California $1B mask order faces new doubt after federal regulators call product 'not acceptable'
OAKLAND — Federal regulators said Wednesday they rejected certification earlier this month of the N95 masks that California had ordered from a Chinese firm in a massive $990 million purchase, a starker characterization of what transpired than Gov. Gavin Newsom gave last week.
The National Institute for Occupational Safety and Health did not detail its reasons for denying the company BYD, saying an on-site assessment of the company’s N95-model respirators deemed the equipment “not acceptable” on May 4. BYD can tweak its design and again seek approval under an expedited review process, federal regulators said.
"The review of the documentation provided to NIOSH for the design, manufacturing and quality inspection of the device was concerning," the agency said in a statement.
A week ago, Newsom conceded that the deal was running into problems, saying it had been "delayed" by a snag in federal approval. A May 6 contract amendment subsequently released by California showed that BYD had to refund nearly $250 million that was budgeted for some 300 million N95s — an agreement that was conditioned on federal approval.
Office of Emergency Services spokesperson Brian Ferguson noted that California's contract stipulated the state would not pay any money for equipment that was not certified.
"It is a condition of the contract, and is incumbent upon the vendor to obtain this required certification," Ferguson said in a statement. "We remain optimistic that the vendor will meet its obligations. Should the contractor fail to meet that high standard, we have built in strong provisions to protect the state."
Federal officials had told BYD the masks did not pass muster two days before Newsom publicly acknowledged the masks would not be arriving as planned.
BYD said Wednesday in a statement that the issues identified by federal inspectors were "related to documentation control paperwork" and are "easily fixable." The company shared a document showing the masks had passed tests of their breathing features.
Reached by phone, BYD North America spokesperson Frank Girardot said the problem was with “document control” related to engineering paperwork and different versions of the models. He said the company was working with NIOSH on a corrective action plan and that it would resubmit the masks for certification.
“We remain confident that we will meet the deadlines,” he said.
The N95 masks are in particularly high demand because they afford far more protection to frontline workers than surgical masks. Newsom won national praise in early April when he announced he'd secured hundreds of millions of N95 masks during an appearance on "The Rachel Maddow Show" as hospital workers struggled to find supplies and California feared a surge in patients that the state predicted could overwhelm hospitals by May.
Despite those N95 masks remaining uncertified, Ferguson said Wednesday the BYD deal "has already proven to be successful, having delivered more than 18 million surgical masks. These life-saving masks have been key to the state’s ability to reopen the economy and protect public health and safety." The state agreed to buy those masks at 55 cents a piece, meaning the state has spent roughly $10 million on those so far.
Newsom had already faced scrutiny for agreeing to buy roughly $1 billion worth of personal protective equipment from BYD as California plunged into the global competition for scarce coronavirus gear. When lawmakers expressed frustration about a lack of details around the purchase, Newsom officials warned that revealing too much could scuttle the deal.
The BYD mask deal was one of multiple Newsom administration PPE pacts that have fallen through. Administration officials have defended those missteps as outliers in a chaotic and ever-evolving market, where fierce competition has fueled fraud.