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TOWN OF BURLINGTON
In the Year One Thousand. Nine Hu·ndred Ninety Four
REGULATIONS FOR THE USE OF RECOMBINANT DNA TECHNOLOGY
I.
purpOse
These regulations provide ~versight to ensure worker and community
health, safety. and welfare, and environmental protection relating'
to l.aboratory and/or production use of recombi nant DNA/RNA. All
laboratory and production use of recombinant DNA/RNA (RONA) in the
Town of Burlington shall be undertaken only in stric-t conformity
with the Guidelines set out in Section IlIA. and the other
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requirements of these regulations.
II.
'Author ity
These regulations are adopted by the Burlington Board of Health,
as authorized by Massachusetts General Laws. Chapter 111,
Section 31 '.
III.
A.
Definitions
Guidelines are defined as:
l) · National Insti·t utes of Health (NIH) Guidelines for Research
Involving Recombinant DNA Molecules as pub~ished in the
Federal Register of May 7, 1986, at 51 F .R. 16957 -1698.5; a
copy of said publication is on file in the Board of Health
office.
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2) Any amendments. revisions or substitutions subsequent to
the above-referenced guidelines as published in the FederalRegister unless . a specific ammendment is denied by -the Board
of Health.
3) In ·the event, that the NIH shall discontinue or abolish its
· guidelines those g~idelines in effect at the time of such
discontinuance shall remain in effect i on Burlington.
8.
"Person" . means any institution. corporation. firm,
partnership, association, executor, administrator, guardian.
trustee, agent. organization and any other group acting as a unit,
as well as a natural person. '
C.
"Recombinant DNA/RNA molecules" and "organisms and viruses
containing RDNA~ are those defined in the Guidelines referred to
in subsection (A)( 1,) above.
IV. Permit Application Requirements
All persons proposing to experiment with or use, or currently
experimenting with or using RONA must submit a permit applicati on
to the Board of Health in order for a permit to be reviewed, and
if in compliance with these regulations. approved by the Board.
No person shall experiment with or use RONA in the Town without a
valid permit from the Board of' Health. ~ The permit application and
the permit requirements , if approved, shall, at a minimum. include
wr i tten agreement to:
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A.
Follow the Guidelin'e s as defined in these regulations.
B. Establish a tralning program of safeguards and procedures for
personnel using RONA. Prepare a Health and Safety manual which
contains all procedures relevant to the use of RDNA at all levels
of containment in use at the .facility, and a program for waste
dispo~al in compliance with all applicable federal, state and
local laws. The manual describing. the training, waste disposal
and the health and safety programs shall be submitted to the Board
of Health along with the permit application.
C. Establish an Institutional Biosafety Committee (IBC) in
accordance with the NIH guidelines. except that the required
composition of each lec shall include at least one (1)
representative from the local community and one (1) member of the
Board "of Health or its designee. The community representative
shall be nominated by the Board of Health and appointed by the
Board of Selectmen. The composition of the proposed lBC shall be
submitted to the Board of Health along with the permit
application. These members shall be bound to the same provisions
as to non-disclosure and non-use of proprietary i nforma-t ion and
trade secrets as all other members of the IBC, e xcept to the
extent necessary to alleviate any public health hazard. The lec
shall be the final arbiter within an institution with regard to
the implementation of the Guidelines.
O. Establish a Medical Surveillance Program. Each . permit-holder
must provid~ an appropriate medical surveillance program as
determined by its Iec and consis~ant with the Guidelines and such
program must be submitted to the Board of Health for its review
and approval.
E. Establish Pest Control Program. Effective rodent and insect
control programs must be in place on premises whe r e RDNA use under
these regulations takes place. Said program shall be submitted to
the Board of H~alth for its review and apprqval.
F. Pay all costs asses~ed by the Town in accordance with Section
X - Assessments within thirty (30) da ys of receipt of an invoice
therefor.
v.
Additional Permit Conditions and Approval Procedure
A.
Follow other conditions set .forth i n
th~se
regulations.
B. Allow inspections of facilities and pertinent records by the
Board of Health or its· agent during normal and reasonable working
hours.
C. The ~person" shall ensure and provide documentation regarding
compliance· with all applicable state. federal and local laws and
regulations.
D. The Board shall hold a public meeting within twenty-one (21)
days of receipt of a completed permit application or letter of
intent to review a permit. The Board shall issue its approval or
denial, in writing and with conditions or reasons therefor, within
twenty-one (21) ~ays of the close of the publi c meeting.
VI.
Permit Expiration and Renewal
Permits shall expire one (l) .year after the date of issuance. In
order to renew a permit, · the person shal l, within thirty (30) days
prior to the expiration date, submit a letter of intent to renew
and any s~bstantive information relating to changes in the
facility's operation and program. The Town and Board of Healt h
m~y charge costs for the issuance and renewal of permits in
acqordance with Section , X.
VII.
Reports
All minutes of lBC meetings must be sent to the Board of Health
within thirty (30) days of the meeting after first removing any
proprietary information and trade secrets therefrom.
VIII.
Board - Notification
1 . Violations of GuidelineS/Problems
The permit-holder shall report in writing and within seven (7)
days. to the Board of Health any problems with or violations of
the Guidelines and any RONA- related accidents, illnesses. or
relea~e~ .
Immediate notification if harm potential.
2 . Any release of RONA molecules from the physical containme nt
faci li ties or into the environment which represents a potential
hazard to employees or the public or the environment shall be
reported to the Board of Health, Police Department, and Fire
Department. or their designees, immediately, and in no case more
than twenty-four (24) hour·s after the release.
IX .
Restrictions
A. RONA use requiring containment defined by the Guidelines as
"BL4 or P4 level of containment shall not be permitted in
Burlington.
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8. There shall be no release into the environment including
sewers, drains or the air. or from the physical c ontainment
facility ·of any live organisms ·conta ining RONA, except those
already authorized by the NIH guidelines. without prior review and
approval from the Board of Health and other relevant agencies.
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x. . Assessments
T~e
salaries and expenses pa id by the To wn o f Burlington for
inspections, revi ews , Istaff and consultants f or war k directl y
. related to carr y ing o ut the requirements of these regulations
shall be assessed to the institutions holding permits under these
regu lation~ .
An accounting of these costs will be furnished
annuall y to each Institution. Not withstanding the preceding
sentences, the ·salar ies and expenses necessary to review and
process a person' s or igi"nal pe r mi t application sha ll not e xc eed
$500 . 00. The salaries and e xpenses t o r e vi e w and process a
person's letter of intent to renew a permit shall not ex ceed
$500.00. The payment of said salaries and expenses sha l l be made
prior to th~ issuance of a final permit or final permit renewal.
XI . . Enfor c ement
A. Any person who violates any prO VI S Ion of these regulations
shall be subject to a fine. Ea ch da y of each v i o lati on shall
constitute a separate and dis tinct o ffense which may be punis hed
b y a fine of not more than $500.00 per da y for each vio lation.
E~ c h day of e ach v iolation may also be p u nished . by a fine of
$50.00 in accordance with G.L.c. 40 . 5 21D and ~r t ic le I, Section
4.0 of the Town's General By- laws as ~mended.
8. Once a per mit has been issued • . it ma y be revoked. sus pended,
modified or not renewed by the Board of Health onl y upon a
determination b y the Board of Health after due no ti ce and hea r ing ,
that the permit-ho lder has materiall y failed to com pl y . with these
regul'ati o ns, the per mit agreemen ts or the Guideli nes.
C. Notwithstand.i ng the above , the Boar d of Health. upon a
de te rminati on that any vio latio n const itutes an immediate and
severe t hre at to the public health and s afet y or the env i ronment.
ma y order the immediate c l osure of any p rem i ses or laboratory
e nga ging in or contribut ing to suc h threat, without prio r notice
a nd hearing . The pe r mit-hold er or its designee may request a n
immediate hearin g before the Board subsequent to the , i ssuance of
an or der to close an y premises or labor ator y . . The Boar d may
resci nd or ame nd its or de r. or take any other action rela tive
theret o . upon a determination that such a threat no longer e xists .
D. The p rovis i ons of these re gulations and an y permit or order
issued t hereunde r ma y be enforceq in the Superior Cou rt o r
District Court as allowed by law .
XI I.
Severability
If any section, subsectio n, sente nce. c lause. or po r ti on of these
regulations for any reaso n b e held invalid b y any court o f
competent ju"r isdiction, such portion sha ll be deemed a se para te,
disti net and .i ndependent p rovisio n, and such hold i og shall not
affect the va lidit y o f t he rema ining portions thereof.
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1XIII.
Variance
Variances from these specific requirements of these Regulations
may be authorized by the Board of Health after' notice and a public
hearing if the Board reasonably determines that the relief sought
will not be detrimental or injurious to the public health.
XIV.
Effective Date
Tliese regj..llations were ' adopted by vote · o.f the Bur 1 i ngton.
Massachusetts Board of Health, at their regularly scheduled
meeting held on January 11. 1994. and are to be in full force and
effect on and after February 11. 1994. Before said date, these
regUlation's shall be published and a copy thereof be placed on
file in the Board of Health offices. Facilities using or
producing RDNA prior to · the implementation of these regulations
shall not be exempted from the requirements established by this
rElgulation.
These regulations or any portions thereof may be amended.
supplemented or repealed from time to time by the Board. with
notice as provided by law, on its own motion or , by petition.
TOWN OF BURLINGTON
BOARD OF HEALTH
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Edward Wei er, Ph.D .• Vice-Chairman
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,thY
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