[Federal Register: January 7, 2008 (Volume 73, Number 4)]
[Notices]
[Page 1198-1200]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ja08-22]
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Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
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[[Page 1198]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2007-0044]
Environmental Impact Statement; Determination of Regulated Status
of Alfalfa Genetically Engineered for Tolerance to the Herbicide
Glyphosate
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice of intent to prepare an environmental impact statement
and proposed scope of study.
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SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service intends to prepare an environmental impact statement
in connection with making a determination on the status of the Monsanto
Company and Forage Genetics International alfalfa lines designated as
events J101 and J163 as regulated articles. 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 regulatory alternatives.
DATES: We will consider all comments that we receive on or before
February 6, 2008.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0044
to submit or view public
comments and to view supporting and related materials available
electronically.
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. APHIS-
2007-0044, 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-2007-0044.
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.
FOR FURTHER INFORMATION CONTACT: Dr. Andrea Huberty, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-0659.
SUPPLEMENTARY INFORMATION: The 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,'' regulate, among other things, the
introduction (importation, interstate movement, or release into the
environment) of organisms and products altered or produced through
genetic engineering that are plant pests or that there is reason to
believe are plant pests. Such genetically engineered organisms and
products are considered ``regulated articles.'' The regulations in
Sec. 340.6(a) provide that any person may submit a petition to the
Animal and Plant Health Inspection Service (APHIS) seeking a
determination that an article should not be regulated under 7 CFR part
340. Paragraphs (b) and (c) of Sec. 340.6 describe the form that a
petition for a determination of nonregulated status must take and the
information that must be included in the petition.
In a notice published in the Federal Register on June 27, 2005 (70
FR 36917-36919, Docket No. 04-085-3), APHIS advised the public of its
determination, effective June 14, 2005, that the Monsanto/Forage
Genetics International (FGI) alfalfa events J101 and J163 were no
longer considered regulated articles under the regulations governing
the introduction of certain genetically engineered organisms. That
determination was subsequently challenged in the United States District
Court for the Northern District of California by the Center for Food
Safety, other associations, and several organic alfalfa growers. The
lawsuit alleged that APHIS' decision to deregulate the genetically
engineered glyphosate-tolerant alfalfa events J101 and J163 violated
the National Environmental Policy Act (NEPA), the Endangered Species
Act, and the Plant Protection Act.
On February 13, 2007, the court in that case issued its memorandum
and order in which it determined that APHIS had violated NEPA by not
preparing an Environmental Impact Statement (EIS) in connection with
its deregulation determination. The court ruled that the environmental
assessment prepared by APHIS for its deregulation determination failed
to adequately consider certain environmental impacts in violation of
NEPA. The deregulation determination was vacated and APHIS was directed
by the court to prepare an EIS in connection with its new determination
on the regulated status of the events.
On March 23, 2007, APHIS published a notice in the Federal Register
(72 FR 13735-13736, Docket No. 04-085-4) announcing that the Monsanto/
FGI alfalfa events J101 and J163 were once again regulated articles
under 7 CFR part 340 and that the requirements pertaining to regulated
articles under those regulations would again apply as of March 30,
2007, for those alfalfa events.
Under the provisions of NEPA, agencies must examine the potential
environmental impacts of proposed Federal actions and regulatory
alternatives. We intend to prepare an EIS in connection with making a
new determination on the status of J101 and J163 alfalfa as regulated
articles. This notice identifies potential issues and regulatory
alternatives we will study in the EIS and requests public comment to
further delineate the issues and the scope of the different
alternatives.
We have identified three broad regulatory alternatives for study in
the EIS:
A. No Action: Continuation as a Regulated Article
Under the ``no action'' alternative, APHIS would not change the
regulated status of these regulated J101 and J163 alfalfa plants under
the regulations in 7 CFR part 340. Permits issued or notifications
acknowledged by APHIS
[[Page 1199]]
would be required for new introductions of J101 and J163 alfalfa
plants. APHIS might choose this alternative if there was insufficient
evidence to demonstrate that the regulated alfalfa events were not
plant pests or the lack of plant pest risk from the unconfined
cultivation of glyphosate-tolerant alfalfa.
B. Determination That J101 and J163 Alfalfa Plants Are No Longer
Regulated Articles, in Whole
Under this alternative, these glyphosate-tolerant alfalfa plants
would no longer be regulated articles under the regulations at 7 CFR
part 340. Permits issued or notifications acknowledged by APHIS would
no longer be required for introductions of glyphosate-tolerant alfalfa
derived from these events.
C. Determination That J101 and J163 Alfalfa Plants Are No Longer
Regulated Articles, in Part
The regulations at 7 CFR 340.6(d)(3)(i) state that APHIS may
``approve the petition in whole or in part.'' Approval in part can be
given in different ways. APHIS proposes three alternatives that employ
approval in part:
Under one type of approval in part, some but not all lines
requested in the petition may be approved. APHIS could approve only one
of the two glyphosate-tolerant lines (events J101 and J163) requested
in this petition.
Under a second type of approval in part, the petition may
be approved with geographic restrictions. APHIS could determine that
the two regulated alfalfa events pose no significant risk in certain
geographic areas, but may pose a significant risk in others. In such a
case, APHIS could choose to approve the petition with a geographic
limitation stipulating that the approved glyphosate-tolerant lines
could only be grown without APHIS authorization in certain geographic
areas.
Under a third type of approval in part, some but not all
lines requested in the petition may be approved with geographic
restrictions. APHIS could approve one of the two glyphosate-tolerant
alfalfa events with geographic limitations, stipulating that the
approved line could only be grown without APHIS authorization in
certain geographic areas.
Scope of the Issues To Be Addressed in the EIS
The review of the petition for deregulation of glyphosate-tolerant
alfalfa by APHIS raised the following potential issues that APHIS may
address in the EIS:
(1) What are the particular management practices for organic
alfalfa, conventional alfalfa, and glyphosate-tolerant alfalfa? What
are the procedures and associated costs of establishing, growing,
harvesting, and marketing (includes selling prices and premiums for
various quality standards) for each of the three types of alfalfa? What
crop rotation regimes are used with each type of alfalfa?
(2) What are the production levels of organic and conventional
alfalfa seed and hay by region, State, and county? Which regions of the
country areas may be affected more than others with the deregulation of
glyphosate-tolerant alfalfa? What is the acreage of cultivated,
volunteer, or feral alfalfa? What are the potential impacts on
adjacent, nonagricultural lands such as natural areas, forested lands,
or along transportation routes that may occur with the use of
glyphosate-tolerant alfalfa?
(3) What is the expected effect of glyphosate-tolerant alfalfa
release on animal production systems?
(4) What are the potential impacts of glyphosate-tolerant alfalfa
release on food and feed? How does glyphosate tolerance affect food or
feed value or nutritional quality? Should the low level presence of
glyphosate-tolerant alfalfa occur in situations where it is unwanted,
unintended, or unexpected, what impact would this have on the ability
of producers to market affected organic or conventional alfalfa or
livestock fed this material? What are the negative impacts, if any, on
food or feed value or quality from the use of glyphosate?
(5) What differences are there in weediness traits of conventional
alfalfa versus glyphosate-tolerant alfalfa under managed crop
production systems as well as in unmanaged ecosystems?
(6) What is the occurrence of common and serious weeds found in
organic alfalfa systems, in conventional alfalfa systems, and in
glyphosate-tolerant alfalfa systems? What are the current impacts of
weeds, herbicide-tolerant weeds, weed management practices, and unmet
weed management needs for organic and conventional alfalfa cultivation?
How may the weed impacts change with the use of glyphosate-tolerant
alfalfa?
(7) What are the particular management practices for controlling
weeds in organic alfalfa systems, in conventional alfalfa systems, and
in glyphosate-tolerant alfalfa systems? What are the potential changes
in crop rotation practices and weed management practices for control of
volunteer alfalfa or herbicide-tolerant weeds in rotational crops that
may occur with the use of glyphosate-tolerant alfalfa? What are the
potential effects on alfalfa stand termination and renovation practices
that may occur with the use of glyphosate-tolerant alfalfa? What is the
potential weediness of glyphosate-tolerant alfalfa?
(8) What is the potential cumulative impact of glyphosate resistant
weeds, especially with the increase in acreage of glyphosate-tolerant
crops? Are there glyphosate resistant weeds and what is their
prevalence in crops and in non-crop ecosystems? Will the release of
glyphosate-tolerant alfalfa cause an increase in glyphosate resistant
weeds in alfalfa and in other crops? Which weeds are the most likely to
gain glyphosate resistance with the use of glyphosate-tolerant alfalfa?
What are the alternatives for management of glyphosate-tolerant or
other herbicide-tolerant weeds in glyphosate-tolerant alfalfa stands or
in subsequent crops? What are the potential changes that may occur in
glyphosate-tolerant alfalfa as to susceptibility or tolerance to other
herbicides?
(9) What are current or prospective herbicide-tolerant weed
mitigation options, including those addressed by the Environmental
Protection Agency-approved label for glyphosate herbicides?
(10) What is the potential for gene flow in all combinations
between seed fields, hay fields, and feral plants? To what extent will
deregulation of glyphosate-tolerant alfalfa impact hybridization
between cultivated and feral alfalfa, alfalfa's introgression or
establishment outside of cultivated lands, and alfalfa's persistence in
situations where it is unwanted, unintended, or unexpected? What are
the risks associated with feral glyphosate-tolerant alfalfa plants? How
will the removal of glyphosate-tolerant alfalfa in situations where it
is unwanted, unintended, or unexpected result in adverse impacts? In
such situations, how will glyphosate-tolerant alfalfa be controlled or
managed differently from other unwanted, unintended, or unexpected
alfalfa? To what extent can organic or conventional alfalfa farmers
prevent their crops from being commingled with unwanted, unintended, or
unexpected glyphosate-tolerant alfalfa?
(11) What are the potential economic and social impacts of
glyphosate-tolerant alfalfa release on organic and conventional alfalfa
farmers? What are the potential impacts of the presence of glyphosate-
tolerant alfalfa caused by pollen movement or seed admixtures? What are
the economic issues associated
[[Page 1200]]
with using alfalfa seed or hay commingled with glyphosate-tolerant
alfalfa? What are the particular economics of growing seed or hay of
organic alfalfa, conventional alfalfa, or glyphosate-tolerant alfalfa?
What are the potential changes in the economics of growing and
marketing organic and conventional alfalfa that may occur with the use
of glyphosate-tolerant alfalfa? What are the potential changes in
production levels of other crops that may occur with the use of
glyphosate-tolerant alfalfa (i.e., will the release of glyphosate-
tolerant alfalfa result in more or fewer acres of corn, wheat, other
forage crops, etc.)? What are the potential changes in growing
practices, management practices, and crop rotational practices in the
production of alfalfa hay or seed for planting or sprouting purposes
that may occur with the use of glyphosate-tolerant alfalfa? What are
the potential changes in the choice of seeds available for organic and
conventional alfalfa farmers that may occur with the use of glyphosate-
tolerant alfalfa?
(12) What are the potential impacts of the deregulation of
glyphosate-tolerant alfalfa on U.S. trade? If the presence of
glyphosate-tolerant alfalfa should occur in organic or conventional
alfalfa where it is unwanted, unintended, or unexpected, what are the
expected impacts on trade with countries that normally import alfalfa
seed or hay? What are the expected impacts on trade with countries that
do not normally import alfalfa? Is there an expected impact on trade in
other commodities?
(13) What is the potential cumulative impact of increased
glyphosate usage with the release of glyphosate-tolerant crops? Have
changes in glyphosate usage impacted soil quality, water quality, air
quality, weed populations, crop rotations, soil microorganisms,
diseases, insects, soil fertility, food or feed quality, crop acreages,
and crop yields? Does the level of glyphosate tolerance within
glyphosate-tolerant alfalfa plants have a major impact on the amount of
glyphosate applied on the glyphosate-tolerant alfalfa crop on a routine
basis?
(14) What are the potential impacts of the release of glyphosate-
tolerant alfalfa on threatened or endangered species and designated
critical habitat? What are the potential effects of glyphosate-tolerant
alfalfa use on listed threatened or endangered species, species
proposed for listing, designated critical habitat, or habitat proposed
for designation? What are the potential effects of glyphosate use on
listed threatened or endangered species, species proposed for listing,
designated critical habitat, or habitat proposed for designation;
including glyphosate used on glyphosate-tolerant alfalfa?
(15) What are the potential health and safety risks to field
workers or other workers that would come into contact with glyphosate-
tolerant alfalfa?
(16) Can any of the potential negative environmental impacts
resulting from the deregulation of glyphosate-tolerant alfalfa be
reasonably mitigated and what is the likelihood that mitigation
measures will be successfully implemented? The EIS will consider the
stewardship measures outlined in the Addendum to section VIII of the
petition, as well as any other mitigation measures APHIS considers
applicable and viable. Such measures, some of which may be outside the
jurisdiction of APHIS, are designed to reduce inadvertent gene flow of
glyphosate-tolerant alfalfa to negligible levels as well as to monitor
and minimize the potential development of glyphosate-tolerant weeds.
(17) What are the impacts of the mitigation measures on coexistence
with organic and conventional alfalfa production and export markets?
(18) Are there any other potential direct, indirect or cumulative
impacts from the release of glyphosate-tolerant alfalfa other than
those mentioned above?
Comments that identify other issues or alternatives that should be
examined in the EIS would be especially helpful. APHIS realizes that
alfalfa growth, crop management, and crop utilization (seed versus hay
or forage) may vary considerably by geographic region, and therefore,
when providing comments on a topic or issue, please provide relevant
information on the specific locality or region in question.
We will fully consider all comments we receive in developing a
final scope of analysis for the draft EIS. When the draft EIS is
completed, we will publish a notice in the Federal Register announcing
its availability and inviting public comment.
Done in Washington, DC, this 28th day of December 2007.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E7-25662 Filed 1-4-08; 8:45 am]
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