November 14, 2013

FDA’s preventive controls rule: hollowed out by OIRA, and less costly than the agency suggests

proposed rule on “preventive controls for human food” would require manufacturers, processors, and warehouses to design a written food safety plan tailored to each facility’s products and operations. (The rule would also apply to mixed-type facilities that conduct processing activities on a farm.) In general, facilities would have to identify the potential hazards in their processes and then implement controls to minimize or prevent them. This system—Hazard Analysis and Risk-Based Preventive Controls, or HARPC—is intended to address microbiological, chemical, physical, and radiological hazards in food processing, as well as undeclared allergens.

CPR Member Scholars Rena Steinzor, Lisa Heinzerling, Sidney Shapiro, Policy Analyst Michael Patoka and I submitted OIRA) eliminated a number of crucial provisions that the FDA had originally proposed, including requirements for:

(1)    Certain sanitation practices;

(2)    Food-safety training for employees;

(3)    Review of consumer complaints;

(4)    Environmental monitoring for pathogens (testing of locations throughout the facility);

(5)    Finished product testing;

(6)    Supplier approval and verification programs; and

(7)    Review of the records associated with these activities.

In the gutted version that emerged from OIRA’s review, the FDA clarified that it is not proposing any of these measures at this time but is instead just requesting comment on them. Meanwhile, all the information prepared by the agency to explain and justify these requirements was relegated to an appendix at the back of the seized on the technical distinction between “proposing” and “requesting comment,” threatening that the FDA would be violating the Administrative Procedure Act if it includes these requirements in the final rule without providing additional opportunities for comment.  In effect they are insisting that if FDA decides to add one of the provisions that OIRA deleted from the text of the proposed rule, the agency would have to promulgate a second proposed rule, with additional months (or years) of needless delay.  This is, of course, a specious argument, because the industry groups have access to all the FDA’s original draft documents, including the draft proposals containing the language that OIRA excised.  Thus, they can see exactly how these requirements would fit into the final rule, and they have ample opportunity to weigh in on them during this comment period—just like we are.  If FDA decides to restore the excised proposals, and we hope that it does, it should not be cowed by the industry objections into sending the proposal through another rulemaking exercise.

According to the FDA’s own research, the top factors responsible for tainted processed foods are (1) deficient employee training, (2) poor sanitation, (3) a lack of supplier controls, and (4) a lack of environmental monitoring. Yet the requirements that were specifically designed to address each of these areas were among those eliminated by the White House.

Many recent outbreaks may have been prevented if facilities had already adopted these measures. For example, thousands of products have become entangled in outbreaks and recalls because they failed to anticipate or detect contamination in their raw ingredients they obtained from suppliers—most notably in the peanut paste outbreak of 2009, which caused 714 illnesses and 9 deaths and resulted in the recall of nearly survey suggested around 44 percent already use electronic food safety records. The rule itself is expected to push many more facilities toward modernization, which will not only make recordkeeping easier but also improve efficiency and profitability in other ways. As a result, the estimated cost of the rule is unrealistically high.

Finally, the experiences of other industries suggest that the costs will be manageable. In the late 1990s, as similar “HACCP” regulations were going into effect for the seafood industry, seafood processors had the same concerns about cost that processors of other foods are expressing now. But HACCP was not the financial disaster that many feared it would be, and the industry here.


Thomas McGarity, CPR Member Scholar; Endowed Chair in Admin. Law, University of Texas School of Law. Bio.

Michael Patoka, Policy Analyst, Center for Progressive Reform. Bio.

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