On March 31, 2008, FDA published a Federal Register notice announcing the availability of Compliance Policy Guide (“CPG”) § 500.500, which sets “guidance levels” for 3-MCPD in acid-hydrolyzed protein (“acid-HP”) and Asian-style sauces. 3-MCPD is a chloropropanol, and chloropropanols have been identified as carcinogens. Under certain conditions, 3-MCPD may be formed during production of acid-HP, which is then used as an ingredient in some Asian-style sauces.
A guidance level is not binding on FDA or on industry, and can not serve as the direct legal basis for an enforcement action. Thus, FDA states that the purpose of CPG § 500.500 is “to provide guidance to help FDA personnel determine whether to take enforcement action based on the presence of 3-MCPD,” and that FDA “will determine whether to take enforcement action . . . on a case-by-case basis, considering the totality of the circumstances. In any given case, FDA may decide to initiate an enforcement action against [products] with concentrations of 3-MCPD below 1 ppm or decide not to initiate an enforcement action against [products] with concentrations of 3-MCPD at or above 1 ppm.” Notably, CPG § 500.500 is silent as to factors that could lead the agency to take enforcement action against products that contain 3-MCPD below the guidance level, or to refrain from taking enforcement action against products that contain 3-MCPD above the guidance level. Thus, it remains to be seen just how FDA will make use of the guidance levels in determining whether to take enforcement action.
FDA previously set guidance levels for radionuclides in food. FDA interprets those guidance levels as indicative of the presence of a poisonous or deleterious substance, or of insanitary conditions, that may render a food injurious to health. But in CPG § 500.500, FDA interprets guidance levels as indicative of the presence of an unsafe food additive. Whatever the underlying legal theory, the nonbinding nature of guidance levels means that FDA will need to rely on a wholly separate evidentiary basis to pursue enforcement actions relating to 3-MCPD and other substances that are the subject of guidance levels. Notwithstanding this important limitation, we expect that FDA will continue to set guidance levels as a means of conserving scarce resources and avoiding the rigidity that setting action levels though rulemaking would impose.
Comments on CPG § 500.500 can be submitted at any time to the FDA Division of Dockets Management (Docket No. FDA-2008-D-0143).