FEMA Extends PPE Export Restrictions, Adds Vaccine-Delivering Needles, Syringes

The Federal Emergency Management Agency will continue export restrictions for an amended list of personal protective equipment, FEMA said in a temporary final rule released Dec. 30. The rule, which now also includes syringes and hypodermic needles that deliver vaccines, expands on two previous versions issued by FEMA this year (see 2008060061 and 2004080018) and renews the export restrictions -- which were scheduled to expire Dec. 31 -- through June 30, 2021.

FEMA said it will now control exports of specific “piston syringes and hypodermic needles.” The controls will apply to piston syringes that “allow for the controlled and precise flow of liquid” and “hypodermic single lumen needles” that have “engineered sharps injury protections.”

The U.S. is unlikely to quickly produce enough needles and syringes to deliver vaccines for both the flu season and the coronavirus, FEMA said. The agency said the U.S. is already producing a “record number” of flu vaccine doses this year and expects the syringes and needles to be in “short supply,” especially as COVID-19 vaccines become widely available. “The projected domestic supply of these materials is not anticipated to meet demand,” FEMA said, adding that “production and distribution will occur over a longer period of time as a result.”

Other PPE and medical items subject to export restrictions largely remain unchanged. FEMA said controls still apply to surgical N95 filtering facepiece respirators, surgical masks, nitrile gloves and certain surgical gowns. FEMA clarified the language for its designation of surgical masks to specify that restrictions apply to masks that “cover the user’s nose and mouth providing a physical barrier to fluids and particulate materials that meet” certain “fluid barrier protection standards.” The agency also corrected several “formatting errors” in the previous version of the rule to “improve clarity and readability.”

The rule also continues the same exemptions for the items outlined in April (see 2004200019) and said FEMA will continue to work with CBP, other agencies and industry to review covered shipments. The agency said it aims to issue decisions on detained exports “as soon as possible.”

FEMA said it renewed the export restrictions over certain PPE because of the large “number of open requests” for the goods by U.S. state, local, tribal and territorial jurisdictions. While the number of requests has decreased since FEMA last renewed the restrictions, the agency said it does not expect U.S. supply of surgical N95 masks “to catch up with demand at this time” due to “increases in confirmed cases and hospitalizations.” As of Dec. 9, FEMA said it had open requests from states and jurisdictions for more than 13 million surgical masks, more than 168 million nitrile gloves and more than 1.2 million surgical gowns.

Although the U.S. has taken “preventative and proactive measures to slow the spread of COVID-19,” FEMA said “the current surge of confirmed COVID-19 cases and deaths within the Nation’s communities is straining the Nation’s healthcare systems.” The agency said “it is imperative that health and medical resources needed to respond to the spread of COVID-19, including the PPE and other health and medical resources affected by this rule, continue to be allocated for domestic use.”