Animal and Plant Health Inspection Service, USDA.
Notice; reopening of comment period.
We are reopening the comment period for a petition submitted by Syngenta Seeds, Inc., seeking a determination of nonregulated status for corn designated as transformation event 3272 and its associated environmental assessment prepared by the Animal and Plant Health Inspection Service under our regulations found at 7 CFR part 340. This action will allow interested persons additional time to prepare and submit comments on the petition, environmental assessment, and the revised plant pest risk assessment.
We will consider all comments that we receive on or before July 6, 2009.Start Printed Page 26833
You may submit comments by either of the following methods:
- Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0016 to submit or view comments and to view supporting and related materials available electronically.
- Postal Mail/Commercial Delivery: Please send two copies of your comment to Docket No. APHIS-2007-0016, Regulatory Analysis and Development, PPD, APHIS, Station 3A03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2007-0016.
Reading Room: You may read any comments that we receive on this docket in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 690-2817 before coming.
Other Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Dr. Andrea Huberty, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 146, Riverdale, MD 20737-1236; (301) 734-0485, e-mail: email@example.com. To obtain copies of the petition, the draft environmental assessment, or the plant pest risk assessment, contact Ms. Cindy Eck at (301) 734-0667, e-mail: firstname.lastname@example.org. The petition, draft environmental assessment, and plant pest risk assessment are also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/05_28001p.pdf, http://www.aphis.usda.gov/brs/aphisdocs/05_28001p_ea.pdf, and http://www.aphis.usda.gov/brs/aphisdocs/05_28001p_ra.pdf.End Further Info End Preamble Start Supplemental Information
The regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe may be plant pests. Such genetically engineered (GE) organisms and products are considered “regulated articles.”
On October 7, 2005, APHIS received a petition seeking a determination of nonregulated status (APHIS Petition No. 05-280-01p) from Syngenta Seeds, Inc., of Research Triangle Park, NC (Syngenta), for corn (Zea mays L.) designated as transformation event 3272, which has been genetically engineered to produce a microbial enzyme that facilitates ethanol production. The petition stated that Event 3272 corn is unlikely to pose a plant pest risk and, therefore, should not be a regulated article under APHIS' regulations in 7 CFR part 340.
In a notice  published in the Federal Register on November 19, 2008 (73 FR 69602-69604, Docket No. APHIS-2007-0016), APHIS announced the availability of the Syngenta petition and a draft environmental assessment (EA) for public comment. APHIS solicited comments on the petition, whether the subject corn is likely to pose a plant pest risk, and on the draft EA. APHIS received over 13,000 comments on the petition, the draft EA, and the plant pest risk assessment by the close of the 60-day comment period, which ended on January 20, 2009.
There were 40 comments from organizations or individuals that supported the deregulation of the Event 3272 corn. Over 13,000 comments opposed to the deregulation were submitted. The vast majority of the approximately 13,000 comments opposing the deregulation were from letters conveying essentially identical points compiled by organizations generally opposed to any genetic engineering of plants. Several individuals and organizations also submitted documents, many popular press articles or documents published by those opposed to genetic engineering of plants in general, which they assert are relevant to this regulatory decision for Event 3272 corn.
Most of the comments supporting nonregulated status for Event 3272 corn came from organizations representing corn farmers and ethanol production interests. These comments include state-wide corn growers' and agribusiness associations from at least 12 different States where most of the nation's corn is grown. Several national organizations also voiced their support for the deregulation. The principal reasons given by these groups are the benefits anticipated for farmers and the ethanol production industry, as well as the ability to meet biofuel production mandates and to promote international trading interests. While APHIS does not determine nonregulated status for GE organisms pursuant to its biotech regulations (Part 340) based on economic or marketing factors, the support from farmers of corn does suggest that individuals with a substantial interest in the health of the national corn crop do not perceive that either plant pest risks or economic/marketing risks will arise if Event 3272 corn is granted nonregulated status.
Several of the comments provided scientific support for the deregulation of Event 3272 corn. Many of these supportive statements were based on scientific studies included in the petition (such as evidence of decreased water use in ethanol production, reduced greenhouse gas emissions, other reduced inputs in ethanol production). There were several comments that also provided additional studies that would support deregulation of Event 3272 corn on the basis of diminished environmental impacts compared to current ethanol production practices. These studies supported the findings of lowered greenhouse gas emissions and reduced inputs, and also suggest that there will be no impacts on wet distilled grains and improved dried distilled grains, and that the Event 3272 corn is equivalent to currently grown corn lines in other agronomic and nutritional qualities, demonstrated through field and feed studies.
Many of the comments that opposed deregulation were based on general opposition to the development and use of GE plants, without citing or addressing any specific environmental issues in the EA or the pest risk assessment for the petition for Event 3272 corn. Many of these comments simply assert that APHIS should prepare an Environmental Impact Statement to fully address all the potential issues associated with a decision to grant nonregulated status to Event 3272 corn without specifically explaining what they perceive to be the inadequacies of the draft EA's environmental analysis. There were many general comments expressing generic, nonspecific concerns over possible gene flow, disruption to organic farming practices, and concerns of food and environmental safety.
Another common comment that APHIS received regarding the determination of nonregulated status for Event 3272 corn is the general “energy” concern related to the effectiveness and value of producing ethanol from corn. Many comments suggested that Start Printed Page 26834producing ethanol from corn is not an efficient method for achieving energy needs or meeting any alternative energy mandates for the United States. However, in determining the nonregulated status for a genetically engineered plant pursuant to its Part 340 biotechnology regulations, APHIS does not have authority to consider the economic, marketing, or commercial usefulness of the plant, or issues such as the feasibility of meeting energy needs through any particular crop and its related harvesting and processing aspects.
APHIS did receive some comments that raised specific issues of concern if Event 3272 corn was granted nonregulated status. These issues included specific food safety concerns such as the potential for Event 3272 corn to be allergenic, as well as concerns surrounding the potential economic and manufacturing issues if Event 3272 corn were to become present in corn wet-milling processes.
APHIS does believe it is appropriate to address in this notice certain comments submitted that questioned the conclusion that Event 3272 corn is not a plant pest, and that there is no basis for regulatory control of this GE plant under our statutory authorities and Part 340 biotechnology regulations. These comments argue that the alpha-amylase enzyme engineered into Event 3272 corn may cause damage (degradation of corn starch products) to manufactured or processed plant products if Event 3272 corn is included in the manufacturing and processing of corn starch products. The comments claim that this type of damage comes within the definition of a plant pest. One of these comments  claims that “a plant pest consists of any living stage of an article similar to or allied with a bacterium or any article similar to or allied with a bacterium that can cause direct damage to a processed plant product. The `article' in this application [petition] is the thermo-stable alpha-amylase enzyme expressed in Event 3272, which has the potential for injury to plant products if misdirected to corn wet milling facilities.
APHIS' statutory authority to regulate genetically engineered organisms under the Plant Protection Act (PPA) (7 U.S.C. 7701 et seq.) and its Part 340 biotechnology regulations is limited to those GE organisms that are plant pests as defined in Section 403, Subsection 14 of the PPA:
Plant Pest—The term “plant pest” means any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product:
(A) A protozoan.
(B) A nonhuman animal.
(C) A parasitic plant.
(D) A bacterium.
(E) A fungus.
(F) A virus or viroid.
(G) An infectious agent or other pathogen.
(H) Any article similar to or allied with any of the articles specified in the preceding subparagraphs.
Thus, in regulating GE organisms under 7 CFR part 340, APHIS takes a “safeguarding” approach and examines the plant pest risk for genetically engineered plants by looking at all regulated genetically engineered plants for their potential to be plant pests (See plant pest risk assessment, pg. 1). However, under its PPA statutory authorities APHIS cannot regulate GE plants that are outside the PPA's plant pest definition in 7 U.S.C. 7702(14). This statutory definition provides specifically that only a parasitic plant can be a plant pest.
One of the central purposes of the PPA is to prevent the introduction into or dissemination of plant pests within the United States. The PPA at 7 U.S.C. 7702(14) provides that a plant pest must be a living stage of one of a specific list of organisms (“articles”) that cause injury, damage, or disease in plants or plant products, or an article similar to or allied with such an organism (article). An “article” is defined in the PPA (7 U.S.C. 7702(1) as follows:
Article—The term `article' means any material or tangible object that could harbor plant pests or noxious weeds.
As mentioned above, there were some comments that questioned the conclusion that Event 3272 corn is not a plant pest. These comments argue that the alpha-amylase enzyme in Event 3272 corn is a plant pest because it may interfere with corn starch processing and thus directly or indirectly damage plants or plant products. The developer of Event 3272 corn submitted a document after the close of the document  period that argues that Event 3272 corn does not meet the PPA statutory definition of a plant pest. In this document, the commenter provided its analysis of APHIS' regulatory authority under the PPA, and among other things, suggests that separate constituent parts of an organism (in this case, an enzyme expressed by Event 3272 corn) are excluded from the definition of plant pest in the PPA because the enzyme “cannot be regarded as `living'.”
APHIS agrees that enzymes such as alpha-amylase are proteins that catalyze chemical reactions. Enzymes are not “living.” Thus, enzymes cannot be plant pests because they are not living and cannot be a “living stage” of any of the organisms (“articles”) listed in the PPA's definition of a plant pest in subparagraphs (A) through (G) of 7 U.S.C. 7702(14). Likewise, the Event 3272 corn alpha-amylase enzyme also cannot be a living stage of any article similar to or allied with any of the articles specified in subparagraphs (A) through (G), and thus does not fall within the statutory definition of a plant pest as listed in subparagraph (H) of the PPA's plant pest definition (i.e., “Any article similar to or allied with any of the articles specified in the preceding subparagraphs”). APHIS has determined that the alpha-amylase enzyme engineered into Event 3272 corn is not a plant pest because the alpha-amylase enzyme in Event 3272 corn is not living and thus cannot itself be a living stage of any organism listed in the PPA's plant pest definition.
Moreover, Event 3272 corn itself is not a plant pest since it is clearly not a living stage of any of the organisms (articles) listed in subparagraphs (A) through (G) of 7 U.S.C. 7702(14). Nor is Event 3272 corn itself the living stage of any article (organism) similar to or allied with any of the articles specified in subparagraphs (A) through (G) as required by subparagraph (H) of 7 U.S.C. 7702(14). Thus, APHIS has likewise determined that Event 3272 corn itself is not a plant pest as defined by the PPA. Nevertheless, APHIS evaluated the ability of Event 3272 corn to harbor plant pests in the Plant Pest Risk Assessment and determined that Event 3272 corn does not harbor any living stage of any of the organisms (articles) that are defined as potential plant pests in subparagraphs (A) through (G). First, APHIS described the genetic material that was inserted into Event 3272 corn, which included sequences from plant pests, and included an assessment analyzing the plant disease risk posed by the genetic sequences. Second, APHIS also analyzed the risk that Event 3272 corn would disseminate plant pests (i.e. act as an `article'). APHIS concluded that the inserted genetic material in Event 3272 corn does not cause plant disease and Event 3272 corn does not increase susceptibility to plant disease or insect pests, and therefore does not harbor plant pests. (The comments received on the docket Start Printed Page 26835during the initial comment period did not dispute or comment on these particular issues related to APHIS' plant pest risk assessment.)
For the reasons explained above, APHIS has determined that neither Event 3272 corn itself, nor the alpha-amylase enzyme in Event 3272 corn, is a plant pest. To make clear APHIS' above determination that neither Event 3272 corn, nor the alpha-amylase enzyme in Event 3272 corn, is a “living stage” of any of the organisms (articles) listed in subparagraphs (A) through (H) of the PPA's plant pest definition, APHIS has revised the plant pest risk assessment for Event 3272 corn to include the PPA's definition of a plant pest. The revised assessment also concludes that neither Event 3272 corn nor the alpha-amylase enzyme in Event 3272 corn is a plant pest because neither Event 3272 corn nor the alpha-amylase enzyme meets the PPA's definition of a plant pest. These revisions to the plant pest risk assessment are for clarity and further explanation, but do not change the overall conclusions made in the draft plant pest risk assessment that Event 3272 corn is unlikely to pose a plant pest risk.
APHIS welcomes additional comment on the issues raised during this process. APHIS is also requesting comment on the revised plant pest risk assessment, and APHIS' conclusion, as explained above, that Event 3272 corn and the alpha-amylase enzyme in Event 3272 corn are not plant pests. APHIS will carefully evaluate all additional comments received during this process, and any other relevant information. All comments received regarding the petition, draft EA, and plant pest risk assessment will be available for public review on the Regulations.gov Web site (see footnote 1 for a link). After reviewing and evaluating the comments on the petition, draft EA, plant pest risk assessment, and other relevant information, APHIS will make its determination, either approving or denying the petition. APHIS will then publish a notice in the Federal Register announcing the regulatory status of Event 3272 corn and the availability of APHIS' written regulatory and environmental decision.
Accordingly, we are reopening the comment period on Docket No. APHIS-2007-0016 for an additional 30 days. This action will allow interested persons additional time to prepare and submit comments. We will also consider all comments received between January 21, 2009 (the day after the close of the original comment period), and the date of this notice.Start Signature
Done in Washington, DC, this 29th day of May 2009.
Acting Administrator, Animal and Plant Health Inspection Service.
1. To view the notice, petition, draft EA, the plant pest risk assessment and the comments we received, go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0016.Back to Citation
[FR Doc. E9-13055 Filed 6-3-09; 8:45 am]
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