# The NIH Recombinant DNA Guidelines: Brief History and Current Status

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/crs%3AIB82057

## Record

- **Collection:** Congressional research report
- **Document type:** CRS Report
- **Published:** July 7, 1982
- **Citation:** IB82057

## Text

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

CRS- 2
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

CRS- 5
Congress, 2d session. Apr. 1 1 , 1978.
Govt. Print. Off., 1978.
182 p.

IB82057

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.

IB82057

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).

CRS- 8
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.

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/crs%3AIB82057. Public record. Not legal advice.