From: John W. Thomas [jthomas@llwlawdc.com] Sent: Monday, July 07, 2003 12:49 PM To: fdadockets@oc.fda.gov Subject: Docket No. 02N-0277 -- Comments of American Wholesale Marketers Association July 7, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, Maryland 20852 Re: Docket No. 02N-0277 -- Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (68 Federal Register 25187 (May 9, 2003)) Dear Sirs: These comments are submitted by the American Wholesale Marketers Association (“AWMA”), the only international trade association working on behalf of convenience distributors in the United States. Our distributor members represent more than $45 billion in U.S. convenience product sales annually. Associate members include manufacturers, brokers, retailers and others allied to the convenience product industry. Our comments focus on the impact of the proposed regulations on AWMA’s distributor member companies. The AWMA recognizes the need to safeguard food security, and our industry is committed to promoting the safety of our food supply to ensure the health and well-being of all Americans. The proposed regulations reflect the efforts by the agency to consider industry issues and concerns that were raised in informal comments last year. AWMA commends FDA for this initiative, and we have only a few additional comments. Unless otherwise indicated, references are to the sections of the proposed amendments to Title 21, Code of Federal Regulations. Virtually every wholesale distributor in the convenience sector carries some food products and, therefore, expects to register with FDA under the Bioterrorism Act and expects to be responsible for the recordkeeping requirements proposed in this Federal Register publication. However, the food products category as a whole constitutes a small part of the inventory and sales of the AWMA member distributor companies. In fact, surveys conducted by the association have consistently found that food product sales account for about 10 to 15 percent of a distributor’s revenues. Our member companies recognize that they are an essential link in the distribution chain, but they are naturally concerned about assuming too great a recordkeeping burden for a small product segment. Proposed Retrieval Requirements Are Too Burdensome. Companies in the convenience distribution industry must have the flexibility to handle small quantities of large numbers of items. Records must be accurate and current. However, the proposed regulations would set requirements for retrievability of these records that would be very burdensome for the industry. We question whether such accessibility is needed: -- Four-Hour Retrieval. Even with computerized invoices and shipping records, a four-hour retrieval time may be unrealistically short in many cases, as would be required by proposed § 1.361. A responsible official at the company would have to drop everything to search the records to come up with this information in this time. This is an unreasonable burden for a small company, in which each employee has multiple tasks over the course of a day or a week. This may not be such a burden in a larger company, which has full-time regulatory personnel who are dedicated to satisfying government requirements, but the typical AWMA distributor member has no one employed to perform this role. The typical company has a total of only about 50 employees from the president to the sales representative to the janitor. For a small company, the proposed requirement of retrieval within eight hours during non-business hours may be even more burdensome, because the companies are not staffed to respond, and it would be very expensive to establish such staffing. -- Two-Year Retention of Records. Typically, AWMA’s distributor members retain invoices and shipping records for approximately six months. The sheer volume of data that accumulates with many items sold in small quantities to many customers becomes overwhelming quickly. Due to computer capacity limitations with many of the companies in this industry, it is still common to keep these records on paper, and storage and retrieval become big challenges as time passes. The preamble to the proposed rule notes that it is simple to file bills of lading and invoices, but AWMA members do not think that it will be simple to find the storage space. Thus, a two-year record retention requirement, as proposed in § 1.360, would constitute a dramatic change in distributors’ operations and lead to a substantial increase in data storage costs. Small Business Flexibility Is Inadequate. The proposed regulations offer to postpone the effective date of the regulations for small businesses (proposed § 1.368). This is the agency’s only response to the directive from Congress in new § 414(b) of the federal Food, Drug, and Cosmetic Act that, regarding the regulations concerning recordkeeping, “The Secretary shall take into account the size of a business in promulgating regulations under this section.” A proposed delay in the effective date does not adequately address small business needs. Sections 1.337 and 1.345 of the proposed rule would require the wholesale distributor to provide more information than is necessary, and the company would have an unreasonably short time to produce it. FDA should consider imposing less detailed data requirements for small businesses, at least in regard to the information that must be supplied within four hours. For instance, some of the data fields in the shipping records could be omitted. If the records contain the brand and the product name, the information on type of packaging and quantities become almost redundant. Similarly, the need to trace back later does not require the detail of records which would be mandated by the proposed rules. During any given time period, a wholesale distributor purchases a particular product brand from only a few sources. To trace back a food product to the supplier, the agency needs only the contact information for those one or two suppliers during the period in question. Industry Education Is Needed. Finally, we encourage the agency to produce as much publicity and education about this program as possible. Very few companies in the food wholesale distribution business have had any significant contact with FDA personnel or procedures. The Bioterrorism Act has received very little coverage in the general press, so knowledge is limited. Thus, there is limited understanding of the requirements of the statute among food wholesale distributors. We also expect that there are few of our member companies that understand that their facilities are subject to warrantless search by FDA compliance officers. AWMA welcomes the opportunity to educate its member companies about this statute and the obligations, in order to help our members comply with the requirements as quickly and efficiently as possible. We are looking to FDA to provide as many resources as possible to help communicate these new obligations. Please contact this association if you have further questions about the convenience distributors industry. Yours truly, AMERICAN WHOLESALE MARKETERS ASSOCIATION Scott Ramminger, President 1128 16th Street, N.W. Washington, D.C. 20036 202-463-2124