


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

EPA Registration Division contact: PV Shah, 703-308-1846

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action.

TEMPLATE:

Ecolab, Inc.


[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from Ecolab, Inc., EPA Company Number 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.

(Options (pick one)
   
   2. to establish an exemption from the requirement of a tolerance for

	Sulfuric acid, CAS No. 7664-93-9, 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. Sulfuric acid is EPA Toxicity Category II for acute oral toxicity and EPA Toxicity Category III for acute dermal and inhalation toxicity.  Sulfuric acid is highly corrosive to the eyes and skin in formulations above 10% and is a strong irritant in formulations below 10%.  Sulfuric acid is EPA Toxicity Category I for eye and dermal irritation.

	2. Genotoxicity. Sulfuric acid has been shown to be without effect in genetic toxicity studies in vitro (bacterial test).  It has been shown to cause chromosomal aberrations in a non-bacterial test in vitro. The chromosomal effects are a well-known consequence of reduced pH, seen as resulting from any strong acid.  

      3. Reproductive and developmental toxicity. Because sulfuric acid is a direct-acting toxicant, and because it is unlikely to reach the reproductive organs, reproductive effects in mammals are not likely to occur following exposure to sulfuric acid by any route.  In a developmental toxicity/teratogenicity study conducted by inhalation with sulfuric acid aerosol, the NOAEL for maternal toxicity appears to be 20 mg/m[3] in mice and rabbits.  No evidence of fetotoxicity or teratogenicity was seen in either species.
      
	4. Subchronic toxicity. The available repeat dose subchronic and chronic toxicity studies described in EPA reviews and the OECD SIDS summary are for inhalation toxicity.  The Agency noted that literature regarding sulfuric acid indicates that "in numerous repeated inhalation studies with sulfuric acid aerosol, toxicity was confined to changes in the structure and function of the respiratory tract, suggesting that it has a local effect and no systemic effects.  The observed changes are related to the irritant properties of sulfuric acid and are most likely due to the H+ ions."  There is one GLP 28-day inhalation study in which the rat was exposed to sulfuric acid aerosol.  In this study "minimal squamous metaplasia was observed in the laryngeal epithelium following exposure to the lowest concentration used (0.3 mg/m[3]).  This effect was fully reversible.  Exposure to 1.38 mg/m3 caused more severe metaplasia accompanied by cell proliferation." It was noted that these types of effects are commonly seen in rats exposed to irritants.

	5. Chronic toxicity. No carcinogenic effect was observed in carcinogenicity studies conducted by inhalation with sulfuric acid aerosol using three different animal species.  

	6. Animal metabolism. Sulfuric acid readily dissociates in water to hydronium cations (H3O[+]) and sulfate anions (SO4[2-]).  Sulfates are a necessary human nutrient and the metabolism of sulfate through the human body is well-understood.  

	7. Metabolite toxicology. There are no metabolites of toxicological concern. 

	8. Endocrine disruption. EPA did not report any information to suggest that sulfuric acid would have any endocrine effects.  When the appropriate screening and/or testing protocols under the EDSP have been developed, sulfuric acid may be subject to additional screening and/or testing to better characterize effects related to endocrine disruption.  This does not impact the current regulatory status of this material.

C. Aggregate Exposure

1. Dietary exposure. In the Reregistration Eligibility Decision Document for Mineral Acids (1993), EPA stated: "The four mineral acids [which included sulfuric acid] pose no human dietary risks.  People may be exposed to these chemicals when they are used as antimicrobials, however this exposure involves such dilute solutions that it is believed to be inconsequential."  Risks associated with mineral acids exposures are expected to be minimal based on limited evidence of any subchronic or chronic systemic effects through the oral route of exposure.  In their 2006 inert ingredient tolerance reassessment document, EPA determined that a quantitative aggregate assessment will not be performed, this was further affirmed in the 2008 Mineral Acids Registration Review documents, which indicated that "the Agency does not anticipate  conducting a dietary assessment for the mineral acids."

	i. Food. Sulfuric acid rapidly dissociates to hydronium cations (H3O+) and sulfate anions (SO42-).  These constituents do not pose a toxicological concern or are naturally occurring.  The FDA considers sulfuric acid generally GRAS for use in foods under 21 CFR 184.1095.  FDA indicated that:

      "Sulfates are natural constituents of foods and normal products of sulfur metabolism in animals. ... There is no evidence in the available information on sulfuric acid, and on ammonium, calcium, potassium, and sodium sulfates that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are used at levels that are now current or that might reasonably be expected in future."

	ii. Drinking water. Drinking water exposures of concern are not anticipated for sulfuric acid.  

	2. Non-dietary exposure. For occupational and residential exposure, the toxicological criteria have not been triggered for dermal and oral exposure, therefore, risk assessments for these exposures are not required.  For inhalation exposure a risk assessment is not anticipated either because there is likely to be minimal potential for inhalation, based on label use directions and low potential to generate aerosolized spray.

D. Cumulative Effects The Agency has not made a common mechanism of toxicity finding for sulfuric acid and it does not appear to produce a toxic metabolite that is produced by other substances.  For the purposes of this tolerance exemption petition, therefore, it is assumed that sulfuric acid does not have a common mechanism of toxicity with other substances.

E. Safety Determination

In previous assessments, EPA concluded, based on the available information for this chemical, that there is a reasonable certainty that no harm will result to the general population and to infants and children from aggregate exposure to this chemical.  The expansion of the current tolerance exemptions to include uses cited at 40 CFR § 180.940(a), up to 600 ppm, would not change this determination.

	1. U.S. population. The agency previously did not use a reference dose and safety factor approach to their risk assessment for sulfuric acid. They determined that a qualitative approach was appropriate given the lack of human health concerns from anticipated exposures.  

	2. Infants and children. EPA completed reassessment of the established tolerance exemption for sulfuric acid in August 2006.  A safety factor analysis was not employed to assess risk, and therefore a 10X FQPA Safety Factor is unnecessary.  The Agency concluded, after considering available information, that there is a reasonable certainty that no harm will result to the general population and to infants and children from aggregated exposure to sulfuric acid, when used in food contact surface sanitizing solutions under 40 CFR Part 180.940.

F. International Tolerances
Currently, there are no known CODEX MRLs established for sulfuric acid.  
