CLCAC Meeting (9/14/21)
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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
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Past Events
Containment Laboratory Community Advisory Committee (4/9/2024)
Containment Laboratory Community Advisory Committee (4/9/2024)
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CLCAC (1/16/24)
CLCAC (1/16/24)
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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 (4/25/23)
CLCAC (4/25/23)
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CLCAC (7/12/22)
CLCAC (7/12/22)
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