15 
of the environmental impact of a Federal action. The document being developed 
by the working group does not address the NEPA provisions and would not affect 
the basis of the lawsuit. 
Dr. Arntzen asked if the Federal agencies ccmmunicate with each other concerning 
biotechnology. Dr. Tolin noted that EPA, FDA, and US DA have liaison represen- 
tatives to RAC and these representatives are members of the Working Group on 
Release into the Environment. 
Dr. Anne Hollander of the EPA explained that at the cabinet level, the Chairman 
Pro Tempore of the Cabinet Council on Natural Resources and the Environment 
has established a Cabinet Council Working Group on Biotechnology to undertake 
a review of the federal regulatory rules and procedures relating to biotechnology 
and to sort out jurisdictional responsibilities. The group is composed of 
representatives of the relevant Departments. 
The Cabinet Council Working Group's study is to include, but not be limited to: 
o Reviewing the regulatory requirements vhich have been applied to 
commercialize biotechnologies; 
o Identifying existing laws and regulations that may be applicable to 
biotechnology ; 
o Reviewing the function of the Recombinant DNA Advisory Committee and its 
role in biotechnology commercialization and safety regulation; 
o Clarifying the regulatory path that a company with a new product would 
follow to meet Federal health and safety requirements; 
o Determining if the current regulatory requirements and Federal review are 
adequate to deal with new products; 
o Developing specific recommendations for administrative or legislative 
actions to provide additional regulatory review if warranted while main- 
taining flexibility to accommodate new developments; 
o Reviewing court rulings regarding the granting of patents for biotechnol- 
ogy; and 
o Identifying ways in which Federal actions such as R&D or regulatory cer- 
tainty could affect commercialization and U.S. competitive position 
vis-a-vis international firms. 
Dr. Arntzen asked what will be the future role of RAC and its working groups, 
and hew long would these roles last. Dr. Hollander said RAC will continue to 
review prcposals involving recombinant DNA technology. Dr. Gartland said for 
the foreseeable future RAC will review field testing proposals. He noted that 
an NIH institute, the National Institute of General Medical Sciences, is the 
funding agency for the project to field test com plants modified using recom- 
binant DNA techniques. 
[ 25 ] 
