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

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A2017-00858

## Record

- **Collection:** Federal Register
- **Document type:** Proposed Rule
- **Published:** January 19, 2017
- **Citation:** 82 FR 7008

## Text

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 § 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 § 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

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 § 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 (§ 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

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

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

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

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

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 § 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 § 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 § 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 § 340.4.

If APHIS evaluates the GE organism in accordance with § 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

release. APHIS' proposed permitting process is set forth in § 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 § 340.3.

The developer would also have to retain certain records regarding permitted activities. These are set forth in proposed § 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 § 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 § 340.6.

Finally, § 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

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 § 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

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 (§ 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 § 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 § 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 § 340.2 and met the definition of
plant pest
in § 340.1. (As § 340.2 currently does, proposed § 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 § 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 § 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 § 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 § 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.

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 § 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.

Taxa That Are or Contain Plant Pests (§ 340.2)

As stated previously, § 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 § 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 § 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 § 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 § 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 § 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, § 340.5 contains provisions for petitioning the Administrator to amend the list of organisms in § 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 § 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 § 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 § 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 § 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 § 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

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 (§ 340.3)

The permitting procedure found in § 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 § 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 § 340.4 before APHIS will issue a permit for its importation, interstate movement, or release into the environment. As mentioned previously in this document, § 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

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 § 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 § 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 § 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 § 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 § 340.4. Second, unlike organisms evaluated in accordance with § 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 § 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 § 340.4.

Paragraph (a)(3) of § 340.3 would state that, except as provided in paragraph (c) of § 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 § 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

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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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.

• 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 § 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 § 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

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 § 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 § 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. C

[Text truncated at 120,000 characters. The full text is on the page linked above.]

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2017-00858. Public record. Not legal advice.