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FDA Releases Two Long-Awaited Food Safety Rules

After a year-long delay, two sweeping new food safety rules that will for the first time mandate produce safety standards and preventive controls nationwide will be released today and published to the Federal Register on Monday, according to the U.S. Food and Drug Administration.

“It’s a big deal that these two are coming out because it’s the central framework for prevention,” said Michael Taylor, FDA’s Deputy Comissioner for Foods and Veterinary Medicine, in an interview with Food Safety News. “We’re eager to get to the next phase of the process.”

The two rules were mandated by the Food Safety Modernization Act (FSMA) — a law that aims to shift the U.S. food safety system from being primarily reactive to focusing on prevention — which President Obama signed into law, with broad bipartisan support, exactly two years ago.

Since the law was enacted, the FDA has failed to keep up with the multiple deadlines set by Congress, in large part because the measures proposed by the agency were under review at the White House Office of Management and Budget’s Office of International and Regulatory Affairs for more than a year — a delay many stakeholders blamed on election politics.

It is still not clear exactly why the Obama administration’s review took so long (OMB officials have long maintained the rules are just complex and take time). According to Taylor, the OMB’s cost-benefit analysis, which will soon be posted online, found that the the economic benefits from the two new rules are much greater than the expected costs to the food industry.

“There are significant benefits that well exceed the estimated costs,” said Taylor, adding that preventing outbreaks and the health care costs associated with them is actually one small part of the expected economic benefit. “There’s a great benefit in reducing the disruption to the markets, the loss of sales, and the loss of consumer confidence each time a major foodborne illness outbreak strikes.”

The agency has made full drafts of the proposed rules, which are lengthy, available online. The public will have 120 days to comment and then the rule will go through the normal rulemaking process, which could take several months.

It will likely take time for stakeholders to review the proposed rules, as the agency has not yet released an overview of what exactly would be required under the proposal, but the early reactions were unanimously positive.

“We applaud the Administration’s release of these important proposals,” said Sandra Eskin, director of the food safety campaign at the Pew Charitable Trusts. “This is a significant step forward in reducing preventable foodborne illnesses and restoring consumer confidence in the food supply.”

The Grocery Manufacturers Association said that industry and government need to work together “to provide Americans and consumers around the world with the safest possible products” and called FSMA implementation a “role mode” for this type of cooperation.

“We are pleased that implementation of FSMA is moving forward and look forward to working with the FDA by continuing to share our food safety expertise and best practices and by evaluating and commenting on the proposed rules,” said Pamela Bailey, the president and CEO of GMA.

Joe Levitt, a partner at Hogan Lovells, which represents food industry clients, called the two new rules “the cornerstone of FSMA.”

“They get to the very heart of the new law’s paradigm shift from reaction to prevention,” said Levitt, who formerly served as Director of FDA’s Center for Food Safety and Applied Nutrition. “As with all FDA proposed rules, public comment is a key component of the process, and the food industry and other stakeholders will review these proposals thoroughly and submit comments to FDA on how to make the final rules as beneficial and cost-effective as possible.”

The agency plans to do extensive outreach to stakeholders to have a “real dialogue” and ensure all elements of the food industry understand the new requirements.

“This is the first time we’ve ever had enforceable standards on the farm. It’s the first time we’ve tried to apply preventive controls across all types of operations,” said Taylor. “What I think we’ll see, especially in the produce community, where standards are new is that we’re going to need to work with the community to explain what we’re proposing and to explain how the flexibilities work.”

“There are many, many examples of where we’ve built flexibility into the rules so the requirements are adaptable to the particular circumstances of a farm: what they’re growing, how they’re growing it, the way they use water, and so forth,” he added.

If produce growers, for instance, are already  paying attention to food safety by implementing good agricultural practices (GAPs), and doing rigorous certifications, there may not be anything new or surprising about the produce rules, according to Taylor.

One of the key elements of the proposed rule for produce focuses on water. If a farm is applying water to the edible part of the crop, it will likely have to meet a microbial standard, or explain why such a standard isn’t relevant to that specific product.

There are three other key draft rules that remain under review at OMB, two that have been there for more than a year, on foreign supplier verification and preventive controls for the feed industry, and one on third party audit certification, which was only recently submitted to the administration.

Taylor said he expects the remaining rules will be released “shortly,” but declined to provide a specific timeline. “I know people are working hard on it.”

While releasing the rules is a big step toward implementing FSMA, many stakeholders remain concerned the agency won’t have the resources to enforce them.

“We’ve said from the beginning we’ll need additional resources to fully implement this,” said Taylor. The Congressional Budget Office estimates FDA would need about $1.5 billion in additional funds over five years to do so, but so far Congress has not provided anywhere near that level of funding.

This article has been updated.

© Food Safety News
  • http://www.facebook.com/people/April-Ward/100003621097153 April Ward

    On the Produce Safety Rule:
    For over six years California leafy greens farmers have been operating under a system (the California Leafy Greens Marketing Agreement or LGMA) where food is produced with mandatory government oversight to provide a safe product for consumers.
    The LGMA trusts our program meets and/or exceeds the requirements that are likely to be in the new Produce Safety Rule, or if need be the LGMA program can be amended to meet any new requirements.
    Hear more about what one industry has been doing to make food safer here:  http://lgma.ca.gov/blog/fsma_fda_produce_rule

  • Russell La Claire

    The rule is only half the answer. As suggested at the end of the article, the other half is money for enforcement. FDA, year in and year out, fails at its assigned mission because it is not funded to accomplish that mission. 

  • Jon Barnes

    Thanks Helena, great post!  We crunched a few numbers too on the implementation cost to industry, this might be interesting:  http://www.fdaimports.com/blog/fda-current-good-manufacturing-practices/