UNITED STATES OF AKERICA

     BEFORE THE

DEPARTMENT OF HEALTH, EDUCATION AND WELFARE

PETITION OF ENVIRONLXENTAL DEFE:gSE FUND, INC.

AND NATURAL PZSOURCES DEFENSE COUNCIL`, INC.

TO THE SECRETARY OF HEALTH, EDUCATION AND WELFARE

TO HOLD HEARINGS AND FROMULGATE REGULATIONS UNDER

THE PUBLIC HEALTH SERVICE ACT GOVERNING RFCOLsIBINANT
         .-

DNA ACTLVITIES

The Environmental Defense Fund (EDF) and the Natural

Resources Defense Council (NRDC) hereby.petition the Secretary
of Health, Education and Welfare (hereafter "the Secretary")
                *
under the authority granted-him by S361 of the Public Health
Services Act (42 U.S.C. 5264) to hold public hearings and

                                                      .       i/
promulgate regulations governing recombinant DNA- research
and technology in which fragments of DNA from different

organisms, cells or viruses are combined in novel ways and
introduced into a living host organism or cell.

L/ DNA - deoxyribonucleic acid, t!\.e chemical substance which
  contains all genetic information.


-2-

   Recombinant DNA technology permits the creation of organisms
or viruses with an unprecedented genetic make-up which may have
                           .

thepotential of causing grave and-irreversible harm to humans'

and the environment.  The extent of our current knowledge does

not allow us to predict all of the possible results of experi-
ments involving the manipulation of genes.   Because most of

the present and proposed recombinant DXA research and technology
involves the genetic modification of bacteria or viiuses,  there

exists the -potential danger of creating a highly deleterious

communicable infectious agent that could be introduced into

and spread among laboratory workers and/or the,general popula-

tion (& infra, pp- g - 12).

Recognizing the potential hazards inherent in recombinant

DNA research? the National Institutes of Health
                                                               1

/ (hereinafter

                                                     2
WI,") on 23 June, 1976 promulgated guidelines which

prohibit certain experiments where the potential risks to

human health are deemed to,be particularly high, and require

.

a graded set of safety procedures for all other experiments

          I
(se 41 Fed; Reg.

1976).   NIH also

(hereinafter the

which.sets forth

DNA research and

No. 131, part II, pp. '27902-27943, July 7,

filed a

"impact

some of

draft environmental impact statement

statement") on 1 September, 1976,

the possible dangers of recombinant

technology (   41 Fed. Reg. No. 176,

pp. 35425-44, Sept. 9, 1976).  NIH indicated that the guide-
lines are not a final statement of public policy on

&/The petitioners take no position at this time concerning
the adequacy of the safety standards set forth in these
guidelines.


-3-

:recombinant DNA research and technology but rather the beginning
                                          .

of full public consideration of all relevant issues.

The guidelines apply only to recombinant DNA research

supported by the NIH.  While Dr. Donald Fredrickson, the

director of NIH, has called on all government agencies .and.
.-

"all who support or conduct s,uch research throughollt the

-United States" (41 E. m. No. 131, p. 27906, July 7, 1976)

to voluntarily adopt the NIH guidelines, only the National

_
Science .FoUndation, Department of Defense, and the Energy Research

and Development Administration have formally done       *
                                              so:,   Therefore,
a significant portion of recombinant DNA research and technology

is not covered by any mandator-y set of safety procedures, leaving

the public unprotected from its potential hazards.
              .*                            Furthermore,
                                                                       .

it is the position'of the petitioners that the public did not
have an adequate opporturiity to participate in the basic policy
Wdecisions underlying the NIH Guidelines.

For these reasons, EDF and NRDC request that:

(1)-a
   public hearing of broader scope than those held this

. `...

yeaf at NIH be held on the questions of to what extent and

under what conditions recombinant DNA research and technology
should be allowed to proceed; (2) final regulations be

promulgated based on the record of that hearing which would

apply to s recombinant DNA research and technology in the

-

*  Dr. Joe Perpich,
  communication.  'National Institutes of Health, personal


-4-

United States; and (3) the pre sent NIH guidelines be promulgated

immediately as interim relief 'regulations governing all parties
conducting or supporting such research.

This document includes:

I.  A'description of the scope of this petition (p. 4);
'iI. A description of the petitioners (p. 6);
III. A discussion of the need to  control recombinant DNA

research and technology in the  interest of public health
(p- 7);

IV.  A discussion of the legal basis for the regulation of
     .
recombinant DNA.research and technology by th'e Secretary of

HEW (p.-13); and

v.  A description of proposed relief (pi 15).

By this petition EDF and NRDC seek interim and

final regulations which will protect the public ,from the
pqtential haiards of uncontrolled recombinant DNA research

and technology.

   In this petition the term "recombinant.DNA research

                                                          .
'and technology" means all procedures in which DNA fragments
from two or more different organisms or viruses which do not normally
                                                                           - _
recombine in nature are recombined in. the laboratory and.inserted

into a living host cell or organism in such a way as to alter its

genetic make-up.  This includes, but is not limited to, any experi-
ments involving transportation of or commercial use of recombinant


-5-

DNA molecules or the products derived therefrom.   NRDC and EDF

seek regulations 'governing all'recombinant DNIA research and

technology including, but not limited to:
      (a) All experiments discussed in the "Guidelines
     for Research Involving Recombinant DNA Molecules"
     issued by the-National Institutes of Health on

June 23, 1976 and published in the Pederal.Register

Part II on July 7, 1976;

(b) All experiments in which chemically or

enzymatically synthesized DNA is inserted into

a living host, plasmid or virus; and

(c) All other procedures in which Z?A from

any two sources which do not normally exchange
gen:tic information may function within the

same cell.

NRDC and EDF seek regulations which would cover ali persons and
organizations conducting or supporting recombinant DNA research
              .
.incLuding, but not limited to:

1.  Recipients of Research grants.,awarded bp

any agency within the Department of Health,

Education and Welfare;

2.  Private corporations;

3.  Private and-public universities; and

4.  Other departments and agencies of the

Federal Government.


- b --

11.  Petitioners

     Petitioner Environmental Defense Fulld, Inc.,  is a

not-for-profit  public-benefit membership corporation organized
and existing under the laws of the State of U&w York.   Its

principal office and place of.business is located at 162 Old

Town Road, East Setauket, New York.  It also maintains offices
in Washington, D.C.; New York, New York; Denve>:, Coiorado;

and Berkeley, California.  EDF has a nationwide metiership of

over 40,000 persons, composed of scientists, educators, lawyers,

and other citizens dedicated to the protection of the cnviron-

ment and the wise use of natural resources.  Many of these

persons and their children will be subjected to the increased
risk of advezse health effects discussed in at pp. 9 - 12, infra,
                                                                           _ .
if the Secretary does not. adop' L effective regulations controlling

the relevant procedures.  By its activities, EDF seeks the

preservation and restoration of environmental quality and the

protection of the country's natural resources on behaif of
              .
the, general'public.  Its objectives include combining "the best

scientific findings with the most appropriate social action
discovered by the social sciences and legal theory in order
that practical decisions shall be made which shall best promote
a quality environment."  (EDP By-laws, Art. 1:2(d)).

  Petitioner Natural Resources Defense Council, Inc.,  is a
not-'for-profit , tax-exempt corporation organized under the laws
of the State of New York, with offices at 15 West 44th Street,
New York, New York; 917 15th Street, N.W., Washington, D.C.;

and 2345 Yale Street, Palo Alto, California.  NRDC is a national

organization dedicated to enviuQnmenta1 protection, including


-7-

protection of the human environment.  NRDC has 24,000 members and

                                         .
contributors  in the United States.  hny of these persons and
                          .                                    .
their children will be subjected,to the increased risk of adverse

health effects discussed in pp. 9 - 12, infra, if the Secretary does

not adopt effective regulations controlling the relevant proce-
.-

durcs.

Among the methods  NRDC uses to achieve its objectives

axe:  (1) improving federal agency decision-making which affects

the environment by conm;enting, furnishing information, partici-

pating-in administrative proceedings, and bringing lawsuits

where legal duties are not being fulfilled; and (2) improving

federal agency decision-making which affects the environment
                                         _ -.

by encouraging agencies to solicit and utilize the vie?=,
                                                                .

knowledge, and expertise of members of the general public.

III.   The Need ,to Control Recombinant DNA Research
    and Technology in the Interest of Public biealth

The techniques defined above enable scientists to

recombine the DNA from two unrelated species and, thus, construct

:..

organisms which may express genes from biologically unrelated

sources.  Because the properties of such deliberately or

.accidentally constructed organisms are unknown and may represent

hitherto nonexistent hazards both to human health and the

ecology, members of the scientific community have raised the

questions of whether or not proceeding with this type of

research.at this time is prudent, and, if so, whether or not

the public and the environment can be adequately protected


-a-

from potentially hazardous novel organisms.which might arise from

such research.

. Addressing these questions, NIH formed a committee (the

Recombinant DNA Molecule Program Advisory Committee) composed of

scientists, many of whom were directly involved in recombinant

DNA research, to draft guidelines governing the conduct of

recombinant DNA research and establish safeguards to protect
the public and the environment from potential hazards.  The

guidelines; applying only to NIH supported research, were made

public June 23, 1976.  Recognizing the far-reaching environmental

consequences which could result if infectious or otherwise

dangerous organisms able to compete successfully with existing

organisms were to be produced by reco,mbinant DNA research, and
               .G

in response to requests from the public, NIH prepared a Draft

Environmental Impact Statement which was released September 1,

1976.

    The

action,!'

research

Impact Statement,, in discussing the alternative of "no
                                            .

unambiguously concludes that regulation of recombinant DNA
   o ?

and technology is essential for the protection of the public:

    "the 'no action'  alternative would greatly
increase the prcbability that possible hazardous
organisms would be released into the environment.
      It is concluded that the 'no action' al-
;e;nitive would not afford adequate protection
of laboratory workers, the general public, and
the environment from the possible hazards des-
cribed in section IV-C-l."  (at p. 48).

Some of the possible hazards which could arise either

directly or as an inadvertent result of recombinant DNA research

are discussed in Section IV-C of the Impact Statement.  One may


expand this list to include additional unt@,>~~~d health effects.
                                                    IT

The following are examples of potential threats to human health
                                 .

which could result from recombinant DNA rysearch and technology:
  1. '. Most of the proposed and ongoing recombinant DXA

research involves strains of the bacttirium Escherichia

coli (E-.
    coli) as a host for plasmids contain'ing DNA -

from other sources. E.  coli is a common resident of
                             --

the human colon, is responsible for nearly 100% of
                      &/

human upper urinary tract infections and for approxi-
                     21

mately 30-403 of the cases of sepsis   (infection of

the human bloodstream), which is' often f'atal.  While

the strains of 5.  coli used in recombinant DNA research
                        --                .

(variants of strain K-12) do not normaliy.colonize the

human .c_olon, they can under unusual conditions, parti-

cularly in patients weakened by another disease state.

Perhaps more serious', however, is the capacity of K-12

strains of g.
        coli to exchange DNA with other similar
            3/
or related organisms.  Genetic exchange between E. coli
                    41                              --

and strains of SalmonellayV a human pathogen, is well

documented.  Since the genetic determinants in infec-

tivity and virulence of bacteria are not understood,

one mrst consider the possibility that even a seemingly

trivial modification of the g.
                  coli genome might greatly

alter its capacity for infection and propagation within

humans.

l/ B. D. Davis, et al., Microbiology 768 (2nd ed. 1973).

2/ Dr.  Halstcd Holman - Oral testimony before a hearing of the Sub-
  committee on Heal(;h of the Senate Committee on Labor and Public
  Welfare, Sept. 22, 1976

g/ Davis, et al., supra at 182-200.
       -_
a/ Id. at 194.
     -


  In view of the ubiquitous nature of g. coli, the fact
that-all strains including K-12 already have the capacity

for human infection, and E. eoli's ability to exchange
                                  --

genetic

genetic

poses a

2.   DNA

material with other bacteria, the deliberate
                                        .,"

modification of even "weakened" .strains of It=   coli
                                                        -* --
potentially serious threat to human health.

can be taken from  organisms that produce toxins

(e.g. botulinurn) creating the possibility that the host

orgCanism, which occupies a different ecological niche,
will acquire the ability to produce the toxin.
This would be particularly serious if such genes were

expressed in strains of E. coli capable of colonizing
                                     --               *.

the human colon.
3.
Gengs  which code for resistance to antibiotics are

transferred by some recombinant DNA experiments to
strains of bacteria that were, not previously resistant.

4.  The animal virus on which the most genetic information

is available is simian virus 40 (SV-40), which produces
       .

tumors in some animals and infects humans, although apparently

with no pathological symptoms.  However, the genetic

basis for the virus causing tumors in monkeys but not
humans is not understood.  Therefore, the possibility
exists that even an apparently  innocuous modification

of SV-40 DNA could render the virus tumorigenic or

otherwise ,pathogcnic to humans, thus creating a serious
hazard to human health.  Yet it is SV-40, and polyoma


virus, which also produces tumors in Canimals, which are the

primary objects of recombinant DNA research in animal

viruses.

5.  The virulence of influenza virus,   and the sponta-

neous occurrence in nature at certain ti&s of devastating

'flu epidemics (such as the one of 1918) is apparently

controlled by  th e reassortment in nature of the 12 sub-
               l/
units of the viral RNA-- Yet the genetic basis'and the
'mechanism by which these viruses are rendered highly

virulent is not understood.  Again, therefore, any

recombinant DNA procedure involving any animal virus

or cells containing such a virus must be considered

'to pose the risk of creating highly viru.!ent or

infectious strains.

6.  The expression of any foreign gene, however seemingly

innocuous it may be in the cells of a human or other

mammal, whether inserted by viral infection or some
other mechanism, poses the risk that-a protein will
be-produced in the infected cells which has never been

seen by the host's immune system.  Thus the possibility

of an auto immune disease exists (as in rheumatic fever
          1

'or degenerative kidney disease) in which the body produces

antibodies against proteins within or produced by its

own cells, ultimately destroying the cells themselves.
The NIH guidelines di'scuss "harmful" genes in the sense
of DNA specifying antibiotic resistance factors or protein toxins.

l/ Davis, et al., suura at 1318.   R??A =                     SCl-22
                          --
Firuses contain RNA rather than DNA.     rihonucleic acid.


-12-

I'n the context of auto. immune disease, however, the gene spcci-

fying any foreign protein'must be considered potentially harmful.
        -
                    ,
7,  The expression of even a "normal" metabolic enzyme

in human, animal or plant cells which was not under the control

of the cell's normal complex regulatory'mechanism,' could lead

to severe metabolic disruptions and

state, similar to existing cases of

where the defect is in a regulatory
once coding for a specific enzyme.

an ensuing disease

metabolic disease


gene I  rather than

  Both the NIH guidelines and the Impact Statement recognize
that humans harboring or infected by bacteria or viruses con-
ta.ining'recombinant DNA may, under certain conditions, suffer

a variety.of serious .adverse health effects.   Ifslch modified

. bacterial or'@viral agents can survive and propagate outside the

.laboratory_ and thus produce new identical organisms capable of

producing infection and/or'toxic effects o.n human beings, there

exists the potential for a."communicable disease" within the

mecaning ,of Section 361 of the Public Health Service Act (42
               .
U.S.C. $264):' (see Section II above).   Because some of the

organisms created by recombinant DNA research have never existed

be fore, the health and environmental ef.fects of such novel
micrcorganisms are inherently unpredictable.  Nevertheless, the

danger. of the creation of a potentially serious communicable

disease organism makes it incumbent upon the Department of

Health, Education and Welfare to exercise its statutory authority
and take whatever regulatory measures are necessary to protect

the public health.


  While EDF cand NRDC commend the monumental effort made by NI!I
to regulate this'potentially hazardous branch of research within

its own jurisdiction, we are disturbed by the fact that the
guidelines cover only NIB supported resear,,ch, leaving large
segments of the scientific and industrial coknknitics subject

to no required safety procedures.  Recombinant DXA research and

technology is now being pursued and supported by private corpora-

tions, agencies of the Federal government, as well as scientists
at universities and private institutions.

General Electric is trying to develop a bacteria which can
degrade petroleum and could be used to consume oil spills.
                                                      . .

Imperial Chemical Industries Ltd.  (ICI) of Britain is trying

to develop a virus which produces insulin.   (Janice Crossland,

"Hands on th.d Code", Environment 18:6, September 1976). .The

drug industry in the United States has also expressed interest
in the commercial use of recombinant D??A techniques.   Federal

agencies such as the Department of Defense may contemplate

conducting experiments.  Scientists at'universities whether

they receivegovernment grants or not are donducting recombinant
DNA research.  Therefore, we consider a unirorm set of regu-
lations covering'   parties engaging in reccmbinant DNA research

to be.absolutely necessary.

IV.  The Secretary of HEW Has the Authority
  To Regulate All Recombinant DNA Activities

  %eckion 3Gl`of the Public Health Services Act (42 U.S.C. S264)

gives the Secretary of Health, Education and Welfare the authority

to regulate all recombinant DNA research and technology.   The

Section empowers the Secretary to:

II    make and enforce such regulations as in
hk'j;dgement arc necessary to prevent the intro-
duction, transmission, or spread of communicable


diseases from foreign countries into the States
or possessions, or from one S`tate or possession
into any other State or possession . . ."

It further provides that:

for purposes of carrying dut and enforcing such
regulations, the (Secrctaiy] may provide for such
inspection, . . . disinfection . . . and other'
measures, as in his judgment may be necessary.

Recombinant DNA research and technology could create novel

infectious agents or increase the virulence and range of existing

infectious agents.  The Draft Environmental Impact Statement recog-

nizes that recombinant DNA activities could produce microcrganisms

that cause disease in laboratory workers and the general public.

In describing the Guidelines the Draft EIS states:

"The emphasis on protection of laboratory workers from
infection reflects the fact that laboratory workers are
the persons at the greatest risk of infection and that
the m&t 1iJ:ely route of escape of possibly hazardous
agents from the laboratory is the laboratory worker."
(41 Fed.  T3AP-v
      s\l;y. 38432 )

In describing the highest level of physical containment required

by the Guidelines  to the Draft EIS states that such facilities are:'

"designed to
haz.ardous to
     n .

contain microorganisms that are extremely
man or may cause serious epidemic disease."

.The kinds of disease which may be caused by recombinant DNA

activities are described in Section III of this petition (infra

at pp. 9 - 12).

  The Secretary has defined "communicable disease" in regulations
promulgdted under Section 361 to govern the importation of animals

and establish drinliing water standards.  For the,purposes of both
these sets Of regulations a communicable disease is "An illness due

to an infectious agent or its toxic product . . ." transmitted by

persons, animals`, plants or the inanimate environment.   (42 C.F.R.

__71.l(b), 72.1(b)).  These regulatory definitions of communicable


- 13 -

disease illustrate that the Secretary has the authority tinder 5361

t0 regulate infectious agents from any source, transmitted by any

means.

Because microorganisms produced by recombinant DNA activities

may spread disease among humans, it has already been recognized
that'rcgulations promulgated pursuant to authority under s361

control transportation of DNA .materials.   Section II-C of the NIH
                 I
Guidelines (41 Fed. Reg. 27914) states that the shipment of

recombinant'DNA materials is governed by 42 C.F.R. S72.25 which

specifies safety requirements for the transportation of etiologic
agents. &/
      An "etiologic agent" is defined as ll. . . a viable micro--

organism or its toxin which causes, or may cause, human disease."

(42 C.F.R. 572,25(a) (1)) Recombinant research and the commercial

use of recombinant technology pose an even greater risk that the
              .-

'public will be exposed to infectious agents than does transporta-

tion.  2he same risk 'of.co&unicable disease which gives the

Secretary the authority to regulate the transportation of reccmbinant

materials under 5361 gives him,the authority. to re'gulatc all re-
. .

cornbinant.DNA activities.

V.   Relief

By this petition EDF and NRDC seek the following relief:

1.  A legislative-type hearing to` develop a policy on

recombinant DNA research and technology.

2.  Regulations binding on all parties conducting recoxkinant

DNA research or otherwise engaged in recombinant DNA .technology.

l/ S72.25. applies to microorganisms listed in subsection (C) which
Lclu&s most microorganisms  uSed in recombinant DIJA rcscarch such
as E. coli,  Simian Viruses, Saln~onella.~


    3. As interim relief, regulations .which ma!ce the 1~111. guidc-
lxxzs binding on .G parties engaged in recombinant DNA research
and tcchnolog-1.

This relief is necessary to insure that the public has an
adequate opportunity to participate in the decision of whether
and under what conditions reco.mbinant DNA research and technology
should be permitted and to insure that the protection provided
the public by the NIH guidelines is immediately extended through
the application of the NIH guidelines to.all recombinant DNA

research and technology.

   'A. The Need for a Legislative-Type Eearina
                                                                  -:
  The NIII guidelines, which at present are the only statement
of government policy on recombinant DNA research and technology,
are the product of the deliberations of scientists who are now
conducting rcco,mbinant DEA research. The NIH guidelines had

their origin in the Asilomar Conference held in Pacific Grover
California in February 1975.  Many of the participants at that

conference were the foremost molecular biologists from all over
the.worlh. -The NIH Recombinant DNA Molecule Program Advisory
                                                                  .
Committee translated the recommen.dations of that conference into
concrete proposais which became the NIH guidelines.  The first
opportunity the public had to participate in the regulation of .

recombinant research was in February of 1976 when the draft
guidelines were released for public comment, and the Advisory
                      1/

.Committee to the Director of NIH- held an open meeting.

L/This committee should not be confused wi'ih the NIII Recombinant
DNA biOlCCUlc Program Advisory Committee,
lines, but is one arr-.           IGhich drafted the guide-
         3J~.mblcd early in 1376 from representatives of
science, law, teaching, public intcrcst grouu?
                             La, studczts, etc. to
advise the director of NIH on the corrccfncss or shortcomings of
. its efforts to regulate recombinant DNA rcscarch.


- 17 -

Although this meeting was not well p*ublicized, many

scientists, public interest groups and laymen.were invited to
                        2.i

attend and to comment on the guidelines.  .,&dditional input was
sought from these same individuals' during the.two-month period

following this meeting.  A considerable'body .of material.was-
received by commentators by the office of the Director of NII-I,

and is summarized, in part,  in the Decision of the Director,

NIH, to Release Guidelines for Research on Recombinant DNA
.

Ilolccules  (see 41 Fed. m. No. 131, pp. 27902-27911, July 7,
   . .

1976)

Little discussion was devoted.to whether or net these esperi-

ments ought to be performed at all,
                                       --. even though the question was
raised both by concerned laymen and by pro,minent scientists.

DNA research has been a tacit assumption on the part of +&e NIH

advisory committee which drafted the guidelines from the onset

of its deliberations.  We believe that this is, at least in part,

a rqflection'of the fact that.'many
     -.
now doing recombinant DNA research

its future.  In the public meeting

bf the cont?ittee members are

and have a vested interest in

held on February 9-10, 1976,

the request was made that such potentially hazardous research
should at least await the development of i strain of bacteria

which is not a ubiquitous inhabitant of the human colon. E. coli
                                                                           --
is the current organism of choice simply because a large body of

genetic information exists  concerning this bacterium.   This

21 A copy of the comments submitted by EDP at that time are
attached as Appcndis 1..


request was denied in an admini rtrative decision by the director
of NIH and not even submitted to the advisory committee for

further debate in its April l-2, 1976 meeting in which final
revisions of the guidelines were madc. _ At this meeting, all of
the outside comments had been.distillcd down to ten typewritten
'pages of questions for the consi dcration of. the recombinant DNA

advisory'commi.ttec, the same committee which had drafted the
'working version prepared early in 1976.  Except for relatively

minor changes in wording, the committee dealt summarily with

the questions from the public, and the final version of the

guidelines did not differ significantly from,the version pre-

pared prior to public input.
  The leg'rslative- type hearing should coilsider the following

issues which were not adequately considered in the NIH pro-

ceedings which led  to the promulgation of the guidelines:

(a) Whether or not recombinant DNA research on any
  level should be permitted at`this time'in view
  oi`our present state of knowledge.

(b) If some areas are to be permitted, what are they
  and what precautions are necessery to adequately
  protect the public and the environment? For

   example, what degree of physical containment

should be considered adequate in light of

human fallibility?


19 -

(c) Whether .or not a strain of bacteria should be

sought and studied to replace c.
                       coli.as the
                                            I'
                                           ,,1'

subject of most recombinant DNA experiments

  before this ~
        work be allowed to proceed.
(d) Whether or not an "ordinary" or normal, non-

hazardous gene from one organism might become

dangerous if expressed in the wrong place and
wrong time in the wrong organism (this important
question was virtually iqnoredlby the advisory

committee) .

A legislative-type hearing conducted by 'HEW is the best

                                                                           .

forum for @ll consideration of the issues-raised by recombs-
nant DZA research and technolocgy.  In effect, such a hearing

would amount to a broad-based public review of the existing NIH
guidelines and would permit open debate on'issues given little

02 no attention by the NIH Drafting Committee or the office of
the dikector, Whether the activity is transportation of
recombinant DXA materials, research, commercial production or

use in the environment, HEW has the authority to regulate

corporations and scientists whether 02 not they receive federal

research support.  Therefore,. it is highly appro;?riate for HEW
                                                       . :

to hold such a hearing.

B.  Final Requlations Governing All Parties Engaqed

Promulgation of the NIH guidcli,nes reflects a consensus

that recombinant DNA research and technology pose a sufficient
hazard to the gub1i.c health and the environment to require the
prohibition of some experiments and the. imposition of safety


- 20 -

procedures for others.  The hazards of recombinant DYA research
and technology are no different if the research is being con-
ducted by scientists employed by private corporations.rather

than the NIH.  The risk that necessitated regulation of

NIH grantees necesstites regulation of other research and
technology. The need for regulation of all parties conducting

recombinant DXA research is particularly great because even
one release of a hazardous genetically altered bacterium,

virus or plasmid could cause widesp, yead illness or disruption
of the environment.

c.  Interim Relief
-Durin$the period before the hearing is held and final

regulations are promulgated the public will bc exposed to the
potential hazards of recombinant DNA research ald technology

not now subject to NIH guidelines.  Individuals' who do not

receive NIH grants or work for NIH are not effectively
            .
              o ?

restrained from conducting any of the experiments which NIH
deemed so dangerous that they should not be conducted at all.
Nor are scientists not now covered by the guidelines required
to practice physical and biological containment of organisms
with recombinant DNA molecules.  To protect the public until

final regulations are promulgated, EDF and NRDC request that

the'secretary immediately promulgate regulations which make
the NIII guidelines binding on all parties engaged in recom-

binant DNA research and technology.


- 21 -

Respectfully submitted,

Staff Scibt/ni;ist-
Environmental Defense Fund

Chai-man
Toxic Chemicals Program
Environmental Defense Fmd

Staff Xttorney                  .
Environmental Defen'sc Fund

l!Y
  , , ~&~&i. &&i-q/
  1
A. I<%?% @mcd, Ph. D.
Staff Scientist
Natural Resourl=e s Defense Council

            -2-L
Marcia Cloveland
Staff Attorney
Natural Resomces Defense Council

November 11, 1976