Details of FDA Final Rule on Recordkeeping Under the Bioterrorism Act (Part I)
The Food and Drug Administration (FDA) has issued a final rule that adds a new Subpart J to 21 CFR Part 1 and a new paragraph (f) to 21 CFR 11.1 to, among other things, require the establishment and maintenance of records by certain persons (unless excepted) who manufacture, import, process, pack, transport, distribute, receive, or hold foods 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.
Effective Date and Various Compliance Dates of Final Rule
Although this final rule is effective February 7, 2005, the final rule and FDA sources state that the compliance date for Subpart J is December 9, 2005, except for small businesses (i.e. fewer than 500 but more than 10 full-time equivalent (FTE) employees) the compliance date is June 9, 2006, and except for very small businesses (i.e. 10 or fewer FTE employees) the compliance date is December 11, 2006.
(FDA sources state that a notice correcting the compliance dates in the final rule for small businesses (the final rule erroneously states that the compliance date is June 9, 2005 or June 9, 2004) is expected to be issued in the next several weeks. Other corrections are also expected to be included.)
This is Part I of a multi-part series of summaries of this final rule. Part I focuses on who is subject to or excluded from (either in whole or in part) Subpart J. (See ITT's Online Archives or 12/08/04 news, 04120810, for BP's announcement of the publication of FDA's final rule.)
Entities Subject to Subpart J Recordkeeping Requirements
New 21 CFR 1.326(a) states that the following (unless excluded) are subject to the new recordkeeping requirements of Subpart J:
Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the U.S. are subject to the regulations in Subpart J, unless they qualify for one of the exclusions in 21 CFR 1.327. If a person conducts more than one type of activity at a location, they are required to keep records with respect to those activities covered by Subpart J, but are not required by this subpart to keep records with respect to activities that fall within one of the exclusions in 21 CFR 1.327.
New 21 CFR 1.326(b) adds that persons who are subject to the regulations in Subpart J must keep records whether or not the food is being offered for or enters interstate commerce.
Entities Excluded (in whole or part) from Subpart J Recordkeeping Requirements
New 21 CFR 1.327 lists those persons and entities that are excluded from all or part of the regulations in Subpart J. These full and partial exclusions include (partial list):
Meat, poultry, or egg products subject to exclusive USDA jurisdiction. Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the U.S. that is within the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act are excluded from all of the requirements in Subpart J with respect to that food while it is under the exclusive jurisdiction of the USDA.
Certain foreign persons. Foreign persons, except for foreign persons who transport food in the U.S., are excluded from all of the requirements of Subpart J.
Packaging. Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food are subject to 21 CFR 1.361 (record availability requirements) and 1.363 (consequences of failing to establish/maintain records or make them available to FDA as required by Subpart J) with respect to its packaging (the outer packaging of food that bears the label and does not contact the food).
All other persons who manufacture, process, pack, transport, distribute, receive, hold, or import packaging are excluded from all of the requirements of Subpart J.
Food contact substances (other than finished containers that directly contact food). Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food contact substances other than the finished container that directly contacts food are excluded from all of the requirements of this subpart, except 21 CFR 1.361 and 1.363.
Finished containers that directly contact food. Persons who place food directly in contact with its finished container are subject to all of the requirements of Subpart J as to the finished container that directly contacts that food. All other persons who manufacture, process, pack, transport, distribute, receive, hold, or import the finished container that directly contacts the food are excluded from the requirements of this subpart as to the finished container, except 21 CFR 1.361 and 1.363.
Food for personal consumption. Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food for personal consumption are excluded from all the requirements of Subpart J.
(See 21 CFR 1.327 for additional full and partial exclusions, including farms; restaurants; certain fishing vessels; etc.)
(See ITT's Online Archives or 05/13/03 news, 03051305, for BP summary of the FDA's proposed rule on recordkeeping.)
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