Monsanto Co. and Forage Genetics International; Availability Determination of Nonregulated Status for Alfalfa Genetically Engineered for Tolerance to the Herbicide Glyphosate, 36917-36919 [E5-3323]

Download as PDF Federal Register / Vol. 70, No. 122 / Monday, June 27, 2005 / Notices You may submit comments by any of the following methods: • EDOCKET: Go to http:// www.epa.gov/feddocket to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once you have entered EDOCKET, click on the ‘‘View Open APHIS Dockets’’ link to locate this document. • Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. 05–046–1, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737–1238. Please state that your comment refers to Docket No. 05–046–1. 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: You may view APHIS documents published in the Federal Register and related information on the Internet at http:// www.aphis.usda.gov/ppd/rad/ webrepor.html. ADDRESSES: For information regarding the Animal Welfare Act regulations for guinea pigs, hamsters, and rabbits, contact Dr. Barbara Kohn, Senior Staff Veterinarian, Animal Care, APHIS, 4700 River Road Unit 84, Riverdale, MD 20737–1234; (301) 734–7833. For copies of more detailed information on the information collection, contact Mrs. Celeste Sickles, APHIS’ Information Collection Coordinator, at (301) 734–7477. SUPPLEMENTARY INFORMATION: Title: Animal Welfare; Guinea Pigs, Hamsters, and Rabbits. OMB Number: 0579–0092. Type of Request: Extension of approval of an information collection. Abstract: The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) administers regulations and standards that have been promulgated under the Animal Welfare Act to promote and ensure the humane care and treatment of regulated animals under the Act. The regulations in title 9, part 3, subparts B and C, of the Code of Federal Regulations (CFR) contain specifications FOR FURTHER INFORMATION CONTACT: VerDate jul<14>2003 18:11 Jun 24, 2005 Jkt 205001 for the humane handling, care, treatment, and transportation of guinea pigs, hamsters, and rabbits. The regulations require, among other things, the documentation of specified information concerning the transportation of these animals. The transportation standards for guinea pigs, hamsters, and rabbits require intermediate handlers and carriers to accept only shipping enclosures that meet the minimum requirements set forth in the regulations (§§ 3.36 and 3.61) or that are accompanied by documentation signed by the consignor verifying that the shipping enclosures comply with the regulations. If guinea pigs, hamsters, or rabbits are transported in cargo space that falls below 45 °F (7.2 C), the regulations specify that the animals must be accompanied by a certificate of acclimation signed by a USDAaccredited veterinarian. In addition, all shipping enclosures must be marked with the words ‘‘Live Animals’’ and have arrows indicating the correct upright position of the container. Intermediate handlers and carriers are required to attempt to contact the consignee at least once every 6 hours upon the arrival of any live animals. Documentation of these attempts must be recorded by the intermediate handlers and carriers and maintained for inspection by APHIS personnel. The above reporting and recordkeeping requirements do not mandate the use of any official government form. The burden generated by APHIS requirements that all shipping documents be attached to the container has been cleared by the Office of Management (OMB) under OMB control number 0579–0036. The reporting and recordkeeping requirements of 9 CFR part 3, subparts B and C, are necessary to enforce regulations intended to ensure the humane treatment of guinea pigs, hamsters, and rabbits during transportation in commerce. We are asking OMB to approve our use of this information collection activity for an additional 3 years. 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 PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 36917 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 0.11555 hours per response. Respondents: Intermediate handlers, carriers, class ‘‘A’’ and ‘‘B’’ dealers (as consignors), USDA-accredited veterinarians. Estimated annual number of respondents: 1,470. Estimated annual number of responses per respondent: 1.5306. Estimated annual number of responses: 2,250. Estimated total annual burden on respondents: 260 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 21st day of June, 2005. Elizabeth E. Gaston, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E5–3322 Filed 6–24–05; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. 04–085–3] Monsanto Co. and Forage Genetics International; Availability Determination of Nonregulated Status for Alfalfa Genetically Engineered for Tolerance to the Herbicide Glyphosate Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: SUMMARY: We are advising the public of our determination that the Monsanto Company and Forage Genetics International alfalfa lines designated as events J101 and J163, which have been genetically engineered for tolerance to the herbicide glyphosate, are no longer considered regulated articles under our E:\FR\FM\27JNN1.SGM 27JNN1 36918 Federal Register / Vol. 70, No. 122 / Monday, June 27, 2005 / Notices regulations governing the introduction of certain genetically engineered organisms. Our determination is based on our evaluation of data submitted by Monsanto Company and Forage Genetics International in their petition for a determination of nonregulated status, our analysis of other scientific data, and comments received from the public in response to a previous notice announcing the availability of the petition for nonregulated status and an environmental assessment. This notice also announces the availability of our written determination document and our finding of no significant impact. EFFECTIVE DATE: June 14, 2005. ADDRESSES: You may read the petition for a determination of nonregulated status submitted by Monsanto Company and Forage Genetics International, the environmental assessment, all comments received on the petition and the environmental assessment, the determination, and the finding of no significant impact with attached response to comments 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. You may view APHIS documents published in the Federal Register and related information on the Internet at http://www.aphis.usda.gov/ppd/rad/ webrepor.html. FOR FURTHER INFORMATION CONTACT: Dr. Virgil Meier, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737–1236; (301) 734–3363. To obtain copies of the petition, the determination, the environmental assessment, or the finding of no significant impact, contact Ms. Ingrid Berlanger, at (301) 734–4885; e-mail: ingrid.e.berlanger@aphis.usda.gov. Those documents are also available on the Internet at http://www.aphis. usda.gov/brs/aphisdocs/04_11001p.pdf and http://www.aphis.usda.gov/brs/ aphisdocs/04_11001p_ea.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 VerDate jul<14>2003 18:11 Jun 24, 2005 Jkt 205001 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 April 16, 2004, APHIS received a petition (APHIS petition number 04– 110–01p) from Monsanto Company of St. Louis, MO, and Forage Genetics International of West Salem, WI (Monsanto/FGI), requesting a determination of nonregulated status under 7 CFR part 340 for alfalfa (Medicago sativa L.) designated as events J101 and J163, which have been genetically engineered for tolerance to the herbicide glyphosate. The Monsanto/FGI petition states that the subject alfalfa should not be regulated by APHIS because it does not present a plant pest risk. On November 24, 2004, APHIS published a notice in the Federal Register (69 FR 68300–68301, Docket No. 04–085–1) announcing that the Monsanto/FGI petition and an environmental assessment were available for public review and soliciting comments for 60 days ending January 24, 2005. The notice also discussed the role of APHIS, the Environmental Protection Agency, and the Food and Drug Administration in regulating the subject alfalfa and products developed from it. In a subsequent notice, APHIS extended the comment period until February 17, 2005 (see 70 FR 5601–5602, Docket No. 04– 085–2, published February 3, 2005). APHIS received 663 comments by the close of the extended comment period. Comments came from alfalfa growers and seed producers, organic growers, animal producers, growers associations, consumer groups, agriculture support industries, university professionals, and private citizens. Five hundred twenty respondents did not support granting nonregulated status to the events identified in the petition, while 137 supported the petition. The majority of the alfalfa growers and seed producers who submitted comments supported granting nonregulated status to alfalfa events J101 and J163, citing market demand for a weed-free product and stating that glyphosate tolerant alfalfa offered a tool to meet that demand. The PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 majority of those academic professionals, agricultural support industries, and growers associations that submitted comments also supported the petition. Those commenters who did not support the petition raised concerns that certain domestic and foreign markets may be closed to growers who cannot guarantee a non-genetically engineered product. Organic growers generally opposed the petition because of concerns that pollination of their crops by the glyphosate tolerant variety will result in the inadvertent generation of unwanted genetically engineered products, resulting in market loss. APHIS has carefully considered these comments and suggestions, and a response to the issues raised in the comments is included as an attachment to the finding of no significant impact. Alfalfa events J101 and J163 have been genetically engineered to express a 5-enolpyruvyshikimate-3-phosphate synthase protein from Agrobacterium sp. strain CP4 (CP4 EPSPS), which confers tolerance to the herbicide glyphosate. Expression of the added genes is controlled in part by the 35S promoter derived from the plant pathogen figwort mosaic virus. The Agrobacterium tumefaciens transformation method was used to transfer the added genes into the proprietary alfalfa line R2336. Alfalfa events J101 and J163 have been considered regulated articles under the regulations in 7 CFR part 340 because they contain gene sequences from plant pathogens. In the process of reviewing the notifications for field trials of the subject alfalfa, APHIS determined that the vectors and other elements 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. Determination Based on its analysis of the data submitted by Monsanto/FGI, a review of other scientific data, field tests of the subject alfalfa, and comments submitted by the public, APHIS has determined that alfalfa events J101 and J163: (1) Exhibit no plant pathogenic properties; (2) are no more likely to become weedy than the nontransgenic parental line or other cultivated alfalfa; (3) are unlikely to increase the weediness potential of any other cultivated or wild species with which it can interbreed; (4) will not cause damage to raw or processed agricultural commodities; (5) will not harm threatened or endangered species or organisms that are beneficial to agriculture; and (6) should not reduce E:\FR\FM\27JNN1.SGM 27JNN1 Federal Register / Vol. 70, No. 122 / Monday, June 27, 2005 / Notices the ability to control pests and weeds in alfalfa or other crops. Therefore, APHIS has concluded that the subject alfalfa and any progeny derived from hybrid crosses with other non-transformed alfalfa varieties will be as safe to grow as alfalfa varieties in traditional breeding programs that are not subject to regulation under 7 CFR part 340. The effect of this determination is that Monsanto/FGI alfalfa events J101 and J163 are no longer considered regulated articles under APHIS’ regulations in 7 CFR part 340. Therefore, the requirements pertaining to regulated articles under those regulations no longer apply to the subject alfalfa or its progeny. However, importation of J101 and J163 alfalfa and seeds capable of propagation are still subject to the restrictions found in APHIS’ foreign quarantine notices in 7 CFR part 319 and imported seed regulations in 7 CFR part 361. National Environmental Policy Act An environmental assessment was prepared to examine any potential environmental impacts associated with the determination of nonregulated status for the subject alfalfa events. The environmental assessment 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). Based on that environmental assessment, APHIS has reached a finding of no significant impact with regard to the determination that Monsanto/FGI J101 and J163 alfalfa events and lines developed from them are no longer regulated articles under its regulations in 7 CFR part 340. Copies of the environmental assessment and the finding of no significant impact are available from the individual listed under FOR FURTHER INFORMATION CONTACT. Authority: 7 U.S.C. 1622n and 7701–7772; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3. Dated: Done in Washington, DC, this 21st day of June 2005. Elizabeth E. Gaston, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E5–3323 Filed 6–24–05; 8:45 am] BILLING CODE 3410–34–P VerDate jul<14>2003 18:11 Jun 24, 2005 Jkt 205001 DEPARTMENT OF AGRICULTURE Commodity Credit Corporation Tobacco Transition Payment Program—Successor-in-Interest Contracts Commodity Credit Corporation, USDA. ACTION: Notice and request for comments. AGENCY: SUMMARY: This notice requests public comment on the documents to be used by the Commodity Credit Corporation (CCC) in the administration of the Tobacco Transition Payment Program (TTPP) with respect to successor-ininterest contracts, which allow a tobacco quota holder or a tobacco producer who is participating in this program to transfer their rights and obligations to a third-party. DATES: CCC requests comments on any aspect of the documents, which are in the Appendix to this notice and at http://www.fsa.usda.gov/tobacco/. Comments must be received by July 11, 2005. ADDRESSES: CCC invites interested persons to submit comments on these documents. The preferred manner to submit comments is by e-mail at: tob_comments@wdc.usda.gov. Comments may also be submitted by any of the following methods: • Fax: Send to (202) 720–1288. • Mail: Send to Director, Tobacco Division, Farm Service Agency, United States Department of Agriculture (USDA), STOP 0514, Room 4080–S, 1400 Independence Ave., SW., Washington, DC 20250–0514. • Hand Delivery or Courier: Deliver to the above address. All comments, including names and addresses, provided by respondents become a matter of public record. Comments may be inspected in the Office of the Director, Tobacco Division, FSA, at the above address. Make inspection arrangements by calling (202) 720–7413. FOR FURTHER INFORMATION CONTACT: Joe Lewis, Tobacco Division (TD), Farm Service Agency, United States Department of Agriculture (USDA), STOP 0514, Room 4080–S, 1400 Independence Avenue, SW., Washington, DC 20250–0514. Phone: (202) 720–0795; e-mail: Joe_Lewis@wdc.usda.gov. Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.) should contact the USDA Target Center at (202) 720–2600 (voice and TDD). PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 36919 CCC is seeking comments on the forms relating to successor in interest contracts, consolidation of multiple contracts, and the process flow relating to these transactions. An entity would submit to CCC form CCC–962, ‘‘Agreement to Purchase Tobacco Transition Payment Contract.’’ Required information includes the contract number associated with the transferor’s original contract, the transferor’s and the successor’s names and addresses and the signatures of both parties. In addition, the value of consideration provided by the successor to the transferor and the date such consideration will be paid must be provided. This agreement, once submitted to CCC, is non-revocable. CCC will date and time stamp each form upon receipt and will honor only the first one received. CCC will notify both parties as to the approval or disapproval of the succession. If approved, the transferor no longer has any right to receive payment from CCC under the TTPP contract that was transferred. The successor has all rights to such payment upon execution of form CCC–957, ‘‘Successor in Interest Contract for Quota Holders,’’ or form CCC–958, ‘‘Successor in Interest Contract for Tobacco Producers,’’ as applicable. This form is available at the FSA Web site or at USDA Service Centers. It will be the responsibility of the successor to submit a signed CCC–957 or CCC–958 to CCC. Successors desiring to consolidate multiple contracts acquired from quota holders and producers must submit the ‘‘Appendix to the Tobacco Transition Payment Program Contract, Request for Payment Consolidation Contract’’. The appendix allows 60 existing contract numbers to be consolidated; a continuation form will allow unlimited contracts to be consolidated. Quota holder contracts and producer contracts may not be consolidated on the same form. Upon CCC approval, a new contract number will be issued. If a party succeeds to a tobacco producer contract, the party must certify on form AD–1026, ‘‘Highly Erodible Land Conservation (HELC) and Wetland Conservation (WC) Certification’’ to the understanding of the conservation compliance requirements under USDA programs. It is not necessary to complete this form if a previously filed AD–1026 is on file with USDA and there has not been a change in the farming operation or the persons affiliated with the operation from what was previously reported. The successor must also complete a SF–1199A, ‘‘Direct Deposit Sign Up SUPPLEMENTARY INFORMATION: E:\FR\FM\27JNN1.SGM 27JNN1

Agencies

[Federal Register Volume 70, Number 122 (Monday, June 27, 2005)]
[Notices]
[Pages 36917-36919]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-3323]


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

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 04-085-3]


Monsanto Co. and Forage Genetics International; Availability 
Determination of Nonregulated Status for Alfalfa Genetically Engineered 
for Tolerance to the Herbicide Glyphosate

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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

SUMMARY: We are advising the public of our determination that the 
Monsanto Company and Forage Genetics International alfalfa lines 
designated as events J101 and J163, which have been genetically 
engineered for tolerance to the herbicide glyphosate, are no longer 
considered regulated articles under our

[[Page 36918]]

regulations governing the introduction of certain genetically 
engineered organisms. Our determination is based on our evaluation of 
data submitted by Monsanto Company and Forage Genetics International in 
their petition for a determination of nonregulated status, our analysis 
of other scientific data, and comments received from the public in 
response to a previous notice announcing the availability of the 
petition for nonregulated status and an environmental assessment. This 
notice also announces the availability of our written determination 
document and our finding of no significant impact.

EFFECTIVE DATE: June 14, 2005.

ADDRESSES: You may read the petition for a determination of 
nonregulated status submitted by Monsanto Company and Forage Genetics 
International, the environmental assessment, all comments received on 
the petition and the environmental assessment, the determination, and 
the finding of no significant impact with attached response to comments 
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.
    You may view APHIS documents published in the Federal Register and 
related information on the Internet at http://www.aphis.usda.gov/ppd/
rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. Virgil Meier, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-3363. To obtain copies of the petition, the 
determination, the environmental assessment, or the finding of no 
significant impact, contact Ms. Ingrid Berlanger, at (301) 734-4885; e-
mail: ingrid.e.berlanger@aphis.usda.gov. Those documents are also 
available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/
04_11001p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/04_
11001p_ea.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 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 April 16, 2004, APHIS received a petition (APHIS petition number 
04-110-01p) from Monsanto Company of St. Louis, MO, and Forage Genetics 
International of West Salem, WI (Monsanto/FGI), requesting a 
determination of nonregulated status under 7 CFR part 340 for alfalfa 
(Medicago sativa L.) designated as events J101 and J163, which have 
been genetically engineered for tolerance to the herbicide glyphosate. 
The Monsanto/FGI petition states that the subject alfalfa should not be 
regulated by APHIS because it does not present a plant pest risk.
    On November 24, 2004, APHIS published a notice in the Federal 
Register (69 FR 68300-68301, Docket No. 04-085-1) announcing that the 
Monsanto/FGI petition and an environmental assessment were available 
for public review and soliciting comments for 60 days ending January 
24, 2005. The notice also discussed the role of APHIS, the 
Environmental Protection Agency, and the Food and Drug Administration 
in regulating the subject alfalfa and products developed from it. In a 
subsequent notice, APHIS extended the comment period until February 17, 
2005 (see 70 FR 5601-5602, Docket No. 04-085-2, published February 3, 
2005).
    APHIS received 663 comments by the close of the extended comment 
period. Comments came from alfalfa growers and seed producers, organic 
growers, animal producers, growers associations, consumer groups, 
agriculture support industries, university professionals, and private 
citizens. Five hundred twenty respondents did not support granting 
nonregulated status to the events identified in the petition, while 137 
supported the petition. The majority of the alfalfa growers and seed 
producers who submitted comments supported granting nonregulated status 
to alfalfa events J101 and J163, citing market demand for a weed-free 
product and stating that glyphosate tolerant alfalfa offered a tool to 
meet that demand. The majority of those academic professionals, 
agricultural support industries, and growers associations that 
submitted comments also supported the petition. Those commenters who 
did not support the petition raised concerns that certain domestic and 
foreign markets may be closed to growers who cannot guarantee a non-
genetically engineered product. Organic growers generally opposed the 
petition because of concerns that pollination of their crops by the 
glyphosate tolerant variety will result in the inadvertent generation 
of unwanted genetically engineered products, resulting in market loss.
    APHIS has carefully considered these comments and suggestions, and 
a response to the issues raised in the comments is included as an 
attachment to the finding of no significant impact.
    Alfalfa events J101 and J163 have been genetically engineered to 
express a 5-enolpyruvyshikimate-3-phosphate synthase protein from 
Agrobacterium sp. strain CP4 (CP4 EPSPS), which confers tolerance to 
the herbicide glyphosate. Expression of the added genes is controlled 
in part by the 35S promoter derived from the plant pathogen figwort 
mosaic virus. The Agrobacterium tumefaciens transformation method was 
used to transfer the added genes into the proprietary alfalfa line 
R2336.
    Alfalfa events J101 and J163 have been considered regulated 
articles under the regulations in 7 CFR part 340 because they contain 
gene sequences from plant pathogens. In the process of reviewing the 
notifications for field trials of the subject alfalfa, APHIS determined 
that the vectors and other elements 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.

Determination

    Based on its analysis of the data submitted by Monsanto/FGI, a 
review of other scientific data, field tests of the subject alfalfa, 
and comments submitted by the public, APHIS has determined that alfalfa 
events J101 and J163: (1) Exhibit no plant pathogenic properties; (2) 
are no more likely to become weedy than the nontransgenic parental line 
or other cultivated alfalfa; (3) are unlikely to increase the weediness 
potential of any other cultivated or wild species with which it can 
interbreed; (4) will not cause damage to raw or processed agricultural 
commodities; (5) will not harm threatened or endangered species or 
organisms that are beneficial to agriculture; and (6) should not reduce

[[Page 36919]]

the ability to control pests and weeds in alfalfa or other crops. 
Therefore, APHIS has concluded that the subject alfalfa and any progeny 
derived from hybrid crosses with other non-transformed alfalfa 
varieties will be as safe to grow as alfalfa varieties in traditional 
breeding programs that are not subject to regulation under 7 CFR part 
340.
    The effect of this determination is that Monsanto/FGI alfalfa 
events J101 and J163 are no longer considered regulated articles under 
APHIS' regulations in 7 CFR part 340. Therefore, the requirements 
pertaining to regulated articles under those regulations no longer 
apply to the subject alfalfa or its progeny. However, importation of 
J101 and J163 alfalfa and seeds capable of propagation are still 
subject to the restrictions found in APHIS' foreign quarantine notices 
in 7 CFR part 319 and imported seed regulations in 7 CFR part 361.

National Environmental Policy Act

    An environmental assessment was prepared to examine any potential 
environmental impacts associated with the determination of nonregulated 
status for the subject alfalfa events. The environmental assessment 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). Based on that environmental assessment, 
APHIS has reached a finding of no significant impact with regard to the 
determination that Monsanto/FGI J101 and J163 alfalfa events and lines 
developed from them are no longer regulated articles under its 
regulations in 7 CFR part 340. Copies of the environmental assessment 
and the finding of no significant impact are available from the 
individual listed under FOR FURTHER INFORMATION CONTACT.

    Authority: 7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR 
2.22, 2.80, and 371.3.

    Dated: Done in Washington, DC, this 21st day of June 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E5-3323 Filed 6-24-05; 8:45 am]
BILLING CODE 3410-34-P