Division of Dockets Management (HFA-305)
Food and Drug Administration
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RE: Comments from the Association of Food and Drug Officials Docket No. FDA-2011-N-0259, “Periodic Review of Existing Regulations; Retrospective Review Under E.O. 13563”
In accordance with Executive Order 13563, “Improving Regulation and Regulatory Review,” the Food and Drug Administration (FDA) is conducting a review of its existing regulations to determine, in part, whether they can be made more effective in light of current public health needs and to take advantage of and support advances in innovation.
The Association of Food and Drug Officials (AFDO) is a non-profit professional organization consisting of state, federal, and local regulatory officials as members, with industry representatives participating as associate members. From its very inception over 115 years ago, AFDO has recognized the need for uniform laws and regulations and has actively promoted uniformity and cooperation among regulatory agencies at all levels. AFDO has also promoted the concept of a fully integrated food safety system for this country, which utilizes the resources and authorities of all levels of government as an effective means for meeting existing food safety challenges. FDA’s wish to determine the effectiveness of current regulations appears to embrace this concept, and AFDO is pleased to offer its specific comments to this review as follows:
1.) The FDA Food Code is the model regulation for retail food establishments. It is updated every four years through the Conference for Food Protection which permits insight from government, industry, consumer, and academic officials. The majority of food protection agencies have adopted at least a version of the FDA Food Code as their regulatory foundation for food safety for conducting food safety inspections at retail food establishments. While the concept of utilizing a model code as the recognized standard has been successful, for the most part, it does not remove the burdensome task of states promulgating new regulations through a time consuming process that includes hearings and scientific testimony. Generally, states cannot adopt a model code or “guideline” and can only use them as resource information. As a result, there are provisions of the FDA Food Code which do not exist in certain state regulations for retail food establishments. This lack of complete uniformity may occur as a result of industry lobbying efforts within a state or the lack of interest on behalf of the state food safety program to pursue specific code provisions. In addition, amendments to the Food Code occur more often than states care to go through their amendment process.requirement. One must ask what regulations FDA enforces when they conduct retail food inspections such as during national or international events such as the Olympics or the Democratic and Republican National Conventions.
A more perfect scenario would be for FDA to codify the FDA Food Code, which would allow states to more easily promulgate it by reference. There is no impact on retail establishments to have a state requirement that is already a federal
It is AFDO’s strong belief that codifying the FDA Food Code would eventually result in uniform national standards and uniformity relating to retail food safety.
2.) The states regulate interstate shipment of Grade “A” pasteurized dairy products through the Grade “A” Pasteurized Milk Ordinance (PMO). This requirement prohibits the distribution and sale of Grade “A” pasteurized dairy products from out-of-state sources unless that source has a verified preventative plan for food safety. While this system works well with domestically produced products, it does not for imported products as FDA does not restrict shipments of Grade “A” pasteurized products from foreign entities. As a result, states are left with the burden of either prohibiting the sale of these products within their states or traveling to these foreign countries for the purpose of verifying product acceptability. Some states have previously suggested that FDA should be the government entity to verify foreign Grade “A” pasteurized products.
Like the Model Food Code, the Grade “A” Pasteurized Milk Ordinance is updated every four years through the National Conference on Interstate Milk Shipments, which provides participation by government, industry, consumer, and academic officials. The federal adoption of the Grade “A” Pasteurized Milk Ordinance as a federal rule would remove the burdensome task of states promulgating new regulations through a time-consuming process that includes hearings and scientific testimony. Codification by FDA of the Grade “A” Pasteurized Milk Ordinance would allow states to more easily promulgate it by reference.
It is AFDO’s opinion that FDA should take a more active role in this matter either by adopting the Grade “A” Pasteurized Milk Ordinance as a federal rule or by prohibiting the export of Grade A pasteurized dairy products into this country where verification has not been established.
AFDO believes uniform regulatory reform is necessary to advance a national integration strategy for addressing food safety issues, and enhancing consumer confidence in the safety of our food supply. These two measures would help to achieve these objectives as would a system of periodic review of regulations.
AFDO appreciates the opportunity to comment. Should you have additional questions or need clarification on any of the topics discussed herein, please do not hesitate to contact me.
Ronald S. Klein