U.S. Prohibits Exports of Personal Protective Equipment

On April 10, 2020, the Department of Homeland Security (“DHS”), through the Federal Emergency Management Agency (“FEMA”), issued a new rule at 44 C.F.R. Part 328 prohibiting exports of certain PPE (“Subject PPE”) used in the global response to the COVID-19 pandemic (the “FEMA Rule”).¹ The FEMA Rule, which is being implemented in conjunction with U.S. Customs and Border Protection (“CBP”), is retroactive effective to April 7, 2020 and will remain in place until August 10, 2020.

Background

On April 3, 2020, President Trump issued a Presidential Memorandum establishing a U.S. policy to prevent exports of scarce PPE outside of the United States.² The Presidential Memorandum instructed DHS, through FEMA, to consult with Health and Human Services to implement the policy. The FEMA Rule implements the policy.

Export Restrictions

Effective April 7, 2020, all exports of Subject PPE (defined below) are prohibited unless FEMA provides explicit approval for the export. The FEMA Rule is not limited to exports by PPE manufacturers. It covers all parties, including U.S. companies exporting to their subsidiaries, and it applies regardless of whether there is a commercial sale.³

The Subject PPE are:

1. N95 Filtering Facepiece Respirators, including devices that are disposable half-face-piece non-powered air-purifying particulate respirators intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates;
   
2. 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 level per 42 CFR 84.181;
   
3. Elastomeric, air-purifying respirators and appropriate particulate filters/cartridges;
   
4. PPE surgical masks, including masks that cover the user’s nose and mouth and provide a physical barrier to fluids and particulate materials; and 
5. PPE gloves or surgical gloves, including those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and such gloves intended for the same purposes. 

This list of Subject PPE is current as of the Federal Register notice and the date of this OnPoint. However, the FEMA Rule grants FEMA the authority to make a future determination that additional items are “scarce and necessary for national defense.” If FEMA makes such a determination, it can add items to the list of products prohibited for export.

The Subject PPE list presently does not include other medical gear or sanitation items such as protective clothing, disinfectants and soaps, thermometers and hand sanitizers.

FEMA Approval

In considering a proposed export of Subject PPE, FEMA is to consider the “totality of the circumstances.” The FEMA Rule provides a list of factors to be considered:

1. The need to ensure that scarce or threatened items are appropriately allocated for domestic use;
2. Minimization of disruption to the supply chain, both domestically and abroad;
3. The circumstances surrounding the distribution of the materials and potential hoarding or price-gouging concerns;
4. The quantity and quality of the materials;
   
5. Humanitarian considerations; and
6. International relations and diplomatic considerations.

FEMA Application Process

Companies can submit export applications to FEMA by letter. While FEMA does not have a form, we suggest addressing each of the factors and including information that would be included in a commercial export license application to the Bureau of Industry and Security.

The FEMA Rule notes the agency will make a determination on the export of Subject PPE “within a reasonable timeframe” but does not provide any deadlines.

In deciding whether to apply to FEMA, exporters should be aware that FEMA’s determination may not be limited to approving or denying the export. FEMA may require the PPE to be returned for domestic commercial order, or issue a “rated order” to procure the PPE under its authority pursuant to the Defense Production Act. FEMA is most likely to approve smaller shipments where there is a compelling argument as to how the exports support U.S. national security objectives.

Conclusion

For companies that need to export PPE for critical reasons, we suggest quickly preparing an application before FEMA receives more applications than it can handle.

Footnotes

1) Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use, 85 Fed. Reg. 20195 (Apr. 10, 2020).

2) The White House, Memorandum on Allocating Certain Scarce or Threatened Health and Medical Resources to Domestic Use (Apr. 3, 2020), available at https://www.whitehouse.gov/presidential-actions/memorandum-allocating-certain-scarce-threatened-health-medical-resources-domestic-use/.

3) There is a limited exception for pre-existing commercial sales. FEMA will not purchase covered materials from shipments made by or on behalf of U.S. manufacturers with continuous export agreements with customers in other countries since at least January 1, 2020, so long as at least 80 percent of such manufacturer’s domestic production of covered materials, on a per item basis, was distributed in the United States in the preceding 12 months. See new 44 C.F.R. 328.102(c).