[HISTORY: Adopted by the City Council of
the City of Fitchburg 6-6-1995 by Ord. No. 44-95. Amendments noted
where applicable.]
The purpose of this chapter is to establish
regulations governing the use of rDNA in research and production in
the City of Fitchburg. These regulations have been promulgated to
protect the safety and health of the City's residents and the employees
of facilities where rDNA is used in Fitchburg. Further, the regulations
are intended to promote the growth of the biotechnology industry in
the City of Fitchburg by establishing reasonable rules that are clear
and consistent with federal law.
For the purpose of these regulations the following
definitions are adopted:
Refers to deoxyribonucleic acid.
Any public or private entity (including federal, state and
local government agencies).
Refers to the "Guidelines for Research Involving Recombinant
DNA Molecules; Notice," promulgated by the National Institutes of
Health (NIH) of the United States Department of Health and Human Services
and published in the Federal Register, Volume 51, Number 88, on May
7, 1986, and as the same may from time to time be amended by the NIH.
In the event that the NIH rescinds its guidelines without promulgating
new guidelines, the most recent guidelines in effect shall remain
in effect in the City of Fitchburg.
Includes any individual, partnership, copartnership, firm,
company, corporation, association, joint-stock company, trust, estate,
governmental entity, whether federal, state or local, or any other
entity or legal representative agency or assigner of any of them.
Either:
These regulations shall apply to all institutions
and persons within the City of Fitchburg which experiment with or
use rDNA technology, except for those activities that are exempt from
the NIH Guidelines because their safety has been adequately documented.
In addition, the growing of crops produced by recombinant DNA technology
and approved by the U.S. Food and Drug Administration is exempt from
this chapter.
Recombitant DNA use classified by NIH guidelines
as requiring BL4 level of containment shall be prohibited in the City
of Fitchburg.
Each institution or person in the City of Fitchburg
which experiments with or uses rDNA technology shall comply with NIH
guidelines, including but not limited to the following administrative
practices:
A.
The establishment of an Institutional Biosafety Committee
(IBC) which shall contain at least five members, of whom at least
two (but not less than 20%) shall not be affiliated with the institution
and shall represent the interests of the community with respect to
health and the protection of the environment.
(1)
The IBC shall contain at least one representative
from the institution's laboratory technical staff.
(2)
The nonaffiliated representatives on the IBC shall
be appointed by the institution.
(3)
The nonaffiliated representatives on the IBC shall
be bound by the same rules prohibiting use and disclosure of proprietary
information and trade secrets as the other members of the IBC.
B.
The preparation of safety plans and manuals which
shall be subject to the approval of the IBC.
C.
The provision of proper training and appropriate safeguards
and procedures for minimizing potential environmental and personal
exposure.
D.
If the institution is engaged in rDNA research at
the BL3 containment level, the appointment of a Biological Safety
Officer who shall be a member of the IBC.
No institution may employ rDNA technology in
the City of Fitchburg without a permit issued by the Director of the
Board of Health. All permits are issued for one year and may be revoked
for good cause.
A.
Institutions seeking a permit from the Director of
the Board of Health shall submit the following:
(1)
A completed application form (forms can be obtained
from the Fitchburg Board of Health in City Hall).
(2)
An annual permit filing fee of $400.
(3)
Certification by the Institutional Biosafety Committee
(IBC) to the Director of the Board of Health or his or her designee
that the institution is in compliance with the provisions of this
chapter and the NIH guidelines. Thereafter, the IBC shall, each six
months, renew the certification that the institution is in compliance
with this chapter and the NIH guidelines.
[Amended 6-3-2014 by Ord.
No. 100-2014]
(4)
A plan for validation of waste systems to assure that
surviving rDNA organisms which may present a public health threat
will not be released into the environment.
(5)
A plan for systematic security of the premises.
(6)
A plan for systematic pest control in laboratories,
contiguous facilities and food service establishments in the same
building.
(7)
Copies of the institution's health monitoring, health
surveillance and safety manuals.
(8)
Three copies of the emergency plans covering accidental
spills and personal contamination (copies will be distributed to the
Fitchburg Police and Fire Departments).
(9)
A list of the names, titles, addresses and phone numbers
of each of the current members of the IBC.
B.
Institutions seeking the renewal of a permit from
the Director of the Board of Health shall submit the following:
(1)
An annual permit filing fee of $400.
(2)
Certification by the IBC to the Director of the Board
of Health that the institution is in compliance with the provisions
of this chapter and NIH guidelines.
(3)
All documents required when initially filing for a
permit unless no significant changes to the documents as previously
submitted are required.
C.
The Director of the Board of Health shall take final
action on a permit application within 90 days after the application
is filed. The time for final action may be extended by written mutual
consent between the Director of the Board of Health and the applicant.
D.
The Director of the Board of Health may retain a professional
consultant to review permit applications, to perform inspections and
to complete any other task necessary to implement these regulations.
The salaries and expenses paid by the City for staff and consulting
work directly related to carrying out the requirements of these regulations
shall be assessed to the permit holders under these regulations. Only
expenses exceeding the permit filing fee of $400 shall be assessed,
in which case an accounting of these expenses will be furnished by
the City.
E.
Any institution aggrieved by a final decision to deny
or to grant a permit may seek relief in any court of competent jurisdiction,
as provided by the laws of this commonwealth.
F.
The Director of the Board of Health shall inspect
at least annually each institution holding such a permit to ensure
compliance with the provisions of this chapter and the NIH guidelines.
G.
The Director of the Board of Health may require from
an institution such information and data as is necessary to ensure
compliance with this chapter.
H.
The Director of the Board of Health and any other
employee, consultant or official of the City shall maintain the confidentiality
of all proprietary information released to them in the performance
of their duties pursuant to this chapter.
I.
The IBC shall notify the Director of the Board of
Health within 30 days of any significant problems with, or violations
of, the guidelines and any significant research or production-related
accidents or illnesses.
J.
The Fitchburg Board of Health, the Fitchburg Fire
Department and the Fitchburg Police Department shall be notified of
any special procedures to be used in the event of an emergency.
K.
Any releases into the environment of recombinant organisms
posing a threat to public health shall be immediately reported to
the Director of the Board of Health.
The Director of the Board of Health may vary
the application of any of these regulations when, in the Director's
opinion, enforcement of the regulation would do manifest injustice,
provided that the decision of the Director is not in conflict with
the spirit of these regulations.
Any person or institution who violates any provisions
of this chapter shall be punishable by a fine of up to $500 for each
separate violation. Each day or portion thereof of continuing violation
shall constitute a separate offense.
Enforcement of this chapter shall be the duty
of the Board of Health of the City of Fitchburg.
