[Federal Register Volume 69, Number 134 (Wednesday, July 14, 2004)]
[Pages 42191-42192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15979]



Food and Drug Administration

[Docket No. 2004N-0291]

Risk Assessment for Cosmetics and Potential Contamination With 
Bovine Spongiform Encephalopathy Agent; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a risk assessment regarding the potential for variant 
Creutzfeldt-Jakob Disease (vCJD) in humans from exposure to cosmetics 
containing cattle-derived protein infected with the bovine spongiform 
encephalopathy (BSE) agent. FDA is making this document available to 
communicate publicly the potential risk to public health from cosmetics 
made with cattle materials that may be contaminated with the BSE agent.

ADDRESSES: Submit written requests for single copies of the risk 
assessment to the Office of Plant and Dairy Foods (HFS-365), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740. Send one self-addressed 
adhesive label to assist that office in processing your request, or 
include a fax number to which the document may be sent. Alternatively, 
you may request a copy of the document by calling 301-436-2367, or you 
may fax your request to 301-436-2632. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the risk assessment.

FOR FURTHER INFORMATION CONTACT: Morris Potter, Center for Food Safety 
and Applied Nutrition (HFS-006), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 404-253-1225.


I. Background

    Cosmetics may be made from a variety of cattle-derived ingredients. 
These ingredients include: Albumin, brain extract, brain lipid, 
cholesterol, fibronectin, sphingolipids, collagen, keratin, and tallow, 
and tallow derivatives. Tallow derivatives, particularly fatty acids 
and glycerin, are the predominant cattle ingredient used by the 
cosmetic industry. Cattle-derived ingredients serve many functions and 
may be used as skin conditioning agents, emollients, binders, and hair 
and nail conditioning agents.

[[Page 42192]]

    There are several routes through which cosmetics contaminated with 
the agent that causes BSE could transmit disease to humans. 
Transmission of the BSE agent to humans through intact skin is not 
likely; however, cosmetics may be ingested or applied to cut or abraded 
skin or to mucosal tissues, particularly in the eye, which could 
provide direct routes for infection.

II. Risk Assessment for Cosmetics and Potential Contamination With the 
BSE Agent

    The risk assessment presents scientific evidence on the risk of 
transmission of vCJD to humans from cattle-derived ingredients used in 
the manufacture of cosmetics. FDA has prepared a qualitative assessment 
that follows the generally accepted framework for risk assessments 
endorsed by the Codex Alimentarius Commission. This framework involves 
the following steps:
    (1) Hazard identification. A review of available information on 
vCJD and its link to BSE-infected cattle.
    (2) Exposure assessment. An evaluation of the range of possible 
cattle-derived ingredients that might be used in the manufacture of 
cosmetics and the likelihood that a contaminated cosmetic results in 
transmission of the BSE agent to humans.
    (3) Hazard characterization. The assessment of the potential for 
BSE transmission and development of vCJD in humans.
    (4) Risk characterization. The integration of information on 
potential hazards with the exposure assessment.
    The risk assessment also discusses the quality of information 
available for, and the uncertainties associated with, the assessment.
    FDA has determined that this risk assessment is appropriate to the 

III. Electronic Access

    The risk assessment is available electronically at http://www.cfsan.fda.gov.

    Dated: July 9, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-15979 Filed 7-13-04; 8:45 am]