The National Nuclear Security Administration’s (NNSA) order of 225,000 Chinese-made personal respirator masks will arrive, at the soonest, weeks later than hoped.
The semiautonomous Department of Energy nuclear-weapon agency ordered the masks from suburban-Atlanta-area small business American Dream Builders on April 27 and had hoped for delivery by this past Monday, May 11.
But on Monday, instead of taking delivery of even a single mask, the NNSA had to extend the delivery date under its vendor’s $240,000, fixed-price contract to May 29. The agency had no choice, after the Food and Drug Administration (FDA) on May 7 removed the respirators the vendor planned to deliver from the list of Chinese-made respirators authorized to protect wearers in the United States from COVID-19.
“Our vendor was notified that the KN-95 manufacturer they selected was one of several manufacturers removed from the US Food and Drug Administration’s (FDA) approved manufacturers list in a May 7 revision to that list,” a spokesperson for NNSA headquarters in Washington wrote in an email Wednesday evening. “As a result, American Dream Builders requested an extension to their delivery date to identify an approved source to provide the masks. NNSA granted the extension.”
The NNSA planned to distribute the disposable respirators it ordered to its own sites, and other DOE facilities, as needed. The masks were supposed to be certified to the KN-95 Chinese standard. That is roughly equivalent to the U.S. N95 standard that signifies the face covering can, if properly fitted, filter out 95% of the particulates in the air, preventing the wearer from inhaling them.
But on May 7, the FDA said the respirators that American Dream Builders wanted to source were among those that flunked tests administered by the Centers for Disease Control and Prevention, which evaluated whether the face wear actually filtered out 95% of airborne particulates.
COVID-19, caused by the novel coronavirus that broke out in Wuhan, China, last year, is a respiratory disease that chiefly attacks the lungs, but also other body parts.
After the FDA’s May 7 culling, just over a dozen Chinese manufacturers are allowed to market their face coverings as respirators in the United States. The FDA had lopped off the approved list at least 47 Chinese respirator manufacturers, as of Thursday.
The FDA’s May 7 decision partially reversed its April 3 order that allowed some Chinese-made face coverings to be sold as respirators in the U.S., so long as either the manufacturer or the importer of the device confirmed that an independent laboratory had verified the mask met the Chinese government’s KN-95 standard. Going forward, only manufacturers will be allowed to apply for approval, the FDA said.
American Dream Builders did not reply to a Thursday email requesting comment. The company, officially organized in Georgia in 2017, has a principle address that matches a home, according to Google Maps. The same address is given for managing partner Alan Ward, according to federal records.
American Dream Builders LLC, in paperwork filed with the Small Business Administration, lists its primary line of business as “perishable prepared food manufacturing.” The company also offers residential home construction, along with trucking and freight transportation, according to Small Business Administration filings.
NNSA sites have their own stockpiles of personal protective equipment, but not always enough for every worker that needs it. The site primes can also place their own orders for protective gear, though standing guidance from the Secretary of Energy advises DOE contractors to source such equipment through the federal government.
