DEPARTMCNT OF HEALTH, EDW~TIqN, AND WELFARE
           ._

  PUBLK: HEALTH SERVICE;.' "' ""
NATIONAL 1NSTITUTES OP WEAtSH
   6ETHESDA. MARYLAND aoOI4
      .

             BY

  Dowa s. &~&RICB;SON, H.D.
DZRRCTOi, RATIONAL INSTITDTRS oFliEtmE

  ONRECcIMBJNA2JT,DNATI&BWBXY

BEFORE THE

SUECCWITTEEONEEALTHAND SCIENTIFICRWliARCH

OF THE

6SNATE COMMTTEE ON NW@ RESOURCES

APRIL 6, 1977


I.   INTRODUCTION

  Good day, Mr. Chairman and other Committee members. It is a
pleasure to have the opportunity to discuss with you Federal policies

concerning recombinant DNA techniques.  The focus of my remarks will be

the activities of two organizations-- the National Institutes of Health

and the Federal Interagency Committee on Recombinant DNA Research.

  AB you know, recent scientific developments in genetics, particularly
in the last four years, have culminated in the development of a powerful
new tool for research--the ability to join together genetic materials
in cell-free systems to form recombinant DNA molecules. This new
technology has generated great hope and excitement and, concomitantly,

some expressions of concern.

  The public should expect this.significant research to continue
under strict conditions ensuring safety, until the potential risks are

better delineated and evaluated in light of developing scientific

knowledge.  This was the fundamental principle that guided the National

Institutes of Health and the Federal Interagency Committee in their

deliberations.  I would like to briefly review with you the activities

of the NIH in developing guidelines to govern this research before

discussing the work of the Interagency Committee.


2

II.  DEVELOPMENT OF THE NIH GUIDELINES

  The first step in the development of the Guidelines was taken by

the scientific community.  Scientists first expressed concern about

the potential biohazards at the Gordon Research Conference on Nucleic

Acids in July 1973. At their request, the National Academy of Sciences

created a committee that called for a moratorium on certain types of

experiments and for an international conference to consider this problem

further.  The committee also called on the NIH to establish an advisory

committee to study containment procedures and to draft guidelines for

the conduct of this research.  At the International Conference on

Recombinant DNA Molecules held at Asilomar, California, in February 1975,

temporary guidelines were issued including a continued moratorium on

some experiments but allowing others to proceed with appropriate

biological and physical safeguards, pending issuance of NIH guidelines.

  o The NIH Recombinant DNA Molecule Program Advisory Committee, in

December 1975, after several open meetings, recommended proposed

guidelines for my review and decision.

   To assist me in the review of the proposed guidelines, a special

meeting of the NIH Advisory Committee was convened in February 1976.

Members of the Committee represented not only science but such other

disciplines as law, ethics, and consumer affairs. Comments received

from committee members and a number of public witnesses represented a

wide range of views.  Meetings for information exchange were also held
                .


3

with other Federal agencies, private industry, and Congressional staffs.

Finally, on June 23, 1976, with the approval of the Secretary of HEW

and the Assistant Secretary of Health, the NIH issued guidelines to

govern the research it supports involving recombinant DNA molecules.

The NIH Guidelines established strict conditions for the conduct of

this research, prohibiting certain types of experiments and requiring

special safety conditions for other types.  The provisions were designed

to afford protection --with a wide margin of safety--to workers and the

environment.  Two weeks later, on July 7, 1976, the NIH Guidelines--

together with a document indicating the basis of my decisions on

principal issues --were published in the Federal Register

  Over 40,000 copies of the Guidelines have been.distributed to

foreign embassies, medical and scientific journals, NIH grantees and

contractors, and major professional research societies.

III,  NIH ACTIVITIES FOLLOWING RELEASE OF THE GUIDELINES

To facilitate implementation of the Guidelines, the NIH, in June

1976, established the Office of Recombinant DNA Activities. To document

the development of the Guidelines, NIH published a document, in August

1976, containing correspondence results of relevant meetings, and my

    volume will be

~~~._~_~                          -
                  Stat ement and HEW patent


                          4


IV.  THE INTERAGENCY COMMITTEE ON RECOMBINANT DNA RESEARCH

   I would now like to discuss the activities of the Interagency

Committee on Recombinant DNA Research. This Committee was created to

address extension of the NIH Guidelines beyond the NIH, to the public

and private sectors.  The Committee includes representatives of Federal

agencies which support recombinant DNA research or could potentially

serve a regulatory role for recombinant DNA. I am the Chairman of the

Committee.


   The first


to areview of

meeting of the Committee, November 4, 1976, was devoted

the development of the NIH Guidelines and a review of

activities in other countries.

  Recombinant DNA research is being conducted in western Europe,

eastern Europe, the Soviet Union, and Japan.

   In many countries, appropriate governmental or scientific bodies

have reviewed the research and have agreed that it should proceed.

Several of the countries, including the United Kingdom and Canada, have

acted to establish guidelines to govern the conduct of this research.

   The European Science Foundation, representing member nations from

Western Europe and Scandinavia, has recommended to its members that they

follow the guidelines of the United Kingdom. These guidelines are, in

intent and substance, very similar to those of the National Institutes

of Health.  The NIH is currently working very closely with the United

Kingdom and the European Science Foundation to ensure a commonality of


5

standards in carrying out this research.  Thus far, there has been very

close cooperation and coordination among the various international and

national scientific bodies, with a view to reaching a consensus on

safety practices, programs, and procedures.

  At the meeting of the Committee held on November 23, 1976, the

agencies discussed their activities and possible role in the implementation

of the NIH Guidelines.  All of the research agencies endorsed the

Guidelines.

A.  Subcommittee Review of Existing Legislation

   In order to further explore the relevant regulatory authorities, a

special Subcommittee was formed to analyze relevant statutory authorities
for possible regulation of research involving recombinant DNA technology.

The Subcommittee consisted of representatives of each regulatory agency

assisted by attorneys from their offices of general counsel.

  . It was the conclusion of the Subcommittee that no single legal

authority or combination of authorities currently existed that would

clearly reach all research and other uses of recombinant DNA techniques.

   The Subcommittee, in reaching this conclusion, reviewed the following

laws that were deemed to warrant detailed consideration: the Occupational

Safety and Health Act, the Toxic Substances Control Act, the Hazardous

Materials Transportation Act,  and section 361 of the Public Health Service


Act.

The full Committee adopted the report of its Subcommittee and agreed

that new legislation was required.


B.  Interagency Committee Analysis of Elements for Legislation

   In considering the elements for legislation, the Committee reviewed

Federal, State, and local activities bearing on the regulation of

recombinant DNA research.  Additionally,  the views of several interested

parties were solicited.  They included agricultural scientists, biomedical

scientists, environmentalists, labor unions, and private industry.

  After detailed delib.erations at meetings on March 10 and 14, 1977,

the Committee agreed on a set of elements for proposed legislation.

The elements agreed upon and the various alternatives reviewed by the

Committee were presented in an Interim Report transmitted to HEW

Secretary Califano on March 15, 1977.  He released the report to the

public the following day.

Mr. Chairman, I would like to submit for the record the Federal

Interagency Committee's "Interim Report on Suggested Elements for

Legislation," along with a copy of the Secretary's press release.

   With your permission, I would like to review briefly some of the

major elements addressed by the Committee.

   The Committee determined that the Department of Health, Education,

and Welfare is the appropriate locus for the regulation of the use and

production of recombinant DNA molecules.

   The Committee reviewed at great length the nature and scope any

legislation should have.  There was general agreement that legislation

should be restricted to recombinant DNA techniques.  However, in


7

recognition of future interest in other biohazards, I have established

a committee at the NIH, chaired by Dr. Richard Krause, Director, NIAID,

to study and recommend, if necessary, safety standards for other NIH-

supported research involving actual or potential biohazards.

  Regulation of just the research aspects of recombinant DNA

techniques presents a problem because of the difficulty in determining

the border between research and pilot production.  Therefore, the

Committee recommends that regulation cover the production or use of

recombinant DNA molecules.  Such language would make immaterial disagree-

ment as to whether a given activity constitutes research, pilot production,

or manufacture.

  The consensus of the Committee was that registration of projects

involving the use or production of recombinant DNA molecules was


necessary.  The Committee also recommends that facilities be licensed

and that the terms of the license include acceptance of responsibility

for the particular activities and individuals at the facility. As

embodied in the HEW bill, licensing and registration would insure that

all users of recombinant DNA techniques would be known and would be

adhering to the Guidelines.

   There are a number of other recommendations, and I can discuss

them further if you have questions.  I would like to emphasize that the

work of the Interagency Committee has been done in a most cooperative

and helpful way, and DHEW is committed to continued cooperation and

coordination with relevant Federal Departments and Agencies.


8

IV.  CONCLUSION

   In conclusion, this much is clear: the international and national

scientific community is in substantial agreement that, until the potential

hazards of recombinant DNA techniques are better understood, a common set

of standards must everywhere exist for the use of those techniques.  The

question being debated now is how this is to be accomplished.

   In the United States, this question has attracted far more public

attention than in other countries; indeed, a number of local jurisdictions

or States are engaged in action or debate.

   Finally, I want to note that biomedical research is entering a

new era in its relationship to society.  It is passing from an extended

period of relative privacy and autonomy to an engagement with new ethical,

legal, and social imperatives under concerned public scrutiny. NIH has

responded to these concerns by requiring the formation of reivew boards

to oversee human experimentation, animal care, and now DNA recombinant

experiments.  Similar bodies may soon have to oversee other hazardous

laboratory work.  These responsibilities are inescapable adjustments to

the rising demand for public governance of science, though this need not--

and, indeed, should not--go beyond what is clearly required for public

safety lest we inadvertently impede successful research and hamper

creativity.  The progress of science will continue to depend on the

initiative and insights--call it inspiration, if you like--of individual

scientists.