Regulatory Transactions

Just over a year ago, President Obama used 15 pens to sign the FDA Food Safety Modernization Act (FSMA) into law. The most sweeping update to U.S. food safety law in more than 70 years, FSMA is a huge undertaking for the U.S. Food and Drug Administration, and, not surprisingly, the agency is already behind on some major deadlines in its efforts to implement it.

As of January 4, exactly one year from the time the law was enacted, the agency was supposed to have initiated the rulemaking process for science-based produce safety standards and finished rules for a foreign supplier verification program.  So far, FDA has not released these two critical rules — though it is rumored they may be released in February.

The FDA was also supposed to have published updated good agricultural practices (GAPs) for fresh produce, a guidance on protecting against the intentional adulteration of food (i.e. bioterrorism), and a National Agriculture and Food Defense Strategy, which, under the law, must be revised and updated every four years.

The agency was also supposed to have have published a guidance to help schools and childcare programs mitigate allergy risks, designated what falls into the “high-risk foods” category (which will face more strict recordkeeping requirements) and have created five Integrated Food Safety Centers of Excellence at health departments.

Michael Taylor, Deputy Commissioner for Foods at FDA, had warned that the agency would not meet all of the deadlines in the new law.

“This law has 50 major deliverables: regulation, guidances for industry, over a dozen reports to Congress, all due over the next two or three years, with timelines that are pretty strict,” said Taylor, during a policy Q&A session in Washington, D.C. last spring. “I’ve conceded publicly that it is physically impossible to get all of those deliverables to the finish line [within the deadlines]… so we are prioritizing.”

Though the one-year deadline has come and gone for some key elements of the new law, food safety advocates, who, along with industry, lobbied for FSMA, seem to be pleased with the agency’s progress on implementation. 

Consumer and public health groups are urging FDA to release the rules that are past due —  the Safe Food Coalition recently asked the Obama administration to release the rules “in a timely manner” — but they are also quick to point out that FDA has made great strides in the past year.    

“We’re been very happy with FDA’s approach to proposal development,” said Sandra Eskin, director of the food safety campaign at the Pew Charitable Trusts, adding that she believes the agency has done a good job of engaging a wide variety of stakeholders in the process. “These are complicated proposals … it’s understandable that it will take some time.”

Caroline Smith DeWaal, the head of food safety at the Center for Science in the Public Interest, reiterated that while advocacy groups are urging FDA to release the rules so the rulemaking process can get started, they are also happy with the progress that’s been made.  

Since FSMA was enacted, the agency has met a number of deadlines, according to its one year progress report.

For example, FDA met its foreign inspection mandate, of 600 facility inspections, for the year — this number is supposed to double each year for five years. There are nearly 200,000 foreign food facilities registered with the FDA to import into the United States.

The agency made its recall website more consumer-friendly, updated a food safety guidance for the seafood industry, and launched two traceability pilots with the Institute of Food Technologists.

The agency’s one year progress report also noted that the agency defined “high risk” and “non high risk” for fiscal year 2011 and between FDA and its contracts with states, 20,000 food facility inspections were conducted. There are more than 140,000 registered food facilities in the United States. 

“At this rate the Agency will most assuredly meet the domestic food inspection frequency mandates defined in FSMA,” the agency said in its report, issued in early January. “In addition, FDA is developing new risk-based approaches to domestic inspection to maximize public health benefit.”

Though FDA reported a lengthy list of accomplishments for FSMA’s first year (see full list here), the agency has a long way to go, with the most critical elements — like the produce safety rule, which some predict could be more than 125 pages, and the preventative control requirements for food and animal feed facilities — still to come.

“Although it can feel frustrating to wait on an overstuffed federal agency to provide more details about how it will soon dramatically enhance its regulatory authority – I do not find it to be too frustrating”, said Ben England, Founder and CEO of FDAImports.com.  “[T]hese are very complicated guidances and regulations FDA is expected to issue. It is better that it take longer and perhaps get it right.”

David Acheson, who served as associate commissioner for foods at FDA and now consults the food industry at Leavitt Partners, agreed that the delay was understandable, but suggested that the agency provide a “tentative time line” for going forward.

“FDA has done a great job so far and it is not unexpected that the deadlines would slip on these major proposed rules,” said Acheson. “Getting them written, approved by HHS and then through [the Office of Management and Budget] is a lot to do and my understanding is that the current hold up is at OMB. I think it would have been appropriate for FDA to announce that fact and let the world know what the adjusted tentative time line is looking like. After all, a lot of folks are waiting to read and begin to act on the new proposed requirements.”

According to an FDA spokesman, the agency doesn’t yet have a “specific timeframe for issuing these rules,” but they are “making significant progress.”