Chronology of Events in Preparation of ENVIRONMENTAL IMPACT STATEMENT: GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT DNA MOLECULES I'- Dramatis Person&e DHEW/PHS Charles Custard, Director, Office of Environmental Affairs Paul Cromwell, Deputy Director, OEA Boris Osheroff, Principal Environmental Officer/H George H. Deming, Deputy Environmental Officer/H NIH: OD Staff Dr. Donald S. Fredrickson, Director, NIH Dr. Ronald Lamont-Havers, Deputy Director (until g/10/76) Dr. Dewitt Stetten, Jr., Deputy Director for Science Dr. Joseph G. Perpich, Associate Director for Program Planning and Evaluation Dr. Leon Jacobs, Associate Director for Collaborative Research Dr. Philip Chen, Jr. , Assistant Director for Intramural Affairs Dr. Bernard Talbot, Special Assistant for Intramural Affairs Other NIH Participants (alphabetical) Michael Adler, Program Analyst, Division of Legislative Analysis Dr. W. Emmett Barkley, Director of Research Safety, OD-NC1 W. T. Carrigan, Chief, Special Projects Branch, Office of Legislative Analysis Donald J. Dunsmore, Assistant to the Chief, Environmental Safety Branch, Division of Research Services Dr. William Gartland, Chief, Office of Recombinant DNA Activities, National Institute of General Medical Sciences Dr. Martin Gellert, Chief, Section on Metabolic Enzymology, Dr. National Institute of Arthritis, Metabolism, & Digestive Diseases Robert Martin, Chief, Section on Microbial Genetics, National Institute of Arthritis, Metaboli.sm, & Digestive Diseases Vinson R. Oviatt, Chief, Environmental Safety Branch, Division of Research Services Dr. Wallace P. Rowe, Chief, Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases Dr. Maxine F. Singer, Head, Nucleic Acid Enzymology Section, Laboratory of Biochemistry, National Cancer Institute Dr. Rudolf G. Wanner, Agency Environmental Officer Advisors Harold P. Green, legal consultant to NIH Director Richard J. Riseberg, Legal Advisor, NIH (Office of the General Counsel, DHEW) 2/5/76 April 1976 4/t-z/7 6 4/26/76 4/30/76 May 1976 5/7/76 5/14/76 5121176 5127176 5128176 6/4/76 6/10-H 2 Chronology NIH work group (drawn from persons listed above) meets with NIH Director on NFPA requirements as applied to recombinant DNA research-; (NIH experience with NEPA process dates from appointment of Environmental Officer in 1973; includes development of Environmental Impact Statement (EIS) for the NIH Master Plan on, Construction, July 197 6. ) . NIH work groups discuss legal aspects of NEPA, ~~~&t environmental impact assessment. NIH Recombinant Advisory Committee (founded in October 1974) meets at NIH; informed of public commentators' request for an EIS on NIH-supported recombinant DNA research. Analysis of issues in preparation for meeting with NIH Director. NIH group meets with Director; dedision to prepare NEPA document. NIH work groups continue assessment. Memo from Custard to Osheroff on applicability of NEPA to NIH actions such as recombinant DNA research. NIH group meets with Director; decision to issue Environ- mental Impact Statement (EIS). NIH meeting with DHEW (and PHS) officials--Custard, Cromwell, and Osheroff--concerning development of the NIH generic analysis, including an EIS on recombinant DNA. Memo from Perpich to NIH Director on May 28 meeting on "NEPA and DNA Research. " NIH Director meets with staff to discuss progress on development of EIS. Analysis in process. NIH staff meets; decision to `produce a Working Draft (#l) by 6/18. Final Draft EIS to be published by 9/l/76. Advisory Committee to Director (DAC) meets at NIH, discusses recombinant DNA, concurs in release of NIH Guidelines 6/23/76. 3 6/11/76 Working Draft #l to Stetten. 6/14/76 Working Draft #I circulated at NIH: 6115176 Singer assigned to write Working Draft #2. 6/22/76 NIH Director and staff meet with Warren Muir and Malcolm Bruce of the Council on Environmental Quality (CEQ). Custard and Cromwell present. Harold Green, consultant to NIH on NEPA, attends (and several subsequent meetings). Singer's outline of Draft #2 approved. Satisfaction with 9/l /76 release daie. 6123176 Public release of NIH Guidelines. Preparation of EIS announced. Draft #2 circulated fo:- comment to Custard, Cromwell, Osheroff, and NIH staff. S/.28/76 Green comments on Draft #2. Cromwell thanks Stetten for Draft #l. 6/30/76 NIH group meets with Osheroff et al. Working Draft #2 reviewed. Decision to rewrite according to original outline as presented to CEQ. 7/l/76 NIH work group meets to discuss Green's comments on Draft #2. Green suggests changing to format similar to Dunsmore/Singer first draft. = 7/2/76 Memo from Wanner to Chen reviewing Working Draft #2. 716176 * Work group meets. Reviews comments on Draft #2, agrees to rewrite in DHEW/CEQ forrrat. 717176 Work group begins Working Draft #3. NIH Guidelines published in Federal Register. 7/13/76 7116176 i/19/76 Meeting of NIH staff with Stetten on status of Draft #3. Work group assembles Draft #3. Draft #3 distributed for review to 30 people, including Osheroff, Cromwell, and some non-Federal scientists. 7128176 Comments on Draft #3 sent to Chen, incorporating oral comments of Osheroff. 812176 NIH staff meets, reports that Draft #3 review is under way, comments still arriving. Cromwell calls, promising comments on format. 4 8/5/76 8/12/76 8/16/76 8/l 9176 8/23/76 8/24/76 8/26/76 8/27/76 8/31/76 g/2./76 g/7/76 g/8/76 g/9/76 g/13/76 Cromwell's comments on Draft #3 received; proposes certain changes. NIH work group distributes Draft #4 to same group of 30. NIH meeting with DHEW (and PHS)--Cromwell, Deming, NIH staff. Discuss Drafts #3 and #4. Larnont-Havers establishes 8/26/76 as date for issuance of Draft EIS (Draft #5) for public circulation. DEIS cleared with NIH Director 8/lb, Wanner 8/20. Memo from Cromwell to Osheroff, 8/19, says he is sending DEIS to CEQ. Wanner receives call from Cromwell, who has received DEIS and requests distribution through Office, of Environ- mental Affairs. Memo from OEA Director Custard to Osheroff advises due date for comments to be 10/18/76. NIH orders 1,000 copies of Draft Environmental Impact Statement (DEIS) for distribution 9/l f76. (Distribution outlined in Perpich memo to Fredrickson, 8/26/76. ) Distribution planned. To include Asilomar Conference participants, Director's Advisory Conmittee members, private industry representatives with whom NIH Director. met, all correspondents on recombinant DNA, health and safety officials at selected universities, local and State officials and organizations, Mayor of Cambridge and City Council members, and internal NIH. Cromwell to distribute to. Federal agencies. : Distribution begun. (Thank-you notes date from 8/31 or earlier. ) Distribution to congressional staff--l0 House, 18 Senate. (See Perpich memo. ) CEQ publishes notice in Federal Register; comments from the public requeste'm/f8/ `( 6. lIEW News gives notice to the media. -- DEIS to Chairmen of Environmental Committees in House and Senate. Notice of DEIS in NIH Record. DEIS appears in Federal Register. Notice of DEIS in NIH Guide for Grants and Contracts to 12,000 NIH awardees,c%g commzs bv 9/18/`;6- 5 9122 f76 Fredrickson testifies on recombinant DNA research at Senate hearings (Mary Miers' memo). llf76 PHS representatives attend B,$logical Safety Conference at Fort Detrick. Dr. A.G. Wedum advises on safety questions. FDA and CDC consulted. 11/4/76 Meeting of Federal Interagency Committee on Recombinant DNA Research. Informed of progress on EIS. 11/16-12/7 Fredrickson meets with staff on comments. 12/29/76 Final EIS (FEIS) in progress. Draft prepared for review underlining proposed changes responsive to comments. [Director's Decision (Appendix J) bridges DEIS and FEIS and explains acceptance or rejection of all recommended changes. ] l/4/77 l/18/77 l/21 f77 Z/2/77 First draft of Final EIS distributed internally for review and comment. NIH meeting with DHEW (and PHS)--Cromwell, Osheroff, Green attend. Cromwell recommends changes in format which Fredrickson agrees to attempt in next version, and Cromwell agrees to respond by 2/l/77. (See memo from Perpich to Fredrickson 1 /19/77. ) Draft of Final EIS distributed. Memo from Cromwell to Fredrickson. Ten-page critique of FEIS draft, advises thorough revision. NIH meeting with DHEW (and PHS)--Crom,well, Osheroff, Deming-- regarding Cromwell's comments. 2/7/77 NIH meeting with DHEW (and PHS). Cromwell's recom- mended changes in format to be carried out in FEIS. 2/15/77 Fredrickson meets with NIH staff, approves FEIS, transmits it to Wanner. 2/l 6/77 FEIS carried to Osheroff. 2/18/77 Copies of FEIS carried (unofficially) from NIH to Cromwell. 2/22/77 Osheroff transmits FEIS to Custard. 2/25/77 Dixon memo to Secretary showing that H approved FEIS.