FDA adoption of WHO policies on BSE-infected bovine materials urged by CTFA.

FDA ADOPTION OF WHO POLICY FOR AVOIDING BSE-INFECTED BOVINE MATERIALS is urged by the Cosmetic, Toiletry, and Fragrance Association in a recent letter to the agency. The approach taken by the World Health Organization directs countries where BSE exists in native cattle to ensure that raw material does not originate from BSE-infected animals and that processing measures are adopted to render the BSE-infective agent harmless.

In its letter, dated July 19, CTFA pointed to the WHO approach as a "prudent alternative" to FDA's policy that no ingredients be imported from cattle "born, raised or slaughtered in countries where BSE exists."

The WHO guidelines, CTFA noted, "direct countries where BSE exists in native cattle to prevent tissues that are likely to contain the BSE agent from entering any food chain, human or animal." The organization's policy also "requires contained surveillance, compulsory notification and slaughter of animals that have shown signs of transmissible spongiform encephalopathy," the letter states.

CTFA additionally proposed that the following factors be considered in selecting raw materials for importation: (1) whether the country [of origin] has "an effective veterinary service capable of detecting a low incidence of disease and is BSE reportable in that country"; (2) "the practice regarding the feeding of ruminant protein from specified offal to other ruminants"; and (3) whether cattle over six months old are "routinely imported from countries with a high incidence of BSE."

Ingredients from countries reporting a low incidence of BSE "may be safely used when steps have been taken to ensure that the infected material is not used to produce the processed ingredient," CTFA said. In addition, the BSE incidence must be "legally notifiable"; "the carcasses of infected animals must be routinely destroyed"; and "progeny of infected animals must not be used," according to the trade group.

CTFA also supported the WHO and the European Commission's position that a combination of appropriate sourcing of bovine material and the "application of minimum processing standards shown to effectively inactivate" the BSE agent provide "adequate assurance of the safety of gelatin, tallow and products derived from tallow intended for either food or cosmetic use."

Current scientific data, CTFA maintained, "show BSE infectivity can be destroyed by appropriate processing, and that such processing conditions are typically employed in the production of cosmetic ingredients." Tallow, gelatin and collagen are among the more important bovine-derived materials used in cosmetics products.

CTFA's comments follow a July 17 letter from FDA reasserting that "sourcing materials from BSE-free countries is the best method to assure products are free of [transmissible spongiform encephalopathy] agents." The agency sent a similar letter to the Independent Cosmetic Manufacturers and Distributors.

FDA also said it is "re-examining the steps that have already been taken to ensure that any possibility of contamination of cosmetic products is avoided," although it "continues to think it prudent and appropriate to keep material derived from BSE-infected animals out of cosmetic products."

The agency pointed out that although the WHO had stated that temperatures in excess of 138C for 20 minutes or 131C for one hour are necessary to inactivate the infectious agent, "these are extreme treatments that are not likely to be applied to some of the more temperature-sensitive ingredients that would be significantly degraded under these conditions."

In response to CTFA arguments that tallow is highly processed, the agency said that "it remains critical that the manufacturer of these substances follows all steps of the rendering process and that adequate and good manufacturing practices are employed." The agency also noted that it is currently "re-examining [its] policy with respect to the safety of gelatin for both foods and cosmetics," noting that the Animal Plant Health Inspection Service does have restrictions placed on importing gelatin.

Consumer concern about products containing bovine-derived ingredients resurfaced this spring following a statement by officials in England that there may be a link between BSE -- a transmissible fatal neurological disease found in cattle -- and a form of Creutzfeldt-Jacob disease in humans. Bovine-derived ingredients are used for various purposes in cosmetic products, acting as antistatic agents, hair and skin conditioning agents, binders and surfactants.