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Response to Comments

Petition 06-354-01

APHIS reviews a petition for nonregulated status to determine if the genetically engineered (GE) 

organism should no longer be considered a regulated article under APHIS biotechnology 

regulations (7 Code of Federal Regulations (CFR) part 340). Prior to reaching a decision, APHIS 

prepared a plant pest risk assessment to evaluate whether Pioneer 305423 soybean is likely to 

pose a plant pest risk. After finding that Pioneer high oleic soybean is not likely to pose a plant 

pest risk, and is eligible for nonregulated status, APHIS prepared a draft environmental 

assessment (EA) to evaluate whether there could be significant impacts on the environment 

arising from a decision to grant a determination of nonregulated status to Pioneer 305423 

soybean. APHIS prepared the EA as part of its obligation to meet the statutory requirements of 

the National Environmental Policy Act (NEPA) of 1969. As part of this process, APHIS 

considered public comments received on the petition for deregulation and associated draft EA. 

This document provides APHIS’ response to these comments.

On September 2, 2009, APHIS published a notice in the Federal Register (74 FR 45413-

45415, Docket no. 2007-0156) announcing the availability of the Pioneer petition requesting 

nonregulated status for 305423 soybean and associated draft EA for public review and comment 

for a 60-day period. This comment period was scheduled to end on November 2, 2009. Because 

the original docket was not the correct APHIS version, a subsequent 60 day comment period was 

published on October 26, 2009 in the Federal Register (74 FR 54950-54951, Docket no. 2007-

0156) announcing the availability of the corrected EA. This comment period ended on December 

28, 2009. APHIS received a total of 40 comments from various groups and individuals during the 

two comment periods. Twenty-two comments supported deregulation, eighteen comments 

generally opposed the development and use of GE foods (twelve from one individual), one 

comment emphasized a need for strict regulation, and one comment generally disagreed about the 

overall need for this soybean crop. 

Those in favor of non regulated status included five state senators or representatives, five 

departments of agriculture, three food or industrial companies, three soybean associations, and 

two soy or food institutes. Those in opposition to granting non regulated status were individual 

consumers, who as noted, mostly did not offer opposition to this specific product, but were 

opposed to all genetically modified plants. Supporters of nonregulated status cited a number of 

benefits if this product were available for commercial production including: (1) the product’s 

fatty acid ratios are more healthful to the public than conventional soy oil; (2) oil derived from 

the product would be useful to the food and non foods industry; and (3) the growers will be able 

to market a new product that expands the potential commercial possibilities for soybean because 

of an improved fatty acid balance. Several comments from various industry associations focused 

on Pioneer/Dupont’s statement of support for adequate risk assessment and risk management 

programs sponsored by the technology provider, and Pioneer’s acceptance of a total life cycle 

approach for the product in domestic and export markets. Of those opposed, none provided 

specific disagreement with the analysis provided by the environmental assessment, but were 

focused primarily on opposition to control of the seed supply by the federal government, or 

control by large corporations that ostensibly desire to increase the cost of seed. Some were 

concerned about consequences of gene splicing, such as creating plant pests, introducing dangers 

from cross-pollination of wild plants, generating unintended consequences in the GE plants, 

producing plants that were poisonous or otherwise hazardous, causing GE plants to become 

mutagenic, or causing organ toxicity, or otherwise generating unknown, long-term risks. Still 

other comments stated that an EIS needs to be done for this proposed product.
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1. Ecological Effects

Two comments suggest that genetically engineered crops will cause chemical harm to the 

environment or that these GE crops endanger wild and native plants near where they are 

planted. 

APHIS response: Based upon information and analysis presented in the petition, plant pest risk 

assessment (USDA 2009), and EA, APHIS has not identified any potential for chemical harm to 

the environment deriving from Pioneer 305423 soybean. Aside from the percentages of poly- and 

mono-unsaturated fatty acids, the chemical composition of high oleic soybean does not differ 

significantly from conventionally bred soybeans. Oleic acid is a naturally occurring, nontoxic 

substance present in soy and many other edible oils, canola and sunflower oils, especially those 

enhanced for high oleic acid expression (see EA Section V, C). Soybean is not a plant native to 

North America, and as a result, does not have any known wild or weedy relatives in the United 

States with which it could interbreed (see EA Section III, A). In addition, soybean is primarily 

self-pollinating, so gene flow beyond modest isolation distances to surrounding cultivated 

soybean (beyond 4.6 m) would be rare and not likely (see EA Section III, A). 

2. Agricultural Impacts

Some comments suggested that inadvertent commingling of the high oleic soybean with 

commodity soybean will impact the accuracy of data on the Nutrition Facts Panel for food 

products, because the percentage of saturated fatty acids, mono- and poly-unsaturates 

would be altered if the product contained as little as 5% of the specialty product.

APHIS response: Pioneer 305423 soybean contains reduced levels of palmitic acid, a saturated 

fat, and elevated levels of high oleic acid, a monounsatured fat (see Section I of the EA). 

Because of the health benefits of an increase in specific fatty acids in Pioneer 305423 soybean as 

compared to commodity soybean, manufacturers may preferentially select these oils for 

manufacturing many food products. FDA requires that product fatty acid ratios be reflected in the 

Nutrition Facts Panel of the product label. If sufficient amounts of Pioneer 305423 soybeans 

inadvertently enter the commodity soybean supply stream and not the appropriate identity 

preserved food chain, the Nutrition Facts Panel of some products may not correctly reflect the 

fatty acid ratios. In public comments submitted to APHIS for this product, Pioneer suggests that 

commingling of above 5% content of high oleic acid soybean oil from Pioneer 305423 in 

commodity oils could be sufficient to require alteration of the labeled fatty acid content. 

Because of the value-added traits of this soybean, growers and processers will preserve product 

identity to the point of sale, thus keeping Pioneer 305423 soybean separate from commodity 

soybean (see Pioneer 305423 petition, amended Section X-XF-7, Potential impact on organic and 

conventional farming). Pioneer proposes to use “an identity preserved (IP) system ...from seed 

development through refined oil produced for delivery to end-use customers” (Pioneer Public 

Comment APHIS Docket 2007-0156-0045; Regulations.gov (2009). The details would 

resemble “similar systems ... throughout the vegetable oil industry.” Other IP oilseed

management systems include sales of the seed only to growers who sign a contract with the 

purchaser to produce the oilseed to specified standards, and to sell their soybeans only to the 

contracted party and to its designated elevator or crushing facility. Oilseed processors would 

likely be required to sign contracts with refiners so that end users would have a trackable product 

that derived only from identified transgenic seed. In the same letter submitted as a public 

comment, Pioneer notes that analytical techniques are available to qualitatively identify fatty acid 
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content in delivered oilseed using NIR (Near infrared) technology. For analysis of fatty acids in 

derived oils, highly accurate gas chromatographic analytical techniques are available. 

Oils derived from Pioneer 305423 soybean will be separately marketed from conventional 

soybean oils, because these oils contain healthy fatty acids (such as the monounsaturated oil, oleic 

acid) when consumed in manufactured food products such as salad oils (See EA Section I. and 

II.). Oleic acid is a natural constituent of a variety of foods, notably for example, olive oil (55-

83% oleic acid, Vossen, 2010). Olive oil has been shown to be a health-promoting dietary 

constituent, and the oleic acid component has been directly shown to be responsible for lowering 

blood pressure (Terés et al., 2008).

To monitor product integrity, manufacturers of food products may need to continuously assay

fatty acid ratios of constituent soybean oil. If manufacturers are vigilant and employ good quality 

control techniques, it is not likely that high oleic soybean oil would be inadvertently incorporated 

in sufficient amounts that would change the accuracy of the fatty acid ratio reflected on the 

Nutrition Facts Panel. In cases of a manufacturer receiving shipment of an ingredient oil (ie.,

high oleic soybean oil) different from that typically used in a specific product, the manufacturer 

could appropriately blend and dilute the oils before commercial sale and release, and the 

Nutrition Facts Panels would accurately reflect fatty acid content.

Regulations.gov (2009). Public Comment from Pioneer Hi-Bred (Natalie Hubbard, Director, 

Biotechnology, North America). 

http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a6ec3a

Terés, S., Barceló-Coblijn, G., Benet, M., Álvarez, R., Bressani, R., Halver, J.E. and Escribá, P. 

V. (2008). Oleic acid content is responsible for the reduction in blood pressure induced by olive 

oil. Proc Natl Acad Sci U S A 105, 13811–13816.

Vossen, P. (2007). International Olive Council (IOC) and California Trade Standards for Olive 

Oil. University of California, Cooperative Extension. 

http://ucce.ucdavis.edu/files/filelibrary/2161/34496.pdf

Two comments state that GE soybeans are “dangerous” and that they are “noxious weeds 

and not food”

APHIS response: As summarized in the EA (Section V. B. A.), the products of these GE 

soybeans are as safe and nutritious as those currently available in the marketplace. Soybean as a 

crop is not weedy (EA Section III A) and the modified Pioneer 305423 soybean according to

APHIS’ assessment is also not weedy (EA Section V. B.B.). The 305423 soybean has been field 

tested since 2002 in the major soybean growing regions of the continental United States. Under 

field permits granted by USDA APHIS, Pioneer conducted comprehensive agronomic 

performance and ecological observations for 305423 soybean in replicated, multi-site field 

studies. In 2005 and 2006 growing seasons, Pioneer made observations and measurements of the 

soybean variety in a total of 13 North American locations. Characteristics such as emergence, 

seedling vigor, plant height, lodging, days to maturity, shattering, seed weight, yield, disease 

incidence and insect damage were measured. Data for seed germination and dormancy were also 

collected in laboratory experiments. From these observations and data submitted in the 

applicant’s petition, APHIS has concluded in its plant pest risk assessment (USDA 2009) that 

there are no weed risk issues associated with Pioneer 305423 (See EA Section V B.B. of the EA).
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USDA (2009). APHIS BRS Website. Petitions for Non-regulated Status. 

http://www.aphis.usda.gov/biotechnology/not_reg.html

Two comments stated that genetic engineering methods are less precise and differ from 

conventional breeding methods, and thus may have unintended harmful effects; one stated 

he had concerns about genetically modified organisms and that they should be treated 

differently than those plants altered through traditional breeding methods.

APHIS response. The insertion of transgenes is an imprecise process, in the sense that one 

cannot predict the insertion site within the host genome. Some unintended changes to the plant 

genome may result and may lead to undesired consequences, but plant breeders place 

considerable importance in avoiding negative effects on agronomic performance and overall 

health of the transformed plants. Potential unintended changes that might affect plant phenotype 

include insertions of the transgene into active host genes, insertion of multiple tandem copies of 

the transgene, and rearrangements of genetic material at the insertion site. Other genetic changes 

may occur at locations distant from the insertion site of the transgene of interest, either as a result 

of the insertion of transgene fragments or deriving from the culture process accompanying the 

transformation process. 

As Pioneer described within the petition (p. 23, Pavely, 2007, Petition for the Determination of 

Nonregulated Status for High Oleic 305423 Soybean), agronomic properties of the plants were 

assessed over several generations, then backcrossed to elite, well-performing soybean lines a total 

of six times. Backcrossing with elite lines dilutes the presence of incidental genetic changes not 

closely linked to the transgene within the transgenic soybean and confers improved agronomic 

properties to the newly transformed line. As a result of backcrosses, the expected transgene is 

obtained within a final stable and predictable soybean line that has a reduced likelihood of 

additional, unexpected genes and traits (see page 20, Figure 2, Pavely, 2007). 

Inadvertent, genetic changes closely linked to the site of insertion for the gene of interest would 

not be so easily removed by backcrossing. For instance, an inserted transgene could conceivably 

interrupt a gene directing a plant function (“insertional mutagenesis”). In many cases however, 

plants have multiple genes that provide the same function, such as the multiple FAD-2 genes of 

soybean that form linoleic acid (Graef et al., 2009). Likewise, plants also may have multiple 

structural proteins that contribute to the same plant parts (Barker, et al., 2008). If insertion sites 

do interrupt essential genes, the resulting plants would most likely be unhealthy and consequently 

be eliminated by developers. 

The process of transformation could potentially lead to new genetic changes by somatic mutation, 

which may occur spontaneously during a procedure for regenerating plant tissues, which is 

typically part of the transgenesis process. However, the developer’s normal process of selection, 

and then hybridization with conventional, non transgenic lines, along with final product 

development may also eliminate most of these unintended mutations. For those genetic changes 

that result in noticeable traits, breeders can assure removal of undesirable traits from future 

product releases.

APHIS requires that any notable changes in the expected plant phenotype, or its agronomic 

properties, and modifications of pest susceptibility be identified, both after it is released under 

APHIS permit and later, as a condition of its deregulation. Finally, developers conduct repeated 

tests to ensure the reproducibility of the trait, as well as its negligible impact on overall plant 

health. APHIS regulatory actions provide oversight of new genetically modified plants, and the 

oversight is extensive compared to those for new traits in conventionally bred plants.
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Conventional breeding techniques to gain new traits are not necessarily more precise than 

biotechnological methods that transpose novel genes into the plant genome. Conventional seed 

breeders may gain new material for the host plant by crossing with other species or even genera

and by subjecting plants to chemical or radiation mutagenesis. Through much trial and error, the 

host may acquire genes from the introgressed plant genus or species, or by mutation, but these 

may incorporate regulatory, structural or functional genes not identified or completely 

understood. The genetic material deriving from “wide crosses” may include large segments of 

chromosomes, or be associated with translocations or inversions (Osborn et al. 2007)). The 

unexpected random genetic changes from these crosses and also from mutations may be more 

extensive than those changes introduced by transgenic technology (Batista et al. 2008). 

References.

Barker, M.S., Kane, N.C., Matvienko, M., Kozik, A., Michelmore, R.W., Knapp, S.J., and 

Rieseberg, L.H. (2008). Multiple paleopolyploidizations during the evolution of the compositae 

reveal parallel patterns of duplicate gene retention after millions of years. Molecular Biology and 

Evolution, 25, 2445-2455

Batista, R., Saibo, N., Lourenco, T., and Oliveira, M.M. (2008). Microarray analyses reveal that 

plant mutagenesis may induce more transcriptomic changes than transgene insertion. Proceedings 

of the National Academy of Sciences. 105: 3640-3645

Graef, G., LaVallee, B.J., Tenopir, P., Tat, M., Schweiger, B., Kinney, A.J., Van Gerpen, 

J.H., and Clemente, T.E. (2009). A high-oleic-acid and low-palmitic-acid soybean:

agronomic performance and evaluation as a feedstock for biodiesel. Plant Biotechnology 

Journal 7, 411–421.

Osborn, T.C., Kramer, C., Graham, E., and Braun, C.J. (2007). Insights and Innovations from 

Wide Crosses: Examples from Canola and Tomato. Crop Science. 47: S-228-S-237. 

Pavely, C. (2007). Petition for the Determination of Nonregulated Status for

High Oleic 305423 Soybean, revised version. Pioneer Hi-Bred International, Inc., 

Johnston, IA. Available USDA BRS website.

One commenter from a food company asserted that these soybeans will reduce use of 

pesticides.

APHIS response: Pioneer 305423 is not genetically engineered to be glyphosate tolerant (see EA 

Section V. B.B.). Weed management practices for Pioneer soybean will not differ from those 

used in conventional soybean (see EA Section III.B.). Although sulfonylurea tolerant traits are 

expressed in this Pioneer soybean, these will not be promoted for this Pioneer line; the tolerance 

was only used for trait selection during product development (see EA Section V). 

3. Human Health Impacts

Foods derived from biotechnology should not require a different or higher standard of 

safety than that of conventional foods, but should be examined if appropriate on a case-bycase basis for safety before commercialization.
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APHIS response: Under the Coordinated Framework for biotechnology products, the FDA will 

continue to assess the safety and quality of GE foods, and the EPA will assess the safety of plant 

incorporated protectants and herbicide tolerant crop varieties (EA Section I). The coordinated 

deliberative process should continue to reduce concerns by the public about the healthfulness and 

safety of these genetically engineered products.

One comment stated that because long-term environmental and health risks of GE crops

have not been studied, and because soybean is a commodity crop and ubiquitous in many 

food products, GE varieties should be strictly regulated, especially soybean.

APHIS response: GE varieties, including this Pioneer 305432 soybean are subject to 

considerable scrutiny by the FDA for food safety and by the USDA for agricultural safety. The 

Coordinated Framework for Products of Biotechnology intends that both health risks and 

environmental impacts will be thoroughly analyzed by the appropriate federal agencies. Products

with undesirable properties causing extensive impacts greater than those from non-transgenic 

products of the same type could be identified by this assessment process. If these products are 

not acceptable under the regulations of an agency within the USDA, they will not be granted non 

regulated status. The FDA is confident that Pioneer 305432 soybean is not materially different 

from soybean already grown, except for the altered fatty acid content (see FDA Consultation 

Document and Section V.B.A.). Based upon information and analysis presented in the petition, 

plant pest risk assessment (USDA 2009), and EA, USDA-APHIS has concluded that Pioneer 

305432 soybean will have no impacts on the agricultural or natural environment beyond those 

already arising from other commercial soybean varieties. Pioneer 305423 soybean has received 

extensive assessment from APHIS and FDA and based upon their assessments, will likely have 

only beneficial impacts on stakeholders and the public. 

Some comments stated that GE soybeans are harmful because they may have as yet 

unrecognized adverse long term effects on human health.

APHIS response: Beginning in December 2006, Pioneer provided data to the FDA establishing

the food safety and nutritional properties of this product. The FDA concurred with Pioneer’s 

determination that the 305423 soybean and downstream products from it are not materially 

different from commercial soybeans in composition, safety or any other relevant parameter (FDA 

Consultation Document). In animal feeding tests using mice and broiler chickens (See studies 

cited in EA Section V. B.C.) no short term impacts could be observed from consumption of 

Pioneer 305423 soybean. No evidence of nutritional deficiencies were found after analysis of 

proteins, fats (except for the intentionally changed fatty acids) or fiber (EA Section V. B.C.). No

differences were found in antinutrient content, when compared with average antinutrient content 

of similar commercial soybean varieties. 

Under FDA supervision of tests of food ingredients, the chemical structure of a proposed additive 

and its expected concentration within foods must be considered in order to assign a concern level; 

the level will determine which types of toxicity tests will be done (NRC, 2006; FDA, 2000). For 

additives of low concern, short term feeding studies are required, and if of highest level of 

concern then lifetime studies and even some multi-generation studies, or studies contingent on 

certain results based on tests results from lower levels of concern are required (NRC, 2006). If 

new food components are rated as high risk to consumers, then successively more lengthy and 

demanding tests are required. FDA’s level of concern is related to hazard and risk and FDA has 

required of Pioneer the types and terms of analyses appropriate to risk for 305423 soybean.

References.
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FDA (2000). Redbook 2000. Revised July 2007. Guidance for Industry and Other Stakeholders 

Toxicological Principles for the Safety Assessment of Food Ingredients. 

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Foo

dIngredientsandPackaging/Redbook/default.htm

NRC (2006). Toxicity Testing for Assessment of Environmental Agents. Interim Report. 

Committee on Toxicity Testing and Assessment of Environmental Agents National Research 

Council of the National Academies. The National Academies Press. Washington, D.C.

One commenter asserts that GE crops have decreased nutritional value. Another comment 

states that GE food should be separated from “natural”, non-genetically modified food.

APHIS response: Under the Federal Food, Drug, and Cosmetic Act, the FDA issued a policy 

statement concerning genetically engineered food and animal feed. Following the announced 

procedure, FDA employs a consultation process for products derived from biotechnology to 

ensure that regulatory issues such as food and feed safety and labeling concerns are addressed and 

resolved (see EA Section I.). Based upon this FDA consultation process, comparisons with 

commercial soybean show that Pioneer 305423 is equally safe and nutritious as other varieties 

currently marketed (FDA Premarketing Consultation: see attachment to EA) From FDA’s 

consultation on foods derived from this soybean, and APHIS’ assessment of the laboratory 

evidence provided by Pioneer (Pavely, 2007) and accompanying scientific literature, APHIS 

concludes that there is no scientific basis to require separate storage, marketing or handling of this 

variety and commodity soybeans. 

Because of the value-added traits of this soybean, growers and processers will preserve product 

identity to the point of sale (Pioneer, see Summary in Pavely, 2007) as is commonly done for 

many specialty oils (Lee and Herbek, 2004), thus keeping Pioneer 305423 soybean separate from 

commodity soybean (see Petition amendment X-XF-7, Potential impact on organic and 

conventional farming). The operational details for Identity Preserved programs with oilseed 

crops are discussed in this Response to Public Comments under “2. Agricultural Impacts.” Oils 

derived from Pioneer 305423 soybean will also be separately marketed from conventional 

soybean oils (Pioneer HiBred, See Summary in Pavely, 2007), because these oils contain healthy 

fatty acids (such as the monounsaturated oil, oleic acid) for manufactured food products such as 

salad oils (See EA Section I. and II.). Oleic acid is a natural constituent of a variety of foods, 

notably for example, olive oil (55-83% oleic acid, Vossen, 2010). Olive oil has been shown to be 

a health-promoting dietary constituent, and the oleic acid component has been directly shown to 

be responsible for lowering blood pressure (Terés 2008). 

Other non transgenic varieties of soybean also express increased oleic acid from extracted oils

(Fehr, 2007; Clemente and Calhoon, 2009). Some of these have been in commercial production

(J.J.G. Minot, Iowa State University Research Foundation, personal communication). Soybean 

expressing a nontransgenic trait to decrease linolenic acid has also been combined with a trait for 

increased oleic acids (>50% oleic; i.e., IA2028 available from Iowa State University Research 

Foundation). These non-transgenic lines of soybean with altered fatty acids have been derived 

from mutagenized soybean and, highly selected lines. Pioneer’s high oleic soybean varieties are 

not significantly different from these varieties derived by conventional means, and the nontransgenic soybeans have already been used commercially without reported environmental 

impacts (J.J.G. Minot, Iowa State University Research Foundation, personal communication)
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References.

Clemente, T.E. and Calhoon, E.B. (2009). Soybean oil: Genetic approaches for modification of 

functionality and total content. Plant Physiology 11: 1030-1040.

Fehr, W.R. (2007). Breeding for modified fatty acid composition in soybean. Crop 

Science, 47, (SUPPL. DEC.) S72-S87

Lee, C and Herbek, J. (2004). Specialty Soybean Production and Management in Kentucky, 

University of Kentucky, Cooperative Agricultural Extension Service. AGR-182. 

http://www.ca.uky.edu/agc/pubs/agr/agr182/agr182.pdf

Terés, S., Barceló-Coblijn, G., Benet, M., Alvarez, R., Bressani, R., Halver, J.E., and Escribá, 

P.V. (2008). Oleic acid content is responsible for the reduction in blood pressure induced by olive 

oil. Proceedings of the National Academy of Sciences 105 (37): 13811.

Vossen, C. (2010 download). International Olive Oil Council (IOOC) Trade Standard for Olive 

Oil. University of Californian Cooperative Extension, UC Davis, Sonoma County Extension. 

http://cesonoma.ucdavis.edu/hortic/pdf/iocc_standards_purity_grade.pdf

One commenter says that GE has caused greater amounts of diseases in consumers since the 

introduction of GE crops.

APHIS response: Although the rate of certain diseases or conditions in consumers may have 

indeed increased since the introduction of GE crops in the mid-1990’s (for example, see Branum 

and Lukacs, 2009), a trend cannot be attributed directly to use of any food item, including GE

crops or their products. An apparent increase may often result from increases in incidence 

reporting (Branum and Lukacs, 2009). Increased incidence of disease could also be attributed to 

any number of environmental or medical causes. The Pioneer 305423 soybean does not contain 

any other constituent likely to enhance disease incidence. For example, measured content of 

antinutrients is not greater than conventional soybean (see EA Section V. B.C.), nor is the 

constitutive GM-HRA protein a known human allergen (see EA Section V. Potential impact on 

nontarget organisms). Pioneer submitted this data to the FDA who reviewed the conclusions to 

complete the FDA consultation. No consequences for other animals consuming products from 

this soybean line are expected on the basis of these tests, and none would be expected from the 

nature of the transformation in Pioneer 305423.

References:

Branum A.M., and Lukacs S.L. (2009). Food allergy among children in the United States. 

Pediatrics. 124, 1549-55. 

4. Animal Impacts

One comment suggests that gene transformation is highly mutagenic and could lead to 

multi-organ toxicity and impacts on blood and immune systems. One commenter states 

that there are many animal studies that show a link between adverse health risks and 
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ingestion of GE foods and asks for a moratorium on GE food approvals. One commenter 

says that animals fed with GE crops show acute signs of aging, and decreased fertility.

APHIS response: Based upon information and analysis presented in the petition, plant pest risk 

assessment (USDA 2009), an EA and an FDA consultation process, APHIS has concluded that 

Pioneer 305423 soybean, and the foods and feeds derived from it are not materially different in 

safety, composition, or any other relevant parameter from soybeans now grown, marketed, and 

consumed. 

Pioneer 305423 soybean contains a modified acetolactate synthase gene, which confers herbicide 

resistance for the purpose of selection during transformation (see EA Section I.). As part of the 

petition, Pioneer submitted studies showing that mice fed with 2000 mg of purified GM-HRA 

protein (derived from the Gm-hra gene, a modified version of the soybean acetolactate synthase 

gene) per kilogram of body weight showed no acute toxicity. Expected concentrations of 

ingested GM-HRA protein soybean grain are far lower, at 2.5 ng/mg, than the purified dosage 

used in the mice trial (See Section VII C., Taveley, 2007). It is not likely that Pioneer 305423 

soybean will attain the high concentration to which these mice were exposed (see EA Section 

V.B.C.). A second transformation in Pioneer 305423 soybean does not produce a novel protein, 

but suppresses the conversion of oleic acid into linoleic acid by an endogenous gene normally 

present in soybean (see Summary in Tavely, 2007). The sequence gm-fad2-1 derived from an 

existing soybean gene, if expressed, would not have any novel nutritional impacts because it does 

not express a novel protein (Tavely, 2007).

In addition, APHIS evaluated evidence submitted by Pioneer of a 42-day study showing that 

broiler chickens, when fed 305423 soybean, did not have statistically significant differences in 

mortality, weight gain, mortality-adjusted feed efficiency, or carcass yields from those fed control 

(non-GE) soybean (see Petition, page 8 to 9). As a result, Pioneer 305423 soybean should not 

adversely affect wildlife feeding in soybean fields planted to 305423 (see EA Section V. Potential 

Impact on Nontarget Organisms). As far as the general assertion of transgenesis causing 

unhealthy mutations, the process of tissue culture used to regenerate a plant from an 

undifferentiated single cell to a mature organism after transformation may cause some somatic 

mutations (see discussion above). Selection and removal of plants with undesirable agronomic 

characteristics after transformation will exclude such mutations in the final commercialized 

product (Filipecki and Malepszy 2006). The issue of mutagenesis by gene disruption (insertional 

mutagenesis) was discussed in the response to a comment above about the precision of transgenic 

methods used to improve crop plants. M.W. Ho and J. Cummins have asserted that certain types 

of promoters used in transgenesis may be mutagenic but this opinion has received no 

confirmation or support from molecular biologists (Hodgson, 2000).

Evidence for impacts of transgenic foods on tissues, organs or blood, while asserted by a limited 

number of authors, is unlikely. For example, an initial report was shown to be inadequate, poorly 

controlled and further evidence was contradictory (Royal Society, 1999; Chassy, 2002). Although

Ewen and Pusztai 1999b endeavored to show pathology of rat intestinal tissue in rats fed lectin 

transformed potatoes, (a line never seriously considered for commercialization or release) there 

are several later studies that contradict these findings of toxicity or pathology for a substantial 

number of histological benchmarks (Hashimoto et al. 1999; Pusztai et al., 1999a; Teshima et al., 

2002; El-Sanhoty et al., 2004). APHIS asserts from considerable evidence that GE plants in 

general do not have any general toxic properties (as noted above, and in the detailed studies 

submitted in support of all petitions to grant nonregulated status for GE crop varieties). Lectins

are known to have toxicities when animal cells are exposed to them (Vasconcellos and Oliveira 
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2004) and if expressed in potatoes could possibly induce pathologies, although even these were 

not substantiated in the case of Ewen and Puszai (1999; see Royal Society, 1999).

References.

Chassy, B.M. (2002). Food Safety Evaluation of Crops Produced through Biotechnology Journal 

of the American College of Nutrition 21, 166S-173S.

El-Sanhoty, R., El-Rahman, A.A.A., and Bögl, K.W. (2004). Quality and safety evaluation of 

genetically modified potatoes Spunta with Cry V gene: compositional analysis, determination of 

some toxins, antinutrients compounds and feeding study in rats. Nahrung: Food,48, 13-18. 

Ewen, S.W.B. and Pusztai, A. (1999b) Effects of diets containing genetically modified potatoes 

expressing Galanthus nivalis lectin on rat small intestine. The Lancet 354, 1353-1354

Filipecki, M. and Malepszy, S. (2006). Unintended consequences of plant transformation:a 

molecular insight. J Appl Genet 47:277–286.

Hashimoto, W., Momma, K., Yoon, H-J, Ozawa, S., Ohkawa, Y., Ishige, T., Kito, M., Utsumi, S, 

and Murata, K. (1999). Safety Assessment of Transgenic Potatoes with Soybean Glycinin by 

Feeding Studies in Rats. Biosci. Biotechnol. Biochem. 63, 1942-1946.

John Hodgson (2000). Scientists avert new GMO crisis. Nature Biotechnology 18, 13 

doi:10.1038/71838.

Palombo, J.D., De Michele, S.J., Liu, J.W., Bistrian, B.R., and Huang, Y.S. (2000). Comparison 

of growth and fatty acid metabolism in rats fed diets containing equal levels of gamma-linolenic 

acid from high gamma-linolenic acid canola oil or borage oil. Lipids 9, 975-81.

Pusztai, A., Grant, G., Bardocz, S., Alonso, R., Chrispeels, M.J., Schroeder, H.E., Tabe, L.M., 

and Higgins, T.J.V. (1999a). Expression of the Insecticidal Bean -Amylase Inhibitor Transgene 

Has Minimal Detrimental Effect on the Nutritional Value of Peas Fed to Rats at 30% of the Diet. 

Journal of Nutrition. 129, 1597-1603.

Royal Society (1999) Review of Data on Possible Toxicity of GM Potatoes (Ref. 11/99). 

London: The Royal Society. http://royalsociety.org/WorkArea/DownloadAsset.aspx?id=5890

Teshima, R., Watanabe, T., Okunuki, H., Isuzugawa, K., Akiyama, H., Onodera, H., Imai, T, 

Toyoda, M., and Sawada, J. (2002). Effect of subchronic feeding of genetically modified corn 

(CBH351) on immune system in BN rats and B10A mice. Shokuhin Eiseigaku Zasshi. 43, 273-9. 

5. Economic Impacts 

One comment asked whether nonregulated status for Pioneer 305423 was necessary if 

naturally occurring oleic acid can be found in other sources, such as grapeseed oil. 

APHIS response: Under the authority of 7 CFR part 340, APHIS has the responsibility for the 

safe development and use of genetically engineered organisms under the provisions of the Plant 

Protection Act. APHIS must respond to petitioners that request a determination of the regulated 

status of genetically engineered organisms, including genetically engineered crop plants such as 
11

Pioneer 305423 soybean. If a petition for nonregulated status is submitted, APHIS must make a 

determination if the genetically engineered organism is unlikely to pose a plant pest risk.

For economic reasons, modified soybeans may provide the best solution for a food 

manufacturer’s needs as well as for growers’ crop choices. High oleic oils can be produced in

other crops, such as sunflower (“NuSun”), safflower and canola (EA, Section V.B.B.) However,

soybean oil is highly economical for use in foods, and soybean production may be more 

profitable for growers than either sunflower or canola in permissive growing regions such as 

eastern North Dakota (Metzger, 2009).

Reference:

Metzger, S. (2009) ND2010 Projected farm cash flow by crop, NDSU Carrington Research 

Extension Center, http://www.ndfarmmanagement.com/2010BEP121509.xls

One trade organization said that APHIS has a responsibility to consider scientific data 

assessing the risks to food functionality, risk mitigation and risk responsibility in its review 

of all special use traits like 305423. 

APHIS response: APHIS’ pest risk assessment for non-regulated status does not require that 

risks to food functionality or risk mitigation for inappropriate product use be considered (See 7 

CFR part 340.6). For products developed using nonregulated GE organisms, APHIS does not 

have the statutory authority to mandate that product developers be assigned risk responsibility or 

provide compensation for adverse consequences to injured parties resulting from the use of a 

nonregulated GE organism (See Title 4. Plant Protection Act, June 20, 2000) . A GE organism is 

no longer subject to the regulatory requirements of 7 CFR part 340 when APHIS determines that 

it is unlikely to pose a plant pest risk. 

As appropriate, APHIS does consider potential food and industrial use impacts in their NEPA 

documents. The EA prepared for this petition and response to comments above, notes that the 

ratios of the typical soybean fatty acids have been altered by this Pioneer 305423 line, and that 

inadvertent entry of Pioneer 305423 into the commodity soybean supply stream is possible. 

However, because of the value-added traits of this soybean, growers and processers will preserve 

product identity to the point of sale (See Petition Amendment: X-XF-7, Potential impact on 

organic and conventional farming), thus keeping Pioneer 305423 soybean separate from 

commodity soybean. The methods that are chosen to prevent oilseed mixing into the commodity 

stream of soybean seed is discussed in Section 2, Agricultural Impacts, of this Response to 

Comments document.

APHIS supports the initiatives of industry associations in addressing issues of risk mitigation and 

responsibility. APHIS understands that the biotechnology industry consortium, BIO, is currently 

discussing stewardship plans with their constituent biotech companies that would address policies 

on these types of issues. When complete, the stewardship plans would likely assist the industry in 

addressing issues associated with risks to food functionality, risk mitigation and risk 

responsibility. 

One food processing trade organization said that any precommercial release must include 

commercial assurances for downstream stakeholders relative to comingling of the product 

into the supply chain.
12

APHIS response: APHIS does not have regulatory authority or responsibility for validating the 

specific properties of a commodity nor mandating commercial assurances. Pioneer in public 

comments to APHIS (2007-0156-0045) plans to establish industry standard oilseed IP 

management procedures, and encourage use of analytic techniques to substantiate oil identity

Oil derived from this variety may be beneficial for many downstream users, but may not be 

optimal for all users (See Pioneer public comment Docket No. APHIS-2007-0156, December 21, 

2009, “Identity Preserved Systems” and “Comingling Implications). Marketing agreements put 

in place by product developers may influence acceptance and use of these oils by soybean 

industry stakeholders. Although many adverse impacts following widespread use of oil deriving 

from Pioneer 305423 soybean are not likely, increased surveillance may be warranted in specific 

instances (See Pioneer public comment Docket No. APHIS-2007-0156, December 21, 2009, 

“Comingling Implications”) to detect novel fatty acid ratios of commodity soybeans and in soy 

oil. For example, characteristics of product stability, taste, and texture depend on fatty acid ratios 

(Warner et al., 1988). Distinction between input soybean varieties would be a necessary part of 

manufacturer procedure when multiple types of soybean fatty acid contents are in the

marketplace. Soybean varieties can be distinguished by scanning cotyledons for differences in 

certain lipid classes using scanning spectroscopy (with Fourier Transformed Infra Red techniques 

(FTIR)), a fast and straightforward assessment (Caires, 2008).

To alleviate concerns surrounding inadvertent mixing of Pioneer 305423 high oleic soybean with 

soybeans in the commodity stream, the Grocery Manufacturers Association (GMA; Jeff Barach, 

personal communication, 2009) has indicated that its constituent members desire more 

information about use and functionality of the high oleic oil. The GMA expects that some of the 

technology providers of seeds with altered fatty acid oils will commit to extensively comparing

physical properties of inadvertent oil mixtures deriving from the altered product and the

commodity oil. By informing producers of the oil’s compatibility with existing food processing

and manufacturing procedures, this testing could avert potential economic losses sustained by 

producers. 

References:

Caires, A.R.L., Teixeira, M.R.O., Suarez, Y.R., Andrade, L.H.C. and Lima, S.M. (2008). 

Discrimination of transgenic and conventional soybean seeds by Fourier transform infrared 

photoacoustic spectroscopy. Applied Spectroscopy, 62, 1044-1047.

Warner, K., Orr, P. and Glynn, M. (1988). Effect of altered fatty acid composition on soybean oil 

stability. Journal of the American Oil Chemists' Society 65, 624-628.

Some comments expressed concerns that without rigorous marketing agreements, or 

stewardship plans from technology companies, and a “higher level of commercial 

responsibility,” commercial disruptions in the export market are possible, and these 

concerns need to be addressed if ‘pre-commercial release” is the chosen production and 

marketing pattern. Precommercial release is the commercial production of a product which 

does not have international regulatory acceptance as a novel GE crop, such as within EU 

countries or Japan. Since some countries maintain a zero threshold for unapproved 

products, a high level of marketing policy measures, and strong enforcement and 

compliance with the policy is necessary for a pre-commercial release program to be 

successful.

APHIS response: APHIS does not have regulatory authority or responsibility for validating the 

specific properties of a commodity nor mandating commercial assurances for purchasers or 
13

distributors of nonregulated products. However, because this soybean variety expresses valueadded traits, growers and processers will voluntarily preserve product identity to the point of sale, 

thus keeping Pioneer 305423 soybean separate from commodity soybean (See Pavely, 2007, 

Pioneer Petition Amendment: X-XF-7). While undesired mixing of this specialty oilseed with 

standard commodity soybean oil is possible, several market forces will minimize its occurrence. 

Pioneer has committed itself to using mechanisms similar to industry standards to maintain 

product identity, which have “established effectiveness” for maintaining the integrity of the 

export and domestic market for soybean oils (Pioneer Public Comment APHIS 2007-0156-0045). 

Furthermore, APHIS supports the initiatives of industry associations in addressing issues of risk 

mitigation and responsibility as part of corporate stewardship of special crop production. 

Some comments noted that Pioneer has proposed taking responsibility for the product 

beyond point of sale for seed, but that “further dialogue” and commitment to sharing of 

information for all stakeholders will be necessary throughout the lifecycle of the product. 

Three trade associations expressed concerns about the details of a Pioneer management 

plan to mitigate the risk of GE soybeans comingling with commodity soybeans and being 

sold abroad where GE is not accepted.

APHIS response: APHIS understands that the industry association, Biotechnology Industry 

Organization (BIO; http://www.bio.org/), has encouraged a common stewardship approach by all 

companies producing GE crop varieties, especially when properties of a standard food 

commodity are altered by a new trait. Pioneer may choose to participate in this stewardship 

approach for Pioneer 305423 soybean. APHIS has no role in these discussions, and advises 

stakeholders to work closely with these providers and BIO, who are both committed to the 

success of these products in domestic and export markets.

Another comment addressed the possible unintended impacts on crop uses or processing 

streams because of higher oleic acid, lower linoleic and linolenic acid content in the 

modified soybean oil deriving from this soybean variety.

APHIS response: As described in the EA, this product improves the qualities of soybean oil, 

decreasing the need to hydrogenate the soybean oil, which produces unhealthy trans fats. Pioneer 

has indicated that the primary use of Pioneer 305423 soybean will be for food oil as well as for 

industrial oil products (See Pavely, 2007, Section I.B., Benefits of 305423 Soybean). Because of 

the value-added traits of this soybean, growers and processers will preserve product identity to

the point of sale, thus keeping Pioneer 305423 soybean separate from commodity soybean (See 

Taveley, 2007, Pioneer Petition Amendment: X-XF-7, and Section I.B.,Pavely, 2007). Pioneer in 

public comments to APHIS (2007-0156-0045) plans to establish industry standard oilseed IP 

management procedures, and encourage use of analytic techniques to substantiate identity of 

constituent fatty acids. The high oleic soybean would also be useful for deriving environmentally 

friendly, renewable, and cost effective industrial oils, such as lubricants and biodiesel oils (see 

Summary and I.B. in Taveley, 2007). Increased oleic acid at the expense of linoleic and linolenic 

would improve cetane numbers (time between injection into a cylinder and autoignition; Refaat, 

2009), and improve lubricity because of higher numbers of unsaturated fatty acids and other 

factors (see I-B. Benefits of 305423 Soybean in Pavely, 2007 and Refaat, 2009). To determine 

which fatty acid ratios are useful for specific products, a use-by-use analysis would be required

for each industry employing soybean oils. Pioneer notes that “Oil functionality considerations for 

[high oleic soybean] are the same as those for existing modified fatty acid oilseed crops, such as 

high oleic canola and mid/high oleic sunflower oil (Pioneer public comment Docket No. APHIS2007-0156, December 21, 2009).”
14

Reference:

Refaat, A.A. (2009). Correlation between the chemical structure of biodiesel and its physical 

properties. Int. J. Environ. Sci. Tech. 6, 677-694.

Three commenters desired Pioneer to establish whether it will cover the costs of regulatory 

interceptions if these soybeans were comingled and then exported to countries in which the 

events were not approved. 

APHIS responds: No requirement exists that APHIS should enforce mitigation standards for 

users of the technology, nor provide for consequences of their failure. This type of action is 

outside APHIS regulatory authority. Although some commenters suggest that Pioneer will cover 

costs of trade disruption caused by the possible presence of the new fatty acid soybean in export 

supplies, APHIS makes no interpretation of intention and takes no position on appropriateness of 

this policy. If Pioneer agrees to comprehensive product liability, they will do so without APHIS

guarantees or support for the guarantee. 

One commenter suggests that large agribusinesses monopolize seed production, and force 

farmers to use GE seeds.

APHIS response. As far as APHIS can determine, while large seed companies sell limited lines 

of non-transgenic soybean seed, some nontransgenic lines are available and can also be provided 

by smaller suppliers and state university foundations. Despite buyers’ displeasure at the high 

technology fees of GE seed, they continue to purchase such GE seed, because growers benefit 

from reduced production expenses and require fewer farm operations for growing soybean. 

Based on USDA survey data, adoption of genetically engineered herbicide-tolerant (HT) 

soybeans increased from 17 percent of U.S. soybean acreage in 1997 to 68 percent in 2001 and 92 

percent in 2008 (Fernandez-Cornejo, 2008). As Traxler and Falck-Zepeda show (1999; for GE

cotton), there are benefits to both producers and technology providers alike. Substantial 

competition exists for soybean seed and for differing oil products, including conventional 

soybean varieties that may serve many of the marketplace needs. 

References.

Fernandez-Cornejo, J. (2008) Adoption of Genetically Engineered Crops in the U.S. (Data Sets). 

USDA-Economic Research Service. http://www.ers.usda.gov/Data/BiotechCrops/ (Accessed 

1/4/2009).

Traxler, G., and Falck-Zepeda, J. (1999). The distribution of benefits from the introduction of 

transgenic cotton varieties. AgBioForum 2, 94-98.

Several commenters said that US growers of soybean have been losing extensive soybean 

acreage to foreign vegetable oil production because US manufacturers have needed to 

replace hydrogenated soybean oil in food products, following imposition of FDA labeling 

requirements. The proposed soybean line would provide an economic benefit to US 

soybean producers.

Pioneer 305423 will help soybean growers produce a desirable oil for food manufacturers (See 

EA Section I. Introduction), and potentially recapture market share that was previously lost

(Balvanz, C., Iowa Soybean Association, public comment on APHIS 2007-0156-0018). When 
15

FDA deemed the desired functionality of hydrogenated soybean oil a health risk, food

manufacturers turned to foreign food grade oils (for example, increased use of palm oils: 

(Unnevehr and Jagmanaite, 2008; Soyatech, 2010)). High oleic oils such as Pioneer 305423 will 

have features of increased oil stability and useful blending properties (Warner and Gupta, 2005) 

and could replace imported oils such as palm oils for the necessary functional and quality 

properties needed by manufacturers. 

References:

Soyatech (2010 download). Transfat facts. Soyatech LLC, Maine. 

http://www.soyatech.com/trans_fats.htm 

Unnevehr, L.J. and Jagmanaite, E. (2008) Getting rid of trans fats in the US diet: Policies, 

incentives and progress. Food Policy 33, 497–503.

Warner, K. and Gupta, M. (2005). Potato chip quality and frying oil stability of high oleic acid 

soybean oil. J. Food Sci. 70. Supplement. Sensory and Nutritive Qualities of Food. S395-S400.

6. Process Comments

One comment stated that USDA is not adequately assessing the environmental impact of the 

genetically modified soybean.

APHIS response. APHIS carefully considered the possible environmental impacts of the 

proposed product, and is satisfied that the EA developed for Pioneer 305423 soybean is adequate

and sufficient. The EA follows all applicable laws, regulations, and guidelines in analyzing 

potential impacts of this action, including those established by NEPA. In making an informed 

decision of potential environmental impacts, APHIS used the best available scientific 

information, data and expert advice. 

One comment stated that an environmental impact assessment is needed.

APHIS response: APHIS has determined that the analysis in its EA showed no significant 

impact on the quality of the human environment if APHIS was to grant the petitioner’s 

request to deregulate Pioneer 305423 soybean and that APHIS did not have to prepare an 

environmental impact statement (EIS). The EA took a hard look at the need for action, 

the issues, alternatives, and environmental consequences. APHIS also reviewed the 

assessment of plant pest risk for Pioneer 305423 soybean and carefully considered all 

comments submitted by respondents to the public involvement efforts. As a result of this 

analysis, APHIS prepared a final EA, from which came the NEPA decision document 

and a finding of no signification impact (FONSI) that discussed, under each of the ten 

Council for Environmental Quality (CEQ) points of significance, why each point was not 

significant, and why an EIS was not required. The agency followed CEQ NEPA 

regulations and Agency NEPA implementing procedures.