[Federal Register Volume 73, Number 4 (Monday, January 7, 2008)]
[Notices]
[Pages 1198-1200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-25662]


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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
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  Federal Register / Vol. 73, No. 4 / Monday, January 7, 2008 / 
Notices  

[[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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