Definitions. As used in this regulation, the following terms shall
have the meaning indicated:
AFFILIATE
Any corporation or other business entity that directly or
indirectly is controlled by, controls, or is under common control
with an institution that holds a permit under these regulations.
BIOLOGICAL AGENT
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.
BIOSAFETY LEVEL 1 OR BSL-1
Includes activities, practices, equipment, safety equipment,
and facility design and construction that are appropriate for undergraduate
and secondary educational training and teaching laboratories, and
for other laboratories in which work is done with defined and characterized
strains of viable microorganisms not known to consistently cause disease
in healthy humans. Biosafety Level 1 represents a basic level of containment
that relies on standard microbiological practices with no special
primary or secondary barriers recommended, other than a sink for hand
washing.
BIOSAFETY LEVEL 2 OR BSL-2
Includes activities, practices, equipment, safety equipment,
and facility design and construction that are appropriate for and
applicable to clinical, diagnostic, teaching, and other laboratories
in which work is done with the broad spectrum of indigenous moderate-risk
biological agents that are present in the community and associated
with human disease of varying severity. To qualify for this designation,
such biological agents shall be, with good microbiological techniques,
capable of being used safely in activities conducted on the open bench,
provided the potential for producing splashes or aerosolization is
low. Hepatitis B virus, HIV, the salmonellae, and Toxoplasma spp.
are representative of microorganisms assigned to this containment
level. Biosafety Level 2 shall be deemed appropriate when work is
done with any human-derived blood, body fluids, tissues, or primary
human cell lines where the presence of an infectious agent is unknown.
Even though organisms routinely manipulated at Biosafety Level 2 are
not known to be transmissible by the aerosol route, procedures with
aerosol or high splash potential that may increase the risk of such
personal exposure shall be conducted in primary containment equipment
or in devices such as a safety centrifuge cup. Other primary barriers
shall be used as appropriate, such as splash shields, face protection,
gowns, and gloves. Secondary barriers such as hand washing sinks and
waste decontamination facilities shall be available to reduce potential
environmental contamination.
BIOSAFETY LEVEL 3 or BSL-3 MATERIALS
Biological materials with a potential for respiratory transmission
and which may cause serious and potential lethal infection upon exposure
but for which there is available vaccines or treatments. Novel (new)
influenza viruses and tuberculosis are representative of microorganisms
assigned to this containment level. BSL-3 is not permitted in the
Town of Plainville.
BIOSAFETY LEVEL 4 or BSL-4 MATERIALS
Biological materials with dangerous and exotic agents of
any type that pose a high individual risk of life-threatening disease,
which may be transmitted via the aerosol route and for which there
is no available vaccine or therapy. BSL-4 is not permitted in the
Town of Plainville.
BIOSAFETY PROFESSIONAL
An individual holding documented university education, or
who has successfully completed a training program, in biological safety
disciplines.
GUIDELINES
(1)
Unless otherwise specified, are defined as:
(a)
NIH GUIDELINESNational Institute of Health (NIH) "Guidelines for Research Involving Recombinant DNA Molecules," as published in the Federal Registrar of April 27, 2016.
(b)
BMBLBiosafety in Microbiological and Biomedical Laboratories 5th Edition 2007.
(2)
For purposes of these regulations, the NIH Guidelines, when
applied to an institution that is subject to the NIH Guidelines solely
by reason of these regulations, shall include the modifications to
the NIH Guidelines set forth in Section IV-D thereof applicable to
persons complying with NIH Guidelines on a voluntary basis. In the
event that there is a conflict between the NIH Guidelines and the
BMBL, the more restrictive shall control.
INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)
A committee that i) meets the requirements for membership
specified in the guidelines and ii) reviews, approves, and oversees
projects in accordance with the responsibilities as defined in the
guidelines.
MASSACHUSETTS GENERAL LAW
(1)
Chapter 111, Section 31: "Boards of health may make reasonable
health regulations."
(2)
Chapter 111, Section 122: "The board of health shall examine
into all nuisances, sources of filth, and causes of sickness within
its town, or on board of vessels within the harbor of such town, which
may, in its opinion, be injurious to the public health, shall destroy,
remove or prevent the same as the case may require, and shall make
regulations for the public health and safety relative thereto and
to articles capable of containing or conveying infection or contagion
or of creating sickness brought into or conveyed form the town."
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 is:
(1)
Identified as a "Recombinant and Synthetic Nucleic Acid Molecule"
in Section I-B (Definition of Recombinant DNA Molecules) of the most
recently adopted revision of the NIH Guidelines, as defined under
"guidelines"; or
(2)
Classified as a Risk Group 3 through 4 Agent in the NIH Guidelines
or the BMBL (as both are defined herein); or
(3)
Identified as a "select agent" by the United States Department
of Health and Human Services (DHHS) or the United States Department
of Agriculture (USDA).
SELECT AGENT
Any microbial and toxic agents listed at 42 Code of Federal
Regulations (CFR) 73.3, 42 CFR 73.4, 42 CFR 73.5, 42 CFR 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" shall not include any de minimus
amount of agents or toxins which are excluded from 42 CFR 73.00 et
seq.