Docket Management
Docket: 02N-0277 - Bioterrorism Preparedness; Establishment and Maintenance of Records, Section 306
Comment Number: EC -20

Accepted - Volume 2

Comment Record
Commentor Mr. Anthony L. Young Date/Time 2002-08-30 16:00:44
Organization Piper Rudnick
Category Other

Comments for FDA General
Questions
1. General Comments Docket No. 02N-0277 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 MAINTENANCE AND INSPECTION OF RECORDS AS REQUIRED BY Section 306 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 certain of the statutory requirements established in Title III of the Act (Protecting Safety and Security of Food and Drug Supply) and their implementation. Joseph Levitt, Director, Center for Food Safety and Applied Nutrition, addressed a letter to the FDA Foods Community dated 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 comments to identify concerns and to provide recommended solutions and supporting data, if applicable, and requested that initial comments be delivered by August 30, 2002. 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 306 of the Act. This section authorizes, in Section 306(a) as it inserts Section 414(a) of the Federal Food, Drug and Cosmetic Act (“FFDCA”), inspection of certain records related to any food for which the Secretary of Health and Human Services has a reasonable belief is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. This section also authorizes but does not require, in Section 306(a) as it inserts Section 414(b) of the FFDCA, the promulgation of requirements regarding the establishment and maintenance of certain records by persons (excluding farms and restaurants) in specifically defined food businesses, including persons that manufacturer, process, pack, distribute, receive, hold or import food. This section also requires, in Section 306(d), that regulations be promulgated by December 12, 2003 to establish recordkeeping requirements as defined in this section and described in the previous sentence, presumably conditional upon FDA’s decision to establish such requirements. Possible impact on AHPA members Most of AHPA’s Active category of members are persons that manufacturer, process, pack, distribute, receive, hold or import herbs and/or herbal products that are dietary supplement food products or that are ingredients in dietary supplement food products. Because this section authorizes inspection of records and envisions the establishment of recordkeeping regulations for all such persons, AHPA has a significant interest in this section and its implementation. Comments and recommendations AHPA has comments and recommendations related to the establishment of regulations for four elements of this section of the Act: 1. that regulations for records inspection be limited to the regulatory authority granted under this section and not be expanded beyond the Congressional intent in granting this authority; 2. that the promulgation of the optional regulations for recordkeeping needed to identify the immediate previous source and the immediate subsequent recipient of food, if undertaken, should be broadly drawn so as to allow for the utilization of existing recordkeeping procedures; 3. that retailers be specifically exempted from any requirement to establish or maintain records related to immediate subsequent recipients of food; 4. that the Secretary assume, in establishing the appropriate measures envisioned by the Act to protect sensitive information, that almost all businesses consider supplier and customer information to be confidential commercial information that is generally not disclosed outside their company and that any regulations take this assumption into account. 1. There is a possibility that the expanded authority for inspection of records defined in this section of the Act, and specifically in Section 306(a) as it inserts Section 414(a) of the FFDCA, could be interpreted more broadly than the Congressional intent in providing this authority. While there is no specific requirement for rulemaking set out in this section for records inspection, in order to protect against interpreting this authority more broadly than the relevant Congressional intent, rulemaking should be established to define, as nearly as possible without diminishing the usefulness of this authority in protecting the public health by preventing, preparing for and responding to bioterrorism, the level of evidence or information necessary to rise to the level of “a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death in humans or animals.” 2. With regard to the authority provided in this section for the establishment of certain recordkeeping requirements, and specifically in Section 306(a) as it inserts Section 414(b) of the FFDCA, AHPA notes that this section does not require, but only authorizes the establishment of such requirements. As a matter of speculation, AHPA believes that the establishment of such requirements is inevitable. AHPA also believes that, given the optional nature of this envisioned requirement, the agency has sufficient authority to establish any such requirement in a manner that minimizes the burden on industry while fully protecting consumers. This authority for the establishment of regulations concerning recordkeeping specifies that such optional regulations should “allow the Secretary to identify the immediate previous sources and the immediate subsequent recipients of food.” AHPA has consulted with several of our members who sell finished consumer goods to try to understand current practices with regard to these companies’ ability to now identify the immediate previous sources of their ingredients and the immediate subsequent recipients of their dietary supplement and food products. These companies consisted of 8 firms representing a wide range of annual sales (estimated at less than $500,000 to over $100 million in U.S. sales) and offering both dietary supplement and food (tea) products. AHPA has no knowledge as to whether the reported practices of these 8 companies are representative of AHPA’s membership or the dietary supplement industry at large. All companies consulted stated that they currently have in place systems that allow them to identify their immediate previous sources of all of their ingredients on a lot-by-lot basis. All of these companies also stated that they have systems in place to identify which lot of raw material is used in every lot of finished products, such that they can trace each ingredient in each separate lot of their finished products to the specific vendor(s) who provided the ingredient. On the other hand, four companies stated that they currently have systems in place that identify the immediate subsequent recipients of their food and dietary supplement products on a lot-by-lot basis, while the other four stated that their current systems allow this traceability only on a product-by-product basis. There appears to be some tendency for larger companies to have more detailed systems in place, but there were noticeable exceptions to this norm. For example, of the two companies believed to produce the smallest annual sales revenue, one of these can trace the immediate subsequent recipient of their product on a lot-by-lot basis and one cannot; similarly, one of the largest companies polled on this matter can trace the immediate subsequent recipient on a product-by-product basis but not on a lot-by-lot basis. Based on this input and assuming that it does have some relevance to industry practices, and emphasizing the fact that the Act does not require but only authorizes the establishment of regulations for recordkeeping of sufficient details to identify the immediate previous sources and the immediate subsequent recipients of foods, AHPA recommends that any such rulemaking, if undertaken, permit as much latitude as possible for the allowance of current industry practices. AHPA also wishes to point out that recordkeeping on a lot by lot basis is key to being able to have a recall limited to products of concern. If lot by lot records are not kept, any recall due to adulteration cannot be limited to affected lots. FDA should point this out as a good business rationale 3. Of additional concern in the implementation of this section of the Act, and specifically in Section 306(a) as it inserts Section 414(b) of the FFDCA, is the potential impact on retailers . It might be reasonable to assume that retailers have records that readily identify the immediate previous sources of their foods, although AHPA has very few members that are retailers and suggests that FDA specifically request information from retailer associations to assure an understanding of this assumption. On the other hand, it must be assumed that retailers do not have records that identify the immediate subsequent recipient of the food that they “hold” and then sell to consumers. It is difficult to believe that the Congress intended that such a burden should be placed on retailers. It is hard to imagine a means by which, short of requiring proof of identity at the point of retail purchase of every food (presumably unless they occur at a farm or a restaurant), such information could possibly be recorded. Again, given the optional nature of this requirement in the Act, AHPA strongly urges that rulemaking clarify an exemption for retailers to any requirements to identify which of their customers purchased which of their foods. 4. Section 306(a) of the Act inserts Section the 414(c) to the FFDCA, and instructs the Secretary to “take appropriate measures to ensure that there are effective procedures to prevent the unauthorized disclosure of any trade secrets or confidential information” obtained pursuant to inspection of records as authorized by this Section. AHPA urges the Secretary to consider that companies consider almost all information about their suppliers and customers to be confidential commercial information as measures are established in the fulfillment of this obligation under the Act. This includes the independent distributors of direct selling companies. These distributors are valuable confidential commercial information of these companies. AHPA appreciates the opportunity to provide these initial comments prior to FDA’s issuance of initial rulemaking in the matter of maintenance and inspection of records, and will continue to be attentive to this important process as it unfolds. Respectfully submitted, /s/ Michael McGuffin President, American Herbal Products Association 8484 Georgia Avenue Suite 370 Silver Spring, MD 20910 /s/ Anthony L. Young General Counsel, American Herbal Products Association Piper Rudnick LLP 1200 19th Street, N.W. Washington, D.C. 20036




EC -20