FDA unveils 2 new rules based on 2011 food safety law

Jan 4, 2013 (CIDRAP News) – The US Food and Drug Administration (FDA) today unveiled two new proposed food safety rules, one aimed at food makers and the other at the produce industry, that are part of implementing the FDA Food Safety Modernization Act (FSMA).

The FDA posted the rules today in the Federal Register and asked for public comments by May 16, which it will take into account before issuing final rules.

Drafts of the two rules are among four major FSMA components that have been held for review by the White House Office of Management and Budget for about a year. Over the summer two consumer advocate groups filed a lawsuit pushing faster implementation of the FSMA, and the FDA on Nov 30 filed a motion to dismiss the suit. The FDA said that it takes time to develop complex regulations that apply to an enormous food industry.

Congress passed the FSMA at the end of December 2010, and President Obama signed it into law exactly 2 years ago today. The law, thought to be the most sweeping piece of food safety reform in nearly a century, took shape after several high-profile foodborne illness outbreaks linked to foods such as fresh greens and peanut butter.

The FDA said in a press release that the proposed rules were crafted following extensive outreach to the produce industry, consumers, other government agencies, and the international community.

Since January 2011 FDA staffers have toured farms and food facilities and have taken part in hundreds of meetings with regulators, industry stakeholders, consumer groups, farmers, state and local partners, and researchers.

Health and Human Services (HHS) Secretary Kathleen Sebelius said in a statement today that the FSMA offers a common-sense approach that shifts the focus from reaction to prevention. "With the support of industry, consumer groups, and the bipartisan leadership in Congress, we are establishing a science-based, flexible system to better prevent foodborne illness and protect American families."

At a press telebriefing today, FDA Commissioner Margaret Hamburg, MD, said the rules are meant to make what's already a safe food supply even safer. "We really need to do more than react after the fact," she said. "The rules help us move forward on this important shift."

Michael Taylor, JD, the FDA's deputy commissioner for foods and veterinary medicine, told reporters that the proposed produce rule is geared toward preventing reasonable foreseeable hazards in four major contamination pathways: water, worker hygiene, materials put in soil, and animal incursions onto produce fields. He also said the rules address conditions in packing houses.

He emphasized that a one-size-fits-all strategy won't work for all growers and that the rule carefully targets requirements to commodities where standards can make a safety difference.

For example, Taylor said the application of irrigation water standards will mostly apply to fruit and vegetables that are sprayed directly, rather than watered by drip irrigation. Also, he said the rules typically wouldn't apply to vegetables such as potatoes and artichokes that are cooked before they are eaten.

The FDA proposes that larger farms comply with the new rule 26 months after it is finalized and that smaller farms would have more time to comply. It added that all farms will have more time to comply with certain water quality requirements.

Meanwhile, Taylor said the proposed food facility rule sets up a hazard analysis and critical control point (HACCP) approach that is already used by, for example, the juice and seafood industries. "This would apply to all food processing settings," he said. The rule would require both domestic- and foreign-based facilities to develop formal plans for preventing foodborne illnesses.

The FDA is proposing that food manufacturers comply with the rule 1 year after the final rules appear in the Federal Register. It said small and very small businesses would have more time to comply.

FDA officials said today that the agency will soon release three more proposed rules. One would require importers to verify that food grown or processed oversees is as safe as domestic counterparts, and another is aimed at strengthening the quality of overseas third-party food safety audits. The third rule proposes prevention controls for animal food facilities.

Hamburg said it was difficult to assess what the rules would cost taxpayers. "There are many moving parts. We recognize that different pieces will occur at different times with different levels of investment," she said. Some health officials and consumer groups have aired concerns that the federal budget doesn't include adequately funding for implementation of the FSMA, some of which is to be supported by fees.

"Resources remain an ongoing concern," she said.

Taylor said that once the 120-day comment period ends, it could take the FDA about a year to analyze the feedback, revise the rules, and release final versions.

Industry groups weigh in
Two major industry groups responded today to the FDA's proposed rules. Bryan Silbermann, president and chief executive officer of the Produce Marketing Association (PMA), in a letter to members today called the rules landmark proposals to improve the safety of the food supply, with implications for every link in the global fresh produce supply chain. The PMA represents 2,200 members of the produce and mass-market floral industry supply chain.

"We are eager to review and assess these rules so that we can provide thoughtful, real-world comments to the FDA that will advance produce safety in ways that are practical for your businesses," he told members.

Silbermann said that over the coming days the PMA would post an online summary of the proposed rules and offer a free webinar with FDA and PMA experts. He added that PMA leaders will analyze the proposed rules over the next few months and submit comments to the FDA.

The Grocery Manufacturers Association (GMA), which represents 300 businesses in the consumer packaged food industry and related fields, issued a statement today welcoming the release of the proposed rules.

"To fully implement FSMA, the FDA will issue more than 50 regulations aimed at improving food safety," it said. "Today, we applaud the Obama Administration and the FDA for releasing the first two sets of proposed regulations from the new FSMA law (preventive controls and produce safety) for public comment."

The group said it was pleased that FSMA implementation is progressing and looks forward to working with the FDA by continuing to share its knowledge and best practices and by commenting on the proposed rules.

Praise from consumer groups
Meanwhile, consumer groups praised the draft rules as a sign of progress. Caroline Smith DeWaal, food safety director for the Center for Science in the Public Interest (CSPI), said in a statement that even though the proposed rules are 12 months behind the congressionally set date, they are an important step toward the FDA's goal of preventing more outbreaks.

"These proposed regulations are a sign of progress that should be welcomed by consumers and the food industry alike. Still needed are protections in the form of rules aimed at ensuring the safety of imported food, also mandated by FSMA and long overdue," she said in the statement.

Jean Halloran, director of food policy initiatives at the Consumers Union, said in a statement, "We look forward to analyzing FDA's proposals. These rules really go to the heart of the problems we've had with food safety in recent years." The group urged federal officials to release pending proposals on food imports and pet food safety.

See also:

Jan 4 FDA statement

Jan 4 PMA statement

Jan 4 GMA statement

Dec 4, 2012, CIDRAP News scan "FDA defense in lawsuit over food safety law: It's complicated"

Jan 4 CSPI statement

Jan 4 CU statement

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