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April 6, 2007

Regulatory Analysis and Development

USDA APHIS PPD

Station 3A-03.8

4700 River Road, Unit 118

Riverdale, MD 20737-1238

Submitted via Federal eRulemaking Portal: Docket No. APHIS-2006-0195

To whom it may concern:

The Center for Food Safety (CFS) submits the following comments on the
draft environmental assessment (EA) conducted by USDA's Animal and Plant
Health Inspection Service (APHIS) on its determination of nonregulated
status for the Monsanto soybean event designated as MON 89788, which has
been genetically engineered for tolerance to the herbicide glyphosate,
and any progeny derived from crosses of MON 89788 with other
non-regulated soybean lines.

CFS is a non-profit public interest and environmental advocacy
membership organization established in 1997 by its sister organization,
International Center for Technology Assessment, for the purpose of
challenging harmful food production technologies and promoting
sustainable alternatives. CFS combines multiple tools and strategies in
pursuing its goals, including litigation and legal petitions for
rulemaking, legal support for various sustainable agriculture and food
safety constituencies, as well as public education, grassroots
organizing and media outreach.

CFS strongly opposes the cultivation and commercial use of genetically
engineered food crops due to unexplored risks to the environment,
biodiversity, specific protected species, and potential risks to human
health that could result. Genetic engineering is a novel technology that
fundamentally alters agriculture, our food supply, and the environment.
Neither standard corporate testing practices for, nor U.S. government
oversight of, genetically engineered (GE) crops is sufficiently
stringent to rule out, with reasonable scientific certainty, unintended
adverse impacts to human health or the environment.[^1] CFS therefore
supports a moratorium on GE crops until the U.S. government establishes
a strict, science-based regulatory system.

Short of such a blanket moratorium on GE crop commercialization, the
deregulation and commercialization of this GE soy (MON 89788) and
progeny derived from it requires the preparation of an EIS under the
National Environmental Policy Act ("NEPA"), because the EA contains
unanswered or inadequately answered health and safety questions.
Specifically, CFS requests that APHIS institute a moratorium on the
commercial introduction, dissemination, interstate movement or
conveyance of MON 89788, including but not limited to all food products
containing any ingredients or material derived from this genetically
engineered soy, until the USDA, as mandated under §102 of NEPA, fully
evaluates the environmental, human health and socio-economic impacts
caused by the commercialization of MON 89788. Such action and analysis
should include completion of an environmental impact statement analyzing
the effects on the human environment resulting from any USDA actions
deregulating (or other action allowing commercial distribution, sale and
planting) MON 89788.

We have numerous serious concerns about this deregulation, as discussed
in detail below.

**BACKGROUND**

On June 27, 2006 APHIS received a petition seeking a determination of
nonregulated status from Monsanto for GE soybean MON 89788. (APHIS
Petition \# 06-178-01p). In the February 5, 2007 *Federal Register*,
USDA APHIS announced a public comment period on a draft environmental
assessment (EA). 72 Fed. Reg. 5262 (Feb. 5, 2007).

**CFS COMMENTS**

*Summary*

The draft EA is wholly inadequate and defective because APHIS failed to
take the "hard look" required by NEPA. An EIS must be prepared for the
deregulation of MON 89788 to properly address the significant
environmental impacts that may result from APHIS' approval. The draft EA
fails to adequately discuss numerous significant environmental and
agronomic impacts, such as potentially reduced micronutrient uptake,
increased susceptibility to plant disease, harm to agriculturally
important soil life, glyphosate-resistant weeds, and harm to wildlife
from the Roundup Ready soybean system. The draft EA fails to adequately
discuss cumulative impacts on the environment, such as the dramatic
increase in the use of glyphosate associated with Roundup Ready (RR)
soybeans and other RR crop systems. APHIS' abysmal history of failing to
contain genetically engineered crops illustrates that APHIS' standards
and operating procedures are inadequate to protect organic agriculture.
The draft EA is arbitrary and capricious. These comments request that
APHIS prepare an Environmental Impact Statement (EIS) to fully analyze
the environmental and public health affects of the deregulation
decision.

*The National Environmental Policy Act ("NEPA")*

The National Environmental Policy Act ("NEPA") requires a federal agency
such as USDA APHIS to prepare a detailed EIS for all "major Federal
actions significantly affecting the quality of the human
environment."[^2] NEPA "ensures that the agency \... will have
available, and will carefully consider, detailed information concerning
significant environmental impacts; it also guarantees that the relevant
information will be made available to the larger \[public\]
audience."[^3]

Recognizing the affects of new technologies on the environment, Congress
explicitly stated in NEPA that "new and expanding technological
advances" are activities that could threaten the environment.[^4] In the
legislative history, Congress expressed its concern with "\[a\] growing
technological power ... far outstripping man's capacity to understand
and ability to control its impact on the environment."[^5] Thus, in
order to understand and control the effects of new technologies,
Congress required federal agencies to consider their environmental
effects by prescribing the requirements of NEPA. In addition to
environmental concerns, the proposed action's possible direct, indirect,
and cumulative impacts on public health must be reviewed.[^6]

A threshold question is whether a proposed project will "significantly
affect" the environment, thereby triggering the requirement for an
EIS.[^7] As a preliminary step, an agency may prepare an EA to decide
whether the environmental impact of a proposed action is significant
enough to warrant preparation of an EIS.[^8] An EA must "provide
sufficient evidence and analysis for determining whether to prepare an
EIS or a finding of no significant impact."[^9]

If an agency decides not to prepare an EIS, it must supply a "convincing
statement of reasons" to explain why a project's impacts are
insignificant.[^10] "The statement of reasons is crucial to determining
whether the agency took a "hard look" at the potential environmental
impact of a project."[^11]

*The Council on Environmental Quality (CEQ)*

NEPA also established the Council on Environmental Quality and charged
CEQ with the duty of overseeing the implementation of NEPA.[^12] The
regulations subsequently promulgated by CEQ, 40 C.F.R. §§ 1500-08,
implement the directives and purpose of NEPA, and "\[t\]he provisions of
\[NEPA\] and \[CEQ\] regulations must be read together as a whole in
order to comply with the spirit and letter of the law."[^13] CEQ's
regulations are applicable to and binding on all federal agencies.[^14]
Among other requirements, CEQ's regulations mandate that federal
agencies address all "reasonably foreseeable" environmental impacts of
their proposed programs, projects, and regulations.[^15]

The CEQ regulations list factors that determine whether a federal
action, such as deregulating MON 89788 is "significant." The CEQ
regulations define the term 'significantly' for purposes of NEPA as
requiring analysis of both the 'context' and the 'intensity' of the
action."[^16] Context is the scope of the agency action.[^17] Intensity
"refers to the severity of the impact" and is defined by the factors in
40 C.F.R. section 1508.27(b). Courts rely on these factors to determine
"significance." Even meeting just one of the factors in 1508.27(b) may
require the preparation of an EIS.[^18]

USDA specifically adopted these CEQ regulations in relation to APHIS'
review of genetically engineered crop.[^19] The factors include:

\- the degree to which the proposed action affects public health or
safety;[^20]

\- the degree to which the possible effects on the human environment are
highly uncertain or involve unique or unknown risks;[^21]

\- Whether the action is related to other actions with individually
insignificant but cumulatively significant impacts.[^22]

As discussed herein, the commercial introduction of genetically
engineered Soybean MON 89788 poses novel human health threats that
constitutes unique environmental impacts and impacts to human health and
safety. Following is a description of some of the impacts that the USDA
must evaluate.

**I. The EA's "Analysis" of the Potential Environmental Impacts Is
Wholly Inadequate Because APHIS Failed to Take the "Hard Look" Required
By NEPA. These Impacts Require An EIS.**

As mandated by Congress, APHIS must comply with NEPA before it attempts
to deregulate and allow the commercialization of genetically engineered
MON 89788 and any progeny derived from it. USDA is the lead federal
agency designated to undertake NEPA analysis for the commercialization
of genetically engineered plant varieties. USDA's decision whether to
deregulate a genetically engineered soy variety is a major federal
action that may significantly affect the environment. The commercial
planting of genetically engineered MON 89788 could impact a vast number
of acres and will have significant impacts on the environment, including
impacts to human health, as well as cumulative impacts.[^23]

The draft EA, is extremely brief (18 pages) and glosses over important
issues, making nothing more than a perfunctory attempt to appear to
cover the impacts stemming from this deregulation. The EA only
superficially covers a number of possible significant environmental
impacts, as detailed below. The draft EA also relies uncritically on
Monsanto's petition, which lacks a variety of important data that APHIS
should have required and assessed in its draft EA.

*A. APHIS Fails to Analyze MON 89788 in Comparison to the Conventional
Soybean Line From Which it Was Derived*

An important general inadequacy that will be addressed in more detail
below is APHIS' near-total reliance on a loose comparison of MON 89788
with previously deregulated soybean line MON-04032-6, the original
Roundup Ready soybean, in the draft EA. APHIS chooses this approach
despite the fact that Monsanto's petition is based primarily on a
comparison (inadequate though it may be) of MON 89788 to A3244, the
conventional soybean from which it was derived (in addition to a variety
of conventional soybean "reference lines").

APHIS' approach is deeply flawed because each new genetically engineered
(GE) crop is the result of a novel transformation event that requires
independent assessment based on close comparison to its closest
conventional counterpart. This standard of assessment, also known as the
"case-by-case" approach, is universally acknowledged among experts in GE
crop testing. It is based on the unique suite of unintended effects to
be expected in any given genetically engineered crop. These unintended
effects are the result of the haphazard nature of the genetic
engineering process, which is known to cause insertional mutagenesis in
the crop's genome in a completely unpredictable manner.[^24] This means
that even when essentially the same gene of interest is inserted in two
different transformation events (here, MON-04032-6 and MON 89788), the
unintended effects accompanying each event can differ substantially.
These unintended effects can include generation of novel toxins or
allergens, increased levels of native toxins or allergens, and decreased
nutritional content. Animal feeding trials and comprehensive assessment
of the composition of the new GE crop via metabolic profiling, among
other tests, are needed to detect any potentially harmful changes.[^25]
In such testing, the new GE crop should be compared to its conventional
progenitor (here, A3244).

APHIS' review of Monsanto's petition for MON 89788 in the draft EA
violates this well-established principle of GE crop testing. APHIS'
assessment of MON 89788 versus A3244 is limited, beyond a bare mention
of the fact that A3244 is the recipient line (EA, pp. 3-4), to a few
cursory sentences reiterating Monsanto's conclusions regarding the
phenotypic characteristics of MON 89788 versus A3244 (EA, pp. 8-9).

The need for a full assessment of MON 89788 versus A3244 is strengthened
by:

1\) Monsanto's use of a completely different transformation method to
generate MON 89788 (Agrobacterium-mediated gene delivery to soybean
meristem) versus particle acceleration to generate MON-04032-6 (EP, p.
3); and

2\) Use of a different promoter for MON 89788 (chimeric, derived from
figwort mosaic virus and *Arabidopsis thaliana*), versus the P-E35S from
cauliflower mosaic virus for MON-04032-6 (EA, p. 3).

These substantial differences in the processes and genetic materials
used to generate MON 89788 versus MON-04032-6 increase the potential for
a different suite of unintended effects that requires analysis through
close comparison of MON 89788 to its conventional progenitor.

*B. APHIS' Analysis of the Roundup Ready Soybean System is Grossly
Inadequate*

Like MON-04032-6, the original Roundup Ready soybean, MON 89788 is to be
deployed as part of a Roundup Ready soybean system, defined by Monsanto
as: "\[t\]he utilization of Roundup agricultural herbicides plus Roundup
Ready soybean..." (petition, p. 4).

APHIS' assessment of MON 89788 and associated herbicide use is grossly
inadequate because it is based almost completely on a comparison to
MON-04032-6, which was deregulated in 1994. By assuming MON-04032-6 as
an unproblematic baseline for its assessment of MON 89788, APHIS
virtually ignores over a decade of research pointing to substantial
agronomic and environmental problems with the Roundup Ready soybean
system (discussed below).

This draft EA represents the first time in 12-13 years that APHIS has
had an opportunity to address the growing agronomic and environmental
problems associated with the Roundup Ready soybean system. This is
because APHIS deregulation of a GE crop is absolute, permanently
removing the deregulated line from regulatory oversight. Thus, APHIS has
not addressed problems that have developed since the deregulation of the
original Roundup Ready soybean in 1994. It would represent a flagrant
dereliction of duty for APHIS to ignore this substantial body of
research in its assessment of the similar Roundup Ready soybean system
based on MON 89788. Furthermore, because deregulation is absolute and
applicable to all progeny derived from MON 89788, APHIS' assessment must
also be prospective in nature, and take account of likely future
ramifications of the deregulation.

It is worth noting that APHIS' sister agency, the Environmental
Protection Agency, grants time-limited registrations to the pesticidal
proteins (so-called "plant-incorporated protectants" or PIPs) produced
in GE crops under its jurisdictions. These registrations are typically
5-7 years in length. EPA grants time-limited registrations to enable it
to consider new data concerning PIPs and the GE crops in which they are
produced. If new scientific research indicates that a PIP has a
previously unnoticed human health or environmental effect, EPA can
choose not to re-register the PIP, or re-register the PIP and associated
GE crop under altered conditions to ameliorate the harm. The fact that
APHIS has no corresponding mechanism for periodic reassessment of GE
crops under its jurisdiction makes it all the more important that APHIS
conduct a rigorous analysis for all deregulation decisions, including
the one at issue here.

Another EPA practice that APHIS should consider emulating is increased
use of external peer-review. EPA regularly convenes Scientific Advisory
Panels of independent experts to advise it on issues related to GE,
pesticide-producing crops, while APHIS has no similar mechanism. The
National Academy Sciences urged APHIS to increase external review of its
decision-making process in a critical report issued in 2002.[^26]

As indicated in detail below, APHIS needs to conduct a thorough and
critical review of MON 89788 in comparison to its conventional
progenitor, A3244, and in addition a thorough and critical review of the
Roundup Ready soybean system, in the context of an environmental impact
statement.

*C. APHIS' Compositional Analysis of MON 89788 is Deficient*

Monsanto's compositional analysis of MON 89788, and APHIS' review of it,
are deficient in several respects. First, Monsanto tested far too few
components of MON 89788 (forage and/or grain) to determine whether or
not it is compositionally equivalent to its conventional progenitor,
A3244. For forage samples, Monsanto conducted a rough proximate analysis
of levels of moisture, overall protein, overall fat, ash, acid detergent
fiber and neutral detergent fiber. For soybean seed, Monsanto conducted
the same tests, and in addition measured levels of amino acids, certain
fatty acids, trypsin inhibitor, lectin, three isoflavones, phytic acid,
stachyose, raffinose and Vitamin E (petition, Appendix E). Completely
absent were any tests on mineral content of forage or seed, in
particular micronutrients that play essential roles in the resistance of
soybeans to disease and the nutritional quality of both forage and
soybean seed.

The need for analysis of micronutrient levels in MON 89788 is
demonstrated by accumulating research that shows glyphosate application
to glyphosate-tolerant soybeans and other glyphosate-tolerant crops can
inhibit uptake of micronutrients, including manganese, iron, potassium,
boron and zinc.[^27] The huge increase in overall glyphosate use over
the past 15 years, driven primarily by the introduction of RR crop
systems, reinforces the need for such analysis. Glyphosate use in
American agriculture has increased by six-fold from just 1992 to
2002.[^28] RR versions of soybeans and corn, and to a lesser extent
cotton, are increasingly grown in rotation, meaning that each year, more
prime cropland is sprayed more frequently with glyphosate, with
increasing rates applied in many areas to control resistant weeds. While
glyphosate is generally regarded as less toxic than many weed killers, a
growing body of research suggests that continual use of this chemical
may make RR plants more susceptible to disease and prone to mineral
deficiencies than conventional crops, as well as reducing their yields.

When glyphosate is sprayed on Roundup Ready crops, much of the herbicide
ends up on the surface of the soil, where it binds to soil particles in
the top layer. Here it is degraded by microorganisms. However, studies
showing that this glyphosate has no adverse effects on soil
microorganisms and the nutrients they make available to crops have been
done without considering the rhizosphere, the zone immediately adjacent
to roots.

New research that focuses on the rhizosphere, where plants obtain most
of their nutrients, shows that glyphosate is exuded from the roots of RR
crops into the rhizosphere, and thus is distributed throughout the soil
wherever roots penetrate.[^29]

Glyphosate in the rhizosphere can alter the community of microorganisms
in such a way as to interfere with availability of important mineral
nutrients. Also, the Roundup Ready crops themselves are less efficient
at taking up these minerals,[^30] and glyphosate in the plants after
they have been sprayed can immobilize mineral nutrients.[^31] The
resultant mineral deficiencies have been implicated in various problems,
from increased disease susceptibility to inhibition of photosynthesis.

This research indicates the need for a thorough analysis of potential
inhibition of micronutrient uptake in MON 89788, including measurement
of micronutrient levels in all soybean plant tissues. In light of the
research cited above, the lack of micronutrient analysis is puzzling, to
say the least. It is even more puzzling when one considers that Monsanto
did provide such data in prior petitions for deregulation of other
Roundup Ready crops, for instance, Roundup Ready alfalfa.

> "Forage samples were collected from all plots and analyzed for
> nutritional components. Compositional analyses of the forage samples
> included proximates (protein, fat, ash and moisture), acid detergent
> fiber (ADF), neutral detergent fiber (NDF), lignin, amino acids, and
> minerals (calcium, copper, iron, magnesium, manganese, phosphorous,
> potassium, sodium and zinc), as well as carbohydrates by calculation.
> In all, 35 different components were analyzed to assess the
> composition of Roundup Ready alfalfa." (RR alfalfa deregulation
> petition 04-110-01p)

APHIS should require Monsanto to submit test results on the levels of a
broad range of micronutrients/minerals in forage and seed samples of
glyphosate-treated MON 89788. APHIS should also require submission of
lignin levels in glyphosate-treated MON 89788 under a range of
temperatures, given studies indicating increased lignin levels and an
associated greater tendency to stem-splitting in the original Roundup
Ready soybean, particularly under conditions of extreme heat. As noted
above, these data were submitted for RR alfalfa. The studies noted above
as well as additional research in this area are appended to these
comments as Appendix I.

APHIS' draft EA provides no analysis of Monsanto's compositional
analysis, merely reiterating Monsanto's conclusions in a few sentences
in section VI. 7 (EA, p. 13).

*D. APHIS Fails to Consider the Potential for the Roundup Ready Soybean
System to Increase Susceptibility to Plant Disease in MON 89788 and
Other Crops*

As noted above, inhibition of micronutrient uptake in RR soybeans
treated with glyphosate can increase the susceptibility of RR soybeans
to disease. The presence of glyphosate in the root zone of RR crops can
also promote the growth of certain plant disease organisms that reside
in the soil, such as *Fusarium* fungi.[^32] Even non-RR crops planted in
fields previously treated with glyphosate are more likely to be damaged
by fungal diseases such as Fusarium head blight, as has been
demonstrated with wheat in Canada.[^33] This research suggests that
glyphosate has long-term effects that persist even after its use has
been discontinued. In addition, glyphosate can persist for a long time
in some soils without being degraded, and can be remobilized under
certain conditions, damaging plants grown later.[^34]

When fields are sprayed with Roundup many times a year, year after year,
as is now the case with the widespread adoption of Roundup Ready
varieties of different crops, these changes in soil microorganisms and
mineral nutrient availability may increase the susceptibility of RR
soybeans or other crops following RR soybeans to certain plant diseases,
and may also create the conditions for serious impediments to future
yields.

Surprisingly, Monsanto's field tests of MON 89788 for its phenotypic and
ecological assessments (petition, pp. 66-84), including disease
susceptibility, were conducted without application of glyphosate
(petition, Appendix G, bottom of page 199). Since Roundup Ready crops
are invariably grown with application of glyphosate as part of the
"Roundup Ready soybean system" (petition, p. 4), Monsanto's field tests
without glyphosate application are virtually meaningless for real world
cultivation conditions.

APHIS provides no analysis of the potential for increased disease
susceptibility of MON 89788 grown in the Roundup Ready soybean system,
or of other crops grown in rotation with MON 89788. Instead, APHIS
merely reiterates Monsanto's conclusions concerning disease and insect
susceptibility of MON 98788 in the space of a single sentence (EA, p.
13). APHIS should demand a repeat of these tests with application of
glyphosate in the context of preparing an environmental impact
statement.

*E. APHIS Fails to Analyze the Potential for Damage to Symbiont
Organisms, Reduced Nitrogen Fixation, Reduced Yields and Related
Effects*

Glyphosate is toxic to *Bradyrhizobium japonicum*, an important
nitrogen-fixing symbiont that colonizes soybean roots, due to the
sensitivity of its EPSPS enzyme to inhibition by glyphosate.[^35] This
raises the concern that glyphosate exuded from the roots of
glyphosate-sprayed, Roundup Ready plants could harm this important
symbiont, and thereby decrease RR soy nitrogen fixation, growth and
yield. Several studies conducted in both growth chambers and in the
field have found that glyphosate application to glyphosate-tolerant
soybeans reduces foliar nitrogen content, seed nitrogen content, biomass
and yields, especially under conditions of water stress, early
application of glyphosate, and high application rates.[^36] Roundup
Ready soybeans have been reported to perform more poorly than
conventional soybeans under hot, dry conditions in Brazil and
Paraguay,[^37] perhaps due to adverse impacts on the interaction with
*B. japonicum*, and/or the increased potential for stem-splitting in RR
soybeans in hot conditions.[^38]

Given this suggestive evidence of harm to the symbiont interaction
between *B. japonicum* and soybean roots, and the consequences this
could have for the nutritional content, health and yield of RR soybeans,
it is obviously necessary to test the Roundup Ready soybean system based
on MON 89788 for such effects. Surprisingly, Monsanto's "symbiont
interaction" tests (petition, p. 81) were performed on MON 89788 to
which glyphosate had NOT been applied. In addition, the tests were
conducted under only one moderate temperature and water moisture regime
(petition, Appendix I, pp. 221-222). Thus, this testing has virtually no
value in determining whether or not the MON 89788 Roundup Ready soybean
system is subject to reduced nitrogen fixation, yields or other effects
noted above under real-world production conditions, which include both
application of glyphosate and a range of temperatures and soil moisture
conditions.

APHIS' draft EA not only fails to consider any of the research cited
above, it does not even mention, much less analyze, Monsanto's symbiont
interaction testing. APHIS must require that Monsanto submit appropriate
tests on MON 89788 treated with glyphosate under a range of temperature
and soil moisture conditions to assess these important parameters.

*F. APHIS' Draft EA Fails to Provide a Meaningful Assessment of
Glyphosate-Resistant Weeds Fostered by the Roundup Ready Soybean System,
Alone and in Combination with Other Roundup Ready Crop Systems*

Glyphosate resistance in weeds has developed with incredible rapidity
over just six years, corresponding with the period of widespread
introduction of Roundup Ready soybeans and cotton. In contrast, there
was only one confirmed glyphosate-resistant weed in the U.S. in the 22
years from 1976, when Monsanto first introduced the chemical in the
U.S., through 1998.[^39] Concern began building in 2001, when a farm
journal reported:

> "Resistance to glyphosate (Roundup) is emerging all around the world,
> potentially jeopardizing the 2.5 billion dollar market for genetically
> modified herbicide tolerant crops"[^40]

According to a joint statement by ten prominent weed scientists:

> "It is well known that glyphosate-resistant horseweed (also known as
> marestail) populations have been selected in Roundup Ready soybean and
> cotton cropping systems. Resistance was first reported in Delaware in
> 2000, a mere 5 years after the introduction of Roundup Ready soybean.
> Since that initial report, glyphosate-resistant horseweed is now
> reported in 12 states and is estimated to affect 1.5 million acres in
> Tennessee alone."

The list of confirmed glyphosate-resistant weeds in the U.S. now stands
at seven: Palmer amaranth, common waterhemp, common ragweed, giant
ragweed, horseweed, Italian ryegrass and rigid ryegrass.[^41] Other
weeds being investigated for glyphosate resistance include cocklebur and
lambsquarters,[^42] morning glories[^43] and tropical spiderwort.[^44]
The spread of tropical spiderwort resistant to glyphosate, particularly
in Georgia, is associated with the dramatic increase in Roundup Ready
cotton acreage in recent years. Other weeds developing resistance to
glyphosate, or at risk of the same, include annual grasses such
goosegrass (confirmed glyphosate-resistant biotypes in Malaysia),
foxtails, crowfootgrass, signal grasses, panicums, crabgrasses and
Johnsongrass.[^45]

While glyphosate-resistant weeds are worst in the South and East, they
are rapidly spreading throughout the Midwest. Missouri is now home to at
least three confirmed glyphosate-resistant weeds -- common waterhemp,
common ragweed and horseweed -- and glyphosate-resistant horseweed was
confirmed in Nebraska in 2006. Weed experts in the Midwest are
predicting further spread of glyphosate-resistant weeds in their states.
For instance, Michael Owen, agronomist at Iowa State University, is
concerned that with over 90% of soybeans in Iowa planted to Roundup
Ready varieties, the rapid adoption of Roundup Ready corn will lead
increasingly to "an increasing number of crop acres where glyphosate
will follow glyphosate" in the popular corn-soybean rotation.[^46]
Appendices II and III submitted with these comments contain a number of
scientific, farm press, and related articles that show the high level of
concern about glyphosate-resistant weeds among America's leading weed
scientists.

Monsanto and APHIS continually point out that herbicide-resistance in
weeds is a well-known phenomenon that occurs with many different
herbicides, implying that glyphosate-resistant weeds are not a serious
or special concern. This view is at stark variance with the consensus of
leading American weed scientists. For instance, weed scientist Alan York
of North Carolina State University concedes that: "Resistance is not
unique with glyphosate," but goes on to state that: ***"What makes
glyphosate resistance so important is our level of dependence on
glyphosate***" (emphasis added).[^47]

This "level of dependence" on glyphosate is precisely what both Monsanto
in its petition and APHIS in its draft EA ignore. APHIS' cursory
treatment of glyphosate-resistant weeds offers no meaningful analysis. A
few of the basic issues that APHIS would need to address in a serious
analysis of glyphosate-resistant weeds, but completely fails to discuss,
include:

1\) A quantitative assessment of the increase in glyphosate use in U.S.
agriculture;

2\) Quantitative assessment of increased glyphosate application rates
needed to control various glyphosate-resistant weed species;

3\) Quantitative assessment of the increased frequency of glyphosate
application needed to control various glyphosate-resistant weed species;

4\) Figures or estimates of the portion of the increased use of
glyphosate attributable to Roundup Ready crop systems, including RR
soybeans;

5\) The potential for vastly increased rates of glyphosate-resistant
weed development from the growing trend to plant RR crops every year,
either RR soy following RR soy, or of special concern, RR corn following
RR soybeans in the popular soybean-corn rotation;

6\) Quantitative assessment of the acreage affected by
glyphosate-resistant weeds in soybeans or any other crop;

7\) Prospective assessment of the growth in acreage affected by
glyphosate-resistant weeds based on current trends in glyphosate use and
adoption of RR crop systems, especially RR corn.

Absent such analysis, APHIS' cursory treatment of the
glyphosate-resistant weed issue does not by any stretch of the
imagination amount to analysis of this issue.

The absence of serious analysis of glyphosate-resistant weeds is
particularly puzzling given APHIS' explicit recognition, in 2001, that
weed resistance was an environmental issue that should be analyzed in
environmental impact assessment of herbicide-tolerant crops.[^48] At
that time, APHIS and EPA established a joint working group that required
APHIS to consult with EPA regarding the development of weed resistance
related to new herbicide-tolerant crops, such as Roundup Ready soybeans.
There is no indication in the draft EA that APHIS consulted with EPA on
this issue.

Glyphosate-resistant weeds are already leading to reductions in
conservation tillage, increasing soil erosion, increased production
costs for growers, and a return to more toxic herbicides to control
weeds no longer readily controlled by glyphosate.

Mechanical tillage, once common, has been on the decline for years as
farmers switch to "no-till" or conservation (minimal) tillage practices
in order to reduce labor costs and fuel expenditures, as well as
decrease the soil erosion that often accompanies plowing. The rise of
glyphosate-resistant weeds is beginning to reverse this trend.[^49] For
instance, acreage under conservation tillage in Tennessee dropped by 18%
in 2004, as farmers turned back to the plow to control
glyphosate-resistant horseweed; Tennessee counties with the largest
cotton acreage experienced the largest decline in conservation tillage,
from 80% to just 40%. It is estimated that resistant horseweed has
reduced the area under conservation tillage in Arkansas by 15%, with
similar trends reported in Missouri and Mississippi.[^50] The reduction
in conservation tillage associated with glyphosate-resistant weeds, and
resulting increased soil erosion, is an agronomic and environmental
impact that APHIS needs to analyze in the context of an environmental
impact statement on MON 89788.

An Arkansas weed scientist estimated that the state's growers would have
to spend as much as \$9 million to combat glyphosate-resistant horseweed
in 2004.[^51] Larry Steckel, weed scientist at the University of
Tennessee, estimates that on average, glyphosate-resistant pigweed will
cost cotton growers in the South an extra \$40 or more per acre to
control.[^52] This represents a substantial burden, as cotton farmers'
average expenditure on ***all*** pesticides (insecticides and
herbicides) was \$61 per acre in 2005.[^53] USDA ERS 2007b). Arkansas
extension agent Mike Hamilton estimates that an uncontrolled outbreak of
glyphosate-resistant horseweed in his state has the potential to cost
Arkansas cotton and soybean producers nearly \$500 million in losses,
based on projected loss in yield of 50% in 900,000 acres of Arkansas
cotton and a 25% yield loss in the over 3 million acres of Arkansas
soybeans.[^54]

The potential for economic losses to farmers from glyphosate-resistant
weeds fostered by the Roundup Ready soybean system, in combination with
other Roundup Ready crops systems (corn, cotton) is a serious issue that
APHIS must address in the context of an environmental impact statement
on MON 89788.

Over-reliance on Roundup Ready crops and glyphosate has dampened
research into new herbicides, meaning none are on the horizon.[^55]
Meanwhile, growers will increasingly turn to older, more toxic
herbicides, such as paraquat and 2,4-D, to control glyphosate-resistant
weeds.[^56] The potential for increased use of more toxic herbicides to
control glyphosate-resistant weeds requires serious analysis by APHIS in
the context of an environmental impact statement on MON 89788.

*G. The EA Is Defective Because APHIS Improperly Relied on EPA's and
FDA's Regulations Instead of Conducting an Independent NEPA Evaluation
of the Environmental and Health and Safety Impacts of MON 89788.*

In its EA, APHIS impermissibly relied on EPA's Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 *et seq*.) and
Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 301 *et seq*.)
regulations and failed to conduct an independent NEPA evaluation of the
environmental effects associated with the deregulation.[^57] APHIS
cannot solely rely on another agency's evaluation of environmental
effects under a separate statute to adequately fulfill its own NEPA
obligations.[^58] In *Save Our Ecosystems*, the Ninth Circuit held that
the Forest Service could not rely on EPA's registration process for
herbicides under FIFRA to address environmental impacts pursuant to
NEPA.[^59]

APHIS' reliance on FDA is more problematic given the limited nature of
FDA's process. FDA created a voluntary consultation process in which FDA
receives from biotechnology companies a bare summary of food safety and
nutritional data regarding its proposed crop. The agency does not even
make its own determinations of safety; rather, it merely states its
understanding that a biotechnology company has concluded the crop is
safe, and that further FDA approval or premarket review is not
required.[^60] Moreover, APHIS relied on a FDA process that was not even
complete, but rather notes that "a final FDA decision is pending."[^61]
This cursory process in no way resembles or can be considered
sufficiently equivalent in scope nor depth to the searching, "hard look"
required of APHIS by NEPA. Thus, APHIS must prepare an EIS to address
the pesticide and food issues that it impermissibly deferred to the
other agencies.

*H. The EA Fails to Adequately Analyze Potential Harm to Wildlife,
Including Endangered Wildlife, From the Deregulation of Monsanto's MON
89788, In Violation of NEPA and the Endangered Species Act.*

Recent studies demonstrate that common versions of Roundup herbicide
that contain a surfactant (i.e. POEA, or polyethoxylated tallowamine) to
aid penetration of the active ingredient (glyphosate) into plant tissue
are extremely toxic to the tadpoles and juvenile stages of certain
species of frogs, killing 96-100% of tadpoles after three weeks exposure
and 68-86% of the juveniles after just one day.[^62]

APHIS' draft EA lacks any analysis of the potential impacts of
glyphosate use on MON 89788 on amphibian populations. This issue should
be considered in the context of an environmental impact statement.

APHIS' EA is also inadequate because it fails to address threats to the
endangered species. NEPA requires the agency to consider "the degree to
which the action may adversely affect an endangered or threatened
species or its habitat . . ."[^63] Potential threat to an endangered
species is a significant environmental impact that must be reviewed in
an EIS. [^64]

APHIS says it analyzed the potential impacts on species, see EA at 9-10.
However APHIS' analysis was anything but specific to the deregulation at
issue. APHIS did not consult with anyone from a Service agency such as
Fish and Wildlife. Rather, APHIS merely looked at the *general*,
non-specific listing of *all* threatened and endangered species on the
FWS website. APHIS determined the new promoter of MON 89788 would have
"no effect" on any protected species because it had love mammalian
toxicity and its potential to be a food allergen was minimal.[^65]

This fails to comport with NEPA or the ESA.

*I. The EA's Analysis of Impacts on Agricultural Commodities and Organic
Farming Is Inadequate.*

The direct socio-economic impact associated with any agency action in
granting a permit for field testing of a regulated article must be
analyzed prior to taking such action. Indeed, the Council on
Environmental Quality (CEQ) regulations implementing NEPA state that
such impacts must be analyzed.[^66] Specifically, the CEQ regulations
state: When an environmental impact statement is prepared and economic
or social and natural or physical environmental impacts are related,
then the environmental impact statement will discuss all of these
effects on the human environment.[^67] The economic impacts are related,
indeed intertwined with the environmental impacts because the economic
impacts stem directly from the fundamental change to the conventional,
organic, or wild plant, i.e., the genetic contamination from GE crops.

Federal courts have also upheld that NEPA requires, where economic
analysis forms the basis of choosing among alternatives, that the
analysis not be misleading, biased or incomplete.[^68] As one court has
noted, "In some instances environmental costs may outweigh economic and
technical benefits and in other instances they may not. But NEPA
mandates a rather finely tuned systematic balancing analysis in each
instance."[^69] Another Court has recently held that the intertwined
economic impacts on organic farmers of the deregulation of a genetically
engineered crop must be analyzed in an EIS.[^70]

In this instance, the USDA has failed to provide adequate analysis of
the socio-economic impacts on farmers and food processors whose crops or
food products are contaminated with MON 89788. The agency's EA fails to
adequately address these impacts on farmers, users or exporters of
either organic and conventional, non-genetically engineered crops.
Indeed, given the Plant Protection Act's (PPA) goal of addressing U.S.
agricultural product exports and imports, this failure is even more
egregious.[^71] The impact of MON 89788 contamination must be adequately
assessed.

With regard to impacts on organic farming, first, the draft EA assumes
that the responsibility for preventing contamination of organic
production falls on the organic producer, rather than on the
manufacturer of this GE soy variety or farmers who grow it. Second, it
fails to evaluate whether and to what extent segregation of MON 89788
from conventional soy is possible. APHIS failed to evaluate, require or
describe steps that Monsanto or those who buy and plant its Roundup
Ready soy could take to minimize or eliminate contamination of
neighboring crops or to limit the spread. Third, the EA assumes that the
only potential problem for organic producers is whether and how they
could continue to be certified as organic. APHIS ignores the separate
and distinct question, whether soy contaminated with genes from
Monsanto's soy could be marketed as organic production.

The EA claims that it is "not likely" that organic farmers or other
farmers will be significantly impacted by the expected commercial use of
MON 89788. EA at 13. APHIS claims there will be no impacts on organic
farmers because the presence of a detectable residue of a product of
excluded methods (i.e. transgenic) does not necessarily constitute a
violation of the National Organic Standards. This analysis is incomplete
and devoid of any analysis about the current organic marketplace. During
the implementation of the Organic Food Production Act the USDA made it
clear that the agency views the organic rule as a marketing standard
based upon consumer expectations. This approach was stated in its
treatment of "excluded methods" (i.e. genetic engineering). The USDA has
stated:

> Products created with modern biotechnology techniques have been
> tested, approved by the appropriate regulatory agencies and can be
> used safely in general agricultural production. At the same time,
> consumers have made clear their opposition to use of these techniques
> in organic food production. This rule is a marketing standard, not a
> safety standard. Since the use of genetic engineering in the
> production of organic foods runs counter to consumer expectations,
> foods produced through excluded methods will not be permitted to carry
> the organic label. 65 Fed. Reg. 13534-35 (March 23, 2000) (emphasis
> added).

Therefore it is not clear whether the marketplace in organic will accept
any "adventitious presence" of genetically engineered soy or other
crops. In addition, many manufacturers and farmers undertake significant
efforts (and financial burdens) to ensure that their products do not use
plants contaminated with "adventitious presence." If APHIS is going to
make such an assertion, it must analyze whether the marketplace and
market-based standards will actually tolerate "adventitious presence"
and the impact that such a tolerance will have on organic agricultural
producers, processors, and consumers.

APHIS must adequately analyze the socio-economic impacts of the proposed
deregulation on organic producers, in compliance with NEPA, in an EIS.

*J. The EA's "Analysis" of Alternatives is Inadequate.*

APHIS' analysis of [alternatives]{.underline} in the EA was insufficient
because APHIS failed to adequately analyze the alternatives it
identified in the EA.[^72] EAs must include analysis of the alternatives
to the proposed action.[^73] APHIS makes nothing more than an
inadequate, perfunctory and cursory showing, lacking any real analysis,
of the other alternatives besides the preferred alternative. The
alternative of partial deregulation (alternative C) is mentioned at the
outset and then never discussed again, let alone "analyzed."[^74] The no
action alternative (alternative A) is also mentioned as an alternative;
[^75] afterwards, the EA adds a meaningless, tacked-on sentence to the
end of several paragraphs, presumably in order to make the appear that
it actually analyzed this alternative. This is not meaningful analysis
and is inadequate to comply with NEPA.

NEPA requires that federal agencies consider alternatives to recommended
actions whenever those actions "involve\[ \] unresolved conflicts
concerning alternative uses of available resources."[^76] The goal of
the statute is to ensure "that federal agencies infuse in project
planning a thorough consideration of environmental values."[^77] The
consideration of alternatives requirement furthers that goal by
guaranteeing that agency decision-makers "\[have\] before \[them\] and
take \[ \] into proper account all possible approaches to a particular
project (including total abandonment of the project) which would alter
the environmental impact and the cost-benefit balance."[^78] NEPA's
requirement that alternatives be studied, developed, and described both
guides the substance of environmental decision-making and provides
evidence that the mandated decision-making process has actually taken
place.[^79] Informed and [meaningful]{.underline} consideration of
alternatives-including the no action alternative-is thus an integral
part of the statutory scheme.[^80]

**III. APHIS Failed to Adequately Assess the Cumulative Impacts of
Deregulation of MON 89788**

The deficient draft EA failed to adequately address several significant
issues, such as the cumulative impacts of increasing glyphosate use from
the Roundup Ready soybean system, combined with other Roundup Ready crop
systems, and the potential impacts from future "stacking" of MON 89788
with other GE soybean varieties.

APHIS utterly fails to address or analyze *any* cumulative impacts
anywhere in the EA. This is arbitrary and capricious action and a
violation of NEPA.[^81]

NEPA requires agencies to consider the cumulative impacts of their
proposed actions.[^82] By definition, cumulative effects must be
evaluated along with direct and indirect effects of a project and its
alternatives. "'Cumulative impact' is the impact on the environment
which results from the incremental impact of the action when added to
other past, present, and reasonably foreseeable future actions
regardless of what agency or person undertakes such other actions."[^83]
Individually minor, but collectively significant actions, taking place
over time, can generate cumulative impacts.[^84]

Analyzing cumulative impacts in EAs is crucial: The Council on
Environmental Quality has noted that "in a typical year, 45,000 EAs are
prepared compared to 450 EISs\.... Given that so many more EAs are
prepared than EISs, adequate consideration of cumulative effects
requires that EAs address them fully."[^85] A meaningful cumulative
impact analysis, according to the D.C. Circuit, must identify

> \(1\) the area in which the effects of the proposed project will be
> felt; (2) the impacts that are expected in that area from the proposed
> project; (3) other actions--past, present, and proposed, and
> reasonably foreseeable--that have had or are expected to have impacts
> in the same area; (4) the impacts or expected impacts from these other
> actions; and (5) the overall impact that can be expected if the
> individual impacts are allowed to accumulate.[^86]

In this case, APHIS [failure to identify and analyze any of those
cumulative impacts]{.underline} is egregiously violative of NEPA.[^87]
Nowhere in the draft EA does APHIS analyze the cumulative affects of the
deregulation of MON 89788; in fact, APHIS [cannot]{.underline}
adequately address those impacts, as [it does not know]{.underline},
*inter alia*, the extent of Monsanto's future crossing of the MON 89788
with progeny. The cumulative impacts of "stacking" require an EIS be
prepared.

*A. APHIS Wholly Fails to Assess the Impacts of Increasing Glyphosate
Use*

The Roundup Ready soybean system, combined with the Roundup Ready cotton
and corn systems, have dramatically increased glyphosate use over the
past 15 years. The adverse impacts addressed in Section II. are all
attributable in whole or in part to the increasing volume and frequency
of glyphosate application in U.S. agriculture. APHIS' failure to
quantitatively assess glyphosate use, Roundup Ready crop acreage, and
associated adverse agronomic and environmental impacts must be remedied
in the context of an environmental impact statement.

Roundup Ready cotton comprised 82% of total cotton acreage in 2006.[^88]
Roundup Ready soybeans comprised 89% of soybean acreage in 2006. The
introduction in 2006 of Roundup Ready Flex cotton, which tolerates twice
the application rate of original RR cotton and also permits glyphosate
application throughout the cotton plant's growing season,[^89] promises
to lead to continued increases in glyphosate use on cotton. Roundup
Ready corn, however, presents the greatest potential for increased
glyphosate use.

Acreage planted to Roundup Ready corn is growing at an extremely rapid
clip, from just 7.8 million acres in 2002 to 24.8 million acres in 2005,
to 32.7 million acres in 2006.[^90] Glyphosate use on corn has increased
even more rapidly, from 3.3 million lbs. in 2002 to an astounding 23.9
million lbs. in 2005, the latest year for which USDA statistics are
available.[^91] Thus, as RR corn acreage roughly tripled in the four
years from 2002 to 2005, glyphosate use on corn has increased by more
than seven-fold. In 2002, Roundup Ready corn represented 11% of overall
U.S. corn acreage, increasing to 26% of corn acreage in 2005.[^92] Thus,
the seven-fold increase in glyphosate use on corn from 2002 to 2005 came
during a period when RR corn acreage increased from just 11% to 26% of
all corn. RR corn acreage jumped to 36% of all corn in 2006.[^93]
Clearly, if present trends continue, glyphosate use on America's most
widely planted crop could easily increase by five- to ten-fold by the
end of the decade.

This development is of great relevance to the Roundup Ready soybean
system because fully 71% of U.S. soybean acreage is rotated to corn
(petition, p. 116). Since 89% of soybean acreage was planted to Roundup
Ready soy in 2006, roughly 63% of U.S. soybean acreage represents
Roundup Ready soy that is rotated to corn. If the RR corn percentage of
overall corn acreage continues to climb, as appears likely, the coming
years will see a huge increase in the frequency and amount of glyphosate
applications. Another 13% of soybean acreage is followed by soybeans
(petition, p. 116), thus another 11.6% of soybeans represents Roundup
Ready soybeans followed by RR soy.

APHIS completely fails to analyze the agronomic and environmental
impacts of this dramatically increasing use of glyphosate driven by the
Roundup Ready soybean system in combination with other Roundup Ready
crop systems. These cumulative impacts must be addressed in the context
of an environmental impact statement.

*B. APHIS' Fails to Adequately Assess the Impacts of Stacking MON 89788
with Other GE Soybean Varieties*

Monsanto's petition requests deregulation not only of MON 89788, but
also of any progeny derived from crosses between MON 89788 and other
soybean lines, including GE soybeans that have been granted nonregulated
status. Thus, the requested deregulation constitutes prospective
deregulation of so-called "stacked" GE soybean varieties with the MON
89788 genetic modification and one or more additional biotechnology
traits, whether already deregulated or to be deregulated in the future.

APHIS' fails to adequately assess the potential agronomic, environmental
and human health impacts of this "free license" to Monsanto to generate
progeny combining MON 89788 with one, two, three or any number of other
GE traits.

According to experts in the risk assessment process for GE foods,
"stacked" crops require application of more sophisticated testing
techniques, such as metabolic profiling, than single-trait GE crops due
to the enhanced potential for hazardous unintended effects that
accompanies trait-stacking.

> "Present approaches to detecting expected and unexpected changes in
> the composition of genetically modified food crops are primarily based
> on measurements of single compounds (targeted approach)."
>
> "The targeted approach has severe limitations with respect to unknown
> anti-nutrients and natural toxins, especially in less well known
> crops."
>
> "In order to increase the possibility of detecting secondary effects
> due to the genetic modification of plants that have been extensively
> modified, new profiling methods are of interest and should be further
> developed and validated (non-targeted approach). ***Application of
> these techniques is of particular interest for genetically modified
> foods with extensive genetic modification (gene stacking)*** meant to
> improve agronomical and/or nutritional characteristics of the food
> plant."[^94]

Therefore, it would be extremely irresponsible of APHIS to grant
permanent deregulation to any and all progeny of MON 89788 containing
both the RR gene and any number of other GE traits introduced into other
lines. APHIS' serious error here lies in its unscientific assumption
that the stacking of various GE traits does nothing more than "add" an
additional trait. As indicated above, the traits expressed by the
various deregulated GE soybean lines that may be combined with MON
89788, and/or unintended effects associated with these stacked lines,
could interact, increasing the potential for hazardous effects such as
generation of novel toxins or allergens, increased levels of naturally
occurring, low-level toxins or allergens, or decreased nutritional
content. We note that soybeans are known as a major allergenic food,
containing a number of allergenic proteins. These effects could be
generated by the interaction of the traits in various individual,
single-trait lines that each, taken by itself, may be unobjectionable.
Therefore, we urge APHIS to deny Monsanto a "free license" to combine
MON 89788 with any and all other deregulated GE soybean lines.

We note that USDA's past practice has been to subject at least some
stacked GE crops to a separate review process. Of currently deregulated
GE crops, 12 of 71 or 17% are stacked varieties. Of the GE crops
currently up for deregulation, 1 of 10 are stacked.[^95] In addition,
APHIS does see fit to address a small subset of possible stacked progeny
of MON 89788 in two paragraphs (EA, pp. 11-12). It defies logic to
consider a small subset of potential stacked varieties containing MON
89788 if the deregulation to be granted is permanent, and allows
prospective stacking of MON 89788 with GE soybeans to be deregulated in
the future.

APHIS considers only the currently deregulated GE LibertyLink soybean
line, which is engineered for tolerance to glufosinate. Yet Pioneer has
two GE soybean varieties up for deregulation (high oleic soybeans and a
soybean line that is resistant to both glyphosate as well as
acetolactate synthase-type herbicides).[^96] Many other GE soybeans are
undergoing field-tests, and may be commercialized in the future.

One potential stacked GE crop that would be covered if USDA grants the
petition is a GE soybean variety derived from a cross of MON 89788 and
MON-04032-6. This could potentially result in a soybean variety with
tolerance to greater levels of glyphosate. This would be very
disturbing, as it would almost surely lead to still greater use of
glyphosate, with all its negative impacts, than would be the case with
MON 89788 alone. Or, MON 89788 could be stacked with Pioneer's
dual-herbicide resistant soybean (which is tolerant to glyphosate), with
a possibly similar effect. A precedent for a RR crop with increased
tolerance to glyphosate is Monsanto's "2^nd^ generation" Roundup Ready
Flex cotton, alluded to above.

APHIS must conduct separate environmental assessments or environmental
impact statements for each stacked variety of soybean containing MON
89788, and not grant a free license to Monsanto to combine MON 89788
with any other GE soybean line it chooses in the future.

As with the other issues (and arguably more so by its very nature),
cumulative impacts analyses are action-specific, site-specific, and must
be undertaken for each EA, for each final agency action for which NEPA
is to be complied. The EA is arbitrary and capricious action.[^97]  

**IV. Failure of FDA to Review or Approve the Monsanto's GE Soybean
Argues Strongly Against Deregulation**

FDA has not completed a voluntary consultation on Monsanto's MON 89788
(EA at 5). APHIS is not competent to judge whether MON 89788 or any of
its prospective stacked progeny present human health risks.

In sum, APHIS' dismal failure to carry out its regulatory
responsibilities provides more than sufficient grounds to justify a
refusal to deregulate MON 89788, [until and unless APHIS proves itself
capable of properly regulating GE crops in general.]{.underline}

**CONCLUSION**

**For the foregoing reasons, we request that the petition for
nonregulated status for MON 89788 be denied, or in the alternative, that
APHIS prepare an EIS adequately addressing all the significant
environmental impacts of this action.**

Respectfully submitted,

Bill Freese

Science Policy Analyst

The Center for Food Safety

George Kimbrell

Staff Attorney

The Center for Food Safety

[^1]: Freese, W. and D. Schubert (2004). "Safety Testing and Regulation
    of Genetically Engineered Foods," *Biotechnology and Genetic
    Engineering Reviews*, Volume 21, November 2004.
    http://www.foe.org/camps/comm/safefood/gefood/testingregbackgrounder.pdf

[^2]: 42 U.S.C. § 4332(2)(C).

[^3]: *Robertson v. Methow Valley Citizens Council,* 490 U.S. 332,
    349(1989).

[^4]: 42 U.S.C. § 4331(a).

[^5]: [Found. on Economic Trends v. Heckler]{.underline}, 756 F.2d 143,
    147 (D.C. Cir. 1985) (quoting S. Rep. No. 91-296 (1969)).

[^6]: 40 C.F.R. § 1508.8(b); [Baltimore Gas & Elec. Co. v.
    NRDC]{.underline}, 462 U.S. 87, 106 (1983)(explaining that "NEPA
    requires an EIS to disclose the significant health, socioeconomic,
    and cumulative consequences of the environmental impact of a
    proposed action.").

[^7]: 42 U.S.C. § 4332(2)(C).

[^8]: 40 C.F.R. § 1508.9.

[^9]: *Id.*

[^10]: *Save the Yaak v. Block*, 840 F.2d 714, 717 (9^th^ Cir. 1988).

[^11]: [Id.]{.underline}

[^12]: [See]{.underline} 42 U.S.C. §§ 4321, 4344.

[^13]: 40 C.F.R. § 1500.3.

[^14]: 40 C.F.R. §§ 1500.3, 1507.1; see, e.g., Hodges v. Abraham, 300
    F.3d 432, 438 (4th Cir. 2002).

[^15]: See 40 C.F.R. §§ 1502.4, 1508.8, 1508.18, & 1508.25.

[^16]: *Anderson v. Evans*, 371 F.3d 475, 487 (9th Cir. 2004).

[^17]: *National Parks & Conservation Ass\'n v. Babbitt*, 241 F.3d 722,
    731 (9th Cir. 2001).

[^18]: *Ocean Advocates v. U.S. Army Corps of Engineers*, 402 F.3d at
    865 (9th Cir. 2005) (*citing Nat'l Parks*, 241 F.3d at 731).

[^19]: 7 C.F.R. § 372.4

[^20]: 40 Fed. Reg. § 1508.27(b)(2).

[^21]: 40 Fed. Reg. § 1508.27(b)(5).

[^22]: 40 Fed. Reg. § 1508.27(b)(7).

[^23]: 40 Fed. Reg. §§ 1508.27(b)(2), (5), (7)

[^24]: Wilson, A.K. et al (2006). "Transformation-induced mutations in
    transgenic plants: analysis and biosafety implications,"
    *Biotechnology and Genetic Engineering Reviews*, Vol. 21, Dec. 2006,
    pp. 209-234.

[^25]: Freese, W. and D. Schubert, op. cit.

[^26]: *Environmental Effects of Transgenic Plants: The Scope and
    Adequacy of Regulation*. Committee on Environmental Impacts
    associated with Commercialization of Transgenic Plants, National
    Research Council, National Academy of Sciences, Washington, DC:
    National Academy Press, 2002.
    http://books.nap.edu/catalog/10258.html.

[^27]: Neumann, G. et al. (2006). "Relevance of glyphosate transfer to
    non-target plants via the rhizosphere," *Journal of Plant Diseases
    and Protection* 20:963-969; Lorenz, N. and R. Dick, eds. (2006).
    "Proceedings of the Glyphosate Potassium Symposium 2006," hosted by
    AG Spectrum of Iowa, and the School of Environment and Natural
    Resources, Ohio State University, July 25-26, 2006.

[^28]: Cerdeira, A.L. and S.O. Duke (2006). "The current status and
    environmental impacts of glyphosate-resistant crops: a review," *J.
    Environ. Quality* 35:1633-1658.

[^29]: Motavalli, P.P. et al. (2004). "Impact of genetically modified
    crops and their management on soil microbially mediated plant
    nutrient transformations," *J. Environ. Qual.* 33:816-824; Kremer,
    R.J. et al. (2005). "Glyphosate affects soybean root exudation and
    rhizosphere microorganisms," *International J. Analytical Environ.
    Chem.* 85:1165-1174; Eker, S. et al. (2006). "Foliar-applied
    glyphosate substantially reduced uptake of iron and manganese in
    sunflower (Helianthus annuus L.) plants," *J. Agric. Food Chem.*,
    published on web 12/08/2006.

[^30]: Gordon, B. (2006). "Manganese nutrition of glyphosate-resistant
    and conventional soybeans," in Great Plains Soil Fertility
    Conference Proceedings, Denver, CO, March 7-8, p. 224-226.

[^31]: Bernards, M.L. et al. (2005). "Glyphosate interaction with
    manganese in tank mixtures and its effect on glyphosate absorption
    and translocation," *Weed Science* 53: 787-794

[^32]: Kremer et al (2005), op. cit.; for an early overview, see
    Benbrook (2001), "Troubled Times Amid Commercial Success for Roundup
    Ready Soybeans: Glyphosate Efficacy is Slipping and Unstable
    Transgene Expression Erodes Plant Defenses and Yields," AgBioTech
    InfoNet Technical Paper No. 4, May 2001.
    http://www.biotech-info.net/troubledtimes.html.

[^33]: Fernandez, M.R., et al. (2005). "Crop production factors
    associated with Fusarium Head Blight in spring wheat in Eastern
    Saskatchewan," *Crop Sci.* 45:1908-1916.

[^34]: Cornish, P.S. and S. Burgin (2005). *Residual effects of
    glyphosate herbicide in ecological restoration, Restoration Ecology*
    13: 695-702.

[^35]: Zablotowicz, R.M. and K.N. Reddy (2007), "Nitrogenase activity,
    nitrogen content, and yield responses to glyphosate in
    glyphosate-resistant soybean," *Crop Protection* 26: 370-376.

[^36]: Zablotowicz et al (2007), op. cit.; King, C.A., L.C. Purcell and
    E.D. Vories (2001). "Plant growth and nitrogenase activity of
    glyphosate-tolerant soybean in response to foliar glyphosate
    applications," Agron. J. 93: 179-186.

[^37]: FoEI (2007). "Who Benefits From GM Crops: An Analysis of the
    Global Performance of GM Crops (1996-2006)," Friends of the Earth
    International, January 2007, Sections 4.10 & 5.2.
    http://www.foei.org/publications/pdfs/gmcrops2007full.pdf.

[^38]: Coghlan, A. (1999). "Monsanto's modified soya beans are cracking
    up in the heat," New Scientist, Nov. 20, 1999.

[^39]: The sole resistant weed by 1998 was rigid ryegrass in California.
    See website of The Weed Science Society of America.
    http://www.weedscience.org/Summary/UspeciesMOA.asp?lstMOAID=12&FmHRACGroup=Go

[^40]: Farmers Weekly (2001). "Glyphosate resistance is showing a
    worldwide rise," *Farmers Weekly*, Nov. 23, 2001.
    http://www.connectotel.com/gmfood/fw231101.txt.

[^41]: http://www.weedscience.org/Summary/UspeciesMOA.asp?lstMOAID=12&FmHRACGroup=Go

[^42]: Roberson, R. (2006). "Pigweed not only threat to glyphosate
    resistance," Southeast Farm Press, Oct. 19, 2006.

[^43]: UGA (2004). "Morning glories creeping their way around popular
    herbicide, new UGA research reports," University of Georgia, August
    23, 2004.

[^44]: USDA ARS (2004). "Little-known weed causing big trouble in
    Southeast," USDA ARS News Service, August 24, 2004.

[^45]: Robinson, E. (2005). "Will weed shifts hurt glyphosate's
    effectiveness?" Delta Farm Press, Feb. 16, 2005.

[^46]: Owen, M.D.K. (2005). "Update 2005 on Herbicide Resistant Weeds
    and Weed Population Shifts," 2005 Integrated Crop Management
    Conference, Iowa State University.

[^47]: Yancy, C. (2005). "Weed scientists develop plan to combat
    glyphosate resistance," Southeast Farm Press, June 3, 2005.

[^48]: 67 Fed. Reg. 60934, 60939, Sept. 27, 2002.

[^49]: APHIS, following Monsanto, attributes the rise of conservation
    tillage to adoption of RR crops in the draft EA (EA, p. 3). It is
    interesting that APHIS adopts Monsanto's view here, in light of the
    fact that a USDA expert notes that the steep rise in conservation
    tillage (at least in soybeans) came from 1990-1996, before the
    introduction of RR soy, and that the share of soybean acres grown
    with conservation tillage stagnated after 1996. See
    Fernandez-Cornejo & McBride (2002), "Adoption of Bioengineered
    Crops," U.S. Dept. of Agriculture, Economic Research Service,
    Agricultural Economic Report No. 810, May 2002, p. 29.

[^50]: Steckel, L., S. Culpepper and K. Smith (2006). "The Impact of
    Glyphosate-Resistant Horseweed and Pigweed on Cotton Weed Management
    and Costs," presentation at Cotton Incorporated's "Crop Management
    Seminar," Memphis, 2006.
    http://www.cottoninc.com/CropManagementSeminar2006/SeminarProceedings/images/Steckle%20Larry.pdf

[^51]: AP (2003). "Weed could cost farmers millions to fight,"
    *Associated Press*, 6/4/03,
    http://www.biotech-info.net/millions_to_fight.html.

[^52]: Laws, F. (2006a). "Glyphosate-resistant weeds more burden to
    growers' pocketbooks," *Delta Farm Press*, November 27, 2006,
    http://deltafarmpress.com/news/061127-glyphosate-weeds/

[^53]: USDA ERS (2007b). Cost and return data for cotton production:
    1997-2005. USDA Economic Research Service, last accessed January 12,
    1997.
    http://www.ers.usda.gov/data/CostsandReturns/data/recent/Cott/R-USCott.xls

[^54]: James, L. (2005). "Resistant weeds could be costly," Delta Farm
    Press, July 21, 2005.

[^55]: Mueller, T.C., P.D. Mitchell, B.G. Young and A.S. Culpepper
    (2005). "Proactive versus reactive management of
    glyphosate-resistant or --tolerant weeds," *Weed Technology*
    19:924-933; Yancy, C.H. (2005). "Weed scientists develop plan to
    combat glyphosate resistance," *Southeast Farm Press*, June 1, 2005.
    http://southeastfarmpress.com/mag/farming_weed_scientists_develop/.

[^56]: Roberson (2006), op. cit.

[^57]: EA at 5.

[^58]: *Save Our Ecosystems v. Clark*, 747 F.2d 1240, 1248 (9th Cir.
    1984); *Or. Envtl. Council v. Kunzman*, 714 F.2d 901, 905 (9th Cir.
    1983).

[^59]: 747 F.2d at 1248 (explaining that FIFRA only requires a
    cost-benefit analysis and holding that FIFRA "does not require or
    even contemplate the same examination that the \[agency\] is
    required to undertake under NEPA"); see also Wash. Toxics Coal. v.
    U.S. EPA, 413 F. 3d 1024, 1032 (9th Cir. 2005).

[^60]: See 57 Fed. Reg. 22984 (FDA's Policy on Foods Derived from New
    Plant Varieties).

[^61]: EA at 5.

[^62]: Relyea, R.A. (2005a). "The impact of insecticides and herbicides
    on the biodiversity and productivity of aquatic communities,"
    *Ecological Applications* 15(2): 618-627; Relyea, R.A. (2005b). "The
    lethal impact of Roundup on aquatic and terrestrial amphibians,"
    *Ecological Applications* 15(4): 1118-1124.

[^63]: 40 Fed. Reg. § 1508.27 (b)(9).

[^64]: 40 Fed. Reg. § 1508.27 (b)(9).

[^65]: EA at 9.

[^66]: The Supreme Court has held that the regulations are entitled to
    substantial deference by the courts. [Marsh v. Oregon Natural
    Resources Council]{.underline}, 490 U.S. 360, 372 (1989).

[^67]: 40 C.F.R. § 1508.14

[^68]: [Seattle Audubon Society v. Lyons]{.underline}, 871 F. Supp.
    1291, 1324 (W.D. WA 1994).

[^69]: [Sierra Club v. Sigler]{.underline}, 695 F.2d 957, 978 (5^th^
    Cir. 1983).

[^70]: *Geertson Seed Farms v. Johanns*, 2007 WL 518624 (N.D. Cal.
    February 12, 2007).

[^71]: [See generally]{.underline} 7 U.S.C. 7701.

[^72]: *See* *Bob Marshall Alliance v. Hodel*, 852 F.2d 1223, 1228 (9th
    Cir. 1988).

[^73]: [Id.]{.underline} at 1229 ("consideration of alternatives
    requirement is both independent of, and broader than, the EIS
    requirement. In short, any proposed federal action involving
    unresolved conflicts as to the proper use of resources triggers
    NEPA\'s consideration of alternatives requirement, whether or not an
    EIS is also required.")

[^74]: EA at 6.

[^75]: EA at 5;

[^76]: 42 U.S.C. § 4332(2)(E).

[^77]: [Conner v. Buford]{.underline}, 836 F.2d 1521, 1532 (9^th^ Cir.
    1988).

[^78]: [Calvert Cliffs\' Coordinating Committee, Inc. v. United States
    Atomic Energy Commission]{.underline}, 449 F.2d 1109, 1114
    (D.C.Cir.1971) (emphasis added).

[^79]: [Id.]{.underline}

[^80]: *See* [Bob Marshall Alliance v. Hodel]{.underline}, 852 F.2d
    1223, 1228 (9th Cir. 1988).

[^81]: *See* 40 C.F.R. § 1508.25; [Kern v. U.S. Bureau of Land
    Mgmt]{.underline}., 284 F.3d 1062, 1076 (9th Cir. 2002).

[^82]: 40 C.F.R. § 1508.25(c); [Utahns for Better Transp. v. United
    States Dep\'t of Transp.]{.underline}, 305 F.3d 1152, 1172 (10th
    Cir.2002); [Kern v. United States Bureau of Land Mgmt.]{.underline},
    284 F.3d 1062, 1076 (9th Cir.2002); [Vill. of Grand View v.
    Skinner]{.underline}, 947 F.2d 651, 659 (2d Cir.1991).

[^83]: 40 C.F.R. § 1508.7.

[^84]: [Id.]{.underline}

[^85]: Council on Environmental Quality, *Considering Cumulative Effects
    Under the National Environmental Policy Act* at 4, Jan. 1997,
    [available at]{.underline} http://
    ceq.eh.doe.gov/nepa/ccenepa/ccenepa.htm (last visited Feb. 26, 2002)
    (emphasis added).

[^86]: [Grand Canyon Trust v. F.A.A.,]{.underline} 290 F.3d 339, 345
    (D.C. Cir. 2002).

[^87]: [Kern v. U.S. Bureau of Land Mgmt.,]{.underline} 284 F.3d 1062,
    1076-77 (9th Cir. 2002).

[^88]: Calculated from: USDA AMS (2006). "Cotton Varieties Planted: 2006
    Crop," U.S. Dept. of Agriculture, Agricultural Marketing Service,
    Cotton Program, August 2006.
    http://www.ams.usda.gov/cottonrpts/MNXLS/mp_cn833.xls.

[^89]: Bennett, D. (2005). "A look at Roundup Ready Flex cotton," *Delta
    Farm Press*, 2/24/05,
    http://deltafarmpress.com/news/050224-roundup-flex/.

[^90]: "Monsanto biotechnology trait acreage: fiscal years 1996 to
    2006," updated Oct. 11, 2006.
    http://www.monsanto.com/monsanto/content/investor/financial/reports/2006/Q42006Acreage.pdf.

[^91]: USDA NASS (2006). "Agricultural Chemical Usage: 2005 Field Crops
    Summary," National Agricultural Statistics Service, U.S. Dept. of
    Agriculture, May 2006.
    <http://usda.mannlib.cornell.edu/usda/nass/AgriChemUsFC//2000s/2006/AgriChemUsFC-05-17-2006.pdf>;
    USDA NASS (2003). "Agricultural Chemical Usage: 2002 Field Crops
    Summary," National Agricultural Statistics Service, U.S. Dept. of
    Agriculture, May 2003.
    <http://usda.mannlib.cornell.edu/usda/nass/AgriChemUsFC//2000s/2003/AgriChemUsFC-05-14-2003.pdf>

[^92]: USDA ERS (2006). "Adoption of Genetically Engineered Crops in the
    U.S.: Corn Varieties," USDA, Economic Research Service,
    <http://www.ers.usda.gov/Data/BiotechCrops/ExtentofAdoptionTable1.htm>.
    Note that the cited percentages of overall corn acreage planted to
    Roundup Ready corn are calculated by adding the figures for
    "herbicide-tolerant only" and "stacked gene varieties." Stacked gene
    varieties contain the herbicide-tolerant trait as well as an
    insect-resistant trait. A small but unknown proportion of
    "herbicide-tolerant only" and "stacked gene" corn varieties are
    engineered for tolerance to Liberty herbicide (LibertyLink corn). We
    follow Monsanto in discounting the contribution of LibertyLink corn
    and assuming all HT corn is Roundup Ready (petition, pp. 116-17).

[^93]: USDA ERS (2006), op. cit.

[^94]: [Kuiper, H.A.., Kleter, G.A., Noteborn, H..P,J.M.,
    Kok,]{.smallcaps} E.J. (2001). Assessment of the food safety issues
    related to genetically modified foods. *The Plant Journal*
    **27**(6), 503-528.

[^95]: See <http://www.aphis.usda.gov/brs/not_reg.html>, updated to
    March 23, 2007.

[^96]: See <http://www.aphis.usda.gov/brs/not_reg.html>, bottom of
    webpage.

[^97]: [See]{.underline} [Klamath-Siskiyou Wildlands Center v. Bureau of
    Land Management]{.underline}, 387 F.3d 989, 997 (9th Cir. 2004)
    (finding EAs to be insufficient for failure to consider the specific
    incremental impact that would be expected from the specific timber
    sales at issue); [Muckleshoot Indian Tribe v. US Forest
    Service]{.underline}, 177 F.3d 800, 811 (9th Cir. 1998)
    (invalidating and EIS because the "cumulative effects" analysis
    "merely provide\[d\] very broad and general statements devoid of
    specific, reasoned conclusions").