[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Proposed Rules]
[Pages 7008-7039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00858]



[[Page 7007]]

Vol. 82

Thursday,

No. 12

January 19, 2017

Part VI





Department of Agriculture





-----------------------------------------------------------------------





Animal and Plant Health Inspection Service





-----------------------------------------------------------------------





7 CFR Parts 340





Importation, Interstate Movement, and Environmental Release of Certain 
Genetically Engineered Organisms; Proposed Rule

  Federal Register / Vol. 82 , No. 12 / Thursday, January 19, 2017 / 
Proposed Rules  

[[Page 7008]]


-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 340

[Docket No. APHIS-2015-0057]
RIN 0579-AE15


Importation, Interstate Movement, and Environmental Release of 
Certain Genetically Engineered Organisms

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: APHIS is proposing to revise its regulations regarding the 
importation, interstate movement, and environmental release of certain 
genetically engineered organisms in order to update the regulations in 
response to advances in genetic engineering and understanding of the 
plant pest and noxious weed risk posed by genetically engineered (GE) 
organisms, thereby reducing burden for regulated entities whose 
organisms pose no plant pest or noxious weed risks. This would be the 
first comprehensive revision of the regulations since they were 
established in 1987.

DATES: We will consider all comments that we receive on or before May 
19, 2017.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0057.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2015-0057, 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-2015-
0057 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. Sidney Abel, Assistant Deputy 
Administrator, Biotechnology Regulatory Services, APHIS, 4700 River 
Road, Unit 147, Riverdale, MD 20737-1238; (301) 851-3896.

SUPPLEMENTARY INFORMATION: 

Background

Overview of the Current Regulations

    The Animal and Plant Health Inspection Service (APHIS) of the 
United States Department of Agriculture (USDA) administers 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). The current regulations govern the introduction 
(importation, interstate movement, or release into the environment) of 
certain genetically engineered (GE) organisms that are considered 
``regulated articles.''
    Under the current regulations, a GE organism is considered to be a 
regulated article if the donor organism, recipient organism, vector, or 
vector agent \1\ 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 
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.'' If a GE organism is a 
regulated article, in order for the organism to be imported into the 
United States, to be moved in interstate commerce, or to be released 
into the environment through a confined release (collectively referred 
to in the regulations as an ``introduction''), a permit must be issued 
or the movement or environmental release must occur under a 
notification procedure. The organism must also be moved in a container 
that meets certain regulatory requirements, and the container must be 
marked in accordance with the regulations.
---------------------------------------------------------------------------

    \1\ These terms are defined in Sec.  340.1 of the regulations.
---------------------------------------------------------------------------

    The regulations also provide a process to petition APHIS to 
determine that a GE organism is nonregulated. A determination of 
nonregulated status means that the regulated article is no longer 
subject to the regulations in 7 CFR part 340 and, therefore, there is 
no longer any authority for APHIS to require a permit or notification 
for the importation, interstate movement, or environmental release of 
the regulated article pursuant to 7 CFR part 340. Agency Actions 
Following Promulgation of the Current Regulations
    APHIS first issued these regulations in 1987 under the authority of 
the Federal Plant Pest Act of 1957 (FPPA) and the Plant Quarantine Act 
of 1912 (PQA), 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 permitting for 
certain microorganisms and Arabidopsis, to institute the notification, 
petition, and extension procedures referenced above, and to exclude 
plants engineered to produce industrial compounds from the notification 
process.
    Although, as discussed above, the current regulations have various 
functions, their primary function to date has been as a means for APHIS 
to authorize the importation, interstate movement, and introduction of 
certain GE organisms via the permit and notification procedures 
referred to above. Permits and notifications are collectively known as 
``authorizations.'' To date, APHIS has issued more than 18,000 
authorizations for the environmental release of GE organisms in 
multiple sites, primarily for research and development of improved crop 
varieties for agriculture. Additionally, APHIS has issued more than 
12,000 authorizations for the importation of GE organisms, and nearly 
12,000 authorizations for the interstate movement of GE organisms. 
APHIS has, to date, denied slightly more than 1,500 requests for 
permits or notifications, many of which were denied because APHIS 
ultimately decided the requests lacked sufficient information on which 
to base an Agency decision.
    For authorizations under notification, the regulations require the 
environmental release to meet performance-based standards set forth in 
the regulations. These include, among other things, that, when the 
regulated article is a plant and is to be used for environmental 
release, it must be planted in such a way that it is not inadvertently 
mixed with non-regulated plant material that is not part of the 
environmental release. In addition, the environmental release must be 
conducted such that the regulated article will not persist in the 
environment, and no offspring can be produced that could persist in the 
environment. This latter requirement is accomplished through various 
measures such as required minimum isolation distances from sexually 
compatible

[[Page 7009]]

plants, effective removal or devitalization of viable plant materials, 
and monitoring of release sites after completion of the tests and 
removal of any ``volunteer'' plants that are found. APHIS conducts 
inspections of authorized facilities or environmental release sites to 
evaluate compliance with the regulations.
    The interstate movement, importation, or environmental release of 
regulated articles may be authorized under permit 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 has 
been found out of compliance 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.
    In addition to issuing permits and authorizing notifications, APHIS 
has responded to petitions requesting nonregulated status under these 
regulations. Under this petition procedure, which is described in Sec.  
340.6, a petitioner must present detailed information and scientific 
data regarding the regulated article indicating why the article should 
not be regulated. To date, APHIS has granted 124 determinations of 
nonregulated status, of 159 submitted for APHIS review, and all of 
these determinations have been for GE plants (more information about 
these is posted at https://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml). Many of these plants are grown for 
agricultural production in the United States. APHIS determinations of 
nonregulated status apply to the GE plant(s) as well as their progeny, 
meaning the deregulated GE plant can be used in plant breeding programs 
and in agriculture without further oversight from APHIS.
Basis for the Proposed Rule
Advances in APHIS' Understanding of Genetically Engineered Organisms
    While the current regulations have been effective in ensuring the 
safe importation, interstate movement, and environmental release of GE 
organisms developed using genetic engineering during the past 29 years, 
advances in genetic engineering have occurred since they were 
promulgated and new challenges have emerged. Additionally, APHIS has 
now accumulated nearly three decades of experience in evaluating GE 
organisms for plant pest risk. The Agency's evaluations to date have 
provided evidence that most genetic engineering techniques, even those 
that use a plant pest as a vector, vector agent, or donor, do not 
result in a GE organism that presents a plant pest risk. This is 
discussed at greater length later in this document, under the section 
titled ``General Restrictions and Scope (Sec.  340.0).'' Additionally, 
genetic engineering techniques, such as genome editing and synthetic 
genomics, have been developed that do not employ plant pests as donor 
organisms, recipient organisms, vectors, or vector agents; such 
techniques could be used to produce GE organisms with plant pest risks 
without falling within the scope of regulated article.
Need To Evaluate GE Plants for Noxious Weed Risks
    Advances in genetic engineering have also made the need to evaluate 
GE plants for noxious weed risk more pressing. When APHIS issued the 
current regulations under the authority of the FPPA and PQA, APHIS' 
authority to regulate noxious weeds was the Federal Noxious Weed Act of 
1974 (7 U.S.C. 2801, FNWA). That act defined noxious weed as ``Any 
living stage (including but not limited to, seeds and reproductive 
parts) of any parasitic or other plant of a kind, or subdivision of a 
kind, which is of foreign origin, is new to or not widely prevalent in 
the United States, and can directly or indirectly injure crops, other 
useful plants, livestock, or poultry or other interests of agriculture, 
including irrigation, or navigation or the fish or wildlife resources 
of the United States or the public health.'' Because APHIS' noxious 
weed authority was limited at the time to plants that were of foreign 
origin and new to or not widely prevalent in the United States, and 
most GE plants at the time were modified crops that were developed in 
the United States and were widely prevalent, in their unmodified form, 
within the United States, APHIS had no basis that would allow it to 
evaluate most GE plants for noxious weed risk.
    In 1994, Congress amended the FNWA to allow APHIS to issue permits 
for the interstate movement of noxious weeds. This amendment, however, 
did not revise the definition of noxious weed in the Act.
    In 2000, the PPA was issued; In addition to subsuming the FPPA and 
PQA, it also replaced the FNWA, and provided a new definition of 
noxious weed: ``Any plant or plant product that can directly or 
indirectly injure or cause damage to crops (including nursery stock or 
plant products), livestock, poultry, or other interests of agriculture, 
irrigation, navigation, the natural resources of the United States, the 
public health, or the environment.'' The PPA also provided explicit 
authority to issue regulations listing noxious weeds that are 
prohibited or restricted from entering the United States or that are 
subject to restrictions on interstate movement within the United 
States, and provided persons with the right to petition APHIS to add or 
remove noxious weeds from this list.
    This revised noxious weed authority led APHIS in 2010 to revise the 
noxious weed regulations, found in 7 CFR part 360, to reflect the 
provisions of the PPA. It also led APHIS to revise the manner in which 
APHIS evaluates plants for noxious weed risk to determine whether to 
list them in part 360. Under the revised approach that APHIS uses for 
part 360, the first two considerations in determining whether a plant 
is a noxious weed are: (1) Identifying what direct injury or damage 
(physical harm) the plant causes; and (2) identifying what indirect 
damage the plant may cause to interests of agriculture, irrigation, 
navigation, the natural resources of the United States, the public 
health, or the environment. APHIS then evaluates how likely the plant 
is to become established in areas within the United States in which it 
was not known to exist, in the absence of Federal regulation; for 
example, if it can only become established in tropical climates, 
Federal regulation is not necessary to prevent its establishment in 
temperate and subarctic climates. APHIS' final consideration is whether 
placing the plant under Federal regulation will affect the likelihood 
of introduction or dissemination of the plant. In general, APHIS lists 
a plant as a Federal noxious weed if APHIS determines the plant to be 
invasive and to have significant negative impacts, if introduced or 
disseminated within the United States, and if APHIS determines that 
Federal regulation could reduce the likelihood of such introduction or

[[Page 7010]]

dissemination. If APHIS determines that Federal regulation of a GE 
plant--pursuant to the authorities granted in the PPA--is incapable of 
mitigating identified noxious weed risks, the plant would not be 
regulated.
    This approach means that there are certain plants that APHIS has 
determined to be weeds, but not to be Federal noxious weeds. This 
distinction between a weed and a Federal noxious weed warrants 
emphasis. ``Weeds,'' in the broadest sense of the term, could include 
any plant growing where and/or when it is unwanted; even plants that 
are desirable in some settings could be considered weeds in others. The 
plants that APHIS evaluates for inclusion on the Federal noxious weed 
list are, in general, a particular type of weed: An invasive, usually 
non-native plant that impacted natural and/or agronomic ecosystems, 
often with significant negative consequences. Of the problematic weeds 
APHIS evaluates, only a fraction \2\ are determined to be ones for 
which Federal regulatory controls to prevent their introduction or 
dissemination are justified; these plant taxa are added to the list of 
Federal noxious weeds in part 360. Part 360 currently lists 111 
aquatic, terrestrial, or parasitic plant taxa as Federal noxious weeds. 
Many weeds in the United States are not regulated as Federal noxious 
weeds because they have reached the extent of their ecological range 
and regulation (i.e., controls on movement) would be costly and provide 
little if any benefit.
---------------------------------------------------------------------------

    \2\ Since 2011, 1700 weeds have been evaluated. Only 24 have 
been deemed to meet the criteria for inclusion on the list of 
Federal noxious weeds.
---------------------------------------------------------------------------

    The regulations in part 360, while effective, continue to have a 
significant restriction that limits their applicability to GE 
organisms: They are predicated on a determination by APHIS that a taxon 
is a Federal noxious weed. This determination is easier for plants that 
have not been genetically engineered, because there are usually many 
reference points that are available and pertinent to this 
determination, including international experience with the weed, 
scientific literature regarding the plant's biology, published studies, 
and other data.
    For GE plants, there is usually a great deal of data and experience 
with the non-GE organism. In most cases these non-GE organisms are 
highly domesticated and cultivated widely within the United States, and 
there is an extensive body of scientific literature regarding their 
biology. However, when a GE trait is introduced into the plant, there 
may in certain instances be little data or previous experience 
available for APHIS to rely on in evaluating the properties of the 
resulting GE plant. Instead, in order to determine whether the GE plant 
could function as a noxious weed, APHIS would have to rely on its own 
independent evaluation of the plant itself, based on information 
provided by the plant's developers.
    Historically, there has not been a significant need for such a 
noxious weed evaluation of GE plants. Most of the GE plants that APHIS 
regulated in the past, such as varieties of corn and soybeans modified 
with common agronomic traits, do not qualify as ``noxious weeds.'' This 
is because most GE plants to date have been agricultural crops, and 
most agricultural crops are not biologically weeds prior to 
modification. Indeed, in order to domesticate a plant for crop 
production, farmers often had to deliberately eliminate weedy traits, 
such as seed shattering, thorns, and seed dormancy, from the plant 
using traditional breeding techniques. Moreover, the phenotypic traits 
that have historically been introduced into crops through genetic 
engineering do not confer weediness. Because the plants have not been 
weeds prior to genetic engineering, and genetic engineering has not 
introduced weediness, evaluating the plant solely for plant pest risk 
has not been problematic.
    Additionally, the means by which most GE plants to date have been 
genetically engineered has brought them under APHIS' regulatory 
authority. To date, most GE plants have been engineered using a plant 
pest as either the donor or vector of genetic material. Because of this 
use of a plant pest as a donor, vector agent, or vector, the resulting 
GE organisms fall within the scope of regulated articles.
    However, in recent years, there has been an increasing diversity of 
both agronomic and non-agronomic traits engineered in plants. There has 
also been an increased use of plants in genetic engineering that, in 
their unmodified state, are known to possess weedy traits. This is 
especially true of plants used in the production of biofuel. For 
example, switchgrass (Panicum virgatum), which has long been used in 
the production of ethanol biofuel, has growth patterns in an unmodified 
state that are characteristic of a weed, and, recently, has been 
genetically engineered for increased ethanol production. Accordingly, 
since such plants are somewhat weedy in their unmodified state, and 
genetic engineering can, in certain instances, enhance the weeediness 
traits that are already present in a plant in its unmodified state, 
there is a correspondingly higher risk that such a plant may be 
genetically engineered into a noxious weed.
    Moreover, APHIS' current regulatory structure, which entails 
evaluating such plants solely for plant pest risk, is not sufficient to 
properly identify all risks that these plants present to other plants 
and plant products. Indeed, under the current structure, such plants 
may entirely escape regulation. While, in the past, GE plants have 
almost always used a plant pest to vector genetic material, as we 
mentioned previously in this document, in recent years, GE techniques 
have arisen that do not use plant pests as donor organisms or vectors. 
Moreover, if plants are genetically engineered without the use of a 
plant pest as a vector or donor, this would require APHIS to consider 
the plant itself to be a plant pest in order to designate it as a 
regulated article. However, under the PPA's definition of plant pest, a 
plant must be parasitic in order to be considered a plant pest. With 
limited exceptions, such as mistletoe, dodder, and striga, few plants 
are known to be parasitic. Thus, APHIS considers it both appropriate 
and necessary to begin to evaluate GE plants for noxious weed risk.
    While APHIS discusses the nature of this proposed evaluation later 
in this document, it is important to delineate, in broad terms, how the 
Agency would consider a GE plant to be a noxious weed under the 
proposed regulations. For purposes of the regulations in part 340, 
APHIS would begin by evaluating whether the plant, in its unmodified 
state, has weedy characteristics, that is, a plant biologically capable 
of causing notable physical injury or damage. This would serve as the 
baseline against which to evaluate the genotype of the GE plant. In 
evaluating the GE plant, APHIS would assess the likelihood that the 
modifications made to the genome of the plant alter its ability to 
cause notable physical harm or injury.
    For GE plants that APHIS determines to be weedy prior to genetic 
modification, APHIS would endeavor to determine whether the plant's 
weediness has been enhanced to an extent that it has been engineered 
into a noxious weed. For GE plants that APHIS determines not to possess 
weedy traits prior to modification, APHIS would endeavor to determine 
whether weediness had been introduced into the organism through genetic 
engineering. Finally, in the event that a Federal noxious weed is 
genetically engineered (something that has not occurred to date), APHIS 
would endeavor to determine whether the GE plant is still

[[Page 7011]]

a noxious weed and warrants continued regulation.
    If APHIS determines that the GE plant is a noxious weed, it would 
endeavor to gauge the direct or indirect injury or damage it could 
cause to crops, livestock, poultry, or other interests of agriculture, 
irrigation, navigation, the natural resources of the United States, the 
public health, or the environment. APHIS would make the results of this 
evaluation publicly available and share both the evaluation and the 
information on which it is based with the Environmental Protection 
Agency (EPA) and the U.S. Food and Drug Administration (FDA), as 
warranted.
    Maintaining communication with EPA and FDA as we evaluate GE plants 
for noxious weed risks is consistent with APHIS' role in the 
Coordinated Federal Framework for Regulation of Biotechnology 
(Coordinated Framework).\3\ Since 1986, the U.S. government has 
regulated GE organisms consistent with the regulatory framework 
described in the Coordinated Framework. The Coordinated Framework, 
published by the Office of Science and Technology Policy, describes the 
comprehensive Federal regulatory policy for ensuring the safety of 
biotechnology research and products, and explains how Federal agencies 
use existing Federal statutes in a manner 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 the three 
major agencies involved in exercising oversight and/or review of GE 
organisms: APHIS, EPA, and FDA.
---------------------------------------------------------------------------

    \3\ To view the framework, go to https://www.aphis.usda.gov/brs/fedregister/coordinated_framework.pdf.
---------------------------------------------------------------------------

    The Coordinated Framework provides as a guiding principle 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 considers this proposed rule to be entirely 
consistent with this principle: It will no longer consider GE organisms 
to be regulated articles solely because of the donor, vector, or vector 
agent used in genetic engineering, thereby focusing APHIS resources on 
those GE organisms that may present a plant pest and/or noxious weed 
risk. However, it is worth noting, as the Coordinated Framework itself 
does, that a ``mosaic'' of statutes have, to date, provided Agencies 
with authority to exercise oversight of GE organisms. APHIS 
acknowledges that the Agencies functioning within the Coordinated 
Framework oversee different aspects of risk and that, accordingly, 
other Federal Agencies may continue to exercise oversight over GE crops 
that APHIS no longer views as plant pests or noxious weeds. To that 
end, APHIS acknowledges that the proposed revisions to 7 CFR part 340 
could have direct or indirect impacts on the manner in which FDA and 
EPA exercise their roles within the Coordinated Framework. To the 
extent that the public health impacts are due to changes in APHIS 
regulatory oversight, APHIS discusses them within this document. 
Economic impacts, in contrast, are discussed in the economic analysis 
prepared for this rule, while potential environmental impacts are 
discussed in the draft programmatic environmental impact statement 
prepared for the rule.
OIG Audits and 2008 Farm Bill
    Audits conducted by USDA's Office of Inspector General (OIG) are 
another basis for this rule. 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 contained to its test field, but 
Agency practices did not require responsible persons to provide written 
protocols detailing the exact methods that person would use to meet the 
standards. OIG suggested that APHIS revise the regulations to minimize 
the risk of inadvertent dissemination of regulated articles from a test 
field. Specific recommendations were to require GPS coordinates of all 
test field sites; to require scientific protocols or study designs from 
applicants prior to authorizing a field test of a GE organism; and to 
seek legislative authority to require applicants to provide proof of 
financial responsibility in the event of an unauthorized release, as 
APHIS considered necessary.
    OIG also suggested that APHIS develop risk-based criteria for 
conducting inspections and exercising oversight of field tests for the 
release of GE organisms, and suggested that APHIS provide more explicit 
guidance regarding how to terminate a field test and document this 
termination.
    In 2015, OIG issued another audit, urging APHIS to implement the 
recommendations from the 2005 audit that APHIS had not yet implemented.
    Finally, in 2008, The Food, Conservation, and Energy Act of 2008 
(Farm Bill) was promulgated. 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,'' \4\ and, where 
appropriate, promulgate regulations. Like the 2005 OIG audit, this 
APHIS document suggested the need for greater regulatory oversight of 
field tests of regulated articles.
---------------------------------------------------------------------------

    \4\ https://www.aphis.usda.gov/biotechnology/downloads/supportingdocs/LessonsLearned10-2007.pdf.
---------------------------------------------------------------------------

    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 evaluation of GE organisms for noxious weed potential, and 
to respond to the recommendations of the 2005 OIG audit and the 
provisions of the Farm Bill.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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. These were received in 5,580 submissions that included 
unique comments, form letters, and signatories to petitions. 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, APHIS 
published a notice in the Federal Register on March 4, 2015, 
withdrawing the proposal to allow APHIS to begin a fresh stakeholder 
engagement process aimed at exploring a variety of regulatory 
approaches.
    Based on the feedback received following the withdrawal of the 
proposed rule, as well as to reflect provisions of The Food, 
Conservation, and Energy Act of 2008 (Farm Bill) and recommendations 
received from the 2005 and 2015 OIG audits, APHIS is proposing to 
update its regulations in 7 CFR part 340. APHIS is proposing to 
evaluate GE organisms for noxious weed potential using a different 
approach

[[Page 7012]]

from that of the 2008 proposed rule, and proposing a new risk analysis 
process to determine which organisms would require a permit. As 
previously proposed in 2008, APHIS is also proposing to eliminate the 
notification process in favor of permitting. APHIS is committed to 
working with stakeholders to ensure a smooth transition from the 
current regulatory process to the proposed regulatory process. We 
request comment on suggestions for ways to smooth the transition 
period, avoiding disruption in the market, while continuing to ensure 
that APHIS meets its statutory requirements.
Regulation of GE Biological Control Agents
    Additionally, under the new approach, APHIS would regulate a GE 
organism that is intended for use as a biological control (biocontrol) 
agent if APHIS determines that it is a plant pest or noxious weed, with 
a limited exception. Biocontrol involves the reduction of plant pest 
and weed populations through the use of natural enemies such as 
parasitoids, predators, pathogens, antagonists, or competitors to 
suppress plant pest and weed populations.
    The exception would be for GE vertebrate biocontrol agents. 
Although such organisms could fall within the scope of the PPA's 
definition of plant pest, particularly if they are herbivores, it is 
long-standing APHIS policy not to regulate vertebrates as plant pests. 
This policy is discussed later in this document.
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).
    When plants are genetically engineered in such a manner, the plants 
and the pharmaceutical and/or industrial products they produce may fall 
within the purview of multiple regulatory Agencies: APHIS, EPA, and/or 
FDA.
    Under the current regulations in 7 CFR part 340, APHIS requires 
permits, as opposed to Notifications, 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. Products obtained from PMPI-producing 
plants may be regulated by FDA (authority over pharmaceuticals) or EPA 
(chemical substances as defined by the Toxic Substances Control Act 
(TSCA)), depending on their intended use. To date, producers of PMPI-
producing plants, or products derived from such plants, have not 
intended for such plants or plant products to be used for human or 
animal food. However, if such a plant or plant product is used for 
human or animal food, the food would be subject to applicable statutory 
and regulatory requirements 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 in 7 CFR part 340. However, under the provisions of 
this proposed rule, as discussed at greater length later in this 
document, a GE plant that is developed using a plant pest as a vector, 
vector agent, or donor of genetic materials would not necessarily be a 
regulated organism. Rather, the GE plant would be a regulated organism 
if it had a plant/trait combination that the Agency has not yet 
evaluated for plant pest and/or noxious weed risk, if it has received 
DNA from a taxon that contains plant pests and the DNA from the donor 
organism is sufficient to produce an infectious entity capable of 
causing plant disease or encodes a compound known to be pathogenesis-
related that is expected to cause plant disease symptoms, or if it was 
evaluated and found to represent plant pest or noxious weed risks. 
Additionally, APHIS' evaluations of GE plants for plant pest or noxious 
weed risk would generally not require data from outdoor plantings.
    Even if the plant represents a new plant/trait 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 not regulated under the provisions of the proposed 
regulations after a regulatory status evaluation because they do not 
represent risks as a plant pest or noxious weed. 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, 
however, could be necessary to prevent unlawful entry into the food 
supply of material from such plants. 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. 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 company plants PMPI-producing plants. For example, for 
PMPI-producing plants whose products fall under FDA authority, FDA has 
no regulations governing planting of such crops. For crops genetically 
engineered to produce pharmaceuticals, companies only have to come 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 with industrial compounds.
    A gap in Federal oversight of PMPI producing-plants could result in 
the intentional or inadvertent introduction into the human or animal 
food supply of unevaluated pharmaceutical or industrial PMPI products, 
even when the principal purpose of the plants is not for human or 
animal food use. For example, a company could self-determine that the 
PMPI produced by the plant was generally recognized as safe (GRAS), and 
therefore conclude it had no legal obligation to keep surplus PMPI-
producing plants out of the human or animal food supply, to keep such 
PMPI-producing plants from spreading pollen to plants grown for human 
and animal food purposes, or even to notify any Federal agency that 
they were planting such crops. In addition to potential 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.
    APHIS has identified several options that have the potential for 
adequate Federal oversight of outdoor plantings of plants engineered to 
produce PMPIs. Under one 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

[[Page 7013]]

PMPI-producing plants and to evaluate GE PMPI-producing plants for all 
possible risks, beyond plant pest and noxious weed risks. For 
industrial-producing plants subject to EPA's jurisdiction, a second 
option is for EPA to develop a program to regulate industrial-producing 
plants and issue regulations if warranted. Under a third option, APHIS 
would enter into a memorandum of understanding (MOU) and services 
agreement with the appropriate Federal Agencies to provide personnel 
and other resources to assist those Agencies in their oversight of 
outdoor plantings of PMPI-producing GE plants, recognizing that Federal 
agencies may not have authority to require notification and/or 
oversight of the outdoor planting of some of these plants. Under a 
fourth option, those Federal Agencies would supply their own personnel 
and resources to exercise oversight of outdoor plantings of PMPI-
producing GE plants, recognizing that Federal agencies may not have 
authority to require notification and/or oversight of the outdoor 
planting of some of these plants.
    APHIS recognizes that there are challenges associated with each of 
these options. For example, the first option would require legislation 
to be enacted, which is not within the purview of the Executive Branch 
of the Federal government. Additionally, all options could require 
Federal Agencies to incur the costs associated with setting up new 
regulatory programs. The second option would require time for EPA to 
stand up a genetically engineered industrial-producing plant oversight 
program for plants subject to EPA jurisdiction. The third option, in 
turn, would require policies, procedures, and guidance regarding APHIS' 
interaction with other Federal Agencies to be developed prior to 
implementation. To that end, it is important to note that APHIS does 
not prefer any of these options over the other, nor does the Agency 
consider the options listed above 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 proposed rule, APHIS would only require 
permits for PIPs planted on 10 acres or less if they present a plant 
pest or noxious weed risk or have not yet been evaluated by APHIS for 
such risk. Under the current regulations in 7 CFR part 340, 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 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 7 CFR part 340. However, under the provisions of 
this proposed rule, as discussed at greater length later in this 
document, a GE plant that is developed using a plant pest as a vector, 
vector agent, or donor of genetic materials would not necessarily be a 
regulated organism. Rather, the GE plant would be a regulated organism 
if it had a plant/trait combination that the Agency has not yet 
evaluated for plant pest and/or noxious weed risk, or if it has 
received DNA from a taxon that contains plant pests and the DNA from 
the donor organism is sufficient to produce an infectious entity 
capable of causing plant disease or that encodes a compound known to be 
pathogenesis-related that is expected to cause plant disease symptoms. 
Additionally, APHIS' evaluations of GE plants for plant pest or noxious 
weed risk would generally not require data from outdoor plantings.
    Even if the plant represents a new plant/trait 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 evaluation because 
they do not represent risks as a plant pest or noxious weed. 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 PIPs to EPA. EPA 
may decide to require experimental use permits (EUP) for all, some, or 
none of such PIPs, and may conduct inspections of all, some, or none of 
those PIPs under permit. EPA would need to develop a program to oversee 
small-scale testing of PIPs and issue regulations if warranted. APHIS 
is fully committed to coordinating with EPA in this matter in order to 
give EPA sufficient time to stand up such a program. 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 of oversight 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.
Herbicide Resistant GE Crops and Herbicides--Synchronous Decisions With 
EPA
    Certain plants are genetically engineered to make them resistant to 
herbicides. EPA registers the herbicide products used on herbicide 
resistant crops, but does not regulate herbicide-resistant crops 
themselves. APHIS has evaluated and deregulate many GE herbicide 
resistant plants. To date, the herbicide-resistant 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 7 CFR part 340. 
However, under the provisions of this proposed rule, as discussed at 
greater length later in this document, a GE plant that is developed 
using a plant pest as a vector, vector agent, or donor of genetic 
materials would not necessarily be a regulated organism. Rather, the GE 
plant would be a regulated organism if it had a plant/trait combination 
that the Agency has not yet evaluated for plant pest and/or noxious 
weed risk, or if it has received DNA from a taxon that contains plant 
pests and the DNA from the donor organism is sufficient to produce an 
infectious entity capable of causing plant disease or that encodes a 
compound known to be pathogenesis-related that is expected to cause 
plant disease symptoms, or has been evaluated by APHIS in accordance 
with and determined to pose a risk as

[[Page 7014]]

a plant pest or noxious weed. Additionally, APHIS' evaluations of GE 
plants for plant pest or noxious weed risk would generally not require 
data from outdoor plantings.
    Even if the plant represents a new plant/trait combination not 
previously reviewed, there is a likelihood that many GE herbicide-
resistant 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 evaluation because 
they do not represent risks as a plant pest or noxious weed. Thus, such 
plants could be grown outdoors without the need for permits and without 
APHIS oversight.
    Commenters to the proposed update to the Coordinated Framework on 
the Regulation of Biotechnology published on September 22, 2016 (81 FR 
65414-65415), expressed the need for coordination between USDA and EPA 
regarding the timing of deregulation/determination of nonregulated 
status of herbicide-resistant crops and the registration of herbicides. 
APHIS recognizes that the asynchronous timing of the deregulation of 
herbicide- resistant plants and the associated herbicide registration 
has led to situations where a developer could sell the herbicide-
resistant plant/seed without waiting for the associated herbicide 
registration. In such a situation, farmers may be tempted to illegally 
use an unregistered herbicide on a crop.
    In light of the challenges associated with the asynchronous 
regulatory actions on the part of APHIS and EPA, APHIS will work with 
EPA to explore possible solutions to better coordinate the commercial 
availability of seed for herbicide resistant crops concomitant with the 
registration of herbicides intended to be used on those crops. 
Furthermore, APHIS intends to limit the scope of its decisions to be on 
an individual/specific herbicide resistant crop basis (e.g., glyphosate 
resistant cotton) so that the EPA and APHIS are making decisions on the 
same specific herbicide resistant crop/herbicide combinations. This 
coordination presents challenges because once APHIS determines a GE 
organism does not represent a risk as a plant pest or noxious weed, 
APHIS cannot continue to regulate the GE organism or delay announcing 
the regulatory status determination. When APHIS receives a request for 
regulatory status determination of an herbicide resistant crop, it is 
likely to be three or more years before a developer is ready to undergo 
registration review at EPA. If APHIS determines that the herbicide 
resistant plant is not a risk as a plant pest or noxious weed, APHIS 
does not have the authority in the PPA to require permits with 
regulatory controls for the movement and outdoor planting of that 
herbicide tolerant plant during those subsequent years. Nor is it 
within APHIS authority for APHIS to withhold making a regulatory status 
evaluation decision for several years and requiring permits for field 
testing during that time. The issue has not been the illegal use of 
pesticide during the field testing of herbicide resistant crops by 
developers but instead is the illegal use of pesticide by farmers on 
seed that has been deregulated by APHIS and is commercially available 
before the commercial availability of the herbicide designed for those 
crops. One option to address this coordination would be to enact a new 
statute or amend an existing statute to make it illegal to sell seeds 
for herbicide resistant crops before the registrations were completed 
for use on those crops. Another option might involve a voluntary 
agreement by seed developers to withhold selling seed of herbicide-
resistant crops until EPA registrations are completed for the herbicide 
products designed for those crops. In cases where APHIS makes a 
decision deregulating an herbicide-resistant crop or determines under 
Sec.  340.4 that an herbicide-resistant crop is unlikely to pose a risk 
as a plant pest and/or noxious weed and will no longer be a regulated 
organism and no herbicide product has been registered by EPA for use on 
that herbicide-resistant crop, APHIS would indicate on the APHIS 
Regulatory Status List Web site and Web sites associated with 
deregulation decisions that no herbicide product is registered bv EPA 
for use on this herbicide-resistant crop and it is illegal to use any 
herbicide product on these crops unless registered by EPA for such use. 
Additionally, APHIS would include language in deregulation decision 
letters sent to the developer and Federal Register notices associated 
with Sec.  340.4 final determinations indicating it is illegal to use 
herbicides on these crops until the herbicide product is registered by 
EPA for use on the herbicide-resistant crop. This decision letter and 
all other information regarding APHIS's decisions would also be made 
available to the public on the APHIS Web site.
    APHIS does not consider the approaches listed above necessarily to 
be exhaustive and recognizes that one of the options listed would 
require legislation to be enacted, which is not within the purview of 
the Executive Branch of the Federal government. However, APHIS puts 
them forward to indicate that the Agency is aware that asynchronous 
timing of the deregulation of herbicide-resistant plants and the 
associated herbicide registrations can lead to significant problems, 
and to request specific public comment regarding the best manner to 
address this issue.
An Overview of Our Proposed Regulatory Structure
    Before discussing the specifics of these proposed revisions, APHIS 
wishes to provide an overview of how the Agency generally envisions the 
various sections of the proposed rule interacting, from the perspective 
of a developer of a GE organism. This overview assumes that the 
organism falls within the scope of our proposed definition of GE 
organism, and is a regulated organism under proposed Sec.  340.0.
    Until such time as the developer wishes to import the organism, 
move it interstate, or release it into the environment, no action would 
be required of the developer. However, if the developer believes that 
it possesses sufficient information to demonstrate that the organism 
presents no plant pest or noxious weed risk, and wished to release it 
into the environment, it would have to submit this information to APHIS 
and request that APHIS conduct an evaluation of such risk. The process 
for submitting such a request, as well as the possibilities for how 
APHIS would act on that request, is set forth in proposed Sec.  340.4.
    If APHIS evaluates the GE organism in accordance with Sec.  340.4 
and determines that it is unlikely to pose a risk as a plant pest and/
or noxious weed, it would no longer be a regulated organism and may be 
imported, moved interstate, or released into the environment without 
further restriction under the proposed regulations. APHIS would 
maintain a list of such organisms on a Web site. If new information is 
obtained which indicates that a previously deregulated GE organism may 
present a plant pest and/or noxious weed risk, APHIS may reevaluate the 
GE organism and reconsider its regulatory decision.
    If the organism is still a regulated organism following such an 
evaluation, with one, limited exception (the interstate movement of GE 
Arabidopsis thaliana under certain conditions, which APHIS discusses 
later in this document) the developer would need to obtain a permit for 
its importation, interstate movement, or environmental

[[Page 7015]]

release. APHIS' proposed permitting process is set forth in Sec.  
340.3.
    If APHIS issues a permit to the developer for the importation, 
interstate movement, or release into the environment of the organism, 
the developer would have to comply with permitting conditions regarding 
such importation, interstate movement, or release into the environment. 
The developer would also have to comply with container and shipment 
requirements that pertain to the movement of regulated organisms. These 
requirements would also be set forth in Sec.  340.3.
    The developer would also have to retain certain records regarding 
permitted activities. These are set forth in proposed Sec.  340.5. 
Failure to retain such records, or comply with other regulatory 
requirements or permitting conditions, could result in enforcement 
activities. These would also be set forth in Sec.  340.5.
    If, in the course of interacting with APHIS, the developer had to 
provide the Agency with confidential business information (CBI), the 
developer could denote such CBI in accordance with Sec.  340.6.
    Finally, Sec.  340.7 would provide the developer with information 
regarding APHIS policy related to costs and charges incident to 
compliance with the regulations.
    This is, again, a general overview of the proposed regulations. As 
such, it does not attempt to capture every nuance of the proposed 
regulations, nor does it apply to every scenario that may occur under 
those regulations.
    What follows is a more in-depth discussion of the provisions of the 
rule.
What Constitutes a Genetically Engineered Organism Under the Proposed 
Regulations
    While APHIS discusses most of its proposed definitions later in 
this document, the Agency considers it necessary, at the outset of 
discussion of the provisions of the proposed rule, to discuss two of 
its proposed definitions, for the terms genetic engineering and 
genetically engineered (GE) organism. This is because the proposed 
regulations would not apply to organisms that are created using 
techniques that APHIS does not consider to constitute genetic 
engineering or that fall outside the scope of GE organism. Such 
organisms, which would not be regulated by APHIS under 7 CFR part 340, 
would not be expected to come to APHIS for evaluation. However, if such 
organisms are submitted to APHIS, APHIS would evaluate them for plant 
pest and/or noxious weed risk and provide guidance on their regulatory 
status.
    By genetic engineering, APHIS would mean techniques that use 
recombinant or synthetic nucleic acids with the intent to create or 
alter a genome. APHIS considers synthetic nucleic acids to be nucleic 
acid molecules that are chemically or by other means synthesized or 
amplified, including those that are chemically or otherwise modified 
but can base pair with naturally occurring nucleic acid molecules.
    APHIS would exclude from the definition of genetic engineering 
traditional breeding techniques (including, but not limited to, marker-
assisted breeding, as well as tissue culture and protoplast, cell, or 
embryo fusion) or chemical or radiation-based mutagenesis. APHIS would 
do so because the Agency has never considered such techniques to 
constitute genetic engineering. Accordingly, organisms created through 
such techniques are currently excluded from regulation under 7 CFR part 
340, and would continue to be so excluded.
    For the purposes of proposed 7 CFR part 340, APHIS would define GE 
organism as an organism developed using genetic engineering. Thus, if 
an organism is created using techniques that do not fall within the 
scope of genetic engineering, the organism itself would not fall within 
the scope of GE organism. APHIS would also exclude, from its definition 
of GE organism, certain organisms that are created using techniques 
that fall within the scope of genetic engineering, but that could 
otherwise have been produced using traditional breeding techniques or 
chemical or radiation-based mutagenesis. Such organisms are essentially 
identical, despite the method of creation, because while there may be 
small genetic differences, those differences are not phenotypically 
observable and these types of changes occur naturally in all organisms. 
APHIS would also exclude ``null segregants,'' that is, the progeny of a 
GE organism where the only genetic modification was the insertion of 
donor nucleic acid into the recipient's genome, but the donor nucleic 
acid is not passed to the recipient organism's progeny and the donor 
nucleic acid has not altered the DNA sequence of the progeny. 
Specifically, for purposes of the revised regulations, an organism 
would not be considered a GE organism if:
     The genetic modification to the organism is solely a 
deletion of any size or a single base pair substitution which could 
otherwise be obtained through the use of chemical- or radiation-based 
mutagenesis.\5\
---------------------------------------------------------------------------

    \5\ A single base pair substitution is the most common type of 
substitution induced by chemical mutagenesis or natural variation 
and, therefore, most similar to the type of genetic variation that 
is possible through conventional breeding.
---------------------------------------------------------------------------

     The genetic modification to the organism is solely 
introducing only naturally occurring nucleic acid sequences from a 
sexually compatible relative that could otherwise cross with the 
recipient organism and produce viable progeny through traditional 
breeding (including, but not limited to, marker-assisted breeding, as 
well as tissue culture and protoplast, cell, or embryo fusion).
     The organism is a ``null segregant.''
    APHIS would exclude the first two types of organisms from the 
definition of GE organism for three reasons. First, as mentioned above, 
it would do so because the organisms could otherwise have been produced 
from practices that APHIS is proposing to exclude from the definition 
of genetic engineering. Genetic engineering is often used instead of 
traditional breeding practices, including chemical or radiation-based 
mutagenesis, in order to expedite development of an organism with a 
desired genotype and/or phenotype.
    Examples from the realm of GE plants illustrate these practices. 
Chemical and radiation-based mutagenesis creates thousands of mutations 
in a single organism, and most of the plant breeders' subsequent 
efforts involve eliminating unwanted mutations by repeated crosses and 
selection, each of which can take months to years to complete. 
Conversely, using genetic engineering, single base pair substitutions, 
as well as deletions of differing sizes, can be precisely administered 
very quickly, avoiding this lengthy process of eliminating unwanted 
mutations. The resulting organism, however, remains identical to one 
that could otherwise have been developed using chemical or radiation-
based mutagenesis.
    Similarly, traditional breeding techniques may require many 
generations of crossing to introduce a naturally occurring trait. For 
example, it can take decades to introduce a disease-resistant trait to 
apples through traditional breeding techniques. However, genetic 
engineering can introduce the same trait in a fraction of the time 
while maintaining all other cultivar characteristics of the apple.
    The second reason for the exclusions is that GE plants as a class, 
which constitute the vast preponderance of GE organisms to date, pose 
no greater plant pest or noxious weed risk than their

[[Page 7016]]

counterparts developed through traditional breeding techniques or 
chemical or radiation-based mutagenesis. Moreover, it is both 
impracticable and unnecessary to regulate plants created through 
traditional breeding techniques or chemical or radiation-based 
mutagenesis for plant pest or noxious weed risk.
    This is not to say that plants with undesirable phenotypes have 
never been bred through traditional breeding, or chemical or radiation-
based mutagenesis never result it mutations that are undesirable. 
Indeed, as mentioned above, chemical and radiation-based mutagenesis 
tend to create thousands of mutations in an organism, most of which are 
undesirable.
    However, traditional breeding techniques, in the form of deliberate 
selection and breeding of those plants with desirable phenotypes, have 
been used since the advent of sedentary agriculture, and nearly every 
domesticated crop has, at one point, been subject to traditional 
breeding techniques. Chemical and radiation-based mutagenesis, in turn, 
have been used for nearly a century in the development of thousands of 
commodities, including such commercial commodities as ruby red 
grapefruit and many commercial varieties of wheat and rice. If APHIS 
were to regulate organisms developed through traditional breeding 
techniques or chemical or radiation-based mutagenesis, that would 
entail the regulation, at least provisionally, of almost every 
commercially available human or animal food crop. This is 
impracticable.
    Such regulations would also fail to take into consideration the 
usual purpose of applying traditional breeding techniques or chemical 
or radiation-based mutagenesis to a plant: To introduce desirable 
phenotypic traits into the organism or remove phenotypically 
undesirable traits from the organism. Additionally, it would fail to 
take into adequate consideration that phenotypic traits that could 
increase the plant pest or noxious weed risk posed by a plant tend to 
also adversely impact its vitality, uniformity, or commercial 
viability. For example, a mutation caused by chemical or radiation-
based mutagenesis could render a plant more susceptible to certain 
viroids or pathogens and able to transfer this increased susceptibility 
to sexually compatible relatives, and thus increase the plant pest risk 
associated with the plant. However, it would also directly adversely 
affect the plant's vitality. For these reasons, farmers and developers 
have long bred out unwanted phenotypic traits that arise as the result 
of traditional breeding techniques and/or chemical or radiation-based 
mutagenesis, and planted and/or commercialized the most phenotypically 
desirable plant produced using such techniques.
    In this regard, it is important to note that genetic engineering is 
used to create this phenotypically desirable organism, rather than the 
other products created through traditional breeding techniques, 
including chemical or radiation-based mutagenesis. In 1987, the Council 
of the National Academy of Sciences concluded that there is no evidence 
of a unique risk inherent in the use of recombinant DNA techniques or 
the movement of genes between unrelated organisms. This means that 
risks associated with the introduction of recombinant DNA engineered 
organisms are the same as those associated with non-genetically 
engineered organisms and organisms modified by other methods and that 
the assessment of such risks should be based on the nature of the 
organism and the environment into which it is introduced rather than 
the methods by which it was produced. Furthermore, this same conclusion 
is a basis of the Coordinated Framework that regulation should be based 
on the risks of the organism and not the process used to create it. 
Accordingly, because the plant pest and noxious weed risk posed by the 
plant is equivalent, regardless of whether it was created through 
genetic engineering or traditional breeding (including chemical or 
radiation-based mutagenesis), and such risk is likely to be low because 
of the purpose of applying traditional breeding techniques, including 
chemical or radiation-based mutagenesis to a plant,, APHIS is proposing 
to exclude GE plants that could have otherwise been developed through 
traditional breeding techniques, including chemical or radiation-based 
mutagenesis, from the definition of ``genetically engineered organism'' 
and hence from regulation under the revised 7 CFR part 340.
    This same exclusion would apply to non-plant organisms. Non-plant 
organisms, which fall under the scope of the regulations as defined in 
Sec.  340.0, are either plant pests, or organisms which have received 
genetic material sufficient to produce an infectious entity capable of 
causing plant disease or that encodes a compound known to be 
pathogenesis-related that is expected to cause plant disease symptoms. 
Organisms of the latter type would not qualify for the exclusion, as 
receipt of genetic material capable of conferring the new properties 
could not be achieved through traditional breeding techniques, 
including chemical or radiation-based mutagenesis. However, it can be 
envisioned that plant pests might be altered in such a way that the 
exclusion would apply. In these cases, since the resulting plant pest 
would not be defined as a genetically engineered organism under 7 CFR 
part 340, they would be regulated, if needed, under APHIS's plant pest 
regulations in7 CFR part 330. This is appropriate since these organisms 
are biologically analogous to non-GE plant pests with mutations. It is 
important to note that, to date, we have not encountered GE organisms 
of this type and that the GE plant pests that we do have experience 
with (e.g., pink bollworm expressing marker genes, citrus tristeza 
virus expressing antimicrobial compounds) would still be regulated 
under 7 CFR part 340 since this exclusion would not apply. The two 
APHIS program areas responsible for regulating under 7 CFR parts 330 
and 340 are coordinating to ensure that together they are prepared to 
regulate any type of plant pest as needed.
    However, APHIS has prepared a proposed rule that would remove this 
exception. In its place, all plant pests would require permits issued 
pursuant to part 330, unless the importation, interstate movement, or 
environmental release of the organism is explicitly authorized in other 
APHIS regulations in 7 CFR. Under APHIS' proposed revision to the 
regulations in part 340, the importation, interstate movement, or 
environmental release of GE organisms that could have otherwise been 
developed through traditional breeding techniques or chemical or 
radiation-based mutagenesis would not be explicitly authorized; rather, 
such organisms would be exempted from the regulations in part 340, with 
no reference to the conditions for movement or environmental release of 
such organisms. Accordingly, GE organisms that could have otherwise 
been created through traditional breeding techniques, including 
chemical or irradiation-based mutagenesis, and could pose a potential 
plant pest risk, would now be subject to 7 CFR part 330.
    This touches on several important caveats with regard to the first 
two proposed exemptions from the definition of genetically engineered 
organism. The first is that the exemptions pertain only to 7 CFR part 
340. As noted above, an organism may be exempted from regulation under 
7 CFR part 340, and yet still subject to other APHIS regulations. The 
second

[[Page 7017]]

caveat is that the proposed exemptions are based on APHIS' statutory 
authority under the PPA. They should therefore be taken as a statement 
of one Agency's regulatory policy, rather than scientific findings 
regarding all possible risks posed by such organisms. Accordingly, for 
organisms that APHIS determines to present negligible plant pest or 
noxious weed risk, FDA and EPA may anticipate more substantial human or 
animal food adulterant or pesticide risks, and therefore not reduce 
their oversight of the same organisms.
    The third caveat is that APHIS is not claiming that additions, 
deletions, and substitutions to an organism's genome are inherently 
risk-free. Indeed, as discussed later in this document, the addition 
into an organism's genome of a sequence that encodes an infectious 
entity capable of causing plant disease or encodes a compound known to 
be pathogenesis-related that is expected to cause plant disease 
symptoms introduces plant pest risk into that organism, and would be 
one of APHIS' criteria for regulating the organism under the proposed 
regulations. Rather, APHIS considers such additions, deletions, or 
substitutions to present an acceptable plant pest and/or noxious weed 
risk when they are used to create an organism that could otherwise have 
been created through traditional breeding techniques and/or chemical or 
radiation-based mutagenesis; in other words, it is the product, rather 
than the techniques used to derive the product, that APHIS considers to 
present an acceptable level of risk. The Agency considers this to be 
consistent with the principles set forth in the Coordinated Framework.
    The third proposed exclusion is for progeny of GE organisms where 
the only genetic modification was the insertion of donor nucleic acid 
into the recipient's genome, but the inserted donor nucleic acid is not 
passed to the recipient organism's progeny and has not altered the DNA 
sequence of the recipient organism's progeny. Such progeny are often 
referred to as null segregants. Traits can sometimes be introduced by 
genetic engineering into breeding lines to simplify breeding without 
altering the DNA sequence of progeny; the traits can be eliminated with 
a simple cross and are no longer present in the final organism. An 
example of use of such techniques to facilitate traditional breeding 
would be the introduction of certain genes into trees solely to reduce 
the time to flowering, thereby speeding up a tree-breeding program. In 
this example, the progeny do not contain the early flowering gene and 
their DNA sequence has not been altered by the early flowering gene. 
Because the DNA of the progeny is no different from the DNA of the 
recipient organism prior to the use of genetic engineering, APHIS does 
not consider the progeny to be GE organisms for purposes of the 
proposed regulations.
    APHIS requests specific comment on its definition of genetically 
engineered organism, specifically the appropriateness of the proposed 
exemptions, and whether commenters can identify any scenarios in which 
they would exempt from APHIS regulation an organism that presents a 
plant pest and/or noxious weed risk. APHIS also requests specific 
comment on whether any other types of organisms should be excluded from 
the definition of genetically engineered organism. Finally, APHIS is 
interested in whether the terms ``traditional breeding techniques'' and 
``chemical or radiation-based mutagenesis'' should be defined, and 
whether the exclusions themselves are sufficiently delineated.
    APHIS wishes to point out that its proposed definition for 
genetically engineered organism is limited to the regulations in 7 CFR 
part 340 and may not reflect the definition of genetically engineered 
organism that is in use by other Federal Agencies. Differences in 
definitions are, in part, attributable to the differences in the 
agencies' statutory and regulatory authorities. Under the Coordinated 
Framework for the Regulation of Biotechnology, we intend to work 
cooperatively with other relevant agencies that may also be considering 
their policies or approaches related to genome editing applications 
within their jurisdictions.
General Restrictions and Scope (Sec.  340.0)
    Section 340.0 would set forth general restrictions regarding the 
movement and environmental release of GE organisms, as well as the 
scope of the revised regulations in part 340.
    Paragraph (a) of Sec.  340.0 would provide that no person may move 
any regulated GE organisms except in accordance with part 340. Movement 
of regulated organisms that is not in accordance with the part could 
present a risk of introducing or disseminating plant pests and noxious 
weeds within the United States.
    Paragraph (b) of Sec.  340.0 would specify the types of GE 
organisms APHIS would consider to be regulated organisms under the 
revised regulations.
    Under our proposed regulations, a GE organism would be a regulated 
organism if:
     Prior to genetic engineering, the GE organism belonged to 
any taxon listed in accordance with Sec.  340.2 and met the definition 
of plant pest in Sec.  340.1. (As Sec.  340.2 currently does, proposed 
Sec.  340.2, which APHIS discusses below, would specify that certain 
taxa are plant pests or are known to contain plant pests. Section 340.1 
would contain definitions of terms used in the proposed regulations.)
     The GE organism has received DNA from any taxon listed in 
accordance with Sec.  340.2, the DNA from the donor organism is 
sufficient to produce an infectious entity capable of causing plant 
disease or encodes a compound known to be pathogenesis-related that is 
expected to cause plant disease symptoms, and the GE organism has not 
been evaluated by APHIS for plant pest risk in accordance with Sec.  
340.4.
     The GE organism is a plant that has a plant and trait 
combination that has not been evaluated by APHIS for plant pest and 
noxious weed risk in accordance with Sec.  340.4 \5\; or
---------------------------------------------------------------------------

    \5\ As APHIS discusses below, APHIS would maintain a list of 
plant and trait combinations that APHIS has evaluated for plant pest 
and noxious weed risk online if this rule is finalized.
---------------------------------------------------------------------------

     The GE organism is any of the foregoing that has been 
evaluated by APHIS in accordance with Sec.  340.4 and determined to 
pose a risk as a plant pest or noxious weed, or is a GE organism that 
has otherwise been determined by the Administrator to pose a risk as a 
plant pest or noxious weed.
    The proposed criteria differ from the current criteria in several 
respects. First, the current criteria consider a GE organism to be a 
regulated article if the donor, vector, or vector agent 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 permits that authorize environmental release of regulated 
organisms, as well as more than 150 petitions for nonregulated status, 
this has not proven to be the case. Although a plant pest may 
contribute or vector genes to a GE organism, this has not been shown in 
APHIS' evaluation of data to cause that 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 resulted in 
plant pest risks of any sort in recipient organisms.

[[Page 7018]]

    Rather, 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. Use of Agrobacterium tumefaciens 
as a vector of genetic material does not leave viable bacteria behind 
in the recipient organism and does 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. Rather, they 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 of safe use and does not result in disease 
or injury to the recipient organism.
    It is conceivable that a donor organism that is a plant pest could 
result in a GE organism that is itself a plant pest if (1) the DNA 
sequence that is encoded in the organism is able in itself to be 
expressed phenotypically or confers plant pest traits, 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. In 
either instance, APHIS would not expect phenotypic expression of plant 
disease unless large portions of a genome from a plant pest were 
introduced to a recipient organism, a practice that APHIS considers 
unlikely for developers to use based on their practices to date.
    Likewise, based on APHIS' evaluation of field trial data to date, 
there is no evidence that the use of plant pests as vectors or vector 
agents in the production of GE organisms results in a GE organism that 
is itself a plant pest.
    Accordingly, APHIS would regulate GE organisms that have received 
DNA from a taxon containing a plant pest only 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. By ``sufficient to produce an infectious entity,'' APHIS 
means that the DNA sequence that is encoded in the organism is able in 
itself to be expressed phenotypically or confers traits that meets the 
definition of plant pest. In such instances, APHIS considers it 
appropriate and prudent to regulate the GE organism until such time as 
APHIS evaluates the risk it poses as a plant pest in accordance with 
proposed Sec.  340.4, and thereafter to regulate it only if APHIS 
determine it to pose a risk as a plant pest.
    Additionally, APHIS would no longer regulate a GE organism solely 
because its vector or vector agent is a plant pest. APHIS adopted this 
approach in 1987 because the use of plant pest vectors in recombinant 
DNA technologies was, at the time, a relatively recent development, and 
there was a corresponding need to exercise precaution in regulating 
such use until the plant pest risk associated with the practice was 
further evaluated. In twenty-nine years of regulating GE organisms 
because of the use a plant pest as a vector or vector agent, APHIS has 
no evidence that using genetic material from plant pests as vectors or 
vector agents for other genetic material results in a GE organism that 
is itself a plant pest. Accordingly, this proposed rule would change 
APHIS' approach, and GE organisms that were created using a plant pest 
as a vector or vector agent would no longer be regulated solely because 
of the use of such a vector or vector agent. Instead, the organisms 
would be regulated if they themselves presented a known or unevaluated 
plant pest risk. This is in keeping with the overarching aim of this 
proposed rule, which is to regulate the products of genetic 
engineering, rather than the methods by which those products are 
developed.
    A second difference from the current criteria is that, for reasons 
discussed previously in this document, APHIS is proposing that APHIS 
may regulate a GE plant under 7 CFR part 340 if APHIS determines that 
it is a noxious weed.
    Our proposed criteria would also attempt to clarify a current 
category of regulated articles, GE plants that are regulated because 
the Administrator has reason to believe they are a plant pest. When the 
current regulations were issued, APHIS had less experience regulating 
GE organisms, and there was corresponding uncertainty regarding the 
degree to which subjecting a plant to genetic engineering, without the 
use of a plant pest as a donor, vector, or vector agent, would cause 
the plant to become a plant pest. This category was intended to allow 
APHIS to consider such plants to be regulated articles, until APHIS had 
sufficient information to classify it either definitively as a plant 
pest, or to determine that it presented no plant pest risk. The 
category was especially useful when a GE plant was developed using 
novel genetic engineering techniques.
    In the 29 years since the current regulations were issued, APHIS' 
evaluation of petitions for nonregulated status for more than 150 GE 
plants has provided a basis to help the Agency delineate the plant and 
trait combinations that cause a GE organism to act as a plant pest from 
the combinations that pose no plant pest risk.
    Accordingly, APHIS now considers there to be two instances in which 
a GE plant should be a regulated organism. The first instance is when 
APHIS has reached a determination that the plant and trait combination 
associated with the GE plant causes it to act as a plant pest or 
noxious weed. APHIS is making a draft list of such combinations 
available along with this proposed rule, as well as a list of 
combinations that APHIS has determined to present no plant pest or 
noxious weed risk,\6\ and APHIS invites public comment on these draft 
lists. For purposes of this proposed rule, the lists would be 
maintained at the following Web site: http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule. If the rule is finalized, APHIS 
would develop a different URL that would contain the lists, as well as 
all other information regarding this rule, and that would indicate that 
the rule had been finalized.
---------------------------------------------------------------------------

    \6\ APHIS encourages stakeholders to review these lists and 
submit specific public comment regarding the listed plant/trait 
combinations. In particular, while the vast majority of listed 
plant/trait combinations correspond to specific organisms that have 
been granted nonregulated status under the current regulations, the 
list would not be event-specific. This means that if a crop-trait 
combination has nonregulated status on the list, all specific events 
that have that crop-trait combination would be nonregulated. 
Practically speaking, this means that the list would grant 
nonregulated status to almost all GE corn and soybean that 
developers have brought to APHIS to date.
---------------------------------------------------------------------------

    The second instance in which APHIS would consider it necessary to 
regulate a GE plant is when APHIS is presented with a GE plant with a 
novel plant and trait combination, and has not yet evaluated this plant 
and trait combination for its plant pest and noxious weed risk.
    On a related matter, APHIS acknowledges that a novel GE organism 
could be developed that does not fall into any of the Agency's other 
categories of regulated organisms, but that APHIS determines poses a 
risk as a plant pest or noxious weed. APHIS's last criteria for 
regulated organisms would allow APHIS to regulate such an organism.

[[Page 7019]]

Taxa That Are or Contain Plant Pests (Sec.  340.2)
    As stated previously, Sec.  340.2 contains a list of taxa that are 
considered to be plant pests. That list has not been amended since it 
was established in 1987.
    To improve regulatory flexibility and help ensure the list remains 
current, APHIS is proposing to remove the list of taxa from Sec.  340.2 
and place it on the Internet at http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule. APHIS would advise the public of 
changes to the list through notices published in the Federal Register. 
These notices would request public comment.
    APHIS is not proposing any changes to the listed taxa at this time, 
however.
    Per the definition of ``plant pest'' in the PPA, any organism 
belonging to any taxon contained within any listed genus or taxon is 
only considered to be a plant pest if the organism ``can directly or 
indirectly injure, or cause disease, or damage in any plants or parts 
thereof, or any processed, manufactured, or other products of plants.'' 
Thus a particular unlisted species within a listed genus would be 
deemed a plant pest if the scientific evidence indicates that the 
organism is a cause of direct or indirect injury, disease, or damage to 
any plants, plant parts, or products of plants.
    Section 7711 of the PPA generally requires permits for the 
importation or interstate movement of plant pests, but allows the 
Secretary to create ``exceptions'' to this general permitting 
requirement when the Secretary deems that a permit is not necessary. 
That is, these regulated activities are allowed, under certain 
conditions, without seeking prior authorization via permit. The current 
APHIS regulations refer to these PPA exceptions as ``exemptions.'' 
Paragraph (b) of current Sec.  340.2 contains a list of exemptions from 
the requirement for a permit for the interstate movement of certain GE 
strains of the microorganisms Escherichia coli, Saccharomyces 
cerevisiae, and Bacillus subtilis, and the plant Arabidopsis thaliana. 
One of the conditions for this exemption for the listed microorganisms 
is that the cloned material does not include the complete infectious 
genome of a known plant pest.
    Because, under Sec.  340.0, APHIS must have determined that a GE 
microorganism is a plant pest in order for it to be a regulated 
organism, the GE microorganism strains mentioned above, which APHIS has 
evaluated and determined to present no plant pest risk, would not be 
regulated organisms. Thus APHIS would not need to retain specific 
permitting exemptions for them in Sec.  340.2.
    APHIS would also retain the exemption from interstate movement 
permits for GE organism A. thaliana due to its historically exempted 
status. The exemption would be contained in Sec.  340.3.
    APHIS would propose changes to the list through publication of a 
Federal Register notice. The notice would state why APHIS has 
determined it necessary to add or remove a taxon from the list, and 
would request public comment.
    APHIS would review the comments received and publish its final 
decision in the Federal Register.
    The PPA also allows for a person to petition the Secretary to add 
or remove a plant pest from the regulations. Currently, Sec.  340.5 
contains provisions for petitioning the Administrator to amend the list 
of organisms in Sec.  340.2 by either adding or deleting any genus, 
species, or subspecies. The list of requirements for petitioning the 
Administrator include formatting and submission procedures that are 
currently contained in Sec.  340.5(b).
    However, these procedures have not been updated since 1994. While 
most of the procedures are still accurate, some of them have changed. 
For example, the requirements do not consider the potential for 
electronic submission of a petition via email. They also provide an 
obsolete address for postal submissions. Therefore, APHIS is proposing 
to remove the specific requirements related to formatting and 
submission procedures for petitions from the regulations. The 
procedures would instead be located on the Internet at http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule. APHIS is also 
proposing to revise the submission procedure to allow petitions to be 
submitted via email, and to update the address for postal submissions.
    These changes would update the submission procedure, and allow for 
greater flexibility in revising procedures, if, for example, the 
address for submissions changes in the future.
    Please note that, regarding the formatting procedures, APHIS is 
proposing to retain a requirement that the petition not contain trade 
secrets or CBI. APHIS often needs CBI for permit applications, 
particularly for those that request the release of a GE organism into 
the environment, in order to determine the appropriate permitting 
conditions, and APHIS may need CBI as part of a regulatory status 
evaluation in accordance with proposed Sec.  340.4 in order to assess 
the plant pest and/or noxious weed risk associated with the organism 
submitted for evaluation. However, a determination that a taxon is or 
contains a plant pest will be based on a review of scientific 
literature, and thus, CBI is not germane to our determination.
    Following the receipt of a petition to amend the list of organisms 
in Sec.  340.2, APHIS would publish a notice announcing the 
availability of the petition in the Federal Register and solicit public 
comment on the petition for 60 days. Following the close of the comment 
period, the Administrator would announce his or her decision to either 
approve the petition in whole or in part or deny the petition in a 
subsequent Federal Register notice.
    Finally, APHIS is proposing to add an appeals process in the event 
that the Administrator denies a request to amend the list of taxa that 
are described in Sec.  340.2. Any person whose petition has been denied 
would be able to appeal the decision in writing to the Administrator 
within 30 days after receiving the written notification of the denial. 
The appeal would have to state all of the facts and reasons upon which 
the person relies to assert that the petition was wrongfully denied. 
The Administrator would then grant or deny the appeal, in writing, 
stating the reasons for the decision as promptly as circumstances 
allow.
Notification
    The current regulations in Sec.  340.3 provide criteria for a 
notification procedure whereby certain GE plants may be authorized for 
importation, interstate movement, or environmental release in lieu of a 
permit. As mentioned previously in this document, rather than using 
customized requirements, like the permitting conditions used for the 
permitting procedure, the notification procedure uses 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.
    Rather, currently, APHIS reviews notifications to verify that the 
GE plants meet the eligibility criteria and also evaluates whether the 
proposed importation, interstate movement, or environmental release can 
be done in a manner that meets the performance-based standards 
described in the regulation. In many ways, these APHIS evaluations for 
notifications are very

[[Page 7020]]

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, 
but the general nature of the standards has made it difficult for APHIS 
inspectors to determine if a notification holder is in compliance with 
the standards. This, in turn, can also make enforcement more difficult.
    For example, under the current regulations, one of the performance-
based standards for notifications relevant to controlled outdoor uses 
states that: ``The field trial must be conducted such that (1) the 
regulated article will not persist in the environment, and (2) no 
offspring can be produced that could persist in the environment.'' 
Conversely, conditions which APHIS places on permits are more specific, 
and do not rely as much on subjective determinations by APHIS 
personnel. A specific permit condition that could be used to address 
just part of the performance-based standard described above might read: 
``After final harvest of the plants covered under this environmental 
release permit, the site will be monitored every 4 weeks for the 
emergence of volunteer seedlings for 1 year, and any emerging volunteer 
plants will be devitalized before they produce pollen. Records of the 
monitoring and management of volunteers must be maintained by the 
permit holder and made available to APHIS upon request.''
    The use of performance-based standards under the notification 
procedure has some benefits, such as providing the responsible person 
with flexibility in how the standard is met, e.g., allowing for 
appropriate changes in protocols used during the growing season. 
However, there are some disadvantages in not specifically enumerating 
the specific measures that constitute compliance with the regulations. 
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.
    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 all 
authorizations for movement be conducted under permit.
    As mentioned earlier in this document, the use of the permitting 
procedure in lieu of notifications is also necessary for APHIS to 
address some of the recommendations arising from the OIG audits and the 
provisions of the 2008 Farm Bill. Both the OIG audit and the Farm Bill 
expressed concern with the use of performance-based standards to 
regulate field tests of regulated organisms, and 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 risks 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 significantly 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 both complex and exhaustive. For 
these reasons, APHIS is proposing to do away with the notification 
procedure, rather than revise it.
Permits (Sec.  340.3)
    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 
include specific conditions that must be followed by the permit holder. 
Standard permit conditions, or ``general conditions,'' are listed in 
the current regulations and APHIS can supplement 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 controlled outdoor use. The current regulations also outline 
requirements for protecting CBI when submitting a permit application.
    APHIS proposes to reorganize the regulations to improve the clarity 
of the permit application and evaluation procedures. In addition, APHIS 
is proposing changes to the regulations to reflect certain provisions 
of the 2008 Farm Bill. As APHIS mentioned previously in this document, 
section 10204 of Title X of the Farm Bill requires the Secretary of 
Agriculture to take action on each issue identified in the document 
entitled ``Lessons Learned and Revisions under Consideration for APHIS' 
Biotechnology Framework'' and, where appropriate, promulgate 
regulations.
    APHIS is proposing certain regulatory changes concerning permit 
application information requirements, permit conditions, records, and 
reports that address many of the considerations outlined in the 
``Lessons Learned and Revisions under Consideration for APHIS' 
Biotechnology Framework.'' The permitting procedure would continue to 
identify and obtain information relevant to evaluating the risks 
associated with a proposed movement, and determine and document 
whether, and under what conditions, the activity should be allowed.
    Paragraph (a)(1) of proposed Sec.  340.3 would provide that, except 
as provided in paragraph (a)(2) of the section, APHIS must have 
evaluated a regulated organism in accordance with Sec.  340.4 before 
APHIS will issue a permit for its importation, interstate movement, or 
release into the environment. As mentioned previously in this document, 
Sec.  340.4 would contain our process for evaluating regulated 
organisms for plant pest or noxious weed risk. In order to draft 
permitting conditions that are commensurate with the risk a GE organism 
poses as a plant pest or noxious weed, it is necessary for APHIS to 
have evaluated this risk.
    If this rule is finalized, when it is fully implemented, APHIS 
believes that such

[[Page 7021]]

evaluations will take a matter of months. Additionally, such 
evaluations could often result in a determination that the organism 
poses no risk as a plant pest and/or noxious weed, and thus is not 
subject to the regulations. For these reasons, APHIS envision that, if 
this rule is finalized, most developers would wait for APHIS to issue a 
final determination of regulatory status, in accordance with Sec.  
340.4, before submitting a permit application to import the regulated 
organism, move it interstate, or release it into the environment.
    However, APHIS also envisions that there could be instances in 
which there would be an immediate need to import a regulated organism 
or move it interstate, even though APHIS has not yet evaluated the risk 
it poses as a plant pest and/or noxious weed. This could occur when, 
for example, a developer consolidates research laboratories. To allow 
for such instances, proposed paragraph (a)(2) of Sec.  340.3 would 
provide that APHIS may issue a permit pursuant to the section for the 
importation or interstate movement of a regulated organism that has not 
been evaluated in accordance with Sec.  340.4. For the purposes of 
permitting conditions, APHIS would assume that the regulated organism 
presents a risk as a plant pest and/or noxious weed. If the regulatory 
status of the organism is evaluated in accordance with Sec.  340.4 
during the duration of the permit, APHIS could amend the permit, or, if 
the organism is determined to pose no risk as a plant pest and/or 
noxious weed, terminate the permit and communicate this termination to 
the permittee.
    While APHIS could foresee the need for the Agency to issue such 
permits, APHIS does wish the public to be aware of some of the issues 
that it has identified with doing so. First, because APHIS would not 
have evaluated the organism for plant pest and/or noxious weed risk, 
the Agency would need to presume a high degree of such risk. 
Accordingly, permitting conditions could be significantly more 
stringent for such unevaluated organisms than they would be for the 
same organisms, following evaluation in accordance with Sec.  340.4. 
Second, unlike organisms evaluated in accordance with Sec.  340.4 prior 
to permitting, determining nonregulated status for such organisms would 
not be a category of action that is exempt under APHIS' regulations 
implementing the National Environmental Policy Act (43 U.S.C. 4321 et 
seq.).
    For these reasons, APHIS requests specific public comment regarding 
whether paragraph (a)(2) of Sec.  340.3 is necessary, or addresses a 
scenario that is unlikely to occur under the proposed regulations. 
APHIS also requests public comment regarding whether there are any 
instances in which there would be an immediate need to issue a permit 
for the environmental release of a regulated organism that had not yet 
been evaluated in accordance with Sec.  340.4.
    Paragraph (a)(3) of Sec.  340.3 would state that, except as 
provided in paragraph (c) of Sec.  340.3, a permit must be issued by 
APHIS for the importation, interstate movement, or release into the 
environment of all regulated organisms. Paragraph (c) would provide 
exemptions from interstate permitting requirements for GE A. thaliana.
    Paragraph (b) of proposed Sec.  340.3 would outline how to submit a 
permit application. Applicants would have to submit a permit 
application through a method listed at the Web address contained in the 
regulations; for purposes of this proposed rule, that address is http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule. That Web site 
specifies that permit applications must be submitted using APHIS' 
current electronic permitting system, ePermits, or the paper-based 
APHIS form 2000.
    APHIS is proposing to list the methods for submitting a permit 
application on the Internet, rather than in the regulations, in order 
to make it easier to ensure they remain up-to-date. For example, APHIS 
is currently developing a new electronic permitting system to replace 
ePermits.
    APHIS is also proposing to remove the specific requirements for 
what should be included in a permit application from the regulations. 
Instead, they would be listed on an APHIS Web site; for purposes of the 
proposed rule, that Web site is http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule.
    That Web site would first list general application requirements for 
all permit applications, and then break out additional requirements for 
specific permit applications. General information requirements that all 
types of permit applications would have to provide include the name, 
title, and contact information of the responsible person and agent, if 
possible; the country and locality where regulated organism was 
collected, developed, manufactured, reared, cultivated or cultured; the 
intended activity (i.e., importation, interstate movement, or release 
into the environment) for the regulated organism; and information 
regarding how the regulated organism was developed using genetic 
engineering.
    For interstate movement or importation, the permit application 
would also have to contain the origin and destination of the regulated 
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 regulated article, to be used in 
the importation or interstate movement; and the manner in which 
packaging material, shipping containers, and any other material 
accompanying the regulated organism will be disposed to prevent the 
unauthorized release of the regulated article.
    Permit applications for release into the environment would have to 
address the spread, persistence risk, and potential harm of the 
regulated organism in the environment, including but not limited to a 
description of how the phenotype of the regulated organism differs from 
the phenotype of the recipient organism, particularly with respect to 
potential interactions with, and its likelihood of spread and/or 
persistence in, the environment; and 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 name and contact information of a person at each 
environmental release site, if different from the responsible person. 
In the even 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.
    The categories of information listed above reflect the categories 
of information that APHIS considers necessary to be included in all 
permit applications, as well as additional basic information required 
for each permit type. APHIS has learned that there are certain areas 
that are not specified in the current regulations where APHIS routinely 
needs information from the applicant in order to ensure safety. These 
areas do not become apparent to applicants until they submit a permit 
application and APHIS subsequently follows up for additional 
information in order to assess the activities listed on each permit 
application for plant pest and/or noxious weed risk. This had led to 
two de facto lists of information requirements for permit applications: 
The list in the regulations themselves, and the list of information 
that APHIS routinely requires in order to decide

[[Page 7022]]

whether to grant a permit. By maintaining a single list of permit 
application requirements on the Internet, APHIS can ensure that the 
list is up-to-date and increase clarity regarding the information that 
the Agency needs.
    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 have led to 
provisions that would enable APHIS to require geographic coordinates 
for the locations of environmental releases.
    As mentioned previously, paragraph (c) of Sec.  340.3 would 
continue to exempt A. thaliana from permitting requirements for 
interstate movement. This is based on that organism's historically 
exempt status, which has not resulted in the dissemination of plant 
pests within the United States. In the 1990 proposed rule (55 FR 28637-
28638, Docket No. 90-052) in which APHIS proposed to grant such an 
exemption, the Agency stated its rationale for the exemption: A. 
thaliana has desirable phenotypic 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; GE A. thaliana 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 associated with such movement. This rationale still 
holds true.
    APHIS contemplated a Web-based list of other regulated organisms 
that have been granted exemptions from permitting requirements for 
interstate movement. However, APHIS was not able to identify any 
organisms that would fall within the same category as A. thaliana: A 
taxon for which certain, but not all, types of movement have been 
evaluated and present no plant pest risk. That said, APHIS requests 
public comment regarding any taxa that may be similarly situated.
    Paragraph (d) of Sec.  340.3 would contain specifics regarding 
APHIS' review of permit applications. APHIS would review permit 
applications to determine completeness. If the application is 
incomplete, APHIS would notify the applicant in writing, and the 
applicant would be provided an opportunity to revise the application. 
APHIS is proposing to institute a time limit for receiving additional 
information in the event that a permit application is determined to be 
incomplete. If the applicant does not respond to a request for more 
information within 30 days of receipt of APHIS' request, APHIS would 
deem the permit application withdrawn and return it to the applicant. 
This time limit would help preclude the Agency from acting on a permit 
application when the responsible person no longer desires a permit, and 
would allow APHIS to focus its review of permit applications, while 
also affording applicants sufficient time to provide APHIS additional 
information in the event that they submit incomplete applications.
    Once an application is complete, APHIS would review it to determine 
whether to approve or deny the permit application.
    Paragraph (d)(2) of proposed Sec.  340.3 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 regulated organism and 
activity. General permit conditions, which APHIS is proposing to list 
in paragraph (e) of Sec.  340.3, would be assigned to all permits. 
Additional or expanded permit conditions may also be assigned that are 
commensurate to the risk that the activities listed on the permit 
application present of disseminating the regulated organism, or other 
plant pests or noxious weeds. Examples of such additional requirements 
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 a regulated organism from becoming contaminated with plant 
pests or noxious weeds.
    Under paragraph (d)(3) of proposed Sec.  340.3, all premises 
associated with the permit would be subject to inspection before and 
after permit issuance. APHIS would require that the responsible person 
provide APHIS inspectors access to inspect any relevant premises, 
facility, location, storage area, waypoint, materials, equipment, means 
of conveyance, and other articles related to the movement of organisms 
regulated under 7 CFR part 340. While this requirement is functionally 
the same as current inspection requirements, 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 revocation of the 
permit.
    While the current regulations provide for review of permit 
applications by State regulatory officials, they do not include review 
by Tribal officials when a permit application is submitted for the 
importation into, interstate movement through, or release into the 
environment on Tribal lands of a regulated organism. To correct this 
oversight, APHIS proposes to state in proposed Sec.  340.3(d)(4) that 
APHIS will include relevant Tribal officials when it provides copies of 
permit applications to State regulatory officials.
    Under the current regulations, the permitting procedure does not 
include a formal acknowledgement from the applicant prior to permit 
issuance that they are aware of and consent to the permit conditions. 
APHIS considers such an acknowledgement to be necessary, however, in 
order to verify that applicants are aware of and willing to abide by 
the conditions. Accordingly, APHIS is proposing to add a requirement in 
Sec.  340.3(d)(5) 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.
    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. However, 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 APHIS mentioned above, APHIS would continue to maintain 
general conditions that APHIS would assign to all permits issued under 
the regulations within the regulations themselves. Paragraph (e) of 
Sec.  340.3 would contain these general conditions. APHIS would require 
that:
     The regulated organism must be maintained and disposed of 
in a manner so as to prevent the unauthorized release of the regulated 
organism.
     The regulated organism must be kept separate from other 
organisms, except as specifically allowed in the permit.

[[Page 7023]]

     The regulated organism must be maintained only in areas 
and premises specified in the permit.
     The regulated organism's identity must be maintained at 
all times.
     In the event of an unauthorized release, the regulated 
organism must undergo the application of remedial measures determined 
by the Administrator to be necessary to prevent the spread of regulated 
organism, and 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.
     The duration that a permit is valid will be listed on the 
permit itself. During that time, the responsible person must maintain 
records related to permitted activities of sufficient quality and 
completeness to demonstrate compliance with all permit conditions and 
requirements under the proposed regulations. 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. 
Inspectors must be allowed access, during regular business hours, to 
the place where the regulated organism is located and to any records 
relating to the movement of a regulated organism. APHIS access to 
records includes visual inspection and reproduction (photocopying, 
digital reproduction, etc.) of all records required to be maintained 
under the proposed regulations, as requested by APHIS.
     The responsible person must notify APHIS in writing if any 
permitted activity associated with environmental release will not be 
conducted.
     Within 28 days after the initiation of any permitted 
activity related to environmental release, the responsible person must 
report to APHIS in writing the actual release site coordinates and 
details of the release, such as how many acres planted, how many 
organisms released, etc., based on permit conditions, as well as every 
28 days thereafter until all releases are completed.
     A person who has been issued a permit must submit to APHIS 
an environmental release report within 6 months after the termination 
of any release into the environment. The report must include the APHIS 
reference number, methods of observation, resulting data, and analysis 
regarding all deleterious effects on plants, non-target organisms, or 
the environment.
    Most of the conditions listed above are drawn from the conditions 
found in the current regulations, although APHIS has added some 
additional 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. APHIS believes that these additional details will better 
communicate with applicants what the general permitting conditions are, 
and will better support administration of the permitting program, 
including compliance and enforcement.
    APHIS is also proposing to specify that regular reporting regarding 
any activities associated with environmental release of a regulated 
organism is a general permitting condition. As APHIS 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 permittees.
    Similarly, to respond to the recommendations of the 2005 and 2015 
OIG audits, APHIS would add a requirement for Agency notification if 
any permitted activity associated with environmental release will not 
be conducted as a general permitting condition. 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.
    In addition, while the current general permitting conditions 
require a field test report following termination of a field test, in 
recent years, APHIS has required a more extensive report, an 
environmental release report, through permitting conditions. Our 
general permitting conditions would reflect this.
    APHIS recognizes that these last three general permitting 
conditions pertain only to activities associated with environmental 
release of a regulated organism. APHIS also recognizes that it is 
possible that certain permit applications may not request to release 
the regulated organism into the environment. However, the permit issued 
would still contain these general conditions to communicate to the 
permittee APHIS' general requirements regarding environmental release 
of regulated organisms. This will ensure that all permitees are aware 
of those requirements, and is consistent with the recommendations of 
the OIG audits. 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 regulated organism, APHIS would not retain this as a 
general permitting condition. This is because it would be covered by 
shipping requirements that APHIS is proposing to add to the regulations 
in paragraph (i) of Sec.  340.3.
    Under the current regulations, the Administrator may deny or cancel 
a permit if the applicant has not complied with one or more of the 
conditions listed on the permit. The Administrator will confirm the 
reasons for the cancellation or denial in writing within 10 days, and 
the applicant may appeal the decision in writing within 10 days after 
receiving the written notification of cancelation or denial. The 
Administrator may then grant or deny the appeal, in writing, stating 
the reason for the decision as promptly as circumstances allow.
    APHIS is proposing to elaborate on the circumstances under which a 
permit application may be denied in Sec.  340.3(f)(1). Such 
circumstances would include when the Administrator concludes that, 
based on the application or additional information, the actions 
proposed under the permit may result in the unauthorized release of a 
regulated organism, or another plant pest or noxious weed; or when the 
Administrator determines that the responsible person or any agent of 
the responsible person has failed to comply at any time with any APHIS 
regulation or the conditions of any permit that has previously been 
issued in accordance with the regulations.
    The first condition pertains to instances in which APHIS cannot 
reach a conclusion that the risk of dissemination of regulated 
organisms, plant pests, or noxious weeds will be adequately mitigated 
if APHIS issued a permit authorizing the actions requested on the 
permit application. This could occur when, for example, a responsible 
person does not formally acknowledge that he or she understands the 
permitting conditions.
    The second condition would pertain to instances in which prior 
actions taken by the applicant or his or her

[[Page 7024]]

agents call into question their ability to abide by permitting 
conditions.
    While the current regulations contain procedures for denying a 
permit application, they do not detail measures for APHIS to revoke a 
permit. Therefore, APHIS proposes to establish explicit procedures for 
the revocation of permits. Procedures for revoking a permit would be 
contained in Sec.  340.3(f)(2). These procedures would state that a 
permit may be revoked 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 of a regulated organism, or another plant pest or 
noxious weed; or if the Administrator determines that the responsible 
person or any agent of the responsible person has failed to comply at 
any time with any APHIS regulation or the conditions of any permit 
issued.
    Paragraph (g) would contain the current procedures for appealing 
the denial of a permit application or revocation of a permit.
    APHIS is also proposing to clarify in Sec.  340.3(h) of the 
regulations the procedure to be used when amendment of existing permit 
conditions is sought by the responsible person or required by APHIS. 
Such amendments may include the transfer of the permit to a new 
responsible person. Currently, the administrative practices that APHIS 
uses to amend permits have not been explicit in the regulations, and 
these additions would provide increased transparency and efficiency.
    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 a 
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 regulated 
organisms 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 a duration that an environmental release permit is valid in the 
regulations. The duration that a permit is valid would instead be 
specified on the permit itself, as a permitting condition. These 
changes should give APHIS the flexibility to issue these permits with 
suitable durations to meet individual circumstances.
    Paragraph (i) of Sec.  340.3 would contain shipping requirements 
for regulated organisms. These would specify that all shipments of 
regulated organisms must be secure shipments, which APHIS would define 
as shipments 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.
    Currently, Sec.  340.8 contains container requirements for 
regulated organisms. These requirements are very prescriptive. While 
they do allow responsible persons to request variances from the 
requirements, this request process, by its nature, results in a case-
by-case determination that other types of containers are acceptable for 
the transportation of regulated organisms. 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 regulated organism during 
movement. Our proposed requirements would maintain this performance-
based standard, while making this standard more explicit and the 
requirements less prescriptive, thus eliminating the need for a request 
process for variances.
    APHIS would, however, retain a provision in the current 
regulations, currently a footnote to Sec.  340.8, that specifies that 
all regulated organisms 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 regulated organisms 
that DOT has designated as hazardous materials.
    Paragraph (i) of Sec.  340.3 would also specify that the container 
must be accompanied by a document that includes the names and contact 
details for the sender and the recipient. It would also specify that, 
following the completion of the shipment, all packing material, 
shipping containers, and any other material accompanying the regulated 
organism would have to be treated or disposed of in such a manner so as 
to prevent the unauthorized dissemination and establishment of 
regulated organisms. As mentioned above, this latter requirement is 
currently a general permitting condition, but could more accurately be 
described as a shipping requirement.
    Finally, paragraph (i) would contain container marking and identity 
requirements for imported GE organisms. These requirements are 
currently found in Sec.  340.7.
    APHIS has occasionally received inquiries from stakeholders 
regarding whether a permit could authorize the commercial distribution 
of a regulated organism. Currently, most developers of GE organisms 
generally have not commercialized their products until after those 
products were granted a determination of nonregulated status. However, 
APHIS does not prohibit commercializing GE organisms that have not been 
granted a determination of nonregulated status. APHIS currently 
authorizes a small number of permits for such commercial production.
    Under the proposed regulations, there may be some regulated 
organisms that an entity wishes to commercialize or grow on a large 
scale, under permit. As currently occurs, 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 permitted actions.
Courtesy Permits
    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 7 CFR 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 for the movement of organisms that are not subject to 
the provisions of part 340.
    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

[[Page 7025]]

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 is proposing to remove 
the regulations concerning courtesy permits. It has been common APHIS 
practice to facilitate the importation of non-regulated articles 
through the use of letters indicating that no permit is required. APHIS 
would continue to work with researchers and relevant government 
regulatory officials to facilitate the transition.
Petitions for Nonregulated Status
    The current regulations in Sec.  340.6(a) provide that any person 
may submit a petition to APHIS seeking a determination that an article 
should not be regulated under 7 CFR 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 information that must be included 
in the petition. Those organisms which are granted nonregulated status 
are free of all requirements under 7 CFR part 340. This nonregulated 
status is different from that of certain organisms that meet the 
definition of regulated articles, but which are exempt from the 
requirement for a permit when moved interstate under the specific 
conditions specified in the regulations.
    Published APHIS decisions made under the current regulations 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. In its determinations, APHIS has conveyed 
the basic standard of ``unlikely to pose a plant pest risk'' by 
concluding that the GE organism ``poses no more of a plant pest risk 
than its non-GE counterpart,'' ``will not pose a plant pest risk''; or 
that there is ``no plant pest risk,'' or ``no direct or indirect plant 
pest effects.'' Regardless of the phrases used in its determination of 
nonregulated status to date, APHIS has applied the same basic 
evaluation criteria 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, among 
other things, 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; 
and potential of the GE organism to transmit the introduced trait to 
organisms with which it does not interbreed.
    The current regulations also have a provision in Sec.  340.6(e) to 
extend a determination of nonregulated status to a GE organism based on 
its similarity to an antecedent organism that has already been granted 
nonregulated status. This existing ``extension procedure'' was designed 
for APHIS to take into account the previous evaluation used to grant 
nonregulated status conducted by APHIS and thereby afford the potential 
for expedited evaluations of a petition for extension.
    These provisions in the current regulations are necessary because 
of the manner in which regulated article is defined in the current 
regulations. As APHIS mentioned previously, the current regulations 
consider a GE organism to be a regulated article if the donor organism, 
recipient organism, vector, or vector agent is a plant pest. However, 
because of complexities in the science, and the changing nature of the 
technologies, questions can arise as to whether certain GE organisms 
meet the definition of regulated article. To address these questions, a 
process is necessary to allow parties to request that APHIS evaluate 
the GE organism for plant pest properties, and deregulate it if the 
Agency determines that it is not.
    APHIS does not consider it necessary to retain this process in the 
regulations. As mentioned in our discussion of proposed Sec.  340.0, 
APHIS would no longer regulate a GE organism solely because the donor 
organism, recipient organism, vector, or vector agent of the organism 
is a plant pest. Rather, for the GE organism to be regulated, APHIS 
would have to determine that it is a plant pest or noxious weed, or the 
GE organism would have to not yet be evaluated for plant pest and/or 
noxious weed risk. In other words, APHIS' focal point would change from 
the method by which the organism is genetically engineered, to the 
resulting GE organism itself, and the Agency would no longer assume 
that the use of a plant pest within the development of the GE organism 
necessarily and in every instance results in a GE organism with plant 
pest properties.
    Based on the manner in which proposed Sec.  340.0 is structured, 
APHIS envisions four types of inquiries from developers of GE organisms 
if this rule is finalized. The first would be from developers of 
organisms that are uncertain of the regulatory status of their 
organism, but that consider it to either be outside the scope of 
regulated organisms or similar to an organism that APHIS has already 
evaluated and assigned nonregulated status. The developers would 
present what they consider to be the regulatory status of the organism, 
as well as the information on which the developers rely to support this 
consideration. In such instances, APHIS would review the information 
\7\ and communicate to the developer whether the regulatory status that 
they presented to APHIS was accurate. This is substantially similar to 
the structure of APHIS' current ``Am I regulated?'' program.\8\ That 
being said, because there would be some changes to that program based 
on the provisions of this proposed rule, if it is finalized APHIS would 
make guidance available to aid developers in making such inquiries of 
APHIS.
---------------------------------------------------------------------------

    \7\ In evaluating the similarity between two GE plants, APHIS 
considers whether the mechanisms of action of the introduced traits 
are functionally equivalent. For example, one mechanism of action 
for resistance in plants to the herbicide glyphosate relies on an 
inability of glyphosate molecules to bind and inactivate an enzyme 
called EPSPS, which is responsible for an essential step in a 
biochemical pathway for the synthesis of certain amino acids. If 
glyphosate cannot bind to the EPSPS enzyme, the plant is resistant 
to the herbicide. APHIS has granted nonregulated status to two very 
similar types of GE plants which differed in the donor organism for 
the EPSPS genes: One version of the gene was derived from corn 
(mEPSPS) and the other from a strain of Agrobacterium (CP4 EPSPS). 
However, in both cases the added gene encodes an EPSPS protein which 
does not bind to glyphosate. Accordingly, these two glyphosate 
resistance traits have mechanisms of action which are functionally 
equivalent.
    \8\ See https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/am-i-regulated.
---------------------------------------------------------------------------

    The second type of inquiries that APHIS would expect to receive 
would come from developers of GE organisms that belonged to taxa that 
are listed in accordance with proposed Sec.  340.2 prior to genetic 
engineering, or that have received DNA from such taxa during genetic 
engineering. The developers would provide information regarding the 
development of the GE organism, and would provide information regarding 
why they do, or not consider, the GE organism to be a plant pest, or to 
have received DNA sufficient to produce an infectious entity or encode 
a pathogenesis-related compound that is expected to cause plant disease 
symptoms. Such requests would have to be made in accordance with 
proposed Sec.  340.4.
    The third category of inquiries would come from developers of GE 
plants that APHIS has not yet evaluated for plant pest and noxious weed 
risk and developers of other GE organisms, such as GE insects and other 
invertebrates,

[[Page 7026]]

that were not plant pests prior to genetic engineering, but that APHIS 
has not yet evaluated for plant pest risk as GE organisms. These 
inquiries would request APHIS to evaluate the regulatory status of the 
GE organism. Such requests would also have to be made in accordance 
with proposed Sec.  340.4.
    The fourth category of inquiries would come from developers of GE 
organisms that APHIS has determined to be plant pests or noxious weeds, 
asking for a reevaluation of this determination. Such requests would 
have to be made in accordance with proposed Sec.  340.4.
Regulatory Status Evaluation (Sec.  340.4)
    Proposed Sec.  340.4 would contain the process by which persons 
could request an initial evaluation or subsequent reevaluation of the 
regulatory status of a GE organism. The outcome of a regulatory status 
evaluation is a determination by the agency that a GE organism is a 
nonregulated organism or a regulated organism subject to permitting.
Requests for Evaluation or Reevaluation
    Paragraph (a) of proposed Sec.  340.4 would state that any person 
may submit a request to APHIS to have a GE organism's regulatory status 
evaluated, or to request the reevaluation of the regulatory status of a 
previously evaluated regulated organism. It would provide that the 
information that would have to be submitted with a regulatory status 
request in order for APHIS to evaluate the request is on the Internet, 
at http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule. Such 
information would include:
     A description of the recipient organism (including common 
name; genus, species, and any relevant subspecies information that 
would distinguish the organism; and, for microorganisms, the strain).
     The genotype of the GE organism, including a detailed 
description of the differences in genotype between the organism subject 
to the request and the non-GE organism. If genetic material is inserted 
into the genome, the method of transformation would also have to be 
described and the following provided for each gene:
    [cir] For gene sequences, the name of the sequence, donor 
organism(s) or source, function of sequence, nucleic acid sequence, and 
publicly available sequence identification. If the genes have been 
modified, the nature of the modification and its purpose would have to 
be stated, and the request would have to identify and highlight the 
modifications by submitting an alignment of the modified sequence with 
the unmodified sequence. If the gene is not naturally occurring, the 
request would have to state whether the sequence is based on that of a 
specific organism, and, if so, identify the organism and gene it was 
based on.
    [cir] For regulatory sequences, the function of each regulatory 
sequence as it relates to the gene sequence and the source of each 
regulatory sequence. Promoters (sites on DNA to which the enzyme RNA 
polymerase can bind to initiate the transcription of DNA into RNA) 
would have to be identified as constitutive, inducible, developmental, 
or tissue-specific. If inducible, the inducer would have to be 
described. If developmental, stages at which the promoter is active 
would have to be described. If tissue-specific, the tissues in which 
the promoter is active would have to be described. The strength of the 
promoter would also have to be described. Finally, for microorganisms, 
descriptions of mobile genetic elements would also have to be included.
    [cir] If the genome is edited, the following would also have to be 
provided: The nature of the edit(s) and the gene(s) and function(s) 
being modified, as well as what pathways are expected to be affected; 
for multiple substituted base pairs, the number of substitutions; the 
original unmodified sequence aligned to the modified sequence; and if 
the edits were created using genetic material which was integrated into 
the chromosome, but later eliminated through segregation, techniques 
used to confirm absence of the genetic material.
     A detailed description of the intended phenotype(s) of the 
GE organism. This would include the purpose of the new phenotype and 
the mechanisms of action by which the intended phenotype is conferred; 
any new enzymes, other gene products, or expected changes in 
metabolism; if applicable, the protein accession number and the enzyme 
commission number; and the known and potential differences from the 
non-GE organism that would substantiate that the GE organism is 
unlikely to pose a greater noxious weed risk or plant pest risk than 
the non-GE organism from which it was derived.
     For plants, any information that exists on known or likely 
changes that may affect any of the following would have to be provided: 
Weediness and plant pest characteristics of the plant; competitive 
growth ability; reproduction, spread, and persistence; stress 
tolerance, including a consideration of abiotic stresses such as cold 
and drought tolerance and biotic stresses such as herbivory 
(consumption of the plant) or diseases; and any other weediness or 
plant pest characteristics identified of the plant or other plants with 
which the plant can interbreed.
     For non-plant, non-vertebrate organisms, any information 
that exists on known or likely differences to herbivory or virulence 
must be provided, including: Any observed or anticipated changes due to 
the genetic modification that might affect the ability of the organism 
to cause direct or indirect damage to plants; a description of any 
changes to known factors of pathogenesis and virulence factors such as 
polysaccharides (complex sugars consisting of multiple sugar molecules 
bonded together) and suppressors (genes that suppress expression of 
another gene); a consideration of changes that might affect geographic 
distributions, host range, means of dissemination, horizontal gene 
transfer, reproductive cycle, and persistence; and a description of any 
characteristics introduced to mitigate harm to plants.
     Any experimental data (including field tests) and 
publications that the developer believes might be relevant to APHIS's 
evaluation of the potential of the organism to affect plant health.
    APHIS considers the categories of information specified above, 
which are drawn from our current conditions in Sec.  340.7 for a 
petition for nonregulated status for a GE organism, to be sufficient 
for APHIS to evaluate a GE organism and determine its appropriate 
regulatory status. That being said, the Agency solicits public comment 
on the adequacy of the requested information in proposed 340.4(a), and 
whether additional or alternate requirements would be more appropriate. 
Specifically, APHIS is interested in instances that commenters identify 
in which the above information may be insufficient to reach a 
regulatory status determination.
    To that end, APHIS wishes to highlight some of the differences 
between the above information and the information currently required 
for a request for deregulated status of a GE organism. With regard to 
the genotype of the GE organism, APHIS would add specific information 
requirements for gene sequences, regulatory sequences, and genome 
editing. The current regulations 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 in order for the 
petitioner to provide a detailed description of the

[[Page 7027]]

genotype, and the revised regulations would reflect this operational 
need.
    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 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.
    With regard to the phenotype of the GE organism, the proposed 
requirements would contain additional details that APHIS considers 
necessary in order to evaluate the plant pest risk of microorganisms, 
insects, and other invertebrates. For GE plants, it would also include 
information that APHIS needs in order to prepare a plant pest risk 
assessment and/or a weed risk assessment (WRA, discussed below).
    APHIS is also proposing a significant departure from the current 
requirements for a petition for nonregulated status. The current 
requirements specify that a petition must contain field 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.
    Currently, most of the field data submitted by the regulated 
community to meet this requirement is 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 plant pest or 
noxious weed issues. In addition, APHIS has not received any 
information in such reports indicating a potential for such effects. 
Rather, the Agency has discovered that the expressed phenotype of the 
regulated organism provides the most reliable indicator of the 
organism's potential for deleterious effects on plants and plant 
products. These observations are expected and are consistent with 
findings of several reports of the National Research Council.\9\
---------------------------------------------------------------------------

    \9\ See: NRC (National Research Council). 1989. Field Testing 
Genetically Modified Organisms: Framework for Decisions. Washington, 
DC: National Academy Press.
     NRC (National Research Council). 2004. Safety of Genetically 
Engineered Foods: Approaches to Assessing Unintended Health Effects. 
Washington, DC: National Academies Press.
---------------------------------------------------------------------------

    Accordingly, APHIS considers information from field tests to not 
always be necessary for a determination of regulatory status under the 
proposed regulations. The approach APHIS is proposing focuses primarily 
on evaluating the genetics and expressed phenotype of the regulated 
organism, and the likelihood that, based on these genetics and 
phenotype, the organism will act as a plant pest or noxious weed if it 
is released into the environment for the uses intended by the 
developer.
    This would not preclude a developer from providing field test 
information, if he or she considered such information to be pertinent 
to our determination. For example, if a developer wished APHIS to 
reevaluate the status of an organism that the Agency had previously 
considered to be a regulated organism, field test information 
demonstrating a lack of 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. However, field test information would not be a generally 
applicable requirement for requests for a regulatory status 
determination, and would only be requested rarely, and on an as-needed 
basis.
Risk Analyses in Response to Regulatory Status Requests
    Paragraph (b) would outline the actions the Administrator would 
take in response to a regulatory status request. If the request is 
complete, APHIS would conduct a risk analysis that includes an 
evidence-based, standardized approach to analyzing plant pest and/or 
noxious weed risks associated with the GE organism.
    Currently, when APHIS receives petitions for a determination of 
regulated status, APHIS conducts risk assessments. Historically, these 
assessments have focused on evaluating the plant pest risk of the 
regulated organism. However, in recent years, they have also included a 
weediness assessment when the regulated organism is a plant.
    The proposed regulations would specify that, if APHIS receives a 
request to evaluate the regulatory status of a GE organism, the Agency 
will conduct a risk analysis. The analysis would include, inter alia, 
preparation of a plant pest risk assessment, a weed risk assessment, or 
both. APHIS would prepare a plant pest risk assessment (PPRA) for 
organisms that have received DNA from any taxon listed in accordance 
with Sec.  340.2, if the DNA from the donor organisms are sufficient to 
produce an infectious entity capable of causing plant disease or 
encodes a compound known to be pathogenesis-related that is expected to 
cause plant disease symptoms, and the GE organisms have not been 
evaluated by APHIS for plant pest risk. APHIS would also prepare a PPRA 
for GE plants, if our initial evaluation of the plant suggested the 
plant may be parasitic. APHIS would also prepare a weed risk assessment 
for GE plants with plant and trait combinations that have not been 
evaluated by APHIS for noxious weed risk.
    APHIS' weed risk analysis processes would use a WRA, a system 
developed by APHIS for the purpose of assessing noxious weed risk of GE 
organisms. Regulatory status decisions for GE plants would be informed 
based on a risk manager's evaluation and interpretation of the results 
of the WRA (and, for parasitic plants or plants that may otherwise fall 
within the scope of the definition of plant pest, the PPRA).
    While this risk analysis would be informed by APHIS's risk 
assessment experience with GE organisms as well as APHIS' evaluation of 
other existing weed risk assessment systems that have been developed, 
since the WRA system for GE organisms is new, APHIS is making the WRA 
system publicly available along with this proposed rule. (To view the 
WRA system or guidance, go to http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule.) Similarly, APHIS will make WRAs available to 
the public to help make our risk management decisions as transparent as 
possible.
Notices of Request for Evaluation of Regulatory Status
    Proposed paragraph (c) of Sec.  340.4 would discuss our proposed 
notice-based process for making evaluation of regulatory status 
available to the public. APHIS would make both the request and the risk 
analysis available for public review through a notice published in the 
Federal Register. This first notice would request public comment, and 
would propose a regulatory status for the organism.
    If no comments are received on the notice, or if the comments do 
not affect the conclusions of the risk analysis or the proposed 
regulatory status of the organism, APHIS would provide notification 
through the APHIS stakeholder registry at the end of the

[[Page 7028]]

comment period announcing that the proposed regulatory status has been 
finalized.\10\ APHIS would subsequently publish a notice in the Federal 
Register compiling these determinations.
---------------------------------------------------------------------------

    \10\ To subscribe to the APHIS stakeholder registry, go to: 
https://public.govdelivery.com/accounts/USDAAPHIS/subscriber/new.
---------------------------------------------------------------------------

    Alternatively, if comments lead APHIS to change its proposed 
regulatory status for the organism, APHIS would publish a subsequent 
notice in the Federal Register characterizing these comments and 
announcing the new regulatory status.
Record Retention, Compliance and Enforcement (Sec.  340.5)
    APHIS is proposing to consolidate all record retention, compliance, 
and enforcement requirements in 7 CFR part 340 into a new Sec.  340.5. 
APHIS is also proposing to strengthen its program in order to manage 
compliance with the regulations more efficiently, to augment the 
approaches used to prevent or remediate potential risks to plant 
health, 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 
records demonstrating that a regulated organism that was imported or 
moved interstate under a permit arrived at its intended destination for 
1 year, but contain no record retention requirements related to 
environmental release of a regulated organism. 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, recommendations that are corroborated by the 
Agency's own experience administering the regulations.
    Therefore, APHIS is proposing that all records related to permit 
conditions, other than those demonstrating that a regulated organism 
that was imported or moved interstate arrived at its intended 
destination, be retained for 10 years following permit expiration, 
unless APHIS determines otherwise and documents an alternate record 
retention requirement. In the event of an investigation into the 
possible unauthorized environmental release of a regulated organism, or 
the escape of a regulated organism from a 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. When APHIS has investigated unauthorized 
environmental releases of regulated organisms, this has necessitated 
obtaining information from field trials that were conducted up to 10 
years prior to the investigation. In instances in which the information 
was not available, this adversely impacted APHIS' ability to do an 
expeditious and thorough investigation.
    APHIS is also proposing to extend the record retention requirement 
that demonstrates that a regulated organism that was imported or moved 
interstate arrived at its intended destination from 1 to 2 years. 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.
    APHIS recognizes that, in practice, our proposed requirements would 
require most records associated with permitted activities to be 
retained 10 years, and that this is a significant duration to retain 
potentially a substantial number of records pertaining to permit 
activities. However, retaining documents for less than 10 years may 
impede an investigation into compliance infractions. 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 an 
investigation of possible regulatory noncompliance.
    The section would specify that responsible persons and their agents 
must comply with the proposed regulations. Failure to comply with the 
regulations could result in denial of a permit application or 
revocation of a permit, application of remedial measures in accordance 
with the PPA, or criminal or civil penalties.
    Pursuant to sections 7714 and 7731 of the PPA, APHIS may seize, 
quarantine, treat, destroy, or apply other remedial measures to a 
regulated organism 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 Notifications or 
administrative order to the owner of the regulated 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.
    Finally, the section 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.
Container and Shipment Requirements
    The regulations in current Sec. Sec.  340.7 and 340.8 provide 
detailed requirements for identifying and securely shipping containers 
of regulated organisms. In the revised regulations, general 
requirements which apply to all shipments of regulated GE organisms 
under permit are now listed in paragraph (i) of Sec.  340.3. Additional 
supplemental conditions will be used when permits are issued to add 
additional case-specific measures. These supplemental conditions will 
be listed on the permit itself as permitting conditions. This will 
allow the agency to take into account the widely varying types and 
quantities of GE organisms to be shipped and apply highly effective yet 
reasonable requirements.
Confidential Business Information (Sec.  340.6)
    As mentioned previously, in the current regulations, there are 
guidelines for denoting information on a permit application or petition 
for a determination of nonregulated status as CBI in different sections 
of the regulations. In the proposed regulations, APHIS is proposing to 
consolidate these guidelines for protecting CBI into a single section, 
Sec.  340.6. This change would support the overall administration of 
the program by consolidating all relevant requirements, thereby making 
it easier for interested persons to find the necessary information.
Definitions (Sec.  340.1)
    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 appear 
in the regulations.
    APHIS is proposing to retain the following definitions from the 
current regulations, without change: Administrator, Animal and Plant 
Health Inspection Service (APHIS), donor organism, environment, 
organism, and person.
    APHIS is proposing to change the definitions of the following terms 
from those in the current regulations:
    As mentioned in the discussion of proposed Sec.  340.0, the 
definition of

[[Page 7029]]

genetic engineering would read ``techniques that use recombinant or 
synthetic nucleic acids with the intent to create or alter a genome,'' 
and would exclude traditional breeding techniques (including, but not 
limited to, marker-assisted breeding and chemical or radiation-based 
mutagenesis, as well as tissue culture and protoplast, cell, or embryo 
fusion).
    This would replace the current definition for genetic engineering, 
``the genetic modification of organisms by recombinant DNA 
techniques.'' The regulations do not define ``recombinant DNA 
techniques,'' and the current definition could also be construed to 
exclude the use of synthetic DNA, in-vivo DNA manipulation, and genome 
editing. For the purposes of this rule, APHIS is proposing to consider 
genome editing to be within the definition of genetic engineering. 
APHIS is also proposing to exclude from the definition of genetically 
engineered organism GE organisms that could have been produced via 
traditional breeding.
    APHIS recognizes that APHIS had previously suggested this proposed 
rule would use the term biotechnology, and would define biotechnology 
in the following manner: ``Laboratory-based techniques to create 
omodify a genome that result in a viable organism with intended altered 
phenotypes. Such techniques include, but are not limited to, deleting 
specific segments of the genome, adding segments to the genome, 
directed altering of the genome, creating additional genomes, or direct 
injection and cell fusion beyond the taxonomic family that overcomes 
natural physiological reproductive or recombination barriers. For the 
purposes of this part, this definition does not include traditional 
breeding, marker-assisted breeding, or chemical or radiation-based 
mutagenesis.''
    A number of stakeholders understood the limitations associated with 
the current definition of genetic engineering, but questioned the need 
to abandon the term in favor of biotechnology. They pointed to APHIS' 
long-standing use of the term genetic engineering, and suggested that 
using a different term could lead to confusion among the regulated 
community and the general public.
    Additionally, several stakeholders expressed concern regarding the 
proposed definition of biotechnology. They pointed out to APHIS that 
traditional breeding often uses laboratory-based techniques, such as 
tissue culture and embryo rescue, to create or modify a genome, and 
radiation-based mutagenesis, which modifies genomes, is often conducted 
in a laboratory. The stakeholders expressed concern that the definition 
could result in widespread confusion regarding which laboratory-based 
techniques to alter a genome are considered biotechnology, and which 
are not.
    Stakeholders also encouraged APHIS to refer to other existing 
definitions used to define biotechnology or genetic engineering.
    When APHIS issued the current regulations, the Agency relied on 
guidelines developed by the National Institutes of Health (NIH) 
regarding research on genetically engineered organisms to craft the 
definition of ``genetic engineering.'' Accordingly, in light of the 
above stakeholder concerns, APHIS revisited NIH guidelines regarding 
research on genetically engineered organisms. The definition that APHIS 
is proposing is based on NIH's ``Guidelines for Research Involving 
Recombinant or Synthetic Nucleic Acid Molecules,'' which are located at 
http://osp.od.nih.gov/sites/default/files/NIH_Guidelines.html. The 
section in that document that pertains to research on plants that have 
been genetically engineered contextually delineates the scope of 
genetic engineering in a manner that is equivalent to the scope of our 
proposed definition.
    Inspector would read ``Any individual authorized by the 
Administrator of APHIS or the Commissioner of Customs and Border 
Protection, Department of Homeland Security, to enforce the regulations 
in this part.'' 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 
Customs and Border Protection.
    Interstate would read ``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 change aligns the definition of ``interstate'' in 7 CFR 
part 340 with the definition of ``interstate'' used in the PPA.
    Move (moving, movement) would read ``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 change aligns the 
definition of ``move'' in 7 CFR part 340 with the definition of 
``move'' used in the PPA.
    Permit would read ``A written authorization, including by 
electronic methods, by the Administrator to move regulated organisms 
and associated articles under conditions prescribed by the 
Administrator.''
    This change generally aligns the definition of permit in 7 CFR 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, APHIS would specify 
that, for purposes of part 340, it pertains to the movement of 
regulated organisms and associated articles. This reflects the scope of 
the proposed regulations.
    Additionally, while the PPA allows for the issuance of oral 
permits, APHIS would not. 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 read ``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, and a seed.'' This change is necessary because the 
current definition of ``plant'' used in the regulations precedes the 
issuance of the PPA, and is broader than that definition. Therefore, 
APHIS would align the definition with the definition in the PPA itself.
    A result of this alignment would be that APHIS would no longer 
consider ``cellular components,'' such as ribosomes, to be plants. 
However, cellular components are not capable of propagating to cause 
plant pest or noxious weed risks.
    Plant pest would read ``Any living stage of a protozoan, 
invertebrate 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 change generally aligns the definition of ``plant 
pest'' in 7 CFR part 340 with the definition of ``plant pest'' 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 considering that 
this would

[[Page 7030]]

require APHIS to consider livestock, such as cows, sheep, and horses, 
to be plant pests.
    Recipient organism would read ``The organism whose nucleic acid 
sequence will be altered through the use of genetic engineering.'' In 
contrast, the current definition is ``the organism which receives 
genetic material from a donor organism.'' This change from the former 
definition is intended to be more precise by distinguishing an organism 
with altered traits from the same organism prior to transformation.
    Release into the environment (environmental release) would read 
``The use of a regulated organism outside the physical constraints 
found in a contained facility.'' This change from the former definition 
removes the word ``regulated article,'' which APHIS proposes to replace 
with the term ``regulated organism.'' This change also removes examples 
of types of physical confinement and replaces them with the term 
``contained facility,'' which APHIS is proposing to define. Finally, 
this term clarifies that ``release into the environment'' and 
``environmental release'' are synonymous terms. This can be inferred 
from the current regulations, but is not explicit.
    Responsible person would read ``The person who has control and will 
maintain control over a regulated organism during its movement and 
ensures compliance with all conditions contained in any applicable 
permit or exemption as well as other requirements in this part. A 
responsible person must be at least 18 years of age and be a legal 
resident of the United States.'' This change would remove the term 
``introduction'' and replace it with the term ``movement.'' It would 
also replace the term ``GE organism'' with the term ``regulated 
organism'' and add that a responsible person must be ``at least 18 
years of age.'' The first two changes are to reflect the nomenclature 
used in the proposed regulations. The last change is necessary because 
individuals under the age of 18 are minors.
    State would read ``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 7 CFR part 340 with 
the definition of ``State'' used in the PPA.
    State or Tribal regulatory official would read ``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 importation, interstate movement, or environmental 
release is to take place.'' The change from the former definition is 
the acknowledgement of Tribal authority on Tribal lands.
    APHIS proposes to add definitions of the following new terms:
    Agent would read ``A person who is authorized to act on behalf of 
the responsible person to maintain control over a regulated organism 
during its movement and ensures compliance with all conditions 
contained in any applicable permit or exemption as well as other 
requirements in this part. 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 clarify that the responsible person may 
designate another person to act on the responsible person's behalf, but 
that the person so designated must comply with all relevant regulations 
regarding the regulated organism as the responsible person must.
    Contained facility would read ``A structure for the storage and/or 
propagation of living organisms designed with physical barriers capable 
of preventing the escape of the enclosed organisms. Examples could 
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.
    Genetically engineered organism (GE organism) would read ``an 
organism developed using genetic engineering.'' As mentioned previously 
in this document, for purposes of the proposed regulations, APHIS would 
not consider an organism to be a GE organism if any of the following 
are the case:
     The genetic modification to the organism is solely a 
deletion of any size or a single base pair substitution which could 
otherwise be obtained through the use of chemical- or radiation-based 
mutagenesis.\4\
     The genetic modification to the organism is solely 
introducing only naturally occurring nucleic acid sequences from a 
sexually compatible relative that could otherwise cross with the 
recipient organism and produce viable progeny through traditional 
breeding (including, but not limited to, marker-assisted breeding, as 
well as tissue culture and protoplast, cell, or embryo fusion).
     The organism is a ``null segregant,'' that is, the progeny 
of a GE organism where the only genetic modification was the insertion 
of donor nucleic acid into the recipient's genome, but the donor 
nucleic acid is not passed to the recipient organism's progeny and the 
donor nucleic acid has not altered the DNA sequence of the progeny.
    Import (importation) would read ``To move into, or the act of 
movement into, the territorial limits of the United States.'' This is 
the definition of ``import'' used in the PPA.
    Interstate movement would read ``To move interstate.'' This 
proposed definition is necessary to clarify the specific type of 
movement referenced in the regulations.
    Noxious weed would read ``Any plant or plant product that can 
directly or indirectly injure or cause damage to crops (including 
nursery stock or plant products), livestock, poultry, or other 
interests of agriculture, irrigation, navigation, the natural resources 
of the United States, the public health, or the environment.'' This is 
the definition for noxious weed found in the PPA.
    Nucleic acid would read ``A chain or chains of nucleotides found in 
either DNA or RNA.'' This proposed definition is necessary to clarify 
the term ``nucleic acid,'' which is used in reference to ``regulatory 
sequences'' in the proposed regulations.
    Plant pest risk assessment would read ``An assessment evaluating 
whether a GE organism is a plant pest.''
    Plant product would read ``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 
is the definition of plant products found in the PPA. This definition 
is more precise than the current definition of ``product'' in 7 CFR 
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 plant pest 
or noxious weed risks.
    Regulated organism would read ``Any GE organism that is regulated 
pursuant to Sec.  340.0.'' This definition would replace the definition 
of ``regulated article.''
    Regulatory sequence would read ``A segment of nucleic acid molecule 
that is capable of increasing or decreasing the expression of specific 
genes within an organism.'' This definition would be added to ensure 
clarity within the

[[Page 7031]]

requirements for regulatory status determinations.
    Secure shipment would read ``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.
    Unauthorized release would read: ``The intentional or accidental 
release of a regulated organism in a manner not authorized by a permit 
issued pursuant to 7 CFR part 340.''
    Weed risk assessment would read ``An assessment of the 
characteristics of a plant as these relate to weediness.''
    APHIS proposes to remove the following definitions from the 
regulations: Antecedent organism, courtesy permit, expression vector, 
introduce or introduction, product, regulated article, Secretary, 
stably integrated, 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 eliminate the term 
regulated article partly because the use of the term ``article'' in 
current part 340 is not consistent with usage in the PPA, which uses 
the term article to mean ``any material or tangible object that could 
harbor plant pests or noxious weeds''--that is, things like packing 
materials, shipping containers, commodities, etc.--and not a plant pest 
or noxious weed itself. Under the current regulation, however, 
regulated article refers exclusively to certain genetically engineered 
organisms. For this reasons, the term ``regulated article'' in the 
current regulations is both inconsistent with the terminology of the 
PPA and difficult for the public to comprehend.
    APHIS also proposes to remove the definition for 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 will 
instead refer to these activities in the regulations as movement in 
accordance with the definition of move in the PPA. Additionally, as 
APHIS mentioned above, the regulations will specify and define the 
types of movements to which the regulations would apply, namely, 
importation, interstate movement, and release into the environment.
    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 title of part 340 to 
``Movement of organisms altered or produced through genetic engineering 
that are noxious weeds or plant pests or that there is reason to 
believe are noxious weeds or plant pests.''
Costs and Charges (Sec.  340.7)
    Section 340.7 would contain APHIS' policy 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 be 
unchanged.
Technical Evaluations
    APHIS recognizes that many aspects of our proposed rule hinge on a 
determination by APHIS regarding the plant pest or noxious weed risk 
posed by a particular GE organism or class of GE organisms. Often, 
APHIS will be able to make a determination of plant pest or noxious 
weed risk based on our collective experience regulating genetic 
engineering and review of relevant scientific literature.
    However, as genetic engineering evolves and new genetic engineering 
techniques are developed, APHIS may lack technical expertise to fully 
evaluate certain GE organisms or classes of GE organisms. This is 
particularly likely when new or emerging genetic engineering techniques 
are applied to recipient organisms that have not previously been 
subject to genetic engineering.
    In such instances, APHIS may rely on researchers or other Federal, 
State, Tribal, or industry experts to provide information to help APHIS 
determines the organism's appropriate regulatory status. APHIS may 
solicit such information through a variety of means, including, but not 
limited to, working groups, workshops, peer review of documents 
(particularly risk analyses), or webinars.
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 Web site 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 and 13563 and Regulatory Flexibility Act
    This proposed rule has been determined to be significant for the 
purposes of Executive Order 12866 and, therefore, has been reviewed by 
the Office of Management and Budget.
    We have prepared an economic analysis for this rule. The economic 
analysis provides a cost-benefit analysis, as required by Executive 
Orders 12866 and 13563, which direct agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, and equity). 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 Web site (see ADDRESSES above for instructions 
for accessing Regulations.gov).
    Under the PPA, the Secretary of Agriculture is authorized to 
regulate the movement into and through the United States of plants, 
plant products, and other articles to prevent the

[[Page 7032]]

introduction or dissemination of plant pests and noxious weeds. As one 
part of its implementation of the PPA, APHIS regulates the safe 
introduction (environmental release, interstate movement, and 
importation) of certain GE organisms that might be plant pests (7 CFR 
part 340). APHIS is proposing to revise its regulation of GE organisms 
to respond to emerging trends in genetic engineering, to more 
efficiently use APHIS resources, and eliminate unnecessary regulatory 
burdens.
    The proposed revisions to 7 CFR part 340 would create the framework 
for more focused, risk-based regulation of the GE organisms that pose 
plant pest and/or noxious weed risks. They would establish a regulatory 
status evaluation process in which risk analysis would be used to 
assess whether permitting of a GE organism is necessary. Shipping 
standards would be less prescriptive and more generally applicable, and 
the rule would provide for the issuance of multi-year permits. The 
proposed rule would also exclude certain techniques from the definition 
of genetic engineering and certain organisms from the definition of 
genetically engineered organism. These changes would improve the 
efficiency and clarity of the regulations.
    The proposed amendments 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, and protection against 
noxious weed risks would be enhanced. The risk-based process used to 
determine regulatory status under the proposed rule would provide cost 
savings to the biotech industry and allow for reallocation of APHIS 
resources to Biotechnology Regulatory Services (BRS) priorities.
    Based on APHIS' experience evaluating field trial data from 
thousands of permits that authorize environmental release of regulated 
organisms, as well as more than 150 petitions for non-regulated status, 
APHIS has determined that most of the GE organisms evaluated by the 
Agency do not merit regulatory oversight under the PPA. There would be 
both direct and indirect economic benefits of not subjecting the 
majority of these organisms to permitting requirements.
    Direct regulatory costs to biotech developers would be reduced for 
those organisms that are not considered to pose plant pest and/or 
noxious weed risk. Savings to the regulated community would result from 
a reduced need to collect field data, fewer reporting requirements, and 
lower management costs. Petitions for non-regulated status--and the 
petition costs incurred--would be eliminated. There would be some new 
costs borne by regulated entities under the proposed rule including 
rule familiarization and recordkeeping. Recordkeeping cost tabulations 
are based on the information collection categories from the paperwork 
burden section of the rule, and are estimated to total about $275,000. 
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 
cost of about $576,000.
    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 biotech developers as they pursue regulatory authorization of 
their innovations. When only USDA has regulatory oversight, compliance 
cost savings under the proposed rule could range from $1.5 million to 
$5.4 million for the development of a given GE trait. If EPA and/or FDA 
also have an oversight role in the development of a given GE trait, 
compliance cost savings could range from $485,000 to $861,000. Since 
1992, between 2 and 14 petitions have been processed (granted non-
regulated status or the petition withdrawn) in a given year, with an 
average of just under 6.
    Because the rule is expected to spur innovation, we expect the 
number of new organisms developed annually to increase over time. In 
the following discussion, the annual number of new GE organisms 
developed under the proposed rule would range from 6 (the current 
annual average), to 12 (twice this average), with 10 as an intermediate 
number. For GE organisms that would have solely required USDA 
oversight, the annual savings could range from $8.8 million to $32.4 
million (6 new organisms), from $14.7 million to $53.9 million (10 new 
organisms), and from $17.6 million to $64.7 million (12 new organisms). 
For organisms that are submitted for multi-agency evaluation, the 
annual savings could range from $2.9 million to $5.2 million (6 new 
organisms), from $4.9 million to $8.6 million (10 new organisms), and 
from $5.8 million to $10.3 million (12 new organisms).
    APHIS costs of regulating GE organisms that may pose plant pest or 
noxious weed risks also are expected to change under the proposed rule. 
Fewer permits would be issued and notifications and petitions for non-
regulated status would be eliminated, but more risk assessments for 
regulatory determination would be performed. Current annual personnel 
costs of conducting GE activities (costs of activities that would be 
affected by the proposed rule) are estimated to total about $5.6 
million. With the proposed rule, annual costs are expected to range 
from $2.5 million to $7.8 million, depending on the volume of permits, 
weed risk assessments, inspections, and NEPA activities. In addition, 
costs to APHIS of implementing the proposed rule 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 $88,000. 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.
    A quicker USDA evaluation process and related reduction to firms' 
regulatory uncertainty may facilitate small companies' ability to raise 
venture capital. Reduced regulatory requirements may also lead to 
greater participation by the public sector in GE research. 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. While the 
proposed rule may help promote biotech innovations, the pace of 
commercialization and volume of GE products commercialized are not 
expected to change dramatically from current levels. Nor is control 
over the development process expected to be materially altered by the 
proposed rule. It would be in a biotech 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.
    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 developers 
consider voluntary consultations with FDA on food safety to be an 
absolute necessity for applicable GE products.\11\ Developers also have 
various legal, quality control

[[Page 7033]]

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

    \11\ 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.
---------------------------------------------------------------------------

    Certain plants are genetically engineered in order to produce 
pharmaceutical or industrial compounds (plant-made pharmaceuticals or 
industrials), or PMPIs. Under the provisions of the proposed rule, 
there is a possibility that APHIS could reach a determination that a GE 
plant that produces PMPIs is not a regulated organism. Such a plant 
would not be subject to field trial oversight by USDA, and could be 
planted before or without an evaluation by FDA or EPA. Several options 
have been identified for addressing this potential gap in oversight. 
APHIS estimates that current PMPI inspections cost roughly $35,000 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 of the PMPI oversight 
scenarios.
    Certain plants are genetically engineered to produce PIPs. PIPs 
fall under the regulatory oversight of EPA. However, APHIS exercises 
regulatory oversight of all PIP plantings on 10 acres or less of land. 
Under the proposed rule, APHIS would only require permits for PIPs 
planted on 10 acres or less if they present a plant pest or noxious 
weed risk or have not yet been evaluated by APHIS for such risk. This 
proposal would shift Federal oversight of small-scale (10 acres or 
less) outdoor plantings of PIPs to EPA. EPA may decide to require EUPs 
for all, some, or none of such PIPs, and may conduct inspections of 
all, some, or none of those PIPs under permit. EPA would need to 
develop a program to oversee small-scale testing of PIPs and issue 
regulations if warranted. APHIS is fully committed to coordinating with 
EPA in this matter in order to give EPA time to stand up such a 
program. APHIS understands that a memorandum of understanding (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 of oversight of outdoor planting of PIPs on 10 acres or 
less. APHIS recognizes that there are challenges associated with such a 
transition that also would require EPA to incur the costs associated 
with setting up a revised regulatory program. Further, it would require 
policies, procedures, and guidance regarding APHIS' interaction with 
EPA.
    Farmers who adopt GE crops also may indirectly 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.
    On the other hand, some farmers (e.g., growers of organic and or 
identity-preserved crops) could be 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'' or organic. When crops intended for the non-GE or identity-
preserved marketplace contain unintended GE products, the value of the 
non-GE or identity-preserved product is diminished. Effects of the 
proposed rule on the variety of GE crop species grown in the United 
States and their wider adoption may increase risks of cross-pollination 
or commingling. As more small acreage crops are modified using genetic 
engineering, the unintended presence of a GE organism becomes 
increasingly possible. 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. APHIS welcomes 
public comment on the proposed rule's possible impacts.
    The following table provides a summary statement of the expected 
direct benefits and costs of the proposed rule:

    Expected Annual Benefits and Costs of the Proposed Rule for the Biotechnology Industry and for USDA, 2015
                                                     Dollars
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
                Entity
----------------------------------------------------------------------------------------------------------------
Biotechnology Industry...............                                Costs ($1,000)
                                      --------------------------------------------------------------------------
Developer costs (recordkeeping and                                        851
 rule familiarization) \1\.
----------------------------------------------------------------------------------------------------------------
                                                            Cost Savings per Trait ($1,000)
----------------------------------------------------------------------------------------------------------------
        Developer Savings \2\                                     Proposed rule, lower     Proposed rule, upper
                                                                          bound                    bound
----------------------------------------------------------------------------------------------------------------
USDA sole regulatory agency..........  .......................  -1,468.................  -5,393
USDA with FDA and/or EPA oversight...                           -485...................  -861
----------------------------------------------------------------------------------------------------------------
APHIS Biotechnology Regulatory                                       Costs ($1,000)
 Services.
----------------------------------------------------------------------------------------------------------------

[[Page 7034]]

 
Costs for public outreach, training,                                       88
 and epermitting \3\.
----------------------------------------------------------------------------------------------------------------
   Activities affected by the rule           Current rule         Proposed rule, lower     Proposed rule, upper
                                                                          bound                    bound
----------------------------------------------------------------------------------------------------------------
Notifications........................  203....................  0......................  0
Petitions............................  2,130..................  0......................  0
Interstate movement and environmental  239....................  139....................  261
 release permits.
Courtesy permits.....................  19.....................  0......................  0
Letters of No Permit Required........  0......................  3......................  3
``Am I Regulated'' Process...........  7......................  0......................  0
Weed risk assessments................  0......................  700....................  1,265
Compliance and Inspections...........  361....................  361....................  1,014
NEPA/ESA.............................  2,648..................  1,324..................  5,297
                                      --------------------------------------------------------------------------
    Total \4\........................  5,607..................  2,527..................  7,840
----------------------------------------------------------------------------------------------------------------
\1\ Becoming familiar with the rule are one-time costs.
\2\ These savings are shown on a per trait basis. If between 6 and 12 GE organisms are developed each year that
  would have solely required USDA oversight, annual savings could range from $9 million to $64.8 million. If
  between 6 and 12 new GE organisms per year are submitted for multi-agency evaluation, the annual savings could
  be from $2.9 million to $10.3 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 new costs.
\4\ Annual staffing costs of APHIS Biotechnology Regulatory Services total about $19 million.

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.
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 and determined that this rule does 
have Tribal implications that require Tribal consultation under E.O. 
13175. If a Tribe requests consultation, the Animal and Plant Health 
Inspection Service will work with the Office of Tribal Relations to 
ensure meaningful consultation is provided where changes, additions, 
and modifications identified herein are not expressly mandated by 
Congress.
Paperwork Reduction Act
    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), some of the reporting, recordkeeping, 
and third party disclosure requirements included in this proposed rule 
have been approved under 0579-0085. The new reporting, recordkeeping, 
and third party disclosure requirements proposed by this rule have been 
submitted as a new information collection package for approval to the 
Office of Management and Budget (OMB). Upon approval of this new 
information collection, it will be merged into the existing 0579-0085.
    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-2015-0057. Please send a copy of your comments to: USDA, 
using one of the methods described under ADDRESSES at the beginning of 
this document.
    APHIS is proposing to revise its regulations governing the 
importation, interstate movement, and release into the environment of 
organisms developed using genetic engineering. Organisms would be 
regulated because APHIS has determined them to present a plant pest or 
noxious weed risk, or has not yet evaluated them for such risk.
    Persons would be able to submit a request for APHIS to evaluate the 
regulatory status of a GE organism. They would also be able to petition 
APHIS to add a genus, species, or subspecies to a list of taxa that are 
or contain plant pests. Finally, permits would be required for the 
importation, interstate movement, and environmental release of all 
regulated GE organisms. Responsible persons who are issued permits 
would be required to retain records, and would have to submit reports 
if they conduct field testing.
    APHIS is soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help APHIS:
    (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

[[Page 7035]]

collection techniques or other forms of information technology; e.g., 
permitting electronic submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 0.828 hours per response.
    Respondents: Developers of organisms regulated under 7 CFR part 
340; businesses and individuals associated with such organisms; Tribal 
governments.
    Estimated Annual Number of Respondents: 311.
    Estimated Annual Number of Responses per Respondent: 16.
    Estimated Annual Number of Responses: 5035.
    Estimated Total Annual Burden on Respondents: 4174 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 Web site 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 E-Government Act to promote the use of the Internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this proposed rule, please contact Ms. Kimberly 
Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.

List of Subjects in 7 CFR Part 340

    Administrative practice and procedure, Biotechnology, Genetic 
engineering, Imports, Packaging and containers, Plant diseases and 
pests, Transportation.

    Accordingly, we are proposing to revise 7 CFR part 340 to read as 
follows:

PART 340--MOVEMENT OF ORGANISMS ALTERED OR PRODUCED THROUGH GENETIC 
ENGINEERING THAT ARE NOXIOUS WEEDS OR PLANT PESTS OR THAT THERE IS 
REASON TO BELIEVE ARE NOXIOUS WEEDS OR PLANT PESTS

Sec.
340.0 General restrictions and scope.
340.1 Definitions.
340.2 Taxa that are or contain plant pests.
340.3 Permits.
340.4 Regulatory status evaluation.
340.5 Record retention, compliance, and enforcement.
340.6 Confidential business information.
340.7 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.  340.0   General restrictions and scope.

    (a) No person may move any regulated organism except in accordance 
with this part.
    (b) A regulated organism is any GE organism that either:
    (1) Prior to genetic engineering, belonged to any taxon listed in 
accordance with Sec.  340.2 and met the definition of plant pest in 
Sec.  340.1; or
    (2) Has received deoxyribonucleic acid (DNA) from any taxon listed 
in accordance with Sec.  340.2, the DNA from the donor organism is 
sufficient to produce an infectious entity capable of causing plant 
disease or encodes a compound known to be pathogenesis-related that is 
expected to cause plant disease symptoms, and the organism has not been 
evaluated by APHIS for plant pest risk in accordance with Sec.  340.4; 
or
    (3) Is a plant that has a plant and trait combination that has not 
been evaluated by APHIS for plant pest and noxious weed risk in 
accordance with Sec.  340.4; or
    (4) Is any of the foregoing that has been evaluated by APHIS in 
accordance with Sec.  340.4 and determined to pose a risk as a plant 
pest and/or noxious weed or is a GE organism that has otherwise been 
determined by the Administrator to pose a risk as a plant pest or 
noxious weed.\1\
---------------------------------------------------------------------------

    \1\ The importation, interstate movement, and release into the 
environment of regulated organisms is subject to any other 
applicable restrictions of this chapter. For example, in ``Subpart--
Plants for Planting'' (Sec. Sec.  319.37-319.37-14 of this chapter), 
a permit is required for the importation of certain plants for 
planting, regardless of whether the plants for planting have been 
genetically engineered.
---------------------------------------------------------------------------


Sec.  340.1  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:
    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 authorized to act on behalf of the 
responsible person to maintain control over a regulated organism during 
its importation, interstate movement, or environmental release and 
ensures compliance with all conditions contained in any applicable 
permit or exemption as well as other requirements in this part. Agents 
may be, but are not limited to, brokers, farmers, researchers, or site 
cooperators. An agent must be at least 18 years of age and be a legal 
resident of the United States.
    Animal and Plant Health Inspection Service (APHIS). An agency of 
the United States Department of Agriculture.
    Contained facility. A structure for the storage and/or propagation 
of living organisms designed with physical barriers capable of 
preventing the escape of the enclosed organisms. Examples include 
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. Techniques that use recombinant or synthetic 
nucleic acids with the intent to create or alter a genome. Genetic 
engineering does not include traditional breeding techniques 
(including, but not limited to, marker-assisted breeding and chemical 
or radiation-based mutagenesis, as well as tissue culture and 
protoplast, cell, or embryo fusion).
    Genetically engineered organism (GE organism). An organism 
developed using genetic engineering. For the purposes of this part, an 
organism will not be considered a genetically engineered organism if:
    (1) The genetic modification to the organism is solely a deletion 
of any size or a single base pair substitution which could otherwise be 
obtained through the use of chemical- or radiation-based mutagenesis; 
or
    (2) The genetic modification to the organism is solely introducing 
only naturally occurring nucleic acid sequences from a sexually 
compatible relative that could otherwise cross with the recipient 
organism and produce viable progeny through traditional breeding 
(including, but not limited to, marker-assisted breeding, as well as

[[Page 7036]]

tissue culture and protoplast, cell, or embryo fusion); or
    (3) The organism is a ``null segregant,'' that is, the progeny of a 
GE organism where the only genetic modification was the insertion of 
donor nucleic acid into the recipient's genome, but the donor nucleic 
acid is not passed to the recipient organism's progeny and the donor 
nucleic acid has not altered the DNA sequence of the progeny.
    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 of APHIS 
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.
    Interstate movement. To move interstate.
    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.
    Noxious weed. Any plant or plant product that can directly or 
indirectly injure or cause damage to crops (including nursery stock or 
plant products), livestock, poultry, or other interests of agriculture, 
irrigation, navigation, the natural resources of the United States, the 
public health, or the environment.
    Nucleic acid. A chain or chains of nucleotides found in either DNA 
or ribonucleic acid.
    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 regulated organisms 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, and a seed.
    Plant pest. Any living stage of a protozoan, invertebrate 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 assessment. An assessment evaluating whether a GE 
organism is 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 altered through the use of genetic engineering.
    Regulated organism. Any GE organism that is regulated pursuant to 
Sec.  340.0.
    Regulatory sequence. A segment of nucleic acid molecule that is 
capable of increasing or decreasing the expression of specific genes 
within an organism.
    Release into the environment (environmental release). The use of a 
regulated organism outside the physical constraints found in a 
contained facility.
    Responsible person. The person who has control and will maintain 
control over a regulated organism during its movement and ensures 
compliance with all conditions contained in any applicable permit or 
exemption as well as other requirements in this part. 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.
    Unauthorized release. The intentional or accidental release of a 
regulated organism in a manner that is not authorized by a permit 
issued pursuant to this part.
    Weed risk assessment. An assessment of the characteristics of a 
plant as these relate to weediness.


Sec.  340.2   Taxa that are or contain plant pests.

    (a) Taxa that are or contain plant pests are listed on the APHIS 
Web site at http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule. Within any taxonomic group included on the list, the lowest unit 
of classification actually listed is the taxon or group which may 
contain organisms that are regulated. Organisms belonging to all lower 
taxa contained within the group listed are included as organisms that 
may be or may contain plant pests, and are regulated if they meet the 
definition of a plant pest in Sec.  340.1.
    (b) APHIS-initiated changes to listed taxa. APHIS may propose to 
add or remove a taxon from the list referred to in paragraph (a) of 
this section through a notice published in the Federal Register. The 
notice will state why APHIS has determined it necessary to add or 
remove the taxon, and will request public comment. If no comments are 
received on the notice, or the comments received do not affect APHIS' 
determination, APHIS will publish a subsequent notice in the Federal 
Register stating that the taxon has been added or removed from the list 
referred to in paragraph (a) of this section.
    (c) Petitions to amend the list of taxa. Any person may submit to 
the Administrator a petition to amend the list of taxa referred to in 
paragraph (a) of this section by adding or removing any taxon. The 
petitioner may supplement, amend, or withdraw a petition in writing 
without prior approval of the Administrator and without prejudice to 
resubmission at any time until the Administrator rules on the request. 
A petition to amend the list of taxa must be submitted in accordance 
with the procedures and format provided on the APHIS Web site at http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule.
    (d) Administrative action on a petition. (1) A petition to amend 
the list of taxa that meets the requirements of paragraph (b) of this 
section as well as the date of the petition will be acknowledged by 
APHIS. If a request does not meet the requirements of paragraph (b) of 
this section, the requester will be sent a notice indicating how the 
request is deficient.

[[Page 7037]]

    (2) APHIS will publish in the Federal Register, for 60 days public 
comment, a notice announcing the availability of a petition to amend 
the list of organisms. Following the close of the comment period, APHIS 
will review the comments received and publish its final decision in the 
Federal Register.
    (e) Appeal of denial. Any person whose petition has been denied may 
appeal the decision in writing to the Administrator within 30 days 
after receiving the written notification of the denial. The appeal must 
state all of the facts and reasons upon which the person relies to 
assert that the petition was wrongfully denied. The Administrator will 
grant or deny the appeal, in writing, stating the reasons for the 
decision as promptly as circumstances allow.


Sec.  340.3  Permits.

    (a)(1) Except as provided in paragraph (a)(2) of this section, 
APHIS must have evaluated a regulated organism in accordance with Sec.  
340.4 before it will issue permits for importation, interstate 
movement, or release into the environment of the organism pursuant to 
this section.
    (2) APHIS may issue a permit pursuant to this section for the 
importation or interstate movement of a regulated organism that has not 
been evaluated in accordance with Sec.  340.4, at the request of an 
applicant. For the purposes of permitting conditions, APHIS will assume 
the regulated organism presents a risk as a plant pest and/or noxious 
weed. If the regulatory status of the organism is evaluated in 
accordance with Sec.  340.4 during the duration of the permit, APHIS 
may amend or terminate the permit accordingly.
    (3) Except as provided in paragraph (c) of this section, a permit 
must be issued by APHIS for the importation, interstate movement, or 
release into the environment of all regulated organisms.
    (b) A responsible person must apply for and obtain a permit through 
a method listed at http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule. The application must also contain all the categories of 
information listed at that Web site for the type of permit being 
requested.
    (c) A permit for interstate movement is not required for 
genetically engineered 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) Administrative actions. (1) APHIS will review the application 
to determine if it is complete. APHIS will notify the applicant in 
writing if the application is incomplete, and the applicant will be 
provided the opportunity to revise the application. If the applicant 
does not respond to the request for additional information within 30 
days of receipt of APHIS's request, APHIS will deem the application 
withdrawn. Once an application is complete, APHIS will review it to 
determine whether to approve or deny the application.
    (2) APHIS assignment of permit conditions. If a permit application 
is approved, the Administrator will assign permit conditions to each 
permit commensurate with the risk of the regulated organism and 
activity. General conditions assigned to all permits are located in 
paragraph (e) of this section. The Administrator may assign additional 
or expanded permit conditions commensurate with the risk that the 
activities listed on the permit application present of disseminating 
the regulated organism, or other plant pests or noxious weeds.
    (3) Inspections. All premises associated with the permit are 
subject to inspection before and after permit issuance. The responsible 
person must provide APHIS inspectors access to inspect any relevant 
premises, facility, release location, storage area, waypoint, 
materials, equipment, means of conveyance, and other articles related 
to the proposed movement of organisms regulated under this part. 
Failure to allow the inspection of a premises prior to the issuance of 
a permit will be grounds for the denial of a permit application. 
Failure to allow the inspection of a premises following permit issuance 
will be grounds for revocation of the permit.
    (4) State or Tribal review and comment. The Administrator will 
submit for notice and review a copy of the permit application and any 
permit conditions to the appropriate State or Tribal regulatory 
official. Comments received from the State or Tribal regulatory 
official may be considered by the Administrator prior to permit 
issuance.
    (5) Agreement with permit conditions. 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.
    (e) General permit conditions. The following conditions will be 
assigned to all permits issued under this section. A responsible 
person, and his/her agents, must ensure compliance with these 
conditions, as well as any additional or expanded conditions listed on 
the permit:
    (1) The regulated organism must be maintained and disposed of in a 
manner so as to prevent the unauthorized release of the regulated 
organism.
    (2) The regulated organism must be kept separate from other 
organisms, except as specifically allowed in the permit.
    (3) The regulated organism must be maintained only in areas and 
premises specified in the permit.
    (4) The regulated organism's identity must be maintained at all 
times.
    (5) In the event of an unauthorized release:
    (i) The regulated organism must undergo the application of remedial 
measures determined by the Administrator to be necessary to prevent the 
spread of regulated organism;
    (ii) 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.
    (6) The duration that the permit is valid will be listed on the 
permit itself. During such time, the responsible person must maintain 
records related to permitted activities of sufficient quality and 
completeness to demonstrate compliance with all permit conditions and 
requirements under this part. 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. Inspectors must 
be allowed access, during regular business hours, to the place where 
the regulated organism is located and to any records relating to the 
movement of a regulated organism. APHIS' access to records includes 
visual inspection and reproduction (photocopying, digital reproduction, 
etc.) of all records required to be maintained under this part, as 
requested by APHIS.
    (7) The responsible person must notify APHIS in writing if any 
permitted activity associated with environmental release will not be 
conducted.
    (8) Within 28 days after the initiation of any permitted activity 
related to environmental release, the responsible person must report to 
APHIS in writing the actual release site coordinates and details of the 
release, such as how many acres planted, how many organisms released, 
etc., based on permit

[[Page 7038]]

conditions, as well as every 28 days thereafter until all releases are 
completed.
    (9) A person who has been issued a permit must submit to APHIS an 
environmental release report within 6 months after the termination of 
any release into the environment. The report must include the APHIS 
reference number, methods of observation, resulting data, and analysis 
regarding all deleterious effects on plants, nontarget organisms, or 
the environment.
    (f) Denial or revocation of a permit. Permit applications may be 
denied, or permits revoked, in accordance with this paragraph.
    (1) Denial. The Administrator may deny, either orally or in 
writing, any application for a permit. If the denial is oral, the 
Administrator will 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 actions proposed under the permit may 
result in the unauthorized release of the regulated organism, or 
another plant pest or noxious weed; 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 or any other part of the regulations, 
or any permit that has previously been issued in accordance with this 
part.
    (2) Revocation. The Administrator may revoke, either orally or in 
writing, any permit which has been issued. If the revocation is oral, 
the Administrator will communicate the revocation and the reasons for 
it in writing as promptly as circumstances allow. The Administrator may 
revoke 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 of the regulated 
organism, or another plant pest or noxious weed; 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 part of the regulations. 
This includes failure to comply with the conditions of any permit 
issued.
    (g) Appeal of denial or revocation of permit. Any person whose 
permit application has been denied or whose permit has been or revoked 
may appeal the decision in writing to the Administrator. Any appeal 
must occur within 10 days after receiving the written notification of 
the denial or revocation. The appeal must state all of the facts and 
reasons upon which the person relies to assert that the permit was 
wrongfully denied or revoked. 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. Rules of practice 
concerning such a hearing will be adopted by the Administrator.
    (h) Amendment of permits.
    (1) Amendment at responsible person's request. If a 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 may 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 may be required 
to agree in writing that he or she, and his or her agents, will comply 
with the amended permit and conditions.
    (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 newly identified considerations concerning the risks 
presented by the organism or the activities being conducted under the 
permit. APHIS may also amend a permit at any time to ensure that the 
permit conditions are consistent with all of the requirements of this 
part. As soon as circumstances allow, APHIS will notify the responsible 
person of the amendment to the permit and the reason(s) for it. 
Depending on the nature of the amendment, the responsible person may 
have to agree in writing or electronically that he or she, and his or 
her agents, will comply with the permit and conditions as amended 
before APHIS will issue the amended permit. If APHIS requests such an 
agreement, and the responsible person does not so agree, the existing 
permit will be revoked.
    (i) Shipping under a permit. All shipments of regulated organisms 
must be secure shipments. Regulated organisms must also be shipped in 
accordance with the regulations in 49 CFR part 178. The container must 
be accompanied by a document that includes the names and contact 
details for the sender and recipient. Following the completion of the 
shipment, all packing material, shipping containers, and any other 
material accompanying the regulated organism must be treated or 
disposed of in such a manner so as to prevent the unauthorized 
dissemination and establishment of regulated organisms. Additionally, 
for any regulated organism to be imported into the United States, the 
outmost container must bear 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 number of written permit authorizing 
the importation. For regulated organisms imported by mail, the 
container must also be addressed to a plant inspection station listed 
in Sec.  319.37-14 of this chapter. All imported containers of 
regulated organisms must be accompanied by an invoice or packing list 
indicating the contents of the shipment.


Sec.  340.4  Regulatory status evaluation.

    (a) Any person may submit a request to APHIS to have a GE 
organism's regulatory status evaluated, or to request the reevaluation 
of the regulatory status of a previously evaluated regulated organism. 
Information needed for such a request is found on the Internet, at 
http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule.
    (b) Administrative action. (1) Upon receiving or initiating a 
regulatory status request, APHIS will evaluate the request for 
completeness, and may contact the person submitting the request for 
additional information.
    (2) If the request is complete, APHIS will conduct an analysis of 
plant pest and/or weed risks of the GE organism.
    (c)(1) APHIS will make both the request and the risk analysis 
available for public review through a notice published in the Federal 
Register. The notice will request public comment, and will propose a 
regulatory status for the organism.
    (2) If no comments are received on the notice, or if the comments 
do not affect the conclusions of the risk analysis or the proposed 
regulatory status of the organism, APHIS will provide notification 
through the APHIS stakeholder registry at the end of the

[[Page 7039]]

comment period announcing that the proposed regulatory status has been 
finalized. APHIS will subsequently publish a notice in the Federal 
Register compiling these determinations.
    (3) If comments lead APHIS to change its proposed regulatory status 
for the organism, APHIS will publish a subsequent notice in the Federal 
Register characterizing these comments and announcing the new 
regulatory status.


Sec.  340.5  Record retention, compliance, and enforcement.

    (a) Record retention. Responsible persons or their agents are 
required to establish and keep the following records and reports:
    (1) All records and reports required as a condition of a permit;
    (2) Addresses and any other information needed to identify all 
contained facilities where the regulated organism was stored or 
utilized, and all locations where the regulated organism was used in an 
environmental release;
    (3) A record identifying which APHIS permit, if any, authorized the 
permitted activity; and
    (4) Copies of contracts between the responsible person and all 
agents that conduct activities subject to this part for the responsible 
person, and copies and documents relating to agreements made without a 
written contract.
    (b) Record retention. Records indicating that a regulated organism 
that was imported or moved interstate reached its intended destination 
must be retained for at least 2 years. All other records must be 
retained for 10 years following permit expiration, unless determined 
otherwise by the Administrator and documented in the supplemental 
permit conditions or other regulatory requirements.
    (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 revocation of a permit;
    (ii) Application of remedial measures in accordance the Plant 
Protection Act, 7 U.S.C. 7701 et seq.; and/or
    (iii) Criminal and/or civil penalties.
    (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.  340.6  Confidential business information.

    Persons submitting 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 each such document must be submitted with all such CBI 
deleted and marked on each page where the CBI was deleted: ``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.  340.7  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.\2\ The U.S. Department 
of Agriculture will not be responsible for any costs or charges 
incident to inspections or compliance with the provisions of this part, 
other than for the services of the inspector.
---------------------------------------------------------------------------

    \2\ The Department's provisions relating to overtime charges for 
an inspector's services are set forth in part 354 of this chapter.

    Done in Washington, DC, this 10th day of January 2017.
Ben Thomas,
Deputy Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2017-00858 Filed 1-18-17; 8:45 am]
 BILLING CODE 3410-34-P