Animal and Plant Health Inspection Service, USDA.
We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment and reached a finding of no significant impact for confined field tests of rice plants genetically engineered to express the protein lactoferrin. The environmental assessment provides a basis for our conclusion that these field tests will not present a risk of introducing or disseminating a plant pest and will not have a significant impact on the quality of the human environment. Based on its finding of no significant impact, the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared for these field tests.
Effective Date: June 21, 2005.
You may read the environmental assessment, the finding of no significant impact, and any comments that we received on Docket No. 05-006-1 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.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Dr. Levis Handley, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-5721. To obtain copies of the environmental assessment, contact Ms. Ingrid Berlanger, at (301) 734-4885; email firstname.lastname@example.org. The environmental assessment and finding of no significant impact are also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/05 _11701r_ea.pdf.End Further Info End Preamble Start Supplemental 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.” 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 into the environment of a regulated article.
On October 28, 2004, the Animal and Plant Health Inspection Service (APHIS) received a permit application (APHIS permit number 04-302-01r) from Ventria Bioscience, Sacramento, CA, for a permit for a confined field planting of rice (Oryza sativa) plants genetically engineered to express a gene coding for the protein lactoferrin, rice line LF164-12. The application was for a field trial in Scott County, MO. On February 23, 2005, APHIS published a notice in the Federal Register (70 FR 8763, Docket No. 05-006-1) announcing the availability of an environmental assessment (EA) for this confined field planting. The 30-day comment period ended on March 25, 2005.
On April 27, 2005, while APHIS was evaluating these comments, we received a request from Ventria Bioscience to plant rice line LF164-12 in a second site in Washington County, NC (APHIS permit number 05-117-01r). Because many of the issues are similar for the two field tests, APHIS chose to extend the comment period to gather additional comments that specifically address any new issues that may exist for the North Carolina location. On May 13, 2005, APHIS published a second Federal Register notice (70 FR 25521-25522, Docket No. 05-006-2) extending the comment period on Docket No. 05-006-1 for a period of 20 days.
APHIS has considered the comments from both comment periods and the comments received during the intervening period. APHIS received 676 comments. Comments were received from rice growers, rice marketing and processing groups, agricultural support businesses, consumer groups, university professionals, private individuals, industry trade organizations, large rice purchasers, Federal, State and local government representatives, and growers of crops other than rice. Five hundred eighty-six respondents did not support the issuance of a permit for a field trial of rice expressing lactoferrin. Forty-eight commenters did support granting a permit for a field trial for rice that expresses lactoferrin. Two commenters provided information only and conveyed no opinion on the proposed field trial. The remaining 40 comments were duplications of submitted comments. Start Printed Page 37080
The majority of the commenters expressed concern that rice from this field trial may inadvertently become mixed with rice intended for food or feed use. Commenters were concerned that birds, mammals, water, or human error might move small amounts of rice from the permitted field into commercially grown rice or rice products. Commenters also suggested that hybridization may occur with weedy rice types and allow the lactoferrin gene to persist in the environment. Commenters also focused on potential market loss for commercial rice if genetically engineered rice were to be grown in the same geographic area. Several of these commenters also expressed concern for food safety if this rice were incorporated in general commodity rice. Supporters of the field trial commented on the safety of the trial, the closed production design for the field trial, and the economic and health benefits that could result from the production of rice that expresses lactoferrin.
APHIS evaluated the impacts on the human environment in the EA, and we have responded to comments in an attachment to the finding of no significant impact (FONSI), which is available as indicated under the heading, FOR FURTHER INFORMATION CONTACT. Between the close of the previous comment period and the publication of this notice, Ventria Bioscience has withdrawn its application to conduct a field test in Scott County, MO. However, because many of the issues in Missouri are similar to those in North Carolina and the public expressed a great deal of interest in the Missouri test site, APHIS has addressed the comments from both Federal Register notices in an attachment to the FONSI.
The subject rice plants have been genetically engineered, using micro-projectile bombardment, to express human lactoferrin protein. Expression of the gene is controlled by the rice glutelin1 promoter, the rice glutelin 1 signal peptide, and the NOS (nopaline synthase) terminator sequence from Agrobacterium tumefaciens. The gene is expressed only in the endosperm. In addition, the plants contain the coding sequence for the gene hygromycin phosphotransferase (hpt), an enzyme which confers tolerance to the antibiotic hygromycin. This gene is a selectable marker that is only expressed during plant cell culture and is not expressed in any tissues of the mature plant. Expression of the gene is controlled by the rice glucanase 9 (Gns 9) promoter and the Rice Alpha Amylase 1A (RAmy1A) terminator.
The genetically engineered rice plants are considered regulated articles under the regulations in 7 CFR part 340 because they contain gene sequences from plant pathogens. The purposes of the field tests are for pure seed production and for the extraction of lactoferrin for a variety of research and commercial products. The planting will be conducted using multiple measures to ensure strict confinement. In addition, the experimental protocols and field plot design, as well as the procedures for termination of the field tests, are designed to ensure that none of the subject rice plants persist in the environment beyond the termination of the experiments.
Pursuant to its regulations in 7 CFR 340, promulgated under the Plant Protection Act of 2000, APHIS has determined that this field trial will not pose a risk of the introduction or dissemination of a plant pest for the following reasons:
1. The field trial is confined. Regulated articles are not likely to be removed from the field site through transport by water or animals. Accidental transport of regulated articles from the site by humans is minimized by strict standard operating procedures and permit conditions.
2. Rice is predominately self-fertilizing, has short pollen viability, and the sites are several miles from commercial rice crops. Therefore, it is extremely unlikely that cross-pollination could occur with commercial rice.
3. The nos sequence is from the soil-inhabiting bacterial plant pathogen, Agrobacterium sp. and does not encode a protein. It does not cause plant disease and has a history of safe use in a number of genetically engineered plants (e.g., rice, corn, cotton and soybean varieties). The regulatory sequences from rice are the Gns9 promoter, Gt1 promoter, gt1 signal peptide, and the RAmyl 1A terminator. None of the DNA regulatory sequences can cause plant disease by themselves or in conjunction with the genes that were introduced into the transgenic rice lines.
4. Lactoferrin is expressed predominantly in seed. Levels of expression in the remainder of the plant are not detectable.
5. Given the history of safe use of lactoferrin supplements in food and oral hygiene products and as nutritional supplements, APHIS concludes that humans are unlikely to be significantly affected by incidental contact with this rice that may occur during this field trial.
6. Based on the lack of toxicity of the proteins that will be produced and the prescribed permit conditions to minimize any seed remaining on the soil surface, APHIS concludes that there will be no significant effect on any native floral or faunal species in Scott County, MO, or Washington County, NC.
The EA and FONSI were 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). Copies of the EA and FONSI are available as indicated under the heading, FOR FURTHER INFORMATION CONTACT.Start Signature
Done in Washington, DC, this 22nd day of June 2005.
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E5-3353 Filed 6-27-05; 8:45 am]
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