318 • Impacts of Applied Genetics— Micro-Organisms, Plants, and Animals 
the question of risk, RAC proposed revisions to the 
Guidelines, which placed most experiments at a 
lower containment level. They were published for 
public comment in September 1977.* * As with the 
original Guidelines, public hearings were held in the 
course of a 2-day meeting of the Advisory Committee 
to the Director in December 1977, in which a diverse 
group of individuals and organizations were permit- 
ted to comment. However, at this point, HEW took a 
much more active role in a situation that had been 
handled almost entirely by NIH.^* 
When RAC’s charter was renewed on June 30, 
1978, Secretary Califano reserved the power to ap- 
point its members instead of delegating it to the 
Director of NIH as in the past.** And the new pro- 
posed Guidelines, published in the Federal Register 
on July 28, 1978, were accompanied by an introduc- 
tory statement by Secretary Califano announcing a 
60 day public comment period to be followed by a 
public hearing before a departmental panel chaired 
by HEW General Counsel Peter Libassi.*** The 
Secretary was particularly interested in comments 
on: new mechanisms to provide for future discre- 
tionary revision of the Guidelines; and the composi- 
tion of the various advisory bodies, especially the 
RAC and the local Institutional Biosafety Committees 
(IBCs).25 
The public hearing called for by Secretary Cali- 
fano and held on September 15, 1978, was a sig- 
nificant event in the history of Federal actions on the 
rDNA issue. Testimony was heard from represent- 
atives of industry, labor, the research community, 
and public interest groups; more than 170 letters of 
comment were received and subsequently reviewed. 
As a result, the revised final Guidelines of December 
22, 1978, were significantly rewritten to increase 
public participation in the decisionmaking process:^® 
• Twenty percent of the members of the IBCs had 
to represent the general public and could have 
no connection with the institution. 
• Most of the records of the IBCs had to be public- 
ly available. 
‘Shortly thereafter, in October 1977, the Final Environmental 
Impact Statement for the 1976 Guidelines was published. 
^‘D. Fredrickson, "A History of the Recombinant DNA Guide- 
lines in the United States,” Recombinant DNA Technical Bulletin, 
vol. 2, July 1979. pp. 87, 90. 
* ‘The statement providing for delegation of authority that ac- 
companied the updated Charter was not signed by Califano. See 
also, footnote 24. 
“‘The other members of the HEW panel were Dr. 
Fredrickson, Julius Richmond, who was the Assistant Secretary 
for Health, and Henry Aaron, who was the Assistant Secretary for 
Planning and Evaluation. 
“43 F.R. 33042, July 28, 1978. 
“Statement of Secretary Califano accompanying the revised 
Guidelines, 43 F.R. 60080, Dec. 22, 1978. 
• Major actions, such as decisions to except other- 
wise prohibited experiments on a case-by-case 
basis or to change the Guidelines, could be made 
only on the advice of RAC and after public and 
Federal agency comment. 
The increased public responsiveness of the IBC’s 
was crucial, since the revised Guidelines placed ma- 
jor responsibility for compliance on them. This had i 
been proposed in the July version and had not been | 
changed by the hearings.* Califano also announced 
he would appoint 14 new members to the RAC, in- 
cluding people knowledgeable in fields such as law, 
public policy, ethics, the environment, and public 
health. ^^^** All of these changes were envisioned to 
"prov'ide the opportunity for those concerned to 
raise any ethical issues posed by recombinant DNA f 
research” and to change the role of the R.AC to "ser\ e 
as the principal advisory body to the Director of Mil 
and the Secretary of HEW on recombinant DNA 
policy.”^®*** ) 
In addition to broadening public participation, | 
Califano attempted to deal with a major limitation of | 
the Federal response— the (iuidelines did not co\er ‘ 
private research. He directed the Food and Drug .Ad- 
ministration (FDA) to take steps to require that any 
firm seeking approval of a product rec|uiring the use 
of rDNA techniques in its de\elopment or manu- 
facture, demonstrate compliance with the Guidelines 
for the work done on that product; an FDA notice of 
its intention to propose such regulations accom- 
panied the revised Guidelines in the Federal K»‘gister. .1 
In addition, he requested the Kn\ ironmental I’rotec- 
tion Agency (EPA) to review its regulatory authority 
in that area. He believed if both agencies could 
regulate research on products within their juiisdic 
tion, "virtually all recombinant DN.A re.search in this 
country would he brought under the re(|uirements 
of the revised guidelines. In the nuMUtime. the 
‘As pari of th(> r(‘visioti process, Hf.W held .1 meeting m (K lobin 
1978 for IBG chairper.sons in order lo exchange miorm.ilion and 
experiences gaineil under the 1976 (,uidelines 
“Ibid. 
* ‘ This was implemenled by an amendmiml lo ihe R \( ( barli'r 
on Dec. 28. 1978, which increased ibe membersinp lo 2.' and 
changed Ibe composition lo the lolliivxing calegorn-s II al Ir.isi 
eight specialists in moleculai- biologx' or rl).\ \ rescan b 21 al least 
six specialists in other scientific lields ,ind :ll al le.isl six persons 
knowledgeable in laxv, |uiblic policy, Ibe enx ironmeni and piiblii 
or occupational health In addition, the ( harlei xx.is amended to 
grant nonvoting representation lo 1 epi esenlalix es ol xanoos li-d 
eral agencies. 
“Ibid. 
“‘Thi’ Charter was nexer amended lo 1 h.ingi’ 01 deli-li- iIm- 
final sentence of the 'I’urpose section xxbii h stales Ibis ( om 
mittee is a technical commillee established lo look al a s|m-» ilu 
problem." 
“Ibid., p 6111181 
