[Added 8-14-1990 (Ch. 10, Art. V of the 1988 Code)]
All activities associated with constructing
recombinant DNA (rDNA) molecules and using organisms and viruses containing
rDNA molecules within the City of Lowell shall be performed in strict
conformity with this article and with the National Institutes of Health
Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)
published in the Federal Register of May 7, 1986, and any subsequent
federal amendment thereto approved by the City of Lowell Board of
Health and the City Council. This article does not apply to finished
products which contain rDNA molecules and which have been approved
for use by other government regulatory agencies.
In the event that the National Institutes of
Health shall discontinue or abolish their guidelines, those guidelines
and amendments in effect and approved by the Lowell Board of Health
and the City Council at the time of such discontinuance shall remain
in effect. Copies of the guidelines and amendments shall be filed
with the City Clerk.
For the purpose of this article the following
definitions are adopted:
Any person, group of persons, business entity, association
or any other organization, whether public or private, for profit or
nonprofit.
The use of more than 10 liters of DNA culture.
The National Institutes of Health Guidelines for Research
Involving Recombinant DNA Molecules published in the Federal Register
of May 7, 1986, and any subsequent federal amendment thereto approved
by the Lowell Board of Health and the City Council.
Deoxyribonucleic acid molecules which are constructed outside
of living cells by joining natural or synthetic DNA segments to DNA
molecules that can replicate in a living cell or DNA molecules which
result from the replication of rDNA molecules.
A Lowell Biosafety Committee (LBC) shall be
established for the purpose of overseeing all rDNA research and technology
in the City of Lowell and advising the Board of Health on matters
related to biotechnology.
A.
Composition. The LBC shall be composed of the Chairperson
of the Board of Health or a Board member designated by the Chairperson,
the Director of the City Health and Human Services Department or his/her
designee, and three other members to be appointed by the City Manager
with the approval of the City Council.
B.
Responsibilities. Specific responsibilities of the
LBC shall include:
(1)
Reviewing all amendments to the NIH guidelines and
submitting recommendations for adoption to the Board of Health and
the City Council.
(2)
Establishing procedures to aid the Board of Health
in implementing this article and the NIH guidelines and adopted amendments.
A copy of such procedures shall be filed in the office of the City
Clerk.
(3)
Reviewing all applications for permits for rDNA research
and use of rDNA technology in the City of Lowell for compliance with
NIH guidelines.
(4)
Reviewing manuals, worker training programs, health/safety
programs and monitoring programs required by institutions involved
in rDNA research and technology for compliance with NIH guidelines.
(5)
Determining requirements and procedures for institutions
and Institutional Biosafety Committee application and report submission
and reviewing submitted institutional documents and reports for compliance.
(6)
Determining institutional procedures for reporting
violations of this article and NIH guidelines to the LBC and the Board
of Health.
A.
Membership.
(1)
The Institutional Biosafety Committee (IBC), established
by the NIH guidelines, shall have five members, of whom two shall
be affiliated with the institution; at least one affiliated representative
shall be a member of the institution's biotechnician staff. Institutional
affiliated members shall be appointed by the institution. Two members
of the IBC shall not be affiliated with the institution. Nonaffiliated
IBC members shall be appointed by the LBC and shall be persons active
in environmental, occupational health or medical occupations in the
City.
(2)
The LBC designated members of the IBC shall have no
financial interest in the institution or any other competitive institution.
LBC designated representatives shall be bound by the same nondisclosure
and nonuse of proprietary information and trade secrets provisions
as all other members of the IBC, except to the extent necessary to
alleviate any public health hazard. As used in this article, "proprietary
information" and "trade secrets" shall be as set forth under the laws
of the Commonwealth of Massachusetts.
B.
Responsibilities.
(1)
The IBC shall meet on a regular basis and forward
all minutes to the LBC and shall file a copy with the City Clerk.
(2)
The IBC shall review all rDNA use for compliance with
the NIH guidelines and approve only 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 or process conforms to NIH guidelines
shall be filed with the LBC and a copy shall be filed with the City
Clerk.
(3)
Information sent to the LBC and the City Clerk shall
not include any proprietary information and/or trade secrets. However,
the full text shall remain on file in the records of the institution
for inspection at all reasonable times by any members of the IBC.
All institutions planning to use rDNA for research or production, including small-scale and large-scale use, 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. The fee for a permit or annual renewal thereof shall be as provided in Chapter 150, Fees.
A.
Institutions seeking such a permit from the Board
of Health must first submit the following to the IBC:
(1)
The location of the institution planning to use rDNA,
which must be in either an industrial zone, which use would constitute
a permitted use in such a zone, or in a B-3 Zone, provided that a
special permit was granted by the Board of Appeals. In any of the
above zones, however, such use is subject to any conditions imposed
by the Board of Health in its issuing permit.
(2)
A plot plan showing the proposed location of the facility
and floor plan showing the internal layout of the facility.
(3)
A list of the major taxonomic groups from which cell
lines are obtained or strains are isolated, a list of all organisms
which are known human pathogens, and containment levels and decontamination
procedures to be employed. Experiments which make use of human fetal
tissue shall be prohibited.
(4)
A certification from the IBC, for any experiment with
known human pathogens, that an applicable protocol exists covering
resistance to antibiotics, symptoms of infection and emergency incident
procedures.
(5)
A plan for validation of waste and ventilation systems
to assure that surviving rDNA organisms will not be released into
the environment.
(6)
A plan for systematic pest control management in laboratories,
production areas, contiguous facilities and food service establishments
in the same building.
(7)
A plan for systematic security of the premises.
(8)
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 pre-employment medical examination for employees.
(b)
Prompt reporting to the IBC and the Board of
Health of employees' 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
only with the consent of the employee.
(d)
A training program of safeguards and safety
procedures for personnel.
(9)
The name(s) of the principal investigator(s) who shall
be responsible for enforcing the policies of the IBC.
(10)
A plan for orienting representatives and the
Regional Hazardous Waste Task Force of the Lowell Health, Fire and
Police Departments as to the physical plant and to procedures to be
utilized in the event of an emergency.
(11)
Written agreement to allow inspection of facilities
and pertinent records by the Board of Health, the Board's designated
inspector and LBC members.
B.
The LBC shall review the institution's application
for a permit and supporting documents and make a recommendation of
the same to the Lowell Board of Health within 30 days of the filing
of such application. The Lowell Board of Health shall take final action
on the permit application within 45 days after the application is
filed with such Board. 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.
A.
All institutions involved in the use of rDNA shall
allow inspection of their facilities, procedures and practices by
the Board of Health or its designee in order to confirm compliance
with this article.
B.
The Lowell 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.
C.
The Lowell Board of Health, its employees, 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.
Recombinant DNA use or experiments requiring BL4 containment
shall not be permitted in the City of Lowell.
B.
The institution shall submit to the LBC documentation
of the approved containment level for any experiment for which the
containment level is not prescribed in the NIH Guidelines prior to
the commencement of such experiment.
Large-scale rDNA use shall be permitted only with prior review and approval by the LBC and having obtained the permit set forth in § 171-26.
There shall be no release into the environment,
that is, to sewers, drains, or the air, of any organism containing
rDNA.
The institution shall report immediately to
the Director of the Board of Health and the Executive Director of
the Lowell Regional Wastewater Utility, and within 24 hours to the
LBC, followed by a written report within five days to the LBC and
the Director of the Board of Health, any deviations from the NIH guidelines
and any 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 judgment of the nature and extent
of the problem.
Violations of the conditions of this article
shall subject the violator to a fine of $300 per day, and in addition
the facility in which the violation occurs may be closed by the Board
of Health. Each day of the violation shall constitute a separate and
distinct offense.
Once a permit has been issued it may be revoked
only after due notice, a hearing, and determination by the Board of
Health that the institution involved has failed to comply with these
regulations, the permit agreements or the guidelines or if in the
opinion of the Board of Health use of rDNA causes a nuisance or adversely
affects the public health, safety and welfare in Lowell.
The City Manager may assess institutions holding
permits under this article reasonable costs of salaries, consulting
fees and expenses paid by the City for inspections, reviews and other
work directly related to carrying out the requirements of this article,
and such amounts shall be paid as part of the annual permit renewal
fee.
