|Over the years, FSIS has received a number of requests from industry, lawyers, academia, and other Federal agencies for isolates from bacteria recovered from sampled meat, poultry, and egg products and from samples of the environment in which these products were produced. FSIS policy has been to deny isolates to the general public, although it has shared isolates with other Federal government laboratories such as those of the Agricultural Research Service and the Department of Defense.
Despite the Agency's consistent denial of isolates, requests have continued to come in at a low but persistent level. Frequently these requests have been accompanied by arguments as to why it would be in the public interest to share isolates. Because FSIS receives no funds to provide isolates to the public, and because FSIS has no means to recoup its costs, FSIS has simply denied the requests. Controversy about the Agency's refusal has resulted.
To try and resolve this issue, FSIS has decided to institute a pilot program under which it will make isolates available to requesters under the circumstances set out below. Because FSIS will need to support this pilot out of its general budget, however, this program is subject to cancellation without notice at the discretion of the Administrator. Factors that may lead the Administrator to cancel the program include number of requests, costs, laboratory time, or other demands on Agency resources.
Therefore, beginning February 1, 2005:
- Anyone may request a specific isolate. To do so, the requestor will need to submit a signed statement that:
- Describes the isolate. It will not be possible to provide multiple or duplicate isolates because of the expenses.
- Explains who the requestor is;
- Explains why it is in the interest of the public health to provide the isolate to the requestor;
- Designates a laboratory that meets biosafety level (BSL) 2 to receive the isolate. The requestor will also need to document and certify that the designated laboratory meets the requirements established by the Centers for Disease Control and Prevention for interstate shipment of etiologic agents ( http://www.cdc.gov/od/ohs/biosfty/shipregs.htm) and by the National Institutes of Health for biosafety in microbiological and biomedical laboratories ( http://bmbl.od.nih.gov). The requestor will also be expected to certify that it will not share the isolate with any other person or entity. Failure to adhere to these certifications could subject the requestor to criminal prosecution for making false statements to the U.S. government.
- Decisions on requests will be made on a case-by-case basis by the Assistant Administrator of the Office of Public Health Science or his/her delegate.
- If FSIS decides to grant a request for an isolate, the requestor will bear the cost of shipment of the isolate to the laboratory that it designated. The requestor should contact Dr. Pat Basu, Office of Public Health Science, via e-mail at IsolatesPilot@fsis.usda.gov to make these arrangements. OPHS will expect the requestor to make provision so that the isolate is properly handled in shipment (see, e.g., the regulations of the Animal and Plant Health Inspection Service on shipment of isolates, 9 CFR Part 122).
- FSIS will defer releasing an isolate until all pending FSIS regulatory actions involving the isolate are complete.
- The Agency will not change any regulatory findings based on results obtained by a requestor from testing a supplied isolate. The Agency may, however, reconsider its procedures on the basis of those results to assess whether any changes in methodology are appropriate.
- After one year, if this pilot has not been terminated, FSIS will assess the costs and benefits of the pilot to decide whether to continue it.