Monsanto Company; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Soybean Genetically Engineered for Glyphosate Herbicide Tolerance, 5261-5263 [E7-1793]

Download as PDF Federal Register / Vol. 72, No. 23 / Monday, February 5, 2007 / Notices Dated: January 30, 2007. Lloyd C. Day, Administrator, Agricultural Marketing Service. [FR Doc. E7–1759 Filed 2–2–07; 8:45 am] Orders or U.S. Import Requirements, no longer appear in the Code of Federal Regulations, but are maintained by USDA, AMS, Fruit and Vegetable Programs. AMS is establishing voluntary United States Standards for Grades of Peppers (Other Than Sweet Peppers) using the procedures that appear in Part 36, Title 7 of the Code of Federal Regulations (7 CFR part 36). BILLING CODE 3410–02–P DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Docket # AMS–FV–2006–0203; FV–06–306] United States Standards for Grades of Peppers (Other Than Sweet Peppers) Agricultural Marketing Service, USDA. ACTION: Notice. AGENCY: SUMMARY: The Agricultural Marketing Service (AMS) of the Department of Agriculture (USDA) is establishing voluntary United States Standards for Grades of Peppers (Other Than Sweet Peppers). The standards will provide industry with a common language and uniform basis for trading, thus promoting the orderly and efficient marketing of peppers that are not sweet peppers. EFFECTIVE DATE: March 7, 2007. FOR FURTHER INFORMATION CONTACT: Cheri L. Emery, Standardization Section, Fresh Products Branch, Fruit and Vegetable Programs, Agricultural Marketing Service, U.S. Department of Agriculture, 1400 Independence Ave., SW., Room 1661, South Building, Stop 0240, Washington, DC 20250–0240, (202) 720–2185, fax (202) 720–8871, or e-mail Cheri.Emery@usda.gov. The United States Standards for Grades of Peppers (Other Than Sweet Peppers) are available either from the above address or by accessing the AMS, Fresh Products Branch Web site at: https://www.ams.usda.gov/standards/ stanfrfv.htm. Section 203(c) of the Agricultural Marketing Act of 1946 (7 U.S.C. 1621–1627), as amended, directs and authorizes the Secretary of Agriculture ‘‘To develop and improve standards of quality, condition, quantity, grade and packaging and recommend and demonstrate such standards in order to encourage uniformity and consistency in commercial practices.’’ AMS is committed to carrying out this authority in a manner that facilitates the marketing of agricultural commodities and makes copies of official standards available upon request. The United States Standards for Grades of Fruits and Vegetables that are not requirements of Federal Marketing mstockstill on PROD1PC66 with NOTICES SUPPLEMENTARY INFORMATION: VerDate Aug<31>2005 15:07 Feb 02, 2007 Jkt 211001 5261 after publication in the Federal Register. Background AMS published a notice in the Federal Register (71 FR 9514), on February 24, 2006, soliciting comments on the possible development of United States Standards for Grades of Peppers (Other Than Sweet Peppers). In response to the request for comments, AMS received two comments, one comment was from an industry group and the other from a shipper. Both comments were in support of developing the standards. The comments are available by accessing AMS, Fresh Products Branch Web site at: https://www.ams.usda.gov/fv/ fpbdocketlist.htm. On July 24, 2006, AMS published a second notice in the Federal Register (71 FR 41755–41756), soliciting comments on the proposed voluntary United States Standards for Grades of Peppers (Other Than Sweet Peppers). The proposed standards contained U.S. Fancy, U.S. No. 1, and U.S. No. 2 grades and tolerances for each grade. In addition, there were ‘‘Application of Tolerances’’ and ‘‘Size’’ sections. AMS also defined ‘‘Injury,’’ ‘‘Damage,’’ and ‘‘Serious Damage,’’ along with specific basic requirements and definitions for defects, definitions for color, diameter, and length. Comments were not received in connection with the second notice. The adoption of the U.S. grade standards will provide the pepper (other than sweet peppers) industry with U.S. grade standards similar to those extensively in use by the fresh produce industry to assist in orderly marketing of other commodities. Accordingly, AMS is adopting the United States Standards for Grades of Peppers (Other Than Sweet Peppers) as proposed in the July 24, 2006, Federal Register notice. The official grades of a lot or shipment of fresh vegetables covered by U.S. standards is determined by the procedures set forth in the Regulations Governing Inspection, Certification, and Standards of Fresh Fruits, Vegetables and Other Products (7 CFR 51.1 to 51.61). The United States Standards for Grades of Peppers (Other Than Sweet Peppers) will become effective 30 days DEPARTMENT OF AGRICULTURE PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 Authority: 7 U.S.C. 1621–1627. Dated: January 30, 2007. Lloyd C. Day, Administrator, Agricultural Marketing Service. [FR Doc. E7–1762 Filed 2–2–07; 8:45 am] BILLING CODE 3410–02–P Animal and Plant Health Inspection Service [Docket No. APHIS–2006–0195] Monsanto Company; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Soybean Genetically Engineered for Glyphosate Herbicide Tolerance Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: SUMMARY: We are advising the public that the Animal and Plant Health Inspection Service has received a petition from Monsanto Company seeking a determination of nonregulated status for soybean designated as MON 89788, which has been genetically engineered for tolerance to the herbicide glyphosate. 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 soybean presents a plant pest risk. 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 April 6, 2007. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://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–2006– 0195 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. E:\FR\FM\05FEN1.SGM 05FEN1 5262 Federal Register / Vol. 72, No. 23 / Monday, February 5, 2007 / Notices • Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. APHIS–2006–0195, 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– 2006–0195. 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: Dr. Virgil Meier, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737–1236; (301) 734–3363, virgil.d.meier@aphis.usda.gov. To obtain copies of the petition or environmental assessment (EA), contact Ms. Cynthia Eck at (301) 734–0667; cynthia.a.eck@aphis.usda.gov. The petition and EA may be viewed on the Internet at https://www.aphis.usda.gov/ brs/aphisdocs/06_17801p.pdf and https://www.aphis.usda.gov/brs/ aphisdocs/06_17801p_ea.pdf. SUPPLEMENTARY INFORMATION: mstockstill on PROD1PC66 with NOTICES 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 VerDate Aug<31>2005 15:07 Feb 02, 2007 Jkt 211001 determination of nonregulated status must take and the information that must be included in the petition. On June 27, 2006, APHIS received a petition seeking a determination of nonregulated status (APHIS Petition Number 06–178–01p) from Monsanto Company of St. Louis, MO (Monsanto), for soybean (Glycine max L.) designated as transformation event MON 89788, which has been genetically engineered for tolerance to the herbicide glyphosate, stating that soybean line MON 89788 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, MON 89788 soybean plants have been genetically engineered to express a 5enolpyruvylshikimate-3-phosphate synthase protein from Agrobacterium sp. strain CP4 (CP4 EPSPS), which confers tolerance to the herbicide glyphosate. Expression of the added gene is controlled, in part, by gene sequences derived from Arabidopsis thaliana and the plant pathogen figwort mosaic virus. The Agrobacterium tumefaciens transformation method was used to transfer the added genetic material into the recipient parental soybean line A3244. MON 89788 soybean plants have been considered regulated articles under the regulations in 7 CFR part 340 because they contain gene sequences from plant pathogens. MON 89788 soybean plants have been field tested in the United States since 2001 under notifications authorized by APHIS. In the process of reviewing the notifications for field trials of the subject soybean plants, APHIS determined that the vectors and other elements were disarmed and that 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 three alternatives based on its analyses of data submitted by Monsanto, a review of other scientific data, and field tests conducted under APHIS oversight. APHIS may: (1) Take no action, (2) deregulate MON 89788 soybeans, or (3) deregulate MON 89788 soybeans in part. In section 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 PO 00000 Frm 00005 Fmt 4703 Sfmt 4703 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. Because of the similarity in tolerance to glyphosate for MON 89788 and the previously deregulated event MON–04032–6, Monsanto has not requested a label change for the application of glyphosate to MON 89788 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. Monsanto submitted a food and feed safety and nutritional assessment summary to the FDA for the MON 89788 soybean. 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 MON 89788, 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 E:\FR\FM\05FEN1.SGM 05FEN1 Federal Register / Vol. 72, No. 23 / Monday, February 5, 2007 / Notices implementing NEPA (7 CFR part 1b), and (4) APHIS’ NEPA Implementing Procedures (7 CFR part 372). In accordance with § 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. We are also soliciting written comments from interested or affected persons on the EA prepared to examine any environmental impacts of the proposed 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 petitions 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 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 Monsanto’s glyphosate-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 30th day of January 2007. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E7–1793 Filed 2–2–07; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2006–0190] Availability of an Environmental Assessment for a Proposed Field Release of Genetically Engineered Safflower Animal and Plant Health Inspection Service, USDA. ACTION: Notice. mstockstill on PROD1PC66 with NOTICES AGENCY: SUMMARY: We are advising the public that an environmental assessment has been prepared for a proposed field release involving a transgenic safflower VerDate Aug<31>2005 15:07 Feb 02, 2007 Jkt 211001 line that has been genetically engineered to express, within the seeds, a carp growth hormone fused to an Arabidopsis oleosin. The purpose of this field release is to obtain a seed increase of material harvested in Chile for future use as a supplement in aquaculture meal. We are making the environmental assessment available to the public for review and comment. DATES: We will consider all comments received on or before March 7, 2007. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://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–2006– 0190 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instruction 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–2006–0190, 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– 2006–0190. Reading Room: You may read the environmental assessment (EA) and any comments 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. The EA is also available on the Internet at https://aphis.usda.gov/brs/ aphisdocs/06_25001r_ea.pdf. Other Information: Additional information about APHIS and its programs is available on the Internet at https://www.aphis.usda.gov. FOR FURTHER INFORMATION CONTACT: Dr. Patricia Beetham, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737– 1236; (301) 734–0664. To obtain copies of the environmental assessment, contact Ms. Cynthia Eck at (301) 734– 0667; e-mail: cynthia.a.eck@aphis.usda.gov. PO 00000 Frm 00006 Fmt 4703 Sfmt 4703 5263 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.’’ A permit must be obtained or a notification acknowledged before a regulated article may be introduced. The regulations set forth the permit application requirements and the notification procedures for the importation, interstate movement, or release in the environment of a regulated article. On September 5, 2006, the Animal and Plant Health Inspection Service (APHIS) received a permit application (APHIS No. 06–250–02r) from SemBioSys Genetics, Inc. of West Sacramento, CA, for a field trial using a line of transgenic safflower. Permit application 06–250–02r describes a transgenic safflower (Carthamus tinctorius) cultivar that has been genetically engineered to express a fusion protein consisting of oleosin from Arabidopsis thaliana and carp growth hormone (somatotropin) from Cyprinus carpio exclusively within its seeds. Expression of the fusion protein is controlled by the phaseolin promoter and terminator sequences from Phaseolus vulgaris L. (common bean). Constructs were inserted into the recipient organisms via a disarmed Agrobacterium tumefaciens vector system. The seed from these safflower plants will be ground and incorporated into aquaculture feed to be used in experimental fish feeding studies by SemBioSys and is not for commercial production. The subject safflower is considered a regulated article under the regulations in 7 CFR part 340 because it has been genetically engineered using the recombinant DNA technique using a vector derived from the plant pest Agrobacterium tumefaciens. To provide the public with documentation of APHIS’ review and analysis of any potential environmental impacts and plant pest risks associated with the proposed release of these transgenic safflowers, an environmental assessment (EA) has been prepared. The EA was prepared in accordance with: (1) The National Environmental Policy Act SUPPLEMENTARY INFORMATION: E:\FR\FM\05FEN1.SGM 05FEN1

Agencies

[Federal Register Volume 72, Number 23 (Monday, February 5, 2007)]
[Notices]
[Pages 5261-5263]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1793]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2006-0195]


Monsanto Company; Availability of Petition and Environmental 
Assessment for Determination of Nonregulated Status for Soybean 
Genetically Engineered for Glyphosate Herbicide Tolerance

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 Monsanto Company 
seeking a determination of nonregulated status for soybean designated 
as MON 89788, which has been genetically engineered for tolerance to 
the herbicide glyphosate. 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 soybean 
presents a plant pest risk. 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 April 6, 
2007.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://
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-2006-0195 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.

[[Page 5262]]

     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. APHIS-
2006-0195, 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-2006-0195.
    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: Dr. Virgil Meier, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-3363, virgil.d.meier@aphis.usda.gov. To obtain 
copies of the petition or environmental assessment (EA), contact Ms. 
Cynthia Eck at (301) 734-0667; cynthia.a.eck@aphis.usda.gov. The 
petition and EA may be viewed on the Internet at https://
www.aphis.usda.gov/brs/aphisdocs/06_17801p.pdf and https://
www.aphis.usda.gov/brs/aphisdocs/06_17801p_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 June 27, 2006, APHIS received a petition seeking a determination 
of nonregulated status (APHIS Petition Number 06-178-01p) from Monsanto 
Company of St. Louis, MO (Monsanto), for soybean (Glycine max L.) 
designated as transformation event MON 89788, which has been 
genetically engineered for tolerance to the herbicide glyphosate, 
stating that soybean line MON 89788 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, MON 89788 soybean plants have been 
genetically engineered to express a 5-enolpyruvylshikimate-3-phosphate 
synthase protein from Agrobacterium sp. strain CP4 (CP4 EPSPS), which 
confers tolerance to the herbicide glyphosate. Expression of the added 
gene is controlled, in part, by gene sequences derived from Arabidopsis 
thaliana and the plant pathogen figwort mosaic virus. The Agrobacterium 
tumefaciens transformation method was used to transfer the added 
genetic material into the recipient parental soybean line A3244.
    MON 89788 soybean plants have been considered regulated articles 
under the regulations in 7 CFR part 340 because they contain gene 
sequences from plant pathogens. MON 89788 soybean plants have been 
field tested in the United States since 2001 under notifications 
authorized by APHIS. In the process of reviewing the notifications for 
field trials of the subject soybean plants, APHIS determined that the 
vectors and other elements were disarmed and that 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 three alternatives based on its analyses of data submitted by 
Monsanto, a review of other scientific data, and field tests conducted 
under APHIS oversight. APHIS may: (1) Take no action, (2) deregulate 
MON 89788 soybeans, or (3) deregulate MON 89788 soybeans in part.
    In section 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. Because 
of the similarity in tolerance to glyphosate for MON 89788 and the 
previously deregulated event MON-04032-6, Monsanto has not requested a 
label change for the application of glyphosate to MON 89788 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. Monsanto submitted a 
food and feed safety and nutritional assessment summary to the FDA for 
the MON 89788 soybean. 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 MON 89788, 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

[[Page 5263]]

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. We are also soliciting written 
comments from interested or affected persons on the EA prepared to 
examine any environmental impacts of the proposed 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 petitions 
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 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 Monsanto's glyphosate-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 30th day of January 2007.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E7-1793 Filed 2-2-07; 8:45 am]
BILLING CODE 3410-34-P
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