G/TBT/N/USA/1602  
15 April 2020  
(20-2916) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  UNITED STATES OF AME RICA  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Centers for Disease Control and Prevention (CDC), Health and 
Human Services (HHS) [1629]  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
Please submit comments to: USA WTO TBT Enquiry Point, Email: usatbtep@nist.gov  
3. Notified under Article 2.9.2 [   ], 2.10.1 [X], 5.6.2 [   ], 5.7.1 [X], other :  
4. Products covered (HS or CCCN  where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Air-
purifying particulate respirators; Other breathing appliances and gas masks, excluding 
protective masks having neither mechanical parts no r replaceable filters (HS 9020); 
Quality (ICS 03.120), Medical equipment (ICS 11.040), Respiratory protective devices 
(ICS 13.340.30), Test conditions and procedures in general (ICS 19.020)  
5. Title, number of pages and language(s) of the notified documen t: Approval Tests 
and Standards for Air -Purifying Particulate Respirators (14 page(s), in English)  
6. Description of content:  Interim final rule with comment - The Department of Health 
and Human Service (HHS) is publishing this interim final rule to updat e the regulatory 
requirements used by the Centers for Disease Control and Prevention's (CDC) National 
Institute for Occupational Safety and Health (NIOSH) to test and approve air -purifying 
particulate respirators for use in the ongoing public health emerge ncy. With this 
rulemaking, parallel performance standards are added to existing regulatory 
requirements for PAPRs to allow for the approval of respirators in a new class, PAPR100, 
that may be better suited to the needs of workers in the healthcare and publ ic safety 
sectors currently experiencing a shortage of air -purifying particulate respirators due to 
Coronavirus Disease 2019 (COVID -19), the disease caused by severe acute respiratory 
syndrome coronavirus 2 (SARS -CoV-2). This rulemaking also consolidates t he technical 
standards for all types of air -purifying particulate respirators into one subpart, and 
standards pertaining to obsolete respirators designed for dust, fume, and mist; pesticide; 
and paint spray are removed from the regulation entirely. This ru lemaking will have no 
substantive impact on the continued certification testing and approval by the NIOSH 
National Personal Protective Technology Laboratory of existing PAPR class HE (high -
efficiency series) respirators or non -powered air -purifying particu late respirators, 
including N95 filtering facepiece respirators, currently in demand by healthcare workers 
and emergency responders. NIOSH expects that the addition of PAPR100 devices to the 
marketplace will help to relieve the current high demand for poss ibly hundreds of 
thousands of additional particulate filtering facepiece respirators needed specifically for 
healthcare and emergency medical response settings.  G/TBT/N/USA/1602  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protecti on of human health or safety; Quality requirements  
8. Relevant documents:   
• 85 Federal Register (FR) 20598, 14 April 2020; Title 42 Code of Federal 
Regulations (CFR) Part 84:  
https://www.govinfo.gov/content/pkg/FR -2020-04-14/html/2020 -07804.htm  
https://www.govinfo.gov/content/pkg/FR -2020-04-14/pdf/2020 -07804.pdf  
9. Propo sed date of adoption:  14 April 2020  
Proposed date of entry into force:  14 April 2020  
10. Final date for comments:  12 August 2020  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
https://members.wto.org/crnattachments/2020/TBT/USA/20_2627_00_e.pdf