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.
Purpose:
Concerned about the risks to human health posed by unsafe feed consumed
by food-producing animals, the GAO was asked by Sen. Durban to examine
(1) the extent to which unsafe feed has been linked to human health problems
in the United States and (2) the actions FDA and the Department of Transportation
are taking to ensure the safety of animal feed.
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 serious deficiencies:
• 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.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,
• 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.
• Twenty-three of the 211 renderers inspected, about 11 percent, were not aware of the BSE regulation.The results for the FDA-licensed feed mills were similar. For example,
• 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.
• Sixty-three of the 1,023 mills, about 6 percent, were not aware of the regulation.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.)
• 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.
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 manufacturer
inspections 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.
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)