Fed. Reg. Proposed Rules — Extension of approval of a…

Agency: Animal and Plant Health Inspection Service, USDA
Action: Extension of approval of an information collection; comment request
Citation: 70 FR (No. 18) · FR Doc. 05-1616 · Docket No. 04-135-1

Summary

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection for self-certification medical statements.

Dates

We will consider all comments that we receive on or before March 29, 2005.

Supplementary Information

Title: Self-Certification Medical Statement. OMB Number: 0579-0196. Type of Request: Extension of approval of an information collection. Abstract: The Marketing and Regulatory Programs (MRP) agencies of the U.S. Department of Agriculture facilitate the domestic and international marketing of U.S. agricultural products and protect the health of domestic animal and plant resources. The MRP agencies are the Agricultural Marketing Service (AMS), the Animal and Plant Health Inspection Service (APHIS), and the Grain Inspection, Packers and Stockyards Administration (GIPSA). Resource management and administrative services, including human resource management, for the three MRP agencies are provided by the MRP Business Services unit of APHIS, which is the lead agency in providing administrative support for MRP. In accordance with 5 CFR part 339, Federal agencies are authorized to obtain medical information from applicants for positions that have approved medical standards. Medical standards may be established for positions for which the duties are arduous or hazardous or require a certain level of health status or fitness. Certain positions in MRP agencies have medical standards. An example of such a position is the agricultural commodity grader position in AMS. Each year, AMS hires a number of agricultural commodity graders. These employees work under dusty conditions, around moving machinery and slippery surfaces, and in areas with high noise levels. They have direct contact with meat and dairy products, fresh and processed fruits and vegetables, and poultry products intended for human consumption or cotton and tobacco products intended for human use. The MRP agencies require a self-certification statement from applicants for these positions regarding their fitness for the positions. The MRP agencies need this information to determine whether the applicants can perform the duties of the positions. Inability to collect this information would adversely affect the MRP agencies' ability to recruit and hire qualified individuals and carry out their missions. We are asking the Office of Management and Budget (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 information collection, 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 information collection 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 0.1666 hours per response. Respondents: Applicants for MRP positions with approved medical standards. Estimated annual number of respondents: 300. Estimated annual number of responses per respondent: 1. Estimated annual number of responses: 300. Estimated total annual burden on respondents: 50 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 24th day of January 2005. Elizabeth E. Gaston, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E5-329 Filed 1-27-05; 8:45 am] BILLING CODE 3410-34-P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. 04-051-1] Syngenta Seeds, Inc.; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Cotton Genetically Engineered for Insect Resistance 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 Syngenta Seeds, Inc., seeking a determination of nonregulated status for cotton designated as transformation Event COT102, which has been genetically engineered for insect resistance. 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 public comments on whether this cotton 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 March 29, 2005. ADDRESSES: You may submit comments by any of the following methods: • EDOCKET: Go to 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. 04-051-1, 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. 04-051-1. • E-mail: Address your comment to . Your comment must be contained in the body of your message; do not send attached files. Please include your name and address in your message and “Docket No. 04-051-1” on the subject line. Reading Room: You may read the petitions, the environmental assessment, and 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, including the names of groups and individuals who have commented on APHIS dockets, on the Internet at . FOR FURTHER INFORMATION CONTACT: Dr. Margaret Jones, Biotechnology Regulatory Services, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-4880. To obtain copies of the petition or the environmental assessment, contact Ms. Terry Hampton at (301) 734-5715; e-mail: . The petition and the EA are also available on the Internet at and . 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 § 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 June 4, 2003, APHIS received a petition (APHIS Petition Number 03-155-01p) from Syngenta Seeds, Inc., (Syngenta) of Research Triangle Park, NC, requesting a determination of nonregulated status under 7 CFR part 340 for cotton ( Gossypium hirsutum L.) designated as transformation Event COT102, which has been genetically engineered for selective lepidopteran insect resistance. The Syngenta petition states that the subject cotton should not be regulated by APHIS because it does not present a plant pest risk. As described in the petition, Event COT102 cotton has been genetically engineered to contain an insecticidal vip3A(a) gene derived from Bacillus thuringiensis (Bt) strain AB88 under the control of the actin-2 promoter derived from Arabidopsis thaliana, which confers expression of the VIP3A(a) protein throughout the plant with the exception of the fiber. Event COT102 cotton also contains the selectable marker gene aph4 derived from Escherichia coli. The aph4 gene encodes the enzyme hygromycinB phosphotransferase and its expression is controlled by the ubiquitin-3 promoter from A. thaliana. Agrobacterium-mediated gene transfer was used to transfer the added genes into the recipient Coker 312 cotton variety. The petitioner states that while the VIP3A protein shares no homology with known Cry proteins, testing has shown that VIP3A is similarly specific in toxicity only to the larvae of certain lepidopteran species. However, the VIP3A apparently targets a different receptor than the Cry1 proteins in sensitive species and therefore may be useful in the management of pest resistance. Event COT102 has been considered a regulated article under the regulations in 7 CFR part 340 because it contains gene sequences from the plant pathogen Agrobacterium tumefaciens. This cotton event has been field tested since 2000 in the United States under APHIS notifications. In the process of reviewing the notifications for field trials of the subject cotton, APHIS determined that the vector was 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. In § 403 of the Plant Protection Act (7 U.S.C. 7701-7772), 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 very broadly. The definition covers direct or indirect injury, disease, or damage not just to agricultural crops, but also to plants in general, for example, native species, as well as to organisms that may be beneficial to plants, for example, honeybees, rhizobia, etc. 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 by EPA regulation. In cases in which genetically modified plants allow for a new use of a pesticide or involve a different use pattern for the pesticide, EPA must approve the new or different use. Accordingly, Syngenta has submitted a request for commercial registration of VIP3A as a plant-incorporated protectant. When the use of the pesticide on the genetically modified plant would result in an increase in the residues in a food or feed crop for which the pesticide is currently registered, or in new residues in a crop for which the pesticide is not currently registered, establishment of a new tolerance or a revision of the existing tolerance would be required. Residue tolerances for pesticides are established by EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended (21 U.S.C. 301 et seq. ), and the Food and Drug Administration (FDA) enforces tolerances set by EPA under the FFDCA. Syngenta has submitted a request to EPA for a tolerance exemption for both the VIP3A and APH4 proteins as expressed in the subject cotton event. Subsequently, EPA granted a time-limited exemption from tolerance for the VIP3A protein and an exemption from tolerance for residues of the APH4 protein. FDA published a statement of policy on foods derived from new plant varieties in the Federal Register on May 29, 1992 (57 FR 22984 23005). The FDA statement of policy includes a discussion of FDA's authority for ensuring food safety under the FFDCA, and provides guidance to industry on the scientific considerations associated with the development of foods derived from new plant varieties, including those plants developed through the techniques of genetic engineering. Syngenta has begun consultation with FDA on the subject cotton event. To provide the public with documentation of APHIS' review and analysis of the environmental impacts and plant pest risk associated with a proposed determination of nonregulated status for Syngenta's Event COT102 cotton, an environmental assessment has been prepared. The EA was prepared in accordance with (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq. ), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372). In accordance with § 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 persons for a period of 60 days from the date of this notice. We are also soliciting written comments from interested persons on the environmental assessment prepared to examine any environmental impacts of the proposed determinations for the subject cotton event. The petition and the environmental assessment and any comments received are available for public review, and copies of the petitions and the environmental assessment 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 environmental assessment 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 Syngenta's insect-resistant cotton event COT102 and the availability of APHIS' written decision. Authority: 7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3. Done in Washington, DC, this 19th day of January 2005. Elizabeth E. Gaston, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E5-328 Filed 1-27-05; 8:45 am] BILLING CODE 3410-34-P DEPARTMENT OF AGRICULTURE Food and Nutrition Service Agency Information Collection Activities: Proposed Collection; Comment Request—Feasibility of Computer Matching in the National School Lunch Program AGENCY: Food and Nutrition Service, Department of Agriculture. ACTION: Notice. SUMMARY: In accordance with the Paperwork Reduction Act of 1995, this notice announces the Food and Nutrition Service's intention to request Office of Management and Budget approval of a new information collection from State Child Nutrition (CN), Education, and Medicaid agencies, as well as School Food Authorities (SFAs). The study will collect information to examine the feasibility of using computer matching in the National School Lunch Program (NSLP) to help improve program integrity and operational efficiency. DATES: Written comments on this notice must be received by March 29, 2005, to be assured of consideration. ADDRESSES: Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to Alberta Frost, Director, Office of Analysis, Nutrition, and Evaluation, Food and Nutrition Service, Department of Agriculture, 3101 Park Center Drive, Room 1014, Alexandria, VA 22302. All responses to this notice will be summarized and included in the request for Office of Management and Budget (OMB) approval of the information collection. All comments will also become a matter of public record. FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of the proposed information collection forms should be directed to Alberta Frost at (703) 305-2017. SUPPLEMENTARY INFORMATION: Title: Feasibility of Computer Matching in the National School Lunch Program. OMB Number: Not yet assigned. Expiration Date: Not applicable. Type of Request: New collection of information. Abstract: The Food and Nutrition Service (FNS) is seeking to improve the process by which SFAs determine and verify the children eligible for free and reduced-price school meals. Recent studies suggest that a significant number of ineligible children are being approved for free and reduced-price meals. Congress expressed concern about these issues in the Child Nutrition and WIC Reauthorization Act of 2004 (Pub. L. 108-265) (the Act). Section 105(a) requires USDA to conduct a study on the feasibility of using computer technology to reduce errors, waste, fraud, and abuse in the NSLP. The study will collect and analyze data through mail surveys of all states and in-depth telephone interviews with six selected States to: Assess current and planned use of computer matching for NSLP certification and application verification; identify benefits, challenges, and barriers to computer matching; collect information on statewide student information systems and education matches with Medicaid and wage data; and identify the types of information maintained by the Medicaid program that could be useful for NSLP certification and verification. Estimate of Burden: The public reporting burden for the survey of State CN Program directors is estimated at 40 minutes for the mail survey. The public reporting burden for the survey of State Education Agency (SEA) liaisons to the National Center for Education Statistics (NCES) is estimated to be 15 minutes for the mail survey. The public reporting burden for the survey of State Medicaid Directors is estimated to be 30 minutes for the mail survey. For the in-depth telephone interviews, the burden estimates per respondent in each of the six States are: State CN officials, 60 minutes; State Student Information Systems administrators, 60 minutes; State Food Stamp Program (FSP) agency officials, 60 minutes; State Medicaid agency officials, 60 minutes; State Wage Information Collection Agency (SWICA) officials, 60 minutes; and SFA administrators, 60 minutes. Respondents: Respondents for the mail survey are State CN Directors, SEA NCES liaisons, and State Medicaid Directors. Respondents for the in-depth telephone interviews include: State CN officials; State Student Information Systems administrators; State FSP agency officials; State Medicaid agency officials, SWICA officials, and SFA administrators. Estimated Number of Respondents: Mail surveys will be conducted with 51 State CN Program Directors, 51 SEA NCES liaisons, and 51 State Medicaid Directors. In-depth telephone interviews will be conducted with: 12 State CN agency officials; 12 State Student Information Systems administrators; 12 State FSP agency officials; 12 State Medicaid agency officials; 12 SWICA officials; and 12 SFA administrators. Number of Responses per Respondent: One response per respondent per data collection effort. Estimated Time per Response: Respondents Number Minutes Total minutes State CN Directors: Mail Survey 51 40 2,040 SEA NCES Liaisons: Mail Survey 51 15 765 State Medicaid Directors: Mail Survey 51 30 1,530 State CN Officials: Telephone Interview 12 60 720 State Student Information System Administrators: Telephone Interview 12 60 720 State FSP Officials: Telephone Interview 12 60 720 State Medicaid Officials: Telephone Interview 12 60 720 SWICA Officials: Telephone Interview 12 60 720 SFA Administrators: Telephone Interview 12 60 720 Total Respondent Burden 8,655 Estimated Total Annual Burden on Respondents: 144 hours. Dated: January 21, 2005. Roberto Salazar, Administrator. [FR Doc. 05-1616 Filed 1-27-05; 8:45 am]

Proposed Rules. Extension of approval of an information collection; comment request

Summary

Dates

Supplementary Information