CLCAC (7/13/21)
Dial 1855-925-2801
Enter Code 9813
Press * for Meeting Options
- Press 1 to listen to the meeting
- Press 2 to record a comment
- Press 3 to be placed in a muted queue to speak during the meeting
You must state your name at the beginning of your phone call, message or voicemail for your message or voicemail to be presented during the meeting. Please do not say your phone number as this will be made public.
- Files 1
- CLCAC Agenda 7.13.21.pdf
Past Events
Containment Lab Community Advisory Committee (10/17/23)
Containment Lab Community Advisory Committee (10/17/23)
I. Call to Order
II. Roll Call and Welcome New Members
III. Old Business
a. Approval of previous CLCAC minutes (April 12, 2022, and July 12, 2022)
b Election of Vice Chair of Committee
c Discussion of Annual Reports to be submitted to Frederick City Government - 2019-2021
d. Update biographical summary of committee members
e. Maryland Open Meetings Act training
f. Changes to By-Laws as recommended by Craig Reed
IV. New Business
a. Resignation of Dr. J. Craig Reed, Vice Chair
b. Resignation of Dr. Matt Sharkey
c. Resignation of CPT Chris Carmody
d. New member: Joseph Fitzgerald
e, New member: Garth Patterson
f. Discuss potential meetings with Fort Detrick leadership
g. General repeal of residency requirement for Frederick County committees with specific exemptions
h. Discussion of the Containment Laboratory Community Advisory Committee By-Laws
i. George Galer, journalist - interview request
j. Correspondence from Dr. Dat Duthinh, former CLCAC member
V. Public Comment - Comments and questions can be submitted post meeting to CLCAC@cityoffrederick.com. All communication submitted will be presented and discussed. Comments submitted after the meeting adjourns will be presented and discussed at the next regular meeting of the CLCAC.
VI. The next meeting of the CLCAC is schedule for January 9, 2024, at 7 p.m.
VII. Adjourn
CLCAC (7/12/22)
CLCAC (7/12/22)
Press *1 to listen to the meeting.
Press *2 to leave a voicemail comment.
Press *3 to give live public comment.
CLCAC (4/12/22)
CLCAC (4/12/22)
Dial 1-855-925-2801
Enter Code 9813
Press * for Meeting Options
- Press 1 to listen to the meeting
- Press 2 to record a comment
- Press 3 to be placed in a muted queue to speak during the meeting
You must state your name at the beginning of your phone call, message or voicemail for your message or voicemail to be presented during the meeting. Please do not say your phone number as this will be made public.
CLCAC Meeting (9/14/21)
CLCAC Meeting (9/14/21)
Dial 1-855-925-2801
Enter Code 9813
Press * for meeting options
- Press 1 to listen to the meeting
- Press 2 to leave a voicemail comment that will be played back to the CLCAC
- Press 3 to be placed into a live speaker queue on mute and you shall not be able to speak until the administrator of the meeting grants access. Please stay on the line until you are introduced. If you are called upon and do not respond, you will lose your place in the queue.
You must state your name and address at the beginning of your phone call, message, or voicemail for your message to be presented during the meeting. Please do not say your phone number as this will be made public.
Agneda
Type of Meeting: Ad-hoc meeting
Meeting Facilitator: Dr. Matt Sharkey, Chair
Invitees:
- Dr. Matt Sharkey, Chair (At-Large Member)
- Dr. Bob Hawley, Vice-Chair (Private-Sector Life Sciences Industry Representative)
- Dr. Joany Jackman, Secretary (Private-Sector Health Field Representative)
- Mr. Chris Carmody (At-Large Member)
- Mr. Alexi Franklin (At-Large Member)
- Mr. Dwayne Oland (Alternate Member)
- Dr. J. Craig Reed (At-Large Member)
- CPT Chris Carmody (At-Large Member – Approved, Pending County Appointment)
- Dr. Gigi Grovall (Guest)
____________________________________________________________________________
- Call to Order
- Roll Call
- New Business: HB 1256: Gene Synthesis Providers and Manufacturers 3 of Gene Synthesis Equipment – Certification
- Gigi Gronvall, JHU Center for Health Security, spoke in favor HB-1256 in March 2021 (https://legiscan.com/MD/text/HB1256/2021). This bill was proffered by Delegate Lewis-Young, and is similar to CA Bill AB-1966. HB-1256.
- HB-1256 (§ 17.802 [A]) requires the MDH to develop gene sequence and customer screening guidelines by Jan 1, 2023.
- The guidelines should “increase gene synthesis security; and improve biosecurity efforts to prevent, deter, detect, attribute, and mitigate the misuse of gene synthesis products in the state.”
- California’s AB-1966 in its currently-amended form relies on the guidelines in place at the International Gene Synthesis Consortium. There are also guidelines in place at the U.S. federal level. Would it be better to rely on those guidelines, which are more likely to be updated to current standards than to have MD responsible for updating?
- The guidelines should “increase gene synthesis security; and improve biosecurity efforts to prevent, deter, detect, attribute, and mitigate the misuse of gene synthesis products in the state.”
- HB-1256 (§ 17.802 [B]) requires that the guidelines should also “include requirements that: a gene synthesis provider identify gene synthesis product orders that include dangerous pathogen sequences and other potentially dangerous sequences; and if a dangerous pathogen or other potentially dangerous sequence is identified by a gene synthesis provider, the gene synthesis order be reviewed by a human and subject to additional screening requirements.”
- Are there other mechanisms that may decrease burden on providers, such as customers notifying providers if their order contains such sequences and providing proof of legitimacy for their order?
- HB-1256 (§ 17.803 [A]) requires that the MDH develop a process to certify gene synthesis providers and manufacturers of gene synthesis equipment, to be recertified bi-annually.
- Dr. Craig Reed has previously voiced that he favors the establishment of a best practices certification instead of a penalty for companies not in compliance and then requiring that recipients of state funds being required to make purchases from MD companies with this certification or so-certified entities from other states or internationally.
- HB-1256 (§ 17.803 [B]) requires that the certification process begin on January 1, 2024 (one year after the establishment of guidelines.
- HB-1256 (§ 17.803 [A]) establishes that certified providers may create gene synthesis products for delivery to a customer in the state; or distribute gene synthesis products in the state; or the manufacturer of gene synthesis equipment may manufacture equipment needed to produce gene synthesis products in the state.
- Would it be a good idea to include a provision for benchtop gene synthesis equipment here? Would it be possible to require that such equipment is hard-wired to not be able to synthesize >20bp of any FSAP or CCL sequence? Would 50bp be more plausible?
- HB-1256 (§ 17.803 [B]) establishes that a gene synthesis provider or manufacturer of gene synthesis equipment that is not certified, or that fails to maintain its certification, while performing the functions described in subsection 19 (a) of this section, is subject to a civil penalty of $1,000 per day that the entity is not certified.
- HB-1256 (§ 17.805) establishes that entities in receipt of state funds may only purchase gene synthesis products from certified entities
- Should this be expanded to cohere with entities so certified by other states with similar regulation (e.g., CA) or by recognized national or international organizations, such as the International Gene Synthesis Consortium?
VIII. Adjourn
******************************************************************
CLCAC (1/12/21)
CLCAC (1/12/21)
Dial 1-855-925-2801
Enter Code 9813
Press * for meeting options
- Press 1 to listen to the meeting
- Press 2 to leave a voicemail comment that will be played back to the CLCAC
- Press 3 to be placed into a live speaker queue on mute and you shall not be able to speak until the administrator of the meeting grants access. Please stay on the line until you are introduced. If you are called upon and do not respond, you will lose your place in the queue.
You must state your name and address at the beginning of your phone call, message, or voicemail for your message to be presented during the meeting. Please do not say your phone number as this will be made public.
Containment Laboratory Community Advisory Committee
Agenda
Zoom Meeting
January 11, 2020; 7:00 PM, Telemeeting
Type of Meeting: Quarterly meeting
Meeting Facilitator: Dr. Matt Sharkey, Chair
Invitees:
- Dr. Matt Sharkey, Chair (At-Large Member)
- Dr. Bob Hawley, Vice-Chair (Private-Sector Life Sciences Industry Representative)
- Dr. Joany Jackman, Secretary (Private-Sector Health Field Representative)
- Mr. Alexi Franklin (At-Large Member)
- Mr. Dwayne Oland (Alternate Member)
- Dr. J. Craig Reed (At-Large Member)
____________________________________________________________________________
- Call to Order
- Roll Call
- Approval of minutes from October 13, 2020
- Old Business
- Personnel
- With unanimous support, it is recommended that Dwayne Oland be elevated from Alternate Member to At Large Member. A letter has been drafted to Joyce Grossnickle. Follow up is underway. Status will be reported.
- Chris Carmody has expressed interest in joining, with unanimous support from members. CLCAC recommendation submitted to Joyce Grossnickle (Frederick County Council) for approval mid-October 2020. Status will be reported.
- We have room for two alternates with approval of both individuals mentioned previously. Joyce Grossnickle has been contacted regarding these openings.
- Dr. Jackman approached ChABSA about presenting information on the new bill to document the location of BSL3 laboratories in Frederick County.
- The ChABSA council declined to present the bill in a format which might indicate that they were behind the bill
- The ChABSA council stated they would notify the membership if any news article or other public announcement could be located and re-disseminated to the membership.
- Dr. Jackman requested from the CLCAC Chair any announcement related to the HB580
- HB580 implementation and notification of laboratories in Frederick
- Dr. Hawley volunteered to improve the survey associated with registration of BSL3 facilities not registered under the select agent program. A status report will be given. A survey was developed by CLCAC members, but we have no insight into who should receive this survey.
- Contacting Emergency Managers
- Dr. Sharkey contacted Frederick City (rsc@cityoffrederickmd.gov)
- Dr. Sharkey contacted Frederick County (Jack Markey, EmergencyManagement@frederickcountymd.gov) Emergency Managers
- No reply from City. Jack Markey replied that he is not obligated to communicate the locations of non-select agent BSL-3 laboratories to CLCAC. Matt Sharkey clarified the request in an email copying Senator and Delegate Young. No subsequent reply.
- Dr. Jackman volunteered to discuss HB580 with Fire Rescue personnel in Montgomery County in October meeting, tabled for discussion in January.
- Personnel
- New Business
- CA Bill AB-1966 may be appropriate for us to consider recommending to Frederick leadership for consideration by the MD legislature. http://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200AB1966
- CLCAC has received no information about any laboratory incidents at Ft Detrick or USAMRIID since the October 2019 public meeting with command staff. Subsequent communications include March 16, 2020, indicating that they would not be sharing further information about environmental impact assessments of the May 2018 steam sterilization plant (SSP) leak; the notice of resumption of full activities at USAMRIID, received March 30, 2020; and a January 4, 2020, request for the agenda prior to attending this meeting. Notably, no annual reports of laboratory incidents have been received from USAMRIID since the shut down in August 2019.
- National Academies Press report that necessitated the establishment of CLCAC calls for specific types of reporting. Many of these have not been consistent, either from USAMRIID or from the other high-containment laboratories at Ft. Detrick. See text from recommendations 1, 2, 5, 6, 7, and 8.[1]
- Strategies to elicit reports on laboratory safety incidents at USAMRIID and other Ft. Detrick containment laboratories. Strategies to fulfill the other mandates in the 2010 NASEM Report.
- Public Comments
- Adjourn
******************************************************************
Meeting Agenda compiled by Dr. Matt Sharkey (January 3, 2020) ; edits and additions by Drs. Joany Jackman and Robert Hawley (January 4, 2020).
- Addendum:
Selected text from Chapter 5, Communications and Cooperation with the Public, from 2010 NASEM Report, emphasis added.
First, environmental studies and hazard assessments should report the type of laboratory incidents and laboratory-acquired infections described in USAMRIID’s scientific literature, as well as actions taken to prevent them. Safety and security failures, along with their countermeasures, should be reported promptly to the public. The tendency to minimize such rare accidents has created mistrust among the local population…
Fourth, USAMRIID and other laboratories handling pathogens could provide fact sheets to describe the pathogens that they are researching. Public testimony suggests that the undifferentiated knowledge of select agents compounds people’s fears.
Fifth, and most important, the committee believes that two-way communications between USAMRIID and the public at large, including its critics and opponents as well as its supporters, would best be served by the creation of a community advisory board that meets regularly. At such meetings, led by USAMRIID personnel with administrative, not just public relations, responsibility, the Army should report regularly on problems, successes, and improvements in policies and practices. It should take suggestions from the public and work with public representatives to prepare fact sheets and other educational materials. By meeting regularly, the advisory group would create a group of lay participants with above-average understanding of the laboratory’s work, establish a mutual problem-solving mentality, and if successful, build trust. While the proposed board would be advisory, with no formal decision-making authority, USAMRIID should obligate itself to respond to all suggestions and comments offered by members of the proposed board. Fort Detrick’s Garrison already operates a Community Liaison Council, which is said to be convened quarterly and attended by local community and political leaders. Its stated intent is to provide a platform for the Garrison Commander to provide information and updates about Fort Detrick programs, construction, and environmental issues and to get feedback from community leadership. Fort Detrick’s Installation Restoration (clean-up) Program also sponsors a Restoration Advisory Board. While similar in structure to the proposed USAMRIID advisory board, these two bodies fulfill different functions.
Sixth, USAMRIID should work with public representatives on the proposed board to develop guidelines for reporting incidents, accidents, and laboratory-acquired infections to the public—that is, who should be notified and when. Some events may merit immediate notification of public officials or the public at large, while for others periodic summaries may prove sufficient.
Seventh, a non-governmental member of the advisory board, as well as a representative of local government, should be invited to serve on the Institutional Biosafety Committee.
Finally, members of the Frederick community have expressed the need for the various laboratories that make up the National Interagency Biodefense Campus to coordinate and streamline their communications with the public. This committee has not reviewed the community relations activities and plans of the other laboratories on the National Interagency Biodefense Campus. Indeed, it is beyond its scope. Nevertheless, the committee urges USAMRIID to consider whether it might strengthen and/or simplify its community relations strategy by combining or coordinating the above-suggested activities with the other agencies on the campus.
[1] See selected text of full recommendations to USAMRIID and the National Interagency Biodefense Campus, from, National Academies of Science, Engineering, and Medicine. Evaluation of the Health and Safety Risks of the New USAMRIID High-Containment Facilities at Fort Detrick, Maryland, National Academies Press, 2010. p. 59-61. Retrieved January 4, 2021, from https://www.nap.edu/download/12871