[HISTORY: Adopted by the Board of Health of the Town of Franklin 11-19-1993;[1] amended in its entirety 6-9-2010 by Bylaw Amendment No. 2010-1. Subsequent
amendments noted where applicable.]
[1]
Editor's Note: This regulation supersedes former Ch.
198, Biotechnology Regulations, adopted 5-5-1993 as Regulation 93-1.
A.
This chapter shall apply to all institutions in the Town of Franklin
engaged in biotechnology activities, including but not limited to
the experiment with or use of rDNA technology.
B.
This chapter concerns the manner of use for uses otherwise permitted
under the zoning bylaws of the Town of Franklin, and sets forth procedures
and performance standards for the regulation of biotechnology in the
Town of Franklin.
C.
This regulation is intended to protect the public health, safety
and welfare from risks and potential risks posed by biotechnology
activities, including but not limited to experimentation with or use
of rDNA technology. This chapter shall be interpreted to supplement
other local, state and federal laws and regulations.
A.
No institution may be engaged in biotechnology activities in the
Town of Franklin without first obtaining a biotechnology operating
protocol permit issued by the Franklin Board of Health.
B.
A biotechnology operating protocol permit shall be issued to an applicant
institution upon the Board of Health making a finding that the proposed
biotechnology use has been described in sufficient detail to allow
the Board of Health to conclude:
As used in this chapter, the following terms shall have the
meanings indicated:
The experimentation with or use of biological processes to
research or develop or produce commercial products for human and animal
health care, food consumption, agricultural applications and environmental
protection by the application of scientific data and the techniques
of engineering and technology to alter the genetic code of cells or
organisms through physical, chemical or biochemical manipulation.
For the purpose of this chapter, "biotechnology" shall not mean the
propagation of, experimentation with or use of plant tissue cultures
for horticultural or agricultural purposes nor shall it include conventional
food or alcohol production activities.
Biotechnology products, biotechnology waste products and
those materials used at the process of experimenting with or developing
such products, excluding the hardware or instrumentation used in such
processes.
The Franklin Board of Health.
Any single individual, group of individuals, partnership,
association, organization, corporation, educational institution or
medical facility engaged or applying to engage in biotechnology activities
within the Town of Franklin.
A committee established by each institution and representing
the interests of the community with respect to the public health and
protection of the environment. Each IBC shall contain at least two
members not affiliated with and not remunerated by the institution
and at least one member from the institution's biotechnician
staff.
Guidelines for Research Involving DNA Molecules as promulgated
by the National Institutes of Health (NIH) of the United States Department
of Health and Human Services and published in the Federal Register
on May 7, 1986, and any subsequent federal amendment thereto.
Either:
Molecules constructed outside living cells by joining natural
or synthetic nucleic acid segments (including but not limited to DNA
and RNA) to other nucleic acid molecules that can replicate in a living
cell.
Nucleic acid molecules resulting from the replication of a molecule described in Subsection A of this definition above.
A.
Experimentation with, or use of, recombinant DNA technology, classified
by NIH guidelines as requiring BSL-4 (BioSafety Level 4) level of
containment, shall not be permitted in the Town of Franklin.
C.
Any person having knowledge of an unlawful release into the environment
of biotechnology materials within the Town shall immediately report
the release, by the quickest available means and in no case later
than 24 hours, to the Town of Franklin Board of Health, Fire Department
and Police Department.
D.
Provisions shall be made to protect against the discharge or loss
of biotechnology materials through corrosion, accidental damage, spillage
or vandalism, through such measures as secure storage areas, indoor
storage protocols including container inspections, and devices and
measures for spill control in laboratory and manufacturing areas and
in the vicinity of delivery points.
E.
Biomedical waste products or by-products shall not be discharged
through the municipal sewer system unless all viable microorganisms
have been rendered noninfectious in accordance with 105 CMR 480.
F.
There shall be no changes in the types of organisms, containment
levels or decontamination procedures used by a permittee without advance
notice to the Franklin Board of Health. Changes that result in exceeding
any limitations established in the institution's biotechnology
operating protocol permit will require a new or amended permit.
A.
Each institution in the Town of Franklin engaging in biotechnology
activities shall conform to applicable federal, state and local-health
regulations which exist or may be promulgated. In addition, each institution
experimenting-with or using rDNA technology shall comply with the
administrative requirements set forth in the NIH guidelines, or any
amendments thereof, established from time to time by the NIH, by other
federal agencies or by act of Congress. No change in Franklin Board
of Health regulations shall apply to work in progress or previously
contracted for by an institution unless the Franklin Board of Health
shall first hold a public hearing on such change after giving written
notice to institutions in Franklin engaged in biotechnology activities.
B.
Institutional biosafety committees.
(1)
The nonaffiliated representatives on each IBC shall be appointed
by the institution with approval by the Chairman of the Franklin Board
of Health. These members shall be officials of local public health
or environmental protection agencies or Franklin residents whose educational
and/or professional backgrounds are appropriate to the IBC's
function, e.g., persons with background in the legal, medical, occupational
health or environmental fields.
(2)
The nonaffiliated representatives on each IBC 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.
(3)
Each IBC shall meet no less than twice a year. Each IBC shall record
minutes of each of its meetings, and a copy of all minutes of IBC
meetings shall be forwarded to the Franklin Board of Health within
14 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.
(4)
Every six months, the IBC shall provide its certification that the
institution remains in compliance with this regulation and any applicable
NIH guidelines.
C.
If the institution is engaged in rDNA research at the BSL-3 (BioSafety
Level 3) containment level (as defined in the NIH guidelines), the
institution shall appoint a biological safety officer (BSO) who shall
be an additional member of the IBC.
D.
If the institution is engaged in rDNA research on a large scale (as
defined by the NIH), the institution shall comply with all additional
administrative requirements contained in the NIH Large Scale Recommendations.
A.
Biotechnology operating protocol permit.
(1)
An applicant for a biotechnology operating protocol permit shall
submit an application and an application review fee to the Board of
Health, and shall file a copy thereof with the Town Clerk, Building
Commissioner and Planning Board.
(2)
The Board shall hold a public hearing within 45 calendar days of
receiving a completed application and act upon the application within
30 calendar days of closure of the public hearing.
(3)
The Board of Health may at any time reject as incomplete or inadequate
any permit application which fails to provide the information required
by this regulation.
(4)
The applicant for a biotechnology operating protocol permit shall
have the burden of convincing the Board that the activities proposed
in the application meet or exceed the permit criteria herein. Failure
to provide adequate evidence to the Board supporting this burden shall
be sufficient cause for the Board to deny a permit. The Board may
impose permit conditions which the Board deems necessary or desirable
to protect human-health, safety-and-welfare.
(5)
The Board shall render a written decision setting forth its findings
and the reasons therefore. Such decision shall be filed in the office
of the Town Clerk and copies mailed to the applicant, Building Commissioner
and Planning Board.
(6)
Institutions seeking such a biotechnology operating protocol permit
from the Board of Health shall prepare and submit the following application
materials:
(a)
A plot plan showing the proposed location of the facility, the
zoning classification of the site, building footprint, points of egress
onto public ways, and available utilities.
(b)
A detailed floor plan showing the following: internal layout
of the facility; containment structures and equipment; and all points
of egress, such as but not limited to:
[1]
Sanitary disposal lines for sewage and wastewater.
[2]
Laboratory or process waste lines.
[3]
Building ventilation (natural and mechanical) exhausts and their
respective quantity values of volumes/time and exit velocities.
[4]
Solid, hazardous, biological and radiological wastes storage
facilities.
(c)
A listing of all organisms, containment levels and decontamination
procedures to be employed.
(d)
A plan, consistent with NIH guidelines, for a screening process
for organisms used in experiments and for testing organisms resulting
from such experiments.
(e)
A plan, consistent with NIH guidelines, for a medical surveillance
program for all employees engaged in the use of rDNA, together with
the institution's health and safety manual. The health and safety
manual shall include procedures required under NIH guidelines for
the use of rDNA at all levels of containment in use at the facility,
proper employee training and health surveillance programs, procedures
for monitoring and minimizing potential environmental and personal
exposure and a program for waste disposal in compliance with all applicable
federal, state and local laws.
(f)
A plan, consistent with NIH guidelines, for an environmental
monitoring program. These shall include but not be limited to the
following:
[1]
A plan for the systematic monitoring of waste and waste processing.
[2]
A plan to orient representatives of the institution's designated
local hospital and the Franklin Board of Health, Fire Department and
Police Department in the procedures to be used in the event of an
emergency.
[3]
A plan for systematic pest control management in laboratories,
contiguous facilities and food service establishments in the same
building.
[4]
A plan for systematic security of the premises.
B.
Fees. Any institution applying for a biotechnology operating protocol permit shall pay an application review fee while submitting its application to the Board of Health. Annually thereafter, a permit renewal fee shall be paid for each biotechnology operating protocol permit. Fee amounts are outlined in Chapter 82, Attachment 1, of Franklin's Town Code.
C.
The Board of Health may select, retain and contract with a professionally
competent person or agency to perform a review of any biotechnology
operating protocol permit application. The payment for these services
will be the responsibility of the applicant institution. Copies of
documents resulting from such evaluations shall be submitted to the
Franklin Planning Board as a party of interest, and for consideration
during site plan review and, if applicable, the special permit approval
process.
D.
Confidentiality of proprietary documents. The Board of Health, its
employees and any party contracted to conduct a permit application
review shall maintain the confidentiality of any proprietary information
released to them while performing their duties, and the institution
may require a nondisclosure agreement to protect such proprietary
information.
The Board of Health shall cause an inspection, at least annually,
of each institution holding such permit to ensure compliance with
the provisions of this regulation and the NIH guidelines. The Board
of Health reserves the right to select, retain and contract with a
professionally competent person or agency to perform inspections and
reviews. The payment for these services will be the responsibility
of the institution.
A.
The Franklin Board of Health shall have the powers and responsibilities
for enforcement of this chapter.
B.
Failure of an institution to comply with one or more of the provisions
of this chapter shall subject the violator to the following:
(1)
A fine of $500 per day. Each day's failure to comply shall constitute
a separate and distinct offense.
(2)
All costs and/or damages incurred against the land and costs incurred
by the Town to mitigate and/or remedy conditions, including spills,
resulting from the permittee's actions or from actions occurring
on the permittee's site. Any such costs incurred by the Town
shall constitute a debt due to the Town upon the completion of the
mitigation and/or remedial work and the rendering of an account thereof
to the owner of the land, his authorized agent or the occupant, and
shall be recoverable from such owner or occupant in an action on contract.
The provisions of MGL c. 139, § 3A, Paragraph 2, relative
to liens for debt, and the collection of the claims for such debt,
shall apply to any debt referred to in this section, except that the
Board of Health shall act hereunder in place of the Mayor or Selectmen.
(3)
An enforcement order which may include without limitation a cease
and desist order, provided that such order provides notice of an opportunity
for a hearing with the Board of Health within seven business days
of receipt of the order.
C.
Once a permit has been issued it may be revoked only after three days' advance written notice, a hearing and determination by the Board of Health that the institution involved has materially failed to comply with these regulations, the permit conditions or the NIH guidelines, including but not limited to a failure to report a release as required in § 198-4C of this chapter.
