U.S. Food and Drug Administration
Performance Plan
2002
The continued absence of BSE, commonly known as "Mad Cow Disease," in the U. S.
| Assure 100 percent compliance with the BSE Regulation through inspection and compliance actions. |
BSE belongs to a group of progressive degenerative neurological diseases known as transmissible spongiform encephalopathies (TSEs). TSE diseases are always fatal. There are six TSE diseases that affect humans: kuru, classical Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD), Gerstamann-Straussler-Scheniker syndrome, fatal familial insomnia, and sporadic fatal insomnia.
To protect consumers it is essential that a multi-layered safeguard system be implemented and monitored to ensure that BSE regulations are followed. A final rule (Title 21 Part 589.2000 of the Code of Federal Regulations) implemented by FDA in August 1997, prohibits the feeding of mammalian protein to ruminant animals.
The Animal and Plant Health Inspection Service (APHIS), of the United States Department of Agriculture, has also placed restrictions banning the importation of live ruminants and certain ruminant products from thirty-one countries to prevent BSE from entering the United States. Many products regulated by FDA contain these banned substances and it is important to establish a comprehensive monitoring system to identify products that may pose a health risk and ensure they do not enter the US.
The FDA also needs to consider areas not covered by the APHIS ban such as: ruminant protein-containing cosmetic products that are packaged and ready for sale; bovine-derived materials intended for human consumption as either finished dietary supplement products or for use as ingredients in dietary supplements; vaccines; blood and blood products; human drugs; and human food other than meat, such as gelatins.
The United States has the safest blood supply in the world. FDA continues to strengthen its efforts to protect the nation's blood supply and to minimize the risks from BSE. FDA will continue to conduct research of blood and blood products and develop regulations to minimize the risk of infectious disease.
Active surveillance efforts have yet to identify BSE in the United States. If BSE was to enter the U S, it could pose a serious health risk to humans, and be financially devastating to the United States beef industry. In a recent survey in Germany, more than 50 percent of those polled said they had little or no confidence in the safety of beef products. So far the ensuing crisis in the farm industry has cost British taxpayers more than $6 billion. In the US the cost of lost revenue to the beef industry alone is estimated to reach over $15 billion.
Monitoring imports for bovine products has proven to be challenging. Often banned animal proteins will be shipped to countries with less stringent BSE regulations, re-labeled, and re - exported, obscuring the true country of origin. It is also difficult for inspectors monitoring imports to verify the presence of high-risk tissues in finished dietary supplements, drugs, vaccines, or cosmetic products.
The Agency developed an enforcement plan with the goal of 100 percent compliance with the BSE feed regulations through education, inspections, and compliance actions for egregious actions or repeated noncompliance. In 1998 District Offices were assigned to conduct inspections of 100 percent of all renderers and feed mills to determine compliance. To date, FDA has conducted initial inspections of approximately 84 percent of renderers, 85 percent of the licensed feed mills, that produce medicated animal feeds, and 82 percent of the known unlicensed feed mills. Of these inspections conducted 79 percent were conducted by State officials, and FDA is seeking assistance from State feed control officials to conduct additional inspections and identify non-FDA licensed feed mills.
|
Percentage of Firms Handling Prohibited Material that
are Out of Compliance
|
|||
|---|---|---|---|
| Commingling | Labeling | Records | |
| Renderers |
14%
|
4%
|
3%
|
| FDA Licensed Feed Mills |
13%
|
15%
|
1%
|
| Non-FDA Licensed Feed Mills |
18%
|
33%
|
.04%
|
| Other* |
12%
|
18%
|
3%
|
| * Examples include ruminant feeders, on-farm mixers, haulers, and distributors. | |||
Field offices have been assigned to re-inspect over 800 firms that handle prohibited material that were not in full compliance with the rule. They will also continue to develop and implement an import monitoring program that will capture all products containing high risk products. In January of 2001 FDA issued an import alert to facilitate the detention of high risk products.
FDA has asked all licensed vaccine manufacturers to evaluate all bovine derived material used at any stage in vaccine production. FDA has asked manufacturers to identify the country from which the animals originated, the date the material was obtained, and the date the material was used in the production of vaccines.
The risk of transmission of vCJD in humans by blood or blood products is still considered to be theoretical. Nevertheless, in 1999, as a precautionary measure the FDA issued recommendations for the deferral of blood donors who resided for 6 months or more in the UK between 1980 and 1996. In January 2001, the FDA's Transmissible Spongiform Encephalopathies Committee recommended that the deferral be expanded to include individuals who resided 10 years or more in the Republic of Ireland, Portugal, or France between 1986 and the present.
FDA continues to chair the Interdepartmental Steering Committee for BSE/TSE Affairs. This group includes representatives of CDC, FDA, NIH, USDA, the United States Trade Representative, the Office of Management and Budget, the Customs Service, the Department of State, the Department of Defense, the State Association of Feed Control Officials, the National Association of State Departments of Agriculture, and the White House Office of Science and Technology Policy. The functions of this committee are to assure ongoing coordination between agencies, to integrate contingency planning for the possibility that a case of BSE or of vCJD might be found in the United States, to identify and address potential vulnerabilities in the United States to BSE and vCJD, and to coordinate development and implementation of risk communication plans by the various agencies.
Finally, FDA has worked closely with the CDC, NIH, and the Office of the Secretary to produce a departmental TSE Action Plan that has recently been submitted to the Secretary for his consideration. This Action Plan outlines further expansion of these initiatives to continue to improve the BSE/TSE safety net.