What’s Happening with FSMA? And How FDA’s Working Around the Delay
Posted Date: 4/24/2012
Last week at the 14th Annual Food Safety Summit in Washington, DC, one subject dominated everyone’s discussion— The Food Safety Modernization Act (FSMA), or more specifically, what was happening with it.
This game-changer set of regulations was signed into law well over a year ago, but implementation in its entirety is stuck, largely due to a slow-grinding process, but also lack of adequate funding. January 2012 was the originally-set deadline for the Food and Drug Administration to put in place four of the most critical rules:
Preventive controls for food facilities;
Preventive controls for animal feed facilities;
Foreign supplier verification program; and
Produce safety rule.
But a good three months later, the rules are under review at the White House Office of Management of Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA). But what’s concerning stakeholders is that they’ve now been there for five months, far longer than the 90-day limit.
At the meet last week, Caroline Smith deWaal, Director of Food Safety for the Center for Science in the Public Interest, remarked: “The review period cannot be open for so long. Why the delay?”
Michael Taylor, FDA’s Deputy Commissioner for Foods, had to explain this delay twice, on consecutive days. The rules were not actually stalled, he assured, but just “caught in the logistical challenge of getting this volume of rulemaking done and out the door at the same time.”
In a subsequent Q&A, Taylor described as each rule being complicated in its own right. “And not only is each complicated, they’re interconnected. They are traveling as a package, because there are linkages between preventive controls and produce safety, linkages between those standard-setting rules and the foreign supplier verification rule. And all of this has to work together as a package,” was his explanation.
Taylor’s comments or answers did little to placate stakeholders, who feel they are increasingly in the dark, especially not really understanding the reason behind the delay. Another concern is that the decision could be stalled further with this being an election year.
Multiple stakeholders are continually exerting pressure on the OMB. Last week, Consumers Union sent a letter to the OIRA (a division of the agency that conducts cost-benefit analysis for major regulations) urging OMB to release the rules “before more consumers become seriously ill.”
Referring to the recent Salmonella outbreak linked to leafy greens, the letter described that “The health and safety of hundreds of thousands of Americans depend upon the rules moving forward. We strongly urge you to release these rules so that the broad public can provide input to FDA, and FDA can proceed to issuing them in final form.”
Pointing to Salmonella-contaminated tuna scrape from India sickening 160 people in 20 states, Senator Bob Casey (D-PA) wrote last week to Jeff Zients, Acting Director at OMB, asking the agency to promptly review the FSMA rules.
“This latest outbreak should be a wakeup call for OMB that it’s time to release these food safety rules,” argued Casey. “OMB has had more than enough time to consider these safety rules. It’s time to get these rules out of the door for public comment and better protect Americans against these outbreaks.”
In the meantime, there are several new announcements from FDA, which is trying to leverage different tools to send strong signals to the agency.
In the first instance, FDA is moving ahead with reinspection fees, and began adding a section to Warning Letters, declaring its authority to assess and collect fees to cover its costs for reinspections.
In another instance, a recent draft guidance, announced by Taylor referred to the judicious use of antibiotics in food-producing animals.
David Acheson, M.D., Managing Director for Food and Import Safety at Leavitt Partners LLC, feels that FDA probably has decided to work around the regulatory process to move forward its initiatives, instead of simply accepting the inherent governmental lags.
“Taylor seems to be (rightly) passing on some of the onus for the delayed publication of FSMA rulings to the OMB on whose desk the pile is pending,” writes Acheson, who was earlier Chief Medical Officer at FDA’s Center for Food Safety and Applied Nutrition, in his latest blog.
FDA seems to be seeking ways to move food safety actions forward despite standard complaints of cumbersome regulatory process. Let’s hope that in the light of FSMA being stalled, FDA will be forced to move forward in other ways.