Ethaboxam; Pesticide Tolerance, 56388-56392 [06-8176]
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Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Rules and Regulations
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
sroberts on PROD1PC70 with RULES
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
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.
requests for hearings must be received
on or before November 27, 2006, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
Dated: September 18, 2006.
docket for this action under docket
James Jones,
identification (ID) number EPA–HQ–
Director, Office of Pesticide Programs.
OPP–2005–0058. All documents in the
docket are listed in the index for the
I Therefore, 40 CFR chapter I is
docket. Although listed in the index,
amended as follows:
some information is not publicly
PART 180—[AMENDED]
available, e.g., Confidential Business
Information (CBI) or other information
I 1. The authority citation for part 180
whose disclosure is restricted by statute.
continues to read as follows:
Certain other material, such as
Authority: 21 U.S.C. 321(q), 346a and 371.
copyrighted material, is not placed on
I 2. Section 180.617 is added to read as
the Internet and will be publicly
follows:
available only in hard copy form.
Publicly available docket materials are
§ 180.617 Metconazole; tolerances for
available in the electronic docket at
residues.
https://www.regulations.gov, or, if only
(a) General. Tolerances are
available in hard copy, at the OPP
established for the residue of the
Regulatory Public Docket in Rm.
fungicide metconazole (5-[(4S–4400, One Potomac Yard (South
chlorophenyl)methyl]-2,2-dimethyl-1Building), 2777 S. Crystal Drive,
(1H-1,2,4-triazol-1Arlington, VA. The Docket Facility is
ylmethyl)cyclopentanol) in or on the
open from 8:30 a.m. to 4 p.m., Monday
following commodity:
through Friday, excluding legal
holidays. The Docket telephone number
Commodity
Parts per million
is (703) 305–5805.
Banana1 ................
0.1 FOR FURTHER INFORMATION CONTACT:
Bryant Crowe, Registration Division
1 No U.S. registration as of August 30, 2006.
(7505P), Office of Pesticide Programs,
(b) Section 18 emergency exemptions. Environmental Protection Agency, 1200
[Reserved]
Pennsylvania Ave., NW., Washington,
(c) Tolerances with regional
DC 20460–0001; telephone number:
registrations. [Reserved]
(703) 305–0025; e-mail address:
(d) Indirect or inadvertent residues.
crowe.bryant@epa.gov.
[Reserved]
SUPPLEMENTARY INFORMATION:
[FR Doc. 06–8256 Filed 9–26–06; 8:45 am]
VII. 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).
[EPA–HQ–OPP–2005–0058; FRL–8091–5]
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I. General Information
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
Ethaboxam; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes a
tolerance for residues of ethaboxam in
or on grape at 6.0 parts per million
(ppm), with no U.S. registration. Landis
International, Inc., agent for LG Life
Sciences, Ltd. requested this tolerance
under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996
(FQPA).
DATES: This regulation is effective
September 27, 2006. Objections and
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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 111), e.g.,
agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather provides a guide
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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.
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B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
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.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2005–0058 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before November 27, 2006.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2005–0058, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
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Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Background and Statutory Findings
In the Federal Register of July 6, 2005
(70 FR 38918) (FRL–7719–3), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 4E6863) by LG
Life Sciences, Ltd., c/o Landis
International, Inc., P.O. Box 5126,
Valdosta, GA 31603–5126. The petition
requested that 40 CFR 180.622 be
amended by establishing a tolerance for
residues of the fungicide ethaboxam, N(cyano-2-thienylmethyl)-4-ethyl-2(ethlyamino)-5-thiazolecarboxamide, in
or on grape, grape juice, and raisins at
6.0 ppm. That notice included a
summary of the petition prepared by the
registrant LG Life Sciences, Ltd., c/o
Landis International, Inc. There were no
comments received in response to the
notice of filing.
Section 408(b)(2)(A)(i) of 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 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 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. For
further discussion of the regulatory
requirements of section 408 of the
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FFDCA and a complete description of
the risk assessment process, see https://
www.epa.gov/oppfead1/trac/science.
III. Aggregate Risk Assessment and
Determination of Safety
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. EPA has sufficient data to assess
the hazards of and to make a
determination on aggregate exposure,
consistent with section 408(b)(2) of
FFDCA, for a tolerance for residues of
ethaboxam on grape at 6.0 ppm. Studies
examining the transfer of ethaboxam to
processed grape commodities (e.g.,
grape juice, raisins) show that some
concentration of ethaboxam may occur
during the production of raisins and
grape juice; however, the supported
tolerance of 6.0 ppm for grape is
sufficient to cover the potential for
residues in the processed commodities,
and separate tolerances for these
commodities are not needed. EPA’s
assessment of exposures and risks
associated with establishing the
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies 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. Specific
information on the studies received and
the nature of the toxic effects caused by
ethaboxam as well as the no observed
adverse effect level (NOAEL) and the
lowest observed adverse effect level
(LOAEL) from the toxicity studies can
be found in the electronic docket
(docket ID number EPA–HQ–OPP–
2005–0058) for this rule at https://
www.regulations.gov or https://
www.epa.gov/opprd001/factsheets.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the dose at which no adverse
effects are observed (the NOAEL) from
the toxicology study identified as
appropriate for use in risk assessment is
used to estimate the toxicological level
of concern (LOC). However, the lowest
dose at which adverse effects of concern
are identified (the LOAEL) is sometimes
used for risk assessment if no NOAEL
was achieved in the toxicology study
selected. An uncertainty factor (UF) is
applied to reflect uncertainties inherent
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in the extrapolation from laboratory
animal data to humans and in the
variations in sensitivity among members
of the human population as well as
other unknowns.
The linear default risk methodology
(Q*) is the primary method currently
used by the Agency to quantify non-
threshold hazards such as cancer. The
Q* approach assumes that any amount
of exposure will lead to some degree of
cancer risk, estimates risk in terms of
the probability of occurrence of
additional cancer cases. More
information can be found on the general
principles EPA uses in risk
characterization at https://www.epa.gov/
pesticides/factsheets/riskassess.htm and
https://www.epa.gov/oppfead1/trac/
science.
A summary of the toxicological
endpoints for ethaboxam used for
human risk assessment is shown in
Table 1. of this unit:
TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR ETHABOXAM FOR USE IN HUMAN RISK ASSESSMENT
Exposure/Scenario
Dose Used in Risk Assessment, Interspecies and
Intraspecies and any Traditional UF
Special FQPA SF and
Level of Concern for Risk
Assessment
Study and Toxicological Effects
NOAEL = 30 mg/kg/day
UF = 100
Acute RfD = 0.3 mg/kg/day
Special FQPA SF = 1
aPAD = acute RfD/Special
FQPA SF = 0.3 mg/kg/
day
Developmental Toxicity Rat LOAEL = 100 mg/
kg/day based on abnormal liver lobation
Acute Dietary (General population including infants and
children)
NOAEL = N/A
UF = N/A
Acute RfD = N/A
Special FQPA SF = N/A
aPAD = acute RfD/Special
FQPA SF = N/A
No appropriate endpoint attributable to a single dose identified. LOAEL = N/A
Chronic Dietary (All populations)
NOAEL= 5.5 mg/kg/day
UF = 100
Chronic RfD = 0.055 mg/kg/
day
Special FQPA SF = 1
cPAD = chronic RfD/Special FQPA SF = 0.055
mg/kg/day
Combined Chronic/Carcinogenicity-Rat LOAEL
= 16.4 mg/kg/day based on effects observed
in the male reproductive organs (testes,
epididymides, prostate, and seminal vesicles).
Cancer (oral, dermal, inhalation)
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Acute Dietary (Females 13–49
years of age)
N/A
N/A
The Agency classified ethaboxam as having
‘‘suggestive evidence of carcinogenicity.’’
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Risk assessments were
conducted by EPA to assess dietary
exposures from ethaboxam in food as
follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a one-day or
single exposure. No such effects were
identified in the toxicological studies
for ethaboxam that pertain to the general
population including infants and
children; however, an effect of concern
was identified for females, 13–49 years
of age. Therefore, a quantitative acute
dietary exposure assessment was
necessary for females, 13–49 years of
age.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the Dietary Exposure
Evaluation Model software with the
Food Commodity Intake Database
(DEEM-FCIDTM), which incorporates
food consumption data as reported by
respondents in the USDA 1994–1996
and 1998 Nationwide Continuing
Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to
the chemical for each commodity. The
following assumptions were made for
the chronic exposure assessment:
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Chronic dietary analysis is based on the
tolerance level residues and an
assumption that 100% of the crop will
be treated.
iii. Cancer. The Agency classified
ethaboxam as having ‘‘suggestive
evidence of carcinogenicity.’’ The
Agency concluded that the
quantification of carcinogenic potential
is not required.
2. Dietary exposure from drinking
water. This petition is not associated
with an application to register
ethaboxam uses in the U.S. Ethaboxam
is proposed for use on fruit commodities
that may be imported into the U.S.,
thus, the source of exposure expected
for ethaboxam is solely from residues in
food. Consequently, an exposure
assessment that includes ethaboxam
residues in drinking water is not
warranted at this time.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Ethaboxam is not registered for use on
any sites that would result in residential
exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of the FFDCA
requires that, when considering whether
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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
ethaboxam and any other substances
and ethaboxam 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 ethaboxam 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 https://
www.epa.gov/pesticides/cumulative.
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D. Safety Factor for Infants and
Children
1. In general. Section 408 of 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 based on reliable data 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. In applying
this provision, EPA either retains the
default value of 10X when reliable data
do not support the choice of a different
factor, or, if reliable data are available,
EPA uses a different additional safety
factor value based on the use of
traditional uncertainty factors and/or
special FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity.
There is evidence of increased
qualitative susceptibility in the rat
developmental and reproduction
studies. Considering the overall toxicity
profile and the doses and endpoints
selected for risk assessment for
ethaboxam, the degree of concern for
prenatal and postnatal effects observed
in the studies is low based on the
following: The developmental/offspring
effects observed in the studies are well
characterized and occur in the presence
of maternal toxicity; a clear NOAEL has
been identified in both of the studies;
and there are no residual uncertainties
for pre-and/or postnatal toxicity.
Furthermore, the toxicology endpoint
established for risk assessment is based
on a lower NOAEL than the
reproductive NOAEL, and thus is
considered protective of developmental/
offspring effects.
3. Conclusion. The Agency
recommends that the FQPA safety factor
be reduced to 1X because there are no/
low concerns and no residual
uncertainties with regard to pre- and
post-natal toxicity. Although there was
evidence of increased qualitative
susceptibility observed in rat
developmental and reproduction
studies, the studies submitted
adequately address questions regarding
pre- and post- natal toxicity, and the
developmental/offspring effects
observed in the studies are well
characterized (clear NOAELs
established). The toxicology endpoint
established for risk assessment is based
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on a lower NOAEL than the
reproductive NOAEL, and is considered
protective of the developmental/
offspring effects observed. In addition,
the toxicology endpoint established for
risk assessment is also considered
protective of the male reproductive
alterations observed in the toxicology
database. There is a complete toxicity
database for ethaboxam and exposure
data are complete or are estimated based
on data that reasonably accounts for
potential exposures.
selected for the chronic reference dose
(cRfD) is based on reproductive toxicity
observed at lower doses than the Leydig
cell tumor response. Thus, the cRfD
would be protective of the cancer
effects.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, and to infants and children
from aggregate exposure to ethaboxam
residues.
E. Aggregate Risks and Determination of
Safety
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food to ethaboxam will
occupy 10% of the aPAD for the U.S.
population and 4% of the aPAD for
females 13 years and older.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to ethaboxam from food
will utilize 6% of the cPAD for the U.S.
population, 9% of the cPAD for all
infants less than 1 year of age, and 31%
of the cPAD for children 1–2 years of
age. There are no residential uses for
ethaboxam that result in chronic
residential exposure to ethaboxam.
3. Short-term risk. Short-term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Ethaboxam is not registered for use on
any sites that would result in residential
exposure or residues in drinking water.
Therefore, the aggregate risk is the sum
of the risk from food only, which does
not exceed the Agency’s level of
concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level).
Ethaboxam is not registered for use on
any sites that would result in residential
exposure or residues in drinking water.
Therefore, the aggregate risk is the sum
of the risk from food only, which does
not exceed the Agency’s level of
concern.
5. Aggregate cancer risk for U.S.
population. The Agency classified
ethaboxam as having ‘‘suggestive
evidence of carcinogenicity based on
Leydig cell tumors observed in male
rats.’’ The Agency has determined that
potential human risk to Leydig cell
tumorigenesis would not be expected at
exposure levels that do not cause
tumors in rats. The NOAEL and LOAEL
IV. Other Considerations
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A. Analytical Enforcement Methodology
Adequate enforcement methodology
(HPLC/MS) is available to enforce the
tolerance expression. The method may
be requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are currently no established
Codex, Canadian, or Mexican maximum
residue levels (MRLs) for ethaboxam.
V. Conclusion
Therefore, an imported tolerance is
established for residues of ethaboxam,
N-(cyano-2-thienylmethyl)-4-ethyl-2(ethylamino)-5-thiazolecarboxamide, in
or on grape at 6.0 ppm. Studies
examining the transfer of ethaboxam to
processed grape commodities (e.g.,
grape juice, raisins) show that some
concentration of ethaboxam may occur
during the production of raisins and
grape juice; however, the supported
tolerance of 6.0 ppm for grape is
sufficient to cover the potential for
residues in the processed commodities,
and separate tolerances for these
commodities are not needed.
VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of 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
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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 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
FFDCA. For these same reasons, the
Agency has determined that this rule
does not have any ‘‘tribal implications’’
VerDate Aug<31>2005
16:20 Sep 26, 2006
Jkt 208001
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.
2. Section 180.622 is added to read as
follows:
I
§ 180.622 Ethaboxam; tolerances for
residues.
(a) General. Tolerances are
established for residues of ethaboxam,
N-(cyano-2-thienylmethyl)-4-ethyl-2(ethlyamino)-5-thiazolecarboxamide in
or on the following commodity:
Commodity
Parts per
million
Grape1 ......................................
6.0
1
There is no U.S. registration as of September 27, 2006
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. 06–8176 Filed 9–26–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
VII. Congressional Review Act
40 CFR Part 180
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).
[EPA–HQ–OPP–2006–0036; FRL–8089–6]
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: September 13, 2006.
James Jones,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
PO 00000
Frm 00058
Fmt 4700
Sfmt 4700
p-Chlorophenoxyacetic acid,
Glyphosate, Difenzoquat, and
Hexazinone; Tolerance Actions
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: EPA is revoking certain
tolerances for the plant growth regulator
p-chlorophenoxyacetic acid and the
herbicide hexazinone. Also, EPA is
modifying certain tolerances for the
plant growth regulator pchlorophenoxyacetic acid and the
herbicides glyphosate, difenzoquat, and
hexazinone. In addition, EPA is
establishing new tolerances for the
herbicides difenzoquat and hexazinone.
DATES: This regulation is effective
September 27, 2006. Objections and
requests for hearings must be received
on or before November 27, 2006, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0036. All documents in the
docket are listed in the index for the
docket. Although listed in the index,
some information is not publicly
available, e.g., Confidential Business
E:\FR\FM\27SER1.SGM
27SER1
]]>Agencies
[Federal Register Volume 71, Number 187 (Wednesday, September 27, 2006)]
[Rules and Regulations]
[Pages 56388-56392]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8176]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0058; FRL-8091-5]
Ethaboxam; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
ethaboxam in or on grape at 6.0 parts per million (ppm), with no U.S.
registration. Landis International, Inc., agent for LG Life Sciences,
Ltd. requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of
1996 (FQPA).
DATES: This regulation is effective September 27, 2006. Objections and
requests for hearings must be received on or before November 27, 2006,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0058. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (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 in the electronic docket at https://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The 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: Bryant Crowe, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-0025; e-mail address: crowe.bryant@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 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide
[[Page 56389]]
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?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
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. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2005-0058 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before November 27, 2006.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2005-0058, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of July 6, 2005 (70 FR 38918) (FRL-7719-3),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 4E6863)
by LG Life Sciences, Ltd., c/o Landis International, Inc., P.O. Box
5126, Valdosta, GA 31603-5126. The petition requested that 40 CFR
180.622 be amended by establishing a tolerance for residues of the
fungicide ethaboxam, N-(cyano-2-thienylmethyl)-4-ethyl-2-(ethlyamino)-
5-thiazolecarboxamide, in or on grape, grape juice, and raisins at 6.0
ppm. That notice included a summary of the petition prepared by the
registrant LG Life Sciences, Ltd., c/o Landis International, Inc. There
were no comments received in response to the notice of filing.
Section 408(b)(2)(A)(i) of 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 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 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. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see https://www.epa.gov/
oppfead1/trac/science.
III. Aggregate Risk Assessment and Determination of Safety
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. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of ethaboxam on grape
at 6.0 ppm. Studies examining the transfer of ethaboxam to processed
grape commodities (e.g., grape juice, raisins) show that some
concentration of ethaboxam may occur during the production of raisins
and grape juice; however, the supported tolerance of 6.0 ppm for grape
is sufficient to cover the potential for residues in the processed
commodities, and separate tolerances for these commodities are not
needed. EPA's assessment of exposures and risks associated with
establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies 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. Specific information on the studies received and the nature
of the toxic effects caused by ethaboxam as well as the no observed
adverse effect level (NOAEL) and the lowest observed adverse effect
level (LOAEL) from the toxicity studies can be found in the electronic
docket (docket ID number EPA-HQ-OPP-2005-0058) for this rule at https://
www.regulations.gov or https://www.epa.gov/opprd001/factsheets.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
[[Page 56390]]
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at https://www.epa.gov/pesticides/factsheets/
riskassess.htm and https://www.epa.gov/oppfead1/trac/science.
A summary of the toxicological endpoints for ethaboxam used for
human risk assessment is shown in Table 1. of this unit:
Table 1.--Summary of Toxicological Dose and Endpoints for Ethaboxam for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment, Special FQPA SF and
Exposure/Scenario Interspecies and Level of Concern for Study and Toxicological
Intraspecies and any Risk Assessment Effects
Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-49 years of NOAEL = 30 mg/kg/day Special FQPA SF = 1 Developmental Toxicity
age) UF = 100............... aPAD = acute RfD/ Rat LOAEL = 100 mg/kg/
Acute RfD = 0.3 mg/kg/ Special FQPA SF = 0.3 day based on abnormal
day. mg/kg/day. liver lobation
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population NOAEL = N/A Special FQPA SF = N/A No appropriate endpoint
including infants and children) UF = N/A............... aPAD = acute RfD/ attributable to a
Acute RfD = N/A........ Special FQPA SF = N/A. single dose
identified. LOAEL = N/
A
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations) NOAEL= 5.5 mg/kg/day Special FQPA SF = 1 Combined Chronic/
UF = 100............... cPAD = chronic RfD/ Carcinogenicity-Rat
Chronic RfD = 0.055 mg/ Special FQPA SF = LOAEL = 16.4 mg/kg/day
kg/day. 0.055 mg/kg/day. based on effects
observed in the male
reproductive organs
(testes, epididymides,
prostate, and seminal
vesicles).
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) N/A N/A The Agency classified
ethaboxam as having
``suggestive evidence
of carcinogenicity.''
----------------------------------------------------------------------------------------------------------------
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Risk assessments were
conducted by EPA to assess dietary exposures from ethaboxam in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a one-day or single exposure. No such effects were
identified in the toxicological studies for ethaboxam that pertain to
the general population including infants and children; however, an
effect of concern was identified for females, 13-49 years of age.
Therefore, a quantitative acute dietary exposure assessment was
necessary for females, 13-49 years of age.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates
food consumption data as reported by respondents in the USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to the chemical for each commodity.
The following assumptions were made for the chronic exposure
assessment: Chronic dietary analysis is based on the tolerance level
residues and an assumption that 100% of the crop will be treated.
iii. Cancer. The Agency classified ethaboxam as having ``suggestive
evidence of carcinogenicity.'' The Agency concluded that the
quantification of carcinogenic potential is not required.
2. Dietary exposure from drinking water. This petition is not
associated with an application to register ethaboxam uses in the U.S.
Ethaboxam is proposed for use on fruit commodities that may be imported
into the U.S., thus, the source of exposure expected for ethaboxam is
solely from residues in food. Consequently, an exposure assessment that
includes ethaboxam residues in drinking water is not warranted at this
time.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Ethaboxam is not
registered for use on any sites that would result in residential
exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. 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 ethaboxam and any other
substances and ethaboxam 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 ethaboxam 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 https://www.epa.gov/pesticides/cumulative.
[[Page 56391]]
D. Safety Factor for Infants and Children
1. In general. Section 408 of 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 based on reliable data 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. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There is evidence of
increased qualitative susceptibility in the rat developmental and
reproduction studies. Considering the overall toxicity profile and the
doses and endpoints selected for risk assessment for ethaboxam, the
degree of concern for prenatal and postnatal effects observed in the
studies is low based on the following: The developmental/offspring
effects observed in the studies are well characterized and occur in the
presence of maternal toxicity; a clear NOAEL has been identified in
both of the studies; and there are no residual uncertainties for pre-
and/or postnatal toxicity. Furthermore, the toxicology endpoint
established for risk assessment is based on a lower NOAEL than the
reproductive NOAEL, and thus is considered protective of developmental/
offspring effects.
3. Conclusion. The Agency recommends that the FQPA safety factor be
reduced to 1X because there are no/low concerns and no residual
uncertainties with regard to pre- and post-natal toxicity. Although
there was evidence of increased qualitative susceptibility observed in
rat developmental and reproduction studies, the studies submitted
adequately address questions regarding pre- and post- natal toxicity,
and the developmental/offspring effects observed in the studies are
well characterized (clear NOAELs established). The toxicology endpoint
established for risk assessment is based on a lower NOAEL than the
reproductive NOAEL, and is considered protective of the developmental/
offspring effects observed. In addition, the toxicology endpoint
established for risk assessment is also considered protective of the
male reproductive alterations observed in the toxicology database.
There is a complete toxicity database for ethaboxam and exposure data
are complete or are estimated based on data that reasonably accounts
for potential exposures.
E. Aggregate Risks and Determination of Safety
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
ethaboxam will occupy 10% of the aPAD for the U.S. population and 4% of
the aPAD for females 13 years and older.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to ethaboxam
from food will utilize 6% of the cPAD for the U.S. population, 9% of
the cPAD for all infants less than 1 year of age, and 31% of the cPAD
for children 1-2 years of age. There are no residential uses for
ethaboxam that result in chronic residential exposure to ethaboxam.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Ethaboxam is not registered for use on any sites that would result
in residential exposure or residues in drinking water. Therefore, the
aggregate risk is the sum of the risk from food only, which does not
exceed the Agency's level of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Ethaboxam is not registered for use on any sites that would result
in residential exposure or residues in drinking water. Therefore, the
aggregate risk is the sum of the risk from food only, which does not
exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. The Agency classified
ethaboxam as having ``suggestive evidence of carcinogenicity based on
Leydig cell tumors observed in male rats.'' The Agency has determined
that potential human risk to Leydig cell tumorigenesis would not be
expected at exposure levels that do not cause tumors in rats. The NOAEL
and LOAEL selected for the chronic reference dose (cRfD) is based on
reproductive toxicity observed at lower doses than the Leydig cell
tumor response. Thus, the cRfD would be protective of the cancer
effects.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to ethaboxam residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (HPLC/MS) is available to enforce
the tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: residuemethods@epa.gov.
B. International Residue Limits
There are currently no established Codex, Canadian, or Mexican
maximum residue levels (MRLs) for ethaboxam.
V. Conclusion
Therefore, an imported tolerance is established for residues of
ethaboxam, N-(cyano-2-thienylmethyl)-4-ethyl-2-(ethylamino)-5-
thiazolecarboxamide, in or on grape at 6.0 ppm. Studies examining the
transfer of ethaboxam to processed grape commodities (e.g., grape
juice, raisins) show that some concentration of ethaboxam may occur
during the production of raisins and grape juice; however, the
supported tolerance of 6.0 ppm for grape is sufficient to cover the
potential for residues in the processed commodities, and separate
tolerances for these commodities are not needed.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
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
[[Page 56392]]
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 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 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.
VII. 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: September 13, 2006.
James Jones,
Director, Office of Pesticide Programs.
0
Therefore, 40 CFR part 180 is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.622 is added to read as follows:
Sec. 180.622 Ethaboxam; tolerances for residues.
(a) General. Tolerances are established for residues of ethaboxam,
N-(cyano-2-thienylmethyl)-4-ethyl-2-(ethlyamino)-5-thiazolecarboxamide
in or on the following commodity:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Grape\1\................................................... 6.0
------------------------------------------------------------------------
\1\ There is no U.S. registration as of September 27, 2006
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 06-8176 Filed 9-26-06; 8:45 am]
BILLING CODE 6560-50-S
