   
  
G/TBT/N/USA/1462  
 
10 April 2019  
(19-2311) 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 Administration (FDA), Health and Human Services 
(HHS) [1490]  
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 [X], 2.10.1 [  ], 5.6.2 [X], 5.7.1 [  ], other :  
4. Products covered (HS or CCCN  where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Mycoplasma; Quality (ICS 03.120), Laboratory medicine (ICS 11.100), Pharmaceutics 
(ICS 11.120)  
5. Title, number of pages and language(s) of t he notified document:  Revocation of 
the Test for Mycoplasma (4 page(s), in English)  
6. Description of content:  The Food and Drug Administration (FDA, Agency, or we) is 
proposing to amend the biologics regulations by removing the specified test for the 
presence of Mycoplasma for live virus vaccines and inactivated virus vaccines produced 
from in vitro living cell cultures. FDA is proposing this action because the existing test for 
Mycoplasma is restrictive in that it identifies only one test method in detai l to be used 
even though other methods also may be appropriate. More sensitive and specific methods 
exist and are currently being practiced, and removal of the specific method to test for 
Mycoplasma provides flexibility for accommodating new and evolving t echnology and 
capabilities without diminishing public health protections. This action is part of FDA's 
implementation of Executive Orders 13771 and 13777. Under these Executive orders, 
FDA is comprehensively reviewing existing regulations to identify oppor tunities for repeal, 
replacement, or modification that will result in meaningful burden reduction, while 
allowing the Agency to achieve our public health mission and fulfill statutory obligations.  
7. Objective and rationale, including the nature of urgent  problems where 
applicable:  Protection of human health or safety; Quality requirements  
8. Relevant documents:   
• 84 Federal Register (FR) 12534, 2 April 2019; Title  21 Code of Federal 
Regulations (CFR) Part 610.  Will appear in the Federal Register when adopted.  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  G/TBT/N/USA/1462  
 
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  10. Final date for comments:  17 June 2019  
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/2019/TBT/USA/19_2038_00_e.pdf  
 