[Federal Register Volume 74, Number 106 (Thursday, June 4, 2009)]
[Notices]
[Pages 26832-26835]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-13055]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2007-0016]


Syngenta Seeds, Inc.; Availability of Petition and Environmental 
Assessment for Determination of Nonregulated Status for Corn 
Genetically Engineered To Produce an Enzyme That Facilitates Ethanol 
Production

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice; reopening of comment period.

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SUMMARY: 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.

DATES: We will consider all comments that we receive on or before July 
6, 2009.

[[Page 26833]]


ADDRESSES: 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.

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 protected]. 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: [email protected]. 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.

SUPPLEMENTARY 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 \1\ 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.
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    \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.
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    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

[[Page 26834]]

producing 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 \2\ 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.
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    \2\ See http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&d=APHIS-2007-0016-0175.1.
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    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 \3\ 
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'.''
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    \3\ See http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&d=APHIS-2007-0016-0222.1.
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    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

[[Page 26835]]

during 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.

    Authority:  7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 
CFR 2.22, 2.80, and 371.3.

    Done in Washington, DC, this 29th day of May 2009.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E9-13055 Filed 6-3-09; 8:45 am]
BILLING CODE 3410-34-P