[Added 9-7-2016]
The Lancaster Board of Health acting under the authority of
MGL c. 31, § 111, and amendments and additions thereto,
and by any other power thereto enabling, has duly made and adopted
the following rules and regulations in the interest of and for the
preservation of the public health.
All activities associated with constructing recombinant DNA (RDNA) molecules and organisms and viruses containing RDNA molecules within the Town of Lancaster shall be performed in strict accordance with these regulations and with the National Institute for Health (NIH) Guidelines as defined in § 303-80.10 below. These regulations shall govern where they differ from the Guidelines. These regulations do not apply to finished products which contain RDNA molecules and which have been approved by other government regulatory agencies for medical or other purposes.
For the purpose of these regulations, the following definitions
are adopted:
NIH Guidelines for Research involving Recombinant or Synthetic
Nucleic Acid Molecules published in the Federal Register of April
2002, and any subsequent federal amendment thereto approved by the
Board of Health.
In the event that the National Institutes of Health shall discontinue
or abolish their guidelines, those guidelines in effect and approved
by the Board of Health at the time of such discontinuance shall remain
in effect.
The use of more than 10 liters but less than 5,000 liters
of RDNA culture.
Any deviation that might have an adverse effect on personal
or public health.
A.
A Lancaster Biosafety Committee (LBC) shall be established for the
purpose of overseeing all use of RDNA in Lancaster and advising the
Board of Health.
B.
Specific responsibilities of the LBC shall include:
(1)
Establishing policies, procedures and criteria to aid in the
implementation of these regulations.
(2)
Reviewing all amendments to the Guidelines before submitting
their recommendations to the Board of Health for approval.
(3)
Reviewing all applications for permits for the use of RDNA in
Lancaster for compliance with the Guidelines and conformity with such
other regulations as the Board of Health may from time to time promulgate.
(4)
Reviewing institutions' manuals, worker training programs, health
safety programs and monitoring procedures.
(5)
Determining the manner in which institutions and Institutional
Biosafety Committees make reports, applications or recommendations
to the LBC and the type of information required. Reviewing such reports,
applications and recommendations and approving where appropriate.
(6)
Carrying out site visits to institutional facilities.
(7)
Approving the community members of the IBCs.
(8)
Developing a procedure for members of institutions to report
to the LBC violations of these regulations, the Guidelines, or any
other health regulations the Board of Health may promulgate.
C.
The LBC shall be composed of the Chairman of the Board of Health
or his/her designee, a health agent from the Nashoba Associated Boards
of Health (NABH), and a minimum of three other members to be appointed
by the Select Board and approved by the Board of Health. Members appointed
by the Select Board shall serve three-year terms; provided, however,
that of the first three members appointed to the Committee one shall
serve for a term of one year, one shall serve for a term of two years,
and one shall serve for a term of three years.
A.
The Institutional Biosafety Committee (IBC), established by the Guidelines,
shall have as members, in addition to the corporate representatives,
one community representative, the Chairman of the Board of Health
or his/her designee, and the NABH Health Agent or his/her designee.
The community representative shall be appointed by the Select Board
and approved by the LBC.
[Amended 6-21-2021 ATM by Art. 7]
B.
The IBC shall meet on a regular basis. All minutes of the IBC meetings
must be forwarded to the Board of Health and the LBC.
C.
The community member of the IBC and the Health Agent, or his/her
designee, shall have no financial interest in the institution or any
other institution in competition therewith, and such representatives
shall be 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 this regulation, proprietary information
and trade secrets shall be defined as set forth under the law of the
Commonwealth of Massachusetts.
D.
In accordance with the Guidelines, the IBC, acting on behalf of the
institution, reviews all RDNA use for compliance with the Guidelines
and approves those projects that conform to the Guidelines. A description
of each protocol approved by the IBC, including all organisms and
the containment to be used, and a statement certifying that the experiment
conforms to the Guidelines shall be filed with the LBC and the Board
of Health.
E.
The LBC shall retain a professional and competent person or agency
to perform an annual inspection and review of procedures and practices
of large-scale RDNA use and compliance with this article. The scope
of this inspection shall be mutually agreed upon by the institution
and the LBC. The institution shall reimburse the Town of Lancaster
for the expense of this inspection and review.
F.
All information sent to the Lancaster Board of Health and the LBC
shall have any propriety information and trade secrets removed therefrom.
The full test shall remain on file in the records of the institution
for inspection at all reasonable times by any member of the IBC.
A.
All institutions planning to use RDNA must obtain a permit from the
Board of Health with the prior approval of the LBC before commencing
said technology. All permits are issued for one year and may be revoked
for cause.
B.
Institutions seeking such a permit from the Board of Health must
first submit the following to the LBC:
(1)
A plot plan showing the proposed location of the facility and
a floor plan showing the internal layout of the facility.
(2)
A listing of all organisms, containment levels, and decontamination
procedures to be employed.
(3)
A plan for a screening process to ensure the purity of the strain
of host organisms used in the experiments and to test organisms resulting
from such experiments for their resistance to commonly used therapeutic
antibiotics. Host organisms obtained from independent laboratories
shall undergo the same screening process.
(4)
A plan for systematic monitoring of waste to assure that surviving
RDNA organisms will not be released into the environment.
(5)
A plan for systematic pest control management in laboratories,
contiguous facilities and food service establishments in the same
building.
(6)
A plan for systematic security of the premises.
(7)
The institution's health monitoring, health surveillance and
safety manuals, together with the plan for an appropriate medical
surveillance program as determined by the IBC for all persons engaged
in the use of RDNA. Such programs shall include, but shall not necessarily
be limited to:
(a)
A preemployment medical examination for employees.
(b)
Prompt reporting to the IBC of employee illnesses that are potentially
related to RDNA use.
(c)
Retention of medical and health records for at least 10 years.
Medical or employee health records shall be made available for inspection
and may be used for public health studies.
(d)
A training program of safeguards and safety procedures for personnel.
(8)
The name(s) of the principal investigator(s) who shall be responsible
for enforcing the policies of the IBC.
(9)
A plan for orienting representatives of the Lancaster Health,
Fire and Police Departments to the physical plant and to procedures
to be utilized in the event of an emergency.
(10)
Written agreement to allow inspection of facilities and pertinent
records by the LBC.
C.
The LBC shall review the institution's application for a permit and
supporting documents and make its recommendation of the same to the
Board of Health. Copies of the application, supporting documents and
the LBC's recommendation shall be filed with the Board of Health and
the Planning Board within 45 days after the application is filed with
the LBC. The Board of Health shall take final action on the permit
application within 75 days after the application is filed with the
LBC. The period within which final action shall be taken may be extended
for a definite period by mutual consent of the Board of Health and
the applicant.
D.
The fee for a permit granted by the Board of Health, or annual renewal
thereof, shall be $500.
A.
All institutions involved in the use of RDNA shall allow inspection
of their facilities, procedures and practices in order to confirm
compliance with this article.
B.
The Board of Health shall retain a professionally competent person,
agency or institution to perform inspections and reviews. The results
shall be reported to the Board of Health, the LBC and the institution
involved. The institution shall reimburse the Town of Lancaster for
the expense of this inspection and review.
C.
The Board of Health, its employees, all members of the LBC and any
individual or institution employed to perform inspections shall maintain
the confidentiality of all proprietary information released to them
by reason of this article.
A.
RDNA use classified by the Guidelines as requiring any BL3 or BL4
physical containment measures as prescribed in Appendix G of the Guidelines
under Standard Microbiological Practices, Special Practices, Containment
Practices, Containment Equipment or Laboratory Facilities shall not
be permitted.
B.
Experiments for which containment levels are not prescribed in the
Guidelines shall be approved by the LBC before the experiment is initiated.
C.
Large-scale RDNA use shall not be permitted without prior review
and approval by the LBC and approval of the Board of Health. Use of
more than 5,000 liters of RDNA culture shall not be permitted.
D.
There shall be no deliberate release into the environment, that is
to sewers, drains or the air, of any organism containing RDNA.
E.
The institution shall report within 24 hours to the Director of Health,
followed by a written report within 15 days to the LBC, any significant
deviations from the Guidelines and any significant accidents or illnesses
or releases related to the use of RDNA. An additional inspection of
facilities and procedures may be deemed necessary by the LBC based
upon its judgment of the nature and extent of the problem.
A.
Violation of the conditions of this article shall subject the violator
to a fine of $500 per day and, in addition, the facility in which
the violation occurs may be closed by the Board of Health. Each day
of violation shall constitute a separate and distinct offense.
B.
Once a permit has been issued it may be revoked by the Board of Health
upon determination, after due notice and hearing, that the institution
involved has materially failed to comply with these regulations, the
permit agreements or the Guidelines; or if in the opinion of the Board
of Health the RDNA use causes a nuisance or adversely affects the
public health, safety and welfare in Lancaster.
The salaries and expenses paid by the Town of Lancaster for
inspections, reviews, staff and consultants for work directly related
to carrying out the requirements of these regulations shall be assessed
to the institutions holding permits under these regulations. An accounting
of these costs will be furnished annually to each institution.
The Board of Health may vary the application of any provision
of these regulations with respect to any particular case when, it
its opinion, the enforcements thereof would do manifest injustice,
provided that the decision of the Board of Health is not in conflict
with the spirit of these standards. Any variance granted by the Board
of Health must be in writing with a copy available to the public at
all reasonable hours in the office of the Town Clerk and in the office
of the Board of Health.
