Two major topics will be considered at a risk-assessment meeting to 
be held in Pasadena in April. The first is the possibility of direct adverse 
effects of hormone-producing strains of E,. col i K-12. The second is the 
possibility of autoantibodies or autoreactive cells due to the production of 
eukaryotic proteins by E_. col i K-12. 
Dr. Morris Levin of EPA then described his agency's risk-assessment 
effort. The mission of EPA is to protect and enhance the environment, and 
there is concern that the release of organisms containing recombinant DNA 
might be harmful. The Office of Research and Development at EPA is focusing 
on emerging environmental problems where anticipatory research is necessary, 
including applied genetics. Two workshops have been held. One, at the 
University of Rhode Island focused on sewage treatment. The issue is 
whether current processes for waste water treatment can deal with large- 
scale release of novel genomes. The other workshop, at the University of 
California, focused on the effect of novel genomes in the environment. 
EPA is soliciting grants and contracts in these areas. (See Attachment B 
for relevant document on EPA activities.) 
Industrial Application of Recombinant DNA Technology 
Recombinant DNA Guidelines— Voluntary Compliance (Part VI) . Dr. Bernard 
Talbot, Special Assistant to the Director, NIH, summarized developments on 
voluntary compliance since the last interagency meeting. The supplement that 
the Committee had reviewed at its July 1979 meeting was published for public 
comment in the Federal Register in August and recommended by the RAC in 
September. It was published again in the Federal Register for comment on 
November 30 and incorporated in the Guidelines promulgated on January 29, 1980 
It encourages voluntary compliance by industry, with protection for pro- 
prietary information. The RAC has considered requests from industry at its 
last two meetings. Large-scale requests were approved from Eli Lilly for 
insulin and from Genentech for insulin and somatostatin. 
Proposed Guideline Supplement for Large-Scale Containment . Dr. W. Emmett 
Barkley, Director, Division of Safety, NIH, discussed a Part VII to the 
Guidelines which is being developed to describe physical containment for 
large-scale use of organisms containing recombinant DNA molecules. The RAC 
has considered a draft, which has been revised and will be resubmitted to 
the Committee at its March meeting. Three levels of containment are described 
Pl-LS, P2-LS, and P3-LS. Work at the Pl-LS level must be confined to closed 
systems. At the P2-LS level, there are more requirements concerning the 
integrity of containment. At the P3-LS level, there are also specific design 
criteria for the facility in which the equipment is located. 
Congressional Activities . Dr. Burke Zimmerman, Director, Division of 
Legislative Analysis, NIH, discussed S.2234, introduced by Senator Stevenson. 
This bill would require registration with HEW of recombinant DNA activities 
in the private sector. (See Attachment C for a copy of S.2234.) 
OSHA Concerns About Industrial Applications of Recombinant DNA 
Technology . Dr. Fredrickson reported that Dr. Eula Bingham, Administrator 
of the Occupational Safety and Health Administration, had written to him 
expressing concern about potential hazards to workers exposed to recombinant 
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