AFIA Issues Bioterrorism Compliance Guide
AFIA industry compliance guide focuses on recordkeeping rule
November 9, 2005
AFIA Issues Bioterrorism Compliance Guide
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, known commonly as the “Bioterrorism Act,” required FDA to issue four regulations. These regulations require registration of food/feed facilities; import notification of food/feed imports; define authority to administratively detain food/feed for serious adverse health consequences or death in man or animals, and the final rule requires transportation, ingredient source and outbound product recordkeeping and access to records. Feed includes pet food and ingredients regardless of whether the products are for food-producing animals or not.
AFIA has held two webcasts on these rules and is issuing an industry compliance guide on all four rules prepared by AFIA’s legal counsel. The guide focuses on the recordkeeping rule, which is effective December 9, 2005 for firms with over 500 employees. For firms with between 10 to 500 employees, the compliance date is June 9, 2006, and for firms with fewer than 10, the compliance date is December 9, 2006.
You can find this industry compliance guide on AFIA’s website by clicking here:
FDA issued a Question and Answer document on September 6, 2005 which can be found by clicking here:
FDA says this document is a work in progress and will be updated as needed. AFIA has updated the industry compliance guide used in its June 2, 2005 webcast, which explains in detail the four FDA Bioterrorism Act rules. A copy of the webcast can be obtained from AFIA for $179 using the order form by clicking here:
Bioterrorism II Webcast CD Order Form
Based on questions received from industry calls, several items should be noted. First, firms may maintain records either in paper form, electronically or a combination of both. Electronic records do NOT need to comply with the Part 11 electronic records and signatures regulations. However, any records must be presented to FDA within 24 hours of a request for records. FDA will likely detail the specific records it needs in the event of a finding of adulterated product. It may ask you to narrow the window of sources, as well.
Retail dealers must also comply with this regulation in terms of recordkeeping and access to records. The only exemption is for firms with less than 10 employees AND selling primarily to customers for their own use (e.g. pet foods or growing one cow for personal slaughter). FDA says firms should keep records of sales to those customers with which the dealer has a business relationship (e.g. business account).
This regulation also has record requirements for transportation information for both incoming and outgoing products, provided these are not your vehicles transporting your products. See the industry guide for information required.
The regulation also requires that records for purchased packaging (e.g. bags, containers) which comes in contact with feed, ingredients or pet food must be maintained for one year. This is also detailed in the industry guide.
The most difficult concept to grasp in this rule is the concept of where lot numbers are required or must be maintained as a record. This rule governs controlling the records from a finished lot of product back to the sources (not lots) of ingredients. If an ingredient supplier has a lot number, this must be captured in your receiving records, but the lot number does not have to become part of the manufacturing or batch records. FDA will only look for the potential sources of ingredients from an adulterated lot of finished product. This means that firms with multiple suppliers, including in large ingredient bins, should provide FDA will all the possible or potential suppliers or sources of ingredients when FDA asks. For bulk bins, this would be all suppliers since the last time the bin was cleaned due to commingling.
Finally, FDA has not indicated, but is considering, whether it will perform recordkeeping compliance inspections or not. AFIA suggests that federally licensed medicated feed mills will be the first inspected if FDA decides to “spot check” for recordkeeping compliance. However, that does not preclude an individual federal investigator from checking for compliance, as we have discovered with past new rules.
FDA says this rule should not require new business practices, and in most cases, that is true. You may find that your firm is already keeping all the records necessary to comply with this rule; but, they must be kept for one year and be available within 24 hours of FDA’s request for records.
AFIA has been working to develop common computer language guidelines to exchange records electronically. The XML Pilot Project is an ongoing AFIA endeavor and remains open to participants. To participate, please contact Jeff Haas of AFIA at 703/524-0810 or email@example.com. This project will assist in providing the tools necessary to collect and maintain the records required under this FDA rule.
Also, the Safe Feed/Safe Food Certification Program has traceability and tracking requirements that mirror the FDA’s recordkeeping rule. You can find out more about SF/SF by clicking here:
Safe Feed/Safe Food Info.
If you have questions about these rules, please contact Richard Sellers at 703/524-0810 or firstname.lastname@example.org.