110
regarding the notification shall be indicated if different from above:
3.
Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:
4. Products covered (HS or CCCN where applicable, otherwise national tariff
heading.
ICS numbers may be provided in addition, where applicable): Cosmetics and
Human Food ICS numbers may be provided in addition, where applicable): (HS
Chapters 33 and 2106) (ICS 67.020 and 71.100)
5.
Title, number of pages and language(s) of the notified document: Use of
Materials Derived From Cattle in Human Food and Cosmetics; and Recordkeeping
Requirements for Human Food and Cosmetics Manufactured From, Processed With,
or Otherwise Containing, Material From Cattle; Final Rule and Proposed Rule (19
pages, in English)
6.
Description of content: The Food and Drug Administration (FDA) is issuing an
interim final rule (interim final rule) to prohibit the use of certain cattle material, to
address the potential risk of bovine spongiform encephalopathy (BSE), in human
food, including dietary supplements, and cosmetics. Prohibited cattle materials
include specified risk materials, small intestine of all cattle, material from non-
ambulatory disabled cattle, material from cattle not inspected and passed for human
consumption, and mechanically separated (MS)(Beef). Specified risk materials are
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.
Prohibited cattle materials do not include tallow that contains no more than
0.15 percent hexane-insoluble impurities and tallow derivatives. FDA is taking this
action in response to the finding of an adult cow, imported from Canada, that tested
positive for BSE in the State of Washington. This action is consistent with the recent
interim final rule issued by the U.S. Department of Agriculture (USDA) declaring
specified risk materials and the carcasses and parts of non-ambulatory disabled
cattle to be inedible, unfit for human food, and prohibiting their use as human food
and requiring that the entire small intestine be removed and disposed of as inedible.
This action will minimize human exposure to materials that scientific studies have
demonstrated are highly likely to contain the BSE agent in cattle infected with the
disease. Scientists believe that the human disease variant Creutzfeldt-Jakob disease
(vCJD) is likely caused by the consumption of products contaminated with the agent
that causes BSE.
Also in this issue of the Federal Register, FDA is proposing to require that
manufacturers and processors of human food and cosmetics that are manufactured
from, processed with, or otherwise contain material from cattle establish and
maintain records sufficient to demonstrate that the food and cosmetics are in
compliance with this interim final rule.
7. Objective and rationale, including the nature of urgent problems where