Monsanto 
WILL D. CARPENTER 
General Manager, Technology 
MONSANTO AGRICULTURAL PRODUCTS CO- 
800 N. Lindbergh Boulevard 
St. Louis, Missouri 63167 
Phone: (314) 694-8880 
April 26, 1985 
Director 
Office of Recombinant DNA Activities 
Building 31 
Room 3B10 
National Institutes of Health 
Bethesda, Maryland 20205 
Dear Sir: 
Monsanto Company is pleased to respond to the National Institutes of 
Health proposed action regarding Proposed Points to Consider for 
Environmental Testing of Microorganisms , which appeared in the Federal 
Register of April 25, 1985, 50 FR 12456-12458. Monsanto has publicly 
disclosed its position on the regulation of products developed through 
the emerging science of biotechnology. We believe an adequate federal, 
legislative, and regulatory framework is in place. New agencies and laws 
are unnecessary, so long as present agencies exercise existing authority 
consistently, cooperatively, and in a scientifically appropriate manner. 
Such a regulatory approach promotes the dual objectives of protecting man 
and the environment, and encouraging growth of the new industry. 
We strongly recommend that the NIH Recombinant DNA Advisory Committee 
coordinate and harmonize its data requirements for environmental testing 
of microorganisms containing recombinant DNA with other Federal Agencies 
that have regulatory jurisdiction over such environmental testing. An 
applicant seeking approval for such environmental testing, whether they 
be an academician applying to the NIH-RAC, or a company applying to the 
Environmental Protection Agency, to the U. S. Department of Agriculture or 
the Food and Drug Administration should face the same data requirements to 
demonstrate the safety of the proposed environmental test. Procedures 
designed to evaluate field test protocols must be consistent whether the 
protocol is submitted by a researcher from a commercial concern, or from 
the non-profit/university sector. 
We believe that reviews for the products of biotechnology should be made 
on a case by case basis. 
We strongly recommend that reviews for such proposed tests and products 
be made in such a manner so as to protect the proprietary nature of 
submitted information. 
[ 637 ] 
