NATIONAL ENVIRONMENTAL POLICY ACT DECISION

AND

PRELIMINARY FINDING OF NO SIGNIFICANT IMPACT

Dow AgroSciences

Event DAS-81419-2 Soybean

United States Department of Agriculture

Animal and Plant Health Inspection Service

Biotechnology Regulatory Services

The United States Department of Agriculture (USDA) Animal and Plant Health Inspection 

Service (APHIS) has developed this decision document to comply with the requirements of the 

National Environmental Policy Act (NEPA) of 1969, as amended, the Council of Environmental 

Quality’s (CEQ) regulations implementing NEPA, and the USDA APHIS NEPA implementing 

regulations and procedures. This NEPA decision document, a Finding of No Significant Impact 

(FONSI), sets forth APHIS’ NEPA decision and its rationale. Comments from the public 

involvement process were evaluated and considered in developing this NEPA decision.

In accordance with APHIS procedures implementing NEPA (7 CFR part 372), APHIS has 

prepared an Environmental Assessment (EA) to evaluate and determine if there are any 

potentially significant impacts to the human environment from a determination on the regulated 

status of genetically engineered (GE) event DAS-81419-2 soybean, the subject of a petition 

request (APHIS Number 12-272-01p) by Dow AgroSciences LLC (Dow AgroSciences). The

DAS-81419-2 soybean is resistant to the herbicide, glufosinate, and also resistant to lepidopteran 

insects. The EA has been prepared in order to specifically evaluate the effects on the quality of 

the human environment that may result from approving the petition seeking nonregulated status 

for DAS-81419-2 soybean. The EA assesses alternatives to a determination of nonregulated 

status of DAS-81419-2 soybean and analyzes the potential environmental and social effects that 

result from the proposed action and the alternatives.

Regulatory Authority

“Protecting American agriculture” is the basic charge of APHIS. APHIS provides leadership in 

ensuring the health and care of plants and animals. The agency improves agricultural 

productivity and competitiveness, and contributes to the national economy and the public health. 

USDA asserts that all methods of agricultural production (conventional, organic, or the use of 

GE varieties) can increase farm income, and provide benefits to the environment and consumers.

Since 1986, the United States government has regulated GE organisms pursuant to a regulatory 

framework known as the Coordinated Framework for the Regulation of Biotechnology 
(Coordinated Framework) (51 FR 23302, 57 FR 22984). The Coordinated Framework, 

published by the Office of Science and Technology Policy, describes the comprehensive federal 

regulatory policy for ensuring the safety of biotechnology research and products and explains 

how federal agencies will use existing Federal statutes in a manner to ensure public health and 

environmental safety while maintaining regulatory flexibility to avoid impeding the growth of 

the biotechnology industry. The Coordinated Framework is based on several important guiding 

principles: (1) agencies should define those transgenic organisms subject to review to the extent 

permitted by their respective statutory authorities; (2) agencies are required to focus on the 

characteristics and risks of the biotechnology product, not the process by which it is created; (3) 

agencies are mandated to exercise oversight of GE organisms only when there is evidence of 

“unreasonable” risk.

The Coordinated Framework explains the regulatory roles and authorities for the three major 

agencies involved in regulating GE organisms: USDA APHIS, the Food and Drug 

Administration (FDA), and the Environmental Protection Agency (EPA).

APHIS is responsible for regulating GE organisms and plants under the plant pest provision in 

the Plant Protection Act of 2000 (PPA), as amended (7 USC §§ 7701 et seq.) to ensure that they 

do not pose a plant pest risk to the environment.

The FDA regulates GE organisms under the authority of the Federal Food, Drug, and Cosmetic 

Act (FFDCA). The FDA is responsible for ensuring the safety and proper labeling of all plantderived foods and feeds, including those that are GE. To help developers of food and feed 

derived from GE crops comply with their obligations under Federal food safety laws, FDA 

encourages them to participate in a voluntary consultation process. The FDA policy statement 

concerning regulation of products derived from new plant varieties, including those GE, was 

published in the Federal Register on May 29, 1992 (57 FR 22984-23005). Under this policy, 

FDA uses what is termed a consultation process to ensure that human food and animal feed 

safety issues or other regulatory issues (e.g., labeling) are resolved prior to commercial 

distribution of bioengineered foods.

The EPA regulates plant-incorporated protectants under the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA). Under FIFRA, EPA is responsible for regulating the sale, 

distribution, and use of pesticides, including pesticides that are produced by an organism through 

techniques of modern biotechnology. EPA also sets tolerance limits for residues of pesticides on 

and in food and animal feed, or establishes an exemption from the requirement for a tolerance, 

under the Federal Food, Drug and Cosmetics Act (FFDCA) and regulates certain biological 

control organisms under the Toxic Substances Control Act (TSCA). 

Regulated Organisms

The APHIS Biotechnology Regulatory Services’ (BRS) mission is to protect America’s 

agriculture and environment using a dynamic and science-based regulatory framework that 

allows for the safe development and use of GE organisms. APHIS regulations at 7 Code of 

Federal Regulations (CFR) part 340, which were promulgated pursuant to authority granted by 

the PPA, as amended (7 United States Code (U.S.C.) 7701-7772), regulate the introduction 

(importation, interstate movement, or release into the environment) of certain GE organisms and 

products. A GE organism is no longer subject to the plant pest provisions of the PPA or to the 

regulatory requirements of 7 CFR part 340 when APHIS determines that it is unlikely to pose a 

plant pest risk. A GE organism is considered a regulated article if the donor organism, recipient 
organism, vector, or vector agent used in engineering the organism is listed in the regulation (7 

CFR 340.2) and is also considered a plant pest. A GE organism is also regulated under Part 340 

when APHIS does not have information to determine if the GE organism is unlikely to pose a 

plant pest risk.

A person may petition the agency for a determination that a particular regulated article is 

unlikely to pose a plant pest risk, and, therefore, is no longer regulated under the plant pest risk 

provisions of the PPA or the regulations at 7 CFR part 340. The petitioner is required to provide 

information under §§340.6(c)(4) related to plant pest risk that the agency may use to determine 

whether the regulated article is unlikely to present a greater plant pest risk than the unmodified 

organism. A GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 

or the plant pest risk provisions of the PPA when APHIS determines that it is unlikely to pose a 

plant pest risk.

APHIS’ Response to Petition for Nonregulated Status

Under the authority of the plant pest provisions of the PPA and 7 CFR part 340, APHIS has 

issued regulations for the safe development and use of GE organisms. As required by 7 CFR 

340.6, APHIS must respond to petitioners who request a determination of the regulated status of 

GE organisms, including GE plants such as DAS-81419-2 soybean. When a petition for 

nonregulated status is submitted, APHIS must make a determination if the GE organism is 

unlikely to pose a plant pest risk. If APHIS determines, based on its Plant Pest Risk Assessment 

(PPRA), that the GE organism is unlikely to pose a plant pest risk, it is no longer subject to the

plant pest provisions of the PPA and 7 CFR part 340.

Dow AgroSciences has submitted a petition (APHIS Number 12-272-01p) to APHIS seeking a 

determination that their DAS-81419-2 soybean is unlikely to pose a plant pest risk and, therefore, 

should no longer be a regulated article under regulations at 7 CFR part 340. 

DAS-81419-2 soybean 

DAS-81419-2 soybean has been genetically engineered to express PAT protein to convey 

resistance to the herbicide glufosinate, and also to express Cry1Ac and CryF for resistance to

lepidopterous pests of soybean. 

The phosphinothricin acetyltransferase (PAT) protein has been expressed in a variety of crops to 

provide tolerance to the herbicide glufosinate, which contains the active ingredient 

phosphinothricin (PPT) (Dow AgroSciences, 2012). The gene for PAT derives from the aerobic 

soil bacterium, Streptomyces viridochromogenes. The L-isomer of PPT is a potent inhibitor of 

glutamine synthetase (GS) in plants and is used as a non-selective herbicide. Inhibition of GS by 

PPT causes rapid accumulation of intracellular ammonia which leads to cessation of 

photorespiration and results in the death of the plant cell (Coetzer and Al-Khatib, 2001; Dow 

AgroSciences, 2012). The pat gene which encodes phosphinothricin acetyltransferase (PAT) 

acetylates the free NH2 group of PPT (in the presence of acetyl coenzyme A) and thereby 

prevents autotoxicity in the producing organism (Wehrmann et al., 1996; Dow AgroSciences, 

2012).

Glufosinate is a broad-spectrum systemic herbicide used to kill weeds. It is registered with the 

Environmental Protection Agency (EPA) for non-selective weed control for both non-food use 

and food use plants. Dow AgroSciences indicates that there will be no change in the use pattern 
for glufosinate on this glufosinate-resistant variety and there was no need to petition EPA for a 

change in the label for the herbicide. APHIS used current glufosinate herbicide labels as the basis 

for its evaluation of the potential impacts associated with the use of and exposure to glufosinate.

As described in Human Health subsection of the EA, under FIFRA, all pesticides (including 

herbicides) sold or distributed in the U.S. must be registered by the EPA (US-EPA, 2011a).

Registration decisions are based on scientific studies that assess the chemical’s potential toxicity

and environmental impact. To be registered, a pesticide must be able to be used without posing

unreasonable risks to people or the environment. All pesticides registered prior to November 1,

1984, such as glyphosate, must also be reregistered to ensure that they meet the current, more

stringent standards and should have a reregistration review every 15 years (US-EPA, 2011a). 

The latest reregistration review for glufosinate was started in March 2008 (US-EPA, 2012). 

Before a pesticide can be used on a food or feed crop, the EPA must establish the tolerance 

value, which is the maximum amount of pesticide residue that can remain on the crop or in foods 

or feed processed from that crop (US-EPA, 2011c). Glufosinate currently has established 

tolerances for residues, including residue concentrations for glufosinate in soybean, corn (field, 

grain), cotton (undelinted seed) and several other crops (US-EPA, 2012b).

The EPA regulates plant-incorporated protectants (PIPs), and the two Bt proteins, Cry1Ac and 

CryF expressed in this soybean are both PIPs under the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA). The EPA is responsible for regulating the sale, distribution and use of 

pesticides, including pesticides that are produced by an organism through techniques of modern

biotechnology. 

DAS-81419-2 soybean provides growers with an additional glufosinate-resistant soybean

product on the market today, but also a variety with insect resistance. Herbicide and insectresistant DAS-81419-2 soybean will provide similar benefits to currently available herbicideresistant soybean varieties by allowing post emergent applications of glufosinate to control 

weeds, but with traits for resistance to lepidopterous pests, will allow growers to use less 

pesticides for the targeted pest species. 

Coordinated Framework Review

Food and Drug Administration

DAS-81419-2 soybean is within the scope of the FDA policy statement concerning regulation of 

products derived from new plant varieties, including those produced by genetic engineering. 

Dow AgroSciences initiated the consultation process with FDA for the commercial distribution 

of DAS-81419-2 soybean and submitted a safety and nutritional assessment of food and feed 

derived from DAS-81419-2 soybean to the FDA on October 15, 2012 (Dow AgroSciences, 

2012). On February 7, 2014, the FDA stated that it had no further questions for Dow 

AgroSciences regarding use of DAS-81419-2 soybean for food or feed.

Environmental Protection Agency

The EPA has authority over the use of pesticide substances and plant-incorporated protectants 

(PIPs) under the FIFRA as amended (7 USC §136, et seq.) and the FFDCA (21 USC §301, et 

seq.). APHIS considers the EPA’s regulatory assessment when assessing potential impacts that 

may result from a determination of nonregulated status of a GE organism. 
EPA has authority under FIFRA to establish pesticide use restrictions; these use restrictions are 

presented on pesticide labels which are prepared during the pesticide registration process. DAS81419-2 soybean is similar to currently available glufosinate-resistant soybean varieties.

Glufosinate is currently labeled for use on resistant soybean varieties and no further EPA 

herbicide evaluation was needed for use of glufosinate on DAS-81419-2 (L. Han, Dow 

AgroSciences, personal communication, 2013). APHIS used the current glufosinate labels as the

basis for its evaluation of the potential impacts associated with the use of and exposure to

glufosinate. EPA has previously assessed Cry proteins Cry1Ac (corn, cotton and soybean) and 

CryF (corn and cotton) and will need to develop a tolerance only for CryF in soybean.

Scope of the Environmental Analysis

Dow AgroSciences has developed DAS 81419-2 primarily for South American production sites, 

but would produce seed in the U.S. for export to these markets. Although an APHIS

determination of nonregulated status of DAS-81419-2 soybean would allow for new plantings of 

DAS-81419-2 soybean anywhere in the U.S., APHIS primarily focused the environmental 

analysis to those states that both support soybean production and have or may have an 

economically important issue with lepidopteran pests of soybean. These are the areas that are 

most likely to adopt DAS-81419-2 soybean should it be offered in the future as a commercial 

product for commodity soybean production under an EPA permit in the U.S. A determination of 

nonregulated status of DAS-81419-2 soybean is not expected to increase soybean production by 

its availability alone or accompanied by other factors, nor should it cause an increase in overall 

GE soybean acreage. While an increase in seed production acres may be observed, this 

production would be on existing soybean acres, and would be small in relation to all the present 

acreage of commodity soybean. To determine areas of soybean production, APHIS used data 

from the National Agricultural Statistics Service (NASS) to determine where soybean is 

produced in the U.S. (USDA-NASS, 2012). In the U.S., soybeans are cultivated in 31 states, with 

approximately 77.2 million acres of soybean cultivated in 2012 (USDA-NASS, 2012). States 

with largest use of insecticides for soybean insect control were determined from USDA data

(USDA-NASS, 2013).

Public Involvement

On February 27, 2013, APHIS published a notice in the Federal Register (78 FR pages 13307-

13308) announcing the availability of the Dow AgroSciences petition for a 60-day public review 

and comment period. Comments were required to be received on or before April 29, 2013. All 

comments were carefully analyzed to identify potential environmental and interrelated economic 

issues and impacts that APHIS may determine should be considered in the evaluation of the 

petition. A total of 5 submissions were received during the comment period1. Submissions also 

contained a total of 561 identical comments. The issues that were raised in the public comments 

which were related to the DAS-81419-2 soybean petition included: 

• Encouraged a thorough USDA-APHIS review of all herbicide resistant crops, in the 

context of the potential for development of weed resistance to herbicides and other 

environmental impacts. APHIS recently reviewed herbicide resistance issues in the Draft 

1 Comment documents may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS2012-0029

 
EIS for 09-349-01 soybean (as well as corn varieties). In addition, recent reviews in EAs 

for other corn and cotton crop petitions have provided USDA’s perspective on the 

development and averting of further weed resistance to herbicides and also of mitigation

practices. Growers are the key participants, and by following the advice and research 

offered by USDA-ARS and state extension agencies can deal with weed resistance. As 

noted in the EA, one mechanism for averting or delaying weed resistance is the 

deployment of new herbicide modes of action to respond to weed resistance to 

glyphosate, as does this glufosinate resistant soybean variety.

• Concerns about the development of insects resistant to the Cry proteins expressed by the 

variety. EPA by mandating insect resistance management programs for all GE plant 

incorporated protectants has actively deterred resistance, and when resistance is detected, 

has promptly responded, and encouraged technology providers to deal with the issue in 

affected locations.

• Concerns about admixture of GE soybean with organic soybean. APHIS notes in the EA 

the mechanisms by which organic growers in partnership with neighbors using 

nonorganic methods routinely use reliable production practices to prevent such mixing. 

• Concerns for admixture of new GE lines with exported commodity soybean when the line 

has not yet been approved in the importing country. Technology companies are 

continually working to gain acceptance by foreign market importers for new varieties of 

GE; domestic commodity buyers do not purchase and receive grain varieties that are not 

yet accepted by key buyers of US soybean when such purchase would plausibly end up in 

the export commodity stream.

The following issues were also raised but are outside the scope of this EA:

• A general dislike of the use of GE organisms, 

• Health concerns for food or feed consumption of any GE plants

• Concerns for use of additional herbicides in agriculture

• Reference to other open dockets and potential effects from the use of the subjects of those 

petitions. 

APHIS evaluated the issues raised and the submitted documents. APHIS has included a 

discussion of these issues in the EA or in the response to comments attached to this document.

Major Issues Addressed in the EA

Issues discussed in the EA were identified by considering public concerns and issues described 

in public comments for the petition for nonregulated status of DAS-81419-2 soybean and other 

environmental assessments of GE organisms. Issues identified in lawsuits, and those submitted 

by various stakeholders were also discussed. These issues, including those regarding the 

agricultural production of soybean using various production methods, and the environmental 

food and feed safety of GE plants, were addressed to analyze the potential environmental 

impacts of DAS-81419-2 soybean.

The EA describes the alternatives considered and evaluated using the issues identified. These 

include the following that were identified as important to the scope of the analysis (40 CFR 

1508.25):
Agricultural Production Considerations:

• Acreage and Areas of soybean Production

• Agronomic/Cropping Practices

Environmental Considerations:

• Soil Quality

• Water Resources

• Air Quality

• Climate Change

• Animals

• Plants

• Gene Flow

• Microorganisms

• Biological Diversity

Human Health Considerations:

• Public Health

• Worker Safety

Livestock Health Considerations:

• Livestock Health/Animal Feed

Socioeconomic Considerations:

• Domestic Economic Environment

• Organic Soybean Production

• Trade Economic Environment

Alternatives That Were Fully Analyzed

The EA analyzes the potential environmental consequences of a determination of nonregulated 

status of DAS-81419-2 soybean. To respond favorably to a petition for nonregulated status, 

APHIS must determine that DAS-81419-2 soybean is unlikely to pose a plant pest risk. Based 

on its Plant Pest Risk Assessment (USDA-APHIS, 2012), APHIS has concluded that DAS81419-2 soybean is unlikely to pose a plant pest risk. Therefore, APHIS must determine that 

DAS-81419-2 soybean is no longer subject to 7 CFR part 340 or the plant pest provisions of the 

PPA. Two alternatives were evaluated in the EA: (1) no action and (2) determination of 

nonregulated status of DAS-81419-2 soybean. APHIS has assessed the potential for 

environmental impacts for each alternative in the Environmental Consequences section of the 

EA.

No Action: Continuation as a Regulated Article

Under the No Action Alternative, APHIS would deny the petition. DAS-81419-2 soybean and 

progeny derived from DAS-81419-2 soybean would continue to be regulated articles under the 

regulations at 7 CFR part 340. Permits issued or notifications acknowledged by APHIS would 

still be required for introductions of DAS-81419-2 soybean and measures to ensure physical and 

reproductive confinement would continue to be implemented. APHIS would choose this 
alternative if there were insufficient evidence to demonstrate the lack of plant pest risk from the 

unconfined cultivation of DAS-81419-2 soybean. 

This alternative is not the preferred alternative because APHIS has concluded through a Plant 

Pest Risk Assessment that DAS-81419-2 soybean is unlikely to pose a plant pest risk (USDAAPHIS, 2012). Choosing this alternative would not satisfy the purpose and need of making a 

determination of plant pest risk status and responding to the petition for nonregulated status.

Preferred Alternative: Determination that DAS-81419-2 soybean is No Longer a Regulated 

Article

Under this alternative, DAS-81419-2 soybean and progeny derived from DAS-81419-2 soybean

would no longer be regulated articles under the regulations at 7 CFR part 340. DAS-81419-2

soybean is unlikely to pose a plant pest risk (USDA-APHIS, 2012). Permits issued or 

notifications acknowledged by APHIS would no longer be required for introductions of DAS81419-2 soybean and progeny derived from this event. The preferred alternative best meets the 

purpose and need to respond appropriately to a petition for nonregulated status based on the 

requirements in 7 CFR part 340 and the agency’s authority under the plant pest provisions of the 

PPA. Because the agency has concluded that DAS-81419-2 soybean is unlikely to pose a plant 

pest risk, a determination of nonregulated status of DAS-81419-2 soybean is a response that is 

consistent with the plant pest provisions of the PPA, the regulations codified in 7 CFR part 340, 

and the biotechnology regulatory policies in the Coordinated Framework.

Alternatives Considered but Rejected from Further Consideration

APHIS assembled a list of alternatives that might be considered for DAS-81419-2 soybean. The 

agency evaluated these alternatives, in light of the agency’s authority under the plant pest 

provisions of the PPA, and the regulations at 7 CFR part 340, with respect to environmental 

safety, efficacy, and practicality to identify which alternatives would be further considered for 

DAS-81419-2 soybean. Based on this evaluation, APHIS rejected several alternatives. These 

alternatives are discussed briefly below along with the specific reasons for rejecting each.

1. Prohibit any DAS-81419-2 soybean from Being Released

In response to public comments that stated a preference that no GE organisms enter the 

marketplace, APHIS considered prohibiting the release of DAS-81419-2 soybean, including 

denying any permits associated with the field testing. APHIS determined that this alternative is 

not appropriate given that APHIS has concluded that DAS-81419-2 soybean is unlikely to pose a 

plant pest risk (USDA-APHIS, 2012).

In enacting the PPA, Congress listed findings in Section 402(4), including the following one:

“[D]ecisions affecting imports, exports, and interstate movement of products regulated 

under this title [the Plant Protection Act] shall be based on sound science;”

On March 11, 2011, in a Memorandum for the Heads of Executive Departments and Agencies, 

the White House Emerging Technologies Interagency Policy Coordination Committee developed 

broad principles, consistent with Executive Order 13563, to guide agencies that develop and 

implement policies for oversight of emerging technologies such as genetic engineering. In

accordance with this memorandum, agencies should adhere to guidance in Executive Order 

13563, and, consistent with it, apply the following principle, among others to the extent 

permitted by law when regulating emerging technologies:
“Decisions should be based on the best reasonably obtainable scientific, technical, 

economic, and other information, within the boundaries of the authorities and mandate of 

each agency”

Based on the PPRA (USDA-APHIS, 2012), and the scientific data evaluated therein, APHIS 

concluded that DAS-81419-2 soybean is unlikely to pose a plant pest risk. Accordingly, there is 

no basis in science for prohibiting the release of DAS-81419-2 soybean.

2. Approve the Petition in Part

The regulations at 7 CFR 340.6(d)(3)(i) state that APHIS may “approve the petition in whole or 

in part.” For example, a determination of nonregulated status in part may be appropriate if there 

is a plant pest risk associated with some, but not all lines described in a petition. Because APHIS 

has concluded that DAS-81419-2 soybean is unlikely to pose a plant pest risk, (USDA-APHIS, 

2012), and it is the only line described in the petition, there is no regulatory basis under the plant 

pest provisions of the PPA for considering approval of the petition only in part.

3. Isolation Distance between DAS-81419-2 soybean and Non-GE Soybean Production 

and Geographical Restrictions

In response to public concerns of gene movement between GE and non-GE plants, APHIS 

considered requiring an isolation distance separating DAS-81419-2 soybean from conventional 

or specialty soybean production. However, because APHIS has concluded that DAS-81419-2

soybean is unlikely to pose a plant pest risk (USDA-APHIS, 2012), an alternative based on 

requiring isolation distances would be inconsistent with statutory authority under the plant pest 

provisions of the PPA and regulations in 7 CFR part 340.

APHIS also considered geographically restricting the production of DAS-81419-2 soybean based 

on the location of production of non-GE soybean in organic production systems or production 

systems for GE-sensitive markets in response to public concerns regarding possible gene 

movement between GE and non-GE plants. However, as presented in APHIS’ PPRA for DAS81419-2 soybean, there are no geographic differences associated with any identifiable plant pest 

risks for DAS-81419-2 soybean (USDA-APHIS, 2012). This alternative was rejected and not 

analyzed in detail because APHIS has concluded that DAS-81419-2 soybean does not present a 

plant pest risk, and will not exhibit a greater plant risk in any geographically restricted area. 

Therefore, such an alternative would not be consistent with APHIS’ statutory authority under the 

plant pest provisions of the PPA and regulations in Part 340 and the biotechnology regulatory 

policies embodied in the Coordinated Framework.

Based on the foregoing, the imposition of isolation distances or geographic restrictions would not 

meet APHIS’ purpose and need to respond appropriately to a petition for nonregulated status 

based on the requirements in 7 CFR part 340 and the agency’s authority under the plant pest 

provisions of the PPA. However, individuals might choose on their own to geographically 

isolate their non-GE production systems from DAS-81419-2 soybean or to use isolation 

distances and other management practices to minimize gene movement between soybean fields. 

Information to assist growers in making informed management decisions for DAS-81419-2

soybean is available from the Association of Official Seed Certifying Agencies (AOSCA, 2011).

4. Requirement of Testing for DAS-81419-2 soybean

During the comment periods for other petitions for nonregulated status, some commenters 

requested that USDA require and provide testing for GE products in non-GE production systems. 
APHIS notes that there are no nationally established regulations involving testing, criteria, or 

limits of GE material in non-GE systems. Such a requirement would be extremely difficult to 

implement and maintain. Additionally, because DAS-81419-2 soybean does not pose a plant 

pest risk (USDA-APHIS, 2012), the imposition of any type of testing requirements is 

inconsistent with the plant pest provisions of the PPA, the regulations at 7 CFR part 340 and 

biotechnology regulatory policies embodied in the Coordinated Framework. Therefore, 

imposing such a requirement for DAS-81419-2 soybean would not meet APHIS’ purpose and 

need to respond appropriately to the petition in accordance with its regulatory authorities.

Environmental Consequences of APHIS’ Selected Action

The EA contains a full analysis of the alternatives to which we refer the reader for specific 

details. The following table briefly summarizes the results for each of the issues fully analyzed 

in the Environmental Consequences section of the EA.

Summary of issues of potential impacts and consequences of Alternatives.

Attribute/Measure Alternative A: No Action Alternative B: Preferred 

Alternative; Determine 

Nonregulated Status

Meets Purpose and Need 

Objectives

No Yes

Unlikely to Pose a Plant 

Pest Risk

Satisfied through use of 

regulated field trials

Satisfied by USDA-APHIS 

Plant Pest Risk 

Assessment

Management Practices

Acreage and Areas of 

Soybean Production

Continuing under APHIS 

notification and EPA permits 

only, no change in current 

soybean acreage

Under EPA seed increase 

permits only, no large 

overall change in total 

soybean acreage is expected; 

existing soybean acres will 

be used for new seed 

production. If DAS chooses 

commodity production for 

DAS-81419-2 , this will 

replace existing varieties
Attribute/Measure Alternative A: No Action Alternative B: Preferred 

Alternative; Determine 

Nonregulated Status

Agronomic Practices Standard practices will be 

maintained

Standard practices will be 

maintained for small scale 

seed production. If the crop 

is commercialized for the US 

market, less insecticide will 

be used in treating 

lepidopteran infestations.

Some increase in glufosinate 

use may occur if the 

developer decides to pursue 

US commercialization of the 

trait

Soybean Seed Production Unchanged Practices for seed 

production will remain 

similar to current seed 

production, including the 

unlikely use of glufosinate 

for weed control. 

Organic Soybean 

Production

No expected changes in 

production of organic 

soybean varieties. Specialty

crop growers employ 

practices and standards for

seed production, cultivation, 

and product handling and 

processing to ensure that 

their products are not 

pollinated by or commingled 

with conventional or GE

crops. Certified organic soybean

acreage is a small butincreasing

percentage of overall soybean

production.

No expected change in 

organic soybean practices or 

increase in present total 

acreage of GE soybean

Environment

Water Resources No expected changes to water 

resources

No expected changes to

soybean seed production or 

to water resources; if used in 

areas with lepidopteran 

pests, use could decrease 

insecticides in water
Attribute/Measure Alternative A: No Action Alternative B: Preferred 

Alternative; Determine 

Nonregulated Status

Soil Quality Unchanged If released commercially for 

commodity soybean 

production, some regions 

with economically important 

lepidopteran pests may have

decreased insecticides in soil

Air Quality Unchanged Unchanged

Climate Change Unchanged Unchanged

Animal Communities Unchanged. Under 

notifications, test protocols 

are required that confine the 

seed and plant variety and 

prevent environmental 

impacts

DAS-81419-2 is not expected 

to have any effect on 

vertebrate animals or most

invertebrate animals. DAS81419-2 exhibits 

insecticidal activity against

certain lepidopteran insects. 

Those pests that feed 

directly on DAS-81419-2 

soybeans would be expected

to die or have delayed 

growth. If DAS-81419-2 

soybean is commercialized 

in the U.S., there are 

potential benefits due to 

reduced insect pressure and 

reduced need for insecticide 

applications

Plant Communities The most agronomically

important members of the

surrounding plant community 

are often those that behave as

weeds. Soybean growers use

production practices to 

manage weeds in and around 

fields. Resistant weeds will 

continue to increase because

of the use of herbicides, 

especially glyphosate.

No increased impacts 

because only seed 

production will be increased 

and glufosinate will likely 

not be used; if 

commercialized, may be a 

trend in some parts of the 

country for increased 

glufosinate use against 

glyphosate resistant weeds.

No large increase in acres

planted to DAS-81419-2 

expected, so considerable 

change in glufosinate use is 

not likely
Attribute/Measure Alternative A: No Action Alternative B: Preferred 

Alternative; Determine 

Nonregulated Status

Gene Flow and 

Weediness

Cultivated soybean varieties

can cross pollinate. Growers 

use various production 

practices to limit undesired 

cross pollination.

Unchanged from No Action 

Alternative

Soil Microorganisms Unchanged Unchanged

Biological Diversity Unchanged Unchanged

Human and Animal Health

Risk to Human Health Unchanged. EPA regulates 

the safe use, handling and 

exemptions for tolerances of 

all pesticides.

Unchanged. EPA regulates 

the safe use, handling and 

exemptions for tolerances of 

all pesticides.

Risk to Animal Feed

Unchanged. Processed 

soybeans are the largest 

source of protein in animal 

feed. 

Unchanged. A

compositional analysis 

concluded that forage and 

grain from DAS-81419-2 

soybean hybrids are 

considered similar in 

composition to forage and

grain from both the nontransgenic comparator and 

conventional soybean

hybrids. Therefore this is 

unchanged from the No 

Action Alternative

Socioeconomic

Domestic Economic 

Environment

No new impacts. The 

widespread adoption of 

herbicide-resistant soybean 

has been attributed to the cost 

savings for production, and 

also other non-monetary 

benefits.

If commercialized, then 

somewhat less use of 

insecticides in some parts of 

the country. 
Attribute/Measure Alternative A: No Action Alternative B: Preferred 

Alternative; Determine 

Nonregulated Status

Trade Economic 

Environment

Likely no change of exported

soybean seed for planting.

Developer will not increase 

foreign sales of seed produced

unless DAS 81419-2 is 

determined as nonregulated. 

May increase exports of 

soybean seed for planting

to some markets, 

especially South American 

markets. Dow 

AgroSciences intends to 

submit dossiers to request 

import approval of DAS81419-2 soybean to the 

proper regulatory 

authorities of several 

countries that already 

have regulatory processes 

in place for GE soybean. 

These include, but are not 

limited to: Canada, Mexico, 

Japan, the EU, South Korea, 

and China. 

Other Regulatory Approvals

U.S. FDA food consultation 

complete, EPA Cry1F tolerance 

exemptions and conditional 

pesticide registrations

complete

FDA food consultation 

complete, EPA Cry1F 

tolerance exemptions and 

conditional pesticide 

registrations complete

Other Countries Currently seeking foreign 

approvals for feed and food

Will seek approvals from 

South American countries 

for planting. Currently 

seeking foreign approvals 

for food and feed.

Finding of No Significant Impact

The analysis in the EA indicates that there will not be a significant impact, individually or 

cumulatively, on the quality of the human environment as a result of this proposed action. I 

agree with this conclusion and therefore find that an EIS need not be prepared. This NEPA 

determination is based on the following context and intensity factors (40 CFR 1508.27).

Context - The term “context” recognizes potentially affected resources, as well as the location 

and setting in which the environmental impact would occur. This action has potential to affect 

conventional and organic soybean production systems, including surrounding environments and 

agricultural workers; human food and animal feed production systems; and foreign and domestic 

commodity markets. 
From 2002-2012, the average soybean production in the U.S. has been about 74.3 million acres 

(USDA-NASS, 2012). In 2012 approximately 77.2 million acres of soybean were cultivated in 

31 states (USDA-NASS, 2012). In 2012, GE herbicide-resistant soybean was estimated to be 

93% of the U.S. soybean crop (USDA-ERS, 2012). A determination of nonregulated status of 

DAS-81419-2 soybean is not expected to directly cause an increase in agricultural acreage 

devoted to soybean production, or those soybean acres devoted to GE soybean cultivation. The 

availability of DAS-81419-2 soybean will not change cultivation areas for soybean production in 

the U.S., and there are no anticipated changes to the availability of GE and non-GE soybean

varieties or seed on the market.

Intensity – Intensity is a measure of the degree or severity of an impact based upon the ten 

factors. The following factors were used as a basis for this decision:

1. Impacts that may be both beneficial and adverse. 

A determination of nonregulated status of DAS-81419-2 soybean will have no significant 

environmental impact on the availability of GE, conventional or organic soybean

varieties. As discussed in Chapter 4 of the EA, a determination of nonregulated status of 

DAS-81419-2 soybean is expected to neither directly cause an increase in overall 

soybean production acreage, nor GE soybean acreage. The availability of DAS-81419-2

soybean will not change the cultivation areas for soybean production in the U.S., and 

there are no anticipated changes in the availability of GE and non-GE soybean varieties 

on the market. A determination of nonregulated status of DAS-81419-2 soybean, if Dow 

AgroSciences elects to do so, could add another GE soybean variety to the conventional 

soybean market, but one with resistance to certain key insect pests. To complete this 

process, it would be necessary to request a commercial permit for commercial production 

of the crop in the US, beyond the permit requested for seed increase. It is not expected to 

change the market demands for GE soybean or soybean produced using organic methods.

In 2011, there were approximately 96,000 acres of organic soybean produced across 

1,203 farms in the United States (USDA-NASS, 2012b). This represented about 0.13 

percent of total U.S. soybean production in 2011 (USDA-NASS, 2012b). Based on the 

data provided by Dow AgroSciences for DAS-81419-2 soybean (Dow AgroSciences, 

2012), APHIS has concluded that the availability of DAS-81419-2 soybean would not 

alter the agronomic practices, locations, and seed production and quality characteristics 

of conventional and GE soybean seed or commodity production (USDA-APHIS, 2012). 

A determination of nonregulated status of DAS-81419-2 soybean will not require a 

change to seed production practices, nor current production practices. The introduction 

DAS-81419-2 soybean provides a soybean variety with both herbicide resistance and 

lepidopteran insect resistance.

2. The degree to which the proposed action affects public health or safety. 

A determination of nonregulated status of DAS-81419-2 soybean would have no 

significant impacts on human or animal health. Compositional tests conducted by the 

petitioner indicate that DAS-81419-2 soybean is compositionally similar to other 

commercially available soybean (DAS, 2012). Dow AgroSciences initiated the 

consultation process with FDA for the commercial distribution of DAS-81419-2 soybean

and submitted a safety and nutritional assessment of food and feed derived for DAS81419-2 soybean to the FDA on October 15, 2012. Based on the information Dow 

AgroSciences submitted, laboratory data and scientific literature provided by Dow 
AgroSciences (Dow AgroSciences, 2012) and safety data available on other herbicideresistant products, and the completed FDA consultation APHIS has concluded that DAS81419-2 soybean would have no significant impacts on human or animal health.

3. Unique characteristics of the geographic area such as proximity to historic or cultural 

resources, park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologically 

critical areas.

There are no unique characteristics of geographic areas such as park lands, prime farm 

lands, wetlands, wild and scenic areas, or ecologically critical areas that would be 

adversely impacted by a determination of nonregulated status of DAS-81419-2 soybean. 

The common agricultural practices that would be carried out under the proposed action 

will not cause major ground disturbance; do not cause any physical destruction or 

damage to property, wildlife habitat, or landscapes; and do not involve the sale, lease, or 

transfer of ownership of any property. This action is limited to a determination of 

nonregulated status of DAS-81419-2 soybean. The product will be deployed on 

agricultural land currently suitable for production of soybean, will replace existing 

varieties, and is not expected to increase the acreage of soybean production. This action 

would not convert land to nonagricultural use and therefore would have no adverse 

impact on prime farm land. Standard agricultural practices for land preparation, planting, 

irrigation, and harvesting of plants would be used on agricultural lands planted to DAS81419-2 soybean including the use of EPA registered pesticides. Applicant’s adherence 

to EPA label use restrictions for all pesticides will mitigate potential impacts to the 

human environment. In the event of a determination of nonregulated status of DAS81419-2 soybean, the action is not likely to affect historic or cultural resources, park 

lands, prime farmlands, wetlands, wild and scenic rivers, or ecologically critical areas 

that may be in close proximity to soybean production sites.

4. The degree to which the effects on the quality of the human environment are likely to be 

highly controversial.

The effects on the quality of the human environment from a determination of 

nonregulated status of DAS-81419-2 soybean are not highly controversial. Although 

APHIS received public comments opposed to a determination of nonregulated status of 

DAS-81419-2 soybean, this action is not highly controversial in terms of size, nature or 

effect on the natural or physical environment. As discussed in Chapter 4 of the EA, a 

determination of nonregulated status is not expected to directly cause an increase in 

agricultural acreage devoted to soybean production, or those acres devoted to GE 

soybean cultivation. The availability of DAS-81419-2 soybean will not change 

cultivation areas for soybean production in the U.S., and there are no anticipated changes 

to the availability of GE and non-GE soybean varieties on the market. A determination 

of nonregulated status of DAS-81419-2 soybean could add another GE soybean variety to 

the conventional soybean market (if Dow AgroSciences decides to offer DAS-8149-2 for 

commodity soybean production) especially for those growers needing protection of the 

crop from lepidopterous insects. DAS-81419-2 is not expected to change the market 

demands for GE soybean or soybean produced using organic methods. A determination 

of nonregulated status of DAS-81419-2 soybean will not change current practices of 

planting, tillage, fertilizer application or use, cultivation, pesticide application or use, or 

control of volunteer soybean. Management practices and seed standards for production 
of certified soybean seed would not change. The effect of DAS-81419-2 soybean on 

wildlife or biodiversity is not different from that of other herbicide resistant soybean

currently used in agriculture, or other GE or non-GE soybean produced in conventional 

agriculture in the U.S. 

5. The degree to which the possible effects on the human environment are highly uncertain 

or involve unique or unknown risks.

Based on the analysis documented in the EA, the possible effects on the human 

environment are well understood. The effects of the proposed activities are not highly 

uncertain and do not involve unique or unknown risks on the natural or physical 

environment. As discussed in Chapter 4 of the EA, a determination of nonregulated 

status of DAS-81419-2 soybean is expected to neither directly cause an increase in 

agricultural acreage devoted to soybean production, nor increase those acres devoted to 

GE soybean cultivation. A determination of nonregulated status of DAS-81419-2

soybean will not result in changes in the current practices of planting, tillage, fertilizer 

application and use, pesticide application and use or volunteer control. Management 

practices and seed standards for production of certified soybean seed would not change. 

The effect of DAS-81419-2 soybean on wildlife or biodiversity is neither different than 

that from other herbicide-resistant crops currently used in agriculture, nor that of other 

GE or non-GE soybean produced in conventional agriculture in the U.S. As described in 

Chapter 3 of the EA, well established management practices, production controls, and 

production practices (GE, conventional, and organic) are currently being used in soybean

production systems (commercial and seed production) in the U.S. Therefore, it is 

reasonable to assume that farmers, who produce conventional soybean (GE and non-GE 

varieties), DAS-81419-2 soybean, or produce soybean using organic methods, will 

continue to use these reasonable, commonly accepted best management practices for their 

chosen systems and varieties during agricultural soybean production. GE soybean is also

planted currently on the majority of soybean acres (93% of acreage in 2012) (USDAERS, 2012). Based upon historic trends, conventional production practices that use GE 

varieties will likely continue to prevail in terms of acreage with or without a 

determination of nonregulated status of DAS-81419-2 soybean. Given the extensive 

experience that APHIS, stakeholders, and growers have with the use of GE soybean

products, the possible effects to the human environment from the release of an additional 

GE soybean product are already well known and understood. Therefore, the impacts are 

not highly uncertain, and do not involve unique or unknown risks.

6. The degree to which the action may establish a precedent for future actions with 

significant effects or represents a decision in principle about a future consideration.

A determination of nonregulated status for DAS-81419-2 soybean would not establish a 

precedent for future actions with significant effects, nor would it represent a decision in 

principle about a future decision. Similar to past regulatory requests reviewed and 

approved by APHIS, a determination of nonregulated status will be based on whether an 

organism is unlikely to pose a plant pest risk pursuant to the regulatory requirements of 7 

CFR part 340. Each petition that APHIS receives is specific to a particular GE organism 

and undergoes this independent review to determine if the regulated article poses a plant 

pest risk. Under the authority of the plant pest provisions of the PPA and 7 CFR part 

340, APHIS has issued regulations for the safe development and use of GE organisms. 
As required by 7 CFR 340.6, APHIS must respond to petitioners who request a 

determination of the regulated status of GE organisms, including GE plants such as DAS81419-2 soybean. When a petition for nonregulated status is submitted, APHIS must 

determine if the GE organism is unlikely to pose a plant pest risk. If APHIS determines,

based on its Plant Pest Risk Assessment, that the GE organism is unlikely to pose a plant 

pest risk, the GE organism is no longer subject to the plant pest provisions of the PPA

and 7 CFR part 340. APHIS regulations at 7 CFR part 340, which were promulgated 

pursuant to authority granted by the PPA, as amended (7 United States Code(U.S.C.) 

7701-7772), regulate the introduction (i.e., importation, interstate movement, or release 

into the environment) of certain GE organisms and products. A GE organism is no 

longer subject to the plant pest provisions of the PPA nor the regulatory requirements of 

7 CFR part 340 when APHIS determines that it is unlikely to pose a plant pest risk. A 

GE organism is considered a regulated article if the donor organism, recipient organism, 

vector, or vector agent used in engineering the organism belongs to one of the taxa listed 

in the regulation (7 CFR 340.2) and is also considered a plant pest. A GE organism is 

also regulated under Part 340 when APHIS has reason to believe that the GE organism 

may be a plant pest or APHIS does not have enough information to determine if the GE 

organism is unlikely to pose a plant pest risk. A person may petition the agency for a 

decision that a particular regulated article is unlikely to pose a plant pest risk, and, 

therefore, is no longer regulated under the plant pest provisions of the PPA or the 

regulations at 7 CFR part 340. The petitioner is required to provide information under 

§340.6(c)(4) related to plant pest risk that the agency may use to determine whether the 

regulated article is unlikely to present a greater plant pest risk than the unmodified 

organism. A GE organism is no longer subject to the regulatory requirements of 7 CFR 

part 340 or the plant pest provisions of the PPA when APHIS determines that it is 

unlikely to pose a plant pest risk.

7. Whether the action is related to other actions with individually insignificant but 

cumulatively significant impacts.

No significant cumulative effects were identified through this assessment. The EA 

discussed cumulative effects on soybean management practices, human and animal 

health, and the environment and concluded that such impacts were not significant. A 

cumulative effects analysis is provided in Chapter 5 of the EA. In the event APHIS 

reaches a determination of nonregulated status of DAS-81419-2 soybean, APHIS would 

no longer have regulatory authority over this soybean. In the event of a determination of 

nonregulated status of DAS-81419-2 soybean, APHIS has not identified any significant 

impact on the environment that may result from the incremental impact of a 

determination of nonregulated status of DAS-81419-2 soybean when added to past, 

present, and reasonably foreseeable future actions.

8. The degree to which the action may adversely affect districts, sites, highways, structures, 

or objects listed in or eligible for listing in the National Register of Historic Places or

may cause loss or destruction of significant scientific, cultural, or historic resources.

A determination of nonregulated status of DAS-81419-2 soybean will not adversely 

impact cultural resources on tribal properties. Any farming activities that may be taken 

by farmers on tribal lands are only conducted at the tribe’s request; thus, the tribes have 

control over any potential conflict with cultural resources on tribal properties. A 
determination of nonregulated status of DAS-81419-2 soybean would not impact 

districts, sites, highways, structures, or objects listed in, or eligible for listing in the 

National Register of Historic Places, nor would they likely cause any loss or destruction 

of significant scientific, cultural, or historic resources. This action is limited to a 

determination of nonregulated status of DAS-81419-2 soybean. Standard agricultural 

practices for land preparation, planting, irrigation, and harvesting of plants would be used 

on these agricultural lands including the use of EPA registered pesticides. Adherence to 

EPA label use restrictions for all pesticides will mitigate impacts to the human 

environment. A determination of nonregulated status of DAS-81419-2 soybean is a

decision that will not directly or indirectly cause alteration in the character or use of 

historic properties protected under the National Historic Preservation Act. In general, 

common agricultural activities conducted under this action do not have the potential to 

introduce visual, atmospheric, or audible elements to areas in which they are used that 

could result in effects on the character or use of historic properties. For example, there is 

potential for audible effects on the use and enjoyment of a historic property when 

common agricultural practices, such as the operation of tractors and other mechanical 

equipment, are conducted close to such sites. A built-in mitigating factor for this issue is 

that virtually all of the methods involved would only have temporary effects on the 

audible nature of a site and can be ended at any time to restore the audible qualities of 

such sites to their original condition with no further adverse effects. These cultivation 

practices are also being conducted currently throughout the soybean production regions. 

The cultivation of DAS-81419-2 soybean does not inherently change any of these 

agronomic practices in ways that would cause any impact under the NHPA.

9. The degree to which the action may adversely affect the endangered or threatened 

species or its habitat that has been determined to be critical under the Endangered 

Species Act of 1973.

As described in Chapter 6 of the EA, APHIS has analyzed the potential for effects from a 

determination of nonregulated status of DAS-81419-2 soybean on federally listed 

threatened and endangered species (TES), species proposed for listing, and designated 

critical habitat and habitat proposed for designation, as required under Section 7 of the 

Endangered Species Act. After reviewing possible effects of a determination of 

nonregulated status of DAS-81419-2 soybean, APHIS has concluded that a determination 

of nonregulated status of DAS-81419-2 soybean would have no effect on federally listed 

TES and species proposed for listing, or on designated critical habitat or habitat proposed 

for designation.

10. Whether the action threatens a violation of Federal, State, or local law or requirements 

imposed for the protection of the environment.

The proposed action would be in compliance with all Federal, state, and local laws. 

Because the agency has concluded that DAS-81419-2 soybean is unlikely to pose a plant 

pest risk, a determination of nonregulated status of DAS-81419-2 soybean is a response 

that is consistent with the plant pest provisions of the PPA, the regulations codified in 7 

CFR part 340, and the biotechnology regulatory policies in the Coordinated Framework. 

Dow AgroSciences initiated the consultation process with FDA for the commercial 

distribution of DAS-81419-2 soybean and submitted a safety and nutritional assessment 

of food and feed derived from DAS-81419-2 soybean on October 15, 2012 (DAS, 2012). 
Based on the information Dow AgroSciences submitted, and that FDA had no further 

questions for Dow AgroSciences regarding DAS-81419-2 soybean as food or feed (FDA, 

BNF 000140, February 7, 2014) APHIS has concluded that a determination of 

nonregulated status of DAS-81419-2 soybean would have no effect on the environment. 

DAS-81419-2 soybean is compositionally similar to currently available glufosinateresistant soybean varieties on the market, with the exception of an opportunity to reduce 

the use of insecticides for control of lepidopteran pests of soybean. A tolerance for Cry1F 

proteins in soybean has been issued by the EPA (Federal Register 79, 8293, February 12, 

2014) although current tolerances already exist for this same protein when expressed in 

corn and cotton. EPA registration for DAS-81419-2 was completed January 30, 2014. 

There are no other Federal, state, or local permits that are needed prior to the 

implementation of this action.

NEPA Decision and Rationale

I have carefully reviewed the EA prepared for this NEPA determination and the input from the 

public involvement process. I believe that the issues identified in the EA are best addressed by 

selecting Alternative 2 (Determination that DAS-81419-2 soybean is No Longer a Regulated 

Article). This alternative meets APHIS’ purpose and need to allow the safe development and use 

of GE organisms consistent with the plant pest provisions of the PPA.

As stated in the CEQ regulations, “the agency’s preferred alternative is the alternative which the 

agency believes would fulfill its statutory mission and responsibilities, giving consideration to 

economic, environmental, technical and other factors.” The preferred alternative has been 

selected for implementation based on consideration of a number of environmental, regulatory, 

and social factors. Based upon our evaluation and analysis, Alternative 2 is selected because (1) 

it allows APHIS to fulfill its statutory mission to protect America’s agriculture and environment 

using a science-based regulatory framework that allows for the safe development and use of GE

organisms; (2) it allows APHIS to fulfill its regulatory obligations. As APHIS has not identified 

any plant pest risks associated with DAS-81419-2 soybean, the continued regulated status of 

DAS-81419-2 soybean would be inconsistent 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. For the reasons stated above, I have determined that a determination of 

nonregulated status of DAS-81419-2 soybean will not have any significant environmental 

effects.

_____________________________ ___________________

Michael J. Firko, Date

(Acting) Deputy Administrator , 

Biotechnology Regulatory Services
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