Two year anniversary of FSMA marked with release of two key rules

It’s been a long road toward new regulations aimed at bolstering food safety in the U.S.

But today, on the two year anniversary of President Obama signing the Food Safety Modernization Act (FSMA) into law, the U.S. Food and Drug Administration (FDA) released two key rules for a public comment period of 120 days.

The first proposed rule stemming from FSMA requires food producers, domestic or foreign, to have a plan in place for preventing their products from “causing foodborne illness,” and to have additional plans for corrective actions if issues do occur, according to an FDA release.

Those affected by the proposed rule would have to be compliant one year after the final version is published, with small business being given extra time.

The second rule creates safety standards for produce that are science and risk-based. Large farms would have to be in compliance 26 months after the final rule is published with small operations being given extra time.

Other rules, including those for import oversight and third party audits, will be released soon, according to the statement.

“The FDA knows that food safety, from farm to fork, requires partnership with industry, consumers, local, state and tribal governments, and our international trading partners,” said FDA Commissioner Margaret A. Hamburg, M.D. in the statement. “Our proposed rules reflect the input we have received from these stakeholders and we look forward to working with the public as they review the proposed rules.”

FSMA is the largest overhaul of the U.S. food safety system since the early 20th century. Since FSMA was signed, however, progress has been slow to meet deadlines set by the legislation. Of the 90 or so “deliverables” required to be published by September 2012, only 11 had reached publication (eight guidance documents and three rules), notes Dr. David Acheson, former head of the FDA’s Center for Food Safety and Nutrition (CFSAN) and partner at Leavitt Partners, on the group’s blog.

The rules have been tangled in the White House’s Office of Management and Budget, many of them missing key implementation deadlines since they were submitted in fall 2011. Many speculated that the presidential election slowed their release, as politics came into play.

However, officials have defended the delay, citing FSMA’s scope and complexity as reasons for the taking extra time. During the time since FSMA was signed, FDA officials have conducted hundreds of meetings with consumers, farmers, industry officials, researchers and government officials, according to the FDA.

“We know one-size-fits-all rules won’t work,” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine, in a statement. “We’ve worked to develop proposed regulations that can be both effective and practical across today’s diverse food system.”

Regardless of the reasons, the delay led to an outcry from food safety groups, including a lawsuit filed late summer of last year seeking the release of the rules.

Those calling for release of rules cite studies such as one released in October by the U.S. Public Interest Group (U.S. PIRG), which noted a 44 percent jump in foodborne illness related to recalls from January to September 2012 over the previous year (1,035 illnesses compared to 718 during the same time period in 2011). Overall, foodborne illness (not necessarily linked to recalls) causes roughly 48 million Americans to fall ill each year and results in about 3,000 deaths, according to figures from the FDA.

Need a quick primer on FSMA?

FSMA has many facets, each aiming to increase food safety in the U.S. Some of the main parts are below (want to read the full text? Here you go.):

  • Preventative controls for human food and animal feed: This provision will allow the FDA to become more proactive rather than reactive to foodborne illness outbreaks by mandating food facilities step up prevention efforts. These include increased hazard evaluations, corrective action plans, and the implementation and monitoring contamination, such as pathogens.
  • Increased import oversight: Much of the U.S. food supply is imported (15 percent overall with 60 percent of fresh produce and 80 percent of seafood, according to the FDA). Under the new rules, importers must have their foreign facilities and suppliers verified with the FDA. The agency also is authorized to reject imports at the border if the supplier or country of origin refuses an FDA inspection of the facility. (Check out this previous Neogen blog post).
  • Produce, produce, produce: The rule will require “minimum science-based standards” for fruits and vegetables, mixes of fruits and vegetables or categories of produce that have a history of foodborne illness outbreaks. These standards can affect all aspects of the process, from growing to harvest to packaging, according to a white paper by United Fresh.
  • International collaboration: In recognition of an increasingly interconnected world, FSMA also calls for increased collaboration between all levels of government, from local to federal to foreign nations.
  • Mandatory recall authority: FSMA expands FDA’s recall ability. What they say goes.

Although some rules still are missing, there have been accomplishments in 2012, according to a list recently published by the FDA. The full list is here, but we’ve pulled out a few highlights:

February 2012

  • Interim final rule and guidance on record’s access published: FSMA allows the FDA to request not only records related to specific food items that may cause health issues, but also food items that may be similarly affected, according to the FDA progress report.
  • FDA reported to Congress that it had established 13 foreign offices.

June 2012

  • FDA hosted a meeting on international cooperation under FSMA and capacity building.

August 2012

  • FDA announced fee rates from facility reinspection (domestic and foreign), and recall and importer reinspections.
  • A draft guidance on food categories and food facility registration was released.

October 2012

November 2012

  • FDA wields some of FSMA’s power to revoke facility registration for a plant.

December 2012

  • FDA once again updates guidance for food facilities registration.
  • For the first time, FDA recognizes another nation’s food safety system as comparable to the United States’. The new partnership with New Zealand is expected to help trade and increase food safety.

Other food safety rules have gone into effect, including the remainder of the 2009 Egg Safety rule and routine verification sampling by the USDA’s Food Safety and Inspection Service (FSIS) for six strains of Shiga toxin-producing E. coli (STEC) in raw beef trim in addition to a more well known STEC, E. coli O157:H7.

Find all of Neogen’s FSMA coverage here.


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