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[Federal Register: October 9, 2008 (Volume 73, Number 197)]
[Proposed Rules]
[Page 60007-60048]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09oc08-45]
[[Page 60007]]
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Part IV
Department of Agriculture
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Animal and Plant Health Inspection Service
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7 CFR Part 340
Importation, Interstate Movement, and Release Into the Environment of
Certain Genetically Engineered Organisms; Proposed Rule
[[Page 60008]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 340
[Docket No. APHIS-2008-0023]
RIN 0579-AC31
Importation, Interstate Movement, and Release Into the
Environment of Certain Genetically Engineered Organisms
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule; notice of public forums.
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SUMMARY: We propose to revise our regulations regarding the
importation, interstate movement, and environmental release of certain
genetically engineered organisms in order to bring the regulations into
alignment with provisions of the Plant Protection Act. The revisions
would also update the regulations in response to advances in genetic
science and technology and our accumulated experience in implementing
the current regulations. This is the first comprehensive review and
revision of the regulations since they were established in 1987. This
rule would affect persons involved in the importation, interstate
movement, or release into the environment of genetically engineered
plants and certain other genetically engineered organisms.
DATES: We will consider all comments that we receive on or before
November 24, 2008. We will also consider comments made at public forums
to be held in Davis, CA; Kansas City, MO; and Riverdale, MD.
ADDRESSES: You may submit comments by any of the following methods:
Federal eRulemaking Portal: Go to http://
www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2008-0023 to submit or view comments and
to view supporting and related materials available electronically.
Postal Mail/Commercial Delivery: Please send two copies of
your comment to Docket No. APHIS-2008-0023, Regulatory Analysis and
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118,
Riverdale, MD 20737-1238. Please state that your comment refers to
Docket No. APHIS-2008-0023.
Public Forums. Written and oral comment will be accepted
at three public forums held during the comment period. See Public
Forums below.
Reading Room: You may read any comments that we receive on this
docket in our reading room. The reading room is located in room 1141 of
the USDA South Building, 14th Street and Independence Avenue, SW.,
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except holidays. To be sure someone is there to
help you, please call (202) 690-2817 before coming.
Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Biotechnology Regulatory Services,
APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-
5710.
For information about the public forums, contact: Dr. T. Clint
Nesbitt, BRS, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-
1238; (301) 734-5673.
SUPPLEMENTARY INFORMATION:
Public Forums
In order to provide additional opportunities for the public to
comment on the proposed rule, APHIS will hold public forums in three
locations: Davis, CA; Kansas City, MO; and Riverdale, MD (see Meeting
Locations below). These informal forums are designed to engage
interested individuals from the public and elicit comments related to
the proposed rule. The format will consist of informational posters and
comment stations. Attendees will be able walk through the forum during
the open hours and interact with other attendees and APHIS personnel.
Short welcoming remarks will be given by APHIS personnel at 4:30 p.m.
and again at 6 p.m. (local time), but there is no set schedule for each
poster station, so the public may come and go at any time during the
forum period. Participants will have the opportunity, if desired, to
record brief oral comments with a court reporter or to submit comments
in writing, following directions provided at the comment stations. A
transcript of the oral comments and a copy of any written comments
submitted at the public forums will be placed in the rulemaking record
and will be available for public inspection.
The purpose of these public forums is to allow the public a venue
in which to interact with APHIS representatives and to allow APHIS to
solicit further information from the public. Comments received at these
public forums will be added to this Docket.
Dates: The public forums will be held in Davis, CA, on October 28,
2008; in Kansas City, MO, on October 30, 2008; and Riverdale, MD, on
November 13, 2008. Each public forum will be held from 4 p.m. to 7
p.m., local time.
Meeting Locations: The public forums will be held at the following
locations:
USDA Riverside, Oklahoma City Memorial Conference Rooms B, C, and
D, 4700 River Road, Riverdale, MD, 20737. For directions or facilities
information, call (301) 734-8010.
Walter A. Buehler Alumni & Visitors Center, Alpha Gamma Rho Hall,
University of California, Davis, CA, 95616. For directions or
facilities information, call (530) 754-9195 or visit http://
www.alumnicenter.ucdavis.edu/.
Hilton Kansas City Airport, Shawnee Room A, 8801 NW 112th Street,
Kansas City, MO, 64153. For directions or facilities information, call
(816) 891-8900 or visit http://www.hiltonkci.com/.
Table of Contents
I. Introduction
II. Background
A. APHIS Role in Federal Regulation of Genetically Engineered
Organisms
B. Current Regulations in 7 CFR part 340
C. Plant Protection Act Authority to Regulate Plant Pests,
Noxious Weeds, and Biological Control Organisms
III. Proposed Rule
A. Proposed Regulatory Scope (Sec. 340.0 Scope and General
Restrictions)
1. Genetically Engineered Organisms Subject to 7 CFR part 340
2. Deleting the List of Organisms Which Are or Contain Plant
Pests
3. Regulating Whole Organisms, Parts, and Nonliving Products
B. Permits for Authorizing Importation, Interstate Movement, and
Release Into the Environment of Certain GE Organisms
1. Elimination of the Notification Procedure
2. Revisions to Permit Procedures
3. Permit Types and Environmental Release Categories (Sec.
340.2(b))
4. Permit Application Information Requirements (Sec. 340.2(c))
5. Permit Conditions (Sec. 340.3)
6. Elimination of Courtesy Permits
C. Conditional Exemptions from Permit Requirement (Sec. 340.4,
Sec. 340.5)
D. Petitions for Nonregulated Status (Sec. 340.6)
E. Compliance, Enforcement, and Remedial Action (Sec. 340.7)
1. Ensuring Compliance with Permits and Exemption Activities
2. Low Level Presence of Regulated GE Plants in Seed or Grain
F. Administrative Changes
1. Confidential Business Information (Sec. 340.8)
2. Time Frames for APHIS Action on Permit Applications and
Petitions
3. Duration Period for Permits
G. Definitions and Miscellaneous Changes
IV. Required Analyses
A. National Environmental Policy Act
[[Page 60009]]
B. Executive Order 12866 and Regulatory Flexibility Act
C. Executive Order 12372
D. Executive Order 12988
E. Paperwork Reduction Act
F. E-Government Act Compliance
I. Introduction
The U.S. Department of Agriculture's (USDA) Animal and Plant Health
Inspection Service (APHIS) regulates the safe introduction
(environmental release, interstate movement, and importation) of
certain genetically engineered (GE) organisms under its regulations in
7 CFR part 340. The regulations govern the introduction of GE organisms
that might be plant pests. APHIS has amended the regulations several
times in an effort to respond to the need for streamlined procedures
and has established clear procedures to remove GE organisms that do not
pose a plant pest risk from obligations under the regulation.
The APHIS regulations have been used most frequently for permits
and notifications for importation, interstate movement, or
environmental releases of GE plants, although a smaller number of
permits have been issued for GE microorganisms and insects. To date,
APHIS has authorized more than 13,000 environmental releases of GE
plants, most of which have been part of the development of improved
crop varieties for agriculture. These controlled environmental releases
are sometimes referred to as field tests or field trials, in
recognition of their relationship to field tests done in the
traditional development of plant varieties, and in this document the
terms field test or field trial should be understood to mean
environmental release. In addition to permits and notifications, APHIS
has completed reviews in response to petitions requesting nonregulated
status under these regulations. To date, APHIS has granted 74
determinations of nonregulated status, and all of these have been for
GE plants (more information about these is posted at http://
www.aphis.usda.gov/brs/not_reg.html ). Many of these plants have since
been used to develop plant varieties that have become part of the
options that growers have for agricultural production in the United
States and other countries. The APHIS determinations of nonregulated
status have been for the GE plant(s) and their progeny. The GE plant
with nonregulated status can be used subsequently in plant breeding
programs or in agriculture just like other plant lines. A GE plant that
has received nonregulated status can be bred with another GE plant with
nonregulated status, and the resulting progeny which could contain
multiple GE traits still retains nonregulated status.
The bulk of APHIS-authorized introductions have been crop plants
bearing genes which confer resistance to certain insects or tolerance
to certain herbicides. Although the current program has been effective
in ensuring the safe environmental release, interstate movement, and
importation of certain genetically engineered organisms, technological
advances have led to new uses and questions about how the current
regulations and APHIS authorities will be used to maintain appropriate
oversight. Advances in technology have created possibilities for new
and different traits, such as those that would produce a compound for
pharmaceutical or industrial use. In addition, researchers have been
producing organisms that may not fall under the scope of our current
regulations and are also beginning to focus more on perennial plants,
such as grasses or trees, which may be capable of establishing and
persisting outside the site of introduction.
APHIS is proposing to revise its regulations in order to respond to
emerging trends in biotechnology, to address the current and future
needs of the agency, to continue to ensure a high level of
environmental protection, to improve regulatory processes so that they
are more transparent to stakeholders and the public, to more
efficiently use agency resources and to eliminate unnecessary
regulatory burdens.
Given the diversity of U.S. agriculture, the USDA Advisory
Committee on Biotechnology and 21st Century Agriculture recently in its
March 2008 consensus report encouraged the continuing support of
coexistence among various agricultural production systems in U.S.
agriculture. APHIS concludes that the changes it is proposing will
continue to support coexistence in U.S. agriculture.
In addition, APHIS is proposing changes to the regulations to
reflect provisions of the 2008 Farm Bill recently enacted. Section
10204 of Title X of the Food, Conservation, and Energy Act of 2008
(Farm Bill) requires the Secretary of Agriculture to take action on
each issue identified in the document entitled ``Lessons Learned and
Revisions under Consideration for APHIS' Biotechnology Framework,'' and
where appropriate, promulgate regulations. APHIS is proposing certain
regulatory changes concerning permit application information
requirements, permit conditions, records, and reports that address many
of the considerations outlined in Section 10204.
APHIS is also aligning this proposed rule with recommendations
arising from the 2005 audit of the USDA Office of Inspector General
entitled ``Controls Over Issuance of Genetically Engineered Release
Permits.''
II. Background
A. APHIS Role in Federal Regulation of Genetically Engineered Organisms
Under the Coordinated Federal Framework for Regulation of
Biotechnology,\1\ USDA works with the Food and Drug Administration
(FDA) and the Environmental Protection Agency (EPA) to ensure that the
development and testing of biotechnology products occur in a manner
that is safe for plant and animal health, human health, and the
environment. USDA and EPA are the agencies responsible for protecting
U.S. agriculture and the environment. EPA is responsible for the human
health, animal health, and environmental safety issues raised by any
pesticidal substance produced in genetically engineered (GE) organisms.
FDA has authority over the safety of the whole food product other than
the pesticidal components regulated by EPA.
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\1\ The Coordinated Framework is described in a notice published
in the Federal Register on June 26, 1986 (51 FR 23302). The notice
may be viewed at http://www.aphis.usda.gov/brs/fedregister/
coordinated_framework.pdf.
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B. Current Regulations in 7 CFR Part 340
APHIS administers regulations in 7 CFR part 340, ``Introduction of
Organisms and Products Altered or Produced Through Genetic Engineering
Which are Plant Pests or Which There is Reason to Believe are Plant
Pests'' (referred to below as the regulations). The current regulations
govern the introduction (importation, interstate movement, or release
into the environment) of certain GE organisms termed ``regulated
articles.'' Regulated articles are essentially GE organisms which might
pose a risk as a plant pest.
APHIS first promulgated these regulations in 1987 under the
authority of the Federal Plant Pest Act of 1957 (FPPA) and the Plant
Quarantine Act of 1912 (PQA), two acts that were subsumed into the
Plant Protection Act (PPA, 7 U.S.C. 7701 et seq.) in 2000, along with
other provisions.
Under the current regulations, a GE organism is a regulated article
if it is a plant pest or if the Administrator has reason to believe it
is a plant pest; more specifically:
[[Page 60010]]
``if the donor organism, recipient organism, or vector or vector
agent belongs to any genera or taxa designated in Sec. 340.2 and
meets the definition of plant pest, or is an unclassified organism
and/or an organism whose classification is unknown, or any product
which contains such an organism, or any other organism or product
altered or produced through genetic engineering which the
Administrator determines is a plant pest or has reason to believe is
a plant pest.'' (Definition of regulated article, Sec. 340.1)
In other words, APHIS regulates the introduction (importation,
interstate movement, and environmental release) of GE organisms if (1)
any of the recipient, genetic donor, or vector organisms are plant
pests or of unknown classification or (2) the Administrator has
determined or has reason to believe the GE organism is a plant pest. As
constructed the regulations apply to GE microorganisms, insects, and
other traditional types of plant pests and to any GE plants if plant
pest organisms (bacterial and viral plant pathogens) are the donor
organisms and vector agents used in the creation of these GE plants.
Taxa containing ``known plant pests'' are those listed in current
Sec. 340.2. Current regulations also include a petition procedure
(Sec. 340.5) which allows petitioners to ask APHIS to add or subtract
taxa from the list in Sec. 340.2. That list has not been amended since
it was established in 1987.
As defined under the current regulations and the PPA, most plants
are not plant pests, with the exception of a few parasitic plant
species, such as striga, witchweed, and dodder.
The primary procedure for regulation under the PPA is the issuance
of a permit, which is an authorization by the Secretary to move plants,
plant products, biological control organisms, plant pests, noxious
weeds, or articles under conditions prescribed by the Secretary. The
PPA also authorizes the Secretary to determine which classes of the
above articles must have a permit to be moved. Conditions associated
with those permits can be tailored to achieve the appropriate level of
regulatory control to make it unlikely that actions under the permit
would result in the introduction or dissemination of a plant pest or
noxious weed.
APHIS currently uses a permit and notification system to authorize
importation, interstate movement and release into the environment
(currently referred to as ``introductions'') of certain GE organisms.
Under the current regulations, all regulated articles are eligible for
the permitting procedure, but only certain plants are eligible for the
notification procedure. Currently, most regulated GE plants are
introduced under notification, which is a streamlined procedure.
Examples of GE plants introduced under the notification procedure are
those GE plants altered to be resistant to certain insects or
herbicides. GE plants that do not meet the notification eligibility
criteria and all other GE organisms, such as microbes and insects, must
be introduced under the permit procedure in current Sec. 340.4. In
recent years, APHIS has processed most notifications and permits
through its electronic, e-permitting system that is accessible by the
internet at http://www.aphis.usda.gov/permits/learn_epermits.shtml.
In making a regulatory determination for a permit or notification
for a GE organism subject to the part 340 regulations, APHIS makes such
a determination on whether the actions under notification or permit are
unlikely to result in the introduction or dissemination of a plant
pest. This determination takes into account various risk factors,
including, among other things, a low risk that the GE organism or its
progeny can persist, reproduce, and establish without human assistance.
Other risk factors that would support an ``unlikely'' determination
would be minimal availability of suitable hosts or habitats for the
organism and low risk that the organism may cause damage to plants and
plant products.
Regarding the risk of introduction or dissemination of the GE
organism as a plant pest, an ``unlikely'' determination takes into
consideration both the nature of the organism (i.e., low risk that the
organism or its progeny can persist, reproduce, establish, and spread
without human assistance) and any additional mitigations that are
placed upon the organism that restrict its movement and make its
unauthorized introduction or dissemination unlikely.
The notification procedure was first added to the regulations in
1993, and then amended in 1997 to allow a broader range of plant
species to be eligible for the procedure. The notification procedure
was designed to be a streamlined procedure with the eligibility
criteria and performance standards already built into the regulations.
Over the past decade, APHIS has typically authorized 700-1200
notifications per year.
As part of the notification procedure, applicants must adhere to
performance standards set forth by APHIS for proper confinement of the
GE plants. The goal of proper confinement is to ensure that the GE
plants do not persist in the environment. Under the notification
procedure applicants provide information about the introduction
sufficient for APHIS to evaluate eligibility for the procedure and
impacts on the environment. This information includes information on
the plant species, introduced gene(s), location(s), and anticipated
time frame for the introduction.
For notifications, the eligibility criteria and the performance
standards stated in the regulations must be met, but APHIS does not
prescribe how the performance standards must be met. For example, one
of the performance standards in Sec. 340.3(c)(5) requires that ``The
field trial must be conducted such that (i) The regulated article will
not persist in the environment, and (ii) No offspring can be produced
that could persist in the environment.'' The responsible person might
meet this standard in a field trial by isolating the regulated GE
plants at a sufficient distance to preclude gene flow from the GE plant
to sexually compatible plants in the vicinity. Another design protocol
might meet the same performance standard by planting the GE plant at a
time in the growing season when surrounding plants of the same species
would not be biologically capable of being fertilized by pollen from
the GE plant (temporal isolation).
The regulations in current Sec. 340.3(e) specify that the APHIS
notification procedure must be completed within 30 days for
environmental release and importations and within 10 days for the
interstate movement of a regulated article. If APHIS completes the
review process and finds that all regulatory requirements have been
met, the notification is authorized in a process termed
``acknowledgement,'' and the applicant can proceed with the
introduction under the terms of the notification. Notifications are
valid for one year from the date of introduction.
Approximately 10% of APHIS authorizations are done under the
permitting procedure. The permitting procedure, found in Sec. 340.4 of
the current regulation, describes the types of permits, information
required for permit application, the standard permit conditions, and
administrative information (e.g., time frames, appeal procedure, etc.).
Permits include specific conditions that must be followed by the permit
holder. Standard permit conditions are listed in the regulation, and
APHIS can supplement these with additional conditions as necessary. The
current regulations specify the amount of time that APHIS is allotted
for review of complete permit applications: 60 days for permits for
importation and interstate movement; 120 days for environmental
release.
[[Page 60011]]
Some regulated articles are conditionally exempt from the
requirement for permits when moved interstate under the conditions
stipulated in the regulation. Conditional exemptions currently exist in
the regulations for the interstate movement of certain GE bacteria
(Escherichia coli, Bacillus subtilis), fungi (Saccharomyces
cerevisiae), as well as the plant species Arabidopsis thaliana. APHIS
established these conditional exemptions from interstate movement
permit by amending the regulations in 1988 and 1990.
APHIS forwards the applications for all permits, and notifications,
with any confidential business information redacted, to State
regulators in the States to which regulated articles will be moved and/
or in which environmental release is planned. This is done to notify
States of the requested action and to allow States to review and
comment on proposed releases or importations or movements.
The current regulations also include various provisions and
prescribed standards for containers, marking, and identity that apply
to shipments of regulated articles. For example, there are instructions
regarding how to label containers of imported regulated articles with
the nature of the contents, origin and destination, and other
information, and detailed instructions on what materials (plastic,
metal, etc.) and dimensions may be used for containers of regulated
articles.
Under the current regulations, APHIS may also grant ``nonregulated
status'' to a GE organism in accordance with the procedure described in
Sec. 340.6. A determination of nonregulated status means that the
organism is no longer subject to the part 340 regulations, and
therefore there is no longer any requirement for APHIS authorization
under part 340 for a permit or notification when the GE organism is
imported, moved interstate, or released into the environment.
C. Plant Protection Act Authority to Regulate Plant Pests, Noxious
Weeds, and Biological Control Organisms
Under the provisions of the PPA, Congress has granted the Secretary
of Agriculture authority to develop regulations in order to detect,
control, eradicate, suppress, prevent, or retard the spread of plant
pests or noxious weeds. The PPA grants the Secretary authority to
regulate the movement into and through the United States of any plant,
plant pest, plant product, biological control organism, noxious weed,
article, or means of conveyance, in order to prevent the introduction
or dissemination of plant pests and noxious weeds.
The current regulations were promulgated under former statutes,
i.e., the FPPA and PQA, which provide USDA authority to regulate
articles that present a risk of plant pest introduction or
dissemination. In addition to the provisions of the FPPA and PQA, the
PPA incorporates authority that previously was under the Noxious Weed
Act of 1974. In order to best evaluate the risks associated with these
GE organisms and regulate them when necessary, APHIS needs to exercise
its authorities regarding noxious weeds and biological control
organisms, in addition to its authority regarding plant pests.
The definition of plant pest in the PPA is broad and includes
living organisms that could directly or indirectly injure, damage, or
cause disease in any plant or plant product (7 U.S.C. Sec. 7702(14)).
Under the PPA, organisms which could be plant pests include:
Protozoans
Non-human animals
Parasitic plants
Bacteria
Fungi
Viruses or viroids
Infectious agents or other pathogens
Any article similar to or allied with any of the above
articles.
The definition of noxious weed in the PPA includes:
* * * any plant or plant product that can directly or indirectly
injure or cause damage to crops (including nursery stock or plant
products), livestock, poultry, or other interests of agriculture,
irrigation, navigation, the natural resources of the United States,
the public health, or the environment. (PPA Sec. 7702(10))
An important distinction between noxious weeds and plant pests is
that noxious weeds under the PPA are always plants or plant products.
Plant pests are usually not plants (with the exception of certain
parasitic plants such as dodder, striga, and witchweed), but are other
types of organisms that harm plants.
III. Proposed Rule
A. Proposed Regulatory Scope (Sec. 340.0 Scope and general
restrictions)
We propose to better align the regulations with the PPA authorities
in order to ensure that the environmental release, importation, or
interstate movement of GE organisms does not pose a risk of introducing
or disseminating plant pests or noxious weeds. Although the current
program has been effective in ensuring the safe environmental release,
interstate movement, and importation of genetically engineered
organisms, technological advances have led to the possibility of
developing GE organisms that do not fit within the plant pest
definition, but may cause environmental or other types of physical harm
or damage covered by the definition of noxious weed in the PPA.
Therefore, we consider that it is appropriate to align the regulations
with both the plant pest and noxious weed authorities of the PPA.
1. Genetically Engineered Organisms Subject to 7 CFR part 340
We are proposing to revise the scope of the regulations in Sec.
340.0 to make it clear that decisions regarding which organisms are
regulated remain science-based and take both plant pest and noxious
weed risks into account. The proposed scope of the regulations states
that genetically engineered organisms whose importation, interstate
movement, or release into the environment would be subject to the
regulations are:
Genetically engineered plants if:
(i) The unmodified parent plant from which the GE plant was derived
is a plant pest or noxious weed, or
(ii) The trait introduced by genetic engineering could increase the
potential for the GE plant to be a plant pest or noxious weed, or
(iii) The risk that the GE plant poses as a plant pest or noxious
weed is unknown, or
(iv) The Administrator determines that the GE plant poses a plant
pest or noxious weed risk.
Genetically engineered non-plant, non-vertebrate organisms if:
(i) The recipient organism can directly or indirectly injure, cause
damage to, or cause disease in plants or plant products; or
(ii) The GE organism has been engineered in such a way that it may
increase the potential for it to be a plant pest: or
(iii) The risk that the GE organism poses as a plant pest is
unknown, or
(iv) The Administrator determines that the GE organism poses a
plant pest risk.
Under the current regulations, there is no explicit statement of
the relative responsibilities of the Administrator and regulated
parties in determining whether an organism met the definition for
regulated article and therefore would be subject to the regulations.
Under the proposed regulations, the responsible person for a GE
organism could correctly apply the criteria in Sec. 340.0 to determine
whether the GE organism is subject to the regulations. Alternatively,
[[Page 60012]]
the Administrator could determine any GE organism to be regulated after
determining that the GE plant poses a plant pest or noxious weed risk.
In many cases, it will be very straightforward for a responsible
person to apply these criteria and determine that a GE organism is
subject to the regulations. For example, the GE organism would clearly
be subject to the regulations if the recipient organism were a plant
pest or noxious weed. A GE organism would also clearly be subject to
the regulations if there was little data or previous experience
available concerning the recipient organism's plant pest or noxious
weed potential, or the type of modification, with the result that it is
difficult to do a reliable evaluation of the risks that the GE organism
may be a plant pest or noxious weed.
In other cases, it may not be readily apparent to the responsible
person for a GE organism whether or not the organism falls within the
scope of Sec. 340.0 and is regulated. For this reason, persons who are
not sure about whether a GE organism falls within the regulations or
who maintain that a particular GE organism is not subject to the
regulations based on their belief that it is not an organism within the
scope of Sec. 340.0 may consult with APHIS.
A GE organism may be within the scope of the regulations based on
the information available at the time of the determination, which is
usually less information than is available when the Administrator
evaluates, for example, whether a regulated GE organism should be
considered for an exemption from the requirement for a permit, or
should be considered for a determination of nonregulated status (see
discussion of Sec. 340.6 below regarding nonregulated status). In
other words, this scope determination has one purpose (to determine
whether regulation is necessary at all) and is based on one level of
knowledge about a GE organism, while determinations regarding such
things as necessary permit conditions or exemptions or nonregulated
status have a different purpose and are based on a different level of
knowledge about a GE organism.
It is important to note that while a GE organism may be within the
scope of the regulations due to certain identified plant pest or
noxious weed risks, it may also be within the scope of the regulations
if there is not enough information about the GE organism's potential
plant pest or noxious weed risks to make a decision regarding those
risks. At the early stages of developing a GE organism, there may not
be sufficient information available about the organism to clearly
determine the potential associated plant pest or noxious weed risks.
Unknown risks might lead to a determination by the Administrator that a
GE organism should be subjected to regulatory oversight if APHIS lacks
familiarity with the non-transformed recipient organism or the
introduced trait.
The proposed scope makes it clear that the mere act of genetic
engineering does not trigger regulatory oversight or mean that a GE
organism will pose risks as a plant pest or noxious weed. Instead, it
clarifies that APHIS would subject a GE organism to regulatory
oversight based upon known plant pest and noxious weed risks of the
parent organisms, or based upon the traits of the GE organism, or based
upon the possibility of unknown risks as a plant pest or noxious weed
when insufficient information is available.
Consultation With APHIS Regarding the Scope of These Regulations
The criteria described in the scope should help developers form a
reasonable expectation as to whether their GE organism is within the
scope of the regulations, based on the nature of the parent organisms,
the engineered traits, and the amount of information available
regarding the organism and similar organisms.
APHIS anticipates that initially the range of GE organisms that the
Administrator may determine to be covered by the proposed regulatory
scope will be broad. This will be due to both an initial measured
implementation of the revised regulatory oversight as well as to the
application of the scope criteria to the transformed organisms and
recipient traits. Over time, the range of GE organisms subject to
oversight is expected to decrease as APHIS becomes more familiar with
these organisms and receives information from which it can reach a
conclusion that these GE organisms or groups of organisms do not
present increased or unfamiliar plant pest or noxious weed risks.
Because the Administrator may make such a determination at any time the
Administrator receives information that a GE organism is within the
scope, APHIS expects that developers will seek early consultation with
APHIS on whether the regulatory scope covers their GE organism. Since
it is generally necessary for research or business plans to include, as
early as possible, elements addressing regulatory processing, approval,
and compliance, it will be in the interest of the developers to
determine the regulatory status of their GE organism prior to
contemplating its movement or environmental release. Therefore, APHIS
will offer to consult with a developer of a GE organism regarding
whether the GE organism is within the scope of the proposed
regulations.
After consultation and review of available information, the
Administrator will respond in writing as to whether the Administrator
has determined that the GE organism is within the scope of the
regulations. APHIS plans to make information publicly available by
posting and maintaining information on its Web site about the
determinations it makes pursuant to this consultation process to help
the public and regulated entities understand which organisms are
subject to the regulations.
We welcome suggestions from the public on the most appropriate ways
to provide administrative guidance to the public on the issue of which
GE organisms are within the scope of the regulations. The Agency is
especially interested in ways which will balance transparency with the
efficient use of Agency resources in conducting consultations and
communicating information to the public regarding which GE organisms
are within the scope of the regulations.
Organisms Specifically Excluded From the Scope of the Regulations
Specifically excluded from the proposed regulatory scope are GE
microorganisms that are regulated as biological control organisms by
the EPA under provisions of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). APHIS concludes that there is no need for such
GE organisms to be evaluated by both agencies. EPA is already
evaluating the environmental safety of such organisms with respect to
their impact on the entire environment, including plants. We also
propose to retain an exclusion from the current regulations for GE
microorganisms where the recipient microorganism is not a plant pest
and which have resulted from the addition of genetic material from a
donor organism where the material is well characterized and contains
only non-coding regulatory regions.
Effect of Noxious Weed Authority on the Scope of the Proposed
Regulations
The definition of noxious weed encompasses plants that pose risks
akin to plant pests, because it includes ``any plant or plant product''
that can ``injure or cause damage to crops * * * other interests of
agriculture * * * or the environment'', but also includes plants that
can pose harm to non-plant organisms, such as humans. Therefore
[[Page 60013]]
evaluation of noxious weed risk expands what we can consider, while
still including those risks examined under the plant pest approach.
When considering risks associated with a GE plant, we would continue to
consider whether it can harm plants, as well as whether it can cause
the other types of physical harm or damage described in the definition
for noxious weed.
The first consideration in determining if a plant is a noxious weed
is identifying what direct injury or damage (physical harm) the plant
causes. If direct harm or damage is established, the next consideration
is to evaluate any indirect damage the plant may cause to interests of
agriculture, irrigation, navigation, the natural resources of the
United States, the public health, or the environment. In general,
federally listed noxious weeds are plants that are likely to be
aggressively invasive, have significant negative impacts, and are
extremely difficult to manage or control once established.
The distinction between a weed and a noxious weed warrants
emphasis. ``Weeds,'' in the broadest sense of the word, could include
any plant growing where and/or when it is unwanted; even plants that
are desirable in some settings may be considered weeds in others. In a
narrower sense, weeds are invasive, often non-native, plants which
impact natural and managed ecosystems, often with significant negative
consequences due to lost yields, changes in management practices,
altered herbicide use, etc. Only a fraction of these problematic weeds
are considered to be so invasive, so harmful, and so difficult to
control that Federal regulatory intervention to prevent their
introduction or dissemination is justified, and these are the focus of
the regulatory controls placed on them by APHIS. However, any weed, and
virtually any plant or plant product, can be evaluated by APHIS to
determine whether its characteristics and potential impacts warrant its
listing as a noxious weed.
APHIS currently lists 98 aquatic, terrestrial, or parasitic plant
taxa as noxious weeds. The species included in the list illustrate the
kinds of plants APHIS considers to be sufficiently invasive, damaging,
and difficult to control to be deemed noxious weeds. Table 1 describes
some specific examples from the Federal noxious weed list and the kinds
of impacts noxious weeds can have, to illustrate the types of effects
APHIS will be looking for when evaluating whether GE plants reviewed
under part 340 have any potential noxious weed traits. The experience
and precedents developed by the APHIS-PPQ noxious weed program provide
a guide for the regulation of plants that may be noxious weeds, and we
intend to apply it to the consideration of GE plants in the same way.
Table 1--Examples of Impacts Caused by Federally Listed Noxious Weeds
------------------------------------------------------------------------
Description of
Impact impact Example species
------------------------------------------------------------------------
Lost productivity of crop Noxious weeds may Cogongrass (Imperata
fields. directly compete cylindrica) infests
with crop plants over 20 crop
for limited species; it releases
resources, chemicals into the
dramatically soil that suppress
reducing yields. crop growth and
causes damaging
puncture wounds to
plant roots, bulbs,
and tubers. Other
examples include
Benghal dayflower
(Commelina
benghalensis), red
rice (Oryza spp.),
and kikuyugrass
(Pennisetum
clandestinum).
Parasitic damage to crops..... Parasitic plants Federally listed
can cause noxious parasitic
significant plants include the
reductions in dodders (Cuscuta
yield by spp.)--with common
attaching names like
themselves to a strangleweed,
host plant, devil's-guts,
removing hellbine, and
nutrients and witch's hair--and
ultimately witchweed (Striga
killing it. spp.), which causes
devastating losses
in corn, sorghum,
and rice.
Reduced productivity of Grazing animals Serrated tussock
pasture. may avoid (Nassella
noxious weeds trichotoma) has
and consume the heavily infested
more favorable large areas, leaving
pasture species, them completely
resulting in incapable of
increased supporting
noxious weed livestock.
populations at
the expense of
more favorable
species. Noxious
weeds may also
outcompete
desirable
pasture species.
Injury to humans or livestock. Many noxious Cape tulip (Homeria
weeds are toxic, spp.) contains a
harming humans cardiac glycoside,
or livestock which can be fatal
either when to livestock.
consumed or by Contact with giant
direct contact. hogweed (Heracleum
mantegazzianum)
causes painful skin
blisters. Three-
cornered jack (Emex
australis) and
devil's thorn (Emex
spinosa) both bear
spiny fruits that
can cripple or cause
injury to livestock
or other animals.
Unchecked overgrowth.......... Noxious weeds may Mile-a-minute vines
be capable of (Mikania cordata and
completely M. micrantha) can
dominating the entirely smother
landscape and fields and forests
preventing the in a dense, tangled
use of mass of vines. A
cultivated or single plant of the
pasture lands aquatic weed giant
for agriculture. salvinia (Salvinia
spp.) can blanket 40
square miles in 3
months, and produce
an underwater mat 3
feet thick.
Physical obstructions......... Growth rate and Certain mesquites
habit of some (Prosopis spp.),
noxious weeds jointed prickly pear
may physically (Opuntia
hamper the aurantiaca), and
movement of African boxthorn
livestock and (Lycium
humans, or ferocissimum) form
interfere with impenetrable
navigation of thickets filled with
waterways. thorns or needles,
blocking the
movement of grazing
animals, injuring
them or preventing
access to food and
water.
Disruption of water flow...... Aquatic noxious Notable examples
weeds may include hydrilla
disrupt water (Hydrilla
flow, adversely verticillata), giant
affecting salvinia (Salvinia
irrigation, spp.), and Chinese
drainage and waterspinach
flood control (Ipomoea aquatica).
canals, city Dense mats of oxygen
water intakes, weed (Lagarosiphon
and recreational major) can
water use. completely shut down
operation of
hydroelectric
plants.
[[Page 60014]]
Habitat alteration............ Noxious weeds may Infestation of lakes
severely alter and ponds with
water quality by hydrilla (Hydrilla
changing oxygen verticillata) can
and nutrient alter aquatic
content, may ecosystems so
dramatically drastically that
lower local native plants are
water tables, or entirely eliminated,
could so rendering the
significantly habitat unsuitable
outcompete or for fish and other
overgrow other wildlife.
vegetation
resulting in a
complete
ecological shift
of the habitat.
------------------------------------------------------------------------
As discussed above, APHIS' determination that a plant is a noxious
weed is based on notable physical harm or injury caused by the plant.
The elements of the noxious weed definition include a number of
interests that might be damaged by noxious weeds including not only
plants but irrigation, navigation, the natural resources of the United
States, the public health, the environment and interests of
agriculture. Often APHIS quantifies the physical harm or injury in
terms of economic losses. Loss in commodity value due to the presence
of noxious weeds in seeds, for example, is a consequence of the
anticipated physical damage that would be caused if the seed containing
a noxious weed were distributed and planted; the economic loss is never
simply the result of market preference to have commodities free of
certain noxious weed seeds in and of itself, in the absence of any
potential physical damage or harm. APHIS does not consider significant
economic effects alone that are not linked to physical damage to be
sufficient to determine a plant is a noxious weed.
Certainly, some noxious weeds can cause physical harm to the health
of humans or livestock and other animals. In general, these impacts
occur when individuals come into direct contact with the noxious plants
or plant parts, which may cause physical injury or are toxic or
otherwise harmful when consumed. Conceivably, noxious weeds growing in
crop fields could potentially threaten public health, for example, if
toxic parts of the noxious weeds are harvested and inadvertently enter
the food supply. If such toxic or otherwise harmful noxious weed parts
were found in food and caused the food to be ``adulterated'' within the
meaning of the FFDCA, FDA could take regulatory action against the
food.
Whereas APHIS has no direct role in evaluating the safety of foods,
the agency plays an important supporting role in safeguarding the food
supply by protecting the health of plants and animals at the farm
level. When evaluating whether a particular GE plant may be a noxious
weed because it poses a public health risk when growing in the
environment, APHIS considers toxicity and other food safety
information, including the type reviewed by EPA and FDA. In the case of
GE plants, APHIS would not assess the safety of the GE plant for human
or animal consumption, but would consider available information about
toxicity and other food safety information in assessing noxious weed
risk posed by the plants growing in the environment.
It should be noted, moreover, that most GE plants that APHIS has
been regulating in the past, such as varieties of GE corn and soybeans
modified with common agronomic traits, do not qualify as ``noxious
weeds''. But with the increasing diversity of both agronomic and non-
agronomic traits being engineered into plants it is appropriate to
place regulatory controls upon GE plants proportionate to the
likelihood that they may present a noxious weed risk until the
potential risk can be appropriately evaluated.
How Non-Plant, Non-Vertebrate GE Organisms Fall Within the Scope of the
Regulations
The proposed revision of the regulations retains control for
potential plant pest risks posed by non-plant, non-vertebrate GE
organisms. We would continue to explicitly use the plant pest
provisions of the PPA for regulating non-plant, non-vertebrate GE
organisms which align with the taxa listed in the PPA definition of
plant pest. In its reviews of GE non-plant and non-vertebrate species,
APHIS will continue to assess GE insects, fungi, bacteria, and other
non-plant, non-vertebrate organisms for their potential to pose risks
as plant pests.
The scope of the regulations as defined above makes it clear that
it is the Administrator, and not the public, who determines whether a
non-plant organism is within or outside the proposed scope of the Part
340 regulations. APHIS welcomes public comment on the proposed concise
criteria that the Administrator would consider when concluding that a
GE organism is not a plant pest. We envision providing additional
information on the Administrator's interpretation on such criteria at
the time of the final rule or in subsequent administrative guidance.
GE Vertebrate Animals Do Not Fall Within the Scope of the Regulations
Although the PPA definition of plant pest includes the potential
for a nonhuman, vertebrate animal to be considered a plant pest, APHIS
decided at this time that there are no demonstrated risks or pending GE
animal developments indicating that it is necessary for the proposed
regulations to evaluate vertebrate GE animals as potential plant pests.
Because other statutory authorities exist for addressing GE animals,
APHIS could guard against any plant pest risks that might be presented
by GE vertebrate animals without directly regulating them under the
regulations in part 340. On the other hand, we propose to regulate GE
invertebrate animals under part 340 because many classes of
invertebrates include known plant pests (e.g., insects, arachnids,
nematodes, gastropods, etc.).
How GE Biological Control Organisms (BCOs) Fall Within the Scope of the
Regulations
The PPA defines biological control organism (BCO) as ``any enemy,
antagonist, or competitor used to control a plant pest or noxious
weed'' (7 U.S.C. 7702(2)). The PPA gives the authority to regulate
plant pests and noxious weeds, not specifically biocontrol organisms.
APHIS recognizes that BCOs may have the potential to affect populations
of noxious weeds or plant pests, or become plant pests themselves. To
fall within the scope of the proposed regulations, the GE BCO would
have to pose a threat as a plant pest or noxious weed. There are
relatively few examples today of GE BCOs, but these may become more
common in the future. For example, some researchers are developing GE
biological control pink bollworms that
[[Page 60015]]
are sterile, which achieve their controlling effect by reducing the
ability of fertile, non-GE pink bollworms to produce offspring. Such GE
pink bollworm BCOs would fall within the scope of the proposed
regulation, because they are plant pests. Although there are currently
no examples of using GE plants as BCOs, such a GE plant would be
evaluated under the proposed regulations to evaluate whether it is a
noxious weed or a plant pest.
Currently, the federal regulation of microbial BCOs is regulated by
EPA under FIFRA, and this covers GE as well as non-GE microorganisms
used to mitigate the effect of pests. Unlike the PPA, which limits the
definition of BCO only to organisms used to control plant pests and
noxious weeds, FIFRA covers microorganisms used as biological control
for any pest. APHIS considers it duplicative to have these regulations
include GE microbial BCOs under its scope since FIFRA already
adequately covers them, so APHIS is proposing that the regulatory scope
language in Sec. 340.0(d) would explicitly exclude GE microorganisms
if they are already being regulated as BCOs by EPA under FIFRA. We are
proposing to only regulate GE BCO macro-organisms that fall under the
proposed regulatory scope (APHIS-PPQ currently regulates the macro-
organism non-GE BCOs used to control plant pests and noxious weeds
pursuant to other regulations). APHIS welcomes public comment on this
aspect of its proposal.
Intrastate Movements of GE Organisms Between Contained Facilities and
Activities in Contained Facilities Do Not Fall Within the Scope of the
Regulations
Under the current regulations, certain GE organisms are only
regulated by APHIS if they are imported, moved interstate, or released
into the environment. The regulations do not govern intrastate
movements between contained facilities such as laboratories, nor do
they govern such activities as creating GE organism in a contained
research laboratory. The proposed revision does not change this aspect
of the regulations.
2. Deleting the List of Organisms Which Are or Contain Plant Pests
In Sec. 340.2 of the current regulations, there is a list of taxa
that are considered to be plant pests. Under the proposed scope, this
list is not needed because we would not use taxonomic classification of
donor and recipient organisms to determine if a GE organism is
regulated. When in the course of evaluating a GE organism APHIS
considers whether a donor or recipient species is likely to be a plant
pest or noxious weed, we would consider the most up-to-date pest
information maintained by PPQ. This information is more specific than
the information in the list of plant pest taxa in the current
regulations, and should be more useful and reliable than static lists
of taxa. APHIS welcomes public comment on deletion of the taxa list and
preferred sources of plant pest and noxious weed information for use
under the proposed regulations.
With deletion of this list from the regulations, there is also no
longer a need for the procedure currently described in Sec. 340.5 for
amending this list.
3. Regulating Whole Organisms, Parts, and Nonliving Products
APHIS proposes to clarify the regulated status of nonliving plant
products in the regulations. First, the PPA defines a plant pest only
as any living stage of any of the articles specifically named in the
plant pest definition that can directly or indirectly injure, cause
damage to, or cause disease in any plant or plant product. Moreover,
APHIS does not consider most GE organisms or parts of GE organisms
which cannot reproduce to present a risk as plant pests or noxious
weeds.
Conversely, we would regulate importation, interstate movement and
release into the environment of GE seedlings, seeds, tubers, cuttings,
bulbs, spores, etc., because there is a reasonable, albeit small,
possibility of reproduction, establishment, and spread if these were
deliberately or accidentally released into the environment without
authorization.
Viable pollen from GE plants imported, moved interstate, or
released into the environment would be subject to the regulations
because such movements of pollen can reasonably lead to genomes
becoming established in the environment. Similarly, in circumstances
where an article incidentally contains viable pollen, during movement,
APHIS would consider the movement regulated. There are many cases,
however, when pollen may be present but is no longer capable of
producing offspring, e.g., nonviable or immature pollen. In such cases,
APHIS would not require permits under this part. The commercial
distribution of cut flowers is one pollen movement situation that APHIS
has considered in light of the regulations, especially in cases where
the flowers are grown in other countries then imported only as cut
flowers. APHIS considers these circumstances to pose little, if any
risk, and therefore would not require permits for these activities.
The PPA defines a noxious weed as encompassing both plants and
plant products. A plant product is defined as ``any flower, fruit,
vegetable, root, bulb, seed, or other plant part that is not included
in the definition of plant; or any manufactured or processed plant or
plant part.'' APHIS has regulated GE organisms under part 340 for over
20 years, and there is no strong evidence to suggest the need to
regulate nonliving (nonviable) plant products in most cases. However,
if in a specific case the importation, interstate movement, or
environmental release of nonliving products of a GE plant may pose
noxious weed risks, APHIS has clear authority to address those risks by
imposing permit conditions on the handling of such nonliving products
of the GE organism in the permit issued for the associated living GE
organism. The proposed regulations state clearly in Sec. 340.3(b) that
the Administrator may also assign permit conditions addressing
nonliving plant materials associated with or derived from GE organisms
when such conditions are needed to make it unlikely that the nonliving
materials would pose a noxious weed risk. APHIS invites consultation
from any person considering a movement or release of nonliving
materials derived from a GE organism who is uncertain as to whether it
would be regulated.
B. Permits for Authorizing Importation, Interstate Movement and Release
Into the Environment of Certain GE Organisms
1. Elimination of the Notification Procedure
APHIS first added the notification procedure to the regulations in
1993 as an administratively streamlined procedure for certain GE plants
that met the eligibility criteria described in the regulation. Rather
than using customized requirements, like the permit conditions used for
the permitting procedure, the notification procedure uses generalized
performance standards that are described in the regulation itself. The
use of the performance standards that do not vary from one notification
to the next is one of the ways that the more rapid administrative
turnaround was achieved. In some ways, the term ``notification'' has
been misleading to the public, since they do not realize that sending a
notification does not mean automatic authorization by APHIS.
APHIS reviews notifications to verify that the GE plant meets the
eligibility criteria, and also evaluates whether the
[[Page 60016]]
proposed importation, interstate movement or environmental release can
be done in a manner that meets the performance standards described in
the regulation. In many ways, these APHIS evaluations for notifications
are very similar to those done for permit applications, but the
notification procedure relies on applicants agreeing to meet the
performance standards described in the regulation rather than
submitting an application for APHIS review describing the specific
measures they will employ for the activity (as is the case for
permits). With permits, but not with notifications, APHIS can accept
the proposed measures or add to them and the result is a set of binding
customized permit conditions.
Because the notification procedure uses only the performance
standards in the regulations, it is more administratively streamlined,
but the general nature of the standards has made it difficult for APHIS
inspectors to determine if a notification holder is in compliance and
can also make enforcement more difficult. For example, under the
current regulations, one of the performance standards for notifications
relevant to environmental releases states that: ``The field trial must
be conducted such that (1) the regulated article will not persist in
the environment, and (2) no offspring can be produced that could
persist in the environment.'' Conversely, specific conditions which
APHIS places on permits are unambiguous, easy to verify at inspection,
and easier to enforce. A specific permit condition that could be used
to address just part of the performance standard described above might
read: ``After final harvest of the GE corn plants covered under this
environmental release permit, the site will be monitored every 4 weeks
for the emergence of volunteer corn seedlings for one year, and any
emerging volunteer plants will be devitalized before they produce
pollen. Records of the monitoring and management of volunteers must be
maintained by the permit holder and made available to APHIS upon
request.''
APHIS employs performance standards in many of its regulations,
where appropriate. For example, we propose to employ a performance
standard in another part of this proposal, container requirements for
shipments of GE organisms. In that case, it is possible to employ a
straightforward standard that the container must not break or leak when
subjected to ordinary handling in transportation. The use of
performance standards under the notification procedure has some
benefits, such as providing the responsible person with flexibility in
how the standard is met, e.g., allowing for appropriate change in
protocols used during the growing season. However, there are some
disadvantages in not specifically enumerating the specific measures
that constitute compliance with the regulations. The permitting
procedure does not have this disadvantage, because the permit
conditions specify which actions need to be taken by the responsible
person to be in compliance.
APHIS considered revising the performance standards and retaining
the notification procedure, but this would not have remedied its
shortcomings, especially the lack of specificity that is a necessity of
using broadly applicable, performance standards in the regulations.
Under the proposed regulations where all authorizations will be
done under a permitting procedure, the permit conditions will provide
more specific information about what procedures the permit holder must
follow in order to be in compliance. In the proposed rule, we are
describing in detail the types of core permit conditions that will be
imposed, plus the additional permit conditions that the Administrator
can place upon the permit holder in order to make it unlikely that
actions under the permit would result in the introduction or
dissemination of a plant pest or noxious weed.
In view of the above discussion, APHIS has determined that it would
have more flexible, risk-appropriate oversight, better regulatory
enforcement and improved transparency if all regulated importations,
interstate movements, and releases into the environment are authorized
under the permitting procedure. The use of the permitting procedure in
lieu of notifications is also necessary for APHIS to address some of
the recommendations arising from the OIG Report and the provisions of
the 2008 Farm Bill. For example, the OIG recommendations have led to
proposed provisions in the regulations that will enable APHIS to add
permit conditions to require additional reports during the course of an
environmental release, the submission of notices to APHIS if the permit
holder decides not to conduct the environmental release, and 7-day,
pre-plant notices in the case of GE plants engineered to produce
pharmaceutical or industrial substances. The last recommendation is
already being implemented as a permit condition, because all of these
authorizations are done under the permitting procedure. The OIG
recommendations cannot be implemented under the notification procedure,
because under the current regulations APHIS does not have the ability
to attach conditions to notifications. This provides additional
justification for APHIS to propose the elimination of the notification
procedure. The APHIS proposal to eliminate the notification procedure
is an effective way to address several of the provisions of the Farm
Bill, such as the changes to the requirements for recordkeeping and
reporting.
2. Revisions to Permit Procedures
APHIS proposes to reorganize the regulations to improve the clarity
of the permit application and evaluation procedures. The proposed
change is more a reorganization than substantive change, and should
enhance the transparency of the regulations to the public. The
permitting procedure will continue to identify and obtain information
relevant to evaluating the risks associated with a proposed
importation, interstate movement, or release into the environment, and
determine and document whether, and under what conditions, the activity
should be allowed. The proposed regulations related to the issuance of
permits are divided into two sections. The first is proposed Sec.
340.2, Procedure for permits, which describes permit types, the
procedure for permit application (including information requirements),
and the Agency's administrative actions for permits. The second is
proposed Sec. 340.3, Permit conditions, which describes the general
types of conditions that APHIS may add to a permit, and the obligations
of the responsible person after permit issuance.
APHIS is proposing explicit procedures for amendment, transfer of
responsibility, and revocation of permits in order to establish clear
regulatory procedures that can increase efficiency yet maintain
adequate safety. Currently the APHIS administrative practices to amend,
transfer, and revoke permits have not been explicit in the regulation,
and this addition will provide increased transparency and efficiency.
The proposed changes organize the regulations to more clearly
reflect the procedural steps in the application, evaluation, and
issuance of a permit (see Figure 1). First, the different types of
permits (importation, interstate movement, and environmental release)
are described in Sec. 340.2(b), as are new subcategories of
environmental release permits. Second, the types of information that
must be submitted with a permit application are described in Sec.
340.2(c). The permit type, as well as
[[Page 60017]]
the nature of the environmental release (if the permit is for a
release), affect the application information requirements. Third, Sec.
340.2(d) outlines the procedural and administrative steps of issuing a
permit. Finally, the attachment of conditions to permits, which is also
dependent upon permit type and release category, is described in Sec.
340.3. Each of these permit-related sections of the proposed
regulations is discussed below.
Figure 1. Schematic of activities associated with issuance and
enforcement of permits, showing associated sections of the proposed
regulation.
Permit Types and Environmental Release Categories (Sec. 340.2(b))
[darr]
Application Information Requirements, by Type (Sec. 340.2(c))
[darr]
Permit Evaluation Procedures (Sec. 340.2(d))
[darr]
Assignment of Permit Conditions (Sec. 340.3)
[darr]
Compliance, Enforcement, and Remediation Activities (Sec. 340.7)
3. Permit Types and Environmental Release Categories (Sec. 340.2(b))
As discussed above in the background section, APHIS currently uses
two procedures--notification and permits--to authorize the importation,
interstate movement and release into the environment of GE organisms
considered to be regulated articles under this part. The permitting
procedure can be used for all regulated articles, but the notification
procedure can be used only for certain GE plants that meet the
eligibility criteria described in the regulations. Whereas permits are
issued with explicit permit conditions which must be met by the permit
holder, notifications have generalized ``performance standards''
described in the regulation and therefore do not vary from one
notification to the next. Currently, approximately 90% of APHIS
authorizations are done under the notification procedure.
Under the proposed system, which would eliminate notifications,
APHIS would continue to issue three types of permits--interstate
movement, importation, and environmental release. The procedures for
the first two types of permits are relatively straightforward, and the
conditions usually required for these permits address risks that are
very similar from one shipment to another. We propose only minor
adjustments to the procedures for interstate movement and import
permits. In general, deliberate release of GE organisms into the
environment presents a greater risk of introducing or disseminating
plant pests and noxious weeds, and thus requires more careful
oversight, than shipments of GE organisms into and across the country
in secure containers. Of the three permit types, only environmental
release permits would be differentiated into broad risk-related
categories by the Administrator. This categorization would occur prior
to the detailed and specific APHIS evaluation of an individual permit
application. Table 2 summarizes the relationship of the three permit
types and categories that pertain to environmental release permits.
Table 2--Proposed Permit Types and Categories for Environmental Release
Permits
------------------------------------------------------------------------
Type Use
------------------------------------------------------------------------
Importation permit.......... For securely moving
a GE organism into
the United States.
Interstate Movement......... For securely moving
a GE organism from
any State into or
through any other
State.
Environmental Release:*..... Release Category A.. For releases into
Release Category B.. the environment,
Release Category C.. outside the
Release Category D.. constraints of
Release Category E physical
(non-plants). containment that
are found in a
laboratory,
contained
greenhouse,
fermenter, other
contained
structure, or
secure shipment.
------------------------------------------------------------------------
* In some cases, an environmental release permit may also incorporate
permits for importation or interstate movement when such movements are
incidental to the environmental release.
The proposed sorting system for environmental release permits
includes five categories: Four for releases of GE plants (Categories A-
D) and one for releases of all other GE organisms (Category E).
Releases of GE non-plant organisms (Category E) would be placed into a
single category and reviewed on a case-by-case basis. APHIS considered
the creation of smaller risk-related subcategories for non-plants, but
APHIS has received too few permit applications to warrant the creation
of these smaller groupings. Releases of plants would be grouped into
four categories, as described below.
APHIS considered a tiered permitting system which would sort
proposed environmental releases of plants into a number of risk-based
categories. Lowest risk releases would be assigned to Tier 1, slightly
higher risk releases in Tier 2, and so on. In such a system, tier
assignment is analogous to a risk rating. In developing the specifics
of implementing such a system in the regulations, however, APHIS found
that it was challenging to pre-assign all conceivable releases into
tiers representing discrete levels of risk. There are a large number of
risk factors that contribute to the overall risk associated with any
given release. These factors include reproductive biology and growth
habit of the species, potential for gene flow to other species,
phenotype engineered into the organism, familiarity with the genetic
material used, safety of any expressed products, scale of the release,
location, duration, experience, and compliance history of the
applicant, proximity to threatened
[[Page 60018]]
and endangered species, and other factors.
Sorting proposed releases considering all relevant factors would
lead to an unwieldy system with many risk-based categories, and would
essentially require a full risk assessment prior to assigning a
proposed release to the appropriate risk category. Consequently, it
would be nearly impossible for applicants and the public to predict the
risk tier to which a proposed release would be assigned.
APHIS proposes that the permitting system for environmental release
permits would assign releases into administrative categories based upon
two primary risk-related factors described below, so that the
categories would identify the general types of releases of plants which
share broadly similar risks and management issues. This initial
administrative sorting would be followed by an evaluation that fully
characterized the risk of the proposed release, which would then be the
primary basis for adding necessary permit conditions. APHIS concludes
that such a system could appropriately sort most releases into
groupings that are alike enough that they could usually be treated
similarly initially, in terms of application information requirements
and evaluation of potential risks. In most cases the initial groupings
would also result in a similar level of oversight of the release and
conditions attached to the permit-but any final determination of the
permit category, oversight and permit conditions would depend on the
results of the APHIS evaluation.
Using this approach, there is no prior conclusion that every
release within the same category poses the same level of risk.
Likewise, releases in different categories do not necessarily pose
greatly different risks. For this reason, APHIS would not refer to
these groupings as ``tiers,'' as this implies an incremental increase
in risk from tier to tier, but would instead label them as
``categories'' which are lettered and not numbered.
APHIS developed the proposed sorting scheme by first examining the
types of releases that typically are authorized under its current
regulations. APHIS then modified the categories to make them more
explicitly connected to plant pest and noxious weed risks.
The two primary factors APHIS identified as most relevant to define
its sorting system for environmental release permits were the (1)
ability of the unmodified recipient plant species to persist in the
wild and (2) potential of the engineered trait to cause harm, injury,
or damage, as described in the definitions of plant pest and noxious
weed. Secondary factors, which in some instances may change the initial
categorization, include: how the recipient plant is commonly used
(e.g., as a food or feed crop); the impact of the engineered trait on
the fitness of the GE plant; and, the degree of uncertainty associated
with the trait and its possible impacts.
Regarding the persistence factor, APHIS proposes to group plant
species according to the risk of persistence of the plant or its
progeny in the environment without human intervention. Based upon the
growth habit of the plant species and presence of wild relatives in the
United States, APHIS proposes to sort all plants into four groups,
listed in order of increasing persistence risk:
Low: Populations of the recipient plant are unlikely to
persist in the environment without human intervention, and the
recipient plant has no interfertile wild relatives in the United
States. Examples include corn, soybeans, and cotton (except in certain
areas).
Moderate: Populations of the recipient plant are known to
be weakly persistent in the environment without human intervention, or
the recipient plant has interfertile wild relatives in the United
States. Examples include alfalfa, beets, canola, rice, and tomato.
High: Populations of the recipient plant are known to be
strongly persistent in the environment without human intervention, or
the recipient plant has interfertile wild relatives in the United
States which are aggressive colonizers. Examples include creeping
bentgrass, poplar, sorghum, and sunflower.
Severe: The recipient plant is a Federally-listed noxious
weed or is known to be similarly aggressive in its ability to colonize
and persist in the environment without human intervention. Examples
include hydrilla and kudzu.
These aspects of plant biology and growth habit are broad
indicators of the increasing likelihood that the plant or its progeny
can reproduce and spread without human intervention. ``Interfertile
wild relatives'' includes both wild relatives in the traditional sense,
as well as feral populations of the same species persisting outside
agroecosystems. The distinction between ``weakly persistent'' and
``strongly persistent,'' is intended to mean survival without human
intervention for one or very few generations (weakly persistent) versus
several to many generations (strongly persistent). APHIS will clarify
which species fall into each group by publishing lists in guidance.
Similarly, with regard to the factor for potential harm caused by
introduced traits, APHIS proposes to group traits engineered into
plants into four simple groupings based upon the definitions of plant
pest and noxious weed. The groups are listed in order of increasing
potential hazard of the engineered trait:
Low:
[cir] Any new proteins or substances produced are unlikely to be
toxic or otherwise cause serious harm to humans, vertebrate animals, or
invertebrate organisms upon consumption of or contact with the plant or
plant parts; and
[cir] No morphological changes which could cause mechanical injury
or damage; and
[cir] Introduced sequences are known not to result in plant
disease, and confers no or very low increased disease susceptibility.
An example would include expression of well characterized proteins
known not to be toxic or harmful, such as a marker gene that does not
pose a food or feed safety concern, or expression of viral genes where
it is demonstrated that no protein is produced
Moderate:
[cir] Any new proteins or substances produced are unlikely to be
toxic or otherwise cause serious harm to humans or vertebrate animals
upon consumption of or contact with the plant or plant parts ; or
[cir] Novel resistance to the application of an herbicide; or
[cir] Has novel ability to cause mechanical injury or damage; or
[cir] Produces proteins or substances that are associated with
plant disease that are not prevalent or endemic in the area of release,
or that confer an increased susceptibility to disease.
Examples include expression of new CRY proteins, ,mechanisms of
herbicide tolerance (e.g., CP4-EPSPS, which confers glyphosate
tolerance), and production of viral movement proteins.
High:
[cir] Any new proteins or substances produced may be toxic or to
otherwise cause serious harm to humans or vertebrate animals, upon
consumption of or contact with the plant or plant parts; or
[cir] Produces an infectious entity which can cause disease in
plants.
Examples include mercury hyper-accumulators or production of some
pharmaceutical compounds.
Severe:
Any new proteins or substances produced are known or likely to be
[[Page 60019]]
highly toxic or fatal to humans or vertebrate animals, upon consumption
of or contact with the plant or plant parts.
These aspects of the engineered trait are related to harms or
damages associated with plant pests or noxious weeds. This takes into
consideration (1) the harmfulness of any substances produced, (2) the
possibility of creating morphological changes that would cause physical
injury, and (3) the likelihood of increasing plant disease, either due
to risk of creating novel pests or increased inoculum source. Novel
resistance to an herbicide is included in the ``moderate'' category due
to the impacts the trait could have on the ability to manage the plant
or its progeny.
The proposed use of plant growth habit and trait harm or injury as
the two main factors for the initial sorting of environmental releases
into categories uses the two factors to roughly approximate
``exposure'' and ``hazard,'' respectively. Thus, using a combination of
these two factors alone, we propose the following initial sorting of
plant-trait combinations into release permit categories (see Table 3).
Once environmental releases of GE plants have been sorted into the
permit categories shown in Table 3, we will review and evaluate the
information submitted by the applicant to determine oversight and
permit conditions. The information requested from applicants will not
be limited to these factors and is, in fact, designed to allow us to
evaluate any of the risks associated with noxious weeds and plant
pests. In some instances, our review may result in a change to the
release category assignment of a GE plant.
Table 3--Initial Sorting Into Administrative Permit Categories (A, B, C, and D) for Environmental Releases of GE
Plants, Based Upon Persistence Risk of the Recipient Plant Species and Potential Harm or Damage of the
Engineered Trait
----------------------------------------------------------------------------------------------------------------
Potential harm or damage of engineered trait
Persistence * -------------------------------------------------------
Low Moderate High Severe
----------------------------------------------------------------------------------------------------------------
Low..................................................... A A C D
Moderate................................................ A B C D
High.................................................... B B C D
Severe.................................................. D D D D
----------------------------------------------------------------------------------------------------------------
* Persistence risk of the recipient plant species.
The sorting system above presumes that there is sufficient
scientific information available about the GE plant to support the
categorization. For example, the phenotype conferred by inserted
sequences and the growth habit of the plant species in the U.S. must be
well-characterized and based upon direct empirical observation of the
genetic construct in the recipient plant species. In cases where less
(or nothing) is known about phenotype of the engineered trait in the
recipient plant species-such as inference based upon sequence
similarity, protein structure modeling, or observation of the genetic
construct in other species-the release category may be changed (from A
to B or B to C) as a result of this uncertainty. Similarly, lack of
familiarity with the plant species' behavior in the U.S. or the
techniques needed to mitigate the likelihood of its persistence could
also change the release category.
APHIS considered whether to adjust the categories table to
acknowledge that an engineered trait could affect (enhance or detract
from) the other factor axis, namely the persistence risk of the
nonmodified recipient plant. Engineered traits such as resistance to
biotic or abiotic stresses could theoretically increase the fitness of
the plant, and thereby increase the likelihood that it will persist in
the environment without human assistance. Considering the range of
persistence risks posed by all of the different plant species sorted
into any one of the proposed groupings, however, APHIS has concluded
that in most instances the engineered trait would not alter the
likelihood of persistence enough to warrant a change in initial release
category. However, in cases where the engineered trait significantly
alters plant growth habit, metabolism, or reproduction to increase the
likelihood of persistence in the environment, APHIS could change the
release category accordingly. Examples of such changes might include
converting an annual species to a perennial or converting a plant with
C3 metabolism to crassulacean acid metabolism (CAM).
The proposed category system should provide a simple, transparent
way for APHIS review information in applications to initially sort
releases into broad, risk-related categories, which can then be more
efficiently assessed for the actual risks posed by the release.
However, it should be emphasized that the categories are intended only
for initial sorting, and other factors are taken into account in the
APHIS evaluation when determining the specific permit conditions.
APHIS intends that release Category A will be associated with a
level of regulatory oversight similar to environmental release
notifications under the current system, and Categories B and C with a
level of regulatory oversight similar to various permits that have been
issued under the current system. However, it will be much clearer to
the public what types of oversight will be applied broadly within each
category. As we discussed above, oversight and permit conditions with
each category will be similar, though not necessarily identical, for
any plant within the category. Category D was created to acknowledge
the possibility that some proposed releases may pose a very high risk
of introducing a highly persistent or harmful plant into the
environment. To date, APHIS has never been requested to allow releases
that would fall into this category. If an applicant were to propose a
Category D release, APHIS would only authorize such releases after
imposing extremely strict levels of oversight akin to high security
quarantine far exceeding that of Category C that would ensure that the
GE plants could not persist in the environment. The information
requirements, permit conditions, and general levels of oversight
associated with each release Category are discussed below.
This simple sorting system places GE plants into categories and
provides a relatively clear, simple rationale for placement in a given
category. What follows is a series of illustrations of common plant-
trait combinations and the release categories to which they would be
assigned:
Category A:
[cir] Bt corn producing CRY1ab toxin. The plant is unlikely to
persist in the
[[Page 60020]]
environment and the safety of the protein has been assessed by the EPA.
[cir] Soybeans engineered with glyphosate tolerance conferred by
CP4-EPSPS. While herbicide tolerance poses a ``moderate'' hazard,
soybean has no interfertile wild relatives in the U.S..
Category B:
[cir] Corn producing a new CRY protein. The plant is unlikely to
persist and the novel CRY protein is likely to be toxic to some species
that live or feed on the plant (normally Category A), but its food/feed
safety is only inferred from similarity to other CRY proteins.
[cir] Random ``knock-out'' or antisense libraries of soybean lines.
While the lines may not likely produce novel proteins or substances
(Category A), because of the uncertainty associated with the impacts of
genetic engineering on these lines, they would be treated as Category
B. Well-characterized lines taken from such libraries that do not
produce new proteins would likely be treated as Category A.
[cir] Kentucky bluegrass engineered with glyphosate resistance
conferred by CP4-EPSPS. Herbicide resistance is a ``moderate'' hazard
and bluegrass has interfertile wild relatives in the U.S.
[cir] Pines producing an enzyme to enhance paper production. Pines
are persistent and have interfertile wild relatives in the United
States.
Category C:
[cir] Poplar engineered to produce enzymes for heavy metal
bioremediation.
Category D:
[cir] Any Federally listed noxious weed that has been genetically
engineered; any GE plant producing a vertebrate toxin.
Permits for Environmental Releases of Plants Making Pharmaceutical and
Industrial (PMPI) Compounds
APHIS considered whether to continue to issue environmental release
permits for GE plants engineered to produce pharmaceutical and
industrial compounds if the GE plant species is the same as, or
sexually compatible with, a species commonly used for food or feed.
APHIS concludes that the proposed permitting procedure and the use of
stringent permit conditions can continue to effectively minimize the
risks that may be associated with the environmental release of such GE
plants. APHIS will continue to impose permit conditions that take into
account the issues related to the safety of proteins or other
substances that these plants have been engineered to produce. Based
upon APHIS experience to date, many releases of GE plants producing
pharmaceutical or industrial substances would fall in Category C, and
would carry the same level of oversight as current permits for PMPI.
4. Permit Application Information Requirements (Sec. 340.2(c))
In the proposed regulations, we provide greater detail about the
basic application information requirements that need to be addressed in
all permit applications, as well as additional basic information
required for each permit type and the categories in the case of
environmental release permits. Under the current regulation, certain
areas where APHIS routinely needs information from the applicant do not
become apparent until the applicant submits the permit application (and
APHIS subsequently follows up for additional information). Some of the
information requirements related to recordkeeping, reporting, and
contractual arrangements among the permit holder and agents are new to
the regulation and reflect, in part, certain provisions of the 2008
Farm Bill and also align with recommendations of USDA's OIG 2005
Report. For example, the OIG recommendations have led to provisions
that will enable APHIS to require geographic coordinates for the
locations of environmental releases.
The differences between the information required for an application
under the current regulations versus the proposed regulations may be
seen by comparing current Sec. 340.4 to proposed Sec. 340.2(c). Both
the current and proposed application procedures require information
characterizing the nature of the GE organism, including detailed
molecular biology information about the expression of the introduced
genetic material. They also both require information about the type of
movement and/or release planned. The proposed rule requires more detail
in some of these areas, and more description of the applicant's plans
and methods to prevent unauthorized releases, and to respond to
unauthorized releases if they occur. This information is used in part
by APHIS to formulate the specific permit conditions. In cases where
the permit is for environmental release, and would be in permit
categories C or D according to the table in Sec. 340.2(b)(3), a
greater level of detail would be required for almost all aspects of the
activity, including the recipient organism, the inserted gene(s), site
location and management practices, and training and communication among
the permit holder and agents involved in the activity covered under the
permit. This information would also address the capability of the
organism to persist or spread in the environment, or include details
about how the engineered traits might be harmful.
5. Permit Conditions (Sec. 340.3)
Conditions are specific practices or requirements that an applicant
must follow upon issuance of a permit. Under the current regulation,
the permit conditions are described in the same section as the permit
procedure itself. In the proposed revision, the permit conditions are
enumerated in a separate section (Sec. 340.3) to accommodate the
additional details to describe conditions for the three permit types as
well as the categories of environmental release permits.
The use of permits and permit conditions gives APHIS and the
responsible person a clearer understanding as to what actions must be
taken for the permit holder to comply with the regulation. In the
proposed regulation, APHIS has strived to provide as much transparency
and predictability as possible about permit conditions while retaining
sufficient flexibility so that the regulations will be adaptable in a
broad range of cases.
Permits will be issued with the core permit conditions described in
Sec. 340.3(a), which are a minimum set of basic conditions for
importation, interstate movement, and release. The Administrator may
add to these conditions additional or expanded conditions when
necessary to make it unlikely that actions under the permit would
result in the introduction or dissemination of a plant pest or noxious
weed.
The Administrator will assign the permit conditions in a manner
that is commensurate with the risk of the individual proposed movement
or release. Additional or expanded permit conditions may include, but
are not limited to, specific requirements for: reproductive, cultural,
spatial, temporal controls; monitoring; post-termination land use; site
security or access restrictions; and management practices such as
training of personnel involved in the release.
The proposed description of permit conditions elaborates on the
``standard'' permit conditions found in the current regulations, and
the additional detail is designed to better communicate with potential
applicants what the requirements are likely to be for their particular
permit, and will better support administration of the program,
including compliance and enforcement.
In the current regulation, only ``standard'' permit conditions are
described, and APHIS has the authority to place other conditions upon
the permit as deemed necessary by the
[[Page 60021]]
Administrator. The proposal for permit conditions will be more
transparent to the public and this transparency will better facilitate
planning by researchers, especially those who have not previously
received permits from APHIS.
The proposed required core permit conditions consolidate six
primary areas addressed in different parts of the current regulations
to ensure compliance with the regulation and to make it unlikely that
the permitted activity will result in the introduction and
dissemination of a plant pest or noxious weed: Identity, shipment,
unauthorized dissemination, communication and training, records,
reports and notices. APHIS intends the list of specific condition areas
we propose in Sec. 340.3 to be used for all permits we issue as they
apply to importation, interstate movement, and release into the
environment. The required permit conditions listed in Sec. 340.3
represent the permit conditions that we propose to apply for any type
of permit. Listing them in the regulations should provide applicants
with the ability to plan their activities with knowledge of the primary
requirements for all activities that would have to be met to comply
with the regulations.
For environmental release permits, proposed Sec.
340.3(a)(4)(iii)(F) would also require the permit holder to notify
APHIS seven days prior to initiation of the release if the release is
Category C or D. For all Categories, permit holders are required to
notify APHIS if they do not conduct the release.
The current regulations require environmental release permit
holders to submit field test reports to APHIS within 6 months after
termination of a field test. Under proposed Sec. 340.3(a), the
requirement simply states that the responsible person shall submit
reports to APHIS at the times specified in the permit conditions and
containing the information specified in the permit conditions.
APHIS is also proposing revision of the regulations to clarify the
procedure it would use for amendment of permit conditions, transfer of
a permit to a different responsible person, and revocation of an
existing permit. Each of these additions to the regulations reflect
current administrative practices and the incorporation of these into
the regulations will make the overall system more transparent.
Currently, APHIS attaches conditions to permits at the moment the
permit is issued to the applicant. Under the current regulations, the
permitting procedure does not include a formal acknowledgement from the
applicant prior to permit issuance that they are aware of and consent
to the permit conditions. To verify that applicants are aware of and
willing to abide by the conditions, APHIS proposes to add an additional
administrative step in the permit procedure in Sec. 340.2(d)(6) to
support administration of the program. We are proposing to require that
applicants agree prior to permit issuance that they will comply with
all the permit conditions. Eventually, APHIS would build this feature
into the existing ePermits system, and in the interim it would provide
alternative mechanisms, such as e-mail communications, to implement
this step of the permitting procedure.
APHIS is also proposing to clarify in Sec. 340.2(h) of the
regulations the procedure to be used when amendment of existing permit
conditions is sought by the responsible person or required by APHIS, as
well as the procedure for transfer of an existing permit to a different
responsible person.
As with the current regulations, APHIS is retaining the flexibility
to modify permit conditions as needed under individual circumstances.
Proposed Sec. 340.3 will increase transparency, yet still allow
sufficient adaptability of the regulations for the full range of permit
applications APHIS expects to receive today and in the future. APHIS
recognizes that transparency and predictability for applicants must be
balanced with maintaining Agency flexibility and adaptability for years
to come under these regulations. APHIS encourages the public to comment
on the choices we are proposing here, and we welcome suggestions for
alternative approaches.
APHIS is proposing to revise the current sections of the
regulations for container requirements for shipments of GE organisms
(Sec. 340.8) and marking and identity requirements for imports of GE
organisms (Sec. 340.7). Rather than the highly prescriptive approach
in the current regulation, we will use an approach that is performance
based and can be adapted to the activity that is being performed. This
should provide greater efficiency for the public as well as APHIS, yet
still achieve the necessary level of containment during shipments. We
have reorganized this information in the regulations so that the
requirements are associated with the related activity under the
proposed regulation. For example, the shipping requirements for
interstate movements under the conditional exemption have the requisite
shipping conditions stipulated in the section for conditional
exemptions. Likewise, the shipping conditions for import and interstate
movement permits have been placed in the section for permit conditions,
rather than retaining them in a separate section as in the current
regulations. The performance-based standards we are proposing
incorporates a simple performance standard in our proposed definition
of secure shipment, discussed below: ``Shipment of a package of
sufficient strength and integrity to withstand leakage of contents,
shocks, pressure changes, and other conditions incident to ordinary
handling in transportation.'' APHIS is also proposing to require
applicants to provide their proposed methods of secure shipment, and
APHIS will specify the methods of secure shipment as a permit
condition.
APHIS proposes to eliminate the marking and identity requirements
for imports of GE organisms as a separate section of the regulations
(current Sec. 340.7). As with the container standard issue discussed
above, appropriate labeling and related requirements would be highly
individual depending on the organism, type of permit, and other
conditions.
APHIS is proposing to include relevant tribal officials when it
provides copies of permit applications to state regulatory officials.
The current regulations state that APHIS provides this information to
state regulatory officials.
6. Elimination of Courtesy Permits
APHIS is also proposing to eliminate the issuance of courtesy
permits. Courtesy permits have been part of the regulations since their
inception in 1987, but in an effort to better allocate APHIS resources,
APHIS is proposing to remove this regulatory feature. The current
regulations provide the ability for APHIS to issue ``courtesy
permits,'' in order to facilitate the movement of organisms which are
outside the scope of these regulations, but whose movement might
otherwise be hindered because of their similarity to organisms
regulated under these regulations. The issuance of courtesy permits has
generated confusion in the public and especially in the research
community. The application form for courtesy permits is identical to
the application for other types of permits, and the courtesy permit
itself looks like other permits. This has led to the widespread
misunderstanding by some researchers that courtesy permits are actually
required for the movement of certain organisms, or that issuance of a
courtesy permit removes the requirement for applicants to have other
authorizations which may be required, under plant
[[Page 60022]]
pest regulations such as those found at 7 CFR part 330. APHIS commits
significant resources to the issuance of these courtesy permits for the
movement of organisms which are not subject to the provisions of part
340. APHIS will work with researchers and relevant government
regulatory officials to facilitate the transition.
APHIS will also be available for consultation by persons who
formerly used courtesy permits and other persons moving similar non-
regulated articles, to discuss how to facilitate their movement. We
also encourage the public to comment on the proposed elimination of
courtesy permits and how APHIS should work with persons moving
organisms for which we might formerly have issued courtesy permits.
C. Conditional Exemptions From Permit Requirement (Sec. 340.4)
The PPA allows the Secretary to create ``exceptions'' to the permit
requirement when the Secretary deems that a permit is not necessary.
That is, these regulated activities are allowed, under certain
conditions, without seeking prior authorization via permit. The current
APHIS regulations contain such PPA exceptions, but they are referred to
as ``exemptions'' in the regulations. The current regulations include
conditional exemptions from the requirement for interstate movement
permits. These conditional exemptions were established in the
regulations during the first few years after the regulations were first
promulgated. The last conditional exemption was established in the
regulations in 1990 for the interstate movement of GE plants of the
species Arabidopsis thaliana as long as the conditions described in the
regulations are met.
In its proposed revision to the regulations, APHIS is retaining the
existing conditional exemptions from interstate movement. We are also
proposing a new regulatory procedure that would enable APHIS to approve
new conditional exemptions more efficiently than using the procedure of
notice and comment rulemaking for each individual exemption. This can
be a transparent and efficient way to provide regulatory relief. This
new procedure for approving conditional exemptions is described in
Sec. 340.5, and it incorporates transparent steps including scientific
review, public input, and adaptability when APHIS establishes the
conditions relevant to the specific conditional exemption. Conditional
exemptions, by their nature, will always include conditions and
continued APHIS oversight to ensure that the conditions are met.
The current regulations provide for conditional exemptions from the
requirement for permits for the interstate movement of certain GE
strains of the microorganisms Escherichia coli, Saccharomyces
cerevisiae, and Bacillus subtilis, and the plant Arabidopsis thaliana
in Sec. 340.2(b), and these conditional exemptions are being retained
under the proposed regulations. Conditional exemptions from permit have
been part of the regulations since the first exemption was established
in 1988 (for the interstate movement of certain GE microorganisms),
with the addition of another conditional exemption, through rulemaking,
in 1990 for certain types of GE Arabidopsis thaliana, one of the most
commonly used plants for scientific studies and which is frequently
distributed among researchers. The essential conditions for each of
these conditional exemptions address the following: (1) Species of the
GE organism, (2) the types of genetic modifications that are allowed or
prohibited for the GE organism, and (3) the manner in which the GE
organism is shipped interstate. The existing conditional exemptions for
the interstate movement of microorganisms were based on APHIS'
conclusion that the exemption from the requirement for permits for
interstate movement of these microorganisms would ``not present a risk
of the introduction or dissemination of a plant pest'' (53 FR 12910,
p.12910).
The existing conditional exemptions for E. coli, Bacillus subtilis,
Saccharomyces cerevisiae and Arabidopsis thaliana are being retained in
the proposed regulations. APHIS has no information that would indicate
that such conditional exemption would be result in the introduction and
dissemination of a plant pest or noxious weed. The text of the
conditional exemption is being updated to place the shipping
requirements with the other conditions associated with the exemption,
instead of the current regulatory organization that has the shipping
requirements in a separate section of the regulation.
In addition to the existing conditional exemptions, APHIS is
proposing a transparent and efficient petition procedure in Sec. 340.5
whereby the Administrator may approve additional conditional exemptions
from permit without having to amend the regulations. This procedure
would provide for a scientific review by APHIS as well as the
opportunity for public review and comment on the scientific basis for
the proposed exemption and the conditions associated with the
exemption. The proposed procedure would provide an adaptable means of
ensuring that the regulatory oversight is proportional to the risks
posed by specific activities with GE organisms.
Proposed Sec. 340.5 describes the procedure whereby a petitioner
would seek a determination by the Administrator that the importation,
interstate movement, and/or release into the environment of a GE
organism is not subject to the requirement to have a permit under this
part. We propose that the Administrator's decision to approve an
exemption would be based upon a determination that the exemption from
the requirement for a permit, when conducted with the associated
conditions, is unlikely to result in the introduction or dissemination
of a plant pest or noxious weed. APHIS anticipates that creating this
new petition procedure to allow approval of additional conditional
exemptions would enhance its ability to customize regulatory oversight
to be proportional to any risks associated with importation, interstate
movement, or release into the environment of a GE organism.
Under the proposed procedure, petitioners have the flexibility to
propose various types of conditional exemptions from the requirement
for a permit: The proposal can be for one or more permit types
(importation, interstate movement, or release into the environment). In
addition, the petitioner can propose the relevant conditions. The
Administrator may approve the proposed conditional exemption as
submitted in the petition, or the Administrator may impose alternatives
to the requested exemption and conditions. The Administrator would
review the scientific information and evaluate potential risks relevant
to the proposal, then make the relevant documents (proposal and any
supporting information) available to the public for review and comment
prior to the Administrator's decision.
The information needed for a petition for conditional exemption
would depend on the nature of the exemption requested and the proposed
conditions for exemption. For example, conditional exemptions for the
interstate movement of narrowly-defined groups of organisms with
restrictive associated conditions might require considerably less
information to justify than exemptions for broadly defined groups of
organisms or less restrictive associated conditions. In making its
determination, APHIS would consider all relevant information, including
information in the scientific literature, copies of unpublished
studies, and reviews by other regulatory agencies.
[[Page 60023]]
APHIS foresees many advantages to the proposed procedure, including
scientific rigor, public involvement, and regulatory efficiency. APHIS
would continue to provide to the public the relevant scientific
information under consideration, its environmental analysis, and the
rationale for its determination. The public would also retain its
ability to provide comments to the agency prior to a decision approving
a new exemption. APHIS decisions regarding these newly approved
conditional exemptions would be published in the Federal Register and
maintained on a list accessible to the public.
In evaluating whether to approve a new conditional exemption, APHIS
would carefully consider issues related to enforceability of the
conditional exemption when proposing to approve a conditional
exemption. Unlike permit conditions, which are binding on the specific
responsible person, the conditions associated with the exemption would
apply to anyone who conducts the activity under the conditional
exemption. Before granting such a conditional exemption, APHIS would
take into consideration the likelihood that such conditions would be
followed and the consequences if they are not.
Conditional exemptions could be used, for example, for the
importation of certain GE commodities. A person could petition for an
exemption from all permits for shipments of a particular GE commodity
grain under the condition that the grain is not grown, but will only be
moved for direct use as food, feed, or for processing. The proposed
procedure to approve new exemptions would be sufficiently adaptable
that it can consider approving exemptions for the shipment of certain
GE commodities that would take into account any conditions necessary to
make it unlikely to result in the introduction and dissemination of
plant pests or noxious weeds.
APHIS considered proposing specific criteria in the regulations
that the Agency would use when evaluating potential risks of imported
GE commodities which are viable propagules such as grains like corn,
wheat, etc. APHIS considered that such a criterion-based system in the
regulations might allow APHIS to conduct expedited reviews of imports
that met the specified criteria. APHIS considered criteria such as
whether the GE plant had undergone a safety review in a foreign
country, whether APHIS had granted nonregulated status to something
similar, and the likelihood that the commodity could be propagated
(seeds, fruit with seeds, nonviable products like flour, etc.).
However, at this time APHIS is not proposing such criteria in the
regulation. APHIS does not rule out the possibility of developing such
a criterion-based system in the future. We welcome comments from the
public on this issue.
We are also proposing regulatory procedures whereby the
Administrator may revoke any exemption under this part after it is
approved. As proposed, the Administrator may revoke any exemption if
the Administrator receives information subsequent to approving the
exemption and makes a determination based upon this information that
the circumstances have changed such that the exemption is likely to
result in the introduction or dissemination of a plant pest or noxious
weed. A revocation may not be appealed. However, any person may file a
new petition in accordance with Sec. 340.5 regarding the same or
similar organisms covered by the exemption if new information relevant
to the revocation becomes available.
In addition to this procedure for completely revoking an exemption
so it would be unavailable for use by any person, we propose to add a
provision in paragraph (e) of the conditional exemptions section, Sec.
340.4, under which the Administrator may revoke the right of an
individual person to use an exemption without revoking the exemption
for other persons. The Administrator could revoke an individual's right
to use an exemption after determining that the person or any agent of
the person has failed to comply at any time with any provision of this
part.
D. Petitions for Nonregulated Status (Sec. 340.5)
The current regulations include a procedure by which anyone may
petition APHIS to grant ``nonregulated status'' to a GE organism, which
means it would no longer be subject to the regulations in part 340.
This nonregulated status is different from that of regulated articles
that might be conditionally exempt from the requirement for a permit
when moved interstate (following the conditions specified in the
regulations).
Published APHIS decisions made under the current regulations have
used different ways to express the basic standard ``unlikely to pose a
plant pest risk'' in determining whether to grant nonregulated status
to a specific GE organism. In its determinations, APHIS has conveyed
the basic standard of ``unlikely to pose a plant pest risk'' by
concluding that the GE organism ``poses no more of a plant pest risk
than its non-genetically engineered counterpart,'' ``will not pose a
plant pest risk''; or that there is ``no plant pest risk,'' or ``no
direct or indirect plant pest effects.'' Regardless of the phrases used
in its determination of nonregulated status to date, APHIS has applied
the same basic evaluation criteria to each determination to conclude
that the GE organism is unlikely to pose a plant pest risk and
therefore is not subject to the part 340 regulations.
APHIS is proposing revisions to Sec. 340.6 that will clarify the
petition procedure, information requirements for petitions, and the
standard upon which the Administrator will make a determination that a
GE organism is approved for nonregulated status. Under the current
regulations, the basic standard for a determination of nonregulated
status of a GE organism has been related to plant pest risk. In Sec.
340.6(b)(4) of this proposed rule, we are proposing to apply a similar
basic standard derived from the proposed regulatory scope in Sec.
340.0(a), namely, whether the GE organism is unlikely to be a plant
pest or noxious weed.
The current regulations also have a provision at Sec. 340.6 to
extend a determination of nonregulated status and grant nonregulated
status to a GE organism based on the similarity of the GE organism to
an antecedent GE organism that has already granted nonregulated status
(Sec. 340.6(e) ``Extensions to determinations of nonregulated
status''). This provision has been in the APHIS regulations since 1997
and has been used fifteen times to grant nonregulated status to
additional GE plants based on similarity to their antecedents. This
existing ``extension procedure'' was designed for APHIS to take into
account the previous evaluation conducted by APHIS and thereby afford
the potential for expedited evaluations of a petition for extension.
The extension procedure has some administrative aspects which are
streamlined but in practice the APHIS scientific reviews for extensions
are similar to those of the antecedent organism.
Some members of the public have misunderstood the nature of the
extension procedure, believing that APHIS has not conducted a thorough
scientific review. Some members of the public have misconstrued the
term ``extension'' to conclude that an extension would extend the
duration of nonregulated status (nonregulated status is not granted
with an expiration date).
For these reasons, APHIS is proposing to eliminate the extension
procedure in
[[Page 60024]]
the regulation. APHIS sees no advantage to retaining the distinction in
the regulations between reviews for antecedents and reviews for
subsequent petitions for extensions. Because the proposed revisions for
petition for nonregulated status provide a high degree of flexibility,
a separate extension procedure is not needed in the regulation. Review
of petitions under the proposed regulations will rely on previous
evaluations of similar GE organisms when they exist. APHIS foresees
that some evaluations for nonregulated status may require less time if
previous evaluations have addressed the issues relevant to a new
petition for nonregulated status.
In Sec. 340.6 we propose some revisions to the information that
the Administrator may require a petitioner to submit in consideration
of the particular petition. In the current regulation, the information
needs are described largely with respect to evaluating GE plants, but
APHIS foresees that other GE organisms may also be suitable candidates.
This provision may become more important as new commercial applications
of biotechnology emerge and new types of information are needed to
properly assess the risks associated with new types of GE organisms. In
all of the nonregulated status requests processed to date, the subject
organisms and the alterations involved did not present unanticipated or
completely novel approaches and APHIS was able to make a determination
based on information in the petitions. When needed, APHIS obtained
additional information from petitioners, in a consultation process
similar to the one proposed.
We are also proposing a regulatory procedure whereby the
Administrator may revoke a previous approval of nonregulated status.
This is consistent with the existing regulations and policies that the
Administrator may place a deregulated GE organism back under the
regulations if the Administrator concludes that the GE organism poses a
plant pest risk. As proposed, the Administrator may revoke any approval
of nonregulated status if the Administrator receives information
subsequent to approval that the GE organism is likely to be a plant
pest or noxious weed. If the Administrator revokes an approval for
nonregulated status, the Administrator may approve for the same GE
organism an exemption from the requirement for permit in accordance
with Sec. 340.5. The revocation, its effective date, and the reasons
for it will be published in the Federal Register. A revocation may not
be appealed. However, any person may file a new petition in accordance
with Sec. 340.5 or Sec. 340.6 regarding the same or similar organisms
covered by the revocation if new information relevant to the revocation
becomes available.
Treatment of GE Organisms That Have Been Granted Nonregulated Status
Although the APHIS evaluations of GE plants that would be conducted
under the proposed regulatory changes will evaluate some additional
factors because of consideration of noxious weed risks, APHIS
nonetheless considers this proposed revision to be sufficiently
consistent with the criteria evaluated in making determinations of
nonregulated status to date under the current regulations. For this
reason, APHIS is proposing that all previous determinations of
nonregulated status made since the early 1990s under the part 340
regulations will be automatically approved for nonregulated status
under the revisions proposed here. The history of safe use of these
nonregulated GE plants in agriculture in the United States and other
countries gives APHIS confidence that it is appropriate to retain
nonregulated status under the revised regulations for all those GE
plants which have been granted nonregulated status under the existing
regulations. Many of these GE plants have been incorporated into plant
breeding programs and been used to develop hundreds of crop varieties
that have been widely and safely used in agriculture around the world.
We also note that although the addition of the term ``noxious
weed'' is new to the proposed regulation, previous evaluations for
determinations of nonregulated status considered the concept of plant
pest risk in a broad context that included consideration of potential
weediness. The evaluations considered, inter alia, whether the
unmodified plant was a weed, whether the GE plant was a weed, and
whether the interbreeding of the GE plant with sexually compatible
plant species would result in offspring that would be weeds. In each
case in which APHIS granted nonregulated status to date, APHIS reached
the conclusion that in each instance that the potential for weediness
was unlikely to occur. In the case of some petitions for nonregulated
status in which the GE plants were engineered with sequences derived
from plant viruses, APHIS also considered in its reviews whether the
genetic modification was unlikely to result in a new plant pest, in
this case a plant virus (through mechanisms such as recombination or
transencapsidation).
E. Compliance, Enforcement, and Remedial Action (Sec. 340.7)
1. Ensuring Compliance With Permits and Exemption Activities
In recent years, APHIS has strengthened its program in order to
improve permit holders' compliance with the regulations, to augment the
approaches used to prevent or remediate potential risks to plant
health, and to utilize appropriate enforcement strategies. This
proposal provides an opportunity to set forth the compliance and
enforcement requirements and the tools and administrative practices
APHIS may employ as part of an integrated approach to prevent the
introduction or dissemination of plant pests and noxious weeds, and to
support overall administration of the program. These matters are
addressed in proposed Sec. 340.7, ``Compliance, enforcement, and
remedial actions.'' These proposed regulatory changes also reflect
certain provisions of the 2008 Farm Bill and align with recommendations
of USDA's OIG.
APHIS seeks to clarify that it will use the full range of
enforcement authorities and penalties granted under the PPA. As
described above, APHIS issues permits with specific conditions or
requirements placed upon the responsible person. Proposed Sec. 340.7
clarifies the requirement for compliance with these conditions, as well
as the approaches available to APHIS to verify compliance. Such
conditions may include requirements for the responsible person to
establish and maintain records related to the permit, as well as
allowing APHIS to review those records. This section underscores APHIS'
ability to conduct inspections and audit records related to the
regulated activities.
In this proposed rule, the requirements for record retention are
being increased. Records indicating that a GE organism that was
imported or moved interstate reached its intended destination must be
retained for at least 2 years after completion of importation or
interstate movement, and all other records must be retained for at
least 5 years after completion of all obligations required under a
relevant permit or exemption. APHIS is also proposing changes to the
nature of the records that are required, a topic discussed in greater
detail in section E of this document, ``E. Paperwork Reduction Act.''
Changes include a requirement to maintain records for activities done
under a conditional exemption, as well as contracts and other
information related to agreements between the responsible person and
all agents that conduct activities subject to this part.
[[Page 60025]]
In a previous section of this proposal we discussed the types of
records proposed as core permit conditions in Sec. 340.3. We also
propose to add certain recordkeeping requirements to Sec. 340.7 that
would apply not just to responsible persons exercising permits, but to
all responsible persons and their agents engaged in the importation,
interstate movement, or release into the environment of any GE organism
that is subject to this part, including persons utilizing the
conditional exemptions from permits.
In recent years, APHIS has accrued a great deal of experience in
enforcing the regulations and investigating possible violations of
them. This experience has helped us identify specific types of records
that may not be required by the current regulations, but that are
necessary for effective enforcement of the proposed regulations.\2\ For
example, in investigations of field trials we have found that we could
not always obtain detailed maps for each planting area used during each
season of the trial. This information is important for the efficient
enforcement of the regulations. We also found that sometimes records of
actual field trial operations over time were not sufficient to confirm
that the procedures, equipment, and safeguards APHIS approved for a
field trial were actually employed. That is, while existing records
could generally confirm plans to use, for example, certain cleaning
equipment or procedures at certain intervals, or to conduct plantings
on certain dates, the records did not confirm that plans were actually
carried out on the approved dates. We also found that records for some
field trials did not identify which staff members or contractors were
responsible for performing which duties, either during a field test or
in the event of an unauthorized release that triggered the field test
contingency plan. When responsibilities cannot be linked to specific
individuals, it makes it very difficult to investigate possible
violations. Another gap in necessary records we discovered through
experience was the absence of clear written records of the
responsibilities of different organizations, when several different
entities were involved in a field trial. During investigations we may
need to review not only any written contracts, but also any written
agreements among researchers, developers, or other parties that are
sharing performance of tasks required by the permit for a field trial.
---------------------------------------------------------------------------
\2\ Details of investigations that have led APHIS to propose
expanded records requirements may be found in the ``Lessons
Learned'' document cited above, and in investigation report
documents on the APHIS Web site, e.g., ``2007 Report of LibertyLink
Rice Incidents'' (http://www.aphis.usda.gov/newsroom/content/2007/
10/content/printable/RiceReport10-2007.pdf) and ``Transcript of
Technical Briefing on Rice Investigation'' (http://www.usda.gov/wps/
portal/!ut/p/_s.7_0_A/7_0_
1OB?contentidonly=true&contentid=2007/10/0285.xml).
---------------------------------------------------------------------------
The proposed regulations would allow APHIS to require these types
of records. As APHIS considered the types of records needed to support
the regulations it became apparent that regulations could not specify
in a ``one size fits all'' fashion all record requirements that might
be needed. Therefore, we propose to add those detailed record
requirements of truly general applicability in Sec. 340.3 and Sec.
340.7. However, we also propose in Sec. 340.3 that we would continue
to impose any necessary additional record requirements appropriate to
each permit situation as individual permit conditions.
Proposed Sec. 340.7 also outlines the possible consequences of
failure to comply with the regulations, including denial of future
permits; revocation of current permits; destruction, treatment, and
removal of GE organisms; issuance of penalties; and a means to settle
alleged civil violations prior to the issuance of an administrative
complaint.
Under this proposal, every person whose activities are within the
scope of the regulations must comply with all the requirements of this
part. Moreover, a responsible person can be held liable for the
violation of any requirement of this part by any agent working for the
responsible person (including persons contracted to conduct or carry
out the environmental release on their own or on leased properties).
We propose to address remediation authority and procedures to a
greater degree of detail than the current regulations. In proposed
Sec. Sec. 340.7(e) and (g) we explicitly state that the APHIS
Administrator has the authority to take remedial actions in the event
that an incident requires such actions. We also specify that the APHIS
Administrator has the authority to order remedial action by others.
These orders could take the form of an Administrative Order, Emergency
Action Notification, or similar regulatory instrument. Additional
information about these types of orders and related procedures are
provided in administrative guidance on the APHIS Web site. The
consequence for failure to abide by the orders of the Administrator is
also described in proposed Sec. 340.7, linking remediation to
enforcement.
Finally, APHIS has clarified in the proposed regulations that in
the event of a permit revocation, it may act or order action of the
responsible person in the handling of the organisms, articles, or means
of conveyances.
2. Low Level Presence of Regulated GE Plants in Seed or Grain
On March 29, 2007, APHIS published a Federal Register notice titled
``Policy on Responding to the Low-Level Presence of Regulated
Genetically Engineered Plant Materials'' (72 FR 14649-14651; Docket No.
APHIS-2006-0167. This notice described how APHIS responds when low
levels of regulated GE plant materials occur in commercial seeds or
grain that may be used for food or feed. This issue was also addressed
in the DEIS in Issue 7. Both of these documents described how APHIS has
addressed these occurrences in the past, and how the Agency intends to
address them in the future. We are proposing to amend the current
regulations to explicitly incorporate APHIS' low level presence policy.
As described in the DEIS, APHIS proposes to establish criteria
under which the occurrence of a low level presence (LLP) of GE plant
materials in seeds or grain may not be cause for agency remedial
action. APHIS would still retain discretion to order corrective or
remedial actions in situations that meet the non-actionable criteria,
when the Administrator determines remedial action is needed to make the
LLP unlikely to result in the introduction or dissemination of a plant
pest or noxious weed. We propose to list criteria and describe possible
enforcement actions in the regulations to improve transparency
regarding how APHIS would respond to LLP in most instances. APHIS will
not predetermine a specific level that is considered non-actionable as
far as taking some remedial and/or enforcement action because this
determination should always be made case-by-case. These criteria are
intended to apply only to APHIS' decision to take or order remedial
action in the event that LLP occurs. The proposed criteria are listed
within the section describing the Administrator's ability to take or
order remedial actions. Regardless of whether APHIS considers the LLP
actionable with regard to remediation, any violations of the
regulations or permit conditions could still result in any of the
compliance and enforcement actions listed in the regulations, including
imposing civil penalties.
APHIS is proposing a new provision in the regulations that would
reflect the current policy cited above. The provision describes the
criteria APHIS will use when determining that a LLP event would be non-
actionable with regard to remediation, namely when the criteria support
a conclusion that the
[[Page 60026]]
LLP is unlikely to result in the introduction or dissemination of a
plant pest or noxious weed. Because the criteria are safety-based, they
will be used for incidents of low level presence originating
domestically (e.g., from field testing) as well as any low level
presence that might be detected in import shipments that may contain
organisms subject to regulation.
APHIS also considered two additional criteria, which we have not
adopted in the proposed rule. First, we considered a criterion that
would require that the genetic material be introduced into the plant
using a method that has been demonstrated to result in integration of
the new sequences into the plant genome, as defined in Sec. 340.1. We
did not include this criterion in our proposal because its relevance in
the LLP context is unclear. A second criterion considered was that the
genetic material engineered into the GE plant does not encode
substances with whose function APHIS is unfamiliar. APHIS did not adopt
this criterion since it is redundant with the proposed criteria that
will be used, i.e., that the function of the introduced genetic
sequences is known and that key food safety issues have been addressed.
The DEIS, in Issue 7, Alternative 3, proposed that APHIS would also
consider the LLP safety criteria when deciding whether to issue a
permit for environmental release, and what type and severity of permit
conditions to assign to the release permit. In its evaluation of permit
applications, APHIS does plan to refer to the LLP criteria, as
described above.
F. Administrative Changes
1. Confidential Business Information
APHIS is proposing a new Sec. 340.8 to provide further guidance on
the manner in which confidential business information (CBI) will be
addressed in the implementation of these regulations. This change will
support the overall administration of the program. The proposed Sec.
340.8 cites the relevance of the Freedom of Information Act (FOIA) and
exemptions from releasing information pursuant to FOIA, namely, 5
U.S.C. 552(b)(4), and states that APHIS may exempt from disclosure to
the public trade secrets and commercial or financial information
obtained from a person that are privileged or confidential. Proposed
Sec. 340.8 also states how persons wishing to protect confidential
business information should communicate with APHIS in permit
applications, petitions, or other submissions to APHIS.
2. Time Frames for APHIS Action on Permit Applications and Petitions
Current regulations specify time frames within which APHIS must
take certain actions, such as issuing permits, acknowledging
notifications or issuing decisions on petitions to grant nonregulated
status. APHIS experience in the last several years has shown that the
time required to complete these actions has increased beyond the time
frames originally stipulated in the regulations in 1987 (permits) and
1993 (petitions for nonregulated status). As stated in the current
regulation, APHIS is obligated to give its reply in the stipulated
time, even if required procedures are not yet complete. Therefore,
APHIS proposes to include in Sec. 340.2(d) of the regulations a
statement that APHIS will generally respond in the time frames
indicated. APHIS believes it is important to continue to meet the
indicated time frames whenever possible, but the most important thing
is to communicate the actual status of reviews and procedures with
applicants rather than be obligated to reach a decision in a certain
number of days despite the complexities involved with a review. APHIS
is particularly seeking comment on this proposed change from persons
with experience under the current time frames.
3. Duration Period for Permits
Under the current regulations, notifications for environmental
release and interstate movement are valid for one year, and the
duration period for a permit issued for an environmental release is not
specified. Currently interstate movement permits are only valid for one
year from the date of issuance, and a new import permit must be
obtained for each imported shipment.
APHIS will continue to retain the flexibility of the permitting
procedure to authorize environmental release permits that can be
effective for any appropriate time period. In some cases, it may be
most efficient to authorize environmental release permits that are
valid for more than a single year. In such cases, APHIS can retain
adequate oversight by performing periodic inspections and requiring
periodic reports. Experience has revealed situations where field tests
lasting more than one year are essential. For example, some
environmental releases of GE fruit trees may take several years to
evaluate the fruit production that often does not begin for several
years after planting.
In order to provide greater flexibility and efficiency, APHIS is
also proposing to eliminate the current restrictions in the regulation
on the duration of permits for interstate movement and importation. The
proposed regulations will remove the requirements that interstate
movement permits are only valid for one year from the date of issuance,
and that importation permits must be obtained for each individual
importation. These changes should give APHIS the flexibility to issue
these permits with suitable durations to meet the individual
circumstances.
G. Definitions and Miscellaneous Changes
APHIS proposes to change certain definitions in Sec. 340.1 of the
regulations, to add certain new definitions, and to remove definitions
for terms that are defined in the PPA or that no longer appear in the
regulations.
Revised Definitions
APHIS proposes to change the definitions of the following terms in
Sec. 340.1:
Release into the environment would read ``Dispersal beyond the
constraints of a contained facility or secure shipment. Synonymous with
the term environmental release.''
Secure shipment is a new term defined below. By adding reference to
secure shipment in this definition, we clarify the distinction between
environmental release and shipments for importation and interstate
movement; any such movements which are not done by secure shipment
constitute an environmental release.
Responsible person would read ``The person who has control and will
maintain control over a GE organism during its importation, interstate
movement, or release into the environment and assures compliance with
all conditions contained in any applicable permit or exemption as well
as other requirements in this part. A responsible person shall be at
least 18 years of age and be a legal resident of the United States or
designate an agent who is at least 18 years of age and a legal resident
of the United States.'' The change from the former definition is the
addition of ``at least 18 years of age,'' added to prevent possible
enforcement difficulties.
New Definitions
APHIS proposes to add definitions of the following new terms:
Confidential business information, CBI would read ``Information
such as trade secrets or commercial or financial information that may
be exempt from disclosure under Exemption 4 of the Freedom of
Information Act (FOIA),
[[Page 60027]]
because disclosure could reasonably be expected to cause substantial
competitive harm. USDA regulations on how the agency will handle CBI
and how to determine what information may be exempt from disclosure
under FOIA (5 U.S.C. 552) are found at 7 CFR Sec. 1.12.'' We propose
to add this definition because APHIS has often been asked to clarify
what is and is not CBI, and how it is handled. The definition describes
typical types of CBI, and the language in proposed Sec. 340.8
describes how persons submitting documents to APHIS can request that
identified information be treated as CBI. There is also additional
guidance on CBI contained in administrative guidance on the APHIS Web
site regarding document preparation for part 340 requests. However, it
is important to realize that in actual situations where someone submits
a FOIA request for particular information, the APHIS FOIA Officer makes
the ultimate determination as to whether particular information shall
be released, in accordance with the standards of FOIA, Executive Order
12600, and 7 CFR 1.12.
Contingency plan would read ``A written plan stating how the
responsible person will respond in the event of the unauthorized
environmental release of GE organisms.'' We propose to define this new
term to describe a document mentioned in both the permit application
information requirements section (Sec. 340.2(c)) and the permit
conditions section (Sec. 340.3).
Exempt, exempted, exemption would read ``A determination by the
Administrator that the importation, interstate movement, and/or release
into the environment of an organism or class of organisms described in
Sec. 340.0(a) is not subject to the requirement to have a permit under
this part. An exemption from one type of permit (e.g., interstate
movement) does not remove remaining obligations to obtain other permits
under this part.'' We propose to add this definition for the term
exemption to refer to situations where a regulated movement is exempt
from the requirement for a permit. The proposed definition is based on
language in Sec. 411(b)(1) of the PPA (7 U.S.C. 7711(c)), titled
``Exception to permit requirement,'' which authorizes the Secretary to
issue regulations to allow the movement of specified plant pests
without further restriction if the Secretary finds that a permit is not
necessary.
Noxious weed would read ``Any plant or plant product that can
directly or indirectly injure or cause damage to crops (including
nursery stock or plant products), livestock, poultry, or other
interests of agriculture, irrigation, navigation, the natural resources
of the United States, the public health, or the environment.'' This is
the definition for noxious weed found in the PPA.
Recipient organism would read ``The organism that will receive the
genetic material from a donor organism in the process of genetic
engineering (once the organism is engineered it is referred to as the
genetically engineered (GE) organism).'' This definition is needed to
properly distinguish organisms and their traits in comparisons of GE
organisms to the same organisms prior to transformation.
State or tribal regulatory official would read ``State or tribal
official with responsibilities for plant health, or any other duly
designated State or tribal official, in the State or on the tribal
lands where the importation, interstate movement, or release into the
environment is to take place.'' This term is used in reference to
consultations with States and tribes under the regulations.
Secure shipment would read ``Shipment in a container or a means of
conveyance of sufficient strength and integrity to withstand leakage of
contents, shocks, pressure changes, and other conditions incident to
ordinary handling in transportation.''
We propose to add the following two definitions to make it clear
that, when the Administrator authorizes it, a signature required under
the regulations may be an electronic signature and a written document
required under the regulations (e.g., a permit application) may be an
electronic document.
Signature, signed would read ``The discrete, verifiable symbol of
an individual which, when affixed to a writing with the knowledge and
consent of the individual, indicates a present intention to
authenticate the writing. This includes electronic signatures when
authorized by the Administrator.''
Write, writing, written would read ``Any document or communication
required by this part to be in writing may also be provided by
electronic communication when authorized by the Administrator.''
Deletion of Definitions
We propose to remove the following definitions from the
regulations: courtesy permit, expression vector, introduce or
introduction, regulated article, stably integrated, vector or vector
agent, and well-characterized and contains only non-coding regulatory
regions.
These definitions would be removed because the terms would no
longer be used in the regulations. We propose to eliminate the term
regulated article partly because the use of the term ``article'' in
current part 340 is not consistent with usage in the PPA, which uses
the term article to mean ``any material or tangible object that could
harbor plant pests or noxious weeds''--that is, things like packing
materials, shipping containers, commodities, etc.--and not a plant pest
or noxious weed itself. Under the current regulation, however,
regulated article refers exclusively to certain GE organisms.
Furthermore, under both the PPA and part 340, ``articles'' are not
regulated, but rather their importation, interstate movement or
environmental release is regulated. For these reasons, the term
``regulated article'' in the current regulations is both inconsistent
with the terminology of the PPA and difficult for the public to
comprehend.
We also propose to remove the definition for introduction. APHIS
currently uses the term in part 340 to denote certain kinds of
activities that fall within the scope of the regulation, namely
importation, interstate movement, and release into the environment. The
PPA, however, does not specifically define the term introduction.
Therefore, to avoid confusion, instead of using the term introduction
to define the different types of regulated activities, APHIS will
instead refer to these specific activities themselves in the
regulations, namely, the importation, interstate movement and release
into the environment.
Miscellaneous Changes
We also propose to make minor miscellaneous changes to the
regulations to improve their clarity and remove redundancies. For
example, in addition to adding the definition for CBI discussed above,
we are consolidating requirements concerning CBI, formerly contained in
several sections of the regulations, into proposed Sec. 340.8.
IV. Required Analyses
A. National Environmental Policy Act
On January 23, 2004 (69 FR 3271), APHIS published a notice of
intent to prepare a draft environmental impact statement (DEIS) in
accordance with the National Environmental Policy Act in connection
with the regulations at 7 CFR part 340 and potential changes to those
regulations. This notice identified potential issues and alternatives
to be studied and requested public comment to shape the scope of the
DEIS.
On July 17, 2007, APHIS published the DEIS evaluating regulatory
alternatives under consideration and solicited public comment on the
DEIS
[[Page 60028]]
(72 FR 39021-39025). The Environmental Protection Agency published a
separate notice on July 13, 2007, soliciting public comment on the DEIS
(72 FR 38576-38577). The notices sought comments on the quality of our
analysis of potential environmental effects of the alternatives under
consideration, and also sought views on how each alternative would
affect areas such as the overall effectiveness of our biotechnology
program, its operational efficiency, industry compliance issues, or
other issues that would be associated with the implementation of an
alternative.
The major elements of this proposed rule were accurately described
in the alternatives contained in the DEIS and their potential
environmental effects were analyzed in the DEIS. Table 4 below provides
a comparison between the proposed changes to part 340 and the DEIS. We
received numerous comments on the DEIS, which will be discussed fully
when we publish a final environmental impact statement (FEIS). The DEIS
and the comments on it were used by APHIS to inform decision makers and
aid the design of this proposal. Information from the DEIS comments,
along with information from many other sources, including certain
provisions of the 2008 Farm Bill and recommendations from USDA's OIG,
was used to inform the drafters of this proposed rule about the issues
perceived to be involved in and addressed by the rulemaking. We will
respond to all DEIS comments in detail in the FEIS since the agency
action (revising the regulations in part 340) is still subject to
change based on comments and information received on this proposed
rule, and thus we cannot provide definitive and final comment responses
until we issue the FEIS and the final rule.
Consideration of the DEIS comments led APHIS to refine and
reorganize some of the regulatory alternatives it considered.
Therefore, the presentation and discussion of the alternatives proposed
in this proposal do not exactly match those described in the DEIS. The
differences are primarily a matter of reorganizing and realigning some
material and their corresponding regulatory alternatives, using more
descriptive terms in some criteria listed in the alternatives, and
choosing between regulatory alternatives that fall within the analysis
of the DEIS. Accordingly, the DEIS is still consistent and applicable
as an analysis of the potential environmental effects of the proposed
action. However, we are interested in receiving comments on whether any
of the proposed regulatory alternatives in this document do not appear
to have been adequately addressed within the DEIS.
Table 4--Summary of Proposed Changes to the Regulations and Relationship
to DEIS
------------------------------------------------------------------------
Summary of proposed substantive
changes to the regulation DEIS issue DEIS alternative
------------------------------------------------------------------------
Redescription of which GE organisms 1 2 (DEIS preferred
are subject to the regulations. alternative) or 3.
Deletion of the list of plant pest ............ ....................
taxa in the regulations and the
petition procedure to amend the
list.
Clarification that APHIS has the 5 2 (DEIS preferred
authority to regulate nonliving alternative).
materials through permit conditions
in cases where such materials may
pose a risk as a noxious weed.
Revision of the application ............ ....................
information requirements and permit
conditions for all permit types.
Elimination of the current 2 4 (DEIS preferred
notification procedure for alternative).
importation, interstate movement,
and release into the environment of
certain types of GE plants
(permitting procedure will be used
instead).
Revision of the permitting system 2 4 (DEIS preferred
for environmental releases: alternative).
Subdivision into 5 4 2 (DEIS preferred
categories of permits for alternative).
environmental releases (4 for
GE plants, 1 for other GE
organisms).
Continue strict permit 6 1 (No action
conditions for environmental alternative).
releases of GE plants
engineered to produce compounds
intended for pharmaceutical or
industrial uses.
Continued use of permits with ............ ....................
appropriate conditions for single
or multiple year releases.
Creation of new administrative ............ ....................
procedures in permitting: (1) The
explicit agreement of the
responsible person to comply with
regulatory requirements of the
permit, (2) amendment of existing
permit conditions, (3) transfer of
permits to a different responsible
person, and (4) revocation of a
permit.
Elimination of the prescribed 10 2 (DEIS preferred
shipping container provisions in alternative).
favor of a performance based
approach specified as permit
conditions for importation and
interstate movement.
Revision of the existing conditional ............ ....................
exemptions for interstate movement
such that the shipping standard is
part of the exemption. Addition of
a recordkeeping requirement for
persons using the existing
conditional exemptions.
Elimination of the option for APHIS ............ ....................
to issue courtesy permits for
importation, interstate movement,
and environmental release of GE
organisms which are not subject to
the regulation.
Creation of a petition procedure for 3 2 (DEIS preferred
the Administrator to approve 8 alternative).
additional conditional exemptions 1 (DEIS No Action
from the requirement for a permit. alternative).
This also includes a description of
administrative steps if
Administrator revokes an exemption,
amends the conditions of an
exemption, or prohibits a person
from using a conditional exemption.
Clarification and revision of the ............ ....................
existing petition procedure for
determining nonregulated status,
including elimination of the
procedure to extend a previous
determination of nonregulated
status, and a description of the
administrative steps if
Administrator revokes nonregulated
status.
Clarification of the actions the ............ ....................
Administrator may take related to
compliance, enforcement, and
remediation.
Clarification of APHIS approach to 7 3 (DEIS preferred
the low level presence of regulated alternative).
GE plants in seed or grain.
Definition of Confidential Business ............ ....................
Information (CBI) and description
of administrative practices for
CBI.
------------------------------------------------------------------------
[[Page 60029]]
We received approximately 23,000 comments on the DEIS, of which
more than 22,000 were variations of several form letters. There were
also several lengthy and detailed evaluations of environmental,
scientific, legal, cultural, and economic issues raised by the DEIS.
APHIS took all comments related to regulatory changes under
consideration as we developed the content of this proposed rule, and
altered a number of preliminary ideas for the proposal based on
comments. We will fully summarize and address the comments received on
the DEIS in a Final Environmental Impact Statement to be prepared in
conjunction with the publication of a final rule. In addition to
specific DEIS issues that were discussed above in the Preamble, the
following section summarizes and discusses those comments on the DEIS
that were most directly related to the regulatory alternatives
discussed in this proposed rule and the ways in which these comments
affected development of the proposal.
Many DEIS commenters addressed how the regulations should use the
PPA authorities regarding noxious weeds, plant pests, and biological
control organisms. Most comments on the DEIS that addressed this issue
stated that APHIS should expand the scope of its regulatory program
beyond plant pests to include both noxious weeds and certain biological
control organisms, consistent with all of the regulatory authorities of
the PPA. The following opinions were expressed regarding PPA authority
regarding noxious weeds and the meaning of the PPA definition of
noxious weed.
Very few commenters suggested that APHIS biotechnology regulations
should implement the PPA's noxious weed definition in its broadest
possible sense. One commenter suggested that APHIS broadly interpret
the phrase ``other interests of agriculture,'' in the PPA definition of
noxious weed such that APHIS would consider a plant to be a noxious
weed if it poses solely economic harm, i.e., in the absence of physical
harm. As explained previously in this proposal, such an interpretation
is not consistent with the PPA, nor with the manner in which APHIS-PPQ
has implemented the noxious weed program pursuant to the PPA. Many
commenters suggested that APHIS needed clear regulations or policies to
describe how it will be evaluating whether GE plants pose threats as
noxious weeds. APHIS agrees and has framed this proposal to clarify the
issue for the public.
Some commenters stated that APHIS should acknowledge limits to its
consideration of potential damage to public health in APHIS
regulations, and the noxious weed definition should not be interpreted
so broadly as to provide APHIS with the legal responsibility or
authority to determine the food safety of GE crops or to prevent GE
crops from entering the food supply. The commenters stated that
Congress clearly intended the FDA to be responsible in this area.
We agree, and this proposal acknowledges FDA authority in the food
safety area. However, it is important that the regulatory procedures in
each agency dovetail and support each other where agency mission areas
come in contact. This proposal recognizes this need for mutual agency
support. When a permit for environmental release, importation, or
interstate movement of a new GE organism is submitted to APHIS, we
would evaluate whether there are any signs that the environmental
release, importation, or interstate movement of the organism could
present risks to the public health. If APHIS is concerned that there
may be food safety risks associated with the GE organism, we would
contact FDA. The decision on whether or how to regulate food and feed
from the GE organism to address food and feed safety risks would then
be FDA's. On the other hand, it is also likely that existing food
safety evaluations will prove to be useful and relevant to APHIS
evaluations of a GE organism. Food safety concerns are one of several
factors APHIS would take into account when considering, for example,
what types of permit conditions are needed for the environmental
release of a GE organism, or whether activities associated with the
organism should qualify for an exemption from the permit requirement.
Several commenters stated that under the current regulations APHIS
has always considered noxious weed risk, or at least ``weediness.'' We
agree that in practice, when APHIS assesses a GE plant it has always
evaluated the potential weediness of the GE plant in relation to its
plant pest potential. In the context of the PPA, ``weediness'' is more
properly a noxious weed risk characteristic than a plant pest one, and
the proposed revision of the regulations will more clearly align the
regulations with the plant pest and noxious weed risk pursuant to the
PPA. Current APHIS regulations and guidance directly address the
importance of including weediness when evaluating risks associated with
GE organisms. For example, when the petition procedure to grant
nonregulated status was added to part 340 in 1993, the traits APHIS
listed for evaluation explicitly included ``weediness of the regulated
article'' (see current Sec. 340.6(c)(4)).
Several DEIS commenters addressed what characteristics should
trigger regulation of a GE organism, or put another way, how to set the
scope of organisms subject to regulation. In the DEIS, APHIS explored
many options including continuing to make its decisions primarily based
upon the transformation event (also sometimes referred to as the
individual transformed line, transgenic line or GE line). Some members
of the public refer to this as an event-by-event approach. It is
sometimes contrasted with a ``trait-based'' approach that focuses more
on the resulting trait or phenotype of the GE organism. In a trait-
based approach, a regulatory decision for an organism engineered for
one phenotype would apply equally to other GE organisms if they had the
same phenotype or trait, regardless of whether they were engineered
with the same genes. APHIS invited comment on the relative merits of
the event-by-event approach and the trait-based approach. The current
regulations do not limit APHIS to one approach or the other. Many
readers equated ``event-by-event'' with a ``process-based'' system and
likewise equated ``trait-based'' regulation with a ``product-based''
system. Thus many comments focused on the relative merits of a product-
based system versus a process-based system.
Some suggested that the trigger be ``process-based'', i.e., the
process of modifying the organism by recombinant DNA techniques would
be the determinant. Others suggested the trigger be ``product-based'',
i.e., the nature of the resulting product (organism) would be the
determinant for whether the organism would be subject to the
regulation. Many of the comments were not actually related to the basis
for the trigger, but rather to the focus of the risk assessment, with
most stating that the risk assessments should be based on the biology
of the organism (product-based), not the technique by which it was made
(process-based). One commenter believes that the process of genetic
engineering is a useful trigger, but once regulated, the
characteristics of the GE organism should dominate APHIS considerations
of safety.
Those supporting a process-based approach for identifying which
organisms should be subject to regulation stated that each GE organism
can have unintended as well as intended changes, and that these
unintended changes to the organism would require that each individual
resulting from genetic engineering must be assessed on a case-by-case
basis.
[[Page 60030]]
Some commenters also suggested that this approach of APHIS assessment
of each individual GE organism better protects the environment and
human health than an approach that focuses primarily on the trait(s) of
the GE organism.
Some commenters against process-based approach stated that this
approach is illogical, on the one hand, to regulate a plant species
with no known risks only because GE techniques were used to modify it,
whereas on the other hand the same plant species modified by other
techniques faces no additional regulatory requirements from APHIS.
Those supporting a product-based regulatory approach stated that it
would be aligned with the preponderance of scientific opinion on the
issue, that the characteristics of the organism should take precedence
over the technique of genetic modification in the APHIS assessment of
the organism. APHIS agrees that any evaluation of risk should be based
on the biology of the product.
Several commenters suggested that the definition of regulated
article would have to be reexamined and possibly redefined to reflect
changes in the PPA. Commenters also stated that the term regulated
article was problematic whether linked to specific taxa in Sec. 340.2,
under the current regulations, or linked to plants produced by
particular technologies. These commenters emphasized that actions under
the regulations usually amount to an investigation of whether an
article (GE organism) needs to be regulated, and that predefining the
subject of the investigation as a regulated article strongly implies
that a decision has been made to require some regulatory oversight.
The proposed elimination of the term ``regulated article'' would
facilitate a clearer understanding that it is not the GE organism that
is regulated, but rather the importation, interstate movement, or
release into the environment of the GE organism.
APHIS determined that eliminating ``introduction'' as a defined
term would facilitate clearer understanding that the activities subject
to the regulations are in fact importation, interstate movement, and
release into the environment.
In the DEIS, APHIS discussed the need to regulate nonliving
products of GE organisms. The preferred alternative was to have a
procedure to regulate non-viable material only in certain rare
circumstances when it might pose a risk. Most of the DEIS comments
addressing this issue agreed that APHIS should regulate nonviable GE
plant material only in certain circumstances, based on the risks posed.
The few comments that provided greater detail identified toxicity risks
and possible persistence in the environment of toxic nonviable plant
parts or debris as the most significant risk associated with nonliving
GE products. A few commenters also stated that adding a clear
definition of ``nonliving'' or ``nonviable'' would aid the regulations.
APHIS has responded to these comments in this proposal by not
usually regulating nonliving GE products, and by providing that when
any control is needed over such a product that is associated with a
living GE organism which is covered by a permit, due to toxicity or
other risks, such controls would be included as permit conditions in
permits issued for the associated living GE organism. We propose to
provide for this by adding the following sentence to paragraph (b) of
Sec. 340.3, Permit conditions: ``The Administrator may also assign
permit conditions addressing nonliving materials associated with or
derived from GE plants when such conditions are needed to make it
unlikely that the nonliving materials would pose a noxious weed risk.''
We received one DEIS comment directly addressing the issuance of
courtesy permits. This comment supported retaining use of courtesy
permits, and stated that courtesy permits facilitate the importation of
GE Drosophila melanogaster strains by the research community and also
ease the workload for APHIS. The continued issuance of courtesy permits
diverts Agency resources unnecessarily from organisms that are within
the scope of the regulations. We intend to help develop informational
materials for the research community and other agencies that are aware
of courtesy permits to clarify that such permits are not required, and
to explain this to any persons who contact us requesting courtesy
permits in the future.
Several DEIS comments addressed the notification procedure and
supported eliminating it. Some comments suggested that the types of
organisms formerly eligible for the notification process should instead
be handled through a two-tiered permitting process, with experimental
permits for field trials and commercial permits for GE crops that are
to be sold in commerce. Other comments suggested that while some
organisms might require permits with minimal conditions rather than
notifications, others with even lower risks could be exempted from
permit requirements. These latter comments also generally suggested
that some of the criteria in the current regulations used to determine
eligibility for the notification process could be preserved in the new
regulations as criteria to identify organisms that should be exempted
from the requirement for a permit. One commenter stated that since the
current ``notification'' process involves acknowledgment by APHIS and
conditions as well as notification, changing to a system of low risk
permits would be a de facto acknowledgment of the current process. To
address these issues, APHIS is proposing to eliminate notifications and
to handle regulated GE organisms that previously would have been
eligible for notifications through a permitting procedure.
We received a few comments on the DEIS generally related to
procedures for reviewing permit applications. Comments stated that the
role of States in reviewing or approving permit applications for GE
crops has been very important and useful under the current regulations,
and should continue in future regulations. Comments also stated the
importance of scientific integrity in the review process, and
emphasized the importance of coordinating with other agencies
(particularly FDA and EPA review) when issues within their mission area
arise during APHIS review of applications.
The proposed changes to the permit application procedure address
these concerns. States would have a continuing role in application
review that is very similar to their existing role, and we have been
increasing interactions with the relevant tribal authorities in recent
years.
Several comments were peripherally related to the DEIS issue of
whether APHIS should establish standard or general permit conditions or
what they should require. These comments emphasized that the purpose of
permit conditions is to control risks not otherwise controlled, and
that permit conditions must be developed in response to careful
consideration of the risks presented by the particular permitted
activity. One comment stated that APHIS should not require permit
conditions that have the primary purpose of preventing crops from
entering the food supply, because APHIS does not have the legal
authority or scientific expertise to set them.
We have taken these views into account in designing this proposed
rule. Proposed Sec. 340.3 describes the core list of general
conditions that APHIS would impose on all permits as well as additional
conditions for specific types of permits. APHIS is also making it clear
that APHIS may also add other specific
[[Page 60031]]
conditions to a permit upon its issuance. Conditions are specific
practices or requirements that an applicant must follow upon issuance
of a permit. Conditions are added as a consequence of the APHIS
evaluation in order to make it unlikely that actions under the permit
would result in the introduction or dissemination of a plant pest or
noxious weed.
Several DEIS comments stressed that APHIS needs to do more to
ensure that the permit conditions it sets are actually followed and
enforced. The changes to permit procedures proposed for Sec. 340.2
contribute to that goal by obtaining written agreement from the
responsible person that he or she, and all of their agents, must comply
with all of the permit conditions before issuance of the permit.
Almost all DEIS comments on containers or marking and identity for
regulated articles supported performance standards for containers. Most
of these commenters made the point that performance criteria are
generally more adaptable and efficient than prescriptive criteria. Some
stated that shipping research organisms interstate in enclosed
containers is a low-risk activity that is very unlikely to result in
release, establishment or harm.
Some commenters stated that the type of container indicated by
performance standards must be appropriate to the level of risk in the
tiered permit system for the shipped GE organism. One commenter
requested that APHIS make its container standards consistent with the
International Air Transporters Association (IATA) requirements for
shipping.
The way this proposed rule deals with container standards is
consistent with the above DEIS comments.
Most of the commenters addressing tiered or categorized permit
systems supported APHIS establishing a tiered permitting system for
plants based on criteria that included risk and other GE organism
characteristics. However, commenters also stressed that risk categories
should be based on a trait by species approach, not on the basis of
individual transformed plant line (referred to as ``event-by-event'' in
some of the comments). Some commenters advised against using limited
broad based categories that include many different species with
different biologies and different risk factors. Several stated the
importance of evaluating permit applications on a case-by-case basis,
to avoid the risk that categorizing permit types could result in
approval of risky releases that were inadvertently seen as ``routine
categories.''
Several commenters stated that a tiered permitting system should be
flexible and allow consideration of any factors that seem relevant, or
allow reclassification of a GE plant from one tier to another based on
additional characterization information and agency familiarity with the
GE plant. Some commenters opposed the development of a tiered risk-
based permitting system because each transformation event can have
unintended effects that must be assessed on a case-by-case basis,
rather than through predefined categories. We have addressed these
views in this proposed rule by changing the permit tier system
described in the DEIS to a proposed permit application categorization
system that is more flexible than the system described in the DEIS.
In the DEIS, APHIS considered whether to continue to issue
environmental release permits for GE plants engineered to produce
pharmaceutical and industrial compounds if the GE plant species is the
same as, or sexually compatible with, a species commonly used for food
or feed. APHIS concludes that the permitting procedure with its
stringent permit conditions can continue to effectively minimize the
risks that may be associated with the environmental release of such GE
plants. APHIS will continue to impose appropriate permit conditions
that take into account the issues related to the public safety of
proteins or other substances that these plants have been engineered to
produce.
Numerous commenters supported banning the outdoor production of
pharmaceuticals and industrial substances in food and feed crops. Some
stated that food crops should not be used for the production of
pharmaceuticals and industrial substances.
Some commenters stated that GE plants used for the production of
pharmaceuticals and industrial substances should be evaluated by
criteria that are different from those used to evaluate crops intended
for food. Other commenters stated that if such GE industrial plants
were made from food crop species, or could spread genes to food crop
species, they should be evaluated based on food safety risk, not the
industrial product's function, and approved only if they pose no food
safety risks. However, with regard to evaluating food safety, several
commenters also stated that FDA should be the agency evaluating these
risks.
We have not seen evidence suggesting that these types of organisms
present unique or uncontrollable risks, or risks higher than those that
may be associated with many other uses for GE plants. Our approach in
this proposed rule addresses the other concerns cited by DEIS
commenters.
Many commenters were concerned that the outdoor cultivation of GE
plants producing pharmaceutical and industrial compounds could be a
source of gene flow to nearby non-GE plants or result in the co-
mingling of grain with related crop species intended for food or feed.
Risks associated with this scenario may be abated by either of two
means: (1) Preventing such gene flow or co-mingling from occurring, or
(2) establishing that if such gene flow or co-mingling to other plants
does occur, it does not present an unacceptable risk of introducing or
disseminating a noxious weed.
Such gene flow can be minimized or substantially prevented through
permit conditions developed for environmental releases of GE
pharmaceutical or industrial plants. In many cases the genetic and
phenotypic characteristics of the organism also serves to discourage
survivability of the plant away from the intended site as well as gene
flow to other plants. During the review prior to permit issuance, APHIS
would also always consider the effects if the GE plant were likely to
spread widely, or if large-scale gene flow to other plants occurred. A
permit for an environmental release would not be approved if APHIS
concluded there was a likelihood of such events causing any of the
types of harm as described in the noxious weed definition.
One DEIS comment on the issue of multiple-year permits stated that
compliance agreements should be used instead of actual multiple-year
permits. Another suggested that multiple-year permits should be limited
to trait/crop combinations not intended for feed or food use. In
contrast, another comment stated that APHIS should consider allowing
multi-year permits for any product, not just GE pharmaceutical or
industrial plants.
Several commenters stated a risk-based opposition to multi-year
permits and stated that crops engineered to produce pharmaceuticals or
industrial compounds should always be regulated under an annually-
reviewed permit system.
This proposed rule addresses the risk-based concerns cited by
commenters in the proposed processes for issuing permits and granting
exemptions, discussed elsewhere in this document. We propose to allow
multi-year permits for any type of regulated activity, when we
determine that appropriate risk-related conditions can be prescribed
for those activities. We have not seen any
[[Page 60032]]
convincing evidence, in DEIS comments or elsewhere, that limiting use
of multi-year permits to certain types of organisms would reduce risk
or otherwise serve the purpose of the regulations.
Of the approximately 67 comments received by APHIS on the
interstate movement exemptions discussion in the DEIS, 30 comments
appear to support APHIS' preferred Alternative 2, under which APHIS
would exempt from permit requirements for interstate movement a class
of GE plants or organisms that are well-studied and present little or
no environmental risk, as is currently done for Arabidopsis. However,
many of these commenters suggested that APHIS choose an approach that
combined this with one or more of the other Alternatives. Several
commenters stated that the regulations should provide a procedure for
APHIS to consider additional exemptions from interstate movement
restrictions on a case-by-case basis.
APHIS has concluded that the most appropriate proposal for the
regulations at this time is to provide a clear and adaptable procedure
whereby it would use a case-by-case approach to consider the merits of
new exemptions from the requirement for a permit. The procedure,
described in proposed Sec. 340.5, would allow for a transparent
procedure in which APHIS would evaluate the proposed exemption, and the
public would have an opportunity to review APHIS' evaluation and
provide comments prior to APHIS decisions on individual cases. The
proposed procedure should provide the benefit of transparency and
scientific rigor while affording a more streamlined and cost-efficient
procedure that would not require formal amendment of the regulations
when each new exemption is approved.
Several DEIS comments addressed what criteria in the regulations
the Agency could use to determine the level of risk assessment applied
to imported GE commodities which are viable propagules. They fell into
two general groups. Both groups stated that any expedited review or
exemption for GE commodity imports needed to be granted based on a
review of risk and a determination that the importation presented no
significant risks. Beyond that, one group emphasized that commodity
imports were in general inherently safe, and such an expedited system
would be appropriate and would also greatly facilitate international
trade. The other group was skeptical about inherent safety of GE
commodities and suggested that exemptions should only be offered when
there are procedures ensuring that the commodities are made non-viable
or safeguards are in place to ensure that propagation will not occur.
Some comments in this group also stated that such exemptions should not
be granted for a GE commodity from any country until APHIS has
confidence that the country has robust regulatory guidelines and
assessment standards with strong, reliable science and trustworthy
regulatory oversight, equivalent in effectiveness to the U.S. system.
One comment included a general statement that it was important that
a petitioner for deregulation or exemption should work closely with
APHIS to develop and evaluate the management plan under which the
subject GE organism would be grown if deregulated or exempted. APHIS
agrees that its regulatory approach should include working closely with
petitioners on their proposals for exemption, especially if management
plans are part of the requisite conditions. APHIS would retain some
degree of oversight and could restrict movements of a GE organism such
that the exemption and its conditions are unlikely to result in the
introduction or dissemination of a plant pest or noxious weed. The
proposed procedure to approve additional conditional exemptions is
sufficiently adaptable even when the exemption is for all forms of
movement (i.e., importation, interstate movement, and environmental
release).
Very few DEIS comments directly addressed enforcement and
compliance. A few comments stated that APHIS regulatory oversight and
enforcement of its regulations in the past have been insufficient and
have provided inadequate containment of GE crops. This proposed rule
would strengthen enforcement and compliance and enhance the
effectiveness of the regulations.
Comments on the discussion in the DEIS of low level presence ranged
from suggestions that APHIS should completely prevent such incidents by
banning all outdoor growth of GE plants to suggestions that LLP is a
minor problem needing only minimal controls, and does not warrant an
increased regulatory burden to control a minor risk. Some commenters
stated that the preferred alternative in the DEIS accepted too high a
level of risk. These commenters generally preferred DEIS alternative 4,
which would impose very strict permit conditions on all environmental
releases to reduce the likelihood of LLP events. Most commenters agreed
that APHIS should adopt an LLP policy that recognizes the wide variety
of risk levels associated with such incidents, and that beyond applying
general criteria APHIS should investigate each unauthorized release
individually and determine actions based on the facts surrounding each
incident. Some commenters stated that any LLP policy should clearly
state that even if an incident was found to be non-actionable (i.e.,
not requiring remedial action), persons involved would still be subject
to enforcement actions such as civil penalties if violations of the
regulations occurred.
APHIS has considered all these views in the development of this
proposed rule and has attempted to find a reasonable balance. It is not
warranted, or practical, to implement a ``zero tolerance'' LLP policy.
Instead, we propose a policy that each LLP incident would be
individually investigated, and APHIS would then make a decision on
whether, or what kind of, remedial action is needed. In making this
determination APHIS would use established criteria to rate the risks
involved in the LLP incident. However, these criteria would not fully
determine the APHIS response. In addition to considering the criteria,
APHIS would evaluate any other relevant information regarding the LLP
incident and order remedial action if it appears necessary.
Also, we propose to clearly state that regardless of whether APHIS
considers the LLP actionable with regard to remediation, any violations
of the regulations or permit conditions can still result in compliance
and enforcement actions for failure to comply with the regulations.
One DEIS comment directly addressed timelines for APHIS to perform
permit- and petition-related activities and urged APHIS to continue to
define specific timelines for regulatory reviews to allow for a
predictable regulatory review system. The comment stated that time
frames are especially critical for field trial permitting activities
since planting occurs during a narrow window each year and a delay of a
month or two in a regulatory decision can result in a year delay due to
the inability to timely plant a field trial.
We understand the concerns, and have decided to keep the time
frames in the text of the regulations. However, as discussed above,
APHIS will view them as performance goals and will generally respond in
the time frames indicated, rather than be obligated to respond at those
times. In recent years, there has been an increase in the time required
for APHIS review due to the increasing complexity of issues related to
environmental effects, new traits, and unfamiliar species. In addition
to
[[Page 60033]]
retaining general time frames in the regulations, APHIS intends to
discuss time frames with each applicant early in the application
process, and to the extent possible give the applicant reliable time
estimates based on the nature and complexity of the particular
application and current APHIS activities and resources that are
expected to affect the application review.
B. Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
The rule has been determined to be significant for the purposes of
Executive Order 12866 and, therefore, has been reviewed by the Office
of Management and Budget.
We have prepared an economic analysis for this proposed rule, which
is summarized below. Copies of the full economic analysis are available
by contacting the person listed under FOR FURTHER INFORMATION CONTACT
or on the Regulations.gov Web site (see ADDRESSES above for
instructions for accessing Regulations.gov). The analysis provides a
cost-benefit analysis, as required by Executive Order 12866, and an
analysis of the potential economic effects of this final rule on small
entities, as required by the Regulatory Flexibility Act.
Background
The adoption of genetically engineered (GE) crops by farmers
worldwide has become increasingly widespread. The United States,
Argentina, Brazil, Canada, and China are the major GE crop adopters. In
2008, 92 percent of soybean, 80 percent of corn, and 86 percent of
cotton acreages planted in the United States were genetically
engineered (USDA NASS, 2008). In addition to the major field crops, GE
varieties of papaya, yellow squash, and zucchini were available for
commercial production in 2008.
Worldwide plantings of transgenic crops grew by 12 percent in 2007,
reaching 282.4 million acres in 23 countries growing biotech crops in
2007, including 12 developing countries. Over the next decade, use of
these ``first-generation'' GE crops, which carry traits such as insect
resistance and herbicide tolerance, should continue to grow while a
second generation of crops promises new applications and traits such as
improved drought tolerance, biofuel-related enhancements, and quality
and nutritional traits.\3\
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\3\ Global Status of Commercialized Biotech/GM Crops, ISAAA
Briefs 37-2007, 35-2006, The International Service for the
Acquisition of Agri-Biotech Applications, Cornell University.
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The benefits associated with the use of some GE crops already in
production include higher yields, lower pesticide costs, and overall
savings in management time. There are also environmental benefits from
reduced pesticide use. Attempts have been made to quantify the benefits
that have occurred as a result of the adoption of GE crops and,
according to a recent survey, farm-level net economic benefits
worldwide from the adoption of GE crops were estimated to be $7 billion
in 2006 (Brookes and Barfoot 2008). Total net benefits, 1996-2006, were
estimated to be $34 billion. Of this total estimated net welfare gains,
the United States experienced the largest benefit, with $15.8 billion;
followed by Argentina, $6.6 billion; China, $5.8 billion; and Brazil,
$1.9 billion (Brookes and Barfoot 2008). U.S. farmers' welfare gains
from the adoption of biotechnology ranged from 29 to 42 percent of
total net welfare gains (Price et al. 2005; Falck-Zepeda, Traxler, and
Nelson 2000).
The high rate of GE crop adoption by farmers has been driven by an
increase in consumption of product developed with the use of GE
techniques. However, studies that quantify consumers' benefits from the
use of biotechnology are limited, as most studies tend to focus on the
direct adopters of biotechnology, i.e., the producers. Price et al.
(2006) found consumers do benefit from the adoption of Bt cotton.
Overall, consumers' gains from the adoption of various GE crops
have been estimated to range from 4 to 17 percent of total net welfare
gains (Price et al. 2005; Falck-Zepeda, Traxler, and Nelson 2000).
Crop producers and consumers are not the only beneficiaries of
recent advances in biotechnology. The providers of biotechnology have
also benefited from the increased adoption of GE products. Intellectual
property right laws have offered incentives for the private sector to
invest in research and development of GE products, and as a result,
plant breeding expenditures have largely shifted from the public to the
private sector (Fuglie 2006). As private research spending has
increased, so has the number of firms engaged in this type of research.
However, consolidation and mergers during the 1990's resulted in an
industry dominated by large companies. Currently, 80 percent of biotech
traits that have been approved are owned or co-owned by four firms
(Bayer Crop Science, DuPont, Monsanto, and Syngenta) or their
subsidiaries (Kalaitzandonakes, Alston, and Bradford 2007).
With regard to the beneficial effects for the environment of GE
plants in commercial production, their production has resulted since
1996 in decreases in the use of pesticides by 286 million kg and in the
use of herbicides by 51 million kg (Brookes and Barfoot 2008). These
declines represent 7.9 percent reductions. In terms of greenhouse
gases, one study estimated cultivation using no-tillage systems
associated with GE crops modified for herbicide tolerance to reduce
fuel use by 32.52 liters/ha (89 percent) compared to conventional
methods, and 14.7 liters/ha (76 percent) compared to reduced tillage
methods (Jasa 2002). An American Soybean Association survey \4\ showed
significant reductions in tillage, and therefore in fuel use, by
growers of glyphosate-tolerant soybeans. The fuel reductions were
estimated as 1.26 gallons per acre, or, for the 56 million acres of
glyphosate-tolerant soybeans planted in 2001, 70 million gallons of
fuel saved and associated greenhouse gas emissions avoided. These fuel-
use reductions translate into reductions of carbon dioxide emissions of
89.44 kg/ha and 40.43 kg/ha, respectively. Overall in 2006, the total
carbon dioxide savings associated with the use of GE crops were 1.2
billion kg. This is equivalent to removing 540,000 cars from the
streets for a year.
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\4\ Cited in Fawcett, Richard and Towery, Dan. Conservation
Tillage and Plant Biotechnology: How New Technologies Can Improve
the Environment By Reducing the Need to Plow. Conservation
Technology Information Center, West Lafayette, Indiana.
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Benefits of the Proposed Rule
The proposed rule would provide benefits by establishing more
efficient regulation of GE organisms and activities subject to part 340
and by continuing to provide a high level of protection against risks
associated with these organisms and activities. Benefits would also
include improved public understanding of and confidence in APHIS'
biotechnology regulatory responsibilities, and improved clarity and
transparency of the regulatory process. Several amendments of the
proposed rule would improve the efficiency of APHIS' biotech regulatory
process. Particular proposed changes that should improve the efficiency
of the regulations include the elimination of courtesy permits and the
establishment of a procedure to evaluate and grant requests for new
exemptions from the requirement that GE organisms have a permit to be
imported, moved interstate, or released into the environment.
Approving new exemptions could be done without amending the
regulations, resulting in considerable time savings
[[Page 60034]]
for regulated parties and reducing APHIS' rulemaking costs. Persons
using an exemption would also avoid the costs and delays associated
with obtaining a permit for each new planned movement or release of a
GE organism covered by the exemption.
APHIS commits considerable resources to issuing courtesy permits
not actually required by or needed to implement the part 340
regulations. These courtesy permits have been issued to facilitate the
movement of GE organisms that are but whose movement may be hindered
due to their similarity to organisms that are subject to part 340. By
improving public awareness that such organisms do not need a permit and
eliminating the courtesy permit process APHIS would improve efficiency
and reduce its regulatory workload, and save time for regulated
entities who would no longer make unnecessary courtesy permit requests.
The Agency currently issues environmental release permits,
including permits that are used for production of pharmaceutical and
industrial compounds sold in commerce. In general, permits for releases
of plants producing pharmaceutical or industrial compounds have been
limited to a one-year duration. However, the proposed regulations
provide a more useful and efficient approach to setting appropriate
risk-related conditions in multi-year environmental release permits.
Under the proposed system, APHIS would likely increase issuance of
multi-year environmental release permits, thereby reducing the time the
regulated entities need to spend submitting applications as well as the
time APHIS spends reviewing the permit applications.
APHIS' biotechnology operations would be aided by more clarity in
terms of required data submissions and administrative procedures. More
detail is provided regarding what applicant information is required for
each permit application type, and how application information relates
to the proposed new permit categories for environmental release
permits. These changes, along with more clearly defined categories for
the environmental release permits, would potentially reduce the time
some entities, large or small, spend on an application or petition
process. Increased efficiency benefits may be most helpful to smaller
companies and public sector entities, where GE research is generally
conducted on a much smaller scale than that of large agri-business
enterprises.
The proposal includes provisions to require necessary recordkeeping
and reporting but to fine-tune this burden through particularized
permit conditions to require only what is needed to ensure regulatory
compliance based on individual cases. This should contribute to greater
efficiency.
The proposed rule's greater clarity and transparency is expected to
enhance the general public's perception of APHIS regulation in this
area, with associated benefits from increased support of and compliance
with the regulations.
In addition to the information provided in the regulations, APHIS
proposes to develop new guidance documents to assist in the preparation
and submission of applications.
Costs of the Proposed Rule
There are several cost areas associated with the proposed rule.
Costs associated with the proposed rule that regulated entities would
incur include costs of learning and adapting procedures to changed
requirements, providing more or different information in permit
applications, and additional recordkeeping for some entities. The
additional recordkeeping burden is discussed below in the Paperwork
Reduction Act section. Annual costs resulting from the additional
recordkeeping may be estimated as the salary and associated costs for
640 additional hours of recordkeeping divided among 160 respondents.
Many provisions of the proposed regulations are revisions of the
current regulations, and it is not expected that familiarization costs
would be substantial. However, estimates of these costs are not
available and therefore APHIS invites public comment on the costs the
regulated community may incur with respect to rule familiarization and
changes to their application systems.
Costs to APHIS are currently incurred in the regulatory assessment
and review of submitted materials. Because the new permit process is
largely similar to the current process, it is expected that ongoing
permit processing costs to APHIS would remain essentially unchanged. As
a start-up cost to change the permit system to accommodate requirements
of the proposed rule, APHIS may potentially incur a one-time additional
cost of $500,000. However the current system is adaptable to the new
regulations and it is not anticipated that there would be any
efficiency loss during the transitional period. APHIS would also
potentially incur incremental costs conducting outreach activities for
the proposed rule, developing guidance documents to ensure that the
regulated community is familiar with the requirements of the rule, and
providing staff training that may be necessary. Because of the new
definition of the scope of the regulations, APHIS may devote more
resources to consultations with regulated parties if they request
consultation to determine whether particular GE organisms are or are
not subject to the regulations. Such consultation should decrease after
the first year or two of implementation, as such determinations of
regulated status accumulate and become the basis for guidance of
general applicability.
Initial Regulatory Flexibility Analysis
In accordance with the Regulatory Flexibility Act of 1980 (Pub. L.
96-354), this analysis considers the economic impact of the proposed
rule on small businesses, small organizations, and small governmental
jurisdictions. Section 603 of the Act requires that the initial
regulatory flexibility analysis (IRFA) be made available for public
comments. This section addresses the IRFA requirements, as stated in
Sections 603(b) and 603(c) of the Act.
Reasons Action Is Being Considered
APHIS is taking action to amend 7 CFR part 340, which was
promulgated in 1987 under the authority of the Federal Plant Pest Act
of 1957 and the Plant Quarantine Act of 1912. These acts were
subsequently subsumed within the Plant Protection Act (PPA) of 2000,
and the proposed revisions would bring part 340 in alignment with this
Act. Advances in biotechnology and accumulation of oversight experience
by APHIS have also made it necessary to revise and update the
regulations, and in addition, the 2008 Farm Bill (The Food,
Conservation, and Energy Act of 2008) enacted most recently contains
provisions that need to be incorporated into the proposed rule. The
proposed changes would improve the regulatory process by providing
greater transparency, flexibility, and efficiency.
Objective and Legal Basis for the Rule
The objectives of this rule are to amend part 340 to provide
consistency with the PPA authorities and to incorporate updates and
improvements to provide a more efficient regulatory process while
controlling potential risk to plant health and the environment. The PPA
authorizes the Secretary of Agriculture to implement programs and
policies designed to prevent the introduction and spread of plant pests
and diseases. Specifically, the Secretary of Agriculture is given the
authority under the PPA to prevent the importation or dissemination of
plant pests and noxious weeds. To do so, the
[[Page 60035]]
Secretary may regulate the importation, interstate movement, and
release into the environment of any plant, plant product, biological
control organism, noxious weed, article, or means of conveyance that
could potentially spread plant pests or noxious weeds.
Description and Estimate of the Number of Small Entities Regulated
The proposed rule may affect a wide range of public and private
biotechnology research facilities, GE crop and seed production, food
processors, grain processors, and paper producers that fall into
various categories of the North American Industry Classification System
(NAICS). For the purpose of this analysis and following the Small
Business Administration (SBA) guidelines, the potentially affected
entities are classified within the following sectors: Agriculture,
Forestry, Fishing and Hunting (Sector 11), Manufacturing (Sectors 31-
33), Wholesale Trade (Sector 42), Retail Trade (Sector 44 and 45),
Transportation (Sectors 48 and 49), and Professional, Scientific and
Technical Services (Sector 54).
For the Agriculture, Forestry, Fishing and Hunting sector, the
subsectors of Crop Production, Animal Production, Forestry and Logging,
and Support Activities for Agriculture and Forestry are potentially
affected by this rule. The proposed rule may affect a wide range of
establishments in the Crop Production category. Establishments in this
category are considered small by SBA standards if annual sales are not
more than $0.75 million. According to the 2002 Census of Agriculture,
97 percent of the farming businesses are considered small. Potentially
affected crop-producing industries, with their NAICS codes in
parentheses, are as follows: Soybean Farming (111110); Oilseed Farming
(except soybean) (111120); Dry Pea and Bean Farming (111130); Wheat
Farming (111140); Corn Farming (111150); Rice Farming (111160); Oilseed
and Grain Combination Farming (111191); All Other Grain Farming
(111199); Potato Farming (111211); Other Vegetable (except potato) and
Melon Farming (111219); Orange Groves (111310); Citrus (except orange)
Groves (111320); Apple Orchards (111331); Grape Vineyards (111332);
Strawberry Farming (111333); Berry (except Strawberry) Farming
(111334); Tree Nut Farming (111335); Fruit and Tree Nut Combination
Farming (111336); Other Noncitrus Fruit Farming (111337); Mushroom
Production (111411); Other Food Crops Grown Under Cover (111419);
Nursery and Tree Production (111421); Floriculture Production (111422);
Tobacco Farming (111910); Cotton Farming (111920); Sugarcane Farming
(111930); Hay Farming (111940); Sugar Beet Farming (111950); Peanut
Farming (111960); and All other Miscellaneous Crop Farming (111970).
Some aspects of animal production may be affected because some GE
plants are used for animal feeds and may have enhanced nutritional
value or other benefits. In terms of animal production, potentially
affected entities include ones within the following industries: Beef
Cattle Ranching and Farming (NAICS 112111); Cattle Feedlots (NAICS
112112); Hog and Pig Farming (NAICS 112210); Sheep Farming (NAICS
112410); Goat Farming (NAICS 112420); and Apiculture (NAICS 112910).
Except for Cattle Feedlots, entities in all of these industries are
considered small by SBA standards if annual sales are not more than
$0.75 million. Cattle Feedlot establishments are considered small by
SBA standards if annual sales are not more than $2 million. According
to the 2002 Census of Agriculture, 93 percent of Cattle Feedlot
businesses, 99 percent of Beef Cattle Ranching and Farming businesses,
81 percent of Hog and Pig Farming businesses, 99 percent of Sheep and
Goat farming businesses, and 99 percent of Apiculture businesses are
considered small.
For the Forestry and Logging subsector the potentially affected
establishments are classified within Timber Tract Operations (NAICS
113110); Forest Nursery and Gathering of Forest Products (NAICS
113210); and Logging (NAICS 113310). Establishments in the category of
Timber Tract Operations and Forest Nursery and Gathering of Forest
Products are considered small by SBA standards if annual sales are not
more than $6.5 million and establishments in the category of Logging
are considered small if employment is not more than 500. According to
the 2002 Survey of Business Owners, 99 percent of establishments in the
Logging category are considered small. Neither the Census of
Agriculture nor the Economic Census tracks revenue for establishments
classified within Timber Tract Operations and Forest Nursery and
Gathering of Forest Products.
In terms of Support Activities for Agriculture and Forestry, the
potentially affected establishments are classified within Cotton
Ginning (NAICS 11511); Soil Preparation, Planting, and Cultivating
(NAICS 115112); Crop Harvesting (NAICS 115113); Postharvest Crop
Activities (NAICS 115114); Farm Management Services (115116) Support
Activities for Animal Production (NAICS 115210); and Support Activities
for Forestry (NAICS 115310). Establishments in these categories are
considered small by SBA standards if annual sales are not more than
$6.5 million. However, neither the Census of Agriculture nor the
Economic Census reports revenue for these establishments.
Entities that may be directly affected by the proposed rule in the
Manufacturing Sector are classified within Ethyl Alcohol Manufacturing
(NAICS 325193); Pesticide and Other Agricultural Chemical Manufacturing
(NAICS 325320); Pharmaceutical Preparation Manufacturing (NAICS
325412); and Medicinal and Botanical Manufacturing (NAICS 325411).
Establishments in the Ethyl Alcohol Manufacturing category are
considered small if they employ not more than 1,000 persons and those
in the category of Pesticide and Other Agricultural Chemical
Manufacturing (NAICS 325320) are considered small if they employ not
more than 500 persons. For both the Pharmaceutical Preparation
Manufacturing (NAICS 325412); and Medicinal and Botanical Manufacturing
(NAICS 325411) categories, establishments are considered small if they
employ not more than 750 persons. According to the 2002 Economic
Census, 98 percent of the establishments in the Chemical Manufacturing
Sector had fewer than 500 employees and 99 percent had fewer than 1000.
Therefore, businesses in the chemical manufacturing are predominantly
small by SBA standards.
In terms of Wholesale Trade, entities that would be potentially
affected may be found in the following categories: Fresh Fruit and
Vegetable Merchant Wholesalers (NAICS 424480); Other Grocery and
Related Products Merchant Wholesalers (NAICS 424490); Grain and Field
Bean Merchant Wholesalers (NAICS 424510); Other Farm Product Raw
Material Merchant Wholesalers (NAICS 424590); Farm Supplies and
Merchant Wholesalers (NAICS 424910); and Flower, Nursery Stock, and
Florists' Supplies Merchant Wholesalers (NAICS 424930). Establishments
in the above categories are considered small by SBA standards if they
employ not more than 100 persons. According to the 2002 Survey of
Business Owners, 97 percent of the establishments in this category
employed fewer than 100 people and are considered small by SBA
standards.
Retail Trade, establishments that would be affected by the rules
are in the following categories: Nursery and Garden Centers (NAICS
444220); Supermarkets and Other Grocery Stores (NAICS 445110); Fruit
and Vegetable
[[Page 60036]]
Markets (NAICS 445230); All Other Specialty Food Stores (NAICS 445299);
Food (Health) Supplement Stores (NAICS 446191); Warehouse Clubs and
Superstores (NAICS 452910); and Florist (NAICS 453110). Establishments
in the Nursery and Garden Center, Fruit and Vegetable Markets, All
other Specialty Food Stores, Food (Health) Supplement Stores; and
Florist categories are considered small by SBA standards if annual
sales are not more than $6.5 million. Supermarkets and Other Grocery
Stores are considered small by SBA standards if annual sales are not
more than $25 million. While the Economic Census reports total annual
sales, the Census does not provide a breakdown of these establishments
by revenue categories.
In terms of the Transportation sector, the potentially affected
entities are in the category Farm Product Warehousing and Storage
(NAICS 493130). Establishments in this category are considered small by
SBA standards if annual sales are not more than $23.5 million. However,
the Economic Census reports only total revenue for all establishments
in this category.
In terms of Professional, Scientific and Technical Services,
establishments in the category of Research and Development in the
Physical, Engineering, and Life Sciences (NAICS 54170) may be affected.
Establishments in this category are considered small by SBA standards
if they employ not more than 500 persons. According to 2002 Economic
Census, 82 percent of the establishments in this category are
considered small.
Although information was not available on the business sizes for
all potentially affected establishments, based on the foregoing
information we can assume that the majority of the entities that may be
affected by the proposed rule are small by SBA standards.
Given the aforementioned, a review of entities that have made
application requests to APHIS shows that of the 420 applicants for the
last 6 years, 263 were universities and colleges and public and private
research institutions. The remainder of the applicants fall under
various NAICS classification codes specified above but given time
constraints their business size could not be readily determined. We
were able to ascertain that the 263 institutions (63 percent) are large
by SBA standards as they fall under NAICS code 54170 Research and
Development in Physical Science. Establishments in this category are
considered small by SBA standards if they employ not more than 500
persons. Even though the 2002 Economic Census suggests that 82 percent
of the establishments in this category are considered small, the
majority of applicants to APHIS are large by SBA standards.\5\
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\5\ The size determination was made using public information
about these entities. This information was primarily obtained from
the entities' Web sites.
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Description and Estimate of Compliance Requirement
The proposed rule would require additional and modified information
collections through recordkeeping, reporting, and notifications to
APHIS when certain events occur. The proposed application process
requires certain new information. The current and proposed rules both
require submission of reports following an environmental release or
field test, but the proposed requirement is more specific about the
contents of such reports. Both the current and proposed rules require
APHIS to be notified if an unauthorized release occurs or if during
release the GE organism is found to have characteristics substantially
different from those anticipated by the permit. The proposed rule is
more specific about the types of records that must be kept for
importations, interstate movements, and environmental releases, where
the current regulations left more of these details to be specified only
in permit conditions. In terms of record retention requirements, the
proposed rule spells out a 2-year retention for records indicating that
a GE organism imported or moved interstate reached its intended
destination, and a 5-year retention for all other required records. By
providing more specific information on what records are required, the
proposed rule should alleviate some current burden that may result from
persons keeping unnecessary records. In addition, APHIS has established
the Biotechnology Quality Management System (BQMS), which is a
voluntary compliance assistance unit within USDA APHIS. BQMS would
facilitate the regulatory efforts of USDA APHIS by conducting outreach
activities and providing compliance assistance to the regulated
community. This would lessen any burden of the proposed rule to the
regulated community.
Duplication, Overlap, and Conflict With Existing Rules and Regulations
APHIS has identified areas where the proposed rule will need to be
closely coordinated with other Federal rules and statutory authorities.
Coordination has been an important aspect of the daily implementation
of the current regulation, and APHIS foresees additional areas for
coordination under the proposed rule. In particular, APHIS will
coordinate with the Food and Drug Administration (FDA) and the
Environmental Protection Agency (EPA). FDA regulates GE organisms under
the authority of the Federal Food, Drug and Cosmetic Act and the Public
Health Service Act (42 U.S.C. 262 et seq.), as appropriate. The EPA
regulates plant-incorporated protectants under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and certain biological control
organisms under the Toxic Substances Control Act (TSCA). As examples of
areas that need coordination, some of the plant-incorporated
protectants regulated by EPA are also subject to APHIS requirements
under the PPA. Also, FDA is the primary U.S. agency responsible for
ensuring the safety of commercial food and food additives, and FDA
authority extends to any nonpesticidal substance that may be introduced
into a new GE plant and that is expected to become a component of food.
The proposed regulations would clarify the regulatory scope and
procedures used by APHIS relative to these other agencies and improve
the coordination process.
Significant Alternatives to the Rule
APHIS considered several significant alternatives during
development of this proposed rule. We have compared the selected
alternatives to others that were not selected to evaluate their
feasibility and to consider whether any alternatives provide ways to
minimize significant economic impacts on small entities. We have not
identified any selected alternative that imposes disproportionate costs
on small businesses, or any non-selected alternative that would both
achieve the regulatory purposes and reduce costs for small businesses.
The selected alternative regarding the scope of the regulatory
oversight was to add considerations of noxious weed risk in addition to
evaluating plant pest risks, and to use genetic transformation, coupled
with a determination by the Administrator as to whether a GE organism
met certain risk-based criteria, as the trigger for regulation. Other
alternatives considered included continuing to base the scope of
regulation only on plant pest risks, or trying to develop a set of
solely trait-based criteria that could be used to predict what articles
would be regulated without the need for determinations by the
Administrator. The first of these alternatives could have resulted in
costs from damages caused by a GE plant with
[[Page 60037]]
noxious weed aspects that was not regulated under the plant pest risks
standard. The second alternative was not considered technically
feasible, and could also have resulted in costs for persons who
erroneously decide their GE plant is not within the scope of the
regulations, but are overruled by a later determination by the
Administrator that the GE plant is regulated.
The selected alternative for providing transparency and
predictability to the permitting system was to establish permit
categories for environmental releases of plants based on newly devised
criteria. We also considered evaluating all requests for environmental
release permits on a case-by-case basis, without categories. This
alternative would have resulted in less predictability for applicants,
and likely would have increased their costs for information collection
because applications known to be in a particular category can contain
less information about non-relevant areas.
The selected alternative regarding the duration period for permits
was to make multi-year permits for interstate movement and importation
more feasible by removing the one-year limit for interstate movement
permits and the requirement to obtain a new importation permit for each
imported shipment. We also considered alternatives to maintain either
the current or alternative specific time limits for such permits. These
alternatives would have resulted in additional costs for applicants who
would have to reapply for permits, rather than having the original
permit issued with an appropriate duration.
C. Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 7 CFR part 3015, subpart V.)
D. Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) No State or
local laws or regulations would be preempted by this rule; (2) no
retroactive effect will be given to this rule; and (3) administrative
proceedings will not be required before parties may file suit in court
challenging this rule.
E. Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in this proposed rule have been
submitted for approval to the Office of Management and Budget (OMB).
The information collection or recordkeeping requirements in current 7
CFR part 340 have been approved under OMB Control No. 0579-0085. Please
send written comments to the Office of Information and Regulatory
Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503.
Please state that your comments refer to Docket No. APHIS-2008-0023.
Please send a copy of your comments to: (1) Docket No. APHIS-2008-0023,
Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700
River Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance
Officer, OCIO, USDA, room 404-W, 14th Street and Independence Avenue
SW., Washington, DC 20250. A comment to OMB is best assured of having
its full effect if OMB receives it within 30 days of publication of
this proposed rule.
This proposed rule contains certain information collection and
recordkeeping requirements that would apply to persons and their agents
engaged in the importation, interstate movement, or release into the
environment of any GE organism that is subject to the regulations. The
majority of the requirements would apply to persons moving GE organisms
under a permit issued by APHIS, but some requirements also apply to
persons engaged in regulatory activities with GE organisms even when no
permit is required, e.g., when they are exempted from the interstate
movement permit requirement.
The proposed information and recordkeeping requirements are found
in Sec. 340.3, Permit conditions, and in Sec. 340.7, Compliance,
enforcement, and remedial action. Permit conditions for individual
permits issued under the regulations may also require that certain
records relevant to the particular movement must be kept.
The proposed permit conditions for shipments imported or moved
interstate include maintaining records of the same types of information
that the current regulations require to be on the package labeling of
such shipments (nature and quantity, sender, destination, permit
number, etc.) We believe that most persons shipping or importing GE
organisms already maintain such records as part of normal business
practices.
The proposed permit conditions for environmental releases include
keeping records of all protocols or guidelines used to direct any
environmental release. The current regulations already require persons
conducting an environmental release under permit or notification to
create and submit to APHIS a field test report, and in many cases the
protocol or guidelines would normally be included in these field
reports. This proposed change would require that the protocols or
guidelines be kept in all cases as distinctly identifiable records,
which may cause some increase in recordkeeping burden.
In some particular environmental release cases where higher risk
levels make it necessary, the proposed rule would allow APHIS to add a
special permit condition requiring the permit holder to maintain and
make available to APHIS written manuals or protocols describing how
specified permit conditions will be met, such as management practices
used for the environmental release, training, communications, and
identity preservation systems. This would be used in cases where it is
deemed necessary to provide specific guidance in addition to the
proposed general condition for all permits (i.e., that the holder must
keep records related to permitted activities of sufficient quality and
completeness to demonstrate compliance with all permit conditions and
requirements under this part). Another proposed permit condition would
require permit holders to develop and keep a written contingency plan
to respond to any unauthorized environmental release. Both of these
recordkeeping requirements would be added because some researchers or
developers were found to be unclear about what management and
communications practices were needed to prevent unauthorized releases,
and also about their responsibilities and the measures they must take
in the event of an unauthorized release.
The proposed procedure to apply for an environmental release permit
requires applicants to submit a great deal of information
characterizing the nature of the GE organism, the type of movement and
release planned, plans and methods used to prevent unauthorized
releases, and other matters. Most of the same information is obtained
through the current application process, which allows the Administrator
to require an applicant to submit any additional information that is
needed for adequate evaluation of the application. The proposed
application procedure is more specific in describing what information
is required, and may result in a slight increase in the amount of
information submitted with the average application.
The reporting burden for permit holders under the proposed rule
would be similar to the burden under the
[[Page 60038]]
current regulations. In both cases they must submit reports of all
field tests to APHIS, report any unauthorized releases, and submit any
additional reports required as individual permit conditions in their
permits.
The current regulations do not specify record retention periods,
although some permits APHIS issued included specific retention
requirements as permit conditions. This proposal would require that
records associated with an importation or interstate shipment must be
retained for at least 2 years after completion of the movement, and all
other records (e.g., regarding environmental releases) must be retained
for at least 5 years after completion of all obligations required under
a relevant permit or exemption.
We are soliciting comments from the public (as well as affected
agencies) concerning our proposed information collection and
recordkeeping requirements. These comments will help us:
(1) Evaluate whether the proposed information collection is
necessary for the proper performance of our agency's functions,
including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the
proposed information collection, including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the information collection on those who
are to respond (such as through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology; e.g., permitting electronic
submission of responses).
Estimate of burden: Public reporting burden for this collection of
information is estimated to average 2 hours per response.
Respondents: Public and private biotechnology research facilities,
GE crop and seed producers, food processors, grain processors, and
paper producers that fall into various categories of the North American
Industry Classification System.
Estimated annual number of respondents: 160.
Estimated annual number of responses per respondent: 2.
Estimated annual number of responses: 320.
Estimated total annual burden on respondents: 640 hours.
Copies of this information collection can be obtained from Celeste
Sickles, the Agency Information Management Specialist, at (301) 851-
2908.
F. E-Government Act Compliance
The Animal and Plant Health Inspection Service is committed to
compliance with the E-Government Act to promote the use of the Internet
and other information technologies, to provide increased opportunities
for citizen access to Government information and services, and for
other purposes. For information pertinent to E-Government Act
compliance related to this proposed rule, please contact Mrs. Celeste
Sickles, the Agency Information Management Specialist, at (301) 851-
2908.
List of Subjects in 7 CFR Part 340
Administrative practice and procedure, Biotechnology, Genetic
engineering, Imports, Packaging and containers, Permits, Plant diseases
and pests, Noxious weeds, Transportation.
Accordingly, we propose to revise 7 CFR part 340 to read as
follows:
PART 340--IMPORTATION, INTERSTATE MOVEMENT, AND RELEASE INTO THE
ENVIRONMENT OF CERTAIN GENETICALLY ENGINEERED ORGANISMS
Sec.
340.0 Scope and general restrictions.
340.1 Definitions.
340.2 Procedure for permits.
340.3 Permit conditions.
340.4 Conditional exemptions from the requirement for a permit for
interstate movement.
340.5 Petition for new conditional exemptions from the requirement
for a permit.
340.6 Petition for nonregulated status.
340.7 Compliance, enforcement, and remedial action.
340.8 Confidential business information.
340.9 Costs and charges.
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.3.
Sec. 340.0 Scope and general restrictions.
(a) In order to prevent the unauthorized introduction or
dissemination of a plant pest or noxious weed, no person shall import,
move interstate, or release into the environment genetically engineered
organisms described in paragraph (b) of this section, unless the
importation, interstate movement, or release into the environment:
(1) Is authorized under a permit issued by the Administrator in
accordance with Sec. 340.2, or
(2) Is exempt from the requirements for a permit in accordance with
Sec. 340.4 or Sec. 340.5, or
(3) Is approved for nonregulated status in accordance with Sec.
340.6 or has previously been approved for nonregulated status pursuant
to former regulations under this part, or
(4) Is excluded in accordance with paragraph (d) of this section.
(b) Genetically engineered organisms whose importation, interstate
movement, or release into the environment is subject to the regulations
in this part are:
(1) Genetically engineered plants if:
(i) The unmodified parent plant from which the GE plant was derived
is a plant pest or noxious weed, or
(ii) The trait introduced by genetic engineering could increase the
potential for the GE plant to be a plant pest or noxious weed, or
(iii) The risk that the GE plant poses as a plant pest or noxious
weed is unknown, or
(iv) The Administrator determines that the GE plant poses a plant
pest or noxious weed risk.
(2) Genetically engineered non-plant, non-vertebrate organisms if:
(i) The recipient organism can directly or indirectly injure, cause
damage to, or cause disease in plants or plant products; or
(ii) The GE organism has been engineered in such a way that it may
increase the potential for it to be a plant pest: or
(iii) The risk that the GE organism poses as a plant pest is
unknown, or
(iv) The Administrator determines that the GE organism poses a
plant pest risk.
(3) Opportunity to consult APHIS. Any person may contact APHIS to
discuss how the criteria of this paragraph apply in the case of a
particular GE organism or group of organisms.
(c) The Administrator may issue permits for the importation,
interstate movement, or release into the environment of certain
genetically engineered organisms described in paragraph (a) of this
section. These permits may include such requirements or conditions as
the Administrator deems necessary to prevent the unauthorized
introduction or dissemination of a plant pest or noxious weed. The
Administrator may also designate certain exemptions from the
requirement to obtain permits. The Administrator may also approve for
nonregulated status a genetically engineered organism described in
paragraph (a) of this section for which a determination has been made
by the Administrator that the organism is unlikely to be a plant pest
or noxious weed.
[[Page 60039]]
(d) Genetically engineered microorganisms that are regulated as
biological control organisms under the Federal Insecticide, Fungicide,
and Rodenticide Act are not subject to the regulations in this part.
Genetically engineered microorganisms where the recipient microorganism
is not a plant pest and which has resulted from the addition of genetic
material from a donor organism where the material is well characterized
and contains only non-coding regulatory regions are not subject to the
regulations in this part.
Sec. 340.1 Definitions.
Terms used in the singular form in this part shall be construed as
the plural, and vice versa, as the case may demand. The following
terms, when used in this part, shall be construed, respectively, to
mean:
Administrator. The Administrator of the Animal and Plant Health
Inspection Service (APHIS) or any other employee of APHIS to whom
authority has been, or may be, delegated to act in the Administrator's
stead.
Animal and Plant Health Inspection Service (APHIS). An agency of
the United States Department of Agriculture.
Confidential business information, CBI. Information such as trade
secrets or commercial or financial information that may be exempt from
disclosure under Exemption 4 of the Freedom of Information Act (FOIA),
because disclosure could reasonably be expected to cause substantial
competitive harm. USDA regulations on how the agency will handle CBI
and how to determine what information may be exempt from disclosure
under FOIA (5 U.S.C. 552) are found at 7 CFR 1.12.
Contained facility, contained structure. A physical structure
designed to minimize release into the outdoor environment. Examples of
contained structures include, but are not limited to, laboratories,
containment greenhouses, bioreactors, and fermenters.
Contingency plan. A written plan stating how the responsible person
will respond in the event of the unauthorized environmental release of
GE organisms.
Donor organism. The organism from which genetic material is
obtained for transfer to the recipient organism in the process of
genetic engineering.
Environmental release. See definition of Release into the
environment.
Exempt, exempted, exemption from permit. A determination by the
Administrator that the importation, interstate movement, and/or release
into the environment of an organism or class of organisms described in
Sec. 340.0(a) is not subject to the requirement to have a permit under
this part. An exemption from one type of permit (e.g., interstate
movement) does not remove remaining obligations to obtain other permits
under this part.
Genetic engineering. The genetic modification of organisms by
recombinant DNA techniques.
Genetically engineered, GE. A term applied to organisms that have
been produced by genetic engineering, e.g., GE organisms, GE plants.
Import and importation. To move into, or the act of movement into,
the territorial limits of the United States.
Inspector. Any employee of the Animal and Plant Health Inspection
Service, U.S. Department of Agriculture, or other person, authorized by
the Administrator, in accordance with law to enforce the provisions of
this part.
Interstate movement. Movement from any State into or through any
other State.
Means of conveyance. Any personal property used for, or intended
for use for, the movement of any other personal property. This
specifically includes, but is not limited to, automobiles, trucks,
railway cars, aircraft, boats, freight containers, and other means of
transportation.
Nonregulated status. A determination by the Administrator that an
organism described in Sec. 340.0(a) is not subject to any of the
regulatory requirements of this part.
Noxious weed. Any plant or plant product that can directly or
indirectly injure or cause damage to crops (including nursery stock or
plant products), livestock, poultry, or other interests of agriculture,
irrigation, navigation, the natural resources of the United States, the
public health, or the environment.
Organism. Any active, infective, or dormant stage or life form of
an entity characterized as living, including vertebrate and
invertebrate animals, plants, bacteria, fungi, mycoplasmas, mycoplasma-
like organisms, as well as entities such as viroids, viruses, or any
entity characterized as living, related to the foregoing.
Permit. A written authorization by the Administrator for the
importation, interstate movement, and/or release into the environment
of a GE organism under this part.
Person. Any individual, partnership, corporation, company, joint
venture, society, association, or other legal entity.
Plant. Any plant (including any plant part) for or capable of
propagation, including trees, tissue cultures, plantlet cultures,
pollen, shrubs, vines, cuttings, grafts, scions, buds, bulbs, roots,
and seeds.
Plant pest. Any living stage of any of the following that can
directly or indirectly injure, cause damage to, or cause disease in any
plant or plant product: A protozoan, a nonhuman animal, a parasitic
plant, a bacterium, a fungus, a virus or viroid, an infectious agent or
other pathogen, or any other living stage similar to or allied with any
of these organisms.
Plant product. Any flower, fruit, vegetable, root, bulb, seed, or
other plant part that is not included in the definition of plant; or
any manufactured or processed plant or plant part.
Recipient organism. The organism that will receive the genetic
material from a donor organism in the process of genetic engineering
(once the organism is engineered it is referred to as the genetically
engineered (GE) organism).
Release into the environment. Dispersal beyond the constraints of a
contained facility or secure shipment. Synonymous with the term
environmental release.
Responsible person. The person who has control and will maintain
control over a GE organism during its importation, interstate movement,
or release into the environment and assures compliance with all
conditions contained in any applicable permit or exemption as well as
other requirements in this part. A responsible person shall be at least
18 years of age and be a legal resident of the United States or
designate an agent who is at least 18 years of age and a legal resident
of the United States.
Secure shipment. Shipment in a container or a means of conveyance
of sufficient strength and integrity to withstand leakage of contents,
shocks, pressure changes, and other conditions incident to ordinary
handling in transportation.
Signature, signed. The discrete, verifiable symbol of an individual
which, when affixed to a writing with the knowledge and consent of the
individual, indicates a present intention to authenticate the writing.
This includes electronic signatures when authorized by the
Administrator.
State. Any State of the United States, the District of Columbia,
American Samoa, Guam, Northern Mariana Islands, Puerto Rico, the Virgin
Islands of the United States, and any other Territories, Possessions,
or Districts of the United States.
State or tribal regulatory official. State or tribal official with
responsibilities for plant health, or any other duly designated State
or tribal official, in the
[[Page 60040]]
State or on the tribal lands where the importation, interstate
movement, or release into the environment is to take place.
United States. All of the States.
Write, writing, written. Any document or communication required by
this part to be in writing may also be provided by electronic
communication when authorized by the Administrator.
Sec. 340.2 Procedure for permits.
(a) General. A permit is required for the importation, interstate
movement, or release into the environment of any GE organism that is
subject to this part, as described in Sec. 340.0, The responsible
person seeking a permit for the importation, interstate movement, or
release into the environment of such organisms shall submit a written
application for a permit to APHIS in accordance with paragraph (c) of
this section and obtain the permit prior to the importation, interstate
movement, or release into the environment.
(b) Types of permits. The Administrator may issue the following
three types of permits under this part.
(1) Import permit. Import permits are for secure shipment via any
means of conveyance from outside the United States into contained
facilities within the United States.
(2) Interstate movement permit. Interstate movement permits are for
secure shipment via any means of conveyance from a contained facility
in any State into or through any other State to another contained
facility.
(3) Environmental release permit. Environmental release permits are
for the environmental release of GE organisms. In cases in which
importation and interstate movements will occur incidental to an
environmental release, the importation and interstate movements will
also be authorized under the environmental release permit.
(c) Permit application information requirements. Applicants must
submit to APHIS sufficient information about the specific nature of the
GE organism and the particular proposed permit conditions, so that the
Administrator is able to consider whether the proposed importation,
interstate movement, or release into the environment is likely to
result in the introduction or dissemination of a plant pest or noxious
weed. The basic information required in permit applications is
described in this paragraph. The type and level of detail needed for
the Administrator to issue a permit may vary by type of permit. For
environmental releases, application information will be used to sort
proposed releases of GE organisms into administrative categories
described in paragraph (d) of this section. Applicants should consult
with APHIS prior to applying for permits in order to obtain further
guidance as to what additional information the Administrator may
require to be submitted with the application.
(1) Information required in all permit applications. Each
application must include all of the following information, and any
other information specified for individual types of permits as
described in this paragraph:
(i) The name, title, and contact information (e.g., mailing
address, e-mail, telephone and fax numbers) of the responsible person;
(ii) The type of permit sought (importation, interstate movement,
or environmental release, and if the permit is for environmental
release, which category);
(iii) Information necessary to identify and characterize the GE
organism(s) for which a permit is sought, including:
(A) The scientific names of all donor and recipient species plus
any designations used for the GE organism(s) (e.g., strain, line,
variety);
(B) The form of the GE organism (e.g., seeds, rootstocks, tubers,
spores, larvae, eggs) and the amount (e.g., numbers, total weight or
volume); and a description of any biological material accompanying the
GE organism under permit (e.g., culture medium, or host organisms,
etc.);
(C) The anticipated phenotype of the GE organism and the nature of
the inserted sequences or other genetic modification intended to confer
the phenotype;
(D) Intended uses of the GE organism after the termination of the
importation, interstate movement, or environmental release (e.g.,
contained research in laboratories or containment greenhouses,
culturing, propagation, breeding, processing for analysis or
manufacture, sale and distribution for consumption); and
(E) Description of how the GE organism will be marked, labeled, or
otherwise identified during the importation, interstate movement, or
environmental release;
(iv) The proposed time frame (estimated start and duration) within
which the importation(s), interstate movement(s) or environmental
release(s) will occur;
(v) Description of how permit requirements will be communicated to
persons having contact with the GE organism under permit;
(vi) Description of any training given to persons having contact
with the GE organism under permit, including but not limited to
detailed information on how this training will facilitate compliance
with conditions imposed under the permit and any other regulatory
requirements under this part; and
(vii) A certification statement signed by the responsible person
that certifies that the application information is correct.
(2) Additional information required in all applications for
importation permits, interstate movement permits, and all environmental
release permits that include importation or interstate movement.
(i) The location(s) of the origin(s) and destination(s), including
information on the addresses, and contact details of the sender(s) and
recipient(s), if different from the responsible person.
(ii) A description of the method of secure shipment.
(iii) A description of the manner in which packaging material,
shipping containers, and any other material accompanying the GE
organism will be disposed.
(3) Additional information required in all environmental release
permit applications. Information should address the persistence risk
and potential harm of the GE organism in the environment, including but
not limited to:
(i) A description of how the phenotype of the GE organism differs
from the phenotype of the recipient organism, particularly with respect
to potential interactions with and its likelihood of persistence in the
environment.
(ii) The location and size of all proposed release sites, including
area, geographic coordinates, addresses, and contact information of a
person at each release site, if different from the responsible person.
Include information about the ecology and agronomy of each site,
including but not limited to:
(A) Presence of any wild or cultivated species that are sexually
compatible with the GE organism;
(B) Presence of any Federally-listed threatened or endangered
species that could interact with the GE organism during the release;
(C) Presence of any designated critical habitat, or habitat
proposed for designation, in the area of the release site; and
(D) Land use history of the site and adjacent areas.
(iii) A description of the site management practices and control
procedures designed to make it unlikely that there will be unauthorized
introduction or dissemination of the GE organism beyond the proposed
area and
[[Page 60041]]
the permit time frame of release. Each of the descriptions shall
include:
(A) Description of the methods and stages of transport of the GE
organism from a contained facility to the environmental release site,
and any storage methods used at the site;
(B) Description of methods of planting, inoculation, or release;
any reproductive or cultural controls; methods of treatment and harvest
used for the GE organism; and a proposed plan for monitoring the site
for pests, diseases, and effects on other organisms during the time the
GE organism is released;
(C) Description of the methods and stages of transport of the GE
organism from release site back into contained facilities, or methods
of devitalization at the site(s) of the environmental release;
(D) Description of the cleaning, disinfection, or other methods
used to make it unlikely that unauthorized dissemination of the GE
organism into the environment could occur via means of conveyance and
other articles (e.g., planters, harvesters, containers);
(E) Description of any post-release land use practices, including
any monitoring plans to ensure that the GE organism or its progeny are
unlikely to reproduce and disseminate in the environment after the
termination of the release (e.g., managing volunteer plants); and
(F) Description of the contingency plans associated with the
release.
(d) Administrator action on permit applications. An initial review
should generally be completed by APHIS within 15 days of the receipt of
the application for importation or interstate movement permits, and
within 30 days for environmental release permits. An application will
be considered complete when the Administrator determines that it
includes all information required by this section and any additional
information that the Administrator determines is needed for review. If
necessary after its initial evaluation of an application, APHIS will
notify the applicant in writing if the submitted application
information is incomplete, and the applicant will be provided the
opportunity, without prejudice, to revise the application information
to meet the needs for administrative processing and scientific review.
Once the Administrator has determined that an application is complete,
the Administrator will commence review. The APHIS review should
generally be completed within 60 days after it is determined to be
complete for importation and interstate movement permits, and within
120 days after it is determined to be complete for environmental
release permits.
(1) Administrative categories for environmental releases. The
Administrator will use the following categories to efficiently
administer the program and tailor regulatory oversight in a manner that
is commensurate with risk. Environmental releases of GE plants are
assigned to one of four categories (A-D), using the factors described
in (i-iv). A fifth category (E) is for environmental releases of all
non-plant organisms; applications in this category will be reviewed on
a case-by-case basis.
(i) Initial sorting into categories. The Administrator will use the
following factors to initially sort environmental releases into
administrative categories.
(A) Persistence of the nonmodified plant, ranked as follows:
(1) Low: Populations of the recipient plant are unlikely to persist
in the environment without human intervention, and the recipient plant
has no interfertile wild relatives in the United States.
(2) Moderate: Populations of the recipient plant are known to be
weakly persistent in the environment without human intervention, or the
recipient plant has interfertile wild relatives in the United States.
(3) High: Populations of the recipient plant are known to be
strongly persistent in the environment without human intervention, or
the recipient plant has interfertile wild relatives in the United
States which are aggressive colonizers.
(4) Severe: The recipient plant is a Federally-listed noxious weed
or is known to be similarly aggressive in its ability to colonize and
persist in the environment without human intervention.
(B) Potential harm or damage of the engineered traits, ranked as
follows:
(1) Low: Any new proteins or substances produced are unlikely to be
toxic or otherwise cause serious harm to humans, vertebrate animals, or
invertebrate organisms upon consumption of or contact with the plant or
plant parts; and
(i) No morphological changes which could cause mechanical injury or
damage; and
(ii) Introduced sequences are known not to result in plant disease,
and confers no or very low increased disease susceptibility.
(2) Moderate: Any new proteins or substances produced are unlikely
to be toxic or otherwise cause serious harm to humans or vertebrate
animals upon consumption of or contact with the plant or plant; or
(i) Novel resistance to the application of an herbicide; or
(ii) Novel ability to cause mechanical injury or damage; or
(iii) Produces proteins or substances that are associated with
plant disease that are not prevalent or endemic in the area of release,
or that confer an increased susceptibility to disease.
(3) High: Any new proteins or substances produced may be toxic or
to otherwise cause serious harm to humans or vertebrate animals, upon
consumption of or contact with the plant or plant parts; or
(i) Produces an infectious entity which can cause disease in
plants.
(4) Severe: Any new proteins or substances produced are known or
likely to be highly toxic or fatal to humans or vertebrate animals,
upon consumption of or contact with the plant or plant parts.
(C) Environmental releases will be initially sorted into
administrative categories A-D as shown in Table 1, based upon the
persistence risk and potential harm described in paragraphs
(d)(1)(i)(A) and (B) of this section.
Table 1 to Sec. 340.2(d)(1)--Initial Sorting Into Permit Administrative Categories (A, B, C, and D) for
Environmental Releases of GE Plants, Based Upon Persistence Risk of the Recipient Plant Species and Potential
Harm or Damage of the Engineered Trait
----------------------------------------------------------------------------------------------------------------
Potential harm or damage of engineered trait
Persistence * -------------------------------------------------------
Low Moderate High Severe
----------------------------------------------------------------------------------------------------------------
Low..................................................... A A C D
Moderate................................................ A B C D
High.................................................... B B C D
[[Page 60042]]
Severe.................................................. D D D D
----------------------------------------------------------------------------------------------------------------
* Persistence risk of the recipient plant species.
(2) Modification of initial sorting based upon additional
considerations. Following initial sorting using the factors described
in paragraph (1)(i) of this section, the Administrator may reassign the
environmental release to a different category based upon one or more of
the following factors:
(i) How the recipient plant is used;
(ii) Whether the added trait significantly alters the persistence
risk of the GE plant;
(iii) Whether the gene function is known and based upon empirical
observation of the added trait in the same species; and
(iv) Any other information the Administrator deems relevant to the
risk of introduction or dissemination of a plant pest or noxious weed.
(3) APHIS review and assignment of permit conditions. The
Administrator will conduct a review and assign appropriate permit
conditions so that the proposed activity will be conducted in a manner
that makes it unlikely to result in the introduction and dissemination
of a plant pest or noxious weed.
(4) State or tribal review and comment. The Administrator will
submit for notice and review a copy of the permit application and any
permit conditions to the appropriate state or tribal regulatory
official. Comments received from the state or tribal regulatory
official may be considered by the Administrator prior to permit
issuance.
(5) Site inspection. Prior to and after permit issuance, an
inspector may inspect the sites or the means of conveyance associated
with the proposed importation, interstate movement, or release into the
environment. The responsible person must allow any such inspections.
(6) Issuance of a permit. The Administrator may issue a permit if
the Administrator concludes that the actions allowed under the permit
are unlikely to result in the introduction or dissemination of a plant
pest or noxious weed.
(i) Prior to the issuance of a permit, the responsible person must
agree in writing, in a manner prescribed by the Administrator, that the
responsible person and all agents of the responsible person will comply
with the permit conditions. The Administrator will deny the permit
application if the responsible person does not agree that both the
responsible person and all of his or her agents will comply with all of
the permit conditions.
(ii) If a permit is issued, the permit will include specific permit
conditions required by the Administrator in accordance with Sec.
340.3. If a permit is denied, within a reasonable time thereafter the
applicant will be informed in writing of the reasons why the permit was
denied and will be given the opportunity to appeal the denial in
accordance with the provisions of paragraph (g) of this section.
(e) Denial or revocation of a permit. Permits may be denied or
revoked in accordance with this paragraph.
(1) Denial. The Administrator may deny an application for a permit
if:
(i) The Administrator cannot conclude based on the application that
the actions proposed under the permit are unlikely to result in
introduction or dissemination of a plant pest or noxious weed; or
(ii) The Administrator receives information apart from the
application that precludes a conclusion by the Administrator that the
actions proposed under the permit would be unlikely to result in the
introduction or dissemination of a plant pest or noxious weed; or
(iii) The Administrator determines that the responsible person or
any agent of the responsible person has failed to comply at any time
with any provision of this part. This would include failure to comply
with the conditions of any permit issued.
(2) Revocation. The Administrator may revoke a permit if:
(i) The Administrator receives information subsequent to issuing a
permit and makes a determination based upon this information that the
circumstances have changed such that actions under the permit would be
likely to result in the introduction or dissemination of a plant pest
or noxious weed; or
(ii) The Administrator determines that the responsible person or
any agent of the responsible person has failed to comply at any time
with any provision of this part. This would include failure to comply
with the conditions of any permit issued.
(f) Notice of revocation. The Administrator may revoke, either
orally or in writing, any permit which has been issued. If the
revocation is oral, the Administrator will communicate the revocation
and the reasons for it in writing as promptly as circumstances allow.
(g) Appeal of denial or revocation of permit. Any person who has
been denied a permit or had a permit revoked may appeal the decision in
writing to the Administrator within ten days after receiving the
written notification of the revocation or denial. The appeal shall
state all of the facts and reasons upon which the person relies to
assert that the permit was wrongfully revoked or denied. The
Administrator will grant or deny the appeal, in writing, stating the
reasons for the decision as promptly as circumstances allow. Upon
request of the applicant, a hearing may be held to resolve any conflict
as to any material fact. Rules of practice concerning such a hearing
will be adopted by the Administrator. This administrative remedy must
be exhausted before a person can file suit in court challenging the
denial or revocation of a permit.
(h) Amendment or transfer of permits. Permits issued under this
part may only be amended or transferred in accordance with this
section.
(1) Amendment at responsible person's request. Where circumstances
have changed so that a responsible person desires to have the permit
amended, such responsible person must submit a written justification
and provide supporting information to APHIS. The Administrator will
review the amendment request, and may amend the permit. Prior to
issuance of an amended permit, the responsible person must agree in
writing that he or she and all of his or her agents will comply with
the amended permit and conditions.
(2) Amendment initiated by APHIS. The Administrator may amend any
[[Page 60043]]
permit and its conditions at any time, upon determining that the
amendment is needed to make it unlikely that actions under the permit
would result in the introduction or dissemination of a plant pest or
noxious weed, or to ensure that the permit is in compliance with all of
the requirements of this part. As soon as circumstances allow, the
Administrator will notify the responsible person in writing of the
amendment to the permit and the reason(s) for it. The responsible
person must agree in writing to comply with the permit and conditions
as amended before the Administrator will issue the amended permit. If
the responsible person does not agree in writing to comply with the
amended permit and conditions, the existing permit will be revoked.
(3) Transfer of permits. Permits issued through this part may only
be transferred by the Administrator in response to a request by both
the responsible person and the proposed transferee, or in the case of a
deceased responsible person, the deceased responsible person's legal
representative and the proposed transferee. Such transfer may occur if
the Administrator determines that:
(i) The proposed transferee meets all of the qualifications of a
responsible person under this part;
(ii) The proposed transferee has provided adequate written
assurances to the Administrator that the proposed transferee and all of
his or her agents will meet the terms and conditions of the permit,
including any outstanding mitigation requirements or commitments under
this part, and that the proposed transferee agrees to assume all
responsibility and liability associated with permit activities and
responsibilities; and
(iii) The proposed transferee has provided such other information
as the Administrator determines is necessary to the processing of the
request for transfer of permit.
Sec. 340.3 Permit conditions.
(a) Core permit conditions. Permits will be issued with the permit
conditions below, which are a minimum set of basic conditions. The
Administrator may add additional or expanded conditions when necessary
to make it unlikely that actions under the permit would result in the
introduction or dissemination of a plant pest or noxious weed.
(1) Permit conditions for all permit types.
(i) Identity. The identity of the GE organism shall be maintained
at all times, in order to maintain control of the GE organism, keep it
distinct from other organisms, and minimize unintended mixing of the GE
organism with other organisms. Conditions for maintaining the identity
of the GE organism include, but are not limited to:
(A) Marking, labeling, or otherwise identifying all GE organisms
during the course of the permit; and
(B) Having the ability to account for all GE materials associated
with the permit.
(ii) Communication and training. The responsible person shall
effectively communicate any and all conditions, activities, actions,
and contingency plans associated with the permit to all his or her
agents and any other persons participating in permit-related
activities, in order to ensure all persons comply with all requirements
under this part. Conditions for communicating and training include, but
are not limited to:
(A) Establishing, implementing, and maintaining the means to
effectively communicate to all his or her agents and any other persons
participating in permit-related activities;
(B) Providing a copy of the permit and conditions to all agents
involved in a permit; and
(C) Training all agents and any other persons participating in
permit-related activities to effectively conduct tasks required under
the permit.
(iii) Records. In addition to any other records required by this
section or Sec. 340.7(b), records, related to permitted activities of
sufficient quality and completeness to demonstrate compliance with all
permit conditions and requirements under this part, must be maintained.
(iv) Notice. The responsible person shall notify APHIS orally
within 24 hours of discovery, and subsequently in writing within 5
business days of discovery, in the event of an unauthorized
importation, interstate movement, or release into the environment of a
GE organism regulated under this part.
(2) Additional permit conditions for interstate movement permits,
importation permits, and environmental release permits which include
either an interstate movement or importation.
(i) Shipment. The GE organism must be transported in such a way as
to minimize the likelihood of the unauthorized release of the GE
organism. Conditions include, but are not limited to:
(A) Ensuring that the GE organism is transported in such a way that
it is a secure shipment, as defined in Sec. 340.1; and
(B) Treating or disposing of all packaging material, shipping
containers, and any other material accompanying the GE organism in such
a manner as to make it unlikely to result in the organism's
unauthorized importation, interstate movement, or release into the
environment.
(ii) Records. In addition to any other records required by this
section or Sec. 340.7(b), the following records shall be maintained:
(A) Information identifying the general nature and quantity of the
organism being shipped;
(B) Name and address of sender, owner, or person shipping the
organism;
(C) Name, address, and telephone number of recipient;
(D) Any invoices, packing lists, or bills of lading used for the
shipment;
(E) The shipper's name and identifying shipper's mark and number;
and
(F) A description of any containers that were used to transport the
GE organisms, and a copy of any label used on these containers during
transport.
(3) Additional permit conditions for import permits, and
environmental release permits which include importation.
(i) Port(s) of Entry. The GE organism shall be presented for entry
only at a port(s) specified in the permit.
(ii) Records. In addition to any other records required by this
section or Sec. 340.7(b), the responsible person shall maintain
records that identify the country and locality where the GE organism
was collected, developed, manufactured, reared, cultivated or cultured.
(4) Additional permit conditions for environmental release permits.
(i) Environmental release controls. Sufficient controls shall be
applied during the environmental release of the GE organism to make it
unlikely to result in the unauthorized release of the GE organism into
the environment. Conditions include, but are not limited to:
(A) Taking adequate precautions as described in the permit to
ensure that the GE organism is not inadvertently released in transit
between contained facilities and the location of environmental release;
(B) Developing and being prepared to implement a written
contingency plan to respond to any unauthorized environmental release;
(C) Following any and all required reproductive, cultural, spatial,
and temporal controls, such as isolation distances, buffer zones, and
flower removal, as described in the permit, and monitor to ensure that
the controls are maintained throughout the duration of the release;
[[Page 60044]]
(D) Cleaning equipment used in the environmental release in order
to remove or devitalize any viable GE organism the equipment may carry,
as described in the permit;
(E) Devitalizing or moving into a contained facility any viable GE
material remaining at the termination of the environmental release,
when applicable, as described in the permit; and
(F) Managing and monitoring the area of release after the
termination of the environmental release and removing or devitalizing
any GE organisms which persist after the release, as required in the
permit.
(ii) Records. In addition to any other records required by this
section or Sec. 340.7(b), the following records shall be maintained
for each release:
(A) All protocols or guidelines used to direct any environmental
release of the GE organism; and
(B) All environmental release reports for the organism. At a
minimum such reports must include the APHIS reference number for the
environmental release, methods of observation used during the
environmental release, resulting information, and analysis regarding
all deleterious effects on plants, nontarget organisms, or the
environment, and any notices sent to APHIS of any unusual occurrence
during the environmental release.
(iii) Reports and Notices. In order for the Administrator to
monitor the progress of the environmental release, and to evaluate
compliance with required permit conditions, permit conditions will
include, but are not limited to:
(A) The responsible person shall submit periodic reports and
notices to APHIS at the times specified in the permit and containing
the information specified within the permit; and
(B) The responsible person shall notify APHIS orally within 24
hours of discovery, and subsequently in writing within 5 business days
of discovery, in the event that the GE organism is found to have
characteristics substantially different from those listed in the permit
or if any circumstances occur which may increase the risk of
disseminating a plant pest or noxious weed.
(C) The responsible person shall notify APHIS in writing if the
authorized release will not be conducted.
(D) Within 28 days after the initiation of the release, the
responsible person shall report to APHIS in writing the final release
site coordinates; number of GE organisms actually released; any
information related to the expected date(s) and quantities of GE
organisms for subsequent planned releases to be done under this permit.
(E) The responsible person shall provide APHIS with a final report
that includes information related to any occurrences during the release
that might result in the dissemination of a plant pest or noxious weed.
(F) For categories C and D, permit holders shall provide APHIS with
written notice no less than seven days prior to the planned initiation
of the release.
(G) For categories C and D, permit holders shall provide APHIS with
a report no less than 21 days prior to release termination (e.g.,
harvest of GE plants) that describes the anticipated date(s) of
termination.
(b) Standard for additional permit conditions assigned by
Administrator. The Administrator will assign the permit conditions
described above in a manner that is commensurate with the risk of the
individual proposed release. Additional or expanded permit conditions
may include, but are not limited to specific requirements for:
Reproductive, cultural, spatial, temporal controls; monitoring; post-
termination land use; site security or access restrictions; and
management practices such as training of personnel involved in the
release. The Administrator may also assign permit conditions addressing
nonliving materials associated with or derived from GE plants when such
conditions are needed to make it unlikely that the nonliving materials
would pose a noxious weed risk.
Sec. 340.4 Conditional exemptions from the requirement for a permit
for interstate movement.
(a) General. Certain GE organisms described in paragraph (b) of
this section may be moved interstate without a permit under this part,
if they meet the shipping conditions enumerated in paragraph (c).
(b) Conditional exemptions from the requirement for a permit for
interstate movement of certain organisms. A permit for interstate
movement will not be required for the following genetically engineered
organisms provided that they meet the requirements of this paragraph
and paragraph (c).
(1) Escherichia coli genotype K-12 (strain K-12 and its
derivatives), sterile strains of Saccharomyces cerevisiae, or
asporogenic strains of Bacillus subtilis, provided that the introduced
genetic sequences:
(i) Are maintained on a nonconjugation proficient plasmid, and the
organism does not contain other conjugation proficient plasmids or
generalized transducing phages;
(ii) Do not cause the production of an infectious entity;
(iii) Are not carried on an expression vector if the cloned genes
code for:
(A) A toxin to plants or plant products, or a toxin to organisms
beneficial to plants; or
(B) Other factors directly involved in eliciting plant disease
(e.g., cell wall degrading enzymes; or
(C) Substances acting as, or inhibitory to, plant growth
regulators.
(2) Arabidopsis thaliana provided that the introduced genetic
sequences:
(i) Do not cause the production of an infectious entity;
(ii) Are not derived from an animal or human pathogen;
(iii) Do not encode products that are toxic to vertebrates;
(iv) Do not encode products known to or likely to be causal agents
of disease in vertebrates; and
(v) Do not encode products intended for pharmaceutical or
industrial use.
(c) Shipping conditions. Organisms that meet the criteria described
in paragraph (b) of this section must be shipped as follows:
(i) The container and means of conveyance must provide secure
shipment to make it unlikely that the introduction or dissemination of
the organisms will occur while in transit.
(ii) The container must contain a document which includes the
following written information:
(A) Names and contact details for the sender and recipient, and
(B) A statement that the contents are genetically engineered and
are eligible for interstate movement without permit under this part,
but are not exempt from permit requirements under this part if the
organism is imported or released into the environment;
(iii) The responsible person shall notify APHIS orally within 24
hours of discovery, and subsequently in writing within 5 business days
of discovery, in the event of an unauthorized release into the
environment of a GE organism regulated under this part.
(d) Revocation of an exemption from requirement for permit. The
Administrator may revoke any existing conditional exemption. The
Administrator may revoke a conditional exemption if the Administrator
receives information subsequent to approving the conditional exemption
and makes a determination based upon this information that the
circumstances have changed such that the conditional exemption is
likely to result in the introduction or dissemination of a plant pest
or noxious weed. The revocation, its effective date, and the reasons
for it will be published in the Federal
[[Page 60045]]
Register. A revocation may not be appealed. However, any person may
file a new petition in accordance with Sec. 340.5 regarding the same
or similar organisms covered by the revocation if new information
relevant to the revocation becomes available.
(e) Revocation of a person's use of a conditional exemption from
requirement for permit. The Administrator may revoke the right of any
person to use a conditional exemption from the requirement for a permit
under this part after determining that the person or any agent of the
person has failed to comply at any time with any provision of this
part. This would include failure to comply with the conditions of any
permit or exemption.
(1) Appeal of revocation of a person's use of a conditional
exemption. Any person who has had the right to use a conditional
exemption revoked may appeal the decision in writing to the
Administrator within ten days after receiving the written notification
of the revocation. The appeal shall state all of the facts and reasons
upon which the person relies to assert that the use of the conditional
exemption was wrongfully revoked. The Administrator will grant or deny
the appeal, in writing, stating the reasons for the decision as
promptly as circumstances allow. Upon request of the applicant, a
hearing may be held to resolve any conflict as to any material fact.
Rules of practice concerning such a hearing will be adopted by the
Administrator. This administrative remedy must be exhausted before a
person can file suit in court challenging the revocation.
Sec. 340.5 Petition for new conditional exemptions from the
requirement for a permit.
(a) General. Any person may petition to initiate the procedure for
establishing a new conditional exemption from the requirement for a
permit under Sec. 340.0(b)(1) of this part. The Administrator may
initiate the procedure without filing a petition. All petitions and all
actions by the Administrator to establish a new conditional exemption
will be evaluated according to the standards for petition approval or
denial contained in paragraph (b)(4) of this section.
(b) Petition submission and evaluation procedure. To petition for a
new conditional exemption from the requirement for a permit under this
part, a petitioner must submit a written petition to the Administrator.
(1) The petition must contain information that supports a
conclusion that use of the conditional exemption is unlikely to result
in the introduction or dissemination of a plant pest or noxious weed.
The information shall include the following:
(i) Description of the biology of the organism prior to genetic
engineering.
(ii) Detailed description of the genetic changes made to the
organism.
(iii) Detailed description of the phenotype of the GE organism,
including known and potential differences from the recipient organism
that could change the likelihood that the GE organism will pose a risk
as a plant pest or noxious weed. Examples of relevant information
include, but are not limited to:
(A) Growth habit and reproduction of the GE organism;
(B) Potential host range or geographic area of distribution;
(C) Potential for other organisms to pose risks as plant pests or
noxious weeds if they acquire the trait from the GE organism (e.g. via
sexual reproduction, horizontal gene transfer);
(D) Susceptibility of the GE organism to disease or damage by
pests;
(E) Pathogenicity of the GE organism and/or ability of the GE
organism to cause damage or injury to plants or plant parts;
(F) Toxicity, allergenicity, and/or ability of the GE organism to
damage or injure other organisms;
(iv) A detailed description of proposed condition(s) to be
associated with the exemption and how the conditions would make the
exemption unlikely to result in the introduction or dissemination of a
plant pest or noxious weed.
(v) Any relevant experimental information, published references, or
scientific information which support the conclusions of the petition;
(vi) All reports required under Sec. 340.3;
(vi) Any information known to the petitioner that the GE organism
may pose a risk as a plant pest or noxious weed;
(vii) Any other information that the Administrator believes to be
relevant to a determination that the proposed conditional exemption
from the requirement for a permit for the importation, interstate
movement, or release into the environment of the GE organism is
unlikely to result in the introduction or dissemination of a plant pest
or noxious weed.
(viii) A signed certification by the petitioner that, to the best
knowledge and belief of the petitioner, the petition includes all
information on which to base a determination, and that it includes all
information known to the petitioner which is unfavorable to the
petition.
(2) Insufficient information. If, upon initial review of the
petition, the Administrator concludes that there is insufficient
information upon which to make a determination on the petition, the
petitioner will be sent a written notice indicating what additional
information may be required.
(3) Public notice. The Administrator should generally complete the
review of the complete petition within 180 days, then publish a notice
in the Federal Register of the availability of documents related to
APHIS' assessment of the proposed conditional exemption. This notice
will specify that comments will be accepted from the public on the
proposal.
(4) Petition approval or denial standard. The Administrator will
assess the GE organism and the conditions of the requested exemption to
determine whether the requested exemption from a permit for
importation, interstate movement, or release into the environment would
be unlikely to result in the introduction or dissemination of a plant
pest or noxious weed. The Administrator will also consider whether any
conditions not contained in the petition would be needed to ensure that
the requested exemption would be unlikely to result in the introduction
or dissemination of a plant pest or noxious weed. After completing
review of the available information and any public comments received on
it, the Administrator will furnish to the petitioner and publish in the
Federal Register one of the following responses:
(i) Approve a conditional exemption from requirement for a permit.
The approval of a conditional exemption from the requirement for a
permit will state which GE organism(s) may be imported, moved
interstate, and/or environmentally released without a permit under this
part, as well as the conditions relevant to the exemption. The
Administrator may also add additional conditions not proposed in the
petition, if the Administrator concludes that additional conditions are
needed to ensure that the conditional exemption would be unlikely to
result in the introduction or dissemination of a plant pest or noxious
weed.
(ii) Deny a conditional exemption from requirement for a permit.
The Administrator will deny a petition if the Administrator cannot
conclude that the proposed exemption would be unlikely to result in the
introduction or dissemination of a plant pest or noxious weed. The
Administrator's written decision will set forth the reason for the
denial.
[[Page 60046]]
(c) Appeal of decision. Any person whose petition under Sec. 340.5
has been denied may appeal the decision in writing to the Administrator
within ten days after receiving the written notification of the
decision. The appeal shall state all of the facts and reasons upon
which the person relies to show that the decision should be changed.
The Administrator will grant or deny the appeal, in writing, stating
the reasons for the decision as promptly as circumstances allow. Upon
request of the applicant, a hearing may be held to resolve any conflict
as to any material fact. Rules of practice concerning such a hearing
will be adopted by the Administrator. This administrative remedy must
be exhausted before a person can file suit in court challenging the
decision.
(d) Amending an exemption after approval. The Administrator may
amend conditions to any conditional exemption approved under this
section. The Administrator may amend a conditional exemption if the
Administrator determines based on information received subsequent to
the approval of the exemption that the exemption needs to be amended to
ensure that the exemption would be unlikely to result in the
introduction or dissemination of a plant pest or noxious weed, and that
additional conditions can successfully mitigate that risk. The
Administrator may also amend a conditional exemption if needed to
ensure that the exemption is in compliance with all of the requirements
of this part. The amended conditional exemption and the reasons for it
will be published in the Federal Register. The addition of conditions
may not be appealed. However, any person may file a new petition in
accordance with paragraph (a) of this section regarding the same or
similar organisms covered by the amended exemption if new information
relevant to the amended exemption becomes available.
(e) Revocation of an exemption from requirement for permit. The
Administrator may revoke any conditional exemption under this section.
The Administrator may revoke a conditional exemption if the
Administrator receives information subsequent to approving the
exemption and makes a determination based upon this information that
the circumstances have changed such that the conditional exemption is
likely to result in the introduction or dissemination of a plant pest
or noxious weed. The revocation, its effective date, and the reasons
for it will be published in the Federal Register. A revocation may not
be appealed. However, any person may file a new petition in accordance
with this section regarding the same or similar organisms covered by
the revocation if new information relevant to the revocation becomes
available.
(f) Revocation of a person's use of a conditional exemption from
requirement for permit. The Administrator may revoke the right of any
person to use a conditional exemption from the requirement for a permit
under this part after determining that the person or any agent of the
person has failed to comply at any time with any provision of this
part. This would include failure to comply with the conditions of any
permit or exemption.
(1) Appeal of revocation of a person's use of a conditional
exemption. Any person who has had the right to use a conditional
exemption revoked may appeal the decision in writing to the
Administrator within ten days after receiving the written notification
of the revocation. The appeal shall state all of the facts and reasons
upon which the person relies to assert that the use of the exemption
was wrongfully revoked. The Administrator will grant or deny the
appeal, in writing, stating the reasons for the decision as promptly as
circumstances allow. Upon request of the applicant, a hearing may be
held to resolve any conflict as to any material fact. Rules of practice
concerning such a hearing will be adopted by the Administrator. This
administrative remedy must be exhausted before a person can file suit
in court challenging the revocation.
(2) [Reserved]
Sec. 340.6 Petition for nonregulated status.
(a) General. Any person may petition to initiate the procedure for
approving nonregulated status under this part for a GE organism. The
Administrator may initiate the procedure without filing a petition. All
petitions and all actions by the Administrator to initiate the
procedure for approving nonregulated status will be evaluated according
to the standards for petition approval or denial contained in paragraph
(b)(4) of this section.
(b) Petition submission and evaluation procedure. To petition for
approval of nonregulated status, a petitioner must submit a written
petition to the Administrator.
(1) The petition must contain information that supports a
conclusion that the GE organism is unlikely to be a plant pest or
noxious weed. The information shall include the following:
(i) Description of the biology of the organism prior to genetic
engineering.
(ii) Detailed description of the genetic changes made to the
organism.
(iii) Detailed description of the phenotype of the GE organism,
including known and potential differences from the recipient organism
that could change the likelihood that the GE organism is unlikely to be
a plant pest or noxious weed. Examples of relevant information include,
but are not limited to:
(A) Growth habit and reproduction of the GE organism;
(B) Potential host range or geographic area of distribution;
(C) Potential for other organisms to pose risks as plant pests or
noxious weeds if they acquire the trait from the GE organism (e.g. via
sexual reproduction, horizontal gene transfer);
(D) Susceptibility of the GE organism to disease or damage by
pests;
(E) Pathogenicity of the GE organism and/or ability of the GE
organism to cause damage or injury to plants or plant parts;
(F) Toxicity, allergenicity, and/or ability of the GE organism to
damage or injure other organisms;
(iv) Any relevant experimental information, published references,
or scientific information which support the conclusions of the
petition;
(v) All reports required under Sec. 340.3;
(vi) Any information known to the petitioner that the GE organism
may pose risk as a plant pest or noxious weed;
(vii) Any other information that the Administrator believes to be
relevant to a determination that the GE organism is unlikely to be a
plant pest or noxious weed.
(viii) A signed certification by the petitioner that, to the best
knowledge and belief of the petitioner, the petition includes all
information on which to base a determination, and that it includes all
information known to the petitioner which is unfavorable to the
petition.
(2) Insufficient information. If, upon initial review of the
petition, the Administrator concludes that there is insufficient
information upon which to make a determination on the petition, the
petitioner will be sent a written notice indicating what additional
information may be required.
(3) Public notice. The Administrator should generally complete the
review of the complete petition within 180 days, then publish a notice
in the Federal Register of the availability of documents related to
APHIS' assessment of the proposal for nonregulated status. This notice
will specify that comments will be accepted from the public on the
proposal.
[[Page 60047]]
(4) Petition approval or denial standard. The Administrator will
assess the GE organism to determine whether the GE organism is unlikely
to be a plant pest or noxious weed. After completing review of the
available information and any public comments received on it, the
Administrator will furnish to the petitioner and publish in the Federal
Register one of the following responses:
(i) Approve nonregulated status. The approval of nonregulated
status will state which GE organism(s) have been determined to have
nonregulated status.
(ii) Deny nonregulated status. The Administrator will deny a
petition if the Administrator cannot conclude that the GE organism is
unlikely to be a plant pest or noxious weed. The Administrator's
written decision will set forth the reason for the denial.
(c) Appeal of decision. Any person whose petition under Sec. 340.6
has been denied may appeal the decision in writing to the Administrator
within ten days after receiving the written notification of the
decision. The appeal shall state all of the facts and reasons upon
which the person relies to show that the decision should be changed.
The Administrator will grant or deny the appeal, in writing, stating
the reasons for the decision as promptly as circumstances allow. Upon
request of the applicant, a hearing may be held to resolve any conflict
as to any material fact. Rules of practice concerning such a hearing
will be adopted by the Administrator. This administrative remedy must
be exhausted before a person can file suit in court challenging the
decision.
(d) Revocation of nonregulated status. The Administrator may revoke
any approval of nonregulated status of a GE organism. The Administrator
may revoke an approval of nonregulated status if the Administrator
receives information subsequent to approving the nonregulated status
and makes a determination based upon this information that the
circumstances have changed such that the GE organism is likely to be a
plant pest or noxious weed. If the Administrator revokes an approval
for nonregulated status, the Administrator may approve for the same GE
organism an exemption from the requirement for permit in accordance
with Sec. 340.5. The revocation, its effective date, and the reasons
for it will be published in the Federal Register. A revocation may not
be appealed. However, any person may file a new petition in accordance
with this section regarding the same or similar organisms covered by
the revocation if new information relevant to the revocation becomes
available.
Sec. 340.7 Compliance, enforcement, and remedial action.
(a) Access for inspection. Inspectors shall have access to inspect
any relevant premises, facility, location, storage area, waypoint,
materials, equipment, means of conveyance, and other articles related
to importation, interstate movement, and environmental releases of GE
organisms regulated under this part.
(b) Access to audit and review records. Inspectors shall have
access to audit and review all records required to be maintained under
this part.
(c) Required records. Responsible persons and their agents engaged
in the importation, interstate movement, or release into the
environment of a GE organism subject to the regulations of this part
are required to establish and keep the following records.
(1) All records required as a condition of a permit or a
conditional exemption approved under the procedure described in Sec.
340.5.
(2) Address and any other information needed to identify all
contained facilities where the GE organism was stored or utilized, and
all locations where the GE organism was released into the environment;
(3) A record identifying which APHIS permit, if any, authorized the
importation, interstate movement, or release into the environment;
(4) A record identifying which exemption under this part, if any,
authorized the importation, interstate movement, or release into the
environment; and
(5) Copies of contracts between the responsible person and all
agents that conduct activities subject to this part for the responsible
person, and copies of other records (e.g., e-mails, telephone records)
for such agreements made without a written contract.
(d) Record retention. Records indicating that such a GE organism
that was imported or moved interstate reached its intended destination
must be retained for at least 2 years after completion of importation
or interstate movement, and all other records must be retained for at
least 5 years after completion of all obligations required under a
relevant permit or exemption.
(e) Enforcement. (1) Failure of any person to comply with any of
the requirements of this part may result in any or all of the
following:
(i) Denial of a permit request by that person;
(ii) After the issuance of a permit, revocation of a permit and
destruction, treatment, or removal of the GE organism, or other
measures as deemed appropriate or necessary by the Administrator;
(iii) Criminal and/or civil penalties, and
(iv) Remedial or other measures as determined appropriate and
necessary by the Administrator.
(2) The Administrator may seek a civil penalty as well as impose
and require corrective action plans, remedial measures or other
measures as determined appropriate and necessary by the Administrator.
(3) Prior to the issuance of a complaint seeking a civil penalty,
the Administrator may enter into a stipulation in which the responsible
person agrees to take certain remedial actions or other measures in
addition to or in lieu of a stipulated civil penalty, in accordance
with 7 CFR Sec. 380.10.
(f) Liability for acts of an agent. For purposes of enforcing this
part, the act, omission, or failure of any agent for a responsible
person as defined in Sec. 340.1 of this part may be deemed also to be
the act, omission, or failure of the responsible person.
(g) Remedial action. The Administrator may hold, seize, quarantine,
treat, apply other remedial measures to, destroy, or otherwise dispose
of any GE organisms subject to this part, in order to ensure the GE
organisms are unlikely to result in the dissemination of a plant pest
or noxious weed. Accordingly, the Administrator may order the
responsible person for an active or revoked permit or any other person,
through an Emergency Action Notification or other administrative order,
to apply remedial measures to a GE organism or means of conveyance
carrying a GE organism subject to regulation by this part. The
Administrator's determination of whether or not to require or order
corrective and/or remedial action in a given situation does not affect,
influence, restrict, or in any other way limit the Administrator's
determination on whether or not to seek criminal or civil penalties or
order other compliance or enforcement requirements as deemed necessary
or appropriate by the Administrator to the given situation.
(1) Failure of a person to comply with the Administrator's order
for corrective and/or remedial action authorizes the Administrator to
take corrective and/or remedial action and recover from the person the
costs of any care, handling, application of remedial measures,
devitalization, or disposal incurred by APHIS in connection with the
corrective and/or remedial actions taken.
(2) Low level presence (LLP) remedial action. The Administrator may
order remedial action for any unauthorized release into the environment
of GE
[[Page 60048]]
organisms, including situations involving a low-level mixing of GE
plants and materials subject to regulation \1\ under this part with
commercial seed and grain. In some LLP situations the Administrator may
determine not to order remedial action, if the Administrator determines
that the low-level mixing is unlikely to result in the introduction or
dissemination of a plant pest or noxious weed. These determinations
will be made in the same way, based on the same factors, regardless of
whether the LLP originates domestically or is found in import shipments
that may contain organisms subject to regulation. The factors the
Administrator will consider that would support a decision not to order
LLP remedial action include, but are not limited to, determinations
that:
---------------------------------------------------------------------------
\1\ ``Subject to regulation'' may include situations where a GE
organism granted nonregulated status subsequently had that status
revoked in accordance with Sec. 340.6(d).
---------------------------------------------------------------------------
(i) A GE plant of the same species expressing nearly identical
proteins or substances has already been approved for nonregulated
status under this part; or
(ii) All of the following statements are true with regard to the GE
plant or plants subject to the regulations under this part.
(A) The function of the introduced genetic sequences is known and
its expression in the GE plant is unlikely to pose plant pest or
noxious weed risk;
(B) Introduced genetic sequences do not cause the production of an
infectious entity;
(C) Any genetic sequences derived from plant viruses are non-coding
regulatory sequences of known function; or, if sense or antisense
genetic sequences, they are derived from viruses prevalent and endemic
in the United States that infect plants of the same host species and do
not encode a functional noncapsid gene product responsible for cell-to-
cell movement of the virus.
(D) The GE plant is not expected to establish outside of a managed
ecosystem, and has no sexually-compatible, wild relatives in the United
States;
(E) The GE plant does not produce new substances that are known or
likely to be toxic to non-target organisms, does not contain genetic
sequences from animal or human pathogens, and does not encode products
known or likely to be causal agents of disease in animals or humans.
(F) If the GE plant is a food or feed crop, then at least one of
the following must be true:
(1) The U.S. Environmental Protection Agency has established a
tolerance or an exemption from tolerance for any plant-incorporated
protectant expressed by the GE plant, or
(2) Key food safety issues of the new protein or other substance
have been addressed, or,
(3) No new protein or substance is produced.
Sec. 340.8 Confidential business information.
In accordance with the Freedom of Information Act (FOIA) and
exemptions from releasing information pursuant to FOIA, namely, 5
U.S.C. 552(b)(4), APHIS may exempt from disclosure to the public trade
secrets and commercial or financial information obtained from a person
that are privileged or confidential. Persons wishing to protect
confidential business information in permit applications, petitions, or
other submissions to APHIS under this part should do so in the
following manner. If there are portions of a document deemed to contain
trade secret or confidential business information, each page containing
such information must be marked ``CBI Copy.'' A second copy of each
such document must be submitted with all such CBI deleted and marked on
each page where the CBI was deleted: ``CBI Deleted.'' In addition,
those portions of the document which are deemed ``CBI'' must be
identified in an attachment to the document, which also must justify
how each piece of information requested to be treated as CBI is a trade
secret or is commercial or financial information and are privileged or
confidential.
Sec. 340.9 Costs and charges.
The services of the inspector related to carrying out this part and
provided during regularly assigned hours of duty and at the usual
places of duty will be furnished without cost.\2\ The U.S. Department
of Agriculture will not be responsible for any costs or charges
incident to inspections or compliance with the provisions of this part,
other than for the services of the inspector.
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\2\ The Department's provisions relating to overtime charges for
an inspector's services are set forth in 7 CFR part 354.0.
Done in Washington, DC, this 1st day of October 2008.
Charles D. Lambert,
Acting Under Secretary for Marketing and Regulatory Programs.
[FR Doc. E8-23584 Filed 10-6-08; 9:30 am]
BILLING CODE 3410-34-P
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/ October
/ Thursday, October 09, 2008
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