From: Dan Sowards [Dan.Sowards@tdh.state.tx.us] Sent: Wednesday, February 05, 2003 8:58 AM To: 'fdadockets@oc.fda.gov' Cc: 'rbarnes@ora.fda.gov'; 'cwogee@dhs.ca.gov'; 'risaunders@vdacs.state.va.us'; 'joe.corby@agmkt.state.ny.us' Subject: DOCKET NO. 02N-0276 REGISTRATION OF FACILITIES..... The following comments are related in Docket No. 02N-0276, Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. In the Federal Register announcement and request for comments dated February 3, 2003, FDA provides 8 possible alternatives for "who should register." We believe that Option 2 is the correct option for FDA to use for this purpose. Our recommendation to FDA is based upon the following rationale: 1. Although the FDA has long used the philosophy that foods whose ingredients and/or packaging has come from interstate sources, are subject to FDA jurisdiction, FDA has not routinely used this interpretation of the law over the past 10 years or so. Further, FDA often uses a "percent interstate sales," and/or dollar value of goods in interstate commerce, as a rationale for regulating under the Federal Food, Drug, and Cosmetic Act. Therefore, it is reasonable to assume that for the purpose of "registration" FDA must be 100 percent even-handed in how it determines who should register and should no longer rely on "interpretations" that are sometimes vague and often unevenly applied throughout the U.S. Such decisions over the years have created Official Establishment Inventories between Districts, and within Districts, that change with time and administrations, rather than remaining constant as the law is constant. Consequently, Option to should be applied as it requires all INTRASTATE manufacturers and processors and distributors to register, in addition to all considered to be "in interstate commerce." This will ensure that all potential targets for a bioterrorist attack are registered and can be notified if/when needed. 2. Even small firms that are considered outside the jurisdiction of FDA for the purposes of inspection (OEI versus "not OEI" or "Auxiliary OEI) often receive raw materials are shipments of finished product from sources outside their home state. These establishments are just as important as larger "interstate" firms when it comes to notification purposes. 3. FDA has tried very hard for over 30 years to reconcile State agency inventories and FDA inventories of the various types of regulated establishments in the OEI. Most if not all of these attempts, according to state regulators in a number of jurisdictions, have been unsuccessful or only partially successful - for a multitude of reasons. Requiring all intrastate and interstate facilities to register will greatly assist both the States and FDA in identifying all regulated facilities. Further, many companies operate multiple facilities, and this will enable FDA (and ultimately the States) to identify all of the facilities being operated, including warehouse facilities that are often overlooked because of their limited size or for some other reason. 4. Since the object of registration is ultimately to protect the consumer from foods that may have been involved in a bioterrorist event, the public needs to feel a sense of security regarding the food supply. And since so many of our food facilities are not currently in FDA's inventory, it seems only reasonable that a sense of security would be greatly enhanced by ensuring that ALL domestic food facilities are registered. 5. The option of including on the registration form the "category" or "type" of food warehoused, produced, or sold by a facility should not be an option, it should be required. This information appears to us to be critical in determining who should be notified in case of a threat or real terrorist event targeting a particular type of food. However, having had many years of experience in dealing with FDA's current system of "typing" foods by type of packaging, type of processing, etc., a much simpler way of classifying food types will be needed. The current system which FDA uses for inspectional typing is very burdensome and requires extensive training, and therefore should not be used for this purpose. General categories, such as those utilized for classifying an establishment (03 for bakeries, 16 for fishery products, 29 for soft drinks, 47 for food warehouses, etc.) should suffice as a means of categorizing establishments. We should like to add a few additional comments as well. We believe that FDA should ensure that the definitions utilized for registration purposes do not exclude facilities that should be registered. These include, but not limited to: a. Warehouse facilities utilized by retail grocery chains even though the foods are technically distributed only to their own retail stores (hence only "retail" sales). b. Commissaries used by large restaurant chains to manufacture various products (buns, etc) that are ultimately distributed to all of their restaurants nationwide. In both of these cases large populations are served from a single source, so it would behoove FDA to include these in the registration process. Further, many of these types of facilities are already in FDA's OEI because they often ship foods interstate. We should also point out to FDA that many retailers utilize ingredients shipped through interstate commerce in "manufacturing" foods in-store. This includes colors, flour, potatoes, spices, and many, many other ingredients. Therefore, although we ultimately agree that it would be extremely burdensome to include true retail operations in the registration process, we should all be aware that they, too, could be subject to a bioterrorist event, at least indirectly. Tampering often occurs at retail rather than at the manufacturer. We should also point out to FDA that State agencies often have much more complete inventories of regulated establishments, including retail. FDA should not hesitate to utilize these resources to ensure that establishments covered in the final regulation do not "escape" the registration process. We would even go so far as to suggest that FDA supply States with copies of the finalized registration forms and instructions to be handed out during routine State inspections of these establishments. However, FDA must ensure that States are not burdened with FDA's responsibilities by having to make copies of these documents or having to mail copies to licensees. States, including Texas, are seeing extreme financial hardships these days, and any additional strain on our resources would not be looked upon kindly. At the same time, we would not object to providing documents to our constituents during inspections to ensure they are not later subject to penalties for failure to comply. But all copies must come from FDA. Finally, we fully concur that registration of "facilities" is the correct approach, rather than simply registering companies, corporations, or partnerships. Although FDA may be able to devise a registration form that would "capture" all of a corporation's locations, it is very important that all locations have separate registration numbers for identification and even inspectional purposes. Thank you for the opportunity to comment. Respectfully submitted, R. D. Sowards, Jr. Director Manufactured Foods Division Texas Department of Health 1100 West 49th Street Austin, TX 78756 Dan Sowards, Director Manufactured Foods Division phone: 512-719-0243 fax: 512-719-0263