[Federal Register Volume 68, Number 33 (Wednesday, February 19, 2003)]
[Rules and Regulations]
[Pages 7935-7940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-3843]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0272; FRL-7278-6]


Decanoic 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 decanoic acid (capric 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. 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), as amended by the Food Quality Protection Act of 1996 
(FQPA), requesting an exemption from the requirement of a tolerance. 
This regulation eliminates the need to establish a maximum permissible 
level for residues of decanoic acid.

DATES: This regulation is effective February 19, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0272, 
must be received on or before April 21, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit X. 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)

[[Page 7936]]

    [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-2002-0272. 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 0F6194) 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 part 180 be amended by 
establishing an exemption from the requirement of a tolerance is 
established for residues of decanoic acid in or on all raw agricultural 
commodities and in processed commodities, when such residues result 
from the use of decanoic acid as an antimicrobial treatment in 
solutions containing a diluted end-use concentration of decanoic acid 
up to 170 parts per million (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 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 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 assesses the 
hazards of the pesticide through examination and review of available 
toxicology data. Second, EPA examines the potential route(s) and 
duration(s) of exposure to the pesticide through food, drinking water, 
and through other exposures that can occur as a result of pesticide use 
in residential settings.

III. Aggregate Risk Assessment and Determination of Safety

    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. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of the FFDCA, for an exemption from the requirement of a 
tolerance for residues of decanoic acid on all food up to 170 ppm. 
EPA's assessment of exposures and risks associated with establishing 
the tolerance follows.

A. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available toxicology data from the open scientific literature as well 
as the data submitted in support of this action and has considered its 
validity, completeness and reliability and the relationship to human 
risk. EPA has also considered available information on potential 
differences in sensitivity to the toxicity of the pesticide in major 
identifiable subgroups of consumers, including infants and children. 
The natures of the toxic effects caused by decanoic acid (capric acid) 
are discussed in this unit.

B. Acute Toxicity

    The acute oral toxicity of decanoic acid is low lethal dose (LD) 
50 >10 grams/kilograms (g/kg) as is the acute dermal 
toxicity (LD50 > 5 g/kg). Decanoic Acid is a moderate too 
severe skin irritant when applied undiluted to intact or abraded rabbit 
skin for 24 hours. Decanoic acid is also a severe eye irritant when 
applied as a 5% solution.

C. Subchronic Toxicity

    As reported in Patty's Industrial Hygiene and Toxicology, 4th ed., 
rats fed capric acid at 10% in the diet for 150 days showed no adverse 
effects from treatment. In another study, rats administered 
approximately 4 g decanoic acid /kg/day for 6 weeks showed reduced body 
weight gain and increased plasma triglyceride levels. In a longer term 
study in which rats were fed 2.5 g/kg/day decanoic acid for 47 weeks, 
no adverse toxicological effects were noted. Dogs administered 4.4 g/
kg/day decanoic acid for 102 days showed no adverse effects of 
treatment.

D. Developmental and Reproductive Effects

    In a study by Hendrich et al. (JAOCS, Vol. 70, no. 8, August 1993, 
pages 797-802), the potential reproductive effects of decanoic acid 
were examined in

[[Page 7937]]

CBA/2 and C57B1/6 mice. Groups of mice received diets containing either 
17.2% beef tallow and 3.5% corn oil or 8.6% crude Cuphea oil and 3.5% 
corn oil. Cuphea oil is composed of 76% decanoic acid, 4.8% octanoic 
acid, 2.5% dodecanoic acid, 2.2% myristate, 3.4% palmitate, 0.7% 
stearate, 3.3% oleate, and 5.5% linoleate. Parental animals were fed 
for various times due to the short supply of Cuphea oil. C57B1/6 mice 
were fed for either 10 months, 8 months, or 5 months (F1, F2, and F3 
generations), while the CBA/2 mice were fed for 11-12 months, 9-11 
months, and 6-8 months (F1, F2, and F3 generations). Body weights, food 
intake, liver weights, and total serum cholesterol were analyzed as 
well as the number of pups born and surviving to weaning. 
Histopathology was performed on liver, left kidney, spleen, heart, 
lung, and one testis. The histopathology appears to have been done only 
on parental mice. Feeding of Cuphea oil containing decanoic acid to 
successive generations of two strains of mice had no effect on 
reproduction in either strain of mouse. In the F1 generation of the 
CBA/2 strain, the reported number of pups per female was decreased in 
the Cuphea-fed mice vs. the mice fed the basal diet without the Cuphea 
oil. However, this effect was not observed in any other generation of 
the CBA/2 strain or in any generation of the C57B1/6 strain and is 
therefore not interpreted as a treatment-related effect. Body weight in 
C57B1/6 and CBA/2 mice was reduced approximately 10% after 13 weeks of 
treatment but this effect was not observed in successive generations. 
Food intake was not consistently affected by treatment. Serum 
cholesterol was significantly increased in C57B1/6 mice after 3 months 
of treatment, and the increase was also observed after 5 and 12 months. 
Fatty vacuolization was observed in the liver of most mice after 
treatment. CBA/2 mice tended to accumulate fat as large vacuoles in 
periportal hepatocytes with smaller vacuoles in centrilobular 
hepatocytes. C57B1/6 mice had a more diffuse fatty change with large 
vacuoles in centrilobular areas.

E. Carcinogenicity/Mutagenicity

    There are no published studies on carcinogenicity of decanoic acid, 
but available mutagenicity data indicate that decanoic acid is negative 
for mutagenic effects.

F. Physiological Effects

    Decanoic acid was observed to enhance the permeability of the 
blood-brain in Wistar rats to several hydrophilic compounds when 
administered into the carotid artery (Ohnishi et al., J. Pharm. 
Pharmacol. 51: 1015-1018, 1998).

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 drinking water (from ground water or surface water) 
and exposure through non-occupational pesticide use.

A. Dietary Exposure

    1. Food; existing tolerances and other clearances. The Food and 
Drug Administration (FDA) has established a food additive clearance for 
decanoic acid at levels up to 234 ppm in sanitizing solutions (21 CFR 
178.1010(c)(22), (30), (31), (34)), and has also cleared this chemical 
for direct addition to food for human consumption without limits.
    Decanoic acid is also permitted for use in food as a lubricant, 
binder and as a defoaming agent as a component in the manufacture of 
other food-grade components, without limits, provided it meets the 
criteria as set forth in 21 CFR 172.860.
    Worst case dietary exposures for the sanitizer use of decanoic acid 
have been calculated assuming that all food consumed by an adult or 
child has contacted a 4,000 cm2 sanitized surface using 
decanoic acid, that a 1 milligram/centimeter (mg/cm)2 
sanitizer residue remains on the surface, and that 100% of the residue 
(28 ppm) is transferred to the food from the surface. Using these 
assumptions a worst case dietary exposure of 113 [mu]g/day is 
calculated. For a 70 kg adult this becomes 1.6 [mu]g/kg/day, and for a 
15 kg child, intake is calculated as 7.5 [mu]g/kg/day.
    2. Drinking water exposure. The use of decanoic acid as a component 
of KX-6116 food surface sanitizer could result in the introduction of 
very low concentrations of decanoic acid into drinking water. However, 
this exposure through drinking water is expected to be minimal.

B. Non-Occupational Exposure

    Based on the intended use of decanoic acid in food handling 
establishments, exposure to decanoic acid as a component of KX-6116 
sanitizer through non-occupational sources is not likely to occur.

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. Based on the information discussed in Section VII below, 
EPA concluded that decanoic acid is sufficiently non-toxic that EPA can 
determine that it does not share a common mechanism of toxicity with 
other substances.

VI. Additional Safety Factor for the Protection of 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 VII. of this 
document, EPA concluded that decanoic 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.

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

    Based on the following considerations, EPA concludes that decanoic 
acid is unlikely to pose a risk under all reasonable exposure 
scenarios:
    1. The fatty acids as a group including decanoic acid have a safe 
history of use as natural components of many foods, as direct food 
additives, and as cosmetic ingredients. Furthermore, fatty acids are 
processed by known metabolic pathways within the body and contribute to 
normal physiological function.
    2. The Joint FAO/WHO Expert Committee on Food Additives did not 
establish a specific allowable daily intake (ADI) for decanoic acid 
(i.e. Reference dose (RfD)) based on the knowledge that the compound is 
already a component of the human diet, has a long history of use, and 
does not present with any significant toxicology concerns and therefore 
does not represent a health hazard.
    3. The Food and Drug Administration has established a food additive 
clearance for decanoic acid at levels up to 234 ppm in sanitizing 
solutions (21 CFR 178.1010(c)(22), (30), (31), (34)),

[[Page 7938]]

and has also cleared this chemical for direct addition to food for 
human consumption without limits. Decanoic acid is also permitted for 
use in food as a lubricant, binder and as a defoaming agent as a 
component in the manufacture of other food-grade components, without 
limits, provided it meets the criteria as set forth in 21 CFR 172.860.
    4. Evidence of adverse reactions to decanoic acid in dietary 
toxicity testing was observed only at doses that were at or above limit 
doses.
    5. The estimated exposures to decanoic 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. For example, adverse effects in toxicity 
testing could only be achieved by doses in the range of several grams 
of decanoic acid per kilogram of body weight per day. A worst case 
dietary exposure for the sanitizer use estimated exposure for a 70 kg 
adult of 1.6 [mu]g/kg/day, and for a 15kg child of 7.5 [mu]g/kg/day.
    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.

VIII. 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 decanoic 
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 Avenue, NW., Washington, D.C. 20460. Office 
location and telephone number: 1921 Jefferson Davis Highway, 3rd Floor, 
Arlington, VA 22202, (703) 308-8253.

B. International Tolerances

    No codex maximum residue levels have been established for decanoic 
acid.

IX. Conclusion

    An exemption from the requirement of a tolerance is established for 
residues of decanoic acid in or on all raw agricultural commodities and 
in processed commodities, when such residues result from the use of 
decanoic acid as an antimicrobial treatment in solutions containing a 
diluted end-use concentration of decanoic 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 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.

X. 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-2002-0272 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-2002-0272, to: Public 
Information

[[Page 7939]]

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).

XI. Stautory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a 
tolerance 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 tolerance 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.

XII. 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 record 
keeping 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 180.1223 is added to subpart D to read as follows:


Sec.  180.1223  Decanoic acid; exemption from the requirement of a 
tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of decanoic acid in or on all raw

[[Page 7940]]

agricultural commodities and in processed commodities, when such 
residues result from the use of decanoic acid as an antimicrobial 
treatment in solutions containing a diluted end-use concentration of 
decanoic 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. 03-3843 Filed 2-18-03; 8:45 am]
BILLING CODE 6560-50-S