[Federal Register: February 19, 2003 (Volume 68, Number 33)]
[Rules and Regulations]
[Page 7935-7940]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19fe03-21]
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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: heyward.adam@epa.gov.
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 tompkins.jim@epa.gov,
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: opp-docket@epa.gov. 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