Browse by Year
/ 2008
/ October
/ Thursday, October 09, 2008
[Federal Register: October 9, 2008 (Volume 73, Number 197)]
[Proposed Rules]
[Page 60007-60048]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09oc08-45]
[[Page 60007]]
-----------------------------------------------------------------------
Part IV
Department of Agriculture
-----------------------------------------------------------------------
Animal and Plant Health Inspection Service
-----------------------------------------------------------------------
7 CFR Part 340
Importation, Interstate Movement, and Release Into the Environment of
Certain Genetically Engineered Organisms; Proposed Rule
[[Page 60008]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
B. Current Regulations in 7 CFR Part 340
APHIS administers regulations in 7 CFR part 340, ``Introduction of
Organisms and Products Altered or Produced Through Genetic Engineering
Which are Plant Pests or Which There is Reason to Believe are Plant
Pests'' (referred to below as the regulations). The current regulations
govern the introduction (importation, interstate movement, or release
into the environment) of certain GE organisms termed ``regulated
articles.'' Regulated articles are essentially GE organisms which might
pose a risk as a plant pest.
APHIS first promulgated these regulations in 1987 under the
authority of the Federal Plant Pest Act of 1957 (FPPA) and the Plant
Quarantine Act of 1912 (PQA), two acts that were subsumed into the
Plant Protection Act (PPA, 7 U.S.C. 7701 et seq.) in 2000, along with
other provisions.
Under the current regulations, a GE organism is a regulated article
if it is a plant pest or if the Administrator has reason to believe it
is a plant pest; more specifically:
[[Page 60010]]
``if the donor organism, recipient organism, or vector or vector
agent belongs to any genera or taxa designated in Sec. 340.2 and
meets the definition of plant pest, or is an unclassified organism
and/or an organism whose classification is unknown, or any product
which contains such an organism, or any other organism or product
altered or produced through genetic engineering which the
Administrator determines is a plant pest or has reason to believe is
a plant pest.'' (Definition of regulated article, Sec. 340.1)
In other words, APHIS regulates the introduction (importation,
interstate movement, and environmental release) of GE organisms if (1)
any of the recipient, genetic donor, or vector organisms are plant
pests or of unknown classification or (2) the Administrator has
determined or has reason to believe the GE organism is a plant pest. As
constructed the regulations apply to GE microorganisms, insects, and
other traditional types of plant pests and to any GE plants if plant
pest organisms (bacterial and viral plant pathogens) are the donor
organisms and vector agents used in the creation of these GE plants.
Taxa containing ``known plant pests'' are those listed in current
Sec. 340.2. Current regulations also include a petition procedure
(Sec. 340.5) which allows petitioners to ask APHIS to add or subtract
taxa from the list in Sec. 340.2. That list has not been amended since
it was established in 1987.
As defined under the current regulations and the PPA, most plants
are not plant pests, with the exception of a few parasitic plant
species, such as striga, witchweed, and dodder.
The primary procedure for regulation under the PPA is the issuance
of a permit, which is an authorization by the Secretary to move plants,
plant products, biological control organisms, plant pests, noxious
weeds, or articles under conditions prescribed by the Secretary. The
PPA also authorizes the Secretary to determine which classes of the
above articles must have a permit to be moved. Conditions associated
with those permits can be tailored to achieve the appropriate level of
regulatory control to make it unlikely that actions under the permit
would result in the introduction or dissemination of a plant pest or
noxious weed.
APHIS currently uses a permit and notification system to authorize
importation, interstate movement and release into the environment
(currently referred to as ``introductions'') of certain GE organisms.
Under the current regulations, all regulated articles are eligible for
the permitting procedure, but only certain plants are eligible for the
notification procedure. Currently, most regulated GE plants are
introduced under notification, which is a streamlined procedure.
Examples of GE plants introduced under the notification procedure are
those GE plants altered to be resistant to certain insects or
herbicides. GE plants that do not meet the notification eligibility
criteria and all other GE organisms, such as microbes and insects, must
be introduced under the permit procedure in current Sec. 340.4. In
recent years, APHIS has processed most notifications and permits
through its electronic, e-permitting system that is accessible by the
internet at http://www.aphis.usda.gov/permits/learn_epermits.shtml.
In making a regulatory determination for a permit or notification
for a GE organism subject to the part 340 regulations, APHIS makes such
a determination on whether the actions under notification or permit are
unlikely to result in the introduction or dissemination of a plant
pest. This determination takes into account various risk factors,
including, among other things, a low risk that the GE organism or its
progeny can persist, reproduce, and establish without human assistance.
Other risk factors that would support an ``unlikely'' determination
would be minimal availability of suitable hosts or habitats for the
organism and low risk that the organism may cause damage to plants and
plant products.
Regarding the risk of introduction or dissemination of the GE
organism as a plant pest, an ``unlikely'' determination takes into
consideration both the nature of the organism (i.e., low risk that the
organism or its progeny can persist, reproduce, establish, and spread
without human assistance) and any additional mitigations that are
placed upon the organism that restrict its movement and make its
unauthorized introduction or dissemination unlikely.
The notification procedure was first added to the regulations in
1993, and then amended in 1997 to allow a broader range of plant
species to be eligible for the procedure. The notification procedure
was designed to be a streamlined procedure with the eligibility
criteria and performance standards already built into the regulations.
Over the past decade, APHIS has typically authorized 700-1200
notifications per year.
As part of the notification procedure, applicants must adhere to
performance standards set forth by APHIS for proper confinement of the
GE plants. The goal of proper confinement is to ensure that the GE
plants do not persist in the environment. Under the notification
procedure applicants provide information about the introduction
sufficient for APHIS to evaluate eligibility for the procedure and
impacts on the environment. This information includes information on
the plant species, introduced gene(s), location(s), and anticipated
time frame for the introduction.
For notifications, the eligibility criteria and the performance
standards stated in the regulations must be met, but APHIS does not
prescribe how the performance standards must be met. For example, one
of the performance standards in Sec. 340.3(c)(5) requires that ``The
field trial must be conducted such that (i) The regulated article will
not persist in the environment, and (ii) No offspring can be produced
that could persist in the environment.'' The responsible person might
meet this standard in a field trial by isolating the regulated GE
plants at a sufficient distance to preclude gene flow from the GE plant
to sexually compatible plants in the vicinity. Another design protocol
might meet the same performance standard by planting the GE plant at a
time in the growing season when surrounding plants of the same species
would not be biologically capable of being fertilized by pollen from
the GE plant (temporal isolation).
The regulations in current Sec. 340.3(e) specify that the APHIS
notification procedure must be completed within 30 days for
environmental release and importations and within 10 days for the
interstate movement of a regulated article. If APHIS completes the
review process and finds that all regulatory requirements have been
met, the notification is authorized in a process termed
``acknowledgement,'' and the applicant can proceed with the
introduction under the terms of the notification. Notifications are
valid for one year from the date of introduction.
Approximately 10% of APHIS authorizations are done under the
permitting procedure. The permitting procedure, found in Sec. 340.4 of
the current regulation, describes the types of permits, information
required for permit application, the standard permit conditions, and
administrative information (e.g., time frames, appeal procedure, etc.).
Permits include specific conditions that must be followed by the permit
holder. Standard permit conditions are listed in the regulation, and
APHIS can supplement these with additional conditions as necessary. The
current regulations specify the amount of time that APHIS is allotted
for review of complete permit applications: 60 days for permits for
importation and interstate movement; 120 days for environmental
release.
[[Page 60011]]
Some regulated articles are conditionally exempt from the
requirement for permits when moved interstate under the conditions
stipulated in the regulation. Conditional exemptions currently exist in
the regulations for the interstate movement of certain GE bacteria
(Escherichia coli, Bacillus subtilis), fungi (Saccharomyces
cerevisiae), as well as the plant species Arabidopsis thaliana. APHIS
established these conditional exemptions from interstate movement
permit by amending the regulations in 1988 and 1990.
APHIS forwards the applications for all permits, and notifications,
with any confidential business information redacted, to State
regulators in the States to which regulated articles will be moved and/
or in which environmental release is planned. This is done to notify
States of the requested action and to allow States to review and
comment on proposed releases or importations or movements.
The current regulations also include various provisions and
prescribed standards for containers, marking, and identity that apply
to shipments of regulated articles. For example, there are instructions
regarding how to label containers of imported regulated articles with
the nature of the contents, origin and destination, and other
information, and detailed instructions on what materials (plastic,
metal, etc.) and dimensions may be used for containers of regulated
articles.
Under the current regulations, APHIS may also grant ``nonregulated
status'' to a GE organism in accordance with the procedure described in
Sec. 340.6. A determination of nonregulated status means that the
organism is no longer subject to the part 340 regulations, and
therefore there is no longer any requirement for APHIS authorization
under part 340 for a permit or notification when the GE organism is
imported, moved interstate, or released into the environment.
C. Plant Protection Act Authority to Regulate Plant Pests, Noxious
Weeds, and Biological Control Organisms
Under the provisions of the PPA, Congress has granted the Secretary
of Agriculture authority to develop regulations in order to detect,
control, eradicate, suppress, prevent, or retard the spread of plant
pests or noxious weeds. The PPA grants the Secretary authority to
regulate the movement into and through the United States of any plant,
plant pest, plant product, biological control organism, noxious weed,
article, or means of conveyance, in order to prevent the introduction
or dissemination of plant pests and noxious weeds.
The current regulations were promulgated under former statutes,
i.e., the FPPA and PQA, which provide USDA authority to regulate
articles that present a risk of plant pest introduction or
dissemination. In addition to the provisions of the FPPA and PQA, the
PPA incorporates authority that previously was under the Noxious Weed
Act of 1974. In order to best evaluate the risks associated with these
GE organisms and regulate them when necessary, APHIS needs to exercise
its authorities regarding noxious weeds and biological control
organisms, in addition to its authority regarding plant pests.
The definition of plant pest in the PPA is broad and includes
living organisms that could directly or indirectly injure, damage, or
cause disease in any plant or plant product (7 U.S.C. Sec. 7702(14)).
Under the PPA, organisms which could be plant pests include:
Protozoans
Non-human animals
Parasitic plants
Bacteria
Fungi
Viruses or viroids
Infectious agents or other pathogens
Any article similar to or allied with any of the above
articles.
The definition of noxious weed in the PPA includes:
* * * any plant or plant product that can directly or indirectly
injure or cause damage to crops (including nursery stock or plant
products), livestock, poultry, or other interests of agriculture,
irrigation, navigation, the natural resources of the United States,
the public health, or the environment. (PPA Sec. 7702(10))
An important distinction between noxious weeds and plant pests is
that noxious weeds under the PPA are always plants or plant products.
Plant pests are usually not plants (with the exception of certain
parasitic plants such as dodder, striga, and witchweed), but are other
types of organisms that harm plants.
III. Proposed Rule
A. Proposed Regulatory Scope (Sec. 340.0 Scope and general
restrictions)
We propose to better align the regulations with the PPA authorities
in order to ensure that the environmental release, importation, or
interstate movement of GE organisms does not pose a risk of introducing
or disseminating plant pests or noxious weeds. Although the current
program has been effective in ensuring the safe environmental release,
interstate movement, and importation of genetically engineered
organisms, technological advances have led to the possibility of
developing GE organisms that do not fit within the plant pest
definition, but may cause environmental or other types of physical harm
or damage covered by the definition of noxious weed in the PPA.
Therefore, we consider that it is appropriate to align the regulations
with both the plant pest and noxious weed authorities of the PPA.
1. Genetically Engineered Organisms Subject to 7 CFR part 340
We are proposing to revise the scope of the regulations in Sec.
340.0 to make it clear that decisions regarding which organisms are
regulated remain science-based and take both plant pest and noxious
weed risks into account. The proposed scope of the regulations states
that genetically engineered organisms whose importation, interstate
movement, or release into the environment would be subject to the
regulations are:
Genetically engineered plants if:
(i) The unmodified parent plant from which the GE plant was derived
is a plant pest or noxious weed, or
(ii) The trait introduced by genetic engineering could increase the
potential for the GE plant to be a plant pest or noxious weed, or
(iii) The risk that the GE plant poses as a plant pest or noxious
weed is unknown, or
(iv) The Administrator determines that the GE plant poses a plant
pest or noxious weed risk.
Genetically engineered non-plant, non-vertebrate organisms if:
(i) The recipient organism can directly or indirectly injure, cause
damage to, or cause disease in plants or plant products; or
(ii) The GE organism has been engineered in such a way that it may
increase the potential for it to be a plant pest: or
(iii) The risk that the GE organism poses as a plant pest is
unknown, or
(iv) The Administrator determines that the GE organism poses a
plant pest risk.
Under the current regulations, there is no explicit statement of
the relative responsibilities of the Administrator and regulated
parties in determining whether an organism met the definition for
regulated article and therefore would be subject to the regulations.
Under the proposed regulations, the responsible person for a GE
organism could correctly apply the criteria in Sec. 340.0 to determine
whether the GE organism is subject to the regulations. Alternatively,
[[Page 60012]]
the Administrator could determine any GE organism to be regulated after
determining that the GE plant poses a plant pest or noxious weed risk.
In many cases, it will be very straightforward for a responsible
person to apply these criteria and determine that a GE organism is
subject to the regulations. For example, the GE organism would clearly
be subject to the regulations if the recipient organism were a plant
pest or noxious weed. A GE organism would also clearly be subject to
the regulations if there was little data or previous experience
available concerning the recipient organism's plant pest or noxious
weed potential, or the type of modification, with the result that it is
difficult to do a reliable evaluation of the risks that the GE organism
may be a plant pest or noxious weed.
In other cases, it may not be readily apparent to the responsible
person for a GE organism whether or not the organism falls within the
scope of Sec. 340.0 and is regulated. For this reason, persons who are
not sure about whether a GE organism falls within the regulations or
who maintain that a particular GE organism is not subject to the
regulations based on their belief that it is not an organism within the
scope of Sec. 340.0 may consult with APHIS.
A GE organism may be within the scope of the regulations based on
the information available at the time of the determination, which is
usually less information than is available when the Administrator
evaluates, for example, whether a regulated GE organism should be
considered for an exemption from the requirement for a permit, or
should be considered for a determination of nonregulated status (see
discussion of Sec. 340.6 below regarding nonregulated status). In
other words, this scope determination has one purpose (to determine
whether regulation is necessary at all) and is based on one level of
knowledge about a GE organism, while determinations regarding such
things as necessary permit conditions or exemptions or nonregulated
status have a different purpose and are based on a different level of
knowledge about a GE organism.
It is important to note that while a GE organism may be within the
scope of the regulations due to certain identified plant pest or
noxious weed risks, it may also be within the scope of the regulations
if there is not enough information about the GE organism's potential
plant pest or noxious weed risks to make a decision regarding those
risks. At the early stages of developing a GE organism, there may not
be sufficient information available about the organism to clearly
determine the potential associated plant pest or noxious weed risks.
Unknown risks might lead to a determination by the Administrator that a
GE organism should be subjected to regulatory oversight if APHIS lacks
familiarity with the non-transformed recipient organism or the
introduced trait.
The proposed scope makes it clear that the mere act of genetic
engineering does not trigger regulatory oversight or mean that a GE
organism will pose risks as a plant pest or noxious weed. Instead, it
clarifies that APHIS would subject a GE organism to regulatory
oversight based upon known plant pest and noxious weed risks of the
parent organisms, or based upon the traits of the GE organism, or based
upon the possibility of unknown risks as a plant pest or noxious weed
when insufficient information is available.
Consultation With APHIS Regarding the Scope of These Regulations
The criteria described in the scope should help developers form a
reasonable expectation as to whether their GE organism is within the
scope of the regulations, based on the nature of the parent organisms,
the engineered traits, and the amount of information available
regarding the organism and similar organisms.
APHIS anticipates that initially the range of GE organisms that the
Administrator may determine to be covered by the proposed regulatory
scope will be broad. This will be due to both an initial measured
implementation of the revised regulatory oversight as well as to the
application of the scope criteria to the transformed organisms and
recipient traits. Over time, the range of GE organisms subject to
oversight is expected to decrease as APHIS becomes more familiar with
these organisms and receives information from which it can reach a
conclusion that these GE organisms or groups of organisms do not
present increased or unfamiliar plant pest or noxious weed risks.
Because the Administrator may make such a determination at any time the
Administrator receives information that a GE organism is within the
scope, APHIS expects that developers will seek early consultation with
APHIS on whether the regulatory scope covers their GE organism. Since
it is generally necessary for research or business plans to include, as
early as possible, elements addressing regulatory processing, approval,
and compliance, it will be in the interest of the developers to
determine the regulatory status of their GE organism prior to
contemplating its movement or environmental release. Therefore, APHIS
will offer to consult with a developer of a GE organism regarding
whether the GE organism is within the scope of the proposed
regulations.
After consultation and review of available information, the
Administrator will respond in writing as to whether the Administrator
has determined that the GE organism is within the scope of the
regulations. APHIS plans to make information publicly available by
posting and maintaining information on its Web site about the
determinations it makes pursuant to this consultation process to help
the public and regulated entities understand which organisms are
subject to the regulations.
We welcome suggestions from the public on the most appropriate ways
to provide administrative guidance to the public on the issue of which
GE organisms are within the scope of the regulations. The Agency is
especially interested in ways which will balance transparency with the
efficient use of Agency resources in conducting consultations and
communicating information to the public regarding which GE organisms
are within the scope of the regulations.
Organisms Specifically Excluded From the Scope of the Regulations
Specifically excluded from the proposed regulatory scope are GE
microorganisms that are regulated as biological control organisms by
the EPA under provisions of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). APHIS concludes that there is no need for such
GE organisms to be evaluated by both agencies. EPA is already
evaluating the environmental safety of such organisms with respect to
their impact on the entire environment, including plants. We also
propose to retain an exclusion from the current regulations for GE
microorganisms where the recipient microorganism is not a plant pest
and which have resulted from the addition of genetic material from a
donor organism where the material is well characterized and contains
only non-coding regulatory regions.
Effect of Noxious Weed Authority on the Scope of the Proposed
Regulations
The definition of noxious weed encompasses plants that pose risks
akin to plant pests, because it includes ``any plant or plant product''
that can ``injure or cause damage to crops * * * other interests of
agriculture * * * or the environment'', but also includes plants that
can pose harm to non-plant organisms, such as humans. Therefore
[[Page 60013]]
evaluation of noxious weed risk expands what we can consider, while
still including those risks examined under the plant pest approach.
When considering risks associated with a GE plant, we would continue to
consider whether it can harm plants, as well as whether it can cause
the other types of physical harm or damage described in the definition
for noxious weed.
The first consideration in determining if a plant is a noxious weed
is identifying what direct injury or damage (physical harm) the plant
causes. If direct harm or damage is established, the next consideration
is to evaluate any indirect damage the plant may cause to interests of
agriculture, irrigation, navigation, the natural resources of the
United States, the public health, or the environment. In general,
federally listed noxious weeds are plants that are likely to be
aggressively invasive, have significant negative impacts, and are
extremely difficult to manage or control once established.
The distinction between a weed and a noxious weed warrants
emphasis. ``Weeds,'' in the broadest sense of the word, could include
any plant growing where and/or when it is unwanted; even plants that
are desirable in some settings may be considered weeds in others. In a
narrower sense, weeds are invasive, often non-native, plants which
impact natural and managed ecosystems, often with significant negative
consequences due to lost yields, changes in management practices,
altered herbicide use, etc. Only a fraction of these problematic weeds
are considered to be so invasive, so harmful, and so difficult to
control that Federal regulatory intervention to prevent their
introduction or dissemination is justified, and these are the focus of
the regulatory controls placed on them by APHIS. However, any weed, and
virtually any plant or plant product, can be evaluated by APHIS to
determine whether its characteristics and potential impacts warrant its
listing as a noxious weed.
APHIS currently lists 98 aquatic, terrestrial, or parasitic plant
taxa as noxious weeds. The species included in the list illustrate the
kinds of plants APHIS considers to be sufficiently invasive, damaging,
and difficult to control to be deemed noxious weeds. Table 1 describes
some specific examples from the Federal noxious weed list and the kinds
of impacts noxious weeds can have, to illustrate the types of effects
APHIS will be looking for when evaluating whether GE plants reviewed
under part 340 have any potential noxious weed traits. The experience
and precedents developed by the APHIS-PPQ noxious weed program provide
a guide for the regulation of plants that may be noxious weeds, and we
intend to apply it to the consideration of GE plants in the same way.
Table 1--Examples of Impacts Caused by Federally Listed Noxious Weeds
------------------------------------------------------------------------
Description of
Impact impact Example species
------------------------------------------------------------------------
Lost productivity of crop Noxious weeds may Cogongrass (Imperata
fields. directly compete cylindrica) infests
with crop plants over 20 crop
for limited species; it releases
resources, chemicals into the
dramatically soil that suppress
reducing yields. crop growth and
causes damaging
puncture wounds to
plant roots, bulbs,
and tubers. Other
examples include
Benghal dayflower
(Commelina
benghalensis), red
rice (Oryza spp.),
and kikuyugrass
(Pennisetum
clandestinum).
Parasitic damage to crops..... Parasitic plants Federally listed
can cause noxious parasitic
significant plants include the
reductions in dodders (Cuscuta
yield by spp.)--with common
attaching names like
themselves to a strangleweed,
host plant, devil's-guts,
removing hellbine, and
nutrients and witch's hair--and
ultimately witchweed (Striga
killing it. spp.), which causes
devastating losses
in corn, sorghum,
and rice.
Reduced productivity of Grazing animals Serrated tussock
pasture. may avoid (Nassella
noxious weeds trichotoma) has
and consume the heavily infested
more favorable large areas, leaving
pasture species, them completely
resulting in incapable of
increased supporting
noxious weed livestock.
populations at
the expense of
more favorable
species. Noxious
weeds may also
outcompete
desirable
pasture species.
Injury to humans or livestock. Many noxious Cape tulip (Homeria
weeds are toxic, spp.) contains a
harming humans cardiac glycoside,
or livestock which can be fatal
either when to livestock.
consumed or by Contact with giant
direct contact. hogweed (Heracleum
mantegazzianum)
causes painful skin
blisters. Three-
cornered jack (Emex
australis) and
devil's thorn (Emex
spinosa) both bear
spiny fruits that
can cripple or cause
injury to livestock
or other animals.
Unchecked overgrowth.......... Noxious weeds may Mile-a-minute vines
be capable of (Mikania cordata and
completely M. micrantha) can
dominating the entirely smother
landscape and fields and forests
preventing the in a dense, tangled
use of mass of vines. A
cultivated or single plant of the
pasture lands aquatic weed giant
for agriculture. salvinia (Salvinia
spp.) can blanket 40
square miles in 3
months, and produce
an underwater mat 3
feet thick.
Physical obstructions......... Growth rate and Certain mesquites
habit of some (Prosopis spp.),
noxious weeds jointed prickly pear
may physically (Opuntia
hamper the aurantiaca), and
movement of African boxthorn
livestock and (Lycium
humans, or ferocissimum) form
interfere with impenetrable
navigation of thickets filled with
waterways. thorns or needles,
blocking the
movement of grazing
animals, injuring
them or preventing
access to food and
water.
Disruption of water flow...... Aquatic noxious Notable examples
weeds may include hydrilla
disrupt water (Hydrilla
flow, adversely verticillata), giant
affecting salvinia (Salvinia
irrigation, spp.), and Chinese
drainage and waterspinach
flood control (Ipomoea aquatica).
canals, city Dense mats of oxygen
water intakes, weed (Lagarosiphon
and recreational major) can
water use. completely shut down
operation of
hydroelectric
plants.
[[Page 60014]]
Habitat alteration............ Noxious weeds may Infestation of lakes
severely alter and ponds with
water quality by hydrilla (Hydrilla
changing oxygen verticillata) can
and nutrient alter aquatic
content, may ecosystems so
dramatically drastically that
lower local native plants are
water tables, or entirely eliminated,
could so rendering the
significantly habitat unsuitable
outcompete or for fish and other
overgrow other wildlife.
vegetation
resulting in a
complete
ecological shift
of the habitat.
------------------------------------------------------------------------
As discussed above, APHIS' determination that a plant is a noxious
weed is based on notable physical harm or injury caused by the plant.
The elements of the noxious weed definition include a number of
interests that might be damaged by noxious weeds including not only
plants but irrigation, navigation, the natural resources of the United
States, the public health, the environment and interests of
agriculture. Often APHIS quantifies the physical harm or injury in
terms of economic losses. Loss in commodity value due to the presence
of noxious weeds in seeds, for example, is a consequence of the
anticipated physical damage that would be caused if the seed containing
a noxious weed were distributed and planted; the economic loss is never
simply the result of market preference to have commodities free of
certain noxious weed seeds in and of itself, in the absence of any
potential physical damage or harm. APHIS does not consider significant
economic effects alone that are not linked to physical damage to be
sufficient to determine a plant is a noxious weed.
Certainly, some noxious weeds can cause physical harm to the health
of humans or livestock and other animals. In general, these impacts
occur when individuals come into direct contact with the noxious plants
or plant parts, which may cause physical injury or are toxic or
otherwise harmful when consumed. Conceivably, noxious weeds growing in
crop fields could potentially threaten public health, for example, if
toxic parts of the noxious weeds are harvested and inadvertently enter
the food supply. If such toxic or otherwise harmful noxious weed parts
were found in food and caused the food to be ``adulterated'' within the
meaning of the FFDCA, FDA could take regulatory action against the
food.
Whereas APHIS has no direct role in evaluating the safety of foods,
the agency plays an important supporting role in safeguarding the food
supply by protecting the health of plants and animals at the farm
level. When evaluating whether a particular GE plant may be a noxious
weed because it poses a public health risk when growing in the
environment, APHIS considers toxicity and other food safety
information, including the type reviewed by EPA and FDA. In the case of
GE plants, APHIS would not assess the safety of the GE plant for human
or animal consumption, but would consider available information about
toxicity and other food safety information in assessing noxious weed
risk posed by the plants growing in the environment.
It should be noted, moreover, that most GE plants that APHIS has
been regulating in the past, such as varieties of GE corn and soybeans
modified with common agronomic traits, do not qualify as ``noxious
weeds''. But with the increasing diversity of both agronomic and non-
agronomic traits being engineered into plants it is appropriate to
place regulatory controls upon GE plants proportionate to the
likelihood that they may present a noxious weed risk until the
potential risk can be appropriately evaluated.
How Non-Plant, Non-Vertebrate GE Organisms Fall Within the Scope of the
Regulations
The proposed revision of the regulations retains control for
potential plant pest risks posed by non-plant, non-vertebrate GE
organisms. We would continue to explicitly use the plant pest
provisions of the PPA for regulating non-plant, non-vertebrate GE
organisms which align with the taxa listed in the PPA definition of
plant pest. In its reviews of GE non-plant and non-vertebrate species,
APHIS will continue to assess GE insects, fungi, bacteria, and other
non-plant, non-vertebrate organisms for their potential to pose risks
as plant pests.
The scope of the regulations as defined above makes it clear that
it is the Administrator, and not the public, who determines whether a
non-plant organism is within or outside the proposed scope of the Part
340 regulations. APHIS welcomes public comment on the proposed concise
criteria that the Administrator would consider when concluding that a
GE organism is not a plant pest. We envision providing additional
information on the Administrator's interpretation on such criteria at
the time of the final rule or in subsequent administrative guidance.
GE Vertebrate Animals Do Not Fall Within the Scope of the Regulations
Although the PPA definition of plant pest includes the potential
for a nonhuman, vertebrate animal to be considered a plant pest, APHIS
decided at this time that there are no demonstrated risks or pending GE
animal developments indicating that it is necessary for the proposed
regulations to evaluate vertebrate GE animals as potential plant pests.
Because other statutory authorities exist for addressing GE animals,
APHIS could guard against any plant pest risks that might be presented
by GE vertebrate animals without directly regulating them under the
regulations in part 340. On the other hand, we propose to regulate GE
invertebrate animals under part 340 because many classes of
invertebrates include known plant pests (e.g., insects, arachnids,
nematodes, gastropods, etc.).
How GE Biological Control Organisms (BCOs) Fall Within the Scope of the
Regulations
The PPA defines biological control organism (BCO) as ``any enemy,
antagonist, or competitor used to control a plant pest or noxious
weed'' (7 U.S.C. 7702(2)). The PPA gives the authority to regulate
plant pests and noxious weeds, not specifically biocontrol organisms.
APHIS recognizes that BCOs may have the potential to affect populations
of noxious weeds or plant pests, or become plant pests themselves. To
fall within the scope of the proposed regulations, the GE BCO would
have to pose a threat as a plant pest or noxious weed. There are
relatively few examples today of GE BCOs, but these may become more
common in the future. For example, some researchers are developing GE
biological control pink bollworms that
[[Page 60015]]
are sterile, which achieve their controlling effect by reducing the
ability of fertile, non-GE pink bollworms to produce offspring. Such GE
pink bollworm BCOs would fall within the scope of the proposed
regulation, because they are plant pests. Although there are currently
no examples of using GE plants as BCOs, such a GE plant would be
evaluated under the proposed regulations to evaluate whether it is a
noxious weed or a plant pest.
Currently, the federal regulation of microbial BCOs is regulated by
EPA under FIFRA, and this covers GE as well as non-GE microorganisms
used to mitigate the effect of pests. Unlike the PPA, which limits the
definition of BCO only to organisms used to control plant pests and
noxious weeds, FIFRA covers microorganisms used as biological control
for any pest. APHIS considers it duplicative to have these regulations
include GE microbial BCOs under its scope since FIFRA already
adequately covers them, so APHIS is proposing that the regulatory scope
language in Sec. 340.0(d) would explicitly exclude GE microorganisms
if they are already being regulated as BCOs by EPA under FIFRA. We are
proposing to only regulate GE BCO macro-organisms that fall under the
proposed regulatory scope (APHIS-PPQ currently regulates the macro-
organism non-GE BCOs used to control plant pests and noxious weeds
pursuant to other regulations). APHIS welcomes public comment on this
aspect of its proposal.
Intrastate Movements of GE Organisms Between Contained Facilities and
Activities in Contained Facilities Do Not Fall Within the Scope of the
Regulations
Under the current regulations, certain GE organisms are only
regulated by APHIS if they are imported, moved interstate, or released
into the environment. The regulations do not govern intrastate
movements between contained facilities such as laboratories, nor do
they govern such activities as creating GE organism in a contained
research laboratory. The proposed revision does not change this aspect
of the regulations.
2. Deleting the List of Organisms Which Are or Contain Plant Pests
In Sec. 340.2 of the current regulations, there is a list of taxa
that are considered to be plant pests. Under the proposed scope, this
list is not needed because we would not use taxonomic classification of
donor and recipient organisms to determine if a GE organism is
regulated. When in the course of evaluating a GE organism APHIS
considers whether a donor or recipient species is likely to be a plant
pest or noxious weed, we would consider the most up-to-date pest
information maintained by PPQ. This information is more specific than
the information in the list of plant pest taxa in the current
regulations, and should be more useful and reliable than static lists
of taxa. APHIS welcomes public comment on deletion of the taxa list and
preferred sources of plant pest and noxious weed information for use
under the proposed regulations.
With deletion of this list from the regulations, there is also no
longer a need for the procedure currently described in Sec. 340.5 for
amending this list.
3. Regulating Whole Organisms, Parts, and Nonliving Products
APHIS proposes to clarify the regulated status of nonliving plant
products in the regulations. First, the PPA defines a plant pest only
as any living stage of any of the articles specifically named in the
plant pest definition that can directly or indirectly injure, cause
damage to, or cause disease in any plant or plant product. Moreover,
APHIS does not consider most GE organisms or parts of GE organisms
which cannot reproduce to present a risk as plant pests or noxious
weeds.
Conversely, we would regulate importation, interstate movement and
release into the environment of GE seedlings, seeds, tubers, cuttings,
bulbs, spores, etc., because there is a reasonable, albeit small,
possibility of reproduction, establishment, and spread if these were
deliberately or accidentally released into the environment without
authorization.
Viable pollen from GE plants imported, moved interstate, or
released into the environment would be subject to the regulations
because such movements of pollen can reasonably lead to genomes
becoming established in the environment. Similarly, in circumstances
where an article incidentally contains viable pollen, during movement,
APHIS would consider the movement regulated. There are many cases,
however, when pollen may be present but is no longer capable of
producing offspring, e.g., nonviable or immature pollen. In such cases,
APHIS would not require permits under this part. The commercial
distribution of cut flowers is one pollen movement situation that APHIS
has considered in light of the regulations, especially in cases where
the flowers are grown in other countries then imported only as cut
flowers. APHIS considers these circumstances to pose little, if any
risk, and therefore would not require permits for these activities.
The PPA defines a noxious weed as encompassing both plants and
plant products. A plant product is defined as ``any flower, fruit,
vegetable, root, bulb, seed, or other plant part that is not included
in the definition of plant; or any manufactured or processed plant or
plant part.'' APHIS has regulated GE organisms under part 340 for over
20 years, and there is no strong evidence to suggest the need to
regulate nonliving (nonviable) plant products in most cases. However,
if in a specific case the importation, interstate movement, or
environmental release of nonliving products of a GE plant may pose
noxious weed risks, APHIS has clear authority to address those risks by
imposing permit conditions on the handling of such nonliving products
of the GE organism in the permit issued for the associated living GE
organism. The proposed regulations state clearly in Sec. 340.3(b) that
the Administrator may also assign permit conditions addressing
nonliving plant materials associated with or derived from GE organisms
when such conditions are needed to make it unlikely that the nonliving
materials would pose a noxious weed risk. APHIS invites consultation
from any person considering a movement or release of nonliving
materials derived from a GE organism who is uncertain as to whether it
would be regulated.
B. Permits for Authorizing Importation, Interstate Movement and Release
Into the Environment of Certain GE Organisms
1. Elimination of the Notification Procedure
APHIS first added the notification procedure to the regulations in
1993 as an administratively streamlined procedure for certain GE plants
that met the eligibility criteria described in the regulation. Rather
than using customized requirements, like the permit conditions used for
the permitting procedure, the notification procedure uses generalized
performance standards that are described in the regulation itself. The
use of the performance standards that do not vary from one notification
to the next is one of the ways that the more rapid administrative
turnaround was achieved. In some ways, the term ``notification'' has
been misleading to the public, since they do not realize that sending a
notification does not mean automatic authorization by APHIS.
APHIS reviews notifications to verify that the GE plant meets the
eligibility criteria, and also evaluates whether the
[[Page 60016]]
proposed importation, interstate movement or environmental release can
be done in a manner that meets the performance standards described in
the regulation. In many ways, these APHIS evaluations for notifications
are very similar to those done for permit applications, but the
notification procedure relies on applicants agreeing to meet the
performance standards described in the regulation rather than
submitting an application for APHIS review describing the specific
measures they will employ for the activity (as is the case for
permits). With permits, but not with notifications, APHIS can accept
the proposed measures or add to them and the result is a set of binding
customized permit conditions.
Because the notification procedure uses only the performance
standards in the regulations, it is more administratively streamlined,
but the general nature of the standards has made it difficult for APHIS
inspectors to determine if a notification holder is in compliance and
can also make enforcement more difficult. For example, under the
current regulations, one of the performance standards for notifications
relevant to environmental releases states that: ``The field trial must
be conducted such that (1) the regulated article will not persist in
the environment, and (2) no offspring can be produced that could
persist in the environment.'' Conversely, specific conditions which
APHIS places on permits are unambiguous, easy to verify at inspection,
and easier to enforce. A specific permit condition that could be used
to address just part of the performance standard described above might
read: ``After final harvest of the GE corn plants covered under this
environmental release permit, the site will be monitored every 4 weeks
for the emergence of volunteer corn seedlings for one year, and any
emerging volunteer plants will be devitalized before they produce
pollen. Records of the monitoring and management of volunteers must be
maintained by the permit holder and made available to APHIS upon
request.''
APHIS employs performance standards in many of its regulations,
where appropriate. For example, we propose to employ a performance
standard in another part of this proposal, container requirements for
shipments of GE organisms. In that case, it is possible to employ a
straightforward standard that the container must not break or leak when
subjected to ordinary handling in transportation. The use of
performance standards under the notification procedure has some
benefits, such as providing the responsible person with flexibility in
how the standard is met, e.g., allowing for appropriate change in
protocols used during the growing season. However, there are some
disadvantages in not specifically enumerating the specific measures
that constitute compliance with the regulations. The permitting
procedure does not have this disadvantage, because the permit
conditions specify which actions need to be taken by the responsible
person to be in compliance.
APHIS considered revising the performance standards and retaining
the notification procedure, but this would not have remedied its
shortcomings, especially the lack of specificity that is a necessity of
using broadly applicable, performance standards in the regulations.
Under the proposed regulations where all authorizations will be
done under a permitting procedure, the permit conditions will provide
more specific information about what procedures the permit holder must
follow in order to be in compliance. In the proposed rule, we are
describing in detail the types of core permit conditions that will be
imposed, plus the additional permit conditions that the Administrator
can place upon the permit holder in order to make it unlikely that
actions under the permit would result in the introduction or
dissemination of a plant pest or noxious weed.
In view of the above discussion, APHIS has determined that it would
have more flexible, risk-appropriate oversight, better regulatory
enforcement and improved transparency if all regulated importations,
interstate movements, and releases into the environment are authorized
under the permitting procedure. The use of the permitting procedure in
lieu of notifications is also necessary for APHIS to address some of
the recommendations arising from the OIG Report and the provisions of
the 2008 Farm Bill. For example, the OIG recommendations have led to
proposed provisions in the regulations that will enable APHIS to add
permit conditions to require additional reports during the course of an
environmental release, the submission of notices to APHIS if the permit
holder decides not to conduct the environmental release, and 7-day,
pre-plant notices in the case of GE plants engineered to produce
pharmaceutical or industrial substances. The last recommendation is
already being implemented as a permit condition, because all of these
authorizations are done under the permitting procedure. The OIG
recommendations cannot be implemented under the notification procedure,
because under the current regulations APHIS does not have the ability
to attach conditions to notifications. This provides additional
justification for APHIS to propose the elimination of the notification
procedure. The APHIS proposal to eliminate the notification procedure
is an effective way to address several of the provisions of the Farm
Bill, such as the changes to the requirements for recordkeeping and
reporting.
2. Revisions to Permit Procedures
APHIS proposes to reorganize the regulations to improve the clarity
of the permit application and evaluation procedures. The proposed
change is more a reorganization than substantive change, and should
enhance the transparency of the regulations to the public. The
permitting procedure will continue to identify and obtain information
relevant to evaluating the risks associated with a proposed
importation, interstate movement, or release into the environment, and
determine and document whether, and under what conditions, the activity
should be allowed. The proposed regulations related to the issuance of
permits are divided into two sections. The first is proposed Sec.
340.2, Procedure for permits, which describes permit types, the
procedure for permit application (including information requirements),
and the Agency's administrative actions for permits. The second is
proposed Sec. 340.3, Permit conditions, which describes the general
types of conditions that APHIS may add to a permit, and the obligations
of the responsible person after permit issuance.
APHIS is proposing explicit procedures for amendment, transfer of
responsibility, and revocation of permits in order to establish clear
regulatory procedures that can increase efficiency yet maintain
adequate safety. Currently the APHIS administrative practices to amend,
transfer, and revoke permits have not been explicit in the regulation,
and this addition will provide increased transparency and efficiency.
The proposed changes organize the regulations to more clearly
reflect the procedural steps in the application, evaluation, and
issuance of a permit (see Figure 1). First, the different types of
permits (importation, interstate movement, and environmental release)
are described in Sec. 340.2(b), as are new subcategories of
environmental release permits. Second, the types of information that
must be submitted with a permit application are described in Sec.
340.2(c). The permit type, as well as
[[Page 60017]]
the nature of the environmental release (if the permit is for a
release), affect the application information requirements. Third, Sec.
340.2(d) outlines the procedural and administrative steps of issuing a
permit. Finally, the attachment of conditions to permits, which is also
dependent upon permit type and release category, is described in Sec.
340.3. Each of these permit-related sections of the proposed
regulations is discussed below.
Figure 1. Schematic of activities associated with issuance and
enforcement of permits, showing associated sections of the proposed
regulation.
Permit Types and Environmental Release Categories (Sec. 340.2(b))
[darr]
Application Information Requirements, by Type (Sec. 340.2(c))
[darr]
Permit Evaluation Procedures (Sec. 340.2(d))
[darr]
Assignment of Permit Conditions (Sec. 340.3)
[darr]
Compliance, Enforcement, and Remediation Activities (Sec. 340.7)
3. Permit Types and Environmental Release Categories (Sec. 340.2(b))
As discussed above in the background section, APHIS currently uses
two procedures--notification and permits--to authorize the importation,
interstate movement and release into the environment of GE organisms
considered to be regulated articles under this part. The permitting
procedure can be used for all regulated articles, but the notification
procedure can be used only for certain GE plants that meet the
eligibility criteria described in the regulations. Whereas permits are
issued with explicit permit conditions which must be met by the permit
holder, notifications have generalized ``performance standards''
described in the regulation and therefore do not vary from one
notification to the next. Currently, approximately 90% of APHIS
authorizations are done under the notification procedure.
Under the proposed system, which would eliminate notifications,
APHIS would continue to issue three types of permits--interstate
movement, importation, and environmental release. The procedures for
the first two types of permits are relatively straightforward, and the
conditions usually required for these permits address risks that are
very similar from one shipment to another. We propose only minor
adjustments to the procedures for interstate movement and import
permits. In general, deliberate release of GE organisms into the
environment presents a greater risk of introducing or disseminating
plant pests and noxious weeds, and thus requires more careful
oversight, than shipments of GE organisms into and across the country
in secure containers. Of the three permit types, only environmental
release permits would be differentiated into broad risk-related
categories by the Administrator. This categorization would occur prior
to the detailed and specific APHIS evaluation of an individual permit
application. Table 2 summarizes the relationship of the three permit
types and categories that pertain to environmental release permits.
Table 2--Proposed Permit Types and Categories for Environmental Release
Permits
------------------------------------------------------------------------
Type Use
------------------------------------------------------------------------
Importation permit.......... For securely moving
a GE organism into
the United States.
Interstate Movement......... For securely moving
a GE organism from
any State into or
through any other
State.
Environmental Release:*..... Release Category A.. For releases into
Release Category B.. the environment,
Release Category C.. outside the
Release Category D.. constraints of
Release Category E physical
(non-plants). containment that
are found in a
laboratory,
contained
greenhouse,
fermenter, other
contained
structure, or
secure shipment.
------------------------------------------------------------------------
* In some cases, an environmental release permit may also incorporate
permits for importation or interstate movement when such movements are
incidental to the environmental release.
The proposed sorting system for environmental release permits
includes five categories: Four for releases of GE plants (Categories A-
D) and one for releases of all other GE organisms (Category E).
Releases of GE non-plant organisms (Category E) would be placed into a
single category and reviewed on a case-by-case basis. APHIS considered
the creation of smaller risk-related subcategories for non-plants, but
APHIS has received too few permit applications to warrant the creation
of these smaller groupings. Releases of plants would be grouped into
four categories, as described below.
APHIS considered a tiered permitting system which would sort
proposed environmental releases of plants into a number of risk-based
categories. Lowest risk releases would be assigned to Tier 1, slightly
higher risk releases in Tier 2, and so on. In such a system, tier
assignment is analogous to a risk rating. In developing the specifics
of implementing such a system in the regulations, however, APHIS found
that it was challenging to pre-assign all conceivable releases into
tiers representing discrete levels of risk. There are a large number of
risk factors that contribute to the overall risk associated with any
given release. These factors include reproductive biology and growth
habit of the species, potential for gene flow to other species,
phenotype engineered into the organism, familiarity with the genetic
material used, safety of any expressed products, scale of the release,
location, duration, experience, and compliance history of the
applicant, proximity to threatened
[[Page 60018]]
and endangered species, and other factors.
Sorting proposed releases considering all relevant factors would
lead to an unwieldy system with many risk-based categories, and would
essentially require a full risk assessment prior to assigning a
proposed release to the appropriate risk category. Consequently, it
would be nearly impossible for applicants and the public to predict the
risk tier to which a proposed release would be assigned.
APHIS proposes that the permitting system for environmental release
permits would assign releases into administrative categories based upon
two primary risk-related factors described below, so that the
categories would identify the general types of releases of plants which
share broadly similar risks and management issues. This initial
administrative sorting would be followed by an evaluation that fully
characterized the risk of the proposed release, which would then be the
primary basis for adding necessary permit conditions. APHIS concludes
that such a system could appropriately sort most releases into
groupings that are alike enough that they could usually be treated
similarly initially, in terms of application information requirements
and evaluation of potential risks. In most cases the initial groupings
would also result in a similar level of oversight of the release and
conditions attached to the permit-but any final determination of the
permit category, oversight and permit conditions would depend on the
results of the APHIS evaluation.
Using this approach, there is no prior conclusion that every
release within the same category poses the same level of risk.
Likewise, releases in different categories do not necessarily pose
greatly different risks. For this reason, APHIS would not refer to
these groupings as ``tiers,'' as this implies an incremental increase
in risk from tier to tier, but would instead label them as
``categories'' which are lettered and not numbered.
APHIS developed the proposed sorting scheme by first examining the
types of releases that typically are authorized under its current
regulations. APHIS then modified the categories to make them more
explicitly connected to plant pest and noxious weed risks.
The two primary factors APHIS identified as most relevant to define
its sorting system for environmental release permits were the (1)
ability of the unmodified recipient plant species to persist in the
wild and (2) potential of the engineered trait to cause harm, injury,
or damage, as described in the definitions of plant pest and noxious
weed. Secondary factors, which in some instances may change the initial
categorization, include: how the recipient plant is commonly used
(e.g., as a food or feed crop); the impact of the engineered trait on
the fitness of the GE plant; and, the degree of uncertainty associated
with the trait and its possible impacts.
Regarding the persistence factor, APHIS proposes to group plant
species according to the risk of persistence of the plant or its
progeny in the environment without human intervention. Based upon the
growth habit of the plant species and presence of wild relatives in the
United States, APHIS proposes to sort all plants into four groups,
listed in order of increasing persistence risk:
Low: Populations of the recipient plant are unlikely to
persist in the environment without human intervention, and the
recipient plant has no interfertile wild relatives in the United
States. Examples include corn, soybeans, and cotton (except in certain
areas).
Moderate: Populations of the recipient plant are known to
be weakly persistent in the environment without human intervention, or
the recipient plant has interfertile wild relatives in the United
States. Examples include alfalfa, beets, canola, rice, and tomato.
High: Populations of the recipient plant are known to be
strongly persistent in the environment without human intervention, or
the recipient plant has interfertile wild relatives in the United
States which are aggressive colonizers. Examples include creeping
bentgrass, poplar, sorghum, and sunflower.
Severe: The recipient plant is a Federally-listed noxious
weed or is known to be similarly aggressive in its ability to colonize
and persist in the environment without human intervention. Examples
include hydrilla and kudzu.
These aspects of plant biology and growth habit are broad
indicators of the increasing likelihood that the plant or its progeny
can reproduce and spread without human intervention. ``Interfertile
wild relatives'' includes both wild relatives in the traditional sense,
as well as feral populations of the same species persisting outside
agroecosystems. The distinction between ``weakly persistent'' and
``strongly persistent,'' is intended to mean survival without human
intervention for one or very few generations (weakly persistent) versus
several to many generations (strongly persistent). APHIS will clarify
which species fall into each group by publishing lists in guidance.
Similarly, with regard to the factor for potential harm caused by
introduced traits, APHIS proposes to group traits engineered into
plants into four simple groupings based upon the definitions of plant
pest and noxious weed. The groups are listed in order of increasing
potential hazard of the engineered trait:
Low:
[cir] Any new proteins or substances produced are unlikely to be
toxic or otherwise cause serious harm to humans, vertebrate animals, or
invertebrate organisms upon consumption of or contact with the plant or
plant parts; and
[cir] No morphological changes which could cause mechanical injury
or damage; and
[cir] Introduced sequences are known not to result in plant
disease, and confers no or very low increased disease susceptibility.
An example would include expression of well characterized proteins
known not to be toxic or harmful, such as a marker gene that does not
pose a food or feed safety concern, or expression of viral genes where
it is demonstrated that no protein is produced
Moderate:
[cir] Any new proteins or substances produced are unlikely to be
toxic or otherwise cause serious harm to humans or vertebrate animals
upon consumption of or contact with the plant or plant parts ; or
[cir] Novel resistance to the application of an herbicide; or
[cir] Has novel ability to cause mechanical injury or damage; or
[cir] Produces proteins or substances that are associated with
plant disease that are not prevalent or endemic in the area of release,
or that confer an increased susceptibility to disease.
Examples include expression of new CRY proteins, ,mechanisms of
herbicide tolerance (e.g., CP4-EPSPS, which confers glyphosate
tolerance), and production of viral movement proteins.
High:
[cir] Any new proteins or substances produced may be toxic or to
otherwise cause serious harm to humans or vertebrate animals, upon
consumption of or contact with the plant or plant parts; or
[cir] Produces an infectious entity which can cause disease in
plants.
Examples include mercury hyper-accumulators or production of some
pharmaceutical compounds.
Severe:
Any new proteins or substances produced are known or likely to be
[[Page 60019]]
highly toxic or fatal to humans or vertebrate animals, upon consumption
of or contact with the plant or plant parts.
These aspects of the engineered trait are related to harms or
damages associated with plant pests or noxious weeds. This takes into
consideration (1) the harmfulness of any substances produced, (2) the
possibility of creating morphological changes that would cause physical
injury, and (3) the likelihood of increasing plant disease, either due
to risk of creating novel pests or increased inoculum source. Novel
resistance to an herbicide is included in the ``moderate'' category due
to the impacts the trait could have on the ability to manage the plant
or its progeny.
The proposed use of plant growth habit and trait harm or injury as
the two main factors for the initial sorting of environmental releases
into categories uses the two factors to roughly approximate
``exposure'' and ``hazard,'' respectively. Thus, using a combination of
these two factors alone, we propose the following initial sorting of
plant-trait combinations into release permit categories (see Table 3).
Once environmental releases of GE plants have been sorted into the
permit categories shown in Table 3, we will review and evaluate the
information submitted by the applicant to determine oversight and
permit conditions. The information requested from applicants will not
be limited to these factors and is, in fact, designed to allow us to
evaluate any of the risks associated with noxious weeds and plant
pests. In some instances, our review may result in a change to the
release category assignment of a GE plant.
Table 3--Initial Sorting Into Administrative Permit Categories (A, B, C, and D) for Environmental Releases of GE
Plants, Based Upon Persistence Risk of the Recipient Plant Species and Potential Harm or Damage of the
Engineered Trait
----------------------------------------------------------------------------------------------------------------
Potential harm or damage of engineered trait
Persistence * -------------------------------------------------------
Low Moderate High Severe
----------------------------------------------------------------------------------------------------------------
Low..................................................... A A C D
Moderate................................................ A B C D
High.................................................... B B C D
Severe.................................................. D D D D
----------------------------------------------------------------------------------------------------------------
* Persistence risk of the recipient plant species.
The sorting system above presumes that there is sufficient
scientific information available about the GE plant to support the
categorization. For example, the phenotype conferred by inserted
sequences and the growth habit of the plant species in the U.S. must be
well-characterized and based upon direct empirical observation of the
genetic construct in the recipient plant species. In cases where less
(or nothing) is known about phenotype of the engineered trait in the
recipient plant species-such as inference based upon sequence
similarity, protein structure modeling, or observation of the genetic
construct in other species-the release category may be changed (from A
to B or B to C) as a result of this uncertainty. Similarly, lack of
familiarity with the plant species' behavior in the U.S. or the
techniques needed to mitigate the likelihood of its persistence could
also change the release category.
APHIS considered whether to adjust the categories table to
acknowledge that an engineered trait could affect (enhance or detract
from) the other factor axis, namely the persistence risk of the
nonmodified recipient plant. Engineered traits such as resistance to
biotic or abiotic stresses could theoretically increase the fitness of
the plant, and thereby increase the likelihood that it will persist in
the environment without human assistance. Considering the range of
persistence risks posed by all of the different plant species sorted
into any one of the proposed groupings, however, APHIS has concluded
that in most instances the engineered trait would not alter the
likelihood of persistence enough to warrant a change in initial release
category. However, in cases where the engineered trait significantly
alters plant growth habit, metabolism, or reproduction to increase the
likelihood of persistence in the environment, APHIS could change the
release category accordingly. Examples of such changes might include
converting an annual species to a perennial or converting a plant with
C3 metabolism to crassulacean acid metabolism (CAM).
The proposed category system should provide a simple, transparent
way for APHIS review information in applications to initially sort
releases into broad, risk-related categories, which can then be more
efficiently assessed for the actual risks posed by the release.
However, it should be emphasized that the categories are intended only
for initial sorting, and other factors are taken into account in the
APHIS evaluation when determining the specific permit conditions.
APHIS intends that release Category A will be associated with a
level of regulatory oversight similar to environmental release
notifications under the current system, and Categories B and C with a
level of regulatory oversight similar to various permits that have been
issued under the current system. However, it will be much clearer to
the public what types of oversight will be applied broadly within each
category. As we discussed above, oversight and permit conditions with
each category will be similar, though not necessarily identical, for
any plant within the category. Category D was created to acknowledge
the possibility that some proposed releases may pose a very high risk
of introducing a highly persistent or harmful plant into the
environment. To date, APHIS has never been requested to allow releases
that would fall into this category. If an applicant were to propose a
Category D release, APHIS would only authorize such releases after
imposing extremely strict levels of oversight akin to high security
quarantine far exceeding that of Category C that would ensure that the
GE plants could not persist in the environment. The information
requirements, permit conditions, and general levels of oversight
associated with each release Category are discussed below.
This simple sorting system places GE plants into categories and
provides a relatively clear, simple rationale for placement in a given
category. What follows is a series of illustrations of common plant-
trait combinations and the release categories to which they would be
assigned:
Category A:
[cir] Bt corn producing CRY1ab toxin. The plant is unlikely to
persist in the
[[Page 60020]]
environment and the safety of the protein has been assessed by the EPA.
[cir] Soybeans engineered with glyphosate tolerance conferred by
CP4-EPSPS. While herbicide tolerance poses a ``moderate'' hazard,
soybean has no interfertile wild relatives in the U.S..
Category B:
[cir] Corn producing a new CRY protein. The plant is unlikely to
persist and the novel CRY protein is likely to be toxic to some species
that live or feed on the plant (normally Category A), but its food/feed
safety is only inferred from similarity to other CRY proteins.
[cir] Random ``knock-out'' or antisense libraries of soybean lines.
While the lines may not likely produce novel proteins or substances
(Category A), because of the uncertainty associated with the impacts of
genetic engineering on these lines, they would be treated as Category
B. Well-characterized lines taken from such libraries that do not
produce new proteins would likely be treated as Category A.
[cir] Kentucky bluegrass engineered with glyphosate resistance
conferred by CP4-EPSPS. Herbicide resistance is a ``moderate'' hazard
and bluegrass has interfertile wild relatives in the U.S.
[cir] Pines producing an enzyme to enhance paper production. Pines
are persistent and have interfertile wild relatives in the United
States.
Category C:
[cir] Poplar engineered to produce enzymes for heavy metal
bioremediation.
Category D:
[cir] Any Federally listed noxious weed that has been genetically
engineered; any GE plant producing a vertebrate toxin.
Permits for Environmental Releases of Plants Making Pharmaceutical and
Industrial (PMPI) Compounds
APHIS considered whether to continue to issue environmental release
permits for GE plants engineered to produce pharmaceutical and
industrial compounds if the GE plant species is the same as, or
sexually compatible with, a species commonly used for food or feed.
APHIS concludes that the proposed permitting procedure and the use of
stringent permit conditions can continue to effectively minimize the
risks that may be associated with the environmental release of such GE
plants. APHIS will continue to impose permit conditions that take into
account the issues related to the safety of proteins or other
substances that these plants have been engineered to produce. Based
upon APHIS experience to date, many releases of GE plants producing
pharmaceutical or industrial substances would fall in Category C, and
would carry the same level of oversight as current permits for PMPI.
4. Permit Application Information Requirements (Sec. 340.2(c))
In the proposed regulations, we provide greater detail about the
basic application information requirements that need to be addressed in
all permit applications, as well as additional basic information
required for each permit type and the categories in the case of
environmental release permits. Under the current regulation, certain
areas where APHIS routinely needs information from the applicant do not
become apparent until the applicant submits the permit application (and
APHIS subsequently follows up for additional information). Some of the
information requirements related to recordkeeping, reporting, and
contractual arrangements among the permit holder and agents are new to
the regulation and reflect, in part, certain provisions of the 2008
Farm Bill and also align with recommendations of USDA's OIG 2005
Report. For example, the OIG recommendations have led to provisions
that will enable APHIS to require geographic coordinates for the
locations of environmental releases.
The differences between the information required for an application
under the current regulations versus the proposed regulations may be
seen by comparing current Sec. 340.4 to proposed Sec. 340.2(c). Both
the current and proposed application procedures require information
characterizing the nature of the GE organism, including detailed
molecular biology information about the expression of the introduced
genetic material. They also both require information about the type of
movement and/or release planned. The proposed rule requires more detail
in some of these areas, and more description of the applicant's plans
and methods to prevent unauthorized releases, and to respond to
unauthorized releases if they occur. This information is used in part
by APHIS to formulate the specific permit conditions. In cases where
the permit is for environmental release, and would be in permit
categories C or D according to the table in Sec. 340.2(b)(3), a
greater level of detail would be required for almost all aspects of the
activity, including the recipient organism, the inserted gene(s), site
location and management practices, and training and communication among
the permit holder and agents involved in the activity covered under the
permit. This information would also address the capability of the
organism to persist or spread in the environment, or include details
about how the engineered traits might be harmful.
5. Permit Conditions (Sec. 340.3)
Conditions are specific practices or requirements that an applicant
must follow upon issuance of a permit. Under the current regulation,
the permit conditions are described in the same section as the permit
procedure itself. In the proposed revision, the permit conditions are
enumerated in a separate section (Sec. 340.3) to accommodate the
additional details to describe conditions for the three permit types as
well as the categories of environmental release permits.
The use of permits and permit conditions gives APHIS and the
responsible person a clearer understanding as to what actions must be
taken for the permit holder to comply with the regulation. In the
proposed regulation, APHIS has strived to provide as much transparency
and predictability as possible about permit conditions while retaining
sufficient flexibility so that the regulations will be adaptable in a
broad range of cases.
Permits will be issued with the core permit conditions described in
Sec. 340.3(a), which are a minimum set of basic conditions for
importation, interstate movement, and release. The Administrator may
add to these conditions additional or expanded conditions when
necessary to make it unlikely that actions under the permit would
result in the introduction or dissemination of a plant pest or noxious
weed.
The Administrator will assign the permit conditions in a manner
that is commensurate with the risk of the individual proposed movement
or release. Additional or expanded permit conditions may include, but
are not limited to, specific requirements for: reproductive, cultural,
spatial, temporal controls; monitoring; post-termination land use; site
security or access restrictions; and management practices such as
training of personnel involved in the release.
The proposed description of permit conditions elaborates on the
``standard'' permit conditions found in the current regulations, and
the additional detail is designed to better communicate with potential
applicants what the requirements are likely to be for their particular
permit, and will better support administration of the program,
including compliance and enforcement.
In the current regulation, only ``standard'' permit conditions are
described, and APHIS has the authority to place other conditions upon
the permit as deemed necessary by the
[[Page 60021]]
Administrator. The proposal for permit conditions will be more
transparent to the public and this transparency will better facilitate
planning by researchers, especially those who have not previously
received permits from APHIS.
The proposed required core permit conditions consolidate six
primary areas addressed in different parts of the current regulations
to ensure compliance with the regulation and to make it unlikely that
the permitted activity will result in the introduction and
dissemination of a plant pest or noxious weed: Identity, shipment,
unauthorized dissemination, communication and training, records,
reports and notices. APHIS intends the list of specific condition areas
we propose in Sec. 340.3 to be used for all permits we issue as they
apply to importation, interstate movement, and release into the
environment. The required permit conditions listed in Sec. 340.3
represent the permit conditions that we propose to apply for any type
of permit. Listing them in the regulations should provide applicants
with the ability to plan their activities with knowledge of the primary
requirements for all activities that would have to be met to comply
with the regulations.
For environmental release permits, proposed Sec.
340.3(a)(4)(iii)(F) would also require the permit holder to notify
APHIS seven days prior to initiation of the release if the release is
Category C or D. For all Categories, permit holders are required to
notify APHIS if they do not conduct the release.
The current regulations require environmental release permit
holders to submit field test reports to APHIS within 6 months after
termination of a field test. Under proposed Sec. 340.3(a), the
requirement simply states that the responsible person shall submit
reports to APHIS at the times specified in the permit conditions and
containing the information specified in the permit conditions.
APHIS is also proposing revision of the regulations to clarify the
procedure it would use for amendment of permit conditions, transfer of
a permit to a different responsible person, and revocation of an
existing permit. Each of these additions to the regulations reflect
current administrative practices and the incorporation of these into
the regulations will make the overall system more transparent.
Currently, APHIS attaches conditions to permits at the moment the
permit is issued to the applicant. Under the current regulations, the
permitting procedure does not include a formal acknowledgement from the
applicant prior to permit issuance that they are aware of and consent
to the permit conditions. To verify that applicants are aware of and
willing to abide by the conditions, APHIS proposes to add an additional
administrative step in the permit procedure in Sec. 340.2(d)(6) to
support administration of the program. We are proposing to require that
applicants agree prior to permit issuance that they will comply with
all the permit conditions. Eventually, APHIS would build this feature
into the existing ePermits system, and in the interim it would provide
alternative mechanisms, such as e-mail communications, to implement
this step of the permitting procedure.
APHIS is also proposing to clarify in Sec. 340.2(h) of the
regulations the procedure to be used when amendment of existing permit
conditions is sought by the responsible person or required by APHIS, as
well as the procedure for transfer of an existing permit to a different
responsible person.
As with the current regulations, APHIS is retaining the flexibility
to modify permit conditions as needed under individual circumstances.
Proposed Sec. 340.3 will increase transparency, yet still allow
sufficient adaptability of the regulations for the full range of permit
applications APHIS expects to receive today and in the future. APHIS
recognizes that transparency and predictability for applicants must be
balanced with maintaining Agency flexibility and adaptability for years
to come under these regulations. APHIS encourages the public to comment
on the choices we are proposing here, and we welcome suggestions for
alternative approaches.
APHIS is proposing to revise the current sections of the
regulations for container requirements for shipments of GE organisms
(Sec. 340.8) and marking and identity requirements for imports of GE
organisms (Sec. 340.7). Rather than the highly prescriptive approach
in the current regulation, we will use an approach that is performance
based and can be adapted to the activity that is being performed. This
should provide greater efficiency for the public as well as APHIS, yet
still achieve the necessary level of containment during shipments. We
have reorganized this information in the regulations so that the
requirements are associated with the related activity under the
proposed regulation. For example, the shipping requirements for
interstate movements under the conditional exemption have the requisite
shipping conditions stipulated in the section for conditional
exemptions. Likewise, the shipping conditions for import and interstate
movement permits have been placed in the section for permit conditions,
rather than retaining them in a separate section as in the current
regulations. The performance-based standards we are proposing
incorporates a simple performance standard in our proposed definition
of secure shipment, discussed below: ``Shipment of a package of
sufficient strength and integrity to withstand leakage of contents,
shocks, pressure changes, and other conditions incident to ordinary
handling in transportation.'' APHIS is also proposing to require
applicants to provide their proposed methods of secure shipment, and
APHIS will specify the methods of secure shipment as a permit
condition.
APHIS proposes to eliminate the marking and identity requirements
for imports of GE organisms as a separate section of the regulations
(current Sec. 340.7). As with the container standard issue discussed
above, appropriate labeling and related requirements would be highly
individual depending on the organism, type of permit, and other
conditions.
APHIS is proposing to include relevant tribal officials when it
provides copies of permit applications to state regulatory officials.
The current regulations state that APHIS provides this information to
state regulatory officials.
6. Elimination of Courtesy Permits
APHIS is also proposing to eliminate the issuance of courtesy
permits. Courtesy permits have been part of the regulations since their
inception in 1987, but in an effort to better allocate APHIS resources,
APHIS is proposing to remove this regulatory feature. The current
regulations provide the ability for APHIS to issue ``courtesy
permits,'' in order to facilitate the movement of organisms which are
outside the scope of these regulations, but whose movement might
otherwise be hindered because of their similarity to organisms
regulated under these regulations. The issuance of courtesy permits has
generated confusion in the public and especially in the research
community. The application form for courtesy permits is identical to
the application for other types of permits, and the courtesy permit
itself looks like other permits. This has led to the widespread
misunderstanding by some researchers that courtesy permits are actually
required for the movement of certain organisms, or that issuance of a
courtesy permit removes the requirement for applicants to have other
authorizations which may be required, under plant
[[Page 60022]]
pest regulations such as those found at 7 CFR part 330. APHIS commits
significant resources to the issuance of these courtesy permits for the
movement of organisms which are not subject to the provisions of part
340. APHIS will work with researchers and relevant government
regulatory officials to facilitate the transition.
APHIS will also be available for consultation by persons who
formerly used courtesy permits and other persons moving similar non-
regulated articles, to discuss how to facilitate their movement. We
also encourage the public to comment on the proposed elimination of
courtesy permits and how APHIS should work with persons moving
organisms for which we might formerly have issued courtesy permits.
C. Conditional Exemptions From Permit Requirement (Sec. 340.4)
The PPA allows the Secretary to create ``exceptions'' to the permit
requirement when the Secretary deems that a permit is not necessary.
That is, these regulated activities are allowed, under certain
conditions, without seeking prior authorization via permit. The current
APHIS regulations contain such PPA exceptions, but they are referred to
as ``exemptions'' in the regulations. The current regulations include
conditional exemptions from the requirement for interstate movement
permits. These conditional exemptions were established in the
regulations during the first few years after the regulations were first
promulgated. The last conditional exemption was established in the
regulations in 1990 for the interstate movement of GE plants of the
species Arabidopsis thaliana as long as the conditions described in the
regulations are met.
In its proposed revision to the regulations, APHIS is retaining the
existing conditional exemptions from interstate movement. We are also
proposing a new regulatory procedure that would enable APHIS to approve
new conditional exemptions more efficiently than using the procedure of
notice and comment rulemaking for each individual exemption. This can
be a transparent and efficient way to provide regulatory relief. This
new procedure for approving conditional exemptions is described in
Sec. 340.5, and it incorporates transparent steps including scientific
review, public input, and adaptability when APHIS establishes the
conditions relevant to the specific conditional exemption. Conditional
exemptions, by their nature, will always include conditions and
continued APHIS oversight to ensure that the conditions are met.
The current regulations provide for conditional exemptions from the
requirement for permits for the interstate movement of certain GE
strains of the microorganisms Escherichia coli, Saccharomyces
cerevisiae, and Bacillus subtilis, and the plant Arabidopsis thaliana
in Sec. 340.2(b), and these conditional exemptions are being retained
under the proposed regulations. Conditional exemptions from permit have
been part of the regulations since the first exemption was established
in 1988 (for the interstate movement of certain GE microorganisms),
with the addition of another conditional exemption, through rulemaking,
in 1990 for certain types of GE Arabidopsis thaliana, one of the most
commonly used plants for scientific studies and which is frequently
distributed among researchers. The essential conditions for each of
these conditional exemptions address the following: (1) Species of the
GE organism, (2) the types of genetic modifications that are allowed or
prohibited for the GE organism, and (3) the manner in which the GE
organism is shipped interstate. The existing conditional exemptions for
the interstate movement of microorganisms were based on APHIS'
conclusion that the exemption from the requirement for permits for
interstate movement of these microorganisms would ``not present a risk
of the introduction or dissemination of a plant pest'' (53 FR 12910,
p.12910).
The existing conditional exemptions for E. coli, Bacillus subtilis,
Saccharomyces cerevisiae and Arabidopsis thaliana are being retained in
the proposed regulations. APHIS has no information that would indicate
that such conditional exemption would be result in the introduction and
dissemination of a plant pest or noxious weed. The text of the
conditional exemption is being updated to place the shipping
requirements with the other conditions associated with the exemption,
instead of the current regulatory organization that has the shipping
requirements in a separate section of the regulation.
In addition to the existing conditional exemptions, APHIS is
proposing a transparent and efficient petition procedure in Sec. 340.5
whereby the Administrator may approve additional conditional exemptions
from permit without having to amend the regulations. This procedure
would provide for a scientific review by APHIS as well as the
opportunity for public review and comment on the scientific basis for
the proposed exemption and the conditions associated with the
exemption. The proposed procedure would provide an adaptable means of
ensuring that the regulatory oversight is proportional to the risks
posed by specific activities with GE organisms.
Proposed Sec. 340.5 describes the procedure whereby a petitioner
would seek a determination by the Administrator that the importation,
interstate movement, and/or release into the environment of a GE
organism is not subject to the requirement to have a permit under this
part. We propose that the Administrator's decision to approve an
exemption would be based upon a determination that the exemption from
the requirement for a permit, when conducted with the associated
conditions, is unlikely to result in the introduction or dissemination
of a plant pest or noxious weed. APHIS anticipates that creating this
new petition procedure to allow approval of additional conditional
exemptions would enhance its ability to customize regulatory oversight
to be proportional to any risks associated with importation, interstate
movement, or release into the environment of a GE organism.
Under the proposed procedure, petitioners have the flexibility to
propose various types of conditional exemptions from the requirement
for a permit: The proposal can be for one or more permit types
(importation, interstate movement, or release into the environment). In
addition, the petitioner can propose the relevant conditions. The
Administrator may approve the proposed conditional exemption as
submitted in the petition, or the Administrator may impose alternatives
to the requested exemption and conditions. The Administrator would
review the scientific information and evaluate potential risks relevant
to the proposal, then make the relevant documents (proposal and any
supporting information) available to the public for review and comment
prior to the Administrator's decision.
The information needed for a petition for conditional exemption
would depend on the nature of the exemption requested and the proposed
conditions for exemption. For example, conditional exemptions for the
interstate movement of narrowly-defined groups of organisms with
restrictive associated conditions might require considerably less
information to justify than exemptions for broadly defined groups of
organisms or less restrictive associated conditions. In making its
determination, APHIS would consider all relevant information, including
information in the scientific literature, copies of unpublished
studies, and reviews by other regulatory agencies.
[[Page 60023]]
APHIS foresees many advantages to the proposed procedure, including
scientific rigor, public involvement, and regulatory efficiency. APHIS
would continue to provide to the public the relevant scientific
information under consideration, its environmental analysis, and the
rationale for its determination. The public would also retain its
ability to provide comments to the agency prior to a decision approving
a new exemption. APHIS decisions regarding these newly approved
conditional exemptions would be published in the Federal Register and
maintained on a list accessible to the public.
In evaluating whether to approve a new conditional exemption, APHIS
would carefully consider issues related to enforceability of the
conditional exemption when proposing to approve a conditional
exemption. Unlike permit conditions, which are binding on the specific
responsible person, the conditions associated with the exemption would
apply to anyone who conducts the activity under the conditional
exemption. Before granting such a conditional exemption, APHIS would
take into consideration the likelihood that such conditions would be
followed and the consequences if they are not.
Conditional exemptions could be used, for example, for the
importation of certain GE commodities. A person could petition for an
exemption from all permits for shipments of a particular GE commodity
grain under the condition that the grain is not grown, but will only be
moved for direct use as food, feed, or for processing. The proposed
procedure to approve new exemptions would be sufficiently adaptable
that it can consider approving exemptions for the shipment of certain
GE commodities that would take into account any conditions necessary to
make it unlikely to result in the introduction and dissemination of
plant pests or noxious weeds.
APHIS considered proposing specific criteria in the regulations
that the Agency would use when evaluating potential risks of imported
GE commodities which are viable propagules such as grains like corn,
wheat, etc. APHIS considered that such a criterion-based system in the
regulations might allow APHIS to conduct expedited reviews of imports
that met the specified criteria. APHIS considered criteria such as
whether the GE plant had undergone a safety review in a foreign
country, whether APHIS had granted nonregulated status to something
similar, and the likelihood that the commodity could be propagated
(seeds, fruit with seeds, nonviable products like flour, etc.).
However, at this time APHIS is not proposing such criteria in the
regulation. APHIS does not rule out the possibility of developing such
a criterion-based system in the future. We welcome comments from the
public on this issue.
We are also proposing regulatory procedures whereby the
Administrator may revoke any exemption under this part after it is
approved. As proposed, the Administrator may revoke any exemption if
the Administrator receives information subsequent to approving the
exemption and makes a determination based upon this information that
the circumstances have changed such that the exemption is likely to
result in the introduction or dissemination of a plant pest or noxious
weed. A revocation may not be appealed. However, any person may file a
new petition in accordance with Sec. 340.5 regarding the same or
similar organisms covered by the exemption if new information relevant
to the revocation becomes available.
In addition to this procedure for completely revoking an exemption
so it would be unavailable for use by any person, we propose to add a
provision in paragraph (e) of the conditional exemptions section, Sec.
340.4, under which the Administrator may revoke the right of an
individual person to use an exemption without revoking the exemption
for other persons. The Administrator could revoke an individual's right
to use an exemption after determining that the person or any agent of
the person has failed to comply at any time with any provision of this
part.
D. Petitions for Nonregulated Status (Sec. 340.5)
The current regulations include a procedure by which anyone may
petition APHIS to grant ``nonregulated status'' to a GE organism, which
means it would no longer be subject to the regulations in part 340.
This nonregulated status is different from that of regulated articles
that might be conditionally exempt from the requirement for a permit
when moved interstate (following the conditions specified in the
regulations).
Published APHIS decisions made under the current regulations have
used different ways to express the basic standard ``unlikely to pose a
plant pest risk'' in determining whether to grant nonregulated status
to a specific GE organism. In its determinations, APHIS has conveyed
the basic standard of ``unlikely to pose a plant pest risk'' by
concluding that the GE organism ``poses no more of a plant pest risk
than its non-genetically engineered counterpart,'' ``will not pose a
plant pest risk''; or that there is ``no plant pest risk,'' or ``no
direct or indirect plant pest effects.'' Regardless of the phrases used
in its determination of nonregulated status to date, APHIS has applied
the same basic evaluation criteria to each determination to conclude
that the GE organism is unlikely to pose a plant pest risk and
therefore is not subject to the part 340 regulations.
APHIS is proposing revisions to Sec. 340.6 that will clarify the
petition procedure, information requirements for petitions, and the
standard upon which the Administrator will make a determination that a
GE organism is approved for nonregulated status. Under the current
regulations, the basic standard for a determination of nonregulated
status of a GE organism has been related to plant pest risk. In Sec.
340.6(b)(4) of this proposed rule, we are proposing to apply a similar
basic standard derived from the proposed regulatory scope in Sec.
340.0(a), namely, whether the GE organism is unlikely to be a plant
pest or noxious weed.
The current regulations also have a provision at Sec. 340.6 to
extend a determination of nonregulated status and grant nonregulated
status to a GE organism based on the similarity of the GE organism to
an antecedent GE organism that has already granted nonregulated status
(Sec. 340.6(e) ``Extensions to determinations of nonregulated
status''). This provision has been in the APHIS regulations since 1997
and has been used fifteen times to grant nonregulated status to
additional GE plants based on similarity to their antecedents. This
existing ``extension procedure'' was designed for APHIS to take into
account the previous evaluation conducted by APHIS and thereby afford
the potential for expedited evaluations of a petition for extension.
The extension procedure has some administrative aspects which are
streamlined but in practice the APHIS scientific reviews for extensions
are similar to those of the antecedent organism.
Some members of the public have misunderstood the nature of the
extension procedure, believing that APHIS has not conducted a thorough
scientific review. Some members of the public have misconstrued the
term ``extension'' to conclude that an extension would extend the
duration of nonregulated status (nonregulated status is not granted
with an expiration date).
For these reasons, APHIS is proposing to eliminate the extension
procedure in
[[Page 60024]]
the regulation. APHIS sees no advantage to retaining the distinction in
the regulations between reviews for antecedents and reviews for
subsequent petitions for extensions. Because the proposed revisions for
petition for nonregulated status provide a high degree of flexibility,
a separate extension procedure is not needed in the regulation. Review
of petitions under the proposed regulations will rely on previous
evaluations of similar GE organisms when they exist. APHIS foresees
that some evaluations for nonregulated status may require less time if
previous evaluations have addressed the issues relevant to a new
petition for nonregulated status.
In Sec. 340.6 we propose some revisions to the information that
the Administrator may require a petitioner to submit in consideration
of the particular petition. In the current regulation, the information
needs are described largely with respect to evaluating GE plants, but
APHIS foresees that other GE organisms may also be suitable candidates.
This provision may become more important as new commercial applications
of biotechnology emerge and new types of information are needed to
properly assess the risks associated with new types of GE organisms. In
all of the nonregulated status requests processed to date, the subject
organisms and the alterations involved did not present unanticipated or
completely novel approaches and APHIS was able to make a determination
based on information in the petitions. When needed, APHIS obtained
additional information from petitioners, in a consultation process
similar to the one proposed.
We are also proposing a regulatory procedure whereby the
Administrator may revoke a previous approval of nonr |
