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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. No. 

867-56-1) and DL-(CAS Reg. No. 72-17-3) when used as inert ingredients. Exponent is requesting

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 ranging between 4.5 and 19 mg/dl. Lactic 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 quantities 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. 

There 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 ingredient in 

pesticide formulations. The EPA, U.S. Food and Drug Administration (FDA), and Joint FAOWHO Expert Committee on Food Additives (JECFA) (2002) have conducted and published lactic 

acid safety assessments. EPA completed the Registration Review of L-lactic 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, virucides and fungicides for 

use on hard, non-porous surfaces. 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 animals. 

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 limitation 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, 2008). 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 conjunction 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 Reg. 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 and regulatory decisions. 

Acute oral and inhalation toxicity of lactic acid to rats and acute dermal toxicity of lactic 

acid to rabbits are low (oral LD50 >3500 mg/kg; inhalation LC50 > 5 mg/l; dermal LD50 > 2000 

mg/kg). L-Lactic acid is severely irritating and corrosive to rabbit skin. Dilute solutions of lactic 
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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 affected 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 agricultural 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 needed to protect the 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 an acute dietary risk 

assessment and chronic dietary risk assessment 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 risk 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 proposed 

use pattern of calcium lactate pentahydrate as an inert ingredient in pesticide products. 

Taking into consideration all available information on sodium L-lactate and DL-lactate, 

EPA concludes that there is a reasonable certainty that no harm to any population subgroup will 

result from aggregate exposure to sodium L-lactate and sodium DL-lactate when considering

residential, occupational, 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 ingredient 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.
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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. LLactic 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 And 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: Lactic acid and its ammonium, calcium, potassium and sodium salts.