


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:

Archer Daniels Midland Company

IN-10693

	EPA has received a pesticide petition (In-10693) from Archer Daniels Midland Company, EPA Company Number 86603, 4666 E. Faries Parkway, Decatur, IL 62526 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. to establish an exemption from the requirement of a tolerance for Sodium lactate, when either of the following isomers: sodium L-lactate (CAS # 867-56-1) and sodium D,L-lactate (CAS # 72-17-3) are used as an inert ingredient in pesticide formulations applied to growing crops, or to raw agricultural commodities after harvest under 40 CFR 180.910.  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 petition

	2. Analytical method. Not applicable to this petition

	3. Magnitude of residues. Not applicable to this petition

B. Toxicological Profile

The publically available robust lactic acid database can be used to bridge the toxicology data for sodium L-lactate and sodium D,L-lactate due to the biological equivalence of lactic acid and its sodium salts.  Upon ingestion, sodium lactate, the sodium salt of lactic acid, is readily converted to lactic acid in the human gut.  Thus, either sodium L- or D,L-lactate is present in vivo as lactic acid (i.e., is therefore biologically equivalent to either L- or D,L-lactic acid).  Accordingly, bridging the robust database of toxicological and environmental data for L- and D,L-lactic acid to support an exemption from tolerance for sodium L-lactate and sodium D,L-lactate is a scientifically sound approach.

	1. Acute toxicity.  Naturally occurring in many foods, lactic acid is shown to be of low acute oral, dermal and inhalation toxicity, and is considered EPA Toxicity Category III or IV. However, due to its acidic character, it is severely irritating and potentially corrosive to eyes and skin, and considered EPA Toxicity Category I. 

An intraperitoneal study and an oral feeding study were conducted with sodium lactate that showed it to be similar to lactic acid in that it is of low toxicity (LD50 > 2000 mg/kg).  

	2. Genotoxicty. Due to its naturally occurring prevalence in food and in humans as a metabolic product, the Agency previously waived mutagenicity data requirements for lactic acid.  Because of the biological equivalence of sodium lactate and lactic acid, it is appropriate to conclude that mutagenicity data would also be waived for sodium lactate.  

	3. Reproductive and developmental toxicity. Due to its naturally occurring prevalence in food and in humans as a metabolic product, the Agency previously waived reproductive and developmental toxicity data requirements for lactic acid.  Because of the biological equivalence of sodium lactate and lactic acid, it is appropriate to conclude that reproductive and developmental toxicity data would also be waived for sodium lactate.  

	4. Subchronic toxicity. Due to its naturally occurring prevalence in food and in humans as a metabolic product, the Agency previously waived subchronic toxicity data requirements for lactic acid.  Because of the biological equivalence of sodium lactate and lactic acid, it is appropriate to conclude that subchronic toxicity data would also be waived for sodium lactate.

	5. Chronic toxicity. Due to its naturally occurring prevalence in food and in humans as a metabolic product, the Agency previously waived chronic toxicity data requirements for lactic acid.  Because of the biological equivalence of sodium lactate and lactic acid, it is appropriate to conclude that chronic toxicity data would also be waived for sodium lactate.

	6. Animal metabolism. Sodium lactate is the sodium salt of lactic acid, and is produced naturally by the fermentation of a sugar source.  Sodium lactate when ingested is broken down into sodium chloride and lactic acid, which is subsequently converted to carbon dioxide and water.

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

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

C. Aggregate Exposure

	1. Dietary exposure.  Dietary exposure (food and drinking water) to lactic acid occurs primarily from naturally occurring sources in foods.  However, risk estimates have not been calculated by EPA for potential exposures to lactic acid on food, in drinking water, or as a result of use in residential settings because there are no toxicological endpoints of concern for lactic acid.  Because of the biological equivalence of sodium lactate and lactic acid, it is appropriate to conclude that there should be no toxicological endpoints of concern for sodium lactate.  

	2. Non-dietary exposure. Based on the proposed 40 CFR §180.910 uses cited herein, residential exposure of sodium lactate is not expected to occur.   

D. Cumulative Effects. EPA has not made a common mechanism of toxicity finding for sodium lactate.

E. Safety Determination

	1. U.S. population. As part of the FQPA tolerance reassessment process, EPA concluded that there are no toxicological endpoints of concern for oral, dermal, or inhalation exposure to lactic acid.  Given the wide spread occurrence in food and in the body, no subchronic or chronic assessment was made.  The Agency determined that the established exemptions from the requirement for a tolerance for lactic acid for current uses met the safety standards under the FQPA amendments to section 408(b)(2)(D) of the FFDCA, and that there is a reasonable certainty no harm will result to the general population or any subgroup from the use of lactic acid in pesticide formulations. 

Because no toxicological endpoints were identified for lactic acid, EPA determined that exposure to lactic acid does not result in human health effects of concern.  Therefore, a quantitative risk assessment was deemed not necessary.  The inclusion of the sodium lactate uses would not change this determination.

	2. Infants and children. EPA determined that the established exemptions from the requirement of a tolerance for lactic acid met the safety standards under the FQPA amendments to section 408(b)(2)(C) of the FFDCA, to establish that there was a "reasonable certainty of no harm" for infants and children. While there are some concerns about the ingestion of lactic acid by premature and very young infants, and lactic acid is not allowed as a food additive in infant formula as a result, the Agency determined that because these infants only consume infant formula or breast milk, that exposure to lactic acid from other foods would not occur.  The inclusion of the sodium lactate uses would not change this determination.

As no toxicological endpoints have been identified for lactic acid and/or sodium lactate, no FQPA Safety Factor is applicable.

F. International Tolerances
Currently there are no known Codex MRLs established for sodium lactate.
