- | Regulation Regulation
- | Policy Briefs Policy Briefs
- |
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
The proposed rule revises the FDA’s current good manufacturing practice (CGMP) regulations regarding the manufacturing, processing, packing, or holding of human food in two ways. First, it adds preventive controls provisions as required by the FDA Food Safety Modernization Act (FSMA) that generally apply to facilities under the FDA’s current food facility registration regulations. It includes requirements for covered facilities to maintain a food safety plan, perform a hazard analysis, institute preventive controls for the mitigation of those hazards, monitor their controls, verify that they are effective, take any appropriate corrective actions, and maintain records documenting these actions. Second, the proposed rule updates, revises, or otherwise clarifies certain requirements of CGMP regulations, which were last updated in 1986. The FDA states that the primary benefit of this rule would be a decrease in the expected incidence of illnesses caused by the manufacturing, processing, packing or holding practices of human food. My comment argues that the FDA has failed to conduct a thorough and quantitative analysis. The FDA admits it is unable to quantify health benefits derived from this rule. Instead, the FDA has developed a qualitative assessment that describes how implementing this rule would likely reduce the level of foodborne illness. The FDA estimates the “breakeven illness percentage” for each of three closely related regulatory options that are not developed within a model of optimal food safety. The FDA thus does not conduct an in-depth benefit-cost analysis of this major revision of our nation’s food safety regulations.
The proposed rule revises the FDA’s current good manufacturing practice (CGMP) regulations regarding the manufacturing, processing, packing, or holding of human food in two ways. First, it adds preventive controls provisions as required by the FDA Food Safety Modernization Act (FSMA) that generally apply to facilities under the FDA’s current food facility registration regulations. It includes requirements for covered facilities to maintain a food safety plan, perform a hazard analysis, institute preventive controls for the mitigation of those hazards, monitor their controls, verify that they are effective, take any appropriate corrective actions, and maintain records documenting these actions. Second, the proposed rule updates, revises, or otherwise clarifies certain requirements of CGMP regulations, which were last updated in 1986. The FDA states that the primary benefit of this rule would be a decrease in the expected incidence of illnesses caused by the manufacturing, processing, packing or holding practices of human food.
My comment argues that the FDA has failed to conduct a thorough and quantitative analysis. The FDA admits it is unable to quantify health benefits derived from this rule. Instead, the FDA has developed a qualitative assessment that describes how implementing this rule would likely reduce the level of foodborne illness. The FDA estimates the “breakeven illness percentage” for each of three closely related regulatory options that are not developed within a model of optimal food safety. The FDA thus does not conduct an in-depth benefit-cost analysis of this major revision of our nation’s food safety regulations.
This rule is a Hazard Analysis Critical Control Point (HACCP) rule without calling it that. The FDA has two HACCP rules in place for seafood and juice that, by now, should have generated ample evidence as to how well these two rules have reduced the rate of foodborne disease. The most logical one to study is rule for seafood, as the FDA promised in the final rule to analyze it and determine if it had been effective, whereas the juice rule primarily moved raw fruit juice producers to either pasteurize their products or go out of business. The analysis for the seafood rule has not been done, but it should be done before implementing HACCP for all other foods under FDA’s jurisdiction. The measure of the seafood HACCP program’s success would be the first indicator of the likely effectiveness of this program for other foods.
Even before that the FDA needs a baseline risk assessment that attributes different pathogens and other contaminants both to specific food categories as well as to failures at the processing level, failures that this proposed rule is intended to address.
Finally, the FDA needs to consider a wider set of alternatives within a model of an optimal level of food safety that can be quantitatively assessed through conventional benefit-cost analysis.