Legislation
SECTION 3222
Certification
Public Health (PBH) CHAPTER 45, ARTICLE 32-A
§ 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.
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.