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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
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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 nonbacterial 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/m3in 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/m3). 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.
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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.
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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.