[Federal Register Volume 68, Number 33 (Wednesday, February 19, 2003)]
[Rules and Regulations]
[Pages 7931-7935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-3842]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0273; FRL-7278-7]


Pelargonic Acid (Nonanoic Acid); Exemption from the Requirement 
of a Pesticide 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 the pelargonic acid in or on all foods 
when applied used as a component of a food contact surface sanitizing 
solution in food handling establishments. Eco Lab Inc. requested this 
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective February 19, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0273, 
must be received on or before April 21, 2003.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, electronically, or in person. Please follow the detailed 
instructions for each method as provided in Unit VI. of the 
SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT:  Adam Heyward, Antimicrobials Division 
(7510C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-6422; 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:
    [sbull] Crop production (NAIC code 111)
    [sbull] Animal production (NAIC code 112)
    [sbull] Food manufacturing (NAIC code 311)
    [sbull] Pesticide manufacturing (NAIC code 32532)

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

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2002-0273. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing 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.
    2. Electronic access. 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 http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of December 7, 2001 (66 FR 63534) (FRL-
6737-9), EPA issued a notice pursuant to section 408 of FFDCA, 21 
U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the 
filing of a pesticide petition (PP 0F6193) by Eco Lab Inc., 370 N. 
Wabasha Street, St. Paul MN 55102. That notice included a summary of 
the petition prepared by Eco Lab, Inc., the registrant. There were no 
comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.1159 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of nonanoic acid. Nonanoic acid is a component of a proposed 
product KX-6116 in which this active ingredient is present at 6.49% in 
the formulation. The proposed sanitizer formulation is applied to food 
contact surfaces such as equipment, pipelines, tanks, vats, fillers, 
evaporators, pasteurizers and aseptic equipment in restaurants, food 
service operations, dairies, breweries, wineries, and beverage and food 
processing plants. The sanitizer is applied by immersion, coarse spray, 
or circulation technique as appropriate to the equipment. The solution, 
once applied, is allowed to drain and dry and there is no potable water 
rinse.
    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) 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. Toxicological Profile

    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

[[Page 7932]]

variability of the sensitivities of major identifiable subgroups of 
consumers, including infants and children. The nature of the toxic 
effects caused by pelargonic acid (nonanoic acid) are discussed in this 
unit.

A. Acute Toxicity

    As a result of a number of acute toxicity studies, technical 
pelargonic acid is placed in the following Toxicity Categories: Primary 
eye irritation (Toxicity Category II), primary eye irritation (Toxicity 
Category II), acute oral toxicity (Toxicity Category IV), acute dermal 
and inhalation toxicity (Toxicity Category III). Sensitization test 
results showed that pelargonic acid cannot be considered a dermal 
sensitizer.

B. Subchronic and Chronic Toxicity

    In an oral toxicity study (conducted for 14-days), no systemic 
toxicity was observed with either sex even at the highest dose tested, 
20,000 parts per million (ppm) (1,834 milligrams/kilogram/day (mg/kg/
day)). In addition, pelargonic acid showed no adverse effects on 
survival, clinical signs, body weight gain, food consumption, 
hematology, clinical chemistry or gross pathology. For each dose, three 
animals per sex were tested. However, the study did not report organ 
weights and histopathology. This was considered a deficiency in this 
study. Nevertheless, the Agency determined that because no toxic 
effects were observed at a very high level of [sim] 2,000 mg/kg, a 90-
day oral study was not necessary.
    A 28-day dermal toxicity study conducted on rabbits was submitted 
to the Agency under TSCA section 8(e). Five male and five female New 
Zealand white rabbits were dermally treated with pelargonic acid 
present in mineral oil. In all, 10 applications were made (5 per week) 
at a dose level of 500 mg/kg/day. A 2-week recovery period was allowed 
for selected rabbits. During the first and second week of treatment, 
slight body weight loss and decreased food consumption were observed. 
One female rabbit showed ocular discharge and hypoactivity during the 
second week of treatment. All rabbits dermally treated with pelargonic 
acid by day 14 showed signs of severe erythema and moderate edema. 
Dermal reactions consisting of moderate desquamation, moderate 
fissuring, eschar, exfoliation and necrosis were also observed at day 
14. By day 29, all dermal reactions had reversed. It was evident that 
at the treatment level of 500 mg/kg/day of pelargonic acid, significant 
dermal signs of toxicity were observed but no significant systemic 
reaction.
    A supplemental study on chronic toxicity/carcinogenicity in mice 
was conducted for 80 weeks. A dose of 50 mg of pelargonic acid was 
dermally applied to each mouse twice/day for 80 weeks. Histopathology 
showed no non-neoplastic or neoplastic lesions on skins and internal 
organs of mice. The Agency concluded that this study although not 
exactly conducted according to guideline, adequately assesses the 
chronic toxicity and the carcinogenic potential of pelargonic acid via 
the dermal route.

C. Developmental Toxicity

    A development toxicity was conducted on a group of 22 pregnant 
Crl:COBS CD(SD)BR rats. These rats were treated with pelargonic acid in 
corn oil at a dose of 1,500 mg/kg on gestation days 6 through 15 (both 
days inclusive). Maternal body weight was not significantly affected 
during the treatment. Only 1 out of 22 animals showed signs of clinical 
toxicity. No significant histopathology signs were observed in the 
maternal animals. Pelargonic acid treatment did not have any 
significant effect on cesarean section observations. Four fetuses in 
one litter showed a higher incidence of cleft palate compared to the 
control mean. For maternal toxicity, the Agency has determined the no 
observed adverse effect level (NOAEL) to be greater than 1,500 mg/kg/
day. Because fetal effects were observed at 1,500 mg/kg/day, the NOAEL 
for developmental toxicity was not determined. The Agency has 
determined that this dose is in excess of the Agency's limit dose for 
toxic effects. The type and level of exposure expected from the use of 
this chemical is much lower than the dose level shown in the study.

D. Mutagenicity/Carcinogenicity

    Ames Test (Salmonella/reverse mutation assay) showed pelargonic 
acid to be non-mutgenic. Similarly, in vivo cytogenetics study using 
micronucleus assay gave a negative result. In a mouse lymphoma forward 
mutation study, pelargonic acid appears to induce a weak mutagenic 
response at or higher than 50 milligrams/milliliter (mg/mL) level. This 
was observed in the presence of increasing toxicity, and may be an 
indication of gross chromosomal changes or damage and not actual 
mutational changes within the thymidine kinese gene locus.
    As described above, a summary of the results of a dermal 
carcinogenicity study in mice with pelargonic acid was submitted. Fifty 
mice were treated twice-weekly with 50 mg doses of undiluted pelargonic 
acid for 80 weeks. No evidence of severe dermal or systemic toxicity 
was seen. Histopathology revealed no tumors of the skin or the internal 
organs

E. Exposure Assessment

    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). The Agency has considered available information on the 
aggregate exposure levels of consumers (and major identifiable 
subgroups of consumers) to the pesticide chemical residue of pelargonic 
acid (nonanoic acid) and to other related substances. In these 
considerations, the Agency has included dietary exposure under the 
tolerance exemption and all other tolerances or exemptions in effect 
for pelargonic acid's chemical residue and exposure from non-
occupational sources. The Food and Drug Administration has cleared 
pelargonic acid as a synthetic food flavoring agent (21 CFR 172.515), 
as an adjuvant, production aid and sanitizer to be used in contact with 
food (21 CFR 178.1010(b)) and in washing or to assist in lye peeling of 
fruits and vegetables (up to 1%) (21 CFR 173.315). Pelargonic acid is 
also exempt from the requirement of a tolerance when used in or on all 
food commodities, as a plant regulator on plants, seeds, or cuttings 
after harvest in accordance with GAP. It is also exempt from a 
tolerance when used as a herbicide on all plant food commodities 
provided that allocations are not made directly to the food commodity 
except when used as a harvest aid or dessicant to any root or tuber 
vegetable, bulb, or cotton (40 CFR 180.1159). Applications of the 
proposed end-use products containing pelargonic acid will not directly 
contact edible portions of food commodities.
    1. Food. For the proposed sanitizer uses, a worst case dietary 
exposure estimate has been calculated, assuming that all food consumed 
by an adult or child has contacted a sanitized surface using pelargonic 
acid, that a 1 mg/cm2 sanitizer residue remains on the 
surface, and that 100% of the residue (170 ppm) is transferred to the 
food from the surface. Using these assumptions, in which all food 
contacts 4,000 cm2 of sanitized non-porous food-contact 
surfaces a worst case dietary exposure of 680 [mu]g/day is calculated. 
For a 70 kg adult this becomes 9.7 [mu]g/kg/day and for

[[Page 7933]]

a 15 kg child, exposure is calculated as 45 [mu]g/kg/day.
    2. Drinking water exposure. KX-6116 as a sanitizer contains 
pelargonic acid as its active component and low concentrations of 
pelargonic acid could be expected to be introduced into drinking water. 
However, exposure through drinking water is expected to be low and not 
of significance.
    3. Other non-occupational exposure. Based on the intended use of 
pelargonic acid in food handling establishments, exposure to pelargonic 
acid as a component of KX-6116 sanitizer through non-occupational, non-
dietary sources is not likely to occur.
    4. 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. Based on the information discussed in 
Unit VII. EPA concluded that pelargonic acid is sufficiently non-toxic 
that EPA can determine that it does not share a common mechanism of 
toxicity with other substances.

F. Safety Factor for Infants and Children

    Section 408 of the 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 that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    Based on the considerations discussed in Unit III.G., EPA concluded 
that pelargonic acid was sufficiently non-toxic that a margin of safety 
analysis was not appropriate. For the same reason, EPA has not applied 
an additional margin of safety for the protection of infants and 
children.

G. Determination of Safety

    Based on the following considerations, EPA concludes that 
pelargonic acid is unlikely to pose a risk under all reasonable 
exposure scenarios:
    1. Fatty acids such as pelargonic acid are processed by known 
metabolic pathways within the body and contribute to normal 
physiological function.
    2. Pelargonic acid is naturally present at levels up to 224 parts 
per billion (ppb) in apples, 385 ppm in the skin of grapes, and 143 ppm 
in grape pulp. It is present in a number of other foods as well. An 
average serving of grapes containing 385 ppm of pelargonic acid in the 
grape skins would result in exposure to pelargonic acid to an average 
consumer of 164 [mu]g/kg/day. In comparison, a worst case estimate of 
dietary exposure to pelargonic acid as a result of its use as sanitizer 
is 9.7 [mu]g/kg/day for a 70 kg adult and 45 [mu]g/kg/day for a 15 kg 
child.
    3. The Food and Drug Administration has cleared pelargonic acid as 
a synthetic food flavoring agent (21 CFR 172.515), as an adjuvant, 
production aid and sanitizer to be used in contact with food (21 CFR 
178.1010(b)) and in washing or to assist in lye peeling of fruits and 
vegetables (up to 1%) (21 CFR 173.315). Pelargonic acid is also exempt 
from the requirement of a tolerance when used in or on all food 
commodities, as a plant regulator on plants, seeds, or cuttings after 
harvest in accordance with Good Agricultural Practices (GAP). It is 
also exempt from a tolerance when used as a herbicide on all plant food 
commodities provided that allocations are not made directly to the food 
commodity except when used as a harvest aid or dessicant to any root or 
tuber vegetable, bulb, or cotton (40 CFR 180.1159).
    4. Dietary toxicity testing evidenced adverse reactions only at 
doses that were at or above limit doses. Dermal toxicity testing showed 
no significant systemic reaction.
    5. The estimated exposures to pelargonic acid and other fatty acids 
from direct or indirect addition to food as well as sanitizer uses are 
well below the doses administered in animal studies that are required 
to elicit an adverse effect. Accordingly, EPA concludes that there is a 
reasonable certainty of no harm to the general population, including 
infants and children, from aggregate exposure to pelargonic acid.

IV. Other Considerations

A. Analytical Method(s)

    Because an exemption from the requirement of a tolerance without 
numerical limitation for residues in food is being granted for 
pelargonic acid, an enforcement analytical method is not needed. 
However, an analytical method is available in cases of gross misuse. 
The analytical method is being made available to anyone interested in 
pesticide enforcement when requested, from Norm Cook, Antimicrobials 
Division (7510C), Office of Pesticide Programs, U.S. Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. Office location and telephone number: 1921 Jefferson Davis 
Highway, 3rd Floor, Arlington, VA 22202, (703) 308-8253.

B. Existing Tolerances

    1. 40 CFR 180.1159. Pelargonic acid is exempted from the 
requirement of a tolerance on all food commodities when used as a plant 
regulator on plants, seeds, or cuttings and all food commodities after 
harvest in accordance with GAP or as a herbicide when applications are 
not made directly to the food commodity except when used as a harvest 
aid or dessicant to: any root and tuber vegetables, bulb vegetable or 
cotton. When pelargonic acid is used as a harvest aid or dessicant, 
application must be made no later than 24 hours prior to harvest.
    2. 21 CFR 178.1010(c)(37). Pelargonic acid is permitted in food 
contact sanitizing solutions at a level up to 90 ppm.
    3. 21 CFR 172.515. Pelargonic acid may be safely used as synthetic 
food flavoring substances and adjuvants in food in the minimum quantity 
required to reproduce the intended effect.
    4. 21 CFR 173.315. Pelargonic acid may be used in an aliphatic acid 
mixture for washing or to assist in the peeling of fruits and 
vegetables. The aliphatic acid mixture may be used at a level not to 
exceed 1% in the lye peeling solution.

C. International Tolerances

    No codex maximum residue levels have been established for the 
pelargonic acid.

V. Conclusion

    An exemption from the requirement of a tolerance is established for 
residues of pelargonic acid in or on all raw agricultural commodities 
and in processed commodities, when such residues result from the use of 
pelargonic acid as an antimicrobial treatment in solutions containing a 
diluted end-use concentration of pelargonic acid up to 170 ppm per 
application on food contact surfaces such as equipment, pipelines, 
tanks, vats, fillers, evaporators, pasteurizers and aseptic equipment 
in restaurants, food service operations, dairies, breweries, wineries, 
beverage and food processing plants. The sanitizer shall be applied by 
immersion, coarse spay, or circulation technique as appropriate to the 
equipment or utensil. No potable

[[Page 7934]]

water rinse is required following the use of the sanitizer.

VI. 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 FFDCA, as was provided in the old 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-2002-0273 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 April 21, 
2003.
    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 (1900C), 
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 Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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 
(703) 603-0061.
    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 VI.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.1. Mail your 
copies, identified by docket ID number OPP-2002-0273, 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 Unit I.B.1. 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).

VII. Statutory and Executive Order Reviews

    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

[[Page 7935]]

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 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.

VIII. 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: January 21, 2003.
James Jones,
Acting Director, 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 180.1159 is amended by adding paragraph (c) to read as 
follows:


Sec.  180.1159  Pelargonic acid; exemption from the requirement of a 
tolerance.

* * * * *
    (c) An exemption from the requirement of a tolerance is established 
for residues of pelargonic acid in or on all raw agricultural 
commodities and in processed commodities, when such residues result 
from the use of pelargonic acid as an antimicrobial treatment in 
solutions containing a diluted end-use concentration of pelargonic acid 
up to 170 ppm per application on food contact surfaces such as 
equipment, pipelines, tanks, vats, fillers, evaporators, pasteurizers 
and aseptic equipment in restaurants, food service operations, dairies, 
breweries, wineries, beverage and food processing plants.

[FR Doc. 03-3842 Filed 2-18-03; 8:45 am]
BILLING CODE 6560-50-S