[Federal Register Volume 69, Number 15 (Friday, January 23, 2004)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-1411]
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
Federal Register / Vol. 69, No. 15 / Friday, January 23, 2004 /
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 340
[Docket No. 03-031-2]
Environmental Impact Statement; Introduction of Genetically
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice of intent to prepare an environmental impact statement
and proposed scope of study.
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service intends to prepare an environmental impact statement
in connection with potential changes to the regulations regarding the
importation, interstate movement, and environmental release of certain
genetically engineered organisms. This notice identifies potential
issues and alternatives that will be studied in the environmental
impact statement and requests public comment to further delineate the
scope of the issues and alternatives.
DATES: We will consider all comments that we receive on or before March
ADDRESSES: You may submit comments by postal mail/commercial delivery
or by e-mail. If you use postal mail/commercial delivery, please send
four copies of your comment (an original and three copies) to: Docket
No. 03-031-2, Regulatory Analysis and Development, PPD, APHIS, Station
3C71, 4700 River Road, Unit 118, Riverdale, MD 20737-1238. Please state
that your comment refers to Docket No. 03-031-2. If you use e-mail,
address your comment to [email protected]. Your comment must
be contained in the body of your message; do not send attached files.
Please include your name and address in your message and ``Docket No.
03-031-2'' on the subject line.
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.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
FOR FURTHER INFORMATION CONTACT: Ms. Stephanie Stephens, Environmental
Services, PPD, APHIS, 4700 River Road Unit 149, Riverdale, MD 20737-
1238; (301) 734-4836.
SUPPLEMENTARY INFORMATION: The Animal and Plant Health Inspection
Service (APHIS) currently regulates the introduction (movement into the
United States or interstate, or release into the environment) of
genetically engineered organisms that may present a plant pest risk
under 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.'' The Agency is considering
amending the regulations pertaining to introductions of genetically
engineered plants and other genetically engineered organisms to, among
other things, include genetically engineered organisms that may pose a
noxious weed risk and genetically engineered biological control agents.
As used in this document, the term genetically engineered organisms
means organisms that have been ``genetically engineered'' as defined in
7 CFR part 340 (i.e., modified by recombinant DNA techniques).
Also, as used in this document, the following terms have the
definitions given to them by the Plant Protection Act (7 U.S.C. 7701-
Biological control organism: Any enemy, antagonist, or competitor
used to control a plant pest or noxious weed.
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.
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) A protozoan.
(B) A nonhuman animal.
(C) A parasitic plant.
(D) A bacterium.
(E) A fungus.
(F) A virus or viroid.
(G) An infectious agent or other pathogen.
(H) Any article similar to or allied with any of the articles
specified in the preceding subparagraphs.
APHIS recognizes that other Federal agencies also have authority to
regulate genetically engineered organisms. For example, the
Environmental Protection Agency (EPA) has authority over certain
biological control agents. This notice only addresses changes to APHIS
regulations. It is not intended to circumscribe, restrict, or otherwise
preclude future actions taken under other Federal authorities.
Under the provisions of the National Environmental Policy Act of
1969, as amended (42 U.S.C. 4321 et seq.), agencies must examine the
potential environmental effects of proposed Federal actions and
alternatives. We intend to prepare an environmental impact statement
(EIS) in connection with the amendments being considered. This notice
identifies potential issues and alternatives that we will study in the
environmental impact statement and requests public comment to further
delineate the issues and the scope of the alternatives.
We have identified two broad alternatives for study in the EIS.
[sbull] Take no action. This alternative contemplates no change in
the existing regulations for genetically engineered organisms that pose
a potential plant pest risk. It represents a baseline against which
proposed revisions may be compared.
[sbull] Revise the regulations for introduction of genetically
engineered organisms. This alternative contemplates revision of the
current regulations to address issues related to scientific advances
and new trends in
biotechnology (e.g., increasing use of genetically engineered plants to
produce pharmaceutical and industrial compounds) and changes in the
scope of the Agency's authority under the Plant Protection Act (7
U.S.C. 7701 et seq.). The proposed revisions would be based in part
upon environmental and pest risk criteria identified and analyzed in
APHIS will reexamine the current regulations for the purpose of
updating those regulations with due regard for the types of products
being tested, and that may be tested in the future; the potential risks
involved; and the quality of the human environment. Issues regarding
possible regulatory changes with the potential to affect the quality of
the human environment include the following:
1. APHIS is considering broadening its regulatory scope beyond
genetically engineered organisms that may pose a plant pest risk to
include genetically engineered plants that may pose a noxious weed risk
and genetically engineered organisms that may be used as biological
control agents. Do regulatory requirements for these organisms need to
be established? What environmental considerations should influence this
change in regulatory scope?
2. APHIS is considering revisions to the regulations that would
define specific risk-based categories for field testing, including (a)
product types shown to pose low pest and environmental risks; (b)
product types considered to pose a noxious weed risk, of unknown plant
pest or noxious weed risk, containing sequences of unknown phenotypic
function, and involving new plant-incorporated protectants that have
not completed applicable review at EPA; and (c) pharmaceutical or
industrial crops not intended for food or feed. What environmental
factors should be considered in further delineating such requirements?
What criteria should be used to establish the risk-based categories?
Should certain low-risk categories be considered for exemption from
permitting requirements? If so, what criteria should apply?
3. APHIS is considering ways to provide regulatory flexibility for
future decisions by allowing for commercialization of certain
genetically engineered organisms while continuing, in some cases, to
regulate the organisms based on minor unresolved risks. Other regulated
articles could be treated as they have been under the current system,
in which all regulatory restrictions are removed. What environmental
factors should be considered in distinguishing between these kinds of
4. Are there changes that should be considered relative to
environmental review of, and permit conditions for, genetically
engineered plants that produce pharmaceutical and industrial compounds?
Should the review process, permit conditions, and other requirements
for non-food crops used for production of pharmaceutical and industrial
compounds differ from those for food crops? How should results of a
food safety evaluation affect the review, permit conditions, and other
requirements for these types of plants? How should the lack of a
completed food safety review affect the requirements for these types of
5. Noxious weed, as defined in the Plant Protection Act, includes
not only plants, but also plant products. Based on that authority,
APHIS is considering the regulation of nonviable plant material. Is the
regulation of nonviable material appropriate and, if so, in what cases
should we regulate?
6. APHIS is considering establishing a new mechanism involving
APHIS, the States, and the producer for commercial production of plants
not intended for food or feed in cases where the producer would prefer
to develop and extract pharmaceutical and industrial compounds under
confinement conditions with governmental oversight, rather than use the
approval process for unconfined releases. What should be the
characteristics of this mechanism? To what extent should this mechanism
be employed for commercial production of plants not intended for food
or feed? What environmental considerations should influence the
development of this mechanism?
7. The current regulations have no provision for adventitious
presence--intermittent and low-level presence in commercial crops,
food, feed, or seed of genetically engineered plant material that has
not completed the required regulatory processes. Should APHIS establish
a separate component within a revised regulatory system to address
adventitious presence? Should the low-level occurrence be exempt from
APHIS regulation? If so, what are the conditions under which the low
level occurrence should be allowed? What environmental considerations
would apply to establishment of such allowances?
8. Should APHIS provide for expedited review or exemption from
review of certain low-risk genetically engineered commodities intended
for importation that have received all necessary regulatory approvals
in their country of origin and are not intended for propagation in the
United States? What environmental considerations should be applied to
determination of any such allowances?
9. Currently, genetically engineered Arabidopsis spp. are exempt
from interstate movement restrictions under part 340 because they are
well understood and extensively used in research. Should the regulation
of other similar genetically engineered plants be consistent with the
regulation of genetically engineered Arabidopsis spp.? Should the
exemption from interstate movement restrictions apply only to those
products that meet specific risk-based criteria? What should these
criteria be? What species and/or traits should be considered for this
exemption? What environmental factors should be considered?
10. What are other areas where APHIS might consider relieving
regulatory requirements based on the low level of risk?
11. What environmental considerations should be evaluated if APHIS
were to move from prescriptive container requirements for shipment of
genetically engineered organisms to performance-based container
requirements, supplemented with guidance on ways to meet the
Comments that identify other issues or alternatives that should be
examined in the EIS would be especially helpful. All comments will be
considered fully in developing a final scope of study. When the draft
EIS is completed, a notice announcing its availability and an
invitation to comment on it will be published in the Federal Register.
Done in Washington, DC, this 16th day of January, 2004.
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 04-1411 Filed 1-22-04; 8:45 am]
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