Fresno County plans to inspect biological research labs. It follows Reedley crisis
Still reeling from the discovery a year ago of a biological laboratory operating secretly – and illegally – in the city of Reedley, Fresno County supervisors unanimously gave initial approval to an ordinance requiring annual inspections of any privately-funded biological research labs that are not regulated under federal law.
The new “Fresno County Infectious Materials Ordinance” passed on a 5-0 vote Tuesday, paving the way for a second reading and final approval on Jan. 9.
Joe Prado, the county’s assistant health department director, said inspections could begin as soon as February or March in cities that ink agreements with Fresno County for health inspectors to conduct unannounced visits to check on their compliance with regulations for biological or infectious disease materials or hazardous waste.
The new ordinance would not apply to labs at hospitals, medical clinics or doctors offices, or commercial diagnostic testing labs, which are already regulated under the federal Clinical Laboratories Improvement Amendments law, or those that have been issued waivers to those regulations.
But it would apply to private labs that receive no public funds for their work. “We don’t think there are a lot of these private labs, but we’re going to find out under this ordinance,” Public Health Director David Luchini said.
WHAT TRIGGERED THIS ORDINANCE?
It was in December 2022 when Jesalyn Harper, a code enforcement officer with the city of Reedley, noticed a green garden hose sticking through the back exterior wall of a large warehouse in the heart of downtown, a code violation. In an inspection, Harper noticed dozens of refrigerators and freezers and an array of laboratory equipment in storage, as well as hundreds of laboratory mice. She also spotted other code violations including electrical modifications made to provide power to the refrigerators and freezers.
The lab was later discovered to be linked to a pair of Chinese-owned companies, Univeral Meditech Inc. and Prestige Biotech Inc., that were operating without a business license after abruptly relocating from Fresno following a dispute with their landlord.
Eventually, collaborative inspections by city, county, state and federal agencies resulted in the closure of the warehouse in March 2023. Among the materials discovered in the lab were an array of viral, bacterial and parasitic agents including chlamydia, E. coli, streptococcus, Hepatitis B and C, human herpes, HIV (the virus that causes AIDS), rubella [measles] and malaria, [also ebola, sars cov2 and others marked in Chinese - that CDC refused to handle and asked they be destroyed, i suppose] as well as numerous laboratory chemicals and cases upon cases of various medical testing kits, including pregnancy tests and COVID-19 tests.
Ultimately, investigations led to the arrest in October of the alleged operator of the lab, a Chinese resident named Jia Bei Zhu, who also goes by the name David He. He faces federal charges of manufacturing and distributing misbranded medical devices and making false statements to federal investigators. Zhu remains in the Fresno County Jail as his case moves through the federal court process.
The discovery of the biological agents at an unlicensed lab stirred a furor of concern, not only for public safety from possible contamination from the materials, but also exposed what Reedley city leaders and county officials described as a loophole in federal laboratory regulations, from which privately funded labs are exempt.
PLUGGING A REGULATORY LOOPHOLE
Earlier this year, the city of Fresno took its own steps to adopt an ordinance requiring code-enforcement inspections of private biological laboratories in an effort to prevent a planned return to Fresno by Universal Meditech.
With Tuesday’s action, county health officials expressed hoped that others among Fresno County’s 15 incorporated cities would enter agreements to allow county inspectors to conduct visits to labs that would fall under the new ordinance in each city. Prado said it will be up to each city to scrutinize operating statements from companies obtaining business tax permits for any references to laboratory operations. The county will provide cities with a link to a national database website of CLIA-regulated labs. “If they’re not on that list, they can refer them to us” for inspections, Prado said.
“There’s going to have to be training in every city that signs on for what to look for,” Prado said. “It’s going to be like a welcome package for the cities that sign on.”
In instances like the Reedley lab, however, in which the operator surreptitiously moved in without getting a business license from the city, it will require each community’s code-enforcement inspectors to keep an eye out for unusual activity. “We all have to be vigilant in our communities,” Prado said. “If there’s a new business or something going on, and people see medical waste trucks, that could be something. … It’s going to be the code enforcement officers out there looking, and if they see something, they can refer it to us” for inspections.
Beside annual inspections, there will be annual site certifications to ensure that labs are operating in compliance with their various permits, Luchini said. “If they don’t have a permit, it means this lab is out of compliance” and subject to operations being suspended or shut down.
PUSHING FOR FEDERAL LAB LEGISLATION
While the local ordinance is a step for Fresno County, it will carry no weight for other counties either in California or across the country. That’s why Zieba and others are advocating for federal legislation to extend the CLIA regulations to cover privately operated labs.
“Why we want national legislation is that is not just to protect us from the Prestige Biotechs and Universal Meditechs,” Zieba said Tuesday, “but if Congress doesn’t take action to have a blanket regulation covering the country, what this country will end up with is a patchwork of regulations that will harm private research and development labs.”
Zieba described the new Fresno County ordinance as “an incredibly important stop-gap measure, a step to keep this county safe while we wait for the federal government to keep our nation safe.”
In a video message, Rep. Jim Costa, D-Fresno, said a report by the House Select Committee on the Chinese Communist Party on the Reedley lab investigation also noted gaps in federal law “that really allow bad actors to take advantage of the current system.”
Costa added that he is working with other members of Congress to strengthen federal oversight of private labs and greater accountability for federal agencies tasked with enforcing the regulations.
In the meantime, however, Costa said, “this ordinance really will provide a template for other counties throughout California and working throughout the country to ensure we have a seamless effort of oversight for public safety between the local, state and federal officials."
