WASHINGTON, August 2, 2012 -The Food Safety Modernization Act, passed with bipartisan support in 2010 and signed into law in January 2011, was touted as a way to decrease food-borne illness outbreaks.

But 18 months later, much of the law has not been implemented. Deadlines for publishing final rules have passed and food safety advocates are crying foul.

The Food and Drug Administration, which has jurisdiction over most of the food supply except for meat, poultry and processed eggs that are under USDA jurisdiction, says the rulemaking process is working.

"This has been a complex and demanding process due to the interrelationships of the proposed rules and the impact that they will have in modernizing the food safety system," an agency spokesman said in a statement. The agency is making every effort to get all stakeholders involved, the spokesman added. "Farmers were important participants ... and they can be assured that we took into consideration and held in high regard their input."

Despite agency assurances, the delay is troubling to food safety advocates in light of a spate of recalls last month of cantaloupe and onion and a variety of onion-containing products due to detection of Listeria monocytogenes in a major California supplier’s shipments.

The Centers for Disease Control (CDC) reported July 27 that the incidence of food-borne illnesses has not decreased.

In 2011, CDC's FoodNet, a network of 10 U.S. sites that tracks the incidence and trends of infection from foodborne pathogens, identified nearly 19,000 infections, including salmonella, campylobacter, shigella, cryptosporidium and shiga toxin-producing E. coli (STEC). All but shigella are pathogens that live in healthy animals and contaminate meat and poultry when animals are slaughtered and processed and contaminate environments in which fruits, nuts, and vegetables are grown and processed, according to the CDC.

Although FDA has moved forward on implementing at least one key provision of the law ‑ an interim final rule expanding record-keeping requirements for food establishments as authorized under FSMA ‑ other key provisions of the law have stalled.

Caroline Smith DeWaal, the Center for Science in the Public Interest's director of food safety, who worked for a decade on the framework of what became the FSMA, said that several FSMA rules have been completed by FDA but were being held up at the White House Office of Management and Budget.

Although OMB typically is allowed three months to review proposed rules – and can extend the review period an additional month – some of the FSMA rules have been at OMB since last year, DeWaal said.

Regulations under OMB scrutiny to measure costs against benefits include produce safety standards, foreign supplier verification programs, requirements that food companies have a plan in place to identify possible sources of contamination and preventive control standards for both food and feed.

"These four rules are building blocks for the rest of the law," DeWaal said, "so nothing else can really advance until these are well through the process of adoption."

Once approved by OMB, rules are subject to notice and comment before they are finalized. DeWaal worries that it can take from six months through the ten years that it took egg regulations to emerge. She decried the current "upside down, backwards process" of allowing economists final approval on public health laws, a process she called "unacceptable from the standpoint of protecting the public from illnesses that are entirely preventable."

Jeff Bender, a public health professor who teaches food safety at the University of Minnesota, actually believes that FDA has a point: the size of this law and the sweeping changes in food safety can be especially complex, particularly when the new initiative may or may not be properly funded or is being threatened with reduced funding.

Still, Bender, who recently served on a produce safety panel, believes that the FSMA rules, particularly those involving produce safety and foreign suppliers, are important and should move forward as soon as possible.

The FDA record-keeping rule is a part of a bioterrorism law that should have been in place since 2002, Bender said. "We shouldn't have to wait ten years to get public health rules out of OMB."

Under the new record-keeping regulation that the FDA has published, FDA can request records not only for adulterated foods it believes present a threat to the public, but also for foods that the FDA reasonably believes are likely to be affected in a similar manner, such as a food product prone to the same type of contamination or a food product held in the same facility where a different food was contaminated during storage. Records and information requested under the regulation must be made available to FDA for inspection within 24 hours from the time of receipt of an official request by FDA.

FSMA, the most sweeping change in food safety legislation in 70 years, is designed to take a forward approach to food-borne illnesses ‑ shifting the FDA toward preventive measures, rather than just reacting to the approximately 1,000 food-borne outbreaks each year, which cause 325,000 hospitalizations and 5,000 deaths in the United States annually.

It gives the FDA expanded authority over approximately 80 percent of the food supply and ‑ for the first time ‑ the authority to mandate food recalls; currently, the agency relies on voluntary compliance. Smaller food producers would not be subject to new federal requirements if they sell the majority of their food directly to consumers, restaurants and retailers within the state or within 275 miles of where it was produced and have less than $500,000 per year in sales.



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