July 02, 2009

Waxman's Food Safety Bill Would Go a Long Way Toward Fixing Regulatory Failures

On Wednesday, Representative Henry Waxman introduced a comprehensive “Food Safety Enhancement Act” (116-page discussion draft) to repair part of a federal food safety protection regime that has been badly broken for several decades. Waxman was joined by Representatives Diana DeGette, John Dingell, Frank Pallone, Bart Stupak, and Betty Sutton; the House Energy and Commerce Committee will hold a hearing on the issue on Wednesday, June 3.

A key problem with the current system is that it employs regulatory tools developed during the early twentieth century to address the risks posed by a radically different twenty-first century food production and delivery system.

The existing regime is built upon the assumption that state and local governments can adequately address the risks of a largely local food supply with occasional assistance from a federal Food and Drug Administration that focuses primarily on animal feeds, food additives and a modest quantity of (mostly exotic) imported food. But we now live in a world in which much of our fresh produce travels long distances (often from other countries) and the processed foods that we consume can come from huge production complexes or tiny “Mom and Pop” facilities located almost anywhere.

The recent highly publicized instances of food poisoning resulting from Salmonella-contaminated peanuts and E. coli-laden packaged salads have focused public attention on the failures of the existing regulatory regime. The Waxman bill provides a much-needed corrective that, if enacted, should go a long way toward correcting those failures.

The bill would address the problem of thinly regulated and anonymous food suppliers like the Georgia and Texas peanut facilities by creating a registry of all food facilities serving American consumers. At the same time, the bill would go a long way toward providing the poorly funded Food and Drug Administration badly needed resources by levying an annual registration fee of $1,000 on each facility.

These facilities would also have to come up with plans to identify and deal with safety hazards. Although the devil will be in the details, these plans would presumably follow the model that FDA has adopted for seafood on a voluntary basis called “hazard analysis at critical control points” (HACCP). If implemented correctly, a HACCP program would bring scientific analysis to bear on the problem as facility operators apply quantitatively measurable criteria at various points in the food production process where the food is most at risk for contamination.

Under the bill, every registered facility would get inspected at least once every three years (far more frequently than the existing rate), and “high-risk” facilities would be inspected every 6-18 months. It is, of course, one thing to mandate an inspection rate and quite another to ensure that the inspections actually do occur on schedule. Since the registration fees standing alone are not likely to cover the full costs of such inspections, Congress would need to recognize its obligation to provide adequate funding to the agency to do the job.

The bill contains several provisions aimed at enhancing the safety of imports, including certification of foreign food facilities by FDA or qualified third parties. The latter possibility is somewhat problematic, given the spotty record of supposedly qualified third party auditors in other contexts (think Arthur Anderson and the mortgage rating agencies). FDA would probably have to come up with an effective program for auditing the auditors.

Finally, the bill greatly expands FDA’s enforcement powers. Most important, it authorizes FDA to impose mandatory recalls. This is a critical addition to the agency’s arsenal, because the agency has in the past been in the position of a beggar, pleading with recalcitrant scofflaws to do the right thing by recalling potentially contaminated products. Another much-needed addition is a provision authorizing FDA to issue subpoenas. The agency would finally have the tool that plantiffs’ attorneys have successfully employed to find the “smoking gun” documents showing what a company knew and when it knew it.

In sum, the Waxman bill is a commendable effort to ensure safe food for American consumers.

At the end of the day, however, the bill would only touch on half of the problem. An entirely separate regulatory regime for ensuring the safety of meat, poultry and eggs is currently being administered by the United States Department of Agriculture, and it is in many ways as badly broken as the FDA regime. Since Representative Waxman’s committee does not have jurisdiction over the USDA regime, however, that must be the subject of another Bill that will be referred to the Agriculture committees.


Thomas McGarity, CPR Member Scholar; Endowed Chair in Admin. Law, University of Texas School of Law. Bio.

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