Coordinated framework regulations

In June 1986, the final revision of the Administration s Coordinated framework for the regulation of Biotechnology was published in the Federal Register. This now constitutes the guidelines but they lack adequate or agreed upon definitions of some very important threshold terms, such as "release into the environment" and "pathogen". 

Proposal for a Coordinated Framework for Regulation of Biotechnology, Executive Office of the President, Office of Science and Technology Policy, Federal Register, 49, 252, pp 50856-50907, December 31, 1984. 

Proposal for a Coordinated Framework for Regulation of Biotechnology. These agency statements delineate some of the agencies overt regulatory concerns. The comments submitted in response to this Federal Register Notice evince the concerns of both the industry and the public. 

Office of Science and Technology Policy. 1986. Coordinated framework for regulation of biotechnology announcement of policy and notice for public comment. Federal Register (26 June 1986) 51 23301-23350. 

The inspections shall be conducted by the competent authority of the Member State concerned, which shall inform the Agency they shall be carried out on behalf of the Community and the results shall be recognised by all the other Member States. These inspections shall be coordinated by the Agency, within the framework of its powers as provided for in Regulation (EEC) No 2309/93. A Member State may request assistance from another Member State in this matter. 

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