. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/470
26 July 2001
(01-3709)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
1. Member to Agreement notifying:  UNITED STATES
If applicable, name of local government involved:           
2. Agency responsible:  Department of Agriculture, Animal and Plant Health Inspection
Service - APHIS
3. Products covered (provide tariff item number(s) as specified in national schedules
deposited with the WTO; ICS numbers may be provided in addition, where
applicable).  Regions or countries likely to be affected, to the extent relevant or
practicable:  Viruses, serums, toxins, and analogous products
4. Title and number of pages of the notified document:  Viruses, Serums, Toxins, and
Analogous Products; Erysipelothrix Rhusiopathiae Bacterin (4 pages)
5. Description of content:  The Animal and Plant Health Inspection Service is proposing to
amend the regulations regarding the standard requirement for Erysipelothrix Rhusiopathiae
Bacterin to specify that those requirements apply only to bacterins recommended for use in
swine and turkeys, to require that the immunog enicity of such bacterins be demonstrated in
a host animal protection study, to establish "protection to market weight/age" as the
minimum duration of immunity requirement, a nd to replace the current mouse protection
potency test used for serial release with an in vitro potency test.  We are proposing these
changes as a result of our evaluation that showed that some swine vaccinated with
Erysipelothrix Rhusiopathiae Bacterins that meet the current standard requirement may be
diagnosed with acute erysipelas infection before they reach market age.  These actions
would update the regulations by standardizing the efficacy and duration of immunityrequirements, provide for the use of a validated serial release potency test, and ensure that
serials that pass the serial release potency test will also protect swine and turkeys to market
weight.
6. Objective and rationale: [    ] food safety,  [  X ] animal health,  [    ] plant protection,
[    ] protect humans from animal/plant pest or disease, [    ] protect territory from
other damage from pests           
7. An international standard, guideline or recommendation does not exist [  X ].
If an international standard, guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:
8. Relevant documents and language(s) in which these are available:  66 FR 37194,
17 July 2001 (Available in English)
9. Proposed date of adoption:  To be determined.G/SPS/N/USA/470
Page 2
10. Proposed date of entry into force:  To be determined.
11. Final date for comments:  APHIS invites you to comment. We will consider all comments
that we receive by 17 September 2001.
Agency or authority designated to handle comments:  Animal and Plant Health
Inspection Service [    ] National notification authority, [     ] National enquiry point, or
address, fax number and E-mail address (if available) of other body:  Detailed
instruction on where and how to send comments is in the body of the full text - which willbe sent upon request to the address in paragraph 12.
12. Texts available from: [  X ] National notification authority, [  X ] National enquiry point
or address, fax number and E-mail address (if available) of other body:
United States SPS Enquiry Point/Notification Authority
USDA/FAS/FSTSD
ATTN: Carolyn F. Wilson
Room 5545 South Agriculture BuildingStop 1027
1400 Independence Avenue, S.W.
Washington, D.C. 20250
Tel:  (202) 720-2239
Fax:  (202) 690-0677
E-mail:  ofsts@fas.usda.gov