G/TBT/N/USA/1216  
 
4 November 2016  
(16-6039) 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 : Food and Drug Admini stration (FDA), Health and Human Services 
(HHS) [1235]  
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 d ifferent from above : 
Please submit comments to : USA WTO TBT Enquiry Point  
Email : usatbtep@nist.gov   
3. Notified under Article 2.9.2 [ X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], other : 
4. Products covered (HS or CCCN whe re applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable) : Ozone -depleting 
substances . Medical equipment (ICS : 11.040), Air quality (ICS : 13.040), Aerosol containers 
(ICS: 55.130), Products of the chemical  industry (ICS : 71.100)  
5. Title, number of pages  and language(s)  of the notified document : Use of Ozone -
Depleting Substances (5 pages, in English)  
6. Description of content : The Food and Drug Administration (FDA, the Agency, or we) is 
proposing to amend  its regulation on uses of ozone -depleting substances (ODSs), including 
chlorofluorocarbons (CFCs), to remove the designation for certain products as "essential 
uses" under the Clean Air Act. Essential -use products are exempt from the ban by FDA on 
the use  of CFCs and other ODS propellants in FDA -regulated products and from the ban by 
the Environmental Protection Agency (EPA) on the use of ODSs in pressurized dispensers. 
This action, if finalized, will remove the essential -use exemptions for sterile aerosol  talc 
administered intrapleurally by thoracoscopy for human use and for metered -dose atropine 
sulfate aerosol human drugs administered by oral inhalation. FDA is proposing this action 
because alternative products that do not use ODSs are now available and because these 
products are no longer being marketed in versions that contain ODSs.  
7. Objective and rationale , including the nature of urgent problems where 
applicable : Protection of the environment  
8. Relevant documents : 
 81 Federal Register (FR) 74364, 26 October 2016; Title 21 Code of Federal 
Regulations (CFR) Part 2.  Will appear in the Federal Register when adopted.  
 Use of Ozone -Depleting Substances, Direct Final Rule published 26 October 2016 will 
be notified as Add.1 : https://www.gpo.gov/fdsys/pkg/FR -2016-10-26/html/2016 -
25851.htm ; https://www.gpo.gov/fdsys/pkg/FR -2016-10-26/pdf/2016 -25851.pdf  G/TBT/N/USA/1216  
 
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  9. Proposed date of adoption : To be determined  
Proposed date of entry into force : To be determined   
10. Final date for comments : 27 December 2016  
11. Texts available from : National enquiry point  [ ] or address, telephone and fax 
number s and e mail and web site address es, if available , of other body : 
https://members.wto.org/crnattachments/2016/TBT/USA/16_4574_00_e.pdf