[Federal Register Volume 73, Number 197 (Thursday, October 9, 2008)]
[Proposed Rules]
[Pages 60008-60048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-23584]



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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

  Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / 
Proposed Rules  

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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:


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    ``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.

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    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 nonregulated status. 
This is consistent with the existing regulations and policies that the 
Administrator may place a deregulated GE organism back under the 
regulations if the Administrator concludes that the GE organism poses a 
plant pest risk. As proposed, the Administrator may revoke any approval 
of nonregulated status if the Administrator receives information 
subsequent to approval that the GE organism is likely to be a plant 
pest or noxious weed. If the Administrator revokes an approval for 
nonregulated status, the Administrator may approve for the same GE 
organism an exemption from the requirement for permit in accordance 
with Sec.  340.5. The revocation, its effective date, and the reasons 
for it will be published in the Federal Register. A revocation may not 
be appealed. However, any person may file a new petition in accordance 
with Sec.  340.5 or Sec.  340.6 regarding the same or similar organisms 
covered by the revocation if new information relevant to the revocation 
becomes available.
Treatment of GE Organisms That Have Been Granted Nonregulated Status
    Although the APHIS evaluations of GE plants that would be conducted 
under the proposed regulatory changes will evaluate some additional 
factors because of consideration of noxious weed risks, APHIS 
nonetheless considers this proposed revision to be sufficiently 
consistent with the criteria evaluated in making determinations of 
nonregulated status to date under the current regulations. For this 
reason, APHIS is proposing that all previous determinations of 
nonregulated status made since the early 1990s under the part 340 
regulations will be automatically approved for nonregulated status 
under the revisions proposed here. The history of safe use of these 
nonregulated GE plants in agriculture in the United States and other 
countries gives APHIS confidence that it is appropriate to retain 
nonregulated status under the revised regulations for all those GE 
plants which have been granted nonregulated status under the existing 
regulations. Many of these GE plants have been incorporated into plant 
breeding programs and been used to develop hundreds of crop varieties 
that have been widely and safely used in agriculture around the world.
    We also note that although the addition of the term ``noxious 
weed'' is new to the proposed regulation, previous evaluations for 
determinations of nonregulated status considered the concept of plant 
pest risk in a broad context that included consideration of potential 
weediness. The evaluations considered, inter alia, whether the 
unmodified plant was a weed, whether the GE plant was a weed, and 
whether the interbreeding of the GE plant with sexually compatible 
plant species would result in offspring that would be weeds. In each 
case in which APHIS granted nonregulated status to date, APHIS reached 
the conclusion that in each instance that the potential for weediness 
was unlikely to occur. In the case of some petitions for nonregulated 
status in which the GE plants were engineered with sequences derived 
from plant viruses, APHIS also considered in its reviews whether the 
genetic modification was unlikely to result in a new plant pest, in 
this case a plant virus (through mechanisms such as recombination or 
transencapsidation).

E. Compliance, Enforcement, and Remedial Action (Sec.  340.7)

1. Ensuring Compliance With Permits and Exemption Activities
    In recent years, APHIS has strengthened its program in order to 
improve permit holders' compliance with the regulations, to augment the 
approaches used to prevent or remediate potential risks to plant 
health, and to utilize appropriate enforcement strategies. This 
proposal provides an opportunity to set forth the compliance and 
enforcement requirements and the tools and administrative practices 
APHIS may employ as part of an integrated approach to prevent the 
introduction or dissemination of plant pests and noxious weeds, and to 
support overall administration of the program. These matters are 
addressed in proposed Sec.  340.7, ``Compliance, enforcement, and 
remedial actions.'' These proposed regulatory changes also reflect 
certain provisions of the 2008 Farm Bill and align with recommendations 
of USDA's OIG.
    APHIS seeks to clarify that it will use the full range of 
enforcement authorities and penalties granted under the PPA. As 
described above, APHIS issues permits with specific conditions or 
requirements placed upon the responsible person. Proposed Sec.  340.7 
clarifies the requirement for compliance with these conditions, as well 
as the approaches available to APHIS to verify compliance. Such 
conditions may include requirements for the responsible person to 
establish and maintain records related to the permit, as well as 
allowing APHIS to review those records. This section underscores APHIS' 
ability to conduct inspections and audit records related to the 
regulated activities.
    In this proposed rule, the requirements for record retention are 
being increased. Records indicating that a GE organism that was 
imported or moved interstate reached its intended destination must be 
retained for at least 2 years after completion of importation or 
interstate movement, and all other records must be retained for at 
least 5 years after completion of all obligations required under a 
relevant permit or exemption. APHIS is also proposing changes to the 
nature of the records that are required, a topic discussed in greater 
detail in section E of this document, ``E. Paperwork Reduction Act.'' 
Changes include a requirement to maintain records for activities done 
under a conditional exemption, as well as contracts and other 
information related to agreements between the responsible person and 
all agents that conduct activities subject to this part.

[[Page 60025]]

    In a previous section of this proposal we discussed the types of 
records proposed as core permit conditions in Sec.  340.3. We also 
propose to add certain recordkeeping requirements to Sec.  340.7 that 
would apply not just to responsible persons exercising permits, but to 
all responsible persons and their agents engaged in the importation, 
interstate movement, or release into the environment of any GE organism 
that is subject to this part, including persons utilizing the 
conditional exemptions from permits.
    In recent years, APHIS has accrued a great deal of experience in 
enforcing the regulations and investigating possible violations of 
them. This experience has helped us identify specific types of records 
that may not be required by the current regulations, but that are 
necessary for effective enforcement of the proposed regulations.\2\ For 
example, in investigations of field trials we have found that we could 
not always obtain detailed maps for each planting area used during each 
season of the trial. This information is important for the efficient 
enforcement of the regulations. We also found that sometimes records of 
actual field trial operations over time were not sufficient to confirm 
that the procedures, equipment, and safeguards APHIS approved for a 
field trial were actually employed. That is, while existing records 
could generally confirm plans to use, for example, certain cleaning 
equipment or procedures at certain intervals, or to conduct plantings 
on certain dates, the records did not confirm that plans were actually 
carried out on the approved dates. We also found that records for some 
field trials did not identify which staff members or contractors were 
responsible for performing which duties, either during a field test or 
in the event of an unauthorized release that triggered the field test 
contingency plan. When responsibilities cannot be linked to specific 
individuals, it makes it very difficult to investigate possible 
violations. Another gap in necessary records we discovered through 
experience was the absence of clear written records of the 
responsibilities of different organizations, when several different 
entities were involved in a field trial. During investigations we may 
need to review not only any written contracts, but also any written 
agreements among researchers, developers, or other parties that are 
sharing performance of tasks required by the permit for a field trial.
---------------------------------------------------------------------------

    \2\ Details of investigations that have led APHIS to propose 
expanded records requirements may be found in the ``Lessons 
Learned'' document cited above, and in investigation report 
documents on the APHIS Web site, e.g., ``2007 Report of LibertyLink 
Rice Incidents'' (http://www.aphis.usda.gov/newsroom/content/2007/10/content/printable/RiceReport10-2007.pdf) and ``Transcript of 
Technical Briefing on Rice Investigation'' (http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&contentid=2007/10/0285.xml).
---------------------------------------------------------------------------

    The proposed regulations would allow APHIS to require these types 
of records. As APHIS considered the types of records needed to support 
the regulations it became apparent that regulations could not specify 
in a ``one size fits all'' fashion all record requirements that might 
be needed. Therefore, we propose to add those detailed record 
requirements of truly general applicability in Sec.  340.3 and Sec.  
340.7. However, we also propose in Sec.  340.3 that we would continue 
to impose any necessary additional record requirements appropriate to 
each permit situation as individual permit conditions.
    Proposed Sec.  340.7 also outlines the possible consequences of 
failure to comply with the regulations, including denial of future 
permits; revocation of current permits; destruction, treatment, and 
removal of GE organisms; issuance of penalties; and a means to settle 
alleged civil violations prior to the issuance of an administrative 
complaint.
    Under this proposal, every person whose activities are within the 
scope of the regulations must comply with all the requirements of this 
part. Moreover, a responsible person can be held liable for the 
violation of any requirement of this part by any agent working for the 
responsible person (including persons contracted to conduct or carry 
out the environmental release on their own or on leased properties).
    We propose to address remediation authority and procedures to a 
greater degree of detail than the current regulations. In proposed 
Sec. Sec.  340.7(e) and (g) we explicitly state that the APHIS 
Administrator has the authority to take remedial actions in the event 
that an incident requires such actions. We also specify that the APHIS 
Administrator has the authority to order remedial action by others. 
These orders could take the form of an Administrative Order, Emergency 
Action Notification, or similar regulatory instrument. Additional 
information about these types of orders and related procedures are 
provided in administrative guidance on the APHIS Web site. The 
consequence for failure to abide by the orders of the Administrator is 
also described in proposed Sec.  340.7, linking remediation to 
enforcement.
    Finally, APHIS has clarified in the proposed regulations that in 
the event of a permit revocation, it may act or order action of the 
responsible person in the handling of the organisms, articles, or means 
of conveyances.
2. Low Level Presence of Regulated GE Plants in Seed or Grain
    On March 29, 2007, APHIS published a Federal Register notice titled 
``Policy on Responding to the Low-Level Presence of Regulated 
Genetically Engineered Plant Materials'' (72 FR 14649-14651; Docket No. 
APHIS-2006-0167. This notice described how APHIS responds when low 
levels of regulated GE plant materials occur in commercial seeds or 
grain that may be used for food or feed. This issue was also addressed 
in the DEIS in Issue 7. Both of these documents described how APHIS has 
addressed these occurrences in the past, and how the Agency intends to 
address them in the future. We are proposing to amend the current 
regulations to explicitly incorporate APHIS' low level presence policy.
    As described in the DEIS, APHIS proposes to establish criteria 
under which the occurrence of a low level presence (LLP) of GE plant 
materials in seeds or grain may not be cause for agency remedial 
action. APHIS would still retain discretion to order corrective or 
remedial actions in situations that meet the non-actionable criteria, 
when the Administrator determines remedial action is needed to make the 
LLP unlikely to result in the introduction or dissemination of a plant 
pest or noxious weed. We propose to list criteria and describe possible 
enforcement actions in the regulations to improve transparency 
regarding how APHIS would respond to LLP in most instances. APHIS will 
not predetermine a specific level that is considered non-actionable as 
far as taking some remedial and/or enforcement action because this 
determination should always be made case-by-case. These criteria are 
intended to apply only to APHIS' decision to take or order remedial 
action in the event that LLP occurs. The proposed criteria are listed 
within the section describing the Administrator's ability to take or 
order remedial actions. Regardless of whether APHIS considers the LLP 
actionable with regard to remediation, any violations of the 
regulations or permit conditions could still result in any of the 
compliance and enforcement actions listed in the regulations, including 
imposing civil penalties.
    APHIS is proposing a new provision in the regulations that would 
reflect the current policy cited above. The provision describes the 
criteria APHIS will use when determining that a LLP event would be non-
actionable with regard to remediation, namely when the criteria support 
a conclusion that the

[[Page 60026]]

LLP is unlikely to result in the introduction or dissemination of a 
plant pest or noxious weed. Because the criteria are safety-based, they 
will be used for incidents of low level presence originating 
domestically (e.g., from field testing) as well as any low level 
presence that might be detected in import shipments that may contain 
organisms subject to regulation.
    APHIS also considered two additional criteria, which we have not 
adopted in the proposed rule. First, we considered a criterion that 
would require that the genetic material be introduced into the plant 
using a method that has been demonstrated to result in integration of 
the new sequences into the plant genome, as defined in Sec.  340.1. We 
did not include this criterion in our proposal because its relevance in 
the LLP context is unclear. A second criterion considered was that the 
genetic material engineered into the GE plant does not encode 
substances with whose function APHIS is unfamiliar. APHIS did not adopt 
this criterion since it is redundant with the proposed criteria that 
will be used, i.e., that the function of the introduced genetic 
sequences is known and that key food safety issues have been addressed.
    The DEIS, in Issue 7, Alternative 3, proposed that APHIS would also 
consider the LLP safety criteria when deciding whether to issue a 
permit for environmental release, and what type and severity of permit 
conditions to assign to the release permit. In its evaluation of permit 
applications, APHIS does plan to refer to the LLP criteria, as 
described above.

F. Administrative Changes

1. Confidential Business Information
    APHIS is proposing a new Sec.  340.8 to provide further guidance on 
the manner in which confidential business information (CBI) will be 
addressed in the implementation of these regulations. This change will 
support the overall administration of the program. The proposed Sec.  
340.8 cites the relevance of the Freedom of Information Act (FOIA) and 
exemptions from releasing information pursuant to FOIA, namely, 5 
U.S.C. 552(b)(4), and states that APHIS may exempt from disclosure to 
the public trade secrets and commercial or financial information 
obtained from a person that are privileged or confidential. Proposed 
Sec.  340.8 also states how persons wishing to protect confidential 
business information should communicate with APHIS in permit 
applications, petitions, or other submissions to APHIS.
2. Time Frames for APHIS Action on Permit Applications and Petitions
    Current regulations specify time frames within which APHIS must 
take certain actions, such as issuing permits, acknowledging 
notifications or issuing decisions on petitions to grant nonregulated 
status. APHIS experience in the last several years has shown that the 
time required to complete these actions has increased beyond the time 
frames originally stipulated in the regulations in 1987 (permits) and 
1993 (petitions for nonregulated status). As stated in the current 
regulation, APHIS is obligated to give its reply in the stipulated 
time, even if required procedures are not yet complete. Therefore, 
APHIS proposes to include in Sec.  340.2(d) of the regulations a 
statement that APHIS will generally respond in the time frames 
indicated. APHIS believes it is important to continue to meet the 
indicated time frames whenever possible, but the most important thing 
is to communicate the actual status of reviews and procedures with 
applicants rather than be obligated to reach a decision in a certain 
number of days despite the complexities involved with a review. APHIS 
is particularly seeking comment on this proposed change from persons 
with experience under the current time frames.
3. Duration Period for Permits
    Under the current regulations, notifications for environmental 
release and interstate movement are valid for one year, and the 
duration period for a permit issued for an environmental release is not 
specified. Currently interstate movement permits are only valid for one 
year from the date of issuance, and a new import permit must be 
obtained for each imported shipment.
    APHIS will continue to retain the flexibility of the permitting 
procedure to authorize environmental release permits that can be 
effective for any appropriate time period. In some cases, it may be 
most efficient to authorize environmental release permits that are 
valid for more than a single year. In such cases, APHIS can retain 
adequate oversight by performing periodic inspections and requiring 
periodic reports. Experience has revealed situations where field tests 
lasting more than one year are essential. For example, some 
environmental releases of GE fruit trees may take several years to 
evaluate the fruit production that often does not begin for several 
years after planting.
    In order to provide greater flexibility and efficiency, APHIS is 
also proposing to eliminate the current restrictions in the regulation 
on the duration of permits for interstate movement and importation. The 
proposed regulations will remove the requirements that interstate 
movement permits are only valid for one year from the date of issuance, 
and that importation permits must be obtained for each individual 
importation. These changes should give APHIS the flexibility to issue 
these permits with suitable durations to meet the individual 
circumstances.

G. Definitions and Miscellaneous Changes

    APHIS proposes to change certain definitions in Sec.  340.1 of the 
regulations, to add certain new definitions, and to remove definitions 
for terms that are defined in the PPA or that no longer appear in the 
regulations.
Revised Definitions
    APHIS proposes to change the definitions of the following terms in 
Sec.  340.1:
    Release into the environment would read ``Dispersal beyond the 
constraints of a contained facility or secure shipment. Synonymous with 
the term environmental release.''
    Secure shipment is a new term defined below. By adding reference to 
secure shipment in this definition, we clarify the distinction between 
environmental release and shipments for importation and interstate 
movement; any such movements which are not done by secure shipment 
constitute an environmental release.
    Responsible person would read ``The person who has control and will 
maintain control over a GE organism during its importation, interstate 
movement, or release into the environment and assures compliance with 
all conditions contained in any applicable permit or exemption as well 
as other requirements in this part. A responsible person shall be at 
least 18 years of age and be a legal resident of the United States or 
designate an agent who is at least 18 years of age and a legal resident 
of the United States.'' The change from the former definition is the 
addition of ``at least 18 years of age,'' added to prevent possible 
enforcement difficulties.
New Definitions
    APHIS proposes to add definitions of the following new terms:
    Confidential business information, CBI would read ``Information 
such as trade secrets or commercial or financial information that may 
be exempt from disclosure under Exemption 4 of the Freedom of 
Information Act (FOIA),

[[Page 60027]]

because disclosure could reasonably be expected to cause substantial 
competitive harm. USDA regulations on how the agency will handle CBI 
and how to determine what information may be exempt from disclosure 
under FOIA (5 U.S.C. 552) are found at 7 CFR Sec.  1.12.'' We propose 
to add this definition because APHIS has often been asked to clarify 
what is and is not CBI, and how it is handled. The definition describes 
typical types of CBI, and the language in proposed Sec.  340.8 
describes how persons submitting documents to APHIS can request that 
identified information be treated as CBI. There is also additional 
guidance on CBI contained in administrative guidance on the APHIS Web 
site regarding document preparation for part 340 requests. However, it 
is important to realize that in actual situations where someone submits 
a FOIA request for particular information, the APHIS FOIA Officer makes 
the ultimate determination as to whether particular information shall 
be released, in accordance with the standards of FOIA, Executive Order 
12600, and 7 CFR 1.12.
    Contingency plan would read ``A written plan stating how the 
responsible person will respond in the event of the unauthorized 
environmental release of GE organisms.'' We propose to define this new 
term to describe a document mentioned in both the permit application 
information requirements section (Sec.  340.2(c)) and the permit 
conditions section (Sec.  340.3).
    Exempt, exempted, exemption would read ``A determination by the 
Administrator that the importation, interstate movement, and/or release 
into the environment of an organism or class of organisms described in 
Sec.  340.0(a) is not subject to the requirement to have a permit under 
this part. An exemption from one type of permit (e.g., interstate 
movement) does not remove remaining obligations to obtain other permits 
under this part.'' We propose to add this definition for the term 
exemption to refer to situations where a regulated movement is exempt 
from the requirement for a permit. The proposed definition is based on 
language in Sec. 411(b)(1) of the PPA (7 U.S.C. 7711(c)), titled 
``Exception to permit requirement,'' which authorizes the Secretary to 
issue regulations to allow the movement of specified plant pests 
without further restriction if the Secretary finds that a permit is not 
necessary.
    Noxious weed would read ``Any plant or plant product that can 
directly or indirectly injure or cause damage to crops (including 
nursery stock or plant products), livestock, poultry, or other 
interests of agriculture, irrigation, navigation, the natural resources 
of the United States, the public health, or the environment.'' This is 
the definition for noxious weed found in the PPA.
    Recipient organism would read ``The organism that will receive the 
genetic material from a donor organism in the process of genetic 
engineering (once the organism is engineered it is referred to as the 
genetically engineered (GE) organism).'' This definition is needed to 
properly distinguish organisms and their traits in comparisons of GE 
organisms to the same organisms prior to transformation.
    State or tribal regulatory official would read ``State or tribal 
official with responsibilities for plant health, or any other duly 
designated State or tribal official, in the State or on the tribal 
lands where the importation, interstate movement, or release into the 
environment is to take place.'' This term is used in reference to 
consultations with States and tribes under the regulations.
    Secure shipment would read ``Shipment in a container or a means of 
conveyance of sufficient strength and integrity to withstand leakage of 
contents, shocks, pressure changes, and other conditions incident to 
ordinary handling in transportation.''
    We propose to add the following two definitions to make it clear 
that, when the Administrator authorizes it, a signature required under 
the regulations may be an electronic signature and a written document 
required under the regulations (e.g., a permit application) may be an 
electronic document.
    Signature, signed would read ``The discrete, verifiable symbol of 
an individual which, when affixed to a writing with the knowledge and 
consent of the individual, indicates a present intention to 
authenticate the writing. This includes electronic signatures when 
authorized by the Administrator.''
    Write, writing, written would read ``Any document or communication 
required by this part to be in writing may also be provided by 
electronic communication when authorized by the Administrator.''
Deletion of Definitions
    We propose to remove the following definitions from the 
regulations: courtesy permit, expression vector, introduce or 
introduction, regulated article, stably integrated, vector or vector 
agent, and well-characterized and contains only non-coding regulatory 
regions.
    These definitions would be removed because the terms would no 
longer be used in the regulations. We propose to eliminate the term 
regulated article partly because the use of the term ``article'' in 
current part 340 is not consistent with usage in the PPA, which uses 
the term article to mean ``any material or tangible object that could 
harbor plant pests or noxious weeds''--that is, things like packing 
materials, shipping containers, commodities, etc.--and not a plant pest 
or noxious weed itself. Under the current regulation, however, 
regulated article refers exclusively to certain GE organisms. 
Furthermore, under both the PPA and part 340, ``articles'' are not 
regulated, but rather their importation, interstate movement or 
environmental release is regulated. For these reasons, the term 
``regulated article'' in the current regulations is both inconsistent 
with the terminology of the PPA and difficult for the public to 
comprehend.
    We also propose to remove the definition for introduction. APHIS 
currently uses the term in part 340 to denote certain kinds of 
activities that fall within the scope of the regulation, namely 
importation, interstate movement, and release into the environment. The 
PPA, however, does not specifically define the term introduction. 
Therefore, to avoid confusion, instead of using the term introduction 
to define the different types of regulated activities, APHIS will 
instead refer to these specific activities themselves in the 
regulations, namely, the importation, interstate movement and release 
into the environment.
Miscellaneous Changes
    We also propose to make minor miscellaneous changes to the 
regulations to improve their clarity and remove redundancies. For 
example, in addition to adding the definition for CBI discussed above, 
we are consolidating requirements concerning CBI, formerly contained in 
several sections of the regulations, into proposed Sec.  340.8.

IV. Required Analyses

A. National Environmental Policy Act

    On January 23, 2004 (69 FR 3271), APHIS published a notice of 
intent to prepare a draft environmental impact statement (DEIS) in 
accordance with the National Environmental Policy Act in connection 
with the regulations at 7 CFR part 340 and potential changes to those 
regulations. This notice identified potential issues and alternatives 
to be studied and requested public comment to shape the scope of the 
DEIS.
    On July 17, 2007, APHIS published the DEIS evaluating regulatory 
alternatives under consideration and solicited public comment on the 
DEIS

[[Page 60028]]

(72 FR 39021-39025). The Environmental Protection Agency published a 
separate notice on July 13, 2007, soliciting public comment on the DEIS 
(72 FR 38576-38577). The notices sought comments on the quality of our 
analysis of potential environmental effects of the alternatives under 
consideration, and also sought views on how each alternative would 
affect areas such as the overall effectiveness of our biotechnology 
program, its operational efficiency, industry compliance issues, or 
other issues that would be associated with the implementation of an 
alternative.
    The major elements of this proposed rule were accurately described 
in the alternatives contained in the DEIS and their potential 
environmental effects were analyzed in the DEIS. Table 4 below provides 
a comparison between the proposed changes to part 340 and the DEIS. We 
received numerous comments on the DEIS, which will be discussed fully 
when we publish a final environmental impact statement (FEIS). The DEIS 
and the comments on it were used by APHIS to inform decision makers and 
aid the design of this proposal. Information from the DEIS comments, 
along with information from many other sources, including certain 
provisions of the 2008 Farm Bill and recommendations from USDA's OIG, 
was used to inform the drafters of this proposed rule about the issues 
perceived to be involved in and addressed by the rulemaking. We will 
respond to all DEIS comments in detail in the FEIS since the agency 
action (revising the regulations in part 340) is still subject to 
change based on comments and information received on this proposed 
rule, and thus we cannot provide definitive and final comment responses 
until we issue the FEIS and the final rule.
    Consideration of the DEIS comments led APHIS to refine and 
reorganize some of the regulatory alternatives it considered. 
Therefore, the presentation and discussion of the alternatives proposed 
in this proposal do not exactly match those described in the DEIS. The 
differences are primarily a matter of reorganizing and realigning some 
material and their corresponding regulatory alternatives, using more 
descriptive terms in some criteria listed in the alternatives, and 
choosing between regulatory alternatives that fall within the analysis 
of the DEIS. Accordingly, the DEIS is still consistent and applicable 
as an analysis of the potential environmental effects of the proposed 
action. However, we are interested in receiving comments on whether any 
of the proposed regulatory alternatives in this document do not appear 
to have been adequately addressed within the DEIS.

Table 4--Summary of Proposed Changes to the Regulations and Relationship
                                 to DEIS
------------------------------------------------------------------------
   Summary of proposed substantive
      changes to the regulation        DEIS issue     DEIS alternative
------------------------------------------------------------------------
Redescription of which GE organisms             1   2 (DEIS preferred
 are subject to the regulations.                     alternative) or 3.
Deletion of the list of plant pest    ............  ....................
 taxa in the regulations and the
 petition procedure to amend the
 list.
Clarification that APHIS has the                5   2 (DEIS preferred
 authority to regulate nonliving                     alternative).
 materials through permit conditions
 in cases where such materials may
 pose a risk as a noxious weed.
Revision of the application           ............  ....................
 information requirements and permit
 conditions for all permit types.
Elimination of the current                      2   4 (DEIS preferred
 notification procedure for                          alternative).
 importation, interstate movement,
 and release into the environment of
 certain types of GE plants
 (permitting procedure will be used
 instead).
Revision of the permitting system               2   4 (DEIS preferred
 for environmental releases:                         alternative).
     Subdivision into 5                 4   2 (DEIS preferred
     categories of permits for                       alternative).
     environmental releases (4 for
     GE plants, 1 for other GE
     organisms).
     Continue strict permit             6   1 (No action
     conditions for environmental                    alternative).
     releases of GE plants
     engineered to produce compounds
     intended for pharmaceutical or
     industrial uses.
Continued use of permits with         ............  ....................
 appropriate conditions for single
 or multiple year releases.
Creation of new administrative        ............  ....................
 procedures in permitting: (1) The
 explicit agreement of the
 responsible person to comply with
 regulatory requirements of the
 permit, (2) amendment of existing
 permit conditions, (3) transfer of
 permits to a different responsible
 person, and (4) revocation of a
 permit.
Elimination of the prescribed                  10   2 (DEIS preferred
 shipping container provisions in                    alternative).
 favor of a performance based
 approach specified as permit
 conditions for importation and
 interstate movement.
Revision of the existing conditional  ............  ....................
 exemptions for interstate movement
 such that the shipping standard is
 part of the exemption. Addition of
 a recordkeeping requirement for
 persons using the existing
 conditional exemptions.
Elimination of the option for APHIS   ............  ....................
 to issue courtesy permits for
 importation, interstate movement,
 and environmental release of GE
 organisms which are not subject to
 the regulation.
Creation of a petition procedure for            3   2 (DEIS preferred
 the Administrator to approve                   8    alternative).
 additional conditional exemptions                  1 (DEIS No Action
 from the requirement for a permit.                  alternative).
 This also includes a description of
 administrative steps if
 Administrator revokes an exemption,
 amends the conditions of an
 exemption, or prohibits a person
 from using a conditional exemption.
Clarification and revision of the     ............  ....................
 existing petition procedure for
 determining nonregulated status,
 including elimination of the
 procedure to extend a previous
 determination of nonregulated
 status, and a description of the
 administrative steps if
 Administrator revokes nonregulated
 status.
Clarification of the actions the      ............  ....................
 Administrator may take related to
 compliance, enforcement, and
 remediation.
Clarification of APHIS approach to              7   3 (DEIS preferred
 the low level presence of regulated                 alternative).
 GE plants in seed or grain.
Definition of Confidential Business   ............  ....................
 Information (CBI) and description
 of administrative practices for
 CBI.
------------------------------------------------------------------------


[[Page 60029]]

    We received approximately 23,000 comments on the DEIS, of which 
more than 22,000 were variations of several form letters. There were 
also several lengthy and detailed evaluations of environmental, 
scientific, legal, cultural, and economic issues raised by the DEIS. 
APHIS took all comments related to regulatory changes under 
consideration as we developed the content of this proposed rule, and 
altered a number of preliminary ideas for the proposal based on 
comments. We will fully summarize and address the comments received on 
the DEIS in a Final Environmental Impact Statement to be prepared in 
conjunction with the publication of a final rule. In addition to 
specific DEIS issues that were discussed above in the Preamble, the 
following section summarizes and discusses those comments on the DEIS 
that were most directly related to the regulatory alternatives 
discussed in this proposed rule and the ways in which these comments 
affected development of the proposal.
    Many DEIS commenters addressed how the regulations should use the 
PPA authorities regarding noxious weeds, plant pests, and biological 
control organisms. Most comments on the DEIS that addressed this issue 
stated that APHIS should expand the scope of its regulatory program 
beyond plant pests to include both noxious weeds and certain biological 
control organisms, consistent with all of the regulatory authorities of 
the PPA. The following opinions were expressed regarding PPA authority 
regarding noxious weeds and the meaning of the PPA definition of 
noxious weed.
    Very few commenters suggested that APHIS biotechnology regulations 
should implement the PPA's noxious weed definition in its broadest 
possible sense. One commenter suggested that APHIS broadly interpret 
the phrase ``other interests of agriculture,'' in the PPA definition of 
noxious weed such that APHIS would consider a plant to be a noxious 
weed if it poses solely economic harm, i.e., in the absence of physical 
harm. As explained previously in this proposal, such an interpretation 
is not consistent with the PPA, nor with the manner in which APHIS-PPQ 
has implemented the noxious weed program pursuant to the PPA. Many 
commenters suggested that APHIS needed clear regulations or policies to 
describe how it will be evaluating whether GE plants pose threats as 
noxious weeds. APHIS agrees and has framed this proposal to clarify the 
issue for the public.
    Some commenters stated that APHIS should acknowledge limits to its 
consideration of potential damage to public health in APHIS 
regulations, and the noxious weed definition should not be interpreted 
so broadly as to provide APHIS with the legal responsibility or 
authority to determine the food safety of GE crops or to prevent GE 
crops from entering the food supply. The commenters stated that 
Congress clearly intended the FDA to be responsible in this area.
    We agree, and this proposal acknowledges FDA authority in the food 
safety area. However, it is important that the regulatory procedures in 
each agency dovetail and support each other where agency mission areas 
come in contact. This proposal recognizes this need for mutual agency 
support. When a permit for environmental release, importation, or 
interstate movement of a new GE organism is submitted to APHIS, we 
would evaluate whether there are any signs that the environmental 
release, importation, or interstate movement of the organism could 
present risks to the public health. If APHIS is concerned that there 
may be food safety risks associated with the GE organism, we would 
contact FDA. The decision on whether or how to regulate food and feed 
from the GE organism to address food and feed safety risks would then 
be FDA's. On the other hand, it is also likely that existing food 
safety evaluations will prove to be useful and relevant to APHIS 
evaluations of a GE organism. Food safety concerns are one of several 
factors APHIS would take into account when considering, for example, 
what types of permit conditions are needed for the environmental 
release of a GE organism, or whether activities associated with the 
organism should qualify for an exemption from the permit requirement.
    Several commenters stated that under the current regulations APHIS 
has always considered noxious weed risk, or at least ``weediness.'' We 
agree that in practice, when APHIS assesses a GE plant it has always 
evaluated the potential weediness of the GE plant in relation to its 
plant pest potential. In the context of the PPA, ``weediness'' is more 
properly a noxious weed risk characteristic than a plant pest one, and 
the proposed revision of the regulations will more clearly align the 
regulations with the plant pest and noxious weed risk pursuant to the 
PPA. Current APHIS regulations and guidance directly address the 
importance of including weediness when evaluating risks associated with 
GE organisms. For example, when the petition procedure to grant 
nonregulated status was added to part 340 in 1993, the traits APHIS 
listed for evaluation explicitly included ``weediness of the regulated 
article'' (see current Sec.  340.6(c)(4)).
    Several DEIS commenters addressed what characteristics should 
trigger regulation of a GE organism, or put another way, how to set the 
scope of organisms subject to regulation. In the DEIS, APHIS explored 
many options including continuing to make its decisions primarily based 
upon the transformation event (also sometimes referred to as the 
individual transformed line, transgenic line or GE line). Some members 
of the public refer to this as an event-by-event approach. It is 
sometimes contrasted with a ``trait-based'' approach that focuses more 
on the resulting trait or phenotype of the GE organism. In a trait-
based approach, a regulatory decision for an organism engineered for 
one phenotype would apply equally to other GE organisms if they had the 
same phenotype or trait, regardless of whether they were engineered 
with the same genes. APHIS invited comment on the relative merits of 
the event-by-event approach and the trait-based approach. The current 
regulations do not limit APHIS to one approach or the other. Many 
readers equated ``event-by-event'' with a ``process-based'' system and 
likewise equated ``trait-based'' regulation with a ``product-based'' 
system. Thus many comments focused on the relative merits of a product-
based system versus a process-based system.
    Some suggested that the trigger be ``process-based'', i.e., the 
process of modifying the organism by recombinant DNA techniques would 
be the determinant. Others suggested the trigger be ``product-based'', 
i.e., the nature of the resulting product (organism) would be the 
determinant for whether the organism would be subject to the 
regulation. Many of the comments were not actually related to the basis 
for the trigger, but rather to the focus of the risk assessment, with 
most stating that the risk assessments should be based on the biology 
of the organism (product-based), not the technique by which it was made 
(process-based). One commenter believes that the process of genetic 
engineering is a useful trigger, but once regulated, the 
characteristics of the GE organism should dominate APHIS considerations 
of safety.
    Those supporting a process-based approach for identifying which 
organisms should be subject to regulation stated that each GE organism 
can have unintended as well as intended changes, and that these 
unintended changes to the organism would require that each individual 
resulting from genetic engineering must be assessed on a case-by-case 
basis.

[[Page 60030]]

Some commenters also suggested that this approach of APHIS assessment 
of each individual GE organism better protects the environment and 
human health than an approach that focuses primarily on the trait(s) of 
the GE organism.
    Some commenters against process-based approach stated that this 
approach is illogical, on the one hand, to regulate a plant species 
with no known risks only because GE techniques were used to modify it, 
whereas on the other hand the same plant species modified by other 
techniques faces no additional regulatory requirements from APHIS.
    Those supporting a product-based regulatory approach stated that it 
would be aligned with the preponderance of scientific opinion on the 
issue, that the characteristics of the organism should take precedence 
over the technique of genetic modification in the APHIS assessment of 
the organism. APHIS agrees that any evaluation of risk should be based 
on the biology of the product.
    Several commenters suggested that the definition of regulated 
article would have to be reexamined and possibly redefined to reflect 
changes in the PPA. Commenters also stated that the term regulated 
article was problematic whether linked to specific taxa in Sec.  340.2, 
under the current regulations, or linked to plants produced by 
particular technologies. These commenters emphasized that actions under 
the regulations usually amount to an investigation of whether an 
article (GE organism) needs to be regulated, and that predefining the 
subject of the investigation as a regulated article strongly implies 
that a decision has been made to require some regulatory oversight.
    The proposed elimination of the term ``regulated article'' would 
facilitate a clearer understanding that it is not the GE organism that 
is regulated, but rather the importation, interstate movement, or 
release into the environment of the GE organism.
    APHIS determined that eliminating ``introduction'' as a defined 
term would facilitate clearer understanding that the activities subject 
to the regulations are in fact importation, interstate movement, and 
release into the environment.
    In the DEIS, APHIS discussed the need to regulate nonliving 
products of GE organisms. The preferred alternative was to have a 
procedure to regulate non-viable material only in certain rare 
circumstances when it might pose a risk. Most of the DEIS comments 
addressing this issue agreed that APHIS should regulate nonviable GE 
plant material only in certain circumstances, based on the risks posed. 
The few comments that provided greater detail identified toxicity risks 
and possible persistence in the environment of toxic nonviable plant 
parts or debris as the most significant risk associated with nonliving 
GE products. A few commenters also stated that adding a clear 
definition of ``nonliving'' or ``nonviable'' would aid the regulations.
    APHIS has responded to these comments in this proposal by not 
usually regulating nonliving GE products, and by providing that when 
any control is needed over such a product that is associated with a 
living GE organism which is covered by a permit, due to toxicity or 
other risks, such controls would be included as permit conditions in 
permits issued for the associated living GE organism. We propose to 
provide for this by adding the following sentence to paragraph (b) of 
Sec.  340.3, Permit conditions: ``The Administrator may also assign 
permit conditions addressing nonliving materials associated with or 
derived from GE plants when such conditions are needed to make it 
unlikely that the nonliving materials would pose a noxious weed risk.''
    We received one DEIS comment directly addressing the issuance of 
courtesy permits. This comment supported retaining use of courtesy 
permits, and stated that courtesy permits facilitate the importation of 
GE Drosophila melanogaster strains by the research community and also 
ease the workload for APHIS. The continued issuance of courtesy permits 
diverts Agency resources unnecessarily from organisms that are within 
the scope of the regulations. We intend to help develop informational 
materials for the research community and other agencies that are aware 
of courtesy permits to clarify that such permits are not required, and 
to explain this to any persons who contact us requesting courtesy 
permits in the future.
    Several DEIS comments addressed the notification procedure and 
supported eliminating it. Some comments suggested that the types of 
organisms formerly eligible for the notification process should instead 
be handled through a two-tiered permitting process, with experimental 
permits for field trials and commercial permits for GE crops that are 
to be sold in commerce. Other comments suggested that while some 
organisms might require permits with minimal conditions rather than 
notifications, others with even lower risks could be exempted from 
permit requirements. These latter comments also generally suggested 
that some of the criteria in the current regulations used to determine 
eligibility for the notification process could be preserved in the new 
regulations as criteria to identify organisms that should be exempted 
from the requirement for a permit. One commenter stated that since the 
current ``notification'' process involves acknowledgment by APHIS and 
conditions as well as notification, changing to a system of low risk 
permits would be a de facto acknowledgment of the current process. To 
address these issues, APHIS is proposing to eliminate notifications and 
to handle regulated GE organisms that previously would have been 
eligible for notifications through a permitting procedure.
    We received a few comments on the DEIS generally related to 
procedures for reviewing permit applications. Comments stated that the 
role of States in reviewing or approving permit applications for GE 
crops has been very important and useful under the current regulations, 
and should continue in future regulations. Comments also stated the 
importance of scientific integrity in the review process, and 
emphasized the importance of coordinating with other agencies 
(particularly FDA and EPA review) when issues within their mission area 
arise during APHIS review of applications.
    The proposed changes to the permit application procedure address 
these concerns. States would have a continuing role in application 
review that is very similar to their existing role, and we have been 
increasing interactions with the relevant tribal authorities in recent 
years.
    Several comments were peripherally related to the DEIS issue of 
whether APHIS should establish standard or general permit conditions or 
what they should require. These comments emphasized that the purpose of 
permit conditions is to control risks not otherwise controlled, and 
that permit conditions must be developed in response to careful 
consideration of the risks presented by the particular permitted 
activity. One comment stated that APHIS should not require permit 
conditions that have the primary purpose of preventing crops from 
entering the food supply, because APHIS does not have the legal 
authority or scientific expertise to set them.
    We have taken these views into account in designing this proposed 
rule. Proposed Sec.  340.3 describes the core list of general 
conditions that APHIS would impose on all permits as well as additional 
conditions for specific types of permits. APHIS is also making it clear 
that APHIS may also add other specific

[[Page 60031]]

conditions to a permit upon its issuance. Conditions are specific 
practices or requirements that an applicant must follow upon issuance 
of a permit. Conditions are added as a consequence of the APHIS 
evaluation 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.
    Several DEIS comments stressed that APHIS needs to do more to 
ensure that the permit conditions it sets are actually followed and 
enforced. The changes to permit procedures proposed for Sec.  340.2 
contribute to that goal by obtaining written agreement from the 
responsible person that he or she, and all of their agents, must comply 
with all of the permit conditions before issuance of the permit.
    Almost all DEIS comments on containers or marking and identity for 
regulated articles supported performance standards for containers. Most 
of these commenters made the point that performance criteria are 
generally more adaptable and efficient than prescriptive criteria. Some 
stated that shipping research organisms interstate in enclosed 
containers is a low-risk activity that is very unlikely to result in 
release, establishment or harm.
    Some commenters stated that the type of container indicated by 
performance standards must be appropriate to the level of risk in the 
tiered permit system for the shipped GE organism. One commenter 
requested that APHIS make its container standards consistent with the 
International Air Transporters Association (IATA) requirements for 
shipping.
    The way this proposed rule deals with container standards is 
consistent with the above DEIS comments.
    Most of the commenters addressing tiered or categorized permit 
systems supported APHIS establishing a tiered permitting system for 
plants based on criteria that included risk and other GE organism 
characteristics. However, commenters also stressed that risk categories 
should be based on a trait by species approach, not on the basis of 
individual transformed plant line (referred to as ``event-by-event'' in 
some of the comments). Some commenters advised against using limited 
broad based categories that include many different species with 
different biologies and different risk factors. Several stated the 
importance of evaluating permit applications on a case-by-case basis, 
to avoid the risk that categorizing permit types could result in 
approval of risky releases that were inadvertently seen as ``routine 
categories.''
    Several commenters stated that a tiered permitting system should be 
flexible and allow consideration of any factors that seem relevant, or 
allow reclassification of a GE plant from one tier to another based on 
additional characterization information and agency familiarity with the 
GE plant. Some commenters opposed the development of a tiered risk-
based permitting system because each transformation event can have 
unintended effects that must be assessed on a case-by-case basis, 
rather than through predefined categories. We have addressed these 
views in this proposed rule by changing the permit tier system 
described in the DEIS to a proposed permit application categorization 
system that is more flexible than the system described in the DEIS.
    In the DEIS, 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 permitting procedure with its 
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 appropriate permit conditions 
that take into account the issues related to the public safety of 
proteins or other substances that these plants have been engineered to 
produce.
    Numerous commenters supported banning the outdoor production of 
pharmaceuticals and industrial substances in food and feed crops. Some 
stated that food crops should not be used for the production of 
pharmaceuticals and industrial substances.
    Some commenters stated that GE plants used for the production of 
pharmaceuticals and industrial substances should be evaluated by 
criteria that are different from those used to evaluate crops intended 
for food. Other commenters stated that if such GE industrial plants 
were made from food crop species, or could spread genes to food crop 
species, they should be evaluated based on food safety risk, not the 
industrial product's function, and approved only if they pose no food 
safety risks. However, with regard to evaluating food safety, several 
commenters also stated that FDA should be the agency evaluating these 
risks.
    We have not seen evidence suggesting that these types of organisms 
present unique or uncontrollable risks, or risks higher than those that 
may be associated with many other uses for GE plants. Our approach in 
this proposed rule addresses the other concerns cited by DEIS 
commenters.
    Many commenters were concerned that the outdoor cultivation of GE 
plants producing pharmaceutical and industrial compounds could be a 
source of gene flow to nearby non-GE plants or result in the co-
mingling of grain with related crop species intended for food or feed. 
Risks associated with this scenario may be abated by either of two 
means: (1) Preventing such gene flow or co-mingling from occurring, or 
(2) establishing that if such gene flow or co-mingling to other plants 
does occur, it does not present an unacceptable risk of introducing or 
disseminating a noxious weed.
    Such gene flow can be minimized or substantially prevented through 
permit conditions developed for environmental releases of GE 
pharmaceutical or industrial plants. In many cases the genetic and 
phenotypic characteristics of the organism also serves to discourage 
survivability of the plant away from the intended site as well as gene 
flow to other plants. During the review prior to permit issuance, APHIS 
would also always consider the effects if the GE plant were likely to 
spread widely, or if large-scale gene flow to other plants occurred. A 
permit for an environmental release would not be approved if APHIS 
concluded there was a likelihood of such events causing any of the 
types of harm as described in the noxious weed definition.
    One DEIS comment on the issue of multiple-year permits stated that 
compliance agreements should be used instead of actual multiple-year 
permits. Another suggested that multiple-year permits should be limited 
to trait/crop combinations not intended for feed or food use. In 
contrast, another comment stated that APHIS should consider allowing 
multi-year permits for any product, not just GE pharmaceutical or 
industrial plants.
    Several commenters stated a risk-based opposition to multi-year 
permits and stated that crops engineered to produce pharmaceuticals or 
industrial compounds should always be regulated under an annually-
reviewed permit system.
    This proposed rule addresses the risk-based concerns cited by 
commenters in the proposed processes for issuing permits and granting 
exemptions, discussed elsewhere in this document. We propose to allow 
multi-year permits for any type of regulated activity, when we 
determine that appropriate risk-related conditions can be prescribed 
for those activities. We have not seen any

[[Page 60032]]

convincing evidence, in DEIS comments or elsewhere, that limiting use 
of multi-year permits to certain types of organisms would reduce risk 
or otherwise serve the purpose of the regulations.
    Of the approximately 67 comments received by APHIS on the 
interstate movement exemptions discussion in the DEIS, 30 comments 
appear to support APHIS' preferred Alternative 2, under which APHIS 
would exempt from permit requirements for interstate movement a class 
of GE plants or organisms that are well-studied and present little or 
no environmental risk, as is currently done for Arabidopsis. However, 
many of these commenters suggested that APHIS choose an approach that 
combined this with one or more of the other Alternatives. Several 
commenters stated that the regulations should provide a procedure for 
APHIS to consider additional exemptions from interstate movement 
restrictions on a case-by-case basis.
    APHIS has concluded that the most appropriate proposal for the 
regulations at this time is to provide a clear and adaptable procedure 
whereby it would use a case-by-case approach to consider the merits of 
new exemptions from the requirement for a permit. The procedure, 
described in proposed Sec.  340.5, would allow for a transparent 
procedure in which APHIS would evaluate the proposed exemption, and the 
public would have an opportunity to review APHIS' evaluation and 
provide comments prior to APHIS decisions on individual cases. The 
proposed procedure should provide the benefit of transparency and 
scientific rigor while affording a more streamlined and cost-efficient 
procedure that would not require formal amendment of the regulations 
when each new exemption is approved.
    Several DEIS comments addressed what criteria in the regulations 
the Agency could use to determine the level of risk assessment applied 
to imported GE commodities which are viable propagules. They fell into 
two general groups. Both groups stated that any expedited review or 
exemption for GE commodity imports needed to be granted based on a 
review of risk and a determination that the importation presented no 
significant risks. Beyond that, one group emphasized that commodity 
imports were in general inherently safe, and such an expedited system 
would be appropriate and would also greatly facilitate international 
trade. The other group was skeptical about inherent safety of GE 
commodities and suggested that exemptions should only be offered when 
there are procedures ensuring that the commodities are made non-viable 
or safeguards are in place to ensure that propagation will not occur. 
Some comments in this group also stated that such exemptions should not 
be granted for a GE commodity from any country until APHIS has 
confidence that the country has robust regulatory guidelines and 
assessment standards with strong, reliable science and trustworthy 
regulatory oversight, equivalent in effectiveness to the U.S. system.
    One comment included a general statement that it was important that 
a petitioner for deregulation or exemption should work closely with 
APHIS to develop and evaluate the management plan under which the 
subject GE organism would be grown if deregulated or exempted. APHIS 
agrees that its regulatory approach should include working closely with 
petitioners on their proposals for exemption, especially if management 
plans are part of the requisite conditions. APHIS would retain some 
degree of oversight and could restrict movements of a GE organism such 
that the exemption and its conditions are unlikely to result in the 
introduction or dissemination of a plant pest or noxious weed. The 
proposed procedure to approve additional conditional exemptions is 
sufficiently adaptable even when the exemption is for all forms of 
movement (i.e., importation, interstate movement, and environmental 
release).
    Very few DEIS comments directly addressed enforcement and 
compliance. A few comments stated that APHIS regulatory oversight and 
enforcement of its regulations in the past have been insufficient and 
have provided inadequate containment of GE crops. This proposed rule 
would strengthen enforcement and compliance and enhance the 
effectiveness of the regulations.
    Comments on the discussion in the DEIS of low level presence ranged 
from suggestions that APHIS should completely prevent such incidents by 
banning all outdoor growth of GE plants to suggestions that LLP is a 
minor problem needing only minimal controls, and does not warrant an 
increased regulatory burden to control a minor risk. Some commenters 
stated that the preferred alternative in the DEIS accepted too high a 
level of risk. These commenters generally preferred DEIS alternative 4, 
which would impose very strict permit conditions on all environmental 
releases to reduce the likelihood of LLP events. Most commenters agreed 
that APHIS should adopt an LLP policy that recognizes the wide variety 
of risk levels associated with such incidents, and that beyond applying 
general criteria APHIS should investigate each unauthorized release 
individually and determine actions based on the facts surrounding each 
incident. Some commenters stated that any LLP policy should clearly 
state that even if an incident was found to be non-actionable (i.e., 
not requiring remedial action), persons involved would still be subject 
to enforcement actions such as civil penalties if violations of the 
regulations occurred.
    APHIS has considered all these views in the development of this 
proposed rule and has attempted to find a reasonable balance. It is not 
warranted, or practical, to implement a ``zero tolerance'' LLP policy. 
Instead, we propose a policy that each LLP incident would be 
individually investigated, and APHIS would then make a decision on 
whether, or what kind of, remedial action is needed. In making this 
determination APHIS would use established criteria to rate the risks 
involved in the LLP incident. However, these criteria would not fully 
determine the APHIS response. In addition to considering the criteria, 
APHIS would evaluate any other relevant information regarding the LLP 
incident and order remedial action if it appears necessary.
    Also, we propose to clearly state that regardless of whether APHIS 
considers the LLP actionable with regard to remediation, any violations 
of the regulations or permit conditions can still result in compliance 
and enforcement actions for failure to comply with the regulations.
    One DEIS comment directly addressed timelines for APHIS to perform 
permit- and petition-related activities and urged APHIS to continue to 
define specific timelines for regulatory reviews to allow for a 
predictable regulatory review system. The comment stated that time 
frames are especially critical for field trial permitting activities 
since planting occurs during a narrow window each year and a delay of a 
month or two in a regulatory decision can result in a year delay due to 
the inability to timely plant a field trial.
    We understand the concerns, and have decided to keep the time 
frames in the text of the regulations. However, as discussed above, 
APHIS will view them as performance goals and will generally respond in 
the time frames indicated, rather than be obligated to respond at those 
times. In recent years, there has been an increase in the time required 
for APHIS review due to the increasing complexity of issues related to 
environmental effects, new traits, and unfamiliar species. In addition 
to

[[Page 60033]]

retaining general time frames in the regulations, APHIS intends to 
discuss time frames with each applicant early in the application 
process, and to the extent possible give the applicant reliable time 
estimates based on the nature and complexity of the particular 
application and current APHIS activities and resources that are 
expected to affect the application review.

B. Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been reviewed under Executive Order 12866. 
The rule has been determined to be significant for the purposes of 
Executive Order 12866 and, therefore, has been reviewed by the Office 
of Management and Budget.
    We have prepared an economic analysis for this proposed rule, which 
is summarized below. Copies of the full economic analysis are available 
by contacting the person listed under FOR FURTHER INFORMATION CONTACT 
or on the Regulations.gov Web site (see ADDRESSES above for 
instructions for accessing Regulations.gov). The analysis provides a 
cost-benefit analysis, as required by Executive Order 12866, and an 
analysis of the potential economic effects of this final rule on small 
entities, as required by the Regulatory Flexibility Act.
Background
    The adoption of genetically engineered (GE) crops by farmers 
worldwide has become increasingly widespread. The United States, 
Argentina, Brazil, Canada, and China are the major GE crop adopters. In 
2008, 92 percent of soybean, 80 percent of corn, and 86 percent of 
cotton acreages planted in the United States were genetically 
engineered (USDA NASS, 2008). In addition to the major field crops, GE 
varieties of papaya, yellow squash, and zucchini were available for 
commercial production in 2008.
    Worldwide plantings of transgenic crops grew by 12 percent in 2007, 
reaching 282.4 million acres in 23 countries growing biotech crops in 
2007, including 12 developing countries. Over the next decade, use of 
these ``first-generation'' GE crops, which carry traits such as insect 
resistance and herbicide tolerance, should continue to grow while a 
second generation of crops promises new applications and traits such as 
improved drought tolerance, biofuel-related enhancements, and quality 
and nutritional traits.\3\
---------------------------------------------------------------------------

    \3\ Global Status of Commercialized Biotech/GM Crops, ISAAA 
Briefs 37-2007, 35-2006, The International Service for the 
Acquisition of Agri-Biotech Applications, Cornell University.
---------------------------------------------------------------------------

    The benefits associated with the use of some GE crops already in 
production include higher yields, lower pesticide costs, and overall 
savings in management time. There are also environmental benefits from 
reduced pesticide use. Attempts have been made to quantify the benefits 
that have occurred as a result of the adoption of GE crops and, 
according to a recent survey, farm-level net economic benefits 
worldwide from the adoption of GE crops were estimated to be $7 billion 
in 2006 (Brookes and Barfoot 2008). Total net benefits, 1996-2006, were 
estimated to be $34 billion. Of this total estimated net welfare gains, 
the United States experienced the largest benefit, with $15.8 billion; 
followed by Argentina, $6.6 billion; China, $5.8 billion; and Brazil, 
$1.9 billion (Brookes and Barfoot 2008). U.S. farmers' welfare gains 
from the adoption of biotechnology ranged from 29 to 42 percent of 
total net welfare gains (Price et al. 2005; Falck-Zepeda, Traxler, and 
Nelson 2000).
    The high rate of GE crop adoption by farmers has been driven by an 
increase in consumption of product developed with the use of GE 
techniques. However, studies that quantify consumers' benefits from the 
use of biotechnology are limited, as most studies tend to focus on the 
direct adopters of biotechnology, i.e., the producers. Price et al. 
(2006) found consumers do benefit from the adoption of Bt cotton.
    Overall, consumers' gains from the adoption of various GE crops 
have been estimated to range from 4 to 17 percent of total net welfare 
gains (Price et al. 2005; Falck-Zepeda, Traxler, and Nelson 2000).
    Crop producers and consumers are not the only beneficiaries of 
recent advances in biotechnology. The providers of biotechnology have 
also benefited from the increased adoption of GE products. Intellectual 
property right laws have offered incentives for the private sector to 
invest in research and development of GE products, and as a result, 
plant breeding expenditures have largely shifted from the public to the 
private sector (Fuglie 2006). As private research spending has 
increased, so has the number of firms engaged in this type of research. 
However, consolidation and mergers during the 1990's resulted in an 
industry dominated by large companies. Currently, 80 percent of biotech 
traits that have been approved are owned or co-owned by four firms 
(Bayer Crop Science, DuPont, Monsanto, and Syngenta) or their 
subsidiaries (Kalaitzandonakes, Alston, and Bradford 2007).
    With regard to the beneficial effects for the environment of GE 
plants in commercial production, their production has resulted since 
1996 in decreases in the use of pesticides by 286 million kg and in the 
use of herbicides by 51 million kg (Brookes and Barfoot 2008). These 
declines represent 7.9 percent reductions. In terms of greenhouse 
gases, one study estimated cultivation using no-tillage systems 
associated with GE crops modified for herbicide tolerance to reduce 
fuel use by 32.52 liters/ha (89 percent) compared to conventional 
methods, and 14.7 liters/ha (76 percent) compared to reduced tillage 
methods (Jasa 2002). An American Soybean Association survey \4\ showed 
significant reductions in tillage, and therefore in fuel use, by 
growers of glyphosate-tolerant soybeans. The fuel reductions were 
estimated as 1.26 gallons per acre, or, for the 56 million acres of 
glyphosate-tolerant soybeans planted in 2001, 70 million gallons of 
fuel saved and associated greenhouse gas emissions avoided. These fuel-
use reductions translate into reductions of carbon dioxide emissions of 
89.44 kg/ha and 40.43 kg/ha, respectively. Overall in 2006, the total 
carbon dioxide savings associated with the use of GE crops were 1.2 
billion kg. This is equivalent to removing 540,000 cars from the 
streets for a year.
---------------------------------------------------------------------------

    \4\ Cited in Fawcett, Richard and Towery, Dan. Conservation 
Tillage and Plant Biotechnology: How New Technologies Can Improve 
the Environment By Reducing the Need to Plow. Conservation 
Technology Information Center, West Lafayette, Indiana.
---------------------------------------------------------------------------

Benefits of the Proposed Rule
    The proposed rule would provide benefits by establishing more 
efficient regulation of GE organisms and activities subject to part 340 
and by continuing to provide a high level of protection against risks 
associated with these organisms and activities. Benefits would also 
include improved public understanding of and confidence in APHIS' 
biotechnology regulatory responsibilities, and improved clarity and 
transparency of the regulatory process. Several amendments of the 
proposed rule would improve the efficiency of APHIS' biotech regulatory 
process. Particular proposed changes that should improve the efficiency 
of the regulations include the elimination of courtesy permits and the 
establishment of a procedure to evaluate and grant requests for new 
exemptions from the requirement that GE organisms have a permit to be 
imported, moved interstate, or released into the environment.
    Approving new exemptions could be done without amending the 
regulations, resulting in considerable time savings

[[Page 60034]]

for regulated parties and reducing APHIS' rulemaking costs. Persons 
using an exemption would also avoid the costs and delays associated 
with obtaining a permit for each new planned movement or release of a 
GE organism covered by the exemption.
    APHIS commits considerable resources to issuing courtesy permits 
not actually required by or needed to implement the part 340 
regulations. These courtesy permits have been issued to facilitate the 
movement of GE organisms that are but whose movement may be hindered 
due to their similarity to organisms that are subject to part 340. By 
improving public awareness that such organisms do not need a permit and 
eliminating the courtesy permit process APHIS would improve efficiency 
and reduce its regulatory workload, and save time for regulated 
entities who would no longer make unnecessary courtesy permit requests.
    The Agency currently issues environmental release permits, 
including permits that are used for production of pharmaceutical and 
industrial compounds sold in commerce. In general, permits for releases 
of plants producing pharmaceutical or industrial compounds have been 
limited to a one-year duration. However, the proposed regulations 
provide a more useful and efficient approach to setting appropriate 
risk-related conditions in multi-year environmental release permits. 
Under the proposed system, APHIS would likely increase issuance of 
multi-year environmental release permits, thereby reducing the time the 
regulated entities need to spend submitting applications as well as the 
time APHIS spends reviewing the permit applications.
    APHIS' biotechnology operations would be aided by more clarity in 
terms of required data submissions and administrative procedures. More 
detail is provided regarding what applicant information is required for 
each permit application type, and how application information relates 
to the proposed new permit categories for environmental release 
permits. These changes, along with more clearly defined categories for 
the environmental release permits, would potentially reduce the time 
some entities, large or small, spend on an application or petition 
process. Increased efficiency benefits may be most helpful to smaller 
companies and public sector entities, where GE research is generally 
conducted on a much smaller scale than that of large agri-business 
enterprises.
    The proposal includes provisions to require necessary recordkeeping 
and reporting but to fine-tune this burden through particularized 
permit conditions to require only what is needed to ensure regulatory 
compliance based on individual cases. This should contribute to greater 
efficiency.
    The proposed rule's greater clarity and transparency is expected to 
enhance the general public's perception of APHIS regulation in this 
area, with associated benefits from increased support of and compliance 
with the regulations.
    In addition to the information provided in the regulations, APHIS 
proposes to develop new guidance documents to assist in the preparation 
and submission of applications.
Costs of the Proposed Rule
    There are several cost areas associated with the proposed rule. 
Costs associated with the proposed rule that regulated entities would 
incur include costs of learning and adapting procedures to changed 
requirements, providing more or different information in permit 
applications, and additional recordkeeping for some entities. The 
additional recordkeeping burden is discussed below in the Paperwork 
Reduction Act section. Annual costs resulting from the additional 
recordkeeping may be estimated as the salary and associated costs for 
640 additional hours of recordkeeping divided among 160 respondents.
    Many provisions of the proposed regulations are revisions of the 
current regulations, and it is not expected that familiarization costs 
would be substantial. However, estimates of these costs are not 
available and therefore APHIS invites public comment on the costs the 
regulated community may incur with respect to rule familiarization and 
changes to their application systems.
    Costs to APHIS are currently incurred in the regulatory assessment 
and review of submitted materials. Because the new permit process is 
largely similar to the current process, it is expected that ongoing 
permit processing costs to APHIS would remain essentially unchanged. As 
a start-up cost to change the permit system to accommodate requirements 
of the proposed rule, APHIS may potentially incur a one-time additional 
cost of $500,000. However the current system is adaptable to the new 
regulations and it is not anticipated that there would be any 
efficiency loss during the transitional period. APHIS would also 
potentially incur incremental costs conducting outreach activities for 
the proposed rule, developing guidance documents to ensure that the 
regulated community is familiar with the requirements of the rule, and 
providing staff training that may be necessary. Because of the new 
definition of the scope of the regulations, APHIS may devote more 
resources to consultations with regulated parties if they request 
consultation to determine whether particular GE organisms are or are 
not subject to the regulations. Such consultation should decrease after 
the first year or two of implementation, as such determinations of 
regulated status accumulate and become the basis for guidance of 
general applicability.
Initial Regulatory Flexibility Analysis
    In accordance with the Regulatory Flexibility Act of 1980 (Pub. L. 
96-354), this analysis considers the economic impact of the proposed 
rule on small businesses, small organizations, and small governmental 
jurisdictions. Section 603 of the Act requires that the initial 
regulatory flexibility analysis (IRFA) be made available for public 
comments. This section addresses the IRFA requirements, as stated in 
Sections 603(b) and 603(c) of the Act.
Reasons Action Is Being Considered
    APHIS is taking action to amend 7 CFR part 340, which was 
promulgated in 1987 under the authority of the Federal Plant Pest Act 
of 1957 and the Plant Quarantine Act of 1912. These acts were 
subsequently subsumed within the Plant Protection Act (PPA) of 2000, 
and the proposed revisions would bring part 340 in alignment with this 
Act. Advances in biotechnology and accumulation of oversight experience 
by APHIS have also made it necessary to revise and update the 
regulations, and in addition, the 2008 Farm Bill (The Food, 
Conservation, and Energy Act of 2008) enacted most recently contains 
provisions that need to be incorporated into the proposed rule. The 
proposed changes would improve the regulatory process by providing 
greater transparency, flexibility, and efficiency.
Objective and Legal Basis for the Rule
    The objectives of this rule are to amend part 340 to provide 
consistency with the PPA authorities and to incorporate updates and 
improvements to provide a more efficient regulatory process while 
controlling potential risk to plant health and the environment. The PPA 
authorizes the Secretary of Agriculture to implement programs and 
policies designed to prevent the introduction and spread of plant pests 
and diseases. Specifically, the Secretary of Agriculture is given the 
authority under the PPA to prevent the importation or dissemination of 
plant pests and noxious weeds. To do so, the

[[Page 60035]]

Secretary may regulate the importation, interstate movement, and 
release into the environment of any plant, plant product, biological 
control organism, noxious weed, article, or means of conveyance that 
could potentially spread plant pests or noxious weeds.
Description and Estimate of the Number of Small Entities Regulated
    The proposed rule may affect a wide range of public and private 
biotechnology research facilities, GE crop and seed production, food 
processors, grain processors, and paper producers that fall into 
various categories of the North American Industry Classification System 
(NAICS). For the purpose of this analysis and following the Small 
Business Administration (SBA) guidelines, the potentially affected 
entities are classified within the following sectors: Agriculture, 
Forestry, Fishing and Hunting (Sector 11), Manufacturing (Sectors 31-
33), Wholesale Trade (Sector 42), Retail Trade (Sector 44 and 45), 
Transportation (Sectors 48 and 49), and Professional, Scientific and 
Technical Services (Sector 54).
    For the Agriculture, Forestry, Fishing and Hunting sector, the 
subsectors of Crop Production, Animal Production, Forestry and Logging, 
and Support Activities for Agriculture and Forestry are potentially 
affected by this rule. The proposed rule may affect a wide range of 
establishments in the Crop Production category. Establishments in this 
category are considered small by SBA standards if annual sales are not 
more than $0.75 million. According to the 2002 Census of Agriculture, 
97 percent of the farming businesses are considered small. Potentially 
affected crop-producing industries, with their NAICS codes in 
parentheses, are as follows: Soybean Farming (111110); Oilseed Farming 
(except soybean) (111120); Dry Pea and Bean Farming (111130); Wheat 
Farming (111140); Corn Farming (111150); Rice Farming (111160); Oilseed 
and Grain Combination Farming (111191); All Other Grain Farming 
(111199); Potato Farming (111211); Other Vegetable (except potato) and 
Melon Farming (111219); Orange Groves (111310); Citrus (except orange) 
Groves (111320); Apple Orchards (111331); Grape Vineyards (111332); 
Strawberry Farming (111333); Berry (except Strawberry) Farming 
(111334); Tree Nut Farming (111335); Fruit and Tree Nut Combination 
Farming (111336); Other Noncitrus Fruit Farming (111337); Mushroom 
Production (111411); Other Food Crops Grown Under Cover (111419); 
Nursery and Tree Production (111421); Floriculture Production (111422); 
Tobacco Farming (111910); Cotton Farming (111920); Sugarcane Farming 
(111930); Hay Farming (111940); Sugar Beet Farming (111950); Peanut 
Farming (111960); and All other Miscellaneous Crop Farming (111970).
    Some aspects of animal production may be affected because some GE 
plants are used for animal feeds and may have enhanced nutritional 
value or other benefits. In terms of animal production, potentially 
affected entities include ones within the following industries: Beef 
Cattle Ranching and Farming (NAICS 112111); Cattle Feedlots (NAICS 
112112); Hog and Pig Farming (NAICS 112210); Sheep Farming (NAICS 
112410); Goat Farming (NAICS 112420); and Apiculture (NAICS 112910). 
Except for Cattle Feedlots, entities in all of these industries are 
considered small by SBA standards if annual sales are not more than 
$0.75 million. Cattle Feedlot establishments are considered small by 
SBA standards if annual sales are not more than $2 million. According 
to the 2002 Census of Agriculture, 93 percent of Cattle Feedlot 
businesses, 99 percent of Beef Cattle Ranching and Farming businesses, 
81 percent of Hog and Pig Farming businesses, 99 percent of Sheep and 
Goat farming businesses, and 99 percent of Apiculture businesses are 
considered small.
    For the Forestry and Logging subsector the potentially affected 
establishments are classified within Timber Tract Operations (NAICS 
113110); Forest Nursery and Gathering of Forest Products (NAICS 
113210); and Logging (NAICS 113310). Establishments in the category of 
Timber Tract Operations and Forest Nursery and Gathering of Forest 
Products are considered small by SBA standards if annual sales are not 
more than $6.5 million and establishments in the category of Logging 
are considered small if employment is not more than 500. According to 
the 2002 Survey of Business Owners, 99 percent of establishments in the 
Logging category are considered small. Neither the Census of 
Agriculture nor the Economic Census tracks revenue for establishments 
classified within Timber Tract Operations and Forest Nursery and 
Gathering of Forest Products.
    In terms of Support Activities for Agriculture and Forestry, the 
potentially affected establishments are classified within Cotton 
Ginning (NAICS 11511); Soil Preparation, Planting, and Cultivating 
(NAICS 115112); Crop Harvesting (NAICS 115113); Postharvest Crop 
Activities (NAICS 115114); Farm Management Services (115116) Support 
Activities for Animal Production (NAICS 115210); and Support Activities 
for Forestry (NAICS 115310). Establishments in these categories are 
considered small by SBA standards if annual sales are not more than 
$6.5 million. However, neither the Census of Agriculture nor the 
Economic Census reports revenue for these establishments.
    Entities that may be directly affected by the proposed rule in the 
Manufacturing Sector are classified within Ethyl Alcohol Manufacturing 
(NAICS 325193); Pesticide and Other Agricultural Chemical Manufacturing 
(NAICS 325320); Pharmaceutical Preparation Manufacturing (NAICS 
325412); and Medicinal and Botanical Manufacturing (NAICS 325411). 
Establishments in the Ethyl Alcohol Manufacturing category are 
considered small if they employ not more than 1,000 persons and those 
in the category of Pesticide and Other Agricultural Chemical 
Manufacturing (NAICS 325320) are considered small if they employ not 
more than 500 persons. For both the Pharmaceutical Preparation 
Manufacturing (NAICS 325412); and Medicinal and Botanical Manufacturing 
(NAICS 325411) categories, establishments are considered small if they 
employ not more than 750 persons. According to the 2002 Economic 
Census, 98 percent of the establishments in the Chemical Manufacturing 
Sector had fewer than 500 employees and 99 percent had fewer than 1000. 
Therefore, businesses in the chemical manufacturing are predominantly 
small by SBA standards.
    In terms of Wholesale Trade, entities that would be potentially 
affected may be found in the following categories: Fresh Fruit and 
Vegetable Merchant Wholesalers (NAICS 424480); Other Grocery and 
Related Products Merchant Wholesalers (NAICS 424490); Grain and Field 
Bean Merchant Wholesalers (NAICS 424510); Other Farm Product Raw 
Material Merchant Wholesalers (NAICS 424590); Farm Supplies and 
Merchant Wholesalers (NAICS 424910); and Flower, Nursery Stock, and 
Florists' Supplies Merchant Wholesalers (NAICS 424930). Establishments 
in the above categories are considered small by SBA standards if they 
employ not more than 100 persons. According to the 2002 Survey of 
Business Owners, 97 percent of the establishments in this category 
employed fewer than 100 people and are considered small by SBA 
standards.
    Retail Trade, establishments that would be affected by the rules 
are in the following categories: Nursery and Garden Centers (NAICS 
444220); Supermarkets and Other Grocery Stores (NAICS 445110); Fruit 
and Vegetable

[[Page 60036]]

Markets (NAICS 445230); All Other Specialty Food Stores (NAICS 445299); 
Food (Health) Supplement Stores (NAICS 446191); Warehouse Clubs and 
Superstores (NAICS 452910); and Florist (NAICS 453110). Establishments 
in the Nursery and Garden Center, Fruit and Vegetable Markets, All 
other Specialty Food Stores, Food (Health) Supplement Stores; and 
Florist categories are considered small by SBA standards if annual 
sales are not more than $6.5 million. Supermarkets and Other Grocery 
Stores are considered small by SBA standards if annual sales are not 
more than $25 million. While the Economic Census reports total annual 
sales, the Census does not provide a breakdown of these establishments 
by revenue categories.
    In terms of the Transportation sector, the potentially affected 
entities are in the category Farm Product Warehousing and Storage 
(NAICS 493130). Establishments in this category are considered small by 
SBA standards if annual sales are not more than $23.5 million. However, 
the Economic Census reports only total revenue for all establishments 
in this category.
    In terms of Professional, Scientific and Technical Services, 
establishments in the category of Research and Development in the 
Physical, Engineering, and Life Sciences (NAICS 54170) may be affected. 
Establishments in this category are considered small by SBA standards 
if they employ not more than 500 persons. According to 2002 Economic 
Census, 82 percent of the establishments in this category are 
considered small.
    Although information was not available on the business sizes for 
all potentially affected establishments, based on the foregoing 
information we can assume that the majority of the entities that may be 
affected by the proposed rule are small by SBA standards.
    Given the aforementioned, a review of entities that have made 
application requests to APHIS shows that of the 420 applicants for the 
last 6 years, 263 were universities and colleges and public and private 
research institutions. The remainder of the applicants fall under 
various NAICS classification codes specified above but given time 
constraints their business size could not be readily determined. We 
were able to ascertain that the 263 institutions (63 percent) are large 
by SBA standards as they fall under NAICS code 54170 Research and 
Development in Physical Science. Establishments in this category are 
considered small by SBA standards if they employ not more than 500 
persons. Even though the 2002 Economic Census suggests that 82 percent 
of the establishments in this category are considered small, the 
majority of applicants to APHIS are large by SBA standards.\5\
---------------------------------------------------------------------------

    \5\ The size determination was made using public information 
about these entities. This information was primarily obtained from 
the entities' Web sites.
---------------------------------------------------------------------------

Description and Estimate of Compliance Requirement
    The proposed rule would require additional and modified information 
collections through recordkeeping, reporting, and notifications to 
APHIS when certain events occur. The proposed application process 
requires certain new information. The current and proposed rules both 
require submission of reports following an environmental release or 
field test, but the proposed requirement is more specific about the 
contents of such reports. Both the current and proposed rules require 
APHIS to be notified if an unauthorized release occurs or if during 
release the GE organism is found to have characteristics substantially 
different from those anticipated by the permit. The proposed rule is 
more specific about the types of records that must be kept for 
importations, interstate movements, and environmental releases, where 
the current regulations left more of these details to be specified only 
in permit conditions. In terms of record retention requirements, the 
proposed rule spells out a 2-year retention for records indicating that 
a GE organism imported or moved interstate reached its intended 
destination, and a 5-year retention for all other required records. By 
providing more specific information on what records are required, the 
proposed rule should alleviate some current burden that may result from 
persons keeping unnecessary records. In addition, APHIS has established 
the Biotechnology Quality Management System (BQMS), which is a 
voluntary compliance assistance unit within USDA APHIS. BQMS would 
facilitate the regulatory efforts of USDA APHIS by conducting outreach 
activities and providing compliance assistance to the regulated 
community. This would lessen any burden of the proposed rule to the 
regulated community.
Duplication, Overlap, and Conflict With Existing Rules and Regulations
    APHIS has identified areas where the proposed rule will need to be 
closely coordinated with other Federal rules and statutory authorities. 
Coordination has been an important aspect of the daily implementation 
of the current regulation, and APHIS foresees additional areas for 
coordination under the proposed rule. In particular, APHIS will 
coordinate with the Food and Drug Administration (FDA) and the 
Environmental Protection Agency (EPA). FDA regulates GE organisms under 
the authority of the Federal Food, Drug and Cosmetic Act and the Public 
Health Service Act (42 U.S.C. 262 et seq.), as appropriate. The EPA 
regulates plant-incorporated protectants under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) and certain biological control 
organisms under the Toxic Substances Control Act (TSCA). As examples of 
areas that need coordination, some of the plant-incorporated 
protectants regulated by EPA are also subject to APHIS requirements 
under the PPA. Also, FDA is the primary U.S. agency responsible for 
ensuring the safety of commercial food and food additives, and FDA 
authority extends to any nonpesticidal substance that may be introduced 
into a new GE plant and that is expected to become a component of food. 
The proposed regulations would clarify the regulatory scope and 
procedures used by APHIS relative to these other agencies and improve 
the coordination process.
Significant Alternatives to the Rule
    APHIS considered several significant alternatives during 
development of this proposed rule. We have compared the selected 
alternatives to others that were not selected to evaluate their 
feasibility and to consider whether any alternatives provide ways to 
minimize significant economic impacts on small entities. We have not 
identified any selected alternative that imposes disproportionate costs 
on small businesses, or any non-selected alternative that would both 
achieve the regulatory purposes and reduce costs for small businesses.
    The selected alternative regarding the scope of the regulatory 
oversight was to add considerations of noxious weed risk in addition to 
evaluating plant pest risks, and to use genetic transformation, coupled 
with a determination by the Administrator as to whether a GE organism 
met certain risk-based criteria, as the trigger for regulation. Other 
alternatives considered included continuing to base the scope of 
regulation only on plant pest risks, or trying to develop a set of 
solely trait-based criteria that could be used to predict what articles 
would be regulated without the need for determinations by the 
Administrator. The first of these alternatives could have resulted in 
costs from damages caused by a GE plant with

[[Page 60037]]

noxious weed aspects that was not regulated under the plant pest risks 
standard. The second alternative was not considered technically 
feasible, and could also have resulted in costs for persons who 
erroneously decide their GE plant is not within the scope of the 
regulations, but are overruled by a later determination by the 
Administrator that the GE plant is regulated.
    The selected alternative for providing transparency and 
predictability to the permitting system was to establish permit 
categories for environmental releases of plants based on newly devised 
criteria. We also considered evaluating all requests for environmental 
release permits on a case-by-case basis, without categories. This 
alternative would have resulted in less predictability for applicants, 
and likely would have increased their costs for information collection 
because applications known to be in a particular category can contain 
less information about non-relevant areas.
    The selected alternative regarding the duration period for permits 
was to make multi-year permits for interstate movement and importation 
more feasible by removing the one-year limit for interstate movement 
permits and the requirement to obtain a new importation permit for each 
imported shipment. We also considered alternatives to maintain either 
the current or alternative specific time limits for such permits. These 
alternatives would have resulted in additional costs for applicants who 
would have to reapply for permits, rather than having the original 
permit issued with an appropriate duration.

C. Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 7 CFR part 3015, subpart V.)

D. Executive Order 12988

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

E. Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
The information collection or recordkeeping requirements in current 7 
CFR part 340 have been approved under OMB Control No. 0579-0085. Please 
send written comments to the Office of Information and Regulatory 
Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503. 
Please state that your comments refer to Docket No. APHIS-2008-0023. 
Please send a copy of your comments to: (1) Docket No. APHIS-2008-0023, 
Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 
River Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance 
Officer, OCIO, USDA, room 404-W, 14th Street and Independence Avenue 
SW., Washington, DC 20250. A comment to OMB is best assured of having 
its full effect if OMB receives it within 30 days of publication of 
this proposed rule.
    This proposed rule contains certain information collection and 
recordkeeping requirements that would apply to persons and their agents 
engaged in the importation, interstate movement, or release into the 
environment of any GE organism that is subject to the regulations. The 
majority of the requirements would apply to persons moving GE organisms 
under a permit issued by APHIS, but some requirements also apply to 
persons engaged in regulatory activities with GE organisms even when no 
permit is required, e.g., when they are exempted from the interstate 
movement permit requirement.
    The proposed information and recordkeeping requirements are found 
in Sec.  340.3, Permit conditions, and in Sec.  340.7, Compliance, 
enforcement, and remedial action. Permit conditions for individual 
permits issued under the regulations may also require that certain 
records relevant to the particular movement must be kept.
    The proposed permit conditions for shipments imported or moved 
interstate include maintaining records of the same types of information 
that the current regulations require to be on the package labeling of 
such shipments (nature and quantity, sender, destination, permit 
number, etc.) We believe that most persons shipping or importing GE 
organisms already maintain such records as part of normal business 
practices.
    The proposed permit conditions for environmental releases include 
keeping records of all protocols or guidelines used to direct any 
environmental release. The current regulations already require persons 
conducting an environmental release under permit or notification to 
create and submit to APHIS a field test report, and in many cases the 
protocol or guidelines would normally be included in these field 
reports. This proposed change would require that the protocols or 
guidelines be kept in all cases as distinctly identifiable records, 
which may cause some increase in recordkeeping burden.
    In some particular environmental release cases where higher risk 
levels make it necessary, the proposed rule would allow APHIS to add a 
special permit condition requiring the permit holder to maintain and 
make available to APHIS written manuals or protocols describing how 
specified permit conditions will be met, such as management practices 
used for the environmental release, training, communications, and 
identity preservation systems. This would be used in cases where it is 
deemed necessary to provide specific guidance in addition to the 
proposed general condition for all permits (i.e., that the holder must 
keep records related to permitted activities of sufficient quality and 
completeness to demonstrate compliance with all permit conditions and 
requirements under this part). Another proposed permit condition would 
require permit holders to develop and keep a written contingency plan 
to respond to any unauthorized environmental release. Both of these 
recordkeeping requirements would be added because some researchers or 
developers were found to be unclear about what management and 
communications practices were needed to prevent unauthorized releases, 
and also about their responsibilities and the measures they must take 
in the event of an unauthorized release.
    The proposed procedure to apply for an environmental release permit 
requires applicants to submit a great deal of information 
characterizing the nature of the GE organism, the type of movement and 
release planned, plans and methods used to prevent unauthorized 
releases, and other matters. Most of the same information is obtained 
through the current application process, which allows the Administrator 
to require an applicant to submit any additional information that is 
needed for adequate evaluation of the application. The proposed 
application procedure is more specific in describing what information 
is required, and may result in a slight increase in the amount of 
information submitted with the average application.
    The reporting burden for permit holders under the proposed rule 
would be similar to the burden under the

[[Page 60038]]

current regulations. In both cases they must submit reports of all 
field tests to APHIS, report any unauthorized releases, and submit any 
additional reports required as individual permit conditions in their 
permits.
    The current regulations do not specify record retention periods, 
although some permits APHIS issued included specific retention 
requirements as permit conditions. This proposal would require that 
records associated with an importation or interstate shipment must be 
retained for at least 2 years after completion of the movement, and all 
other records (e.g., regarding environmental releases) must be retained 
for at least 5 years after completion of all obligations required under 
a relevant permit or exemption.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 2 hours per response.
    Respondents: Public and private biotechnology research facilities, 
GE crop and seed producers, food processors, grain processors, and 
paper producers that fall into various categories of the North American 
Industry Classification System.
    Estimated annual number of respondents: 160.
    Estimated annual number of responses per respondent: 2.
    Estimated annual number of responses: 320.
    Estimated total annual burden on respondents: 640 hours.
    Copies of this information collection can be obtained from Celeste 
Sickles, the Agency Information Management Specialist, at (301) 851-
2908.

F. E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the Internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this proposed rule, please contact Mrs. Celeste 
Sickles, the Agency Information Management Specialist, at (301) 851-
2908.

List of Subjects in 7 CFR Part 340

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

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

PART 340--IMPORTATION, INTERSTATE MOVEMENT, AND RELEASE INTO THE 
ENVIRONMENT OF CERTAIN GENETICALLY ENGINEERED ORGANISMS

Sec.
340.0 Scope and general restrictions.
340.1 Definitions.
340.2 Procedure for permits.
340.3 Permit conditions.
340.4 Conditional exemptions from the requirement for a permit for 
interstate movement.
340.5 Petition for new conditional exemptions from the requirement 
for a permit.
340.6 Petition for nonregulated status.
340.7 Compliance, enforcement, and remedial action.
340.8 Confidential business information.
340.9 Costs and charges.

    Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 
CFR 2.22, 2.80, and 371.3.


Sec.  340.0  Scope and general restrictions.

    (a) In order to prevent the unauthorized introduction or 
dissemination of a plant pest or noxious weed, no person shall import, 
move interstate, or release into the environment genetically engineered 
organisms described in paragraph (b) of this section, unless the 
importation, interstate movement, or release into the environment:
    (1) Is authorized under a permit issued by the Administrator in 
accordance with Sec.  340.2, or
    (2) Is exempt from the requirements for a permit in accordance with 
Sec.  340.4 or Sec.  340.5, or
    (3) Is approved for nonregulated status in accordance with Sec.  
340.6 or has previously been approved for nonregulated status pursuant 
to former regulations under this part, or
    (4) Is excluded in accordance with paragraph (d) of this section.
    (b) Genetically engineered organisms whose importation, interstate 
movement, or release into the environment is subject to the regulations 
in this part are:
    (1) 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.
    (2) 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.
    (3) Opportunity to consult APHIS. Any person may contact APHIS to 
discuss how the criteria of this paragraph apply in the case of a 
particular GE organism or group of organisms.
    (c) The Administrator may issue permits for the importation, 
interstate movement, or release into the environment of certain 
genetically engineered organisms described in paragraph (a) of this 
section. These permits may include such requirements or conditions as 
the Administrator deems necessary to prevent the unauthorized 
introduction or dissemination of a plant pest or noxious weed. The 
Administrator may also designate certain exemptions from the 
requirement to obtain permits. The Administrator may also approve for 
nonregulated status a genetically engineered organism described in 
paragraph (a) of this section for which a determination has been made 
by the Administrator that the organism is unlikely to be a plant pest 
or noxious weed.

[[Page 60039]]

    (d) Genetically engineered microorganisms that are regulated as 
biological control organisms under the Federal Insecticide, Fungicide, 
and Rodenticide Act are not subject to the regulations in this part. 
Genetically engineered microorganisms where the recipient microorganism 
is not a plant pest and which has resulted from the addition of genetic 
material from a donor organism where the material is well characterized 
and contains only non-coding regulatory regions are not subject to the 
regulations in this part.


Sec.  340.1  Definitions.

    Terms used in the singular form in this part shall be construed as 
the plural, and vice versa, as the case may demand. The following 
terms, when used in this part, shall be construed, respectively, to 
mean:
    Administrator. The Administrator of the Animal and Plant Health 
Inspection Service (APHIS) or any other employee of APHIS to whom 
authority has been, or may be, delegated to act in the Administrator's 
stead.
    Animal and Plant Health Inspection Service (APHIS). An agency of 
the United States Department of Agriculture.
    Confidential business information, CBI. Information such as trade 
secrets or commercial or financial information that may be exempt from 
disclosure under Exemption 4 of the Freedom of Information Act (FOIA), 
because disclosure could reasonably be expected to cause substantial 
competitive harm. USDA regulations on how the agency will handle CBI 
and how to determine what information may be exempt from disclosure 
under FOIA (5 U.S.C. 552) are found at 7 CFR 1.12.
    Contained facility, contained structure. A physical structure 
designed to minimize release into the outdoor environment. Examples of 
contained structures include, but are not limited to, laboratories, 
containment greenhouses, bioreactors, and fermenters.
    Contingency plan. A written plan stating how the responsible person 
will respond in the event of the unauthorized environmental release of 
GE organisms.
    Donor organism. The organism from which genetic material is 
obtained for transfer to the recipient organism in the process of 
genetic engineering.
    Environmental release. See definition of Release into the 
environment.
    Exempt, exempted, exemption from permit. A determination by the 
Administrator that the importation, interstate movement, and/or release 
into the environment of an organism or class of organisms described in 
Sec.  340.0(a) is not subject to the requirement to have a permit under 
this part. An exemption from one type of permit (e.g., interstate 
movement) does not remove remaining obligations to obtain other permits 
under this part.
    Genetic engineering. The genetic modification of organisms by 
recombinant DNA techniques.
    Genetically engineered, GE. A term applied to organisms that have 
been produced by genetic engineering, e.g., GE organisms, GE plants.
    Import and importation. To move into, or the act of movement into, 
the territorial limits of the United States.
    Inspector. Any employee of the Animal and Plant Health Inspection 
Service, U.S. Department of Agriculture, or other person, authorized by 
the Administrator, in accordance with law to enforce the provisions of 
this part.
    Interstate movement. Movement from any State into or through any 
other State.
    Means of conveyance. Any personal property used for, or intended 
for use for, the movement of any other personal property. This 
specifically includes, but is not limited to, automobiles, trucks, 
railway cars, aircraft, boats, freight containers, and other means of 
transportation.
    Nonregulated status. A determination by the Administrator that an 
organism described in Sec.  340.0(a) is not subject to any of the 
regulatory requirements of this part.
    Noxious weed. Any plant or plant product that can directly or 
indirectly injure or cause damage to crops (including nursery stock or 
plant products), livestock, poultry, or other interests of agriculture, 
irrigation, navigation, the natural resources of the United States, the 
public health, or the environment.
    Organism. Any active, infective, or dormant stage or life form of 
an entity characterized as living, including vertebrate and 
invertebrate animals, plants, bacteria, fungi, mycoplasmas, mycoplasma-
like organisms, as well as entities such as viroids, viruses, or any 
entity characterized as living, related to the foregoing.
    Permit. A written authorization by the Administrator for the 
importation, interstate movement, and/or release into the environment 
of a GE organism under this part.
    Person. Any individual, partnership, corporation, company, joint 
venture, society, association, or other legal entity.
    Plant. Any plant (including any plant part) for or capable of 
propagation, including trees, tissue cultures, plantlet cultures, 
pollen, shrubs, vines, cuttings, grafts, scions, buds, bulbs, roots, 
and seeds.
    Plant pest. Any living stage of any of the following that can 
directly or indirectly injure, cause damage to, or cause disease in any 
plant or plant product: A protozoan, a nonhuman animal, a parasitic 
plant, a bacterium, a fungus, a virus or viroid, an infectious agent or 
other pathogen, or any other living stage similar to or allied with any 
of these organisms.
    Plant product. Any flower, fruit, vegetable, root, bulb, seed, or 
other plant part that is not included in the definition of plant; or 
any manufactured or processed plant or plant part.
    Recipient organism. The organism that will receive the genetic 
material from a donor organism in the process of genetic engineering 
(once the organism is engineered it is referred to as the genetically 
engineered (GE) organism).
    Release into the environment. Dispersal beyond the constraints of a 
contained facility or secure shipment. Synonymous with the term 
environmental release.
    Responsible person. The person who has control and will maintain 
control over a GE organism during its importation, interstate movement, 
or release into the environment and assures compliance with all 
conditions contained in any applicable permit or exemption as well as 
other requirements in this part. A responsible person shall be at least 
18 years of age and be a legal resident of the United States or 
designate an agent who is at least 18 years of age and a legal resident 
of the United States.
    Secure shipment. Shipment in a container or a means of conveyance 
of sufficient strength and integrity to withstand leakage of contents, 
shocks, pressure changes, and other conditions incident to ordinary 
handling in transportation.
    Signature, signed. The discrete, verifiable symbol of an individual 
which, when affixed to a writing with the knowledge and consent of the 
individual, indicates a present intention to authenticate the writing. 
This includes electronic signatures when authorized by the 
Administrator.
    State. Any State of the United States, the District of Columbia, 
American Samoa, Guam, Northern Mariana Islands, Puerto Rico, the Virgin 
Islands of the United States, and any other Territories, Possessions, 
or Districts of the United States.
    State or tribal regulatory official. State or tribal official with 
responsibilities for plant health, or any other duly designated State 
or tribal official, in the

[[Page 60040]]

State or on the tribal lands where the importation, interstate 
movement, or release into the environment is to take place.
    United States. All of the States.
    Write, writing, written. Any document or communication required by 
this part to be in writing may also be provided by electronic 
communication when authorized by the Administrator.


Sec.  340.2  Procedure for permits.

    (a) General. A permit is required for the importation, interstate 
movement, or release into the environment of any GE organism that is 
subject to this part, as described in Sec.  340.0, The responsible 
person seeking a permit for the importation, interstate movement, or 
release into the environment of such organisms shall submit a written 
application for a permit to APHIS in accordance with paragraph (c) of 
this section and obtain the permit prior to the importation, interstate 
movement, or release into the environment.
    (b) Types of permits. The Administrator may issue the following 
three types of permits under this part.
    (1) Import permit. Import permits are for secure shipment via any 
means of conveyance from outside the United States into contained 
facilities within the United States.
    (2) Interstate movement permit. Interstate movement permits are for 
secure shipment via any means of conveyance from a contained facility 
in any State into or through any other State to another contained 
facility.
    (3) Environmental release permit. Environmental release permits are 
for the environmental release of GE organisms. In cases in which 
importation and interstate movements will occur incidental to an 
environmental release, the importation and interstate movements will 
also be authorized under the environmental release permit.
    (c) Permit application information requirements. Applicants must 
submit to APHIS sufficient information about the specific nature of the 
GE organism and the particular proposed permit conditions, so that the 
Administrator is able to consider whether the proposed importation, 
interstate movement, or release into the environment is likely to 
result in the introduction or dissemination of a plant pest or noxious 
weed. The basic information required in permit applications is 
described in this paragraph. The type and level of detail needed for 
the Administrator to issue a permit may vary by type of permit. For 
environmental releases, application information will be used to sort 
proposed releases of GE organisms into administrative categories 
described in paragraph (d) of this section. Applicants should consult 
with APHIS prior to applying for permits in order to obtain further 
guidance as to what additional information the Administrator may 
require to be submitted with the application.
    (1) Information required in all permit applications. Each 
application must include all of the following information, and any 
other information specified for individual types of permits as 
described in this paragraph:
    (i) The name, title, and contact information (e.g., mailing 
address, e-mail, telephone and fax numbers) of the responsible person;
    (ii) The type of permit sought (importation, interstate movement, 
or environmental release, and if the permit is for environmental 
release, which category);
    (iii) Information necessary to identify and characterize the GE 
organism(s) for which a permit is sought, including:
    (A) The scientific names of all donor and recipient species plus 
any designations used for the GE organism(s) (e.g., strain, line, 
variety);
    (B) The form of the GE organism (e.g., seeds, rootstocks, tubers, 
spores, larvae, eggs) and the amount (e.g., numbers, total weight or 
volume); and a description of any biological material accompanying the 
GE organism under permit (e.g., culture medium, or host organisms, 
etc.);
    (C) The anticipated phenotype of the GE organism and the nature of 
the inserted sequences or other genetic modification intended to confer 
the phenotype;
    (D) Intended uses of the GE organism after the termination of the 
importation, interstate movement, or environmental release (e.g., 
contained research in laboratories or containment greenhouses, 
culturing, propagation, breeding, processing for analysis or 
manufacture, sale and distribution for consumption); and
    (E) Description of how the GE organism will be marked, labeled, or 
otherwise identified during the importation, interstate movement, or 
environmental release;
    (iv) The proposed time frame (estimated start and duration) within 
which the importation(s), interstate movement(s) or environmental 
release(s) will occur;
    (v) Description of how permit requirements will be communicated to 
persons having contact with the GE organism under permit;
    (vi) Description of any training given to persons having contact 
with the GE organism under permit, including but not limited to 
detailed information on how this training will facilitate compliance 
with conditions imposed under the permit and any other regulatory 
requirements under this part; and
    (vii) A certification statement signed by the responsible person 
that certifies that the application information is correct.
    (2) Additional information required in all applications for 
importation permits, interstate movement permits, and all environmental 
release permits that include importation or interstate movement.
    (i) The location(s) of the origin(s) and destination(s), including 
information on the addresses, and contact details of the sender(s) and 
recipient(s), if different from the responsible person.
    (ii) A description of the method of secure shipment.
    (iii) A description of the manner in which packaging material, 
shipping containers, and any other material accompanying the GE 
organism will be disposed.
    (3) Additional information required in all environmental release 
permit applications. Information should address the persistence risk 
and potential harm of the GE organism in the environment, including but 
not limited to:
    (i) A description of how the phenotype of the GE organism differs 
from the phenotype of the recipient organism, particularly with respect 
to potential interactions with and its likelihood of persistence in the 
environment.
    (ii) The location and size of all proposed release sites, including 
area, geographic coordinates, addresses, and contact information of a 
person at each release site, if different from the responsible person. 
Include information about the ecology and agronomy of each site, 
including but not limited to:
    (A) Presence of any wild or cultivated species that are sexually 
compatible with the GE organism;
    (B) Presence of any Federally-listed threatened or endangered 
species that could interact with the GE organism during the release;
    (C) Presence of any designated critical habitat, or habitat 
proposed for designation, in the area of the release site; and
    (D) Land use history of the site and adjacent areas.
    (iii) A description of the site management practices and control 
procedures designed to make it unlikely that there will be unauthorized 
introduction or dissemination of the GE organism beyond the proposed 
area and

[[Page 60041]]

the permit time frame of release. Each of the descriptions shall 
include:
    (A) Description of the methods and stages of transport of the GE 
organism from a contained facility to the environmental release site, 
and any storage methods used at the site;
    (B) Description of methods of planting, inoculation, or release; 
any reproductive or cultural controls; methods of treatment and harvest 
used for the GE organism; and a proposed plan for monitoring the site 
for pests, diseases, and effects on other organisms during the time the 
GE organism is released;
    (C) Description of the methods and stages of transport of the GE 
organism from release site back into contained facilities, or methods 
of devitalization at the site(s) of the environmental release;
    (D) Description of the cleaning, disinfection, or other methods 
used to make it unlikely that unauthorized dissemination of the GE 
organism into the environment could occur via means of conveyance and 
other articles (e.g., planters, harvesters, containers);
    (E) Description of any post-release land use practices, including 
any monitoring plans to ensure that the GE organism or its progeny are 
unlikely to reproduce and disseminate in the environment after the 
termination of the release (e.g., managing volunteer plants); and
    (F) Description of the contingency plans associated with the 
release.
    (d) Administrator action on permit applications. An initial review 
should generally be completed by APHIS within 15 days of the receipt of 
the application for importation or interstate movement permits, and 
within 30 days for environmental release permits. An application will 
be considered complete when the Administrator determines that it 
includes all information required by this section and any additional 
information that the Administrator determines is needed for review. If 
necessary after its initial evaluation of an application, APHIS will 
notify the applicant in writing if the submitted application 
information is incomplete, and the applicant will be provided the 
opportunity, without prejudice, to revise the application information 
to meet the needs for administrative processing and scientific review. 
Once the Administrator has determined that an application is complete, 
the Administrator will commence review. The APHIS review should 
generally be completed within 60 days after it is determined to be 
complete for importation and interstate movement permits, and within 
120 days after it is determined to be complete for environmental 
release permits.
    (1) Administrative categories for environmental releases. The 
Administrator will use the following categories to efficiently 
administer the program and tailor regulatory oversight in a manner that 
is commensurate with risk. Environmental releases of GE plants are 
assigned to one of four categories (A-D), using the factors described 
in (i-iv). A fifth category (E) is for environmental releases of all 
non-plant organisms; applications in this category will be reviewed on 
a case-by-case basis.
    (i) Initial sorting into categories. The Administrator will use the 
following factors to initially sort environmental releases into 
administrative categories.
    (A) Persistence of the nonmodified plant, ranked as follows:
    (1) 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.
    (2) 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.
    (3) 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.
    (4) 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.
    (B) Potential harm or damage of the engineered traits, ranked as 
follows:
    (1) Low: 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
    (i) No morphological changes which could cause mechanical injury or 
damage; and
    (ii) Introduced sequences are known not to result in plant disease, 
and confers no or very low increased disease susceptibility.
    (2) Moderate: 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; or
    (i) Novel resistance to the application of an herbicide; or
    (ii) Novel ability to cause mechanical injury or damage; or
    (iii) 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.
    (3) High: 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
    (i) Produces an infectious entity which can cause disease in 
plants.
    (4) Severe: Any new proteins or substances produced are known or 
likely to be highly toxic or fatal to humans or vertebrate animals, 
upon consumption of or contact with the plant or plant parts.
    (C) Environmental releases will be initially sorted into 
administrative categories A-D as shown in Table 1, based upon the 
persistence risk and potential harm described in paragraphs 
(d)(1)(i)(A) and (B) of this section.

    Table 1 to Sec.   340.2(d)(1)--Initial Sorting Into Permit Administrative 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

[[Page 60042]]

 
Severe..................................................            D             D             D             D
----------------------------------------------------------------------------------------------------------------
* Persistence risk of the recipient plant species.

    (2) Modification of initial sorting based upon additional 
considerations. Following initial sorting using the factors described 
in paragraph (1)(i) of this section, the Administrator may reassign the 
environmental release to a different category based upon one or more of 
the following factors:
    (i) How the recipient plant is used;
    (ii) Whether the added trait significantly alters the persistence 
risk of the GE plant;
    (iii) Whether the gene function is known and based upon empirical 
observation of the added trait in the same species; and
    (iv) Any other information the Administrator deems relevant to the 
risk of introduction or dissemination of a plant pest or noxious weed.
    (3) APHIS review and assignment of permit conditions. The 
Administrator will conduct a review and assign appropriate permit 
conditions so that the proposed activity will be conducted in a manner 
that makes it unlikely to result in the introduction and dissemination 
of a plant pest or noxious weed.
    (4) State or tribal review and comment. The Administrator will 
submit for notice and review a copy of the permit application and any 
permit conditions to the appropriate state or tribal regulatory 
official. Comments received from the state or tribal regulatory 
official may be considered by the Administrator prior to permit 
issuance.
    (5) Site inspection. Prior to and after permit issuance, an 
inspector may inspect the sites or the means of conveyance associated 
with the proposed importation, interstate movement, or release into the 
environment. The responsible person must allow any such inspections.
    (6) Issuance of a permit. The Administrator may issue a permit if 
the Administrator concludes that the actions allowed under the permit 
are unlikely to result in the introduction or dissemination of a plant 
pest or noxious weed.
    (i) Prior to the issuance of a permit, the responsible person must 
agree in writing, in a manner prescribed by the Administrator, that the 
responsible person and all agents of the responsible person will comply 
with the permit conditions. The Administrator will deny the permit 
application if the responsible person does not agree that both the 
responsible person and all of his or her agents will comply with all of 
the permit conditions.
    (ii) If a permit is issued, the permit will include specific permit 
conditions required by the Administrator in accordance with Sec.  
340.3. If a permit is denied, within a reasonable time thereafter the 
applicant will be informed in writing of the reasons why the permit was 
denied and will be given the opportunity to appeal the denial in 
accordance with the provisions of paragraph (g) of this section.
    (e) Denial or revocation of a permit. Permits may be denied or 
revoked in accordance with this paragraph.
    (1) Denial. The Administrator may deny an application for a permit 
if:
    (i) The Administrator cannot conclude based on the application that 
the actions proposed under the permit are unlikely to result in 
introduction or dissemination of a plant pest or noxious weed; or
    (ii) The Administrator receives information apart from the 
application that precludes a conclusion by the Administrator that the 
actions proposed under the permit would be unlikely to result in the 
introduction or dissemination of a plant pest or noxious weed; or
    (iii) The Administrator determines that the responsible person or 
any agent of the responsible person has failed to comply at any time 
with any provision of this part. This would include failure to comply 
with the conditions of any permit issued.
    (2) Revocation. The Administrator may revoke a permit if:
    (i) The Administrator receives information subsequent to issuing a 
permit and makes a determination based upon this information that the 
circumstances have changed such that actions under the permit would be 
likely to result in the introduction or dissemination of a plant pest 
or noxious weed; or
    (ii) The Administrator determines that the responsible person or 
any agent of the responsible person has failed to comply at any time 
with any provision of this part. This would include failure to comply 
with the conditions of any permit issued.
    (f) Notice of revocation. The Administrator may revoke, either 
orally or in writing, any permit which has been issued. If the 
revocation is oral, the Administrator will communicate the revocation 
and the reasons for it in writing as promptly as circumstances allow.
    (g) Appeal of denial or revocation of permit. Any person who has 
been denied a permit or had a permit revoked may appeal the decision in 
writing to the Administrator within ten days after receiving the 
written notification of the revocation or denial. The appeal shall 
state all of the facts and reasons upon which the person relies to 
assert that the permit was wrongfully revoked or denied. The 
Administrator will grant or deny the appeal, in writing, stating the 
reasons for the decision as promptly as circumstances allow. Upon 
request of the applicant, a hearing may be held to resolve any conflict 
as to any material fact. Rules of practice concerning such a hearing 
will be adopted by the Administrator. This administrative remedy must 
be exhausted before a person can file suit in court challenging the 
denial or revocation of a permit.
    (h) Amendment or transfer of permits. Permits issued under this 
part may only be amended or transferred in accordance with this 
section.
    (1) Amendment at responsible person's request. Where circumstances 
have changed so that a responsible person desires to have the permit 
amended, such responsible person must submit a written justification 
and provide supporting information to APHIS. The Administrator will 
review the amendment request, and may amend the permit. Prior to 
issuance of an amended permit, the responsible person must agree in 
writing that he or she and all of his or her agents will comply with 
the amended permit and conditions.
    (2) Amendment initiated by APHIS. The Administrator may amend any

[[Page 60043]]

permit and its conditions at any time, upon determining that the 
amendment is needed to make it unlikely that actions under the permit 
would result in the introduction or dissemination of a plant pest or 
noxious weed, or to ensure that the permit is in compliance with all of 
the requirements of this part. As soon as circumstances allow, the 
Administrator will notify the responsible person in writing of the 
amendment to the permit and the reason(s) for it. The responsible 
person must agree in writing to comply with the permit and conditions 
as amended before the Administrator will issue the amended permit. If 
the responsible person does not agree in writing to comply with the 
amended permit and conditions, the existing permit will be revoked.
    (3) Transfer of permits. Permits issued through this part may only 
be transferred by the Administrator in response to a request by both 
the responsible person and the proposed transferee, or in the case of a 
deceased responsible person, the deceased responsible person's legal 
representative and the proposed transferee. Such transfer may occur if 
the Administrator determines that:
    (i) The proposed transferee meets all of the qualifications of a 
responsible person under this part;
    (ii) The proposed transferee has provided adequate written 
assurances to the Administrator that the proposed transferee and all of 
his or her agents will meet the terms and conditions of the permit, 
including any outstanding mitigation requirements or commitments under 
this part, and that the proposed transferee agrees to assume all 
responsibility and liability associated with permit activities and 
responsibilities; and
    (iii) The proposed transferee has provided such other information 
as the Administrator determines is necessary to the processing of the 
request for transfer of permit.


Sec.  340.3  Permit conditions.

    (a) Core permit conditions. Permits will be issued with the permit 
conditions below, which are a minimum set of basic conditions. The 
Administrator may add 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.
    (1) Permit conditions for all permit types.
    (i) Identity. The identity of the GE organism shall be maintained 
at all times, in order to maintain control of the GE organism, keep it 
distinct from other organisms, and minimize unintended mixing of the GE 
organism with other organisms. Conditions for maintaining the identity 
of the GE organism include, but are not limited to:
    (A) Marking, labeling, or otherwise identifying all GE organisms 
during the course of the permit; and
    (B) Having the ability to account for all GE materials associated 
with the permit.
    (ii) Communication and training. The responsible person shall 
effectively communicate any and all conditions, activities, actions, 
and contingency plans associated with the permit to all his or her 
agents and any other persons participating in permit-related 
activities, in order to ensure all persons comply with all requirements 
under this part. Conditions for communicating and training include, but 
are not limited to:
    (A) Establishing, implementing, and maintaining the means to 
effectively communicate to all his or her agents and any other persons 
participating in permit-related activities;
    (B) Providing a copy of the permit and conditions to all agents 
involved in a permit; and
    (C) Training all agents and any other persons participating in 
permit-related activities to effectively conduct tasks required under 
the permit.
    (iii) Records. In addition to any other records required by this 
section or Sec.  340.7(b), records, related to permitted activities of 
sufficient quality and completeness to demonstrate compliance with all 
permit conditions and requirements under this part, must be maintained.
    (iv) Notice. The responsible person shall notify APHIS orally 
within 24 hours of discovery, and subsequently in writing within 5 
business days of discovery, in the event of an unauthorized 
importation, interstate movement, or release into the environment of a 
GE organism regulated under this part.
    (2) Additional permit conditions for interstate movement permits, 
importation permits, and environmental release permits which include 
either an interstate movement or importation.
    (i) Shipment. The GE organism must be transported in such a way as 
to minimize the likelihood of the unauthorized release of the GE 
organism. Conditions include, but are not limited to:
    (A) Ensuring that the GE organism is transported in such a way that 
it is a secure shipment, as defined in Sec.  340.1; and
    (B) Treating or disposing of all packaging material, shipping 
containers, and any other material accompanying the GE organism in such 
a manner as to make it unlikely to result in the organism's 
unauthorized importation, interstate movement, or release into the 
environment.
    (ii) Records. In addition to any other records required by this 
section or Sec.  340.7(b), the following records shall be maintained:
    (A) Information identifying the general nature and quantity of the 
organism being shipped;
    (B) Name and address of sender, owner, or person shipping the 
organism;
    (C) Name, address, and telephone number of recipient;
    (D) Any invoices, packing lists, or bills of lading used for the 
shipment;
    (E) The shipper's name and identifying shipper's mark and number; 
and
    (F) A description of any containers that were used to transport the 
GE organisms, and a copy of any label used on these containers during 
transport.
    (3) Additional permit conditions for import permits, and 
environmental release permits which include importation.
    (i) Port(s) of Entry. The GE organism shall be presented for entry 
only at a port(s) specified in the permit.
    (ii) Records. In addition to any other records required by this 
section or Sec.  340.7(b), the responsible person shall maintain 
records that identify the country and locality where the GE organism 
was collected, developed, manufactured, reared, cultivated or cultured.
    (4) Additional permit conditions for environmental release permits.
    (i) Environmental release controls. Sufficient controls shall be 
applied during the environmental release of the GE organism to make it 
unlikely to result in the unauthorized release of the GE organism into 
the environment. Conditions include, but are not limited to:
    (A) Taking adequate precautions as described in the permit to 
ensure that the GE organism is not inadvertently released in transit 
between contained facilities and the location of environmental release;
    (B) Developing and being prepared to implement a written 
contingency plan to respond to any unauthorized environmental release;
    (C) Following any and all required reproductive, cultural, spatial, 
and temporal controls, such as isolation distances, buffer zones, and 
flower removal, as described in the permit, and monitor to ensure that 
the controls are maintained throughout the duration of the release;

[[Page 60044]]

    (D) Cleaning equipment used in the environmental release in order 
to remove or devitalize any viable GE organism the equipment may carry, 
as described in the permit;
    (E) Devitalizing or moving into a contained facility any viable GE 
material remaining at the termination of the environmental release, 
when applicable, as described in the permit; and
    (F) Managing and monitoring the area of release after the 
termination of the environmental release and removing or devitalizing 
any GE organisms which persist after the release, as required in the 
permit.
    (ii) Records. In addition to any other records required by this 
section or Sec.  340.7(b), the following records shall be maintained 
for each release:
    (A) All protocols or guidelines used to direct any environmental 
release of the GE organism; and
    (B) All environmental release reports for the organism. At a 
minimum such reports must include the APHIS reference number for the 
environmental release, methods of observation used during the 
environmental release, resulting information, and analysis regarding 
all deleterious effects on plants, nontarget organisms, or the 
environment, and any notices sent to APHIS of any unusual occurrence 
during the environmental release.
    (iii) Reports and Notices. In order for the Administrator to 
monitor the progress of the environmental release, and to evaluate 
compliance with required permit conditions, permit conditions will 
include, but are not limited to:
    (A) The responsible person shall submit periodic reports and 
notices to APHIS at the times specified in the permit and containing 
the information specified within the permit; and
    (B) The responsible person shall notify APHIS orally within 24 
hours of discovery, and subsequently in writing within 5 business days 
of discovery, in the event that the GE organism is found to have 
characteristics substantially different from those listed in the permit 
or if any circumstances occur which may increase the risk of 
disseminating a plant pest or noxious weed.
    (C) The responsible person shall notify APHIS in writing if the 
authorized release will not be conducted.
    (D) Within 28 days after the initiation of the release, the 
responsible person shall report to APHIS in writing the final release 
site coordinates; number of GE organisms actually released; any 
information related to the expected date(s) and quantities of GE 
organisms for subsequent planned releases to be done under this permit.
    (E) The responsible person shall provide APHIS with a final report 
that includes information related to any occurrences during the release 
that might result in the dissemination of a plant pest or noxious weed.
    (F) For categories C and D, permit holders shall provide APHIS with 
written notice no less than seven days prior to the planned initiation 
of the release.
    (G) For categories C and D, permit holders shall provide APHIS with 
a report no less than 21 days prior to release termination (e.g., 
harvest of GE plants) that describes the anticipated date(s) of 
termination.
    (b) Standard for additional permit conditions assigned by 
Administrator. The Administrator will assign the permit conditions 
described above in a manner that is commensurate with the risk of the 
individual proposed 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 Administrator may also assign permit conditions addressing 
nonliving materials associated with or derived from GE plants when such 
conditions are needed to make it unlikely that the nonliving materials 
would pose a noxious weed risk.


Sec.  340.4   Conditional exemptions from the requirement for a permit 
for interstate movement.

    (a) General. Certain GE organisms described in paragraph (b) of 
this section may be moved interstate without a permit under this part, 
if they meet the shipping conditions enumerated in paragraph (c).
    (b) Conditional exemptions from the requirement for a permit for 
interstate movement of certain organisms. A permit for interstate 
movement will not be required for the following genetically engineered 
organisms provided that they meet the requirements of this paragraph 
and paragraph (c).
    (1) Escherichia coli genotype K-12 (strain K-12 and its 
derivatives), sterile strains of Saccharomyces cerevisiae, or 
asporogenic strains of Bacillus subtilis, provided that the introduced 
genetic sequences:
    (i) Are maintained on a nonconjugation proficient plasmid, and the 
organism does not contain other conjugation proficient plasmids or 
generalized transducing phages;
    (ii) Do not cause the production of an infectious entity;
    (iii) Are not carried on an expression vector if the cloned genes 
code for:
    (A) A toxin to plants or plant products, or a toxin to organisms 
beneficial to plants; or
    (B) Other factors directly involved in eliciting plant disease 
(e.g., cell wall degrading enzymes; or
    (C) Substances acting as, or inhibitory to, plant growth 
regulators.
    (2) Arabidopsis thaliana provided that the introduced genetic 
sequences:
    (i) Do not cause the production of an infectious entity;
    (ii) Are not derived from an animal or human pathogen;
    (iii) Do not encode products that are toxic to vertebrates;
    (iv) Do not encode products known to or likely to be causal agents 
of disease in vertebrates; and
    (v) Do not encode products intended for pharmaceutical or 
industrial use.
    (c) Shipping conditions. Organisms that meet the criteria described 
in paragraph (b) of this section must be shipped as follows:
    (i) The container and means of conveyance must provide secure 
shipment to make it unlikely that the introduction or dissemination of 
the organisms will occur while in transit.
    (ii) The container must contain a document which includes the 
following written information:
    (A) Names and contact details for the sender and recipient, and
    (B) A statement that the contents are genetically engineered and 
are eligible for interstate movement without permit under this part, 
but are not exempt from permit requirements under this part if the 
organism is imported or released into the environment;
    (iii) The responsible person shall notify APHIS orally within 24 
hours of discovery, and subsequently in writing within 5 business days 
of discovery, in the event of an unauthorized release into the 
environment of a GE organism regulated under this part.
    (d) Revocation of an exemption from requirement for permit. The 
Administrator may revoke any existing conditional exemption. The 
Administrator may revoke a conditional exemption if the Administrator 
receives information subsequent to approving the conditional exemption 
and makes a determination based upon this information that the 
circumstances have changed such that the conditional exemption is 
likely to result in the introduction or dissemination of a plant pest 
or noxious weed. The revocation, its effective date, and the reasons 
for it will be published in the Federal

[[Page 60045]]

Register. 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 revocation if new information 
relevant to the revocation becomes available.
    (e) Revocation of a person's use of a conditional exemption from 
requirement for permit. The Administrator may revoke the right of any 
person to use a conditional exemption from the requirement for a permit 
under this part after determining that the person or any agent of the 
person has failed to comply at any time with any provision of this 
part. This would include failure to comply with the conditions of any 
permit or exemption.
    (1) Appeal of revocation of a person's use of a conditional 
exemption. Any person who has had the right to use a conditional 
exemption revoked may appeal the decision in writing to the 
Administrator within ten days after receiving the written notification 
of the revocation. The appeal shall state all of the facts and reasons 
upon which the person relies to assert that the use of the conditional 
exemption was wrongfully revoked. The Administrator will grant or deny 
the appeal, in writing, stating the reasons for the decision as 
promptly as circumstances allow. Upon request of the applicant, a 
hearing may be held to resolve any conflict as to any material fact. 
Rules of practice concerning such a hearing will be adopted by the 
Administrator. This administrative remedy must be exhausted before a 
person can file suit in court challenging the revocation.


Sec.  340.5  Petition for new conditional exemptions from the 
requirement for a permit.

    (a) General. Any person may petition to initiate the procedure for 
establishing a new conditional exemption from the requirement for a 
permit under Sec.  340.0(b)(1) of this part. The Administrator may 
initiate the procedure without filing a petition. All petitions and all 
actions by the Administrator to establish a new conditional exemption 
will be evaluated according to the standards for petition approval or 
denial contained in paragraph (b)(4) of this section.
    (b) Petition submission and evaluation procedure. To petition for a 
new conditional exemption from the requirement for a permit under this 
part, a petitioner must submit a written petition to the Administrator.
    (1) The petition must contain information that supports a 
conclusion that use of the conditional exemption is unlikely to result 
in the introduction or dissemination of a plant pest or noxious weed. 
The information shall include the following:
    (i) Description of the biology of the organism prior to genetic 
engineering.
    (ii) Detailed description of the genetic changes made to the 
organism.
    (iii) Detailed description of the phenotype of the GE organism, 
including known and potential differences from the recipient organism 
that could change the likelihood that the GE organism will pose a risk 
as a plant pest or noxious weed. Examples of relevant information 
include, but are not limited to:
    (A) Growth habit and reproduction of the GE organism;
    (B) Potential host range or geographic area of distribution;
    (C) Potential for other organisms to pose risks as plant pests or 
noxious weeds if they acquire the trait from the GE organism (e.g. via 
sexual reproduction, horizontal gene transfer);
    (D) Susceptibility of the GE organism to disease or damage by 
pests;
    (E) Pathogenicity of the GE organism and/or ability of the GE 
organism to cause damage or injury to plants or plant parts;
    (F) Toxicity, allergenicity, and/or ability of the GE organism to 
damage or injure other organisms;
    (iv) A detailed description of proposed condition(s) to be 
associated with the exemption and how the conditions would make the 
exemption unlikely to result in the introduction or dissemination of a 
plant pest or noxious weed.
    (v) Any relevant experimental information, published references, or 
scientific information which support the conclusions of the petition;
    (vi) All reports required under Sec.  340.3;
    (vi) Any information known to the petitioner that the GE organism 
may pose a risk as a plant pest or noxious weed;
    (vii) Any other information that the Administrator believes to be 
relevant to a determination that the proposed conditional exemption 
from the requirement for a permit for the importation, interstate 
movement, or release into the environment of the GE organism is 
unlikely to result in the introduction or dissemination of a plant pest 
or noxious weed.
    (viii) A signed certification by the petitioner that, to the best 
knowledge and belief of the petitioner, the petition includes all 
information on which to base a determination, and that it includes all 
information known to the petitioner which is unfavorable to the 
petition.
    (2) Insufficient information. If, upon initial review of the 
petition, the Administrator concludes that there is insufficient 
information upon which to make a determination on the petition, the 
petitioner will be sent a written notice indicating what additional 
information may be required.
    (3) Public notice. The Administrator should generally complete the 
review of the complete petition within 180 days, then publish a notice 
in the Federal Register of the availability of documents related to 
APHIS' assessment of the proposed conditional exemption. This notice 
will specify that comments will be accepted from the public on the 
proposal.
    (4) Petition approval or denial standard. The Administrator will 
assess the GE organism and the conditions of the requested exemption to 
determine whether the requested exemption from a permit for 
importation, interstate movement, or release into the environment would 
be unlikely to result in the introduction or dissemination of a plant 
pest or noxious weed. The Administrator will also consider whether any 
conditions not contained in the petition would be needed to ensure that 
the requested exemption would be unlikely to result in the introduction 
or dissemination of a plant pest or noxious weed. After completing 
review of the available information and any public comments received on 
it, the Administrator will furnish to the petitioner and publish in the 
Federal Register one of the following responses:
    (i) Approve a conditional exemption from requirement for a permit. 
The approval of a conditional exemption from the requirement for a 
permit will state which GE organism(s) may be imported, moved 
interstate, and/or environmentally released without a permit under this 
part, as well as the conditions relevant to the exemption. The 
Administrator may also add additional conditions not proposed in the 
petition, if the Administrator concludes that additional conditions are 
needed to ensure that the conditional exemption would be unlikely to 
result in the introduction or dissemination of a plant pest or noxious 
weed.
    (ii) Deny a conditional exemption from requirement for a permit. 
The Administrator will deny a petition if the Administrator cannot 
conclude that the proposed exemption would be unlikely to result in the 
introduction or dissemination of a plant pest or noxious weed. The 
Administrator's written decision will set forth the reason for the 
denial.

[[Page 60046]]

    (c) Appeal of decision. Any person whose petition under Sec.  340.5 
has been denied may appeal the decision in writing to the Administrator 
within ten days after receiving the written notification of the 
decision. The appeal shall state all of the facts and reasons upon 
which the person relies to show that the decision should be changed. 
The Administrator will grant or deny the appeal, in writing, stating 
the reasons for the decision as promptly as circumstances allow. Upon 
request of the applicant, a hearing may be held to resolve any conflict 
as to any material fact. Rules of practice concerning such a hearing 
will be adopted by the Administrator. This administrative remedy must 
be exhausted before a person can file suit in court challenging the 
decision.
    (d) Amending an exemption after approval. The Administrator may 
amend conditions to any conditional exemption approved under this 
section. The Administrator may amend a conditional exemption if the 
Administrator determines based on information received subsequent to 
the approval of the exemption that the exemption needs to be amended to 
ensure that the exemption would be unlikely to result in the 
introduction or dissemination of a plant pest or noxious weed, and that 
additional conditions can successfully mitigate that risk. The 
Administrator may also amend a conditional exemption if needed to 
ensure that the exemption is in compliance with all of the requirements 
of this part. The amended conditional exemption and the reasons for it 
will be published in the Federal Register. The addition of conditions 
may not be appealed. However, any person may file a new petition in 
accordance with paragraph (a) of this section regarding the same or 
similar organisms covered by the amended exemption if new information 
relevant to the amended exemption becomes available.
    (e) Revocation of an exemption from requirement for permit. The 
Administrator may revoke any conditional exemption under this section. 
The Administrator may revoke a conditional 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 conditional exemption is 
likely to result in the introduction or dissemination of a plant pest 
or noxious weed. The revocation, its effective date, and the reasons 
for it will be published in the Federal Register. A revocation may not 
be appealed. However, any person may file a new petition in accordance 
with this section regarding the same or similar organisms covered by 
the revocation if new information relevant to the revocation becomes 
available.
    (f) Revocation of a person's use of a conditional exemption from 
requirement for permit. The Administrator may revoke the right of any 
person to use a conditional exemption from the requirement for a permit 
under this part after determining that the person or any agent of the 
person has failed to comply at any time with any provision of this 
part. This would include failure to comply with the conditions of any 
permit or exemption.
    (1) Appeal of revocation of a person's use of a conditional 
exemption. Any person who has had the right to use a conditional 
exemption revoked may appeal the decision in writing to the 
Administrator within ten days after receiving the written notification 
of the revocation. The appeal shall state all of the facts and reasons 
upon which the person relies to assert that the use of the exemption 
was wrongfully revoked. The Administrator will grant or deny the 
appeal, in writing, stating the reasons for the decision as promptly as 
circumstances allow. Upon request of the applicant, a hearing may be 
held to resolve any conflict as to any material fact. Rules of practice 
concerning such a hearing will be adopted by the Administrator. This 
administrative remedy must be exhausted before a person can file suit 
in court challenging the revocation.
    (2) [Reserved]


Sec.  340.6  Petition for nonregulated status.

    (a) General. Any person may petition to initiate the procedure for 
approving nonregulated status under this part for a GE organism. The 
Administrator may initiate the procedure without filing a petition. All 
petitions and all actions by the Administrator to initiate the 
procedure for approving nonregulated status will be evaluated according 
to the standards for petition approval or denial contained in paragraph 
(b)(4) of this section.
    (b) Petition submission and evaluation procedure. To petition for 
approval of nonregulated status, a petitioner must submit a written 
petition to the Administrator.
    (1) The petition must contain information that supports a 
conclusion that the GE organism is unlikely to be a plant pest or 
noxious weed. The information shall include the following:
    (i) Description of the biology of the organism prior to genetic 
engineering.
    (ii) Detailed description of the genetic changes made to the 
organism.
    (iii) Detailed description of the phenotype of the GE organism, 
including known and potential differences from the recipient organism 
that could change the likelihood that the GE organism is unlikely to be 
a plant pest or noxious weed. Examples of relevant information include, 
but are not limited to:
    (A) Growth habit and reproduction of the GE organism;
    (B) Potential host range or geographic area of distribution;
    (C) Potential for other organisms to pose risks as plant pests or 
noxious weeds if they acquire the trait from the GE organism (e.g. via 
sexual reproduction, horizontal gene transfer);
    (D) Susceptibility of the GE organism to disease or damage by 
pests;
    (E) Pathogenicity of the GE organism and/or ability of the GE 
organism to cause damage or injury to plants or plant parts;
    (F) Toxicity, allergenicity, and/or ability of the GE organism to 
damage or injure other organisms;
    (iv) Any relevant experimental information, published references, 
or scientific information which support the conclusions of the 
petition;
    (v) All reports required under Sec.  340.3;
    (vi) Any information known to the petitioner that the GE organism 
may pose risk as a plant pest or noxious weed;
    (vii) Any other information that the Administrator believes to be 
relevant to a determination that the GE organism is unlikely to be a 
plant pest or noxious weed.
    (viii) A signed certification by the petitioner that, to the best 
knowledge and belief of the petitioner, the petition includes all 
information on which to base a determination, and that it includes all 
information known to the petitioner which is unfavorable to the 
petition.
    (2) Insufficient information. If, upon initial review of the 
petition, the Administrator concludes that there is insufficient 
information upon which to make a determination on the petition, the 
petitioner will be sent a written notice indicating what additional 
information may be required.
    (3) Public notice. The Administrator should generally complete the 
review of the complete petition within 180 days, then publish a notice 
in the Federal Register of the availability of documents related to 
APHIS' assessment of the proposal for nonregulated status. This notice 
will specify that comments will be accepted from the public on the 
proposal.

[[Page 60047]]

    (4) Petition approval or denial standard. The Administrator will 
assess the GE organism to determine whether the GE organism is unlikely 
to be a plant pest or noxious weed. After completing review of the 
available information and any public comments received on it, the 
Administrator will furnish to the petitioner and publish in the Federal 
Register one of the following responses:
    (i) Approve nonregulated status. The approval of nonregulated 
status will state which GE organism(s) have been determined to have 
nonregulated status.
    (ii) Deny nonregulated status. The Administrator will deny a 
petition if the Administrator cannot conclude that the GE organism is 
unlikely to be a plant pest or noxious weed. The Administrator's 
written decision will set forth the reason for the denial.
    (c) Appeal of decision. Any person whose petition under Sec.  340.6 
has been denied may appeal the decision in writing to the Administrator 
within ten days after receiving the written notification of the 
decision. The appeal shall state all of the facts and reasons upon 
which the person relies to show that the decision should be changed. 
The Administrator will grant or deny the appeal, in writing, stating 
the reasons for the decision as promptly as circumstances allow. Upon 
request of the applicant, a hearing may be held to resolve any conflict 
as to any material fact. Rules of practice concerning such a hearing 
will be adopted by the Administrator. This administrative remedy must 
be exhausted before a person can file suit in court challenging the 
decision.
    (d) Revocation of nonregulated status. The Administrator may revoke 
any approval of nonregulated status of a GE organism. The Administrator 
may revoke an approval of nonregulated status if the Administrator 
receives information subsequent to approving the nonregulated status 
and makes a determination based upon this information that the 
circumstances have changed such that the GE organism is likely to be a 
plant pest or noxious weed. If the Administrator revokes an approval 
for nonregulated status, the Administrator may approve for the same GE 
organism an exemption from the requirement for permit in accordance 
with Sec.  340.5. The revocation, its effective date, and the reasons 
for it will be published in the Federal Register. A revocation may not 
be appealed. However, any person may file a new petition in accordance 
with this section regarding the same or similar organisms covered by 
the revocation if new information relevant to the revocation becomes 
available.


Sec.  340.7  Compliance, enforcement, and remedial action.

    (a) Access for inspection. Inspectors shall have access to inspect 
any relevant premises, facility, location, storage area, waypoint, 
materials, equipment, means of conveyance, and other articles related 
to importation, interstate movement, and environmental releases of GE 
organisms regulated under this part.
    (b) Access to audit and review records. Inspectors shall have 
access to audit and review all records required to be maintained under 
this part.
    (c) Required records. Responsible persons and their agents engaged 
in the importation, interstate movement, or release into the 
environment of a GE organism subject to the regulations of this part 
are required to establish and keep the following records.
    (1) All records required as a condition of a permit or a 
conditional exemption approved under the procedure described in Sec.  
340.5.
    (2) Address and any other information needed to identify all 
contained facilities where the GE organism was stored or utilized, and 
all locations where the GE organism was released into the environment;
    (3) A record identifying which APHIS permit, if any, authorized the 
importation, interstate movement, or release into the environment;
    (4) A record identifying which exemption under this part, if any, 
authorized the importation, interstate movement, or release into the 
environment; and
    (5) Copies of contracts between the responsible person and all 
agents that conduct activities subject to this part for the responsible 
person, and copies of other records (e.g., e-mails, telephone records) 
for such agreements made without a written contract.
    (d) Record retention. Records indicating that such a GE organism 
that was imported or moved interstate reached its intended destination 
must be retained for at least 2 years after completion of importation 
or interstate movement, and all other records must be retained for at 
least 5 years after completion of all obligations required under a 
relevant permit or exemption.
    (e) Enforcement. (1) Failure of any person to comply with any of 
the requirements of this part may result in any or all of the 
following:
    (i) Denial of a permit request by that person;
    (ii) After the issuance of a permit, revocation of a permit and 
destruction, treatment, or removal of the GE organism, or other 
measures as deemed appropriate or necessary by the Administrator;
    (iii) Criminal and/or civil penalties, and
    (iv) Remedial or other measures as determined appropriate and 
necessary by the Administrator.
    (2) The Administrator may seek a civil penalty as well as impose 
and require corrective action plans, remedial measures or other 
measures as determined appropriate and necessary by the Administrator.
    (3) Prior to the issuance of a complaint seeking a civil penalty, 
the Administrator may enter into a stipulation in which the responsible 
person agrees to take certain remedial actions or other measures in 
addition to or in lieu of a stipulated civil penalty, in accordance 
with 7 CFR Sec.  380.10.
    (f) Liability for acts of an agent. For purposes of enforcing this 
part, the act, omission, or failure of any agent for a responsible 
person as defined in Sec.  340.1 of this part may be deemed also to be 
the act, omission, or failure of the responsible person.
    (g) Remedial action. The Administrator may hold, seize, quarantine, 
treat, apply other remedial measures to, destroy, or otherwise dispose 
of any GE organisms subject to this part, in order to ensure the GE 
organisms are unlikely to result in the dissemination of a plant pest 
or noxious weed. Accordingly, the Administrator may order the 
responsible person for an active or revoked permit or any other person, 
through an Emergency Action Notification or other administrative order, 
to apply remedial measures to a GE organism or means of conveyance 
carrying a GE organism subject to regulation by this part. The 
Administrator's determination of whether or not to require or order 
corrective and/or remedial action in a given situation does not affect, 
influence, restrict, or in any other way limit the Administrator's 
determination on whether or not to seek criminal or civil penalties or 
order other compliance or enforcement requirements as deemed necessary 
or appropriate by the Administrator to the given situation.
    (1) Failure of a person to comply with the Administrator's order 
for corrective and/or remedial action authorizes the Administrator to 
take corrective and/or remedial action and recover from the person the 
costs of any care, handling, application of remedial measures, 
devitalization, or disposal incurred by APHIS in connection with the 
corrective and/or remedial actions taken.
    (2) Low level presence (LLP) remedial action. The Administrator may 
order remedial action for any unauthorized release into the environment 
of GE

[[Page 60048]]

organisms, including situations involving a low-level mixing of GE 
plants and materials subject to regulation \1\ under this part with 
commercial seed and grain. In some LLP situations the Administrator may 
determine not to order remedial action, if the Administrator determines 
that the low-level mixing is unlikely to result in the introduction or 
dissemination of a plant pest or noxious weed. These determinations 
will be made in the same way, based on the same factors, regardless of 
whether the LLP originates domestically or is found in import shipments 
that may contain organisms subject to regulation. The factors the 
Administrator will consider that would support a decision not to order 
LLP remedial action include, but are not limited to, determinations 
that:
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    \1\ ``Subject to regulation'' may include situations where a GE 
organism granted nonregulated status subsequently had that status 
revoked in accordance with Sec.  340.6(d).
---------------------------------------------------------------------------

    (i) A GE plant of the same species expressing nearly identical 
proteins or substances has already been approved for nonregulated 
status under this part; or
    (ii) All of the following statements are true with regard to the GE 
plant or plants subject to the regulations under this part.
    (A) The function of the introduced genetic sequences is known and 
its expression in the GE plant is unlikely to pose plant pest or 
noxious weed risk;
    (B) Introduced genetic sequences do not cause the production of an 
infectious entity;
    (C) Any genetic sequences derived from plant viruses are non-coding 
regulatory sequences of known function; or, if sense or antisense 
genetic sequences, they are derived from viruses prevalent and endemic 
in the United States that infect plants of the same host species and do 
not encode a functional noncapsid gene product responsible for cell-to-
cell movement of the virus.
    (D) The GE plant is not expected to establish outside of a managed 
ecosystem, and has no sexually-compatible, wild relatives in the United 
States;
    (E) The GE plant does not produce new substances that are known or 
likely to be toxic to non-target organisms, does not contain genetic 
sequences from animal or human pathogens, and does not encode products 
known or likely to be causal agents of disease in animals or humans.
    (F) If the GE plant is a food or feed crop, then at least one of 
the following must be true:
    (1) The U.S. Environmental Protection Agency has established a 
tolerance or an exemption from tolerance for any plant-incorporated 
protectant expressed by the GE plant, or
    (2) Key food safety issues of the new protein or other substance 
have been addressed, or,
    (3) No new protein or substance is produced.


Sec.  340.8  Confidential business information.

    In accordance with the Freedom of Information Act (FOIA) and 
exemptions from releasing information pursuant to FOIA, namely, 5 
U.S.C. 552(b)(4), APHIS may exempt from disclosure to the public trade 
secrets and commercial or financial information obtained from a person 
that are privileged or confidential. Persons wishing to protect 
confidential business information in permit applications, petitions, or 
other submissions to APHIS under this part should do so in the 
following manner. If there are portions of a document deemed to contain 
trade secret or confidential business information, each page containing 
such information must be marked ``CBI Copy.'' A second copy of each 
such document must be submitted with all such CBI deleted and marked on 
each page where the CBI was deleted: ``CBI Deleted.'' In addition, 
those portions of the document which are deemed ``CBI'' must be 
identified in an attachment to the document, which also must justify 
how each piece of information requested to be treated as CBI is a trade 
secret or is commercial or financial information and are privileged or 
confidential.


Sec.  340.9  Costs and charges.

    The services of the inspector related to carrying out this part and 
provided during regularly assigned hours of duty and at the usual 
places of duty will be furnished without cost.\2\ The U.S. Department 
of Agriculture will not be responsible for any costs or charges 
incident to inspections or compliance with the provisions of this part, 
other than for the services of the inspector.
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    \2\ The Department's provisions relating to overtime charges for 
an inspector's services are set forth in 7 CFR part 354.0.

    Done in Washington, DC, this 1st day of October 2008.
Charles D. Lambert,
Acting Under Secretary for Marketing and Regulatory Programs.
[FR Doc. E8-23584 Filed 10-6-08; 9:30 am]
BILLING CODE 3410-34-P