[1]
Editor's Note: Ordinance No. 24883, adopted Jan. 12, 1981, amended the Code by adding provisions designated as Ch. 22, which provisions have been redesignated by the editor as §§ 7.5-21—7.5-24 for purposes of classification and in order to maintain the alphabetical sequence of chapters.
Cross reference—Health department, § 2-106 et seq.
[Ord. No. 24883, 1-12-1981; Ord. No. 28126, 5-13-1996]
(a)
NIH Guidelines. The experimentation with or use of recombinant DNA
technology in the city shall be undertaken only in strict conformity
with all applicable provisions of the General Ordinances of the City
of Waltham, and the guidelines, so-called, of the National Institute
of Health (NIH), as set forth in the Federal Register of May 7, 1986,
or any amendment thereof, or as may be established from time to time
by the NIH, by any other federal agency or by any Act of Congress;
and in conformity also with such other health regulations as the Board
of Health of the City of Waltham may from time to time promulgate;
provided, however, that no change in the city health regulations shall
apply to work in progress or previously contracted for by an institution
unless the Board of Health shall first hold a public hearing on such
change giving written notice to institutions in Waltham carrying on
recombinant DNA work, and by advertisement in a newspaper of general
circulation within the city at least once 10 days in advance.
(b)
Manual. Individuals, associations, organizations, corporations, educational
institutions or medical facilities (all hereinafter referred to as
"institutions") proposing to experiment with or use recombinant DNA
technology, as defined and regulated by the NIH guidelines, shall
prepare a manual, which contains all procedures included in the NIH
guidelines, to regulate said uses at all levels of containment in
use at the institution. Training in appropriate safeguards and procedures
for minimizing potential accidents shall be mandatory for all laboratory
personnel. Said manual, and all amendments thereto, shall be submitted
in a timely manner to the Waltham Biosafety Committee for its review.
(c)
Waltham Biosafety Committee established. There is hereby established
a Waltham Biosafety Committee (WBC). Committee members shall be classified
as special municipal employees.
(d)
Composition of WBC. The Waltham Biosafety Committee (WBC) shall be
composed of the Director of Public Health or his/her designee, the
Chairperson of the Board of Health or a board member designated by
the Chairperson, and three other members to be appointed by the Mayor,
subject to confirmation by the City Council, for terms of one year
from the first day of January and until their successors are appointed
and confirmed. The members of the WBC shall organize annually by electing
one member as Chairperson.
(e)
Powers and duties of WBC. The powers and duties of the WBC shall
be as follows:
(1)
Recommending and reviewing proposals for regulations to be promulgated
pursuant to this article, and advising the Board of Health regarding
the adoption of said regulations.
(2)
Determining the manner in which permit holders make reports
to the WBC and the type of information required in such reports; reviewing
reports and recommendations by the Institutional Biosafety Committee
(IBC) and approving them where appropriate; conducting site visits
to permitted facilities.
(3)
Reviewing manuals and worker training programs, approving health-safety
programs and monitoring compliance with the requirements of this article
and all regulations promulgated thereunder.
(4)
Developing procedures for persons to report to the WBC violations
of this article or any regulations promulgated thereunder and making
recommendations to the Board of Health regarding the enforcement of
the same.
(5)
Reviewing all applications for permits under this article and
making recommendations to the Board of Health regarding the granting,
renewal, suspension or revocation of such permits.
(f)
Permit requirements. All persons proposing to use RDNA must obtain
a permit from the Board of Health, which may issue such permit after
a review of the application by the WBC. Permit requirements shall,
at a minimum, include written agreement to:
(1)
Follow the guidelines as defined in this article, and any regulations
duly adopted by the Board of Health pursuant to the provisions of
this article.
(2)
Adhere to any restrictions that may be required by the Board
of Health as a condition of granting such permit.
(3)
Allow reasonable inspections of facilities and pertinent records
by the WBC or the Director.
(4)
Prepare a health and safety manual and establish a training
program as required by Subsection (b) of this section.
(g)
Permit fees and renewals. Permits shall take effect on the date on
which they are issued, and shall be renewed annually. The fee for
issuance or renewal of any such permit shall be $300.
(h)
Institutional Biosafety Committee required. For each organization
receiving a permit under this chapter there shall be established an
Institutional Biosafety Committee (IBC). Committee members shall be
classified as special municipal employees.
(i)
Composition of Institutional Biosafety Committee. The Institutional
Biosafety Committee mandated by the NIH guidelines should be broad
based in its composition. It should include members from a variety
of disciplines, representation from the biotechnician's staff
and it shall include at least two community representatives who shall
be appointed by the Mayor, one of whom shall be the Director of Public
Health and both of whom shall have no financial interest in the institution
or any other institution in competition therewith, and such two 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 Institutional Biosafety Committee, except to the extent necessary
to alleviate any public health hazard. As used in this article "proprietary
information and trade secrets" shall be defined as set forth under
the law of the Commonwealth of Massachusetts.
(j)
Minutes of meetings of IBC. The minutes of all meetings of the Institutional
Biosafety Committee shall be delivered to the Director and the WBC
within 10 days of the meeting, after first removing any proprietary
information and trade secrets therefrom. The full text shall remain
on file in the records of the institution for inspection at all reasonable
times by any member of the IBC or the WBC.
(k)
Screening of hosts; testing of resultant organisms. Institutions
undertaking research with or use of recombinant DNA technology as
defined by and regulated by the NIH guidelines shall perform adequate
screening to ensure the purity of the strain of host organisms used
in the experiments and shall test organisms resulting from such experiments
for their resistance to commonly used therapeutic antibiotics.
(l)
Medical surveillance program.
(1)
All institutions are to provide an appropriate medical surveillance
program as determined by the IBC for all persons engaged in experimentation
with or use of recombinant DNA technology, as defined by and regulated
by the NIH guidelines. Such programs must be approved by the WBC.
(2)
As part of the institution's health monitoring responsibilities
it shall, in good faith, make every attempt, subject to the limitation
of the available technology, to apply monitoring of the organism involved
appropriate to the degree of hazard as determined by the IBC, in the
laboratory worker and inside and outside the containment laboratory.
This shall include whatever means are available to monitor the intestinal
flora of the laboratory worker.
(3)
The permit holder shall report, within 30 days, to the Director
and the WBC any significant problems with or violations of the guidelines
and any significant RDNA-related accidents or illnesses.
(m)
Protection against rodents and insects. Effective rodent and insect
control programs must be in place on the premises where RDNA use,
under this article, takes place.
(n)
Regulations. The Board of Health may adopt, subject to review by
the WBC and approval by the City Council, such rules and regulations
as may be necessary to effectively implement the provisions of this
article.
[Ord. No. 24883, 1-12-1981]
(a)
Experimentation with, or use of, recombinant DNA technology, classified
by NIH guidelines as requiring P4 level of containment, shall not
be permitted in the city.
(b)
The use of humans as experimental subjects in recombinant DNA research,
as defined and regulated by the NIH guidelines, shall not be permitted
in the city.
[Ord. No. 24883, 1-12-1981]
A violation of any of the provisions of this article shall subject
the violator to a fine of $200 per day and, in addition, the specific
laboratory in which the violation occurs may be closed by the director.
Each day of violation shall constitute a separate and distinct offense;
provided, however, that no monetary fine shall be imposed for any
violation which occurred at any time before the day of written notice
of the violation by the city to the institution.
[Ord. No. 24883, 1-12-1981]
If any section, subsection, sentence, clause, phrase or portion
of this article is for any reason held invalid or unconstitutional
by any court of competent jurisdiction, such portion shall be deemed
a separate, distinct and independent provision, and such holding shall
not affect the validity of the remaining portions thereof.
