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From: Food Quality & Safety magazine, June/July 2008

Beefing Up the FDA

Lawmakers seek to give the agency more authority and funding

by Ted Agres

This summer federal lawmakers are hoping to enact two pieces of legislation that would give the Food and Drug Administration (FDA) more authority and funding to better regulate the safety of domestic and imported foods.

A House bill, the Food and Drug Administration Globalization Act of 2008, would grant the agency authority for mandatory registration, certification, and inspection of all food facilities. To pay for the extra resources needed to carry out these new responsibilities, the measure would also impose $600 million in new annual food industry user fees.
“Rather than continuing to simply react to outbreak after outbreak of contaminated products, it is about time that we put in place a stronger and more thorough system to prevent contaminated food products from reaching store shelves,” says Rep. Frank Pallone Jr. (D-N.J.), chairman of the House Committee on Energy and Commerce’s Subcommittee on Health and one of the bill’s sponsors.

The bill was crafted with input from industry, regulators, and policy analysts. Three hearings on the draft measure were held earlier this year, and the House Energy and Commerce Committee is pushing to finalize the bill and bring it to a full floor vote this summer, committee spokeswoman Brin Frazier tells Food Quality. “The goal is to strengthen the FDA and ultimately protect consumers,” Frazier says.

Implications for Industry

But not everyone is pleased. Among other things, the bill would require all food facilities in the United States to register with and pay a $2,000 annual fee to the FDA. Food importers would pay $10,000 annually.

“We strongly oppose food taxes and ‘fees’ that are not tailored to provide a government service to our industry,” says Cal Dooley, president and chief executive of the Grocery Manufacturers Association. Increased FDA resources, he told lawmakers in April, should come from congressionally appropriated funds, not user fees.

The bill would also require that foreign and domestic food facilities establish safety plans to identify and mitigate hazards; the FDA would review these plans during mandatory inspections every four years. Facilities wishing to certify that they are meeting all applicable safety requirements could voluntarily seek documentation from FDA-accredited certifying agents.

Dooley objects to third-party certification, saying it would “improperly delegate FDA responsibilities.” Others argue that independent certifications are essential if the FDA is to maintain an arms-length distance from the entities it regulates. Granting a “government stamp of approval creates a commonality of interest between the agency and the company and erodes the independence and objectivity of the agency,” says Michael R. Taylor, professor of health policy at the George Washington University School of Public Health and Health Services in Washington, D.C. “FDA should accredit certifiers but not grant certification itself,” says Taylor, who is also a former administrator of the U.S. Department of Agriculture’s Food Safety and Inspection Service.

Dooley is also critical of the idea that FDA inspectors would have broad authority to review the adequacy of food safety plans, mandate specific controls, and establish performance standards for facilities. While supporting the requirement of safety plans for food companies, he maintains that companies “should be given the discretion to identify appropriate safety controls and measures.” And giving the FDA power to assign fees and fines, Dooley says, “will create a powerful incentive for the FDA to find violations regardless of merit.”

A separate issue under debate is granting subpoena power to the FDA. The FDA’s only current recourse when attempting to obtain critical data being withheld is to threaten criminal prosecution by the Justice Department.

Show Me the Money!

Also pending in Congress is a measure that would give the FDA an immediate $275 million boost in spending to bolster inspections of food products and pharmaceuticals manufactured abroad. Of this, about $119 million would be allocated for food safety issues.

“The FDA needs to get its house in order on food and drug safety, and these funds are targeted to do just that,” said Sen. Herb Kohl (D-Wis.), ranking member of the Senate appropriations panel that oversees the FDA’s budget.

After prodding from lawmakers, FDA Commissioner Andrew C. von Eschenbach, MD, told the Senate in May that the agency could use an immediate infusion of $275 million this year, of which $125 million would be dedicated to food safety, $100 million to drugs, devices, and biologics, and $50 million to modernize FDA’s science and information technology systems.

The Senate took Dr. von Eschenbach at his word and included these amounts in a measure that was part of a $165 billion Defense Department supplemental appropriations bill. The Senate approved the massive bill in May, but it would also have to pass the House before it could be signed into law. President Bush had threatened to strike down the measure since it exceeded his domestic spending limits sets the stage for a likely veto battle later this year. But in early June, the administration announced the additional $275 million would be added to its overall Fiscal 2009 request for the FDA, setting the stage for approval without a fight.

The FDA’s own board of scientific advisers and others say the agency requires far greater resources, however. “The nation’s food supply is at risk,” the FDA’s Science Board concluded in a November report. While noting that advocates like the Coalition for a Stronger FDA are urging an additional $250 million to promote food safety, the Science Board stated that even this amount may not be enough.

Struggling to Stay Safe

These legislative efforts come as the FDA struggles to implement food safety requirements mandated in the Food and Drug Administration Amendments Act of 2007 (PL 110-85), which was signed into law in September, as well as the agency’s own Food Protection Plan, announced in November.

Mindful of 2007’s Chinese melamine contamination, the former requires, among other things, that the FDA establish a food registry and notification system to respond to adulterations of human and pet foods. The latter focuses on three core elements intended to secure the safety of both imported and domestic foods:

  • Prevention based on corporate responsibility for risk reduction;
  • Intervention focused on risk-based inspections, sampling, and surveillance at high-risk points in the supply chain; and
  • Response, including improved communication and coordination with other government agencies and industry during and after emergencies.

“The plans seek to build in safety measures across a product’s life cycle, from the time a food is produced to the time it is distributed and consumed,” says Stephen F. Sundlof, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition.

The task is daunting. The FDA oversees about 80% of the U.S. food supply, including $417 billion in domestic food and $49 billion in imported food annually, according to the Government Accountability Office, the investigative arm of Congress. There are 44,000 food manufacturers and processors, 114,000 food retailers, and 935,000 restaurants in the country. According to the Centers for Disease Control and Prevention, 76 million Americans get sick annually due to unsafe food products; 325,000 of them will be hospitalized, and 5,000 will die from foodborne hazards.

Recent outbreaks of Escherichia coli in spinach, Salmonella in peanut butter, and melamine contamination of pet food and other food products highlight some vulnerabilities. “All of this raises questions about our current food safety laws, many of which were enacted in the 1900s,” Rep. Pallone says. “Obviously, laws that were written in the early 20th century are no longer current, particularly as the food industry becomes increasingly more global.”

To implement its plans, the FDA is looking to fill more than 1,300 science and medical positions, nearly tripling the number of people it hired from 2005 to 2007. The agency is holding job fairs around the country to recruit biologists, chemists, medical officers, statisticians, and investigators. “It takes a large pool of talented people for the FDA to protect and promote the public health,” says John Dyer, the FDA’s deputy commissioner for operations and chief operating officer.

ChinA: Improving Take-Out

The FDA also wants to enhance the safety of food and animal feed products exported from China to the United States. In December, Michael Leavitt, secretary of the Department of Health and Human Services, negotiated an agreement for enhanced registration and certification requirements, information sharing, and faster access to food production facilities in China. But, as of press time, the U.S. was still waiting for the Chinese to grant approval for FDA offices in Beijing, Shanghai, and Guangzhou.

In addition to being a major food and food products exporter, China is the world’s largest supplier of active pharmaceutical ingredients (APIs), producing 14% ($4.4 billion) of the $31.0 billion total in 2005. By 2010, its share is expected to grow 17.2% annually to 21.5% ($9.9 billion) of the world’s $46.0 billion API market, according to the Chemical Pharmaceutical Generic Association. After opening offices in China, the FDA hopes to open facilities in India, another major API supplier, and in Central America, because of the increase of fruits and vegetables being imported from that region.

But the FDA needs statutory authority to implement the more significant changes proposed in its Food Protection Plan. The agency has already requested authority from Congress to require food facilities to renew their FDA registrations every two years; to authorize the FDA to accredit “highly qualified” third parties to conduct voluntary food inspections; to require new re-inspection fees from facilities that fail to meet current Good Manufacturing Practices; to allow the FDA to issue mandatory recalls if voluntary recalls are not effective; and to give the agency greater access to food records during emergencies.

Agres is a freelance writer based in Laurel, Md. Reach him at tagres@comcast.net.

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