. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/770
30 July 2003
(03-4045)
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 should be provided in addition, where
applicable):  Any product that carries the pesticide Lactic Acid, n-Butyl Ester and Lactic
Acid, Ethyl Ester when used in accordance with good agricultural or manufacturing
practices
4. Regions or countries likely to be affected, to the extent relevant or practicable:  Any
US trading partners.
5. Title, language and number of pages of the notified document:   Lactic Acid, n-Butyl
Ester and Lactic Acid, Ethyl Ester; Notice of Filing a Pesticide Petition to Establish a
Tolerance for a Certain Pesticide Chemical in or on Food  (Available in English, 2 pages)
6. Description of content:  EPA has received an amendment to pesticide petitions PP
5E4510 and 5E4515 from PURAC America, Inc.  proposing, pursuant to section 408(d) of
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFRpart 180 the existing exemption from the requirement of a tolerance for lactic acid, n-butyl
ester (CAS No. 138-22-7) and lactic acid, ethy l ester (CAS No. 97-64-3), to also include
lactic acid, n-butyl ester, (S) (CAS No. 34451- 19-9) and lactic acid, ethyl ester, (S) (CAS
No. 687-47-8) as also exempt from the requirement for a tolerance under 40 CFR 180.950,
when used in accordance with good agricultural or manufacturing practice.
The existing exemptions for lactic acid, ethyl ester and lactic acid, butyl ester were
established using the general CAS Registry Numbers.  These CAS numbers are correct and
do adequately identify the chemical substance.  However, the actual test substance for many
of the studies submitted by PURAC were performed using an isomeric form of the lactate
ester. The form of the lactate ester produced by fermentation from sugar can be referred toas the L (+) or the (S) isomer.  The basic chemical and physical properties for these
stereochemical isomers are identical to that of the general substances.  Use of both the
general CAS number and the (S) isomer CAS number better identify the product produced
and sold by PURAC.
7. Objective and rationale:  [  X ] food safety, [   ] animal health, [   ] plant protection,
[ X ] protect humans from animal/plant pest or disease, [   ] protect territory from other
damage from pestsG/SPS/N/USA/770
Page 2
8. International standard, gu ideline or recommendation:
[   ] Codex Alimentarius Commission, [   ] Office International des Epizooties,
[   ] International Plant Prot ection Convention, [ X ] None
If an international standard , guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:   not applicable
9. Relevant documents and language(s) in which these are available:  DOCID: fr11jy03-57,
Federal Register: 11 July 2003 (Volume 68, Number 133) Pages 41351-41353;
http://www.epa.gov/fedrgstr/EPA-PEST/2003/July/Day-11/p17619.htm (Available in
English)
10. Proposed date of adoption:  not applicable
11. Proposed date of entry into force:  not applicable
12. Final date for comments:  11 August 2003
Agency or authority designated to handl e comments:  [ X ] National notification
authority, [   ] National enquiry point, or address, fax number and E-mail address (ifavailable) of other body:
Public Information and Records Integrity Branch (PIRIB), Information Resources and
Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. opp-docket@epa.gov
Note: Identify docket name "OPP-2003-0227" in subject line of your response.
13. Texts available from:  [   ] National notification authority,  [ X ] National enquiry point,
or address, fax number and E-mail address (if available) of other body:
Ms. Roseanne Freese, US Department of Agriculture, Stop 1027, Washington, DC  20250.
Tel (202) 690-1642, Roseanne.Freese@usda.gov