Donald S. Fredrickson - October 17, 1977 - page 2 
microbial strains may have slow-acting noxious effects (e.g., elaboration of 
carcinogens or cumulative toxins) which have thus far escaped detection. 
(D) As molecular biology proceeds, it will become possible to create many complex 
recombinants not producible today. Hence, even were it established that present- 
day techniques pose no hazard, advancing technology may at any time achieve the 
creation of a virulent and uncontrollable microorganism. 
li) No government agency has yet issued an environmental impact statement on 
the widespread application of recombinant DNA technology (as distinct from the brief 
draft ETS by NIH on the impact of the Guidelines, issued August 19, 1976). The just- 
announced legal ruling that the Upjohn company will be permitted to patent its novel 
form of Strep tomyces sets a precedent which portends legal and commercial anarchy. 
In the absence of comprehensive environmental-impact review, and with the profit 
incentive inherent in patent rights, and unfettered even by the provisions of the 
Guidelines, private industry may be expected to kill and injure humans with self- 
distributing, self-maintaining biological pollutants as it has with radioisotopes 
and organic chemicals. 
5) The proposed revised Guidelines totally disregard any requirement for health 
insurance for laboratory personnel, or liability insurance to indemnify the public 
(see the section, "Roles and Responsibilities," p. b960b). Such omissions could be 
loeically justified only on the assumption that no biohazard was involved in DIA 
recombination work, in which case the Guidelines would be unnecessary. Given Litton 
Pionetics' inability to obtain insurance coverage for its prospective Pb NIH contract 
work at Fort Detrick, and its resultant withdrawal from that research, it is incumbent 
on the federal government to deal decisively with the matter of insurance. A very- 
serious neglect of public trust in involved in the government's continuing refusal 
to address the issue. 
6) The proposed revised Guidelines, like their predecessors, do not even attempt 
to deal with human malfeasance in any of its pertinent manifestations. These include 
use of unauthorized vectors ( Science. 30 September 1977, p. 13b2), quasi-deliberate 
release to the environment through calculated negligence regarding containment, theft 
from laboratories or during transportation, sabotage resulting in loss of containment, 
and malevolent attempts to create or distribute noxious novel organisms. It has been 
said, by way of dismissing this topic, that inventor Henry Ford should not be held 
accountable for the adverse consequences of tne automotive industry — smog, military 
tanks, and b5,000 American motor vehicle fatalities per year. But to properly complete 
the analogy, if adequate foresight and control could have been applied early in the 
history of the automobile, millions of lives could have been saved through the use of 
acceptable safety measures. Again, if the budding nuclear industry had early recog- 
nized the burden of security and safeguards which would eventually be found necessary 
to its functioning, past and future history might be quite different. 
7) The proposed revised Guidelines do not refer to pursuit of international 
agreements, achievement of which was deemed "essential" in your introduction to the 
1976 Guidelines (FR, July 7, 1976, p. 27905). 
Forceful representations to Congress are necessary to safeguard public health 
and to preserve your estimable professional reputation. Federal monopoly is the 
logical institutional model to pursue. 
Enclosure: Curtiss letter critique 
[Appendix A — 18] 
