DATE: December 12, 2023
TO: Board of Supervisors
SUBMITTED BY: David Luchini, RN, PHN, Director, Department of Public Health
SUBJECT: Proposed Amendment to the Ordinance Code of Fresno County, Adding
8.52, “Fresno County Infectious Materials Ordinance” to Title 8, “Health and Safety”
RECOMMENDED ACTION(S):
TITLE
1. Conduct first hearing to amend the Fresno County Ordinance code, Title 8, to add Chapter 8.52, “Fresno County Infectious Materials Ordinance;” waive reading of the Ordinance in its entirety and set the second hearing for January 9, 2024;
2. Direct County Counsel to draft a Memorandum of Understanding for incorporated cities within the County of Fresno which may grant authority to the County of Fresno’s Department of Public Health to enforce the proposed ordinance within city jurisdictional boundaries;
3. Designate County Counsel to prepare a fair and adequate summary of the proposed Ordinance; and
4. Direct the Clerk of the Board to post and publish the required summary in accordance with Government Code, Section 25124 (b) (1).
REPORT
Approval of the recommended actions is the first step to enable the County to address the lack of federal regulation for laboratories that currently do not fall under federal regulations 42 United States Code (USC) § 263a and 42 Code of Federal Regulations (CFR) § 493. These actions would also provide staff direction to draft a Memorandum of Understanding (MOU) for your Board’s approval at a later date for incorporated cities to grant authority to the County of Fresno to provide oversight of these unregulated laboratories. This item is countywide.
ALTERNATIVE ACTION(S):
Your Board can reject the recommended actions; however, the County would be unable to regulate labs in the unincorporated areas of the County and possibly incorporated cities under the proposed MOU.
FISCAL IMPACT:
There is no increase in Net County Cost associated with the recommended actions. The cost of permitting and providing oversight of laboratories will be evaluated by the Department and a future Master Schedule of Fees update would be presented to your Board for consideration and to ensure that actual cost will be recovered for these activities. Approval of a future fee schedule would provide sufficient revenue to fully support these activities.
DISCUSSION:
On August 8, 2023 the Department provided a presentation to your Board detailing the chronology of activities that occurred in 2022 through August 2023 with a privately funded laboratory that was conducting laboratory research and manufacturing/distributing medical test kits. Through collaboration and consultation of 14 federal, state, and local agencies the County and the City of Reedley took action against the business owner. Establishment of jurisdictional authority was key in assessing which agency could take action and when. Due to the absence of federal regulation to this particular laboratory operation, the jurisdictional authority for the biologicals fell to the County of Fresno, Department of Public Health; chemical destruction is being evaluated by United States Environmental Protection Agency; general equipment and items destruction by City of Reedley; and unlicensed/embargoed test kits by California Department of Public Health - Food and Drug Branch.
Proposal of the Ordinance will provide authority for the County to conduct onsite visits on private property and evaluate if laboratories that are not regulated by Clinical Laboratory Improvement Amendments (CLIA), 42 USC 263a and 42 CFR 493 are in compliance with Hazardous Materials laws and general applicable clinical laboratory safety requirements (e.g. medical waste, environmental controls, policy and procedures). This ordinance will not apply to CLIA operated laboratories which include commercial laboratories (e.g. Quest, Lab Corp), doctors’ offices that obtain a CLIA license or waiver from CLIA, and/or clinics operating under a CLIA license or waiver from CLIA. The Department would operationalize a team from its Hazardous Materials program and its Public Health Laboratory. This team would conduct annual onsite visits to confirm compliance with Hazardous materials and laboratory operations.
The second recommended action provides direction to staff to draft a Memorandum of Understanding (MOU) for your Board’s approval at a later date. The proposed MOU would allow the County of Fresno’s expertise to extend out to all incorporated cities that agree to grant the authority to the County of Fresno. This would allow the Department to go onto private property within the incorporated cities to conduct oversight of laboratories that are not regulated by current federal regulation. The proposed MOU will restrict the County’s authority to only apply to hazardous materials and laboratory operations as specified in the proposed ordinance. Incorporated cities will retain all other jurisdictional authority. In responding to the incident at the City of Reedley, it was beneficial and efficient that both local agencies were able to exercise their authority under their existing legal processes.
REFERENCE MATERIAL:
BAI #7, August 8, 2023
ATTACHMENTS INCLUDED AND/OR ON FILE:
Ordinance
On file with Clerk - Summary of Ordinance
CAO ANALYST:
Ron Alexander