On Friday, January 4, 2013, the U.S. Food and Drug Administration (“FDA”) issued a Proposed Rule which proposed revisions to the current Good Manufacturing Practices (“cGMPs”) requirements for foods along with proposing the regulation for Hazard Analysis and Risk-Based Preventive Controls (“HARPC”) under the Food Safety Modernization Act (“FSMA”). This is noteworthy because FDA has not substantively revised the Food cGMP regulations since their establishment in 1986. The Proposed Rule makes several important proposed revisions to the regulatory requirements.
FDA Proposal: Food Sanitation “Shoulds” to Become “Musts”
The most significant change in the proposed rule is this: What historically have been recommendations for food sanitation would become mandatory requirements if FDA’s Proposed Rule is finalized as currently drafted. Under FDA’s proposed food cGMP regulation, the Agency would delete twenty-one appearances of the word “should” and change nine instances of “should” to “must”. Where this is certainly significant, we note that FDA inspectors have been treating the “shoulds” in FDA’s food sanitation regulation as “musts” for years. But under this proposal, these “musts” would have the force and effect of federal law and enforcement.
One of the more significant proposed should-to-must changes would require food facility personnel responsible for identifying sanitation failures or instances of food contamination to have adequate education or experience. This would ensure the adequate competency resides at the facility to promote the production of clean and safe food. Additionally, food handlers and supervisors must be trained in proper food-handling techniques and informed of the dangers associated with insanitary practices.
Certainly having competent and trained food facility staff is rational and even intuitive. But the proposed regulatory requirement will cause hiring and training costs, as well as the related documentation requirements, to skyrocket.
Curiously, FDA predicts complying with this proposed requirement will represent $1,000-$25,000 in additional costs per facility. This range, of course is quite broad, and very significant to most firms, which are small. But, FDA also believes the total cost of this proposed requirement is $93 million for domestic facilities and $101.4 million for foreign facilities.
Now, FDA admits that its Official Establishment Inventory of regulated firms contains significant data integrity problems (the Agency doesn’t know how many registered facilities are active, operational, etc.), and the new database receiving the biennial food facility registration (under FSMA Section 415) is currently incomplete. (As of December 10, 2011, FDA was still counting registered facilities using the old registration database established for compliance under the Bioterrorism Act amendments). FDA nevertheless counts about 167,000 domestic facilities and about 254,000 foreign facilities. It should also be noted that the proposed rule leaves open whether this educational requirement will exempt farm workers and farm mixed-type facilities or whether it would exempt persons in facilities subject to seafood / juice HACCP. Thus, some registered facilities aren’t counted in FDA’s cost analysis, although it’s difficult to say how many.
Nevertheless, assuming about a 25% exemption rate, FDA’s estimated total cost for this aspect of the proposed rule is plainly too low — and perhaps grossly so. For instance, the Agency’s estimated total cost is $93-$101.4 million dollars. But if you divide that number by the number of firms that would probably be subject to the new requirement, you end up with only $742 per domestic firm ($93 million divided by 125,250 [which is 75% of 167,000 registered domestic food firms]) and only $532 per foreign firm ($101.4 million divided by 190.500 [which is 75% of 254, 000 registered foreign food firms]. That is one cheap educated and experienced food sanitation expert! Not only is FDA’s cost estimate per firm ($1,000-$25,000) extremely broad, FDA’s total cost estimate is grossly underestimated.
Food cGMP Controls Against New Hazards and Intentional Adulteration
Under its amended hazard analysis requirements, FSMA requires food facility owners / operators to identify and evaluate “known or reasonably foreseeable hazards that may be associated with the facility, including…radiological hazards…” Section 418(1)(b)(A). FDA proposes to define “hazard” as “any [biological, chemical, physical, or] radiological agent that is reasonably likely to cause illness or injury in the absence of its control. Thus, the statute requires that food facilities subject to reasonably foreseeable radiological risk (say, because they’re located near nuclear facilities) must now explicitly develop Food cGMP controls for exposure to such radioactive agents
Of course, one of the most significant FSMA amendments is the requirement to control for intentional adulterants, including those introduced by acts of terrorism. See Section 418(1)(b)(B). The proposed rule did not provide any Food cGMP regulatory changes to implement this requirement, and the agency explicitly indicated that this consideration is being left for another day (perhaps because it will likely be developed in collaboration with the U.S. Department of Homeland Security).
However, FDA explicitly requested comments on another type of intentional adulterant: those introduced for economic motives. Melamine is a famous recent example of such an economic adulterant: a nitrogen-based compound, it was added to animal feed because it could falsely create the impression (under laboratory analysis) that the food to which it was added contained more protein than the food actually contained. The proposed rule requests comments on whether such economic adulterants will be reasonably likely to occur, and therefore require mandatory Food cGMP preventative controls. If the final Food cGMP rule include such controls, then industry will likely need to develop increased competence about how their particular food products could reasonably be subject to economic adulteration (i.e., market analysis of these types of fraud), and also how to prevent it (e.g., gray market elimination).
Request for Comments and Deadline
The proposed rule covers many important revisions not discussed in this brief introduction. Interestingly, in the Proposed Rule for Food cGMPs, FDA did not incorporate the “opportunities” suggested by its 2005 Food CGMP Modernization Working Group. (However, some of those recommendations were implemented in the proposed HARPC regulation. Indeed, the proposed regulation indicate that FDA, in the future, will rely less on the Food cGMP regulation and instead rely on HARPC.) Thus, in its proposed rule, FDA requests comment as to whether it should incorporate such opportunities. The agency’s public comment period is open until May 16, 2013. Please contact FDAImports.com if you would like our assistance in developing comments to submit to the agency to impact the final rule concerning the most important modifications to Food cGMPs in over 25 years.
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