After settling with the U.S. Environmental Protection Agency (EPA) over environmental violations at one of its former plants, Genentech is on the hook for a fine of $158,208.The findings came out of a 2021 inspection of the company's now-closed plant in South San Francisco. During the visit, EPA inspectors found several instances of the company skirting requirements related to the disposal of hazardous materials, the agency said.
For one, the company stored waste without a permit and didn’t correctly monitor air emissions from the materials, according to the EPA.
Plus, the overfill protection controls for a hazardous waste tank weren’t maintained at all, the agency said. Inspectors also found manifests for the waste that didn’t include all necessary federal waste codes.
“When a company fails to comply with hazardous waste storage and monitoring requirements, that company puts workers and communities at risk of harmful exposures,” EPA pacific southwest regional administrator Martha Guzman said in the EPA’s release.
Genentech “immediately implemented several new measures” and strengthened existing ones to address the EPA’s findings “as soon as we were made aware of them,” a company spokesperson told Fierce Pharma in an emailed statement.
“Of note, the EPA did not identify any releases of hazardous waste emissions and found no condition that presented a substantial risk to human health or the environment,” the spokesperson added.
Genentech’s South San Francisco campus is home to more than 40 buildings with various functions. In March, the company executed its long-held plan to wind down operations at its South San Francisco production facility, laying off roughly 265 employees in the process. Most staffers were transferred to a new clinical supply center on the campus, an executive told Fierce Pharma in an interview at the time.
The plant was built in the late 1970s. Since then, the facility has been a launchpad for 14 molecules.
Now, Genentech is turning to a new launch center in Oceanside, California, for some of its production needs. That $450 million plant will be “essentially a replica” of the South San Francisco site, vice president and general manager of Oceanside biologics operations, Nazeli Dertsakian, said in a February interview with Fierce Pharma.
Construction at that facility should wrap up in 2024.

Reference: https://www.raps.org/News-and-Articles/News-Articles/2023/8/Recon-FDA-Oks-J-J%E2%80%99s-Talvey-for-blood-cancer;-Novo