FDA's Final Rule on Recordkeeping Under the Bioterrorism Act (Part V - Final)
The Food and Drug Administration (FDA) has issued a final rule that adds a new Subpart J to 21 CFR Part 1 (Subpart J) and a new paragraph (f) to 21 CFR 11.1 to, among other things, require the establishment and maintenance of records by persons (unless excluded) who manufacture, import, process, pack, transport, distribute, receive, or hold food in the U.S.
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According to the FDA, such records are to allow for the identification of the immediate previous sources and immediate subsequent recipients of food.
This is Part V, the final part of a multi-part series of summaries of this final rule. Part V focuses on record retention and availability requirements, records excluded from Subpart J's requirements, and the consequences of failing to establish and maintain records.
Records Required to be Retained Under Subpart J
New 21 CFR 1.360(a) states that persons subject to Subpart J must create the required records when they receive and release food, except to the extent that the information is contained in existing records. The regulations contained in new 21 CFR 1.360 further provide:
Record retention requirements for nontransporters. Under new 21 CFR 1.360(b), nontransporters must retain for 6 months after the dates they receive and release the food all required records for any food having a significant risk of spoilage, loss of value, or loss of palatability within 60 days after the date they receive or release the food.
In addition, new 21 CFR 1.360(c) states that nontransporters must retain for 1 year after the dates they receive and release the food all required records for any food for which a significant risk of spoilage, loss of value, or loss of palatability occurs only after a minimum of 60 days, but within 6 months, after the date they receive or release the food.
New 21 CFR 1.360(d) states that nontransporters must retain for 2 years after the dates they receive and release the food all required records for any food for which a significant risk of spoilage, loss of value, or loss of palatability does not occur sooner than 6 months after the date they receive or release the food, including foods preserved by freezing, dehydrating, or being placed in a hermetically sealed container.
In addition, new 21 CFR 1.360(e) provides that nontransporters must retain for 1 year after the dates they receive and release the food all required records for animal food, including pet food.
Requirements for records retained by transporters, or nontransporters on behalf of a transporter. Under new 21 CFR 1.360(f), transporters, or nontransporters retaining records on behalf of a transporter, must retain for 6 months after the dates they receive and release the food all required records for any food having a significant risk of spoilage, loss of value, or loss of palatability within 60 days after the date the transporter receives or releases the food.
Furthermore, transporters, or nontransporters retaining records on behalf of a transporter, must retain for 1 year after the dates they receive and release the food, all required records for any food for which a significant risk of spoilage, loss of value, or loss of palatability occurs only after a minimum of 60 days after the date the transporter receives or releases the food.
Location of records. New 21 CFR 1.360(g) states that subject persons must retain all records at the establishment where the covered activities described in the records occurred (onsite) or at a reasonably accessible location.
Electronic records. New 21 CFR 1.360(h) provides that the maintenance of electronic records is acceptable, and states that electronic records are considered to be onsite if they are accessible from an onsite location.
Final Rule's Record Availability Requirementsunder Subpart J
According to new 21 CFR 1.361, when FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, any records and other information accessible to FDA under section 414 or 704(a) of the Federal Food, Drug, and Cosmetic Act (Act), 21 USC 350c and 374(a)) must be made readily available for inspection and photocopying or other means of reproduction.
Such records and other information must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request, from an officer or employee duly designated by the Secretary of Health and Human Services who presents appropriate credentials and a written notice.
Records Excluded from Subpart J
New 21 CFR 1.361 explains that the establishment and maintenance of records as required by Subpart J does not extend to recipes for food as defined in 21 CFR 1.328; financial data, pricing data, personnel data, research data, or sales data (other than shipment data regarding sales).
Consequences for Failing to Establish Records Required by Subpart J
New 21 CFR 1.363(a) states that the failure to establish or maintain records as required by section 414(b) of the Act and this final rule or the refusal to permit access to or verification or copying of any such required record is a prohibited act under section 301 of the Act.
In addition, under 21 CFR 1.363(b), the failure of a nontransporter immediate previous source or a nontransporter immediate subsequent recipient who enters an agreement under 21 CFR 1.352(c) to establish, maintain, or establish and maintain, records required under 21 CFR 1.352(a) or (b), or the refusal to permit access to or verification or copying of any such required record, is a prohibited act under section 301 of the Act.
It is also provided at new 21 CFR 1.363(c) that the failure of any person to make records or other information available to FDA as required by section 414 or 704(a) of the Act and this regulation is a prohibited act under section 301 of the Act.
(See ITT's Online Archives or 12/08/04, 01/05/05, 01/06/05, 01/11/05, and 01/12/05 news, 04120810, 05010510, 05010615, 05011125, and 05011220, for BP summary announcing the publication of this final rule, as well as Parts I-IV of BP's summary of the final rule's regulations.)
FDA Contact - Nega Beru (301) 436-1400
FDA Final Rule (D/N 2002N-0277, FR Pub 12/09/04) available at http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-26929.pdf