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STATE OF NEW YORK OS? Dr. J CREB

 

 

DEPARTMENT OF HEALTH ——
WD 4 Teg
MEFAORANDUM | hi » . - be iw

March 12, 1979

Addressees

   

Devid Axelrod

Regulation

Article 32-A of the Public Health Law, enacted by Chapter 488
of the Laws of 1978, provides for the regulation of all recombinant DNA
activity conducted in this State. The law serves the dual legislative
purpose of permitting research with great potential value to go forward
while requiring adequate safeguards for the health of the public and the
research workers themselves.

The law prohibits any recombinant DNA activity which is not
conducted pursuant to a certificate issued. by the Commissioner of
Health. As required by the statute, the Commissioner has promulgated
implementing regulations which are contained in Subpart 61-1 of the
Department's Administrative Rules and Regulations. The regulations,
effective February 22, 1979, follow closely the recombinant DNA
research guidelines issued by NIH December 22, 1978. One important
difference between the State law and regulations and the NTH Guidelines
is that the latter apply only to recombinant DNA research at institutions
receiving Federal support for such research, whereas the New York law
applies to ail recombinant DNA activity without regard to funding. This
includes activity by industries and scientific and educational institu-
tions which are not recipients of Federal funding for recombinant DNA
research or activity.

One other ixportant difference concerns experiments in categories
which the NIH Guidelines list as exempt from their requirements. Public
Heaith Law Article _32-A does not make provision for exempt activities.

Until an amenément of the statute can be effected, the regulations contain
authority for the issuance of a certificate limited to exempt-type activity
without requiring compliance with provisicns applicable to other recombinant

DNA activity, including the necessity of establishing an IBC,

The following administrative guidance is provided to facilitate
compliance with requirements of the Law and Subpart 61-1, a copy of which
is enclosed:

1. The application of an institution which has registered one
or more recombinant DNA projects with NIH or another
Federal funding agency for a certificate to engage in
recombinant DNA activity shall consist_of (1) a copy of
the registration document(s) received from NIH or the

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Federal funding agency with respect to one or more of
the recombinant DNA projects submitted to NIH or the

Federal agency, and (2) a list of the members of the

TRC with their curricula vitae.

2, An institution will be issued a certificate to engage in
recombinant DNA activity limited to the recombinant DNA
molecules specified in Section 61-1.3 (c) of the Regulations
upon submission of a statement certified by the chief
executive officer of the institution that the institution
will so limit its recombinant DNA activity.

3. (a) An institution which has not registered any recombinant
DNA research project with NIH or another Federal funding
agency may qualify for a certificate to engage in recombinant
DNA activity if it registers one or more of its projects
with NIH under the Voluntary Registration provisions
(IV-F-3) of the NIH Guidelines as revised in December, 1978
and submits a copy of the NIH registration document(s).

(b) I£ NIH advises an institution that its voluntary
registration will be delayed because of logistical problems,
the institution should apply for certification by the
Commissioner of Health. The application shall consist

of a photocopy of the Memorandum of Understanding and
Agreement (MUA) submitted to NIH with respect to the
recombinant DNA activity, a copy of NIH's notification that
voluntary registration will be delayed for other than
substantive reasons, and a list of the proposed IBC members
with their curricula vitae.

4. An institution may not undertake any, recombinant DNA
activity which wouid require prior approval by NIH,or another
funding agency designated by NIH for the purpose,if the
institution were an applicant for or the recipient of
Federal funding fof recombinant DNA activity until-the>
activity is approved and registered by NIH or the designated
funding agency and the Commissioner receives satisfactory
evidence thereof, or in accordance with 3 (b) above.

Section 61-1.3 (d) also contains provisions respecting new
host-vector systems.

Article 32-A of the Public Health Law provides that, if the NIH
Guidelines are revised, the Commissioner of Health shall make corresponding
revisions in his regulations, Accordingly, pending ccmpletion of admini-
strative steps required for amendment of state regulations, recombinant
DNA activity which is in conformity at a given time with the NIH Guidelines
and supplements thereto as most recently revised will be considered in
State compliance,

Applications for certification should be filed with Roger C. Herdman,
M. D., Director of Public Health, New York State Department of Health,
Tower Building, Governor Nelson A. Rockefeller Empire State Plaza,
Albany, N.Y. 12237.
Amendment to SUBCHAPTER E, SUBPART 61-1. Recombinant DNA research.
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(b) An activity in a category specified in paragraph (a) may be excepted
by the commissioner and conducted in accordance with an express approval given
for the experiment by the Director, NIH.

61-1.3 Certification. (a) An institution may be issued a certificate
by the commissioner to engage in recombinant DNA activity if it:

(1) establishes an institutional biosafety committee (IBC) composed
of members approved by the commissioner as satisfying the requirements of section
61-1.31;

(2) adopts a statement of policy, approved by the commissioner, assuring
compliance with the-requiréments of article 32-A of the Public Health Law and
this Subpart.

(b) An institution engaged in recombinant DNA activity subject to, and
in compliance with, policies and regulations or guidelines promulgated by any agency
of the federal government for the regulation of recombinant DNA activity may submit
to the commissioner copies of the documentation approved by the. federal _agency,
including information relating to the institutional-biosafety committee of .the
institution. Such documentation may be accepted by the commissioner as authority
for issuance of a certificate to engage in recombinant DNA activity upon the same
conditions and limitations, if any, as imposed by the federal agency.

(c) Unless the activity is prohibited by section 61-1.2, an institution
may be issued a certificate by the commissioner to engage in recombinant DNA
activity limited to the following recombinant DNA molecules and for such
certificate shall not be required to comply with the provisions of section 61-1.30:

(1) Those that are not in organisms or viruses.

(2) Those that consist entirely of DNA segments from a single nonchromosomal
or viral DNA source, though one or more of the segments may be a synthetic equivalent.

(3) Those that consist entirely of DNA from a prokaryotic host, including
its indigenous plasmids or viruses, when propagated ohly in that host (or a closely
related strain of the same species) or when transferred to another host by well-
established physiological means; also those that consist entirely of DNA from a
eukaryotic host, including its chloroplasts, mitochondria, or plasmids (but excluding
viruses), when propagated only in that host (or a closely related strain of the
same species).

(4) Certain recombinant DNA molecules that consist entirely of DNA segments
from different species that exchange DNA by known physiological processes, though one
or more of the segments may be a synthetic equivalent, as specified in a list of such
exchangers prepared and periodically revised by the Director, NIH.

(5) Other recombinant DNA molecules and procedures listed in the NIH
guidelines as exempt therefrom.

(6) Other classes of recombinant DNA molecules if the Director, NIH, finds
that they do not present a significant risk to health or the environment and the
commissioner is furnished satisfactory evidence of such finding.

(d) The commissioner will not certify or will suspend or revoke the
certification of an institutian which proposes to conduct or conducts a recombinant DNA
activity which would requir kpproval by Nit if the institution were required to
comply with the NIH guidelines, unless the institution registers the recombinant DNA
activity with NIH and provides the commissioner with satisfactory evidence: thereof,