Docket Management
Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC -15

Accepted - Volume 2

Comment Record
Commentor Dr. Rhona Applebaum Date/Time 2002-08-30 14:03:32
Organization National Food Processors Association
Category Association

Comments for FDA General
Questions
1. General Comments August 30, 2002 Dockets Management Branch (HFA-305) Food and Drug Administration Room 1061 5630 Fishers Lane Rockville, MD 20852 Re: Docket No. 02N-0276; Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Section 305, Registration of Food Facilities. Dear Sir or Madam: The National Food Processors Association (NFPA) appreciates the opportunity to submit comments in anticipation of a proposed rulemaking on the above referenced section of the Bioterrorism Act as applicable to the statutory provisions for registration of food facilities. NFPA recognizes that, under the Act, the Secretary is required to issue final regulations addressing Section 305 by December 12, 2003. NFPA is providing these comments to assist FDA in meeting that statutory deadline. NFPA is the voice of the $500 billion food processing industry on scientific and public policy issues involving food safety, food security, nutrition, technical and regulatory matters and consumer affairs. NFPA’s three scientific centers, its scientists and professional staff represent food industry interests on government and regulatory affairs and provide research, technical services, education, communications and crisis management support for the Association’s U.S. and international members. NFPA members produce processed and packaged fruit, vegetable, and grain products, meat, poultry, and seafood products, snacks, drinks and juices, or provide supplies and services to food manufacturers. NFPA members would be affected by the rulemaking on facility registration that has been mandated under the Act. General Comments The purpose of the registration requirements under the Act is to authorize the Secretary to compile an up-to-date list of relevant facilities to enable the Secretary to rapidly identify and contact potentially affected facilities in the context of an investigation of bioterrorism involving the food supply. Regulations promulgated for this purpose should not impose unnecessary and burdensome requirements on registrants. Rather, regulatory requirements should allow for flexibility in gathering needed information in a manner that suits the structure of an individual facility or corporation. NFPA urges FDA to consider the remarks of Congressman John Shimkus, a sponsor of H.R. 3448, who noted on its introduction in the House on December 11, 2001, that the Department should work in a cooperative manner with facilities in terms of their obligations to register, and should be reasonable in situations where facilities are making good faith efforts to comply. NFPA also supports the remarks from the Congressman urging that the registration process be made as simple as possible, and that the Secretary assure that implementation does not unnecessarily disrupt the flow of commerce. Furthermore, NFPA members support congressional remarks calling for registration to be a one-time process with no imposition of a registration fee. This would provide that once a facility is registered, it would not be required to re-register but only to amend the original registration as necessary to reflect significant changes. NFPA also strongly supports statements made by FDA officials about the need to complete rulemaking on facility registration in advance of the December 12, 2003, statutory deadline for registration, in order to allow covered facilities the opportunity to register in advance of the deadline. NFPA believes it is essential to the smooth conduct of the registration process to accommodate a registration period in advance of the statutory deadline, and a 60-day period for such registrations is reasonable. Were FDA to fail to provide such a registration period, through delays in publishing the anticipated final rule, NFPA believes the international system of food production and transport would be in chaos. The absence of a registration period prior to December 12, 2003 would be burdensome and confusing to industry. Thousands of covered facilities registering simultaneously, even in the absence of a rule, will result in gridlock of any registration system, paper or electronic, that might be contemplated. Further, covered facilities would be required to register twice, once to meet the statutory deadline, and again to adjust information based on the requirements of the final rule. This type of double registration must be avoided, as it would be a waste of resources for both the food industry and the FDA. Thus, NFPA strongly encourages FDA to propose and complete the registration rulemaking as expeditiously as possible. Clarification of the Registering Entity NFPA strongly urges FDA to define the concept of “registering entity” with appropriate flexibility to allow companies to register as best suits their corporate structure. The flexibility that NFPA envisions would accommodate either a parent corporation that wished to register all of its facilities, or individual facilities that intend to register on their own behalf. Regulatory language also should make clear that business offices in which food is not processed, stored, or packed are exempt from the facility registration requirement. With respect to the registration of foreign facilities, especially food processing establishments, NFPA recommends that FDA urge such establishments to submit a facility registration, even if the foreign processing facility is uncertain whether its food products are sold into United States’ markets. NFPA is confident that food processors that produce products in the United States will ensure that their foreign facilities are registered. Registration of an ample proportion of foreign production facilities would ensure that food products produced at these facilities would enter U.S. markets without delays since they will have complied with the registration requirements. Please note that in the case of food from a foreign production facility that does not regularly export product to the United States, the facility registration does not necessarily suggest, in and of itself, that food products from such facility would comply with the adulteration and misbranding provisions of the FFDCA. Flexibility for Format and Procedures The Act requires the registering entity to include the name and address of each facility at which, and all trade names under which, the registrant conducts business. NFPA urges FDA to clarify that the meaning of “trade names” refers to the names under which the business itself operates. The Agency should allow for wording such as: “doing business as,” “operating under,” “division,” and “subsidiary” to characterize trade name. NFPA supports the use of electronic submission of the information, with the appropriate controls and assurances in place for authenticity and confidentiality. We believe many of the entities registering will prefer electronic submission. Many companies may already have the information on hand that would be required for facility registration, and this information easily could be submitted to FDA electronically. NFPA recommends that FDA establish clear and easy-to-follow procedures for electronic registration. Simple procedures will minimize reporting burden. NFPA emphasizes the need to allow for a company or corporation headquarters to register all its facilities in a single electronic submission. NFPA believes it is essential for FDA also to accept paper registration, to accommodate those not adept, uncomfortable with, or unable to use electronic submissions. NFPA recommends that any form for paper registration be as simple and easy to complete as possible. For companies that elect to file paper registrations, NFPA recommends that FDA allow company or corporation headquarters to register all its facilities with a single paper submission. With respect to the assignment of registration numbers, it is important that FDA provide these numbers as quickly as possible after receipt of registration information. Prompt issuance of registration numbers will be essential to the smooth continuance of commerce and international trade. NFPA would support any electronic registration system that would assign registration numbers automatically. NFPA expects that, when the Agency begins to implement the final rule on facility registration, FDA will be flooded with registration submissions. An automatic registration number generating system will minimize any disruptions caused by failure to assign registration numbers promptly. With respect to registrations filed on paper, NFPA urges FDA to develop a system that ensures speedy assignment of registration numbers. In these cases, a clerical performance standard will be essential to managing the flow of any paper registrations. After the initial wave of registrations is completed, NFPA expects that FDA will implement a system to assign a registration number promptly upon receipt of a registration, whether paper or electronic submission. The prompt issuance of a registration number will be critical for any importing facilities that have not previously registered. Especially for perishable products received at port, FDA should provide a mechanism that ensures that registration numbers are issued to previously unregistered facilities within 24 hours, so that such products will not be denied entry into the U.S. market. NFPA urges FDA to make provisions for food processing firms that wish to use specific establishment numbers issued by federal regulatory agencies as their facility registration number, provided that the registration number is not already assigned. This approach would allow food processors that process both meat and/or poultry, regulated by the USDA Food Safety and Inspection Service (FSIS), and FDA-regulated food products in the same facility to use the numeric portion of the USDA official establishment number as the facility registration number. Similarly, provision should be made to permit an establishment that processes FDA-regulated low acid canned foods to use its FCE number as its facility registration number, provided those registration numbers have not been assigned. This approach would reduce confusion and simplify administrative procedures in food processing facilities. Such a schematic would assume that the FDA facility registration number is a numeric designation, as differentiated from alpha-numeric. As the numeric portion of the FSIS establishment number, and the FDA FCE number, both use the same number of digits, NFPA recognizes that there may be some conflict among discrete numbers. Thus, NFPA recommends that the pre-assigned numbers might be elected as facility registration numbers if available, but that FDA need not reserve any numbers that may be used already in the two noted federal regulatory applications. NFPA recognizes notifying FDA to advise of any change in the registration information could pose challenges. NFPA believes that it would be an appropriate and efficient use of Agency resources for FDA to establish a reasonable time frame from the date of any change in the data in a facility registration for a registrant to make amendments to the registration. NFPA believes that 60 days would constitute such a reasonable time period for these amendments. Clarification of Exemptions The Act provides language for exemption of certain types of facilities. NFPA believes that the exemptions defined in the statute and in legislative history are appropriate. Exemptions should cover retail food establishments including grocery stores, convenience stores, cafeterias, lunch rooms, food stands, saloons, taverns, bars, lounges, catering or vending facilities, or other similar establishments that store, prepare, package, serve or otherwise provide food directly to a retail consumer. NFPA notes that many of these types of facilities exempted from registration parallel the types of establishments exempt from the requirements to provide nutrition labeling, as described in 21 CFR 101.9(j)(2) and (j)(3). NFPA recommends that FDA consider the regulatory language in these two sections of established rules in clarifying and specifying the types of facilities exempt from registration. In addition, NFPA urges FDA to clarify in the registration regulations that fishing vessels not engaged in processing, as defined under FDA’s seafood HACCP rule (21 CFR 123.3(k)), are excluded from the definition of “facilities,” as are trucks or other motor carriers in their usual course of business as carriers. Information on the Content of the Registration NFPA notes that the Act includes language on information that may be required for registration: “…when determined necessary by the Secretary through guidance, the general food category (as identified under section 170.3 of title 21 Code of Federal Regulations) of any food manufactured, processed, packed, or held at such facility.” NFPA urges FDA to give careful thought to the wisdom of including the food categories, as defined in 21 CFR 170.3, as part of the registration requirements. Many food processing and handling facilities will regularly produce or handle products in more than one category, so the information would not necessarily be useful in identifying products by facility. NFPA believes that when such descriptive lists as represented in 170.3 are used for different purposes than originally designed, the second and subsequent applications are often disappointing in their results. NFPA believes that the food product categories in 170.3, which were designed to help facilitate the approval of food additive uses, are ill suited to application as a food product identification device for facility registration. We note that some of the categories in 170.3 involve food products not regulated by FDA (see 170.3(n)(2), (n)(17)). In addition, only one of the categories is specific to a single food product, 170.3(n)(41), for white granulated sugar. Furthermore, NFPA notes that 170.3 constitutes part of the framework defining food additives, and, consequently, NFPA doubts that FDA could amend 170.3 to include a category for dietary supplements, because of the exclusion of dietary supplements from the definition of food additives, in section 201(s)(6) of the FFDCA. NFPA also notes that other types of food product lists established by FDA do not improve the situation associated with use of 170.3. Not even the list of foods for serving sizes, in FDA’s nutrition labeling rules (21 CFR 101.12), is consistently detailed to the food product level. NFPA notes that a useful list of food products would be thousands of items long. Reporting under such a list would be too burdensome for industry, not to mention the unbelievable burden on regulators to develop such a list in short order. Conclusion NFPA thanks you for consideration of these comments, anticipates an opportunity to respond to FDA’s regulatory proposals and welcomes the challenge of working with FDA towards a safer and more secure food supply. Sincerely, Rhona S. Applebaum, Ph.D. Executive Vice President Scientific and Regulatory Affairs




EC -15