


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.


IN-10526

	EPA has received a pesticide petition (IN-10526) 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 180.940a to establish an exemption from the requirement of a tolerance for Sodium Bisulfate, CAS Reg. No. 7681-38-1, 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.  Because bisulfate/sulfate anion is a naturally-occurring constituent in many food substances and a mammalian (human) metabolite, the existing toxicology database is limited.  Since the bisulfate anion is converted to sulfate in solution, toxicology studies for sodium sulfate are generally considered as relevant for sodium bisulfate as well. 

The World Health Organization (WHO, 2010a) reported a low level of acute oral toxicity in mammals, including 2800 mg/kg bw in male rats and >2500 mg/kg bw in female rats.  The oral LD50 results from the rat toxicity study are equivalent to EPA Toxicity Category III.  

Sodium bisulfate is not irritating to skin.

	2. Genotoxicity. There are no reported genotoxicity studies for sodium bisulfate and it is not listed as a carcinogen by NTP, IARC, or OSHA.

The UNEP (2005) SIDs for Sodium Sulfate reported negative AMES results.  Additionally, UNEP reported that a non-GLP chronic feeding study (1975) in which male Sprague-Dawley rats were fed 0.84% sodium sulfate in the diet for up to 27 and 44 weeks as the control in a toxicity study for Azo Dyes did not result in mortality or the formation of tumors.  Moreover, there were no significant differences in overall body weight gain or in liver weight. 

      3. Reproductive and developmental toxicity. Groups of pregnant CF-1 albino mice were injected subcutaneously on gestation day 8 or 9 with sodium sulfate at 60 mg/kg bw given as 10 mg/ml in water.  Although skeletal abnormalities were observed in both groups, the difference seen from saline controls after dosing on day 9 of gestation was not significant, and the anomalies did not appear to involve fusions of the axial skeleton.
      
Pregnant ICR/SIM mice were given a saturated aqueous solution of sodium sulfate orally by gavage, with a dose of 2800 mg/kg bw/day on days 8-12 of gestation. No maternal deaths occurred and the average maternal weight gain during the treatment period was not significantly different from that of water-treated controls.  Twenty-four litters were delivered alive, and none were resorbed.  The mean numbers of neonates delivered alive and dead in each litter and the survival of neonates on day 3 were not statistically significantly different from those of controls. 

	4. Subchronic toxicity. Due to its naturally occurring prevalence in food, subchronic toxicity data specific to sodium bisulfate are not readily available.

	5. Chronic toxicity. Due to its naturally occurring prevalence in food, chronic toxicity data specific to sodium bisulfate are not readily available. 


	6. Animal metabolism. Sodium bisulfate mammalian metabolism is essentially that of sodium cation and sulfate anion.  When sodium hydrogen sulfate is added to food products containing water or after ingestion of sodium hydrogen sulfate, it ionizes to sodium ions, hydrogen ions and sulfate ions.  

Excess sulfate anions, naturally-occurring components in food and a metabolite of in vivo sulfur oxidation, are highly water soluble and therefore eliminated in urine unchanged without the formation of toxic metabolites.  

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

	8. Endocrine disruption. EPA did not report having any available information to suggest that sodium bisulfate would have any endocrine effects.  When the appropriate screening and/or testing protocols under the EDSP have been developed, sodium bisulfate 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 sodium bisulfate.

C. Aggregate Exposure

1. Dietary exposure. In the Reregistration Eligibility Decision Document for Mineral Acids (1993), EPA stated: "The four mineral acids [which included sodium bisulfate] 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."

	i. Food.  Sodium bisulfate (and its hydrolyzed congener sodium sulfate) occurs naturally (at non-toxic levels) in many food products, which humans may be exposed to on a daily basis without apparent harmful effects.

	ii. Drinking water.  Sulfates can occur naturally in drinking water.  A 1999 United States Environmental Protection Agency and Centers for Disease Control and Prevention on the health effects from exposure to high levels of sulfate in the drinking-water in two sensitive populations (infants and transient adults) did not show statistically significant effects. 

	2. Non-dietary exposure. Residential exposure could come from use of sodium bisulfate in consumer products, such as a toilet bowl cleaners.  There are no risk concerns for these exposures. 

D. Cumulative Effects JECFA (2010) confirms that bisulfate/sulfate anions do not constitute toxic metabolites.  Thus, the Agency would assume that sodium bisulfate does not have a common mechanism of toxicity with other substances.  As a result, any potential human health risks would be those that result only from the use of sodium bisulfate as a household use sanitizer for toilet bowls and as an inert ingredient in pesticide formulations applied to growing crops according to 40 CFR §180.920 applications. 


E. Safety Determination

	1. U.S. population. EPA has not reported toxicological endpoints of concern for the current non-food residential use and the use as an inert ingredient in pesticide formulations according to 40 CFR §180.920 applications. Based on this, EPA has determined that a quantitative risk assessment is not required for sodium bisulfate. The anticipated food, drinking water and residential exposure should not be of concern since toxicological endpoints for risk assessment were not identified based on the available data.  

	2. 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 sodium bisulfate residues in this population subgroup.  The Agency has previously determined that there are no additional risks to infants and children from sodium bisulfate.  The inclusion of the uses supported by adding the tolerance exemption at 40 CFR § 180.940(a) would not change this determination. 

F. International Tolerances
Currently, there are no CODEX MRLs established for sodium bisulfate.  
