Notice of Request for Approval of an Information Collection

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

New information collection; comment request.

SUMMARY:

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to initiate the Bluetongue Surveillance Pilot Project sentinel trial, which will be an information collection activity. The purpose of the sentinel trial, which will be voluntary, is to support international export trade through the identification and development of an economically feasible and highly representative surveillance system to substantiate the regionalization of the United States for bluetongue. The sentinel trial will take place on farms in Montana, Nebraska, North Dakota, and South Dakota.

DATES:

We invite you to comment on this docket. We will consider all comments that we receive by January 2, 2001.

ADDRESSES:

Please send four copies (an original and three copies) of your comment to: Docket No. 00-099-1, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03, 4700 River Road, Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 00-099-1.

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.

APHIS documents published in the Federal Register, and related information, including the names of organizations and individuals who have commented on APHIS dockets, are available on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT:

For information on the Bluetongue Surveillance Pilot Program sentinel trial, contact Ms. Marj Swanson, Management Analyst, Centers for Epidemiology and Animal Health, VS, APHIS, 555 S. Howes, Fort Collins, CO 80521; (970) 490-7978. 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: Bluetongue Surveillance Pilot Program.

OMB Number: 0579-XXXX.

Type of Request: Approval of a new information collection.

Abstract: The United States Department of Agriculture is responsible for protecting the health of our Nation's animals and poultry by preventing the spread of contagious, infectious, or communicable animal diseases from one State to another and by eradicating such diseases from the United States when feasible. In connection with this mission, the Animal and Plant Health Inspection Service (APHIS), Veterinary Services, Center for Animal Health Monitoring, is requesting approval to initiate the Bluetongue Surveillance Pilot Program (BSPP) sentinel trial information collection activity.

Bluetongue viruses are transmitted by blood-feeding midges (Culicoides spp.), which breed in cattle manure and transmit the viruses between hosts, which include antelope, cattle, deer, elk, goats, and sheep. Cattle are infected naturally by these viruses but rarely show clinical signs. However, sheep and other ruminants show signs of the disease, including abortion, birth defects, emaciation, ulcers in the digestive system and mouth, lameness, pneumonia, and death. Twenty-four serotypes of bluetongue virus are distributed throughout the tropical and temperate regions of the world; except for Greece and Italy on occasion, Europe is bluetongue virus-free. The viruses and vectors (insects) have evolved to establish well-defined regional complexes of selected serotypes adapted to specific midge populations. In the United States, four serotypes of bluetongue virus are known to occur; however, their range is restricted to Western and Southern States. This is the result of climatic and ecologic conditions that determine the distribution of the North American vector, Culicoides sonorensis.

Bluetongue is an Office International des Epizooties (OIE) List A disease. The criteria for inclusion on this list are transmissibility, potential for serious and rapid spread, and major economic importance in the international trade of animals and animal products. For these reasons, countries, especially those entirely free of bluetongue, take action to minimize the risk of introducing exotic serotypes of the virus, thus restricting trade. These restrictions are estimated to cost the United States $125 million annually (USDA Agricultural Research Service, 1999).

The current method of bluetongue surveillance tests blood samples taken from animals at the time of slaughter through the APHIS Market Cattle Identification (MCI) system. Every 2 years, slaughter samples are tested from 18 Northeastern and North Central States, Alaska, Hawaii, and western Washington, which are considered to be free of bluetongue. In the MCI slaughter survey in 1996, 9,053 slaughter samples were tested. Four of the 14 geographic areas sampled had 2 percent or greater positive samples, which exceeds the OIE standard and leads to restrictions on the export of animals from those areas. Slaughter surveillance as the method for bluetongue surveillance has limited specificity and geographic representativeness with regard to the demands of international trade. Detection of low levels of bluetongue antibody may reflect animal movement rather than disease occurrence at the sampling locations, as the life history of the animals sampled is unknown.

The purpose of the BSPP sentinel trial is to support international export trade through the identification and development of an economically feasible and more representative surveillance system to substantiate the regionalization of bluetongue. The BSPP sentinel trial is a surveillance methodology development activity. In the surveillance trial, specific sentinel animals and farms will be tested serologically over time in contrast to the randomized on-farm and slaughter market surveillance currently practiced. Neither one-time, on-farm nor slaughter market surveillance allows animals to be tracked over time, and the geographic history of the origin of the animals is difficult to establish with consistent reliability.

The Center for Animal Health Monitoring is proposing the BSPP sentinel trial, which will use active serosurveillance, adult insect trapping, and soil sampling for insect larvae from suspect vector breeding sites. The objectives of this study include: (1) Develop a pilot sentinel system as a tool to substantiate disease freedom and compare it to other surveillance options; (2) test for bluetongue status in two demarcated populations (free and infected); and (3) develop data on the epidemiology of bluetongue in a seasonally infected area.

The ideal choice of States is a contiguous north-south group, (e.g., Montana, North Dakota, South Dakota, and Nebraska) that transects the border between the disease-free (North Dakota) and the seasonally affected zone (Montana and Nebraska) with a transitional State (South Dakota) having both free and infected zones. This provides a continuous gradient of environmental determinants of vector distribution that can be measured when moving from north to south.

The Sanitary and Phytosanitary Agreement of the World Trade Organization provides that countries can create disease-free and low-prevalence zones. Determination of such areas must be based on factors such as geography, ecosystems, epidemiological surveillance, and the effectiveness of sanitary and phytosanitary controls. Further, it is up to the exporting country to develop a regionalization proposal with sufficient information to substantiate zoning for a disease. The importing country is charged with reviewing the proposal and providing a transparent and science-based decision. In the case of bluetongue, a vector-borne disease, it is largely the ecology of the vector that determines the distribution of the disease.

The potential benefits to trade from better bluetongue surveillance include access to new export markets and preservation of existing markets through increased confidence in disease freedom.

Information from this study will be disseminated and used by livestock producers, animal health officials, private veterinary practitioners, animal industry groups, policymakers, public health officials, the media, educational institutions, and others to improve agricultural productivity and competitiveness.

Participation in the BPSS sentinel trial is voluntary, and all data are confidential.

We are asking the Office of Management and Budget (OMB) to approve the use of this information collection activity.

The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning this 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 .93814 hours per response.

Respondents: Industry personnel, private veterinary practitioners, company and independent producers, academicians, State veterinary medical officers, and State public health officials.

Estimated annual number of respondents: 1,365.

Estimated annual number of responses per respondent: 1.06593.

Estimated annual number of responses: 1,455.

Estimated total annual burden on respondents: 1,373 hours. (Due to rounding, the total annual burden hours may not equal the product of the annual number of responses multiplied by the average 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.