Docket Management
Docket: 02N-0277 - Bioterrorism Preparedness; Establishment and Maintenance of Records, Section 306
Comment Number: EC -16

Accepted - Volume 2

Comment Record
Commentor Mr. Bob Bauer Date/Time 2002-08-30 14:27:18
Organization Association of Food Industries
Category Association

Comments for FDA General
1. General Comments Docket No. 02N-0277: Comments on Recordkeeping, Public Health Security and Bioterrorism Preparedness and Response Act of 2002 President Bush signed Public Law No. 107-188 into law on June 12, 2002. The Association of Food Industries, Inc., an association of 300+ U.S. companies in the international food trade, commends FDA’s Center for Food Safety and Applied Nutrition for its wise decision to call for comments from interested parties regarding factors the agency should consider as it proceeds to draft the regulations implementing Public Law No. 107-188. AFI offers the following comments on implementation of the recordkeeping provisions of Public Law No. 107-188. Objective In developing regulations under Sec. 414(b) of the FFDCA, Regulations Concerning Recordkeeping, the primary objective of the statutory provision should be viewed as providing FDA with information, which can be accessed if necessary, for identifying the immediate previous sources and immediate subsequent recipients of the specific food for which FDA needs to address credible threats of serious adverse health consequences or death to humans or animals. FDA should focus on the information that a regulated person is responsible for providing to the Agency within the limitation that the person is responsible for maintaining records regarding transactions to which he or she was a party. Overview – Goal AFI offers the following suggestions: · It is recommended FDA rulemaking focus on determining what information is appropriate and allow for the use of available documents to satisfy any inspection requirements. · Each regulated business should have the flexibility to determine if a different record is needed and what that record should be. This approach minimizes recordkeeping burdens and accommodates the diversity and complexity of the channels of trade within the food chain and differences in the operational characteristics of individual food businesses. · FDA should assess implementation of the regulation following a reasonable period of implementation and adjust the regulations as appropriate. Appropriate Information The information required of each person should determine, to the extent possible, the immediate previous source(s) and subsequent immediate recipient(s) of the food and its packaging. However, the ability of a given person to identify the exact immediate source of specific food will vary considerably, particularly with co-mingled products. FDA should recognize that in some cases information can be obtained that will allow reducing the number of potential sources for a specific food, but not necessarily identify the exact immediate previous source. Maintenance of Records Existing business records such as invoices, bills of lading, and purchase orders that accurately disclose a company’s suppliers and customers of ingredients or finished goods should be appropriate records with the need for modifications to be determined and acted on by the relevant company. Additionally, · FDA should not require new and unnecessary records. Given that Section 414(b) potentially affects a huge number of businesses, it is impractical and unnecessary to impose a single, specified record system that does not provide needed flexibility to accommodate the diversity of the channels of trade for food; · Determining how the term “transaction” will be applied could aid in establishing how existing business records can satisfy the statutory requirement; · Regulated businesses should be given the flexibility to modify existing records to prevent disclosure of confidential or trade secret information; and · Consideration should be given to exempting selected businesses. AFI thanks FDA for the opportunity to submit these comments. Sincerely, Robert Bauer, President, Association of Food Industries

EC -16