BIO/MEDICAL TECHNOLOGY BREAKFAST CLUB 
P.O. BOX 800310 
HOUSTON, TX 77280-0310 
(713) 973-2870 
September 3, 1987 
Director 
OFFICE OF RECOMBINANT DNA ACTIVITIES 
12441 Parklawn Drive 
Suite 58 
Rockville, MD 20852 
Dear Sir, 
The Bio/Medical Technology Breakfast Club of Houston represents academic 
scientists, biotechnology companies, entrepreneurs, and various support groups in 
the Greater Houston Area. The goals of this group include promoting education, 
facilitating communication, participating in the formulation and development of 
responsible regulatory and ethical policies, and fostering biotechnology. The 
Steering Committee, on behalf of the above membership, is submitting this letter 
to you in response to your invitation for comments on the proposed, dated January 
9, 1987, by Mr. Edward Lee Rogers and Mr. Jeremy Rifkin to amend Section I-C 
(General Applicability) of the GUIDELINES FOR RESEARCH INVOLVING 
RECOMBINANT DNA MOLECULES. We wish to express our strong disapproval of 
the proposed amendment. 
The wording of the proposed amendment is vague and ambiguous and will lead 
to endless arguments and litigation. Who is going to define what is "work that is 
reasonably forseeable when NIH support is received"? What is "reasonable" to us 
may not be "reasonable" to Mssrs. Rogers and Rifkin. What is "forseeable"? In our 
experience, serendipity is more common in science than clairvoyance. Is it 
supposed to be "reasonably forseeable" by the PI, by NIH Staff, by Mssrs. Rodgers 
and Rifkin, by a Federal Judge, or by any or all of the above? Is "reasonably 
forseeable" to be interpreted prospectively or retrospectively? What are the 
definitions for "biological materials" and "indirect in-kind support"? 
If NIH support is defined as "any type of in-kind support, including research 
conducted directly (or indirectly ) by NIH, supplies ..., and biological research 
materials," then, perhaps, journal and symposia publications are in-kind NIH 
support, as well as antisera, cells, microorganisms, and plasmids deposited by an 
NIH investigator or an NIH grantee with the ATCC. So, for example, if we send 
reprints paid for by the NIH or antisera or plasmids or microorganisms to Dr. X, is 
it to be understood that Dr. X has received in-kind NIH support? 
[348] 
Recombinant DNA Research, Volume 13 
