Palaces For The People
Saturday, January 03, 2004
HUMAN EVENTS ONLINE :: Page 3 -- Mad Cow Meets Bad Bureaucrats

Page 3 -- Mad Cow Meets Bad Bureaucrats

Posted Jan 2, 2004

The federal government does many things that are unconstitutional and unnecessary—from interfering with local public schools to providing seniors with tax-subsidized drugs. But it does have constitutional authority to defend our borders generally and to regulate foreign and interstate commerce. That would seem to give it some responsibility for protecting the U.S. from diseased foreign foods.

The good news last week was that the mad cow discovered in Washington State appears to have been born in Canada before the U.S. in 1997 imposed a ban on feeding cattle with meal made from cattle parts—the means by which mad cow disease spreads. The bad news is the Food and Drug Administration enforced this ban about as well as—well, about as well as the Department of Homeland Security enforces the immigration laws.

On Jan. 25, 2002, the General Accounting Office published a prophetic and scathing report on the FDA's mad-cow performance record. Here are some telling excerpts from the report, entitled, "Mad Cow Disease—Improvements in the Animal Feed Ban and Other Regulatory Areas Would Strengthen U.S. Prevention Efforts."

While BSE [Mad Cow Disease] has not been found in the United States, federal actions do not sufficiently ensure that all BSE-infected animals or products are kept out 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. . . .

According to FDA 's October 2001 quarterly update that summarized results of feed ban inspections, 364 [animal-feed-manufacturing] firms were out of compliance. In addition, FDA believes that not all firms that should be subject to the ban have been identified and inspected, at least 1,200 or more based on industry estimates. However, we could not verify these data because we found significant flaws in FDA's database, which we discuss later in this report. FDA did not take prompt enforcement action to compel firms to comply with the feed ban. When we began this study, in April 2001, the only enforcement action FDA had taken was to issue two warning letters in 1999.

The first letter was issued in May 1999—21 months after inspections began.

However, since inspections began in 1997, FDA has reported hundreds of firms out of compliance—most often for failure to meet requirements to label feed that contained prohibited proteins or for including prohibited proteins in cattle feed.

In our analysis of individual inspection forms, we found several instances in which firms were out of compliance in repeated inspections, yet FDA had not issued a warning letter. We also found instances in which firms were out of compliance but had not been re-inspected for a year or more—and in some cases for more than 2 years.

Between February and November 2001, FDA issued warning letters to another 48 firms. In addition, 17 firms voluntarily recalled feed, including 9 that had been issued a warning letter. As of Nov. 30, 2001, FDA or states had re-inspected 33 of the total of 50 firms that had been issued warning letters (2 in 1999 and 48 in 2001). Six of the firms were still out of compliance on re-inspection.

FDA has no enforcement strategy for feed ban compliance that includes a hierarchy of enforcement actions, criteria for actions to be taken, time frames for firms to correct violations, and time frames for follow-up inspections to confirm that violations have been corrected.

According to FDA, rather than taking enforcement actions, it has emphasized educating firms subject to the feed ban about the ban's requirements and working with those firms to establish cooperative relationships.

FDA reported that some states might have taken enforcement actions, including requiring firms to recall noncompliant feed. However, FDA does not track enforcement actions taken by states; therefore, it does not know the extent of such actions.

Even if FDA were to actively enforce the feed ban, its inspection database is so severely flawed that—until corrected—it should not be used to assess compliance...

Indecipherable Records

From our review of FDA's database of 12,046 feed ban inspection records (as of Oct. 26, 2001), we found records lacked unique identifiers, were incomplete, contained inconsistent or inaccurate information, and were not entered into the database in a timely manner. Examples of the severe flaws we found include:

# Entries for 5,446 inspections—or about 45% of all inspections—lack information to uniquely identify individual firms. As a result, the data cannot be used to reliably determine the number of firms inspected, compliance trends over time, or the inspection history of an individual firm. . . .

# Entries for 301 inspections of firms that handle prohibited proteins contain no response to whether feed was properly labeled; entries for 438 inspections of firms that handled both prohibited and non-prohibited proteins had no response to whether prohibited proteins were included in feed intended for cattle.

# Entries where responses to questions about feed labeling or whether prohibited proteins were included in feed intended for cattle indicated that the firms were in compliance; however, inspectors' notes contained in other sections of the database contradicted the responses and indicated the firms were not in compliance.

# Inspections were not entered into the database. In assessing the warning letters, we discovered references to inspections that do not appear in the database. In fact, the inspection record for the firm that received the first warning letter—in May 1999—does not appear in the database. . . .

# The database is incomplete. It does not include all firms subject to the feed ban. FDA officials relied on the personal knowledge of state and FDA field staff and on membership lists from industry groups to identify and locate firms. However, our review of membership records for the National Renderers Association—for the years 1998 to 2001—disclosed 21 rendering firms that were not in FDA's database. According to association records, those firms process meat and bone meal and other products that could contain proteins subject to the feed ban.

FDA did not count data entries with blanks—no responses—in the selected data fields it uses when it reports on compliance. Therefore, when FDA provided compliance information to the Congress—and when it publishes that information electronically—the data are misleading and the number of firms identified as out of compliance are undercounted...

An FDA official told us that the database was not originally intended to track compliance of individual firms, but rather to guide the agency's efforts to educate firms subject to the ban by illustrating particular states or practices that needed more intensive focus. However, FDA has no information system other than the inspection database to track compliance with the feed ban.

FDA has not placed a priority on oversight of the feed ban. From the implementation of the feed ban in August 1997 until early 2001, one person in FDA 's Center for Veterinary Medicine was responsible for feed ban management...

BSE and vCJD [Creutzfeldt-Jakob Disease] are devastating, incurable, inevitably fatal diseases. If they enter the country, they can bring dire economic consequences to the cattle and beef industries. Therefore, forceful federal prevention efforts are warranted to keep BSE away from U.S. shores. Nevertheless, Customs has reported significant error rates in importer-provided information for BSE-risk shipments, import controls over bulk mail are weak, and inspection capacity has not kept pace with the growth in imports. Because of these import weaknesses—and because BSE may have entered in imports from countries that have since developed the disease—BSE may be silently incubating somewhere in the United States. If that is the case, then FDA 's failure to enforce the feed ban may already have placed U.S. herds and, in turn, the human food supply at risk.

Powered by Blogger