. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/484
6 August 2001
(01-3891)
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:  Environmental Protection Agency - EPA
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:  Pesticides
4. Title and number of pages of the notified document:  Pesticide Chemicals Not Requiring a
Tolerance or an Exemption from a Tolerance; Rhodamine B; Revocation of Unlimited
Tolerance Exemptions (5 pages)
5. Description of content:  EPA is proposing to create a new subpart E in 40 CFR part 180. This
subpart will be titled Pesticide Chemicals Not Requiring a Tolerance or an Exemption from a
Tolerance.  It will contain a list of the pesticide chemicals (including, as appropriate, their
limitations and use patterns) for which the Agency has determined that neither a tolerance nor
an exemption from the requirement of a tolerance is needed under the Federal Food Drug andCosmetic Act (FFDCA).  This document also proposes to revoke two unlimited tolerance
exemptions for the inert ingredient Rhodamine B.  These tolerance exemptions were
established under Section 408 of the FFDCA, 21 U.S.C. 346a.  EPA is proposing to revoke
these tolerances because all food-use products containing Rhodamine B have been voluntarily
cancelled.  Concurrent with the revocation of the two unlimited tolerances for Rhodamine B,
the Agency is also proposing to designate the use of the inert (other) ingredient Rhodamine B
as a dye for seed treatment only, a use for which neither a tolerance nor an exemption from therequirement of a tolerance is needed.  This determination is based on the Agency's review and
evaluation of submitted data, which indicated that there was no uptake of Rhodamine B when
used as a dye for seed treatment.  The Agency is acting on its own initiative. These regulatory
actions are part of the tolerance reassessment requirements of the Federal Food, Drug, and
Cosmetic Act (FFDCA) section 408(q), as am ended by the Food Quality Protection Act
(FQPA) of 1996.  By law, EPA is required to reassess 66 per cent of the tolerances in existence
on 2 August 1996, by August 2002, or about 6,400 tolerances.  The regulatory actions proposed
in this document, the proposed revocation of two tolerance exemptions, would be counted
toward the August 2002 deadline.
6. Objective and rationale: [  X ] food safety,  [     ] 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:G/SPS/N/USA/484
Page 2
8. Relevant documents and language(s) in which these are available:  66 FR 40170,
2 August 2001 (Available in English)
9. Proposed date of adoption:  To be determined.
10. Proposed date of entry into force:  To be determined.
11. Final date for comments:  Comments must be received on or before 1 October 2001.
Agency or authority designated to handle comments:  Environmental Protection Agency
[    ] National notification authority, [     ] National enquiry point, or address, fax number
and E-mail address (if available) of other body:  Detailed instructions on where and how to
send comments are in the body of the full text - which will be 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
Attn:  Carolyn F. Wilson
Room 5545 South Agriculture Building
Stop 1027
1400 Independence Avenue, S.W.
Washington, D.C.20250Tel:  (202) 720-2239
Fax:  (202) 690-0677
E-mail:  ofsts@fas.usda.gov