It’s been well over a year since the monumental Food Safety Modernization Act (FSMA) was signed into law and so far implementation has been riddled with speed bumps, not to mention funding woes.
Four of the most critical rules that Congress mandated the U.S. Food and Drug Administration to write and put in place — preventative controls for food facilities, preventive controls for animal feed facilities, the foreign supplier verification program, and the produce safety rule — were supposed to be out in January, so that the arduous rulemaking process could officially begin.
The rules are under review at the White House Office of Management of Budget’s Office of Information and Regulatory Affairs, which is a normal stepping stone for major regulations. What has stakeholders concerned is that they’ve now been there for five months, far longer than the 90-day limit.
Michael Taylor, Deputy Commissioner for Foods, told Food Safety News in late January that the rules were not stalled, but it was simply “the logistical challenge of getting this volume of rulemaking done and out the door at the same time.”
In the months since, key industry groups, consumer advocates, lawmakers, food safety experts, and editorial boards, even the Scranton Times-Tribune, have all called on OMB to release the rules. It seems just about every stakeholder wants the rules to be made public, and yet, four months after the statutory deadline, there is no indication of what exactly is holding up the process.
“Each one is complicated in its own right,” said Taylor, during a Q&A session at the 14th Annual Food Safety Summit in Washington, DC last week. “Each document is substantial. Not only is each complicated…they’re interconnected. This is why they’re traveling as a package, because there are linkages between preventative controls and produce safety, there are very significant linkages between those standard-setting rules and the foreign supplier verification rule. This all has to to work together as a package, so there are a lot of issues.”
Taylor said the agency is working closely with OMB to resolve remaining issues, describing the process as “highly interactive” and ongoing. “I feel very comfortable sharing with folks that we’ll get these out as soon as possible and you all will have a lot to read in the not too distant future,” said Taylor.
But stakeholders are growing anxious, especially given the fact that most are at a loss for what is causing the delay.
“We don’t have any details. We’re eager for them to come out,” said Kathy Means, vice president of government relations at the Produce Marketing Association, whose member companies handle more than 90 percent of the fresh produce sold domestically.
PMA wrote to President Obama earlier this month asking that the stalled rules be made public, so that the industry can have a greater degree of certainty moving forward.
“Over the past 10 years, enormous advances in our understanding and implementation of food safety practices have made fresh fruits and vegetables safer than ever before and we continue to innovate,” read the letter. “However, the lengthy congressional debate over food safety combined with draft regulations that have missed the statutory deadlines create uncertainty and paralysis. It is much more difficult for companies to invest in additional food safety safeguards without knowing what the FDA rules will be. At the same time, the unreleased rules damage the confidence of consumers who await the new requirements.”
“We don’t know exactly what’s in the rules, but we’re hearing that they’re very long,” said Means. “We want to be sure they are science-based and risk-based.”
Consumer and public health groups don’t seem to have any idea what is causing the delay either.
“If I was one of the typical political pundits, I would say I know, but I really don’t,” said Sandra Eskin, director of the Pew Health Group Food Safety Campaign. “There are probably still some substantive concerns, but also some political calculations here.”
Though the Obama administration has given food safety issues high level attention, some advocates worry that major regulations, even ones generally backed by the food industry, could be stalled with the 2012 presidential election looming on the horizon.
“I think everyone understands where we are on the calendar, but public health and consumer advocates understand that [food safety] is hugely important to consumers,” added Eskin, citing polls commissioned by Pew. “It would be a good thing for the President to move this forward.”
Consumers Union sent a letter last week to OIRA administrator Cass Sunstein, urging OMB to release the rules “before more consumers become seriously ill” — OIRA is the subset of agency charged with conducting cost-benefit analyses of major regulations. CU cited the recent leafy greens recall linked to Salmonella, writing that it “underlined the serious risks to consumers that exist in our food supply.”
“The health and safety of hundreds of thousands of Americans depend upon the rules moving forward,” read the letter. “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.”
Senator Bob Casey (D-PA) points to a different food safety issue as reason to move on the FSMA rules: 160 people in 20 states, including Pennsylvania, have fallen ill and the likely culprit is Salmonella-contaminated tuna scrape from India.
“This latest Salmonella outbreak should be a wakeup call for OMB that it’s time to release these food safety rules,” said 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.”
Casey wrote to Jeff Zients, Acting Director at OMB, last week, asking the agency to “promptly review the food safety rules.”
“OMB must take seriously its responsibility to promptly review the rules in order to improve food safety and allow FDA to direct its attention toward this issue in order to ensure that the American food supply is safe,” wrote the senator.
Part of the challenge in tracking rules at OMB is that the process is shrouded in mystery. The agency doesn’t comment on rules under review and even when measures are released the public will likely never know what changes were made during the review process, no matter how substantial.
“The disclosure over there is a huge problem,” says Katie Greenhaw, a federal regulatory policy analyst at OMB Watch. “It’s really difficult. Even in an administration like Obama’s, they don’t want to limit the power of an executive agency.”
According to Greenhaw, it’s not uncommon for rules to languish at OIRA. The agency is reviewing more than 100 rules and around 60 of them have been there past the 90-day deadline.
Oftentimes, though, the rules are stuck because they are controversial — viewed as job-killers, loathed by industry, or otherwise tied to political baggage — but that’s not the case for the FSMA measures.
The major industry groups, all the players along the food chain, from farm-to-fork, have been highly engaged with FDA
on these issues and lobbied for Congress to pass FSMA.
“That’s an interesting case. That tends to not happen,” said Greenhaw.
There’s been some quiet speculation that the produce safety rule has perhaps had more problems than the other proposed rules — and a review of OMB meeting logs shows only three food-related FDA meetings in 2012, all in March, all regarding produce safety — but no one knows for sure.
For now, stakeholders continue to write letters and wait.
“We will continue to beat the drum here until the rules come out,” said Eskin. “The longer this takes, the more everything else in the bill will be pushed back.”