The NIH Recombinant DNA Guidelines: Brief History and Current Status

T H E N I H R E C O M B I N A N T DNA G U I D E L I N E S : B R I E F H I S T O R Y AND C U R R E N T S T A T U S

ISSUE BRIEF NUMBER IB82057

AUTHOR:

J u d i t h A. J o h n s o n

Science Policy Research Division

T H E L I B R A R Y OF C O N G R E S S

CONGRESSIONAL RESEARCH SERVICE

MAJOR ISSUES SYSTEM

DATE ORIGINATED 05/24/82

DATE UPDATED 07/07/82

FOR ADDITIONAL

INFORMATION CALL 287-5700

0707

CRS- 1

ISSUE DEFINITION

In June 1976, the National Institutes of Health issued the initial version

of the Recombinant DNA guidelines.

The guidelines were developed i n response

to concern from both scientists and the general public about the potential

hazards of genetic engineering.

Other Federal agencies which support

research have adopted the guidelines, and most industries

recombinant

have decided to comply with them voluntarily The techniques associated with

genetic engineering enable t h e , r e s e a r c h e r to recombine DNA

(the hereditary

material of the cell) in a very precise manner.

The recombinant DNA can be

used to manufacture products which have never been produced before by

bacteria and to manufacture products a t a higher rate and yield than

previously possible.

After 1 0 years of experience with recombinant DNA, many believe that

earlier estimates of risk were exaggerated.

This change in perception i s

reflected in the successive modifications of the guidelines over the past 6

years. Recombinant DNA and the NIH guidelines remain topics of continuing

concern to the Congress and have been the subject of legislation in previous

sessions.

BACKGROUND AND POLICY ANALYSIS

During a 1968 Senate Subcommittee hearing on a Joint Resolution (S.J. Res.

145) to establish a new health

science commission, Dr. Arthur Kornberg

directed the subcommittee's attention toward the rapidly progressin'g field of

molecular biology. He noted that important developments were near fruition

and that the potential social impact of these advances could be far-reaching.

Dr. Kornberg was referring to discoveries which would provide the technical

framework for the spe'cialty commonly known a s genetic engineering.

New

techniques have been developed in this field which enable a researcher to

recombine DNA (the hereditary material of the cell) in a very precise manner.

The recombinant DNA can provide a cell with the ability to manufacture

products (for example, insulin) which were previously not part of the cell's

make-up.

In 1 9 7 3 , a group of scientists attending a Gordon Conference Session

chaired by Drs. Maxine Singer and Dieter Sol1 discussed the possibility of

public health risk associated with genetic engineering.

Their concern was

based upon the conjecture that the new techniques could accidently produce a

recombinant molecule with hazardous characteristics.

For example, i t has

been speculated that an inadvertant modification

of DNA in a previously

harmless organism might enhance its capability of producing

a highly

infectious disease.

The session's participants voted in favor of sending a

letter to the National Academy of Sciences (NAS) suggesting that the academy

consider the risks associated with genetic engineering and "recommend

specific actions o r guidelines" (Science, July 1973).

In response to the

Gordon Conference letter, NAS appointed a panel of experts to study the risk

question. After a year of discussion, the panel issued the following three

recommendations:

1. Scientists should temporarily postpone certain experiments

until the risk associated with genetic engineering could be

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adequately assessed;

2. The National Institutes of Health (NIH) should establish a n

Advisory Committee which would devise guidelines for

investigators working with recombinant DNA; and

3. An international conference of experts should be organized

to discuss the risk questions associated with recombinant

DNA.

The international conference was held

in February 1975 a t Asilomar,

California, and was attended by a group of 1 5 0 eminent scientists. The final

report recommended that biological and physical containment standards should

be assigned to experiments based on their perceived hypothetical risk.

The original Asilomar report was formalized into the guidelines by the

newly formed NIH Recombinant DNA Advisory Committee (RAC, which was formed in

response to the NAS panel's recommendations).

After an analysis of the R A C 1 s

proposed guidelines and public comments, the Director of NIH, Dr.

Donald S.

Fredrickson, issued the initial version of the guidelines i n June 1976

(Federal Register, v. 41:

27902-27943).

This original version of the

guidelines was only binding on research supported by NIH.

A special interagency advisory committee

was

later

formed

with

representatives from all Federal agencies which perform, fund, or regulate

recombinant DNA research. The committee succeeded in gaining agreement among

its member agencies to adopt the NIH guidelines and to require compliance by

federally funded researchers in work involving recombinant DNA.

While the'

guidelines are not promulgated by law, an agency can enforce the compliance

of researchers who receive Federal funds. Even though the guidelines do not

cover non-federally supported research, most industries have decided to

comply voluntarily with the guidelines.

By 1978 i t was found that the original guidelines were unnecessarily

restrictive and that a mechanism for the revision of the guidelines needed to

be incorporated directly into the document.

A series of scientific and

public meetings were held to discuss the matter, and subsequently a new

version of the guidelines was published for public Comment i n July 1978

(Federal Register, v. 43:

60080-601005).

Following a public hearing in

September 1 9 7 8 , the guidelines were reissued and became effective on Dec.

The 1978 version contains

22, 1978 (Federal Register, v. 43: 60108-60131).

a mechanism for the future revision of the document.

Proposals which would

modify any section or introduce a new section into the guidelines must be

published in the Federal Register a t least 3 0 days prior to a RAC meeting.

The proposal and any public comments are discussed by the RAC in a n open

public session. The NIH Director then reviews the RAC's recommendations and

makes a final decision upon the proposal.

On Dec. 29, 1978, 1 4 new members were added to the RAC, including six

non-biologists.

This broadening of the committee's composition was in

compliance with a new provision contained within the 1978 version of the

guidelines.

There have been many modifications

of the

implementation of the revision procedures.

Three

have been issued since 1978:

guidelines

since

the

complete republications

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IB82057

UPDATE-07/07/82

1. January 1980 -- This modification lowered the physical

containment requirements for some, but not a l l , recombinant

DNA experiments which use a particular strain of bacterium

(E. coli K-12).

Approximately 80% of all studies use this

laboratory strain of bacteria a s a host cell for recombinant

DNA.

In addition, a large percentage of principal investigators

using this particular strain of bacteria were no longer required

to notify NIH of the details of their experiments.

Notification

of a local review board (the Institutional Biosafety Committee

or IBC) was all that was required (Federal Register, v. 45:

6724-6749, 1980).

--

The physical containment requirements

2. November 1980

were lowered and more changes were made in the notification

procedures required of principal investigators (Federal

Register, v. 45: 77384-77408).

-- In response to a letter from representatives

of tire Institutional Biosafety Committees (IBCs), the RAC

voted to exempt research with E. coli K-12 (and

a few other host systems) from the guideline regulations

(Federal Register, v. 46: 34462-34487).

3. July .I1981

Several attempts were made in previous Congresses to focus attention on

recombinant DNA issues through hearings, proposed legislation, and reports.

Congressional committees have identified the evolution of this issue a s a

matter of vital public policy concern and have suggested the need to monitor

research continuously in order to be prepared for further legislative action

if necessary. Legislation which would regulate and study the implications of

research involving recombinant DNA was introduced during the 95th Congress.

Several bills proposed the establishment of new Federal regulatory .powers,

ranging from declaring a total moratorium

on the research until a risk

assessment could be completed to setting up licensing and certification

procedures for researchers and laboratories.

Four congressional committees

(2 House, 2 Senate) held extensive hearings on the DNA issues in 1977, with

some continued legislative hearings in 1978.

Two major bills

(S. 1217 and

H.R. 11192) each received final full committee action i n their respective

houses, but none of the legislation reached the floor during the 95th

Congress.

In the 96th Congress, one major

bill was introduced, S.

2234.

This bill would have required persons not covered by the NIH guidelines to

notify the Secretary of the U.S.

Department of Health, Education, and

(HHS)) of

Welfare (HEW -- now the Department of Health and Human Services

their activities in the area of

genetic

engineering

research

and

applications.

Non-federally supported institutions and industry would have

been affected by this bill, but there was no congressional action on S. 2234.

While the Federal Government has not passed any legislation directly

regulating recombinant DNA research, several States and local governments

have adopted ordinances regulating this type of research.

In addition, bills

were introduced on this subject in a number of States i n recent years.

On Apr. 2 3 , 1981, the RAC discussed a proposal, introduced by Drs. Allen

Campbell and David Baltimore, which would transform

the guidelines into a

voluntary code of laboratory practice.

The Baltimore-Campbell proposal would

have reduced the physical containment levels for most

recombinant DNA

experiments with the exception of prohibited experiments. T h e proposal also

would have eliminated all punishments for failing to follow the guidelines.

The committee voted to have a special panel review the guidelines and make

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recommendations. The Working Group on Revision

appointed a t the April meeting and met on June 1 and

did not agree that the NIH guidelines should be made

did suggest that detailed rules for the composition

removed from the guidelines.

UPDATE-07/07/82

of the Guidelines was

July 9 , 1981. T h e group

voluntary.

However, it

of the local IBCs be

At the RAC's September 10-11 meeting, Dr. David Baltimore offered a new

proposal which mixed portions of the original Baltimore-Campbell proposal

with the working group's recommendations.

The RAC developed its own proposal

for publication i n the Federal Register, (v. 46: 59368-59425, Dec. 4 , 1981)

by modifying Dr. Baltimore's proposal.

T h e new RAC proposal differed from

the Baltimore-Campbell proposal in that i t eliminated the prohibition of

experiments, but instead retained admonishments against the cloning of toxin

genes and drug resistance traits in organisms which do not already have these

characteristics.

-

-

An alternative proposal appeared in the Federal Register, on Dec. 7 , 1981

(v. 46: 59734-59737) a t the request of Dr. Susan Gottesman, Chairman of the

Working Group.

The Gottesman proposal differs from the previously discussed

proposals in that the guidelines would remain mandatory

for institutions

receiving NIH funding.

In addition, certain experiments would require prior

review by either NIH or a n IBC. At the Feb. 8 , 1982, meeting of the RAC, the

committee voted i n favor of the Gottesman proposal, 1 7 for and 3 against.

The Gottesman proposal was accepted by the Acting Director of NIH and

published in the April 21, 1 9 8 2 , Federal Register.

At the June 28, 1 9 8 2 , RAC

meeting, the committee decided not to include within the guidelines a

prohibition against the use of recombinant DNA for the development of

biological warfare agents. An existing international convention, adopted in

1972 by many countries including the U.S.. and the Soviet Union, prohibits

development of biological weapons.

The committee concluded that

the

convention's prohibitions were broad enough to cover work involving the use

of recombinant DNA techniques.

HEARINGS

U.S.

Congress.

House.

Committee o n Interstate and Foreign Commerce.

Subcommittee on Health and the Environment.

Recombinant DNA

Research Act of 1977. Hearings, 95th Congress, 1st session,

on H.R. 4 7 5 9 , H.R. 4 8 4 9 , H.R. 3191, H.R. 3591, H.R. 3592,

H.R. 5 0 2 0 , H.R. 4232, and H.Res. 131. Mar. 15-17, 1977.

Washington, U.S. Govt. Print. Off., 1977. 4 8 0 p.

"Serial no. 95-18"

U.S.

Congress.

House. Committee on Science and Astronautics.

International science policy.

Panel on Science and Technology

(twelfth meeting), 92d Congress, 1st session. Jan. 26-28,

1971. Washington, U.S. Govt. Print. Off., 1971. p. 336-366.

U.S.

Congress.

House. Committee on Science and Technology.

Subcommittee on Science, Research, and Technology.

Science

Policy Implications of DNA Recombinant Molcule Research.

Hearings,

95th Congress, 1st session. Mar. 29-31, Apr. 27-28, May 3-5,

25, 26, Sept. 7 - 8 , 1977. Washington, U.S. Govt. Print. Off.,

1977. 1293 p.

----- Recombinant DNA Act.

Hearings on H.R.

11192, 95th

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Congress, 2d session. Apr. 1 1 , 1978.

Govt. Print. Off., 1978.

182 p.

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UPDATE-07/07/82

Washington, U.S,

U.S.

Congress.

House. Committee on Science and Technology.

Subcommittee on Investigations and Oversight and

Subcommittee on Science, Research and Technology.

Commercialization of academic biomedical research.

Hearings, 97th Congress, 1st session. June 8-9,

1981. Washington, U.S. Govt. Print. Off., 1981.

1 6 6 p.

U.S.

Congress.

Senate. Committee on Commerce, Science, and

Transportation.

Subcommittee on Science, Technology, and

Space. Regulation of recombinant DNA research.

Hearings, 95th Congress, 1st session.

Nov. 2 , 8 , and 1 0 , 1977.

Washington, U.S. Govt. Print. Off., 1978. 4 3 2 p.

U.S.

Congress.

Senate. Committee on Commerce, Science, and

Transportation.

Subcommittee on Science, Technology, and

Space.

Industrial applications of recombinant DNA techniques.

Hearing, 96th Congress, 2d session.

May 20, 1980. Washington,

U.S. Govt. Print. Off., 1980.

9 0 p.

U.S.

Congress.

Senate. Committee on Human Resources.

Subcommittee on Health and Scientific Research.

Biomedical

research and the public.

Edited transcript of a conference

on the relationship Setween biomedical research and the

public, held a t Airlie House, Airlie, Va., Apr. 1-3, 1976;

sponsored by the Hastings Institute of Society, Ethics,

and the Life Sciences, and by the Case Western Reserve

University Medical School. Washington, May 1977. 1 5 4 p.

At head of title:

95th Congress, 1st session.

Committee

print.

----- Recombinant DNA Regulation Act, 1977.

Hearings, 95th

Congress, 1st session, on S. 1217 and related bills.

Apr. 6 , 1977. Washington, U.S. Govt. Print. Off., 1977.

4 7 2 p.

U.S.

Congress.

Senate. Committee on Labor and Public Welfare.

Subcommittee on Health.

Genetic engineering, 1975. Hearings,

94th Congress, 1st session. Apr. 22, 1975. Washington,

U.S. Govt. Print. Off., 1975.

35 p.

U.S.

Congress.

Senate. Committee on Labor and Public Welfare.

Subcommittee on Health./ Committee on the Judiciary.

Subcommittee on Administrative Practice and Procedure.

Implementation of NIH guidelines governing recombinant D N A

research.

Oversight hearing, 94th Congress, 2 6 session.

Sept. 22, 1976. Washington, U.S. Govt. Print. Off., 1976.

1 5 9 p.

REPORTS A N D CONGRESSIONAL DOCUMENTS

U.S.

Congress.

House.

Committee on Interstate and Foreign Commerce.

Recombinant DNA Act.

Report (together with dissenting and

separate views and including the Congressional Budget Office

cost estimate) to accompany H.R. 11192. Kar. 24, 1978.

Washington, U.S. Govt. Print. Off., 1978. 44 p.

(95th

CRS- 6

Congress, 2d session.

U.S.

House.

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UPDATE-07/07/82

Report no. 95-1005, Part I.)

Congress.

House.

Committee on Science and Astronautics.

Subcommittee on Science, Research, and Technology.

Genetic

engineering: evolution of a technological issue.

92d Congress,

2d session. Prepared by the Science Policy Research Division,

Congressional Research Service, Library of Congress. Washington,

U.S. Govt. Print. Off., 1972. 119 p.

----- Genetic engineering: evolution of a technological issue;

93d Congress, 2d session. Prepared

Supplemental Report I.

by the Science Policy Research Division, Congressional Research

Service, Library of Congress.

Washington, U.S. govt. Print.

Off., December 1974.

215 p.

U.S.

Congress.

House.

Committee on Science and Technology.

Recombinant DNA Act.

Report (together with dissenting views and

including a Congressional Budget Office cost estimate)

to accompany H.R. 11192. Apr. 21, 1978. Washington, U.S.

3 2 p.

(95th Congress, 2d session.

Govt. Print. Off., 1978.

House. Report no. 95-1005, Part 11)

----- Subcommittee on Science, Research, and Technology.

Genetic engineering, human genetics, and cell biology: evolution

of technological issues -- DNA recombinant molecule research;

Supplemental Report 11. 94th Congress, 2d session. Prepared

by the Science Policy Research Division, Congressional Research

Service, Library of Congress. Washington, U.S. Govt. Print.

Off., December 1976. 259 p.

At head of title: 94th Congress, 2 6 session. Committee print. .

(See appendixes for a selected bibliography, selected articles

on DNA recombinant research, and copies of the NIH Guidelines

and Draft Environmental Impact Statement.)

----- Biotechnology (Supplemental Report 111).

96th

Congress, 2d session. Prepared by the Science

Policy Research Division, Congressional Research

Service, Library of Congress.

Washington,

U.S. Govt. Print. Off., August 1980.

1 4 4 p.

-

----- Science policy implications of DNA recombinant molecule

research.

Prepared by the Subcommittee on Science,

Research, and Technology. March 1978. Washington, U.S.

78 p.

(95th Congress, 2d session.

Govt. Print. Off., 1978.

House.

Serial X)

U.S.

Congress.

Senate. Committee on Commerce, Science, and

Transportation.

Subcommittee on Science, Technology,

and Space. Recombinant DNA research and its applications.

Oversight report. August 1978. Washington, U.S. Govt. Print.

Off., 1978. 106 p.

U.S.

Congress.

Senate. Committee on Human Resources. Recombinant

DNA Safety Regulation Act; report together with supplemental

views to'accompany S. 1217. July 22, 1977. Washington,

(95th Congress, 1st

U.S. Govt. Print. Off., 1977. 6 3 p.

session.

Senate. Report no. 95-359)

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CHRONOLOGY OF EVENTS

06/28/82

-- RAC voted against including within the guidelines

prohibitions against the use of recombinant DNA

in developing biological warfare agents.

04/21/82

-- Republication of NIH Guidelines in Federal

Register, Gottesman revision.

17180-17198)

(v. 47:

02/09/82

-- RAC voted in favor of Gottesman proposal 1 7 to 3.

12/07/81

-- Gottesman Proposal published in the Federal Register

(v. 46:

12/04/81

59734-59737)

-- R A C t s Guideline revision published in Federal

Register (v. 46:

09/10/81

.

59368-59425).

-- David Baltimore proposed a compromise between

Baltimore Campbell proposal and the Working Group

RAC modified the Baltimore proposal.

proposal.

07/09/81

-- Working Group on the Revision of the NIH Guidelines

met for second time.

07/01/81

-- Republication of NIH Guidelines in Federal Register

exempting all research with E coli K-12 from the

Guidelines (v.. 46: 34462-34487).

06/01/81

-- Working Group o n the Revision of the NIH Guidelines,

met for first time.

-- Baltimore-Campbell proposal discussed by RAC.

11/21/80 -- Republication of NIH Guidelines in Federal

04/23/81

Register lowering physical containment requirements

for additional host cells.

Change notification

procedures required of principal investigators ( v .

45:

77384-77408).

Supreme Court rules 5-4 that life forms created

in the laboratory by genetic engineering may be

patented like any other invention.

06/16/80

--

01/29/80

-- S. 2234 introduced by Senator Stevenson and

referred to Committee on Labor and Human Resources.

01/29/80

-- Republication of the NIH Guidelines in Federal

Register lowering physical containment requirements

for experiments using E. coli K-12 ( v . 45:

6724-6749).

11/30/79

-- NIH recombinant DNA research proposed guidelines

published in the Federal Register (v. 44:

69210-69251).

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04/02/79

UPDATE-07/07/82

-- NIH proposed plan for a program to assess the risks

of recombinant DNA research.

(v. 44: 19301-19304)

.

12/29/78

IB82057

Federal Register,

-- Fourteen new members were named to the NIH

Recombinant DNA Advisory Committee.

12/22/78

-- FDA announced intent to propose regulations for

recombinant DNA (Federal Register, Dec. 22, 1978:

60134-60135).

-- NIH Revised Guidelines regarding the conduct of

research involving recombinant DNA were published

(Federal Register, Dec. 22, 1978: 60080-60105;

60108-60131).

07/28/78

-- Proposed revised guidelines for the conduct of

recombinant DNA research published Federal

Register, v. 43:

33041-33178.

Also includes a n Environmental Impact Assessment).

H.R. 11192 introduced in House.

-12/15/77 - 12/16/77 -- NIH Public Meeting on the Recombinant

02/28/78

DNA Guidelines.

11/28/77

-- The availability of the NIH Environmental

Impact Statement on Guidelines for Research

Involving Recombinant DNA Molecules (October

1977) was noted in the Federal Register.

10/26/77

-- S. 1217' (Recombinant DNA Regulation Act) was

placed on the Senate calendar under "Subject

on the Tablep1 a t the request of Senator Robert

Byrd.

09/27/77

-- Proposed revised NIH guidelines for the conduct

of recombinant DNA research were published

(Federal Register v. 4 2 , no. 187, part 111:

49595-49609).

06/22/77-06/23/77 -- The NIH Advisory Committee met again

(see May 14-15, 1977 entry) to continue consideration

of the DNA research guidelines revision.

-- The NIH Recombinant DNA Molecule Program

05/14/77-05/15/77

Advisory Committee met to consider revision of the

recombinant DNA research guidelines.

03/15/77

- 03/17/77 -- Subcommittee on Health and Environment,

House Interstate and Foreign Commerce Committee,

held hearings on H.R. 4759 (and other bills):

recombinant DNA.

03/06/77

-- House Science and Technology Committee released

report "Genetic Engineering, Human Genetics,

and Cell Biology" (see REPORTS).

09/06/76

-- DHEW-NIH Recombinant DNA Research Guidelines -Draft Environmental Impact Statement, was

CRS- 9

published (Federal Register:

07/07/6

--

38426-38438).

DHEW-NIH Recombinant DNA Research Guidelines

were published (Federal Register:

27942-27943).

02/10/76 -- First meeting of the NIH Director's

Advisory Committee was held to review the

proposed guidelines concerning recombinant DNA

research.

02/09/76

-

04/22/75

-- Genetic Engineering was the s u b j e c t - o f hearings

before the Subcommittee on Health, Senate

Committee on Labor and Public Welfare.

02/24/75

-- NAS-NSF-NIH supported Conference on Recombinant

DNA Research, held in Asilomar, Calif.

l0/07/74

-- NIH Recombinant DNA Advisory Committee was

established.

06/11/73

-- Gordon Conference on Nucleic Acids was held in

New Hampton, N.H.

ADDITIONAL REFERENCE SOURCES

Abelson, John and Eleanore Butz. Recombinant DNA.

Sept. 9 , 1 9 8 0 , entire issue.

Science,

Bodde, Tineke. RAC votes to relax recombinant DNA

Guidelines.

Bioscience, June 1981. p. 423-425.

Ca-rmen, Ira H. The constitution in the laboratory:

recombinant DNA research a s "free expression." Journal

of politics, August 1981. p. 737-762.

Cohen, Carl.

When may research be stopped? New England journal

of medicine, May 26, 1977: p. 1203-1210.

Dickson, David. DNA guidelines:

OCt. 2, 1980.

-----

-------------

DNA guidelines:

p. 529-530.

more relaxation.

Nature,

bowing out, Nature, Dec. 1 1 , 1980.

DNA guidelines f o further attenuation.

Mar. 26, 1981. p. 281-282.

Nature,

Recombinant DNA guidelines wear thin.

May 7, 1981. p. 3.

Nature,

Changing the guard.

p. 189-190.

Nature, July 1 6 , 1981.

DNA research guidelines likely to be eased.

Chemical and

engineering news. Sept. 21, 1981: p. 6-7.

Evaluation of the risks associated with recombinant DNA

research:

the working group on the guidelines.

Recombinant DNA Technical Bulletin.

December 1981.

F O X , Jeffrey L. Genetic engineering industry emerges.

Chemical and Engineering News, Mar. 1 7 , 1980:

15-23.

Grobstein, Clifford.

The recombinant DNA debate.

American, July 1977: p. 22-23.

Scientific

Krimsky, Sheldon and David Ozonoff. Recombinant DNA research:

the scope and limits of regulation.

American journal

of public health.

December 1979. p. 1252-1259.

Lyman, Francesca and Peter Gillon.

Unchaining DNA.

Environmental action.

September 1981. p. 25-28.

Milewski, Elizabeth A.

Evolution of the NIH guidelines.

Recombinant DNA Technical Bulletin.

December 1981.

p. 160-165National Institutes of Health environmental impact statement

on NIH guidelines for research involving recombinant

DNA molecules.

Washsington, Oct. 1977: 1 3 7 p.

Plus

appendix. Available throu-gh the Supt. of Docs. DHEW

publication nos.

(NIH) 1489 and (NIH) 1490.

Proposal to remove penalties in DNA rules.

Sept. 1 9 , 1981. p. 180-181.

Stience news,

Recombinant DNA research: Government regulation. Science,

July 1 5 , 1977: p; 208.

(Includes open letter to Congress from 1 1 0 Gordon

conference participants.)

Regulation of recombinant DNA research.

p. 447-456.

Chemtech.

July 1980.

Singer, Maxine F.

The recombinant DNA debate.

(Editorial)

Science, Apr. 8 , 1977: 127.

This issue of Science contains a series of other

articles on the recombinant DNA research issue.

Stockton, William.

On the brink of altering life. New York

Times magazine.

Feb. 1 7 , 1980. p.16-19, 62-64, 76-80.

U.S. Dept. of Health, Education, and Welfare.

Public Health

Service.

National Institutes of Xealth.

The patenting

of recombinant DNA research inventions developed under

DHEW support:

an analysis by the Director, National

Institutes of Health. Washington, U.S. Govt. Print.

Off., November 1977: 1 8 p.

Plus appendix material.

-----

-----

Recombinant DNA research. Volume 1. Documents

relating to "NIH guidelines for research involving

recombinant DNA molecules."

February 1975 - June

1976.

(Published August 1976) DHEW publication no.

(NIH) 76-1138.

592 p.

Recombinant DNA research.

Volume 2.

Documents

relating to "NIH guidelines for research involving

recombinant DNA m o i e c ~ l e s . ~June 1976 - ~ o v e m b e r1977.

(Published March 1978) DHEW publication no. (NIH)

78-1139.

9 0 2 p.

----- .Recombinant DNA research.

Volume 3. Documents

relating to "NIH guidelines for research involving

recombinant DNA m o l e c ~ l e s . ~November 1977 - Sept. 1978.

(Published Sept. 1978) DHEW publication no. (NIH)

78-1843 and (NIH) 78-1844.

6 0 8 p.

Plus appendices.

-----

Recombinant DNA research.

Volume 4. Documents

relating to "NIH guidelines for research involving

recombinant DNA molecules."

August-December 1978.

(Published December 1978) DHEW publication no. (NIH)

79-1875 and (NIH) 79-1876.

4 4 9 p.

Plus appendices.

-----

Recombinant DNA research. Volume 5. Documents

relating to "NIH guidelines for research involving

recombinant DNA molecule^.^ January 1979 - January 1980.

(Published Mar. 1980) DHEW publication no. (NIH)

80-2130.

p. 648.

-----

Recombinant DNA research.

Volume 6. Documents

relating to "NIH guidelines for research involving

recombinant DNA molecules.

January 1980 - December 1980.

(.Published Apr. 1981) DHHS publication no. (NIH)

81-2386.

.

----U.S.

RAC retreats from regulatory role.

July 1980. p. 4 4 8 , 487.

Bioscience.

Library of Congress.

Congressional Research Service. DNA

Recombinant molecule research [by] Vikki Zegel. Archived

Issue Brief 77024.

Walton, Susan. Biosafety committees advise less but better

DNA research oversight.

Bioscience, January 1981.

p. 14-15.

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NIH moves toward further easing DNA guidelines.

p. 97-98.

Bioscience, February 1981.

Will the DNA guidelines wither away?

1980.

p. 473-474.

Nature, Oct. 9 ,

Wright, Susan. Recombinant DNA policy:

controlling large

scale processing.

Environment, Sept. 1980. p. 29-33.