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Safety first: Lawmakers tasked to overhaul FDA’s rules

Safety first: Lawmakers tasked to overhaul FDA’s rules

Since President Barack Obama’s calls earlier this year to improve the safety of the U.S. food supply, agency officials recently have issued several draft guidelines related to specific types of produce, and lawmakers now are working on a major bill that would overhaul the Food and Drug Administration.

But while many of the measures are aimed more directly at the produce industry and manufacturers, restaurateurs still could face new record-keeping requirements, legal responsibilities and possibly onerous fines for infractions, observers say.

“There’s a lot coming ahead in the next couple of years,” says Kathy Means, the Produce Marketing Association’s senior vice president of government relations and public affairs. “If there are foodservice operators that don’t have strong food safety programs and that are not talking to their suppliers, that will have to change.”

The FDA recently introduced draft guidelines that are the first to govern specific types of produce, including melons, leafy greens and tomatoes. The produce industry had a large hand in helping to craft the draft guidelines, which now await comments from the public before being reworked into final guidelines and promulgated as regulations, Means says.

All of the guidelines would require producers to perform their own risk assessments of foodborne-illness contamination and take measures to prevent them. The recommendations for tomato producers include keeping the fruits away from run-off from animal production, taking measures to ensure that the water being used on them is free of contamination, and enacting protocols for hygiene of farm workers.

For melons, the guidelines include close monitoring of melon scars to help prevent infestation from pests or disease, to which the scars are prone.

Among the recommendations for leafy greens is maximizing the amount of time between adding fertilizers and pesticides to soil and harvesting the crop.

Already in place is a new rule from the FDA regarding eggs that requires producers only to buy chicks and young hens from suppliers who monitor for Salmonella bacteria, establish pest and biosecurity measures, and test their own poultry houses for Salmonella.

Separate from those regulations is the bill currently in Congress, the Food Safety Enhancement Act of 2009, which was passed in late July by the House of Representatives as House Resolution 2749 and is being considered in the Senate. If it passes there, the two houses will have to rectify any differences between their two versions of the bill. Then if President Obama signs it into law, the FDA will interpret it and write specific regulations based on it.

A lot could still happen before the bill becomes law, and restaurant industry lobbyists are working to make sure that undue obligations won’t be foisted on operators.

The act is designed to help prevent the outbreak of foodborne illnesses such as those that have occurred recently involving items like peanut products, peppers and spinach.

It gives the FDA more power to investigate food producers and requires food manufactures to write and facilitate safety plans and to track and recall unsafe food products. It also gives the FDA greater authority to initiate such recalls if the producers or suppliers don’t do it themselves. But as it’s written now, it might also require that restaurant owners, operators, managers and possibly even hourly employees alert the FDA of potential risks of outbreaks of foodborne illness.

For the most part, the National Restaurant Association supports the Food Safety Enhancement Act.

“The NRA has obviously supported enhancements to food safety,” says Dan Roehl, an NRA public-affairs specialist. “We count on food to be safe so our customers can get the experience they expect.… But there are a couple of areas where we hope to work with Congress,” to clarify the new rules, he says.

In general, Roehl explains, the law is intended to make it easier to prevent outbreaks of foodborne illness and to prevent the spread of those that do occur by finding the source of the problem as quickly as possible.

He says the act, in essence, intends to focus resources on high-risk areas. It requires that suppliers and manufacturers perform risk assessments of their facilities and submit them to the FDA for approval—except in areas, such as livestock, that are already covered by the U.S. Department of Agriculture.

Suppliers and manufacturers must also develop processes to control potential hazards and minimize the risk of outbreaks of food-borne illnesses. It also requires the FDA to develop, within two years of the law’s enactment, a system for tracing contaminated food to its source within two business days and also to regularly identify the most dangerous contaminants and to issue standards for food companies to follow to reduce risk.

In addition, it requires implementation of a public education program on food safety.

That’s all well and good as far as restaurant industry lobbyists are concerned. The sticky point comes in the regulations involving pooling and processing information about foodborne illness across government agencies.

Roehl explains that the 2002 Bioterrorism Act called for the creation a Reportable Food Registry, to which members of the food-supply chain would announce through an electronic portal, accessible to all agencies, any problem that would qualify as a Class 1 food recall—defined as a health-hazard situation in which there is a reasonable probability that eating the food would cause health problems or death.

Farms and restaurants were exempted from that registry, which was created in 2007 and is set to be implemented by the FDA this September.

The pending act removes that exemption, and that could mean, according to Roehl, that restaurant owners and managers would be required to identify Class 1 recall situations, something they’re not necessarily equipped to do.

He says the registry was created to help the FDA target its resources by quickly identifying hazardous situations.

Adding retailers and restaurateurs to the mix would likely clutter the data with unusable information, Roehl says.

“If you’re going to meet the intended goal of the registry, having the restaurants report doesn’t help you get to your goal of targeting your resources effectively,” he says.

The NRA and other restaurant industry lobbies, such as the National Council of Chain Restaurants, also want clarification on what types of records restaurants will have to keep.

Right now, the legislation would require that restaurants identify their suppliers of products that might be traced to foodborne illnesses. Roehl says that’s preferable to making restaurants keep supply-chain records similar to those already required to be kept by suppliers.

“Certainly having restaurants keep a duplicate copy of their supply chain does not affect food safety,” he says.

Still, it’s unclear to what degree and in what manner restaurants would have to keep records that would lead to identifying their suppliers, and those details need to be clarified, Roehl says.

The NCCR also has concerns about the legislation, particularly the way the penalties are structured.

It voiced those concerns in a recent letter it sent to members of the House Energy and Commerce Committee, which initiated the legislation.

“In particular,” the letter says, “we are concerned regarding the dramatically increased penalties for even the most minor violations, potentially subjecting restaurants to fines far beyond what is necessary.”

It also voiced concern about the same possible reporting requirements that the NRA takes issue with, as well as the broad nature of the FDA’s authority over traceability requirements that might require recordkeeping at restaurants that would not help in tracing the causes of foodborne illnesses but would expose restaurants to considerable legal risk.

It says the bill, as written, “would mean that every restaurant employee, from kitchen staff to waiters, would be legally obligated to report hazardous foods to FDA or face possible criminal prosecution and large civil fines,” Roehl says.

The letter also says that the law would require that waiters “investigate the cause of the problem and maintain records for two years.”

“We cannot believe this was intended,” Roehl says.

The NCCR also notes that the bill authorizes civil penalties of as high as $7.5 million for corporations and $100,000 for individuals “for violations as minor as recordkeeping errors or failure to present label information in the required type size.”

In food law, the NCCR explains in a letter to the House Energy and Commerce Committee, where the bill originated, each lot of food product that violates food safety laws is a separate offense, and the new bill makes each day of violation punishable as a separate fine.

“A simple recordkeeping error could easily affect scores of products and remain undiscovered for several weeks, meaning that under this legislation FDA would often have authority to impose civil money penalties that exceed the value of many businesses,” the NCCR says in the letter. “Moreover, this authority to fine would operate without meaningful judicial oversight. While penalties and enforcement measures are a critical tool to punish those who violate food safety laws, they should be within reasonable limits for violations that do not result in a danger to the public, and they should not be exercised without accountability by FDA personnel.”

The possible changes looming on the horizon could also change the operator-supplier relationship, Means of the PMA says.

Noting that it’s common practice for restaurants to switch suppliers as prices fluctuate, they will have to pay more attention to the safety programs of their suppliers to make sure that they don’t expose themselves, or their customers, to risk.

“It’s the price of doing business in the produce industry,” she says. “Pathogens are equal-opportunity offenders. They don’t pay attention to the size of the farm, and they don’t care about borders.”— [email protected]

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