HomeMy Public PortalAbout5. a) Public Comments_201905091212032513Comments
Heather Mc Manus
• Typo on Page 2 Exempt section 3F
• Concerned about the 3 of members and make-up of the WBSC recommends increasing the size
of the committees
• Committees must be more balanced
Mia Leiberman
• Clearly spell out fines and penalties
• The Variance procedure should be clearly spelled out
• BL2 work is not regulated
• Need to add further definitions
• Define Community member
• Add more clarity to qualifications for IBC member who is not a municipal employee
Elodia Thomas
• Lexington does not allow BSL3
• Include penalties for compliance failure
• Questions why changes made to draft
• Need to have a better handle on biosafety
• Sam Lipson of Cambridge Health Department is an expert we should get his input
Vincent Picirilli
• Clarify how the WBSC is comprised
• How is the person selected, define designee
• S.4 Committee member needs to be better defined i.e resident who is not an employee or
affiliated with the applicant
Paula Halpin
• There should be at 2 other members with at least 1 being a public member
• S.6 ' All institutions shall allow at least one inspection per year
• P5. Restrictions: edit having outside agency or institution conflict. Should indicate that individual
should not be in an way be associated with the institution
• The board should consider the appropriateness of BSI 3 facilities in Watertown
David Stokes
• The Board should provide a red -lined copy of future drafts that indicate changes so the public
can follow the original script and changes
My name is John Athanasopoulos and I'm the director of operations at C4 Therapeutics, the first
biotechnology company to take residence at the LINX building. It has come to my attention that
Watertown's Board of Health is planning to institute a Biosafety Committee to provide guidelines and
monitor the use of rDNA work. I applaud your efforts in having the public safety in mind whilst allowing
our collective biotechnology ecosystem to carry out our science in an expedient fashion. To that end, I
humbly submit my general comments, see below, to the draft proposal of the rDNA regulation with the
understanding that this is a review period and there is time to incorporate public feedback.
Furthermore, I've attached the draft document with my thoughts as I going through the draft.
Should you have any questions, feel free to contact me via email or by phone at 617 2310717
Thank you in advance for your thoughtful consideration of my comments.
Best,
John Athanasopoulos
General comments:
• It appears that companies with exempt rDNA projects would need a registration while
companies performing experiments covered by NIH guidelines will need a permit. What if a
company performs exempt and non-exempt experiments. Would they need both a
registration and a permit?
• Under definitions, large scale, are the ten liters is one vessel or would a run of 10 x 1L flasks fall
under the definition of large scale?
• Will the permit and registration application forms be available on line?
• Under WBSC section, item B #3, will the WBSC review permit applications only or will review
extend to registration applications?
• Under WBSC item B #5, how will the IBC members be approved? Do you just have to send them
the roster?
• With notifying the town of any incident, what information becomes public domain from these
notifications?
• Under Registration section D it states that incidents need to be reported to the IBC but it's not
clear if a company that only holds a registration would actually be required to have an
IBC. Does a company that holds a registration need an IBC? If not, then who do they report
incidents to?
• Under Permits section, items A and B should add a statement that clarifies that the section
refers only to permitted activities and not activities covered under the Registration.
• Under Permits section, item C #2 please clarify if only rDNA organisms listed or all organisms.
• Under Permits section, item C #7a, who reports back to the Director of Public Health? Is this the
Board of Health member, since asking a community member to report back may be not ideal
as they may not be properly skilled
• Under Permit section, item C#7b, do the IBC minutes need to go to both Board of Health and
WBSC?
• Under Permits section, item C #7d, how often does the summary of protocols needs to be
submitted?
• Under Permits section, item D (p.5) does the application need to be submitted to both Board of
Health and WBSC? Also, if I looked at the timeline correctly it seems like it can be a 4.5
month process from application to approval. This is quite long.
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Comments regarding the draft of the Watertown Biosafety Committee 10-17-18
Mia Lieberman, DVM, PhD, DACLAM
Section 2: Definitions
1. Recombinant DNA is not defined. The following definition is recommended for addition to section 2:
Recombinant DNA molecules (rDNA): in the context of the NIH Guidelines, Section I -B, recombinant
and synthetic DNA molecules are defined as: (i) molecules that a) are constructed by joining nucleic acid
molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids; (ii) nucleic acid
molecules that are chemically or by other means synthesized or amplified, including those that are
chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e.,
synthetic nucleic acids, or (iii) molecules that result from the replication of those described in (i) or (ii)
above.
2. In section 4, rDNA users are defined as exempt from the NIH guidelines which is section III -F, not III -
E as currently listed. The following definition of exempt rDNA is recommended for addition to Section 2:
Exempt Recombinant DNA: Recombinant or synthetic nucleic acid molecules as defined in section III -F
of the NIH guidelines, for which registration with the Institutional Biosafety Committee is not required,
however are still subject to biosafety standards as outlined in the current version of the CDC/NIH "
Biosafety in Microbiological and Biomedical Laboratories (BMBL)" .
Section 3: Watertown Biosafety Committee
1. Part C: Most surrounding communities (Belmont, Waltham, Cambridge, Lexington, Newton) BSCs
include the Chairperson of the Board of Health, the Director of Public Health and a minimum of 3 other
members (Newton has a total of 9). For Belmont, and Lexington BSCs the first 3 members serve varying
terms: 1 serves 1 year, 1 serves 2 years and 1 serves 3 years.
It is recommended that a minimum of 3 individuals be added to the Watertown BSC to align with the
structure of surrounding community BSCs.
Section 4: Registration
1. Part 4: initial registration fee of $100.00 is listed due on initial application and upon annual renewals
but section 5 (Permits), part 12D lists the fee for a permit and annual renewals is $500.00 '
Section 5: Permits
1. Part 12: BSL3 permit information is listed, however this contradicts section 7 part A: "rDNA use
classified by the guidelines as requiring any BL3 or BL4 physical containment measures• • •.shall not be
permitted"
2. Some surrounding community BSCs (i.e. Belmont and Arlington) require evidence of liability insurance,
in an amount of at least $1,000,000 for personal injury or death to any one person, and at least
$5,000,000 for personal injury or death from any one incident, and at least $1,000,000 for property
damage.
Watertown should consider whether requiring evidence of insurance should be included,
especially given the potential for mixed -used spaces proposed.
T own
Belmont
Waltham
Arlin gto n
Bedford
Cambridge
Lex in gton
Newton
Town BSC T ow n BSC members
member #
5
5
chairman of b oard of health. Director of health, 3
commu nity members appointed by board of health
director of public health , chairperson of b oard of
health, 3 other members app ointed by mayor
director of 1iH5 rev iews application and submit
recommendation to board of h ealth with hearing
schedueld within 60d
board of health rev iews within 45d
commissioner, chairperson of bambridge health
5 policy board, 3 other members appo inte d by city
manger
5
9
charrman of boa rd of health, director of health, 3
other members appoin ted by to wn man ager
commissioner of HHS, 4 members appo inted by the
mayor including at least 1 scientist, othe r 3
representing fields of public health, occupa tiona l
health, infectious disease or env ironme ntal health
and preferably include 1 member of Newton health
advisory council; 4 me mbers appointed by city
council at least o ne represen tin g public heatlh/occ
health/infectious dz/env ironmental health
Term l ength for community member: P ermit fee
3 years; of the first 3, 1 serves 1
year, 1 serves 2 years, 1 serves 3
years
Restrictions? Vi olation fee
no BL3/BL4 , no more than 10001
initi al rDNA/culture , no deliberate release to
application: $200; en vironment, report de viati ons within $500/day
ren ewal $100 24h with writte n foll ow-up within 15d,
requires liability insur ance
1 year; Jan 1 to whene ver succ ess ors $300
a ppo i nt m ed/conf i rm e d
salaried members , not specified
3 years; of the first 3, 1 s erves 1
year, 1 serves 2 years, 1 ser ves 3
years
3 years; of the first 3 (4?) appo inte d
by mayor and city council, 2 serv e 1
year, 1 serves 2 years, 1 se rves 3
years
$2000 initial
application, then
$500 annually;
$1000 mi nim um
kept in escrow
report violations within 30d; must have
effecti ve rodent and inse ct c ontrol not listed
programs
no BL4, requir es ann ual report
s ubmitted, requires liability insu rance ,
special approval required f or large
scale use, violations reported verbally
withi n 24h with written follow up by
30d
$300/day
no 913/4, must i nclude pest control
plan, report within 30d for employee
illn ess, 24h for de viation with written $500/day
15d followup, no more than 5000L of
li ve culture within variance
report violati ons/ill ness within 30d,
requires pest control, no BL4
$300/day
$200 exempt ,
$500 no n-
exempt; + variance required for m ore than 5000L,
salaries/expense no BL3/BL4; r ep ort de viations within $500/day
24h with written f oll owup within 15d
s assessed to
i nstitutions
annually
$250
no BL4; 30d notice requir ed for BL3 $300/day
j' Gmail
Files for Biosafety Committee
Mon, Feb 11, 2019 at 1:45 PM
Dear Mr. Ramdin,
Please find attached the written statement I gave at the October Board of Health meeting and the compilation of the four adjacent communities biosafety regulations I
provided at the January meeting. I have also attached the history of the Cambridge regulation as I think it ads important context. Please pass them along to the
Board of Health as well as the quick notes below summarizing my comments at the January meeting.
1) The appointed member(s) of the biosafety committee should be a Watertown Resident. This is how adjacent towns operate and is true to the intent of the
committee (please see the attached History of the Cambridge BSC)
2) The committee should have at least three residents with varying research and technology backgrounds.
• This is Important for the large breadth of knowledge needed to keep abreast of the constantly changing nature of science and innovation (see my statement
from the October meeting). It is also important as the new multi -floor building at Arsenal Yards will primarily cater to small startups and thus will have new
technologies being developed at fledgling companies.
• Because of the current level of mistrust between the town residents, developers, and the Planning Board, the presence of only 1 community member on the
BSC is concerning to residents. This is no fault of the Board of Health or the Department of Health, The past several years have seen unpopular decisions on
the part of the Planning Board in favor of developers. To start the committee off on the right foot, I feel having the majority of BSC filled by resident scientists
will foster trust and will also mean the WBSC is better able to address community concerns. • There are many factors that go into deciding if a BSL3 facility is appropriate for a specific location and/or specific company. Having multiple scientists on the
WBSC will allow for robust discussion, decision making, and reports.
3) The reasoning for aliowing BSL3 facilities in Watertown needs to be addressed. I know it is a sensitive matter. There are security and legal concerns that arise
from disclosing if a Watertown company already has a BSL3 facility. But this question is not going to go away and I think it could possibly derail the process of
forming a WBSC. I believe it's crucial that members of the Board reach out to Sam Lipson at the Cambridge Department of Public Health to gain a better
understanding of how to address this issue with the community.
h ttp://.wnv.ca mbridgepublichealth.org/se rrices/regula tcrpactivities/b iosafetylndex. php
Please let me know if you have any questions and please pass my email along to the members of the Board of Health.
All the best,
Heather Rose McManus PhD
3 attachments
-.� HlstoryOfCambrldgeBSC.pdf
789K
elh McManus_Statement_10_17_18_BHmeeting.docx
24K
Compilation of current rDNA and blosafety regulations in 4 communities surrounding Watertown.docx
273K
Heather R. McManus, Ph.D.
17 Hall Ave., Watertown MA 02472 + (617) 504-5933 ♦ heather.rose82@gmail.com
Prepared Statement given at the October 17'I', 2018 meeting of the Watertown Board of Health.
My name is Heather McManus. I live at 17 Hall Ave. I am here to talk about the proposed Biosafety Committee
(BSC).
I've been impressed with how our town has addressed the community concerns that were raised only two
months ago. This topic has been discussed at multiple town meetings and our new Director of Public Health has
already put together a draft of the proposed regulations.
I myself am a research scientist. I received my PhD in Microbiology and Molecular Genetics ftom Harvard
Medical School, went on to do post -doctoral work, and then left the workforce when I started a family. With
plans to go back to work at some point, having more local job opportunities would be fantastic. There are a lot
of research and biotech professionals who live in Watertown and many of them probably feel the same way.
But having spoken to several of my former colleagues who now live in Watertown, I also know that they are
concerned about the level of biotech regulation in our city. Many of them were surprised to know that we have
no restrictions on BSL3 and BSL4 facilities and that companies are not required to have Institutional Biosafety
Committees (IBC) with one community member. This is standard practice at the companies they work at in
neighboring cities.
When talking with these colleagues about the recent proposal to add laboratories to the mixed -use space at the
Arsenal Mall, all of them scoffed at Boylston's Properties (BP) claim that it is common practice for a
biotechnology company to have all deliveries and waste coming in and out through a main entrance of the
building — let alone in a mixed -use space. This is not industry best practice. In fact, when I investigated BP's
examples of Mixed -Use Life Science Buildings in Cambridge and Boston, all of them have loading bays, docks,
or delivery areas that are separate from major entrances. All of the restaurants and daycares I was able to
identify in these buildings had their own entrances to the street. Additionally, Sam Lipson, the chair of the
Cambridge Biosafety Committee, told me he was unaware of any company in Cambridge that moves
biohazardous waste through this type of space. He further stated that since this is a development -in -progress, it
would be standard practice to request that the developer undertake some effort and expense to bring the project
in line with industry standards. This would not only improve worker and community safety, it would improve
tenant acquisition and retention. None of this is surprising to research professionals.
I think this illustrates an untapped resource of the Watertown community. We have research professionals of
diverse backgrounds, like myself who has worked on BSL2 organisms and in laboratories with BSL3 facilities,
like Dr. Lieberman who has extensive training and experience in safe and ethical animal research, like my
former colleagues who have nanoparticle experience, or work at global pharmaceutical companies, or at small
startups.
Scientific research is full of specialized technologies and is an ever -shifting landscape. Therefore, I think any
BSC should have at least 3 community members with diverse backgrounds and areas of expertise. I know that
the proposed regulations recommend only 1, but I think this will be inadequate to the task and will fail to utilize
a wealth of community knowledge. I also think that the proposal should be amendable by the final BSC to allow
multiple expert opinions on topics like BSL3 regulation, select agents, and the appropriate development of labs
in mixed -use spaces. Thank you