PRODUCTION OF LG QUANTITIES OF BOTULLNUM TOXIN AND ANTHRAX PA

File: 980404_aug97_decls3_0001.txt
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Subject = PRODUCTION OF LG QUANTITIES OF BOTULLNUM TOXIN AND ANTHRAX PA

Box ID = BX007008

Folder Title = PRODUCTION OF LARGE QUANTIES OF BT AND ANTHRAX PA

Unit = OSAGWI

Parent Org = USAGWD

DECLASSIFIED
ON: 13 MAR 98
BY: SEC ARMY (DAMH) UNDER SEC 3.4 EO 12958
INFOP.KATION PAPER
SARD-TM
17 December 1990

SUBJECT: Production of Large Quantities of Botulinum Toxin and
Anthrax PA Protein for Use in the Development of
Medical BW Defense Measures

1. ISSUE. Is the production of large quantities of botulinum
toxin to be used in the formulation of botulinum toxoid
(vaccine),.and large quantities of anthrax PA protein to produce
anthrax vaccine in contravention of the Biological Weapons
Convention?

2. FACTS.

a. The production of botulinum toxoid intended for use in
man for the induction of immunity to the toxic effects of
botulinum toxin, and/or to stimulate the production in horses of
botulinum antitoxin intended for use in humans, requires the
production of large quantities of lethal toxin.

b. However, the toxin produced in the process of formulating
botulinum toxoid is not stockpiled; but instead, rapidly toxoided
(detoxified) by a process that renders it non-toxic/non-lethal
and suitable only for the induction of immunity to botulinum
toxin.

c. Enclosure 1, a 6 Nov 90 authoritative memorandum
reflecting a consultation on the issue of the production of
botulinum toxin for the formulation of botulinum toxoid, is
provided as documentation that the production of botulinum toxin
for the peaceful purpose of producing botulinum toxoid (vaccine)
is permitted by the B4.ological Weapons Convention.

d. Anthrax PA protein, when produced in the process of
formulating anthrax vaccine intended for use in U.S. forces, Is
derived from a non-pathogenic (non-lethal) strain of Bacillus
anthracis.

e. PA protein is not lethal or toxic and cannot in of itself
cause the disease known as anthrax.

f. The production of large quantities of anthrax PA protein,
derived from a non-pathogenic strain of Bacillus anthracis,
int,ended for the formulation of an anthrax vaccin'ii' do@es n@ot
constitute the stockpiling of a SW agent.

3. CONCLUSION. The production of large quantities of botulinum
toxin and/or anthrax PA protein, each for the formulation of the
respective toxoid/vaccine, is an allowable activity within the
provisions of the Biological Weapons Convention and as such
should not provide a factual basis for negative ramifications of
medical Bw defense activities (production of botulinum toxoid and
anthrax vaccine) conducted by the Department of Defense.
I ]Nri A-R-RIFIFN COE, Lewis/55615