New York Public Health Law Section 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.


Last modified: February 3, 2019