[Federal Register Volume 72, Number 60 (Thursday, March 29, 2007)]
[Rules and Regulations]
[Pages 14649-14651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-1536]
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Rules and Regulations
Federal Register
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This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
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The Code of Federal Regulations is sold by the Superintendent of Documents.
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Federal Register / Vol. 72, No. 60 / Thursday, March 29, 2007 / Rules
and Regulations
[[Page 14649]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 340
[Docket No. APHIS-2006-0167]
APHIS Policy on Responding to the Low-Level Presence of Regulated
Genetically Engineered Plant Materials
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice of availability of policy statement.
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SUMMARY: This notice describes the Animal and Plant Health Inspection
Service's (APHIS) policy for responding to low-levels of regulated
genetically engineered plant materials which may occur in commercial
seeds or grain. This notice is intended to provide clarification for
the public and developers of genetically engineered plants on APHIS'
response to such situations. The policy statement does not confer any
rights upon or create any rights for any person and does not operate to
bind APHIS or the public, nor does it address how other Federal
agencies might respond to such situations.
ADDRESSES: Copies of the policy statement are available on the Internet
at http://www.aphis.usda.gov/biotechnology/current_initiatives.shtml.
Copies may also be obtained by contacting Dr. John Turner, Director,
Policy Division, BRS, APHIS, 4700 River Road Unit 146, Riverdale, MD
20737-1238; (301) 734-8365.
FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director, Policy
Division, BRS, APHIS, 4700 River Road Unit 146, Riverdale, MD 20737-
1238; (301) 734-8365.
SUPPLEMENTARY INFORMATION:
Background
APHIS works to protect America's agriculture and environment using
a science-based regulatory framework that allows for the safe
development and use of genetically engineered (GE) plants. Under the
authority of the Plant Protection Act \1\ (PPA), APHIS regulates the
introduction (importation, interstate movement, and field release) of
GE organisms in order to prevent direct or indirect risks to plant
health and the environment.
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\1\ The Plant Protection Act is found at 7 U.S.C. 7701 et seq.
APHIS' biotechnology regulations are found at 7 CFR part 340.
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Genetic engineering is a method used to introduce new traits into
plants by moving genes from one or more organism(s) into a second
organism. GE plants that can tolerate herbicides, resist insects or
viruses, or enhance nutrition and provide other health or environmental
benefits are examples of crops currently being grown and tested.
Plant breeding may occasionally result in low-level mixing of genes
and gene products from unintended plant sources. This is true for both
conventionally bred plants as well as biotechnology-derived plants.
These occurrences can result from natural processes such as the
movement of seeds or pollen, or human-mediated processes associated
with field testing, plant breeding, or seed production. The mixing of
low levels of GE plant materials may result in unauthorized
introductions of regulated materials in, for example, commercial seeds
and grain. The potential for these occurrences may increase with the
expansion of GE crop research, development, and use. This document is
intended to describe how APHIS protects agriculture and the environment
by responding to situations involving a low-level mixing with
commercial seeds and grains of genes and gene products from GE plants
subject to regulation by APHIS under 7 CFR part 340.
Overview of the APHIS Regulatory System for GE Plants
A developer wishing to introduce a new GE plant must obtain APHIS'
authorization before proceeding. Depending on the nature of the GE
plant, the developer files either a notification or a permit
application with APHIS. With either process, the developer must adhere
to APHIS regulations and requirements to ensure, through appropriate
measures, confinement of the regulated material. An applicant must
submit required information on the movement, importation, or field
release, which APHIS scientists review to determine whether to
authorize the applicant's request. To ensure compliance with the permit
or notification conditions, APHIS performs targeted inspections and
audits of field tests using the relative risk of each type of trial to
determine the frequency and number of inspections performed. For
example, for sites where developers are cultivating GE plants
engineered to produce pharmaceutical and industrial proteins, APHIS
generally inspects seven times throughout field testing, including
before, during, and after the field trial. APHIS also maintains
oversight of the movement of regulated plants to and from field trial
locations. Regulated plants must be transported according to the
regulations and as described in the permit. The methods of transport
are subject to verification by inspectors at the receiving facility.
This permitting and notification system is designed to restrict
introductions of GE plants and plant materials as long as they are
regulated by the Agency.
Permits are generally more restrictive than notifications and are
used for any type of GE plant that may pose an elevated risk to plant
health or the environment or for which APHIS has less regulatory
experience and familiarity, such as plants engineered to produce
pharmaceutical or industrial compounds. In addition to detailed
information on the biological properties of the GE plant, the permit
applicant also must provide detailed descriptions of how field tests
will be performed, including specific measures for ensuring confinement
and reducing any potential risk that may be associated with the GE
plant. Using this information, APHIS scientists create a set of permit
conditions that applicants must meet when conducting approved field
trials or transporting the GE plants.
Most GE plants qualify for, and are field tested under, the
notification process. The notification process is used only for plants
and traits with which APHIS has a great deal of regulatory experience
and familiarity and that do not pose an elevated risk for plant
[[Page 14650]]
health or the environment. To qualify for the notification process, a
plant or trait must meet six safety-related eligibility criteria that
center on the plant's potential to pose a risk to plant health or the
environment. To ensure confinement, the developer must perform the
field test in a way that meets performance standards that are specified
in APHIS' regulations.\2\ If a GE plant does not meet the criteria for
notification, the applicant must follow the permitting process.
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\2\ Performance standards are found at 7 CFR 340.3(c).
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After a GE plant has been field-tested extensively and the
developer can show that the GE plant does not pose a plant pest risk,
the developer may file a petition for deregulation. The developer must
submit extensive information about the plant's biology and field test
results. After conducting an environmental assessment (EA) or an
environmental impact statement (EIS) and seeking public comment, APHIS
may approve a petition for deregulation if it reaches the conclusion
that the GE plant does not pose a plant pest risk.\3\ Alternatively, an
extension process can be used in cases where the GE plant is similar to
a previously deregulated plant. The extension process, which was
established in 1997 and has been used numerous times since, is based on
the premise that a GE plant that is similar to a previously deregulated
plant with respect to plant genotype and the expressed protein(s) is
also similar in terms of any potential risk. Based on a thorough review
of information in the extension request, which includes data showing
similarity, APHIS may conclude that the new GE plant, like the
previously deregulated GE plant, does not pose a plant pest risk and
therefore will no longer be regulated.\4\
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\3\ Deregulation requirements are found at 7 CFR 340.6.
\4\ Regulatory authority to conduct extension requests is found
at 7 CFR 340.6(e).
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APHIS' Future Biotechnology Regulations
APHIS continually evaluates its policies and regulations and makes
changes as necessary as the complexity and scope of biotechnology
continue to grow. One of the key changes has been the strengthening of
the requirements for the field testing of certain GE plants. As
announced in a notice in the Federal Register on January 23, 2004
(Docket No. 03-031-2; 69 FR 3271-3272) and in a January 2004 USDA press
release,\5\ APHIS is preparing a draft EIS to evaluate the current
regulatory system and analyze several possible changes in order to keep
pace with science and to more fully utilize the authority provided by
the PPA. APHIS will solicit public comments on the possible changes
analyzed in the draft EIS. In any event, APHIS will continue to
regulate each GE plant in a manner that is proportionate to the risks
associated with that GE plant.
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\5\ USDA Press Release, ``USDA Announces First Steps to Update
Biotechnology Regulations,'' January 22, 2004.
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Interagency Coordination on Low Level Presence
APHIS works in concert with the U.S. Department of Health and Human
Services' Food and Drug Administration (FDA) and the U.S. Environmental
Protection Agency (EPA) to provide regulatory oversight of the
development of GE organisms, consistent with the Coordinated Framework
for Regulation of Biotechnology \6\, adopted in 1986. The Coordinated
Framework is a comprehensive Federal regulatory policy for ensuring the
safety of biotechnology research and products. APHIS is responsible for
protecting agriculture and the environment. FDA has primary
responsibility for ensuring the safety of food (including food for
animals). EPA regulates pesticides to ensure they can be used without
unreasonable adverse effects on the environment, and to ensure public
safety from the use of pesticides, including the residue of pesticides
on food and animal feed.
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\6\ Coordinated Framework for Regulation of Biotechnology, 51 FR
23302, June 26, 1986.
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The biological conditions of plant breeding, whether with
conventional or GE plants, are such that there is a potential for low
levels of genes and gene products to occasionally move beyond confined
research sites into commercial seeds and grain that enter commerce.
Recognizing this fact, the Federal Government, in an August 2002 notice
in the Federal Register,\7\ proposed measures aimed at strengthening
the controls for preventing low levels of regulated materials from GE
plants from entering commerce until appropriate safety standards have
been met. The proposed actions to be taken by the three agencies were
based on three fundamental principles:
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\7\ Proposed Federal Actions To Update Field Test Requirements
for Biotechnology Derived Plants and To Establish Early Food Safety
Assessments for New Proteins Produced by Such Plants, 67 FR 50578,
August 2, 2002.
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The level of confinement for a field test must be
consistent with the level of risk associated with the introduced
protein or trait;
Field test confinement measures must be rigorous to
restrict the low-level occurrence in commerce for those traits or
proteins that present an unacceptable or unknown risk; and
Regardless of risk, field test requirements should
minimize out-crossing and commingling of seed.
Since the 2002 notice, FDA issued guidance for industry on early
food safety assessments of new nonpesticidal proteins produced by new
plant varieties intended for food use,\8\ and EPA clarified its
guidance for field testing of plant-incorporated protectants
(pesticides intended to be produced and used in a living plant).\9\
APHIS strengthened its field testing requirements for plants producing
pharmaceutical or industrial compounds to ensure that regulated
material from these plants is not found, even at low levels, in
commerce. In addition, as discussed above, APHIS has initiated a
process to amend its biotechnology regulations under 7 CFR part 340. As
part of that process, the Agency will consider establishing new
criteria to determine whether low levels of regulated materials would
be acceptable in commercial seeds and grain based on risks to plant
health, public health and the environment.
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\8\ FDA issued its guidance in June 2006, which can be found at
http://www.cfsan.fda.gov/~dms/bioprgu2.html#ftn7.
\9\ EPA released its draft guidance on September 29, 2006, which
can be found at http://www.epa.gov/fedrgstr/EPA-PEST/2006/September/Day-29/p16072.htm.
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Through practical experience, APHIS has developed a policy based on
current regulations for responding to the low-level presence of
regulated materials in commercial seeds and grain. This policy provides
the foundation for Agency actions in these cases. For purposes of
transparency, this policy is set forth below for the public.
APHIS Policy on Responding to the Low-Level Presence of Regulated GE
Plant Materials
APHIS requirements for both permits and notifications minimize the
likelihood that regulated GE plant materials will occur in commercial
seeds and grain. APHIS' policy is to respond to occurrences of
regulated materials in commercial seeds and grain with remedial action
that is appropriate to the level of risk and warranted by the facts in
each case. In every such case, APHIS will initiate an inquiry to
determine the circumstances surrounding the release, evaluate the risk
attendant to the release, and determine what regulatory actions,
[[Page 14651]]
including remedial and enforcement actions, are required.
If APHIS determines that action is not necessary to mitigate low-
level presence of a regulated material in commerce to protect plant
health or the environment, this determination does not preclude
enforcement action against a company or individual for violation of
APHIS regulations. APHIS will investigate and take appropriate
enforcement action whenever regulated materials are detected in
commerce.
APHIS coordinates closely with EPA and FDA on investigations, risk
evaluations, and the determination of what remediation measures, if
any, will be necessary. This cooperation is crucial and helps to ensure
that there are no unresolved safety issues. Any regulatory action taken
by APHIS will not preclude FDA or EPA from pursuing action under their
own authorities, as necessary, to ensure the safety of food as well as
to protect human health and the environment from the sale,
distribution, or use of any pesticide.
APHIS has authority under the PPA to take or order remedial
measures which include the authority to hold, seize, quarantine, treat,
apply other remedial measures to, destroy, or otherwise dispose of
regulated materials if it is determined that such measures are
necessary to prevent the dissemination of a plant pest within or
throughout the United States.\10\ Any remedial action taken would be
determined on a case-by-case basis. Key considerations include the
extent of the occurrence, the nature of the regulated material, as well
as any potential risks to plant health or the environment. In any case
where APHIS determines that an incident involving a GE plant would
result in the introduction or dissemination of material that could pose
a threat to plant health or the environment, remediation measures will
be required. It is important to note that, due to the strict
requirements that APHIS has developed in recent years for GE plants
that pose elevated risks, such occurrences would be unlikely.
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\10\ See 7 U.S.C. 7714; 7 CFR 340.0(b).
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There are two principal situations in which APHIS may determine
that action under the PPA was not necessary. Even though remedial
measures would not generally be applied in these two situations,
applicants field testing these types of plants must be authorized
through either notifications or permits and must follow all APHIS
requirements.
The first situation would be when the regulated material is derived
from plants that meet all of the criteria to qualify for APHIS'
notification process. The six eligibility requirements are: \11\
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\11\ The specific criteria for GE crops planted under
notification are found at 7 CFR 340.3.
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The plant must not be listed on the Federal Noxious Weed
list or be considered a weed in the area of proposed release.
The introduced genetic material must be stably integrated,
which means the introduced DNA must remain inside the living cell and
replicate only with the plant DNA.
The function of the introduced genetic material is known,
and its presence in the regulated article does not result in a plant
disease.
The introduced genetic material does not cause the
production of an infectious entity, produce substances that are known
to be, or are likely to be, toxic to nontarget organisms, or produce
products intended for pharmaceutical or industrial use.
The introduced genetic sequences derived from plant
viruses do not pose a significant risk of creating a new plant virus.
The plant has not been modified to contain certain genetic
material derived from animal or human pathogens. In addition, plants
containing coding sequences whose products are known agents of diseases
in humans or nontarget animals are not eligible.
The majority of GE plants field tested under APHIS regulations
qualify for the notification process because they present minimal risk
to plant health and the environment. Many of the plants that have been
engineered for common traits such as pest resistance, herbicide
tolerance, male sterility, and improved product quality such as delayed
fruit ripening meet the criteria for notification. APHIS has extensive
experience with these types of plants and has overseen thousands of
field tests involving them.
The second situation in which APHIS may not take remedial action is
if the GE plant is similar to another GE plant that has already been
deregulated by APHIS with respect to both plant genotype and any novel
protein(s) expressed. APHIS will carefully assess the GE plant
material, including the plant genotype, the introduced genes, and any
proteins produced. When these are sufficiently similar to those of a
previously deregulated plant, APHIS is able to conclude confidently
that, like the previously deregulated plant, the new GE plant poses no
significant safety risk to plant health or the environment, and thus,
remedial action may not be necessary.
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 26th day of March 2007.
Bruce Knight,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 07-1536 Filed 3-27-07; 2:00 pm]
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