[Federal Register Volume 69, Number 15 (Friday, January 23, 2004)]
[Proposed Rules]
[Pages 3271-3272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-1411]

Proposed Rules
                                                Federal Register

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 / 
Proposed Rules

[[Page 3271]]


Animal and Plant Health Inspection Service

7 CFR Part 340

[Docket No. 03-031-2]

Environmental Impact Statement; Introduction of Genetically 
Engineered Organisms

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 
23, 2004.

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

[[Page 3272]]

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 
the EIS.
    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 
performance standards?
    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.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 04-1411 Filed 1-22-04; 8:45 am]