Critical Food Safety Rules Still in Regulatory Limbo, Now Stuck at White House for a Full Year

One of the crowning legislative achievements of the Obama Administration’s first term was the enactment of the Food Safety Modernization Act. 

Like any safety statute, however, the new law will have no practical bite until the implementing rules are issued. In this case, that’s until the Food and Drug Administration (FDA) promulgates regulations fleshing out the obligations of growers, producers and importers of food.  Unfortunately, after almost two years, the regulations for the three most critical programs enacted by the new law have been written, but have not yet been promulgated.

On Thanksgiving Day, one set of implementing regulations will have been bottled up at the White House’s Office of Information and Regulatory Affairs (OIRA) for exactly one year.  Two other critical sets of regulations will pass the one-year milestone between Thanksgiving and December 9. 

Signed by President Obama in January 2011, the new law was enacted in response to a series of crises throughout the Bush Administration involving, among other things, peanuts contaminated with Salmonella during processing at a Georgia facility, fresh vegetables contaminated with an especially virulent form of E. coli bacteria, and Salmonella-contaminated imported jalapeno peppers.

The FSMA tells the Food and Drug Administration (FDA) to write regulations requiring most food processors and manufacturers to come up with hazard analysis at critical control point (HACCP) programs and to write “science-based” minimum sanitation standards for growers to follow during the production and harvesting of fruits and vegetables.  The new law also told FDA to write regulations requiring importers to verify that their products were produced under conditions that complied with FDA food safety requirements.

All three of these regulations have the potential to make the food we eat much safer.  HACCP programs require companies to undertake a hazard analysis of the entire facility, identify “critical control points” where hazards can be reduced, monitor the performance of the program at those control points, and take immediate corrective action if the prescribed safety technologies and practices do not perform as expected.  The regulations should also require periodic sampling and monitoring of the product for the presence of contaminants.

The produce sanitation standards will represent the first time that the federal government has attempted to prescribe safety practices for growers.  Although they may not be as effective as HACCP, the standards will represent a giant step in the direction of produce safety.

The import requirements are increasingly critical to a safe food supply in this country, because we import 15 percent of our food supply, 50 percent of our fresh fruit, 20 percent of our fresh vegetables, and 80 percent of our seafood.

Under the statute, all three of these regulations should have been fully promulgated by last July, but the agency has not even published a proposed rule for public comment. 

Exactly a year ago, FDA sent drafts of its notices of proposed rulemaking for the regulations to OIRA.  Under the executive order under which OIRA reviews major federal regulations, OIRA was supposed to have finished its review within 90 days, or 120 days at most with an extension.  But the Obama Administration apparently did not want to give the conservative media echo chamber a target during the election year (despite strong public support for stronger food safety rules), and the draft notices are still trapped in OIRA.

The election is over.  President Obama won.  It’s time for the Administration to show some leadership on the issue of food safety.  Even much of the food industry, including the largest food retailers, are anxious to get these rules on the books. 

It is time for OIRA to free up the regulations so that FDA can start the process of soliciting public comment on its proposal.  Once they are published, we are still likely at least a year away from final regulations. 

In the meantime, we can expect another series of food safety crises to fill the newspapers as thousands of Americans become afflicted with foodborne diseases, and too many Americans will die because OIRA has allowed political considerations to trump public safety in delaying FDA’s promulgation of these critical regulations.