19 
approved or natural substance. 36 / 
Because of the testing for safety and 
efficacy necessary for new drugs, FDA 
will inspect all genetically engineered 
drugs for bacterial and immunogenic 
contamination and for genetic stability. 
(6) Veterinary medicines are also regulated 
under the Virus, Serum and Toxic Act of 
1913. 37/ 
3. The Scope of Authority EPA Desires 
Would Produce Considerable Harm 
If EPA assumed the extent of regulatory authority over 
genetic engineering that it desires, the new industry would be 
subjected to unpredictable, overlapping and possibly contradic- 
tory regulatory authority by different agencies for all products 
’’excluded” from TSCA. This concern is not a theoretical prob- 
lem; the genetic engineering pharmaceutical industry has already 
experienced the regrettable situation of agencies competing for 
jurisdiction over the same product. Both the Food and Drug 
Administration and the United States Department of Agriculture 
have authority over veterinary biologies. 3JJ / Concerned that 
jurisdictional distinctions had been blurred by genetic 
engineering technology, the FDA and USDA developed a memorandum 
36/ IcL at 360. 
37/ 21 U.S.C. §§ 151-58. 
38/ USDA has authority under the Virus, Serum and Toxin Act, 
~ 21 U.S.C. §§ 151-58; FDA has authority under the Federal 
Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301-92. 
[719] 
