G/TBT/N/USA/1202  
 
5 October 2016  
(16-5305) 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:  Animal and Plant H ealth Inspection Service (APHIS), Department of 
Agriculture (USDA) [1221]  
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 [  ], 5.6.2 [  ], 5.7.1 [  ], other: X 
4. Products co vered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Veterinary biological 
products . Veterinary medicine (ICS 11.220)  
5. Title, number of pages  and language(s)  of the notified d ocument:  Viruses, Serums, 
Toxins, and Analogous Products; Packaging and Labeling , (10 pages, in English).  
6. Description of content:  We are amending the Virus -Serum -Toxin Act regulations 
regarding the packaging and labeling of veterinary biological produ cts to provide for the 
use of an abbreviated true name on small final container labeling for veterinary biologics; 
require labeling to bear a consumer contact telephone number; change the format used to 
show the establishment or permit number on labeling a nd require such labeling to show 
the product code number; change the storage temperature recommended in labeling for 
veterinary biologics; require vaccination and revaccination recommendations in labeling to 
be consistent with licensing data; require label ing information placed on carton tray covers 
to appear on the outside face of the tray cover; remove the restriction requiring multiple -
dose final containers of veterinary biologics to be packaged in individual cartons; require 
labeling for bovine virus di arrhea vaccine containing modified live virus to bear a 
statement warning against use in pregnant animals; reduce the number of copies of each 
finished final container label, carton label, or enclosure required to be submitted for review 
and approval; requ ire labels for autogenous biologics to specify the organism(s) and/or 
antigen(s) they contain; and require labeling for conditionally licensed veterinary biologics 
to bear a statement concerning efficacy and potency requirements. In addition, we are 
also a mending the regulations concerning the number of labels or label sketches for 
experimental products required to be submitted for review and approval, and the 
recommended storage temperature for veterinary biologics at licensed establishments. 
These changes  are necessary in order to update and clarify labeling requirements and to 
ensure that information provided in labeling is accurate with regard to the expected 
performance of the product.  
7. Objective and rationale , including the nature of urgent problems  where applicable: 
Protection of animal or plant life or health  G/TBT/N/USA/1202  
 
- 2 - 
 
  8. Relevant documents:  81 Federal Register (FR) 59427, 30 August 2016; Title 9 Code of 
Federal Regulations (CFR) Parts 101, 103, 112, 113 and 114.  
Viruses, Serums, Toxins, and Analogous Produ cts; Packaging and Labeling - Proposed Rule 
published 13 January 2011:  
https://www.gpo.gov/fdsys/pkg/FR -2011-01-13/html/2011 -648.htm  
https://www.gpo.gov/fdsys/pkg/FR -2011-01-13/pdf/2011 -648.pdf    
9. Proposed date of adoption: 31 October 2016  
Proposed date of entry into force: 31 October 2016  
10. Final date for comments:  None 
11. Texts available from : National enquiry point  [ ] or address, telephone and fax 
number s and e mail and website address es, if available , of other body:   
https://members.wto .org/crnattachments/2016/TBT/USA/16_4125_00_e.pdf