Snippets from GAO-04-259T - BIOTERRORISM: A Threat to Agriculture and the Food Supply

This 11/19/03 GAO document is congressional testimony- it mostly repeats what's in GAO-02-183 (summary).  Here are links to the report in two formats:   PDF file  (169.3KB)   Text File  (42 kB)

The following are snippets I think are important. I've tried to indicate editorial stuff I've added in italic.   Read the full text for details which may be ommitted.


Snippets:
Included in this discussion are our 2002 reports on federal efforts to prevent devastating animal diseases—foot- and-mouth and bovine spongiform encephalopathy (BSE), also known as mad cow—from entering the United States, and our 2003 reports
on security at food-processing facilities and at the ...
 
We also reported that discrepancies in the accuracy of documents provided by the importer posed a risk that BSE-contaminated food might not be flagged for further inspection. Those careful controls over imported foods help prevent pathogens from contaminating American cattle with devastating diseases that have struck many other countries.
    <snip>
As part of our study (report GAO-02-183), we assessed the effectiveness of federal actions to prevent the emergence and spread of BSE and ensure compliance with the animal feed ban.
 We found, among other things, that federal actions could not sufficiently ensure that all BSE-infected animals or products would be kept out of the United States or that if BSE were found, it would be detected promptly and not spread to other cattle through animal feed or enter the human food supply. The United States had imported about 125 million pounds of beef (0.35 percent of total imported) and about 1,000 cattle (0.003 percent of total imported) from countries that later discovered BSE--during the period when BSE would have been incubating. We reported that USDA's and the Food and Drug Administration's (FDA) import inspection capacity had not kept pace with the growth of imports. We also found that the one international bulk mail facility that used the newest technology in scanning equipment that would help inspectors more accurately identify products that could carry BSE was not being used during periods of operation when inspectors were not on duty. We further reported that Customs found discrepancies with the accuracy of importer-provided information and, as a result, BSE-risk imports may go undetected.
We also reported that FDA's enforcement of the feed ban, which was put in place to prevent the spread of BSE if it were found in U.S. cattle, was limited and that FDA inspection data were flawed. FDA had not identified and inspected all firms subject to the ban and had not acted promptly to compel firms to keep prohibited proteins out of cattle feed and to label animal feed that cannot be fed to cattle. FDA's data on inspections of feed facilities were so severely flawed that the agency could not know the full extent of industry compliance.
We noted that, if BSE were found in the United States, the economic impact on the $56 billion beef industry could be devastating--consumers might refuse to buy domestic beef; beef exports could decline dramatically; and sales in related industries, such as hamburger chains and soup and frozen dinner manufacturers, could be similarly affected.
We recommended that USDA and FDA, among other things, develop a coordinated strategy to identify resources needed to increase inspections of imported goods and that FDA strengthen enforcement of the feed ban and its management of inspection data. USDA and FDA agreed with these recommendations. Additional funds were requested and approved to strengthen border inspections. FDA has increased the number of feed-ban compliance inspections, and implemented a new feed-ban inspection data system.


GAO-03-96 Highlights Major Management Challenges and Program Risks: Department of Agriculture
(Sorry there's no link - ! could not find DPF of full report)
 USDA has taken steps to address some of the specific performance and management challenges that GAO
 previously identified. However, a variety of challenges continue, including a significant expansion of the one
 involving ...
 Hightlights 66.1KB   Text file - 88.5KB

FOOD SAFETY Controls Can Be Strengthened to Reduce the Risk of Disease Linked to Unsafe Animal ...
Report to the Honorable Richard J. Durbin, United States Senate September 2000
http://www.gao.gov/new.items/rc00255.pdf - 355.5KB - GAO Reports - rc00255: 9

In 1997, FDA issued a regulation to prevent BSE in the United States.  To assess compliance with this regulation, FDA and state inspectors have visited over 9,100 firms, such as farms that produce their own feed and rendering plants that process meat scraps for animal feed. Inspectors found that, among other things, nearly 1,700 firms were not aware of the regulation and thus could produce or use animal feed that was not in compliance.  FDA officials also told us that the agency is developing a regulation to further strengthen controls over bacterial and other contaminants by, among other things, directing feed manufacturers to determine which hazards pose the greatest risks to the safety of their products and to establish controls to minimize these risks. However, FDA has not set time frames for completing this regulation. In addition, the Department of Transportation has not issued regulations to ensure the safe transportation of animal feed, as directed by the Sanitary Food Transportation Act of 1990.

Re: the FDA inspections under the Feed Contaminants program:
Most of these inspections are performed by state inspectors, and FDA does not maintain a database on the number of inspections completed or their results.  During fiscal years 1998 and 1999, FDA devoted a total of about 27 staff years to this program.

FDA issued a new regulation in June 1997 that prohibits the feeding of certain proteins derived from mammals to ruminant animals, such as cattle......
From January 1998 through January 2000, FDA and state inspectors inspected over 9,100 firms to increase industry awareness of this regulation. FDA told us the primary purpose of these inspections was to educate the industry about the new required procedures. According to FDA, it took only limited enforcement actions against firms that were not in full compliance with the new regulation.

From page 11 of  the report:

The BSE inspection results revealed that 1,688 of the 9,184 firms were not aware of the new BSE feed regulation.  Furthermore, inspection results of the 2,481 firms that were identified as handling “prohibited” material- material that is not allowed to be fed to ruminants—revealed some seriousdeficiencies.

• Required cautionary statement not on product label. Of the firms inspected, 699, or 28 percent, did not label their products with the required cautionary statement that the feed should not be fed to cattle or other ruminants.
• Required records not properly maintained. One-hundred and thirty-seven firms, or about 6 percent, did not properly maintain the name and address of the consignee of their products, which would make it difficult to trace sales of contaminated feed.
• In addition, of the 1,771 firms that manufacture both prohibited and nonprohibited material, 361, or 20 percent, did not have a system in place to prevent commingling and cross-contamination, as required by the regulation.

Because renderers and FDA-licensed feed mills are at the greatest risk of introducing BSE to a wide segment of the animal feed market, the inspection results for these firms were particularly disturbing. For example,
• Twenty-three of the 211 renderers inspected, about 11 percent, were not aware of the BSE regulation.
• Twenty-seven of the 163 renderers that handle prohibited material, about 17 percent, did not label their products with the required cautionary statement.
• Ten of the 63 renderers that manufacture both prohibited and nonprohibited material, about 16 percent, did not have a system in place to prevent commingling.

The results for the FDA-licensed feed mills were similar. For example,
• Sixty-three of the 1,023 mills, about 6 percent, were not aware of the regulation.
• Eighty-five of the 409 mills that handle prohibited material, about 21 percent, did not label their products with the required cautionary statement.
• Thirty-seven of the 300 mills that manufacture both prohibited and nonprohibited material, about 12 percent, did not have a system in place to prevent commingling.

FDA told us that as a result of the BSE inspections, two warning letters have been issued and five firms have voluntarily recalled products. (ed:  the GAO's previous description of this as "limited enforcement" is very generous.  The "enforcement seems very puny to me given the risk of BSE from animal feed.)

Conclusion:
Few incidents of human illness in the United States have been linked directly to contaminated animal feed because public health investigations of foodborne illness cannot usually determine if the original source of the contamination is the feed, handling of the product, or another factor. However, the serious deficiencies disclosed by recent feed manufacturerinspections and the potentially major public health and economic consequences that could result from the introduction of contaminants into the feed supply, suggest a need for strong regulatory controls.

Recommendations for Executive Action
To ensure that animal feed in the United States remains free of contaminants that would cause BSE, we recommend that the Commissioner of FDA develop and implement an enforcement strategy that contains specific goals and time frames for establishing a system to correct the deficiencies identified during the agency’s 2 years of inspecting animal feed firms and to ensure that firms in the future continue to remain in compliance with the regulation.
We further recommend that the Commissioner establish a schedule for completing the agency’s HACCP-based approach for ensuring the safety of animal feeds. To ensure the safe transportation of animal feed, we recommend that the President’s Council on Food Safety work with the Department of Transportation and FDA, among others, to develop a strategy to regulate animal feed while in transport.

Agency Comments
FDA agreed with all three of our recommendations and
stated that it (1) has initiated an enforcement strategy that will correct the deficiencies identified during the initial round of BSE inspections to help ensure a high rate of compliance in the future; (2) has placed issuing the new feed regulation on its priority list; and (3) agreed to cooperate with and assist the President’s Council on Food Safety and the Department of Transportation to develop a strategy for regulating animal feed while it is in transit. With regard to FDA’s response to the first recommendation, while we agree that FDA has initiated an enforcement strategy, we believe that the strategy, which was developed in December 1998, needs to be updated to include specific goals and time frames to correct existing deficiencies and to ensure that firms continue to remain in compliance with the regulation.

ME: For further research:
USDA officials told us, however, that sheep on three farms in Vermont have recently tested positive for a BSE-like disease.  (ed: scrapies?)    These sheep had been imported from Belgium and the Netherlands in 1996.  The USDA studies are currently underway to determine if the disease is BSE or a related disease. Health officials have not reported any incidents of new variant Creutzfeldt-Jakob Disease in the United States.

The President’s Council on Food Safety may be a vehicle for helping to
resolve implementation issues associated with regulating animal feed
during transport. The Council, formed on August 25, 1998, by executive
order of the President, was established to improve the safety of the nation’s
food supply through science-based regulation and well-coordinated
inspection, enforcement, research and education.   (Neal Lane- ass. to prez for science and tech and co-chair of the council reviewed report)