16 October 2008
N-95 Respirator fit-testing required for US postal carriers to receive a "Household Antibiotic Kit" (doxycycline) for use during an Anthrax attack
On October 3, 2008 a letter was
sent from the Food and Drug Administration (FDA)/HHS Deputy Commissioner for
Policy (Randall Lutter, Ph.D.) to the Director of the Biomedical Advanced
Research and Development Authority (BARDA)/HHS (Robin Robinson, PhD) in
response to BARDA's request for the FDA "to issue an Emergency Use
Authorization (EUA) for the pre-event provision and potential use of
doxycycline hyclate tablet emergency kits for inhalational
anthrax...specifically for eligible United States Postal Service (USPS)
participants in the Cities Readiness Initiative (CRI)...and their household
members." The complete 17-page pdf can be accessed via the FDA website at:
A brief but critically important reference in the letter from the FDA to BARDA appears on page 9, and in a footnote (#20) on page 12, stating the requirement for successful N-95 respirator fit-testing in order for US Postal Service (USPS) postal carriers to be eligible to receive the Household Antibiotic Kit (HAK):
Page 9: "Policies and procedures must also include screening for fitness to receive OSHA-required personal protective equipment (PPE) (i.e., N-95 masks) and provision of PPE to eligible USPS participants. "
Page 12: "USPS postal carriers are not eligible to receive a doxycycline hyclate tablet emergency kit if they have not passed their N-95 mask fit test."
The explicit rationale for successful N-95 fit-testing is not stated in this letter. Given that inhalational anthrax is NOT transmitted from person-to-person, however, the rationale is most likely due to concern that anthrax spores in the environment following an aerosolized release (attack) might put the postal carriers at risk of infection when they are delivering preventive antibiotics to persons in their homes.
If this is the actual rationale for use of N-95 respirators as part of the PPE to be worn by postal workers delivering antibiotics to the homes of persons who were possibly exposed to aerosolized anthrax spores as part of the Cities Readiness Initiative, then a key part of the associated risk communication will need to focus on explaining this rationale to the general public, who are unlikely to have N-95 respirators for their own use.
Such risk communication could be a formidable challenge.
Daniel R. Lucey, MD, MPH
Adjunct Professor of Microbiology and Immunology
Website for this posting: www.BePast.org