STATE OF NEW YORK 
TOWER BUILDING • THE GOVERNOR NELSON A. ROCKEFELLER EMPIRE STATE PLAZA 
DEPARTMENT 
OF HEALTH 
• ALBANY, N.Y. 12237 
DAVID AXELROD. M.D. 
Commissioner 
August 22, 1979 
Dear Dr, Fredrickson: 
I offer the following comments on the Proposed Supplement 
to the NIH Guidelines for Recombinant DNA Research published in the 
August 3, 1979 Federal Register , relative to voluntary compliance. 
Article 32-A of New York State's Public Health Law prohibits 
recombinant DNA activity except pursuant to certification by the 
Commissioner of Health, As required by the statute, the implementing 
regulations follow the NIH Guidelines, The law and the regulations, 
unlike the NIH Guidelines, apply to all recombinant DNA activity 
regardless of sponsorship. Institutions, including industry, which 
are not recipients of Federal funds for recombinant DNA research or 
which are not required to register with a Federal agency for such 
research are not required to comply with the NIH Guidelines, For 
these, the State's regulations would mandate registration with NIH 
under the provisions of the Guidelines authorizing voluntary regis- 
tration. Dr, Gartland has indicated that, within its resources, ORDA 
is prepared to support the State in its approach. 
The proposed expansion of the Guidelines to provide in 
greater detail for voluntary compliance by individuals, corporations 
and institutions not otherwise covered-in would not require amending 
our regulations as the Guideline procedures automatically become part 
of the State registration requirement under State law. 
Comment was also invited on the basic issue of how best to 
achieve compliance by all sectors engaged in recombinant DNA activity 
in both research and production. As it is questionable whether suf- 
ficient authority exists to support the comprehensive regulations 
needed, it seems clear that Federal legislation offers the best pros- 
pect of establishing a uniform, enforceable set of minimum standards. 
The individual states could retain the option of setting more stringent 
requirements, 
I hope that these comments will be helpful to you and to the 
Recombinant DNA Advisory Committee 
Commissioner of 
Donald S, Fredrickson 
Director 
National Institutes of Health 
Bethesda, Md. 20205 
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