Download G/TBT/N/USA/1202

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 AMERICA
If applicable, name of local government involved (Article 3.2 and 7.2):
2.
Agency responsible: Animal and Plant Health 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: [email protected]
3.
Notified under Article 2.9.2 [ ], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other: X
4.
Products covered (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 document: 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 products 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 and 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 labeling information placed on carton tray covers
to appear on the outside face of the tray cover; remove the restriction requiring multipledose final containers of veterinary biologics to be packaged in individual cartons; require
labeling for bovine virus diarrhea 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; require 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 amending 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
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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 Products; 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
numbers and email and website addresses, if available, of other body:
https://members.wto.org/crnattachments/2016/TBT/USA/16_4125_00_e.pdf