As used in this regulation, the following terms shall have the
meanings indicated:
BEVERLY BIOSAFETY COMMITTEE or BBC
A committee established by the Board of Health for the purpose
of assisting the Board of Health in carrying out its responsibilities
under this regulation.
BIOLOGICAL RISK GROUP
Equivalent to the risk group for any biological pathogen
as defined in Subsection II-A-1 (Risk Groups) of the latest amendment
of the NIH Guidelines for Research Involving Recombinant DNA Molecules
and as specified in the latest edition of Biosafety in Microbiological
and Biomedical Laboratories (BMBL). This designation pertains to the
natural risk to human health and the likelihood of transmission associated
with the unaltered form of that biological agent.
BIOSAFETY LEVEL or BSL
Physical containment as defined in Appendix G-II (Physical
Containment Levels) of the latest amendment of the NIH Guidelines
for Research Involving Recombinant DNA Molecules (published by the
National Institutes of Health, Recombinant DNA Advisory Committee)
and the latest edition of Biosafety in Microbiological and Biomedical
Laboratories (published by the Centers for Disease Control and Prevention).
BMBL
The current edition of the Department of Health and Human
Services' Centers for Disease Control (CDC) Publication No. 21-1112,
entitled "Biosafety in Microbiological and Biomedical Laboratories."
INSTITUTION
An individual person or a group of persons, and/or a corporation,
firm, partnership, association, executor, administrator, guardian,
trustee, agent, organization and any other group acting as a unit
responsible for compliance with the requirements set forth in this
regulation.
INSTITUTIONAL BIOSAFETY COMMITTEE or IBC
A committee established in accordance with Subsection IV-B-2
(institutional biosafety committee or IBC) of the NIH Guidelines and
any applicable requirements of this regulation. The IBC shall be the
final arbiter within an institution with regard to the implementation
of this regulation, with oversight by the Board of Health as described
herein.
NIH GUIDELINES
The National Institutes of Health Guidelines for Research
Involving Recombinant DNA Molecules published in the Federal Register
of June 1, 1983, and any subsequent federal amendments thereto adopted
by the Recombinant DNA Advisory Committee (RAC) within the National
Institutes of Health (NIH).
REGULATED BIOLOGICAL AGENTS
Any microorganism (including, but not limited to, bacteria,
viruses, fungi, rickettsia or protozoa) or infectious substance, or
any naturally occurring, bioengineered or synthesized component of
any such microorganism or infectious substance that:
A.
Is identified as a "Recombinant DNA Molecule" in Section I-B
(Definition of Recombinant DNA Molecules) of the most recent revision
of the NIH Guidelines (as defined herein); or
B.
Is classified as a Risk Group 3 or Risk Group 4 Agent in the
NIH Guidelines or the BMBL (as both are defined herein); or
C.
Is identified as a "select agent" by the United States Department
of Health and Human Services (USDHHS) or the United States Department
of Agriculture (USDA), which shall mean any microbial and toxic agents
listed at 42 CFR 73.3, 73.4, 73.5, 73.6, 7 CFR 331.3 and 9 CFR 121.4,
and the rulings made by the CDC and the USDA relative thereto, as
such regulations and rulings may be amended from time to time. However,
"select agent" as herein defined shall not include any de minimus
amount of agents or toxins which are excluded from 42 CFR 73.00 et
seq.
Any institution, person or entity aggrieved by the decision
of the Board of Health in connection with the Board of Health's enforcement
of this regulation may request a hearing by filing a written petition
with the Board of Health within 10 days of such action. Upon receipt
of such petition, the Board of Health shall set a time and place for
such hearing and not later than 30 days upon written request, and
shall so inform the petitioner, and the institution if other than
the petitioner, in writing. At the hearing, the petitioner shall be
given an opportunity to be heard and to show cause why the Board of
Health's decision was inconsistent with the requirements set forth
in this regulation. The Board of Health, upon presentation of all
evidence, shall issue a final decision in connection with the relief
sought.
Any institution or person aggrieved by the final decision of
the Board of Health shall seek relief from any court of competent
jurisdiction located in the County of Essex, Commonwealth of Massachusetts.