March 29, 1977 INTERAGENCY COMMITTEE REVIEW OF PATENT POLICY 
The Committee recommended "that recombinant DNA research inventions 
developed under DREW-NIH support should, at least for the present, 
continue to be administered within current DHEW patent agreements 
with the universities. But each agreement shou'd be amended to ensure 
that the licensees will comply with the physical and biological contain- 
ment standards set forth in the Guidelines in any production or use of 
recombinant DNA molecules under the license." 
May 9, 1977 FRIENDS OF THE EARTH SUIT FILED 
Brought in the Federal District Court in New York, the plaintiffs allege 
that NIH failed to comply with NEPA by not completing an Environmental 
.Impact Statement before supporting recombinant DNA research and before 
releasing the original Guidelines. The Government has answered the 
allegations, and the case is pending in New York. 
May 31, 1977 MACK v. CALIFANO SUIT FILED 
A resident of Fredrick, Maryland filed suit in :he Federal District 
Court in Washington, D.C., seeking an injunction to prevent NIH from 
conducting a DNA risk-assessment experiment at the Frederick Cancer 
Research Center (formerly Ft. Detrick) without filing an Environmental 
Impact Statement ^EIS). Once NIH completed its EIS, plaintiff further 
contended that the statement did not comply with the requirements of 
the National Environmental Policy Act (NEPA). 
June 20-21, 1977 FALMOUTH WORKSHOP 
A "Workshop on Studies for Assessment of Potential Risks Associated with 
Recombinant DNA Experimentation" was held in Falmouth, Mass., upon the 
recommendation of the DAC. Its purpose was to bring together diverse 
disciplines in order to discuss the basic biology of col i (the host 
most used in recombinant DNA experiments) and risk assessment in this 
area of research. From this Workshop came a consensus that the chances 
of this host being converted to an epidemic patnogen are negligible. 
September 27, 1977 RAC-PROPOSED REVISIONS PUBLISHED 
Early in 1977 the RAC (the scientific and technical committee responsible 
for proposing revisions to the Guidelines) began its task of identifying 
changes needed in the Guidelines and forwarded suggestions to tne 
Director of NIH for consideration. The RAC-proposed revisions were 
published in the Federal Register on September 27, 1977 in order to 
solicit public comment and review for subsequent NIH consideration. 
October 1977 ENVIRONMENTAL IMPACT STATEMENT (FINAL) PUBLISHED 
Comments received in response to the draft statement were analyzed and 
responded to in the final Environmental Impact Statement published by NIH. 
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