

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

EPA Registration Division contact: Janet Whitehurst

Ecolab, Inc.

Docket Number 2012-0945

Petition Number IN-10528

	EPA has received a pesticide petition IN-10528 from Ecolab, Inc., EPA Company # 1677,  370 N. Wabasha Street, St. Paul, MN 55102 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.

   1. To establish an exemption from the requirement of a tolerance for FD&C Yellow No. 5 (Tartrazine), CAS No. 1934-21-0 for use as an inert ingredient in antimicrobial pesticide formulations applied to food-contact surfaces in public eating places, dairy processing equipment and food processing equipment and utensils in accordance with 40 CFR §180.940(a).  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. Not applicable to this inert ingredient petition.

	2. Analytical method. Not applicable to this inert ingredient petition.

	3. Magnitude of residues. Not applicable to this inert ingredient petition. 

B. Toxicological Profile

      1. Acute toxicity. FD&C Yellow No. 5 is of low acute toxicity, and is not a dermal-irritant or a sensitizer.  The acute oral LD50 in mice was 12,750 mg/kg bw, and the LD50 in rats was >2000 mg/kg bw. It is approved by FDA as a colorant added directly to food, drugs and cosmetics.

	2. Genotoxicity. In the Agency's previous reassessment of FD&C Yellow No. 5 they reported that it is not mutagenic in the standard Ames assay with or without metabolic activation.  

	3. Reproductive and developmental toxicity. In previous reassessment of tolerance exemptions, the Agency's review of developmental and reproductive toxicity of  FD&C Yellow No. 5 the noted there were no harmful effects on prenatal development and no adverse reproductive effects.

	4. Subchronic toxicity.  See the discussion of chronic toxicity below. 

	5. Chronic toxicity. The Agency reported that a chronic oral toxicity study in dogs showed no effects at the highest dose tested (500 mg/kg day).  The Agency also noted that there was no evidence of carcinogenicity observed in studies with rats and mice.  

      6. Animal metabolism. FD&C Yellow No. 5 is poorly absorbed and is primarily excreted unchanged in the urine.
	
      7. Metabolite toxicology. There are no metabolites identified of toxicological concern. 
	
      8. Endocrine disruption. EPA did not report having any available information to suggest that FD&C Yellow No. 5 would have any endocrine effects.

C. Aggregate Exposure. In the Agency's reassessment they did not use a reference dose and safety factor approach to their risk assessment for FD&C Yellow No. 5.  It was determined that a qualitative assessment for all pathways of human exposure (food, drinking water, and residential) was appropriate given the low toxicity and low human health concerns associated with the uses as an FDA color additive and pesticide inert ingredient.

1. Dietary exposure. In the Agency's reassessment of FD&C Yellow No. 5 exemptions, the Agency determined that dietary exposure to FD&C Yellow No. 5 occurs primarily from foods where it is used as a color additive.  The Agency estimated that based on pesticide use rate information, coupled with the weight fraction of colorant used, that dietary exposures from use as a pesticide inert ingredient were several orders of magnitude lower than both the exposures from the FDA approved uses and the established ADI.

i. Food.  Primary sources for exposure to FD&C Yellow No. 5 from food will come from its use as a direct food additive.  Additional sources of exposure, including use as an inert ingredient in pesticide formulations, will be relatively minimal. 

	ii. Drinking water. In the Agency's reassessment of FD&C Yellow No. 5 tolerance exemptions, the Agency concluded that any estimated environmental concentrations were very low and potential drinking water exposure was several orders of magnitude lower than the current ADI. 

	2. Non-dietary exposure. Residential exposure could come from use of FD&C Yellow No. 5 in consumer products, including pesticide products and cosmetics.   Given the low content (less than 0.1%) of FD&C Yellow No. 5 in pesticide products, the exposure from pesticide products will be minimal.

D. Cumulative Effects
EPA has not made a common mechanism of toxicity finding for FD&C Yellow No. 5 or any metabolite(s).


E. Safety Determination

	1. U.S. population. As part of the FQPA tolerance reassessment process,  EPA has previously concluded that taking into consideration all available information on FD&C Yellow No. 5, including the extensive toxicity database in which no adverse effects were noted, low toxicity, lack of risk concerns and low exposures, that there was reasonable certainty of no harm to all population subgroups as a result of aggregate exposure to FD&C Yellow No. 5  from dietary and other non-occupational sources of exposure from use in pesticide products.  The Agency determined that the established exemptions from the requirement for a tolerance for FD&C Yellow No. 5 for current uses met the safety standards under the FQPA amendments to section 408(b)(2)(D) of the FFDCA. The expansion of the tolerance exemption to include uses cited at 40 CFR § 180.940(a) would not change this determination.

	2. Infants and children. EPA previously determined that the established exemptions from a requirement for a tolerance for FD&C Yellow No. 5 met the safety standards under the FQPA amendments to section 408(b)(2)(C) of the FFDCA, and that there was a reasonable certainty of no harm for infants and children. The safety determination for infants and children considers factors of the toxicity, use practices, and environmental behavior noted above for the general population, but also takes into account the possibility of increased dietary exposure due to the specific consumption patterns of infants and children, as well as the possibility of increased susceptibility to the toxic effects of FD&C Yellow No. 5 residues in this population subgroup. The expansion of the tolerance exemption to include uses cited at 40 CFR § 180.940(a) would not change this determination. 

F. International Tolerances
Currently there are no Codex MRLs established for FD&C Yellow No. 5.  JECFA has established an ADI of 7.5 mg/kg bw/day for FD&C Yellow No. 5.
