EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE

PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: P.V. Shah, 703-308-1846

TEMPLATE:

Cognis Corporation

Pesticide Petition (PP) Number 9E7638

EPA has received a pesticide petition ( PP No. 9E7638) from Cognis Corporation ( c/o

Lewis & Harrison, LLC, 122 C Street NW, Suite 740, Washington DC 20001) proposing, pursuant to section 408 (d) of the Federal Food, Drug, and Co smetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by consolidati ng and moving (recodifying) existing tolerance exemptions for the alkyl polyglycosides (CAS Reg. Nos. 68515-73-1, 110615-47-9, and 132778- 08-6). Currently, there are three separate listings in 40 CFR §180.910 and §180.930 for the alkyl polyglycosides. This petition proposes to unify these separate listing in to a single listing (Dglucopyranose, oligomeric C 8-16 – alkyl glycosides) and move the new listing to §180.950.

EPA has determined that the petition c ontains data or info rmation regarding the elements set forth in Section 408(d)(2) of FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this tim e or whether the data supports granting of the petition. Additional data may be need ed before EPA rules on the petition.

A. Residue Chemistry

Residue data, including an analy tical method, is not pertinent or required for this petition since the petition merely proposes to consolidate existi ng tolerances and move the unified tolerance to

another section in the CFR.

B. Toxicological Profile

An extensive safety data base has been complie d on the alkyl polyglycosides. The safety data base includes acute, sub-chronic, developmental toxicity, mutagenicity and metabolism studies.

1. Acute toxicity.

The acute oral toxicity of the alkyl polyglycosides is greater than 5.0 g/ kg-b.w indicating a low order of acute toxicity. At high concentrations, the alky l polyglycosides can be irritating to eyes and skin. The alkyl polyglycosides are not dermal sensitizers.

2. Genotoxicity.

No evidence of genotoxicity or chromosomal ef fects were observed in mutagenicity studies2

conducted with the alkyl polyglycosides.

3. Reproductive and developmental toxicity.

In a rat teratology study, no matern al or developmental effects were noted in any of the test

groups.

4. Subchronic toxicity

.

In a 90-day feeding study, the only treatment related effect was reversible dose-dependent irritation and ulceration of the mucous membranes of the forestomach. This effect only occurred at high-dose levels (500 and 1000 mg/kg-b.w.) that gr eatly exaggerates anticipated dietary intake.

5. Chronic toxicity.

There are no chronic/oncogencity studies available on the alkyl polyglycosides.

6. Animal metabolism

.

Animal metabolism studies show that the alkyl po lyglycosides are rapidly hydrolyzed into sugars and long-chain alcohols.

7. Metabolite toxicology

.

There are no metabolites of toxicological concern.

8. Endocrine disruption

.

Based on available studies, there is no informati on or evidence that the alkyl polyglycosides are endocrine disruptors.

C. Aggregate Exposure

An aggregate exposure discussion is not applicable sin ce this petition is no t requesting any new food uses or a modification of existing tolerances.

D. Cumulative Effects

A cumulative effects discussion is not applicable since this petition is not requesting any new food uses or a modification of existing tolerances.

E. Safety Determination

Cognis believes that moving the existing tolerance exemptions for the alkyl polyglycosides from3

40 CFR §180.910 and §180.930 to §180.950 is supported by the available safety and metabolism

data on these substances.

As part of the toleran ce reassessment process for the alkyl polyglycosides, the Agency reviewed the safety data base and concl uded that the alkyl polyglycosides are lower toxicity substances. The safety test data clearly s hows that the alkyl polyglycosides, except for localized irritation at high concentrations, are practica lly non-toxic after bot h acute and repeated exposures. The one effect that was observed in the sub-chronic study – irritation of the forest omach – is typical of surfactants, such as the soap sa lts, which are listed in §180.950. In terms of meeting the minimal risk characteristic of §180.950, C ognis believes that the safety and metabolism data on the alkyl polyglycosides are similar to some of the ingr edients currently listed in this section. In particular, the alkyl polygl ycosides have a similar safety profil e when compared to the lactic acid esters and soap salts.

F. International Tolerances

There are no CODEX MRLs establis hed for the alkyl polyglycosides.