Dithianon; Pesticide Tolerance, 54917-54922 [E6-15460]
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Federal Register / Vol. 71, No. 182 / Wednesday, September 20, 2006 / Rules and Regulations
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 11, 2006.
James J. Jones,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I 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.
2. Section 180.624 is added to subpart
C to read as follows:
I
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§ 180.624 Metrafenone, tolerances for
residues.
(a) General. Tolerances are
established for residues of metrafenone,
(3-bromo-6-methoxy-2methylphenyl)(2,3,4-trimethoxy-6methylphenyl)methanone, in or on the
following commodities.
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18:46 Sep 19, 2006
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Parts per
million
Commodity
0.61
Grape ........................................
1 There
is no U.S. registration on grapes as
of September 20, 2006.
(b) Section 18 emergency exemption.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. E6–15475 Filed 9–19–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0623; FRL–8090–5]
Dithianon; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes a
tolerance for residues of dithianon,
(5,10-dihydro-5,10-dioxonaphtho(2,3-b)1,4-dithiin-2,3-dicarbonitrile in or on
imported fruit, pome, group 11, and
hop, dried cones. BASF Corporation
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 20, 2006. Objections and
requests for hearings must be received
on or before November 20, 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–2006–0623. 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
PO 00000
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54917
a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Rose
Mary Kearns, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460-0001; telephone number:
(703) 305-5611; e-mail address:
kearns.rosemary@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
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
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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–2006–0623. 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 20, 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–2006–0623, 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.
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II. Background and Statutory Findings
In the Federal Register of April 12,
2006 (71 FR 19733) (FRL–7767–7), EPA
issued a notice pursuant to section
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408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 6E4781) by BASF
Corporation, 26 Davis Drive, P.O. Box
13528, Research Triangle Park, N.C.
22709. The petition requested that 40
CFR part 180 be amended by
establishing a tolerance for residues of
the fungicide dithianon, 5,10-dihydro5,10-dioxonaphtho(2,3-b)-1,4-dithiin2,3-dicarbonitrile, in or on imported
fruit, pome, group 11 at 5 parts per
million (ppm) and hop, dried cones at
100 ppm. 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/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 residues of
dithianon on fruit, pome, group 11 at 5
parts per million and hop, dried cones
at 100 ppm. EPA’s assessment of
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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
dithianon as well as the no-observedadverse-effect-level (NOAEL) and the
lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can
be found either in the docket ID number
HQ–EPA–2006–0623 at https://
www.regulations.gov or at 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
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/factsheets/riskassess.htm or
https://www.epa.gov/oppfead1/trac/
science.
A summary of the toxicological
endpoints for dithianon used for human
risk assessment is shown in Table 1 of
this unit:
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54919
TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR DITHIANON 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
Acute Dietary (Females 13–49
years of age).
NOAEL = 20 mg/kg/day ..............
UF = 1,000
aAcute RfD = 0.02 mg/kg/day
Special FQPA SF = 1 ..................
aPAD = acute RfD/Special FQPA
SF = 0.02 mg/kg/day
Developmental toxicity study in
rats.
LOAEL = 50 mg/kg/day based on
post implantation loss due to
early resorptions
Acute Dietary (General population
including infants and children).
None ............................................
None ............................................
Not selected.
No appropriate dose and endpoint could be identified for
these population groups.
Chronic Dietary (All populations) ..
NOAEL = 6 mg/kg/day ................
UF = 1,000
a Chronic RfD = 0.006 mg/kg/day
Special FQPA SF = 1 ..................
cPAD = chronic RfD/ Special
FQPA SF = 0.006 mg/kg/day
Combined
chronic
toxicity/
oncogenicity study in rats.
LOAEL = 30 mg/kg/day based on
decreased body weight gains
and increased relative to body
kidney weights (M and F),
grossly observed kidney lesions in males (irregular surfaces, pale kidneys, cysts, and
enlarged kidneys) and females
(masses), and non-neoplastic
lesions of the kidney in males
(tubular nephrosis, renal cysts,
and end-stage kidney lesions)
and females (tubular nephrosis,
proliferative
tubules,
and
glomerulonephropathy).
Cancer (oral, dermal, inhalation)
......................................................
......................................................
Classification: Classification is
‘‘Suggestive Evidence of Carcinogenic Potential’’. The risk
assessment for chronic effects
is considered protective of any
cancer effect.
UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed effect level,
PAD = population adjusted dose (a = acute, c = chronic), RFD = reference dose, MOE = margin of exposure, LOC = level of concern, N/A = Not
Applicable, a Additional 10x database uncertainty factor for lack of an acceptable developmental rabbit study.
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have not been
established for the residues of
dithianon, in or on a variety of raw
agricultural commodities because it is a
new pesticide chemical. Risk
assessments were conducted by EPA to
assess dietary exposures from dithianon
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.
An appropriate endpoint attributable
to a single exposure for females 13-49
years of age was identified in the
toxicological studies for dithianon,
therefore, a quantitative acute dietary
exposure assessment is necessary for
this population. In conducting the acute
dietary exposure assessment EPA used
the Dietary Exposure Evaluation Model
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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 acute exposure
assessment. This acute analysis was
based on tolerance-level residues, and
an assumption of 100% crop treated.
No appropriate dose and endpoint
could be identified attributable to a
single exposure for the general
population, including infants and
children. Therefore, an acute dietary
exposure assessment is not necessary for
these populations.
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
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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: This
chronic analysis was based on
anticipated (average) residues and an
assumption of 100% crop treated.
Exposure to dithianon would originate
from food only, because the proposed
tolerances would only be established on
imported commodities. With no
proposed U.S. registration, there is no
expectation that dithianon residues
would occur in surface or ground water
sources of drinking water.
iii. Cancer. The Agency classified
dithianon as having ‘‘Suggestive
Evidence of Carcinogenicity’’, based on
the presence of renal adenomas and
carcinomas in the female rat at doses
that were adequate to assess
carcinogenicity. This classification is
based on several weight-of-evidence
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considerations. First treatment-related
rare kidney tumors, primarily
adenomas, were seen only at the highest
dose tested (HDT) (600 ppm) in one sex
(females) and in one species (rats). The
HDT was considered adequate, but not
excessive, to assess the carcinogenicity
of dithianon; however, significant renal
toxicity occurred at this dose. Second,
there is no mutagenicity concern for
dithianon. Finally, the Agency
concluded that the registrant’s
hypothesized non-genotoxic mode of
action involving nephrotoxicity and
sustained regenerative proliferation is
biologically plausible. The risk
assessment for chronic effects is
considered protective of any cancer
effects.
2. Dietary exposure from drinking
water. Since dithianon is proposed for
use only on imported pome fruit and
imported hops commodities, the sole
anticipated exposure route for the U.S.
population is via dietary (food)
exposure. With no proposed U.S.
registration, there is no expectation that
dithianon residues would occur in
surface or ground water sources of
drinking water.
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).
Dithianon 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
dithianon and any other substances and
dithianon 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 dithianon 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.
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 no indication of increased
quantitative or qualitative susceptibility
of the offspring in the developmental
and 2-generation reproduction studies.
In the developmental toxicity study in
rats, reductions in maternal body
weights, body weight gains, and food
consumption were seen at 50 mg/kg/
day, but a higher dose (100 mg/kg/day)
was required to produce a reduction in
fetal body weights. The significant
increase in post-implantation loss due
to early resorptions occurred at 50 mg/
kg/day, including dams that
experienced total litter loss, is not
evidence of increased qualitative
susceptibility; instead, it is likely due to
maternal toxicity. In the 2-generation
reproduction study, decreased body
weights, body weight gains, and food
consumption were observed in the
parents but no adverse effects were seen
in the offspring up to the HDT.
3. Conclusion. The toxicology
database shows no evidence of
increased qualitative or quantitative
susceptibility in the offspring. The
dietary food exposure assessment
utilizes tolerance level residues and
100% crop treated assumptions for
acute risk, and average residues from
crop field trials and 100% crop treated
assumptions for chronic risk; by using
these conservative assumptions,
exposures/risks will not be
underestimated. There are no existing or
proposed residential uses for dithianon
at this time. Nonetheless, because an
acceptable rabbit developmental study
is not available, the Agency retained the
10x FQPA safety factor, in the form of
data base uncertainty factor of (UFDB).
E. Aggregate Risks and Determination of
Safety
1. Acute risk. An acute endpoint was
selected for only one population
subgroup, females 13-49. Using the
exposure assumptions discussed in this
unit for acute exposure, EPA has
concluded that acute exposure to
dithianon from food will utilize 66% of
the aPAD for females 13 to 49 years of
age.
TABLE 2.—AGGREGATE RISK ASSESSMENT FOR ACUTE AND CHRONIC EXPOSURE TO DITHIANON
Acute dietary (95th Percentile)*
Population subgroup
Exposure
(mg/kg/day)
General U.S. Population
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aPAD (mg/
kg)
Not
applicable.
Not
applicable.
All Infants <1 year
Not
applicable.
Children 1-2 years
Not
applicable.
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Chronic dietary*
cPAD (mg/
kg)
Exposure
(mg/kg/day)
Not
applicable.
0.006
.000738
12
Not
applicable.
Not
applicable.
0.006
0.003268
55
Not
applicable.
Not
applicable.
0.006
0.002773
46
Sfmt 4700
% aPAD
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Federal Register / Vol. 71, No. 182 / Wednesday, September 20, 2006 / Rules and Regulations
54921
TABLE 2.—AGGREGATE RISK ASSESSMENT FOR ACUTE AND CHRONIC EXPOSURE TO DITHIANON—Continued
Acute dietary (95th Percentile)*
Population subgroup
aPAD (mg/
kg)
Exposure
(mg/kg/day)
Children 3-5 years
Not
applicable.
Not
applicable.
Children 6-12 years
Not
applicable.
Youths 13-19 years
Chronic dietary*
cPAD (mg/
kg)
Exposure
(mg/kg/day)
Not
applicable.
0.006
0.001995
33
Not
applicable.
Not
applicable.
0.006
0.000903
15
Not
applicable.
Not
applicable.
Not
applicable.
0.006
0.000313
5
Adults 20-49 years
Not
applicable.
Not
applicable.
Not
applicable.
0.006
0.000583
10
Adults 50+ years
Not
applicable.
Not
applicable.
Not
applicable.
0.006
0.000483
8
0.02
.013119
66
0.006
0.000369
6
Females 13-49 years
% aPAD
% cPAD
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* Values for the population with the highest risk are bolded.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to dithianon from
food will utilize 12% of the cPAD for
the U.S. population and 55% of the
cPAD for all infants less than 1 year of
age. There are no residential uses for
dithianon that result in chronic
residential exposure to dithianon.
3. Short-term risk. Dithianon is not
registered for use on any sites that
would result in residential exposure.
Therefore, the aggregate risk is the risk
from food only, which does not exceed
the Agency’s level of concern.
4. Intermediate-term risk. Dithianon is
not registered for use on any sites that
would result in residential exposure and
is intended only for imported fruit,
pome, group 11 and hops, dried cones.
Therefore, the aggregate risk is the risk
from food only, which does not exceed
the Agency’s level of concern.
5. Aggregate cancer risk for U.S.
population. In accordance with EPA’s
Final Guidelines for Carcinogen Risk
Assessment (March, 2005), the Agency
classified dithianon into the category
‘‘Suggestive Evidence of
Carcinogenicity’’, based on the presence
of renal adenomas and carcinomas in
the female rat at doses that were
adequate to assess carcinogenicity.
However, as noted in Unit.III.C.1.iii., the
chronic risk assessment is protective of
any possible cancer effect.
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 dithianon
residues.
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IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(HPLC/UV for pome fruit and HPLC/
ECD for hops) 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
Codex MRLs have been established
for residues of dithianon in or on pome
fruit at 5 ppm and hops at 100 ppm; the
proposed tolerances on imported
commodities are harmonized with
established MRLs. There are currently
no established Canadian or Mexican
MRLs for dithianon.
V. Conclusion
Therefore, a tolerance is established
for residues of dithianon, 5,10-dihydro5,10-dioxonaphtho(2,3-b)-1,4-dithiin2,3-dicarbonitrile, in or on imported
fruit, pome, group 11 at 5 ppm and hop,
dried cones at 100 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
PO 00000
Frm 00029
Fmt 4700
Sfmt 4700
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,
E:\FR\FM\20SER1.SGM
20SER1
54922
Federal Register / Vol. 71, No. 182 / Wednesday, September 20, 2006 / Rules and Regulations
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 11, 2006.
James Jones,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I 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.
2. Section 180.621 is added to read as
follows:
I
§ 180.621
residues.
Dithianon; tolerances for
(a) General. Tolerances are
established for residues of the fungicide
dithianon, (5,10-dihydro-5,10dioxonaphtho(2,3-b)-1,4-dithiin-2,3dicarbonitrile) in or on the following
commodities:
Commodity
Parts per million
Fruit, pome, group 111 ..........................................................................................................................
Hop, dried cones1 ..................................................................................................................................
1No
U.S. registration as of September 5, 2006.
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. E6–15460 Filed 9–19–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0613.; FRL–8089–2]
rwilkins on PROD1PC63 with RULES
5
100
Etofenprox; Pesticide Tolerances for
Emergency Exemptions
Environmental Protection
Agency (EPA).
AGENCY:
ACTION:
Final rule.
VerDate Aug<31>2005
18:46 Sep 19, 2006
Jkt 208001
SUMMARY: This regulation establishes
time-limited tolerances for residues of
etofenprox (2-[ethoxyphenyl]-2methylpropyl-3-phenoxy benzyl ether)
in or on rice grain and rice straw. This
action is associated with an emergency
exemption under section 18 of the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) authorizing
use of the pesticide on rice. This
regulation establishes a maximum
permissible level for residues of
etofenprox in these food commodities.
The tolerances expire and are revoked
on December 31, 2009.
This regulation is effective
September 20, 2006. Objections and
requests for hearings must be received
on or before November 20, 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).
DATES:
PO 00000
Frm 00030
Fmt 4700
Sfmt 4700
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0613. All documents in the
docket are listed on the regulations.gov
website. 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 either in the electronic docket
at https://www.regulations.gov, or, if only
available in hard copy, at the Office of
Pesticide Programs (OPP) Regulatory
Public Docket in Rm. S–4400, One
Potomac Yard (South Building), 2777 S.
Crystal Drive Arlington, VA. The hours
of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday
ADDRESSES:
E:\FR\FM\20SER1.SGM
20SER1
]]>Agencies
[Federal Register Volume 71, Number 182 (Wednesday, September 20, 2006)]
[Rules and Regulations]
[Pages 54917-54922]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-15460]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0623; FRL-8090-5]
Dithianon; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
dithianon, (5,10-dihydro-5,10-dioxonaphtho(2,3-b)-1,4-dithiin-2,3-
dicarbonitrile in or on imported fruit, pome, group 11, and hop, dried
cones. BASF Corporation 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 20, 2006. Objections and
requests for hearings must be received on or before November 20, 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-2006-0623. 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: Rose Mary Kearns, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-5611; e-mail address:
kearns.rosemary@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 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
[[Page 54918]]
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-2006-0623. 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 20, 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-2006-0623, 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 April 12, 2006 (71 FR 19733) (FRL-7767-
7), 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
6E4781) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research
Triangle Park, N.C. 22709. The petition requested that 40 CFR part 180
be amended by establishing a tolerance for residues of the fungicide
dithianon, 5,10-dihydro-5,10-dioxonaphtho(2,3-b)-1,4-dithiin-2,3-
dicarbonitrile, in or on imported fruit, pome, group 11 at 5 parts per
million (ppm) and hop, dried cones at 100 ppm. 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/
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 residues of dithianon on fruit,
pome, group 11 at 5 parts per million and hop, dried cones at 100 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 dithianon 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 either in the
docket ID number HQ-EPA-2006-0623 at https://www.regulations.gov or at
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
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 or https://www.epa.gov/oppfead1/trac/science.
A summary of the toxicological endpoints for dithianon used for
human risk assessment is shown in Table 1 of this unit:
[[Page 54919]]
Table 1.--Summary of Toxicological Dose and Endpoints for Dithianon 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 = 20 mg/kg/day... Special FQPA SF = 1.... Developmental toxicity
age). UF = 1,000............. aPAD = acute RfD/ study in rats.
aAcute RfD = 0.02 mg/kg/ Special FQPA SF = 0.02 LOAEL = 50 mg/kg/day
day. mg/kg/day. based on post
implantation loss due
to early resorptions
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population None................... None................... Not selected.
including infants and children). No appropriate dose and
endpoint could be
identified for these
population groups.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations).... NOAEL = 6 mg/kg/day.... Special FQPA SF = 1.... Combined chronic
UF = 1,000............. cPAD = chronic RfD/ toxicity/oncogenicity
a Chronic RfD = 0.006 Special FQPA SF = study in rats.
mg/kg/day. 0.006 mg/kg/day. LOAEL = 30 mg/kg/day
based on decreased
body weight gains and
increased relative to
body kidney weights (M
and F), grossly
observed kidney
lesions in males
(irregular surfaces,
pale kidneys, cysts,
and enlarged kidneys)
and females (masses),
and non-neoplastic
lesions of the kidney
in males (tubular
nephrosis, renal
cysts, and end-stage
kidney lesions) and
females (tubular
nephrosis,
proliferative tubules,
and
glomerulonephropathy).
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) ....................... ....................... Classification:
Classification is
``Suggestive Evidence
of Carcinogenic
Potential''. The risk
assessment for chronic
effects is considered
protective of any
cancer effect.
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest
observed effect level, PAD = population adjusted dose (a = acute, c = chronic), RFD = reference dose, MOE =
margin of exposure, LOC = level of concern, N/A = Not Applicable, \a\ Additional 10x database uncertainty
factor for lack of an acceptable developmental rabbit study.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have not
been established for the residues of dithianon, in or on a variety of
raw agricultural commodities because it is a new pesticide chemical.
Risk assessments were conducted by EPA to assess dietary exposures from
dithianon 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.
An appropriate endpoint attributable to a single exposure for
females 13-49 years of age was identified in the toxicological studies
for dithianon, therefore, a quantitative acute dietary exposure
assessment is necessary for this population. In conducting the acute
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 acute
exposure assessment. This acute analysis was based on tolerance-level
residues, and an assumption of 100% crop treated.
No appropriate dose and endpoint could be identified attributable
to a single exposure for the general population, including infants and
children. Therefore, an acute dietary exposure assessment is not
necessary for these populations.
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: This chronic analysis was based on anticipated (average)
residues and an assumption of 100% crop treated. Exposure to dithianon
would originate from food only, because the proposed tolerances would
only be established on imported commodities. With no proposed U.S.
registration, there is no expectation that dithianon residues would
occur in surface or ground water sources of drinking water.
iii. Cancer. The Agency classified dithianon as having ``Suggestive
Evidence of Carcinogenicity'', based on the presence of renal adenomas
and carcinomas in the female rat at doses that were adequate to assess
carcinogenicity. This classification is based on several weight-of-
evidence
[[Page 54920]]
considerations. First treatment-related rare kidney tumors, primarily
adenomas, were seen only at the highest dose tested (HDT) (600 ppm) in
one sex (females) and in one species (rats). The HDT was considered
adequate, but not excessive, to assess the carcinogenicity of
dithianon; however, significant renal toxicity occurred at this dose.
Second, there is no mutagenicity concern for dithianon. Finally, the
Agency concluded that the registrant's hypothesized non-genotoxic mode
of action involving nephrotoxicity and sustained regenerative
proliferation is biologically plausible. The risk assessment for
chronic effects is considered protective of any cancer effects.
2. Dietary exposure from drinking water. Since dithianon is
proposed for use only on imported pome fruit and imported hops
commodities, the sole anticipated exposure route for the U.S.
population is via dietary (food) exposure. With no proposed U.S.
registration, there is no expectation that dithianon residues would
occur in surface or ground water sources of drinking water.
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).
Dithianon 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 dithianon and any other
substances and dithianon 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 dithianon 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.
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 no indication of
increased quantitative or qualitative susceptibility of the offspring
in the developmental and 2-generation reproduction studies. In the
developmental toxicity study in rats, reductions in maternal body
weights, body weight gains, and food consumption were seen at 50 mg/kg/
day, but a higher dose (100 mg/kg/day) was required to produce a
reduction in fetal body weights. The significant increase in post-
implantation loss due to early resorptions occurred at 50 mg/kg/day,
including dams that experienced total litter loss, is not evidence of
increased qualitative susceptibility; instead, it is likely due to
maternal toxicity. In the 2-generation reproduction study, decreased
body weights, body weight gains, and food consumption were observed in
the parents but no adverse effects were seen in the offspring up to the
HDT.
3. Conclusion. The toxicology database shows no evidence of
increased qualitative or quantitative susceptibility in the offspring.
The dietary food exposure assessment utilizes tolerance level residues
and 100% crop treated assumptions for acute risk, and average residues
from crop field trials and 100% crop treated assumptions for chronic
risk; by using these conservative assumptions, exposures/risks will not
be underestimated. There are no existing or proposed residential uses
for dithianon at this time. Nonetheless, because an acceptable rabbit
developmental study is not available, the Agency retained the 10x FQPA
safety factor, in the form of data base uncertainty factor of
(UFDB).
E. Aggregate Risks and Determination of Safety
1. Acute risk. An acute endpoint was selected for only one
population subgroup, females 13-49. Using the exposure assumptions
discussed in this unit for acute exposure, EPA has concluded that acute
exposure to dithianon from food will utilize 66% of the aPAD for
females 13 to 49 years of age.
Table 2.--Aggregate Risk Assessment for Acute and Chronic Exposure to Dithianon
----------------------------------------------------------------------------------------------------------------
Acute dietary (95th Percentile)* Chronic dietary*
-----------------------------------------------------------------------------
Population subgroup aPAD (mg/ Exposure cPAD (mg/ Exposure
kg) (mg/kg/day) % aPAD kg) (mg/kg/day) % cPAD
----------------------------------------------------------------------------------------------------------------
General U.S. Population Not Not Not 0.006 .000738 12
applicable. applicable. applicable.
----------------------------------------------------------------------------------------------------------------
All Infants <1 year Not Not Not 0.006 0.003268 55
applicable. applicable. applicable.
----------------------------------------------------------------------------------------------------------------
Children 1-2 years Not Not Not 0.006 0.002773 46
applicable. applicable. applicable.
----------------------------------------------------------------------------------------------------------------
[[Page 54921]]
Children 3-5 years Not Not Not 0.006 0.001995 33
applicable. applicable. applicable.
----------------------------------------------------------------------------------------------------------------
Children 6-12 years Not Not Not 0.006 0.000903 15
applicable. applicable. applicable.
----------------------------------------------------------------------------------------------------------------
Youths 13-19 years Not Not Not 0.006 0.000313 5
applicable. applicable. applicable.
----------------------------------------------------------------------------------------------------------------
Adults 20-49 years Not Not Not 0.006 0.000583 10
applicable. applicable. applicable.
----------------------------------------------------------------------------------------------------------------
Adults 50+ years Not Not Not 0.006 0.000483 8
applicable. applicable. applicable.
----------------------------------------------------------------------------------------------------------------
Females 13-49 years 0.02 .013119 66 0.006 0.000369 6
----------------------------------------------------------------------------------------------------------------
* Values for the population with the highest risk are bolded.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
dithianon from food will utilize 12% of the cPAD for the U.S.
population and 55% of the cPAD for all infants less than 1 year of age.
There are no residential uses for dithianon that result in chronic
residential exposure to dithianon.
3. Short-term risk. Dithianon is not registered for use on any
sites that would result in residential exposure. Therefore, the
aggregate risk is the risk from food only, which does not exceed the
Agency's level of concern.
4. Intermediate-term risk. Dithianon is not registered for use on
any sites that would result in residential exposure and is intended
only for imported fruit, pome, group 11 and hops, dried cones.
Therefore, the aggregate risk is the risk from food only, which does
not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. In accordance with
EPA's Final Guidelines for Carcinogen Risk Assessment (March, 2005),
the Agency classified dithianon into the category ``Suggestive Evidence
of Carcinogenicity'', based on the presence of renal adenomas and
carcinomas in the female rat at doses that were adequate to assess
carcinogenicity. However, as noted in Unit.III.C.1.iii., the chronic
risk assessment is protective of any possible cancer effect.
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 dithianon residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (HPLC/UV for pome fruit and HPLC/
ECD for hops) 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
Codex MRLs have been established for residues of dithianon in or on
pome fruit at 5 ppm and hops at 100 ppm; the proposed tolerances on
imported commodities are harmonized with established MRLs. There are
currently no established Canadian or Mexican MRLs for dithianon.
V. Conclusion
Therefore, a tolerance is established for residues of dithianon,
5,10-dihydro-5,10-dioxonaphtho(2,3-b)-1,4-dithiin-2,3-dicarbonitrile,
in or on imported fruit, pome, group 11 at 5 ppm and hop, dried cones
at 100 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,
[[Page 54922]]
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 11, 2006.
James Jones,
Director, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I 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 180.621 is added to read as follows:
Sec. 180.621 Dithianon; tolerances for residues.
(a) General. Tolerances are established for residues of the
fungicide dithianon, (5,10-dihydro-5,10-dioxonaphtho(2,3-b)-1,4-
dithiin-2,3-dicarbonitrile) in or on the following commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Fruit, pome, group 11\1\....... 5
Hop, dried cones\1\............ 100
------------------------------------------------------------------------
\1\No U.S. registration as of September 5, 2006.
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E6-15460 Filed 9-19-06; 8:45 am]
BILLING CODE 6560-50-S
