[Federal Register Volume 72, Number 193 (Friday, October 5, 2007)]
[Notices]
[Pages 56981-56983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19801]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2007-0019]


Pioneer Hi-Bred International, Inc.; Availability of Petition and 
Environmental Assessment for Determination of Nonregulated Status for 
Soybean Genetically Engineered for Tolerance to Glyphosate and 
Acetolactate Synthase-Inhibiting Herbicides

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has received a petition from Pioneer Hi-Bred 
International, Inc., seeking a determination of nonregulated status for 
soybean designated as transformation event 356043, which has been 
genetically engineered for tolerance to glyphosate and acetolactate 
synthase-inhibiting herbicides. The petition has been submitted in 
accordance with our regulations concerning the introduction of certain 
genetically engineered organisms and products. In accordance with those 
regulations, we are soliciting comments on whether this genetically 
engineered soybean is or could be a plant pest. We are also making 
available for public comment an environmental assessment for the 
proposed determination of nonregulated status.

DATES: We will consider all comments we receive on or before December 
4, 2007.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov, select ``Animal and Plant Health Inspection 
Service'' from the agency drop-down menu, then click ``Submit.'' In the 
Docket ID column, select APHIS-2007-0019 to submit or view public 
comments and to view supporting and related materials available 
electronically. Information on using Regulations.gov, including 
instructions for accessing documents, submitting comments, and viewing 
the docket after the close of the comment period, is available through 
the site's ``User Tips'' link.
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. APHIS-
2007-0019, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. APHIS-2007-0019.
    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: Mr. John Cordts, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-5531, [email protected]. To obtain 
copies of the petition or environmental assessment (EA), contact Ms. 
Cynthia Eck at (301) 734-0667; [email protected]. The 
petition and EA may be viewed on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/06_27101p.pdf and

[[Page 56982]]

http://www.aphis.usda.gov/brs/aphisdocs/06_27101p_ea.pdf.

SUPPLEMENTARY INFORMATION: 

Background

    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 are plant pests. Such genetically 
engineered organisms and products are considered ``regulated 
articles.''
    The regulations in Sec.  340.6(a) provide that any person may 
submit a petition to the Animal and Plant Health Inspection Service 
(APHIS) seeking a determination that an article should not be regulated 
under 7 CFR part 340. Paragraphs (b) and (c) of Sec.  340.6 describe 
the form that a petition for a determination of nonregulated status 
must take and the information that must be included in the petition.
    On September 28, 2006, APHIS received a petition seeking a 
determination of nonregulated status (APHIS Petition Number 06-271-01p) 
from Pioneer Hi-Bred International, Inc., of Johnston, IA (Pioneer), 
for soybean (Glycine max L.) designated as transformation event 356043, 
which has been genetically engineered for tolerance to glyphosate and 
acetolactate synthase (ALS)-inhibiting herbicides, stating that soybean 
line 356043 does not present a plant pest risk and, therefore, should 
not be a regulated article under APHIS' regulations in 7 CFR part 340.
    As described in the petition, 356043 soybean plants have been 
genetically engineered to express modified glyphosate acetyltransferase 
(GAT 4601) and acetolactate synthase (ALS) proteins, which confers 
tolerance to glyphosate and acetolactate synthase-inhibiting 
herbicides. The gat4601 gene is derived from gat genes from Bacillus 
licheniformis, a common soil bacterium. Expression of the gat4601 gene 
is driven by a synthetic constitutive promoter (SCP1). The gene that 
confers tolerance to ALS-inhibiting herbicides is gm-hra and is a 
modified soybean ALS gene. Expression of the gm-hra gene is driven by a 
constitutive soybean S-adenosyl-L-methionine synthetase (SAMS) 
promoter. A single copy of these genes and their regulatory sequences 
were introduced into soybean somatic embryos using microprojectile 
bombardment.
    Pioneer's 356043 soybean plants have been considered regulated 
articles under the regulations in 7 CFR part 340 because they contain 
gene sequences from plant pathogens. Pioneer's 356043 soybean plants 
have been field tested in the United States since 2003 under permits 
issued by APHIS. In the process of reviewing the permits for field 
trials of the subject soybean plants, APHIS determined that the vectors 
and other elements used to introduce the new genes were disarmed and 
that the trials, which were conducted under conditions of reproductive 
and physical confinement or isolation, would not present a risk of 
plant pest introduction or dissemination.
    APHIS has prepared an environmental assessment (EA) in which it 
presents two alternatives based on its analyses of data submitted by 
Pioneer, a review of other scientific data, and field tests conducted 
under APHIS oversight. APHIS may: (1) Take no action, i.e., APHIS would 
not change the regulatory status of 356043 soybeans and they would 
continue to be regulated articles, or (2) deregulate 356043 soybeans in 
whole.
    In Sec.  403 of the Plant Protection Act (7 U.S.C. 7701 et seq.), 
``plant pest'' is defined as 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 protozoan, a nonhuman animal, 
a parasitic plant, a bacterium, a fungus, a virus or viroid, an 
infectious agent or other pathogen, or any article similar to or allied 
with any of the foregoing. APHIS views this definition broadly to cover 
direct or indirect injury, disease, or damage not just to agricultural 
crops, but also to other plants, for example, native species, as well 
as organisms that may be beneficial to plants, such as honeybees.
    The U.S. Environmental Protection Agency (EPA) is responsible for 
the regulation of pesticides under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et seq.). FIFRA 
requires that all pesticides, including herbicides, be registered prior 
to distribution or sale, unless exempt from EPA regulation. Under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended (21 U.S.C. 301 
et seq.), pesticides added to (or contained in) raw agricultural 
commodities generally are considered to be unsafe unless a tolerance or 
exemption from tolerance has been established. Residue tolerances for 
pesticides are established by the EPA under the FFDCA, and the Food and 
Drug Administration (FDA) enforces tolerances set by the EPA. Pioneer 
submitted the appropriate regulatory package to the EPA for registering 
the use of glyphosate herbicide on 356043 soybeans.
    The FDA's policy statement concerning regulation of products 
derived from new plant varieties, including those genetically 
engineered, was published in the Federal Register on May 29, 1992 (57 
FR 22984-23005). Under this policy, FDA uses what is termed a 
consultation process to ensure that human and animal feed safety issues 
or other regulatory issues (e.g., labeling) are resolved prior to 
commercial distribution of a bioengineered food. Pioneer submitted a 
food and feed safety and nutritional assessment summary to the FDA for 
356043 soybeans. A final FDA decision is pending.

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with the 
proposed determination of nonregulated status for 356043 soybeans, an 
EA has been prepared. The EA was prepared in accordance with: (1) The 
National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 
4321 et seq.), (2) regulations of the Council on Environmental Quality 
for implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) 
APHIS' NEPA Implementing Procedures (7 CFR part 372).
    In accordance with Sec.  340.6(d) of the regulations, we are 
publishing this notice to inform the public that APHIS will accept 
written comments regarding the petition for a determination of 
nonregulated status from interested or affected persons for a period of 
60 days from the date of this notice. During the same comment period, 
we are also soliciting written comments from interested or affected 
persons on the EA prepared to examine any environmental impacts of the 
proposed deregulation determination for the subject soybean event. The 
petition and the EA and any comments we receive are available for 
public review, and copies of the petition and the EA are available as 
indicated in the FOR FURTHER INFORMATION CONTACT section of this 
notice.
    After the comment period closes, APHIS will review the data 
submitted by the petitioner, all written comments received during the 
comment period, and any other relevant information. After reviewing and 
evaluating the

[[Page 56983]]

comments on the petition and the EA and other data and information, 
APHIS will furnish a response to the petitioner, either approving the 
petition in whole or in part, or denying the petition. APHIS will then 
publish a notice in the Federal Register announcing the regulatory 
status of Pioneer's glyphosate and ALS-inhibiting, herbicide-tolerant 
soybean and the availability of APHIS' written decision.

    Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 
CFR 2.22, 2.8, and 371.3.

    Done in Washington, DC, this 3rd day of October 2007.
Cindy J. Smith,
Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E7-19801 Filed 10-4-07; 8:45 am]
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