[HISTORY: Adopted by the Board of Health of the Town of Walpole
as indicated in article histories. Amendments noted where applicable.]
[Adopted 9-14-2010]
The Board of Health, Town of Walpole, Massachusetts, acting
under the authority of Section 31, Chapter 111 of the General Laws
and amendments and additions thereto, and by any other power thereto
enabling, hereby adopts the following rules and regulations in the
interest of and for the preservation of public health.
These rules and regulations shall apply to all institutions
in the Town of Walpole which use or experiment with recombinant DNA
("rDNA") technology in any Biosafety Level and/or BSL-3 Materials
as defined herein. Use of BSL-4 materials as defined herein shall
be prohibited in the Town of Walpole.
A.
AFFILIATE
BIOSAFETY PROFESSIONAL
BIOSAFETY LEVEL 1 or BSL-1
BIOSAFETY LEVEL 2 or BSL-2
BIOSAFETY LEVEL 3 or BSL-3 MATERIALS
BIOSAFETY LEVEL 4 or BSL-4 MATERIALS
CHANGE OF CONTROL
CONTROL
GUIDELINES
(1)
(a)
(b)
(2)
INITIAL APPLICATION
INSTITUTION
rDNA TECHNOLOGY
TRANSFER APPLICATION
As used in this article, the following terms shall have the meanings
indicated:
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.
An individual holding documented university education, or
who has successfully completed a training program, in biological safety
disciplines.
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.
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.
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. All procedures for Biosafety Level
2 also apply to this category.
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 Walpole.
The acquisition of control of an institution holding a permit
under these regulations by an institution that was not an affiliate
of such permit holder prior to such transfer.
The direct or indirect beneficial ownership of at least 50%
of the voting stock of, or at least an interest of 50% in the income
of, an institution, or the power to elect at least 50% of the directors
or trustees of such institution, or such other relationship which
in fact constitutes actual control.
Unless otherwise specified, are defined as:
NIH GuidelinesNational Institutes of Health (NIH) "Guidelines for Research Involving Recombinant DNA Molecules," as published in the Federal Register of September 22, 2009.
BMBLBiosafety in Microbiological and Biomedical Laboratories 5th Ed. 2007.
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.
An application for a permit by an institution that intends
to use recombinant DNA molecular technology and/or Biosafety Level
3 materials in the Town of Walpole.
Any person, sole proprietor, corporation, limited-liability
company, partnership, trust, association, public or private organization,
federal, state or local government agency, or any other individual
or entity acting on its own or in any representative capacity.
Constructing or handling for experimental purposes or otherwise
(i) recombinant DNA molecules (rDNA), defined as molecules which are
constructed outside living cells by joining natural or synthetic DNA
segments to DNA molecules that can replicate in a living cell or DNA
molecules which can result from the replication of a molecule, and
(ii) organisms and viruses containing such recombinant DNA molecules,
except for any such activity that is the subject of an exemption under
the NIH Guidelines.
An application for a new permit by an institution that certifies
its intention to acquire the operations of a current permit holder,
to continue such operations in accordance with all terms of the existing
permit, to establish an Institutional Biosafety Committee (IBC) with
the same membership as the IBC of the current permit holder, and not
to change such membership without the approval of the Board of Health
or change in any material aspect any of the facilities or procedures
of the current permit holder without the approval of such IBC.
B.
Any other terms, not specifically defined herein, shall have the
meanings as defined in the Guidelines. If the Guidelines do not define
the term, it shall have the meaning as is commonly used.
A.
The Board of Health and/or its agent shall be responsible for overseeing
all activities to which these regulations apply.
B.
The Board of Health shall:
(1)
Review and act on all initial and transfer applications for permits
under these regulations.
(2)
Determine the manner in which permit holders make reports or applications
to the Board of Health, and the type of information required.
(3)
Review reports, applications and recommendations from all IBC meetings
and approve where appropriate.
(4)
Be responsible for revocation of a permit when an institution is
not in compliance with these regulations.
A.
All institutions proposing any use of rDNA technology and/or BSL-3
materials shall obtain a permit from the Board of Health before commencing
any such use. Any institution already using rDNA technology and/or
BSL-3 materials as of the effective date of these regulations shall
apply for and obtain a permit or cease such use within six months
from such effective date.
B.
Permit requirements shall, at minimum, include written agreement
and evidence to demonstrate the capacity to:
(1)
Follow the Guidelines as defined in these regulations.
(2)
Adhere to any other conditions as set forth in these regulations
or permit conditions.
(3)
Allow inspections, during normal operating hours or at a scheduled
appointment, of both the institution's facilities and records
as related to these regulations.
(4)
Adhere to a set of safety documents prepared by the institution, according to the Guidelines listed in § 760-3, the definition of "Guidelines," of these regulations, which contains all procedures relevant to the use of BSL-3 materials and/or rDNA technology at all levels of containment in use at the institution. The safety documents shall also include a plan for waste disposal in compliance with all applicable federal, state, and local regulations.
(5)
Establish and implement a training program of safeguards and procedures
for personnel using rDNA technology and/or BSL-3 materials which shall
include standard operating procedures (SOPS) for each manufacturing
process and protocols for each experimental process.
(7)
Provide relevant training (either in-house or through workshops)
to all community and Board of Health IBC members in order for them
to fulfill their roles on the IBC.
C.
Initial application. The Board of Health shall hold a public hearing
to review the institution's initial application for a permit
including supporting documentation. The Board of Health shall take
final action on the Initial Application for permit within 60 days.
D.
Transfer application. The Board of Health shall hold a public hearing
to review the institution's transfer application for a permit
including supporting documentation. The Board of Health shall take
final action on the transfer application within 30 days.
E.
"Final action" shall mean a vote to grant or deny an initial application or a transfer application. In the event that the Board of Health fails to take final action within the prescribed period (as noted in Subsection C and D), no constructive grant shall result, only a right to compel, by an action in the nature of mandamus, the Board of Health to act. Any extension of time shall be mutually agreed upon by the Board of Health and the applicant.
F.
Annual review of permit. The Board of Health shall review the institution's
permit annually (at least 30 days prior to the annual maintenance
fee). At a minimum, the Board of Health will review its permit conditions
and any possible violations. The Health Director or his/her designee
shall inspect the laboratories which have been permitted to conduct
work with rDNA technology and/or BSL-3 materials to ensure compliance
with these regulations.
G.
A permit shall remain in force and effect unless and until it is revoked by the Board of Health pursuant to § 760-13 of these regulations. An application fee shall be paid by the applicant with each application for the issuance or reinstatement of a permit, and an annual maintenance fee shall be paid by each permit holder, on or before March 15 of each calendar year after the calendar year in which the permit was issued. The fees for permits issued by the Board of Health under these regulations shall be:
H.
A permit shall be obtained and maintained by the institution conducting
the activities for which such permit is required, regardless of the
ownership of the facility in which the activities are conducted.
I.
The permit shall not be assignable except in the case of an assignment
to an affiliate of the current permit holder where the proposed assignee
certifies to the Board of Health that:
(1)
The proposed assignee is an affiliate of the current permit holder
as defined in these regulations.
(2)
The proposed assignee will acquire the operations of the current
permit holder and continue such operations in accordance with all
terms of the existing permit.
(3)
The proposed assignee has established an IBC with the same membership
as the IBC of the current permit holder and will not change such membership
except in accordance with these regulations.
(4)
Except as approved by the proposed assignee's IBC, the proposed
assignee will not change in any material aspect any of the facilities
or procedures of the current permit holder required by the current
permit holder's IBC.
J.
In connection with any change of control of a permit holder, the
permit may be revoked upon a finding by the Board of Health, after
notice to the permit holder and an opportunity for the permit holder
to be heard, that the change in control is likely to affect the safety
of operations under the permit.
A.
The institution shall establish an IBC in accordance with the Guidelines
with a minimum of five members. The IBC shall have as members, in
addition to the institution's representatives, two members designated
by the Board of Health to represent the community, of which one shall
be the Health Director or designee and the other a member of the Board
of Health or a community representative approved by the Board of Health.
B.
The IBC shall meet at least three times a year with the membership
noted above. The IBC can meet more often to review new SOPS for new
or current manufacturing procedures or new protocols for experimental
processes. The minutes of each IBC meeting shall be kept on file for
so long as any activities approved therein are continuing and an additional
period of three years after all activities approved at such meeting
have terminated.
C.
Noninstitutional members of the IBC shall have no controlling or
substantial financial interest in the institution or any other institution
in competition therewith. All financial interests shall be disclosed
prior to appointment. Such representatives shall be subject to confidentiality
agreements and bound to the same provisions as to nondisclosure and
nonuse of proprietary information and trade secrets as all other members
of the IBC, except to the extent necessary to alleviate any public
health hazard. As used in these regulations, "proprietary information"
and "trade secrets" shall be defined as set forth under the laws of
the Commonwealth of Massachusetts or federal statutes.
D.
The IBC reviews all projects of the institution involving use of
rDNA technology and/or BSL-3 materials for compliance with the Guidelines.
Project protocols must be approved by the IBC and a statement certifying
that each project protocol conforms to the Guidelines shall be kept
on file during the continuation of the project and for an additional
period of three years after project completion. At a minimum, the
IBC shall discuss proposed changes since its last meeting (e.g., standard
operating procedures, quality control, effluent testing, water usage,
new materials). In the event of dissenting votes with respect to approval
of a protocol, each dissenting voter shall provide a statement of
reasons why the proposed protocol does not comply with the Guidelines,
and all such statements shall be submitted to the Board of Health
within five business days after the IBC meeting at which the vote
occurred. Any protocol with respect to which a dissenting vote is
given shall not be implemented until after the next meeting of the
Board of Health following the submission of the dissenter's statements.
If the Board of Health finds by a majority vote that the proposed
protocol does not comply with the Guidelines, such protocol shall
not be implemented, provided that the decision of the Board of Health
shall be subject to appeal to a court of competent jurisdiction.
E.
Information sent by the IBC to the Board of Health shall not contain
proprietary information and/or trade secrets. Full documentation of
IBC reviews and determinations shall remain on file in the records
of the institution for inspection by authorized individuals.
All institutions using rDNA technology and/or BSL-3 Materials
within the Town of Walpole shall provide appropriate medical surveillance
programs as determined by their IBC and shall be consistent with the
Guidelines.
Uses of BSL-4 materials shall be prohibited in the Town of Walpole.
A.
Applicability. The Board of Health may determine that the review
of the permit or the activities of the institution or the IBC warrants
the use of outside consultants. Such consultants shall assist the
Board of Health or the IBC in overseeing all activities to which these
regulations apply (e.g., review reports, applications and recommendations
from the IBC where appropriate).
B.
Selection. The Board of Health shall provide a list of three proposed
consultants together with a scope of work and cost estimate to the
institution. The institution shall have at least seven days to accept
one of the proposed consultants or object on grounds that the proposed
consultants have a conflict of interest or do not possess the minimum
qualifications of an appropriate educational degree and three or more
years of practice in or closely related to the field at issue. In
such an event, the institution and the Board of Health shall endeavor
to mutually agree upon a consultant within seven days and should an
impasse remain, to arbitrate the same through established state conflict
resolution processes.
C.
Special account. The institution shall deposit with the Town of Walpole
Treasurer-Collector the amount of money agreed upon as necessary for
the consultant to complete its assignment. Such funds shall be deposited
into a special account to be established by the Town of Walpole Treasurer-Collector.
Expenditures from this special account may be made at the direction
of the Board of Health without further appropriation, but only in
connection with the review of a specific project for which a consultant
review fee has been collected. An additional fee shall be deposited
as mutually agreed upon if the amount deposited is insufficient to
complete the assignment. Any unexpended balance, including all accrued
interest from the date of deposit, shall be repaid to the applicant
or its successor-in-interest at the completion of the consultant's
services.
It shall be a violation when the institution does not follow
these Guidelines or the conditions of operation under the permit.
Institutions shall report to the Board of Health, no later than
30 days but as soon as the institution is aware of the violation,
any violations of the Guidelines or conditions of operation under
their permit. Any release that results in a potential hazard to employees
or public health shall be reported immediately to the Board of Health
(by calling the Health Department during normal Town Hall hours or
by calling the Police Department outside of normal Town Hall hours
and then the Police Department will contact an agent of the Board
of Health). The Health Director or designee will then determine who
shall be notified of the release to start any procedures necessary
as outlined in the Town's Comprehensive Emergency Management
Plan.
Any institution that violates any provision of these regulations
shall be punished by a fine of $300 for each separate violation under
the noncriminal disposition procedure and/or court action. Each day
that a violation continues shall be considered a separate offense
and shall be subject to a separate fine.
Enforcement of these regulations shall be the responsibility
of the Board of Health and/or its agent. The Board of Health may also
deem any violation of these regulations, as they may be amended by
the Board of Health, to be a nuisance pursuant to Massachusetts General
Laws Ch. 111 and may take such action as it deems proper. In addition
to any other penalties set forth herein, the Board of Health, after
notice to the permit holder and an opportunity for the permit holder
to be heard, may revoke, in whole or in part, any permit granted hereunder
if it finds the permit holder has violated any provisions of these
regulations.
Each part of these regulations is construed as separate to the
end, and that if any section item, sentence, clause, or phrase is
held invalid for any reason, the remainder of these regulations shall
continue in full force and effect.
These regulations become effective September 23, 2010.
[Adopted 9-14-2010]
A.
Pursuant to the Town of Walpole Regulations for the Use of Recombinant
DNA Molecular Technology and Biosafety Level 3 Materials the following
policies and procedures applicable to the administration of permits
are herein promulgated.
B.
All communications and submissions shall be sent to the Walpole Health
Department at 135 School Street, Walpole, MA 02081.
C.
Applicants are responsible for obtaining copies of the NIH Guidelines
and the BMBL.
All terms used herein shall have the same meanings as set forth
in the Town of Walpole Regulations for the Use of Recombinant DNA
Molecular Technology and Biosafety Level 3 Materials.[1]
Any institution seeking to use recombinant DNA molecular technology
and/or Biosafety Level 3 materials shall first obtain a permit pursuant
to the regulations from the Walpole Board of Health. Any institution
applying for a permit shall appear before a regularly scheduled meeting
of the Walpole Board of Health to present that institution's
application. Thereafter, the agent of the Board of Health may conduct
a site visit of the institution's facility in conjunction with
the Board of Health's review of the institution's application.
Any institution applying for a permit shall submit the following:
A.
Application form and fee.
B.
Executive summary of proposed work with a statement explaining the
basis for the selection of the proposed biosafety level or use of
recombinant DNA molecular technology.
C.
Labeled floor plan of the facility, including BSL areas and access
routes and an estimate of the laboratory and waste storage floor area
(square feet).
D.
Health and safety manual with procedures relevant to the operations
at the facility and a protocol for accidental employee or community
exposure and/or illness.
E.
Employee biosafety training program summary.
F.
Documentation of pest control program to be employed at the facility.
G.
Description of protocol for disposal or decontamination of infectious
waste.
H.
Documentation of medical surveillance.
I.
Documentation pertaining to IBC memberships (names and contact information).
J.
Documentation establishing the retention of a third-party laboratory
commissioning agent with the appropriate experience in the evaluation
of facilities employing BSL-3 containment.
An institution applying for a permit may redact (black out) specific information required by § 760-19 above which the institution believes should be confidential and unavailable for inspection by members of the public. If the Board of Health is unable to evaluate the application for a permit without the redacted information, the Board of Health shall go into executive session to discuss the redacted information.
Institutions applying for a permit shall be responsible for
obtaining all required federal, state and local permits and regulatory
approvals for the use of the institution's facility.
Upon submission of an application, the Health Department will
schedule applicants to present an overview of its request by the institution
at a regularly scheduled Board of Health meeting. The presentation
shall include a general introduction of the institution, its mission,
its research or production plans, a timeline of the use of rDNA or
a biological agent and a discussion of the facilities.
Prior to approval of the permit, any institution applying for
a permit shall submit to and arrange a visit to the facility by the
Board of Health and/or an agent. Areas of particular interest for
the site visit include:
A.
General housekeeping and biological hygiene.
B.
Physical separation and access control for BSL-3 laboratories.
C.
Proper signage indicating biosafety level and emergency contact information.
D.
Proper equipment, such as appropriate biosafety cabinets, for meeting
the biosafety level containment standards, with performance ratings
clearly indicated.
E.
Proper general ventilation and hygiene facilities (e.g., sinks) for
the biosafety level
F.
Proper personal protective equipment in use by personnel (e.g., lab
coats, gloves, eye protection).
G.
Possession of all required federal, state, and local permits and
approvals.
H.
Establishment of an appropriate medical surveillance program for
all employees coming into contact with regulated materials.
I.
All maintenance and laboratory safety records.
