Rockville, MD (Jan. 12)—To prevent the spread of bovine spongiform encephalopathy (BSE) and related diseases, the US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) has proposed banning certain cattle tissues and tissue-products from the manufacture of drugs for human and ruminant use.
The proposal, “Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants; Proposed Rule” (published in the January 12 Federal Register, pp 1581-1619), estimates that cattle products of some kind are used in 75% of pharmaceutical manufacturing—and 90% of biotechnology processes. The proposal notes, however, that the agency has reviewed 10 years of data on cattle products used in drug-manufacturing and “we are aware of no approved drugs and no investigational drugs that are manufactured with cattle material that would be prohibited under this proposed rule....”
The rule will, however, impose new record-keeping requirements on some 1,200 manufacturing establishments (including an estimated 674 pharma plants and 253 biotech facilities), which must show that their processes do not employ the proscribed “Specified Risk Materials.” These SRMs are defined as the brain, skull, eyes, trigeminal ganglia, spinal cord, most of the vertebral column, and dorsal root ganglia of cattle 30 months and older, and the tonsils and distal ileum of the small intestine of all cattle.
Manufacturers would be required—under 21 CFR Sections 300.200(c)(1), 500.200(c)(1), 600.16(c)(1), 895.102(c)(1) and 1271.470(c)(1))—to maintain records that demonstrate that all cattle-derived materials conform to the prohibition. These could include signed and dated affirmations from slaughterhouses or renderer. The agency estimates the cost of compliance will be small, about $45 to $90 per year, depending on the size of the establishment.
The rule notes that cattle products may be used in manufacturing gelatin, heparin, surfactants, hormones, enzymes, glycosphingolipids, amino acids, glycerol, detergents, blood, collagen, fetal calf serum, bovine meat, and tallow and tallow derivatives.
BSE is a transmissible spongiform encephalopathy (TSE) thought to be caused by prions, for which no screening tests now exist. Human TSEs include Creutzfeld-Jakob Disease (CJD),variant Creutzfeld-Jakob Disease, Gerstmann-Strauussler-Scheinker syndrome, kuru, fatal familial insomnia, and sporadic fatal insomnia. Nonhuman TSEs include, in addition to BSE in cattle, scrapie in sheep and goats, transmissible mink encephalopathy, feline spongiform encephalopathy, and chronic wasting disease (CWD) in deer and elk.