NATIONAL ENVIRONMENTAL POLICY ACT DECISION AND PRELIMINARY FINDING OF NO SIGNIFICANT IMPACT Genective Company VCO

- 01981

- 5 Corn United States Department of Agriculture Animal and Plant Health Inspection Service Biotechnology Regulatory Services
The United S tates 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 Environmenta l 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 t he 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 a petition request (APHIS Number 11

- 3 42

- 01p) by Genective Company ( hereafter referred to as Genective ) for their genetically engineered VCO

- 01981

- 5 Corn that expresses an epsps grg23ace5 gene that confers resistance to glyphosate . This 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 nonreg ulated status for VCO

- 01981

- 5 Corn. The EA assesses alternatives to a determination of nonregulated status of VCO

- 01981

- 5 Corn and analyzes the potential environmental and social effects that result from the proposed action and the alternatives. Regulator y 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 nationa l economy and the public health. USDA asserts that all methods of agricultural production (conventional, organic, or the use of genetically engineered (GE) varieties can provide benefits to the environment, consumers, and farm income. Since 1986, the Unit ed States government has regulated genetically engineered (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 Framewor k, 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 mann er 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 arerequired to focus on the characteristics and risks of the biotechnology product, not the process by which it is created; (3) a gencies are mandated to exercise oversight of GE organisms only when there is evidence of “unreasonable” risk. The Coordinated Framewo rk explains the regulatory roles and authorities for the three major agencies involved in regulating GE organisms: USDA’s 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, 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 plant

derived foods and feeds, including those that are genetically engineered. 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 consultatio n process. The FDA policy statement concerning regulation of products derived from new plant varieties, including those genetically engineered, 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). 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 Co smetics Act (FFDCA) and regulates certain biological control organisms under the Toxic Substances Control Act (TSCA). The EPA is responsible for regulating the sale, distribution, and use of pesticides, including pesticides that are produced by an organis m through techniques of modern biotechnology. 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 Plant Protection Act, as amended (7 United States Code (U.S.C.) 7701

- 7772), regulate the i ntroduction (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 Plant Protection Act or to the regulatory requirements of 7 CFR pa rt 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 taxa listed i n 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 agen cy 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 Plant Protection Act or the regulations at 7 CFR 340. The petitioner is required to provide in formationunder §§ 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 Plant Protection Act 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 pro visions of the Plant Protection Act 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 VCO

- 01981

- 5 Corn. 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 Asse ssment (PPRA) that the genetically engineered organism is no longer subject to the plant pest provisions of the Plant Protection Act and 7 CFR part 340. Genective h as submitted a petition (APHIS N umber 11

- 342

- 01p) to APHIS seeking a determination that thei r genetically engineered VCO

- 01981

- 5 Corn is unlikely to pose a plant pest risk and, therefore, should no longer be a regulated article under regulations at 7 CFR Part 340. VCO

- 01981

- 5 Corn Genective SA of Chappes, France , with the Bayer Company of Resear ch Triangle Park, North Carolina , submitted a petition (APHIS Number 11

- 342

- 01) to APHIS in 2011 for determination of nonregulated status for VCO

- 01981

- 5 Corn that expresses an epsps grg23ace5 gene ( Genective, 2012 ) . This gene was transformed from the common s oil bacterium , Arthrobacter globiformis , into corn for resistance to glyphosate. The protein expressed by the gene, 5

- enolpyruvylshikimate

- 3

- phosphate synthase (EPSPS) protein, EPSPS ACE5, confers resistance to the common herbicide glyphosate and has great er enzymatic half

- life than the native protein, but somewhat less than the native enzyme from corn. The corn protein ACE5 EPSPS expressed in VCO

- 01981

- 5 Corn is similar to other EPSPS proteins in other glyphosate resistant soy bean and corn hybrids includi ng the CP4 EPSPS protein of glyphosate resistant (Roundup Resistant) soy bean and corn. Genective SA indicates that there will be no change in the use pattern for glyphosate on this glyphosate

- resistant variety and there will be no need to petition EPA for a change in the label fo r insert herbicide. APHIS use d current glyphosate herbicide labels as the basis for its evaluation of the potential impacts associated with the use of and exposure to gly phosate. Glyphosate ( N

- (phosphonomethyl) glycine) 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. Glyphosate's mode of action is to inhibit the enzyme 5

- enolpyruvylsh ikimate

- 3

- phosphate synthase (EPSPS) involved in the synthesis of the aromatic amino acids : tyrosine , tryptophan and phenylalanine . Glyphosate functions due to its resemblance to the structure of the substrate for EPSPS enzyme and thereby competing with th is substrate for the enzyme’s active site, thus preventing the synthesis of aromatic amino acids and killing the plant.In the event of a determination of nonregulated status, the nonregulated status for VCO

- 01981

- 5 Corn would include VCO

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- 5 Corn , an y progeny derived from crosses between VC

- 01981

- 5 and conventional corn, and crosses of event VCO

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- 5 Corn with other biotechnology

derived corn that has been deregulated pursuant to Part 340 and the Plant Protection Act. If VCO

- 01981

- 5 Corn is deregu lated, growers and corn seed suppliers would have another trait available for glyphosate resistance in weed management, and are expected to see benefits such as an alternative to the application of conventional insecticides and economic benefits, through i ncreased crop yield, and increased marketplace competition for insect

- protected seed products. Event VCO

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- 5 Corn is currently regulated under 7 CFR part 340. Interstate movements and field trials of event VCO

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- 5 Corn have been conducted under pe rmits issued or notifications acknowledged by APHIS since 2007 from Puerto Rico and since 2008 from Iowa. Data resulting from these field trials are described in the petition ( Genective, 2012 )

. Coordinated Framework Review Food and Drug Administration VCO

- 019 81

- 5 Corn is within the scope of the FDA policy statement concerning regulation of products derived from new plant varieties, including those pr oduced by genetic engineering. In June 2006, FDA published recommendations in “Guidance for Industry: Recommend ations for the Early Food Safety Evaluation of New Non

- Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use” ( US

- FDA, 2011 ) for establishing voluntary food safety
eva luations for new non

- pesticidal proteins produced by new plant varieties intended to be used as food, including bioengineered plants. Early food safety evaluations help make sure that potential food safety issues related to a new protein in a new plant va riety are addressed early in development. These evaluations are not intended as a replacement for a biotechnology consultation with FDA, but the information may be used later in the biotechnology consultation. Genective (predecessor organization, Athenix Corporation) initiated a consultation with the FDA by submitting an early food safety evaluation of the ACE5 epsps protein expressed in VCO

01981

- 5 Corn (NPC 000012: Agency Response Letter) on October 7, 2009

. FDA completed its evaluation with no further questions on October 15, 2010, ( US

- FDA, 2010 ) . Genective also submitted a safety and nutritional assess ment of food and feed derived from VCO

- 01981

- 5 Corn to the FDA on March 5, 2012 (BNF

- 000137). FDA is presently eva luating this submission. No questions have been raised thus far ( p ersonal communication, I. Coats, Bayer, May 22, 2012) pursuant to §408(d) of the Feder al Food, Drug, and Cosmetic Act

. Environmental Protection Agency As described in Subsection 2.4, Human Health, 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 envi ronment. 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, 2 011a )

. The latest reregistration decision for glyphosate was issued in 1993 and the reregistration review was started in July 2009 ( US

- EPA, 2009b ) ; ( US

- EPA, 2009a )

. Before a pesticide can be used on a food or feed crop, the EPA must establish the tolerance valu e, which is the maximum amountof pesticide residue that can remain on the crop or in foods or feed processed from that crop ( US

EPA, 2011c ) . Glyphosate currently has established tolerances for residues, including established residue conce ntrations for glyphosate in field corn for forage, grain, and stover ( US

- EPA, 2011b ) . Pesticide tolerance levels for glyphosate have been established for corn and are published in the Federal Register , CFR, and the Indexes to Part 18 0 Tolerance Information for Pesticide Chemicals in Food and Feed Commodities ( US

- EPA, 2011b ) . The glyphosate tolerance level established for field corn intended for forage is 6.0 ppm and for grain corn is 5.0 ppm (40 CFR §180.364). The EPA regulates plant

- incorporated protectants (PIPs), although the epsps grg23ace5 gene expressed in this corn is not a PIP, under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and certain biological control organisms under the Toxic S ubstances Control Act (TSCA). 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. As VCO

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- 5 C orn does not express any pes ticidal properties, the EPA has no FIFRA review authority over this corn pro duct. However, if VCO

- 01981

- 5 C orn provides for a change in use of registered herbicides, the EPA would review proposed label changes relating to these new herbicide uses. But Ge nective does not indicate any change in glyphosate use with the crop that would differ from that currently registered for other, similar glyphosate resistant crops. Scope of the Environmental Analysis Although approving the petition for nonregulated status of VCO

- 01981

- 5 Corn would allow for new plantings of VCO

- 01981

- 5 Corn anywhere in the U.S., APHIS primarily focused the environmental analysis to those geographic areas that current support corn production. A

pproving the petition for nonregulated status of VCO

- 01981

- 5 Corn is not expected to increase corn production, either by its availability alone or accompanied by other factors, or cause an increase in overall GE corn acreage. To determine areas of corn production, APHIS used data from the National Ag ricu ltural Statistics Service ( USDA

- NASS, 2010 ) to determine wher e corn is produced in the U.S. ( USDA

- NASS, 2010 ) . Corn is primar ily pro duced in an area of the U.S. commonly known as the Corn Belt, which includes Iowa, Illinois, Nebraska, and Minnesota, and parts of Indiana, South Dakota, Kansas, Ohio, Wisconsin, and Missouri. These ten states comprised approximately 73 percent of the nation’s corn production in 2011 ( USDA

- NASS, 2012b ; USDA

- NASS, 2012a )

. Public Involvement On July 13, 2012, APHIS pub lished a notice in the Federal Register (77 FR 41353

- 41354, Docket no. APHIS

- 2012

- 0046 ) announcing the availability of the Genective petition for a 60

- day public review and comment period. Comments were required to be received on or before September 11, 2 012. All comments were carefully analyzed to identify new issues, alternatives, or information. A total of 4,693 comments were received from individu als during the comment period , of which 4,601 were form letters

. Comment documents may be viewed at : http://www.regulations.gov/#!searchResults;rpp=50;so=ASC;sb=docId;po=0;s=APHIS

- 2012

- 0046

. . Most comments received were in form letters from indivi duals expressing an opinion of general opposition to GE food, the belief that GE crops harm the environment, or the belief thatGE crops are not beneficial to farmers. Many of the comments also objected to APHIS publishing multiple dockets for review on t he same day.

Issues related to Genective VCO

- 01981

- 5 Corn which were raised in these comments are addressed in our EA; the issues raised included:

• Development of glyphosate resistant weeds

. • The fate of glyphosate in water

. • The effects of glyphosate use on biological organisms

. • Concern that cross

- pollination between GE and organic or crops for GE

- sensitive markets will affect sales for growers of these crops.

• Concerns that Genective VCO

- 01981

- 5 Corn is not approved in all export markets. APHIS evaluated the se issues raised in the comments and provided citations

. A discussion of these issues is incorporated in th e EA where appropriate. Major Issues Addressed in the EA The issues considered in the EA were developed based on APHIS’ determination that certain ge netically engineered organisms are no longer subject to the plant pest provisions of the Plant Protection Act and 7 CFR part 340, and for this particular EA, the specific petition seeking a determination of nonregulated status for VCO

- 01981

- 5 Corn. Issues discussed in the EA were developed by considering public concerns as well as issues raised in public comments submitted for other environmental assessments of genetically engineered organisms, concerns raised in lawsuits, as well as those issues that have been raised by various stakeholders. These issues, including those regarding the agricultural production of corn using various production methods, and the environmental food/feed safety of genetically engineered plants were addressed to analyze the poten tial environmental impacts of VCO

- 01981

- 5 Corn. The list of resource areas considered were developed by APHIS through experience in considering public concerns and issues raised in public comments submitted for other EAs of GE organisms. The resource area s considered also address concerns raised in previous and unrelated lawsuits, as well as issues that have been raised by various stakeholders in the past. The following issues were identified as important to the scope of t he analysis (40 CFR 1508.25). The se resource areas can be categorized as follows: Agricultural Production Considerations:

• Acreage and Areas of Corn Production

• Agronomic/Cropping Practices

• Corn Seed Production

• Organic Corn Production
Environmental Considerations:

• Water Resources

• Soil

• 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 Env ironment

• Organic Farming

• Trade Economic Environment Alternatives that were fully analyzed The EA analyzes the potential environmental consequences of a determination of nonregulated status of VCO

- 01981

- 5 Corn. To respond favorably to a petition for nonreg ulated status, APHIS must determine that VCO

- 01981

- 5 Corn is unlikely to pose a plant pest risk. Based on its Plant Pest Risk Assessment ( USDA

- APHIS, 2012a ) , APHIS has concluded that VCO

- 01981

- 5 Corn is unlikely to pose a plant pest risk. Therefor e, APHIS must determine that VCO

- 01981

- 5 Corn is no longer subject to 7 CFR part 340 or the plant pest provisions of the Plant Protection Act. Two alternatives were evaluated in the EA: (1) no action and (2) determination of nonregulated status of VCO

- 019 81

- 5 Corn. 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. VCO

- 01981

- 5 Corn and progeny derived from VCO

- 01981

- 5 Corn would continue to be regulated articles under the regulated articles under the regulations at 7 CFR part 340. Permits or notifications acknowledged by APHIS would still be required for introduct ions of VCO

- 01981

- 5 Corn and measures to ensure physical and reproductive confinement would continue to be implemented. APHIS might choose this alternative if there were insufficient evidence to demonstrate the lack of plant pest risk from the unconfined cultivation of VCO

- 01981

- 5 Corn. This alternative is not the preferred alternative because APHIS has concluded through a Plant Pest Risk Assessment that VCO

- 01981

- 5 Corn is unlikely to pose a plant pest risk ( USDA

APHIS, 2012a ) . Choosing this alter native 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 VCO

- 01981

- 5 Corn is No Longer a Regulated Article Under this alternative, VCO

- 01981

- 5 Corn and progeny derived from them would no longer be regulated articles under the regulations at 7 CFR part 340. VCO

- 01981

- 5 Corn is unlikely to pose a plant pest risk (USDA

- APHIS, 2012 ( USDA

- APHIS, 2012a ) ) . Permits issue d or notifications acknowledged by APHIS would no longer be required for introductions of VCO

01981

- 5 Corn and progeny derived from this event. The Preferred Alternative, i.e., a determination of nonr egulated status of VCO

- 01981

- 5 C orn, is not expected to increase corn production, either by its availability alone or associated with other factors, or result in an increase in overall acreage of GE corn. Potential impacts would be similar to the No Action Alternative. This 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 Plant Protection Act. Because the agency has concluded that VCO

- 01981

- 5 Corn is unl ikely to pose a plant pest risk, a determination of nonregulated status of VCO

- 01981

- 5 Corn 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 VCO

- 01981

- 5 Corn. The agency evaluated these alternatives, in light of the agency’s authority under the plant pest provisions of the Plant Protection Act, 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 VCO

- 01981

- 5 Corn. 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 VCO

- 01981

- 5 Corn 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 VCO

- 01981

- 5 Corn, including denying any permits associated with the field testing. APHIS determined that this alternative is not appropriate given that A PHIS has concluded that VCO

- 01981

- 5 Corn is unlikely to pose a plant health risk ( USDA

- APHIS, 2012a )

. In enacting the Plant Protection Act, Congress found that [D] ecisions affecting imports, exports, and interstate movement of product s regulated
u nder [the Plant Protection Act] shall be based on sound science... § 402(4). 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 the development and implementation policies for oversight of emerging technologies (such as genetic engineering) at the agency level. In accordance with this memorandum, agencies should adhere t o Executive Order 13563, and, consistent with that Executive Order, the following principle, among others to the extent permitted by law when r egulating emerging technologies:“[D}ecisions should be based on the best reasonably obtainable scientific, techn ical, economic, and other information, within the boundaries of the authorities and mandate of each agency” Based on the PPRA ( USDA

- APHIS, 2012a ) , and the scientific data evaluated therein, APHIS concluded that VCO

- 01981

- 5 Corn is unlikely to pose a plant pest risk. Accordingly, there is no basis in science for prohibiting the release of VCO

- 01981

- 5 Corn. 2. Approve the petition in part T he regulations at 7 CFR 340.6(d)(3)(i) state that APHIS may “approve the petition in whole or in part.” For exampl e, 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 VCO

- 01981

- 5 Corn is unlikely to pose a plant pest risk, ( USDA

- APHIS, 2012a ) , there is no regulatory basis under the plant pest provisions of the Plant Protection Act for considering approval of the petition only in part. 3. Isolation Distance between VCO

- 01981

- 5 Corn and Non

- GE Corn Production and Geographica l Restrictions However, because APHIS has concluded that VCO

- 01981

- 5 Corn is unlikely to pose a plant pest risk ( USDA

- APHIS, 2012a ) , an alternative based on requiring isolation distances would be inconsistent with the statutory authority under the p lant pest provisions of the Plant Protection Act and regulations in 7 CFR part 340. In response to public concerns of gene movement between GE and non

- GE plants, APHIS considered requiring an isolation distance separating VCO

- 01981

- 5 Corn from conventiona l or specialty corn production. APHIS also considered geographically restricting the production of VCO

- 01981

- 5 C orn based on the location of production of non

- GE corn 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’ plant pest risk assessment for VCO

- 01981

- 5 Corn , there are no geographic differences associated with any identifiable plant pest risks for V CO

- 01981

- 5 Corn ( USDA

- APHIS, 2012a ) . This alternative was rejected and not analyzed in detail because APHIS has concluded that VCO

01981

- 5 Corn does not pose a plant pest risk, and will not exhibit a greater plant pest risk in any geographically re stricted area. Therefore, such an alternative would not be consistent with APHIS’ statutory authority under the plant pest provisions of the Plant Protection Act and regulations in Part 340 and the biotechnology regulatory policies embodied in the Coordin ated 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 t he agency’s authority under the plant pest provisions of the Plant Protection Act. However, individuals might choose on their own to geographically isolate their non

- GE corn production systems from VCO

- 01981

- 5 C orn or to use isolation distances and other management practices to minimize ge ne movement between VCO

01981

- 5 Corn and non

- GE corn fields. Information to assist growers in making informed management decisions for VCO

- 01981

- 5 Corn is available from the Association of Official Seed Certifying Agenci es ( AOSCA, 2010 )

. 4. Requirement of Testing for VCO

- 01981

- 5 CornDuring the comment periods for other petitions for nonregulated status, some commenters requested that USDA require and provide testing fo r 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 mainta in. Additionally, because VCO

- 01981

- 5 Corn does not pose a plant pest risk ( USDA

- APHIS, 2012a ) , the imposition of any type of testing requirements is inconsistent with the plant pest provisions of the Plant Protection Act, the regulations at 7 CFR part 340 and biotechnology regulatory policies embodied in the Coordinated Framework. Therefore, i mposing such a requirement for VCO

- 01981

- 5 Corn would not meet APHIS’ purpose and need to respond appropriately to the petition in accordance with its regula tory 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 a nalyzed in the Environmental Consequences section of the EA. Attribute/Measure Alternative A: No Action Alternative B: Determination of Nonregulated Status
Meets Purpose and Need and Objectives No Yes

**Unlikely to pose a**

**plant pest risk** Satisfied through use of regulated field trials Satisfied

— risk assessment ( USDA

APHIS, 2012b ) Mana gement

Practices **Acreage and Areas of Corn** 

**Production** Yearly f luctuation but no or small net increase of acreage

and no new regions of corn planted Unchanged from No Action Alternative

**Agronomic**

**Practices** Cropping practices will remain the same as curr ent practices for commercial corn production Unchanged from No Action Alternative

**Pesticide Use** Herbicide use patterns are related to weed management strategies Unchanged from No Action Alternative

**Corn Seed Production**  Fluctuates yearly somewhat; foreign seed production is used

to respond to specific needs Unchanged from No Action Alternative
**Organic Corn**

**Production** Yearly production not affected by conventional corn production Unchanged from No Action Alternative

Environment

**Land Use** Corn acreage generally stable but fluctuates yearly Unchanged from No Action Alternative **Water Resources** Herbicides in water fluctuate with weather, climate and Unchanged from No Action Alternativeusage **Soil** Glyphosate in soil has a short half

- life. Conservation tillage

may be increasing slightly Unchanged from No Action Alternative
**Air Quality** Air quality (particulates) affected by tillage and weather Unchanged from No Action Alternative **Climate Change** Climate changes affected by land use, tillage and greenho use gases Unchanged from No Action Alternative

Animals and Plants **Animals** Vertebrates interact infrequently with corn agriculture; invertebrates not likely to have new impacts from

corn production compared to any other agricultural production Unchange d from No Action Alternative

**Plants** Natural vegetation highly reduced near farms; herbicide

resistant weeds increasing Unchanged from No Action Alternative

**Gene Movement** No gene flow to wild plants; gene flow to other corn easily

controlled. Horizontal gene flow not observed Unchanged from No Action Alternative

**Soil Microorganisms**  Microorganisms affected by tillage, agronomic activity and pesticides Unchanged from No Action Alternative
**Biological Diversity**  Contemporary agriculture impacts diversity b ut new

impacts not likely to be significant Unchanged from No Action Alternative

Human and Animal Health **Risk to Human Health**  EPA rates glyphosate impacts from glyphosate resistant corn as having no reasonable certainty of harm Unchanged from No Acti on Alternative

**Risk to Animal Feed**  Corn is a major feed protein for animal nutrition; quality is unchanging and adequate to animal needs Unchanged from No Action Alternative

Socioeconomic **Domestic and**

**Economic Environment**  Corn seed with various traits has a competitive market in the US, with four major seed suppliers, and over a hundred smaller ones Unchanged from No Action Alternative**Trade Economic Environment**  Corn export levels decreased by 23% from 2010 to 2012 in the US Unchanged from No Action A lternative
Other Regulatory Approvals Completed FDA early food safety consultation; final consultation in progress. EPA

tolerance exemptions and conditional pesticide registrations granted C ompleted FDA early food safety consultation, final consultation i n progress. EPA tolerance exemptions and conditional pesticide

registrations granted
Compliance with Other Laws **CWA, CAA, Eos** Fully compliant Fully compliant Finding of No Significant Impact The analysis in the EA indicates that there will not be a s ignificant 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 follow ing 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 corn production systems, including surrounding environments and agricultural workers; human food and animal feed production systems; and foreign a nd domestic commodity markets. I n 2009, the U.S. p r odu c e d 40% of the to t a l wo r ld supp l y of c o rn ( USDA

- OCE, 2011 )

. Co r n i s c ul t ivat e d wo r ldwide, i n c lud i ng A r g e nt i n a , S outh A f ri ca , B r a z i l , C a n a d a , China, a nd the f o r mer S oviet Union States , including the Ukraine ( USDA

- OCE, 2011 )

. Eg y pt, the EU , Japan , Me x ico, S outhe a st Asi a , a nd S outh Ko r e a a r e n e t i m port e rs of c o r n ( USDA

- OCE, 2011 ) . App r o x i m a te l y 15 to 2 0 % of the U.S. c o r n p r o d u c t i on is e x port e d ( USDA

- OCE, 2011 )

. Co r n is the most wid e l y c ul t i v a ted f e e d g r a in, a c c ount i ng for mo r e than 9 5% of to t a l v a lue
a nd p r odu c t i on of f ee d g ra i n s ( USDA

- ERS, 2011b )

. Co r n is g r own in a ll 48 of the c ont i n e n t a l U.S. stat e s with p r odu c t i on c on ce ntr a te d in the C o r n B e l t , loose l y d e fi n e d a s the stat e s of I l l ino i s, I o w a , I ndian a , the ea ste r n portions of S outh D a k ota a nd N e b r a ska, w e ste r n K e ntuc k y a nd Ohio, a nd the north e rn two

- th ir ds of Missouri ( USDA

- ERS, 2011a ) ; ( USDA

- NASS, 2010 )

. I owa a nd I l l ino i s, the two top c o r n p r od u c ing stat e s, t y pic a l l y a c c o u nt for sl i g h tl y mo r e than
o ne

- th i rd of the to t a l U.S. c rop ( USDA

- E RS, 2011b )

. I n t he U.S. for the 2012 p r o du c t i on y e a r, c o r n w a s c ul t ivat e d on over 96 m i l l i o n ac r e s , a 5% in c re a se in c o r n a c re a g e f rom 2011 ( USDA

- NASS, 2012a ) . Within t h e 20 1 0 ac r e a g e , c o r n for si la ge w a s c ul t ivat e d on a ppro x i m a te l y 5.6 m i l l ion ac r e s, or a p p ro x i m a te l y 6% of the to t a l c o r n p rodu c t i on a r e a ( USDA

- NASS, 2012b ) . Co r n p r odu c t i on in 2010 w a s e st i mat e d a t 12.4 bi l l i on bush e ls,
v a lued a t a n e st i mat e d $5.18 p e r bush e l in 2010 and $6.20 in 2011 ( USDA

- NASS, 2012a ) , ( USDA

- NASS, 2012c )

. GE herbicide

- resistant corn comprised approximately 21% of the total corn acreage in th e U.S., insect

- resistant varieties comprised 15% of the acreage, and stacked varieties comprising 52% of the total corn acreage ( USDA

- NASS, 2012a ) . The costs for GE corn seed are higher than that for conventional seed. Growers pay a premium for GE seed, withgrowers in 2008 paying as much as 50% more for GE corn seed than conventional seed ( NRC, 2010 ) . This seed premium includes a technology fee for the cultivation of the seed ( NRC, 2010 )

. Approximately 88% of corn fields were planted with transgenic corn in 2011 ( USDA

- NASS, 2011 )

. Introduction o f herbicide

- resistant corn varieties, in particular glyphosate

- resistant corn, has not significantly affected corn acreage managed with total herbicide application. A determination of nonregulated status of VCO

- 01981

- 5 Corn is not expected to directly cau se an increase in agricultural acreage devoted to corn production, or those corn acres devoted to GE corn cultivation. The availability of VCO

- 01981

- 5 Corn will not change cultivation areas for corn production in the U.S. and there are no anticipated chan ges to the availability of GE and
non

- GE corn varieties on the market. Results of the agronomic and morphologic assessments conducted by Genective indicate that the introduced herbicide resistance trait does not confer any competitive advantage in terms of weediness ( USDA

- APHIS, 2012a ) . Gene ctive asserts that VCO

- 01981

- 5 C orn will be a replacement product for other varieties of corn currently cultivated, so new acreage is not expected to accommodate the cultivation of VCO

- 01981

- 5 C orn ( Genective, 2012 )

. The glyphosate resistance trait, already in commercial use for fifteen years, is not expected to extend the range of cultivation for VCO

- 01981

- 5 C orn outside of existing cultivation areas ( Genective, 2012 )

. Intensity

– Intensity is a measure of the degree or s everity 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. In the past 30 years, the public’s consumption of corn

- based products has more than doubled. Per capita consumption of corn products rose from 12.9 pounds annually per capita in 1980 to 33 pounds in 2008; and corn sweeteners increased from 35.3 pounds annually per capita to 69.2 pounds during that period ( USCB, 2011 ) . As of 2012, 88% of the corn cultivated is GE ( USDA

- NASS, 2012a ) . Public health concerns associated with the use of GE corn, such as VCO

- 01981

- 5 Corn , and GE corn products focus primarily on human and animal (livestock) consumption of GE food and feed commodities. A determination of nonregulated status of VCO

- 01981

- 5 Corn will have no significant environmental impact in relation to the availability of G E, conventional, and organic corn varieties. As discussed in Chapter 4 of the EA, a determination of nonregulated status of VCO

- 01981

- 5 Corn is not expected to directly cause an increase in agricultural acreage devoted to corn production, or those corn ac res devoted to GE corn cultivation. The availability of VCO

- 01981

- 5 Corn will not change the cultivation areas for corn production in the U.S. and there are no anticipated changes in the availability of GE and
non

- GE corn varieties on the market. A deter mination of nonregulated status of VCO

01981

- 5 Corn could add another GE corn variety to the conventional corn market and is not expected to change the market demands for GE corn or corn produced using organic methods. GE and organic corn are planted on a bout 88% and 0.2% of corn acreage , respectively ( USDA

- ERS, 2010 )

. As of 2008, the most recent year for which data are available, approximately 168,000 acres of certified organ ic corn were grown in the U.S. B ased on the data provided by Genective for VCO

- 01981

- 5 Corn ( Genective, 2012 ) , APHIS has concluded that the availability of VCO

- 01981

- 5 Corn would not alter theagronomic practices, locations, and seed production and quality characteristics of conventional and GE corn seed production ( USDA

- APHIS, 2011 ) . A determination of nonregulat ed status of VCO

- 01981

- 5 Corn will not require a change to seed production practices, nor current production practices. 2. The degree to which the proposed action affects public health or safety. Non

- GE corn varieties, both those developed for conventional use and for use in organic production systems, are not routinely required to be evaluated by any regulatory agency in the U.S. for human food or animal feed safety prior to release in the market. Under the FFDCA, it is the responsibility of food and feed manufacturers to ensure that the products they market are safe and labeled properly. As a GE product, however, food and feed derived from VCO

- 01981

- 5 C orn must be in compliance with all applicable legal and regulatory requirements. GE organisms for food and feed may undergo a voluntary consultation process with the FDA prior to release onto the market. Although a voluntary process, thus far all applicants who have wished to commercialize a GE variety that would be included in the food supply have complet ed a consultation with the FDA. In such consultation, a developer who intends to commercialize a bioengineered food meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the bioengineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food. This process includes: 1) an evaluation of the amino acid sequence introduced into the food crop to confirm whether the protein is related to known toxins and allerge ns; 2) an assessment of the protein’s potential for digestion; and 3) an evaluation of the history of safe use in food ( Hammond and Jez, 2011 ) . FDA evaluates the submissio n and responds to the developer by letter with any concerns it may have or additional information it may require. Several international agencies also review food safety associated with GE

- derived food items, including the European Food Safety Agency (EFSA ) and the Australia and New Zealand Food Standards Agency (ANZFS). Genective has provided the FDA with information on the identity, function, and characterizati on of the genes for VCO

- 1981

- 5 C orn, including expression of the gene products. The FDA has com pleted its early food safety evaluation, but has not yet completed its food and nutrition Biotechnology Consultation. A determination of nonregulated status of VCO

- 01981

- 5 Corn would have no significant impacts on human or animal health. VCO

- 01981

- 5 Corn is compositionally similar to currently available corn on the market with the exception of the epsps grg23ace5 gene. Based on the FDA’s consultation, laboratory data and scientific literature provided by Genective ( Genective, 2012 ) , APHIS has concluded that VC O

- 01981

- 5 Corn would have no significant im pacts 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
cr itical 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 adversely impacted by a determination of nonregulated status of VCO

- 01981

- 5 Corn. 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 sa le, lease, or transfer of ownership of any property. This action is limited to a determination of nonregulated status of VCO

01981

- 5 Corn. The product will be deployed on agricultural land currently suitable for production of corn, will replace existing varieties, and is not expected to increase the acreage of corn 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, plan ting, irrigation, and harvesting of plants would be used on agricultural lands planted to VCO

- 01981

- 5 Corn including the use of EPA registered pesticides. Applicant’s adherence to EPA label use restrictions for all pesticides will mitigate potential impac ts to the human environment. In the event of a determination of nonregulated status of VCO

- 01981

- 5 Corn, the action is not likely to affect historic or cultural resources, park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologically crit ical areas that may be in close proximity to corn 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 VCO

- 01981

- 5 Corn are not highly controversial. Although APHIS received public comments opposed to a determination of nonregulated status of VCO

- 01981

- 5 Corn, this action is not highly controversial in terms of size, nature or effect on the natural or physical enviro nment. 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 corn production, or those acres devoted to GE corn cultiv ation. The availability of VCO

- 01981

- 5 Corn will not change cultivation areas for
corn production in the U.S., and there are no anticipated changes to the availability of GE and non

- GE corn varieties on the market. It will not result in changes in the current practices of planting, tillage, fertilizer application/use, cultivation, pesticide application use/volunteer control. Mana gement practices and seed standards for production of certified corn seed would not change. The effect of VCO

- 01981

- 5 Corn on wildlife or biodiversity is not different than that of other glyphosate

- resistant crops currently used in agriculture, or other G E or non

- GE corn 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 environ ment. As discussed in Chapter 4 of the EA, a determination of nonregulated status of VCO

- 01981

- 5 Corn is not expected to directly cause an increase in agricultural acreage devoted to corn production, or t hose acres devoted to GE corn cultivation. A determination of nonregulated status of VCO

- 01981

- 5 Corn will not result in changes in the current practices of planting, tillage, fertilizer application/use, and volunteer control. Management practices and se ed standards for production of certified corn seed would not change. The effect of VCO

- 01981

- 5 Corn on wildlife or biodiversity is no different than that from other glyphosate

- resistant crops currently used in agriculture, or other GE or
non

- GE corn produ ced in conventional agriculture in the U.S. As described in Chap t er2of the EA, well established management practices, production controls, and production practices (GE, conventional, and organic) are currently being used in corn production systems (comme rcial and seed production) in the U.S. Therefore, it is reasonable to assume that farmers, who produce conventional corn (GE and non

- GE varieties), VCO

01981

- 5 Corn, or pro duce corn using organic methods , will continue to use these reasonable, commonly ac cepted best management practices for their chosen systems and varieties during agricultural corn production. Add itionally, GE corn currently is planted on the majority of co rn acres (88% of acreage in 2010) ( USDA

- NASS, 2012a )

. Based upon historic trends , conventional production practices that use GE varieties will likely continue to dominate in terms o f acreage with or without a determination of nonregulated status of VCO

- 01981

- 5 Corn. Given the extensive experience that APHIS, stakeholders, and growers have in dealing with the use of GE corn products and glyphosate

- resistant agricultural crops, the po ssible effects to the human environment from the release of an additional GE corn 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 ma y 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 VCO

- 01981

- 5 Corn would not establish a precedent for future actions with sign ificant effects or 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 autho rity of the plant pest provisions of the Plant Protection Act 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 t he regulated status of GE organisms, including GE plants such as VCO

- 01981

- 5 Corn. 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 o n its Plant Pest Risk Assessment that the genetically engineered organism is unlikely to pose a plant pest risk, the genetically engineered organism is no longer subject to the plant pest provisions of the Plant Protection Act and 7 CFR part 340. APHIS re gulations at 7 CFR part 340, which were promulgated pursuant to authority granted by the Plant Protection Act, 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 Plant Protection Act 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 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 that a particular regulated article is unlikely to pose a plant pest risk, and, therefore, is no longerregulated under the plant pest provisions of the Plant Protection Act or the regulations at 7 CFR part 340. The petitioner is required to provid e 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 regulat ory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act 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 corn management practices, human and animal health, and the environment and concluded that such impacts were not signif icant. A cumulative effects analysis is provided in Chapter 5 of the EA. In the event APHIS reaches a determination of nonregulated status of VCO

- 01981

- 5 Corn, APHIS would no longer have regulatory authority over this corn. In the event of a determinati on of nonregulated status of VCO

- 01981

- 5 Corn, APHIS has not identified any significant impact on the environment which may result from the incremental impact of a determination of nonregulated status of VCO

- 01981

- 5 Corn when added to past, present, and re asonably forseeable 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 sig nificant scientific, cultural, or historic resources. A determination of nonregulated status of VCO

- 01981

- 5 Corn will not adversely impact cultural resources on tribal properties. Any farming activities that may be taken by farmers on tribal lands are onl y 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 VCO

- 01981

- 5 Corn would have no impact on districts, sites, highways, stru ctures, 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 VCO

- 01981

- 5 Corn. 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. Applicant’s adherence to EPA label use restrictions for all pesticides will mitigate impacts to the human environment. A determination of nonregulated status of VCO

- 01981

- 5 Corn is not an undertaking that may directly or indirectly cause alteration in the character or use of h istoric 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 us ed that could result in effects on the use and enjoyment of a historic property when 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 results 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 oth er 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. Additionally, these cultivation practices are already being conducted throughout the corn production regions. The cultivation of VCO

- 01981

- 5 Corn does not i nherently change any of these agronomic practices so as to give rise to an 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 Enda ngered 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 VCO

- 01981

- 5 Corn on federally listed threatened and endangered species (TES) and species proposed f or listing, as well as 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 VCO

- 01981

- 5 Corn, APHIS has d etermined that a determination of nonregulated status of VCO

- 01981

- 5 Corn 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 v iolation 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 VCO

- 01981

- 5 Corn is unl ikel y to pose a plant pest risk, a determination of nonregulated status of VCO

- 01981

- 5 Corn 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. 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 th e public involvement process. I believe that the issues identified in the EA are best addressed by selecting Alternative 2 (Determination that VCO

- 01981

- 5 Corn is No Longer a Regulated Article). This alternative meets APHIS’ purpose and need to allow the safe development and use of genetically engineered organisms consistent with the plant pest provisions of the Plant Protection Act. As stated in the CEQ regulations, “the agency’s preferred alternative is the alternative which the agency believes would fu lfill 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 fo r the safe development and use of genetically engineered organisms; and (2) it allows APHIS to fulfill its regulatory obligations.As APHIS has not identified any plant pest risks associated with VCO

- 01981

- 5 Corn, the continued regulated status of VCO

- 019 81

- 5 Corn 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 determina tion of nonregulated status of VCO

- 01981

- 5 Corn will not have any significant environmental effects.

_____________________________ ___________________ Michael C. Gregoire Date Deputy Administrator Biotechnology Regulatory ServicesBibliograp y AOSCA. (2010). "General IP Protocols Standards." The Association of Official Seed Certifying Agencies. http://www.identitypreserved.com/handbook/aosca

- general. htm >. Genective. (2012). "Petition for Determination of Non

- regulated Status for Even VCO

- 01981

- 5. submitted by I. Coats, US Registration Manager, Bayer CropScience LP." Genective S.A. Hammond, B. G., and J. M. Jez. (2011). "Impact of food processing on the safety assessment for proteins introduced into biotechnology

- derived soy bean and corn crops." Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association 49 (4): p 711

- 21. http://www.ncbi.nlm.nih.gov/pubmed/21167896 >. NRC. (2010). The Impact of Genetically Engineered Crops on Farm Sustainability in the United States

. Washington, DC: National Academies Press. http://www.nap.edu/catalog.php?record_id=12804
>. US

- EPA. (2009a). "Glyphosate. Human Health Assessment Scoping Document in Support of Registration Review. U.S. Environmental Protection Agency

. " Agency, U.S. Envir onmental Protection. Last Accessed: January 20, 2012 < http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPP

2009

- 0361

- 0006 >. US

- EPA. (2009b). "Problem Formula tion for the Ecological Risk and Drinking Water Exposure Assessments in Support Of the Registration Review of Glyphosate and Its Salts." U.S. Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances, Environmental Fate and Effe cts Division, Environmental Risk Branch III. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPP

- 2009

- 0361

- 0007 . >. US

- EPA. (2011a). "Federal Insecticide, Fun gicide, and Rodenticide Act (FIFRA)." http://www.epa.gov/agriculture/lfra.html >. US

- EPA. (2011b). "Pesticides: Regulating Pesticides, Pesticide Tolerances." U.S. Environmental Protection Agency. http://www.epa.gov/pesticides/regulating/tolerances.htm >. US

- EPA. (2011c). "Summary of the Federal Food, Drug, and Cosmetic Act (FFDCA)." U.S. Environmental Protection Agency. http://www.epa.gov/regulations/laws/ffdca.html >. US

- FDA. (2010). "Biotechnology Consultation Note to the File NPC No. 000012, EPSPS ACE5, Herbicide Tolerant Corn." http://www.fda.gov/Food/Biotechnology/Submissions/ucm231052.htm >. US

- FDA. (2011). "Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non

- Pesticidal Proteins Produced by New Plant V arieties Intended for Food Use

. " Office of Food Additive Safety, Division of Biotechnology & GRAS Notice Review, Center for Food Safety and Applied Nutrition, Food and Drug Administration. Health and Human Services. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Bi otechnology/ucm096156.htm >. USCB. (2011). "Table 213. Per Capita Consumption of Majo r food Commodities: 1980 to 2008." http://www.census.gov/compendia/statab/2011/tables/11s0213.pdf >. USDA

- APHIS. (2011). "Draft Environmental Impact Statement, Glyphosate

- Toler ant H7

- 1 Sugar Beets: Request for Nonregulated Status." http://www.aphis.usda.gov/biotechnology/not_reg.html >. USDA

- APHIS. (2012a). "Plant Pest Risk Assessment for Genective Event VCO

- Ø1 981

- 5 Corn." US Department of Agriculture, Animal and Plant Health Inspection Service, Biotechnology Regulatory Services. USDA

- APHIS. (2012b). "Plant Pest Risk Assessment for MON 87427 Corn." Riverdale Park, MD. United States Department of Agriculture, An imal and Plant Health Inspection Service, Biotechnology Regulatory Services. Last Accessed: July 2012 < http://www.aphis.usda.gov/biotechnology/not_reg.html >.USDA

- ERS. (2010). "Adoption of Genetically Engineered Crops in the U.S.: Corn Varieties." http://www.ers.usda.gov/Data/BiotechCrops/ExtentofAdoptionTable1.htm >. USDA

- ERS. (2011a). "Corn: Backgroun d." http://www.ers.usda.gov/Briefing/Corn/background.htm >. USDA

- ERS. (2011b). "Feed Outlook, FDS

- 11a, January 14, 2011." Last Accessed: March 21, 2011 < http://usda.mannlib.cornell.edu/usda/ers/FDS/2010s/2011/FDS

- 01

- 14

- 2011.pdf >. USDA

- NASS. (2010). "Acreage." http: //usda.mannlib.cornell.edu/usda/current/Acre/Acre

- 06

- 30

- 2010.pdf >. USDA

- NASS. (2011). "Agricultural Chemical Usage 2010 Corn, Upland Cotton, Fall Potatoes." http://www.nass.usda.gov/Surveys/Guide_to_NASS_Surveys/Chemical_Use/FieldCropChemical UseFactSheet06.09.11.pdf >. USDA

- NASS. "Acreage." Washington, DC: National Agricultural Statistics Service, Agricultural Statistics Board, USD A, 2012a. 42. http://www.usda.gov/nass/PUBS/TODAYRPT/acrg0612.pdf

. USDA

- NASS. (2012b). "Crop Production 2011 Summary." http://usda01.library.cornell.edu/usda/current/CropProdSu/CropProdSu

- 01

- 12

- 2012.pdf >. USDA

- NASS. (2012c). "Crop Values 2011 Summary." U.S. Department of Agriculture

– National Agricultural Statistics Service. http://usda.mannlib.cornell.edu/MannUsda/viewDocumentInfo.do?documentID=1050 >. USDA

- OCE. (2011). "World Agricultural Supply and Demand Estimates." http://usda.mannlib.cornell.edu/usda/waob/wasde//2010s/2011/wasde

- 03

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- 2011.pdf >.