WASHINGTON — The combination of a string of high profile food-borne illness outbreaks combined with a new administration may bring efforts to reform the nation’s food safety system to fruition. In the wake of the Peanut Corporation of America recall, legislation aimed at dividing the Food and Drug Administration so as to give greater resources and authority to the agency’s food safety units was introduced in the House of Representatives, and leaders of the Senate Committee on Agriculture, Nutrition and Forestry indicated a new approach to food safety was needed.
Representative Rosa L. DeLauro of Connecticut, a long-standing advocate of reforming the food safety system, on Feb. 4 introduced with 29 co-sponsors the Food Safety Modernization Act (H.R.875). Ms. DeLauro’s bill would split the F.D.A. intoan agency responsible for food safety, the Food Safety Administration, and another agency responsible for regulation of drugs and medical devices. Both agencies would remain parts of the Department of Health and Human Services, and the food safety administrator would report directly to the secretary of the department.
"With every recall, the American people grow more concerned and the momentum for reform grows," Ms. DeLauro said. "For eight long years, our food safety system has been crippled by disinvestment, mismanagement, and a failure to meet its most basic regulatory responsibilities."
In addition to the structural change, the bill would update food laws and increase emphasis on preventing disease-causing contamination. It would require food processors to control health hazards in their plants, meet federal standards for preventing contamination and removing pathogens from food, and be subject to regular inspections by federal officials based on the risk profile of the foods produced. The food safety administrator would have enhanced enforcement authority, including authority to order recalls, seize unsafe food and impose fines on companies violating the law.
In the Senate, Senator Tom Harkin of Iowa, chairman of the Senate agriculture committee, opened a Feb. 5 hearing of the full committee on food safety stating he was "nothing short of outraged at the increasing number of outbreaks of food-borne illnesses in this country."
Mr. Harkin said, "To say that food safety in this country is a patchwork system is giving it too much credit. Food safety in America has too often become a hit-or-miss gamble, and that is truly frightening … We have to come up with a better, smarter approach to food safety. We have to make the investments both in better systems, and in putting more inspectors on the ground."
Senator Saxby Chambliss of Georgia, ranking minority member on the agriculture committee, said the current outbreak of Salmonella traced to tainted peanut butter products manufactured at a P.C.A. plant at Blakely, Ga., and subsequently used in the manufacture of hundreds of other food items "has challenged the food safety system to a new degree."
Mr. Chambliss added, "An effective public-private sector partnership is critical to ensuring a safe food supply. The private sector has the responsibility to follow federal guidelines and ensure the safety of their products. The federal and state governments have the responsibility to oversee these efforts and take corrective actions when necessary. We need to quickly identify gaps in the system and act swiftly to correct them."
Testifying before the committee were Dr. Stephen F. Sundlof, director of the F.D.A.’s Center for Food Safety and Applied Nutrition; Dr. Ali Khan, assistant surgeon general and deputy director, National Center for Zoonotic, Vector-borne & Enteric Diseases at the Centers for Disease Control and Prevention; Caroline Smith DeWaal, director of food safety, Center for Science in the Public Interest; and William K. Hubbard, former F.D.A. associate commissioner for regulations and policy development, who testified on behalf of the Alliance for a Stronger F.D.A.
With regard to the P.C.A. recall, Dr. Sundlof said the F.D.A. was able get off to an early start because the health authorities in Minnesota already had a strong lead linking the outbreak to peanut butter and to a distributor of what turned out to be P.C.A.-manufactured product.
Dr. Sundlof explained the F.D.A. during the course of its investigation at the P.C.A. plant discovered the P.C.A. in the past couple of years detected Salmonella in its products on 12 separate occasions. Nevertheless, product was shipped. There were instances where the company after detecting Salmonella sent specimens to a private laboratory that subsequently indicated the specimens tested negative for Salmonella. Dr. Sundlof affirmed a criminal investigation was under way and the practice of "testing products into compliance," i.e. testing samples until you get the result you want, is universally condemned in the food industry and he was certain the practice wasn’t rampant and instead was a problem with the P.C.A.
Mr. Chambliss asked precisely when the F.D.A. learned of the 12 positive tests for Salmonella at the P.C.A., and Dr. Sundloff indicated there was no one occasion when the F.D.A. was made aware of those results, instead, as the F.D.A. requested additional records during the course of the investigation, the positive tests were uncovered case by case.
Dr. Sundloff indicated the P.C.A. did not disclose the test results to the F.D.A. or state inspectors during earlier routine inspections. Under law, companies are not required to notify the F.D.A. of test results indicating Salmonella contamination, and only by invoking the Bioterrorism Act can the F.D.A. compel the release of records.
Mr. Harkin and Mr. Chambliss said this was a loophole that had to be closed. Mr. Harkin said companies and private laboratories in their hire must be required to notify the F.D.A. when products test positive for Salmonella or other contaminants that may put health at risk.
Dr. Khan was asked what the C.D.C. needed to shorten the time required to identify and respond to food-borne illness outbreaks. He said there must be investment in advanced technology and laboratory tools at local, state and federal levels. He also said there must be greater investment in local and state health systems, including funding for more trained personnel.
"There have to be more boots on the ground," Dr. Khan said, so state health authorities may expedite testing specimens and conduct surveys of individuals contracting a food-borne illness and communicate the information more rapidly to the C.D.C. and other PulseNet participants. That message resonated with Mr. Harkin, who said he was a strong supporter of greater investment in local and state health systems.
Ms. DeWaal outlined C.S.P.I. proposals for reforming the food safety system, many of which were in accord with the legislation introduced by Ms. DeLauro in the House. Ms. DeWaal said companies must be required to develop food safety plans and be held accountable to implementing them with performance standards set by the F.D.A.
Mr. Harkin asked whether a single food safety agency created by merging the food inspection units of the F.D.A. with the U.S. Department of Agriculture’s Food Safety and Inspection Service might be a better option than a freestanding agency within the H.H.S. Ms.
DeWaal said the position of many food safety reform advocates evolved to emphasize modernizing both the F.D.A. and the F.S.I.S. before attempting to join the two inspection agencies.
Mr. Hubbard agreed food safety reform should emphasize prevention. He said Congress should empower the F.D.A. to require each food processing plant to establish and implement a food safety plan akin to Hazard Analysis and Critical Control Point (HACCP) plans in place in the meat and poultry processing industry. Mr. Hubbard also argued for a significant increase in funding for the F.D.A. to increase the number of field inspectors and laboratory scientists.
Mr. Hubbard advocated enhanced enforcement authorities for the F.D.A., including mandatory recall authority, annual registration of all food facilities, accreditation of private laboratories and stronger trace-back procedures. He further called for the H.H.S. to develop "an effective crisis management system that coordinates response to food-borne disease outbreaks among C.D.C., F.D.A. and state and local governments." Mr. Hubbard also suggested Congress authorize and fund a food safety training academy to provide uniform, science-based training for all food inspectors at all levels of government and in private sector.
This article can also be found in the digital edition of Food Business News, February 17, 2009, starting on Page 1. Click