Docket Management
Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC -18

Accepted - Volume 2

Comment Record
Commentor Mr. James Skiles Date/Time 2002-08-30 14:24:24
Organization Grocery Manufacturers of America, Inc.
Category Food Industry

Comments for FDA General
Questions
1. General Comments August 30, 2002 Dockets Management Branch Food and Drug Administration Room 1061 5630 Fishers Lane Rockville, MD 20852 Re: Docket No. 02N-0276 Enclosed please find the Grocery Manufacturers of America's preliminary comments and suggestions to the Food and Drug Administration concerning implementation of Section 305 (facility registration) of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Sincerely yours, James H. Skiles Vice President, General Counsel Before the U.S. Food and Drug Administration Implementation of Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PL 107-188) Docket No. 02N-0276 (Establishment Registration) COMMENTS OF THE GROCERY MANUFACTURERS OF AMERICA, INC. August 30, 2002 Introduction The Grocery Manufacturers of America, Inc. (GMA) appreciates the opportunity to provide preliminary comments and suggestions to the Food and Drug Administration concerning implementation of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act or the Act) (PL 107-188). GMA is the world's largest association of food, beverage and consumer product companies. With U.S. sales of more than $460 billion, GMA members employ more than 2.5 million workers in all 50 states. The organization applies legal, scientific and political expertise from its member companies to vital food, nutrition and public policy issues affecting the industry. Led by a board of 42 Chief Executive Officers, GMA speaks for food and consumer product manufacturers at the state, federal and international levels on legislative and regulatory issues. The association also leads efforts to increase productivity, efficiency and growth in the food, beverage and consumer products industry. FDA is to be commended for the orderly, open, and efficient manner in which it has approached the implementation of the Bioterrorism Act. As FDA well knows, the time period provided by the Congress for the adoption of regulations required to implement various provisions of the Act is only 18 months. The regulations that FDA is required to adopt--on establishment registration, recordkeeping, and prior notice of food imports--have the potential to disrupt seriously the flow of food in commerce. It is, therefore, critically important that FDA's process for the development of proposed regulations, consideration of comments, and adoption of final regulations continue to provide for maximum public input and that FDA remain fully committed to the issuance of final regulations within the time period provided in the Bioterrorism Act. GMA intends to cooperate fully with FDA to achieve timely and appropriate implementation of the Act. These comments address section 305 of the Bioterrorism Act, which requires that certain food facilities register with FDA. GMA has also filed comments on section 306 (recordkeeping), 307 (prior notice of food imports), and 303 (administrative detention). General Suggestions on Registration The task of registering tens of thousands of domestic and foreign facilities is daunting and the potential, especially in the initial registration period, for problems is great. Some facilities may not learn of the registration requirement in time to register while others may inadvertently provide incomplete or inaccurate registration information. The supply of imported food and food ingredients to domestic companies and consumers may be impaired if foreign food processors are unaware of or confused or uncertain about their obligation to register. The spectacle of large quantities of food rotting at U.S. ports of entry due to the failure to register is real. Problems may also arise as individual food companies evolve and implement policies to ensure that the food products they buy are from registered facilities. There are several actions that FDA can take to minimize the potential disruption when the registration requirement takes effect. · Simplicity The regulations to implement the registration requirement should be as simple and straightforward as possible. Definitions for such terms as facility and the scope of the retail and farm exemptions should be clear and unambiguous. · Flexibility The regulations should, where feasible, provide alternative means of compliance. For example, while the Act encourages registration through electronic means (and GMA expects that many companies will in fact register that way), it is clear that a simple non-electronic means of registration will also be needed. Some domestic and many foreign facilities will not have ready access to electronic registration. · FAQs When the regulations are published, FDA should simultaneously issue (through the agency's website and otherwise) a series of anticipated frequently asked questions (FAQs) to assist persons subject to the regulations in determining how to comply. Furthermore, FDA should convene a public meeting shortly after the publication of the regulations to address questions and issues that arise after review of the regulations. · Compliance Policy FDA should adopt and announce as part of the proposed regulations on registration a compliance policy that would embody a minimum of six months' deferral of regulatory action for failure to comply with the registration regulation. Under the suggested compliance policy, FDA should make clear that during the six-month period following the effective date of the regulations, it will focus its efforts on assisting persons to comply with or come into compliance with the regulations and will not resort to enforcement actions. Such a policy will help to allay concerns about the consequences of the failure to register (by, for example, a foreign ingredient supplier to a domestic manufacturer) and the potential for disruption of the food supply. Specific Comments · Definitions 1. Facility The Bioterrorism Act requires that any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States be registered (section 415(a)(1)). The Act does not define the term facility, but it is critical to the efficient implementation of the Act that the regulations incorporate a clear definition of facility. We suggest the following definition: A facility is a fixed enclosed structure or structures controlled by a single owner, operator or agent in which food is manufactured, processed, packed or held for consumption in the United States. A facility may consist of one or more contiguous structures. A domestic facility is any facility located in any State or Territory of the United States. A foreign facility is subject to a separate definition. 2. Foreign Facility A foreign facility is a facility that manufactures, processes, packs or holds food outside the United States, but only if food from the facility is exported to the United States without further processing or packaging outside the United States. Further processing or packaging, within the meaning of the preceding sentence does not include the affixing of a label to a package or other de minimis activity related to the food. A foreign facility is required to register if, for example, it prepares a finished food and causes it to be packaged into packages suitable for sale and distribution in the United States. A foreign facility that prepares an ingredient that is distributed to food processors outside the United States for incorporation into finished foods need not register. Facilities located outside the United States that take custody or control of finished foods for storage or transportation to the United States, are required to register. Transportation vehicles and containers, as defined, need not register. · Exclusions The Act contains several exclusions from the registration requirement and others will help to clarify the scope of the term facility. We suggest the following exclusions from registration: 1. Farm A farm, meaning a tract of land devoted to the raising of animals and/or the growing of crops, is exempt from registration. The storage of raw agricultural commodities, including minimally processed commodities, on a farm does not trigger the requirement to register. A facility located on or adjacent to a farm in which food is processed is required to register. A facility that stores raw agricultural commodities, including minimally processed commodities, off of a farm is required to register. 2. Transportation Vehicles and Containers Vehicles used to transport food products between facilities, including railcars, airplanes, ships, cars, shipping containers, and trucks are exempt from registration. Vehicles or containers used to process, manufacture, or package food are required to register. 3. Retail Establishments A retail establishment is any business or facility whose primary activity is the sale of food products directly to consumers. The term includes establishments that store, prepare, package, serve or otherwise provide articles of food directly to the retail consumer for human consumption. The term includes grocery and convenience stores, cafeterias, lunch rooms, food stands, saloons, taverns, bars, lounges, and catering or vending facilities. The incidental or occasional sale of wholesale quantities of food products from a retail establishment is permitted. Retail establishments are exempt from registration. 4. Restaurant A restaurant is a facility that serves prepared food for consumption on or off the premises of the facility. A restaurant is not required to register. 5. Nonprofit Food Establishment A nonprofit food establishment is a charitable entity that prepares, serves, or otherwise provides food, typically to needy persons. The term includes food banks, soup kitchens, homebound food delivery services, or other charitable organizations that provide food or meals for human consumption. To qualify as a nonprofit food establishment, the entity must be organized under a provision of the Internal Revenue Code that provides for exemption from Federal income tax. Nonprofit food establishments are exempt from registration. 6. Fishing Vessel A fishing vessel is exempt from registration unless one or more of the activities described in section 123.3(k) of title 21 of the Code of Federal Regulations, is engaged in on the vessel. 7. Research and Development Facilities The regulations should exempt facilities that engage in research and development from the registration requirement. Typically, these are facilities operated by food companies that do product development and testing. A limited quantity of product may be produced in such facilities for acceptance testing by company employees and/or consumer volunteers. No product from research and development facilities is introduced into interstate commerce. There would appear to be no benefit in having such facilities be subject to the registration requirement. · Registration Process 1. Electronic Filing The Bioterrorism Act encourages the use of electronic filing of registrations (section 415(d)). GMA urges FDA to develop an easy to use electronic registration system that would function in much the same way as the purchase of merchandise on the Internet operates. Authorized representatives of companies subject to the registration requirement would access the site and enter the appropriate information. When all of the required fields have been completed, the registrant would complete the registration form and then immediately receive a registration number unique to a single facility. The system should permit the registration of multiple facilities of a single company during one registration session. FDA will need to develop mechanisms to ensure that the electronic registration system is not susceptible to bogus registrations and hackers. 2. Alternative Filing Mechanism For a variety of reasons, some facilities that are required to register may not have access to or may choose not to file electronically. The use of non-electronic filing is likely to be more prevalent outside the United States, especially in countries where access to the Internet is less common than it is in the United States. To accommodate this circumstance, FDA should create a registration from which could be made available, both domestically and internationally, through consular offices, FDA district offices, post offices and the like. 3. Registration of Multiple Facilities Under Common Ownership Some companies, which own or operate multiple facilities, may prefer to have a single individual undertake the responsibility to register all of the company's facilities. Others may elect to delegate the registration responsibility to each of its facilities. The regulations should permit both approaches to registration. 4. Information in Registration The Bioterrorism Act provides that the registration contain information necessary to notify the Secretary of the name and address of each facility at which, and all trade names under which, the registrant conducts business… (section 415(a)(2)). To register, a company should be required to provide the: (i) name and address of each facility; (ii) name of the entity that owns or operates the facility; (iii) trade names which the registrant uses; and (iv) name, telephone number, and email address of a contact person for the facility (US agent in the case of foreign facilities) The contact person should be, at the option of the registrant, either a person located at the facility or, for companies with multiple facilities, a person authorized by the company to receive communications for the facility. The registration should not require the listing of the names of the various brands of food that are handled by the facility, as this changes frequently and is not necessary for the efficient functioning of the registration system. The Bioterrorism Act also permits FDA by guidance to determine that general food categories (as defined in section 170.3 of title 21, Code of Federal Regulations) are necessary for inclusion in the registration system. GMA suggests that FDA defer consideration of inclusion of general food categories in the registration system. First, the general food categories set forth in section 170.3 have not been updated in nearly three decades. As a result, they do not accurately or comprehensively describe all of the categories of food in commerce today. Second, including the general food categories in the initial registration will greatly complicate the process-in part because those categories are outdated-and thus increase the likelihood of confusion and ineffective registrations. It seems more important to GMA to ensure that the initial registration proceeds smoothly, than to attempt to get marginally useful information about outdated food categories. We have substantial concerns about the ability of FDA and the food industry to complete the registration process in a timely fashion if food categories are required. Once the registration system is up and running, FDA could then consider whether to: (1) update the food categories in section 170.3 (there may well be reasons independent of the registration requirement to update 170.3); and (2) issue a guidance that would incorporate the food categories into new and updated registrations. 5. Updating of Registrations The Bioterrorism Act provides that a registrant is to notify the FDA in a timely manner of changes to the information contained in a prior registration. The regulations should provide that a registrant should amend a registration within 30 days of the date on which a significant event occurs. Significant events would include a change in ownership of a facility, location of a facility or the closing of a facility. Registrants should be permitted to notify FDA of other changes annually. Once a facility is registered, however, no supplemental filing is needed if no changes have occurred. The regulations should also provide that new facilities must be registered within 30 days of the date on which the facility began operations. 6. Confidentiality of Registration Information The Bioterrorism Act provides that the list of registered facilities, which FDA is required to maintain, and registration documents submitted by registrants are exempt from disclosure under the Freedom of Information Act. We believe that the term registration documents includes the information provided by a registrant, whether electronically or a paper record. Further, the Act provides that the identity or location of a registrant, if derived from the list of registered facilities or the registration documents is also exempt from disclosure. FDA should adopt appropriate procedures to ensure that this confidential commercial information is protected from public disclosure when in FDA's possession and when in the possession of other governmental entities (federal, state or foreign) with which FDA may have shared the information. · Conclusions The registration system can be implemented without serious disruption if the registration process is kept simple, questions are promptly answered, and the focus is kept on getting facilities registered and not on enforcement actions. GMA appreciates the opportunity to contribute to the efficient implementation of the registration provision through these comments and other opportunities that FDA should provide for input from the industry.




EC -18