[Federal Register Volume 67, Number 170 (Tuesday, September 3, 2002)]
[Rules and Regulations]
[Pages 56225-56229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-22369]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0217; FRL-7196-6]


Lactic acid, ethyl ester and Lactic acid, n-butyl ester; 
Exemptions from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes two exemptions from the 
requirement of a tolerance for residues of lactic acid, ethyl ester and 
lactic acid, n-butyl ester when used in pesticide formulations. PURAC 
America, Inc. submitted two petitions to EPA under the Federal Food, 
Drug, and Cosmetic Act, as amended by the Food Quality Protection Act 
of 1996, requesting these exemptions from the requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of lactic acid, ethyl ester and lactic 
acid, n-butyl ester.

DATES: This regulation is effective September 3, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0217, 
must be received on or before November 4, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket ID number OPP-2002-0217 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Kathryn Boyle, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: 703-305-6304; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
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Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations, '' ``Regulations and Proposed Rules,'' and then look up 
the entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml --00/Title --40/40cfr180 --00.html, a beta site 
currently under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-2002-0217. The official 
record consists of the documents specifically referenced in this 
action, and other information related to this action, including any 
information claimed as Confidential Business Information (CBI). This 
official record includes the documents that are physically located in 
the docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of April 12, 2000 (65 FR 19759) (FRL-6498-
8), EPA issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food 
Quality Protection Act (FQPA) (Public Law 104-170), announcing the 
filing of pesticide tolerance petitions (PP 5E4510 and 5E4515) by PURAC 
America, Inc., Barclay Boulevard, Lincolnshire Corporate Center, 
Lincolnshire, IL 60069. This notice included a summary of the petitions 
prepared by the petitioner PURAC. There were no comments received in 
response to the notice of filing.
    The petitions requested that 40 CFR 180.1001(c) and (e) be amended 
by establishing an exemption from the requirement of a tolerance for 
residues of ethyl lactate (CAS Reg. No. 97-64-3), also known as lactic 
acid, ethyl ester, and butyl lactate (CAS Reg. No. 138-22-7), also 
known as lactic acid, n-butyl ester.
    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

[[Page 56226]]

determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) 
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) 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. Human Health Assessment

    Consistent with section 408(b)(2)(D) of 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, ethyl ester and lactic acid, n-butyl ester are discussed in this 
unit.

A. Toxicological Profile (Agency-Reviewed Studies) for Lactic Acid, 
Ethyl Ester (Ethyl Lactate)

    1. Acute oral toxicity in the rat. Groups of five young adult 
outbred rats/sex were given a single oral dose of 2,000 milligrams/
kilogram (mg/kg). All animals survived the 14-day observation period. 
No significant treatment-related effects on body weight were observed 
during the study, and gross necropsies of animals sacrificed after 14 
days revealed no observable abnormalities. The lethal dose 
(LD50) is greater than 2,000 mg/kg (males; females).
    2. Dermal developmental toxicity in the rat. Lactic acid, ethyl 
ester was administered percutaneously to 25 rats/dose at dose levels of 
0 (sham), 517, 1,551, or 3,619 mg/kg/day for 6 hours/day on days 6-15 
of gestation. No systemic toxicity was noted at any dose level. Body 
weights, body weight gains, feed consumption, mortality, clinical signs 
of toxicity, and cesarean section parameters were unaffected by 
treatment. There were no treatment-related effects found on caesarean 
section examinations of the dams or external, visceral, or skeletal 
examinations of the fetuses. Both the maternal and developmental no 
observed adverse effect level (NOAEL) was 3,619 mg/kg/day, the highest 
dose tested. The lowest observed adverse effect level (LOAEL) was not 
determined, but would be greater than 3,619 mg/kg/day.
    3. Inhalation studies. Three inhalation studies using lactic acid, 
ethyl ester were also submitted. However, the Agency was not able to 
use this information since the aerodynamic particle sizes (the mass 
median aerodynamic diameter (MMAD) and distribution of measurements) 
and the time required to reach equilibrium of the generated aerosols 
were not provided.

B. Toxicological Profile (Agency-Reviewed Studies) for Lactic Acid, n-
Butyl Ester (Butyl Lactate)

    1. Acute oral toxicity in the rat. Groups of five young adult 
outbred rats/sex were given a single oral dose of 2,000 mg/kg. All 
animals survived the 14-day observation period. No treatment-related 
effect on body weight was observed during the study and gross 
necropsies of animals sacrificed after 14 days revealed no observable 
abnormalities. The LD50 is greater than 2,000 mg/kg (males; 
females)
    2. Acute inhalation toxicity in the rat. Groups of five young adult 
outbred rats/sex were given a whole body exposure to n-butyl-S-(-)- 
lactate vapor at 5.14 milligrams/liter (mg/L) (greater than 2X limit 
concentration) for 4 hours. All animals survived the 4-hour exposure 
period and 14-day observation periods. Moderately decreased breathing 
frequencies, wet fur (nose/head), were observed in 10/10 animals during 
and just following exposure. Effects subsided from all animals by day 
1. No treatment-related effects on body weight were observed during the 
study, and gross necropsy after 14 days revealed no abnormalities. The 
lethal concentration (LC50) is greater than 5.14 mg/L.

C. Structure Activity Relationship Assessment

    For lactic acid, ethyl ester and lactic acid, n-butyl ester], 
toxicity was assessed, in part, by a process called structure-activity 
relationship (SAR). In this process, the chemical's structural 
similarity to other chemicals (for which data are available) is used to 
determine toxicity. For human health, this process, can be used to 
assess absorption and metabolism, mutagenicity, carcinogenicity, 
developmental and reproductive effects, neurotoxicity, systemic 
effects, immunotoxicity, and sensitization and irritation. This is a 
qualitative assessment using terms such as good, not likely, poor, 
moderate, or high.
    For lactic acid, ethyl ester and lactic acid, n-butyl ester the SAR 
assessment determined that the chemical was not structurally related to 
any known carcinogens or developmental/reproductive toxicants. The 
following human exposures were examined as part of the analysis: 
inhalation, dermal, exposures to the eyes, and drinking water. For both 
chemicals, absorption is expected to be good (well-absorbed) for all 
routes based on analog data. It was noted that ester hydrolysis would 
be expected to release the corresponding alcohol. Both chemicals would 
be expected to be irritating to mucous membranes, and there is the 
possibility of irritation to the lungs and eyes. For both lactic acid, 
ethyl ester and lactic acid, n-butyl ester, the overall rating for 
human health is low concern.
    The SAR did note a concern for solvent neurotoxicity, i.e., 
neurotoxic effects that can occur due to high and/or prolonged dermal 
and inhalation exposures to organic solvents. According to the SAR, the 
greatest concerns for both ethyl and butyl lactate, based on their 
structural chemistry and chemical class, are concerns for possible 
solvent neurotoxicity and irritation to mucous membranes, lungs and 
eyes. It should be noted that the inclusion of the phrase concerns for 
solvent-type neurotoxicity in the SAR assessment does not necessarily 
indicate chemical-specific concerns. By including this statement those 
performing the assessment are acknowledging that the chemical is a 
member of a class of chemicals that can exhibit solvent neurotoxicity.

D. Findings of the FAO/WHO Expert Committee on Food Additives

    Ethyl lactate has been examined at several meetings of the (United 
Nations Food and Agriculture Organization/World Health Organization) 
FAO/WHO Joint Expert Committee on Food Additives (JECFA). At the last 
meeting, the absorption and metabolism of ethyl lactate was extensively 
studied. There has long been evidence that in mammals simple esters 
such as ethyl lactate readily undergo hydrolysis, yielding the

[[Page 56227]]

alcohol and acid from which the ester was formed. In the case of ethyl 
lactate, this would be ethyl alcohol (ethanol) and lactic acid. The 
human metabolism of ethanol is well understood: it is oxidized to 
carbon dioxide and water. The metabolism of lactic acid is also 
understood: it is an intermediate in human metabolism of glucose. The 
Committee determined that recent in vivo and in vitro studies indicated 
that ethyl-L-lactate was hydrolysed to ethyl alcohol and lactic acid 
mainly prior to absorption. Based on this understanding of the 
metabolism of ethyl lactate, the Committee also determined that it was 
not necessary to specify an estimate of acceptable daily intake.

E. Conclusions

    The SAR assessments did not identify any concerns for 
carcinogenicity or developmental toxicity for either of these lactate 
esters. In fact, both lactic acid, ethyl ester and lactic acid, n-butyl 
ester were judged to be of low concern. The only concerns identified 
were for possible solvent neurotoxicity and irritation to mucous 
membranes, lungs and eyes. These identified concerns are for the dermal 
and inhalation exposure routes and are addressed through the use of 
protective equipment such as gloves and respirators, not through 
establishment of tolerance exemptions.
    The lactic acid, ethyl ester dermal developmental toxicity study 
indicates low toxicity to both the mother and the developing fetus. 
Both the developmental and maternal NOAELs (3,619 mg/kg/day) are the 
highest dose tested. Given the structural similarities of the two 
chemicals, the Agency believes that the developmental toxicity study 
can be bridged to lactic acid, n-butyl ester.
    The JECFA monograph deemed lactic acid, ethyl ester to be of such 
low concern that the acceptable daily intake is not specified. A 
consideration in this decision was the understanding that hydrolysis 
would occur in the human body thus yielding ethanol and lactic acid. 
The same hydrolysis would occur for lactic acid, n-butyl ester but 
would yield butanol and lactic acid. Butanol is also metabolized in the 
human body butanol is oxidized to butyraldehyde, which is oxidized to 
butyric acid, which is then metabolized via the fatty acid and 
tricarboxylic acid pathways. Thus, the human body has a known pathway 
to metabolize lactic acid, ethyl ester and lactic acid, n-butyl ester, 
and their metabolites.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 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).
    For lactic acid, ethyl ester and lactic acid, n-butyl ester a 
qualitative assessment for all pathways of human exposure (food, 
drinking water, and residential) is appropriate given the SARs which 
judged lactic acid, ethyl ester and lactic acid, n-butyl ester to be of 
low concern and the body's ability to metabolize lactic acid, ethyl 
ester and lactic acid, n-butyl ester, and their metabolites.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) 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, ethyl ester and lactic acid, n-butyl ester 
are structurally related; however, both are lower toxicity chemicals; 
therefore, the resultant risks separately and/or combined should also 
be low. EPA does not have, at this time, available data to determine 
whether lactic acid, ethyl ester and lactic acid, n-butyl ester have a 
common mechanism of toxicity with other substances or how to include 
these pesticide chemicals in a cumulative risk assessment.

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

    Based on the available date, the SAR assessment indicating low 
concern, and information on the metabolism of lactic acid, ethyl ester 
and lactic acid, n-butyl ester, EPA concludes that lactic acid, ethyl 
ester and lactic acid, n-butyl ester do not pose a dietary risk under 
reasonably foreseeable circumstances. Accordingly, EPA finds that there 
is a reasonable certainty that no harm will result to the general 
population, and to infants and children from aggregate exposure to 
lactic acid, ethyl ester and lactic acid, n-butyl ester. For both 
lactic acid, ethyl ester and lactic acid, n-butyl ester, due to the 
expected low oral toxicity, a safety factor analysis has not been used 
to assess the risk. For the same reasons and especially considering the 
developmental toxicity NOAEL, the additional tenfold safety factor for 
the protection of infants and children is unnecessary.

VII. 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 lactic acid, ethyl 
ester and lactic acid, n-butyl ester 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 Tolerances

    There are no existing tolerances or tolerance exemptions for ethyl 
and butyl lactate.

D. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 
lactic acid, ethyl ester and lactic acid, n-butyl ester nor have any 
CODEX Maximum Residue Levels (MRLs) been established for any food crops 
at this time.

E. List 4A Classification

    It has been determined that lactic acid, ethyl ester and lactic 
acid, n-butyl ester are to be classified as List 4A inert ingredients. 
Thus, the tolerance exemptions will be established in 40 CFR 180.950 
instead of 40 CFR 180.1001(c) and (e) as requested by the petitioner 
PURAC.

VIII. Conclusions

    Based on the information in the record, summarized in this 
preamble, EPA concludes that there is a reasonable certainty of no harm 
from aggregate exposure to residues of lactic acid, ethyl ester and 
lactic acid, n-butyl ester. Accordingly, EPA finds that exempting 
lactic acid, ethyl ester and lactic acid, n-butyl ester from the 
requirement of a tolerance will be safe.

IX. 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

[[Page 56228]]

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 of 1996, EPA will continue 
to use those procedures, with appropriate adjustments, until the 
necessary modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 
and 409. 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 control number OPP-2002-0217 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 November 
4, 2002.
    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 (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. 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) 260-4865.
    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.
    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.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VIII.A., 
you should also send a copy of your request to the PIRIB for its 
inclusion in the official record that is described in Unit I.B.2. Mail 
your copies, identified by docket control ID number OPP-2002-0217, 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. In person or by courier, bring a copy to the 
location of the PIRIB described in Unit I.B.2. 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 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).

X. Regulatory Assessment Requirements

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) 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 FFDCA section 408(d), such as the exemption in this 
final rule, do not

[[Page 56229]]

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 FFDCA section 408(n)(4). 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.

XI. Submission to Congress and the Comptroller General

    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: August 19, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

    Authority: 21 U.S.C. 321(q), 346(a) and 374.

    2. Section 180.950 is amended by adding and reserving paragraph (d) 
and adding a new paragraph (e) to read as follows:


Sec. 180.950  Tolerance exemptions for minimal risk active and inert 
ingredients.

* * * * *
    (d) [Reserved]
    (e) Specific chemical substances. Residues resulting from the use 
of the following substances as either an inert or an active ingredient 
in a pesticide chemical formulation, including antimicrobial pesticide 
chemicals, are exempted from the requirement of a tolerance under FFDCA 
section 408, if such use is in accordance with good agricultural or 
manufacturing practices.

------------------------------------------------------------------------
                          Chemical                             CAS No.
------------------------------------------------------------------------
Lactic acid, n-butyl ester.................................     138-22-7
Lactic acid, ethyl ester...................................     197-64-3
------------------------------------------------------------------------


[FR Doc. 02-22369 Filed 8-30-02; 8:45 am]
BILLING CODE 6560-50-S