[Federal Register Volume 69, Number 120 (Wednesday, June 23, 2004)]
[Rules and Regulations]
[Pages 34945-34950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-14221]



[[Page 34945]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0040; FRL-7362-3]


Lactic acid, n-propyl ester, (S); Exemption from the Requirement 
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: 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).

DATES: This regulation is effective June 23, 2004. Objections and 
requests for hearings must be received on or before August 23, 2004.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
ID number OPP-2004-0040. All documents in the docket are listed in the 
EDOCKET index at http://www.epa.gov/edocket. Although listed in the 
index, some information is not publicly available, i.e., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either electronically in 
EDOCKET or in hard copy at the Public Information and Records Integrity 
Branch (PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis 
Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: 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: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    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 FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET at (http://www.epa.gov/edocket/), you 
may access this Federal Register document electronically through the 
EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 
CFR part 180 is available at E-CFR BetaSite Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of October 24, 2003 (68 FR 60987) (FRL-
7330-6), EPA issued a notice pursuant to section 408(d)(3) of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d)(3), 
announcing the filing of a pesticide tolerance petition (PP OF6180) by 
PURAC America, Inc., 111 Barclay Blvd., Lincolnshire Corporate Center, 
Lincolnshire, IL 60069. This notice included a summary of the petition 
prepared by the petitioner PURAC America, Inc.
    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.

III. Inert Ingredient Definition

    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.

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IV. Toxicological Profile

    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.

A. Agency-Reviewed Studies

    1. Acute dermal toxicity in the rat. Five males and five female 
adult outbred albino rats received 24-hour occluded dermal exposure to 
a dose of 2,000 milligram per kilogram (mg/kg) of n-propyl lactate 
(99.5%). There was no mortality. All five males and four of five 
females lost weight from day 0 to day 3, but five males and three 
females had slight weight gains during the period from day 0 to day 14. 
Two males and one female had slight dermal encrustation on day 1. No 
treatment related findings were observed on necropsy. The dermal lethal 
dose (LD)50 was greater than 2,000 milligrams/liter (mg/L). 
This is Toxicity Category III.
    2. Acute dermal irritation study in the rabbit. One half milliliter 
(mL) of n-propyl lactate (99.5%) was distributed over each of three 
patches measuring approximately 2.5 x 2.5 centimeter (cm). Three 
rabbits were used and each rabbit received one patch applied to a skin 
site with 4-hour occluded exposure. All scores were zero for erythema 
and for oedema at 7 and 14 days. There was slight scaliness at all 
three sites at day 7 but not at day 14. This is Toxicity Category IV.
    3. Acute eye irritation study in the rabbit. One-tenth mL of n-
propyl lactate (99.5%) was instilled into the right eye of a single 
young adult New Zealand White rabbit with no subsequent wash. The 
exposed eye scored positive for corneal opacity at 1, 24, 48, and 72 
hours, and at 7, 14, 21, 25, 28, 35, and 42 days. At 35, and 42 days 
three quarters of the cornea was still showing opacity and there was a 
vascularization of the cornea. Iridial and conjunctival effects were 
also present. The iridial irritation cleared by day 14 and the eye was 
no longer positive for chemosis and conjunctival redness at 21 days. 
This is Toxicity Category I.

B. Structure-Activity-Relationship (SAR) Assessment

    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.

                                     Table 1.--Physicial/Chemical Properties
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                                                        Test Results (M) measured (E) estimated
                                      --------------------------------------------------------------------------
                                                                                           Butyl Lactate (taken
              Parameter                  Ethyl Lactate (taken                              from SAR Assessment,
                                         from SAR Assessment,       n-Propyl lactate       NIOSH pocket guide,
                                        submitted information)                            submitted information)
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Physical form                          Liquid                   Liquid                   Liquid
-----------------------------------------------------------------------------------------
Molecular weight                       118                      132.16                   146
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Solubility (water) @ 20 [deg]C         Completely miscible      Miscible                 Slight (NIOSH)
                                                                                         4.5 g in 100 g water
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Vapor pressure (mmHg) @ 20 [deg]C      1.7                      1.3                      0.4 (NIOSH)
                                                                                         0.2
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Octanol/water partition coefficent     0.06                     0.51                     1.1
 log Kow                               0.31 (E) (SAR).........                           1.4 (E) (SAR)
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    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 Federal Register of September 3, 
2002 (67 FR 56225) (FRL-7196-6). Table 2 below compares the toxicity 
data discussed in that final rule and the available data for lactic 
acid, n-propyl ester, (S).

C. Comparison of Toxicity Data for Lactate Esters



                            Table 2.--Comparison of Toxicity Data for Lactate Esters
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            Toxicity Study                  Ethyl Lactate           n-Propyl Lactate          Butyl Lactate
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Acute oral                             LD50 > 2,000 mg/kg       *LD50 > 2,000 mg/kg      LD50 > 2,000 mg/kg
                                                                 (Toxicity Category
                                                                 III)
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Acute inhalation                       ----                     *LC50 > 5,000 mg/m3      LC50 > 5.14 mg/L
                                                                 (Toxicity Category IV)
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Acute dermal                           *LD50 >5 g/kg            LD50 > 2,000 mg/kg       *LD50 > 5 g/kg
                                                                 (Toxicity Category
                                                                 III)
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Dermal irritation                      Non-irritating           Non-irritating to skin   Irritating
                                                                 (Toxicity Category IV)
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Eye irritation                         Possible eye irritant    Severely irritating to   Possible eye irritant
                                                                 eye (Toxicity Category
                                                                 I)
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Dermal developmental                   NOAEL 3,619 mg/kg        ----                     ----
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*These values were obtained from an article entitled ``Safety Assessment of n-Propyl-L-Lactate,'' published by
  Clary et al., 1998, in the Journal of Regulatory Toxicology and Pharmacology. The Agency did not review these
  studies which were supplied as supporting information; however, the studies which provided these results were
  conducted according to OECD guidelines.

D. Metabolism of Lactate Esters

    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.

V. Aggregate Exposures

    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.

VI. Cumulative Effects

    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 http://www.epa.gov/pesticides/cumulative/.

VII. Safety Factor for Infants and Children

    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.

VIII. Determination of Safety for U.S. Population, Infants and Children

    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).

IX. Other Considerations

A. Endocrine Disruptors

    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

[[Page 34948]]

lactic acid, n-propyl ester, (S) for endocrine effects may be required.

B. Analytical Method(s)

    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.

C. Existing Exemptions

    There are no existing tolerances or tolerance exemptions for lactic 
acid, n-propyl ester, (S).

D. International Tolerances

    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.

E. List 4B Classification

    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.

X. Conclusions

    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.

XI. Objections and Hearing Requests

    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.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    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.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    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\th\ St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    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 [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    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.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit XI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2004-0040, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    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

[[Page 34949]]

that available evidence identified by the requestor would, if 
established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

XII. Statutory and Executive Order Reviews

    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 Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the exemption in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

XIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: June 9, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.910, the table is amended by adding alphabetically the 
following inert ingredient to read as follows:


Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
Lactic acid, n-propyl ester,      ..................  Solvent
 (S); (CAS Reg. No. 53651-69-7).
                                * * * * *
------------------------------------------------------------------------



0
3. In Sec.  180.930, the table is amended by adding alphabetically the 
following inert ingredient to read as follows:


Sec.  180.930  Inert ingredients applied to animals; exemptions from 
the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
Lactic acid, n-propyl ester,      ..................  Solvent
 (S); (CAS Reg. No. 53651-69-7).

[[Page 34950]]

 
                                * * * * *
------------------------------------------------------------------------


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