Ethyl Maltol; Exemption from the Requirement of a Tolerance
[Federal Register: June 30, 2005 (Volume 70, Number 125)]
[Rules and Regulations]
[Page 37688-37692]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jn05-15]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0153; FRL-7717-1]
Ethyl Maltol; Exemption from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of 2-ethyl-3-hydroxy- 4H-pyran-4-one, also
known as ethyl maltol when used as an inert ingredient in or on growing
crops, when applied to raw agricultural commodities after harvest, or
to animals. Firmenich Incorporated 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 ethyl maltol.
DATES: This regulation is effective June 30, 2005. Objections and
requests for hearings must be received on or before August 29, 2005.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit XI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number OPP-2005-0153. All documents in the docket
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although
listed in the index, some information is not publicly available, i.e.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed on
the Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S.
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The docket
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Princess Campbell, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8033; e-mail address:
campbell.princess@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
? Crop production (NAICS code 111)
? Animal production (NAICS code 112)
? Food manufacturing (NAICS code 311)
? Pesticide manufacturing (NAICS code 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (http://www.regulations.gov/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
In the Federal Register of December 20, 2000 (65 FR 79834) (FRL-
6751-9), EPA issued a notice pursuant to section 408(d)(3) of the
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
tolerance petition (PP 6E4758) by Firmenich Incorporated, P.O. 5880,
Princeton, NJ 08543. The petition requested that 40 CFR 180.1001(c) and
(e), re-designated as 40 CFR 180.910 and 40 CFR 180.930, respectively
(69 FR 23113, April 28, 2004 (FRL-7335-4)), be
[[Page 37689]]
amended by establishing an exemption from the requirement of a
tolerance for residues of ethyl maltol (CAS Reg. No. 4940-11-8) when
used as an inert ingredient. This notice included a summary of the
petition prepared by the petitioner, Firmenich Incorporated. There were
no comments received in response to the notice of filing.
In later correspondence with the Agency, the petitioner, Firmenich
Incorporated, offered to accept a limitation for ethyl maltol of not
more than 0.2% of the formulated product. The tolerance exemption
established today includes that limitation.
Section 408(c)(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(c)(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. Pursuant to section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C), which requires EPA to give special consideration
to exposure of infants and children to the pesticide chemical residue
in establishing a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue. . . .''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert ingredients.
IV. 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 variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. The nature of the toxic effects caused by ethyl
maltol are discussed in this unit.
A. Toxicity Data
The following table summarizes the toxicological aspects of ethyl
maltol. Even though the studies which yielded the data were not
conducted in accordance with the Agency guidelines, and lacked some
experimental details, the studies appear to be well conducted. Thus,
the results of these studies can be used for regulatory purposes. In
addition to using the toxicity data, the Agency also conducted a
Structure Activity Relationship (SAR) analysis for ethyl maltol. This
analysis supports the conclusions suggested by the toxicity data,
namely, that ethyl maltol poses a low concern for adverse effects on
human health.
Toxicity Data for Ethyl Maltol
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Study Result
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Acute oral toxicity mice (male) Lethal Dose (LD) 50 = 780
Dose= 5%.................................. milligram/kilogram/day (mg/
kg/day)
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Acute oral toxicity rats (male) LD 50 = 1,150 mg/kg/day
Dose = 10%................................
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Acute oral toxicity rats (female) LD 50 = 1,200 mg/kg/day
Dose = 10%................................
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90-Day subchronic oral toxicity (rats) NOAEL = 250 mg/kg/day
Dose = 0, 250, 500, or 1,000 mg/kg/day.... LOAEL = 500 mg/kg/day
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90-Day subchronic oral toxicity (dogs) NOAEL >= 500 mg/kg/day
Dose = 0, 125, 250, or 500 mg/kg/day...... (highest dose tested (HDT))
LOAEL = not observed but
would be > 500 mg/kg/day
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2-year chronic oral toxicity (rats) NOAEL >= 200 mg/kg/day
Dose= 0, 50, 100, or 200 mg/kg/day........ LOAEL = not observed but
would be > 200 mg/kg/day
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2-year chronic toxicity (dogs) NOAEL >= 200 mg/kg/day
Dose= 0, 50, 100, or 200 mg/kg/day........ LOAEL = not observed but
would be > 200 mg/kg/day
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Reproduction and fertility effects Parental/Systemic NOAEL >=
200 mg/kg/day
Parental/Systemic LOAEL =
not observed but would be >
200 mg/kg/day
No significant treatment
related effects on
fertility, gestation,
parturition, lactation, or
fetal development.
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Carcinogenicity rats no evidence of
carcinogenicity
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Carcinogenicity mice no evidence of
carcinogenicity
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Gene Mutation - Ames (5 strains of S. non-mutagenic
typhimurium)
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Gene Mutation- Drosophila no increase in sex linked
recessive lethal mutations
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Gene Mutation- mouse micronucleus no increase in polynucleated
cells
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Metabolism and pharmacokinetics 64% of the 10 mg/kg total
dose excreted within 24
hours
------------------------------------------------------------------------
B. Structure Activity Relationship
Toxicity for ethyl maltol was assessed, in part, by a process
called SAR. In this process, the chemical's structural similarity to
other chemicals (for which data are available) is used to determine
toxicity. For human health, this process, can be used to assess
[[Page 37690]]
absorption and metabolism, mutagenicity, carcinogenicity, developmental
and reproductive effects, neurotoxicity, systemic effects,
immunotoxicity, and sensitization and irritation. This is a qualitative
assessment using terms such as good, not likely, poor, moderate, or high.
Ethyl maltol is not absorbed from the skin if it is not in
solution, and moderately absorbed from the skin if it is in solution
based on physio-chemical properties (pchem). It is absorbed from the
lung and GI tract based on data from surrogate chemicals. There is an
uncertain concern for mutagenicity. Overall, health concern is rated as
low.
C. Regulatory Characterizations of Toxicity by Other Governmental
Organizations
The Food and Drug Administration has classified ethyl maltol as
GRAS (generally recognized as safe) for use as a direct food additive
as a flavoring agent (21 CFR 172.515-Synthetic Flavoring Substances and
Adjuvants). In 1970, the Joint Food and Agricultural Organization of
the United Nations/World Health Organization (FAO/WHO) Expert Committee
on Food Additives established a group ADI (Acceptable Daily Intake) of
0-2mg/kg-bodyweight (bw) for ethyl maltol (http://www.inchem.org/
documents/jecfa/jecmono/v048aje01.htm)
D. Conclusions
Ethyl maltol is a member of a class of chemicals known as flavor
enhancers. It is almost completely absorbed from the gut and appears in
the urine as gluconamide or sulfate within two hours. The toxicity data
in the previous Table was used to assess the toxicity of ethyl maltol.
The acute oral LD50 values which ranged from 780 mg/kg and
1,270 mg/kg place ethyl maltol in Toxicity Category III. EPA
categorizes acute toxicity as I, II, III, or IV, with Category IV being
the Agency's lowest level of acute toxicity. Also, there were no
effects observed on the skin of rabbits when ethyl maltol was used at a
dose of 5,000 mg/kg.
The report from the structure activity team (SAT) cites an
uncertain concern for mutagenicity. This uncertainty was based on
positive dose-related activity against only one Salmonella strain (TA
100), but the mutagenic effects were not reproducible. Given the lack
of reproducibility, ethyl maltol was classified as non-mutagenic in the
Ames test.
The SAR assessment did not indicate any concerns for
carcinogenicity, developmental or reproductive concerns. The available
repeated dose toxicity studies have NOAELs that are equal to or greater
than 200 mg/kg/day.
V. Aggregate Exposures
In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).
A. Dietary Exposure
1. Food. Ethyl maltol has been used in foodstuffs as a flavoring
agent since the 1950's. Ethyl maltol is estimated to have a per capita
daily intake of 0.0045 mg/kg from use as a food additive
(http://www.inchem.org/documents/jecfa/jecmono/v048aje01.htm). Using a
60 kg person the daily intake becomes 0.27 mg/day, based on ethyl maltol's
use as a food additive. The use of ethyl maltol as an inert ingredient
in a pesticide product, especially considering the limitation of no
more than 0.2% of the formulated product, should not significantly
increase this estimate.
2. Drinking water exposure. The SAT report states that migration of
ethyl maltol to ground water is moderate to rapid. Ethyl maltol has an
estimated water solubility of 1.5 to 24 grams/Liter (g/L), a
volatilization half-life of 81 hours in rivers and 41 days in lakes,
and biodegrades rapidly. Based on biodegradation models and on the
SAT's professional judgement, ethyl maltol undergoes primary (partial)
aerobic biodegradation in days to weeks, and is completely biodegraded
in weeks. The biodegradability estimate and Henry's Law Constant
suggest that the residence time of ethyl maltol in surface waters is
controlled by the biodegradation rate and not the rate of
volatilization. Ethyl maltol has the potential to be mobile in soil,
but if released to aerobic soils its migration would be mitigated by
biodegradation. If it enters anaerobic soils (as in a landfill leachate
scenario) biodegradation would be expected to be somewhat slower but
still relatively rapid. Therefore, significant concentrations of ethyl
maltol are very unlikely in sources of drinking water.
B. Other Non-Occupational Exposure
Ethyl maltol is used as a flavor enhancer for cigarettes,
antiseptics, and perfumes. Because use as a flavoring substance
generally constitutes such a low percentage of the formulation exposure
is likely to be minimal.
VI. Cumulative Effects
Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to the above chemical
substances and any other substances. Ethyl maltol does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has not assumed that
this chemical substance has a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at
http://www.epa.gov/pesticides/cumulative/.
VII. Safety Factor for Infants and Children
FFDCA section 408 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 unless EPA concludes that a different
margin of safety will be safe for infants and children. For ethyl
maltol, based on the expected minimal oral toxicity, as demonstrated by
toxicity studies with NOAELs greater than 200 mg/kg/day, the available
toxicity data which indicates no significant treatment related effects
on fertility, gestation, parturition, lactation, or fetal development,
EPA has not used a safety factor analysis to assess the risk. For the
same reasons a tenfold safety factor is unnecessary.
VIII. Determination of Safety for U.S. Population
Based on its review and evaluation of the available data on
toxicity and exposure, and considering the 0.2% limitation in the
formulation offered by the petitioner, EPA finds that exempting ethyl
maltol (CAS Reg. No. 4940-11-8)
[[Page 37691]]
from the requirement of a tolerance will be safe for the general
population including infants and children.
IX. Other Considerations
A. Endocrine Disruptors
FQPA requires EPA to develop a screening program to determine
whether certain substances, including all pesticide chemicals (both
inert and active ingredients), may have an effect in humans that is
similar to an effect produced by a naturally occurring estrogen, or
such other endocrine effect. EPA has been working with interested
stakeholders to develop a screening and testing program as well as a
priority setting scheme. As the Agency proceeds with implementation of
this program, further testing of products containing ethyl maltol for
endocrine effects may be required.
B. Analytical Method
An analytical method is not required for tolerance enforcement
purposes since the Agency is establishing an exemption from the
requirement of a tolerance.
C. Existing Tolerances
There are no existing tolerance exemptions for ethyl maltol.
D. International Tolerances
The Agency is not aware of any country requiring a tolerance for
ethyl maltol nor have any CODEX Maximum Residue Levels (MRLs) been
established for any food crops at this time.
X. Conclusions
Therefore, EPA is establishing a tolerance exemption for ethyl
maltol (CAS Reg. No. 4940-11-8) with a limitation in the pesticide
formulation of not more than 0.2%.
XI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2005-0153 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before August
29, 2005.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit XI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2005-0153, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in ADDRESSES. 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).
XII. 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,
[[Page 37692]]
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the exemption in this
final rule, do not 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 (59 FR 22951, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
XIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 20, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
? Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
? 1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
? 2. In Sec. 180.910 the table is amended by adding alphabetically the
following inert ingredient to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemption
from the requirement of a tolerance.
* * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Ethyl maltol (CAS Reg. No.4940- Not more than 0.2 Odor masking agent
11-8) % of the
pesticide
formulation
* * * * * * *
------------------------------------------------------------------------
* * * * *
? 3. In Sec. 180.930 the table is amended by adding alphabetically the
following inert ingredient to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemption from the
requirement of a tolerance.
* * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Ethyl maltol (CAS Reg. No.4940- Not more than 0.2 Odor masking agent
11-8) % of the
pesticide
formulation
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 05-12920 Filed 6-29-05; 8:45 am]
BILLING CODE 6560-50-S