N95 masks OKd for California
Chinese firm earns U.S. certification in a deal to ship 150 million respirators.
SACRAMENTO — California will begin receiving shipments of much-needed N95 masks from Chinese automaker BYD in the coming days after federal regulators approved the company’s respirators, Gov. Gavin Newsom announced Monday.
The masks are part of a $1-billion deal Newsom struck with BYD in April, which had been delayed after the carmaker had difficulty certifying the effectiveness of its masks. After BYD missed a second deadline to obtain the National Institute for Occupational Safety and Health certification, state officials granted the company an extension on Friday.
With the certification approval announced Monday, Newsom said the deal with BYD will ensure California has a reliable pipeline of masks to protect essential workers during the pandemic.
“Providing California’s front-line healthcare workers and responders the protective equipment they need is a critical part of our response to COVID-19,” Newsom said in a statement Monday. “This new supply of N95 masks, as well as the surgical masks this contract has already provided, are game-changing and play a crucial role in our state’s public safety and reopening strategy.”
California had originally planned to order 300 million of the highly protective respirators for $990 million, with state officials paying the company $495 million upfront. After BYD, which has a U.S. subsidiary headquartered in Los Angeles County, failed to meet a contractual deadline on April 30 for its N95 masks to be certified, the company was forced to refund half of California’s down payment. BYD missed a revised deadline of May 31 for the masks to be approved by federal regulators before the deadline was pushed back again, this time to June 12.
The state’s contract with BYD says 150 million masks will be delivered to California this month and next. California is paying $3.30 for each N95 mask. That price is higher than N95 masks would cost in nonpandemic times, but there is a worldwide shortage of the respirators, which filter 95% of particles and provide crucial protection to nurses and other essential workers.
California’s deal with BYD has been met with skepticism since Newsom announced its existence on MSNBC’s “The Rachel Maddow Show” in April. The contract was then kept under seal for a month. The governor’s office at first refused to disclose the public document or much of its details to lawmakers and journalists, citing concerns that the masks might be seized if the information was released.
In addition to the N95 masks, the state agreed to pay BYD $54.9 million to purchase 100 million surgical masks. Those masks have already been delivered to the state.
Over the next two months, BYD’s contract with California also gives the state the option of buying an additional 250 million N95 respirators for $825 million and 112.5 million surgical masks for $61.8 million.
Newsom’s office said the contract with BYD will ensure California has a sufficient supply of masks now and in the future. California’s contract with BYD required that the N95 masks meet federal health and safety standards by obtaining a NIOSH certification. It’s unclear what led to the delay for BYD to have its masks certified until Monday’s announcement.
In a statement last month to The Times, NIOSH said it notified BYD on May 4 that on-site visits to the company’s manufacturing and production facilities in China had resulted in a rating of “not acceptable.” The agency also said its “review of documentation provided to NIOSH for the design, manufacturing and quality inspection of the device was concerning.”
NIOSH declined to elaborate on the specific reasons for its denial, saying such information is confidential under federal rules, but added in a statement that the decision was “based on a number of factors.”
BYD submitted a total of four applications for N95 respirators, according to a letter from the regulatory agency. Three of the applications were denied and a fourth was withdrawn, a NIOSH official told The Times.