5 
Most insulin, as made today from calf or pig pancreas, is only about 80-90 
percent pure. Identity and puri ty are checked by relatively crude analytical 
techniques. When checking insulin made in bacteria by recombinant DNA 
techniques, more sophisticated tests for identity and purity, such as high- 
pressure liquid chromatography and amino acid sequence, will probably be 
used. Contaminants in this case will be different, including bacterial 
polypeptides and polysaccharides, and different tests for antigenicity and 
pyrogenicity will probably be required. Higher standards will probably be 
set, leading to higher purity of the product. 
Dr. Goldberg said FDA inspectors are primarily concerned with contamination 
of the product. However, according to the inspection referral system instituted 
by the Interagency Regulatory Liaison Group, he expects that an FDA inspector 
noting a possible violation in the regulatory domain 'of another agency, such 
as OSHA or EPA, would make the appropriate referral. 
Report from USDA 
Dr. Still reported that to vaccinate against Foot and Mouth Disease an 
attenuated virus is used at present, which in a certain percent of cases actually 
causes the disease. If current attempts to use recombinant DNA techniques to 
produce a vaccine, involving only viral coat proteins with no live virus, are 
successful, this would be a major advance in control of this economically 
important disease. 
Other uses of recombinant DNA techniques of importance to agriculture are 
highly speculative. These include: 
• production in bacteria of agriculturally and economically important 
materials such as plant growth regulators, natural products with 
insecticidal properties or amino actds, -vitamins, etc., required for 
the nutrition and sustenance of man; 
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