Officials address regulations on privately funded illegal Reedley lab
REEDLEY, Calif. (KFSN) -- The fallout continues over an illegal lab uncovered in Reedley, which contained hazardous materials, biological agents, and nearly one-thousand mice.
Local leaders are addressing how a lab like this, could've found its way to Fresno County.
Reedley officials say when they noticed an unpermitted lab in Reedley last December, they immediately contacted state and federal partners.
And they say while the city helped with the investigation, state and federal law loopholes allowed the business to operate.
At the end of 2022, city code enforcement staff noticed an unpermitted business operating at 850 I Street, in Reedley.
City Manager Nicole Zieba says they reached out to the county, as well as state and federal government agencies.
"From December 21st was when our federal partners started to tell us, not to tell the public yet because we didn't know what we had," said Zieba.
Fresno County Supervisor Nathan Magsig says, because the lab is a privately funded business, there were extra steps they had to take to find out more about what was going on inside.
"So initially, when the county, as well as the city of Reedley, became aware of this situation, we began to work through the courts and work through State agencies, so we could gain access to the site," said Magsig.
Through inspection and abatement warrants, they learned the lab was creating illegal covid and pregnancy tests, and testing on rodents.
But both Zieba and Magsig say they quickly confirmed there was no threat to public safety. Still, they are now calling for more regulations to ensure this doesn't happen again.
"The public doesn't need to fear for their safety, but they should have concern for how this lab started in the first place, and the federal and state loopholes that allowed privately funded labs - now these were bad actors but even legal labs - to operate within their communities and really no one knows," said Zieba.
Magsig adds they will work with legislators to create more laws to help address this.
"It appears that there are some loopholes in the law when it relates to privately funded laboratories. And so there wasn't enough oversight for Meditech and some of these other operators that were involved. So we are asking our state partners as well as the Federal Government to get involved to not only look at this site here, but make sure that something like this doesn't happen again," said Magsig.
Officials say they waited to inform the public until they knew what was taking place.
They also knew once everything was out, the company would stop communicating with investigating agencies.
EXPLAINER: What are the steps if a business wanted to open a lab?
Action News reached out to the California Department of Public health about protocols in place when it comes to labs like the illegal Reedley lab.
The state agency responded say it is working with local, state and federal partners as well as law enforcement authorities, to assess the situation at an unlicensed and unpermitted company at a warehouse in Reedley.
The California Department fo Public Health then provided what are the steps if a business wanted to open a lab:
"To receive licensure to operate a clinical laboratory in California, a business must apply through the California Department of Public Health's Laboratory Field Services (LFS) branch in the Department's Center for Laboratory Sciences (CLS). Licensure is available to and required for all clinical and public health laboratories.
In addition to a California state license, a clinical laboratory must hold a federal Clinical Laboratory Improvement Amendments (CLIA) certificate. Applications for both the state license and the federal Clinical Laboratory Improvement Amendments certificate are submitted to Laboratory Field Services, which is the state agency for the federal Centers for Medicare & Medicaid Services (CMS), which administers the federal Clinical Laboratory Improvement Amendments program.
Note that this requirement applies to clinical and public health laboratories performing diagnostic testing on specimens derived from humans for the purpose of diagnosis, prevention, or treatment of any disease or physiological condition of a human being or the assessment of the health of an individual.
Clinical laboratories are regulated under California law and federal Clinical Laboratory Improvement Amendments regulations. Neither Centers for Medicare & Medicaid Services nor Laboratory Field Services regulates laboratories performing testing for academic, research, forensic, manufacturing, or veterinary purposes.
State and federal applications for a clinical or public health laboratory license must include:
Once the application has been submitted with the required state fee, the state license application is reviewed by Laboratory Field Services. The federal certificate application is processed by Laboratory Field Services and issued by Centers for Medicare & Medicaid Services, once the federal fee has been paid.
