E7-25662. 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.

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 [phone] before coming.

FOR FURTHER INFORMATION CONTACT:

Dr. Andrea Huberty, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone].

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 § 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 § 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 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 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.