Movement of Certain Genetically Engineered Organisms

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1

To view the framework, go to https://

www.aphis.usda.gov/brs/fedregister/coordinated_

framework.pdf.

2

These terms are defined in the current §340.1

of the regulations.

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

7 CFR Parts 340 and 372

[Docket No. APHIS–2018–0034]

RIN 0579–AE47

Movement of Certain Genetically

Engineered Organisms

AGENCY

: Animal and Plant Health

Inspection Service, USDA.

ACTION

: Proposed rule.

SUMMARY

: We are proposing to revise

our regulations regarding the movement

(importation, interstate movement, and

environmental release) of certain

genetically engineered organisms in

response to advances in genetic

engineering and our understanding of

the plant pest risk posed by them,

thereby reducing regulatory burden for

developers of organisms that are

unlikely to pose plant pest risks. This

proposed rule, which would mark the

first comprehensive revision of the

regulations since they were established

in 1987, would provide a clear,

predictable, and efficient regulatory

pathway for innovators, facilitating the

development of new and novel

genetically engineered organisms that

are unlikely to pose plant pest risks.

DATES

: We will consider all comments

that we receive on or before August 5,

2019.

ADDRESSES

: You may submit comments

by either of the following methods:

•Federal eRulemaking Portal: Go to

http://www.regulations.gov/#!docket

Detail;D=APHIS-2018-0034.

•Postal Mail/Commercial Delivery:

Send your comment to Docket No.

APHIS–2018–0034, Regulatory Analysis

and Development, PPD, APHIS, Station

3A–03.8, 4700 River Road Unit 118,

Riverdale, MD 20737–1238.

Supporting documents and any

comments we receive on this docket

may be viewed at http://

www.regulations.gov/#!docketDetail;D=

APHIS-2018-0034 or in our reading

room, which is located in Room 1141 of

the USDA South Building, 14th Street

and Independence Avenue SW,

Washington, DC. Normal reading room

hours are 8 a.m. to 4:30 p.m., Monday

through Friday, except holidays. To be

sure someone is there to help you,

please call (202) 799–7039 before

coming.

FOR FURTHER INFORMATION CONTACT

: Dr.

Alan Pearson, Assistant Deputy

Administrator, Biotechnology

Regulatory Services, APHIS, 4700 River

Road Unit 98, Riverdale, MD 20737–

1238; (301) 851–3944.

SUPPLEMENTARY INFORMATION

:

Background

The Animal and Plant Health

Inspection Service (APHIS) of the

United States Department of Agriculture

(USDA) administers the regulations in 7

CFR part 340, ‘‘Introduction of

Organisms and Products Altered or

Produced Through Genetic Engineering

Which are Plant Pests or Which There

is Reason to Believe are Plant Pests’’

(referred to below as the regulations).

These regulations govern the

introduction (importation, interstate

movement, or release into the

environment) of certain genetically

engineered (GE) organisms.

Along with the Environmental

Protection Agency (EPA), and the Food

and Drug Administration (FDA), APHIS

is responsible for the oversight and

review of GE organisms. In 1986, the

Coordinated Framework for Regulation

of Biotechnology (Coordinated

Framework)

1

was published by the

Office of Science and Technology

Policy. It describes the comprehensive

Federal regulatory policy for ensuring

the safety of biotechnology research and

products and explains how Federal

agencies use existing federal statutes to

ensure public health and environmental

safety while maintaining regulatory

flexibility to avoid impeding the growth

of the biotechnology industry. The

Coordinated Framework explains the

regulatory roles and authorities for

APHIS, EPA, and the FDA.

APHIS first issued these regulations

in 1987 under the authority of the

Federal Plant Pest Act of 1957 and the

Plant Quarantine Act of 1912, two acts

that were subsumed into the Plant

Protection Act (PPA, 7 U.S.C. 7701 et

seq.) in 2000, along with other

provisions. Since 1987, APHIS has

amended the regulations six times, in

1988, 1990, 1993, 1994, 1997, and 2005,

to institute exemptions from the

requirement for permits to conduct

activities for certain microorganisms

and Arabidopsis, to institute the current

notification process and petition

procedure, and to exclude plants

engineered to produce industrial

compounds from the notification

process. Under APHIS’ current

regulations, a GE organism is considered

to be a regulated article if the donor

organism, recipient organism, vector, or

vector agent

2

is a plant pest or if the

Administrator has reason to believe the

GE organism is a plant pest. A plant pest

is defined in current § 340.1 as ‘‘Any

living stage (including active and

dormant forms) of insects, mites,

nematodes, slugs, snails, protozoa, or

other invertebrate animals, bacteria,

fungi, other parasitic plants or

reproductive parts thereof; viruses; or

any organisms similar to or allied with

any of the foregoing; or any infectious

agents or substances, which can directly

or indirectly injure or cause disease or

damage in or to any plants or parts

thereof, or any processed,

manufactured, or other products of

plants.’’ For a GE organism that is a

regulated article to be introduced, a

permit authorizing the introduction

must be issued by APHIS, or the

introduction must occur under a

notification acknowledged by APHIS, a

procedure that is discussed in detail

below. If the introduction entails

movement of the organism, it must be

moved in a container that meets the

requirements of current § 340.8, and the

container must be marked in accordance

with the requirements listed under

§ 340.7.

A permit may authorize the

introduction of regulated articles if

developers follow the permit conditions

specified by the Administrator to be

necessary for each activity to prevent

the dissemination and establishment of

the GE organism. Such conditions

include, but are not limited to,

maintenance of the regulated article’s

identity through labeling, retention of

records related to the article’s specified

use, segregation of the regulated article

from other organisms, inspection of a

site or facility where regulated articles

are to undergo environmental release or

will be contained after their interstate

movement or importation, and the

maintenance and disposal of the

regulated article and all packing

material, shipping containers, and any

other material accompanying the

regulated article to prevent the

dissemination and establishment of

plant pests. If a permit holder does not

comply with any of the permit

conditions, the permit may be canceled,

and if so, further movement or

environmental release of GE organisms

under that permit will be prohibited.

For authorizations under the

notification process, the regulations

contain performance-based standards

applicable to shipping, environmental

release, and field trials of GE organisms.

These standards are aimed at preventing

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3

https://www.aphis.usda.gov/biotechnology/

downloads/supportingdocs/LessonsLearned10-

2007.pdf.

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.

5

To view the 2017 proposed rule, the subsequent

withdrawal, all supporting documents, and

comments APHIS received, go to http://

www.regulations.gov/#!docketDetail;D=APHIS-

2015-0057.

the unwanted dissemination of such

organisms during transit or as a result of

an environmental release and the

persistence of the organisms in the

environment. APHIS conducts

inspections of authorized facilities or

environmental release sites to evaluate

compliance with the regulations.

In addition to issuing permits and

acknowledging notifications, APHIS

responds to petitions requesting

nonregulated status under these

regulations. Under the petition

procedure, which is currently described

in § 340.6, any person may submit a

petition to APHIS seeking a

determination as to whether or not an

article is regulated under part 340.

Paragraphs (b) and (c) of § 340.6

describe the form that a petition for a

determination of nonregulated status

must take and the detailed information

and scientific data supporting the

petition. As of December 2018, of 162

petitions submitted for APHIS review

since July 1992, APHIS has granted 130

determinations of nonregulated status.

Thirty-two petitions have been

withdrawn. All of these determinations

have been for GE plants. More

information about these determinations

is posted at https://

www.aphis.usda.gov/aphis/ourfocus/

biotechnology/permits-notifications-

petitions/petitions/petition-status. Many

of these plants are grown for agricultural

production in the United States. APHIS’

determinations of nonregulated status

apply to the GE plants as well as their

progeny, meaning the nonregulated GE

plant can be used in plant breeding

programs and in agriculture without

further oversight from APHIS.

Although, as discussed above, the

current regulations have various

functions, their primary function to date

has been as a means for APHIS to

regulate the introduction of certain GE

organisms via the permit and

notification procedures referred to

above. Permits and notifications are

collectively known as ‘‘authorizations.’’

As of July 2018, APHIS has issued more

than 19,500 authorizations for the

environmental release of GE organisms

in multiple sites, primarily for research

and development of crop varieties for

agriculture. Additionally, APHIS has

issued nearly 14,000 authorizations for

the importation of GE organisms, and

more than 12,000 authorizations for the

interstate movement of GE organisms.

APHIS has denied slightly more than

1,600 requests for authorizations, many

of which were denied because APHIS

ultimately decided the requests lacked

sufficient information on which to base

an Agency decision. Some of these were

resubmitted with the additional

necessary information.

While the current regulations have

been effective in ensuring the safe

introduction of GE organisms during the

past 30 years, advances in genetic

engineering have occurred since they

were promulgated. APHIS has now

accumulated three decades of

experience in evaluating GE organisms

for plant pest risk. The Agency’s

evaluations to date have provided

evidence that genetically engineering a

plant with a plant pest as a vector,

vector agent, or donor does not in and

of itself result in a GE plant that

presents a plant pest risk. Additionally,

GE techniques have been developed that

do not employ plant pests as donor

organisms, recipient organisms, vectors,

or vector agents yet may result in GE

organisms that pose a plant pest risk.

Given these developments, as well as

legal and policy issues discussed below,

it has become necessary, in our view, to

update our regulations accordingly.

OIG Audits and 2008 Farm Bill

Audits conducted by USDA’s Office

of Inspector General (OIG) have

provided another impetus for updating

our regulations. In 2005, OIG conducted

an audit of APHIS’ regulatory program

for GE organisms. OIG found that the

use of performance-based standards in

APHIS’ notification process allowed for

a broad spectrum of methods to meet

the standards, particularly regarding

how the release would be confined to its

test field, but Agency practices did not

require responsible persons to provide

written protocols detailing the exact

methods that would be used to meet the

standards. OIG suggested that APHIS

revise the regulations to ‘‘minimize the

risk of inadvertent release’’ of regulated

articles ‘‘into the environment.’’ Among

other things, OIG recommended that we

include in the regulations a provision

that would ‘‘require developers to

provide written protocols prior to

approval of the field trial.’’ Other

recommendations regarding reporting

have been met by the issuance of

policies, procedures, and guidelines, but

OIG indicated that these

recommendations should ultimately be

made permanent in regulation.

In 2015, OIG issued another audit,

urging APHIS to implement the

recommendations from the 2005 audit

that APHIS had not yet implemented,

including that APHIS ‘‘revise its

regulations to consolidate all

requirements for conducting field tests

of regulated materials.’’

In addition, in 2008, The Food,

Conservation, and Energy Act of 2008

(Farm Bill) was enacted. Section 10204

of the Farm Bill requires the Secretary

of Agriculture to take action on each

issue identified in the APHIS document

entitled ‘‘Lessons Learned and

Revisions under Consideration for

APHIS’ Biotechnology Framework,’’

3

and, where appropriate, promulgate

regulations. Like the 2005 and 2015 OIG

audits, the lessons learned document

suggested revising the regulations to

provide for greater regulatory oversight

of field tests of regulated articles.

On October 9, 2008, APHIS published

a proposal

4

in the Federal Register (73

FR 60007–60048, Docket No. APHIS–

2008–0023) to amend the regulations to

address advances in genetic

engineering, to make explicit our

criteria for evaluation of GE organisms

for noxious weed potential, and to

respond to the remaining

recommendations of the 2005 OIG audit

and the provisions of the Farm Bill.

APHIS sought public comment on the

proposal from October 9, 2008, to June

29, 2009. APHIS received more than

88,300 comments during the comment

period. Many commenters expressed

concerns regarding the lack of details

surrounding a proposed risk-based

system that would determine which

organisms would fall under APHIS

oversight, as well as concerns about a

proposed multi-tiered permit system.

Commenters also expressed concern

about what they perceived to be a

significant expansion of Agency

regulatory authority.

Based on the breadth and nature of

the comments received, we

subsequently withdrew that proposed

rule and began a fresh stakeholder

engagement process aimed at exploring

a variety of regulatory approaches.

On January 19, 2017, we published in

the Federal Register (82 FR 7008–7039,

Docket No. APHIS–2015–0057) a second

proposed rule.

5

In that document, we

proposed to revise our regulatory

approach from ‘‘regulate first before

analyzing risks’’ to ‘‘analyze plant pest

and noxious weed risks of GE organisms

prior to imposing regulatory

restrictions.’’ Under the January 2017

proposed rule, a stakeholder could

request that we conduct a risk

assessment to determine whether a GE

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organism would pose plant pest or

noxious weed risks and thus need to be

regulated. Regulated GE organisms

could be imported, moved interstate, or

released into the environment under a

flexible, risk-based permitting

procedure. Over time, APHIS would

build up a library of such assessments

and their results and post the

information on its website. For a GE

organism with the same organism-trait

combination (traits are discussed in

detail below) as another GE organism

that we had already concluded did not

require regulation, neither the request

nor the risk assessment would be

necessary. Additionally, APHIS

proposed to exclude from regulation

some GE organisms that could have

been produced using traditional

breeding methods. These provisions

were intended to provide regulatory

relief to developers.

APHIS sought public comment on the

proposal from January 19, 2017, until

June 19, 2017. APHIS received 203

comments during the comment period.

Commenters expressed concerns

about many provisions of the proposed

rule. Many thought that the proposed

requirements would be too burdensome

and had the potential to stifle

innovation.

After reviewing the comments, APHIS

published a document in the Federal

Register on November 7, 2017 (82 FR

51582–51583, Docket No. APHIS–2015–

0057), withdrawing the proposal to

allow APHIS to reengage with

stakeholders and deliberate further on

how best to revise the regulations in

part 340.

Following the withdrawal of the

January 2017 proposed rule, APHIS

conducted extensive outreach to Land

Grant and public university researchers,

as well as small-scale biotechnology

developers, agriculture innovators, and

other interested stakeholders. In total,

APHIS met with more than 80

organizations, including 17 universities,

State Departments of Agriculture, and

farmer organizations. Much of the

feedback received during this process

centered on the need to focus regulatory

efforts and oversight upon risk, rather

than the method used to develop GE

organisms. Stakeholders also expressed

a desire for flexible and adaptable

regulations so that future innovations do

not invalidate the regulations. We also

received feedback urging us to keep

international trade objectives in mind

when proposing new regulations and

ensuring that new regulatory

requirements are transparent and clearly

articulated.

Overview of the New APHIS Regulatory

Framework

Based on the feedback we received

from stakeholders and on our internal

Agency deliberations, we are proposing

to revise the regulations in accordance

with a new regulatory framework. The

new framework will provide a clear,

predictable, and efficient regulatory

pathway for innovators while

facilitating the development of new and

novel GE plants that are unlikely to pose

a plant pest risk. It will protect the

health and value of America’s

agriculture and natural resources and

help foster safe and predictable

agricultural trade worldwide. We

anticipate that adopting the new

framework will result in significant

savings for developers of GE organisms.

The revised regulatory framework

would reflect the Secretary of

Agriculture’s March 28, 2018, statement

that provided clarification on the

USDA’s oversight of plants produced

through plant breeding innovations. The

statement and further details are

available at: https://

www.aphis.usda.gov/aphis/ourfocus/

biotechnology/brs-news-and-

information/2018_brs_news/plant_

breeding.

The proposed framework is also

consistent with the OIG

recommendations, the 2008 Farm Bill

requirements, as outlined above, and

with the guiding principle of the

Coordinated Framework that, ‘‘[i]n order

to ensure that limited Federal oversight

resources are applied where they will

accomplish the greatest net beneficial

protection of public health and the

environment, oversight will be

exercised only where the risk posed by

the introduction is unreasonable.’’

APHIS’ new regulatory approach is

intended to prepare the Agency for

future advances in the genetic

modification of plants. (APHIS’

approach to the regulation of non-plant

GE organisms is discussed below.) For

convenience, in this document we

sometimes refer to plant varieties

produced with innovative techniques

that could otherwise have been

achieved using methods of traditional

plant breeding as plant breeding

innovations. Where genetic

modifications are similar in kind to

those modifications made through

traditional breeding, the plant pest risks

should also be similar. These types of

plants are equivalent to those that have

a history of safe use and would be

exempted from our proposed regulation.

On the other hand, genetic

modifications made in the future may

result in increasingly complex products

which, in turn, may pose new types of

risks with which the Agency has less

familiarity. This latter category of

engineered plants would be subject to

review under our new regulations. Once

products are reviewed by the Agency

and found unlikely to pose a plant pest

risk, similar products would be exempt

from further review.

Our approach for GE organisms is

consistent with the 2017 National

Academy of Sciences Future Products of

Biotechnology report, which stated that

regulation should take into account

familiarity. The report, which is

available at https://www.nap.edu/

catalog/24605/preparing-for-future-

products-of-biotechnology, noted that

unfamiliar products, and those that may

be developed in the future, may have

few or no comparators with existing

products within the regulatory system.

Such products, therefore, would require

more regulatory oversight than familiar

products until enough is known about

the new products to enable us to assess

accurately the plant pest risks

associated with them. By focusing

regulatory resources and risk analyses

on unfamiliar products, APHIS will be

able to avoid conducting repetitive

analyses, utilize its staff time more

efficiently, and provide better

stewardship of taxpayer dollars.

Key Features of the Proposed Rule

The approach we are proposing

would differ from the current regulatory

framework in that regulatory efforts

would focus on the properties of the GE

organism itself rather than on the

method used to produce it. We believe

that this new approach, which reflects

our current knowledge of the field of

biotechnology, would enable us to

evaluate GE organisms for plant pest

risk with greater precision than the

current approach allows. GE organisms

that pose a plant pest risk would fall

within the scope of the proposed

regulations and require permits for

movement. As discussed in more detail

later in this document, we would define

plant pest risk in this proposed rule as

‘‘[t]he possibility of harm resulting from

introducing, disseminating, or

exacerbating the impact of a plant pest.’’

APHIS will continue to regulate GE

organisms that are, in and of

themselves, plant pests, as well as other

GE non-plant organisms that pose plant

pest risks. Such organisms would

require permits for movement. Other GE

non-plant organisms that do not pose a

plant pest risk would not fall under the

scope of the regulations and therefore

would not require permits for

movement.

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Under the current system, when

making decisions regarding regulatory

oversight of GE plants, APHIS assesses

each transformation event (also

sometimes referred to as the individual

transformed line, transgenic line, or GE

line) separately, even though the

inserted genetic material may be

identical or very similar to

transformation events already assessed.

This has sometimes been referred to as

an ‘‘event-by-event’’ approach.

Under the proposed rule, developers

would have the option of requesting a

permit or a regulatory status review of

a GE plant that has not been previously

reviewed and determined to be

nonregulated. Decisions on regulatory

status would be based on our

assessment of plant pest risk. If

movement of a GE plant, by which we

mean its importation, interstate

movement, or environmental release

(throughout the discussion that follows,

the terms move and movement are used

to refer to all of those activities, except

where otherwise indicated) is found to

be unlikely to pose a plant pest risk,

APHIS would not have authority under

the PPA to regulate the plant in

accordance with part 340. If we were

unable to reach such a finding, APHIS

would regulate the subject plant, which

would be allowed to move only under

permit.

Under § 340.1(b) of the proposed rule,

certain categories of modified plants

would be exempted from the regulations

in part 340 because they could be

produced through traditional breeding

techniques and thus are unlikely to pose

a greater plant pest risk than

traditionally bred crops, which APHIS

has historically not regulated. These

products of biotechnology are likely to

pose no greater plant pest risk than their

traditionally bred comparators. These

exemptions are restricted to plants

because the long history of plant

breeding gives us extensive experience

in safely managing associated plant pest

risks. The categories of plants that

would be exempted under § 340.1(b) are

discussed further below.

Proposed § 340.1(c) would exempt GE

plants with plant-trait-mechanism of

action (MOA) combinations that we

have already evaluated by conducting a

regulatory status review and found to be

unlikely to pose a plant pest risk. As

discussed in further detail later in this

document, MOA refers to the

biochemical basis for the new trait. The

results of all completed regulatory status

reviews would be publicly accessible on

the APHIS website. The regulatory

status review process is discussed in

detail below.

Under our proposed new regulatory

framework, a developer would have the

option to make a self-determination as

to whether his or her GE plant belongs

to one of the categories listed under

§ 340.1(b) or (c) and is therefore exempt

from the regulations. A developer who

determines that his or her GE plant

belongs to an exempted category would

have the option under proposed

§ 340.1(d), to request written

confirmation from APHIS that the self-

determination is valid. These

confirmation letters, which would

provide a clear and succinct statement

about the regulatory applicability of the

GE plant and the nexus to plant health,

may be useful to developers wishing to

market their products domestically or

overseas by allowing them to provide

verification to an importing country or

other party that APHIS concurs with

their self-determinations. APHIS

anticipates a timely turnaround time in

developing and providing these

confirmation letters to developers.

Allowing for self-determinations would

provide developers with regulatory

relief and open more efficient and

predictable pathways for innovators to

get new modified plants that are

unlikely to pose a plant pest risk to

market, in turn supporting further

innovation. APHIS anticipates that

benefits will accrue to developers of all

sizes, including small and mid-sized

ones, as well as academic institutions.

At the same time, APHIS would be able

to allocate its resources more efficiently

than under the current regulations.

Because we would no longer have to

perform the redundant task of assessing

GE plants with plant-trait-MOA

combinations that we have already

determined are not subject to these

regulations, we would be able to devote

more attention to assessing and

regulating those GE organisms that are

likely to be associated with potential

plant pest risks.

We would note here that a developer

making a self-determination that APHIS

determines not to be valid may be

subject to remedial measures or

penalties in accordance with the

compliance and enforcement

provisions, which are discussed below,

in proposed § 340.6(c) if the organism is

moved without proper authorization

under part 340. In addition, penalties

and remedial measures (including but

not limited to, quarantine, seizure and/

or destruction) under the authority of

the PPA may be exercised.

Under § 340.4 of the proposed rule,

the process by which we would evaluate

GE plants for plant pest risk would be

called a regulatory status review. When

evaluating the plant pest risk posed by

a newly developed GE plant, APHIS

would consider three fundamental

elements in combination and

individually: (1) The basic biology of

the plant prior to modification; (2) the

trait that resulted from the genetic

modification; and (3) the MOA. Since

any one or any combination of these

three elements may affect plant pest

risk, APHIS would determine the need

for regulatory oversight by appraising

the risk posed by the plant’s unique

combination of the three elements.

This proposed rule would define trait

as an observable (able to be seen or

otherwise identified) characteristic of an

organism. We would define mechanism

of action as the ‘‘biochemical

process(es) through which genetic

material determines a trait.’’ For

example, a plant may be modified to

confer the trait of male sterility by either

of two MOAs in pollen: Expression of a

protein that is toxic to the pollen grain

(barnase system) or expression of a

protein which changes

deoxyribonucleic acids (DNA) in pollen-

producing tissues (DNA adenine

methylase system) in a disruptive way

that ultimately results in death of those

tissues.

For reasons described in greater detail

below, the regulatory status review

process would apply only to plants and

not to genetically engineered plant pests

or other genetically engineered non-

plant organisms that fall within the

scope of the regulations. We are

requesting comments from the public,

however, on whether the scope of the

regulatory status review should be

expanded to include non-plant GE

organisms as well as GE plants, whether

some equivalent process for evaluating

such organisms for regulatory status

should be developed instead, and, if so,

what factors the Agency should

consider in its analyses.

Information pertaining to the results

of all completed regulatory status

reviews would be publicly accessible on

the APHIS website. This information

would include a comprehensive list of

GE plant-trait-MOA combinations that

we have evaluated for plant pest risk via

the regulatory status review process

under proposed § 340.4. The list would

also include GE plants for which we

have made determinations of

nonregulated status under the petition

process. Developers could use the list to

aid them in making their self-

determinations. For example, if a

developer were to find that his or her

newly developed GE plant had the same

plant-trait-MOA combination as a GE

plant previously found by APHIS to be

not subject to the Agency’s regulations,

the developer would know immediately

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that the newly developed plant would

not be subject to APHIS regulation. We

anticipate that should this rule be

implemented, this list would grow as

new regulatory status reviews are

completed.

For GE plants that do not fall into one

of the exempted categories and have not

previously been assessed through the

regulatory status review process,

developers would have the option of

either requesting an immediate

regulatory status review or requesting a

permit for the movement of their GE

plant in lieu of a regulatory status

review. (A developer who initially

requests a permit would also have the

option of following up with a request for

a regulatory status review.) Providing

these options would allow for maximum

flexibility in the research and

development of novel GE plants for all

types of developers (multi-national

companies, small companies, and

public sector researchers). Developers of

GE organisms that are plant pests would

continue to need permits to move those

organisms.

Regulation of Plants That Produce

Plant-Made Industrials and

Pharmaceuticals

APHIS recognizes that certain plants

are genetically engineered in order to

produce pharmaceutical and industrial

compounds, also known as plant-made

pharmaceuticals and industrials

(PMPIs). Federal oversight of outdoor

plantings of PMPI-producing plants

could be necessary to prevent the

unlawful introduction into the human

or animal food supply of

pharmaceutical or industrial PMPI

products, even when the principal

purpose of the plants is not for human

or animal food use. In addition to

potential adulteration issues (such as

the potential of an unapproved food

additive and other food safety risks)

posed by such plants should they enter

the food supply, a gap in Federal

oversight could generate concerns from

the general public regarding the safety

and wholesomeness of the human or

animal food supply, which could

adversely impact agricultural interests.

Establishing growing and handling

conditions to confine such plants, and

inspecting to ensure such conditions are

followed, may enable corrective actions

before material from the plants is

inadvertently released and causes

public health or economic impacts.

Under the current regulations, APHIS

requires permits for the environmental

release of all GE plants that meet the

definition of a regulated article and

produce PMPIs. APHIS exercises

oversight of all outdoor plantings of

these regulated PMPI-producing plants.

This oversight includes establishment of

appropriate environmental release

conditions, inspections, and monitoring.

PMPI-producing plants and the

products obtained from them may also

be regulated by FDA (authority over

food and drugs) or EPA (chemical

substances as defined by the Toxic

Substances Control Act (TSCA)),

depending on their use or intended use.

If a PMPI-producing plant or plant

product were potentially to be used for

human or animal food, food additive

approval might be required under the

Federal Food, Drug, and Cosmetic Act.

To date, PMPI-producing GE plants

regulated by APHIS have been

genetically engineered using a plant

pest as the donor, vector, or vector

agent, and thus fall under the scope of

‘‘regulated article’’ in the current

regulations. However, under the

provisions of this proposed rule, a GE

plant that is developed using a plant

pest as a vector, vector agent, or donor

of genetic materials would not

necessarily be regulated. Rather, the GE

plant would be regulated only if it had

a plant-trait-MOA combination that the

Agency has not yet evaluated for plant

pest risk or if it was evaluated and

found to pose a potential plant pest risk.

Additionally, APHIS’ evaluations of GE

plants for plant pest risk would

generally not require data from outdoor

plantings. Even if the plant represents a

new plant-trait-MOA combination not

previously reviewed, there is a

likelihood that most, if not all, GE

PMPI-producing plants that are

currently under APHIS permits could be

determined to be not regulated under

the provisions of the proposed

regulations after a regulatory status

review because they are unlikely to pose

a plant pest risk. Thus, such plants

could be grown outdoors without the

need for APHIS permits and without

APHIS oversight.

One of the reasons APHIS’ oversight

of such crops has been an important

part of the coordinated framework for

oversight of GE plants is that companies

are not necessarily required to notify

FDA or EPA when the developer plants

PMPI-producing plants. For example,

for PMPI-producing plants whose

products are subject to FDA oversight,

FDA has no regulations governing

planting of such crops. For crops

genetically engineered to produce

human drugs, companies only have to

go to FDA when they have reached the

point that they are ready to begin

clinical trials with the pharmaceutical

derived from the plant. This could be

years after they first started growing the

pharmaceutical-producing plant in the

field.

Under TSCA, EPA has requirements

for new chemical substances, including

industrial compounds produced in

genetically engineered plants. However,

given existing APHIS oversight, EPA

does not currently have an oversight

program nor regulations for genetically

engineered plants that produce

industrial compounds.

APHIS has identified two options that

have the potential for adequate Federal

oversight of outdoor plantings of plants

engineered to produce PMPIs. Under

one option, APHIS would use other

authorities (e.g., 7 CFR part 360) to

regulate outdoor planting of plants

engineered to produce PMPIs. Under a

second option, a statute would be

enacted, or existing statutory authority

amended, to grant one or more Federal

agencies explicit authority to provide

oversight of outdoor plantings of all GE

PMPI-producing plants and to evaluate

GE PMPI-producing plants for all

possible risks, beyond plant pest and

noxious weed risks. APHIS does not

prefer one of these options over the

other, nor does the Agency consider the

two options necessarily to be

exhaustive. Rather, we put them

forward to indicate that the Agency is

aware of the implications of this rule

with regard to PMPIs, and to request

specific public comment regarding the

best manner to address this issue.

Plant-Incorporated Protectant Small-

Scale Field Testing

Certain plants are genetically

engineered to produce plant-

incorporated protectants (PIPs),

meaning that they produce pesticides.

PIPs fall under the regulatory oversight

of EPA. However, currently only APHIS

exercises regulatory oversight of PIP

plantings on 10 acres or less of land.

Under the current regulations, APHIS

requires permits or notifications for the

environmental release of all GE plants

that meet the definition of a regulated

article and produce PIPs. APHIS

exercises oversight of all outdoor

plantings of these regulated PIP-

producing plants. This oversight

includes the establishment of

appropriate environmental release

conditions, inspections, and monitoring.

To date, PIP-producing GE plants

regulated by APHIS have been

genetically engineered using a plant

pest as the donor, vector, or vector

agent, and thus fall under the scope of

regulated article in the current

regulations in part 340. However, under

the provisions of this proposed rule, a

GE plant that is developed using a plant

pest as a vector, vector agent, or donor

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6

Introduction of Recombinant DNA-Engineered

Organisms Into the Environment: Key Issues. 1987.

National Research Council. Washington, DC.

National Academies Press (US).

7

Field Testing Genetically Modified Organisms:

Framework for Decisions. 1989. National Research

Council (US) Washington (DC). National Academies

Press (US).

8

National Academies of Sciences, Engineering,

and Medicine. 2016. Genetically Engineered Crops:

Experiences and Prospects. Washington, DC: The

National Academies Press. doi: 10.17226/23395.

of genetic materials would not

necessarily be regulated. Rather, the GE

plant would be regulated only if it had

a plant-trait-MOA combination that the

Agency has not yet evaluated for plant

pest risk or if it was evaluated and

found to pose a potential plant pest risk.

Additionally, APHIS’ evaluations of GE

plants for plant pest risk would

generally not require data from outdoor

plantings. Even if the plant represents a

new plant-trait-MOA combination not

previously reviewed, there is a

likelihood that many GE PIP-producing

plants that are currently regulated under

APHIS permits or notifications could be

determined not regulated under the

provisions of the proposed regulations

after a regulatory status review because

they are unlikely to pose plant pest

risks. Thus, such plants could be grown

outdoors without the need for an APHIS

permit and without undergoing APHIS

oversight.

APHIS understands that this proposal

would shift Federal oversight of small-

scale (10 acres or less) outdoor plantings

of some PIPs to EPA. EPA may decide

to require experimental use permits for

all, some, or none of such PIPs, and may

conduct inspections of all, some, or

none of those PIPs under permit. APHIS

is fully committed to coordinating with

EPA on these issues.

APHIS understands that an MOU and

services agreement may be necessary to

provide personnel and other resources

to assist EPA during the interim period

while EPA implements its own program

for the oversight of outdoor planting of

PIPs 10 acres or less.

APHIS recognizes that there are

challenges associated with such a

transition that would also require EPA

to incur the costs associated with setting

up a revised regulatory program.

Further, such a transition would require

policies, procedures, and guidance

regarding APHIS’ interaction with EPA.

APHIS does not consider the approach

listed above necessarily to be

exhaustive. Rather, APHIS puts it

forward to indicate that the Agency is

aware of the implications of this rule

with regard to small-scale testing of PIPs

and to request specific public comment

regarding the best manner to address

this issue.

Specific provisions of the proposed

rule are discussed in detail below.

Applicability of the Regulations

Proposed § 340.1(a) would refer the

reader to § 340.2 for information on

what GE organisms would be subject to

the proposed regulations.

Under proposed § 340.1(b)(1) through

(4), modified GE plants would not be

regulated or subject to a regulatory

status review in accordance with

§ 340.4, if:

•The genetic modification is solely a

deletion of any size; or

•The genetic modification is a single

base pair substitution; or

•The genetic modification is solely

introducing nucleic acid sequences from

within the plant’s natural gene pool or

from editing nucleic acid sequences in

a plant to correspond to a sequence

known to occur in that plant’s natural

gene pool; or

•The plant is an offspring of a GE

plant and does not retain the genetic

modification in the GE plant parent.

As noted above, non-plant GE

organisms that are plant pests or pose a

plant pest risk would require permits for

movement under the proposed

regulations; these proposed exemptions

would apply only to GE plants.

The exemptions reflect the Secretary

of Agriculture’s March 28, 2018,

statement that USDA does not plan to

regulate plants that could otherwise

have been developed through traditional

breeding techniques. Such products of

biotechnology are likely to pose no

greater plant pest risk than their

traditionally bred comparators, which

APHIS does not regulate. All four

categories of plants listed in the

exemptions above could otherwise have

been produced by traditional breeding

methods. Traditional breeding

techniques generally involve deliberate

selection of those plants with desirable

traits either from existing population

genetic variations or from new genetic

variations created through artificial

hybridization or induced mutations, and

have been used since the advent of

sedentary agriculture. Every

domesticated crop has been subjected to

extensive traditional breeding. Genetic

engineering relies on a newer toolset

that may be used in addition to

traditional breeding practices, including

chemical or radiation-based

mutagenesis, in order to expedite

development of a plant with a desired

genotype and/or traits.

In two reports, issued in 1987 and

1989, respectively, by the National

Research Council of the National

Academies of Science,

67

it was stated

that there was no evidence for unique

hazards inherent in the use of

recombinant DNA techniques and that

with respect to plants, crops modified

by molecular and cellular methods

should pose risks no different from

those modified by classical genetic

methods for similar traits. A key

conclusion from these reports taken

together, is that it is not the process of

genetic engineering per se that imparts

the risk, but the trait or traits which are

introduced. A recent National

Academies of Sciences, Engineering,

and Medicine report, issued in 2016,

reaffirmed this conclusion.

8

The 1989 report elaborated on the

safety of traditionally bred crops, stating

that ‘‘plants modified by classical

genetic methods are judged safe for field

testing on the basis of experience with

hundreds of millions of genotypes field

tested over decades.’’ This does not

mean there are no conceivable risks, but

rather that those risks are, in the words

of the committee, ‘‘manageable by

accepted standards.’’ Thus, given the

accepted safety of traditionally bred

crops, and the principle that the use of

recombinant DNA does not itself

introduce unique risks, it is logical and

appropriate to exempt from our

regulation plants produced by any

method if they also could have been

produced by traditional breeding.

APHIS recognizes that there is no

universally applicable, sharp

delineation between what is and what is

not possible to achieve with traditional

breeding methods in an agriculturally

relevant timeframe. There are many

biological and practical factors that

affect the likelihood of success in a

breeding program. These include the

number of targeted loci and type of

desired genetic changes, the genetic

distance between the desired changes,

generation time, breeding system

(sexual or asexual, self-compatibility),

ploidy level and genomic complexity,

resource availability (time, money,

labor, and genomic resources), and other

factors. There is such variation in these

factors among plant species that the

probability of a plant breeding program

being able to achieve specific, desired

changes in a given species will differ on

a case-by-case basis. Developing a

standard for all species based on what

is possible to achieve with traditional

breeding methods in any given species

is not a practical measure. Furthermore,

plants that qualify for an exemption

would not be reviewed by APHIS. For

these reasons, the exemptions are based

on measures that are easily recognizable

and on genetic changes that could be

achieved by traditional plant breeding

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Information about determinations of

nonregulated status pursuant to the petition process

currently in part 340 is available at https://

www.aphis.usda.gov/aphis/ourfocus/biotechnology/

permits-notifications-petitions/petitions/petition-

status.

10

Information about decisions made pursuant to

the AIR process is available at https://

www.aphis.usda.gov/aphis/ourfocus/biotechnology/

am-i-regulated/regulated_article_letters_of_inquiry/

regulated_article_letters_of_inquiry.

in any system. A single deletion or a

single base pair change is a conservative

estimate of what could be achieved in

any system through traditional breeding.

Changes beyond those in the

exemptions would be assessed on a

case-by-case basis for plant pest risk. We

acknowledge there will be examples of

plants created that do not qualify for the

exemptions that pose little plant pest

risk. We believe these examples will be

promptly handled through the process

of regulatory status review. In this way

we believe we can offer both regulatory

relief and appropriate regulation as

needed.

In general, the natural gene pool of a

plant is determined by those plants with

which the plant is sexually compatible.

This is most typically considered to be

restricted to crosses that can take place

without human management. However,

a number of traditional breeding

techniques have been developed to

enable wide crosses between distantly

related species or plants that would not

encounter each other in nature. Where

such techniques have been developed

for a given plant, distantly related plants

are also considered part of the natural

gene pool.

In some cases, a GE parent plant will

contain inserted donor nucleic acid, but

after some number of breeding steps,

there are progeny that are produced

which contain neither the inserted

donor nucleic acid nor any

modifications made directly by the

inserted nucleic acid. APHIS does not

consider the progeny to be associated

with a greater plant pest risk. Therefore,

such progeny would not be subject to

regulation under the fourth exemption.

APHIS requests comment from the

public regarding the categories of plants

listed under proposed § 340.1 as not

subject to the regulations, including

their breadth, whether we need to

provide greater specificity in the

exemptions, and whether additional

categories should also be considered for

exemption from the requirements of part

340.

In addition to the categories listed in

proposed paragraph (b), under proposed

§ 340.1(c), GE plants that would not be

subject to these proposed regulations if

they have plant-trait-MOA combinations

that are the same as those of GE plants

that APHIS has found, after conducting

a regulatory status review in accordance

with proposed § 340.4, not to be subject

to the regulations under part 340. We

would list such GE plant-trait-MOA

combinations on our website, as noted

above, and developers could use this

information to aid them in making their

self-determinations.

As noted earlier, we would also list

GE plants for which we have made

determinations of nonregulated status

under the petition process,

9

which is

described in further detail below.

Though the proposed regulatory status

review would represent a change in our

regulatory approach, GE plants for

which determinations of nonregulated

status have been made under the current

system have been evaluated for the same

plant pest risk factors which will be

used under the proposed rule.

Specifically, both reviews analyze the

biology of the GE plant and its non-GE

comparator, potential changes in plant

pest impacts, impacts on nontarget

organisms, and the propensity for

increased weediness of the GE plant and

any sexually compatible relatives. The

initial list of plant-trait-MOA

combinations that are not subject to the

regulations is available on

Regulations.gov as a separate document

to this proposed rule. The list will

include identification of the MOA of

nonregulated plants reviewed under the

petition process, which can be used for

comparisons of future GE plants to

determine regulatory status.

Plants produced using biotechnology

which were reviewed in response to an

‘‘Am I Regulated?’’ (AIR)

10

inquiry were

not reviewed using all the plant pest

risk factors listed above, but rather were

reviewed for regulatory status based on

whether the modified plant conformed

to the definition of a ‘‘regulated article’’

in the current regulations and in a some

instances on one or more of the factors,

but not all. We know of no plant pest

issues raised during the review of the

AIR inquiry, and none have arisen from

use of any of these plants. GE plants

determined not to require regulation

pursuant to the current AIR process

would retain their nonregulated status

under the new regulations to prevent

potential market disruptions and

provide regulatory certainty for

developers. These plants would be

listed separately from those evaluated at

the MOA level, and this list would not

be used for determining regulatory

status based on MOA.

We would note again that plants that

are not subject to these regulations

could still be subject to other APHIS or

USDA regulations or to the regulations

of the other Federal Agencies

functioning within the Coordinated

Framework.

Scope of the Regulations

Proposed § 340.2 would set forth

general restrictions regarding the

movement of GE organisms that would

be subject to these regulations. The

following categories of GE organisms

would be allowed to move only under

permit:

•The GE organism is a plant that has

a plant-trait-MOA combination that has

not been subjected to a regulatory status

review in accordance with § 340.4; or

•The GE organism meets the

definition of plant pest in § 340.3; or

•The GE organism is not a plant but

has received DNA from a plant pest, as

defined in § 340.3, and the DNA from

the donor organism either is capable of

producing an infectious agent that

causes plant disease or encodes a

compound that is capable of causing

plant disease; or

•The GE organism is a

microorganism used to control plant

pests or an invertebrate predator or

parasite (parasitoid) used to control

invertebrate plant pests and could pose

a plant pest risk.

GE plants that have not yet been

evaluated for plant pest risk by means

of a regulatory status review would be

subject to permitting under § 340.2(a).

While APHIS has found that most plants

evaluated to date do not pose plant pest

risks, it is conceivable that some of

those produced in the future may. For

example, certain modifications may

change the relationship of the plant to

plant pests. In most cases, this would

not be of concern, as APHIS

understands that resistance to disease

and insects varies widely among

varieties. Still, if as a result of the

modification, the plant became a

reservoir for pests or diseases in such a

way that plant pest issues were

exacerbated not just for those who used

the new variety, but for others in the

surrounding area, APHIS might find it

appropriate to take regulatory action.

For instance, plants and their wild

relatives could have increased

importance as reservoirs for plant pests

if the introduced trait resulted in an

increase in their prevalence and/or

caused a change in their distribution.

For these reasons, APHIS believes it is

appropriate to examine novel plant-

trait-MOA combinations for plant pest

risk. Regulatory oversight is needed for

such plants until the level of plant pest

risk associated with their movement is

known.

As noted earlier, under the current

criteria, a GE organism is considered a

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regulated article not only if the recipient

organism itself is a plant pest, but also

if the donor, vector, or vector agent used

in the engineering process is a plant

pest. This reflects the concern in the

1980s that if an organism was modified

using genetic material taken from a

plant pest, or a plant pest was used as

a vector or vector agent to carry genetic

material into an organism, the resulting

GE organism could also be a plant pest.

Based on APHIS’ experience

evaluating field trial data from

thousands of authorized environmental

releases of regulated organisms, as well

as the 130 determinations of

nonregulated status for GE plants, this

generally stated concern has not proven

to be valid. Although a plant pest may

contribute or vector genes to a GE

organism, the mere presence of plant

pest sequences has not been shown in

APHIS’ evaluation of data to cause a GE

organism, particularly if it is a plant, to

become a plant pest. Indeed, experience

has shown that the use of genes from

donor organisms which are plant pests,

as well as the use of vectors which are

from plant pests, has not to date

resulted in plant pest risks of any sort

in recipient organisms that are not

already plant pests.

The most common use of plant pest

components in genetic engineering

involve either the use of a disarmed

version of the plant pathogenic

bacterium Agrobacterium tumefaciens

to vector genes into a plant or use of

genetic material from plant pest donors

which function as regulatory sequences

in the plant. Currently, methods that use

Agrobacterium tumefaciens as a vector

of genetic material do not leave viable

bacteria behind in the recipient

organism and do not cause disease.

Likewise, regulatory sequences such as

the 35S promoter from Cauliflower

Mosaic Virus and the nopaline synthase

(nos) terminator from A. tumefaciens are

themselves unable to be expressed and

do not confer plant pest traits, though

they do facilitate the expression of other

genes in the GE organism. The use of

plant pests in these ways either as

donors of regulatory sequences or for

vectoring genetic material into a

recipient organism has a long history

and has not resulted in disease or injury

to the recipient organism or to other

organisms.

These advances in our knowledge of

biotechnology notwithstanding, under

§ 340.2(b), we would continue to

regulate GE organisms in those cases

where the organism which is engineered

is itself a plant pest as defined in the

PPA.

Our approach to regulating such

organisms, however, would differ from

that of the existing regulations. In

current § 340.2, there is a list of taxa

that contain plant pests. Under our

proposed regulatory framework,

however, we would not use taxonomic

classification of donor organisms to

determine if a GE organism is regulated.

We would, therefore, remove the list

from the regulations, along with the

procedures described in current § 340.5

for amending this list.

Instead, when determining whether a

GE non-plant organism is subject to the

regulations, APHIS will assess whether

a recipient organism is likely to be a

plant pest, based on the most up-to-date

pest information maintained by APHIS.

This information is more specific than

the information in the list of plant pest

taxa in the current regulations, and

should be more useful and reliable than

static lists of taxa, which become

outdated. APHIS will maintain a list of

taxa that contain plant pests on its

website and would be available for

consultation by developers to help them

determine whether or not their GE non-

plant organism is or is not a plant pest.

APHIS welcomes public comment on

this proposed change.

Under proposed § 340.2(c), we would

also regulate GE organisms that are not

plants but have received DNA from a

plant pest if the DNA from the donor

organism is sufficient to produce an

infectious entity or encodes a

pathogenesis-related compound that is

expected to cause plant disease

symptoms. DNA from a donor organism

that is a plant pest could, when inserted

into an organism which is not a plant

pest, result in a GE organism that is a

plant pest if: (1) The DNA sequence that

is encoded in the organism is able to be

expressed as a functioning infectious

entity capable of causing plant disease;

or (2) if the inserted DNA enables the

organism to produce pathogenesis-

related compounds, that is, compounds

that are typically produced by

pathogens and involved in producing

disease symptoms. Examples of such

compounds would include plant

degrading enzymes, plant growth

regulators, phytotoxins, or compounds

that can clog plant vascular systems.

APHIS intends this criterion to be

specific to GE organisms other than

plants, such as nonpathogenic soil

bacteria that through genetic

engineering may become capable of

producing plant disease symptoms in

plants. This contrasts with the current

regulations, under which we regulate

GE organisms based merely on the

presence of DNA from a plant pest.

In addition, under § 340.2(d), we

would regulate GE organisms that are

microbial pathogens used to control

plant pests, microbial parasites used to

control plant pathogens, or invertebrate

predators or parasites (parasitoids) used

to control plant pests if they could pose

a plant pest risk. These organisms are

generally not plant pests but their

potential effects on organisms beneficial

to agriculture (referred to below as

‘‘beneficial’’) could indirectly affect

plant health. The PPA provides the

authority to regulate such biological

control organisms used to control plant

pests to ensure they do not pose a plant

pest risk. As with non-GE biological

control organisms, the types of GE

biological control organisms APHIS

would regulate could pose a plant pest

risk by lacking sufficient specificity for

the target pest and thereby harming

beneficial non-target organisms, such as

other invertebrate predators or parasites

(parasitoids), pollinators, or microbes

that promote plant health. Because

biological control organisms are almost

always intended for eventual release

into the environment, it is not sufficient

for us only to consider their use in

controlling their target plant pest. We

must also take into consideration the

indirect plant pest risks that the

organism may pose due to harmful

impacts on non-target organisms that are

beneficial to agriculture (e.g., harm to

natural enemies of plant pests). If the GE

organism is known to have harmful

impacts on beneficial non-target

organisms, it is consistent with APHIS’

authority under the PPA to prohibit or

restrict its release. To the extent that we

do not know whether a GE biological

control organism is sufficiently specific

to avoid harming beneficial non-target

organisms, it is also prudent for us to

place regulatory controls on the

movement and release of the GE

biological control organism until the

impacts on beneficial non-target

organisms and any resulting direct or

indirect plant pest effects are better

understood.

APHIS requests comment from the

public regarding the categories of GE

organisms listed under proposed § 340.2

as subject to the regulations and

whether additional categories, such as

pollinators, should also be considered.

Definitions

Definitions would be listed in

proposed § 340.3. APHIS proposes to

retain certain definitions currently

found in § 340.1 of the regulations, to

change other definitions, to add some

new definitions, and to remove

definitions that no longer need to

appear in the regulations.

APHIS is proposing to retain the

following definitions from the current

regulations, without change:

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Administrator, Animal and Plant Health

Inspection Service (APHIS), donor

organism, environment, organism, and

person.

APHIS is proposing to revise the

definitions of the following terms from

those in the current regulations:

We would define genetic engineering

(GE) as techniques that use recombinant

or synthetic nucleic acids to modify or

create a genome. This proposed

definition is clearer than the existing

one, which refers to modification using

‘‘recombinant DNA techniques,’’ a term

that is not defined in the regulations.

The current definition could also be

construed, contrary to our intentions, to

exclude the use of synthetic DNA, in

vivo DNA manipulation, and genome

editing. The proposed definition of

genetic engineering would not cover

traditional breeding techniques, such as

marker-assisted breeding, as well as

tissue culture and protoplast, cell, or

embryo fusion, or chemical or radiation-

based mutagenesis. APHIS has never

considered such techniques to

constitute genetic engineering.

Accordingly, organisms created through

such techniques are currently excluded

from the definition under part 340, and

would continue to be so.

We would define inspector as any

individual authorized by the

Administrator or the Commissioner of

Customs and Border Protection,

Department of Homeland Security, to

enforce the regulations in part 340. The

current definition predates the

establishment of the Department of

Homeland Security, as well as the

transfer of certain inspection

responsibilities for imported organisms

from APHIS to U.S. Customs and Border

Protection.

The definition of interstate would be

from one State into or through any other

State or within the District of Columbia,

Guam, the Virgin Islands of the United

States, or any other territory or

possession of the United States. This

proposed revision aligns the definition

of interstate in part 340 with the

definition used in the PPA.

Move (moving, movement) would be

defined as to carry, enter, import, mail,

ship, or transport; aid, abet, cause, or

induce the carrying, entering, importing,

mailing, shipping, or transporting; to

offer to carry, enter, import, mail, ship,

or transport; to receive to carry, enter,

import, mail, ship, or transport; to

release into the environment; or to allow

any of the above activities to occur. This

proposed revision aligns the definition

of move in part 340 with the definition

of move used in the PPA.

The definition of permit would be a

written authorization, including by

electronic methods, by the

Administrator to move organisms

regulated under part 340 and associated

articles under conditions prescribed by

the Administrator. This proposed

revision would generally align the

definition of permit in part 340 with the

definition of permit used in the PPA.

However, whereas the definition in the

PPA mentions that a permit may

authorize the movement of plants, plant

products, and biological control

organisms, plant pests, noxious weeds,

and associated articles, our proposed

definition would pertain to the

movement of organisms regulated under

part 340 and associated articles. This

change reflects the scope of the

proposed regulations.

Additionally, while the PPA allows

for the issuance of oral permits, APHIS

would not under these regulations. Oral

permits do not provide adequate

documentation that a responsible

person was aware of and understood

permitting conditions at the time the

permit was issued.

Plant would be defined as any plant

(including any plant part) for or capable

of propagation, including a tree, a tissue

culture, a plantlet culture, pollen, a

shrub, a vine, a cutting, a graft, a scion,

a bud, a bulb, a root, or a seed. This

revision is necessary because the

current definition of plant used in the

regulations precedes the issuance of the

PPA, and is broader than the PPA

definition. The proposed definition

would align with the definition used in

the PPA. A result of this alignment

would be that APHIS would no longer

consider ‘‘cellular components,’’ such as

ribosomes, to be plants. Cellular

components are not capable of

propagating to cause plant pest risks.

Plant pest would be defined as any

living stage of a protozoan, nonhuman

animal, parasitic plant, bacterium,

fungus, virus or viroid, infectious agent

or other pathogen, or any article similar

to or allied with any of the foregoing

that can directly or indirectly injure,

cause damage to, or cause disease in any

plant or plant product. This proposed

definition would generally align the

definition of plant pest in part 340 with

that used in the PPA. However, while

the PPA gives APHIS authority to

regulate any nonhuman animal as a

plant pest, it is longstanding APHIS

policy not to regulate vertebrate animals

as plant pests. In the absence of such a

policy, all herbivores and omnivores

could be considered plant pests, and

thus subject to regulation, an untenable

position since this would require APHIS

to consider livestock, such as cows,

sheep, and horses, to be plant pests.

Recipient organism would be defined

as the organism whose nucleic acid

sequence will be modified through the

use of genetic engineering. In contrast,

the current definition is ‘‘the organism

which receives genetic material from a

donor organism.’’ This change would

differ from the current definition by

distinguishing an organism with

modified traits from the same organism

prior to transformation; in some cases

the recipient organism’s nucleic acid

sequence may be modified using genetic

material from the same species.

We propose to define release into the

environment (environmental release) as

the use of a GE organism outside the

physical constraints of a contained

facility. The existing definition of

release into the environment refers to

the release of a regulated article;

however, in this proposed rule we are

no longer using the latter term. Our

proposed definition of release into the

environment (environmental release),

would also clarify that release into the

environment and environmental release

are synonymous terms.

Responsible person would be defined

as the person responsible for

maintaining control over a GE organism

under permit during its movement and

ensuring compliance with all conditions

contained in any applicable permit as

well as other requirements of part 340.

The proposed definition would further

state that the responsible person may be,

but would not be limited to, the

signatory of a permit or the institution

that the signatory represented at the

time of the application. The responsible

person must be at least 18 years of age

and be a legal resident of the United

States.

The current regulations define

responsible person as the person (at

least 18 years of age and a U.S. resident)

who has control and will maintain

control over the introduction of the

regulated article and assure that all

conditions contained in the permit and

requirements in part 340 are complied

with. We are proposing to replace it

with the new definition to clarify that

the term refers to both individuals and

institutions. That dual responsibility is

implied in the existing definition,

because we define the term person to

include institutions, but it is not stated

explicitly, potentially resulting in

confusion over who ultimately is the

responsible party. Attributing

responsibility for a regulated organism

only to an institution may be

problematic for enforcement of the

regulations, because such responsibility

can be diffused, resulting in no

individual being held accountable for

violations. Attributing it only to an

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individual may be similarly problematic

because the signatory of the permit may

change his or her institutional affiliation

and location. The proposed definition

would ensure that some individual or

party would be held accountable for

violating permit conditions and/or

regulatory requirements.

State would be defined as any of the

several States of the United States, the

Commonwealth of the Northern Mariana

Islands, the Commonwealth of Puerto

Rico, the District of Columbia, the

Virgin Islands of the United States, or

other Territories or possessions of the

United States. This change aligns the

definition of State in part 340 with that

used in the PPA.

We currently define State regulatory

official as the State official with

responsibilities for plant health, or any

other duly designated State official, in

the State where the introduction is to

take place. We would change the term

to State or Tribal regulatory official. We

would define the State or Tribal

regulatory official as the State or Tribal

official with responsibilities for plant

health, or any other duly designated

State or Tribal official, in the State or on

the Tribal lands where the movement is

to take place. Under the proposed

definition, the official’s responsibilities

would not change. The proposed change

from the former definition is to

acknowledge Tribal authority on Tribal

lands.

APHIS proposes to add definitions of

the following new terms:

We would define access as the ability

during regular business hours to enter,

or pass to and from, a location, inspect

and/or obtain or make use or copies of

any records, data, or samples necessary

to evaluate compliance with part 340

and all conditions of a permit issued in

accordance with § 340.5. This proposed

definition is in line with APHIS’

authority under the PPA to conduct

inspections and, where necessary,

sampling activities to verify that

premises associated with permits meet

our requirements.

Because the responsible person, as

defined above, may have an agent acting

on his or her behalf, it is necessary to

add to the regulations a definition of the

latter term. Agent would be defined as

‘‘[a] person who is designated by the

responsible person to act in whole or in

part on behalf of the permittee to

maintain control over an organism

under permit during its movement and

ensure compliance with all conditions

contained in any applicable permit and

the requirements in part 340. Multiple

agents may be associated with a single

responsible person or permit. Agents

may be, but are not limited to, brokers,

farmers, researchers, or site cooperators.

An agent must be at least 18 years of age

and be a legal resident of the United

States.’’ This proposed definition would

codify the responsibilities of a

designated agent acting on behalf of the

responsible person.

We would define article as any

material or tangible object that could

harbor plant pests or noxious weeds.

This proposed definition is needed to

clarify the meaning of the term as used

throughout these proposed regulations

and also aligns with the PPA definition

of the term.

Contained facility would be defined

as a structure for the storage and/or

propagation of living organisms

designed with physical barriers capable

of preventing the escape of the

organisms, and that examples include

laboratories, growth chambers,

fermenters, and containment

greenhouses. While the current

regulations use the term contained

facility, the term is not currently

defined. APHIS proposes to add this

definition to clarify what constitutes a

contained facility.

Import (importation) would be

defined as to move into, or the act of

movement into, the territorial limits of

the United States. This is the definition

used in the PPA.

We would define mechanism of

action, as discussed earlier in this

document, as the biochemical

process(es) through which genetic

material determines a trait. We would

add this definition because it is an

element that we would consider, along

with organism and trait, when

evaluating a GE organism for plant pest

risk.

As discussed earlier, we would define

plant pest risk as the possibility of harm

to plants resulting from introducing or

disseminating a plant pest or

exacerbating the impact of a plant pest.

It is necessary to add this definition

because our regulatory status review

process, described below, hinges on our

evaluation of the plant pest risk posed

by a GE plant.

Parasitic plants can pose plant pest

risks directly by injuring plants

themselves, while other types of plants

pose plant pest risks indirectly, either

by serving as reservoirs, which can

increase the numbers or distribution of

plant pests, or by serving as hosts in

which new plant pests can be created.

Non-plant GE organisms may also

pose both direct and indirect plant pest

risks. Direct plant pests risks are limited

to GE organisms which are themselves

plant pests, i.e., capable of causing

injury of, damage to or disease in plants

or plant products. Indirect plant pest

risks involve interactions of a GE

organism with other organisms or the

environment in such a way that injury

of, damage to, or disease in plants or

plant products by plant pests occurs or

is increased. As with GE plants, an

important mechanism by which a non-

plant GE organism could have an

indirect plant pest impact would be the

suppression of populations of a

beneficial organism which, in turn,

suppresses plant pests. With decreased

levels of the beneficial organism, injury,

damage, or disease from the plant pest

it suppresses might be increased.

Plant product would be defined as

any flower, fruit, vegetable, root, bulb,

seed, or other plant part that is not

included in the definition of plant or

any manufactured or processed plant or

plant part. This matches the definition

of plant products found in the PPA.

This definition is more precise than the

current definition of product in part

340, which this definition would

replace. For example, the current

definition of product includes

‘‘anything made by or from, or derived

from an organism, living or dead.’’

APHIS does not plan to regulate dead

organisms as APHIS has found that they

do not present a plant pest risk.

Secure shipment would be defined as

shipment in a container or a means of

conveyance of sufficient strength and

integrity to withstand leakage of

contents, shocks, pressure changes, and

other conditions incident to ordinary

handling in transportation. This

definition would be used to clarify the

container requirements in the proposed

rule.

We would define trait, as discussed

earlier in this document, to mean an

observable (able to be seen or otherwise

identified) characteristic of an organism.

This proposed definition would provide

clarity regarding the relationship

between trait and MOA.

Unauthorized release would be

defined as the intentional or accidental

movement of an organism under a

permit issued pursuant to part 340 in a

manner not authorized by the permit; or

the intentional or accidental movement

without a permit of an organism that is

subject to the regulations in part 340.

We would add this definition to ensure

that the Administrator would have the

ability to enforce regulatory

requirements that are accidentally or

intentionally violated and maintain

effective compliance oversight.

APHIS proposes to remove the

following definitions from the

regulations: Antecedent organism,

courtesy permit, expression vector,

introduce or introduction, product,

regulated article, Secretary, stably

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integrated, United States, vector or

vector agent, and well-characterized and

contains only non-coding regulatory

regions.

These definitions would be removed

because the terms would no longer be

used in the regulations.

APHIS proposes to remove the

definition for introduce or introduction.

APHIS currently uses the term in part

340 to denote certain kinds of activities

that fall within the scope of the

regulations, namely importation,

interstate movement, and release into

the environment. The PPA, however,

does not specifically define the term

introduction. Therefore, to avoid

confusion, instead of using the term

introduction to define the different

types of regulated activities, APHIS

would refer to these activities in the

regulations as movement in accordance

with the definition of move in the PPA.

Additionally, as mentioned above, the

regulations will specify and define as

necessary the types of movements to

which the regulations would apply,

namely, importation, interstate

movement, and release into the

environment.

APHIS proposes to remove the

definition of regulated article. APHIS

currently uses the term in part 340 to

refer to which organisms fall within the

scope of the regulations. A GE organism

is considered to be a regulated article

under the current definition if the

donor, vector, or vector agent is a plant

pest. However, GE techniques, such as

genome editing and synthetic genomics,

have recently been developed that need

not employ plant pests as donor

organisms, recipient organisms, vectors,

or vector agents but that may pose plant

pest risks. APHIS proposes to identify

the categories of organisms that are

subject to the regulations in § 340.2

instead of through the definition of

regulated article.

Finally, based on the terms that

APHIS is proposing to add or remove

from the regulations, as well as the

revised scope of the regulations, the

Agency would revise the heading of part

340 to ‘‘Movement of Organisms

Modified or Produced Through Genetic

Engineering.’’

Regulatory Status Review

Under the existing regulations, APHIS

deems GE organisms ‘‘regulated

articles’’ based upon the use of a plant

pest in the genetic engineering process.

APHIS receives requests from

developers who wish to ascertain, prior

to conducting a potentially regulated

activity, whether a specific organism

that they have developed meets our

definition of regulated article and is

therefore subject to the regulations.

APHIS has been responding to such

inquiries from developers since the late

1990’s. In 2011, APHIS implemented a

formal ‘‘Am I Regulated’’ (AIR) process,

providing a web page that instructs

developers on how to submit an AIR

inquiry. We developed the AIR process

because we saw an increasing number of

such requests. The process was

intended to guide developers to provide

consistent and predictable information

that would enable the Agency to

respond to inquiries in a timely manner

so as to not inhibit innovation. This

process is not codified in the existing

regulations, however.

The primary analysis conducted

under this process is to determine

whether or not the organism described

in the AIR inquiry is a regulated article

as defined in part 340. The organisms in

question have ranged from clearly

regulated (e.g., GE plants that DNA that

was inserted by the plant pest

Agrobacterium tumefaciens) to clearly

not regulated ones, such as GE

organisms that are genetically

engineered without the use of a plant

pest. Products of new genome editing

techniques, such as TALENs and

CRISPR, have presented intermediate

scenarios that have been evaluated over

the past few years. Additional

considerations by APHIS under this

process include weediness potential. If

the organism in question is weedy or

has weedy wild relatives, these

concerns are also addressed in APHIS’

response.

The current petition process for GE

plants stems from the manner in which

regulated article is defined. As noted

above, the current regulations consider

a GE organism to pose a plant pest risk

and therefore be a regulated article if the

donor organism, recipient organism,

vector, or vector agent is a plant pest.

Published APHIS decisions made under

the current regulations in § 340.6 have

used different ways to express the basic

standard ‘‘unlikely to pose a plant pest

risk’’ in determining whether to grant

nonregulated status to a specific GE

organism. Alternative characterizations

that have been used include ‘‘poses no

more of a plant pest risk than its non-

GE counterpart,’’ ‘‘will not pose a plant

pest risk,’’ ‘‘no plant pest risk,’’ and ‘‘no

direct or indirect plant pest effects.’’

Regardless of the phrases used, APHIS

has applied the same basic evaluation

criteria, specified in current

§ 340.6(c)(4), to each determination to

conclude that the GE organism is

unlikely to pose a plant pest risk and

therefore is not subject to the part 340

regulations. Those criteria include,

conclusions on the potential of the GE

organism to create pest or disease

problems, the potential for nontarget

effects that might affect organisms

beneficial to agriculture, changes in

agricultural practices that might

exacerbate pest or disease problems, the

potential for a GE organism to become

a weed or increase its weediness or that

of sexually compatible species, and the

potential of the GE organism to transmit

the introduced trait to organisms with

which it does not interbreed.

Under the proposed regulations,

however, we would evaluate whether an

organism would require a permit for

movement based on the characteristics

of the organism itself rather than on the

method by which the organism is

genetically engineered. Based on the

proposed change in approach, the

Agency believes the petition process is

no longer necessary and is proposing to

remove the petition process from the

regulations.

In this document, APHIS is proposing

to provide developers of novel GE

plants that have not been previously

evaluated by APHIS the option of either

requesting a regulatory status review by

the Agency to determine regulatory

status or applying for a permit for

movement under the regulations.

Developers choosing to apply for a

permit would, upon approval of the

permit application, be able to

immediately import, move interstate, or

field test their plant under APHIS-

imposed conditions and oversight. If

they choose to request a regulatory

status review, and the Agency finds that

the plant-trait-MOA combination is not

likely to pose a plant pest risk and

therefore is not subject to the

regulations, the developer could

proceed with product development and

marketing activities free from regulation

under part 340.

The current petition process

contained in the regulations is only

applicable to GE plants; likewise, the

proposed regulatory status review

described in proposed § 340.4 would

apply only to plants and not to GE plant

pests or other GE non-plant organisms.

The latter two categories would fall

within the scope of the proposed

regulations in § 340.2 and therefore

require permits for movement. Unlike

most plants, other organisms described

in § 340.2(b), (c), and (d) are either

known to be plant pests, engineered in

such a way that they are likely to be

plant pests, or will be used to control

plant pests and therefore need to be

regulated for direct or indirect plant

pest risks. As noted earlier, we are

requesting public comment on whether

the regulatory status review process or

some equivalent process should apply

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to non-plant GE organisms and, if so,

what factors should be analyzed.

Proposed § 340.4(a) describes the

process for submitting a request for a

regulatory status review. Since APHIS

may also initiate a regulatory status

review, that process is described as

well.

Under proposed § 340.4(a)(1), any

person could submit a request to APHIS

for a regulatory status review of a GE

plant that has not previously been

reviewed for plant pest risk based on its

plant-trait-MOA combination. Proposed

paragraph (a)(2) would allow any person

to request a re-review of a GE plant

listed as subject to part 340, provided

that the person making the request can

provide new, scientifically valid

evidence bearing on the plant pest risk

associated with movement of the plant.

Proposed paragraph (a)(3) would state

that APHIS could also initiate a

regulatory status review or re-review of

a GE plant. This provision would

provide another means of enabling us to

respond quickly to scientific

developments when making decisions

on whether or not GE plants are subject

to the regulations. APHIS could initiate

a re-review of a GE plant, regardless of

the initial finding, if new information

warrants such a reevaluation.

Proposed paragraph § 340.4(a)(4),

would state that information submitted

in support of a request for a regulatory

status review would have to meet the

requirements listed in paragraphs

(a)(4)(i) through (iii), which are as

follows:

•A description of the comparator

plant, to include genus, species, and any

relevant subspecies information;

•The genotype of the modified plant,

including a detailed description of the

differences in genotype between the

modified and unmodified plant; and

•A detailed description of the new

trait(s) of the modified plant.

Additional guidance on how to meet

these requirements will be available on

the APHIS website and is included

below:

I. A description of the comparator

plant to include:

a. Common name(s);

b. Genus, species, and any relevant

subspecies information (e.g., variety)

that would distinguish the plant; and

II. The genotype of the modified

plant, including a detailed description

of the differences in genotype between

the modified and unmodified plant.

a. If genetic material is inserted into

the genome, the following information

shall be provided:

i. For gene sequences, the name of the

sequence, the donor organism(s) or

source, the function of sequence, the

nucleotide sequence, and if applicable,

the publicly available sequence

identification, protein accession

number, and enzyme commission

number. If genes have been modified

(e.g., codon usage efficiency, gene

shuffling, etc.), a statement regarding

the nature of the modification and its

purpose would be needed. The

developer would also have to identify

and highlight the modifications by

submitting an alignment of the modified

sequence with the unmodified

sequence.

ii. For regulatory sequences, the

function of each regulatory sequence as

it relates to the gene sequence and the

source of each regulatory sequence

would need to be described. Promoters

must be identified as constitutive,

inducible, developmental, or tissue

specific. If inducible, known inducers

must be described (e.g., chemical,

temperature, light, stress, wounding,

etc.). If developmental/tissue specific,

the stage(s)/tissue at/in which the

promoter is intended to be active must

be described.

b. If genetic material is not inserted

into the genome, and the genome is

modified in a way that does not fall

under the exemptions in § 340.1(b), the

following must be provided:

i. The nature of the modification(s)

and the gene(s) and function(s) being

modified.

ii. For substituted base pairs, the

number of substitutions.

iii. The original unmodified sequence

aligned to the modified sequence.

III. A detailed description of the new

trait(s) of the modified plant, including:

a. The purpose of the new trait and

the expected MOA by which the

intended trait is conferred;

b. Any expected changes in

metabolism, physiology, and

development due to the trait/genetic

modification;

c. If available, any additional

experimental data, publications, and

other science-based assessments that are

relevant to APHIS’ evaluation of the

potential of the plant to pose plant pest

risks. (APHIS does not intend for

submitters to generate experimental data

specifically for a regulatory status

review. However, if a submitter is aware

of information or experimental data in

the public domain that may support our

assessment, they may include it.)

APHIS considers the categories of

information specified above to be

sufficient for assessing a GE plant and

identifying the plant pest risks, if any,

associated with it. That being said, the

Agency solicits public comment on the

adequacy of the requested information,

and whether additional or alternate

information requirements would be

more appropriate. Specifically, APHIS is

interested in whether commenters think

the above information requirements may

be insufficient to identify whether the

plant poses a plant pest risk.

To that end, APHIS wishes to

highlight some of the differences

between the above information

requirements and the information

currently required for either a petition

for nonregulated status of a GE plant or

an AIR inquiry. With regard to the

genotype of the GE organism, APHIS

would add specific information

requirements for gene sequences,

regulatory sequences, and genome

modifications. The current regulations

in § 340.6 require the petitioner to

supply a detailed description of the

genotype of the GE organism, but do not

specify that a description of the gene

sequences, regulatory sequences, or

genome editing of the organism is

required. Operationally, however,

APHIS considers this information to be

necessary. APHIS anticipates using the

information to confirm the intended

trait(s) of the GE plant and to assess

similarity with previously reviewed

plants, which will assist the Agency in

understanding the impacts the

modification(s) will have on

characteristics of the plant.

The current regulations specify that a

petition must contain field test reports

for all trials conducted under permit or

notification procedures involving the

regulated organism, including the

APHIS reference number, methods of

observation, resulting data, and analysis

regarding all deleterious effects on

plants, non-target organisms, or the

environment. A petition is typically

requested after lengthy field testing.

Currently, most of the field data

submitted are intended to demonstrate

that there have not been unintended

deleterious effects on plants, non-target

organisms, or the environment.

To date, APHIS has authorized more

than 100,000 field trials—a single

permit or notification may authorize

multiple trials—and APHIS has not

received a report of unintended

deleterious effects on plants, non-target

organisms, or the environment. Based

on the risk assessments we have

performed in accordance with the

petition process over 30 years, we have

determined that, in many cases, we

would have been able to evaluate the

plant pest risks associated with a GE

organism without field-test data. Rather,

the Agency has discovered that the

introduced trait of the GE organism

provides the most reliable indicator of

the organism’s potential for deleterious

effects on plants and plant products.

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11

See: NRC (National Research Council). 1989.

Field Testing Genetically Modified Organisms:

Framework for Decisions. Washington, DC: National

Academy Press.

12

National Academies of Sciences, Engineering,

and Medicine. 2016. Genetically Engineered Crops:

Experiences and Prospects. Washington, DC: The

National Academies Press. doi: 10.17226/23395.

These observations are expected and are

consistent with findings of reports of the

National Academies of Science,

Engineering, and Medicine.

11 12

Accordingly, field test information

would not be a generally applicable

requirement for the initial regulatory

status review and would only be

requested on an as-needed basis when

further analysis is needed. APHIS

considers information from field tests to

be unnecessary, in most cases, for a

determination of regulatory status under

the proposed regulations. The approach

APHIS is proposing focuses primarily

on evaluating the genetics and

characteristics of the GE plant-trait-

MOA combination and the likelihood

that, based on these genetics and

characteristics, the plant will pose a

plant pest risk if it is released into the

environment for the uses intended by

the developer.

This approach would not preclude a

developer from providing information

from field tests, if he or she considered

it to be pertinent to our analysis. For

example, if a developer wished for

APHIS to reevaluate the status a GE

plant that the Agency had previously

considered to be subject to the

regulations, field-test information

demonstrating a lack of direct or

indirect adverse effects on plants and

plant products could be provided in

support of that request. Nor would the

provisions preclude APHIS from asking

for field-test information if APHIS

considers it necessary in order to

conclude review of a particular request.

APHIS would also remove a current

regulatory requirement that requires the

petition to state the country and locality

of the donor organism from which a GE

organism has received genetic material

in order for APHIS to evaluate the

genotype of the GE organism. In the

Agency’s experience, this information

has not proven germane to evaluating

risk associated with modifying the

genome of the GE organism, since it

does not provide information regarding

the modified genome of the GE

organism, or the manner in which the

genome was modified.

Information pertaining to the MOA

may include, to the extent that it is or

could be known, information about any

new enzymes or other gene products

produced; where, when, and at what

level the introduced or modified genetic

material is expressed in the plant; the

biochemical action of the genetic

material or its product; and how the

genetic material or its product

participates in or interacts with

metabolic, physiological, or

developmental processes in the

engineered plant or in other organisms.

This information is useful to us because

these factors may affect the level of

plant pest risk associated with the GE

plant.

The above information is needed to

allow APHIS to evaluate the plant pest

risk posed by the GE plant. The general

description of the plant-trait-MOA

combination will not be eligible for CBI

designation. Making this information

available would facilitate APHIS’

transparent regulatory approach and

thereby increase public understanding

of what combinations the Agency has

already assessed and the regulatory

status of those combinations, aiding

developers in making self-

determinations as to whether their

products would be exempt from the

regulations in accordance with § 340.1.

Certain technical information that could

be used to re-create an organism,

however, may be eligible for CBI

designation under existing statutory

authorities.

Proposed § 340.4(b) would set out the

regulatory review process. Under

proposed § 340.4(b)(1), upon receiving a

request for a regulatory status review of

a GE plant, APHIS would conduct an

initial review of the potential plant pest

risk posed by the GE plant and any

sexually compatible relatives that could

acquire the engineered trait, based on

following factors:

I. The biology of the comparator plant

and its sexually compatible relatives;

II. The trait and mechanism-of-action

of the modification(s); and

III. The effect of the trait and

mechanism-of-action on:

a. The distribution, density, or

development of the plant and its

sexually compatible relatives;

b. The production, creation, or

enhancement of a plant pest or a

reservoir for a plant pest;

c. Harm to non-target organisms

beneficial to agriculture; and

d. The weedy impacts of the plant and

its sexually compatible relatives.

APHIS uses existing knowledge and

information on the biology of the

comparator plant and its sexually

compatible relatives, including their

spatial and temporal distribution in the

absence of intentional human assistance

and their interactions with or impacts

on other organisms and the

environment, as the foundation for

considering whether alterations in the

GE plant are likely to pose plant pest

risks.

As noted earlier, the MOA is the

specific manner by which the genetic

modification of the GE plant confers the

intended trait on the plant. It is

necessary for a regulatory status review

to evaluate both trait and MOA because

the same trait may be obtained by

different MOAs, which may pose greater

or lesser plant pest risks. For example,

the trait of coleopteran resistance can

result from either of at least two MOAs:

Expression of a Cry protein, or

expression of a silencing complex

targeting ribonucleic acids (RNA) in the

coleopteran pest. Plants with insect-

resistant traits can potentially cause

plant pest risks through harms to

organisms beneficial to agriculture, such

as predator insects that can suppress

pest populations. Though the two

MOAs in the example both produce a

coleopteran resistant trait, they would

need to be evaluated separately for

nontarget impacts to beneficial insects.

Nontarget impacts related to Cry

proteins depend on whether the

nontarget insect has the correct protein

in its gut to bind the Cry protein.

Ribonucleic acid interference (RNAi)-

based resistance could, on the other

hand, be designed to target RNA

encoding for any number of essential

proteins in the target insect. The

sequence could be very specific to the

target insect or widely preserved across

varying taxa. Only through extensive

testing or bioinformatics analysis could

risks to nontarget insects be determined.

In summary, because these two MOAs

are different, one would not expect the

analysis of risks to nontarget organisms

for one MOA to be informative in

evaluating the risks to nontarget

organisms of the other. The important

principle is that it is not just the trait,

but also the MOA, which is critical for

differentiating GE plants in order to

determine whether new reviews of plant

pest risk are needed.

As in plant pest risk assessments

(PPRAs) prepared in response to

petitions for nonregulated status under

the current regulations, APHIS would

evaluate whether planting or release of

the GE plant could result in direct or

indirect harm to non-target organisms

that are beneficial to agriculture, such as

pollinators and predators of plant pests.

We would also evaluate the potential of

the plant to displace native/established

organisms or otherwise alter community

composition or structure in a manner

that harms beneficial non-target

organisms.

APHIS recognizes that genetic

engineering may be used to introduce a

trait that increases the distribution,

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density, or development of a plant or

the weedy impacts of the plant, factors

that are considered aspects of a plant’s

weediness. As such, we would continue

the current practice of considering the

weediness of the unmodified plant and

whether the new trait could in any way

change the weediness. We would also

consider potential effects on the

weediness of other plants with which

the engineered plant can interbreed,

because it is relevant to the assessment

of the plant’s plant pest risk. Plants and

their sexually compatible relatives

could have increased importance as

reservoirs for plant pests if they are

distributed differently, are more

prevalent, or are altered in the timing

during which they serve as a host for

plant pests due to the introduced trait.

As part of the regulatory status review,

APHIS would continue to consider

whether the trait might change plant

pest interactions, establishment, and

persistence for both the plant

engineered, and any other plants with

which it can interbreed. Second, if the

plant had the potential to be a truly

troublesome and impactful weed, we

would need to consider whether the

plant with the specific trait being

evaluated should be considered for

regulation and listing as a Federal

noxious weed under the regulations in

part 360. The proposed regulation does

not change this analysis.

Because the initial review is objective,

rapid, and based on transparent

predetermined criteria, it has functional

similarity to the current AIR process. In

both processes, the outcome is merely a

finding of whether a GE organism is

subject to the regulations in part 340.

APHIS will maintain on our website a

list of all GE plant-trait-MOA

combinations which have been

evaluated. The list will include the

inquiry, and the Agency finding. In

cases where no potential plant pest risks

are identified, APHIS will conclude that

the plant-trait-MOA combination is not

likely to pose a plant pest risk, and,

therefore, the agency will have no

discretion to regulate. As such, and

consistent with our current process for

AIR inquiries, there will be no comment

period or need for publication in the

Federal Register.

Proposed § 340.4(b)(2) states that if we

do not identify potential plant pest risk

in the initial review, the GE plant would

not be subject to the regulations in part

340, and APHIS would post the finding

on its website.

Under proposed § 340.4(b)(3), in cases

where the Agency identifies potential

plant pest risks, APHIS would conduct

a PPRA, a more robust analysis than the

initial review, to evaluate the factor(s) of

concern and to determine the likelihood

and consequences of the potential plant

pest risks identified in the initial

review. In some cases, the Agency may

be able to reach a finding that the plant-

trait-MOA combination is not subject to

the regulations based on the outcome of

the PPRA. In other cases, the Agency

may determine that additional

information is needed to evaluate the

potential plant pest risks and field trials

or greenhouse studies may be necessary

to collect additional information to

inform the risk assessment.

Proposed § 340.4(b)(3) also states that

APHIS would make available

information on the results of both the

initial review and the subsequent PPRA

conducted pursuant to this paragraph in

a notice in the Federal Register and take

public comments. After reviewing the

comments, we would make a final

determination of regulatory status and

notify the public via a subsequent notice

in the Federal Register. If the GE plant

were found unlikely to pose a plant pest

risk and therefore not to require

regulation under part 340, APHIS would

post the finding on its website. If the

Agency could not reach such a finding,

movement of the GE plant would be

allowed only under permit.

Along with this proposed rule, we are

publishing a document entitled

‘‘Framework for USDA APHIS’ Plant

Pest Risk Assessment (PPRA) for

Genetically Engineered Plants.’’ The

framework will provide more detailed

information on the PPRA process than

is contained in this document. We

welcome public comment on the

framework.

Proposed § 340.4(c) states that APHIS

would maintain on its website

information on all requests for and

results of regulatory status reviews. We

would protect CBI associated with

individual regulatory status reviews on

the website, except that, as noted

earlier, plant, trait, and MOA would not

be eligible for consideration as CBI.

Permits

The current regulations in § 340.3

provide criteria for a notification

procedure whereby certain GE plants

may be authorized for introduction in

lieu of a permit. Rather than using

customized requirements, like the

permitting conditions used for the

permitting procedure, the notification

procedure relies on performance-based

standards that are described in the

regulations themselves. The use of the

performance-based standards that do

not vary from one notification to the

next facilitates rapid administrative

turnaround on notifications. However,

in some ways, the term ‘‘notification’’

has been misleading to the public, since

sending a notification does not mean

automatic authorization by APHIS.

In many ways, the APHIS evaluations

for notifications are very similar to those

done for permit applications, but the

notification procedure relies on

applicants agreeing to meet the

performance-based standards described

in the regulations rather than submitting

an application for APHIS review

describing the specific measures they

will employ for the activity (as is the

case for permits). With permits, but not

with notifications, APHIS can accept the

proposed measures or add to them, and

the result is a set of binding customized

permit conditions.

Because the notification procedure

uses only the performance-based

standards in the regulations, it is more

administratively streamlined and

provides the responsible person with

flexibility in how the standard is met,

e.g., by allowing for appropriate changes

in protocols used during the growing

season. There are, however, some

disadvantages to this approach. Since

the specific measures that constitute

compliance with the regulations are not

enumerated in the performance

standards, it can be difficult for APHIS

inspectors to determine if a notification

holder is in compliance. This

uncertainty can make enforcing the

regulations, and thereby protecting U.S.

agriculture from plant pest risks, more

difficult than it would be if compliance

measures were clearly enumerated as

they are in specific conditions under a

permit.

The permitting procedure avoids this

disadvantage, because the permit

conditions specify which actions need

to be taken by the responsible person to

be in compliance with the regulations

and do not rely as much on subjective

determinations by both the responsible

person and APHIS personnel. Because

of this, APHIS has determined that it

would have more risk-appropriate

oversight, better regulatory enforcement,

and improved transparency if all

regulated movements are authorized

under the permitting procedure.

Therefore, APHIS is proposing to

remove current notification provisions

from the regulations and require that

movement of all GE organisms subject to

part 340 be conducted under permit.

The use of the permitting procedure

in lieu of notifications is also necessary

for APHIS to address a number of the

recommendations from the OIG audits

and the 2008 Farm Bill. In both the OIG

audits and the 2008 Farm Bill, concern

was expressed regarding the use of

performance-based standards to regulate

field tests of regulated articles. It was

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recommended that APHIS amend the

regulations to exercise greater oversight

and enforcement of such field tests and

to require more extensive reporting and

record retention regarding such tests.

These requirements can be added to a

permit as permitting conditions, but do

not lend themselves to performance-

based standards. Some permit

conditions, however, are and have

always been performance-based. APHIS

acknowledges that there is more than

one way to manage risk and works with

the permit applicant to find a mutually

acceptable way to do so. In some

instances, permit conditions may allow

for the flexibility inherent in

performance standards, while ensuring

a specific requirement is addressed,

something not possible with the

notification procedure.

In short, if APHIS were to retain the

notification procedure, in order to be

responsive to the risk factors that may

be associated with certain field trials but

not others, to make it easier to assess

compliance, and to be responsive to

both the OIG audits and the 2008 Farm

Bill, APHIS would need to revise the

procedure to substantially reduce its

reliance on performance-based

standards. However, doing so would

eliminate the primary benefit of the

current notification procedure, which is

that it is more administratively

streamlined than the permitting

procedure. Indeed, a revised procedure

which took into consideration all risk

factors that may be associated with

specific field trials would be overly

burdensome. For these reasons, APHIS

is proposing to eliminate the

notification procedure, rather than

revise it.

The permitting procedure found in

§ 340.4 of the current regulations

describes types of permits, information

required for permit applications,

standard permit conditions, and

administrative information (e.g., time

frames, appeal procedure, etc.). Permits

contain specific conditions that must be

followed by the permit holder. Standard

permit conditions, or ‘‘general

conditions,’’ are listed in the current

regulations, and APHIS supplements

these with additional conditions as

necessary. The current regulations

specify the amount of time that APHIS

is allotted for review of complete permit

applications: 60 days for permits for

importation and interstate movement,

120 days for environmental release. The

current regulations also outline

requirements for protecting CBI when

submitting a permit application.

APHIS is proposing certain changes

concerning permit application

information requirements, permit

conditions, records, and reports. We are

proposing to remove the specified

timeframes for APHIS review of permit

applications to ensure the Agency has

the appropriate time to evaluate each

permit application based upon the risk

the GE organism poses and the

complexity of the permit application.

Currently, some permit and notification

applications take a minimal amount of

time and others take longer, APHIS

anticipates this to continue. We are also

proposing to reorganize the regulations

to improve the clarity of the permit

application and evaluation procedures.

As noted earlier, under proposed

§ 340.2, GE plants that have not

undergone a regulatory status review

and those that have and were not found

to be unlikely to pose a plant pest risk

would both be subject to the regulations

and could be moved only under permit.

In some cases, a developer may opt to

move a GE plant under permit initially

while also requesting a regulatory status

review. If a GE plant is subject to a

regulatory status review during the time

the permit is in effect, depending on the

results, APHIS could amend the permit,

or, if the plant is found not to require

regulation, terminate the permit and

communicate this termination to the

permittee.

Paragraph (a) of proposed § 340.5

would state that movement of any GE

organism subject to the regulations in

part 340 would require a permit issued

by APHIS.

Paragraph (b) of proposed § 340.5

would state that the responsible person

would have to submit a permit

application using a method listed on our

website. The permit application would

have to contain all the categories of

information listed below.

Proposed paragraph (b)(1) would list

general information requirements for all

types of permit applications. All

applications would have to include the

name, title, and contact information of

the responsible person and agent; the

country and locality where the organism

was collected, developed,

manufactured, reared, cultivated, or

cultured; the intended activity (i.e.,

importation, interstate movement, or

release into the environment of the GE

organism); and information on the

intended trait and genotype of the

intended trait. These information

requirements would be very similar to

those for current permits.

Under proposed paragraph (b)(2),

applications for permits for interstate

movement or importation would, in

addition to meeting the requirements of

paragraph (b)(1), have to include the

origin and destination of the GE

organism, including information on the

addresses and contact details of the

sender and recipient, if different from

the responsible person; the method of

shipment, and means of ensuring the

security of the shipment against

unauthorized release of the organism;

and the manner in which packaging

material, shipping containers, and any

other material accompanying the

organism will be disposed of to prevent

unauthorized release.

Under proposed paragraph (b)(3),

permit applications for release into the

environment would have to address the

general information requirements in

paragraph (b)(1) and provide the

following additional information: The

location and size of all proposed

environmental release sites, including

area, geographic coordinates, addresses,

land use history of the site and adjacent

areas; and the name and contact

information of a person at each

environmental release site, if different

from the responsible person. In the

event that additional release sites are

requested after the issuance of a permit,

APHIS would continue the practice of

evaluating and amending permits to add

new release sites.

Finally, proposed paragraph (b)(4)

would state that APHIS would request

additional information as needed. Based

on APHIS’ extensive experience with

the current permitting process, there are

additional pieces of information that

APHIS proposes to routinely request,

such as multiple GPS coordinates for

requested acreage, as well as multiple

GPS coordinates for actual release

acreage to appropriately describe the

approved area. This information would

allow APHIS to fully utilize GIS

capabilities to oversee what was

released within an authorized area.

Additional documentation or notices

may be required commensurate with

risk of persistence in the environment.

APHIS currently has to follow up

with applicants for this information;

under this proposed rule, we would

obtain it up front, as it would be

required to support the permit

application.

The categories of information above

also align with the recommendations of

the 2005 and 2015 OIG audits, and the

provisions of the 2008 Farm Bill. For

example, the OIG recommendations are

reflected in the provisions that would

enable APHIS to require geographic

coordinates for the locations of

environmental releases.

Proposed paragraph (c) of § 340.5

would continue to exempt Arabidopsis

thaliana from permitting requirements

for interstate movement, provided that it

is moved in a secure shipment and the

cloned genetic material is stably

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integrated into the plant genome and

does not include the complete

infectious genome of a plant pest. This

exemption is based on that organism’s

historically exempt status, which exists

because interstate movement of the

organism has not resulted in the

dissemination of plant pests within the

United States. A. thaliana has desirable

traits (including small size, short

generation times, high seed set, and ease

of growth) that lend themselves to use

in scientific studies. A. thaliana’s small

genome size, lack of repetitive DNA,

and ease of genetic modification using

Agrobacterium tumefaciens make it

especially useful for molecular genetic

analysis. Though GE A. thaliana often

needs to be moved interstate between

laboratories and other containment

facilities as part of scientific studies,

safeguards exist which can adequately

mitigate the plant pest risk.

Proposed paragraph (d) of § 340.5

would exempt disarmed Agrobacterium

tumefaciens from permitting

requirements for interstate movement,

subject to the same conditions as A.

thaliana. This exemption is granted

because, like A. thaliana, disarmed GE

A. tumefaciens often needs to be moved

interstate between laboratories and

other containment facilities as part of

scientific studies, and safeguards exist

which can adequately mitigate the plant

pest risk. In addition, while some

strains of disarmed Agrobacterium may

cause mild plant disease symptoms in

some cases, our extensive experience

has shown that given its specific usage

in transforming plants and its lack of

persistence in the newly transformed

plants, there is a very low plant pest

risk.

Proposed paragraph (e) of § 340.5

would exempt biological control

organism-containing microbial pesticide

products that are currently registered

with EPA as a microbial pesticide

product and that are not plant pests.

Under the authority of the Federal

Insecticide, Fungicide and Rodenticide

Act (FIFRA, 7 U.S.C. 136 et seq.), EPA

regulates certain biological control

organisms (including eukaryotic

microorganisms, prokaryotic

microorganisms, and parasitically

replicating microscopic elements,

including, but not limited to, viruses) as

‘‘pesticides,’’ (see 40 CFR 152.20(a)(3))

and has established a regulatory process

for their use as microbial pesticides.

Proposed paragraph (f) of § 340.5

would contain specifics regarding

APHIS’ review of permit applications.

Under proposed (f)(1), APHIS would

review permit applications to determine

completeness. As under the current

regulations, if the application is

incomplete, APHIS would notify the

applicant orally or in writing, and the

applicant would be provided a

sufficient opportunity to revise the

application. Once an application is

complete, APHIS would review it to

determine whether to approve or deny

the permit application.

Paragraph (f)(2) of § 340.5 would

contain provisions regarding APHIS’

assignment of permit conditions. If a

permit application is approved, permit

conditions would be assigned to each

permit commensurate with the risk of

the organism under permit and activity.

Under the current regulations, the

permitting procedure does not require a

formal acknowledgement from the

applicant prior to permit issuance that

they are aware of and consent to the

permit conditions, though it has been

our practice to request such

acknowledgment. APHIS considers such

an acknowledgement to be necessary in

order to verify that applicants are aware

of and willing to abide by the

conditions. Accordingly, we are

proposing to codify our current practice

by adding to the regulations a

requirement that, prior to permit

issuance, applicants must agree, in

writing and in a manner prescribed by

the Administrator, that they are aware

of, understand, and will comply with all

permit conditions. If an applicant fails

to comply with this provision, their

application would be denied.

Under paragraph (f)(3) of § 340.5, all

premises associated with the permit

would be subject to inspection before

and after permit issuance, and all

materials associated with activities

conducted under permit would be

subject to sampling. APHIS would

require that the responsible person

provide inspectors with access, as

defined under proposed § 340.3, to

inspect any relevant premises, facility,

location, storage area, waypoint,

materials, equipment, means of

conveyance, records, and other articles

related to the movement of organisms

regulated under part 340. While this

requirement is functionally the same as

the current one, it clarifies what

locations and articles may be subject to

inspection. Failure to allow the

inspection of premises prior to the

issuance of a permit would be grounds

for the denial of a permit application.

Failure to allow an inspection after

permit issuance would be grounds for

withdrawal of the permit.

While the current regulations provide

for review of permit applications by

State regulatory officials, they do not

provide for review by Tribal officials.

Recognizing that Tribal officials may

exercise oversight on Tribal lands

equivalent to that of State officials

within States, APHIS proposes in

§ 340.5(f)(4) to submit copies of permit

applications to appropriate State and

Tribal officials for review. Timely

comments received from the State or

Tribal regulatory official would be

considered by the Administrator prior to

permit issuance.

General permit conditions, which

APHIS is proposing to list in paragraph

(g) of § 340.5, would be assigned to all

permits. As under the current

regulations, additional or expanded

permit conditions may also be assigned

if determined by the Administrator to be

necessary to ensure confinement of the

GE organism. Examples of such

supplemental requirements may

include, but are not limited to, specific

requirements for reproductive, cultural,

spatial, and temporal controls;

monitoring; post-termination land use;

site security or access restrictions;

management practices such as training

of personnel involved in the movement;

and practices to prevent articles

associated with the movement of an

organism under permit from spreading

the organism.

The use of permits and permit

conditions gives APHIS and the

responsible person an understanding as

to what actions must be taken for the

permit holder to comply with the

regulations. In the current regulations,

APHIS also provides a list of general

permitting conditions that are assigned

to all permits in order to provide as

much transparency and predictability as

possible about permit conditions. To

that end, as mentioned above, APHIS

would continue to maintain a list of

general conditions that APHIS would

assign to all permits issued under the

regulations within the regulations

themselves. Paragraph (g) of § 340.5

would contain these general conditions.

APHIS would require that:

I. The organism under permit must be

maintained and disposed of in a manner

so as to prevent its unauthorized release

spread, dispersal, and/or persistence in

the environment.

II. The organism under permit must

be kept separate from other organisms,

except as specifically allowed in the

permit.

III. The organism under permit must

be maintained only in areas and

premises specified in the permit.

IV. The organism under permit’s

identity must be maintained and

verifiable at all times.

V. Authorized activities may only be

done while the permit is valid; the

duration for which the permit is valid

will be listed on the permit itself.

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VI. The responsible person would

have to maintain records related to

activities performed under permit of

sufficient accuracy, quality, and

completeness to demonstrate

compliance with all permit conditions

and requirements under the regulations.

APHIS would be allowed access to all

records, to include visual inspection

and reproduction (photocopying, digital

reproduction, etc.). The responsible

person would have to submit reports

and notices regarding the status of the

organism under permit and actions and

activities associated with the organism

to APHIS at the times specified on the

permit and containing the specified

information. These reports would

include, at a minimum:

a. Environmental release reports:

i. Following an environmental release,

environmental release reports would

have to be submitted for all authorized

release locations where an

environmental release occurred.

Environmental release reports would

have to contain details of sufficient

accuracy, quality, and completeness to

identify the location, shape, and size of

the release and the organisms released

into the environment.

ii. In the event no release occurs at an

authorized location, an environmental

release report of no environmental

release would have to be submitted for

all authorized locations where an

environmental release did not occur.

iii. When the environmental release is

that of a plant, reports of volunteer

monitoring activities and findings

would have to be submitted for all

authorized release locations where an

environmental release occurred. If no

monitoring activities are conducted, a

volunteer monitoring report of no

monitoring would have to be submitted

indicating why no volunteer monitoring

was done.

VII. Inspectors would have to be

allowed access, during regular business

hours, to all locations where the

organism under permit is or has been

located and any equipment used with

the organism under permit.

VIII. The organism under permit

would have to undergo the application

of remedial measures determined by the

Administrator to be necessary to prevent

its unauthorized release, spread,

dispersal, and/or persistence in the

environment.

IX. In the event of a possible or actual

unauthorized release, the responsible

person would have to contact APHIS, as

described in the permit, within 24 hours

of discovery, and subsequently supply a

statement of facts in writing or

electronically no later than 5 business

days after discovery.

X. The responsible person for a permit

remains the responsible person for the

duration of the permit unless a transfer

of responsibility is approved by APHIS.

The responsible person must contact

APHIS to initiate any transfer. The new

responsible person assumes all

responsibilities for ensuring compliance

with the existing permit and permit

conditions and for meeting the

requirements of part 340.

Most of the conditions listed above

are drawn from the current regulations,

although APHIS has added some details

to clarify their meaning. For example,

while the existing regulations provide

that APHIS inspectors shall be allowed

access to records related to the permit,

they do not specify what ‘‘access to

records’’ means. APHIS would clarify

that this includes visual inspection and

reproduction (photocopying, digital

reproduction, etc.) of all records

required to be maintained under the

proposed regulations or under the

conditions of the permit. APHIS

believes that these additional details

will better communicate to applicants

what the general permitting conditions

are and will better support

administration of the permitting

program, including compliance and

enforcement.

The conditions related to permit

duration are new. Under the current

regulations, notifications for

environmental releases and interstate

movement are valid for 1 year. Interstate

movement permits are only valid for 1

year from the date of issuance, and a

new import permit must be obtained for

each imported shipment. These permits

are referred to as ‘‘limited permits.’’ The

duration period for a permit issued

solely for an environmental release is

not currently specified.

APHIS has found that it often takes

considerably longer than 1 year for

activities authorized under a permit to

be completed. For example, with a

perennial plant such as a tree, it may

take much longer than 1 year to gather

relevant data about the plant for the

purpose of determining risk.

Additionally, monitoring activities may

be required for several years after a field

test is complete. In other cases,

multiyear research projects may require

multiple shipments of GE organisms

under permit for analysis. APHIS is

therefore proposing to eliminate the

current limits in the regulations on the

duration of permits for interstate

movement and importation. APHIS also

would continue not to specify in the

regulations the duration for which an

environmental release permit is valid.

The duration for which a permit is valid

would instead be specified on the

permit itself, although as is currently

true, some reporting requirements may

extend beyond the expiration of the

permit. APHIS would work with the

developer to ensure that the duration

would be appropriate, so that APHIS

would have the flexibility to issue these

permits with suitable durations to meet

individual circumstances.

APHIS is also proposing to make

regular reporting regarding any

activities associated with environmental

release of a GE organism under permit

a general permitting condition. As

mentioned previously in this document,

the 2005 and 2015 OIG audits suggested

that APHIS exercise greater and more

coordinated oversight over field tests of

GE organisms. APHIS identified regular

reporting regarding actual release site

coordinates and details of the release as

a key means of exercising such

oversight. Adding this reporting

requirement as a general permitting

condition will ensure that it is

communicated to all responsible

persons.

Similarly, to respond to the

recommendations of the 2015 OIG audit,

APHIS would add a requirement as a

general permitting condition that the

responsible person must notify the

Agency in writing if any activity

associated with environmental release

under permit will not be conducted.

OIG recommended that APHIS

implement improvements to track the

status of all authorized test field

locations in order to account for and

sufficiently monitor all such locations

and thereby prevent the inadvertent

release of GE organisms into the

environment. Thus, APHIS is proposing

to require the submission of reports so

APHIS knows the status and location of

authorized field trials. Specifically,

APHIS is proposing to require the

submission of a report of no release to

account for all approved test fields

under an authorization. For example,

APHIS may approve 50 test fields

within various locations in the United

States, but test field releases only occur

in 30 of the 50 approved locations.

Thus, a report of no release would allow

APHIS to account for the 20 other test

fields. This will lead to efficient

compliance oversight of the 30 test

fields that have permitted releases. This

general condition would work in

tandem with the reporting requirement

mentioned above, and help APHIS

resolve what could otherwise be

considered inconsistencies between the

permit conditions and the regular

reports.

APHIS recognizes that some of these

general permitting conditions pertain

only to activities associated with

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environmental release under permit of a

GE organism. APHIS also recognizes

that it is possible that certain permit

applications may not include a request

to release the organism into the

environment. Where conditions apply to

a specific activity, e.g., movement into

the United States, movement interstate,

or release into the environment, the

appropriate condition will be

acknowledged. However, the permit

issued would still contain these general

conditions to communicate to the

responsible person APHIS’ general

requirements regarding environmental

release of GE organisms under permit.

This will ensure that, consistent with

the recommendations of the OIG audits,

all responsible persons are aware of

those requirements. The conditions

would also prove useful, should the

responsible person subsequently request

amendments to the permit to authorize

environmental release.

While the general permitting

conditions that are currently in the

regulations contain a condition that

pertains to packing material used to

transport the organism under permit,

APHIS would not retain this as a general

permitting condition. Instead, as

discussed below, requirements for

shipping under permit would be

contained in paragraph (k) of § 340.5.

Conditions for denial of a permit

application or withdrawal of an existing

permit are contained in current

§ 340.4(g). We are proposing to amend

these conditions to make them clearer

and provide additional protection

against plant pest risks.

Proposed § 340.5(h)(1) lists

circumstances under which a permit

application may be denied. An

application could be denied either

orally or in writing. If the denial is oral,

the Administrator will then

communicate the denial and the reasons

for it in writing as promptly as

circumstances allow. A denial may

occur when the Administrator

concludes that, based on the application

or additional information, the proposed

actions, i.e., movements under permit,

may result in the unauthorized release,

spread, dispersal, and/or persistence of

a GE organism in the environment. Such

a situation would arise if we determined

that the possibility of the unauthorized

release would exist regardless of any

permit conditions we could assign. A

second cause for denial would be the

failure of the responsible person or any

agent of the responsible person to

comply at any time with part 340 or any

APHIS regulation pursuant to the PPA

or with the conditions of any permit

that has previously been issued in

accordance with the regulations. A

previous record of noncompliance

would call into question the applicant’s

ability or willingness to abide by our

permitting conditions. Finally, if all

other application requirements are met,

we would still decline to issue the

permit if the applicant does not agree in

writing to comply with the permit

conditions we assign for movement of

the organism or does not allow

inspection, in accordance with the

regulations, of the premises associated

with the permit.

Conditions for the withdrawal of

permits would be contained in

§ 340.5(h)(2). A permit could be

withdrawn if, following issuance of the

permit, the Administrator receives

information that would otherwise have

provided grounds for APHIS to deny the

permit application; if the Administrator

determines that actions taken under the

permit have resulted in the

unauthorized release, spread, dispersal,

and/or persistence in the environment

of a GE organism; or if the

Administrator determines that the

responsible person or any agent of the

responsible person has failed to comply

at any time with the regulations in part

340, any other regulations pursuant to

the PPA, or any permit conditions. The

first two of these proposed conditions

are new. They would provide additional

protections against plant pest risks that

may be associated with the movement of

GE organisms under permit. Failure to

comply with permit conditions is

grounds for withdrawal under the

current regulations, but we would

provide additional protection against

plant pest risks by broadening the

provision to include failure to comply

with any APHIS regulation as well.

Under proposed § 340.5(h), the

Administrator would communicate the

denial or withdrawal and the reasons for

it in writing as soon as circumstances

allow.

Proposed § 340.5(i) would retain the

current procedures for appealing the

denial of a permit application or

withdrawal of a permit, with one

modification. Any person whose permit

application has been denied or whose

permit has been withdrawn could

appeal the decision in writing or

electronically to the Administrator.

Under the current regulations, the

appeal must be submitted within 10

days after the applicant receives the

written notification of the denial or

withdrawal and must state all of the

facts and reasons that, in the view of the

applicant, demonstrate that the permit

was wrongfully denied or withdrawn.

The Administrator grants or denies the

appeal, in writing, stating the reasons

for the decision, as promptly as

circumstances allow. If there is a

conflict as to any material fact, a hearing

is held to resolve the conflict. Under

this proposed rule, we would require an

acknowledgment by the applicant of the

denial or withdrawal within 10 days

after receiving the written notification,

along with a statement of the applicant’s

intent to appeal. The proposed change

is intended to allow the applicant

adequate time to gather the necessary

information and prepare the appeal.

APHIS is also proposing to clarify in

§ 340.5(j) of the regulations the

procedure to be used when amendment

of existing permit conditions is sought

by the responsible person or required by

APHIS. In the current regulations, the

administrative practices that APHIS

uses to amend permits are not stated

explicitly. Adding them to the

regulations would provide increased

transparency and efficiency.

Proposed paragraph (j)(1) would state

that if a responsible person determines

that circumstances have changed since

the permit was issued, he or she may

contact APHIS directly and request an

amendment or amendments. Supporting

information may need to be submitted

to justify the request. APHIS may amend

the permit if only minor changes are

needed. Requests for more substantive

changes may require a new permit

application. Prior to issuance of an

amended permit, the responsible person

or his or her agent(s) will be required to

agree in writing to comply with the

conditions of amended permit. If the

responsible person does not agree to the

conditions, the amendment will be

denied.

APHIS may also initiate amendments

to permits and permit conditions upon

determining that such an amendment is

needed to address the plant pest risk

posed by the GE organism or the

activities allowed under the permit. In

such cases, APHIS would provide notice

to the responsible person of the

amendment(s) and, as soon as

circumstances allow, the reasons for it.

The responsible person and his or her

agents would have to agree in writing to

comply with the new conditions before

APHIS would issue the amended

permit. Failure to provide such an

agreement may result in the withdrawal

of an existing permit.

Section 340.8 of the current

regulations lists container requirements

for the shipping of regulated articles,

i.e., shipping under permit. These

requirements are very prescriptive.

While they do allow a responsible

person to request variances from the

requirements, this request process, by

its nature, results in a case-by-case

determination of whether other types of

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containers are acceptable for the

transportation of the organism. The

current regulations also do not clearly

reflect the performance-based standard

that APHIS used to develop the

requirements, which was that the

container should be sufficient to prevent

dissemination of a GE organism during

movement under permit.

Proposed paragraph (k) of § 340.5

would update the requirements for

shipping under permit to resolve the

issues discussed above.

Paragraph (k)(1) would state that

shipping containers or means of

conveyance would have to meet the

standards listed under our proposed

definition of secure shipment, i.e.,

would have to be of sufficient strength

and integrity to withstand leakage of

contents, shocks, pressure changes, and

other conditions incident to ordinary

handling in transportation. These

requirements would make the

performance standard referred to above

more explicit in the regulations than it

is now, while at the same time making

the requirements less prescriptive, thus

eliminating the need for a request

process for variances.

In that paragraph, we would also

retain a provision from the current

regulations, currently a footnote to

§ 340.8, that specifies that all organisms

shipped under permit must be shipped

in accordance with the regulations in 49

CFR part 178. Those regulations, which

are administered by the Department of

Transportation (DOT), provide

packaging requirements for materials,

including organisms that DOT has

designated as hazardous materials.

Paragraph (k)(2) would state that the

container would have to be

accompanied by a document that

included the names and contact details

for both the sender and the recipient.

These details are essential for purposes

of enforcement.

Paragraph (k)(3) would list container-

labeling and documentation

requirements for GE organisms imported

under permit into the United States.

These requirements are currently found

in § 340.7 and would not be changed.

Finally, paragraph (k)(4) would state

that following the completion of the

shipment, all packing material, shipping

containers, and any other material

accompanying the organism would have

to be treated or disposed of in such a

manner so as to prevent the

unauthorized dissemination and

establishment of the organism. This

requirement is currently a general

permitting condition, but could more

accurately be described as a shipping

requirement.

APHIS currently authorizes a small

number of permits for commercial

production. APHIS has occasionally

received inquiries from stakeholders

regarding whether a permit could

authorize the commercial distribution of

an organism subject to the regulations.

Currently, most developers of GE

organisms do not commercialize their

products until after those products are

granted a determination of nonregulated

status. However, APHIS does not

prohibit commercializing GE organisms

that have not been granted a

determination of nonregulated status.

Under the proposed regulations, there

may be some GE organisms that an

entity wishes to commercialize or grow

on a large scale, under permit. As it

does currently, APHIS would evaluate

these permit applications on a case-by-

case basis to determine whether

permitting conditions can be developed

that adequately address the risk

associated with the organism.

The current regulations in § 340.4(h)

provide APHIS with the ability to issue

courtesy permits in order to facilitate

the movement of GE organisms that are

not subject to the regulations in part 340

but whose movement might otherwise

be hindered because of their similarity

to organisms or articles that are

regulated by other APHIS programs.

APHIS commits significant resources to

the issuance of these courtesy permits.

Courtesy permits have been part of

the regulations since their inception in

1987, and have been useful to inform

shippers and State and Federal

inspectors not yet fully familiar with

requirements for GE organisms that the

shipments in question were not

regulated. However, their continued use

has led to the widespread

misunderstanding by some researchers

that courtesy permits are actually

required for the movement of certain

organisms or that issuance of a courtesy

permit removes the requirement for

applicants to follow other applicable

regulations, such as the plant pest

regulations found in 7 CFR part 330.

This confusion partially stems from the

similarities between the application

form for courtesy permits and those for

other types of permits, as well as

between the courtesy permit itself and

other permits. Therefore, in an effort to

alleviate confusion and to better focus

and allocate APHIS resources, APHIS

would no longer issue courtesy permits.

It has been common APHIS practice to

facilitate the importation of

nonregulated articles through the use of

letters indicating that no permit is

required; under the proposed

regulations, APHIS would move to this

approach. APHIS would continue to

work with researchers and relevant

government regulatory officials to

facilitate the transition.

Record Retention, Compliance, and

Enforcement

APHIS is proposing to consolidate all

record retention, compliance, and

enforcement requirements in part 340

into a new § 340.6. APHIS is also

proposing to strengthen these provisions

in order to manage compliance with the

regulations more efficiently, to augment

the approaches used to prevent or

remediate plant pest risks, and to utilize

appropriate enforcement strategies.

These proposed regulatory changes also

reflect certain provisions of the 2008

Farm Bill and align with

recommendations of the 2005 and 2015

OIG audits.

The current regulations require a

responsible person to retain for 1 year

records demonstrating that an organism

that was imported or moved interstate

under a permit arrived at its intended

destination but contain no record-

retention requirements related to

environmental release of an organism

under permit. While APHIS has

frequently added this record retention

requirement as a permitting condition,

both the 2005 and 2015 OIG audits and

the 2008 Farm Bill recommended that

the Agency specify the retention

requirement in the regulations

themselves. These recommendations

have been corroborated by the Agency’s

own experience administering the

regulations.

Proposed § 340.6(a) would require

that a responsible person and his or her

agent(s) would have to establish and

keep the following records and reports:

•All records and reports required as

a condition of a permit;

•Addresses and any other

information, e.g., GPS coordinates and

maps, needed to identify all locations

where the organism under permit was

stored or used, including all contained

facilities and environmental release

locations;

•A copy of the APHIS permit

authorizing the permitted activity; and

•Legible copies of contracts between

the responsible person and all agents

that conduct activities subject to the

regulations for the responsible person

and copies and documents relating to

agreements made without a written

contract.

We are proposing these requirements

for compliance assurance, evaluation,

and enforcement purposes, including

fact findings and investigations into the

possible unauthorized environmental

release of a GE organism subject to

permitting or its escape from a

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containment facility. A thorough record

of activities taken under the permit is

necessary in order for APHIS to assess

compliance and determine whether

enforcement actions are needed.

Proposed paragraph (b) of § 340.6 lists

requirements for record retention.

Records indicating that an organism that

was imported or moved interstate under

permit reached its intended destination

would have to be retained for at least 2

years. The current requirement is 1 year.

In the event that there is uncertainty

regarding whether the organism arrived

at this location, it may take APHIS more

than 1 year to investigate the matter.

All other records related to the permit

would have to be retained for 5 years

following permit expiration, unless the

Administrator determines that a longer

time period is appropriate and

documents that determination in the

supplemental conditions of the permit.

APHIS recognizes that, in practice,

our proposed requirements would

require most records associated with

activities conducted under permit to be

retained for 5 years (or longer), and that

this is a significant duration to retain a

potentially substantial number of

records pertaining to permit activities,

especially for a researcher or small

company. However, retaining

documents for less than 5 years may

impede fact findings and investigations

into possible compliance infractions. In

conducting such investigations, APHIS

has found it necessary to obtain

information from field trials conducted

up to 5 years prior to an investigation.

In instances in which the information

was not available, APHIS’ ability to do

an expeditious and thorough

investigation was adversely impacted.

The Agency requests specific public

comment regarding whether a shorter

duration is warranted for certain records

pertaining to permit activities and

which activities these may be.

Additionally, APHIS requests comment

on any alternate means that

stakeholders may identify for the

Agency to obtain necessary information

from developers in the event of a fact

finding or an investigation of possible

regulatory noncompliance.

Proposed paragraph (c) of § 340.6

would state that responsible persons

and their agents must comply with the

proposed regulations. Failure to comply

with the regulations could result in any

or all of the following: Denial of a

permit application or withdrawal of a

permit, application of remedial

measures in accordance with the PPA,

and criminal or civil penalties in

accordance with the PPA.

Pursuant to sections 7714 and 7731 of

the PPA, APHIS may seize, quarantine,

treat, destroy, or apply other remedial

measures to an organism covered under

the regulations that is new to or not

widely prevalent or distributed in the

United States to prevent dissemination

of the organism. APHIS typically issues

an Emergency Action Notification or

administrative order to the owner of the

organism to specify these remedial

measures.

If APHIS intends to issue a civil

penalty, the Agency may enter into a

stipulation prior to issuance of the

complaint seeking the penalty. Our

regulations regarding such stipulations

are located in 7 CFR 380.10.

Proposed paragraph (d) of § 340.6

would specify that for purposes of

enforcing the regulations, the act,

omission, or failure of any agent for a

responsible person may be deemed also

to be the act, omission, or failure of the

responsible person. We would note,

however, that in enforcing the

regulations, we will take the least

drastic action that is commensurate

with the mitigating factors of the

noncompliance. It is expected,

therefore, that major and/or repeated

infractions would be dealt with more

harshly than minor ones.

Confidential Business Information

The current regulations contain

requirements pertaining to CBI in

various sections. APHIS is proposing to

consolidate these requirements for

protecting CBI into a single section,

§ 340.7, thereby making it easier for

interested persons to find the necessary

information. Under proposed § 340.7,

persons submitting any document to

APHIS in accordance with the

regulations must identify those portions

of the document deemed to be CBI. Each

page containing such information must

be marked ‘‘CBI Copy.’’ A second copy

of the document must be submitted with

all such CBI deleted, and each page

where the CBI was deleted must be

marked ‘‘CBI Deleted.’’ In addition, any

person submitting CBI must justify how

each piece of information requested to

be treated as CBI is a trade secret or is

commercial or financial information and

is privileged or confidential. As noted

earlier, in order to facilitate APHIS’

transparent regulatory approach, a

general description of the plant-trait-

MOA combination will not be eligible

for CBI designation. Certain technical

information, however, such as GPS

location data, or data that could be used

to recreate an organism, may be deemed

as CBI under existing statutory

authorities.

Costs and Charges

Proposed § 340.8 would contain

APHIS’ requirements regarding costs

and charges for the services of inspector,

which are found in the current

regulations in § 340.9. Currently, the

section provides that the services of an

inspector during regularly assigned

hours of duty are provided free of

charge, but that APHIS will not be

responsible for any other costs or

charges incident to inspections or

compliance, apart from the services of

this inspector. These provisions would

remain unchanged in this proposed

rule.

Miscellaneous

Because, as described above, we are

proposing to eliminate the notification

procedure from these regulations, we

would also remove language pertaining

to notifications from 7 CFR

372.5(c)(3)(iii). Because we are

proposing to eliminate petitions for

determinations of nonregulated status,

we are also removing language

pertaining to that process in paragraphs

(b)(7) and (c)(4) of § 372.5. These

changes would make those regulations

consistent with the proposed ones

contained in this document.

National Environmental Policy Act

To provide the public with

documentation of APHIS’ review and

analysis of any potential environmental

impacts associated with the revision of

our regulations regarding the movement

of certain GE organisms, APHIS has

prepared a programmatic environmental

impact statement (PEIS). The PEIS was

prepared in accordance with: (1) The

National Environmental Policy Act of

1969 (NEPA), as amended (42 U.S.C.

4321 et seq.), (2) regulations of the

Council on Environmental Quality for

implementing the procedural provisions

of NEPA (40 CFR parts 1500–1508), (3)

USDA regulations implementing NEPA

(7 CFR part 1b), and (4) APHIS’ NEPA

Implementing Procedures (7 CFR part

372). The PEIS may be viewed on the

Regulations.gov website or in our

reading room. (A link to Regulations.gov

and information on the location and

hours of the reading room are provided

under the heading

ADDRESSES

at the

beginning of this proposed rule.) In

addition, copies may be obtained by

calling or writing to the individual

listed under

FOR FURTHER INFORMATION

CONTACT

.

Executive Orders 12866, 13563, and

13771 and Regulatory Flexibility Act

This proposed rule has been

determined to be significant for the

purposes of Executive Order 12866 and,

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13

One × $3,560,245 = $3,560,245. Four ×

$730,600 = $2,922,400. $3,560,245 + $2,922,400 =

$6,482,645.

14

Two × $3,560,245 = $7,120,490. Eight ×

$730,600 = $5,844,800. $7,120,490 + $5,844,800 =

$12,965,290.

therefore, has been reviewed by the

Office of Management and Budget. This

proposed rule, if finalized as proposed,

is expected to be an Executive Order

13771 deregulatory action. Details on

the estimated cost savings of this

proposed rule can be found in the rule’s

economic analysis.

We have prepared an economic

analysis for this rule. The economic

analysis provides a cost-benefit analysis,

as required by Executive Orders 12866

and 13563, which direct agencies to

assess all costs and benefits of available

regulatory alternatives and, if regulation

is necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety

effects, and equity). Executive Order

13563 emphasizes the importance of

quantifying both costs and benefits, of

reducing costs, of harmonizing rules,

and of promoting flexibility. The

economic analysis also provides an

initial regulatory flexibility analysis that

examines the potential economic effects

of this rule on small entities, as required

by the Regulatory Flexibility Act. The

economic analysis is summarized

below. Copies of the full analysis are

available by contacting the person listed

under

FOR FURTHER INFORMATION

CONTACT

or on the Regulations.gov

website (see

ADDRESSES

above for

instructions for accessing

Regulations.gov).

We are proposing to revise our

regulations regarding the movement of

certain genetically engineered

organisms in response to advances in

genetic engineering and our

understanding of the plant pest risk

posed by them, thereby reducing

regulatory burden for developers of

organisms that are unlikely to pose

plant pest risks. The proposed rule

would provide a clear, predictable, and

efficient regulatory pathway for

innovators, facilitating the development

of new and novel genetically engineered

organisms that are unlikely to pose

plant pest risks.

The proposed regulations would

benefit developers, producers, and

consumers of certain GE organisms,

public and private research entities, and

the Agency. There would not be any

decrease in the level of protection

provided against plant pest risks. The

regulatory framework, including the

regulatory status review process used to

determine regulatory status of GE

plants, established under the proposed

rule would provide cost savings to the

biotechnology industry and allow

APHIS to allocate its resources more

effectively than it can under the present

regulations.

Under the proposed rule, APHIS

regulatory oversight (through

permitting) would not be required for

GE plants that fall into an exempted

category or have been assessed by

means of a regulatory status review and

found unlikely to pose plant pest risks.

Direct regulatory costs to GE plant

developers would be reduced for the

development of GE plants for which

permits are no longer necessary. Savings

to the regulated community would

result from a reduced need to collect

field data, fewer reporting requirements,

and lower management costs. Costs now

associated with petitions for non-

regulated status would be reduced or

eliminated where permits are no longer

necessary.

Cost savings for these entities are

expected to more than offset the new

costs. APHIS estimated the cost savings

for two regulatory oversight scenarios,

based on a study of the costs

encountered by private biotechnology

developers as they pursue regulatory

authorization of their innovations.

When only APHIS has regulatory

oversight, compliance cost savings

under the proposed rule could range

from $1.5 million to $5.6 million ($3.6

million on average) for the development

of a given GE plant. If EPA and/or FDA

also have an oversight role in the

development of a given GE plant,

compliance cost savings could range

from $538,000 to $924,000 ($730,600 on

average). From 1993 through 2017, an

average of just under 5 petitions were

processed (granted non-regulated status

or the petition withdrawn) in a given

year, with a high of 12 in 1995. As the

rule is expected to spur innovation, we

expect the number of new organisms

developed annually to increase over

time. In particular, the proposed rule

may provide impetus to the

development of new horticultural

varieties, where the costs of acquiring

non-regulated status may have been

high in the past relative to the potential

market.

In the following estimate of impacts,

we use average cost savings per GE

plant developed and assume the annual

number of new GE organisms developed

under the proposed rule without APHIS

permits would range from 5 (the current

annual average of processed petitions)

to 10 (twice this average). We further

assume that about 20 percent of those

new GE organisms would have required

only APHIS oversight, and the

remaining would still require FDA and/

or EPA oversight. If 5 new GE plants are

developed annually without APHIS

permits (all with no APHIS permit, but

4 still with EPA and/or FDA

evaluation), the annual savings would

be $6.5 million.

13

If 10 new GE plants

are developed annually without APHIS

permits (all with no APHIS permit, but

8 still with EPA and/or FDA

evaluation), the annual savings would

be $13.0 million.

14

There would be some new costs borne

by regulated entities under the proposed

rule pertaining to rule familiarization

and recordkeeping. Annual

recordkeeping costs are based on

information collection categories in the

paperwork burden section of the rule

and are estimated would total about

$714,000. About 1,100 distinct entities

have applied for permits or notifications

under part 340. APHIS estimates that

those entities would spend about 8

hours becoming familiar with the

provisions of this rule at a total one-time

cost of about $576,000.

In accordance with guidance on

complying with Executive Order 13771,

the primary estimate of the annual net

private sector cost savings for this rule

is $9 million. This value is the mid-

point estimate of the net private cost

savings annualized in perpetuity using

a 7 percent discount rate.

Current annual APHIS personnel

costs for conducting those GE activities

that would be affected by the proposed

rule total about $3.5 million. These

include compliance activities,

inspection activities, AIR process

activities, notification activities, permit

activities, and petition activities. Under

the proposed rule, APHIS’ overall

annual personnel costs of regulating GE

organisms are not expected to change.

While the volume of specific activities

would change, the overall volume of

regulatory activities, the general nature

of those activities and level of skill

necessary to perform those activities

would not. There would be costs to

APHIS of implementing the proposed

rule, which would include outreach

activities, developing guidance

documents, training, and adjusting the

current permit system. APHIS estimates

that the public outreach, guidance and

training would cost about $77,000.

Requests for regulatory status and

response letters under the proposed rule

could be handled in a manner similar to

the current AIR process outside the

electronic permitting system without

incurring new costs.

PMPIs are plants genetically

engineered in order to produce

pharmaceutical and industrial

compounds. There is a likelihood that

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15

Genetically Engineered Crops: Past Experience

and Future Prospects. Committee on Genetically

Engineered Crops: Past Experience and Future

Prospects; Board on Agriculture and Natural

Resources; Division on Earth and Life Studies;

National Academies of Sciences, Engineering, and

Medicine.

most, if not all, GE PMPI-producing

plants that are currently under APHIS

permits could be determined to be not

regulated under the provisions of the

proposed regulations after a regulatory

status review because they are unlikely

to pose a plant pest risk. Thus, such

plants could be grown outdoors without

the need for permits and without APHIS

oversight. Federal oversight of outdoor

plantings of PMPI-producing plants

could be necessary to prevent the

unlawful introduction into the human

or animal food supply of

pharmaceutical or industrial PMPI

products, even when the principal

purpose of the plants is not for human

or animal food use. APHIS estimates

that current PMPI inspections cost

roughly $26,000 in total annually or

about $800 each on average. Assuming

that oversight continues in the same

manner as APHIS oversight, a similar

government expenditure could be

expected under any Federal PMPI

oversight scenario.

PIPs are plants that are genetically

engineered to produce plant-

incorporated protectants, i.e., pesticides.

APHIS regulates those that are captured

by our current regulations, i.e., when

plant pests are used. PIPs also fall under

the regulatory oversight of EPA.

However, currently only APHIS

exercises regulatory oversight of PIP

plantings on 10 acres or less of land.

Many GE PIP-producing plants that are

currently regulated under APHIS

permits or notifications could be

determined not regulated under the

provisions of the proposed regulations

after a regulatory status review because

they are unlikely to pose plant pest

risks. Thus, such plants could be grown

outdoors without the need for an APHIS

permit and without undergoing APHIS

oversight. This proposal would shift

Federal oversight of small-scale (10 or

fewer acres) outdoor plantings of some

PIPs to EPA. EPA may decide to require

experimental use permits for all, some,

or none of such PIPs, and may conduct

inspections of all, some, or none of

those PIPs under permit. As described

above, current inspection costs incurred

by APHIS average roughly $800 per

inspection.

A quicker APHIS evaluation process

and related reduction to regulatory

uncertainty may facilitate small

companies’ ability to raise venture

capital. Reduced regulatory

requirements may also lead to greater

participation by the public and private

academic institutions in GE research

and product development. These

indirect benefits of the proposed rule

may spur GE innovations, particularly

in small acreage crops where genetic

engineering has not been widely

utilized due to the expense of

regulation.

GE crop varieties, in general, are not

required to be reviewed or approved for

safety by the FDA before going to

market. However, the developer is

responsible for ensuring product safety,

and some developers consider voluntary

consultations with FDA on food safety

to be an absolute necessity for

applicable GE products.

15

It would be in

a GE plant developer’s own best interest

to maintain the same level of

supervision and control over the

development process as at present to

prevent undesired cross-pollination or

commingling with non-GE crops.

Developers also have various legal,

quality control and marketing

motivations to maintain rigorous

voluntary stewardship measures. APHIS

therefore believes that developers would

continue to utilize such measures for

field testing even in cases where USDA

would not require a permit.

Farmers who adopt GE crops may

benefit from the proposed rule. The

adoption of GE crops in the United

States has generally reduced costs and

improved profitability at the farm level.

As mentioned, under the proposed rule,

regulatory costs are expected to be

lower, thereby potentially spurring

developer innovation, especially among

small companies and universities.

Farmers may benefit by having access to

a wider variety of traits as well as a

greater number of new GE crop species,

affording them a broader selection of

crops to suit their particular

management needs. Among the types of

innovations expected are crops with

greater resistance to disease and insect

pests, greater tolerance of stress

conditions such as drought, high

temperature, low temperature, and salt,

and more efficient use of fertilizer.

These types of traits can lower farmer

input costs (water, fertilizer, pesticide)

and increase yields during times of

adverse growing conditions.

In addition to the compliance costs

associated with regulation, there are

opportunity costs of delayed innovation

if the approval process for a plant is

longer than necessary to ensure safety

with reasonable scientific certainty.

Regulatory delays mean that the benefits

of innovation occur later than they

otherwise would have and most likely,

at lower levels. The forgone benefits due

to delayed innovation can be substantial

and developers, producers, and

consumers all lose from regulatory

delays. The foregone benefits stemming

from even a relatively brief delay in

product release overshadow both

research and regulatory costs. It should

be noted that while the proposed rule

would alter the evaluation process of GE

plants for APHIS, it does not affect the

evaluation by FDA or EPA, which

operate under different authorities and

evaluate for different endpoints, or

international regulatory agencies, all of

whom would have impact opportunity

costs. When FDA and/or EPA also have

a regulatory role, time savings would

only be realized in those instances in

which APHIS’ process takes the longest

time. When APHIS is the only agency

with oversight, such as for some new

horticultural varieties, there could be

significant time savings over the current

petition process.

Some farmers (e.g., growers of organic

and or identity-preserved crops) could

be indirectly negatively impacted by

these same innovations. Some

consumers choose not to purchase

products derived from GE crops and

instead purchase commodities such as

those labeled ‘‘non-GMO (Genetically

Modified Organism)’’ or organic. In

addition, the organic standard does not

allow for the use of GE seeds. When

crops intended for the non-GE or

identity-preserved marketplace contain

unintended GE products, the

profitability of the non-GE or identity-

preserved product may be diminished.

Effects of the proposed rule on the

variety of GE crop species grown in the

United States and their wider adoption

may increase the possibility of cross-

pollination or commingling. As acreage

of any given GE crop increases and as

a greater variety of crops are modified

using genetic engineering, the potential

for more instances of unintended

presence of a GE organism increases.

Unauthorized releases of regulated GE

crop plants and the entry of regulated

plant material in the commercial food

and feed supply can have impacts on

domestic or international markets.

While such releases have occurred and

may occur again, such incidents are

expected to be rare.

Entities potentially affected by the

proposed rule fall under various

categories of the North American

Industry Classification System. While

economic data are not available on

business size for some entities, based on

industry data obtained from the

Economic Census and the Census of

Agriculture we can assume that the

majority of the businesses affected by

the proposed rule would be small.

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APHIS welcomes public comment on

the proposed rule’s possible impacts.

The following table provides a summary

statement of the expected direct costs

and cost savings of the proposed rule:

T

ABLE

1—E

XPECTED

C

OSTS AND

C

OSTS

S

AVINGS OF THE

P

ROPOSED

R

ULE FOR THE

B

IOTECHNOLOGY

I

NDUSTRY AND

FOR

USDA, 2016

DOLLARS

Entity: Biotechnology Industry .......................................................................... Costs ($1,000).

Developer costs (recordkeeping and rule familiarization)

1

.................. 1,290.

Cost savings per Trait ($1,000)

Developer Savings

2

Proposed Rule,

lower bound Proposed Rule,

upper bound

USDA sole regulatory agency ............................................................................. ¥1,546 ¥5,574

USDA with FDA and/or EPA oversight ............................................................... ¥538 ¥924

APHIS Biotechnology Regulatory Services ........................................................ Costs ($1,000).

Costs for public outreach, training, and e-permitting

3

........................................ 77.

1

Costs of rule familiarization, one-time costs, would total about $576,000. Annual recordkeeping costs would total about $714,000.

2

These savings are shown on a per trait basis. On average, if 5 new GE organisms are developed annually without USDA permits (all with no

USDA permit, but 4 still with EPA and/or FDA evaluation), the annual savings would be $6.5 million. If 10 new GE organisms are developed an-

nually without USDA permits (all with no USDA permit, but 8 still with EPA and/or FDA evaluation), the annual savings would be $13.0 million.

3

Requests for regulatory status and response letters under the proposed rule could be handled in a manner similar to the current ‘Am I Regu-

lated’ process outside the electronic permitting system without incurring new costs.

As shown in the economic analysis

accompanying this proposed rule, we

have some data pertaining to the

potential effects of this proposed rule on

small entities; however, we do not

currently have all of the data necessary

for a comprehensive analysis of those

potential effects. Therefore, we are

inviting comments on the potential

effects. In particular, we are interested

in additional information on the number

and kind of small entities that may

incur benefits or costs from the

implementation of this proposed rule.

Executive Order 12372

This program/activity is listed in the

Catalog of Federal Domestic Assistance

under No. 10.025 and is subject to

Executive Order 12372, which requires

intergovernmental consultation with

State and local officials. (See 2 CFR

chapter IV.)

Executive Order 12988

This proposed rule has been reviewed

under Executive Order 12988, Civil

Justice Reform. If this proposed rule is

adopted: (1) All State and local laws and

regulations that are inconsistent with

this rule will be preempted; (2) no

retroactive effect will be given to this

rule; and (3) administrative proceedings

will not be required before parties may

file suit in court challenging this rule.

Executive Order 13175

This rule has been reviewed in

accordance with the requirements of

Executive Order 13175, ‘‘Consultation

and Coordination with Indian Tribal

Governments.’’ Executive Order 13175

requires Federal agencies to consult and

coordinate with Tribes on a

government-to-government basis on

policies that have Tribal implications,

including regulations, legislative

comments or proposed legislation, and

other policy statements that have

substantial direct effects on one or more

Indian Tribes, on the relationship

between the Federal Government and

Indian Tribes, or on the distribution of

power and responsibilities between the

Federal Government and Indian Tribes.

The Animal and Plant Health

Inspection Service has assessed the

impact of this rule on Indian Tribes.

APHIS sent a letter to Tribal leaders

upon publication of a notice of intent to

conduct a programmatic environmental

impact statement in support of the

proposed rule. In addition, APHIS held

a conference call for Tribal leaders to

provide information and answer

questions regarding our plan to publish

a proposed rule.

In an email dated December 21, 2018,

one California Tribe contacted APHIS

requesting consultation on the proposed

rule. This request has led USDA’s Office

of Tribal Relations (OTR) to determine

that the rule has potential tribal

implications that require continued

outreach efforts to determine if tribal

consultation under Executive Order

13175 is required. As of February 2019,

APHIS is following up with that Tribe

to determine whether formal

consultation is warranted or needed. If

this or another tribe requests formal

consultation, APHIS will work with the

OTR to ensure meaningful consultation

is provided where changes, additions,

and modifications identified herein are

not expressly mandated by Congress.

Paperwork Reduction Act

In accordance with section 3507(d) of

the Paperwork Reduction Act of 1995

(44 U.S.C. 3501 et seq.), reporting and

recordkeeping requirements included in

this proposed rule have been submitted

for approval to the Office of

Management and Budget (OMB). Please

send comments on the Information

Collection Request (ICR) to OMB’s

Office of Information and Regulatory

Affairs via email to oira_submissions@

omb.eop.gov, Attention: Desk Officer for

APHIS, Washington, DC 20503. Please

state that your comments refer to Docket

No. APHIS–2018–0034. Please send a

copy of your comments to the USDA

using one of the methods described

under

ADDRESSES

at the beginning of

this document.

We are proposing to revise our

regulations regarding the movement

(importation, interstate movement, and

environmental release) of certain GE

organisms. The proposed revisions

include, but are not limited to, the

following new information collection

activities: Requests for confirmation

from APHIS of developers’ self-

determinations that the GE plant is not

within the scope of part 340, procedures

for permits and record reporting,

marking and labeling of organisms

under permit, State and Tribal

regulatory officials’ review of permit

applications, regulatory status reviews,

and recordkeeping. In addition, the

proposed revisions would remove the

current petition process for

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nonregulated status and associated

burdens.

We are soliciting comments from the

public (as well as affected agencies)

concerning our proposed information

collection and recordkeeping

requirements. These comments will

help us:

(1) Evaluate whether the proposed

information collection is necessary for

the proper performance of our agency’s

functions, including whether the

information will have practical utility;

(2) Evaluate the accuracy of our

estimate of the burden of the proposed

information collection, including the

validity of the methodology and

assumptions used;

(3) Enhance the quality, utility, and

clarity of the information to be

collected; and

(4) Minimize the burden of the

information collection on those who are

to respond (such as through the use of

appropriate automated, electronic,

mechanical, or other technological

collection techniques or other forms of

information technology; e.g., permitting

electronic submission of responses).

Estimate of burden: Public burden for

this collection of information is

estimated to average 17.73 hours per

response.

Respondents: Businesses and State

and Tribal regulatory officials.

Estimated annual number of

respondents: 321.

Estimated annual number of

responses per respondent: 3.

Estimated annual number of

responses: 1,097.

Estimated total annual burden on

respondents: 19,453 hours. (Due to

averaging, the total annual burden hours

may not equal the product of the annual

number of responses multiplied by the

reporting burden per response.)

A copy of the information collection

may be viewed on the Regulations.gov

website or in our reading room. (A link

to Regulations.gov and information on

the location and hours of the reading

room are provided under the heading

ADDRESSES

at the beginning of this

proposed rule.) Copies can also be

obtained from Ms. Kimberly Hardy,

APHIS’ Information Collection

Coordinator, at (301) 851–2483. APHIS

will respond to any ICR-related

comments in the final rule. All

comments will also become a matter of

public record.

E-Government Act Compliance

The Animal and Plant Health

Inspection Service is committed to

compliance with the EGovernment Act

to promote the use of the internet and

other information technologies, to

provide increased opportunities for

citizen access to Government

information and services, and for other

purposes. For information pertinent to

E-Government Act compliance related

to this proposed rule, please contact Ms.

Kimberly Hardy, APHIS’ Information

Collection Coordinator, at (301) 851–

2483.

List of Subjects

7 CFR Part 340

Administrative practice and

procedure, Packaging and containers,

Plant diseases and pests, Reporting and

recordkeeping requirements,

Transportation.

7 CFR Part 372

Environmental impact statements.

Accordingly, we are proposing to

amend 7 CFR parts 340 and 372 as

follows:

■1. Part 340 is revised to read as

follows:

PART 340—MOVEMENT OF

ORGANISMS MODIFIED OR

PRODUCED THROUGH GENETIC

ENGINEERING

Sec.

340.1 Applicability of this part.

340.2 Scope of this part.

340.3 Definitions.

340.4 Regulatory status review.

340.5 Permits.

340.6 Record retention, compliance, and

enforcement.

340.7 Confidential business information.

340.8 Costs and charges.

Authority: 7 U.S.C. 7701–7772 and 7781–

7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and

371.3.

§ 340.1 Applicability of this part.

(a) The regulations in this part apply

to those genetically engineered (GE)

organisms described in § 340.2.

(b) The regulations in this part do not

apply to plants modified such that they

belong to one of the categories listed

below:

(1) The genetic modification is solely

a deletion of any size; or

(2) The genetic modification is a

single base pair substitution; or

(3) The genetic modification is solely

introducing nucleic acid sequences from

within the plant’s natural gene pool or

from editing of nucleic acid sequences

in a plant to correspond to a sequence

known to occur in that plant’s natural

gene pool; or

(4) The plant is an offspring of a GE

plant that does not retain the genetic

modification in the parent.

(c) The regulations in this part do not

apply to a GE plant-trait-mechanism of

action combination that has previously

undergone an analysis in accordance

with § 340.4 and has been found by the

Administrator to be unlikely to pose a

plant pest risk.

(d) Developers may request

confirmation from APHIS that the plant

is not within the scope of this part.

§ 340.2 Scope of this part.

Except under a permit issued by the

Administrator in accordance with

§ 340.5, no person shall move any GE

organism that:

(a) Is a plant that has a plant-trait-

mechanism of action combination that

has not been evaluated by APHIS in

accordance with § 340.4; or

(b) Meets the definition of a plant pest

in § 340.3; or

(c) Is not a plant but has received

deoxyribonucleic acid (DNA) from a

plant pest, as defined in § 340.3, and the

DNA from the donor organism either is

capable of producing an infectious agent

that causes plant disease or encodes a

compound that is capable of causing

plant disease; or

(d) Is a microorganism used to control

plant pests or an invertebrate predator

or parasite (parasitoid) used to control

invertebrate plant pests and could pose

a plant pest risk.

§ 340.3 Definitions.

Terms used in the singular form in

this part shall be construed as the

plural, and vice versa, as the case may

demand. The following terms, when

used in this part, shall be construed,

respectively, to mean:

Access. The ability during regular

business hours to enter, or pass to and

from, a location, inspect, and/or obtain

or make use or copies of any records,

data, or samples necessary to evaluate

compliance with this part and all

conditions of a permit issued in

accordance with § 340.5.

Administrator. The Administrator of

the Animal and Plant Health Inspection

Service (APHIS) or any other employee

of APHIS to whom authority has been

or may be delegated to act in the

Administrator’s stead.

Agent. A person who is designated by

the responsible person to act in whole

or in part on behalf of the permittee to

maintain control over an organism

under permit during its movement and

ensure compliance with all conditions

contained in any applicable permit and

the requirements in this part. Multiple

agents may be associated with a single

responsible person or permit. Agents

may be, but are not limited to, brokers,

farmers, researchers, or site cooperators.

An agent must be at least 18 years of age

and be a legal resident of the United

States.

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Animal and Plant Health Inspection

Service (APHIS). An agency of the

United States Department of

Agriculture.

Article. Any material or tangible

object that could harbor plant pests or

noxious weeds.

Contained facility. A structure for the

storage and/or propagation of living

organisms designed with physical

barriers capable of preventing the

escape of the organisms. Examples

include but are not limited to

laboratories, growth chambers,

fermenters, and containment

greenhouses.

Donor organism. The organism from

which genetic material is obtained for

transfer to the recipient organism.

Environment. All the land, air, and

water; and all living organisms in

association with land, air, and water.

Genetic engineering (GE). Techniques

that use recombinant or synthetic

nucleic acids to modify or create a

genome.

Import (importation). To move into, or

the act of movement into, the territorial

limits of the United States.

Inspector. Any individual authorized

by the Administrator or the

Commissioner of Customs and Border

Protection, Department of Homeland

Security, to enforce the regulations in

this part.

Interstate. From one State into or

through any other State or within the

District of Columbia, Guam, the Virgin

Islands of the United States, or any

other territory or possession of the

United States.

Mechanism of action. The

biochemical process(es) through which

genetic material determines a trait.

Move (moving, movement). To carry,

enter, import, mail, ship, or transport;

aid, abet, cause, or induce the carrying,

entering, importing, mailing, shipping,

or transporting; to offer to carry, enter,

import, mail, ship, or transport; to

receive to carry, enter, import, mail,

ship, or transport; to release into the

environment; or to allow any of the

above activities to occur.

Organism. Any active, infective, or

dormant stage of life form of an entity

characterized as living, including

vertebrate and invertebrate animals,

plants, bacteria, fungi, mycoplasmas,

mycoplasma-like organisms, as well as

entities such as viroids, viruses, or any

entity characterized as living, related to

the foregoing.

Permit. A written authorization,

including by electronic methods, by the

Administrator to move organisms

regulated under this part and associated

articles under conditions prescribed by

the Administrator.

Person. Any individual, partnership,

corporation, company, society,

association, or other organized group.

Plant. Any plant (including any plant

part) for or capable of propagation,

including a tree, a tissue culture, a

plantlet culture, pollen, a shrub, a vine,

a cutting, a graft, a scion, a bud, a bulb,

a root, or a seed.

Plant pest. Any living stage of a

protozoan, nonhuman animal, parasitic

plant, bacterium, fungus, virus or viroid,

infectious agent or other pathogen, or

any article similar to or allied with any

of the foregoing, that can directly or

indirectly injure, cause damage to, or

cause disease in any plant or plant

product.

Plant pest risk. The possibility of

harm to plants resulting from

introducing or disseminating a plant

pest or exacerbating the impact of a

plant pest.

Plant product. Any flower, fruit,

vegetable, root, bulb, seed, or other

plant part that is not included in the

definition of plant or any manufactured

or processed plant or plant part.

Recipient organism. The organism

whose nucleic acid sequence will be

modified through the use of genetic

engineering.

Release into the environment

(environmental release). The use of a GE

organism outside the physical

constraints of a contained facility.

Responsible person. The person

responsible for maintaining control over

a GE organism under permit during its

movement and ensuring compliance

with all conditions contained in any

applicable permit as well as other

requirements in this part. A responsible

person may be, but is not limited to, the

signatory of a permit, or the institution

the signatory represents at the time of

application. A responsible person must

be at least 18 years of age and be a legal

resident of the United States.

Secure shipment. Shipment in a

container or a means of conveyance of

sufficient strength and integrity to

withstand leakage of contents, shocks,

pressure changes, and other conditions

incident to ordinary handling in

transportation.

State. Any of the several States of the

United States, the Commonwealth of the

Northern Mariana Islands, the

Commonwealth of Puerto Rico, the

District of Columbia, the Virgin Islands

of the United States, or other Territories

or possessions of the United States.

State or Tribal regulatory official.

State or Tribal official with

responsibilities for plant health, or any

other duly designated State or Tribal

official, in the State or on the Tribal

lands where the movement is to take

place.

Trait. An observable (able to be seen

or otherwise identified) characteristic of

an organism.

Unauthorized release. The intentional

or accidental movement of an organism

under a permit issued pursuant to this

part in a manner not authorized by the

permit; or the intentional or accidental

movement without a permit of an

organism that is subject to the

regulations in this part.

§ 340.4 Regulatory status review.

(a)(1) Any person may submit a

request to APHIS for an Agency

regulatory status review of whether a GE

plant is subject to the regulations in this

part, based on its plant-trait-mechanism

of action combination.

(2) Any person may request re-review

of a GE plant previously found to be

subject to this part, provided that the

request is supported by new,

scientifically valid evidence bearing on

the plant pest risk associated with

movement of the plant.

(3) APHIS may also initiate a

regulatory status review or re-review of

a GE plant to identify whether it is

subject to regulation under this part.

(4) Information submitted in support

of a request for a regulatory status

review or re-review must meet the

requirements listed in this paragraph.

Additional guidance on how to meet

these requirements may be found on the

APHIS website.

(i) A description of the comparator

plant, to include genus, species, and any

relevant subspecies information;

(ii) The genotype of the modified

plant, including a detailed description

of the differences in genotype between

the modified and unmodified plant; and

(iii) A detailed description of the new

trait(s) of the modified plant.

(b)(1) When APHIS receives a request

for a regulatory status review of a GE

plant, the Agency will conduct an initial

review of the potential plant pest risk

posed by the GE plant and any sexually

compatible relatives that could acquire

the engineered trait, relative to that of

the plant pest risk posed by their

respective non-GE or other appropriate

comparator(s), based on the following

factors:

(i) The biology of the comparator

plant and its sexually compatible

relatives;

(ii) The trait and mechanism-of-action

of the modification(s); and

(iii) The effect of the trait and

mechanism-of-action on:

(A) The distribution, density, or

development of the plant and its

sexually compatible relatives;

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(B) The production, creation, or

enhancement of a plant pest or a

reservoir for a plant pest;

(C) Harm to non-target organisms

beneficial to agriculture; and

(D) The weedy impacts of the plant

and its sexually compatible relatives.

(2) If the Agency is unable to identify

potential plant pest risks in the initial

review, the GE plant will not be subject

to the regulations in this part, and

APHIS will post the finding on its

website.

(3)(i) If the Agency does identify

potential plant pest risks in the initial

review, APHIS will conduct a more

robust evaluation of the factor(s) of

concern to determine the likelihood and

consequence of the potential plant pest

risk posed by the GE plant.

(ii) APHIS will make available

information on the results of both the

initial review and one conducted

pursuant to this paragraph in a notice in

the Federal Register and will take

comments on its findings from the

public. After reviewing the comments,

APHIS will make a final determination

regarding the regulatory status of the GE

plant and announce that determination

in a subsequent Federal Register notice.

(iii) If the GE plant is found unlikely

to pose a plant pest risk and, therefore,

not to require regulation under this part,

APHIS will post the finding on its

website.

(iv) If APHIS is unable to find the GE

plant unlikely to pose a pest risk it will

require regulation under this part and

its movement will be allowed only

under permit in accordance with

§ 340.5.

(c) APHIS will maintain on its website

information on all requests for and

results of regulatory status reviews.

§ 340.5 Permits.

(a) Permit issuance. A permit must be

issued by APHIS for the movement of

all GE organisms subject to the

regulations under this part.

(b) Permit application requirements

and permitting exemptions. The

responsible person must apply for and

obtain a permit through a method listed

on APHIS’ website. The application

must also include the following

information:

(1) General information requirements.

All permit applications must include

the name, title, and contact information

of the responsible person and agent; the

country and locality where the organism

was collected, developed,

manufactured, reared, cultivated, or

cultured; the intended activity (i.e.,

importation, interstate movement, or

release into the environment of the GE

organism); and information on the

intended trait and the genotype of the

intended trait.

(2) Permits for interstate movement or

importation. Applications for permits

for interstate movement or importation

of GE organisms must meet the

requirements of paragraph (b)(1) of this

section and include the following

additional information:

(i) The origin and destination of the

GE organism, including information on

the addresses and contact details of the

sender and recipient, if different from

the responsible person;

(ii) The method of shipment, and

means of ensuring the security of the

shipment against unauthorized release

of the organism; and

(iii) The manner in which packaging

material, shipping containers, and any

other material accompanying the

organism will be disposed of to prevent

unauthorized release.

(3) Permits for release into the

environment. Applications for permits

for release of GE organisms into the

environment must meet the

requirements of paragraph (b)(1) of this

section and include information on the

size of all proposed environmental

release sites, including area, geographic

coordinates, addresses, and land use

history of the site and adjacent areas;

and the name and contact information

of a person at each environmental

release site, if different from the

responsible person. In the event that

additional release sites are requested

after the issuance of a permit, APHIS

will continue the practice of evaluating

and amending permits to add new

release sites.

(4) Additional information. APHIS

will require additional information as

needed.

(c) Exemption for GE Arabidopsis

thaliana. A permit for interstate

movement is not required for GE

Arabidopsis thaliana, provided that it is

moved as a secure shipment, the cloned

genetic material is stably integrated into

the plant genome, and the cloned

material does not include the complete

infectious genome of a plant pest.

(d) Exemption for GE disarmed

Agrobacterium tumefaciens. A permit

for interstate movement is not required

for GE disarmed Agrobacterium

tumefaciens, provided that it is moved

as a secure shipment, the cloned genetic

material is stably integrated into the

genome, and the cloned material does

not include the complete infectious

genome of a plant pest.

(e) Exemption for certain microbial

pesticides. A permit is not required for

any GE microorganism that is currently

registered with the Environmental

Protection Agency as a microbial

pesticide so long as it is not a plant pest

as defined in § 340.3.

(f) Administrative actions—(1) Review

of permit applications. APHIS will

review the permit application to

determine if it is complete. APHIS will

notify the applicant orally or in writing

if the application is incomplete, and the

applicant will be provided the

opportunity to revise the application.

Once an application is complete, APHIS

will review it to determine whether to

approve or deny the application in

accordance with paragraph (h) of this

section.

(2) APHIS assignment of permit

conditions. If a permit application is

approved, the Administrator will issue

a permit with conditions as described in

paragraph (g) of this section. Prior to

issuance of a permit, the responsible

person must agree in writing, in a

manner prescribed by the

Administrator, that the responsible

person and all agents of the responsible

person are aware of, understand, and

will comply with the permit conditions.

Failure to comply with this provision

will be grounds for the denial of a

permit.

(3) Inspections. All premises

associated with the permit are subject to

inspection before and after permit

issuance, and all materials associated

with the movement are subject to

sampling after permit issuance. The

responsible person and agents must

provide inspectors access to premises,

facilities, release locations, storage

areas, waypoints, materials, equipment,

means of conveyance, documents, and

records related to the movement of

organisms permitted under this part.

Failure to provide access for inspection

prior to the issuance of a permit will be

grounds for the denial of a permit.

Failure to provide access for inspection

following permit issuance will be

grounds for withdrawal of the permit.

(4) State or Tribal review and

comment. The Administrator will

submit for notification and review a

copy of the permit application, without

confidential business information (CBI),

and any permit conditions to the

appropriate State or Tribal regulatory

official. Timely comments received from

the State or Tribal regulatory official

will be considered by the Administrator

prior to permit issuance.

(g) Permit conditions. The standard

conditions listed in this paragraph will

be assigned to all permits issued under

this section. The Administrator may

assign supplemental permit conditions

as deemed necessary to ensure

confinement of the GE organism. The

responsible person, and his or her

agents, must ensure compliance with

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these conditions, as well as any

supplemental conditions listed in the

permit:

(1) The organism under permit must

be maintained and disposed of in a

manner so as to prevent its

unauthorized release, spread, dispersal,

and/or persistence in the environment.

(2) The organism under permit must

be kept separate from other organisms,

except as specifically allowed in the

permit.

(3) The organism under permit must

be maintained only in areas and

premises specified in the permit.

(4) The identity of the organism under

permit must be maintained and

verifiable at all times.

(5) Authorized activities may only be

done while the permit is valid; the

duration for which the permit is valid

will be listed on the permit itself.

(6) Records related to activities

carried out under the permit must be

maintained by the responsible person

and be of sufficient accuracy, quality,

and completeness to demonstrate

compliance with all permit conditions

and requirements under this part.

APHIS must be allowed access to all

records, to include visual inspection

and reproduction (photocopying, digital

reproduction, etc.). The responsible

person must submit reports and notices

to APHIS at the times specified in the

permit and containing the information

specified within the permit. At a

minimum:

(i) Following an environmental

release, environmental release reports

must be submitted for all authorized

release locations where the release

occurred. Environmental release reports

must contain details of sufficient

accuracy, quality, and completeness to

identify the location, shape, and size of

the release and the organism(s) released

into the environment. In the event no

release occurs at an authorized location,

an environmental release report of no

environmental release must be

submitted for all authorized locations

where an environmental release did not

occur.

(ii) When the environmental release is

of a plant, reports of volunteer

monitoring activities and findings must

be submitted for all authorized release

locations where an environmental

release occurred. If no monitoring

activities are conducted, a volunteer

monitoring report of no monitoring

must be submitted indicating why no

volunteer monitoring was done.

(7) Inspectors must be allowed access,

during regular business hours, to all

locations related to the permitted

activities.

(8) The organism under permit must

undergo the application of measures

determined by the Administrator to be

necessary to prevent its unauthorized

release, spread, dispersal, and/or

persistence in the environment.

(9) In the event of a possible or actual

unauthorized release, the responsible

person must contact APHIS as described

in the permit within 24 hours of

discovery and subsequently supply a

statement of facts in writing no later

than 5 business days after discovery.

(10) The responsible person for a

permit remains the responsible person

for the permit unless a transfer of

responsibility is approved by APHIS.

The responsible person must contact

APHIS to initiate any transfer. The new

responsible person assumes all

responsibilities for ensuring compliance

with the existing permit and permit

conditions and for meeting the

requirements of this part.

(h) Denial or withdrawal of a permit.

Permit applications may be denied, or

permits withdrawn, in accordance with

this paragraph.

(1) Denial of permits. The

Administrator may deny, either orally or

in writing, any application for a permit.

If the denial is oral, the Administrator

will then communicate the denial and

the reasons for it in writing as promptly

as circumstances allow. The

Administrator may deny a permit

application if:

(i) The Administrator concludes that,

based on the application or on

additional information, the proposed

actions, e.g., movements under permit,

may not prevent the unauthorized

release, spread, dispersal, and/or

persistence in the environment of the

organism; or

(ii) The Administrator determines that

the responsible person or any agent of

the responsible person has failed to

comply at any time with any provision

of this part, any permit that has

previously been issued in accordance

with this part or any other regulations

issued pursuant to the Plant Protection

Act, 7 U.S.C. 7701 et seq.;

(iii) In addition, no permit will be

issued if the responsible person and his

or her agents do not agree in writing, in

accordance with paragraph (f)(2) of this

section, to comply with the permit

conditions or, in accordance with

paragraph (f)(3) of this section, to allow

inspection by APHIS.

(2) Withdrawal of permits. The

Administrator may withdraw, either

orally or in writing, any permit that has

been issued. If the withdrawal is oral,

the Administrator will communicate the

withdrawal and the reasons for it in

writing as promptly as circumstances

allow. The Administrator may withdraw

a permit if:

(i) Following issuance of the permit,

the Administrator receives information

that would otherwise have provided

grounds for APHIS to deny the permit

application;

(ii) The Administrator determines that

actions taken under the permit have

resulted in the unauthorized release,

spread, dispersal, and/or persistence in

the environment of the organism under

permit; or

(iii) The Administrator determines

that the responsible person or any agent

of the responsible person has failed to

comply at any time with any provision

of this part or any other regulations

issued pursuant to the Plant Protection

Act, 7 U.S.C. 7701 et seq. This includes

failure to comply with the conditions of

any permit issued.

(i) Appeal of denial or withdrawal of

permit. Any person whose permit

application has been denied or whose

permit has been withdrawn may appeal

the decision in writing to the

Administrator. The applicant must

submit in writing an acknowledgment of

the denial or withdrawal and a

statement of intent to appeal within 10

days after receiving written notification

of the denial or withdrawal. The

applicant may request additional time to

prepare the appeal. The appeal must

state all of the facts and reasons upon

which the person relies to assert that the

permit was wrongfully denied or

withdrawn. The Administrator will

grant or deny the appeal in writing,

stating the reasons for the decision as

promptly as circumstances allow. If

there is a conflict as to any material fact,

a hearing shall be held to resolve such

conflict.

(j) Amendment of permits—(1)

Amendment at responsible person’s

request. If the responsible person

determines that circumstances have

changed since the permit was initially

issued and wishes the permit to be

amended accordingly, he or she must

request the amendment by contacting

APHIS directly. The responsible person

will have to provide supporting

information justifying the amendment.

APHIS will review the amendment

request, and may amend the permit if

only minor changes are necessary.

Requests for more substantive changes

may require a new permit application.

Prior to issuance of an amended permit,

the responsible person will be required

to agree in writing or electronically that

he or she and his or her agents will

comply with the conditions of the

amended permit. If the responsible

person does not agree to the conditions,

the amendment will be denied.

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1

The Department’s provisions relating to

overtime charges for an inspector’s services are set

forth in part 354 of this chapter.

(2) Amendment initiated by APHIS.

APHIS may amend any permit and its

conditions at any time, upon

determining that the amendment is

needed to address plant pest risks

presented by the organism. APHIS will

notify the responsible person of the

amendment to the permit and, as soon

as circumstances allow, the reason(s) for

it. The responsible person may have to

agree in writing or electronically that he

or she and his or her agents will comply

with the conditions of the amended

permit before APHIS will issue it. If

APHIS requests such an agreement, and

the responsible person does not accept

it, the existing permit will be

withdrawn.

(k) Shipping under a permit. (1) All

shipments of organisms under permit

must be secure shipments. Organisms

under permit must also be shipped in

accordance with the regulations in 49

CFR part 178.

(2) The container must be

accompanied by a document that

includes the names and contact details

for the sender and recipient.

(3) For any organism to be imported

into the United States, the outmost

container must bear information

regarding the nature and quantity of the

contents; the country and locality where

collected, developed, manufactured,

reared, cultivated, or cultured; the name

and address of the shipper, owner, or

person shipping or forwarding the

organism; the name, address, and

telephone number of the consignee; the

identifying shipper’s mark and number;

and the permit number authorizing the

importation. For organisms imported

under permits by mail, the container

must also be addressed to a plant

inspection station listed in the USDA

Plants for Planting Manual, which can

be accessed at: https://

www.aphis.usda.gov/import_export/

plants/manuals/ports/downloads/

plants_for_planting.pdf. All imported

containers of organisms under permits

must be accompanied by an invoice or

packing list indicating the contents of

the shipment.

(4) Following the completion of the

shipment, all packing material, shipping

containers, and any other material

accompanying the organism must be

treated or disposed of in such a manner

so as to prevent its unauthorized

dissemination and establishment in the

environment.

§ 340.6 Record retention, compliance, and

enforcement.

(a) Recordkeeping. Responsible

persons and their agents are required to

establish, keep, and make available to

APHIS the following records:

(1) Records and reports required

under § 340.5(g);

(2) Addresses and any other

information (e.g., GPS coordinates,

maps) needed to identify all locations

where the organism under permit was

stored or used; including all contained

facilities and environmental release

locations;

(3) A copy of the APHIS permit

authorizing the permitted activity; and

(4) Legible copies of contracts

between the responsible person and

agents that conduct activities subject to

this part for the responsible person, and

copies of documents relating to

agreements made without a written

contract.

(b) Record retention. Records

indicating that an organism under

permit that was imported or moved

interstate reached its intended

destination must be retained for at least

2 years. All other records related to a

permit must be retained for 5 years

following the expiration of the permit,

unless a longer retention period is

determined to be needed by the

Administrator and documented in the

supplemental permit conditions.

(c) Compliance and enforcement. (1)

Responsible persons and their agents

must comply with all of the

requirements of this part. Failure to

comply with any of the requirements of

this part may result in any or all of the

following:

(i) Denial of a permit application or

withdrawal of a permit in accordance

with § 340.5(h);

(ii) Application of remedial measures

in accordance with the Plant Protection

Act, 7 U.S.C. 7701 et seq.; and

(iii) Criminal and/or civil penalties in

accordance with the Plant Protection

Act, 7 U.S.C. 7701 et seq.

(2) Prior to the issuance of a

complaint seeking a civil penalty, the

Administrator may enter into a

stipulation, in accordance with § 380.10

of this chapter.

(d) Liability for acts of an agent. For

purposes of enforcing this part, the act,

omission, or failure of any agent for a

responsible person may be deemed also

to be the act, omission, or failure of the

responsible person.

§ 340.7 Confidential business information.

Persons including confidential

business information in any document

submitted to APHIS under this part

should do so in the following manner.

If there are portions of a document

deemed to contain confidential business

information, those portions must be

identified, and each page containing

such information must be marked ‘‘CBI

Copy.’’ A second copy of the document

must be submitted with all such CBI

deleted, and each page where the CBI

was deleted must be marked ‘‘CBI

Deleted.’’ In addition, any person

submitting CBI must justify how each

piece of information requested to be

treated as CBI is a trade secret or is

commercial or financial information and

is privileged or confidential.

§ 340.8 Costs and charges.

The services of the inspector related

to carrying out this part and provided

during regularly assigned hours of duty

and at the usual places of duty will be

furnished without cost.

1

The U.S.

Department of Agriculture will not be

responsible for any costs or charges

incidental to inspections or compliance

with the provisions of this part, other

than for the services of the inspector.

PART 372—NATIONAL

ENVIRONMENTAL POLICY ACT

IMPLEMENTING PROCEDURES

■2. The authority citation for part 372

continues to read as follows:

Authority: 42 U.S.C. 4321 et seq.; 40 CFR

parts 1500–1508; 7 CFR parts 1b, 2.22, 2.80,

and 371.9.

§ 372.5 [Amended]

■3. Section 372.5 is amended as

follows:

■a. By removing paragraph (b)(7);

■b. In paragraph (c)(3)(iii), by removing

the words ‘‘, or acknowledgment of

notifications for,’’ and adding the word

‘‘for’’ in their place; and

■c. By removing and reserving

paragraph (c)(4).

Done in Washington, DC, this 30th day of

May 2019.

Greg Ibach,

Under Secretary for Marketing and Regulatory

Programs.

[FR Doc. 2019–11704 Filed 6–5–19; 8:45 am]

BILLING CODE 3410–34–P

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Published date	06 June 2019
Record Number	2019-11704
Section	Proposed rules
Court	Animal And Plant Health Inspection Service

Movement of Certain Genetically Engineered Organisms

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