Docket Management
Docket: 02N-0278 - Bioterrorism Preparedness; Prior Notice of Imported Food Shipments, Section 307
Comment Number: EC -28

Accepted - Volume 2

Comment Record
Commentor Mr. Anthony L. Young Date/Time 2002-08-30 16:03:19
Organization Piper Rudnick
Category Other

Comments for FDA General
1. General Comments Docket No. 02N-0278 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 PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS AS REQUIRED BY Section 307 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 307 of the Act, which will require, not later than 18 months after the enactment of the Act (i.e., by December 12, 2003), submission of certain information regarding any article of imported food prior to that food’s importation. This section also requires that certain regulations related to these requirements for prior notice of imported food shipments be promulgated by December 12, 2003 and sets forth certain defaults in the event that these regulations are not promulgated within the statutory timeframe. Possible impact on AHPA members AHPA’s members include persons that import botanical ingredients that are further processed; used as ingredients in consumer food products (including but not limited to dietary supplements); sold to other persons; and for other purposes. AHPA’s members also include persons that import finished food products containing botanical ingredients. AHPA and its members therefore have significant interest in the promulgation of regulations to govern the requirements established in this section of the Act. Comments and recommendations Of all of the sections of the Act that will impact persons who are engaged in the manufacturer of food products containing herbs, the requirements established by this section for prior notification of imports has the greatest potential to create significant additional costs for a business. AHPA believes that the majority of the most widely sold herbal raw material ingredients (both processed and unprocessed) are imported into the United States. It is essential that the regulations promulgated for this section be written in a manner that minimizes any potential disruption to and costs for commerce while simultaneously preventing public health emergencies. AHPA has comments and recommendations related to the establishment of regulations for three elements of this section of the Act: 1. that the variety of industry practices related to importing food be considered in establishing regulations for prior notice of imported food shipments 2. that the specified period of time that a notice is required to be made in advance of importation be defined in a manner that minimizes the administrative burdens and associated costs for industry and takes into account the full range of imported products while fully protecting against public health emergencies; 3. that electronic methods be provided for as a means to submit the requisite information under this section 4. that sufficient controls be placed on the collection and storage of information under this section to protect confidential commercial information. 1. In promulgating rulemaking, FDA must take into account the variety of industry practices that are relevant to importing herbal ingredients and foods or dietary supplements containing herbs. Examples of common practices include but are not limited to: import of small quantities of herbal ingredients or products as single shipments; import of large quantities (e.g., container loads) of single ingredients or products; import of large quantities (e.g., container loads) of mixed goods, whether ingredients or products; and imports of partial shipments of a single order of an ingredient or product on an occasional and regularly scheduled basis (e.g., a company may order 12 tons of an ingredient to be delivered at a rate of one ton each month). 2. AHPA is aware that the Act states, in Section 307(a) as it inserts Section 801(m)(2)(A), of the Federal Food, Drug and Cosmetic Act (“FFDCA”), that the specified period of time that a notice is required to be made in advance of importation may not exceed five days. This section also states, however, that “the Secretary may consider…the effect on commerce of such periods of time.” In discussing this particular detail with an AHPA member in preparation for developing these comments, great concern was expressed about this statutory limitation. It was noted that the most efficient time to prepare and submit a document to meet the requirements of this section of the Act would almost certainly be simultaneous to the vendor shipping the product that will be imported. AHPA requests that the Secretary seriously consider whether efforts should be undertaken to provide greater flexibility in this time limit based on the effect on commerce of a period of time that will increase the cost of filing notices under this section. At the same time, AHPA recommends that the minimum specified period of time that a notice is required to be made in advance of importation be defined to be the shortest possible time for the completion of the administrative process necessary to meet the requirements of this section. From the perspective of AHPA’s members, the need for a minimal time is especially important for herbal ingredients that are in a non-dehydrated state and so are perishable. While the majority of herbal food products are manufactured using dehydrated plant materials, AHPA’s members include persons that manufacturer products that have as ingredients botanicals that are not dehydrated. Thus, procedures that are provided in the implementing regulations for instituting prior notice of imported food shipments should provide a minimum time that takes into account the special needs of importers of these products. 3. While other sections of the Act authorize the Secretary to provide for and encourage the use of electronic methods for submitting certain information required by the Act, no such authorization is made for the prior notice of imported foods. Nevertheless, AHPA believes that electronic methods for submitting the information required prior to the import of a food are essential to minimizing any burden that might be involved in the notification process, and notes that nothing in this section prohibits such methods. AHPA encourages FDA to assure that any electronic system that might be used for this purpose 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 draft electronic systems. 4. While other sections of the Act require that the Secretary of Health and Human Services take appropriate measures to protect sensitive information, such as trade secrets and confidential information, no such requirement is made of the Secretary in this section. Nevertheless, AHPA believes that firms may consider information regarding the quantities, sources, countries of origin and other information about their imported products required to be disclosed under this section, to be confidential commercial information. AHPA therefore strongly encouraged that the regulations promulgated under this section specify that information gathered in accordance with this section, including both specific information and company aggregate data generated from such information, be considered to be confidential, and that appropriate safeguards be established to assure the protection of this information. 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 prior notice of imported food shipments, 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 -28