Federal Register / Vol. 69, No. 120 / Wednesday, June 23, 2004 / Rules and Regulations 34945 ENVIRONMENTAL PROTECTION Agency, 1200 Pennsylvania Ave., NW., tolerance for residues of n-propyl AGENCY Washington, DC 20460–0001; telephone lactate, also known as lactic acid, n- number: (703) 308–8033; e-mail address: propyl ester, (S) (CAS Reg. No. 53651– 40 CFR Part 180 [email protected]. 69–7). There were no comments [OPP–2004–0040; FRL–7362–3] SUPPLEMENTARY INFORMATION: received in response to the notice of filing. I. General Information Lactic acid, n-propyl ester, (S); Section 408(b)(2)(A)(i) of the FFDCA Exemption from the Requirement of a A. Does this Action Apply to Me? allows EPA to establish an exemption Tolerance You may be potentially affected by from the requirement for a tolerance (the AGENCY: Environmental Protection this action if you are an agricultural legal limit for a pesticide chemical Agency (EPA). producer, food manufacturer, or residue in or on a food) only if EPA ACTION: Final rule. pesticide manufacturer. Potentially determines that the tolerance is ‘‘safe.’’ affected entities may include, but are Section 408(b)(2)(A)(ii) of the FFDCA SUMMARY: This regulation establishes an not limited to: defines ‘‘safe’’ to mean that ‘‘there is a exemption from the requirement of a • Crop production (NAICS code 111) reasonable certainty that no harm will tolerance for residues of lactic acid, n- • Animal production (NAICS code result from aggregate exposure to the propyl ester, (S) on raw agricultural 112) pesticide chemical residue, including commodities when used as an inert • Food manufacturing (NAICS code all anticipated dietary exposures and all ingredient in pesticide formulations 311) other exposures for which there is • applied to growing crops or to raw Pesticide manufacturing (NAICS reliable information.’’ This includes agricultural commodities after harvest, code 32532) exposure through drinking water and in or animals. PURAC America, Inc. This listing is not intended to be residential settings, but does not include submitted a petition to EPA under the exhaustive, but rather provides a guide occupational exposure. Section Federal Food, Drug, and Cosmetic Act, for readers regarding entities likely to be 408(b)(2)(C) of the FFDCA requires EPA as amended by the Food Quality affected by this action. Other types of to give special consideration to Protection Act of 1996, requesting an entities not listed in this unit could also exposure of infants and children to the exemption from the requirement of a be affected. The North American pesticide chemical residue in tolerance. This regulation eliminates the Industrial Classification System establishing a tolerance and to ‘‘ensure (NAICS) codes have been provided to need to establish a maximum that there is a reasonable certainty that assist you and others in determining permissible level for residues of lactic no harm will result to infants and whether this action might apply to acid, n-propyl ester, (S). children from aggregate exposure to the certain entities. If you have any DATES: This regulation is effective June pesticide chemical residue. .’’ 23, 2004. Objections and requests for questions regarding the applicability of EPA performs a number of analyses to hearings must be received on or before this action to a particular entity, consult determine the risks from aggregate August 23, 2004. the person listed under FOR FURTHER INFORMATION CONTACT. exposure to pesticide residues. First, ADDRESSES: To submit a written EPA determines the toxicity of objection or hearing request follow the B. How Can I Access Electronic Copies pesticides. Second, EPA examines detailed instructions as provided in of this Document and Other Related exposure to the pesticide through food, SUPPLEMENTARY Information? Unit VIII. of the drinking water, and through other INFORMATION. EPA has established a In addition to using EDOCKET at exposures that occur as a result of docket for this action under Docket ID (http://www.epa.gov/edocket/), you may pesticide use in residential settings. number OPP–2004–0040. All access this Federal Register document documents in the docket are listed in electronically through the EPA Internet III. Inert Ingredient Definition the EDOCKET index at http:// under the ‘‘Federal Register’’ listings at www.epa.gov/edocket. Although listed Inert ingredients are all ingredients http://www.epa.gov/fedrgstr/. A that are not active ingredients as defined in the index, some information is not frequently updated electronic version of in 40 CFR 153.125 and include, but are publicly available, i.e., CBI or other 40 CFR part 180 is available at E–CFR not limited to, the following types of information whose disclosure is BetaSite Two at http:// ingredients (except when they have a restricted by statute. Certain other www.gpoaccess.gov/ecfr/. material, such as copyrighted material, pesticidal efficacy of their own): is not placed on the Internet and will be II. Background and Statutory Findings Solvents such as alcohols and publicly available only in hard copy In the Federal Register of October 24, hydrocarbons; surfactants such as form. Publicly available docket 2003 (68 FR 60987) (FRL–7330–6), EPA polyoxyethylene polymers and fatty materials are available either issued a notice pursuant to section acids; carriers such as clay and electronically in EDOCKET or in hard 408(d)(3) of the Federal Food, Drug, and diatomaceous earth; thickeners such as copy at the Public Information and Cosmetic Act (FFDCA), 21 U.S.C. carrageenan and modified cellulose; Records Integrity Branch (PIRIB), Rm. 346a(d)(3), announcing the filing of a wetting, spreading, and dispersing 119, Crystal Mall #2, 1921 Jefferson pesticide tolerance petition (PP OF6180) agents; propellants in aerosol Davis Hwy., Arlington, VA. This docket by PURAC America, Inc., 111 Barclay dispensers; microencapsulating agents; facility is open from 8:30 a.m. to 4 p.m., Blvd., Lincolnshire Corporate Center, and emulsifiers. The term ‘‘inert’’ is not Monday through Friday, excluding legal Lincolnshire, IL 60069. This notice intended to imply nontoxicity; the holidays. The docket telephone number included a summary of the petition ingredient may or may not be is (703) 305–5805. prepared by the petitioner PURAC chemically active. Generally, EPA has FOR FURTHER INFORMATION CONTACT: America, Inc. exempted inert ingredients from the Princess Campbell, Registration The petition requested that 40 CFR requirement of a tolerance based on the Division (7505C), Office of Pesticide 180.950 be amended by establishing an low toxicity of the individual inert Programs, Environmental Protection exemption from the requirement of a ingredients. VerDate jul<14>2003 17:38 Jun 22, 2004 Jkt 203001 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 E:\FR\FM\23JNR1.SGM 23JNR1 34946 Federal Register / Vol. 69, No. 120 / Wednesday, June 23, 2004 / Rules and Regulations IV. Toxicological Profile one female had slight dermal opacity and there was a vascularization Consistent with section 408(b)(2)(D) encrustation on day 1. No treatment of the cornea. Iridial and conjunctival of the FFDCA, EPA has reviewed the related findings were observed on effects were also present. The iridial available scientific data and other necropsy. The dermal lethal dose (LD)50 irritation cleared by day 14 and the eye relevant information in support of this was greater than 2,000 milligrams/liter was no longer positive for chemosis and action and considered its validity, (mg/L). This is Toxicity Category III. conjunctival redness at 21 days. This is completeness and reliability and the 2. Acute dermal irritation study in the Toxicity Category I. rabbit. One half milliliter (mL) of n- relationship of this information to B. Structure-Activity-Relationship (SAR) propyl lactate (99.5%) was distributed human risk. EPA has also considered Assessment available information concerning the over each of three patches measuring variability of the sensitivities of major approximately 2.5 x 2.5 centimeter (cm). Lactic acid, n-propyl ester, (S), identifiable subgroups of consumers, Three rabbits were used and each rabbit belongs to the same class of lactate including infants and children. The received one patch applied to a skin site esters as lactic acid, ethyl ester and nature of the toxic effects caused by with 4–hour occluded exposure. All lactic acid, n-butyl ester. Structurally lactic acid, n-propyl ester, (S) are scores were zero for erythema and for these three chemicals which are all discussed in this unit. oedema at 7 and 14 days. There was esters of lactic acid differ only in the slight scaliness at all three sites at day presence of the ethyl, n-propyl, or n- A. Agency-Reviewed Studies 7 but not at day 14. This is Toxicity butyl side chain. SAR assessments in 1. Acute dermal toxicity in the rat. Category IV. which the chemical’s structural Five males and five female adult 3. Acute eye irritation study in the similarity to other chemicals is used to outbred albino rats received 24–hour rabbit. One-tenth mL of n-propyl lactate determine toxicity have been performed occluded dermal exposure to a dose of (99.5%) was instilled into the right eye for all three chemicals. The assessments 2,000 milligram per kilogram (mg/kg) of of a single young adult New Zealand did not identify any concerns for n-propyl lactate (99.5%). There was no White rabbit with no subsequent wash. carcinogenicity or developmental mortality. All five males and four of five The exposed eye scored positive for toxicity for the lactate esters. In fact, all females lost weight from day 0 to day corneal opacity at 1, 24, 48, and 72 three chemicals were judged to be of 3, but five males and three females had hours, and at 7, 14, 21, 25, 28, 35, and low concern. For comparison purposes slight weight gains during the period 42 days.