G/TBT/N/USA/1673  
2 December 2020  
(20-8676) 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 AMERICA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Centers for Disease Control and Prevention's (CDC), National 
Institute for Occupational Safety and Health (NIOSH), Health and Human Services (HHS) 
[1702]  
Name and address (including telephone and fax numbers , email and website 
addresses, if av ailable) 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 [   ], 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; Breathing appliances and gas masks (excl. protective 
masks having neither mechanical parts nor replaceable filters, and artificial respiration or 
other therapeutic respiration apparatus) (HS 9020); Quality (ICS 03.12 0), Medical 
equipment (ICS 11.040), Test conditions and procedures in general (ICS 19.020)  
5. Title, number of pages and language(s) of the notified document:  21 August 2020 
Conformity Assessment Letter to Manufacturers, NIOSH CA 2020 -1031 (3 page(s), in 
English)  
6. Description of content:  The coronavirus disease 2019 (COVID -19) outbreak has placed 
enormous strain on the resources of the National Institute for Occupational Safety and 
Health (NIOSH). In response to the nation's effort to control the spread  of COVID -19, and 
to utilize resources more effectively, NIOSH is accepting and prioritizing certain 
applications to increase the supply of NIOSH -approved particulate filtering (air -purifying) 
respirators and ensure quality products providing the intended protections are 
available.   The applications accepted can include those seeking or modifying approval for 
filtering facepiece respirators (FFR), half mask and full facepiece air -purifying respirators 
(APR) and powered air -purifying respirators (PAPR). Duri ng the response, NIOSH is not 
accepting applications for approval of FFRs with novel head suspensions, e.g. ear 
loops.   NIOSH is focusing its resources to approve designs with traditional two head -strap 
suspensions, commonly used in respirator designs demo nstrating the fit and protection 
required by the Occupational Safety and Health Administration (OSHA), U.S. Department 
of Labor (DOL).  
7. Objective and rationale, including the nature of urgent problems where 
applicable:   Protection of human health or saf ety; Quality requirements  G/TBT/N/USA/1673  
 
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  8. Relevant documents:   
• NIOSH Conformity Assessment Letter to Manufacturers NIOSH CA 2020 -1031 
August 2020: 
https://www.cdc.gov/niosh/npptl/resources/pressrel/letters/conformitymanuf/p
dfs/CA -2020-1031-P.pdf 
• National Personal Protective Tec hnology Laboratory (NPPTL), Conformity 
Assessment Notices and Letters to Respirator Manufacturers and Interested 
Parties: 
https://www.c dc.gov/niosh/npptl/resources/pressrel/letters/conformitymanuf/C
A-2020-1031.html  
9. Proposed date of adoption:  21 August 2020  
Proposed date of entry into force:  21 August 2020  
10. Final date for comments:  None 
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_7412_00_e.pdf