On April 10, 2020, FEMA published a temporary final rule giving the Agency the authority to block the export of critical PPE during the COVID-19 pandemic, including masks, respirators (and their filters and cartridges), non-sterile gloves and surgical gloves. The rule is effective until August 8, 2020.
Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use
The rule requires FEMA approval before covered materials can be exported from the U.S. The covered materials are:
- N95 Filtering Facepiece Respirators;
- Other Filtering Facepiece Respirators (e.g., those designated as N99, N100, R95, R99, R100, or P95, P99, P100), including single-use, disposable half-mask respiratory protective devices that cover the user’s airway (nose and mouth) and offer protection from particulate materials at an N95 filtration efficiency;
- Elastomeric, air-purifying respirators and appropriate particulate filters/cartridges;
- PPE surgical masks, including masks that cover the user’s nose and mouth and provide a physical barrier to fluids and particulate materials; and
- PPE gloves or surgical gloves.
Any covered materials attempted to be exported will be detained by U.S. Customs and Border Protection and then inspected by FEMA. Before any shipments of covered PPE can leave the country, FEMA will decide whether permitting a shipment to be exported is consistent with promoting national defense. In making this decision, FEMA can consult with other agencies and consider:
- The need to ensure that scarce or threatened items are appropriately allocated for domestic use;
- Minimizing disruption to domestic and global supply chain;
- Circumstances surrounding the distribution of PPE and potential hoarding or price gouging;
- Quantity and quality of materials;
- Humanitarian considerations; and
- International relations and diplomatic considerations.
The rule states that FEMA will review and make determinations quickly to minimize supply chain disruptions.
Exception to Export Rules
Manufacturers with contracts executed before January 1, 2020, who have distributed 80 percent of their production within the U.S. in the previous 12 months are exempt from the rule. The FEMA administrator may also develop additional exemptions under the rule.
Practical Takeaways
The rule reflects other federal government initiatives to increase the availability of PPE to address the COVID-19 pandemic. It is unclear whether FEMA will strictly or flexibly apply the rule, as it gives broad parameters for application. For example, the covered materials enumerated were intended to reflect domestic scarcity but could be broadened to include other categories of goods, such as face shields or food safety gloves. However, FEMA’s tracking of PPE and limiting exports will likely improve coordination to distribute PPE to providers and entities that need it most.
For more information about FEMA’s relief efforts for health care providers, for assistance related to FEMA Public Assistance or any questions related to this matter, please contact:
- Melissa Markey at (248) 457-7853 or mmarkey@wp.hallrender.com;
- Drew Howk at (317) 429-3607 or ahowk@wp.hallrender.com; or
- Your regular Hall Render attorney.
Special thanks to Macauley Rybar, law clerk, for his assistance with the preparation of this article.
Hall Render’s attorneys and professionals continue to maintain the most up-to-date information and resources at our COVID-19 Resource page, through our 24/7 COVID‑19 Hotline at (317) 429-3900, or your regular Hall Render attorney.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
