Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of lactic acid, n-propyl ester, (S) on raw agricultural commodities when used as an inert ingredient in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest, or animals. PURAC America, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996, requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of lactic acid, n-propyl ester, (S).
This regulation is effective June 23, 2004. Objections and requests for hearings must be received on or before August 23, 2004.
To submit a written objection or hearing request follow the detailed instructions as provided in Unit VIII. of the
Princess Campbell, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–8033; e-mail address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
• Crop production (NAICS code 111)
• Animal production (NAICS code 112)
• Food manufacturing (NAICS code 311)
• Pesticide manufacturing (NAICS code 32532)
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
In addition to using EDOCKET at
In the
The petition requested that 40 CFR 180.950 be amended by establishing an exemption from the requirement of a tolerance for residues of n-propyl lactate, also known as lactic acid, n-propyl ester, (S) (CAS Reg. No. 53651–69–7). There were no comments received in response to the notice of filing.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.
Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by lactic acid, n-propyl ester, (S) are discussed in this unit.
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Lactic acid, n-propyl ester, (S), belongs to the same class of lactate esters as lactic acid, ethyl ester and lactic acid, n-butyl ester. Structurally these three chemicals which are all esters of lactic acid differ only in the presence of the ethyl, n-propyl, or n-butyl side chain. SAR assessments in which the chemical's structural similarity to other chemicals is used to determine toxicity have been performed for all three chemicals. The assessments did not identify any concerns for carcinogenicity or developmental toxicity for the lactate esters. In fact, all three chemicals were judged to be of low concern. For comparison purposes the physical/chemical properties are given in Table 1 below.
Detailed discussions of the toxicity data for ethyl and butyl lactate esters were published in the Final Rule entitled “Lactic Acid, n-Butyl Ester and Lactic Acid, Ethyl Ester”; Exemptions from the Requirement of a Tolerance, in the
In mammals simple esters such as ethyl, butyl, and n-propyl lactate readily undergo hydrolysis, yielding the alcohol and acid from which the ester was formed. For example in the case of ethyl lactate, the breakdown products would be ethyl alcohol (ethanol) and lactic acid, and in the case of n-propyl-lactate, this would be n-propyl alcohol (1-propanol) and lactic acid. The metabolism of lactic acid is well understood; it is an intermediate in human metabolism of glucose. The World Health Organization (WHO) has examined the metabolism of 1-propanol, and has determined that it is rapidly absorbed and distributed throughout the body following ingestion.
In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).
As previously stated, lactic acid, n-propyl ester, (S) belongs to the same class of lactate esters as lactic acid, ethyl ester, and lactic acid, n-butyl ester. The SAR assessments for each of these three chemicals supports the conclusion that as a class, lactate esters, including lactic acid, n-propyl ester, (S) are of low toxicity.
Given their physical/chemical properties, lactate esters could have a variety of uses in and around the home. According to information on the Internet they are being considered as “green” replacements for many of the organic solvents traditionally used in the manufacturing industry. The Agency has estimated a generic dietary exposure estimate for an inert ingredient of 0.12 milligrams/kilogram/day (mg/kg/day). To assure that the exposure is not underestimated, it is assumed that the inert ingredients are used on all crops and 100% of all crops are “treated” with the inert ingredient. Given the low toxicity of the lactate esters as a class and the body's ability to metabolize lactic acid, n-propyl ester, (S) to n-propyl alcohol and lactic acid, which are well-absorbed and metabolized by the human body, a qualitative assessment for all pathways of human exposure (food, drinking water, and residential) is appropriate.
Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”
Lactic acid, n-propyl ester, (S) is structurally related to lactic acid, ethyl ester and lactic acid, n-butyl ester. All are lower toxicity chemicals; therefore, the resultant risks separately and/or combined should also be low. These chemicals do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that these chemical substances have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at
Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Due to the expected low oral toxicity of lactic acid, n-propyl ester, (S), a safety factor analysis has not been used to assess its risk. For the same reasons, the additional tenfold safety factor for the protection of infants and children is unnecessary.
Lactic acid, n-propyl ester, (S) belongs to the same class of lactate esters as lactic acid, ethyl ester, and lactic acid, n-butyl ester. The hydrolysis products of lactic acid, n-propyl ester, (S) are n-propanol and lactic acid which are readily metabolized by the human body. The SAR assessment did not identify any concerns for carcinogenicity or developmental toxicity. EPA concludes that lactic acid, n-propyl ester, (S) does not pose a dietary risk under reasonably foreseeable circumstances, and that there is a reasonable certainty of no harm from aggregate exposure to residues of lactic acid, n-propyl ester, (S).
FQPA requires EPA to develop a screening program to determine whether certain substances, including all pesticide chemicals (both inert and active ingredients), may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect. EPA has been working with interested stakeholders to develop a screening and testing program as well as a priority setting scheme. As the Agency proceeds with implementation of this program, further testing of products containing
An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.
There are no existing tolerances or tolerance exemptions for lactic acid, n-propyl ester, (S).
The Agency is not aware of any country requiring a tolerance for lactic acid, n-propyl ester, (S) nor have any CODEX maximum residue levels been established for any food crops at this time.
It has been determined that lactic acid, n-propyl ester, (S) is to be classified as a List 4B inert ingredient. This classification is due to the Toxicity Category I determination for the acute eye irritation study. Tolerance exemptions for lactic acid, n-propyl ester, (S) will be established in 40 CFR 180.910 and 180.930 instead of 40 CFR 180.950 as requested by the petitioner PURAC.
Based on the Agency's review and evaluation of information on the toxicity of lactic acid, n-propyl ester, (S) as summarized in this preamble, and the previous evaluation of the structurally-related chemicals, lactic acid, ethyl ester and lactic acid, n-butyl ester (see the September 3, 2002 Final Rule), and considering the SAR assessments, and an understanding of the metabolism of lactate esters as a chemical class, EPA concludes that there is a reasonable certainty of no harm from aggregate exposure to residues of lactic acid, n-propyl ester, (S). Accordingly, EPA finds that exempting lactic acid, n-propyl ester, (CAS Reg. No. 53651–69–7) from the requirement of a tolerance will be safe.
Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of the FFDCA, as was provided in the old FFDCA sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.
You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP–2004–0040 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before August 23, 2004.
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Mail your written request to: Office of the Hearing Clerk (1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. You may also deliver your request to the Office of the Hearing Clerk in Suite 350, 1099 14
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EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305–5697, by e-mail at
If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001.
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A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility
This final rule establishes an exemption from the tolerance requirement under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled
The Congressional Review Act, 5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
21 U.S.C. 321(q), 346a and 371.