If NIOSH certification is not obtained on May 31, BYD will lose all subsequent purchase orders for California N95 masks.
Editor’s note: This article from the public micro-channel number ” travel a passenger “(ID: carcaijing) , author: Shi Zhiliang team.
BYD, the world ’s largest mask manufacturer with a daily output of over 20 million pieces, is caught in the US mask export trouble.
The N95 mask produced by BYD was originally planned to be certified by the National Institute of Occupational Safety and Health (NIOSH) before May 8. According to the purchase contract previously signed between BYD and the California government, if the certification is not obtained before May 8, all advance payments will be refunded.
As of May 8, the N95 masks produced by BYD have not yet obtained NIOSH certification. Therefore, the California government and BYD negotiated to modify the delivery date and refund date.
According to the latest contract, BYD needs to refund half of the deposit to the California government (US $ 247.5 million). At the same time, if BYD cannot obtain NIOSH certification before May 31, BYD will refund all the deposit, but the contract does not set compensation clauses. The above deposit accounted for about 2.7% of BYD’s 2019 revenue.
In addition to the 300 million N95 masks, there are 250 million N95 alternative N95 orders. The contract also involved 100 million surgical masks. Because surgical masks do not require NIOSH certification, BYD may be able to keep this part of the order.
BYD said to a traveler that it is currently tracking the order, and any further information will be disclosed in time.
NOISH is BYD ’s exam
As of May 7, BYD masks have received the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA).
The process of obtaining the EUA for BYD masks is slightly thrilling. Most of the Chinese manufacturers in the same batch have gone through the process of certification and cancellation, and BYD has kept its own license.
On April 3, due to the severe shortage of N95 masks, the FDA allowed the import of masks with similar functions, but not tested by the US regulatory agency, namely KN95 masks, of which BYD was listed.
At that time, the FDA only required the inspection of these masks by certified testing laboratories to prove that they met the standards of the US Centers for Disease Control and Prevention (CDC). These standards require masks to filter 95% of particles with a diameter of 0.3 microns and above, including new coronaviruses.
After issuing an emergency use permit, FDA began to conduct simultaneous testing of these masks. A month later, on May 7, the FDA believed that “too many masks imported from China failed to filter a sufficient percentage of particles, and one of them even filtered only about 1% of the particles”, withdrawing more than 80% due to poor quality. With this permission, the number of Chinese N95 mask manufacturers approved for export to the United States has been sharply reduced from 80 to 14.
The BYD mask is one-fourth of the FDA’s test, but this is not the end point, it also needs to pass the higher standard NIOSH certification. Although the mask option is included in the EUA, most N95 masks are certified by NIOSH.
NIOSH was founded in 1970 and is affiliated with the US Centers for Disease Control. According to official guidelines, masks that lack this certification can only be used as an alternative, and only masks that have obtained NIOSH certification can really be reassuring.