N.Y. Public Health Law § 3222: Certification

§ 3222. Certification. 1. One hundred eighty days after the effective

date of this article, no individual shall engage in a recombinant DNA

activity unless such individual has been issued a certificate by the

commissioner or such individual is affiliated with and is acting under

the direction of and in a facility controlled by a person who has been

issued such a certificate.

2. Within one hundred eighty days of the effective date of this

article, the commissioner shall prescribe regulations for the conduct of

recombinant DNA activity which shall be the substantial equivalent of

sections II (entitled "containment") and III (entitled "experimental

guidelines") of the recombinant DNA research guidelines of the National

Institutes of Health of the Department of Health, Education and Welfare

published in part II of the Federal Register for July seventh, nineteen

hundred seventy-six. If the National Institutes of Health guidelines are

revised, the commissioner shall revise the regulations for the conduct

of recombinant DNA activity accordingly.

3. Within one hundred eighty days of the effective date of this

article the commissioner shall prescribe regulations for the:

(a) training and qualifications for individuals engaging in

recombinant DNA activities;

(b) personnel health monitoring programs;

(c) establishment of institutional committees to oversee such

activities; and

(d) periodic reports of the progress of such activities.

Regulations adopted pursuant to this section shall be reviewed

periodically by the commissioner in light of current scientific

knowledge to determine their continued adequacy and appropriateness.

4. The commissioner shall by regulation, establish procedures for

application for a certificate to conduct recombinant DNA activity. All

proprietary information in applications or reports to the department by

persons certified pursuant to this section, not available to the public

or protected by a patent or copyright, shall be kept confidential.

5. The commissioner may approve or deny an application for a

certificate to engage in recombinant DNA activity or may approve it upon

such conditions as he shall prescribe.

6. The commissioner by regulation may prescribe reasonable fees for

certification, not exceeding the cost of administrative services

rendered by the department.

7. The commissioner shall, by regulation, provide for an abbreviated

certification process for the conduct of recombinant DNA activity which

is subject to, and which is in compliance with, policies and regulations

promulgated by any agency of the federal government for the regulation

of recombinant DNA activity.

8. No local authority shall enact or enforce any local law, ordinance,

rule or regulation which would regulate or restrict recombinant DNA

activity. Further, no local authority shall enact or duplicate any

provision of this article as local law, ordinance, rule or regulation.