[Federal Register: June 4, 2009 (Volume 74, Number 106)]
[Notices]
[Page 26832-26835]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04jn09-34]
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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: andrea.f.huberty@aphis.usda.gov. 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: cynthia.a.eck@aphis.usda.gov. 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