Docket Management
Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC -24

Accepted - Volume 2

Comment Record
Commentor Mr. Anthony Young Date/Time 2002-08-30 15:55:43
Organization Piper Rudnick
Category Other

Comments for FDA General
1. General Comments Docket No. 02N-0276 BEFORE THE UNITED STATES OF AMERICA DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION INITIAL COMMENTS OF THE AMERICAN HERBAL PRODUCTS ASSOCIATION ON THE IMPLEMENTATION OF REGULATIONS FOR REGISTRATION OF FOOD FACILITIES AS REQUIRED BY Section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 August 30, 2002 The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal products industry, comprised of companies doing business as growers, processors, manufacturers, and marketers of herbs and herbal products. AHPA serves its members by promoting the responsible commerce of products that contain herbs. Background The United States Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“the Bioterrorism Act” or “the Act”) to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies, and President Bush signed this legislation into law on June 12, 2002. The Act consists of five separate titles. AHPA and its members have significant interest in the interpretation and implementation of certain of the statutory requirements established in Title III of the Act (Protecting Safety and Security of Food and Drug Supply). Joseph Levitt, Director, Center for Food Safety and Applied Nutrition, addressed a letter to the FDA Foods Community on July 17, 2002. This letter provided, among other things, an overview of those provisions of Title III of the Act that require the Food and Drug Administration (FDA) to issue regulations in an expedited time period. The July 17 letter also solicited initial comments by August 30, 2002 to identify concerns and to provide recommended solutions and supporting data. This request was repeated at a meeting at FDA’s College Park, MD offices on July 30, 2002. Subject of these comments The Comments provided here are in response to these requests, and specifically in relation to concerns and recommendations that AHPA has identified with regard to Section 305 of the Act, which will require, not later than 18 months after the enactment of the Act (i.e., by December 12, 2003), registration of domestic and foreign food facilities with the Secretary of Health and Human Services (“the Secretary”). Facilities are defined as “any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs or holds food.” Specifically exempted from this definition are farms, restaurants and “other retail food establishments,” among others. This section also requires that certain regulations related to this registration requirement be promulgated by December 12, 2003 and sets forth certain defaults in the event that these regulations are not promulgated within the statutory timeframe. The registration section of the Act also describes the information that will be required to be included on all facility registrations as consisting of:  the name and address of each facility  all trade names under which business is conducted In addition, the general food category, as defined in 21 CFR 170.3(n), should also be provided “when determined necessary by the Secretary through guidance.” Foreign facilities must include, in addition to the information required for a domestic facility, the name of the United States agent for the facility. The Secretary also “may provide for, and encourage the use of, electronic methods of submitting…registrations required pursuant to this section.” Possible impact on AHPA members Most of AHPA’s members are companies that either sell bulk herbs or herbal extracts; that manufacture or process herbal ingredients or consumer goods containing herbs, including dietary supplement and food products; or that market consumer goods containing herbs, including dietary supplement and food products. All such members will be required to register their facilities in accordance with this section of the Act. AHPA’s members also include farms, retailers, and companies that sell drug products that contain herbs. These members may not be affected by this section of the Act. Comments and recommendations AHPA has comments and recommendations related to the establishment of regulations for five elements of this section of the Act: 1. that the regulations that come into effect do not seek to expand on the limited information required for registrants under the Act; 2. that the exemption for retailers be clearly defined, and that this exemption be clearly identified to be relevant to all retail channels of trade; 3. that the Act’s stated support for electronic methods of registering be maximized; 4. that the regulations take into account, to the degree possible under the Act, the present registration requirements of the several states, if any; 5. that 21 CFR 170.3(n) be amended to add a single general food category for “dietary supplements” if the Secretary determines that this information is to be included in registrations. 1. The Act is very specific in identifying the information that must be provided in a facility’s registration, and limits this information for domestic facilities to the name and address of the facility and the trade names under which the registrant conducts business, and also, should the Secretary determine by guidance as necessary, the general food category per 21 CFR 170.3(n); and for foreign facilities, all of the above and also the name of the United States agent for the facility. AHPA believes that the regulations that are implemented for registration of food facilities should identify only these elements and should not seek to require any additional information, except that it may be useful and appropriate to obtain information as to whether a facility engages in manufacturing, or in processing, or in packing, or in holding foods, or in some combination of these activities. 2. The Act specifically exempts farms, restaurants and “other retail food establishments” (among others) in which food is prepared for or served directly to consumers, from registration under this section. AHPA believes that there is some potential for confusion with regard to this exemption, as many retailers “pack” food (e.g., in offering foods, such as dried fruit, that are purchased in bulk and repacked by the retailer). In addition, retail food establishments such as groceries and convenience stores are clearly involved in holding food for sale to the food’s actual consumer and not necessarily involved in preparing or serving food directly to consumers. . The plain language of the Act could be read such that all such retailers would be exempt from registration since these are “other retail food establishments” as that term is commonly understood. The regulations for this part should provide examples and propose clear and consistent rules that plainly state which establishments the agency believes to be exempt from registration. It is AHPA’s position that all food retail establishments should be exempted from registration including, but not limited to: grocery stores, health food stores, convenience food stores, multi-product mass retailers, and drug stores – all of which sell food products. Another potential point of confusion with this retailer exemption arises in other channels of trade, and specifically the channel identified as practitioners who sell products in their practices and the channel known as “direct-selling” or “multi-level marketing.” Several of AHPA’s members utilize these channels of trade, and so rely on practitioners such as naturopaths, chiropractors, acupuncturists and others or on individual direct distributors to actually sell and deliver their dietary supplement and food products to the consumer. As a rule these practitioners and distributors do not manufacture, process, or pack any foods, though they do hold these products for sale in a fashion that is similar to a retail establishment. It is AHPA’s position that these practitioners and distributors should be included in the definition of “other retail food establishments” and that the regulation creating exemptions for registration of food facilities should also state this clearly. 3. The Act authorizes the Secretary to provide for and encourage the use of electronic methods for submitting registrations. AHPA is strongly supportive of this suggestion and believes that it will be essential to minimizing any burden that might be involved in the registration process. AHPA encourages FDA to assure that any electronic system is designed in a manner that maximizes ease of use and would be pleased to work with the agency to organize companies in our trade to serve as reviewers of proposed electronic systems. 4. AHPA is aware that several states require registration of facilities where food is manufactured, processed, packed or held. Thus it is possible, or even likely, that the information included in the federal and state registrations will contain some redundancies. AHPA believes that FDA’s priority in this rulemaking should be on the regulations for federal registration of food facilities. Nevertheless, AHPA suggests that the regulations take into account, to the degree possible under the Act, the registration requirements of the several states. For example, FDA might consider providing options in the registration process that allow a facility to authorize information in the registration to be forwarded to those states that presently require registration. 5. The Act authorizes but does not require the Secretary to include the general food category, as defined in 21 CFR 170.3(n), as part of the requisite information in a facility’s registration. Most of AHPA’s members sell food products that are defined at 21 U.S.C. 321(ff) as “dietary supplements.” AHPA is aware that this class of product is not included in the 43 general food categories that are defined in 21 CFR 170.3(n) but believes that, if the Secretary does determine that this information be required for registration of a food facility, it would be useful to these AHPA members to be able to identify their products in this specific category. AHPA appreciates the opportunity to provide these initial comments prior to FDA’s issuance of an advance notice of proposed rulemaking in the matter of food facility registration, and will continue to be attentive to this important process as it unfolds. Respectfully submitted, Michael McGuffin President, American Herbal Products Association 8484 Georgia Avenue Suite 370 Silver Spring, MD 20910 Anthony L. Young General Counsel, American Herbal Products Association Piper Rudnick LLP 1200 19th Street, N.W. Washington, D.C. 20036

EC -24