. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/770/Add.1
24 February 2004
(04-0774)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
Addendum
The following communication, dated 19 February 2004, is being circulated at the request of
the Delegation of the United States.
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Products using Lactic Acid, n-Butyl Ester, (S) and Lactic Acid, Ethyl Ester, (S); Exemption from the
Requirement of a Tolerance
In the Federal Register of 11 July 2003 (68 FR 41351) (FRL-7315-8) and in G/SPS/N/770,
EPA issued a notice announcing the filing of amendments to pesticide tolerance petitions (PP 5E4510
and 5E4515) by PURAC America Inc., 111 Barclay Boulevard, Lincolnshire, IL  60069.  There were
no comments received in response to the notice of filing.
The petitions requested that 40 CFR 180.950 be amended by establishing two exemptions
from the requirement of a tolerance for residues of lactic acid, n-butyl ester, (S) and lactic acid, ethyl
ester, (S), CAS Reg. Nos. 34451-19-9 and 687-47-8, respectively.  These are the stereochemical
isomers of lactic acid, n-butyl ester and lactic acid, ethyl ester.
PURAC did not submit any new information as part of the amended petitions.  PURAC is
relying on the studies that were submitted in support of their 1995 petitions.
In response to the original pesticide petitions (5E4510 and 5E4515) submitted in 1995 by
PURAC, EPA established tolerance exemptions for la ctic acid, n-butyl ester and lactic acid, ethyl
ester.  For a discussion of the information submitted and the results of the Agency's review andevaluation, see the Federal Register of 3 September 2002 (67 FR 56225) (FRL-7196-6).  In
establishing these two tolerance exemptions, EPA identified the two chemical substances bynomenclature and CAS Reg. Nos. in what could be  termed a general or non-specific manner.  The
general CAS Reg. Nos. are correct and do adequately identify the two lactic acid esters.
PURAC is now requesting that the Agency establish tolerance exemptions for the (S)
isomers of lactic acid, ethyl ester (S) and lactic acid, n-butyl ester (S).  Based on the information in
the record, summarized in this preamble, and the Final Rule published on 3 September 2002, EPA
concludes that there is a reasonable certainty of no harm from aggregate exposure to residues of lactic
acid, n-butyl ester, (S) and lactic acid, ethyl ester, (S).  Accordingly, EPA finds that exempting lacticacid, n-butyl ester, (S) (CAS Reg. No. 34451-19-9 ) and lactic acid, ethyl ester, (S) (CAS Reg.
No. 687-47-8) from the requirement of a tolerance will be safe.
This regulation is effective 28 January 2004.  Objections and requests for hearings,
identified by docket ID number OPP-2003-0341, must be received on or before 29 March 2004.G/SPS/N/USA/770/Add.1
Page 2
The full text of this addendum (final rule) can be found at the address below.
DOCID:  fr28ja04-9, Federal Register:  28 January 2004 (Volume 69, Number 18),
Page 4073-4077; http://www.epa.gov/fedrgstr/EPA-PEST/2004/January/Day-28/p1447.htm;
Available in English.
Public Information and Records Integrity Branch, Information Resources and Services
Division (7502C), Office of Pesticide Pr ograms, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.  opp-docket@epa.gov.  Note:  identify
docket ID number "OPP-2003-0341" in the subject line.
Ms. Julie Morin, United States SPS Enquiry Point Officer, USDA Foreign Agricultural
Service, Food Safety and Technical Services Division, Stop 1027, Washington, DC  20250.Tel:  (202) 720-4051, Fax:  (202) 720-7772, E-mail:  fstsd@fas.usda.gov
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