[Adopted effective 1-1-2014]
A.
In order to safeguard the health and welfare of the citizens of the
City of Beverly (the "City"), the City of Beverly Board of Health
(the "Board of Health") hereby promulgates this regulation governing
the use of all regulated biological agents (as defined herein) in
the City. The use of regulated biological agents requiring Biosafety
Level 4 (BSL-4) containment (as defined herein) shall not be permitted
in the City of Beverly.
B.
Unless specifically exempted under this regulation, all research
or manufacturing involving regulated biological agents, as defined
below, in the City shall be undertaken only in strict conformity with
the National Institutes of Health Guidelines for Research ("NIH Guidelines"),
the current edition of the Department of Health and Human Services'
Centers for Disease Control (CDC) publication entitled "Biosafety
in Microbiological and Biomedical Laboratories" (BMBL), and all other
health regulations as the Board of Health may from time to time promulgate.
As used in this regulation, the following terms shall have the
meanings indicated:
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.
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.
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).
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."
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.
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.
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).
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 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
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
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.
A.
The Board of Health retains all final responsibility for enforcement
of this regulation. Notwithstanding the foregoing, the Board of Health,
whenever the facts and circumstances deem necessary, shall be authorized
to:
(1)
Convene a municipal biosafety committee (known as the "Beverly
Biosafety Committee" or "BBC") with three appointed members or any
number of members deemed appropriate by the Board.
(2)
Retain assistance from a professional consultant with appropriate
professional and academic experience and training to support review
of applications and required documentation.
(3)
Engage the services of the Beverly Health Department for site
inspection or review of compliance with documentation requirements.
B.
Costs incurred by the Board of Health in utilizing any one or combination of the resources set forth in Subsection A may be assessed to a BSL-3 permit holder/applicant according to the time required to inspect facilities and to review documentation for said permit holder/applicant. This cost assessment is in addition to any established permit fee(s).
C.
The BBC, if established by the Board of Health as authorized in Subsection A(1), will serve as an advisory committee to the Board of Health on general biosafety matters that fall within the provisions of this regulation. All appointees will be approved by the Board of Health and will have no direct conflict of interest with companies holding or requesting a permit under this regulation. All members will be subject to all ethics requirements and documents required by the City or the Board of Health. The Board of Health shall retain final authority on all matters relative to research or manufacturing of regulated biological agents performed within the City.
D.
Responsibilities of the BBC, if established by the Board of Health,
shall include:
(1)
Recommending policies, procedures and criteria to aid in the
implementation of this regulation, including recommendations related
to permit application requirements, reporting requirements and inspection
requirements;
(2)
Reviewing biosafety permit applications and indicating support
for or opposition to all such permit applications;
(3)
Reviewing reports and other required documentation submitted
by institutions subject to this regulation, and providing recommendations
to the Board of Health regarding approval, where appropriate;
(4)
Carrying out site visits to permitted facilities or facilities
requesting a permit, where appropriate; and
(5)
Performing other functions as may be specified by the Board
of Health, to assist the Board in carrying out its duties under this
regulation.
A.
All institutions proposing to use or continue the use of regulated
biological agents at BSL-1, BSL-2 or BSL-3 containment levels must
obtain a permit from the Board of Health before commencing or continuing
said research, manufacturing, or other use of regulated biological
agents and annually thereafter. Institutions receiving such a permit
shall conduct research, manufacturing or other use only as specifically
set out in their permit applications, and supporting documents filed
with such application. The use of regulated biological agents requiring
BSL-4 containment shall not be permitted in the City.
B.
Permit holder's responsibilities.
(1)
Each institution seeking permit approval in the City shall certify
and attest to its understanding that it shall:
(a)
Conform with the NIH Guidelines.
(b)
Conform with the biosafety standards established in the BMBL.
(c)
Conform with other conditions set forth in this regulation.
(d)
Conform with any special or specific requirements prescribed
by the City as a condition of permit approval.
(e)
Allow access for site inspection of facilities and pertinent
records by the Board of Health or its designees upon reasonable notice,
should it be deemed necessary by the Board of Health.
(f)
Submit (with permit application and renewal) a copy of all minutes
from IBC meetings held during the previous year. These minutes should
provide sufficient detail to allow the Board of Health and its staff,
members of the BBC, or professional consultants to understand the
risk assessment or risk assignment process by which the IBC determined
that all work approved by the committee would be conducted safely
at the assigned biosafety level using corresponding safety practices
and any additional special safety practices as specified by the IBC.
(g)
Submit (with permit application and renewal) a detailed table
of all protocols reviewed and approved by the IBC within the previous
year, including, at a minimum, a listing of all biological agents
utilized (e.g., host cell lines, biological vectors), any inserted
gene sequences that would elevate risk (e.g., oncogenes), the BSLs
assigned after IBC review and the rationale or guidance document upon
which the selected BSL was based, and the name(s) of the principal
investigator(s) who shall be responsible for each protocol.
(h)
Submit (with permit application and renewal) a protocol for
strain verification of all known human pathogens that are considered
to be attenuated or noninfectious approved by the IBC within the previous
year for use within the permitted facility, if any, or sufficient
documentation to demonstrate that such a screening process has been
completed by another laboratory, in order to ensure the proper characterization
of the virulence, replication competence, and extent of resistance
to therapeutic antibiotics.
(2)
Laboratories permitted to operate at BSL-3 containment will
additionally be required to submit a summary of protocols approved
for BSL-3 containment that identifies the specific regulated biological
agents and describes the nature of the associated research, manufacturing
and/or use to be conducted in the City. This summary may conform to
the NIH project registration format or may follow any other format
that provides sufficient detail to understand the nature and extent
of the biological risk associated with that project. Any IBC approval
of a protocol or experiment that is deemed to require BSL-3 containment
must be reported to the Board of Health within 30 days of that decision.
C.
Requirement for an institutional biosafety committee.
(1)
Institutions seeking such a permit from the Board of Health
shall establish an IBC. The IBC shall be composed as described in
the NIH Guidelines. In addition, in order to ensure that all facilities
engaged in research or manufacturing involving regulated biological
agents are conforming to the NIH Guidelines and the BMBL, the Board
of Health will appoint to each IBC one member, who shall be the Chairman
of the Board of Health or its designee. In addition, each IBC will
also be required to identify a second noninstitutional member, as
required by the NIH Guidelines. The IBC is required to meet no less
than once a year, and all minutes of the institutional biosafety committee
meetings must be forwarded to the Board of Health or the BBC as instructed.
(2)
A complete roster of all IBC members, including names, home
addresses, phone numbers, e-mail addresses and resumes or curriculum
vitae (CVs), including institutional and community members, shall
be maintained and submitted upon initial application or within 30
days after submission of a completed application. An updated roster
of IBC members, with resumes or CVs of new members (community or institutional)
appointed to the IBC since the previous roster submission shall be
provided with IBC minutes and other required annual documentation.
D.
Permit application requirements. Institutions seeking a permit from
the Board of Health must submit a completed application form obtained
from the Board of Health, accompanied by a nonrefundable permit application
fee, that will include the following information:
(1)
Company name and address.
(2)
Name(s) of corporate officer(s) authorized to sign the application
and full contact information for those individuals signing on behalf
of the institution.
(3)
State of incorporation.
(4)
Name of the institution's designated official responsible for
compliance with this regulation. This is most often the designated
biosafety officer, as defined in the NIH Guidelines.
(5)
Designation of the appropriate biosafety levels (as defined
in this regulation) for all laboratory areas, which are consistent
with the NIH Guidelines or BMBL for all IBC-approved protocols. This
designation should be reflected in the IBC minutes before work commences
in the permitted facility or, at latest, no more than 30 days after
that work commences.
(6)
Copy of a completed biosafety manual. Copies of updated biosafety
manual(s) are to be submitted upon annual permit renewal.
(7)
Floor plans showing laboratory areas. All biosafety containment,
biosafety levels, and designated waste storage areas should be indicated.
Updated floor plans to reflect any changes in assigned biosafety level
or expansion of laboratory areas shall be submitted upon annual permit
renewal.
(8)
An emergency response plan for the purpose of orienting City
representatives, including, but not limited to, the Board of Health,
Fire and Police Departments, to the physical plant and to procedures
to be utilized in the event of an emergency. This documentation must
include a floor plan showing the internal layout of the facility with
specific biological containment and nonbiological laboratory areas,
biological waste storage areas, and biological waste removal routes
clearly indicated. Amendments to this plan must be submitted as they
are incorporated.
(9)
Medical surveillance agreement. This service may be provided
through the institution's internal clinical resources or through an
independent third-party provider. A letter indicating the completion
of a contractual agreement for provision of occupational medicine
and medical surveillance services shall be submitted upon application
and whenever the clinical provider of these services has changed thereafter.
E.
Reporting of releases or adverse events. In addition to the aforementioned
requirements, each institution shall provide a written summary of
any incidents or adverse event involving regulated biological agents
that may have resulted in an exposure to a human pathogen within the
facility or in the release of a human pathogen from the facility through
wastewater or direct airborne release or through improper disposal
of potentially contaminated solid waste. This report shall be sent
to the Board of Health as soon as it is feasible, but not more than
seven days from the date of the incident. Animal bites will be considered
to represent potential human exposures, unless the animal was known
to be free of infection and this can be documented upon request.
F.
Annual renewal fee. Permits granted by the Board of Health shall
be renewed annually, subject to submission of the annual renewal fee
and required documentation as described in this section. The fee for
a permit granted by the Board of Health or annual renewal thereof
shall be determined by the Board of Health.
A.
For the purposes of this regulation, research or manufacturing will
not include clinical or health-care services or professional analytical
services that directly support clinical or health-care services.
B.
Educational institutions utilizing only commercially available molecular
biology teaching kits that have been designated by the manufacturer
for use at Biosafety Level 1 shall not be required to obtain a permit
or comply with any permit requirements stated herein.
A.
Violation of any provision of this regulation may subject the violator
to a fine of $200 per day. Each day of violation shall constitute
a separate and distinct offense. The Board of Health shall be empowered
to enforce this regulation in any court of competent jurisdiction
as well as the noncriminal method of disposition provided in MGL c.
40, § 21D. In addition to a fine, an institution which violates
any provisions of this regulation or for which continued conduct or
recombinant DNA technology or other activity covered under this regulation
poses an immediate threat to the public health or environment may
be closed by the Board of Health.
B.
Any penalty assessed pursuant to this section shall be in addition
to the actual costs, losses, expenses, damages, fees or other assessments
incurred by the City as a result of a violation of this regulation.
C.
Revocation of permit. The Board of Health may revoke a permit if it determines that the institution has materially failed to comply with this regulation, or other applicable permit conditions. Unless there is a threat to human health, safety or the environment, no revocation shall take place until the institution has been afforded the procedural requirements set forth in § 400-12.7 of this regulation.
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.
A.
Information submitted to the Board of Health may be subject to the
Commonwealth of Massachusetts' Public Records Law. Any institution
seeking to qualify any particular document or submission as confidential
shall:
B.
Notwithstanding this designation by the institution, any documents
that are referred to during a public meeting may be subject to public
review. The exchange of information pertaining to compliance with
the permit may take place in an executive session, if the information
shared in a public meeting would pose a security threat or compromise
proprietary information.
A.
The Board of Health may vary the application of any provision of
this regulation with respect to any particular case when the Board
of Health finds the enforcement thereof would do manifest injustice
and the applicant has provided that the same degree of protection
required by this regulation can be achieved without strict application
of the particular provision.
B.
Every request for a variance shall be submitted in writing to the
Board of Health and shall set forth the specific variance sought and
the reasons therefor.
C.
The Board of Health may establish additional conditions in connection
with the granting of a variance where the interest of public health
so requires.
D.
No determination with respect to a variance shall be binding unless
issued in writing by the Board of Health. Copies of said determination
shall be available to the public at all reasonable hours in the office
of the Board of Health.
E.
The institution shall post any variance granted by the Board of Health
at the permitted facilities in a prominent location for the duration
that the variance is in effect.
