Reminder: FDA to Ease BSE Restrictions on Food and Cosmetics (Effective July 16, 2008)
The Food and Drug Administration's April 2008 interim final rule easing certain bovine spongiform encephalopathy (BSE) restrictions on food and cosmetics becomes effective July 16, 2008. Comments on the interim rule are also due July 16, 2008.
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The interim final rule will allow cattle-derived materials from negligible risk countries to be excluded from the BSE-related prohibition on the use of such materials in human food (including dietary supplements) and cosmetics. Under the rule, negligible risk countries must apply to the FDA and meet certain requirements in order to be exempt from the prohibition.
Countries that are officially recognized as having a ''negligible BSE risk'' include Australia, Argentina, New Zealand, Singapore, and Uruguay.
(BSE is also known as 'mad cow disease')
FDA-Designated Countries May Not Face BSE Food/Cosmetics Restrictions
The FDA is amending its regulations under 21 CFR 189.5 and 700.27 to provide that the FDA may designate a country as not subject to the restrictions applicable to human food and cosmetics manufactured from, processed with, or that otherwise contain specified risk materials (SRMs1), the small intestine (with the distal ileum) of cattle, material from nonambulatory disabled cattle, or mechanically separated (MS) (beef), as certain countries may be able to demonstrate to the FDA that its BSE case history, risk factors, and measures to prevent the introduction and transmission of BSE make these restrictions unnecessary.
Cattle materials inspected and passed from such a designated country will not be considered prohibited cattle materials, and their use will not render a human food or cosmetic adulterated. However, material from cattle not inspected and passed for human consumption will continue to be prohibited, regardless of the country of origin.
Countries Must Request Exemption, Be Evaluated to Receive Designation
The interim final rule will also amend 21 CFR 189.5 and 21 CFR 700.27 by adding new paragraphs (e) requiring foreign countries wishing to be designated countries to send a written request to the FDA for its consideration, including information about:
a country's BSE case history and risk factors (see notice for list);
measures to prevent the introduction and transmission of BSE; and
any other information relevant to determining whether SRM, the small intestine (with the distal ileum) of cattle, material from nonambulatory disabled cattle, or MS from cattle from the country should be considered prohibited cattle materials.
Conditions, future reviews, revocations. The interim final rule states that the FDA may impose conditions in granting any such request. In addition, country designations granted by FDA under 21 CFR 189.5(e) and 21 CFR 700.27(e) will be subject to future review, and may be revoked if the FDA determines that they are no longer appropriate.
(This interim rule amends a July 2004 FDA interim final rule and subsequent September 2005 amendment.)
1SRMs include the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal ileum of the small intestine of all cattle.
(See ITT's Online Archives or 04/22/08 news, 08042225, for BP summary of the FDA's April 2008 interim final rule.
See ITT's Online Archives or 07/16/04 news, 04071615, for BP summary of the FDA's July 2004 interim final rule that prohibited the use of certain cattle materials in FDA-regulated human food (including dietary supplements) and cosmetics.
See ITT's Online Archives or 09/14/05 news, 05091420, for BP summary of the FDA/FSIS interim final rule which amended the July 2004 rule to provide for the use of most parts of beef small intestine.
See ITT's Online Archives or 07/18/07 news, 07071899 3, for BP summary of a FSIS final rule excluding from its definition of SRMs cattle materials that come from countries that can demonstrate low BSE risk status, etc.)
- comments are due July 16, 2008
FDA contact - Rebecca Buckner (301) 436-1486
FDA interim final rule (D/N 2004N-0081, dated 04/17/08) available at http://edocket.access.gpo.gov/2008/pdf/08-1142.pdf