2 Exponent (1150 Connecticut Ave., NW Washington, DC 20036) on behalf of Archer Daniels Midland Co. ( 4666 E. Faries Parkway, Decatur, IL 62526 ) is requesting that EPA establish an exemption from the requirement of a tolerance for residues sodium lactate L - (CAS Reg. N o. 867 - 56 - 1) and DL - (CAS Reg. No. 72 - 17 - 3) when used as inert ingredients . Exponent is request ing that EPA establish a tolerance exemption for the use of sodium lactate L - and DL - isomers as an inert ingredient ( surfactant ) in pesticide formulations applied to pre - and post - harvest crops in accordance with 40 CFR 180.910. Sodium lactate , the sodium salt of lactic acid, readily dissociates to the lactate anion upon ingestion. Lactate is a normal constituent in the human body and part of the normal metabolic process with blood levels r anging between 4.5 and 19 mg/dl. L actic acid will also typically convert to lactate in the human body . L - lactic acid (CAS Reg. No. 79 - 33 - 4) is also a naturally occurring compound in many foods . Humans are generally exposed to lactic acid on a daily basis in significant quanti ti es because it is naturally present in many food products that are derived through natural fermentation, such as cheese, yogurt, soy sauce, sourdough, meat products, and pickled vegetables. Lactic acid is also deliberately added to various foods as flavoring agent and to regulate pH. T here are a significant number of regulatory approvals for lactic acid and its isomers, including tolerance exemptions for use as an active ingredient and as an inert ingre dient in pesticide formulations. The EPA, U.S. Food and Drug Administration (FDA), and Joint FAO WHO Expert Committee on Food Additives (JECFA) (2002) have conducted and published lactic acid safety assessments. EPA completed the Registration Review of L - l actic acid as an active ingredient in June 2009 for antimicrobial and biopesticide products. Lactic acid is formulated as an active ingredient into disinfectants, indirect food contact sanitizers, vir ucides and fungicides for use on hard, non - porous surfac es. Lactic acid is also used as a biopesticide in mosquito control lures. EPA has also established inert ingredient tolerance exemptions for lactic acid including 40 CFR 180.910 for pre - and post - harvest uses as well as 40 CFR 180.930 when applied to anima ls. EPA has established a tolerance exemption for DL - lactic acid (CAS Reg. No. 50 - 21 - 5) in 40 CFR 180.940(b) for ingredients in antimicrobial pesticide formulation applied to dairy processing equipment, and food - processing equipment and utensils with a lim itation of 138 ppm when ready for use in the end - use concentration and40 CFR 180.940(c) for ingredients in an antimicrobial pesticide formulation applied to food - processing equipment and utensils without use limits. Additionally EPA has reviewed DL - lactic acid and L - lactic acid in conjunction with the TSCA HPV program (EPA, 2 008). Because sodium L - lactate and sodium DL - lactate readily disassociate to lactate and sodium ions in the body, the Agency has concluded that the data on lactic acid can be used in co njunction with the data on sodium L - lactate and sodium DL - lactate and that these data are adequate to characterize the toxicity of sodium L - lactate and sodium DL - lactate. A previous risk assessment has been performed on calcium lactate pentahydrate (CAS Re g. No. 5743 - 47 - 5) using a similar rational of lactic acid as a surrogate compound based on the disassociation of the lactate salt in the human body. There are no new toxicological data available in the open literature that may impact previous assessment an d regulatory decisions. Acute oral and inhalation toxicity of lactic acid to rats and acute dermal toxicity of lactic acid to rabbits are low (oral LD 50 >3500 mg/kg; inhalation LC 50 > 5 mg/l; dermal LD 50 > 2000 mg/kg) . L - Lactic acid is severely irritati ng and corrosive to rabbit skin. Dilute solutions of lactic3

acid are irritating to the eyes of rabbits. L - Lactic acid is not a dermal sensitizer in guinea pigs. (WHO, 1974). In an oral feeding study, two groups of rats ( species not specified) received daily doses of 1,000 and 2,000 mg/kg bw of sodium lactate (as lactic acid) over 14 to 16 days. Body analyses of the animals showed no accumulation of lactate (WHO, 1974). No developmental or reproductive toxicity studies are available for sodium L - lactate or sodium DL - lactate, however, developmental toxicity study for lactic acid resulted in no maternal or developmental effects and none of the reproductive parameters were a ffected in mice at 570 mg/kg/day. Additionally sodium L - lactate and DL - lactate are not expected to be mutagenic or carcinogenic based on the presence of the lactic acid metabolite in the human body. Previously EPA also concluded that the FQPA be reduced to 1X for calcium lactate. Based on this information there is no concern at this time for increased sensitivity to infants and children to sodium L and DL - lactate when used as an inert ingredient in pesticide formulations applied to growing crops or to raw a gricultural commodities after harvest and a safety factor analysis has not been used to assess risk. For the same reason, EPA has determined that an additional safety factor for sodium L - lactate and sodium DL - lactate is not need ed to protect t h e safety of infants and children. Residues of concern are not anticipated for dietary exposure (food or drinking water) and not toxicological endpoint of concern was identified in the database therefore a n a cute dietary risk assessment and chronic dietary risk asse ssment were not conducted . Residential exposure from sodium L - lactate and DL - lactate are not anticipated for the proposed use pattern as an inert ingredient. EPA expects aggregate exposure to sodium L - lactate and DL - lactate to pose no appreciable dietary r isk given that the data on lactic acid show a lack of any systemic toxicity and any apparent developmental effects as well as being a normal component of human metabolism. Environmental fate and ecological effects of concern are not expected from the pro posed use pattern of calcium lactate pentahydrate as an inert ingredient in pesticide products. Taking into consideration all available inf ormation on sodium L - lactate and DL - lactate , EPA concludes that there is a reasonable certainty that no harm to an y population subgroup will result from aggreg ate exposure to sodium L - lactate and sodium DL - lactate when considering residential, occupation al , dietary exposure and all other non - occupational sources of pesticide exposure. Therefore, the establishment of an exemption from tolerance under 40 CFR 180.910 for residues of sodium L - lactate (CAS Reg. No. 867 - 56 - 1 ) and sodium DL - lactate (CAS Reg. No. 72 - 17 - 3) when used as an inert ingredi ent surfactant in pesticide formulations when applied to pre - or post - harvest crops can be considered assessed as safe under section 408(q) of the FFDCA.4

REFERENCES Joint FAO/WHO Expert Committee on Food Additives, 2002. Evaluation of certain food additives and contaminants: fifty - seventh report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Technical Report Series 909. US EPA Antimicrobial Division and Biopesticides and Pollution Prevention Divison, 2009. L Lactic Acid Final Registration Review Decision Registration Review Case 6062. Docket Number EPA - HQ - OPP - 2008 - 0383. US EPA Registration Division, 2009. Decision Document for Petition number 7F7311 Calcium lactate pentahydrate (CAS Reg. No. 5743 - 47 - 5). Docket Number EPA - HQ - OPP - 2008 - 0093. World Health Organization (WHO) Food Additives Series: 48 Safety Evaluation of Certain Food Additives A nd Contaminants, 2001. Aliphatic Acyclic Diols, Triols, and Related Substances. World Health Organization (WHO) International Programme on Chemical Safety, 1974. WHO Food Additives Series No. 5: Lacti c acid and its ammonium, calcium, potassium and sodium salts.