------------------------

    There would be some new costs borne by regulated entities under the 
proposed rule pertaining to rule familiarization and recordkeeping. 
Annual recordkeeping costs are based on information collection 
categories in the paperwork burden section of the rule and are 
estimated would total about $714,000. About 1,100 distinct entities 
have applied for permits or notifications under part 340. APHIS 
estimates that those entities would spend about 8 hours becoming 
familiar with the provisions of this rule at a total one-time cost of 
about $576,000.
    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 $9 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 those GE 
activities that would be affected by the proposed rule total about $3.5 
million. These include compliance activities, inspection activities, 
AIR process activities, notification activities, permit activities, and 
petition activities. Under the proposed rule, APHIS' overall annual 
personnel costs of regulating GE organisms are not expected to change. 
While the volume of specific activities would change, the overall 
volume of regulatory activities, the general nature of those activities 
and level of skill necessary to perform those activities would not. 
There would be costs to APHIS of implementing the proposed rule, which 
would include outreach activities, developing guidance documents, 
training, and adjusting the current permit system. APHIS estimates that 
the public outreach, guidance and training would cost about $77,000. 
Requests for regulatory status and response letters under the proposed 
rule could be handled in a manner similar to the current AIR process 
outside the electronic permitting system without incurring new costs.
    PMPIs are plants genetically engineered in order to produce 
pharmaceutical and industrial compounds. There is a likelihood that

[[Page 26535]]

most, if not all, GE PMPI-producing plants that are currently under 
APHIS permits could be determined to be not regulated under the 
provisions of the proposed regulations after a regulatory status review 
because they are unlikely to pose a plant pest risk. Thus, such plants 
could be grown outdoors without the need for permits and without APHIS 
oversight. Federal oversight of outdoor plantings of PMPI-producing 
plants could be necessary to prevent the unlawful introduction into the 
human or animal food supply of pharmaceutical or industrial PMPI 
products, even when the principal purpose of the plants is not for 
human or animal food use. APHIS estimates that current PMPI inspections 
cost roughly $26,000 in total annually or about $800 each on average. 
Assuming that oversight continues in the same manner as APHIS 
oversight, a similar government expenditure could be expected under any 
Federal PMPI oversight scenario.
    PIPs are plants that are genetically engineered to produce plant-
incorporated protectants, i.e., pesticides. APHIS regulates those that 
are captured by our current regulations, i.e., when plant pests are 
used. PIPs also fall under the regulatory oversight of EPA. However, 
currently only APHIS exercises regulatory oversight of PIP plantings on 
10 acres or less of land. Many GE PIP-producing plants that are 
currently regulated under APHIS permits or notifications could be 
determined not regulated under the provisions of the proposed 
regulations after a regulatory status review because they are unlikely 
to pose plant pest risks. Thus, such plants could be grown outdoors 
without the need for an APHIS permit and without undergoing APHIS 
oversight. This proposal would shift Federal oversight of small-scale 
(10 or fewer acres) outdoor plantings of some PIPs to EPA. EPA may 
decide to require experimental use permits for all, some, or none of 
such PIPs, and may conduct inspections of all, some, or none of those 
PIPs under permit. As described above, current inspection costs 
incurred by APHIS average roughly $800 per inspection.
    A quicker APHIS evaluation process and related reduction to 
regulatory uncertainty may facilitate small companies' ability to raise 
venture capital. Reduced regulatory requirements may also lead to 
greater participation by the public and private academic institutions 
in GE research and product development. These indirect benefits of the 
proposed rule may spur GE innovations, particularly in small acreage 
crops where genetic engineering has not been widely utilized due to the 
expense of regulation.
    GE crop varieties, in general, are not required to be reviewed or 
approved for safety by the FDA before going to market. However, the 
developer is responsible for ensuring product safety, and some 
developers consider voluntary consultations with FDA on food safety to 
be an absolute necessity for applicable GE products.\15\ It would be in 
a GE plant developer's own best interest to maintain the same level of 
supervision and control over the development process as at present to 
prevent undesired cross-pollination or commingling with non-GE crops. 
Developers also have various legal, quality control and marketing 
motivations to maintain rigorous voluntary stewardship measures. APHIS 
therefore believes that developers would continue to utilize such 
measures for field testing even in cases where USDA would not require a 
permit.
---------------------------------------------------------------------------

    \15\ Genetically Engineered Crops: Past Experience and Future 
Prospects. Committee on Genetically Engineered Crops: Past 
Experience and Future Prospects; Board on Agriculture and Natural 
Resources; Division on Earth and Life Studies; National Academies of 
Sciences, Engineering, and Medicine.
---------------------------------------------------------------------------

    Farmers who adopt GE crops may benefit from the proposed rule. The 
adoption of GE crops in the United States has generally reduced costs 
and improved profitability at the farm level. As mentioned, under the 
proposed rule, regulatory costs are expected to be lower, thereby 
potentially spurring developer innovation, especially among small 
companies and universities. Farmers may benefit by having access to a 
wider variety of traits as well as a greater number of new GE crop 
species, affording them a broader selection of crops to suit their 
particular management needs. 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.
    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 otherwise would have 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 foregone benefits stemming from 
even a relatively brief delay in product release overshadow both 
research and regulatory costs. It should be noted that while the 
proposed rule would alter the evaluation process of GE plants for 
APHIS, it does not affect the evaluation by FDA or EPA, which operate 
under different authorities and evaluate for different endpoints, or 
international regulatory agencies, all of whom would have impact 
opportunity costs. When FDA and/or EPA also have a regulatory role, 
time savings would only be realized in those instances in which APHIS' 
process takes the longest time. When APHIS is the only agency with 
oversight, such as for some new horticultural varieties, there could be 
significant time savings over the current petition process.
    Some farmers (e.g., growers of organic and or identity-preserved 
crops) could be indirectly negatively impacted by these same 
innovations. Some consumers choose not to purchase products derived 
from GE crops and instead purchase commodities such as those labeled 
``non-GMO (Genetically Modified Organism)'' or organic. In addition, 
the organic standard does not allow for the use of GE seeds. When crops 
intended for the non-GE or identity-preserved marketplace contain 
unintended GE products, the profitability of the non-GE or identity-
preserved product may be diminished. Effects of the proposed 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 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. 
Unauthorized releases of regulated GE crop plants and the entry of 
regulated plant material in the commercial food and feed supply can 
have impacts on domestic or international markets. While such releases 
have occurred and may occur again, such incidents are expected to be 
rare.
    Entities potentially affected by the proposed rule fall under 
various categories of the North American Industry Classification 
System. While economic data are not available on business size for some 
entities, 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 proposed rule would be small.

[[Page 26536]]

APHIS welcomes public comment on the proposed rule's possible impacts. 
The following table provides a summary statement of the expected direct 
costs and cost savings of the proposed rule:

Table 1--Expected Costs and Costs Savings of the Proposed Rule for the Biotechnology Industry and for USDA, 2016
                                                     dollars
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
Entity:
    Biotechnology Industry...........                               Costs ($1,000).
    Developer costs (recordkeeping                                       1,290.
     and rule familiarization) \1\.
----------------------------------------------------------------------------------------------------------------
                                                            Cost savings per Trait ($1,000)
----------------------------------------------------------------------------------------------------------------
Developer Savings \2\                                                         Proposed Rule,      Proposed Rule,
                                                                                 lower bound         upper bound
----------------------------------------------------------------------------------------------------------------
USDA sole regulatory agency..........                                                 -1,546              -5,574
USDA with FDA and/or EPA oversight...                                                   -538                -924
----------------------------------------------------------------------------------------------------------------
APHIS Biotechnology Regulatory                                      Costs ($1,000).
 Services.
Costs for public outreach, training,                                      77.
 and e-permitting \3\.
----------------------------------------------------------------------------------------------------------------
\1\ Costs of rule familiarization, one-time costs, would total about $576,000. Annual recordkeeping costs would
  total about $714,000.
\2\ These savings are shown on a per trait basis. On average, if 5 new GE organisms are developed annually
  without USDA permits (all with no USDA permit, but 4 still with EPA and/or FDA evaluation), the annual savings
  would be $6.5 million. If 10 new GE organisms are developed annually without USDA permits (all with no USDA
  permit, but 8 still with EPA and/or FDA evaluation), the annual savings would be $13.0 million.
\3\ Requests for regulatory status and response letters under the proposed rule could be handled in a manner
  similar to the current `Am I Regulated' process outside the electronic permitting system without incurring new
  costs.

    As shown in the economic analysis accompanying this proposed rule, 
we have some data pertaining to the potential effects of this proposed 
rule on small entities; however, we do not currently have all of the 
data necessary for a comprehensive analysis of those potential effects. 
Therefore, we are inviting comments on the potential effects. In 
particular, we are interested in additional information on the number 
and kind of small entities that may incur benefits or costs from the 
implementation of this proposed rule.

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 proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are inconsistent with this rule 
will be preempted; (2) no retroactive effect will be given to this 
rule; and (3) administrative proceedings will not be required before 
parties may file suit in court challenging this rule.

Executive Order 13175

    This rule has been reviewed in accordance with the requirements of 
Executive Order 13175, ``Consultation and Coordination with Indian 
Tribal Governments.'' Executive Order 13175 requires Federal agencies 
to consult and coordinate with Tribes on a government-to-government 
basis on policies that have Tribal implications, including regulations, 
legislative comments or proposed legislation, and other policy 
statements that have substantial direct effects on one or more Indian 
Tribes, on the relationship between the Federal Government and Indian 
Tribes, or on the distribution of power and responsibilities between 
the Federal Government and Indian Tribes.
    The Animal and Plant Health Inspection Service has assessed the 
impact of this rule on Indian Tribes. APHIS sent a letter to Tribal 
leaders upon publication of a notice of intent to conduct a 
programmatic environmental impact statement in support of the proposed 
rule. In addition, APHIS held a conference call for Tribal leaders to 
provide information and answer questions regarding our plan to publish 
a proposed rule.
    In an email dated December 21, 2018, one California Tribe contacted 
APHIS requesting consultation on the proposed rule. This request has 
led USDA's Office of Tribal Relations (OTR) to determine that the rule 
has potential tribal implications that require continued outreach 
efforts to determine if tribal consultation under Executive Order 13175 
is required. As of February 2019, APHIS is following up with that Tribe 
to determine whether formal consultation is warranted or needed. If 
this or another tribe requests formal 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.), reporting and recordkeeping 
requirements included in this proposed rule have been submitted for 
approval to the Office of Management and Budget (OMB). Please send 
comments on the Information Collection Request (ICR) to OMB's Office of 
Information and Regulatory Affairs via email to 
[email protected], Attention: Desk Officer for APHIS, 
Washington, DC 20503. Please state that your comments refer to Docket 
No. APHIS-2018-0034. Please send a copy of your comments to the USDA 
using one of the methods described under ADDRESSES at the beginning of 
this document.
    We are proposing to revise our regulations regarding the movement 
(importation, interstate movement, and environmental release) of 
certain GE organisms. The proposed revisions include, but are not 
limited to, the following new information collection activities: 
Requests for confirmation from APHIS of developers' self-determinations 
that the GE plant is not within the scope of part 340, procedures for 
permits and record reporting, marking and labeling of organisms under 
permit, State and Tribal regulatory officials' review of permit 
applications, regulatory status reviews, and recordkeeping. In 
addition, the proposed revisions would remove the current petition 
process for

[[Page 26537]]

nonregulated status and associated burdens.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public burden for this collection of 
information is estimated to average 17.73 hours per response.
    Respondents: Businesses and State and Tribal regulatory officials.
    Estimated annual number of respondents: 321.
    Estimated annual number of responses per respondent: 3.
    Estimated annual number of responses: 1,097.
    Estimated total annual burden on respondents: 19,453 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    A copy of the information collection may be viewed on the 
Regulations.gov website or in our reading room. (A link to 
Regulations.gov and information on the location and hours of the 
reading room are provided under the heading ADDRESSES at the beginning 
of this proposed rule.) Copies can also be obtained from Ms. Kimberly 
Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483. 
APHIS will respond to any ICR-related comments in the final rule. All 
comments will also become a matter of public record.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the EGovernment 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 proposed rule, please contact Ms. Kimberly 
Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.

List of Subjects

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 proposing to amend 7 CFR parts 340 and 372 as 
follows:

0
1. 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 genetically 
engineered (GE) organisms described in Sec.  340.2.
    (b) The regulations in this part do not apply to plants modified 
such that they belong to one of the categories listed below:
    (1) The genetic modification is solely a deletion of any size; or
    (2) The genetic modification is a single base pair substitution; or
    (3) The genetic modification is solely introducing nucleic acid 
sequences from within the plant's natural gene pool or from editing of 
nucleic acid sequences in a plant to correspond to a sequence known to 
occur in that plant's natural gene pool; or
    (4) The plant is an offspring of a GE plant that does not retain 
the genetic modification in the parent.
    (c) The regulations in this part do not apply to a GE plant-trait-
mechanism of action 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.
    (d) Developers may request confirmation from APHIS that the plant 
is not within the scope of this part.


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
    (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.


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 ensure compliance with 
all conditions contained in any applicable permit 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.

[[Page 26538]]

    Animal and Plant Health Inspection Service (APHIS). An agency of 
the United States Department of Agriculture.
    Article. Any material or tangible object that could harbor plant 
pests or noxious weeds.
    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, 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.
    Genetic engineering (GE). Techniques that use recombinant or 
synthetic 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 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, Guam, the Virgin Islands of the United 
States, or any other territory or possession of the United States.
    Mechanism of action. 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 possibility of harm to plants resulting from 
introducing or disseminating a plant pest or exacerbating the impact of 
a plant pest.
    Plant product. Any flower, fruit, vegetable, root, bulb, seed, or 
other plant part that is not included in the definition of plant or 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 a 
GE organism outside the physical constraints of a contained facility.
    Responsible person. The person responsible for maintaining control 
over a GE organism under permit during its movement and ensuring 
compliance with all conditions contained in any applicable permit as 
well as other requirements in this part. A responsible person may be, 
but is not limited to, the signatory of a permit, or the institution 
the signatory represents at the time of application. A responsible 
person must be at least 18 years of age and 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, the Virgin Islands of the United 
States, or 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 an Agency 
regulatory status review of whether a GE plant is subject to the 
regulations in this part, based on its plant-trait-mechanism of action 
combination.
    (2) Any person may request re-review of a GE plant previously found 
to be subject to this part, 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 this 
paragraph. Additional guidance on how to meet these requirements may be 
found on the APHIS website.
    (i) A description of the comparator plant, 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.
    (b)(1) When APHIS receives a request for a regulatory status review 
of a GE plant, the Agency 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 that of the plant pest risk posed by their respective non-GE or 
other appropriate comparator(s), based on the following factors:
    (i) The biology of the comparator plant and its sexually compatible 
relatives;
    (ii) The trait and mechanism-of-action of the modification(s); and
    (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;

[[Page 26539]]

    (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) If the Agency is unable to identify potential plant pest risks 
in the initial review, the GE plant will not be subject to the 
regulations in this part, and APHIS will post the finding on its 
website.
    (3)(i) If the Agency does identify potential plant pest risks in 
the initial review, APHIS will conduct a more robust evaluation of the 
factor(s) of concern to determine the likelihood and consequence of the 
potential plant pest risk posed by the GE plant.
    (ii) APHIS will make available information on the results of both 
the initial review and one conducted pursuant to this paragraph in a 
notice in the Federal Register and will take comments on its findings 
from the public. After reviewing the comments, APHIS will make a final 
determination regarding the regulatory status of the GE plant and 
announce that determination in a subsequent Federal Register notice.
    (iii) If the GE plant is found unlikely to pose a plant pest risk 
and, therefore, not to require regulation under this part, APHIS will 
post the finding on its website.
    (iv) If APHIS is unable to find the GE plant unlikely to pose a 
pest risk it will require regulation under this part and its movement 
will be allowed only under permit in accordance with Sec.  340.5.
    (c) APHIS will maintain on its website information on all requests 
for and results of regulatory status reviews.


Sec.  340.5  Permits.

    (a) Permit issuance. A permit must be issued by APHIS for the 
movement of all GE organisms subject to the regulations under this 
part.
    (b) Permit application requirements and permitting exemptions. The 
responsible person must apply for and obtain a permit through a method 
listed on APHIS' website. The application must also include the 
following information:
    (1) General information requirements. All permit applications must 
include the name, title, and contact information of the responsible 
person and agent; the country and locality where the organism was 
collected, developed, manufactured, reared, cultivated, or cultured; 
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.
    (2) Permits for interstate movement or importation. Applications 
for permits for interstate movement or importation of GE organisms must 
meet the requirements of paragraph (b)(1) of this section and 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 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) Permits for release into the environment. Applications for 
permits for release of GE organisms into the environment must meet the 
requirements of paragraph (b)(1) of this section and include 
information on the size of all proposed environmental release sites, 
including area, geographic 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 continue the 
practice of evaluating and amending permits to add new release sites.
    (4) Additional information. APHIS will require additional 
information as needed.
    (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 cloned genetic material is stably 
integrated into the plant genome, and the cloned material does not 
include the complete infectious genome of a plant pest.
    (d) Exemption for GE disarmed Agrobacterium tumefaciens. A permit 
for interstate movement is not required for GE disarmed Agrobacterium 
tumefaciens, provided that it is moved as a secure shipment, the cloned 
genetic material is stably integrated into the genome, and the cloned 
material does not include the complete infectious genome of a plant 
pest.
    (e) Exemption for certain microbial pesticides. A permit is not 
required for any GE microorganism that is currently registered with the 
Environmental Protection Agency as a microbial pesticide so long as it 
is not a plant pest as defined in Sec.  340.3.
    (f) Administrative actions--(1) Review of permit applications. 
APHIS will review the permit application to determine if it is 
complete. APHIS will notify the applicant orally or in writing if the 
application is incomplete, and the applicant will be 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 in accordance with paragraph (h) of this section.
    (2) APHIS assignment of permit conditions. If a permit application 
is approved, the Administrator will issue a permit with conditions as 
described in paragraph (g) 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.
    (g) Permit conditions. The standard conditions listed in this 
paragraph 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. The responsible 
person, and his or her agents, must ensure compliance with

[[Page 26540]]

these conditions, as well as any supplemental conditions listed in the 
permit:
    (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 only be done 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 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 
(photocopying, digital reproduction, etc.). The responsible person must 
submit reports and notices to APHIS at the times specified in the 
permit and containing the information specified within 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.
    (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 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.
    (h) 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 the denial and the reasons for it 
in writing as promptly as circumstances allow. The Administrator may 
deny a permit application if:
    (i) The Administrator concludes that, based on the application or 
on additional information, 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 at any time 
with any provision of this part, any permit that has previously been 
issued in accordance with this part or any other regulations issued 
pursuant to the Plant Protection Act, 7 U.S.C. 7701 et seq.;
    (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 (f)(2) of this section, to comply with the permit 
conditions or, in accordance with paragraph (f)(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 the withdrawal 
and the reasons for it in writing as promptly as circumstances allow. 
The Administrator may withdraw a permit if:
    (i) Following issuance of the permit, the Administrator receives 
information that would otherwise have provided grounds for APHIS to 
deny the 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 provision of this part or 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.
    (i) 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. 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.
    (j) 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, he or she 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 may amend the permit if only minor changes are 
necessary. Requests for more substantive changes may 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.

[[Page 26541]]

    (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. 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.
    (k) Shipping under a permit. (1) All shipments of organisms under 
permit must be secure shipments. Organisms under permit must also 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 and locality where collected, 
developed, manufactured, reared, cultivated, or cultured; 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 packing material, 
shipping containers, and any other material accompanying the organism 
must be treated or disposed of in such a manner so as to prevent its 
unauthorized dissemination and establishment in the environment.


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(g);
    (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 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 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(h);
    (ii) Application of remedial measures in accordance with the Plant 
Protection Act, 7 U.S.C. 7701 et seq.; and
    (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.


Sec.  340.7  Confidential business information.

    Persons including confidential business information 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 is commercial or financial information and 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 without cost.\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.
---------------------------------------------------------------------------

    \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
2. 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
3. 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 30th day of May 2019.
Greg Ibach,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2019-11704 Filed 6-5-19; 8:45 am]
 BILLING CODE 3410-34-P