Details of FDA Final Rule on Recordkeeping Under the Bioterrorism Act (Part II)
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 certain persons (unless excluded) 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.
This is Part II of a multi-part series of summaries of this final rule. Part II focuses on use of existing records, compliance with other statutory regulations and provisions and certain definitions applicable to this final rule. (See ITT's Online Archives or 12/08/04 and 01/05/05 news, 04120810 and 05010510, for BP's announcement of the publication of this final rule and Part I of BP's summary of the final rule, respectively.)
Use of Existing Records to Satisfy the Requirements of Subpart J
New 21 CFR 1.330 states that the regulations in Subpart J do not require duplication of existing records if those records contain all of the information required by this subpart. If a covered person keeps records of all of the information as required by this subpart to comply with other Federal, State, or local regulations, or for any other reason, then those records may be used to meet these requirements.
Moreover, FDA states that persons do not have to keep all of the information required by this final rule in one set of records. If they have records containing some of the required information, they may keep those existing records and keep, either separately or in a combined form, any new information required by this final rule.
- CFR 1.330 further provides that there is no obligation to create an entirely new record or compilation of records containing both existing and new information, even if the records containing some of the required information were not created at the time the food was received or released.
Regulations of Subpart J are in Addition to Existing Recordkeeping Regulations
New 21 CFR 1.329(a) provides that in addition to the regulations in Subpart J, persons must comply with all other applicable statutory provisions and regulations related to the establishment and maintenance of records for foods except as described in 21 CFR 1.329(b) (see below). For example, the regulations in Subpart J are in addition to existing recordkeeping regulations for low acid canned foods, juice, seafood, infant formula, color additives, bottled water, animal feed, and medicated animal feed.
New 21 CFR 1.329(b) states that records established or maintained to satisfy the requirements of Subpart J that meet the definition of electronic records in 21 CFR 11.3(b)(6) are exempt from the requirements of 21 CFR Part 11. Records that satisfy the requirements of this subpart but that are also required under other applicable statutory provisions or regulations remain subject to 21 CFR Part 11.
Highlights of Definitions Added by New Subpart J
The following are a selection of the definitions that are applicable to this final rule and found in 21 CFR 1.328 (partial list):
Food. Food has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act (Act). Examples of food include, but are not limited to fruits; vegetables; fish; dairy products; eggs; raw agricultural commodities for use as food or as components of food; animal feed, including pet food; food and feed ingredients and additives, including substances that migrate into food from the finished container and other articles that contact food; dietary supplements and dietary ingredients; infant formula; beverages, including alcoholic beverages and bottled water; live food animals; bakery goods; snack foods; candy; and canned foods.
Holding. Holding means storage of food. Holding facilities include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.
Nontransporter. Nontransporter means a person who owns food or who holds, manufactures, processes, packs, imports, receives, or distributes food for purposes other than transportation.
Packaging. Packaging means the outer packaging of food that bears the label and does not contact the food. Packaging does not include food contact substances as they are defined in section 409(h)(6) of the Act (21 U.S.C. 348(h)(6)).
Transporter. Transporter means a person who has possession, custody, or control of an article of food in the U.S. for the sole purpose of transporting the food, whether by road, rail, water, or air. Transporter also includes a foreign person that transports food in the U.S., regardless of whether that foreign person has possession, custody, or control of that food for the sole purpose of transporting that food.
(See ITT's Online Archives or 05/13/03 news, 03051305, for BP summary of the FDA's proposed rule on recordkeeping requirements under the Bioterrorism Act.)
FDA Contact - Nega Beru (301) 436-1400
FDA Final Rule (D/N 2002N-0277, FR Pub 12/09/04) available athttp://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-26929.pdf