Federal regulators contradict California Gov. Newsom, say BYD masks denied certification
Federal regulators say certification of masks California purchased from Chinese company BYD was denied, not delayed, contradicting comments Gov. Gavin Newsom made last week.
The National Institute for Occupational Safety and Health, which regulates equipment like masks, informed BYD on May 4 that it had rated BYD’s application for mask certification “Not Acceptable,” said Katie Shahan, a spokeswoman for the federal regulator.
She declined to give specific reasons that the masks were not approved, citing NIOSH policy, but wrote that “the review of the documentation provided to NIOSH for the design, manufacturing and quality inspection of the device was concerning.”
The federal institute, known as NIOSH, is giving the company a chance to correct the issues it found, Shahan said.
“The certification of the BYD device was not delayed, NIOSH made the decision to deny the approval based on a number of factors,“ Shahan wrote in an email to The Bee on Wednesday morning.
Newsom said last week that certification was delayed.
“We needed some certification from federal (regulators), for these N95 respirator masks. That’s been delayed a little bit,” he said during a press conference. “It’s going to push back the N95s, the respirators, a few weeks.”
The Newsom administration is in contract with BYD, a China-based manufacturer, for 300 million N95 respirator masks that are thought to be most effective in protecting the wearer from contracting the coronavirus that causes COVID-19. The state’s contract with BYD, which the governor’s office released last week under pressure from lawmakers and journalists, requires that the masks secure NIOSH certification.
The more than $1 billion contract also outlines terms for the state to purchase surgical masks, believed to be less effective in preventing spread of the coronavirus. BYD has already begun sending surgical masks to the state.
“The state’s agreement with BYD has already proven to be successful, having delivered more than 18 million surgical masks,” Brian Ferguson, a spokesman for the governor’s Office of Emergency Services, wrote in an email to The Bee. “It is a condition of the contract, and is incumbent upon the vendor to obtain this required certification. We remain optimistic that the vendor will meet its obligations.”
California paid BYD nearly $500 million up front for the N95 masks, half of which has been refunded to the state because the company failed to obtain certification by the April 30 deadline set in the contract.
If California ultimately receives all the 300 million masks it agreed to buy from BYD, the state will have to repay the refunded money, Ferguson said.
The masks passed NIOSH’s physical lab tests, BYD spokesman Frank Girardot said. The issues NIOSH identified to BYD were related to “documentation control paperwork.”
“All are easily fixable,” Girardot wrote in an email to The Bee. “BYD is in daily contact with NIOSH and will coordinate with the agency to complete the qualification procedure as instructed by NIOSH by the end of May or early June.
NIOSH’s review included both physical testing of sample masks and an on-site production assessment, which was conducted in China by a contractor due to international travel restrictions, Shahan said. BYD provided the required documents and sample respirators for testing to NIOSH on April 22.
The contractor, Underwriters Laboratory, assessed the BYD production facilities in Shenzhen and Changsha in late April, Shahan said. NIOSH scientists performed physical tests on mask samples in the agency’s Pittsburgh facilities on April 23.
NIOSH fails about 30 percent of applications for respirators like BYD’s N95 masks, Shahan said, and the rate “may be higher for a manufacturer’s initial application attempt.”
This story was originally published May 13, 2020 at 12:44 PM with the headline "Federal regulators contradict California Gov. Newsom, say BYD masks denied certification."