FDA and USDA Rulemakings to Prevent Risk of BSE in Human Food (Including Dietary Supplements) and Cosmetics, Etc
The Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) have issued a press release announcing three rulemakings to further strengthen existing safeguards that protect consumers against the agent that causes Bovine Spongiform Encephalopathy (BSE), also known as mad cow disease.
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In addition, the FDA has issued a notice announcing the availability of a risk assessment regarding the potential for variant Creutzfeldt-Jakob Disease (vCJD) in humans from exposure to cosmetics containing cattle protein infected with the BSE agent.
This is Part II of a multi-part series of summaries on the three rulemakings and one notice. Part II highlights FDA's interim final rule that prohibits the use of certain cattle materials in FDA-regulated human food (including dietary supplements) and FDA-regulated cosmetics. (See ITT's Online Archives or 07/15/04 news, 04071520, for Part I.)
Highlights of FDA's Interim Final Rule
The FDA's interim final rule adds a new Subpart B to 21 CFR 189 (which would consist of 21 CFR 189.5) pertaining to FDA-regulated human food, and a new 21 CFR 700.27 pertaining to FDA-regulated cosmetic products. The following are highlights of the interim final rule from both the regulatory text and its preceding explanatory text:
Prohibition would affect U.S. and imported human food/cosmetics. According to the FDA, new 21 CFR 189.5(b) provides that no human food shall be manufactured from, processed with, or otherwise contain "prohibited cattle materials," and new 21 CFR 700.27(b) provides that no cosmetic shall be manufactured from, processed with, or otherwise contain, "prohibited cattle materials."
The FDA states that it is applying these requirements for "prohibited cattle materials" to all FDA-regulated human food and cosmetic products or ingredients of products manufactured in the U.S. or imported into the U.S.
(According to the interim final rule, "prohibited cattle materials" means specified risk materials (SRMs), small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated (MS) (Beef). "Prohibited cattle materials" do not include tallow that contains no more than 0.15% hexane-insoluble impurities and tallow derivatives. See new 21 CFR 189.5 and 21 CFR 700.27 for detailed definitions of tallow and tallow derivatives.)
Scope of "human food." According to the FDA, "human food" is "food" as that term is defined in 21 USC 321(f), except for animal food. Specifically, "human food" is: (1) articles used for food or drink for man, (2) chewing gum, and (3) articles used for components of any such article. "Human food" includes, but is not limited to, food additives, including substances that migrate into food from food packaging and other articles that contact food, color additives, dietary supplements and dietary ingredients, and infant formula.
Scope of "cosmetic." The FDA states that "cosmetic" is defined in 21 USC 321(i) as: (1) articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap. The FDA notes that in 21 CFR 701.20, it explains the criteria articles must meet to be considered "soap" under 21 USC 321(i).
Effective date of interim final rule turns on date of slaughter. The FDA states that this interim final rule applies to FDA-regulated human food and cosmetics manufactured from, processed with, or that otherwise contain, material from cattle slaughtered on or after its effective date (i.e., July 14, 2004).
FDA adds that it realizes that it may be difficult, in certain instances, for manufacturers and processors to comply immediately with all of the provisions of this interim final rule, and this may be considered in enforcing the interim final rule.
Records must be available for FDA-regulated human food/cosmetics that contain cattle material. According to the interim final rule, manufacturers and processors of FDA-regulated human food or cosmetics that are manufactured from, processed with, or otherwise contain, cattle material must make existing records relevant to compliance with the interim final rule available to FDA for inspection and copying.
(See future issue of ITT for BP summary of FDA proposed rule on recordkeeping relating to this interim final rule.)
- written comments are due by October 12, 2004.
FDA contact - Rebecca Buckner (301) 436-1486
FDA interim final rule (D/N 2004N-0081, FR Pub 07/14/04) available at http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-15881.pdf