Kresoxim-methyl; Pesticide Tolerance, 50354-50359 [E6-14165]
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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
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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).
kresoxim-methyl in or on vegetable,
cucurbit, group 9. Interregional
Research Project No. 4 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
August 25, 2006. Objections and
requests for hearings must be received
on or before October 24, 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).
List of Subjects in 40 CFR Part 180
ADDRESSES: EPA has established a
Environmental protection,
docket for this action under docket
Administrative practice and procedure,
identification (ID) number EPA–HQ–
Agricultural commodities, Pesticides
OPP–2006–0333. All documents in the
and pests, Reporting and recordkeeping
docket are listed in the index for the
requirements.
docket. Although listed in the index,
some information is not publicly
Dated: August 16, 2006.
available, e.g., Confidential Business
Lois Rossi,
Information (CBI) or other information
Director, Registration Division, Office of
whose disclosure is restricted by statute.
Pesticide Programs.
Certain other material, such as
I Therefore, 40 CFR chapter I is
copyrighted material, is not placed on
amended as follows:
the Internet and will be publicly
available only in hard copy form.
PART 180—[AMENDED]
Publicly available docket materials are
I 1. The authority citation for part 180
available in the electronic docket at
continues to read as follows:
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Authority: 21 U.S.C. 321(q), 346a and 371.
Regulatory Public Docket in Rm. S-4400,
I 2. Section 180.588 is amended by
One Potomac Yard (South Building),
alphabetically adding commodities to
2777 S. Crystal Drive, Arlington, VA.
the table in paragraph (a) to read as
The Docket Facility is open from 8:30
follows:
a.m. to 4 p.m., Monday through Friday,
§ 180.588 Quinoxyfen; tolerances for
excluding legal holidays. The Docket
residues.
telephone number is (703) 305-5805.
(a) * * *
FOR FURTHER INFORMATION CONTACT:
Barbara Madden, Registration Division
Commodity
Parts per million
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
*
*
*
*
*
Lettuce, head ..................
7.0 Pennsylvania Ave., NW., Washington,
Lettuce, leaf ....................
19 DC 20460-0001; telephone number:
Melon, subgroup 9A .......
0.08 (703) 305-6463; e-mail address:
Pepper, bell ....................
0.35 madden.barbara@epa.gov.
Pepper, nonbell ..............
Strawberry ......................
1.7
0.90
[FR Doc. E6–14065 Filed 8–24–06; 8:45 am]
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0333; FRL–8088–1]
Kresoxim-methyl; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes a
tolerance for combined residues of
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I. General Information
A. Does this Action Apply to Me?
BILLING CODE 6560–50–S
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SUPPLEMENTARY INFORMATION:
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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;
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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
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. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines at https://www.epa.gpo/
opptsfrs/home/guidelin.htm
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–2006–0333 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 October 24, 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
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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–2006–0333, 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 telephone number is (703) 3055805.
II. Background and Statutory Findings
In the Federal Register of June 7, 2006
(71 FR 32950) (FRL–8068–1), 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 3E6594) by
Interregional Research Project No. 4,
Rutgers, the State University of New
Jersey, 681 U.S. Highway No. 1, South
Brunswick, NJ 08902-3390. The petition
requested that 40 CFR 180.554 be
amended by establishing a tolerance for
combined residues of the fungicide
kresoxim-methyl (methyl (E)-2-[2-(2methylphenoxy)-methyl]phenyl-2(methoxyimido)acetate) and its
metabolites as follows: (E)-2-[2-(2methylphenoxy)methyl]-phenyl-2(methoxyimido)acetic acid; (E)-2-[2-(2hydroxymethylphenoxy)methyl]phenyl-2-(methoxyimido)acetic acid
(free and glucose conjugated); and (E)-2[2-(4-hydroxy-2-methylphenoxy)methyl]phenyl-2-(methoxyimido)acetic
acid (free and glucose conjugated), in or
on vegetable, cucurbit, group 9 at 0.5
parts per million (ppm). That notice
included a summary of the petition
prepared by BASF Corporation, the
registrant. There were no comments
received in response to the notice of
filing. Petition (PP 3E6594) was
subsequently amended to lower the
residue level for vegetable, cucurbit,
group 9 to 0.40 ppm.
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
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50355
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/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
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 combined
residues of kresoxim-methyl on
vegetable, cucurbit, group 9 at 0.40
ppm. 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
kresoxim-methyl as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at https://www.epa.gov/
EPA-PEST/1999/June/Day-10/
p14761.htm.
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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
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 nonthreshold 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/health/human.htm.
A summary of the toxicological
endpoints for kresoxim-methyl used for
human risk assessment is discussed in
Unit III.B. of the final rule published in
the Federal Register of June 10, 1999
(64 FR 31129) (FRL–6085–4) https://
www.epa.gov/EPA-PEST/1999/June/
Day-10/p14761.htm.
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have been
established (40 CFR 180.554) for the
combined residues of kresoxim-methyl,
in or on a variety of raw agricultural
commodities. In addition, tolerances
have been established for the residues of
the kresoxim-methyl metabolite (E)-2-[2(2-methylphenoxy)methyl]-phenyl-2(methoxyimido)acetic acid in meat
byproducts of cattle, goat, and sheep.
Risk assessments were conducted by
EPA to assess dietary exposures from
kresoxim-methyl 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 kresoxim-methyl; therefore, a
quantitative acute dietary exposure
assessment is unnecessary.
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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 assessments: A
partially-refined, Tier 3 chronic dietary
risk assessment incorporated average
field-trial residues for all food
commodities, available processing data
for grapes, apples, and screening-level
percent crop treated (PCT) data for most
of the registered commodities.
iii. Cancer. In conducting the cancer
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 cancer exposure
assessment: A partially-refined, Tier 3
cancer dietary risk assessment
incorporated average field-trial residues
for all food commodities, available
processing data for grapes, apples, and
screening-level percent crop treated
(PCT) data for most of the registered
commodities.
iv. Anticipated residue and percent
crop treated (PCT) information. Section
408(b)(2)(E) of the FFDCA authorizes
EPA to use available data and
information on the anticipated residue
levels of pesticide residues in food and
the actual levels of pesticide chemicals
that have been measured in food. If EPA
relies on such information, EPA must
pursuant to section 408(f)(1) require that
data be provided 5 years after the
tolerance is established, modified, or
left in effect, demonstrating that the
levels in food are not above the levels
anticipated. Following the initial data
submission, EPA is authorized to
require similar data on a time frame it
deems appropriate. For the present
action, EPA will issue such data call-ins
for information relating to anticipated
residues as are required by FFDCA
section 408(b)(2)(E) and authorized
under FFDCA section 408(f)(1). Such
data call-ins will be required to be
submitted no later than 5 years from the
date of issuance of this tolerance.
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Section 408(b)(2)(F) of FFDCA states
that the Agency may use data on the
actual percent of food treated for
assessing chronic dietary risk only if the
Agency can make the following
findings: Condition 1, that the data used
are reliable and provide a valid basis to
show what percentage of the food
derived from such crop is likely to
contain such pesticide residue;
Condition 2, that the exposure estimate
does not underestimate exposure for any
significant subpopulation group; and
Condition 3, if data are available on
pesticide use and food consumption in
a particular area, the exposure estimate
does not understate exposure for the
population in such area. In addition, the
Agency must provide for periodic
evaluation of any estimates used. To
provide for the periodic evaluation of
the estimate of PCT as required by
section 408(b)(2)(F) of FFDCA, EPA may
require registrants to submit data on
PCT.
The Agency used PCT information as
follows:
Apple, 10%; grape, 5%; pear, 5%; and
pecan, 1%.
EPA uses an average PCT for chronic
dietary risk analysis. The average PCT
figure for each existing use is derived by
combining available Federal, state, and
private market survey data for that use,
averaging by year, averaging across all
years, and rounding up to the nearest
multiple of five percent except for those
situations in which the average PCT is
less than one. In those cases <1% is
used as the average and <2.5% is used
as the maximum. EPA uses a maximum
PCT for acute dietary risk analysis. The
maximum PCT figure is the single
maximum value reported overall from
available Federal, state, and private
market survey data on the existing use,
across all years, and rounded up to the
nearest multiple of five percent. In most
cases, EPA uses available data from
United States Department of
Agriculture/National Agricultural
Statistics Service (USDA/NASS),
Proprietary Market Surveys, and the
National Center for Food and
Agriculture Policy (NCFAP) for the most
recent 6 years.
This method of projecting PCT for a
new pesticide, with or without regard to
specific pest(s), produces an upper-end
projection that is unlikely, in most
cases, to be exceeded in actuality in the
next 5 years because one or more of the
following conditions will likely apply:
the dominant pesticide is better
established and accepted by farmers
than the new pesticide, the dominant
pesticide is more efficacious than the
new pesticide, the dominant pesticide
controls a broader spectrum and/or
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more important pests than the new
pesticide, the dominant pesticide is
more cost-effective than the new
pesticide, and other conditions.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for
kresoxim-methyl in drinking water.
Because the Agency does not have
comprehensive monitoring data,
drinking water concentration estimates
are made by reliance on simulation or
modeling taking into account data on
the physical characteristics of kresoximmethyl. Further information regarding
EPA drinking water models used in
pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/
models/water/index.htm.
Estimated drinking water
concentrations (EDWCs) were calculated
for both kresoxim-methyl and (E)-2-[2(2-methylphenoxy)methyl]-phenyl-2(methoxyimido)acetic acid. Based on
the PRZM/EXAMS and SCI-GROW
models, the estimated environmental
concentrations (EECs) of kresoximmethyl for chronic exposures are
estimated to be 14.91 parts per billion
(ppb) for surface water and 6.27 ppb for
ground water. The EECs for cancer
chronic exposures are estimated to be
7.88 ppb for surface water and 6.27 ppb
for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model (DEEMFCIDTM). Since the surface water
EDWCs are higher than the ground
water EDWC, the Agency selected these
values for use in the dietary assessment.
The 1-in-10 year mean of 14.91 ppb was
used for the chronic (non-cancer)
analysis, and the 30–year mean of 7.88
ppb was used for the cancer analysis.
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).
Kresoxim-methyl 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.’’
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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
kresoxim-methyl and any other
substances and kresoxim-methyl 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
kresoxim-methyl 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. 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.’’
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.
In the prenatal developmental toxicity
studies in rat and rabbit fetuses, no
evidence of developmental toxicity in
fetuses was seen at the limit dose. In the
2-generation reproduction study in rats,
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50357
offspring effects occurred only at
parentally toxic dose levels.
3. Conclusion. There is a complete
toxicity data base for kresoxim-methyl
and exposure data are complete or are
estimated based on data that reasonably
accounts for potential exposures. Taking
into account the lack of any special preor post-natal susceptibility and the
completeness of the toxicity and
exposure data base, EPA determined
that the 10X SF to protect infants and
children should be reduced to 1X.
E. Aggregate Risks and Determination of
Safety
1. Acute risk.An acute risk assessment
was not performed. No toxicological
endpoint attributable to a single (acute)
dietary exposure was identified.
Therefore, acute risk from exposure to
kresoxim-methyl is not expected.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to kresoxim-methyl from
food and water will utilize <1 % of the
cPAD for the U.S. population and all
subpopulations including all infants <1
year old, the subpopulation at greatest
exposure. There are no residential uses
for kresoxim-methyl. Therefore, EPA
does not expect the aggregate exposure
to exceed 100% of the cPAD.
3. Short-and intermediate term risk.
Short- and intermediate-term aggregate
exposure takes into account residential
exposure plus chronic exposure to food
and water (considered to be a
background exposure level). Kresoximmethyl is not registered for use on any
sites that would result in residential
exposure. Therefore, the aggregate risk
is the sum of the risk from food and
water, which do not exceed the
Agency’s level of concern.
4. Aggregate cancer risk for U.S.
population. Using the exposure
assumptions described in this unit for
cancer exposure, EPA has concluded
that the estimated exposure of the
general U.S. population to kresoximmethyl is 0.000234 mg/kg/day.
Applying the Q1* of 0.0029 (mg/kg/
day)-1 to the exposure value results in a
lifetime cancer risk estimate of 6.80 x
10-7. The EPA considers cancer risk
estimates between 1 x 10-6 and 3 x 10-6
to fall within the acceptable range of
cancer risk (i.e., less than the range of
10-6); therefore, the cancer risk estimate
for kresoxim-methyl is below the
Agency’s level of concern.
5. 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
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Federal Register / Vol. 71, No. 165 / Friday, August 25, 2006 / Rules and Regulations
from aggregate exposure to kresoximmethyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(BASF Methods 350/3-US and D9611A
are high-performance liquid
chromatography (HPLC)/columnswitching methods with ultraviolet (UV)
detection (270 nm)) are 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; email address: residuemethods@epa.gov.
B. International Residue Limits
Codex has established maximum
residue limits (MRLs) for kresoximmethyl on various crop commodities.
The Codex residue definitions for
kresoxim-methyl in plant commodities
are in terms of the parent only, and a
Codex MRL is established for cucumber
at 0.05 ppm. The U.S. and Codex
tolerances/MRLs are not compatible
with regard to tolerance expression and
therefore, the levels can not be
harmonized as the recommended
tolerance (0.40 ppm) is significantly
higher than the Codex MRL (0.05 ppm).
cprice-sewell on PROD1PC66 with RULES
V. Conclusion
Therefore, the tolerance is established
for combined residues of kresoximmethyl (methyl (E)-2-[2-(2methylphenoxy)-methyl]phenyl-2(methoxyimido)acetate) and its
metabolites as follows: (E)-2-[2-(2methylphenoxy)methyl]-phenyl-2(methoxyimido)acetic acid; (E)-2-[2-(2hydroxymethylphenoxy)methyl]phenyl-2-(methoxyimido)acetic acid
(free and glucose conjugated); and (E)-2[2-(4-hydroxy-2-methylphenoxy)methyl]phenyl-2-(methoxyimido)acetic
acid (free and glucose conjugated), in or
on vegetable, cucurbit, group 9 at 0.40
ppm.
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
VerDate Aug<31>2005
15:27 Aug 24, 2006
Jkt 208001
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any
enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104-4). Nor does it require any
special considerations under Executive
Order 12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994); or OMB review or any Agency
action under Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section
12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are
established on the basis of a petition
under section 408(d) of 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
PO 00000
Frm 00040
Fmt 4700
Sfmt 4700
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: August 16, 2006.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
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25AUR1
Federal Register / Vol. 71, No. 165 / Friday, August 25, 2006 / Rules and Regulations
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.
2. Section 180.554 is amended by
alphabetically adding a commodity to
the table in paragraph (a)(1) to read as
follows:
I
§ 180.554 Kresoxim-methyl; tolerances for
residues.
(a) General. (1) * * *
Commodity
*
*
Parts per million
*
*
Vegetable, cucurbit,
group 9
0.40
*
*
*
*
*
*
[FR Doc. E6–14165 Filed 8–24–06; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 64
[Docket No. FEMA–7941]
Suspension of Community Eligibility
Mitigation Division, Federal
Emergency Management Agency
(FEMA), Department of Homeland
Security.
ACTION: Final rule.
cprice-sewell on PROD1PC66 with RULES
AGENCY:
SUMMARY: This rule identifies
communities, where the sale of flood
insurance has been authorized under
the National Flood Insurance Program
(NFIP), that are scheduled for
suspension on the effective dates listed
within this rule because of
noncompliance with the floodplain
management requirements of the
program. If FEMA receives
documentation that the community has
adopted the required floodplain
management measures prior to the
effective suspension date given in this
rule, the suspension will not occur and
a notice of this will be provided by
publication in the Federal Register on a
subsequent date.
DATES: Effective Dates: The effective
date of each community’s scheduled
suspension is the third date (‘‘Susp.’’)
listed in the third column of the
following tables.
ADDRESSES: If you want to determine
whether a particular community was
suspended on the suspension date,
VerDate Aug<31>2005
15:27 Aug 24, 2006
Jkt 208001
contact the appropriate FEMA Regional
Office.
FOR FURTHER INFORMATION CONTACT:
David Stearrett, Mitigation Division, 500
C Street, SW., Washington, DC 20472,
(202) 646–2953.
SUPPLEMENTARY INFORMATION: The NFIP
enables property owners to purchase
flood insurance which is generally not
otherwise available. In return,
communities agree to adopt and
administer local floodplain management
aimed at protecting lives and new
construction from future flooding.
Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42
U.S.C. 4022, prohibits flood insurance
coverage as authorized under the NFIP,
42 U.S.C. 4001 et seq.; unless an
appropriate public body adopts
adequate floodplain management
measures with effective enforcement
measures. The communities listed in
this document no longer meet that
statutory requirement for compliance
with program regulations, 44 CFR part
59 et seq. Accordingly, the communities
will be suspended on the effective date
in the third column. As of that date,
flood insurance will no longer be
available in the community. However,
some of these communities may adopt
and submit the required documentation
of legally enforceable floodplain
management measures after this rule is
published but prior to the actual
suspension date. These communities
will not be suspended and will continue
their eligibility for the sale of insurance.
A notice withdrawing the suspension of
the communities will be published in
the Federal Register.
In addition, FEMA has identified the
Special Flood Hazard Areas (SFHAs) in
these communities by publishing a
Flood Insurance Rate Map (FIRM). The
date of the FIRM, if one has been
published, is indicated in the fourth
column of the table. No direct Federal
financial assistance (except assistance
pursuant to the Robert T. Stafford
Disaster Relief and Emergency
Assistance Act not in connection with a
flood) may legally be provided for
construction or acquisition of buildings
in identified SFHAs for communities
not participating in the NFIP and
identified for more than a year, on
FEMA’s initial flood insurance map of
the community as having flood-prone
areas (section 202(a) of the Flood
Disaster Protection Act of 1973, 42
U.S.C. 4106(a), as amended). This
prohibition against certain types of
Federal assistance becomes effective for
the communities listed on the date
shown in the last column. The
Administrator finds that notice and
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Frm 00041
Fmt 4700
Sfmt 4700
50359
public comment under 5 U.S.C. 553(b)
are impracticable and unnecessary
because communities listed in this final
rule have been adequately notified.
Each community receives 6-month,
90-day, and 30-day notification letters
addressed to the Chief Executive Officer
stating that the community will be
suspended unless the required
floodplain management measures are
met prior to the effective suspension
date. Since these notifications were
made, this final rule may take effect
within less than 30 days.
National Environmental Policy Act.
This rule is categorically excluded from
the requirements of 44 CFR part 10,
Environmental Considerations. No
environmental impact assessment has
been prepared.
Regulatory Flexibility Act. The
Administrator has determined that this
rule is exempt from the requirements of
the Regulatory Flexibility Act because
the National Flood Insurance Act of
1968, as amended, 42 U.S.C. 4022,
prohibits flood insurance coverage
unless an appropriate public body
adopts adequate floodplain management
measures with effective enforcement
measures. The communities listed no
longer comply with the statutory
requirements, and after the effective
date, flood insurance will no longer be
available in the communities unless
remedial action takes place.
Regulatory Classification. This final
rule is not a significant regulatory action
under the criteria of section 3(f) of
Executive Order 12866 of September 30,
1993, Regulatory Planning and Review,
58 FR 51735.
Executive Order 13132, Federalism.
This rule involves no policies that have
federalism implications under Executive
Order 13132.
Executive Order 12988, Civil Justice
Reform. This rule meets the applicable
standards of Executive Order 12988.
Paperwork Reduction Act. This rule
does not involve any collection of
information for purposes of the
Paperwork Reduction Act, 44 U.S.C.
3501 et seq.
List of Subjects in 44 CFR Part 64
Flood insurance, Floodplains.
Accordingly, 44 CFR part 64 is
amended as follows:
I
PART 64—[AMENDED]
1. The authority citation for part 64 is
revised to read as follows:
I
Authority: 42 U.S.C. 4001 et seq.;
Reorganization Plan No. 3 of 1978, 3 CFR,
1978 Comp.; p. 329; E.O. 12127, 44 FR 19367,
3 CFR, 1979 Comp.; p. 376.
E:\FR\FM\25AUR1.SGM
25AUR1
]]>Agencies
[Federal Register Volume 71, Number 165 (Friday, August 25, 2006)]
[Rules and Regulations]
[Pages 50354-50359]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14165]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0333; FRL-8088-1]
Kresoxim-methyl; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for combined residues
of kresoxim-methyl in or on vegetable, cucurbit, group 9. Interregional
Research Project No. 4 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 August 25, 2006. Objections and
requests for hearings must be received on or before October 24, 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-2006-0333. 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: Barbara Madden, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6463; e-mail address: madden.barbara@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;
[[Page 50355]]
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 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. To access the OPPTS Harmonized Guidelines
referenced in this document, go directly to the guidelines at https://
www.epa.gpo/opptsfrs/home/guidelin.htm
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-2006-0333 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 October 24, 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-2006-0333, 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 telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of June 7, 2006 (71 FR 32950) (FRL-8068-1),
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 3E6594)
by Interregional Research Project No. 4, Rutgers, the State University
of New Jersey, 681 U.S. Highway No. 1, South Brunswick, NJ 08902-3390.
The petition requested that 40 CFR 180.554 be amended by establishing a
tolerance for combined residues of the fungicide kresoxim-methyl
(methyl (E)-2-[2-(2-methylphenoxy)-methyl]phenyl-2-
(methoxyimido)acetate) and its metabolites as follows: (E)-2-[2-(2-
methylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid; (E)-2-[2-(2-
hydroxymethylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid (free
and glucose conjugated); and (E)-2-[2-(4-hydroxy-2-methylphenoxy)-
methyl]phenyl-2-(methoxyimido)acetic acid (free and glucose
conjugated), in or on vegetable, cucurbit, group 9 at 0.5 parts per
million (ppm). That notice included a summary of the petition prepared
by BASF Corporation, the registrant. There were no comments received in
response to the notice of filing. Petition (PP 3E6594) was subsequently
amended to lower the residue level for vegetable, cucurbit, group 9 to
0.40 ppm.
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/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
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 combined residues of kresoxim-
methyl on vegetable, cucurbit, group 9 at 0.40 ppm. 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 kresoxim-methyl 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 at https://
www.epa.gov/EPA-PEST/1999/June/Day-10/p14761.htm.
[[Page 50356]]
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
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/health/human.htm.
A summary of the toxicological endpoints for kresoxim-methyl used
for human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of June 10, 1999 (64 FR 31129) (FRL-
6085-4) https://www.epa.gov/EPA-PEST/1999/June/Day-10/p14761.htm.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.554) for the combined residues of kresoxim-
methyl, in or on a variety of raw agricultural commodities. In
addition, tolerances have been established for the residues of the
kresoxim-methyl metabolite (E)-2-[2-(2-methylphenoxy)methyl]-phenyl-2-
(methoxyimido)acetic acid in meat byproducts of cattle, goat, and
sheep. Risk assessments were conducted by EPA to assess dietary
exposures from kresoxim-methyl 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 kresoxim-methyl; therefore,
a quantitative acute dietary exposure assessment is unnecessary.
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
assessments: A partially-refined, Tier 3 chronic dietary risk
assessment incorporated average field-trial residues for all food
commodities, available processing data for grapes, apples, and
screening-level percent crop treated (PCT) data for most of the
registered commodities.
iii. Cancer. In conducting the cancer 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 cancer exposure assessment:
A partially-refined, Tier 3 cancer dietary risk assessment incorporated
average field-trial residues for all food commodities, available
processing data for grapes, apples, and screening-level percent crop
treated (PCT) data for most of the registered commodities.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must pursuant
to section 408(f)(1) require that data be provided 5 years after the
tolerance is established, modified, or left in effect, demonstrating
that the levels in food are not above the levels anticipated. Following
the initial data submission, EPA is authorized to require similar data
on a time frame it deems appropriate. For the present action, EPA will
issue such data call-ins for information relating to anticipated
residues as are required by FFDCA section 408(b)(2)(E) and authorized
under FFDCA section 408(f)(1). Such data call-ins will be required to
be submitted no later than 5 years from the date of issuance of this
tolerance.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if the Agency can make the following findings: Condition 1,
that the data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit
data on PCT.
The Agency used PCT information as follows:
Apple, 10%; grape, 5%; pear, 5%; and pecan, 1%.
EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available Federal, state, and private market survey data for that use,
averaging by year, averaging across all years, and rounding up to the
nearest multiple of five percent except for those situations in which
the average PCT is less than one. In those cases <1% is used as the
average and <2.5% is used as the maximum. EPA uses a maximum PCT for
acute dietary risk analysis. The maximum PCT figure is the single
maximum value reported overall from available Federal, state, and
private market survey data on the existing use, across all years, and
rounded up to the nearest multiple of five percent. In most cases, EPA
uses available data from United States Department of Agriculture/
National Agricultural Statistics Service (USDA/NASS), Proprietary
Market Surveys, and the National Center for Food and Agriculture Policy
(NCFAP) for the most recent 6 years.
This method of projecting PCT for a new pesticide, with or without
regard to specific pest(s), produces an upper-end projection that is
unlikely, in most cases, to be exceeded in actuality in the next 5
years because one or more of the following conditions will likely
apply: the dominant pesticide is better established and accepted by
farmers than the new pesticide, the dominant pesticide is more
efficacious than the new pesticide, the dominant pesticide controls a
broader spectrum and/or
[[Page 50357]]
more important pests than the new pesticide, the dominant pesticide is
more cost-effective than the new pesticide, and other conditions.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for kresoxim-methyl in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of kresoxim-methyl. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
Estimated drinking water concentrations (EDWCs) were calculated for
both kresoxim-methyl and (E)-2-[2-(2-methylphenoxy)methyl]-phenyl-2-
(methoxyimido)acetic acid. Based on the PRZM/EXAMS and SCI-GROW models,
the estimated environmental concentrations (EECs) of kresoxim-methyl
for chronic exposures are estimated to be 14.91 parts per billion (ppb)
for surface water and 6.27 ppb for ground water. The EECs for cancer
chronic exposures are estimated to be 7.88 ppb for surface water and
6.27 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model (DEEM-FCID\TM\). Since the
surface water EDWCs are higher than the ground water EDWC, the Agency
selected these values for use in the dietary assessment. The 1-in-10
year mean of 14.91 ppb was used for the chronic (non-cancer) analysis,
and the 30-year mean of 7.88 ppb was used for the cancer analysis.
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).
Kresoxim-methyl 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 kresoxim-methyl and any
other substances and kresoxim-methyl 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 kresoxim-methyl
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. 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.''
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. In the prenatal
developmental toxicity studies in rat and rabbit fetuses, no evidence
of developmental toxicity in fetuses was seen at the limit dose. In the
2-generation reproduction study in rats, offspring effects occurred
only at parentally toxic dose levels.
3. Conclusion. There is a complete toxicity data base for kresoxim-
methyl and exposure data are complete or are estimated based on data
that reasonably accounts for potential exposures. Taking into account
the lack of any special pre- or post-natal susceptibility and the
completeness of the toxicity and exposure data base, EPA determined
that the 10X SF to protect infants and children should be reduced to
1X.
E. Aggregate Risks and Determination of Safety
1. Acute risk.An acute risk assessment was not performed. No
toxicological endpoint attributable to a single (acute) dietary
exposure was identified. Therefore, acute risk from exposure to
kresoxim-methyl is not expected.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to kresoxim-
methyl from food and water will utilize <1 % of the cPAD for the U.S.
population and all subpopulations including all infants <1 year old,
the subpopulation at greatest exposure. There are no residential uses
for kresoxim-methyl. Therefore, EPA does not expect the aggregate
exposure to exceed 100% of the cPAD.
3. Short-and intermediate term risk. Short- and intermediate-term
aggregate exposure takes into account residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Kresoxim-methyl is not registered for use on any sites that
would result in residential exposure. Therefore, the aggregate risk is
the sum of the risk from food and water, which do not exceed the
Agency's level of concern.
4. Aggregate cancer risk for U.S. population. Using the exposure
assumptions described in this unit for cancer exposure, EPA has
concluded that the estimated exposure of the general U.S. population to
kresoxim-methyl is 0.000234 mg/kg/day. Applying the Q1* of 0.0029 (mg/
kg/day)-1 to the exposure value results in a lifetime cancer
risk estimate of 6.80 x 10-7. The EPA considers cancer risk
estimates between 1 x 10-6 and 3 x 10-6 to fall
within the acceptable range of cancer risk (i.e., less than the range
of 10-6); therefore, the cancer risk estimate for kresoxim-
methyl is below the Agency's level of concern.
5. 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
[[Page 50358]]
from aggregate exposure to kresoxim-methyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (BASF Methods 350/3-US and D9611A
are high-performance liquid chromatography (HPLC)/column-switching
methods with ultraviolet (UV) detection (270 nm)) are 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
Codex has established maximum residue limits (MRLs) for kresoxim-
methyl on various crop commodities. The Codex residue definitions for
kresoxim-methyl in plant commodities are in terms of the parent only,
and a Codex MRL is established for cucumber at 0.05 ppm. The U.S. and
Codex tolerances/MRLs are not compatible with regard to tolerance
expression and therefore, the levels can not be harmonized as the
recommended tolerance (0.40 ppm) is significantly higher than the Codex
MRL (0.05 ppm).
V. Conclusion
Therefore, the tolerance is established for combined residues of
kresoxim-methyl (methyl (E)-2-[2-(2-methylphenoxy)-methyl]phenyl-2-
(methoxyimido)acetate) and its metabolites as follows: (E)-2-[2-(2-
methylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid; (E)-2-[2-(2-
hydroxymethylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid (free
and glucose conjugated); and (E)-2-[2-(4-hydroxy-2-methylphenoxy)-
methyl]phenyl-2-(methoxyimido)acetic acid (free and glucose
conjugated), in or on vegetable, cucurbit, group 9 at 0.40 ppm.
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 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: August 16, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
[[Page 50359]]
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 180.554 is amended by alphabetically adding a commodity to
the table in paragraph (a)(1) to read as follows:
Sec. 180.554 Kresoxim-methyl; tolerances for residues.
(a) General. (1) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Vegetable, cucurbit, group 9 0.40
------------------------------------------------------------------------
* * * * *
[FR Doc. E6-14165 Filed 8-24-06; 8:45 am]
BILLING CODE 6560-50-S
