Microbial Production Capability as a Trigger for Declarations:
Estimate of the Number of
US SITES WITH MICROBIAL PRODUCTION CAPACITY GREATER THAN 50 LITERS
(Active producers of human food and drink excluded)*
Federation of American Scientists Working Group on BW Verification - August 1997
1. Biologics Producers
a) Licensed Producers of Biologics for Human Use
(Source: FDA, "Establishments and Products Licensed Under Section 351 of the Public Health Service Act, 1 Mar. 1991)
About 22 companies make licensed products requiring microbial production, some probably with less than 50 l. capacity; there may also be a few unlicensed producers.
Total with >50 l fermentation capacity: about 25
b) Producers of Veterinary Biologics and Feed
(Sources: Institute for Biotechnology Information (IBI): "Biotech Industry Guide, 1996"; Center for Veterinary Biologics, APHIS, USDA: "Veterinary Biological Products, Licensees and Permittees, Feb. 1997; K. Johnston, Bayer Agriculture Division)
IBI lists 26 companies that make products "using living cells" for "animal agriculture," some of which may carry out microbial production (eg, to produce feed supplements such as amino acids) (Note: all feed ingredient manufacturers are licensed by the States, from which exact information can be obtained.)
Total number of microbial feed, etc. producers with >50 l capacity: est. <20
There are 124 veterinary biologics companies licensed by USDA for interstate commerce; some of these produce serum or other non-microbial products not involving fermentation; some buy and reformulate pre-made materials--about 41 companies produce microbials for further manufacture. Only about 20 companies produce 99% of the marketed products. There are also a number of very small unlicensed intrastate companies. Few other than the largest companies have >50 l capacity.
Total no. of vet. biologics producers with >50 l microbial production capacity: est. 30
c) Producers of Agricultural Biologics (biopesticides, plant innocula, etc.)
(Sources: IBI (ibid); EPA, Biopesticides and Pollution Division, Office of Pesticide Programs; Farm Chemicals Handbook '96)
IBI lists 55 biotech companies in the field of "plant agriculture"; not all are likely to use fermentation, and fewer still with >50 l capacity.
EPA registers all manufacturers of microbial products for pesticide or plant innoculum use; there are 146, many of which only buy and reformulate (eg, 116 companies have products containing B. thuringiensis, but only 11 companies worldwide produce it). Some producers have less than 50 l capacity.
The Farm Chemicals Handbook lists about 21 US companies producing microbial biocontrols.
Total no. ag. biologics producers with >50 l microbial production capacity: about 20
2. Other Commercial Sites (pharmaceutical and biotech companies and producers of industrial, agricultural, etc. chemicals of any kind using fermentation)
(Sources: IBI: "Pharmaceutical Industry Guide 1997" and "Biotech Industry Guide, 1996," and telephone consultation; Dr. Lynn Klotz, biotechnology industry consultant and company founder; SRI International: "Directory of Chemical Producers, USA," 1988 and 1989; and Dr. Leo Zeftel, DuPont (retired) and CWC expert)
IBI lists 1330 US companies "using living cells for commercial purposes" of any kind (excluding companies that are primarily pharmaceutical), of which about 900 have >15 employees. A great many do not yet have marketed products.
About 16 of the listed companies cite fermentation (contract work) as their primary focus; some of these may have >50 l capacity: total <16
IBI also lists 108 pharmaceutical companies.
According to IBI, few pharmaceutical or biotechnology companies use fermentation for production; many use living cells for small-scale research purposes only.
According to Klotz, few biotech companies use fermentation for production; small companies that do are mostly bench-scale (<50 l).
According to SRI and Dr. Zeftel, about 200-250 producers of chemicals of any kind use fermentation for production. Most of those that do are small companies producing specialty chemicals on a scale <50 l. The number of large companies using fermentation is small. For example, there are 33 sites producing antibiotics in commercial quantities, but some use chemical methods rather than fermentation.
Sites that produce any chemical by fermentation and have >50 l capacity est. <75
3. Research Institutions and Accredited Universities and Technical Institutes
(Sources: World of Learning, 1982-3; Lovejoy's College Guide, 1995; American Assn. of Engineering Societies; US Institute of Engineering; Dr. George Georgiou, Prof. of Chemical and Bioengineering, Univ. Texas, Austin)
None of these institutions is likely to have more than 1-2 fermenters, if any; many of the fermenters in the range 50-300 l capacity are old and unused. Today, because of the efficiency of production by cloned organisms, capacities of 20-50 l are preferred. (The efficiency of pathogen production, however, remains unchanged.) Moreover, a large variety of cell products that once had to be isolated by researchers are now commercially available. Thus, if required to be declared, fermenters >50 l intended for production of research materials in institutions of this type would probably be discarded.
There are 29 biological and 38 agricultural engineering schools, which are likely to have fermentation pilot plants, but not all >50 l; those with >50 l capacity, <67
There are 145 chemical engineering schools, some of which have fermentation pilot plants; those with >50 l capacity, est.<30
4. Government Sites
USAMRIID and probably a few others est. 10
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Approximate Maximum No. US Sites with Microbial Production >50 L (based on high estimates for each category) Total <293
PROBABLE TOTAL NUMBER OF US SITES WITH MICROBIAL PRODUCTION CAPACITY >50 L about 250
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* Active, bonafide human food or drink production could not be interrupted safely for pathogen production on a routine basis. Such facilities could, however, be designed for rapid conversion to BW production if called upon to do so in the future.