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Browse by Year / 2008 / October / Thursday, October 09, 2008
[Federal Register: October 9, 2008 (Volume 73, Number 197)]
[Proposed Rules]               
[Page 60007-60048]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09oc08-45]                         


[[Page 60007]]

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Part IV





Department of Agriculture





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Animal and Plant Health Inspection Service



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7 CFR Part 340



Importation, Interstate Movement, and Release Into the Environment of 
Certain Genetically Engineered Organisms; Proposed Rule


[[Page 60008]]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 340

[Docket No. APHIS-2008-0023]
RIN 0579-AC31

 
Importation, Interstate Movement, and Release Into the 
Environment of Certain Genetically Engineered Organisms

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule; notice of public forums.

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SUMMARY: We propose to revise our regulations regarding the 
importation, interstate movement, and environmental release of certain 
genetically engineered organisms in order to bring the regulations into 
alignment with provisions of the Plant Protection Act. The revisions 
would also update the regulations in response to advances in genetic 
science and technology and our accumulated experience in implementing 
the current regulations. This is the first comprehensive review and 
revision of the regulations since they were established in 1987. This 
rule would affect persons involved in the importation, interstate 
movement, or release into the environment of genetically engineered 
plants and certain other genetically engineered organisms.

DATES: We will consider all comments that we receive on or before 
November 24, 2008. We will also consider comments made at public forums 
to be held in Davis, CA; Kansas City, MO; and Riverdale, MD.

ADDRESSES: You may submit comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2008-0023 to submit or view comments and 
to view supporting and related materials available electronically.
     Postal Mail/Commercial Delivery: Please send two copies of 
your comment to Docket No. APHIS-2008-0023, Regulatory Analysis and 
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238. Please state that your comment refers to 
Docket No. APHIS-2008-0023.
     Public Forums. Written and oral comment will be accepted 
at three public forums held during the comment period. See Public 
Forums below.
    Reading Room: You may read any comments that we receive on this 
docket in our reading room. The reading room 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) 690-2817 before coming.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Biotechnology Regulatory Services, 
APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-
5710.
    For information about the public forums, contact: Dr. T. Clint 
Nesbitt, BRS, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-
1238; (301) 734-5673.

SUPPLEMENTARY INFORMATION:

Public Forums

    In order to provide additional opportunities for the public to 
comment on the proposed rule, APHIS will hold public forums in three 
locations: Davis, CA; Kansas City, MO; and Riverdale, MD (see Meeting 
Locations below). These informal forums are designed to engage 
interested individuals from the public and elicit comments related to 
the proposed rule. The format will consist of informational posters and 
comment stations. Attendees will be able walk through the forum during 
the open hours and interact with other attendees and APHIS personnel. 
Short welcoming remarks will be given by APHIS personnel at 4:30 p.m. 
and again at 6 p.m. (local time), but there is no set schedule for each 
poster station, so the public may come and go at any time during the 
forum period. Participants will have the opportunity, if desired, to 
record brief oral comments with a court reporter or to submit comments 
in writing, following directions provided at the comment stations. A 
transcript of the oral comments and a copy of any written comments 
submitted at the public forums will be placed in the rulemaking record 
and will be available for public inspection.
    The purpose of these public forums is to allow the public a venue 
in which to interact with APHIS representatives and to allow APHIS to 
solicit further information from the public. Comments received at these 
public forums will be added to this Docket.
    Dates: The public forums will be held in Davis, CA, on October 28, 
2008; in Kansas City, MO, on October 30, 2008; and Riverdale, MD, on 
November 13, 2008. Each public forum will be held from 4 p.m. to 7 
p.m., local time.
    Meeting Locations: The public forums will be held at the following 
locations:
    USDA Riverside, Oklahoma City Memorial Conference Rooms B, C, and 
D, 4700 River Road, Riverdale, MD, 20737. For directions or facilities 
information, call (301) 734-8010.
    Walter A. Buehler Alumni & Visitors Center, Alpha Gamma Rho Hall, 
University of California, Davis, CA, 95616. For directions or 
facilities information, call (530) 754-9195 or visit http://
www.alumnicenter.ucdavis.edu/.
    Hilton Kansas City Airport, Shawnee Room A, 8801 NW 112th Street, 
Kansas City, MO, 64153. For directions or facilities information, call 
(816) 891-8900 or visit http://www.hiltonkci.com/.

Table of Contents

I. Introduction
II. Background
    A. APHIS Role in Federal Regulation of Genetically Engineered 
Organisms
    B. Current Regulations in 7 CFR part 340
    C. Plant Protection Act Authority to Regulate Plant Pests, 
Noxious Weeds, and Biological Control Organisms
III. Proposed Rule
    A. Proposed Regulatory Scope (Sec.  340.0 Scope and General 
Restrictions)
    1. Genetically Engineered Organisms Subject to 7 CFR part 340
    2. Deleting the List of Organisms Which Are or Contain Plant 
Pests
    3. Regulating Whole Organisms, Parts, and Nonliving Products
    B. Permits for Authorizing Importation, Interstate Movement, and 
Release Into the Environment of Certain GE Organisms
    1. Elimination of the Notification Procedure
    2. Revisions to Permit Procedures
    3. Permit Types and Environmental Release Categories (Sec.  
340.2(b))
    4. Permit Application Information Requirements (Sec.  340.2(c))
    5. Permit Conditions (Sec.  340.3)
    6. Elimination of Courtesy Permits
    C. Conditional Exemptions from Permit Requirement (Sec.  340.4, 
Sec.  340.5)
    D. Petitions for Nonregulated Status (Sec.  340.6)
    E. Compliance, Enforcement, and Remedial Action (Sec.  340.7)
    1. Ensuring Compliance with Permits and Exemption Activities
    2. Low Level Presence of Regulated GE Plants in Seed or Grain
    F. Administrative Changes
    1. Confidential Business Information (Sec.  340.8)
    2. Time Frames for APHIS Action on Permit Applications and 
Petitions
    3. Duration Period for Permits
    G. Definitions and Miscellaneous Changes
IV. Required Analyses
    A. National Environmental Policy Act

[[Page 60009]]

    B. Executive Order 12866 and Regulatory Flexibility Act
    C. Executive Order 12372
    D. Executive Order 12988
    E. Paperwork Reduction Act
    F. E-Government Act Compliance

I. Introduction

    The U.S. Department of Agriculture's (USDA) Animal and Plant Health 
Inspection Service (APHIS) regulates the safe introduction 
(environmental release, interstate movement, and importation) of 
certain genetically engineered (GE) organisms under its regulations in 
7 CFR part 340. The regulations govern the introduction of GE organisms 
that might be plant pests. APHIS has amended the regulations several 
times in an effort to respond to the need for streamlined procedures 
and has established clear procedures to remove GE organisms that do not 
pose a plant pest risk from obligations under the regulation.
    The APHIS regulations have been used most frequently for permits 
and notifications for importation, interstate movement, or 
environmental releases of GE plants, although a smaller number of 
permits have been issued for GE microorganisms and insects. To date, 
APHIS has authorized more than 13,000 environmental releases of GE 
plants, most of which have been part of the development of improved 
crop varieties for agriculture. These controlled environmental releases 
are sometimes referred to as field tests or field trials, in 
recognition of their relationship to field tests done in the 
traditional development of plant varieties, and in this document the 
terms field test or field trial should be understood to mean 
environmental release. In addition to permits and notifications, APHIS 
has completed reviews in response to petitions requesting nonregulated 
status under these regulations. To date, APHIS has granted 74 
determinations of nonregulated status, and all of these have been for 
GE plants (more information about these is posted at http://
www.aphis.usda.gov/brs/not_reg.html ). Many of these plants have since 
been used to develop plant varieties that have become part of the 
options that growers have for agricultural production in the United 
States and other countries. The APHIS determinations of nonregulated 
status have been for the GE plant(s) and their progeny. The GE plant 
with nonregulated status can be used subsequently in plant breeding 
programs or in agriculture just like other plant lines. A GE plant that 
has received nonregulated status can be bred with another GE plant with 
nonregulated status, and the resulting progeny which could contain 
multiple GE traits still retains nonregulated status.
    The bulk of APHIS-authorized introductions have been crop plants 
bearing genes which confer resistance to certain insects or tolerance 
to certain herbicides. Although the current program has been effective 
in ensuring the safe environmental release, interstate movement, and 
importation of certain genetically engineered organisms, technological 
advances have led to new uses and questions about how the current 
regulations and APHIS authorities will be used to maintain appropriate 
oversight. Advances in technology have created possibilities for new 
and different traits, such as those that would produce a compound for 
pharmaceutical or industrial use. In addition, researchers have been 
producing organisms that may not fall under the scope of our current 
regulations and are also beginning to focus more on perennial plants, 
such as grasses or trees, which may be capable of establishing and 
persisting outside the site of introduction.
    APHIS is proposing to revise its regulations in order to respond to 
emerging trends in biotechnology, to address the current and future 
needs of the agency, to continue to ensure a high level of 
environmental protection, to improve regulatory processes so that they 
are more transparent to stakeholders and the public, to more 
efficiently use agency resources and to eliminate unnecessary 
regulatory burdens.
    Given the diversity of U.S. agriculture, the USDA Advisory 
Committee on Biotechnology and 21st Century Agriculture recently in its 
March 2008 consensus report encouraged the continuing support of 
coexistence among various agricultural production systems in U.S. 
agriculture. APHIS concludes that the changes it is proposing will 
continue to support coexistence in U.S. agriculture.
    In addition, APHIS is proposing changes to the regulations to 
reflect provisions of the 2008 Farm Bill recently enacted. Section 
10204 of Title X of the Food, Conservation, and Energy Act of 2008 
(Farm Bill) requires the Secretary of Agriculture to take action on 
each issue identified in the document entitled ``Lessons Learned and 
Revisions under Consideration for APHIS' Biotechnology Framework,'' and 
where appropriate, promulgate regulations. APHIS is proposing certain 
regulatory changes concerning permit application information 
requirements, permit conditions, records, and reports that address many 
of the considerations outlined in Section 10204.
    APHIS is also aligning this proposed rule with recommendations 
arising from the 2005 audit of the USDA Office of Inspector General 
entitled ``Controls Over Issuance of Genetically Engineered Release 
Permits.''

II. Background

A. APHIS Role in Federal Regulation of Genetically Engineered Organisms

    Under the Coordinated Federal Framework for Regulation of 
Biotechnology,\1\ USDA works with the Food and Drug Administration 
(FDA) and the Environmental Protection Agency (EPA) to ensure that the 
development and testing of biotechnology products occur in a manner 
that is safe for plant and animal health, human health, and the 
environment. USDA and EPA are the agencies responsible for protecting 
U.S. agriculture and the environment. EPA is responsible for the human 
health, animal health, and environmental safety issues raised by any 
pesticidal substance produced in genetically engineered (GE) organisms. 
FDA has authority over the safety of the whole food product other than 
the pesticidal components regulated by EPA.
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    \1\ The Coordinated Framework is described in a notice published 
in the Federal Register on June 26, 1986 (51 FR 23302). The notice 
may be viewed at http://www.aphis.usda.gov/brs/fedregister/
coordinated_framework.pdf.
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B. Current Regulations in 7 CFR Part 340

    APHIS administers regulations in 7 CFR part 340, ``Introduction of 
Organisms and Products Altered or Produced Through Genetic Engineering 
Which are Plant Pests or Which There is Reason to Believe are Plant 
Pests'' (referred to below as the regulations). The current regulations 
govern the introduction (importation, interstate movement, or release 
into the environment) of certain GE organisms termed ``regulated 
articles.'' Regulated articles are essentially GE organisms which might 
pose a risk as a plant pest.
    APHIS first promulgated these regulations in 1987 under the 
authority of the Federal Plant Pest Act of 1957 (FPPA) and the Plant 
Quarantine Act of 1912 (PQA), two acts that were subsumed into the 
Plant Protection Act (PPA, 7 U.S.C. 7701 et seq.) in 2000, along with 
other provisions.
    Under the current regulations, a GE organism is a regulated article 
if it is a plant pest or if the Administrator has reason to believe it 
is a plant pest; more specifically:


[[Page 60010]]


    ``if the donor organism, recipient organism, or vector or vector 
agent belongs to any genera or taxa designated in Sec.  340.2 and 
meets the definition of plant pest, or is an unclassified organism 
and/or an organism whose classification is unknown, or any product 
which contains such an organism, or any other organism or product 
altered or produced through genetic engineering which the 
Administrator determines is a plant pest or has reason to believe is 
a plant pest.'' (Definition of regulated article, Sec.  340.1)

    In other words, APHIS regulates the introduction (importation, 
interstate movement, and environmental release) of GE organisms if (1) 
any of the recipient, genetic donor, or vector organisms are plant 
pests or of unknown classification or (2) the Administrator has 
determined or has reason to believe the GE organism is a plant pest. As 
constructed the regulations apply to GE microorganisms, insects, and 
other traditional types of plant pests and to any GE plants if plant 
pest organisms (bacterial and viral plant pathogens) are the donor 
organisms and vector agents used in the creation of these GE plants.
    Taxa containing ``known plant pests'' are those listed in current 
Sec.  340.2. Current regulations also include a petition procedure 
(Sec.  340.5) which allows petitioners to ask APHIS to add or subtract 
taxa from the list in Sec.  340.2. That list has not been amended since 
it was established in 1987.
    As defined under the current regulations and the PPA, most plants 
are not plant pests, with the exception of a few parasitic plant 
species, such as striga, witchweed, and dodder.
    The primary procedure for regulation under the PPA is the issuance 
of a permit, which is an authorization by the Secretary to move plants, 
plant products, biological control organisms, plant pests, noxious 
weeds, or articles under conditions prescribed by the Secretary. The 
PPA also authorizes the Secretary to determine which classes of the 
above articles must have a permit to be moved. Conditions associated 
with those permits can be tailored to achieve the appropriate level of 
regulatory control to make it unlikely that actions under the permit 
would result in the introduction or dissemination of a plant pest or 
noxious weed.
    APHIS currently uses a permit and notification system to authorize 
importation, interstate movement and release into the environment 
(currently referred to as ``introductions'') of certain GE organisms. 
Under the current regulations, all regulated articles are eligible for 
the permitting procedure, but only certain plants are eligible for the 
notification procedure. Currently, most regulated GE plants are 
introduced under notification, which is a streamlined procedure. 
Examples of GE plants introduced under the notification procedure are 
those GE plants altered to be resistant to certain insects or 
herbicides. GE plants that do not meet the notification eligibility 
criteria and all other GE organisms, such as microbes and insects, must 
be introduced under the permit procedure in current Sec.  340.4. In 
recent years, APHIS has processed most notifications and permits 
through its electronic, e-permitting system that is accessible by the 
internet at http://www.aphis.usda.gov/permits/learn_epermits.shtml.
    In making a regulatory determination for a permit or notification 
for a GE organism subject to the part 340 regulations, APHIS makes such 
a determination on whether the actions under notification or permit are 
unlikely to result in the introduction or dissemination of a plant 
pest. This determination takes into account various risk factors, 
including, among other things, a low risk that the GE organism or its 
progeny can persist, reproduce, and establish without human assistance. 
Other risk factors that would support an ``unlikely'' determination 
would be minimal availability of suitable hosts or habitats for the 
organism and low risk that the organism may cause damage to plants and 
plant products.
    Regarding the risk of introduction or dissemination of the GE 
organism as a plant pest, an ``unlikely'' determination takes into 
consideration both the nature of the organism (i.e., low risk that the 
organism or its progeny can persist, reproduce, establish, and spread 
without human assistance) and any additional mitigations that are 
placed upon the organism that restrict its movement and make its 
unauthorized introduction or dissemination unlikely.
    The notification procedure was first added to the regulations in 
1993, and then amended in 1997 to allow a broader range of plant 
species to be eligible for the procedure. The notification procedure 
was designed to be a streamlined procedure with the eligibility 
criteria and performance standards already built into the regulations. 
Over the past decade, APHIS has typically authorized 700-1200 
notifications per year.
    As part of the notification procedure, applicants must adhere to 
performance standards set forth by APHIS for proper confinement of the 
GE plants. The goal of proper confinement is to ensure that the GE 
plants do not persist in the environment. Under the notification 
procedure applicants provide information about the introduction 
sufficient for APHIS to evaluate eligibility for the procedure and 
impacts on the environment. This information includes information on 
the plant species, introduced gene(s), location(s), and anticipated 
time frame for the introduction.
    For notifications, the eligibility criteria and the performance 
standards stated in the regulations must be met, but APHIS does not 
prescribe how the performance standards must be met. For example, one 
of the performance standards in Sec.  340.3(c)(5) requires that ``The 
field trial must be conducted such that (i) The regulated article will 
not persist in the environment, and (ii) No offspring can be produced 
that could persist in the environment.'' The responsible person might 
meet this standard in a field trial by isolating the regulated GE 
plants at a sufficient distance to preclude gene flow from the GE plant 
to sexually compatible plants in the vicinity. Another design protocol 
might meet the same performance standard by planting the GE plant at a 
time in the growing season when surrounding plants of the same species 
would not be biologically capable of being fertilized by pollen from 
the GE plant (temporal isolation).
    The regulations in current Sec.  340.3(e) specify that the APHIS 
notification procedure must be completed within 30 days for 
environmental release and importations and within 10 days for the 
interstate movement of a regulated article. If APHIS completes the 
review process and finds that all regulatory requirements have been 
met, the notification is authorized in a process termed 
``acknowledgement,'' and the applicant can proceed with the 
introduction under the terms of the notification. Notifications are 
valid for one year from the date of introduction.
    Approximately 10% of APHIS authorizations are done under the 
permitting procedure. The permitting procedure, found in Sec.  340.4 of 
the current regulation, describes the types of permits, information 
required for permit application, the standard permit conditions, and 
administrative information (e.g., time frames, appeal procedure, etc.). 
Permits include specific conditions that must be followed by the permit 
holder. Standard permit conditions are listed in the regulation, and 
APHIS can supplement these with additional conditions as necessary. The 
current regulations specify the amount of time that APHIS is allotted 
for review of complete permit applications: 60 days for permits for 
importation and interstate movement; 120 days for environmental 
release.

[[Page 60011]]

    Some regulated articles are conditionally exempt from the 
requirement for permits when moved interstate under the conditions 
stipulated in the regulation. Conditional exemptions currently exist in 
the regulations for the interstate movement of certain GE bacteria 
(Escherichia coli, Bacillus subtilis), fungi (Saccharomyces 
cerevisiae), as well as the plant species Arabidopsis thaliana. APHIS 
established these conditional exemptions from interstate movement 
permit by amending the regulations in 1988 and 1990.
    APHIS forwards the applications for all permits, and notifications, 
with any confidential business information redacted, to State 
regulators in the States to which regulated articles will be moved and/
or in which environmental release is planned. This is done to notify 
States of the requested action and to allow States to review and 
comment on proposed releases or importations or movements.
    The current regulations also include various provisions and 
prescribed standards for containers, marking, and identity that apply 
to shipments of regulated articles. For example, there are instructions 
regarding how to label containers of imported regulated articles with 
the nature of the contents, origin and destination, and other 
information, and detailed instructions on what materials (plastic, 
metal, etc.) and dimensions may be used for containers of regulated 
articles.
    Under the current regulations, APHIS may also grant ``nonregulated 
status'' to a GE organism in accordance with the procedure described in 
Sec.  340.6. A determination of nonregulated status means that the 
organism is no longer subject to the part 340 regulations, and 
therefore there is no longer any requirement for APHIS authorization 
under part 340 for a permit or notification when the GE organism is 
imported, moved interstate, or released into the environment.

C. Plant Protection Act Authority to Regulate Plant Pests, Noxious 
Weeds, and Biological Control Organisms

    Under the provisions of the PPA, Congress has granted the Secretary 
of Agriculture authority to develop regulations in order to detect, 
control, eradicate, suppress, prevent, or retard the spread of plant 
pests or noxious weeds. The PPA grants the Secretary authority to 
regulate the movement into and through the United States of any plant, 
plant pest, plant product, biological control organism, noxious weed, 
article, or means of conveyance, in order to prevent the introduction 
or dissemination of plant pests and noxious weeds.
    The current regulations were promulgated under former statutes, 
i.e., the FPPA and PQA, which provide USDA authority to regulate 
articles that present a risk of plant pest introduction or 
dissemination. In addition to the provisions of the FPPA and PQA, the 
PPA incorporates authority that previously was under the Noxious Weed 
Act of 1974. In order to best evaluate the risks associated with these 
GE organisms and regulate them when necessary, APHIS needs to exercise 
its authorities regarding noxious weeds and biological control 
organisms, in addition to its authority regarding plant pests.
    The definition of plant pest in the PPA is broad and includes 
living organisms that could directly or indirectly injure, damage, or 
cause disease in any plant or plant product (7 U.S.C. Sec.  7702(14)). 
Under the PPA, organisms which could be plant pests include:
     Protozoans
     Non-human animals
     Parasitic plants
     Bacteria
     Fungi
     Viruses or viroids
     Infectious agents or other pathogens
     Any article similar to or allied with any of the above 
articles.
    The definition of noxious weed in the PPA includes:

    * * * any plant or plant product that can directly or indirectly 
injure or cause damage to crops (including nursery stock or plant 
products), livestock, poultry, or other interests of agriculture, 
irrigation, navigation, the natural resources of the United States, 
the public health, or the environment. (PPA Sec.  7702(10))

    An important distinction between noxious weeds and plant pests is 
that noxious weeds under the PPA are always plants or plant products. 
Plant pests are usually not plants (with the exception of certain 
parasitic plants such as dodder, striga, and witchweed), but are other 
types of organisms that harm plants.

III. Proposed Rule

A. Proposed Regulatory Scope (Sec.  340.0 Scope and general 
restrictions)

    We propose to better align the regulations with the PPA authorities 
in order to ensure that the environmental release, importation, or 
interstate movement of GE organisms does not pose a risk of introducing 
or disseminating plant pests or noxious weeds. Although the current 
program has been effective in ensuring the safe environmental release, 
interstate movement, and importation of genetically engineered 
organisms, technological advances have led to the possibility of 
developing GE organisms that do not fit within the plant pest 
definition, but may cause environmental or other types of physical harm 
or damage covered by the definition of noxious weed in the PPA. 
Therefore, we consider that it is appropriate to align the regulations 
with both the plant pest and noxious weed authorities of the PPA.
1. Genetically Engineered Organisms Subject to 7 CFR part 340
    We are proposing to revise the scope of the regulations in Sec.  
340.0 to make it clear that decisions regarding which organisms are 
regulated remain science-based and take both plant pest and noxious 
weed risks into account. The proposed scope of the regulations states 
that genetically engineered organisms whose importation, interstate 
movement, or release into the environment would be subject to the 
regulations are:
    Genetically engineered plants if:
    (i) The unmodified parent plant from which the GE plant was derived 
is a plant pest or noxious weed, or
    (ii) The trait introduced by genetic engineering could increase the 
potential for the GE plant to be a plant pest or noxious weed, or
    (iii) The risk that the GE plant poses as a plant pest or noxious 
weed is unknown, or
    (iv) The Administrator determines that the GE plant poses a plant 
pest or noxious weed risk.
    Genetically engineered non-plant, non-vertebrate organisms if:
    (i) The recipient organism can directly or indirectly injure, cause 
damage to, or cause disease in plants or plant products; or
    (ii) The GE organism has been engineered in such a way that it may 
increase the potential for it to be a plant pest: or
    (iii) The risk that the GE organism poses as a plant pest is 
unknown, or
    (iv) The Administrator determines that the GE organism poses a 
plant pest risk.
    Under the current regulations, there is no explicit statement of 
the relative responsibilities of the Administrator and regulated 
parties in determining whether an organism met the definition for 
regulated article and therefore would be subject to the regulations. 
Under the proposed regulations, the responsible person for a GE 
organism could correctly apply the criteria in Sec.  340.0 to determine 
whether the GE organism is subject to the regulations. Alternatively,

[[Page 60012]]

the Administrator could determine any GE organism to be regulated after 
determining that the GE plant poses a plant pest or noxious weed risk.
    In many cases, it will be very straightforward for a responsible 
person to apply these criteria and determine that a GE organism is 
subject to the regulations. For example, the GE organism would clearly 
be subject to the regulations if the recipient organism were a plant 
pest or noxious weed. A GE organism would also clearly be subject to 
the regulations if there was little data or previous experience 
available concerning the recipient organism's plant pest or noxious 
weed potential, or the type of modification, with the result that it is 
difficult to do a reliable evaluation of the risks that the GE organism 
may be a plant pest or noxious weed.
    In other cases, it may not be readily apparent to the responsible 
person for a GE organism whether or not the organism falls within the 
scope of Sec.  340.0 and is regulated. For this reason, persons who are 
not sure about whether a GE organism falls within the regulations or 
who maintain that a particular GE organism is not subject to the 
regulations based on their belief that it is not an organism within the 
scope of Sec.  340.0 may consult with APHIS.
    A GE organism may be within the scope of the regulations based on 
the information available at the time of the determination, which is 
usually less information than is available when the Administrator 
evaluates, for example, whether a regulated GE organism should be 
considered for an exemption from the requirement for a permit, or 
should be considered for a determination of nonregulated status (see 
discussion of Sec.  340.6 below regarding nonregulated status). In 
other words, this scope determination has one purpose (to determine 
whether regulation is necessary at all) and is based on one level of 
knowledge about a GE organism, while determinations regarding such 
things as necessary permit conditions or exemptions or nonregulated 
status have a different purpose and are based on a different level of 
knowledge about a GE organism.
    It is important to note that while a GE organism may be within the 
scope of the regulations due to certain identified plant pest or 
noxious weed risks, it may also be within the scope of the regulations 
if there is not enough information about the GE organism's potential 
plant pest or noxious weed risks to make a decision regarding those 
risks. At the early stages of developing a GE organism, there may not 
be sufficient information available about the organism to clearly 
determine the potential associated plant pest or noxious weed risks. 
Unknown risks might lead to a determination by the Administrator that a 
GE organism should be subjected to regulatory oversight if APHIS lacks 
familiarity with the non-transformed recipient organism or the 
introduced trait.
    The proposed scope makes it clear that the mere act of genetic 
engineering does not trigger regulatory oversight or mean that a GE 
organism will pose risks as a plant pest or noxious weed. Instead, it 
clarifies that APHIS would subject a GE organism to regulatory 
oversight based upon known plant pest and noxious weed risks of the 
parent organisms, or based upon the traits of the GE organism, or based 
upon the possibility of unknown risks as a plant pest or noxious weed 
when insufficient information is available.
Consultation With APHIS Regarding the Scope of These Regulations
    The criteria described in the scope should help developers form a 
reasonable expectation as to whether their GE organism is within the 
scope of the regulations, based on the nature of the parent organisms, 
the engineered traits, and the amount of information available 
regarding the organism and similar organisms.
    APHIS anticipates that initially the range of GE organisms that the 
Administrator may determine to be covered by the proposed regulatory 
scope will be broad. This will be due to both an initial measured 
implementation of the revised regulatory oversight as well as to the 
application of the scope criteria to the transformed organisms and 
recipient traits. Over time, the range of GE organisms subject to 
oversight is expected to decrease as APHIS becomes more familiar with 
these organisms and receives information from which it can reach a 
conclusion that these GE organisms or groups of organisms do not 
present increased or unfamiliar plant pest or noxious weed risks. 
Because the Administrator may make such a determination at any time the 
Administrator receives information that a GE organism is within the 
scope, APHIS expects that developers will seek early consultation with 
APHIS on whether the regulatory scope covers their GE organism. Since 
it is generally necessary for research or business plans to include, as 
early as possible, elements addressing regulatory processing, approval, 
and compliance, it will be in the interest of the developers to 
determine the regulatory status of their GE organism prior to 
contemplating its movement or environmental release. Therefore, APHIS 
will offer to consult with a developer of a GE organism regarding 
whether the GE organism is within the scope of the proposed 
regulations.
    After consultation and review of available information, the 
Administrator will respond in writing as to whether the Administrator 
has determined that the GE organism is within the scope of the 
regulations. APHIS plans to make information publicly available by 
posting and maintaining information on its Web site about the 
determinations it makes pursuant to this consultation process to help 
the public and regulated entities understand which organisms are 
subject to the regulations.
    We welcome suggestions from the public on the most appropriate ways 
to provide administrative guidance to the public on the issue of which 
GE organisms are within the scope of the regulations. The Agency is 
especially interested in ways which will balance transparency with the 
efficient use of Agency resources in conducting consultations and 
communicating information to the public regarding which GE organisms 
are within the scope of the regulations.
Organisms Specifically Excluded From the Scope of the Regulations
    Specifically excluded from the proposed regulatory scope are GE 
microorganisms that are regulated as biological control organisms by 
the EPA under provisions of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA). APHIS concludes that there is no need for such 
GE organisms to be evaluated by both agencies. EPA is already 
evaluating the environmental safety of such organisms with respect to 
their impact on the entire environment, including plants. We also 
propose to retain an exclusion from the current regulations for GE 
microorganisms where the recipient microorganism is not a plant pest 
and which have resulted from the addition of genetic material from a 
donor organism where the material is well characterized and contains 
only non-coding regulatory regions.
Effect of Noxious Weed Authority on the Scope of the Proposed 
Regulations
    The definition of noxious weed encompasses plants that pose risks 
akin to plant pests, because it includes ``any plant or plant product'' 
that can ``injure or cause damage to crops * * * other interests of 
agriculture * * * or the environment'', but also includes plants that 
can pose harm to non-plant organisms, such as humans. Therefore

[[Page 60013]]

evaluation of noxious weed risk expands what we can consider, while 
still including those risks examined under the plant pest approach. 
When considering risks associated with a GE plant, we would continue to 
consider whether it can harm plants, as well as whether it can cause 
the other types of physical harm or damage described in the definition 
for noxious weed.
    The first consideration in determining if a plant is a noxious weed 
is identifying what direct injury or damage (physical harm) the plant 
causes. If direct harm or damage is established, the next consideration 
is to evaluate any indirect damage the plant may cause to interests of 
agriculture, irrigation, navigation, the natural resources of the 
United States, the public health, or the environment. In general, 
federally listed noxious weeds are plants that are likely to be 
aggressively invasive, have significant negative impacts, and are 
extremely difficult to manage or control once established.
    The distinction between a weed and a noxious weed warrants 
emphasis. ``Weeds,'' in the broadest sense of the word, could include 
any plant growing where and/or when it is unwanted; even plants that 
are desirable in some settings may be considered weeds in others. In a 
narrower sense, weeds are invasive, often non-native, plants which 
impact natural and managed ecosystems, often with significant negative 
consequences due to lost yields, changes in management practices, 
altered herbicide use, etc. Only a fraction of these problematic weeds 
are considered to be so invasive, so harmful, and so difficult to 
control that Federal regulatory intervention to prevent their 
introduction or dissemination is justified, and these are the focus of 
the regulatory controls placed on them by APHIS. However, any weed, and 
virtually any plant or plant product, can be evaluated by APHIS to 
determine whether its characteristics and potential impacts warrant its 
listing as a noxious weed.
    APHIS currently lists 98 aquatic, terrestrial, or parasitic plant 
taxa as noxious weeds. The species included in the list illustrate the 
kinds of plants APHIS considers to be sufficiently invasive, damaging, 
and difficult to control to be deemed noxious weeds. Table 1 describes 
some specific examples from the Federal noxious weed list and the kinds 
of impacts noxious weeds can have, to illustrate the types of effects 
APHIS will be looking for when evaluating whether GE plants reviewed 
under part 340 have any potential noxious weed traits. The experience 
and precedents developed by the APHIS-PPQ noxious weed program provide 
a guide for the regulation of plants that may be noxious weeds, and we 
intend to apply it to the consideration of GE plants in the same way.

  Table 1--Examples of Impacts Caused by Federally Listed Noxious Weeds
------------------------------------------------------------------------
                                  Description of
            Impact                    impact          Example species
------------------------------------------------------------------------
Lost productivity of crop       Noxious weeds may  Cogongrass (Imperata
 fields.                         directly compete   cylindrica) infests
                                 with crop plants   over 20 crop
                                 for limited        species; it releases
                                 resources,         chemicals into the
                                 dramatically       soil that suppress
                                 reducing yields.   crop growth and
                                                    causes damaging
                                                    puncture wounds to
                                                    plant roots, bulbs,
                                                    and tubers. Other
                                                    examples include
                                                    Benghal dayflower
                                                    (Commelina
                                                    benghalensis), red
                                                    rice (Oryza spp.),
                                                    and kikuyugrass
                                                    (Pennisetum
                                                    clandestinum).
Parasitic damage to crops.....  Parasitic plants   Federally listed
                                 can cause          noxious parasitic
                                 significant        plants include the
                                 reductions in      dodders (Cuscuta
                                 yield by           spp.)--with common
                                 attaching          names like
                                 themselves to a    strangleweed,
                                 host plant,        devil's-guts,
                                 removing           hellbine, and
                                 nutrients and      witch's hair--and
                                 ultimately         witchweed (Striga
                                 killing it.        spp.), which causes
                                                    devastating losses
                                                    in corn, sorghum,
                                                    and rice.
Reduced productivity of         Grazing animals    Serrated tussock
 pasture.                        may avoid          (Nassella
                                 noxious weeds      trichotoma) has
                                 and consume the    heavily infested
                                 more favorable     large areas, leaving
                                 pasture species,   them completely
                                 resulting in       incapable of
                                 increased          supporting
                                 noxious weed       livestock.
                                 populations at
                                 the expense of
                                 more favorable
                                 species. Noxious
                                 weeds may also
                                 outcompete
                                 desirable
                                 pasture species.
Injury to humans or livestock.  Many noxious       Cape tulip (Homeria
                                 weeds are toxic,   spp.) contains a
                                 harming humans     cardiac glycoside,
                                 or livestock       which can be fatal
                                 either when        to livestock.
                                 consumed or by     Contact with giant
                                 direct contact.    hogweed (Heracleum
                                                    mantegazzianum)
                                                    causes painful skin
                                                    blisters. Three-
                                                    cornered jack (Emex
                                                    australis) and
                                                    devil's thorn (Emex
                                                    spinosa) both bear
                                                    spiny fruits that
                                                    can cripple or cause
                                                    injury to livestock
                                                    or other animals.
Unchecked overgrowth..........  Noxious weeds may  Mile-a-minute vines
                                 be capable of      (Mikania cordata and
                                 completely         M. micrantha) can
                                 dominating the     entirely smother
                                 landscape and      fields and forests
                                 preventing the     in a dense, tangled
                                 use of             mass of vines. A
                                 cultivated or      single plant of the
                                 pasture lands      aquatic weed giant
                                 for agriculture.   salvinia (Salvinia
                                                    spp.) can blanket 40
                                                    square miles in 3
                                                    months, and produce
                                                    an underwater mat 3
                                                    feet thick.
Physical obstructions.........  Growth rate and    Certain mesquites
                                 habit of some      (Prosopis spp.),
                                 noxious weeds      jointed prickly pear
                                 may physically     (Opuntia
                                 hamper the         aurantiaca), and
                                 movement of        African boxthorn
                                 livestock and      (Lycium
                                 humans, or         ferocissimum) form
                                 interfere with     impenetrable
                                 navigation of      thickets filled with
                                 waterways.         thorns or needles,
                                                    blocking the
                                                    movement of grazing
                                                    animals, injuring
                                                    them or preventing
                                                    access to food and
                                                    water.
Disruption of water flow......  Aquatic noxious    Notable examples
                                 weeds may          include hydrilla
                                 disrupt water      (Hydrilla
                                 flow, adversely    verticillata), giant
                                 affecting          salvinia (Salvinia
                                 irrigation,        spp.), and Chinese
                                 drainage and       waterspinach
                                 flood control      (Ipomoea aquatica).
                                 canals, city       Dense mats of oxygen
                                 water intakes,     weed (Lagarosiphon
                                 and recreational   major) can
                                 water use.         completely shut down
                                                    operation of
                                                    hydroelectric
                                                    plants.

[[Page 60014]]


Habitat alteration............  Noxious weeds may  Infestation of lakes
                                 severely alter     and ponds with
                                 water quality by   hydrilla (Hydrilla
                                 changing oxygen    verticillata) can
                                 and nutrient       alter aquatic
                                 content, may       ecosystems so
                                 dramatically       drastically that
                                 lower local        native plants are
                                 water tables, or   entirely eliminated,
                                 could so           rendering the
                                 significantly      habitat unsuitable
                                 outcompete or      for fish and other
                                 overgrow other     wildlife.
                                 vegetation
                                 resulting in a
                                 complete
                                 ecological shift
                                 of the habitat.
------------------------------------------------------------------------

    As discussed above, APHIS' determination that a plant is a noxious 
weed is based on notable physical harm or injury caused by the plant. 
The elements of the noxious weed definition include a number of 
interests that might be damaged by noxious weeds including not only 
plants but irrigation, navigation, the natural resources of the United 
States, the public health, the environment and interests of 
agriculture. Often APHIS quantifies the physical harm or injury in 
terms of economic losses. Loss in commodity value due to the presence 
of noxious weeds in seeds, for example, is a consequence of the 
anticipated physical damage that would be caused if the seed containing 
a noxious weed were distributed and planted; the economic loss is never 
simply the result of market preference to have commodities free of 
certain noxious weed seeds in and of itself, in the absence of any 
potential physical damage or harm. APHIS does not consider significant 
economic effects alone that are not linked to physical damage to be 
sufficient to determine a plant is a noxious weed.
    Certainly, some noxious weeds can cause physical harm to the health 
of humans or livestock and other animals. In general, these impacts 
occur when individuals come into direct contact with the noxious plants 
or plant parts, which may cause physical injury or are toxic or 
otherwise harmful when consumed. Conceivably, noxious weeds growing in 
crop fields could potentially threaten public health, for example, if 
toxic parts of the noxious weeds are harvested and inadvertently enter 
the food supply. If such toxic or otherwise harmful noxious weed parts 
were found in food and caused the food to be ``adulterated'' within the 
meaning of the FFDCA, FDA could take regulatory action against the 
food.
    Whereas APHIS has no direct role in evaluating the safety of foods, 
the agency plays an important supporting role in safeguarding the food 
supply by protecting the health of plants and animals at the farm 
level. When evaluating whether a particular GE plant may be a noxious 
weed because it poses a public health risk when growing in the 
environment, APHIS considers toxicity and other food safety 
information, including the type reviewed by EPA and FDA. In the case of 
GE plants, APHIS would not assess the safety of the GE plant for human 
or animal consumption, but would consider available information about 
toxicity and other food safety information in assessing noxious weed 
risk posed by the plants growing in the environment.
    It should be noted, moreover, that most GE plants that APHIS has 
been regulating in the past, such as varieties of GE corn and soybeans 
modified with common agronomic traits, do not qualify as ``noxious 
weeds''. But with the increasing diversity of both agronomic and non-
agronomic traits being engineered into plants it is appropriate to 
place regulatory controls upon GE plants proportionate to the 
likelihood that they may present a noxious weed risk until the 
potential risk can be appropriately evaluated.
How Non-Plant, Non-Vertebrate GE Organisms Fall Within the Scope of the 
Regulations
    The proposed revision of the regulations retains control for 
potential plant pest risks posed by non-plant, non-vertebrate GE 
organisms. We would continue to explicitly use the plant pest 
provisions of the PPA for regulating non-plant, non-vertebrate GE 
organisms which align with the taxa listed in the PPA definition of 
plant pest. In its reviews of GE non-plant and non-vertebrate species, 
APHIS will continue to assess GE insects, fungi, bacteria, and other 
non-plant, non-vertebrate organisms for their potential to pose risks 
as plant pests.
    The scope of the regulations as defined above makes it clear that 
it is the Administrator, and not the public, who determines whether a 
non-plant organism is within or outside the proposed scope of the Part 
340 regulations. APHIS welcomes public comment on the proposed concise 
criteria that the Administrator would consider when concluding that a 
GE organism is not a plant pest. We envision providing additional 
information on the Administrator's interpretation on such criteria at 
the time of the final rule or in subsequent administrative guidance.
GE Vertebrate Animals Do Not Fall Within the Scope of the Regulations
    Although the PPA definition of plant pest includes the potential 
for a nonhuman, vertebrate animal to be considered a plant pest, APHIS 
decided at this time that there are no demonstrated risks or pending GE 
animal developments indicating that it is necessary for the proposed 
regulations to evaluate vertebrate GE animals as potential plant pests. 
Because other statutory authorities exist for addressing GE animals, 
APHIS could guard against any plant pest risks that might be presented 
by GE vertebrate animals without directly regulating them under the 
regulations in part 340. On the other hand, we propose to regulate GE 
invertebrate animals under part 340 because many classes of 
invertebrates include known plant pests (e.g., insects, arachnids, 
nematodes, gastropods, etc.).
How GE Biological Control Organisms (BCOs) Fall Within the Scope of the 
Regulations
    The PPA defines biological control organism (BCO) as ``any enemy, 
antagonist, or competitor used to control a plant pest or noxious 
weed'' (7 U.S.C. 7702(2)). The PPA gives the authority to regulate 
plant pests and noxious weeds, not specifically biocontrol organisms. 
APHIS recognizes that BCOs may have the potential to affect populations 
of noxious weeds or plant pests, or become plant pests themselves. To 
fall within the scope of the proposed regulations, the GE BCO would 
have to pose a threat as a plant pest or noxious weed. There are 
relatively few examples today of GE BCOs, but these may become more 
common in the future. For example, some researchers are developing GE 
biological control pink bollworms that

[[Page 60015]]

are sterile, which achieve their controlling effect by reducing the 
ability of fertile, non-GE pink bollworms to produce offspring. Such GE 
pink bollworm BCOs would fall within the scope of the proposed 
regulation, because they are plant pests. Although there are currently 
no examples of using GE plants as BCOs, such a GE plant would be 
evaluated under the proposed regulations to evaluate whether it is a 
noxious weed or a plant pest.
    Currently, the federal regulation of microbial BCOs is regulated by 
EPA under FIFRA, and this covers GE as well as non-GE microorganisms 
used to mitigate the effect of pests. Unlike the PPA, which limits the 
definition of BCO only to organisms used to control plant pests and 
noxious weeds, FIFRA covers microorganisms used as biological control 
for any pest. APHIS considers it duplicative to have these regulations 
include GE microbial BCOs under its scope since FIFRA already 
adequately covers them, so APHIS is proposing that the regulatory scope 
language in Sec.  340.0(d) would explicitly exclude GE microorganisms 
if they are already being regulated as BCOs by EPA under FIFRA. We are 
proposing to only regulate GE BCO macro-organisms that fall under the 
proposed regulatory scope (APHIS-PPQ currently regulates the macro-
organism non-GE BCOs used to control plant pests and noxious weeds 
pursuant to other regulations). APHIS welcomes public comment on this 
aspect of its proposal.
Intrastate Movements of GE Organisms Between Contained Facilities and 
Activities in Contained Facilities Do Not Fall Within the Scope of the 
Regulations
    Under the current regulations, certain GE organisms are only 
regulated by APHIS if they are imported, moved interstate, or released 
into the environment. The regulations do not govern intrastate 
movements between contained facilities such as laboratories, nor do 
they govern such activities as creating GE organism in a contained 
research laboratory. The proposed revision does not change this aspect 
of the regulations.
2. Deleting the List of Organisms Which Are or Contain Plant Pests
    In Sec.  340.2 of the current regulations, there is a list of taxa 
that are considered to be plant pests. Under the proposed scope, this 
list is not needed because we would not use taxonomic classification of 
donor and recipient organisms to determine if a GE organism is 
regulated. When in the course of evaluating a GE organism APHIS 
considers whether a donor or recipient species is likely to be a plant 
pest or noxious weed, we would consider the most up-to-date pest 
information maintained by PPQ. 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. APHIS welcomes public comment on deletion of the taxa list and 
preferred sources of plant pest and noxious weed information for use 
under the proposed regulations.
    With deletion of this list from the regulations, there is also no 
longer a need for the procedure currently described in Sec.  340.5 for 
amending this list.
3. Regulating Whole Organisms, Parts, and Nonliving Products
    APHIS proposes to clarify the regulated status of nonliving plant 
products in the regulations. First, the PPA defines a plant pest only 
as any living stage of any of the articles specifically named in the 
plant pest definition that can directly or indirectly injure, cause 
damage to, or cause disease in any plant or plant product. Moreover, 
APHIS does not consider most GE organisms or parts of GE organisms 
which cannot reproduce to present a risk as plant pests or noxious 
weeds.
    Conversely, we would regulate importation, interstate movement and 
release into the environment of GE seedlings, seeds, tubers, cuttings, 
bulbs, spores, etc., because there is a reasonable, albeit small, 
possibility of reproduction, establishment, and spread if these were 
deliberately or accidentally released into the environment without 
authorization.
    Viable pollen from GE plants imported, moved interstate, or 
released into the environment would be subject to the regulations 
because such movements of pollen can reasonably lead to genomes 
becoming established in the environment. Similarly, in circumstances 
where an article incidentally contains viable pollen, during movement, 
APHIS would consider the movement regulated. There are many cases, 
however, when pollen may be present but is no longer capable of 
producing offspring, e.g., nonviable or immature pollen. In such cases, 
APHIS would not require permits under this part. The commercial 
distribution of cut flowers is one pollen movement situation that APHIS 
has considered in light of the regulations, especially in cases where 
the flowers are grown in other countries then imported only as cut 
flowers. APHIS considers these circumstances to pose little, if any 
risk, and therefore would not require permits for these activities.
    The PPA defines a noxious weed as encompassing both plants and 
plant products. A plant product is 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.'' APHIS has regulated GE organisms under part 340 for over 
20 years, and there is no strong evidence to suggest the need to 
regulate nonliving (nonviable) plant products in most cases. However, 
if in a specific case the importation, interstate movement, or 
environmental release of nonliving products of a GE plant may pose 
noxious weed risks, APHIS has clear authority to address those risks by 
imposing permit conditions on the handling of such nonliving products 
of the GE organism in the permit issued for the associated living GE 
organism. The proposed regulations state clearly in Sec.  340.3(b) that 
the Administrator may also assign permit conditions addressing 
nonliving plant materials associated with or derived from GE organisms 
when such conditions are needed to make it unlikely that the nonliving 
materials would pose a noxious weed risk. APHIS invites consultation 
from any person considering a movement or release of nonliving 
materials derived from a GE organism who is uncertain as to whether it 
would be regulated.

B. Permits for Authorizing Importation, Interstate Movement and Release 
Into the Environment of Certain GE Organisms

1. Elimination of the Notification Procedure
    APHIS first added the notification procedure to the regulations in 
1993 as an administratively streamlined procedure for certain GE plants 
that met the eligibility criteria described in the regulation. Rather 
than using customized requirements, like the permit conditions used for 
the permitting procedure, the notification procedure uses generalized 
performance standards that are described in the regulation itself. The 
use of the performance standards that do not vary from one notification 
to the next is one of the ways that the more rapid administrative 
turnaround was achieved. In some ways, the term ``notification'' has 
been misleading to the public, since they do not realize that sending a 
notification does not mean automatic authorization by APHIS.
    APHIS reviews notifications to verify that the GE plant meets the 
eligibility criteria, and also evaluates whether the

[[Page 60016]]

proposed importation, interstate movement or environmental release can 
be done in a manner that meets the performance standards described in 
the regulation. In many ways, these APHIS evaluations for notifications 
are very similar to those done for permit applications, but the 
notification procedure relies on applicants agreeing to meet the 
performance standards described in the regulation 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 
standards in the regulations, it is more administratively streamlined, 
but the general nature of the standards has made it difficult for APHIS 
inspectors to determine if a notification holder is in compliance and 
can also make enforcement more difficult. For example, under the 
current regulations, one of the performance standards for notifications 
relevant to environmental releases states that: ``The field trial must 
be conducted such that (1) the regulated article will not persist in 
the environment, and (2) no offspring can be produced that could 
persist in the environment.'' Conversely, specific conditions which 
APHIS places on permits are unambiguous, easy to verify at inspection, 
and easier to enforce. A specific permit condition that could be used 
to address just part of the performance standard described above might 
read: ``After final harvest of the GE corn plants covered under this 
environmental release permit, the site will be monitored every 4 weeks 
for the emergence of volunteer corn seedlings for one year, and any 
emerging volunteer plants will be devitalized before they produce 
pollen. Records of the monitoring and management of volunteers must be 
maintained by the permit holder and made available to APHIS upon 
request.''
    APHIS employs performance standards in many of its regulations, 
where appropriate. For example, we propose to employ a performance 
standard in another part of this proposal, container requirements for 
shipments of GE organisms. In that case, it is possible to employ a 
straightforward standard that the container must not break or leak when 
subjected to ordinary handling in transportation. The use of 
performance standards under the notification procedure has some 
benefits, such as providing the responsible person with flexibility in 
how the standard is met, e.g., allowing for appropriate change in 
protocols used during the growing season. However, there are some 
disadvantages in not specifically enumerating the specific measures 
that constitute compliance with the regulations. The permitting 
procedure does not have this disadvantage, because the permit 
conditions specify which actions need to be taken by the responsible 
person to be in compliance.
    APHIS considered revising the performance standards and retaining 
the notification procedure, but this would not have remedied its 
shortcomings, especially the lack of specificity that is a necessity of 
using broadly applicable, performance standards in the regulations.
    Under the proposed regulations where all authorizations will be 
done under a permitting procedure, the permit conditions will provide 
more specific information about what procedures the permit holder must 
follow in order to be in compliance. In the proposed rule, we are 
describing in detail the types of core permit conditions that will be 
imposed, plus the additional permit conditions that the Administrator 
can place upon the permit holder in order to make it unlikely that 
actions under the permit would result in the introduction or 
dissemination of a plant pest or noxious weed.
    In view of the above discussion, APHIS has determined that it would 
have more flexible, risk-appropriate oversight, better regulatory 
enforcement and improved transparency if all regulated importations, 
interstate movements, and releases into the environment are authorized 
under the permitting procedure. The use of the permitting procedure in 
lieu of notifications is also necessary for APHIS to address some of 
the recommendations arising from the OIG Report and the provisions of 
the 2008 Farm Bill. For example, the OIG recommendations have led to 
proposed provisions in the regulations that will enable APHIS to add 
permit conditions to require additional reports during the course of an 
environmental release, the submission of notices to APHIS if the permit 
holder decides not to conduct the environmental release, and 7-day, 
pre-plant notices in the case of GE plants engineered to produce 
pharmaceutical or industrial substances. The last recommendation is 
already being implemented as a permit condition, because all of these 
authorizations are done under the permitting procedure. The OIG 
recommendations cannot be implemented under the notification procedure, 
because under the current regulations APHIS does not have the ability 
to attach conditions to notifications. This provides additional 
justification for APHIS to propose the elimination of the notification 
procedure. The APHIS proposal to eliminate the notification procedure 
is an effective way to address several of the provisions of the Farm 
Bill, such as the changes to the requirements for recordkeeping and 
reporting.
2. Revisions to Permit Procedures
    APHIS proposes to reorganize the regulations to improve the clarity 
of the permit application and evaluation procedures. The proposed 
change is more a reorganization than substantive change, and should 
enhance the transparency of the regulations to the public. The 
permitting procedure will continue to identify and obtain information 
relevant to evaluating the risks associated with a proposed 
importation, interstate movement, or release into the environment, and 
determine and document whether, and under what conditions, the activity 
should be allowed. The proposed regulations related to the issuance of 
permits are divided into two sections. The first is proposed Sec.  
340.2, Procedure for permits, which describes permit types, the 
procedure for permit application (including information requirements), 
and the Agency's administrative actions for permits. The second is 
proposed Sec.  340.3, Permit conditions, which describes the general 
types of conditions that APHIS may add to a permit, and the obligations 
of the responsible person after permit issuance.
    APHIS is proposing explicit procedures for amendment, transfer of 
responsibility, and revocation of permits in order to establish clear 
regulatory procedures that can increase efficiency yet maintain 
adequate safety. Currently the APHIS administrative practices to amend, 
transfer, and revoke permits have not been explicit in the regulation, 
and this addition will provide increased transparency and efficiency.
    The proposed changes organize the regulations to more clearly 
reflect the procedural steps in the application, evaluation, and 
issuance of a permit (see Figure 1). First, the different types of 
permits (importation, interstate movement, and environmental release) 
are described in Sec.  340.2(b), as are new subcategories of 
environmental release permits. Second, the types of information that 
must be submitted with a permit application are described in Sec.  
340.2(c). The permit type, as well as

[[Page 60017]]

the nature of the environmental release (if the permit is for a 
release), affect the application information requirements. Third, Sec.  
340.2(d) outlines the procedural and administrative steps of issuing a 
permit. Finally, the attachment of conditions to permits, which is also 
dependent upon permit type and release category, is described in Sec.  
340.3. Each of these permit-related sections of the proposed 
regulations is discussed below.
    Figure 1. Schematic of activities associated with issuance and 
enforcement of permits, showing associated sections of the proposed 
regulation.




   Permit Types and Environmental Release Categories (Sec.   340.2(b))

                                 [darr]

     Application Information Requirements, by Type (Sec.   340.2(c))

                                 [darr]

             Permit Evaluation Procedures (Sec.   340.2(d))

                                 [darr]

             Assignment of Permit Conditions (Sec.   340.3)
                                  [darr]

   Compliance, Enforcement, and Remediation Activities (Sec.   340.7)


3. Permit Types and Environmental Release Categories (Sec.  340.2(b))
    As discussed above in the background section, APHIS currently uses 
two procedures--notification and permits--to authorize the importation, 
interstate movement and release into the environment of GE organisms 
considered to be regulated articles under this part. The permitting 
procedure can be used for all regulated articles, but the notification 
procedure can be used only for certain GE plants that meet the 
eligibility criteria described in the regulations. Whereas permits are 
issued with explicit permit conditions which must be met by the permit 
holder, notifications have generalized ``performance standards'' 
described in the regulation and therefore do not vary from one 
notification to the next. Currently, approximately 90% of APHIS 
authorizations are done under the notification procedure.
    Under the proposed system, which would eliminate notifications, 
APHIS would continue to issue three types of permits--interstate 
movement, importation, and environmental release. The procedures for 
the first two types of permits are relatively straightforward, and the 
conditions usually required for these permits address risks that are 
very similar from one shipment to another. We propose only minor 
adjustments to the procedures for interstate movement and import 
permits. In general, deliberate release of GE organisms into the 
environment presents a greater risk of introducing or disseminating 
plant pests and noxious weeds, and thus requires more careful 
oversight, than shipments of GE organisms into and across the country 
in secure containers. Of the three permit types, only environmental 
release permits would be differentiated into broad risk-related 
categories by the Administrator. This categorization would occur prior 
to the detailed and specific APHIS evaluation of an individual permit 
application. Table 2 summarizes the relationship of the three permit 
types and categories that pertain to environmental release permits.

 Table 2--Proposed Permit Types and Categories for Environmental Release
                                 Permits
------------------------------------------------------------------------
            Type                                             Use
------------------------------------------------------------------------
Importation permit..........                        For securely moving
                                                     a GE organism into
                                                     the United States.
Interstate Movement.........                        For securely moving
                                                     a GE organism from
                                                     any State into or
                                                     through any other
                                                     State.
Environmental Release:*.....  Release Category A..  For releases into
                              Release Category B..   the environment,
                              Release Category C..   outside the
                              Release Category D..   constraints of
                              Release Category E     physical
                               (non-plants).         containment that
                                                     are found in a
                                                     laboratory,
                                                     contained
                                                     greenhouse,
                                                     fermenter, other
                                                     contained
                                                     structure, or
                                                     secure shipment.
------------------------------------------------------------------------
* In some cases, an environmental release permit may also incorporate
  permits for importation or interstate movement when such movements are
  incidental to the environmental release.

    The proposed sorting system for environmental release permits 
includes five categories: Four for releases of GE plants (Categories A-
D) and one for releases of all other GE organisms (Category E). 
Releases of GE non-plant organisms (Category E) would be placed into a 
single category and reviewed on a case-by-case basis. APHIS considered 
the creation of smaller risk-related subcategories for non-plants, but 
APHIS has received too few permit applications to warrant the creation 
of these smaller groupings. Releases of plants would be grouped into 
four categories, as described below.
    APHIS considered a tiered permitting system which would sort 
proposed environmental releases of plants into a number of risk-based 
categories. Lowest risk releases would be assigned to Tier 1, slightly 
higher risk releases in Tier 2, and so on. In such a system, tier 
assignment is analogous to a risk rating. In developing the specifics 
of implementing such a system in the regulations, however, APHIS found 
that it was challenging to pre-assign all conceivable releases into 
tiers representing discrete levels of risk. There are a large number of 
risk factors that contribute to the overall risk associated with any 
given release. These factors include reproductive biology and growth 
habit of the species, potential for gene flow to other species, 
phenotype engineered into the organism, familiarity with the genetic 
material used, safety of any expressed products, scale of the release, 
location, duration, experience, and compliance history of the 
applicant, proximity to threatened

[[Page 60018]]

and endangered species, and other factors.
    Sorting proposed releases considering all relevant factors would 
lead to an unwieldy system with many risk-based categories, and would 
essentially require a full risk assessment prior to assigning a 
proposed release to the appropriate risk category. Consequently, it 
would be nearly impossible for applicants and the public to predict the 
risk tier to which a proposed release would be assigned.
    APHIS proposes that the permitting system for environmental release 
permits would assign releases into administrative categories based upon 
two primary risk-related factors described below, so that the 
categories would identify the general types of releases of plants which 
share broadly similar risks and management issues. This initial 
administrative sorting would be followed by an evaluation that fully 
characterized the risk of the proposed release, which would then be the 
primary basis for adding necessary permit conditions. APHIS concludes 
that such a system could appropriately sort most releases into 
groupings that are alike enough that they could usually be treated 
similarly initially, in terms of application information requirements 
and evaluation of potential risks. In most cases the initial groupings 
would also result in a similar level of oversight of the release and 
conditions attached to the permit-but any final determination of the 
permit category, oversight and permit conditions would depend on the 
results of the APHIS evaluation.
    Using this approach, there is no prior conclusion that every 
release within the same category poses the same level of risk. 
Likewise, releases in different categories do not necessarily pose 
greatly different risks. For this reason, APHIS would not refer to 
these groupings as ``tiers,'' as this implies an incremental increase 
in risk from tier to tier, but would instead label them as 
``categories'' which are lettered and not numbered.
    APHIS developed the proposed sorting scheme by first examining the 
types of releases that typically are authorized under its current 
regulations. APHIS then modified the categories to make them more 
explicitly connected to plant pest and noxious weed risks.
    The two primary factors APHIS identified as most relevant to define 
its sorting system for environmental release permits were the (1) 
ability of the unmodified recipient plant species to persist in the 
wild and (2) potential of the engineered trait to cause harm, injury, 
or damage, as described in the definitions of plant pest and noxious 
weed. Secondary factors, which in some instances may change the initial 
categorization, include: how the recipient plant is commonly used 
(e.g., as a food or feed crop); the impact of the engineered trait on 
the fitness of the GE plant; and, the degree of uncertainty associated 
with the trait and its possible impacts.
    Regarding the persistence factor, APHIS proposes to group plant 
species according to the risk of persistence of the plant or its 
progeny in the environment without human intervention. Based upon the 
growth habit of the plant species and presence of wild relatives in the 
United States, APHIS proposes to sort all plants into four groups, 
listed in order of increasing persistence risk:
     Low: Populations of the recipient plant are unlikely to 
persist in the environment without human intervention, and the 
recipient plant has no interfertile wild relatives in the United 
States. Examples include corn, soybeans, and cotton (except in certain 
areas).
     Moderate: Populations of the recipient plant are known to 
be weakly persistent in the environment without human intervention, or 
the recipient plant has interfertile wild relatives in the United 
States. Examples include alfalfa, beets, canola, rice, and tomato.
     High: Populations of the recipient plant are known to be 
strongly persistent in the environment without human intervention, or 
the recipient plant has interfertile wild relatives in the United 
States which are aggressive colonizers. Examples include creeping 
bentgrass, poplar, sorghum, and sunflower.
     Severe: The recipient plant is a Federally-listed noxious 
weed or is known to be similarly aggressive in its ability to colonize 
and persist in the environment without human intervention. Examples 
include hydrilla and kudzu.
    These aspects of plant biology and growth habit are broad 
indicators of the increasing likelihood that the plant or its progeny 
can reproduce and spread without human intervention. ``Interfertile 
wild relatives'' includes both wild relatives in the traditional sense, 
as well as feral populations of the same species persisting outside 
agroecosystems. The distinction between ``weakly persistent'' and 
``strongly persistent,'' is intended to mean survival without human 
intervention for one or very few generations (weakly persistent) versus 
several to many generations (strongly persistent). APHIS will clarify 
which species fall into each group by publishing lists in guidance.
    Similarly, with regard to the factor for potential harm caused by 
introduced traits, APHIS proposes to group traits engineered into 
plants into four simple groupings based upon the definitions of plant 
pest and noxious weed. The groups are listed in order of increasing 
potential hazard of the engineered trait:
     Low:
    [cir] Any new proteins or substances produced are unlikely to be 
toxic or otherwise cause serious harm to humans, vertebrate animals, or 
invertebrate organisms upon consumption of or contact with the plant or 
plant parts; and
    [cir] No morphological changes which could cause mechanical injury 
or damage; and
    [cir] Introduced sequences are known not to result in plant 
disease, and confers no or very low increased disease susceptibility.
    An example would include expression of well characterized proteins 
known not to be toxic or harmful, such as a marker gene that does not 
pose a food or feed safety concern, or expression of viral genes where 
it is demonstrated that no protein is produced
     Moderate:
    [cir] Any new proteins or substances produced are unlikely to be 
toxic or otherwise cause serious harm to humans or vertebrate animals 
upon consumption of or contact with the plant or plant parts ; or
    [cir] Novel resistance to the application of an herbicide; or
    [cir] Has novel ability to cause mechanical injury or damage; or
    [cir] Produces proteins or substances that are associated with 
plant disease that are not prevalent or endemic in the area of release, 
or that confer an increased susceptibility to disease.
    Examples include expression of new CRY proteins, ,mechanisms of 
herbicide tolerance (e.g., CP4-EPSPS, which confers glyphosate 
tolerance), and production of viral movement proteins.
     High:
    [cir] Any new proteins or substances produced may be toxic or to 
otherwise cause serious harm to humans or vertebrate animals, upon 
consumption of or contact with the plant or plant parts; or
    [cir] Produces an infectious entity which can cause disease in 
plants.
    Examples include mercury hyper-accumulators or production of some 
pharmaceutical compounds.
     Severe:
    Any new proteins or substances produced are known or likely to be

[[Page 60019]]

highly toxic or fatal to humans or vertebrate animals, upon consumption 
of or contact with the plant or plant parts.
    These aspects of the engineered trait are related to harms or 
damages associated with plant pests or noxious weeds. This takes into 
consideration (1) the harmfulness of any substances produced, (2) the 
possibility of creating morphological changes that would cause physical 
injury, and (3) the likelihood of increasing plant disease, either due 
to risk of creating novel pests or increased inoculum source. Novel 
resistance to an herbicide is included in the ``moderate'' category due 
to the impacts the trait could have on the ability to manage the plant 
or its progeny.
    The proposed use of plant growth habit and trait harm or injury as 
the two main factors for the initial sorting of environmental releases 
into categories uses the two factors to roughly approximate 
``exposure'' and ``hazard,'' respectively. Thus, using a combination of 
these two factors alone, we propose the following initial sorting of 
plant-trait combinations into release permit categories (see Table 3). 
Once environmental releases of GE plants have been sorted into the 
permit categories shown in Table 3, we will review and evaluate the 
information submitted by the applicant to determine oversight and 
permit conditions. The information requested from applicants will not 
be limited to these factors and is, in fact, designed to allow us to 
evaluate any of the risks associated with noxious weeds and plant 
pests. In some instances, our review may result in a change to the 
release category assignment of a GE plant.

Table 3--Initial Sorting Into Administrative Permit Categories (A, B, C, and D) for Environmental Releases of GE
     Plants, Based Upon Persistence Risk of the Recipient Plant Species and Potential Harm or Damage of the
                                                Engineered Trait
----------------------------------------------------------------------------------------------------------------
                                                               Potential harm or damage of engineered trait
                      Persistence *                      -------------------------------------------------------
                                                               Low        Moderate        High         Severe
----------------------------------------------------------------------------------------------------------------
Low.....................................................            A             A              C            D
Moderate................................................            A             B              C            D
High....................................................            B             B              C            D
Severe..................................................            D             D             D            D
----------------------------------------------------------------------------------------------------------------
* Persistence risk of the recipient plant species.

    The sorting system above presumes that there is sufficient 
scientific information available about the GE plant to support the 
categorization. For example, the phenotype conferred by inserted 
sequences and the growth habit of the plant species in the U.S. must be 
well-characterized and based upon direct empirical observation of the 
genetic construct in the recipient plant species. In cases where less 
(or nothing) is known about phenotype of the engineered trait in the 
recipient plant species-such as inference based upon sequence 
similarity, protein structure modeling, or observation of the genetic 
construct in other species-the release category may be changed (from A 
to B or B to C) as a result of this uncertainty. Similarly, lack of 
familiarity with the plant species' behavior in the U.S. or the 
techniques needed to mitigate the likelihood of its persistence could 
also change the release category.
    APHIS considered whether to adjust the categories table to 
acknowledge that an engineered trait could affect (enhance or detract 
from) the other factor axis, namely the persistence risk of the 
nonmodified recipient plant. Engineered traits such as resistance to 
biotic or abiotic stresses could theoretically increase the fitness of 
the plant, and thereby increase the likelihood that it will persist in 
the environment without human assistance. Considering the range of 
persistence risks posed by all of the different plant species sorted 
into any one of the proposed groupings, however, APHIS has concluded 
that in most instances the engineered trait would not alter the 
likelihood of persistence enough to warrant a change in initial release 
category. However, in cases where the engineered trait significantly 
alters plant growth habit, metabolism, or reproduction to increase the 
likelihood of persistence in the environment, APHIS could change the 
release category accordingly. Examples of such changes might include 
converting an annual species to a perennial or converting a plant with 
C3 metabolism to crassulacean acid metabolism (CAM).
    The proposed category system should provide a simple, transparent 
way for APHIS review information in applications to initially sort 
releases into broad, risk-related categories, which can then be more 
efficiently assessed for the actual risks posed by the release. 
However, it should be emphasized that the categories are intended only 
for initial sorting, and other factors are taken into account in the 
APHIS evaluation when determining the specific permit conditions.
    APHIS intends that release Category A will be associated with a 
level of regulatory oversight similar to environmental release 
notifications under the current system, and Categories B and C with a 
level of regulatory oversight similar to various permits that have been 
issued under the current system. However, it will be much clearer to 
the public what types of oversight will be applied broadly within each 
category. As we discussed above, oversight and permit conditions with 
each category will be similar, though not necessarily identical, for 
any plant within the category. Category D was created to acknowledge 
the possibility that some proposed releases may pose a very high risk 
of introducing a highly persistent or harmful plant into the 
environment. To date, APHIS has never been requested to allow releases 
that would fall into this category. If an applicant were to propose a 
Category D release, APHIS would only authorize such releases after 
imposing extremely strict levels of oversight akin to high security 
quarantine far exceeding that of Category C that would ensure that the 
GE plants could not persist in the environment. The information 
requirements, permit conditions, and general levels of oversight 
associated with each release Category are discussed below.
    This simple sorting system places GE plants into categories and 
provides a relatively clear, simple rationale for placement in a given 
category. What follows is a series of illustrations of common plant-
trait combinations and the release categories to which they would be 
assigned:
     Category A:
    [cir] Bt corn producing CRY1ab toxin. The plant is unlikely to 
persist in the

[[Page 60020]]

environment and the safety of the protein has been assessed by the EPA.
    [cir] Soybeans engineered with glyphosate tolerance conferred by 
CP4-EPSPS. While herbicide tolerance poses a ``moderate'' hazard, 
soybean has no interfertile wild relatives in the U.S..
     Category B:
    [cir] Corn producing a new CRY protein. The plant is unlikely to 
persist and the novel CRY protein is likely to be toxic to some species 
that live or feed on the plant (normally Category A), but its food/feed 
safety is only inferred from similarity to other CRY proteins.
    [cir] Random ``knock-out'' or antisense libraries of soybean lines. 
While the lines may not likely produce novel proteins or substances 
(Category A), because of the uncertainty associated with the impacts of 
genetic engineering on these lines, they would be treated as Category 
B. Well-characterized lines taken from such libraries that do not 
produce new proteins would likely be treated as Category A.
    [cir] Kentucky bluegrass engineered with glyphosate resistance 
conferred by CP4-EPSPS. Herbicide resistance is a ``moderate'' hazard 
and bluegrass has interfertile wild relatives in the U.S.
    [cir] Pines producing an enzyme to enhance paper production. Pines 
are persistent and have interfertile wild relatives in the United 
States.
     Category C:
    [cir] Poplar engineered to produce enzymes for heavy metal 
bioremediation.
     Category D:
    [cir] Any Federally listed noxious weed that has been genetically 
engineered; any GE plant producing a vertebrate toxin.
Permits for Environmental Releases of Plants Making Pharmaceutical and 
Industrial (PMPI) Compounds
    APHIS considered whether to continue to issue environmental release 
permits for GE plants engineered to produce pharmaceutical and 
industrial compounds if the GE plant species is the same as, or 
sexually compatible with, a species commonly used for food or feed. 
APHIS concludes that the proposed permitting procedure and the use of 
stringent permit conditions can continue to effectively minimize the 
risks that may be associated with the environmental release of such GE 
plants. APHIS will continue to impose permit conditions that take into 
account the issues related to the safety of proteins or other 
substances that these plants have been engineered to produce. Based 
upon APHIS experience to date, many releases of GE plants producing 
pharmaceutical or industrial substances would fall in Category C, and 
would carry the same level of oversight as current permits for PMPI.
4. Permit Application Information Requirements (Sec.  340.2(c))
    In the proposed regulations, we provide greater detail about the 
basic application information requirements that need to be addressed in 
all permit applications, as well as additional basic information 
required for each permit type and the categories in the case of 
environmental release permits. Under the current regulation, certain 
areas where APHIS routinely needs information from the applicant do not 
become apparent until the applicant submits the permit application (and 
APHIS subsequently follows up for additional information). Some of the 
information requirements related to recordkeeping, reporting, and 
contractual arrangements among the permit holder and agents are new to 
the regulation and reflect, in part, certain provisions of the 2008 
Farm Bill and also align with recommendations of USDA's OIG 2005 
Report. For example, the OIG recommendations have led to provisions 
that will enable APHIS to require geographic coordinates for the 
locations of environmental releases.
    The differences between the information required for an application 
under the current regulations versus the proposed regulations may be 
seen by comparing current Sec.  340.4 to proposed Sec.  340.2(c). Both 
the current and proposed application procedures require information 
characterizing the nature of the GE organism, including detailed 
molecular biology information about the expression of the introduced 
genetic material. They also both require information about the type of 
movement and/or release planned. The proposed rule requires more detail 
in some of these areas, and more description of the applicant's plans 
and methods to prevent unauthorized releases, and to respond to 
unauthorized releases if they occur. This information is used in part 
by APHIS to formulate the specific permit conditions. In cases where 
the permit is for environmental release, and would be in permit 
categories C or D according to the table in Sec.  340.2(b)(3), a 
greater level of detail would be required for almost all aspects of the 
activity, including the recipient organism, the inserted gene(s), site 
location and management practices, and training and communication among 
the permit holder and agents involved in the activity covered under the 
permit. This information would also address the capability of the 
organism to persist or spread in the environment, or include details 
about how the engineered traits might be harmful.
5. Permit Conditions (Sec.  340.3)
    Conditions are specific practices or requirements that an applicant 
must follow upon issuance of a permit. Under the current regulation, 
the permit conditions are described in the same section as the permit 
procedure itself. In the proposed revision, the permit conditions are 
enumerated in a separate section (Sec.  340.3) to accommodate the 
additional details to describe conditions for the three permit types as 
well as the categories of environmental release permits.
    The use of permits and permit conditions gives APHIS and the 
responsible person a clearer understanding as to what actions must be 
taken for the permit holder to comply with the regulation. In the 
proposed regulation, APHIS has strived to provide as much transparency 
and predictability as possible about permit conditions while retaining 
sufficient flexibility so that the regulations will be adaptable in a 
broad range of cases.
    Permits will be issued with the core permit conditions described in 
Sec.  340.3(a), which are a minimum set of basic conditions for 
importation, interstate movement, and release. The Administrator may 
add to these conditions additional or expanded conditions when 
necessary to make it unlikely that actions under the permit would 
result in the introduction or dissemination of a plant pest or noxious 
weed.
    The Administrator will assign the permit conditions in a manner 
that is commensurate with the risk of the individual proposed movement 
or release. Additional or expanded permit conditions may include, but 
are not limited to, specific requirements for: reproductive, cultural, 
spatial, temporal controls; monitoring; post-termination land use; site 
security or access restrictions; and management practices such as 
training of personnel involved in the release.
    The proposed description of permit conditions elaborates on the 
``standard'' permit conditions found in the current regulations, and 
the additional detail is designed to better communicate with potential 
applicants what the requirements are likely to be for their particular 
permit, and will better support administration of the program, 
including compliance and enforcement.
    In the current regulation, only ``standard'' permit conditions are 
described, and APHIS has the authority to place other conditions upon 
the permit as deemed necessary by the

[[Page 60021]]

Administrator. The proposal for permit conditions will be more 
transparent to the public and this transparency will better facilitate 
planning by researchers, especially those who have not previously 
received permits from APHIS.
    The proposed required core permit conditions consolidate six 
primary areas addressed in different parts of the current regulations 
to ensure compliance with the regulation and to make it unlikely that 
the permitted activity will result in the introduction and 
dissemination of a plant pest or noxious weed: Identity, shipment, 
unauthorized dissemination, communication and training, records, 
reports and notices. APHIS intends the list of specific condition areas 
we propose in Sec.  340.3 to be used for all permits we issue as they 
apply to importation, interstate movement, and release into the 
environment. The required permit conditions listed in Sec.  340.3 
represent the permit conditions that we propose to apply for any type 
of permit. Listing them in the regulations should provide applicants 
with the ability to plan their activities with knowledge of the primary 
requirements for all activities that would have to be met to comply 
with the regulations.
    For environmental release permits, proposed Sec.  
340.3(a)(4)(iii)(F) would also require the permit holder to notify 
APHIS seven days prior to initiation of the release if the release is 
Category C or D. For all Categories, permit holders are required to 
notify APHIS if they do not conduct the release.
    The current regulations require environmental release permit 
holders to submit field test reports to APHIS within 6 months after 
termination of a field test. Under proposed Sec.  340.3(a), the 
requirement simply states that the responsible person shall submit 
reports to APHIS at the times specified in the permit conditions and 
containing the information specified in the permit conditions.
    APHIS is also proposing revision of the regulations to clarify the 
procedure it would use for amendment of permit conditions, transfer of 
a permit to a different responsible person, and revocation of an 
existing permit. Each of these additions to the regulations reflect 
current administrative practices and the incorporation of these into 
the regulations will make the overall system more transparent.
    Currently, APHIS attaches conditions to permits at the moment the 
permit is issued to the applicant. Under the current regulations, the 
permitting procedure does not include a formal acknowledgement from the 
applicant prior to permit issuance that they are aware of and consent 
to the permit conditions. To verify that applicants are aware of and 
willing to abide by the conditions, APHIS proposes to add an additional 
administrative step in the permit procedure in Sec.  340.2(d)(6) to 
support administration of the program. We are proposing to require that 
applicants agree prior to permit issuance that they will comply with 
all the permit conditions. Eventually, APHIS would build this feature 
into the existing ePermits system, and in the interim it would provide 
alternative mechanisms, such as e-mail communications, to implement 
this step of the permitting procedure.
    APHIS is also proposing to clarify in Sec.  340.2(h) of the 
regulations the procedure to be used when amendment of existing permit 
conditions is sought by the responsible person or required by APHIS, as 
well as the procedure for transfer of an existing permit to a different 
responsible person.
    As with the current regulations, APHIS is retaining the flexibility 
to modify permit conditions as needed under individual circumstances. 
Proposed Sec.  340.3 will increase transparency, yet still allow 
sufficient adaptability of the regulations for the full range of permit 
applications APHIS expects to receive today and in the future. APHIS 
recognizes that transparency and predictability for applicants must be 
balanced with maintaining Agency flexibility and adaptability for years 
to come under these regulations. APHIS encourages the public to comment 
on the choices we are proposing here, and we welcome suggestions for 
alternative approaches.
    APHIS is proposing to revise the current sections of the 
regulations for container requirements for shipments of GE organisms 
(Sec.  340.8) and marking and identity requirements for imports of GE 
organisms (Sec.  340.7). Rather than the highly prescriptive approach 
in the current regulation, we will use an approach that is performance 
based and can be adapted to the activity that is being performed. This 
should provide greater efficiency for the public as well as APHIS, yet 
still achieve the necessary level of containment during shipments. We 
have reorganized this information in the regulations so that the 
requirements are associated with the related activity under the 
proposed regulation. For example, the shipping requirements for 
interstate movements under the conditional exemption have the requisite 
shipping conditions stipulated in the section for conditional 
exemptions. Likewise, the shipping conditions for import and interstate 
movement permits have been placed in the section for permit conditions, 
rather than retaining them in a separate section as in the current 
regulations. The performance-based standards we are proposing 
incorporates a simple performance standard in our proposed definition 
of secure shipment, discussed below: ``Shipment of a package of 
sufficient strength and integrity to withstand leakage of contents, 
shocks, pressure changes, and other conditions incident to ordinary 
handling in transportation.'' APHIS is also proposing to require 
applicants to provide their proposed methods of secure shipment, and 
APHIS will specify the methods of secure shipment as a permit 
condition.
    APHIS proposes to eliminate the marking and identity requirements 
for imports of GE organisms as a separate section of the regulations 
(current Sec.  340.7). As with the container standard issue discussed 
above, appropriate labeling and related requirements would be highly 
individual depending on the organism, type of permit, and other 
conditions.
    APHIS is proposing to include relevant tribal officials when it 
provides copies of permit applications to state regulatory officials. 
The current regulations state that APHIS provides this information to 
state regulatory officials.
6. Elimination of Courtesy Permits
    APHIS is also proposing to eliminate the issuance of courtesy 
permits. Courtesy permits have been part of the regulations since their 
inception in 1987, but in an effort to better allocate APHIS resources, 
APHIS is proposing to remove this regulatory feature. The current 
regulations provide the ability for APHIS to issue ``courtesy 
permits,'' in order to facilitate the movement of organisms which are 
outside the scope of these regulations, but whose movement might 
otherwise be hindered because of their similarity to organisms 
regulated under these regulations. The issuance of courtesy permits has 
generated confusion in the public and especially in the research 
community. The application form for courtesy permits is identical to 
the application for other types of permits, and the courtesy permit 
itself looks like other permits. This 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 have other 
authorizations which may be required, under plant

[[Page 60022]]

pest regulations such as those found at 7 CFR part 330. APHIS commits 
significant resources to the issuance of these courtesy permits for the 
movement of organisms which are not subject to the provisions of part 
340. APHIS will work with researchers and relevant government 
regulatory officials to facilitate the transition.
    APHIS will also be available for consultation by persons who 
formerly used courtesy permits and other persons moving similar non-
regulated articles, to discuss how to facilitate their movement. We 
also encourage the public to comment on the proposed elimination of 
courtesy permits and how APHIS should work with persons moving 
organisms for which we might formerly have issued courtesy permits.

C. Conditional Exemptions From Permit Requirement (Sec.  340.4)

    The PPA allows the Secretary to create ``exceptions'' to the permit 
requirement when the Secretary deems that a permit is not necessary. 
That is, these regulated activities are allowed, under certain 
conditions, without seeking prior authorization via permit. The current 
APHIS regulations contain such PPA exceptions, but they are referred to 
as ``exemptions'' in the regulations. The current regulations include 
conditional exemptions from the requirement for interstate movement 
permits. These conditional exemptions were established in the 
regulations during the first few years after the regulations were first 
promulgated. The last conditional exemption was established in the 
regulations in 1990 for the interstate movement of GE plants of the 
species Arabidopsis thaliana as long as the conditions described in the 
regulations are met.
    In its proposed revision to the regulations, APHIS is retaining the 
existing conditional exemptions from interstate movement. We are also 
proposing a new regulatory procedure that would enable APHIS to approve 
new conditional exemptions more efficiently than using the procedure of 
notice and comment rulemaking for each individual exemption. This can 
be a transparent and efficient way to provide regulatory relief. This 
new procedure for approving conditional exemptions is described in 
Sec.  340.5, and it incorporates transparent steps including scientific 
review, public input, and adaptability when APHIS establishes the 
conditions relevant to the specific conditional exemption. Conditional 
exemptions, by their nature, will always include conditions and 
continued APHIS oversight to ensure that the conditions are met.
    The current regulations provide for conditional exemptions from the 
requirement for permits for the interstate movement of certain GE 
strains of the microorganisms Escherichia coli, Saccharomyces 
cerevisiae, and Bacillus subtilis, and the plant Arabidopsis thaliana 
in Sec.  340.2(b), and these conditional exemptions are being retained 
under the proposed regulations. Conditional exemptions from permit have 
been part of the regulations since the first exemption was established 
in 1988 (for the interstate movement of certain GE microorganisms), 
with the addition of another conditional exemption, through rulemaking, 
in 1990 for certain types of GE Arabidopsis thaliana, one of the most 
commonly used plants for scientific studies and which is frequently 
distributed among researchers. The essential conditions for each of 
these conditional exemptions address the following: (1) Species of the 
GE organism, (2) the types of genetic modifications that are allowed or 
prohibited for the GE organism, and (3) the manner in which the GE 
organism is shipped interstate. The existing conditional exemptions for 
the interstate movement of microorganisms were based on APHIS' 
conclusion that the exemption from the requirement for permits for 
interstate movement of these microorganisms would ``not present a risk 
of the introduction or dissemination of a plant pest'' (53 FR 12910, 
p.12910).
    The existing conditional exemptions for E. coli, Bacillus subtilis, 
Saccharomyces cerevisiae and Arabidopsis thaliana are being retained in 
the proposed regulations. APHIS has no information that would indicate 
that such conditional exemption would be result in the introduction and 
dissemination of a plant pest or noxious weed. The text of the 
conditional exemption is being updated to place the shipping 
requirements with the other conditions associated with the exemption, 
instead of the current regulatory organization that has the shipping 
requirements in a separate section of the regulation.
    In addition to the existing conditional exemptions, APHIS is 
proposing a transparent and efficient petition procedure in Sec.  340.5 
whereby the Administrator may approve additional conditional exemptions 
from permit without having to amend the regulations. This procedure 
would provide for a scientific review by APHIS as well as the 
opportunity for public review and comment on the scientific basis for 
the proposed exemption and the conditions associated with the 
exemption. The proposed procedure would provide an adaptable means of 
ensuring that the regulatory oversight is proportional to the risks 
posed by specific activities with GE organisms.
    Proposed Sec.  340.5 describes the procedure whereby a petitioner 
would seek a determination by the Administrator that the importation, 
interstate movement, and/or release into the environment of a GE 
organism is not subject to the requirement to have a permit under this 
part. We propose that the Administrator's decision to approve an 
exemption would be based upon a determination that the exemption from 
the requirement for a permit, when conducted with the associated 
conditions, is unlikely to result in the introduction or dissemination 
of a plant pest or noxious weed. APHIS anticipates that creating this 
new petition procedure to allow approval of additional conditional 
exemptions would enhance its ability to customize regulatory oversight 
to be proportional to any risks associated with importation, interstate 
movement, or release into the environment of a GE organism.
    Under the proposed procedure, petitioners have the flexibility to 
propose various types of conditional exemptions from the requirement 
for a permit: The proposal can be for one or more permit types 
(importation, interstate movement, or release into the environment). In 
addition, the petitioner can propose the relevant conditions. The 
Administrator may approve the proposed conditional exemption as 
submitted in the petition, or the Administrator may impose alternatives 
to the requested exemption and conditions. The Administrator would 
review the scientific information and evaluate potential risks relevant 
to the proposal, then make the relevant documents (proposal and any 
supporting information) available to the public for review and comment 
prior to the Administrator's decision.
    The information needed for a petition for conditional exemption 
would depend on the nature of the exemption requested and the proposed 
conditions for exemption. For example, conditional exemptions for the 
interstate movement of narrowly-defined groups of organisms with 
restrictive associated conditions might require considerably less 
information to justify than exemptions for broadly defined groups of 
organisms or less restrictive associated conditions. In making its 
determination, APHIS would consider all relevant information, including 
information in the scientific literature, copies of unpublished 
studies, and reviews by other regulatory agencies.

[[Page 60023]]

    APHIS foresees many advantages to the proposed procedure, including 
scientific rigor, public involvement, and regulatory efficiency. APHIS 
would continue to provide to the public the relevant scientific 
information under consideration, its environmental analysis, and the 
rationale for its determination. The public would also retain its 
ability to provide comments to the agency prior to a decision approving 
a new exemption. APHIS decisions regarding these newly approved 
conditional exemptions would be published in the Federal Register and 
maintained on a list accessible to the public.
    In evaluating whether to approve a new conditional exemption, APHIS 
would carefully consider issues related to enforceability of the 
conditional exemption when proposing to approve a conditional 
exemption. Unlike permit conditions, which are binding on the specific 
responsible person, the conditions associated with the exemption would 
apply to anyone who conducts the activity under the conditional 
exemption. Before granting such a conditional exemption, APHIS would 
take into consideration the likelihood that such conditions would be 
followed and the consequences if they are not.
    Conditional exemptions could be used, for example, for the 
importation of certain GE commodities. A person could petition for an 
exemption from all permits for shipments of a particular GE commodity 
grain under the condition that the grain is not grown, but will only be 
moved for direct use as food, feed, or for processing. The proposed 
procedure to approve new exemptions would be sufficiently adaptable 
that it can consider approving exemptions for the shipment of certain 
GE commodities that would take into account any conditions necessary to 
make it unlikely to result in the introduction and dissemination of 
plant pests or noxious weeds.
    APHIS considered proposing specific criteria in the regulations 
that the Agency would use when evaluating potential risks of imported 
GE commodities which are viable propagules such as grains like corn, 
wheat, etc. APHIS considered that such a criterion-based system in the 
regulations might allow APHIS to conduct expedited reviews of imports 
that met the specified criteria. APHIS considered criteria such as 
whether the GE plant had undergone a safety review in a foreign 
country, whether APHIS had granted nonregulated status to something 
similar, and the likelihood that the commodity could be propagated 
(seeds, fruit with seeds, nonviable products like flour, etc.).
    However, at this time APHIS is not proposing such criteria in the 
regulation. APHIS does not rule out the possibility of developing such 
a criterion-based system in the future. We welcome comments from the 
public on this issue.
    We are also proposing regulatory procedures whereby the 
Administrator may revoke any exemption under this part after it is 
approved. As proposed, the Administrator may revoke any exemption if 
the Administrator receives information subsequent to approving the 
exemption and makes a determination based upon this information that 
the circumstances have changed such that the exemption is likely to 
result in the introduction or dissemination of a plant pest or noxious 
weed. A revocation may not be appealed. However, any person may file a 
new petition in accordance with Sec.  340.5 regarding the same or 
similar organisms covered by the exemption if new information relevant 
to the revocation becomes available.
    In addition to this procedure for completely revoking an exemption 
so it would be unavailable for use by any person, we propose to add a 
provision in paragraph (e) of the conditional exemptions section, Sec.  
340.4, under which the Administrator may revoke the right of an 
individual person to use an exemption without revoking the exemption 
for other persons. The Administrator could revoke an individual's right 
to use an exemption after determining that the person or any agent of 
the person has failed to comply at any time with any provision of this 
part.

D. Petitions for Nonregulated Status (Sec.  340.5)

    The current regulations include a procedure by which anyone may 
petition APHIS to grant ``nonregulated status'' to a GE organism, which 
means it would no longer be subject to the regulations in part 340. 
This nonregulated status is different from that of regulated articles 
that might be conditionally exempt from the requirement for a permit 
when moved interstate (following the conditions specified in the 
regulations).
    Published APHIS decisions made under the current regulations have 
used different ways to express the basic standard ``unlikely to pose a 
plant pest risk'' in determining whether to grant nonregulated status 
to a specific GE organism. In its determinations, APHIS has conveyed 
the basic standard of ``unlikely to pose a plant pest risk'' by 
concluding that the GE organism ``poses no more of a plant pest risk 
than its non-genetically engineered counterpart,'' ``will not pose a 
plant pest risk''; or that there is ``no plant pest risk,'' or ``no 
direct or indirect plant pest effects.'' Regardless of the phrases used 
in its determination of nonregulated status to date, APHIS has applied 
the same basic evaluation criteria to each determination to conclude 
that the GE organism is unlikely to pose a plant pest risk and 
therefore is not subject to the part 340 regulations.
    APHIS is proposing revisions to Sec.  340.6 that will clarify the 
petition procedure, information requirements for petitions, and the 
standard upon which the Administrator will make a determination that a 
GE organism is approved for nonregulated status. Under the current 
regulations, the basic standard for a determination of nonregulated 
status of a GE organism has been related to plant pest risk. In Sec.  
340.6(b)(4) of this proposed rule, we are proposing to apply a similar 
basic standard derived from the proposed regulatory scope in Sec.  
340.0(a), namely, whether the GE organism is unlikely to be a plant 
pest or noxious weed.
    The current regulations also have a provision at Sec.  340.6 to 
extend a determination of nonregulated status and grant nonregulated 
status to a GE organism based on the similarity of the GE organism to 
an antecedent GE organism that has already granted nonregulated status 
(Sec.  340.6(e) ``Extensions to determinations of nonregulated 
status''). This provision has been in the APHIS regulations since 1997 
and has been used fifteen times to grant nonregulated status to 
additional GE plants based on similarity to their antecedents. This 
existing ``extension procedure'' was designed for APHIS to take into 
account the previous evaluation conducted by APHIS and thereby afford 
the potential for expedited evaluations of a petition for extension. 
The extension procedure has some administrative aspects which are 
streamlined but in practice the APHIS scientific reviews for extensions 
are similar to those of the antecedent organism.
    Some members of the public have misunderstood the nature of the 
extension procedure, believing that APHIS has not conducted a thorough 
scientific review. Some members of the public have misconstrued the 
term ``extension'' to conclude that an extension would extend the 
duration of nonregulated status (nonregulated status is not granted 
with an expiration date).
    For these reasons, APHIS is proposing to eliminate the extension 
procedure in

[[Page 60024]]

the regulation. APHIS sees no advantage to retaining the distinction in 
the regulations between reviews for antecedents and reviews for 
subsequent petitions for extensions. Because the proposed revisions for 
petition for nonregulated status provide a high degree of flexibility, 
a separate extension procedure is not needed in the regulation. Review 
of petitions under the proposed regulations will rely on previous 
evaluations of similar GE organisms when they exist. APHIS foresees 
that some evaluations for nonregulated status may require less time if 
previous evaluations have addressed the issues relevant to a new 
petition for nonregulated status.
    In Sec.  340.6 we propose some revisions to the information that 
the Administrator may require a petitioner to submit in consideration 
of the particular petition. In the current regulation, the information 
needs are described largely with respect to evaluating GE plants, but 
APHIS foresees that other GE organisms may also be suitable candidates. 
This provision may become more important as new commercial applications 
of biotechnology emerge and new types of information are needed to 
properly assess the risks associated with new types of GE organisms. In 
all of the nonregulated status requests processed to date, the subject 
organisms and the alterations involved did not present unanticipated or 
completely novel approaches and APHIS was able to make a determination 
based on information in the petitions. When needed, APHIS obtained 
additional information from petitioners, in a consultation process 
similar to the one proposed.
    We are also proposing a regulatory procedure whereby the 
Administrator may revoke a previous approval of nonr