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<div class="ocr">Record of Decision

Glyphosate —Tolerant Alfalfa Events J101 and J163: Request for Nonregulated
Status

Overview

The United States Department of Agriculture (USDA), Animal and Plant Health Inspection
Service (APHIS) has completed and published a Final Environmental Impact Statement FEIS) in
response to a petition for nonregulated status of glyphosate tolerant alfalfa events J101 and J163
(GT alfalfa) and is announcing the agency’s decision for this request in this record of decision
(ROD). APHIS is announcing its decision to grant nonregulated status to alfalfa events J101 and
J163 and progeny derived from these events. APHIS is choosing Alternative 2 as described in
the FEIS. Nonregulated status will be granted to GT alfalfa upon publication in the Federal
Register a document entitled “Determination of Nonregulated Status for Monsanto and Forage
Genetics International RoundupReady” Alfalfa Events J101 and J163.”

APHIS prepared an FEIS to examine the potential environmental impacts of GT alfalfa and
interrelated socioeconomic impacts associated with granting the petition for nonregulated status.
In the FEIS, APHIS examined three alternatives: deny the petition (No Action Alternative),
grant the petition in full (Deregulation Alternative), and grant the petition in part
(Isolation/Geographic Restrictions Alternative). The two action alternatives were identified as
co-preferred alternatives.

Background

Coordinated framework

APHIS is one of the Federal agencies with regulatory responsibilities under the 1986 Federal
Coordinated Framework for the Regulation of Biotechnology (hereafter Coordinated
Framework) published by the Office of Science and Technology Policy (OSTP), Executive
Office of the President. The Coordinated Framework is a policy statement which "describes the
comprehensive federal regulatory policy for ensuring the safety of biotechnology research and
products.” The Coordinated Framework explains the proper allocation and coordination of
oversight responsibilities under the several relevant statutes and among the several relevant
federal agencies.

The Coordinated Framework thus addressed who shall have oversight authority in each instance,
but did not address how that authority should be exercised in the frequent situations in which a
statute leaves the implementing agency latitude for discretion. To that end, OSTP published a
notice of Federal policy in the Federal Register in 1992 in which it set forth “the proper basis for
agencies’ exercise of oversight authority within the scope of discretion afforded by statute.”

The notice describes “a risk-based, scientifically sound approach to the oversight of planned
introductions of biotechnology products into the environment that focuses on the characteristics
of the biotechnology product and the environment into which it is being introduced, not the
process by which the product is created. Exercise of oversight in the scope of discretion afforded

1
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<div class="page"><p></p>
<div class="ocr">by statute should be based on the risk posed by the introduction and should not turn on the fact

that-an-organism-has_been.modified_by_a_particular_process_or_technique.”” _ oe .

The policy statement of 1992 states further: “In order to ensure that limited federal oversight
resources are applied where they will accomplish the greatest net beneficial protection of public
health and the environment, oversight will be exercised only where the risk posed by the
introduction is unreasonable, that is, when the value of the reduction in risk obtained by
additional oversight is greater than the cost thereby imposed. The extent and type of oversight
measure(s) will thus be commensurate with the gravity and type of risk being addressed, the
costs of alternative oversight options, and the effect of additional oversight on existing safety
incentives.”

APHIS regulation of biotechnology

In 1987, APHIS promulgated its biotechnology regulations (7 CFR Part 340) under the authority
of the Federal Plant Pest Act (FPPA) and the Plant Quarantine Act (PQA)’ to address potential
risks that certain genetically engineered (GE) organisms might pose as plant pests. The
regulations refer to such GE organisms as “regulated articles.”””

The APHIS regulations codified at 7 CFR part 340 were amended in 1993 to provide a procedure
for the release from regulation of such plants which do not present a plant pest risk and therefore
should no longer be regulated. 7 CFR 340.6 describes the petition process, the data
requirements, and actions that the Administrator may take on the petition. It is under this
procedure that APHIS received the petition to grant nonregulated status to alfalfa events J101
and J163.

| The FPPA and PQA were consolidated along with other statutory authorities into the Plant Protection Act of 2000,
in which Congress found that: “it is the responsibility of the Secretary to facilitate exports, imports, and interstate
commerce in agricultural products and other commodities that pose a risk of harboring plant pests ... in ways that
will reduce, to'the extent practicable, as determined by the Secretary, the risk of dissemination of plant pests . . . ;
decisions affecting imports, exports, and interstate movement of products regulated under this title shall be based on
sound science... .”
The PPA defines a plant pest as:

PLANT PEST.—The term ‘‘plant pest’’ means 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.
7US.C. §7702(14}.
? A” regulated article” is defined as: “Any organism which has been altered or produced through genetic
engineering, ifthe donor organism, recipient organism, or vector or vector agent belongs to any genera or taxa
designated in § 340.2 and meets the definition of plant pest, or is an unclassified organism and/or an organism
whose classification is unknown, or any product which contains such an organism, or any other organism or product
altered or produced through genetic engineering which the Administrator, determines is a plant pest or has reason to
believe is a plant pest. Excluded are recipient microorganisms which are not plant pests and which have resulted
from the addition of genetic material from a donor organism where the material is well characterized and contains
only non-coding regulatory regions.” (7 CFR 340.0).

2

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<div class="page"><p></p>
<div class="ocr">On April 16, 2004, APHIS received a petition from Monsanto Company and Forage Genetics
International (Monsanto and FGI), requesting a determination of nonregulated status under 7
CFR part 340 for two alfalfa events designated as J101 and J163, which have been genetically
engineered for resistance to the herbicide glyphosate.

APHIS assessed the plant pest risks posed by the use of GT alfalfa events J101 and J163 and
prepared an Environmental Assessment (EA). The EA was prepared to identify and evaluate any
environmental impacts that could result from the approval of the petition. In a notice published
in the Federal Register (FR) 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 and
FGI GT alfalfa events J101 and J163 did not pose a plant pest risk and were therefore no longer
considered regulated articles under 7 CFR part 340.

Approximately 9 months later, a group of organic alfalfa growers and several other associations
filed a lawsuit in the United States District Court for the Northern District of California that
challenged APHIS’ decision to grant nonregulated status to GT alfalfa events J101 and J163. On
February 13, 2007, the Court issued an opinion finding that the APHIS EA failed to consider
certain environmental and interrelated economic impacts adequately, as required by the National
Environmental Policy Act (NEPA). The Court, however, did not question the validity of
APHIS?’ Plant Pest Risk Assessment, which concluded that the alfalfa events J101 and J163 did
not pose a plant pest risk: The Court also accepted APHIS’ determination that the GT alfalfa did
not have any harmful health effects on humans or livestock. The Court vacated APHIS' decision
to grant nonregulated status to GT alfalfa events J101 and J163 based on its finding that the EA
was inadequate and ordered APHIS to prepare an Environmental Impact Statement (EIS) before
deciding whether to grant nonregulated status to GT alfalfa events J101 and J163.

With respect to the NEPA violations, the Court found that the EA failed to adequately analyze
the possibility of gene transmission from GT alfalfa and conventional and organic alfalfa, which
could occur through cross pollination or by seed admixture. The Court found that if this
occurred, it would have significant negative economic and socioeconomic effects on organic
farmers. The Court also found that the deregulation of GT alfalfa could contribute to the
development of glyphosate resistant weeds and that APHIS failed to consider the cumulative
impacts of deregulating numerous glyphosate resistant crops on weed resistance. Finally, the
Court found that APHIS did not adequately analyze whether the deregulation of GT alfalfa
would result in increased use of glyphosate.

The Court’s-order provided that as of March 12, 2007, all GT alfalfa sales were halted, and as of
March 30, 2007, any further planting of GT alfalfa was prohibited. On March 23, 2007, APHIS
published a notice in the Federal Register (72 FR 13735-13736 APHIS Docket No. 04-085-1)
announcing the Court’s decision that Monsanto and FGI GT alfalfa events J101 and J163 were
once again regulated articles under 7 CFR part 340.

The Court decided that growers who had already planted GT alfalfa during the two years that the
product had been deregulated would not have to remove the plants. Those plants were permitted
to be harvested, used and sold. In the two growing seasons that GT alfalfa was on the market
(2005 and 2006), approximately 200,000 total acres were planted in 1,552 counties in 48 states
(no plantings occurred in Alaska and Hawaii). These GT alfalfa fields were permitted to be

3

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<div class="ocr">harvested, but the fields were subject to court-ordered stewardship practices to minimize the
potential that GT alfalfa will be present in harvests of non-GT alfalfa.

APHIS prepared an EIS in compliance with the order by the Court that vacated the determination
of nonregulated status of J101 and J163 alfalfa. In December 2009, APHIS released the draft EIS
(DEIS) for public comment. The DEIS was available for an extended 75-day comment period,
which closed on March 3, 2010. APHIS also held four public meetings across the United States
during the comment period. Approximately 133 people attended these public meetings.
Approximately 244,000 comments were received. All comments and recommended study
reports were considered by APHIS and revisions of the final EIS (FEIS) were made by the
agency as appropriate.

On December 23, 2010, the EPA published a notice announcing the availability of the FEIS to
the public. Prior to publication of this notice in the FR, APHIS had distributed the FEIS and also
posted it on its website.”

USDA hosted a meeting on December 20, 2010, with representatives from a wide array of
stakeholders, including representatives from the plaintiffs in the alfalfa litigation. The meeting
brought together this diverse group of stakeholders for a dialogue, to explore practical,
reasonable approaches that would support coexistence among the various forms of alfalfa
production. More than fifty persons participated in the meeting, including representatives of
industry and grower groups, technology developers, and various non-governmental
organizations. A full transcript of the meeting is available on APHIS’ website.*

Purpose and Need for Agency Action

In the FEIS, APHIS identified a purpose and need to review the petition for nonregulated status
in accordance with its authority under the current regulatory scheme. “APHIS is required by 7
CFR § 340.6 to make a determination on petitions submitted to the agency under this part. The
agency may grant the petition in whole or in part, or it may deny the petition. The determination
is based on the data required in 7 CFR 340.6(c), which are provided by the applicant and
supported by the best available science. The purpose of this action is to determine if the use of
GT alfalfa in the U.S. agricultural environment presents a greater plant pest risk than varieties on
non-GE, commercially available alfalfa.” (FEIS p.9). In summary, the agency’s need is to make
a decision on the petition that is consistent with the regulatory requirements in 7 CFR part 340.

APHIS also indicated that, “the USDA values and promotes coexistence of many different
agricultural production practices. These practices include the use of GE organisms and non-GE
organisms in conventional agricultural management systems and the use of non-GE organisms in
organic production systems. The Department’s purpose and need is to promote programs that
support coexistence of all types of agricultural practices. The analysis in this EIS will help to
inform USDA on the interaction of GT alfalfa and coexistence programs.”({ (FEIS p.9).

3 The FEIS can be viewed at http:/Avww.aphis.usda.gov/biotechnology/downloads/alfalfa/et_alfalfa%20_feis.pdf
‘ A transcript of the meeting can be found at
http://www.aphis.usda,gov/newsroom/content/2010/12/printable/alfalfa_meeting 12 20 10 transcript.pdf

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<div class="ocr">Public comment on the FEIS

APHIS received over 16,000 comments on the FEIS between December 16 and January 24,
2011. None of these comments presented information that would require preparation of a
supplement to the FEJS. None of the comments provide new information beyond what was ~
already received during the comment period on the draft EIS and analyzed in the FEIS. The
majority of the comments were form letters that expressed support for alternative 1, the no action
alternative. Many of these comments were generally against GE products. Others expressed
their opinion that GT alfalfa was not necessary because the commenter did not need it to manage
his own alfalfa. There were also comments from beekeepers that supported alternative 1 because
they were concerned that the types of management practices used for GT alfalfa could affect
their bees.

APHIS also received comments from trade organizations and growers that supported Alternative
2. Many of these commenters believe that APHIS lacks the authority to implement Alternative
3. Many also believe that Alternative 3 restricts grower choice. Many of these commenters also
believe that adopting Alternative 2 is consistent with past deregulation decisions.

Another group of growers and trade organizations supported Alternative 3, or requested a delay
in the decision until measures to address the economic issues related to low-level presence of the
GE trait in non GE alfalfa were in place. These growers believe that the adoption of Alternative
2 will preclude them from producing alfalfa for their markets under their current production
practices. Many of these growers market their alfalfa to GE sensitive markets.

The Environmental Protection Agency (EPA) submitted comments on the FEIS in accordance
with their responsibilities under Section 309 of the Clean Air Act and Section 102(2) (e) of the
National Environmental Policy Act (NEPA), APHIS has reviewed these comments and has taken
them into consideration before making a decision on the FEIS.

Decision -

Based on APHIS’ Plant Pest Risk Assessment, the analysis in the EIS, and public comments on
the DEIS and FEIS, APHIS is selecting Alternative 2 and granting nonregulated status to alfalfa
events J101 and Ji63. These events have been genetically engineered to resist the over the top
application of glyphosate, a broad spectrum herbicide. , .

APHIS is selecting Alternative 2 because:

e Alternative 2 best meets the purpose and need for agency action. As stated in the FEIS,
“The purpose of this action is te determine if the use of GT alfalfa in the U.S. agricultural
environment presents a greater plant pest risk than varieties of non-GE, commercially
available alfalfa. The agency’s need is to make a decision on the petition that is consistent
with the regulatory requirements in 7 CFR part 340.” We have determined that alfalfa
events J101 and J163 do not pose a greater plant pest risk than other conventional alfalfa
varieties, In fact, there is no evidence of plant pest risk associated with these two alfalfa

5

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<div class="page"><p></p>
<div class="ocr">events. The selection of Alternative 2 is consistent with the plant pest provisions of the
PPA, the regulations codified at 7 CFR part 340, and the biotechnology regulatory
policies in the Coordinated Framework.

e The FEIS informed USDA on the interaction of GT alfalfa and coexistence programs.
As noted above, USDA hosted a meeting on December 20, 2010, with representatives
from a wide array of stakeholders, including representatives from the plaintiffs in the
alfalfa litigation. The meeting brought together this diverse group of stakeholders for a
dialogue, to explore practical, reasonable approaches that would support coexistence
among the various forms of alfalfa production. The preparation of the FEIS, the
stakeholder discussion that followed, and the comments received on the FEIS have
clarified for USDA the broad range of coexistence issues and stakeholder needs, and
highlighted the complexities and difficulties of finding solutions that meet the needs of
all stakeholders involved.

e In view of the regulatory requirements in the PPA, the complexity and broad scope of
issues involved in fostering coexistence, and considering the positive steps already taken
by industry groups to promote best management practices and stewardship measures’,
APHIS believes Alternative 2 best meets the overall purpose and need for agency action
identified in the FEIS.

Plant Pest Risk Assessment

The Plant Pest Risk Assessment characterizes the potential plant pest risks associated with the
subject of the petition relative to conventional varieties. It is based on information supplied in
the petition for determination of nonregulated status together with other relevant scientific data.
The regulations codified at 7CFR 340.6 (c) list the information to be submitted for APHIS’
consideration of a petition for nonregulated status.

APHIS is selecting Alternative 2 because alfalfa events J101 and J163 do not present a greater
plant pest risk than other conventional alfalfa varieties. In fact, APHIS has not found any direct
or indirect plant pest risks associated with J101 and J163. APHIS concluded in its Plant Pest
Risk Assessment (PPRA) that alfalfa Events J101 and J163 are not likely to pose a plant pest risk
and should be granted nonregulated status for the following reasons:

(1) They exhibit no plant pathogenic properties — although a plant pathogen was used in their
development, these plants are not infected by this organism nor do they contain genetic material from
pathogens used as a donor organism that can cause plant disease.

(2) They exhibit no characteristics that would cause them to be weedier than the non-transgenic
parent alfalfa or other cultivated alfalfa and several control options besides glyphosate are available
for control of feral or volunteer plants or for stand take-out.

(3) Gene introgression from J101 and J163 to native, introduced, or naturalized species of Medicago
in the United States is extremely unlikely and even if it were to occur, is not likely to increase the
weediness potential of any resulting progeny any more than would introgression from other
cultivated alfalfa.

> http://www.alfalfa.org/CSCoexistenceDocs.html

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<div class="page"><p></p>
<div class="ocr">(4) Disease and insect susceptibility and compositional profiles (other than the intended CP4 EPSPS
protein conferring glyphosate tolerance) of J101 and J163 are similar to those of the parent variety
and other alfalfa cultivars grown in the United States, therefore pest and disease control methods are
expected to be similar and no direct or indirect plant pest effect on raw or processed plant commodity
is expected. .

(5) Field observations, compositional data including components related to nitrogen fixation and
nodulation, and data on the safety of the engineered EPSPS protein all indicate that J101 and J163
should not have a greater potential than other cultivated alfalfa to damage or harm organisms
beneficial to agriculture.

(6) Horizontal gene transfer from these alfalfa events to organisms with which they cannot interbreed
is highly unlikely to occur, and is not expected to pose a plant pest risk. In addition to considering
the potential plant pest risks posed by J101 and J163, APHIS prepared an EIS to examine the
impacts on the human environment of granting nonregulated status to these alfalfa events.
APHIS has identified and evaluated impacts in the FEIS associated with the decision to grant
nonregulated status, A summary of the analysis contained in the FEIS is set forth below in the
section entitled “Environmental Consequences Associated with Granting Nonregulated Status.”

Alternatives considered in the FEIS

Alternative I: Ne Action Alternative

Under the No Action Alternative, APHIS would deny the petition to grant nonregulated status to
glyphosate-tolerant (GT) alfalfa events J101 and J163. The events would continue to be subject
to the regulation pursuant to 7 CFR part 340. Permits or notifications would continue to be
required to introduce viable GT alfalfa plant material®. Permit conditions would be specified by
APHIS. These conditions would be designed to confine GT alfalfa. The size of planting would
be limited to help maintain confinement. In addition, the number of permits granted would be
limited by agency resources, both in terms of the number of permits which could be reviewed by
APHIS, and in APHIS’ ability to inspect the fields and enforce compliance with regulations.
Therefore, the number of acres planted and the amount of seed and hay transported between
states would likely be far less than the current commercial production of conventionally-bred
alfalfa for seed and hay in the U.S. In time it is expected that the number of acres of GT alfalfa
would decrease because the alfalfa that was planted while GT alfalfa had nonregulated status
would be replaced by conventional varieties.

Alternative 2: Grant the petition for nonregulated status

Under Alternative 2, GT alfalfa would be granted nonregulated status and would no longer be
subject to regulation pursuant to 7 CFR part 340. Permits or notifications issued by APHIS
would no longer be required for introductions of GT alfalfa derived from these events. Under
this alternative, growers could freely move and plant GT alfalfa seed without further oversight
from APHIS. Although APHIS would no longer have any regulatory control over the planting,
distribution, or other actions related to GT alfalfa, Monsanto’s technology use agreement

6 The term “Introduce” is defined in 7CFR 340.1 as: To move into or through the United States, to release inte the
environment, to move interstate, or any attempt thereat.

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<div class="ocr">imposes contract restrictions on growers.’ These nonregulatory restrictions include managing
hay to prevent seed production, harvesting at or before ten percent bloom in areas where seed is
produced, and prohibitions on use in wildlife feed plots. Similarly, Forage Genetics International
(FGD) requires contracted growers who raise alfalfa seed to follow FGI Best Practices. These
management practices include pollinator management, specific isolation distances, stand
termination documentation, and product segregation’, The developer, Forage Genetics
International, predicts that approximately 50 percent of the alfalfa acres may eventually be
planted with GT alfalfa. The majority of these acres are predicted to be located in the western
U.S. Glyphosate is not labeled for use on seed in all states. Therefore, GT alfalfa seed
production will likely only occur in the states where glyphosate can be used in its production.

Alternative 3: Grant the petition for nonregulated status in part

Alternative 3 describes a combination of isolation distances and geographic restrictions on hay
and seed production to address and resolve concerns about risks of cross pollination and other
potential impacts to organic and other non GE alfalfa producers while allowing the
commercialization of GT alfalfa. This third alternative would impose management practices on
the planting, harvesting, use or sale of GT alfalfa seed and in some locations hay. This
alternative could be implemented by an APHIS decision to approve the petition in part, or
through a Federal/industry partnership arrangement. Under this alternative, the developer
(marketer) of GT alfalfa would ensure that end users are using the required management
practices. They might choose to do this through contracts or licenses, or by other means. A
training component would also be part of the program to educate producers about the required
stewardship practices. Reporting requirements for the developer (marketer) subject to -
verification would be used to ensure compliance with the terms of the program. Under this
alternative, failure to comply with the requirements could result in penalties to the developer
(marketer). The required management practices would undergo periodic reviews to determine if
modifications were warranted. Changes to the management practices would be approved based
on available data on their effectiveness in addressing concems about risks of cross pollination
and other potential impacts to organic and other non GE alfalfa producers.

A description of the specific management practices can be found in the FEIS (section 2.b.3).

Environmental Consequences Associated with Granting Nonregulated Status
The following is a summary of the conclusions APHIS has reached on the environmental

consequences of Alternative 2 granting the petition for nonregulated status for GT alfalfa events
J101 and J163.

Gene flow in Alfalfa

¢ Movement of genes between alfalfa plants depends on weather, timing of flowering,
availability of pollinators, successful pollination, distance between plants, and time
needed for seed maturity.

e Alfalfa does not naturally hybridize with any wild relatives in North America.

” http://www.monsanto.com/SiteCollectionDocuments/Technology-Use-Guide.pdf
* htp://www.foragegenetics.com/pdf/ValidationFGIBestPractices.pdf.

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<div class="ocr">Gene flow could occur via transfer of pollen, most commonly by insect pollinators, or by
dispersal or accidental mixing of seeds. GT alfalfa genes therefore may occur in non GT
alfalfa.

We note that the National Alfalfa and Forage Alliance (NAFA) has developed best
management practices that are designed to limit the presence of the GE trait to below
0.5% in conventional alfalfa seed lots.

The Association of Seed Certifying Agencies has developed a management practice
standard, ASSP-2010, intended to limit the presence of the GE trait to levels that are not
detectable by standard industry tests.

Herbicide Use .

Glyphosate use in the United States would increase under deregulation due primarily to
the greater use of glyphosate for establishing and maintaining GT alfalfa stands compared
to conventional alfalfa stands. The magnitude of this increase depends on a number of
factors, including the fraction of conventional alfalfa acreage that would be replaced by
GT alfalfa, the co-use (tank mixing) of glyphosate with other herbicides for GT alfalfa
establishment and maintenance, and the stand life.

Other (non-glyphosate} herbicides used for establishing and maintaining GT alfalfa
stands could either increase or decrease, depending on the same factors as above.
Glyphosate is currently used on conventional alfalfa to “take out” (remove) an alfalfa
field. Thus, although glyphosate use overall for alfalfa would increase, its use to take out
conventional alfalfa stands would decrease as GT alfalfa replaces conventional alfalfa
(glyphosate cannot be used for removal of GT alfalfa stands).

Glyphosate i is less environmentally adverse than other herbicides because it has a lower
environmental impact quotient compared to other herbicides currently used in alfalfa
production. The net effect on alfalfa production with the increased adoption and planting
of GT alfalfa will likely be some increased use of glyphosate with a decreased, an

- unchanged, or an increased use of other herbicides.

Threatened and Endangered (T&E) animal species are not at risk. Terrestrial and semi-
aquatic T&E plants might be at some risk of direct effects from exposure to glyphosate
used in agriculture, if they are found near alfalfa fields. All plants are at some risk of
direct effects from exposure to herbicides currently used in alfalfa production.

Weeds in Alfalfa

Deregulation of GT alfalfa would encourage the use of glyphosate, as that would be the
most effective way of achieving weed-free alfalfa stands. The Deregulation Alternative
when combined with other past, present, and reasonably foreseeable actions, could result
in cumulative impacts because it could contribute to an increase in the total number of
glyphosate-resistant weeds.

Evolution of glyphosate-resistant weeds may occur in GT alfalfa stands. However,
because alfalfa is a perennial crop that is regularly mowed, glyphosate use in GT alfalfa
is relatively low when compared to annual GT crops, and that once alfalfa is established

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<div class="page"><p></p>
<div class="ocr">it acts as a suppressor of weeds, it may contribute less to the development of glyphosate
resistant weeds than other GT row crops. If GT alfalfa is widely adopted in areas where
alfalfa is a major crop, the potential that alfalfa acreage would overlap with glyphosate-
resistant weed locations increases, and such weeds could arise in GT alfalfa fields. Thus,
itis more likely that weeds that are already tolerant or resistant to glyphosate will occur
in GT alfalfa fields than that novel glyphosate resistant biotypes will emerge.

' Management regimes that incorporate only glyphosate are more likely to result in

selection of glyphosate resistant weeds than management practices that incorporate
additional herbicides or other cultural methods.
BMPs can help control the development of glyphosate-resistant weeds. BMPs include:
- a) identifying weeds and monitoring for escapes to determine if current practices
need to be modified to achieve acceptable levels of weed control
- b) using proper herbicide rates and timing
- c) using crop rotation to facilitate use of different modes of action over time
- d) using agronomic management practices to supplement herbicide weed control;
- e) alternating herbicides with different modes of action
-  f} tank mixing herbicides of different modes of action

Additional potential Impacts of GT Alfalfa

The GT alfalfa gene product is not expected to adversely affect plants and animals, including
threatened and endangered (T&E) species.

Several agronomic traits were evaluated and no biological differences between GT and
non-GT alfalfa were noted for traits that could influence weediness, including seed
dormancy, seed germination, seedling emergence, seedling vigor, winter survival, spring
vigor, seed yield, vegetative growth, plant dormancy, survival, and relationship with
symbiotic organisms. Therefore GT alfalfa is not expected to become more invasive in
natural environments or have any different effect on critical habitat than their parental
non-GT event. In addition, the nutritional profiles of GT alfalfa and non-GT alfalfa are

_ not different (within normal cultivar variations); therefore animal nutrition is not

expected to be different. There are also no palatability differences.

Analysis of forage samples from several locations demonstrated that GT alfalfa is
compositionally and nutritionally equivalent to other alfalfa varieties currently on the
market except for the expression of the transgene protein, and therefore is not expected to
have nutritional effects on any animals that feed upon it.

GT alfalfa is not expected to be toxic or allergenic to plants or animals. The
5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) protein from plants and from the
CP4 Agrobacterium strain is not known to have pathogenic or toxic effects on humans,
animals, or plants based on numerous laboratory and field studies with these purified
proteins or plants expressing these proteins.

Hybrids between alfalfa and other Medicago species in the United States are limited to
hybridization between M. sativa subspecies. Evidence of any sexually compatible, free-
living, or native relatives of Medicago species in the United States or North America is
nonexistent. Hence, the genetic resources of these plant species will not be affected by

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<div class="ocr">the release of GT alfalfa in the United States. Possible movement of the transgene via
pollen from GT alfalfa to other species of Medicago would not occur in the United States,
or it would only occur following the introduction and establishment of a reproductively
compatible, non-native species growing near GT alfalfa.

e APHIS reached a no effect determination and therefore concluded that the GT alfalfa
gene product would have no effect on federally listed T&E species or species proposed
for listing, and has concluded it will have no effect on designated critical habitat or
habitat proposed for designation, compared to current agricultural practices. As we
discussed in the EIS: APHIS has determined that GT alfalfa would not be sexually
compatible with any listed TES plant or plant proposed for listing. Based on the
composition and nutritional quality of GT alfalfa, APHIS concluded it would not be toxic
to TES animals that consume GT alfalfa. Based on toxicity studies of the EPSPS protein
and laboratory exposure studies with representative pollinators, soil organisms, beneficial
arthropods, and pest species exposed to tissues from GE crops that contain the CP4
EPSPS protein, a lack of toxicity was observed. Other studies concluded that its potential
to be a food allergen is minimal. As these studies revealed that GT alfalfa is unlikely to
pose a hazard, the risk of GT alfalfa harming TES animal species is unlikely. APHIS
considered whether the new phenotype would expand the range of alfalfa and concluded
it would not because alfalfa is not weedy, GT alfalfa is not weedier than conventional
alfalfa, and the agronomic properties of GT alfalfa are not statistically different from
currently available alfalfa varieties. Thus it would not be planted in new lands not already
used for agricultural production. APHIS has not identified any stressor that could affect
the reproduction, numbers, or distribution of a listed TES or species proposed for listing.
APHIS has considered the effect of GT alfalfa production on designated critical habitat or
habitat proposed for designation and could identify no difference from effects that would
occur from the production of other alfalfa varieties.

Increased glyphosate use, due to the adoption of GT alfalfa, could affect non-target plants, but is
not expected to adversely affect animals.

e Because of the high toxicity of glyphosate to plants, adoption of GT alfalfa could
adversely affect individual plants near GT alfalfa fields if they are exposed to glyphosate.
Glyphosate exposure could occur through aerial drift, runoff of surface waters containing
glyphosate, or leaching of glyphosate into drainage systems. Plants exposed to .
glyphosate via aerial drift might experience impaired germination or growth
characteristics. To mitigate potential adverse effects due to glyphosate drift, the U.S.
Environmental Protection Agency (EPA) has imposed specific label use restrictions for
glyphosate use when applied with aerial equipment, including “the product should only
be applied when the potential for drift to adjacent sensitive areas (e.g., residential areas,
bodies of water, known habitat for threatened or endangered species, non-target crops) is
minimal (¢.g., when wind is blowing away from the sensitive areas).” The potential for
glyphosate transport from terrestrial to aquatic environments is limited and glyphosate is
not expected to reach groundwater due to sorption and degradation in the soil.

* Glyphosate has low toxicity to mammals, birds, and fish, but is slightly toxic to
amphibians. However, amphibians exhibited greater sensitivity to Roundup®
formulations than to glyphosate tested as an acid or isopropylamine (IPA) salt, likely due

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<div class="ocr">to the surfactant, polyethoxylated tallowamine (POEA), which has been used for a long
time in agricultural formulations. POEA has been found to be more toxic to amphibians
and other aquatic animals than the herbicide itself. Adoption of GT alfalfa, however, is
unlikely to adversely affect amphibians, if glyphosate formulations without POEA are
used near water. EPA labeled a glyphosate product (EPA Reg No. 71368-25) for aquatic
use after publication of the FEIS. This product is not currently labeled for use on GT
alfalfa.

APHIS does not regulate herbicide use associated with GT plants that are granted
nonregulated status. The use of glyphosate is regulated under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). Under FIFRA, EPA registers pesticides and
prescribes the conditions for use of the pesticide. Applying pesticides in a way that is
inconsistent with the label is illegal. On the label, EPA includes instructions on how
glyphosate herbicides should be applied. Directions include application restrictions that
minimize impacts on nearby environments. EPA has determined that there is no
unreasonable environmental risk if the user adheres to the labeled directions. EPA's
pesticide registration process considers the potential for risk to non-target organisms, and
label use restrictions are required when necessary to avoid unreasonable adverse effects
to the environment. Through registration review, EPA is reviewing each registered
pesticide every 15 years to determine whether it still meets the FIFRA standard for
registration. In this way, EPA is ensuring that all registered pesticides do not cause
unreasonable risks to human health, workers, or the environment when used as directed
on product labeling. EPA intends to meet its responsibility under the Endangered Species
Act in the registration review program. Glyphosate is scheduled to complete registration
review in 2015, at which time EPA will complete its national endangered species
assessment of all registered uses of the herbicide.

Socioeconomic Impacts

There is evidence that GT alfalfa can offer alfalfa hay farmers high quality alfalfa hay at
relatively lower costs,

To the extent that GT alfalfa is adopted by alfalfa hay farmers, the overall supply curve
for high quality alfalfa could shift, increasing the quantity of high quality alfalfa hay and
decreasing its price.

There is evidence that some U.S. consumers prefer nonGE foods in the United States

over products containing GE components. This preference is likely more prevalent
among consumers of organic products. However, the extent to which this preference
translates to decreased demand (sales) for conventional and organic products if there
were low-level GE presence in feed used for dairy and meat cattle in the production chain
of organic foods is unclear. The impact of GT alfalfa deregulation on domestic demand
might best be analyzed by analogizing it to a small GT-sensitive market within the -
domestic conventional and organic alfalfa markets. .

Producers of organic and non GE alfalfa may incur costs to create additional buffer zones
or to implement testing protocols. Some of these producers are concerned that it will not
be possible to produce alfalfa seed with non-detectable levels of the GE trait in areas
where GT alfalfa is also grown.

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<div class="ocr">e Among U.S. main export markets for alfalfa hay and seed, there is evidence of some
sensitivity to GE alfalfa products. The GT alfalfa sensitive segment is likely to be only a
portion of the existing export market.

e The extent to which GE sensitive domestic and foreign alfalfa markets are affected by GT
alfalfa deregulation depends on the extent to which gene flow can be controlled through
stewardship programs. These programs may increase the costs of seed production for
sensitive markets. To the extent that they do, the impact on overall demand is likely to be
low, given the low sensitivity of the demand for alfalfa seeds to changes in its price.

Human Health and Safety
e GT alfalfa has no adverse effects on human health and worker safety.

e Overall risk of glyphosate and other herbicide use on human health and worker safety
does not change with the adoption of GT alfalfa. EPA has determined that use of
herbicides in accordance with the labeling of currently registered pesticide products
containing glyphosate has a reasonable certainty of no harm to humans and no
unreasonable adverse effects to the environment.

Land Use and Physical Environment

° Overall, land devoted to alfalfa cultivation would be affected largely by the price of
alfalfa hay and not by the availability of GT technology.

e GT alfalfa is not expected to have an adverse impact on soils, climate or air quality, or
water and water use.

Decision not to choose Alternative 3

APHIS identified Alternative 3, the Isolation/Geographic restrictions alternative, as a co-
preferred alternative in the FEIS. This alternative was developed in the FEIS based on public
comments received in response to the DEIS. Alternative 3 is described briefly in-the section of
the FEIS entitled “Alternatives considered in the EIS.”

APHIS considered the impacts to the human environment associated with Alternative 3. We
concluded that the comparative impacts of Alternative 2 and Alternative 3 on biological
resources, the physical environment, and human health are similar. If Alternative 3 were to
result in fewer acres planted with GT alfalfa, the associated impacts of increased glyphosate use
would not be realized in the areas where GT alfalfa was not adopted. However, it is not at all
certain that fewer acres of GT alfalfa would in fact be planted under Alternative 3. If Alternative
3 were selected, there could be a shift in acres planted with GT alfalfa forage to counties where it
would be allowed to be planted. Ultimately, under both Alternatives 2 and 3, the amount of GT
alfalfa planted would be determined by the market for the hay.

Under Alternative 3 the socioeconomic impacts of the use of GT alfalfa are different than under
Altemative 2, Under Alternative 2, alfalfa growers who cater to GE sensitive markets might
incur additional costs to produce their product. These additional costs may come in the form of

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<div class="ocr">additional testing for the GE trait or changes in management practices to avoid low level
presence of GT alfalfa in their product. Some alfalfa seed producers may lose market share to
alfalfa seed produced outside the US, where GT alfalfa is not grown. Under Alternative, 3 these
costs either would not be incurred or would be reduced compared to Alternative 2 because the
seed supplies would be geographically isolated. Under Alternative 3, growers in restricted areas
(certain counties in Tier IIT) who might have otherwise chosen to use GT alfalfa to produce their
forage crop would not be allowed to plant GT alfalfa. APHIS estimates that approximately 3
percent of the nation’s hay production falls into this category. That is, APHIS estimates that the
land which produces approximately 23% of the hay in the US could not be used under
Alternative 3 to grow GT alfalfa.

The FEIS includes a market projection that about 75% of the likely adopters of GT alfalfa will be
in Tier III states. This is presumably because herbicide use for growing alfalfa is used more
frequently in Tier III states than other regions. Alternative II would remove the choice for
growing GT alfalfa for the substantial number of farmers who are most likely to choose to use
this technology. To the extent that GT alfalfa hay allows for the production of high quality hay at
a lower price, these growers may lose profits.

APHIS has decided not to select Alternative 3 because:

*e GT alfalfa does not exhibit a greater plant pest risk in the geographically restricted areas
described in Alternative 3. As described above, APHIS has not identified any plant pest
risks associated with J101 and J163. In light of these findings and after further —
consideration of Alternative 3, we have determined that the restrictions in Alternative 3
are not consistent with APHIS’ regulatory authorities or the biotechnology regulatory
policies embodied in the Coordinated Framework. Therefore Alternative 3 does not meet
the agency’s purpose and need to act on the petition in accordance with its regulatory
authorities. .

e The impacts on biological resources, the physical environment, and human health are
similar to Alternative 2.

e Itis uncertain whether the economic benefits associated with Alternative 3 offset the
losses associated with Alternative 3. There was limited data available to quantify the
economic effects of adventitious presence of GT alfalfa in conventional or organic
alfalfa. APHIS analyzed some scenarios comparing the costs of GT alfalfa production
with the costs of conventional alfalfa production. APHIS has described these analyses in
the FEIS. However, the scenarios described in the FEIS were based on limited data and
predicted changes in specific production practices.

e Other non-regulatory options are available to manage low level presence of GE traits.
These mechanisms can be effective and can help promote coexistence. These methods
include industry led best management practices, USDA process verification certification,
or private testing and verification programs.

Environmentally Preferred Alternative ;

The environmentally preferred alternative is that alternative that causes the least harm to the
biological and physical environment. APHIS has analyzed the impacts of three alternatives on
the biological and physical environment. APHIS has concluded that the GT alfalfa plants will

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<div class="ocr">not have a different impact of the physical and biological environment than ‘conventional alfalfa
plants. However, using GT alfalfa under recommended management strategies will likely result
in an increase in glyphosate use on alfalfa. This could be accompanied by either an increase or a
decrease in other herbicide use. Increased use of glyphosate could increase the likelihood of
exposure of nearby plants to glyphosate. As described in the FEIS, this exposure could lead to
increased mortality of nontarget plants in the vicinity of GT alfalfa fields. Under FIFRA, EPA
registers pesticides and prescribes the conditions for use of the pesticide. Applying pesticides in
a way that Is inconsistent with the label is illegal. On the label, EPA includes instructions on
how glyphosate herbicides should be applied. Directions include application restrictions that
minimize impacts on nearby environments. EPA has determined that there is no unreasonable
environmental risk if the user adheres to the labeled directions.

APHIS has identified the no action alternative as the environmentally preferred alternative.
Under the no action alternative, the increase in glyphosate use associated with the use of GT
alfalfa would not occur. As analyzed in the FEIS, the majority of alfalfa hay acres (83%) are not
treated with herbicides so the adoption of GT alfalfa beyond 17% of the acres where herbicide is
used would result in an increased use of glyphosate that would not result in a decrease in other
herbicide use on the untreated acres. On alfalfa acres that are intensively managed with
herbicides, a decrease in other herbicide use may occur, but that decrease could be negated if
weed shifts to glyphosate resistant or tolerant weeds occur. Therefore, because both of the action
alternatives are likely to result in an increase in herbicide use on alfalfa, the no action alternative
is the environmentally preferred alternative. The no action alternative may not be the
environmentally preferred alternative in the case of other GT crops that have different herbicide -
use patterns and other agricultural practices.

APHIS also considered the contribution of GT alfalfa to the development of glyphosate resistant
weeds. Based on the analysis in the FEIS, glyphosate resistant weeds are less likely to develop
in GT alfalfa than in annual row crops because management practices associated with alfalfa can
break the life cycle of many weeds. Selection cannot act in the absence of complete life cycles.
Weeds that are controlled by regular mowing or other cultural practices are less likely to develop
resistance in GT alfalfa fields. However, GT alfalfa may still contribute to the development of
glyphosate resistant weeds because its use will likely increase the number of acres of glyphosate
resistant crops on the landscape and the number of acres in a continual GT crop rotation.
Therefore, with respect to the development of glyphosate resistant weeds, GT alfalfa could
contribute to the development of these weeds in agricultural systems. The FEIS recommends
management strategies that can reduce the likelihood of glyphosate resistant weed developing.
USDA funds research both to understand the mechanism of herbicide resistance in weed
populations and to develop management strategies for herbicide resistance weeds.

APHIS is not choosing the environmentally preferred alternative because it does not meet the
agency’s purpose and need. As stated in the FEIS, it is the agency’s need to make a decision
that is consistent with its existing statutory authority and regulatory program. As described
above, APHIS has not identified any plant pest risks associated with J101 and J163. Therefore,
it would be inconsistent with the PPA, the regulations codified at 7 CFR part 340, and the
biotechnology regulatory policies embodied in the Coordinated Framework, to prevent the
commercial release of alfalfa events J101 and J163.

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<div class="ocr">Mitigations of Impacts Associated with Alternative 2

APHIS has identified the potential for impacts for the increased use of glyphosate associated
with the adoption of GT alfalfa. Impacts to plants can be mitigated by following the EPA label.
EPA regulates the use of pesticides under FIFRA. EPA labels products containing glyphosate
for use on GT alfalfa; they have concluded that using glyphosate products according to the label
will not result in unreasonable adverse effects to the environment and a reasonable certainty of
_no harm to people. APHIS also concluded that the use of GT alfalfa could contribute to the
development of glyphosate resistant weeds or weed shifts to glyphosate tolerant and resistant
weeds in alfalfa. Because GT alfalfa adds an additional glyphosate resistant crop which could be
used in rotation with other glyphosate resistant crops, the use of GT alfalfa may contribute to the
overall emerging problem of glyphosate resistant weeds. The USDA has recognized that the
development of herbicide resistant weeds is an issue for US agriculture and has committed
resources to the understanding of the development of these weeds and control of them in
agricultural systems. USDA currently has committed resources in a variety of programs related
to herbicide resistance and weedy invasive species, including $4.4 million dollars for
Agricultural Research Service (in house) research, $4.6 million in competitive grants through the
National Institute of Food and Agriculture (NIFA) and additional support through Land-Grant
University funding. ARS programs include research for weed biology and integrated
management practices for herbicide resistant weeds. NIFA funds research in biology of invasive
species in agroecosystems, supports extension outreach to growers, and a new web-based
training system, IPM3, with a module in herbicide resistance and management strategies,

As part of the effort to mitigate and prevent development of herbicide resistant weeds, several
ARS research projects have been initiated or redirected to address herbicide resistance. The
following are some specific examples:

1. Scientists at the Global Change and Photosynthesis Research Unit in Urbana, IL are
identifying seed survival traits that might be manipulated to control weed species, such as Palmer
amaranth and waterhemp, that are known to develop herbicide resistance.

2. Scientists at the Crop Production Systems Research Unit in Stoneville, MS are conducting
studies to determine the development and management of herbicide resistant weeds based on the
biology, physiology, and ecology of weeds. Through an understanding of the mode-of-action of
herbicides and mechanisms of resistance, the reproduction and spread of weeds, and the
development of integrated weed management techniques, strategies will be developed for the
sustainable management of existing populations and to prevent future incursions of herbicide-
resistant weeds.

3. Other research at the Crop Production Systems Research Unit will develop herbicide programs
that utilize different modes of action coupled with residual herbicides to reduce late season
weeds in glyphosate-resistant soybean and develop best management practices for difficult to

_ control weeds in herbicide resistant crops.

4. Scientists at the Crop Protection and Management Research Unit in Tifton, GA are conducting
studies to determine the ecological and edaphic factors affecting the reproduction, spread, and
survival of invasive, herbicide-resistant, and herbicide-tolerant weeds of agronomic and
vegetable crops. The results of these studies will be used to develop integrated systems for the
management of herbicide-resistant and invasive weeds.

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<div class="ocr">5. Scientists at the Natural Products Utilization Research Unit in University, MS are conducting
studies to discover natural product-based chemistries with new modes of action for the control of
weeds. The results of these studies will provide new tools to control weeds resistant to current
herbicides.

Compliance with Applicable Laws, Executive Orders, and Regulations.

The record of decision has been prepared in accordance with: (1) the National Environmental
Policy Act (NEPA), (2) regulations of the Council on Environmental Quality for implementing
the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations
implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR
part 372).

The decision considered the directives of Executive Order (EO) 12898 (US-NARA, 2008),
“Federal Actions to Address Environmental Justice in Minority Populations and Low-Income
Populations;” EO 13045 (US-NARA, 2008), “Protection of Children from Environmental Health
Risks and Safety Risks;” EO 13112 (US-NARA, 2008), “Invasive Species;” EO 13186 (US-
NARA, 2008); “Responsibilities of Federal Agencies to Protect Migratory Birds;” and EO
12114 (US-NARA, 2008), “Environmental Effects Abroad of Major Federal Actions.”

The decision was determined to be in compliant with other Federal Statutes including, the Clean
Water Act; the Clean Air Act; the Federal Insecticide, Fungicide, and Rodenticide Act; the
Pollution Prevention Act; and the Endangered Species Act.

The decision was made under the authority of the Plant Protection Act as amended (7 United
States Code (U.S.C.) 7701-7772), as codified in the Code of Federal Regulations at 7 CFR part
340, and in consideration of Executive Policy (Executive Office of the President, Office of
Science and Technology Policy “Exercise of Federal Oversight within Scope of Statutory
Authority; Planned introductions of biotechnology products into the environment.” FR Feb 27
1992.vol 57 (39):6753).

Ong SSork fay
Cindy J. saith Date
Administrator

Animal and Plant Health Inspection Service
U.S. Department of Agriculture

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