Pioneer Hi-Bred International, Inc.; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Genetically Engineered High-Oleic Soybeans, 45413-45415 [E9-21277]

Download as PDF jlentini on DSKJ8SOYB1PROD with NOTICES Federal Register / Vol. 74, No. 169 / Wednesday, September 2, 2009 / Notices 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– 2009–0064. 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 https://www.aphis.usda.gov. FOR FURTHER INFORMATION CONTACT: For information on regulations for the importation of unshu oranges from the Republic of Korea into Alaska, contact Mr. Alex Belano, Branch Chief, Risk Management and Plants for Planting Policy, RPM, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737; (301) 734–5333. For copies of more detailed information on the information collection, contact Mrs. Celeste Sickles, APHIS’ Information Collection Coordinator, at (301) 851–2908. SUPPLEMENTARY INFORMATION: Title: Importation of Unshu Oranges from the Republic of Korea into Alaska. OMB Number: 0579–0314. Type of Request: Extension of approval of an information collection. Abstract: The Plant Protection Act (PPA, 7 U.S.C. 7701 et seq.) authorizes the Secretary of Agriculture to restrict the importation, entry, or interstate movement of plants, plant products, and other articles to prevent the introduction of plant pests into the United States or their dissemination within the United States. As authorized by the PPA, APHIS regulates the importation of citrus fruit from certain parts of the world as provided in ‘‘Subpart—Citrus Fruit’’ (7 CFR 319.28). In accordance with these regulations, unshu oranges from the Republic of Korea may be imported into Alaska only under certain conditions to prevent the introduction of plant pests into the United States. These conditions involve the use of information collection activities, including a phytosanitary certificate with an additional declaration statement and box labeling. We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for an additional 3 years. VerDate Nov<24>2008 16:56 Sep 01, 2009 Jkt 217001 The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us: (1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses. Estimate of burden: The public reporting burden for this collection of information is estimated to average 0.0056932 hours per response. Respondents: Importers and the national plant protection organization of the Republic of Korea. Estimated annual number of respondents: 5. Estimated annual number of responses per respondent: 1,089. Estimated annual number of responses: 5,445. Estimated total annual burden on respondents: 31 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.) All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record. Done in Washington, DC, this 26th day of August 2009. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E9–21276 Filed 8–31–09; 11:15 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Forest Service Boundary Establishment for Whitefish, Indian and Carp National Wild and Scenic Rivers; Hiawatha National Forest; Alger, Delta, Schoolcraft, Mackinac Counties; Michigan Forest Service, USDA. Notice of availability. AGENCY: ACTION: PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 45413 SUMMARY: In accordance with Section 3(b) of the Wild and Scenic Rivers Act, the USDA Forest Service, Washington Office, is transmitting the final boundaries of the Whitefish, Indian and Carp National Wild and Scenic Rivers to Congress. FOR FURTHER INFORMATION CONTACT: Information may be obtained by contacting Ted Schiltz, Recreation Program Manager, Hiawatha National Forest, 2727 North Lincoln Road, Escanaba, MI 49829. Telephone 906– 789–3346. SUPPLEMENTARY INFORMATION: The Whitefish, Indian and Carp Wild and Scenic River boundaries are available for review at the following offices: USDA Forest Service, Office of the Chief, 1400 Independence Avenue SW., Washington, DC 20024; USDA Forest Service, Eastern Region, Suite 400, 626 East Wisconsin Avenue, Milwaukee, WI 53202 and; Hiawatha National Forest, 2727 North Lincoln Road, Escanaba, MI 49829. A detailed legal description is available upon request. The Michigan Wild and Scenic Rivers Act (Pub. L. 102–249) of March 3, 1991, designated the Whitefish, Indian and Carp Rivers, Michigan, as a National Wild and Scenic Rivers, to be administered by the Secretary of Agriculture. As specified by law, the boundary will not be effective until ninety days after Congress receives the transmittal. Dated: August 19, 2009. Thomas A. Schmidt, Forest Supervisor. [FR Doc. E9–21078 Filed 9–1–09; 8:45 am] BILLING CODE 3410–11–M DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2007–0156] Pioneer Hi-Bred International, Inc.; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Genetically Engineered High-Oleic Soybeans AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice. 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 E:\FR\FM\02SEN1.SGM 02SEN1 jlentini on DSKJ8SOYB1PROD with NOTICES 45414 Federal Register / Vol. 74, No. 169 / Wednesday, September 2, 2009 / Notices event 305423, which has been genetically engineered to have higher levels of oleic acid, and lower levels of linoleic and linolenic acids in the soybean oil. 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 November 2, 2009. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/fdmspublic/ component/ main?main=DocketDetail&d=APHIS2007-0156 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–2007–0156, 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– 2007–0156. 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 https://www.aphis.usda.gov. FOR FURTHER INFORMATION CONTACT: Mrs. Karen Green, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737–1236; (301) 734–0672, e-mail: karen.c.green@aphis.usda.gov. To obtain copies of the petition or the draft environmental assessment, contact Ms. Cindy Eck at (301) 734–0667, e-mail: cynthia.a.eck@aphis.usda.gov. The petition, the draft environmental assessment, and the plant pest risk assessment are also available on the Internet at https://www.aphis.usda.gov/ brs/aphisdocs/06_35401p.pdf, https:// VerDate Nov<24>2008 16:56 Sep 01, 2009 Jkt 217001 www.aphis.usda.gov/brs/aphisdocs/ 06_35401p_ea.pdf, and https:// www.aphis.usda.gov/brs/aphisdocs/ 06_35401p_pra.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 § 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 § 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 December 20, 2006, APHIS received a petition seeking a determination of nonregulated status (APHIS Petition No. 06–354–01p) from Pioneer Hi-Bred International, Inc., of Johnston, IA (Pioneer), for soybean (Glycine max L.) designated as transformation event 305423, which has been genetically engineered for higher levels of oleic acid, a monounsaturated fat in soybean oil, stating that soybean line 305423 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, 305423 soybean has been genetically engineered to suppress the expression of the soybean endogenous microsomal omega-6 desaturases gene (FAD2–1). The introduced endogenous FAD2–1 gene fragment acts to silence expression of the endogenous FAD2–1 gene, which is responsible for an increased level of oleic acid and decreased levels of linoleic acid, a major polyunsaturated fatty acid present in soybean oil. In addition, Pioneer 305423 soybean contains a slightly modified version of an endogenous acetolactate synthase gene (ALS). Expression of the protein can increase the inherent tolerance level to the ALS-inhibiting class of herbicides. This trait is intended for PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 selecting and identifying this bioengineered event, rather than as a separate commercial trait as this version of the gene does not confer commercial levels of herbicide tolerance in Pioneer 305423 soybean. APHIS has prepared an environmental assessment (EA) that presents two alternatives based on APHIS’ analyses of data submitted by Pioneer, a review of other scientific data, and information obtained during field tests conducted under APHIS oversight. APHIS may either: (1) Take no action, i.e., APHIS would not change the regulatory status of 305423 soybeans and they would continue to be regulated articles, or (2) deregulate 305423 soybeans in whole. Section 403 of the Plant Protection Act (7 U.S.C. 7701 et seq.), defines ‘‘plant pest’’ 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 plant pest 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 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 305423 soybeans. On January 15, 2009, the FDA concluded their review of the data submitted by Pioneer and had no further questions regarding the safety of 305423 soybean. 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 305423 soybeans, an EA has been prepared. The EA was prepared in accordance with: (1) The National Environmental Policy Act of 1969 E:\FR\FM\02SEN1.SGM 02SEN1 Federal Register / Vol. 74, No. 169 / Wednesday, September 2, 2009 / Notices (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 7 CFR 340.6(d), 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 plant pest risk assessment and on the EA prepared to examine any environmental impacts of the proposed deregulation determination for the subject soybean event. The petition, plant pest risk assessment, EA, and any comments we receive are available for public review, and copies of the petition, plant pest risk assessment, and EA are available as indicated in the FOR FURTHER INFORMATION CONTACT section of this notice. After the comment period closes, APHIS will review all written comments received during the 60-day comment period and any other relevant information. All public comments received regarding the petition, plant pest risk assessment, and draft EA will be available for public review. After reviewing and evaluating the comments on the petition, plant pest risk assessment, draft EA, and other data, APHIS will furnish a response to the petitioner, either approving in whole or denying the petition. APHIS will then publish a notice in the Federal Register announcing the regulatory status of Pioneer’s 305423 soybean and the availability of APHIS’ written decision. jlentini on DSKJ8SOYB1PROD with NOTICES 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 26th day of August 2009. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E9–21277 Filed 8–31–09; 11:15 am] BILLING CODE 3410–34–P VerDate Nov<24>2008 16:56 Sep 01, 2009 Jkt 217001 DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2008–0119] Implementation of Revised Lacey Act Provisions AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice. SUMMARY: The Food, Conservation, and Energy Act of 2008 amended the Lacey Act to provide, among other things, that importers submit a declaration at the time of importation for certain plants and plant products. The declaration requirements of the Lacey Act became effective on December 15, 2008, and enforcement of those requirements is being phased in. The purpose of this notice is to inform the public of the Federal Government’s revised plan to phase in enforcement of the declaration requirement and other implementation plans. DATES: We will consider all comments that we receive on or before November 2, 2009. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/fdmspublic/ component/ main?main=DocketDetail&d=APHIS2008-0119 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–2008–0119, 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– 2008–0119. 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 https://www.aphis.usda.gov. FOR FURTHER INFORMATION CONTACT: Mr. Alex Belano, Branch Chief, Risk Management and Plants for Planting PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 45415 Policy, RPM, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737– 1231; (301) 734–8758. SUPPLEMENTARY INFORMATION: Background The Lacey Act (16 U.S.C. 3371 et seq.), first enacted in 1900 and significantly amended in 1981, is the United States’ oldest wildlife protection statute. The Act combats trafficking in ‘‘illegal’’ wildlife, fish, or plants. The Food, Conservation, and Energy Act of 2008, effective May 22, 2008, amended the Lacey Act by expanding its protection to a broader range of plants and plant products (Section 8204, Prevention of Illegal Logging Practices). As amended, the Lacey Act now makes it unlawful to import, export, transport, sell, receive, acquire, or purchase in interstate or foreign commerce any plant, with some limited exceptions, taken in violation of the laws of a U.S. State or any foreign law that protects plants. The Lacey Act also now makes it unlawful to make or submit any false record, account, or label for, or any false identification of, any plant. In addition, Section 3 of the Lacey Act, as amended (16 U.S.C. 3372), makes it unlawful to import certain plants and plant products without an import declaration. The declaration must contain, among other things, the scientific name of the plant, value of the importation, quantity of the plant, and name of the country from where the plant was harvested. For paper and paperboard products containing recycled content, the declaration also must include the average percent of recycled content without regard for species or country of harvest. Comment Analysis On October 8, 2008, we published a notice in the Federal Register (73 FR 58925–58927, Docket No. APHIS–2008– 0119) announcing our plans to begin phased-in enforcement of the declaration requirement on April 1, 2009, and provided dates and products covered for the first three phases of enforcement. We solicited comments on the proposed phase-in plan for 60 days ending on December 8, 2008, and received 124 comments by that date. On February 3, 2009, we published a second notice in the Federal Register (74 FR 5911–5913, Docket No. APHIS– 2008–0119) and provided a revised, more detailed phase-in schedule based on comments we received in response to the October notice. We solicited comment on the revised phase-in plan for 60 days ending on April 6, 2009, and received 41 comments by that date. The comments covered a range of topics, E:\FR\FM\02SEN1.SGM 02SEN1

Agencies

[Federal Register Volume 74, Number 169 (Wednesday, September 2, 2009)]
[Notices]
[Pages 45413-45415]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-21277]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2007-0156]


Pioneer Hi-Bred International, Inc.; Availability of Petition and 
Environmental Assessment for Determination of Nonregulated Status for 
Genetically Engineered High-Oleic Soybeans

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

-----------------------------------------------------------------------

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

[[Page 45414]]

event 305423, which has been genetically engineered to have higher 
levels of oleic acid, and lower levels of linoleic and linolenic acids 
in the soybean oil. 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 November 
2, 2009.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0156 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-2007-0156, 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-2007-0156.
    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 https://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Mrs. Karen Green, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-0672, e-mail: karen.c.green@aphis.usda.gov. To 
obtain copies of the petition or the draft environmental assessment, 
contact Ms. Cindy Eck at (301) 734-0667, e-mail: 
cynthia.a.eck@aphis.usda.gov. The petition, the draft environmental 
assessment, and the plant pest risk assessment are also available on 
the Internet at https://www.aphis.usda.gov/brs/aphisdocs/06_35401p.pdf, 
https://www.aphis.usda.gov/brs/aphisdocs/06_35401p_ea.pdf, and https://www.aphis.usda.gov/brs/aphisdocs/06_35401p_pra.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 December 20, 2006, APHIS received a petition seeking a 
determination of nonregulated status (APHIS Petition No. 06-354-01p) 
from Pioneer Hi-Bred International, Inc., of Johnston, IA (Pioneer), 
for soybean (Glycine max L.) designated as transformation event 305423, 
which has been genetically engineered for higher levels of oleic acid, 
a monounsaturated fat in soybean oil, stating that soybean line 305423 
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, 305423 soybean has been genetically 
engineered to suppress the expression of the soybean endogenous 
microsomal omega-6 desaturases gene (FAD2-1). The introduced endogenous 
FAD2-1 gene fragment acts to silence expression of the endogenous FAD2-
1 gene, which is responsible for an increased level of oleic acid and 
decreased levels of linoleic acid, a major polyunsaturated fatty acid 
present in soybean oil.
    In addition, Pioneer 305423 soybean contains a slightly modified 
version of an endogenous acetolactate synthase gene (ALS). Expression 
of the protein can increase the inherent tolerance level to the ALS-
inhibiting class of herbicides. This trait is intended for selecting 
and identifying this bioengineered event, rather than as a separate 
commercial trait as this version of the gene does not confer commercial 
levels of herbicide tolerance in Pioneer 305423 soybean.
    APHIS has prepared an environmental assessment (EA) that presents 
two alternatives based on APHIS' analyses of data submitted by Pioneer, 
a review of other scientific data, and information obtained during 
field tests conducted under APHIS oversight. APHIS may either: (1) Take 
no action, i.e., APHIS would not change the regulatory status of 305423 
soybeans and they would continue to be regulated articles, or (2) 
deregulate 305423 soybeans in whole.
    Section 403 of the Plant Protection Act (7 U.S.C. 7701 et seq.), 
defines ``plant pest'' 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 plant pest 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 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 
305423 soybeans. On January 15, 2009, the FDA concluded their review of 
the data submitted by Pioneer and had no further questions regarding 
the safety of 305423 soybean.

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 305423 soybeans, an 
EA has been prepared. The EA was prepared in accordance with: (1) The 
National Environmental Policy Act of 1969

[[Page 45415]]

(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 7 CFR 340.6(d), 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 plant pest risk assessment 
and on the EA prepared to examine any environmental impacts of the 
proposed deregulation determination for the subject soybean event. The 
petition, plant pest risk assessment, EA, and any comments we receive 
are available for public review, and copies of the petition, plant pest 
risk assessment, and EA are available as indicated in the FOR FURTHER 
INFORMATION CONTACT section of this notice.
    After the comment period closes, APHIS will review all written 
comments received during the 60-day comment period and any other 
relevant information. All public comments received regarding the 
petition, plant pest risk assessment, and draft EA will be available 
for public review. After reviewing and evaluating the comments on the 
petition, plant pest risk assessment, draft EA, and other data, APHIS 
will furnish a response to the petitioner, either approving in whole or 
denying the petition. APHIS will then publish a notice in the Federal 
Register announcing the regulatory status of Pioneer's 305423 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 26th day of August 2009.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E9-21277 Filed 8-31-09; 11:15 am]
BILLING CODE 3410-34-P
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