Document ID: EPA-HQ-OPP-2010-0138-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-03-24T04:00Z

<EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER  >

<EPA Registration Division contact: Donald Leming, 816-510-5231>

<>

<TEMPLATE:>

<Lamberti USA Inc.>

<#091214>

<	EPA has received a pesticide petition #9E7621 from Lamberti USA Inc.,
161 Washington Street – Conshohocken, PA 19428 proposing, pursuant to
section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(d), to amend 40 CFR part 180.>

<	2. to establish an exemption from the requirement of a tolerance for>

<	40CFR§ 180.910 Alkyl polyGlucoside Esters (AGEs) group, formed by 

D-Glucopyranose, oligomeric, 6-(dihydrogen
2-hydroxy-1,2,,3-propanetricarboxylate), 1-(C8-C20 linear and branched
alkyl) ethers, sodium salts (CAS No. 1079993-97-7); 

D-Glucopyranose, oligomeric, 6-(hydrogen sulfobutanedioate), 1-(C8-C20
linear and branched alkyl) ethers, sodium salts (CAS No. 1079993-92-2) 

D-Glucopyranose, oligomeric, Propanoic acid, 2-hydroxy-, 1-(C8-C20
linear and branched alkyl) ethers (CAS No. 1079993-94-4); 

40CFR§ 180.920 Alkyl polyGlucoside Esters (AGE) group, formed by 

D-Glucopyranose, oligomeric, 6-(dihydrogen
2-hydroxy-1,2,,3-propanetricarboxylate), 1-(C8-C20 linear and branched
alkyl) ethers, sodium salts (CAS No. 1079993-97-7); 

D-Glucopyranose, oligomeric, 6-(hydrogen sulfobutanedioate), 1-(C8-C20
linear and branched alkyl) ethers, sodium salts (CAS No. 1079993-92-2) 

D-Glucopyranose, oligomeric, Propanoic acid, 2-hydroxy-, 1-(C8-C20
linear and branched alkyl) ethers (CAS No. 1079993-94-4)

in or on the raw agricultural commodity [All] at [N/A-remove] parts per
million (ppm).  EPA has determined that the petition contains data or
information regarding the elements set forth in section 408 (d)(2) of 
FDDCA; however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data supports granting of the
petition. Additional data may be needed before EPA rules on the
petition.>

<A. Residue Chemistry

>

<	1. Plant metabolism. [No plant metabolism studies have been submitted
in support of this petition since an exemption from the requirement of a
tolerance is being requested. Based on available physicochemical data
(measured and calculated) it is anticipated that AGEs will degrade
rapidly and result in no appreciable crop residues]>

<	2. Analytical method. [NA – Remove Analytical methods for crop
commodities are not required for the establishment of a tolerance
exemption]>

<	3. Magnitude of residues. [AGEs surfactants have be exempted from
tolerance when used in accordance with good agricultural practices as
inert ingredients in pesticide formulations applied on growing crops
(pre-harvest and post-harvest) under 40 CFR § 180.910 and on growing
crops (pre-harvest) under 40 CFR § 180.920. Based on measured and
calculated physicochemical data, it is anticipated the use of AGEs
surfactants will not result in appreciable crop residues and that
environmental persistence and bioaccumulation are unlikely and not
anticipated.]>

<B. Toxicological Profile>

<	1. Acute toxicity.  [AGEs surfactants show in an acute oral toxicity
to rats an LD50 greater than 5,000 mg/kg and thus non-toxic by
ingestion. No acute dermal data are available]>

<	2. Genotoxicty. [Mutagenicity data on AGEs surfactants are available
for similar chemicals. All results indicate that AGEs have not mutagenic
potential in Ames test]>

<	3. Reproductive and developmental toxicity. [No Reproductive and
Developmental toxicity data were submitted for these category members.
However, information for the metabolites of these category members
(Alkyl polyglucoside, organic acids) shows no significant toxicity.> No
Reproductive and Developmental toxicity data were submitted for these
category members. However, information for the metabolites of these
category members (Alkyl polyglucoside, organic acids)  don’t show
significant toxicity. Available data for the organic acid and alkyl
polyglucoside category member address this endpoint for these two
category members using read across. For the embryo/fetotoxicity, the
teratogenicity and the maternal toxicity a NOAEL of 1000 mg/kg was
deduced for Alkyl polyglucosides. Carboxylic acids (Lactic and Citrate
Acid) are studied in different studies also for the implication in use
as food additives. No evidence of Reproductive and Developmental
toxicity were reported in different monographs and reports  under WHO
activities.  Succinates show NOAEL for reproduction/developmental
toxicity of 1,000 mg/kg bw/day in rats. An overall NOAEL of 1,000 mg/kg
bw/days can be considered for AGEs.]

<	4. Subchronic toxicity. [No sub-chronic or repeated dose toxicity data
were submitted for these category members. However, information for the
metabolites of these category members (Alkyl polyglucoside, organic
acids) shows no significant toxicity. Available data for the organic
acid and alkyl polyglucoside category member address this endpoint for
these two category members using read across. For the repeated dose
toxicity a NOAEL of 1000 mg/kg was deduced for Alkyl polyglucosides.
Carboxylic acids (Lactic and Citrate Acid) are studied in different
studies also for the implication in use as food additives. No evidence
of repeated dose toxicity was reported in different monographs and
reports under WHO activities.  Succinates show NOAEL for repeated dose
toxicity of 100 mg/kg bw/day in rats. An overall NOAEL of 100 mg/kg
bw/days can be considered for AGEs]>

<	5. Chronic toxicity. [No chronic toxicity data were submitted for
these category members. However, information for the metabolites of
these category members (Alkyl polyglucoside, organic acids) shows no
significant toxicity at chronic levels.]>

<	6. Animal metabolism. [There are no animal metabolism studies for the
AGEs  supporter herein but a metabolic pathway can be based on predicted
degradation products which are formed though the break of ester bond,
based on alkypolyglucoside cluster and Carboxylic acids or
sulfosuccinate moiety, for which metabolic pathway are known by
literature.]>

<	7. Metabolite toxicology. [The primary carboxylic acids, sodium
sulfosuccinate and the alkyl alcohol are not of toxicological concern
nor the alkylpolyglucoside. It is proposed that all metabolites are
rapidly conjugated and excreted. Toxicological studies indicate that the
alkyl alcohol or alkylpolyglucosides are non-mutagenic and have very low
acute and chronic toxicity.]>

<	8. Endocrine disruption. [The AGEs do not belong to a class of
chemical known or suspected of having adverse effects on the estrogen
receptor or endocrine system.]>

<C. Aggregate Exposure>

<	1. Dietary exposure. [The exposure assessment of AGEs was calculated
using

the Exposure and Fate Assessment Screening Tool, Version 2.0 (E-FAST2).

The calculated AGEs NOAELs are from 100 to 1000 mg/kg-bw/day and in

any case the potential exposure to all the AGEs is to be considered very

low in the case of dietary/food.]>

<	i. Food. [There are no data available on Alkyl polyGlucosides Esters
(AGEs) residues in food or on non occupational exposures to Alkyl
polyGlucosides Esters (AGEs).] >

<	ii. Drinking water. [The calculated AGEs NOAELs are from 100 to 1000

mg/kg-bw/day, corrected in Reference dose of 1-0.1 mg/kg-bw/day and in

any case the potential overall exposure to AGEs (considering the most

conservative estimation) is to be considered negligible in the case of

drinking water.]

>

<	2. Non-dietary exposure. [AGEs are used as surfactant, considering as

conservative approach, in concentration of 50% w/w in spray tank, and in
the

final pesticide formulation. The possible exposure to workers is derived

from the preparation and use.

A inhalation Unit Exposure of 2.00 mg/lb was used for an application

rate of 2.2 gal/day, the final result for the possible exposure

prediction is 25.14 mg/kg/day to compare with the NOAEL value of 100

mg/kg-bw/day, finally also the occupational (handler) potential

exposure to all the AGEs is to be considered low.]>

<D. Cumulative Effects>

<	[From the results of the tests conducted on AGEs and the results
obtained by main degradation products, no evidence of any specific
target organ toxicity has been produced. Therefore, there is no evidence
of a common mechanism of toxicity with any other substance, and there is
no reason to expect that the use of AGEs will contribute to any
cumulative toxicity resulting from exposures to other substances having
a common mechanism of toxicity.]>

<E. Safety Determination>

<	1. U.S. population. [The results of the acute, genotoxic, sub-acute
and developmental toxicity studies conducted on AGEs or similar
chemicals indicate a relatively low order of toxicity. A similar AGE
ester and structurally similar alkyl glucopyranosides currently exempted
from the requirement of a tolerance, also appear on EPA's List 4B Inert
List, and in  Inert Ingredients Permitted for Use in  Nonfood Use
Pesticide Products Last Updated January 27, 2009. Therefore, due to the
low order of toxicity of AGEs and the lack of known adverse human health
effects associated with this class of chemicals, the exemption from the
requirement of a tolerance on growing crops only is not expected to
result in any new, or adverse effects to human health or the
environment].

>

<	2. Infants and children. [Exposure to AGEs to infants and children is
not expected to occur. The substances will be used as an inert
ingredients at low levels on growing crops, and any residual levels are
expected to be insignificant and consistent with structurally similar
alkyl glucopyranosides currently exempted from the requirement of a
tolerance.]>

<F. International Tolerances>

<	[There is no known international tolerance for AGEs.]>

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