Clofentezine; Pesticide Tolerance, 11563-11572 [05-4335]
Download as PDF
<![CDATA[
Federal Register / Vol. 70, No. 45 / Wednesday, March 9, 2005 / Rules and Regulations
EPA time necessary to develop a further
proposal to address storm water
discharges from such activities.
I. National Technology Transfer And
Advancement Act
As noted in the proposed rule, 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)
directs EPA to use voluntary consensus
standards in its regulatory activities
unless to do so would be inconsistent
with applicable law or otherwise
impractical. Voluntary consensus
standards are technical standards (e.g.,
materials specifications, test methods,
sampling procedures, and business
practices) that are developed or adopted
by voluntary consensus standard bodies.
The NTTAA directs EPA to provide
Congress, through OMB, explanations
when the Agency decides not to use
available and applicable voluntary
consensus standards.
This rulemaking does not involve
technical standards. Therefore, EPA did
not consider the use of any voluntary
consensus standards. However, EPA is
exploring the availability and potential
use of voluntary consensus standards
developed consistent with the NTTAA
and the requirements of the CWA as a
means of addressing storm water runoff
from oil and gas construction activities
as part of a future rulemaking.
J. 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 the rule in
the Federal Register. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2). This rule
will be effective March 9, 2005.
List of Subjects in 40 CFR Part 122
Administrative practice and
procedure, Confidential business
information, Environmental protection,
Hazardous substances, Reporting and
recordkeeping requirements, Water
pollution control.
or on grapes and persimmons.
Makhteshim-Agan of North America,
Inc. and the Interregional Research
Project Number 4 (IR-4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection
Act of 1996 (FQPA).
Dated: March 3, 2005.
DATES: This regulation is effective
Stephen L. Johnson,
March 9, 2005. Objections and requests
Acting Administrator.
for hearings must be received on or
before May 9, 2005.
I For the reasons set forth in the
preamble, chapter I of title 40 of the Code ADDRESSES: To submit a written
of Federal Regulations is amended as
objection or hearing request, follow the
follows:
detailed instructions as provided in
Unit VI of the SUPPLEMENTARY
PART 122—EPA ADMINISTERED
INFORMATION. EPA has established a
PERMIT PROGRAMS: THE NATIONAL
docket for this action under Docket
POLLUTANT DISCHARGE
identification (ID) number OPP–2005–
ELIMINATION SYSTEM
0022. All documents in the docket are
listed in the EDOCKET index at http:/
I 1. The authority citation for part 122
/www.epa.gov/edocket. Although listed
continues to read as follows:
in the index, some information is not
Authority: The Clean Water Act, 33 U.S.C.
publicly available, i.e., CBI or other
1251 et seq.
information whose disclosure is
restricted by statute. Certain other
Subpart B—[Amended]
material, such as copyrighted material,
is not placed on the Internet and will be
I 2. Revise § 122.26(e)(8) to read as
publicly available only in hard copy
follows:
form. Publicly available docket
§ 122.26 Storm water discharges
materials are available either
(applicable to State NPDES programs, see
electronically in EDOCKET or in hard
§ 123.25).
copy at the Public Information and
*
*
*
*
*
Records Integrity Branch (PIRIB), Room
(e) * * *
119, Crystal Mall #2, 1801 S. Bell Street,
(8) For any storm water discharge
Arlington, VA 22202–4501. This docket
associated with small construction
facility is open from 8:30 a.m. to 4 p.m.,
activity identified in paragraph (b)(15)(i) Monday through Friday, excluding legal
of this section, see § 122.21(c)(1).
holidays. The docket telephone number
Discharges from these sources, other
is (703) 305–5805.
than discharges associated with small
FOR FURTHER INFORMATION CONTACT:
construction activity at oil and gas
Carmen Rodia, Registration Division
exploration, production, processing, and (7505C), Office of Pesticide Programs,
treatment operations or transmission
Environmental Protection Agency, 1200
facilities, require permit authorization
Pennsylvania Avenue, NW.,
by March 10, 2003, unless designated
Washington, DC 20460–0001; telephone
for coverage before then. Discharges
number: (703) 306–0327; fax number:
associated with small construction
(703) 305–6596; e-mail address:
activity at such oil and gas sites require
rodia.carmen@epa.gov.
permit authorization by June 12, 2006.
SUPPLEMENTARY INFORMATION:
*
*
*
*
*
I. General Information
[FR Doc. 05–4467 Filed 3–8–05; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2005–0022; FRL–7699–8]
K. Petitions for Judicial Review
Clofentezine; Pesticide Tolerance
Under section 509(b)(1) of the Clean
Water Act, judicial review of this action
may only be had by filing a petition for
review in the United States Court of
Appeals within 120 days after March 9,
2005.
AGENCY:
VerDate jul<14>2003
17:19 Mar 08, 2005
Jkt 205001
11563
Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes
tolerances for residues of clofentezine in
PO 00000
Frm 00029
Fmt 4700
Sfmt 4700
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;
E:\FR\FM\09MRR1.SGM
09MRR1
11564
Federal Register / Vol. 70, No. 45 / Wednesday, March 9, 2005 / Rules and Regulations
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 and Other Related
Information?
In addition to using EDOCKET
(https://www.epa.gov/edocket/), you may
access this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of
40 CFR part 180 is available at E-CFR
Beta Site Two at https://
www.gpoaccess.gov/ecfr/. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines athttps://www.epa.gov/
opptsfrs/home/guidelin.htm/.
II. Background and Statutory Findings
In the Federal Register of July 12,
2000 (65 FR 43004) (FRL–6591–8), 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 0F6119) by
Aventis CropScience, 2 T.W. Alexander
Drive, Research Triangle Park, NC
27709. The petition requested that 40
CFR 180.446 be amended by
establishing a tolerance for residues of
the miticide clofentezine [(3,6-bis(2chlorophenyl)-1,2,4,5-tetrazine), in or
on grapes at 0.35 parts per million
(ppm). Subsequently, Aventis
CropScience sold all proprietary rights
for clofentezine to Makhteshim-Agan of
North America, Inc., 551 Fifth Avenue,
Suite 1100, New York, NY 10176.
Further, in the Federal Register of
August 27, 2004 (69 FR 52688) (FRL–
7676–3), EPA issued a similar notice
announcing the filing of a pesticide
petition (PP 4E6824) by the
Interregional Research Project Number 4
(IR-4), 681 U.S. Highway 1 South, North
Brunswick, NJ 08902, requesting that 40
CFR 180.446 be amended by
establishing a tolerance for residues of
clofentezine, in or on persimmons at
0.05 ppm. These notices included a
summary of the petitions prepared by
the registrants. In order to harmonize
with existing Codex maximum residue
limits (MRLs) for grapes, the proposed
tolerance level for grapes was
subsequently revised to 1.0 ppm. There
were no substantive comments received
in response to these notices.
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 FFDCA
and a complete description of the risk
assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR
62961, November 26, 1997) (FRL–5754–
7).
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
clofentezine per se on grapes at 1.0 ppm
and on persimmons at 0.05 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. The nature of the
toxic effects caused by clofentezine are
discussed below in Table 1 as well as
the no observed adverse effect level
(NOAEL) and the lowest observed
adverse effect level (LOAEL) from the
toxicity studies reviewed.
TABLE 1.—SUBCHRONIC AND CHRONIC TOXICITY PROFILE OF CLOFENTEZINE TECHNICAL.
Guideline No.
Study Type
Results
870.3100
90–Day subchronic feeding toxicity,
mouse
Incorporated into the 2–year mouse oncogenicity study.
870.3100
90–Day subchronic feeding toxicity,
rat
NOAEL (systemic): 2.0 mg/kg/day
LOAEL (systemic): 20.0 mg/kg/day based on increased cholesterol levels, liver-to-body weight ratios, liver weights, and
centrilobular hepatocellular enlargement.
870.3150
90–Day subchronic feeding, nonrodent (dog)
NOAEL was not established.
LOAEL (systemic): <80.0 mg/kg/day based on increased liver
weights in both sexes and electrocardiographic changes in
females.
VerDate jul<14>2003
17:19 Mar 08, 2005
Jkt 205001
PO 00000
Frm 00030
Fmt 4700
Sfmt 4700
E:\FR\FM\09MRR1.SGM
09MRR1
Federal Register / Vol. 70, No. 45 / Wednesday, March 9, 2005 / Rules and Regulations
11565
TABLE 1.—SUBCHRONIC AND CHRONIC TOXICITY PROFILE OF CLOFENTEZINE TECHNICAL.—Continued
Guideline No.
Study Type
Results
870.3700
Prenatal
Rat
Developmental
Toxicity,
Maternal NOAEL: 1,280 mg/kg/day (above the Limit Dose of
1,000 mg/kg/day)
Maternal LOAEL: 3,200 mg/kg/day based on differential staining
and slight enlargement of the centrilobular hepatocytes.
Developmental NOAEL: >3,200 mg/kg/day (above the Limit
Dose)
Developmental LOAEL: >3,200 mg/kg/day (above the Limit
Dose)
870.3700
Prenatal
Rabbit
Developmental
Toxicity,
Maternal NOAEL: 1,000 mg/kg/day (Limit Dose)
Maternal LOAEL: 3,000 mg/kg/day based on decreased body
weight and food consumption.
Developmental NOAEL: 1,000 mg/kg/day (Limit Dose)
Developmental LOAEL: 3,000 mg/kg/day based on decreased
mean fetal weight.
870.3800
2-Generation Reproductive and Fertility Effects, Rat
Parental/Systemic NOAEL: ≥20.0 mg/kg/day
Parental/Systemic LOAEL: >20.0 mg/kg/day
Reproductive NOAEL: ≥20.0 mg/kg/day
Reproductive LOAEL: >20.0 mg/kg/day
Offspring NOAEL: ≥20.0 mg/kg/day
Offspring LOAEL: >20.0 mg/kg/day
870.4100
Chronic Feeding Toxicity, Nonrodent
(Dog)
NOAEL (systemic): 1.25 mg/kg/day
LOAEL (systemic): 25.0 mg/kg/day based on increased liver
weights, hepatocellular enlargement, and increased serum
cholesterol, triglycerides, and alkaline phosphatase levels.
870.4200
Chronic Carcinogenicity (Feeding),
Mouse
NOAEL (systemic): 50.70 mg/kg/day
LOAEL (systemic): 543.0 mg/kg/day based on decreased body
weights and body weight gains, increased incidence of
eosinophilic areas in hepatocytes of males. In females, increased incidence of basophilic and/or eosinophilic foci or
areas of hepatocyte alterations, mortality with amyloidosis as
a contributing factor for increased mortality. No evidence of
carcinogenicity.
870.4300
Combined Chronic Feeding Toxicity/
Carcinogenicity Study, Rat
NOAEL (systemic): 1.72 mg/kg/day
LOAEL (systemic): 17.3 mg/kg/day based on increased liver
weights and liver-to-body weight ratios and increased thyroxin
levels; and centrilobular hepatocellular hypertrophy and
vacuolation, focal cystic degeneration of hepatocytes, and diffuse distribution of fat deposits in liver (M). Evidence of carcinogenicity in male rats [thyroid tumors].
870.5200
Mouse Lymphoma
Non-mutagenic (±) activation.
870.5250
Gene Mutation, Salmonella
Non-mutagenic (±) activation.
870.5395
In vitro Mammalian Cytogenetics
Test (Erythocyte Micronucleus
Assay), Mice
Non-mutagenic.
870.5450
Rodent Dominant Lethal Assay, Rat
Non-mutagenic.
870.5575
Mitotic Gene Conversion in Saccharomyces cerevisiae
Non-mutagenic and negative for mitotic recombination.
870.7485
General Metabolism, Rat
Male and female rats given clofentezine technical at 1,000 mg/
kg manifested peak plasma levels of between 14 and 16 ppm
at 6-8 hours post-dosing which then declined to 3 ppm at 24
hours post-dosing. Plasma half-life was approximately 3.5
hours. Whole body autoradiography of rats given a 10 mg/kg
dose indicated poor gastrointestinal absorption with 60-70%
of the given dose excreted in the feces during the first 24
hours and about 20% excreted in the urine. Major metabolites were 3-(2′-methyl-thio-3′ hydroxy phenyl)-6-(2′-chlorophenyl)-1,2,4,5-tetrazine
and
3-,4-,
and
5hydroxyclofentezine. Both liver and kidney had the highest
tissue concentration after 72 hours.
VerDate jul<14>2003
17:19 Mar 08, 2005
Jkt 205001
PO 00000
Frm 00031
Fmt 4700
Sfmt 4700
E:\FR\FM\09MRR1.SGM
09MRR1
11566
Federal Register / Vol. 70, No. 45 / Wednesday, March 9, 2005 / Rules and Regulations
B. Toxicological Endpoints
The dose at which 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 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. An UF of 100 is routinely
used, 10x to account for interspecies
differences and 10x for intraspecies
differences.
Three other types of safety or
uncertainty factors may be used: The
‘‘traditional uncertainty factor;’’ the
‘‘special FQPA safety factor;’’ and the
‘‘default FQPA safety factor.’’ By the
term ‘‘traditional uncertainty factor,’’
EPA is referring to those additional
uncertainty factors used prior to FQPA
passage to account for database
deficiencies. These traditional
uncertainty factors have been
incorporated by the FQPA into the
additional safety factor for the
protection of infants and children. The
term ‘‘special FQPA safety factor’’ refers
to those safety factors that are deemed
necessary for the protection of infants
and children primarily as a result of the
FQPA. The ‘‘default FQPA safety factor’’
is the additional 10x safety factor that is
mandated by the statute unless it is
decided that there are reliable data to
choose a different additional factor
(potentially a ‘‘traditional uncertainty
factor’’ or a ‘‘special FQPA safety
factor’’).
For dietary risk assessment (other
than cancer) the Agency uses the UF to
calculate an acute or chronic reference
dose (acute RfD or chronic RfD) where
the RfD is equal to the NOAEL divided
by an UF of 100 to account for
interspecies and intraspecies differences
and any traditional uncertainty factors
deemed appropriate (RfD = NOAEL/UF).
Where a special FQPA safety factor or
the default FQPA safety factor is used,
this additional factor is applied to the
RfD by dividing the RfD by such
additional factor. The acute or chronic
Population Adjusted Dose (aPAD or
cPAD) is a modification of the RfD to
accommodate this type of safety factor.
For non-dietary risk assessments
(other than cancer) the UF is used to
determine the LOC. For example, when
100 is the appropriate UF (10x to
account for interspecies differences and
10x for intraspecies differences) the
LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of
exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
The linear default risk methodology
(Q*) is the primary method currently
used by the Agency to quantify
carcinogenic risk. The Q* approach
assumes that any amount of exposure
will lead to some degree of cancer risk.
A Q* is calculated and used to estimate
risk which represents a probability of
occurrence of additional cancer cases
(e.g., risk). An example of how such a
probability risk is expressed would be to
describe the risk as one in one hundred
thousand (1 x 10-5), one in a million (1
x 10-6), or one in ten million (1 x 10-7).
Under certain specific circumstances,
MOE calculations will be used for the
carcinogenic risk assessment. In this
non-linear approach, a ‘‘point of
departure’’ is identified below which
carcinogenic effects are not expected.
The point of departure is typically a
NOAEL based on an endpoint related to
cancer effects though it may be a
different value derived from the dose
response curve. To estimate risk, a ratio
of the point of departure to exposure
(MOEcancer = point of departure/
exposures) is calculated.
In general, clofentezine has low acute
toxicity by the oral, dermal and
inhalation routes of exposure
(Categories III and IV) although mild eye
irritation has been observed in rabbits.
No appropriate toxicological endpoint
(effect) attributable to a single exposure
(dose) was identified in any study
including the available oral studies in
the rat and developmental studies in the
rat and rabbit; therefore, an acute RfD
was not established and no risk is
expected from acute exposure. Longterm dermal exposure and risk is not
expected, based on the current use
pattern. In addition, based on the
overall low toxicity of clofentezine,
there is minimal concern for short-,
intermediate-, and long-term inhalation
exposure and risk. A summary of the
toxicological endpoints used for the
clofentezine human health risk
assessment is shown below in Table 2.
TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR CLOFENTEZINE FOR USE IN HUMAN RISK
ASSESSMENT.
Dose Used in Risk Assessment, Interspecies and
Intraspecies and any Traditional UF
Exposure/Scenario
Special FQPA SF and
Level of Concern for Risk
Assessment
Study and Toxicological Effects
Chronic Dietary
(General U.S. Population including infants and children)
NOAEL= 1.25 mg/kg/day
UF = 100
Chronic RfD =
0.013 mg/kg/day
Special FQPA SF = 1x
cPAD = chronic RfD
Special FQPA SF = 0.013
mg/kg/day
Chronic Feeding Toxicity, Nonrodent (Dog)
LOAEL = 25.0 mg/kg/day based on
histopathology in the liver and elevated
serum cholesterol, triglycerides, and alkaline
phosphatase observed at the LOAEL.
Short-Term Dermal
(1 to 30 days)
(Residential)
Oral study NOAEL = 2 mg/
kg/day
(dermal absorption rate =
1%)
LOC for MOE =
100 (Residential)
90–Day subchronic feeding toxicity, Rat
LOAEL = 20 mg/kg/day based on increased
cholesterol, increased liver weights, thyroid
colloid depletion and thyroid follicular cell
hypertrophy.
Intermediate-Term Dermal
(1 to 6 months)
(Residential)
Oral study NOAEL = 2 mg/
kg/day
(dermal absorption rate =
1%)
LOC for MOE =
100 (Residential)
90–Day Subchronic Feeding Toxicity, Rat
LOAEL = 20 mg/kg/day based on increased
cholesterol, increased liver weights, thyroid
colloid depletion and thyroid follicular cell
hypertrophy.
VerDate jul<14>2003
17:19 Mar 08, 2005
Jkt 205001
PO 00000
Frm 00032
Fmt 4700
Sfmt 4700
E:\FR\FM\09MRR1.SGM
09MRR1
11567
Federal Register / Vol. 70, No. 45 / Wednesday, March 9, 2005 / Rules and Regulations
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have been
established (40 CFR 180.446) for the
residues of clofentezine per se, in or on
a variety of raw agricultural
commodities (RACs). Specifically,
tolerances for clofentezine are
established for almonds, apples,
apricots, cherries, nectarines, peaches,
pears, and walnuts. Risk assessments
were conducted by EPA to assess
dietary exposures from clofentezine in
food as follows:
i. Acute exposure. As discussed in
Unit III.B, an acute dietary exposure
assessment was not performed because
an endpoint of concern attributable to a
single oral dose was not selected for any
population subgroup (including infants
and children).
ii. Chronic exposure. In conducting
the chronic and cancer dietary (food
only) exposure assessments for
clofentezine, EPA used the Dietary
Exposure Evaluation Model software
with the Food Commodity Intake
Database (DEEM-FCIDTM), Version 2.03,
and the LifelineTMModel, Version 2.0,
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 and cancer
dietary exposure assessments: The
Agency has determined that
clofentezine per se and the 3-(2-chloro4-hydroxyphenyl)-6-(2-chlorophenyl)1,2,4,5-tetrazine metabolite are the
residues of concern for the chronic
dietary analysis. The chronic dietary
analysis for clofentezine was based on
anticipated residue levels (ARs) in the
form of average field trial residue
values, and the analysis included
estimates for percent crop treated (PCT).
iii. Cancer. As explained in Unit
III.C.1.ii above, the Agency assessed
cancer dietary exposure for clofentezine
using the same assumptions used for
chronic dietary exposure. Cancer risk is
determined for the general U.S.
population only. The estimated
exposure of the general U.S. population
to clofentezine is 0.000023 mg/kg/day.
iv. Anticipated residue and 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
VerDate jul<14>2003
17:19 Mar 08, 2005
Jkt 205001
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 (food only)
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:
For existing uses, the Agency used
estimates of PCT for the chronic dietary
(food only) risk assessment, which was
determined using USDA’s National
Agricultural Statistics Service (NASS)
usage data and EPA 2003 proprietary
usage data (DOANE 2003). Table 3
below displays the chronic PCT
estimates used for the existing uses of
clofentezine. When the PCT for a
commodity is estimated as <1%, the
PCT used for risk assessment purposes
is 1%.
TABLE 3.—CLOFENTEZINE ESTIMATES
OF PERCENT CROP TREATED FOR
EXISTING USES.
PO 00000
Percent Crop
Treated
Commodity
Almonds
<1
Apples
5
Apricots
5
Cherries
<1
Frm 00033
Fmt 4700
Sfmt 4700
TABLE 3.—CLOFENTEZINE ESTIMATES
OF PERCENT CROP TREATED FOR
EXISTING USES.—Continued
Percent Crop
Treated
Commodity
Nectarines
10
Peaches
5
Pears
5
Prunes & Plums
<1
Walnuts
<1
For the new uses, the Agency used
PCT estimates for the chronic dietary
(food only) risk assessment based on
‘‘screening level’’ usage data for
agricultural crops. This information was
retrieved from 1998–2003 USDA
National Agricultural Statistics Service
(NASS) usage data and EPA 2003
proprietary usage data (DOANE 2003)
for the historically, most widely used
miticide for control of pests for each
crop. The 2003 NASS data were
compared to the DOANE 2003 data,
both yielded similar results and did not
make a difference. As a result of this
comparison, the highest, most
conservative PCT estimate for each crop
was used for the chronic dietary (food
only) risk assessment. These highly
conservative estimates should not
underestimate actual usage of
clofentezine on the new crops/sites.
Some of these numbers may be based on
information that does not cover all 50
states; therefore, it is possible that if the
remaining (usually minor states for the
crop) had been included, the quantity
(pounds) of active ingredient would be
slightly higher.
To further support the reliability of
these PCT estimates, as a condition of
registration, the registrant will be
required to agree to report annually on
the market share attained for the new
uses for which clofentezine is
registered. As a condition of
registration, they will also be required to
agree to mitigate dietary risk as deemed
appropriate by the Agency should the
market share data raise a concern for
increased dietary risk. The Agency will
then compare that market share
information with the PCT estimates
used to evaluate potential dietary risk.
In those instances where percent market
share is approaching or exceeding the
predicted PCT estimate used in the
Agency’s risk assessment, EPA will
conduct a new dietary risk assessment
to evaluate the new dietary risk. If the
market share data raise a concern for
increased pesticide risk, the Agency will
act to mitigate that dietary risk and
E:\FR\FM\09MRR1.SGM
09MRR1
11568
Federal Register / Vol. 70, No. 45 / Wednesday, March 9, 2005 / Rules and Regulations
could employ several approaches,
including but not limited to production
caps, geographical limitations, removal
of uses, or other means deemed
appropriate by the Agency. Table 4
below displays the chronic PCT
estimates used for the new uses of
clofentezine. When the PCT for a
commodity is estimated as <1%, the
PCT used for risk assessment purposes
is 1%.
TABLE 4.—CLOFENTEZINE ESTIMATES
OF PERCENT CROP TREATED FOR
NEW USES.
Percent Crop
Treated
Commodity
Grapes
13
Persimmons
<1
The Agency believes that the three
conditions listed in this Unit have been
met. With respect to Condition 1, PCT
estimates are derived from Federal and
private market survey data, which are
reliable and have a valid basis. EPA uses
a weighted average PCT for chronic
dietary exposure estimates. This
weighted average PCT figure is derived
by averaging State-level data for a
period of up to 10 years, and weighting
for the more robust and recent data. A
weighted average of the PCT reasonably
represents a person’s dietary exposure
over a lifetime, and is unlikely to
underestimate exposure to an individual
because of the fact that pesticide use
patterns (both regionally and nationally)
tend to change continuously over time,
such that an individual is unlikely to be
exposed to more than the average PCT
over a lifetime. As to Conditions 2 and
3, regional consumption information
and consumption information for
significant subpopulations is taken into
account through EPA’s computer-based
model for evaluating the exposure of
significant subpopulations including
several regional groups. Use of this
consumption information in EPA’s risk
assessment process ensures that EPA’s
exposure estimate does not understate
exposure for any significant
subpopulation group, and allows the
Agency to be reasonably certain that no
regional population is exposed to
residue levels higher than those
estimated by the Agency. Other than the
data available through national food
consumption surveys, EPA does not
have available information on the
regional consumption of food to which
clofentezine may be applied in a
particular area.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
VerDate jul<14>2003
17:19 Mar 08, 2005
Jkt 205001
monitoring exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for
clofentezine 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
clofentezine.
The Agency uses the FQPA Index
Reservoir Screening Tool (FIRST) to
produce estimates of pesticide
concentrations in an index reservoir.
The SCI-GROW model is used to predict
pesticide concentrations in shallow
ground water. For a screening-level
assessment for surface water EPA will
use FIRST (a tier 1 model) before using
PRZM/EXAMS (a tier 2 model). The
FIRST model is a subset of the PRZM/
EXAMS model that uses a specific highend runoff scenario for pesticides. Both
FIRST and PRZM/EXAMS incorporate
an index reservoir environment, and
both models include a percent crop area
factor as an adjustment to account for
the maximum percent crop coverage
within a watershed or drainage basin.
None of these models include
consideration of the impact processing
(mixing, dilution, or treatment) of raw
water for distribution as drinking water
would likely have on the removal of
pesticides from the source water. The
primary use of these models by the
Agency at this stage is to provide a
screen for sorting out pesticides for
which it is unlikely that drinking water
concentrations would exceed human
health levels of concern.
Since the models used are considered
to be screening tools in the risk
assessment process, the Agency does
not use estimated environmental
concentrations (EECs), which are the
model estimates of a pesticide’s
concentration in water. EECs derived
from these models are used to quantify
drinking water exposure and risk as a
%RfD or %PAD. Instead, drinking water
levels of comparison (DWLOCs) are
calculated and used as a point of
comparison against the model estimates
of a pesticide’s concentration in water.
DWLOCs are theoretical upper limits on
a pesticide’s concentration in drinking
water in light of total aggregate exposure
to a pesticide in food, and from
residential uses. Since DWLOCs address
total aggregate exposure to clofentezine,
they are further discussed in the
aggregate risk sections in Unit III.E.
Based on the FIRST and SCI-GROW
models, the EECs of clofentezine for
acute exposures are estimated to be 4.2
parts per billion (ppb) for surface water
and 0.1 ppb for ground water. The EECs
PO 00000
Frm 00034
Fmt 4700
Sfmt 4700
for chronic exposures are estimated to
be 0.2 ppb for surface water and 0.1 ppb
for ground water.
3. From nondietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to
nonoccupational, nondietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Clofentezine is not registered for use on
any sites that would result in residential
exposure. Therefore, a residential
exposure assessment was not
conducted.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of 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
clofentezine and any other substances
and clofentezine 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 clofentezine 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 OPP concerning
common mechanism determinations
and procedures for cumulating effects
from substances found to have a
common mechanism on EPA’s web site
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 database 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 an MOE
analysis or through using uncertainty
(safety) factors in calculating a dose
E:\FR\FM\09MRR1.SGM
09MRR1
Federal Register / Vol. 70, No. 45 / Wednesday, March 9, 2005 / Rules and Regulations
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 an increased
susceptibility of rat or rabbit fetuses/
pups to in utero and/or postnatal
exposure in the developmental and
reproductive toxicity studies.
3. Conclusion. EPA has determined
that there are reliable data supporting
removal of the additional 10x factor for
the protection of infants and children.
This decision was based on the
following conclusions:
i. The toxicology database is
complete;
ii. There is no indication of increased
susceptibility of rats or rabbit fetuses/
pups [quantitatively or qualitatively] to
in utero and/or postnatal exposure to
clofentezine in the developmental and
reproductive toxicity studies;
iii. A developmental neurotoxicity
study (DNT) is not required;
iv. Exposure data are complete or are
estimated based on data that reasonably
accounts for potential exposures; and
v. There are currently no registered
residential uses of clofentezine.
E. Aggregate Risks and Determination of
Safety
To estimate total aggregate exposure
to a pesticide from food, drinking water,
and residential uses, the Agency
calculates DWLOCs which are used as a
point of comparison against EECs.
DWLOC values are not regulatory
standards for drinking water. A DWLOC
is a theoretical upper limit on a
pesticide’s concentration in drinking
water in light of total aggregate exposure
to a pesticide in food, drinking water,
and through residential uses. In
calculating a DWLOC, the Agency
determines how much of the acceptable
exposure (i.e., the PAD) is available for
exposure through drinking water (e.g.,
allowable chronic water exposure (mg/
kg/day) = cPAD - (average food +
residential exposure)). This allowable
exposure through drinking water is used
to calculate a DWLOC.
A DWLOC will vary depending on the
toxicological endpoint, drinking water
consumption, and body weights. Default
body weights and consumption values
as used by the EPA’s Office of Water are
used to calculate DWLOCs: 2 liter (L)/
70 kg (adult male), 2L/60 kg (adult
female), and 1L/10 kg (child). Default
body weights and drinking water
consumption values vary on an
individual basis. This variation will be
taken into account in more refined
screening-level and quantitative
drinking water exposure assessments.
Different populations will have different
DWLOCs. Generally, a DWLOC is
calculated for each type of risk
assessment used: Acute, short-term,
intermediate-term, chronic, and cancer.
When EECs for surface water and
ground water are less than the
calculated DWLOCs, EPA concludes
with reasonable certainty that exposures
to the pesticide in drinking water (when
considered along with other sources of
exposure for which EPA has reliable
data) would not result in unacceptable
levels of aggregate human health risk at
this time. Because EPA considers the
aggregate risk resulting from multiple
exposure pathways associated with a
pesticide’s uses, levels of comparison in
drinking water may vary as those uses
change. If new uses are added in the
future, EPA will reassess the potential
impacts of residues of the pesticide in
11569
drinking water as a part of the aggregate
risk assessment process.
Human health aggregate risk
assessments have been conducted for
the chronic and cancer (food + drinking
water) exposure scenarios. An acute
aggregate risk assessment was not
performed because an endpoint of
concern attributable to a single oral dose
was not identified for any population
subgroup (including infants and
children). Short-, intermediate- and
long-term aggregate risk assessments
were not performed because there are no
registered or proposed residential uses
for clofentezine. All potential exposure
pathways were assessed in the aggregate
risk assessment. All aggregate exposure
and risk estimates do not exceed EPA’s
LOC for the chronic and cancer (food +
drinking water) exposure scenarios.
1. Acute risk. As discussed in Unit
III.E., clofentezine is not expected to
pose an acute risk because an endpoint
of concern attributable to a single oral
dose was not identified for any
population subgroup (including infants
and children).
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to clofentezine from food
will utilize 0.1% of the cPAD for the
general U.S. population, 0.3% of the
cPAD for all infants (<1 year old), and
0.4% of the cPAD for children (1–2
years old). There are no residential uses
for clofentezine that result in chronic
residential exposure to clofentezine. In
addition, there is potential for chronic
dietary exposure to clofentezine in
drinking water. After calculating
DWLOCs and comparing them to the
EECs for surface and ground water, EPA
does not expect the aggregate exposure
to exceed 100% of the cPAD, as shown
below in Table 5.
TABLE 5. —AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO CLOFENTEZINE.
cPAD/mg/kg/
day
%/cPAD/(Food)
Surface Water
EEC/(ppb)
Ground/Water
EEC/(ppb)
General U.S. population
0.013 ...............
0.1 ...................
0.2 ..................
0.1 ......................
450
All infants (<1 year old)
0.013 ...............
0.3 ...................
0.2 ..................
0.1 ......................
130
Children (1–2 years old)
0.013 ...............
0.4 ...................
0.2 ..................
0.1 ......................
130
Females (13–49 years old)
0.013 ...............
0.1 ...................
0.2 ..................
0.1 ......................
390
Population/Subgroup
3. Short-term risk. Short-term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Clofentezine is not registered for use on
VerDate jul<14>2003
17:19 Mar 08, 2005
Jkt 205001
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 LOC.
PO 00000
Frm 00035
Fmt 4700
Sfmt 4700
Chronic/DWLOC
(ppb)
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level). Clofentezine is not
E:\FR\FM\09MRR1.SGM
09MRR1
11570
Federal Register / Vol. 70, No. 45 / Wednesday, March 9, 2005 / Rules and Regulations
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 LOC.
5. Aggregate cancer risk for U.S.
population. In conducting the aggregate
cancer risk assessment, only food and
drinking water pathways of exposure
were considered. At this time, there are
no uses for clofentezine that would
result in any non-occupational, nondietary exposure (i.e., there are no
dermal or inhalation routes of exposure
that should be included in an aggregate
assessment). The cancer risk from
exposure to clofentezine residues in
food was calculated as 4.31 x 10-7. This
is below EPA’s level of concern for
cancer risk (risks in the range of one in
a million). A DWLOC was derived for
the general U.S. population based on
EPA’s LOC for cancer or a risk in the
range of one in one million (using the
value of 1 x 10-6 as a first Tier value in
calculating a conservative estimate of
DWLOC that is consistent with the
range of one in one million). The
DWLOC is compared to the EECs of
clofentezine in surface and ground
water and is used to determine whether
or not aggregate cancer exposures are
likely to result in risk estimates that
exceed EPA’s LOC. Table 6 below
summarizes the cancer aggregate
exposure estimates to clofentezine
residues.
TABLE 6.—AGGREGATE RISK ASSESSMENT FOR CANCER EXPOSURE TO CLOFENTEZINE.
Maximum Exposure (mg/
kg/day)
2.66 x 10-5
Population/Subgroup
General U.S. Population
The EECs calculated for ground and
surface water are less than EPA’s
calculated cancer DWLOC. Therefore,
the cancer aggregate risk associated with
the proposed use of clofentezine does
not exceed EPA’s level of concern for
the general U.S. population and all
population subgroups.
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 U.S.
population, and to infants and children,
from aggregate exposure to clofentezine
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
A high-performance liquid
chromatography (HPLC) analytical
method exists for the determination of
clofentezine residues. A petition
method validation (PMV) was
successfully completed by the analytical
chemistry laboratory (ACL), and the
method was found acceptable. The limit
of quantitation (LOQ) and limit of
detection (LOD) reported were 0.01 ppm
and 0.003 ppm, respectively. The
Agency concluded that the method was
suitable for enforcement purposes. The
method was forwarded to FDA for
inclusion in Pesticide Analytical
Manual (PAM)-Volume II. PAM-Volume
I multiresidue methods are not
acceptable for tolerance enforcement.
Adequate enforcement methodology
(example —gas chromatography) is
available to enforce the tolerance
expression. The method may be
requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Road, Ft.
Meade, MD 20755–5350; telephone
VerDate jul<14>2003
17:19 Mar 08, 2005
Jkt 205001
Food Exposure (mg/kg/
day)
1.1 x 10-5
Maximum
Water Exposure (mg/kg/
day)
1.56 x 10-5
Cancer DWLOC
(ppb)
0.6
Ground/Water
EEC/(ppb)
Surface
Water
EEC/
(ppb)
0.1
0.2
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov.
A. What Do I Need to Do to File an
Objection or Request a Hearing?
B. International Residue Limits
You must file your objection or
request a hearing on this regulation in
accordance with the instructions
provided in this unit and in 40 CFR part
178. To ensure proper receipt by EPA,
you must identify docket ID number
OPP–2005–0022 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 May 9, 2005.
1. Filing the request. Your objection
must specify the specific provisions in
the regulation that you object to, and the
grounds for the objections (40 CFR
178.25). If a hearing is requested, the
objections must include a statement of
the factual issues(s) on which a hearing
is requested, the requestor’s contentions
on such issues, and a summary of any
evidence relied upon by the objector (40
CFR 178.27). Information submitted in
connection with an objection or hearing
request may be claimed confidential by
marking any part or all of that
information as CBI. Information so
marked will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2. A copy of the
information that does not contain CBI
must be submitted for inclusion in the
public record. Information not marked
confidential may be disclosed publicly
by EPA without prior notice.
Mail your written request to: Office of
the Hearing Clerk (1900L),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001. You may also deliver
your request to the Office of the Hearing
Clerk in Suite 350, 1099 14th Street,
NW., Washington, DC 20005–3419. The
Codex MRLs exist for clofentezine on
grapes. The Codex MRLs for grapes and
the U.S. tolerances established for
clofentezine on grapes by this rule are
harmonized at 1.0 ppm. No Codex MRLs
exist for clofentezine on persimmons.
V. Conclusion
Therefore, tolerances are established
for residues of clofentezine per se, (3,6bis(2-chlorophenyl)-1,2,4,5-tetrazine), in
or on grapes at 1.0 ppm and
persimmons at 0.05 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as
amended by FQPA, any person may file
an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
Although the procedures in those
regulations require some modification to
reflect the amendments made to FFDCA
by FQPA, EPA will continue to use
those procedures, with appropriate
adjustments, until the necessary
modifications can be made. The new
section 408(g) of FFDCA provides
essentially the same process for persons
to ‘‘object’’ to a regulation for an
exemption from the requirement of a
tolerance issued by EPA under new
section 408(d) of FFDCA, as was
provided in the old sections 408 and
409 of FFDCA. However, the period for
filing objections is now 60 days, rather
than 30 days.
PO 00000
Frm 00036
Fmt 4700
Sfmt 4700
E:\FR\FM\09MRR1.SGM
09MRR1
Federal Register / Vol. 70, No. 45 / Wednesday, March 9, 2005 / Rules and Regulations
Office of the Hearing Clerk is open from
8 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Office of the
Hearing Clerk is (202) 564–6255.
2. Copies for the Docket. In addition
to filing an objection or hearing request
with the Hearing Clerk as described in
Unit VI.A, you should also send a copy
of your request to the PIRIB for its
inclusion in the official record that is
described in ADDRESSES. Mail your
copies, identified by docket ID number
OPP–2005–0022, to: Public Information
and Records Integrity Branch,
Information Resources and Services
Division (7502C), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Avenue,
NW., Washington, DC 20460–0001. In
person or by courier, bring a copy to the
location of the PIRIB described in
ADDRESSES. You may also send an
electronic copy of your request via email to: opp-docket@epa.gov. Please use
an ASCII file format and avoid the use
of special characters and any form of
encryption. Copies of electronic
objections and hearing requests will also
be accepted on disks in WordPerfect
6.1/8.0 or ASCII file format. Do not
include any CBI in your electronic copy.
You may also submit an electronic copy
of your request at many Federal
Depository Libraries.
B. When Will the Agency Grant a
Request for a Hearing?
A request for a hearing will be granted
if the Administrator determines that the
material submitted shows the following:
There is a genuine and substantial issue
of fact; there is a reasonable possibility
that available evidence identified by the
requestor would, if established resolve
one or more of such issues in favor of
the requestor, taking into account
uncontested claims or facts to the
contrary; and resolution of the factual
issues(s) in the manner sought by the
requestor would be adequate to justify
the action requested (40 CFR 178.32).
VII. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to petitions 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 jul<14>2003
17:19 Mar 08, 2005
Jkt 205001
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 00037
Fmt 4700
Sfmt 4700
11571
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.
VIII. 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 record keeping
requirements.
Dated: February 25, 2005.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
E:\FR\FM\09MRR1.SGM
09MRR1
11572
Federal Register / Vol. 70, No. 45 / Wednesday, March 9, 2005 / Rules and Regulations
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 180.446 is amended by
alphabetically adding commodities to
the table in paragraph (a) to read as
follows:
I
§ 180.446 Clofentezine; tolerances for
residues.
(a) * * *
Commodity
Parts per million
*
*
*
Grapes
*
*
*
*
*
*
*
*
1.0
Persimmons
*
*
*
0.05
*
*
*
EPA has established a
docket for this action under docket
identification (ID) number OPP–2004–
0410. All documents in the docket are
listed in the EDOCKET index athttps://
www.epa.gov/edocket. Although listed
in the index, some information is not
publicly available, i.e., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either
electronically in EDOCKET or in hard
copy at the Public Information and
Records Integrity Branch (PIRIB), Rm.
119, Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA. This docket facility is
open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The docket telephone number
is (703) 305–5805.
INFORMATION.
PART 180—[AMENDED]
*
*
*
40 CFR Part 180
J. R.
Tomerlin, Registration Division (0705C),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–0598; e-mail address:
tomerlin.bob@epa.gov.
[OPP–2004–0410; FRL–7699–2]
SUPPLEMENTARY INFORMATION:
Fenbuconazole; Time-Limited
Pesticide Tolerance
I. General Information
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 05–4335 Filed 3–8–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
A. Does this Action Apply to Me?
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes a
time-limited tolerance for the combined
residues of fenbuconazole [alpha-[2-(4chlorophenyl)-ethyl]-alpha-phenyl-3(1H-1,2,4-triazole)-1-propanenitrile] and
its metabolites cis- andtrans-5-(4chlorophenyl)-dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3Hfuranone, expressed as fenbuconazole in
or on bananas (whole fruit); pecans; and
stone fruit crop group (except plums
and prunes). Dow AgroSciences, LLC
requested this tolerance under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA).
The tolerance will expire on December
31, 2008.
DATES: This regulation is effective
March 9, 2005. Objections and requests
for hearings must be received on or
before May 9, 2005.
ADDRESSES: To submit a written
objection or hearing request follow the
detailed instructions as provided in
Unit VI. of theSUPPLEMENTARY
VerDate jul<14>2003
17:19 Mar 08, 2005
Jkt 205001
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS code 111)
• Animal production (NAICS code
112)
• Food manufacturing (NAICS code
311)
• Pesticide manufacturing (NAICS
code 32532)
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed underFOR FURTHER
INFORMATION CONTACT.
PO 00000
Frm 00038
Fmt 4700
Sfmt 4700
B. How Can I Access Electronic Copies
of this Document and Other Related
Information?
In addition to using EDOCKET (http:/
/www.epa.gov/edocket/), you may
access this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of
40 CFR part 180 is available at E-CFR
Beta Site Two at https://
www.gpoaccess.gov/ecfr/. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines athttps://www.epa.gpo/
opptsfrs/home/guidelin.htm/.
II. Background and Statutory Findings
In the Federal Register of November
17, 2004 (69 FR 67351) (FRL–7686–6),
EPA issued a notice pursuant to section
408(d)(3) of the FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of
pesticide petitions (PP 1F3989, 1F3995,
and 2F4154) by Dow AgroSciences,
LLC, 9330 Zionsville Road,
Indianapolis, IN 46268. The petitions
requested that 40 CFR 180.480 be
amended by establishing a tolerance for
combined residues of the fungicide
fenbuconazole [alpha-[2-(4chlorophenyl)-ethyl]-alpha-phenyl-3(1H-1,2,4-triazole)-1-propanenitrile] and
its metabolites cis- andtrans-5-(4chlorophenyl)-dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3Hfuranone, in or on banana (whole fruit)
at 0.3 parts per million (ppm) (2F4154);
fruit, stone, group 12 (except plum,
prune) at 2.0 ppm (1F3989); pecan at 0.1
ppm (1F3995). This notice included a
summary of the petition prepared by
Dow AgroSciences, LLC, the registrant.
The tolerances will expire on
December 31, 2008.
Comments were received in response
to the notice of filing from one
individual. These comments are
addressed in Unit IV.C.
Section 408(b)(2)(A)(i) of the FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of the FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of the FFDCA requires EPA
to give special consideration to
E:\FR\FM\09MRR1.SGM
09MRR1
]]>Agencies
[Federal Register Volume 70, Number 45 (Wednesday, March 9, 2005)]
[Rules and Regulations]
[Pages 11563-11572]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4335]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0022; FRL-7699-8]
Clofentezine; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
clofentezine in or on grapes and persimmons. Makhteshim-Agan of North
America, Inc. and the Interregional Research Project Number 4 (IR-4)
requested these tolerances 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 March 9, 2005. Objections and
requests for hearings must be received on or before May 9, 2005.
ADDRESSES: To submit a written objection or hearing request, follow
the detailed instructions as provided in Unit VI of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number OPP-2005-0022. All documents in the docket
are listed in the EDOCKET index at https://www.epa.gov/edocket. Although
listed in the index, some information is not publicly available, i.e.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed on
the Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Room 119, Crystal Mall 2, 1801 S.
Bell Street, Arlington, VA 22202-4501. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Carmen Rodia, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001; telephone
number: (703) 306-0327; fax number: (703) 305-6596; e-mail address:
rodia.carmen@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 11564]]
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 and Other
Related Information?
In addition to using EDOCKET (https://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.
To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines athttps://www.epa.gov/opptsfrs/home/
guidelin.htm/.
II. Background and Statutory Findings
In the Federal Register of July 12, 2000 (65 FR 43004) (FRL-6591-
8), 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
0F6119) by Aventis CropScience, 2 T.W. Alexander Drive, Research
Triangle Park, NC 27709. The petition requested that 40 CFR 180.446 be
amended by establishing a tolerance for residues of the miticide
clofentezine [(3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine), in or on
grapes at 0.35 parts per million (ppm). Subsequently, Aventis
CropScience sold all proprietary rights for clofentezine to Makhteshim-
Agan of North America, Inc., 551 Fifth Avenue, Suite 1100, New York, NY
10176. Further, in the Federal Register of August 27, 2004 (69 FR
52688) (FRL-7676-3), EPA issued a similar notice announcing the filing
of a pesticide petition (PP 4E6824) by the Interregional Research
Project Number 4 (IR-4), 681 U.S. Highway 1 South, North Brunswick, NJ
08902, requesting that 40 CFR 180.446 be amended by establishing a
tolerance for residues of clofentezine, in or on persimmons at 0.05
ppm. These notices included a summary of the petitions prepared by the
registrants. In order to harmonize with existing Codex maximum residue
limits (MRLs) for grapes, the proposed tolerance level for grapes was
subsequently revised to 1.0 ppm. There were no substantive comments
received in response to these notices.
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 FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
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 clofentezine per se
on grapes at 1.0 ppm and on persimmons at 0.05 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. The nature of the toxic effects caused by clofentezine are
discussed below in Table 1 as well as the no observed adverse effect
level (NOAEL) and the lowest observed adverse effect level (LOAEL) from
the toxicity studies reviewed.
Table 1.--Subchronic and Chronic Toxicity Profile of Clofentezine
Technical.
------------------------------------------------------------------------
Guideline No. Study Type Results
------------------------------------------------------------------------
870.3100 90-Day subchronic Incorporated into
feeding toxicity, the 2-year mouse
mouse oncogenicity
study.
------------------------------------------------------
870.3100 90-Day subchronic NOAEL (systemic):
feeding toxicity, 2.0 mg/kg/day
rat LOAEL (systemic):
20.0 mg/kg/day
based on
increased
cholesterol
levels, liver-to-
body weight
ratios, liver
weights, and
centrilobular
hepatocellular
enlargement.
------------------------------------------------------
870.3150 90-Day subchronic NOAEL was not
feeding, established.
nonrodent (dog) LOAEL (systemic):
<80.0 mg/kg/day
based on
increased liver
weights in both
sexes and
electrocardiograp
hic changes in
females.
------------------------------------------------------
[[Page 11565]]
870.3700 Prenatal Maternal NOAEL:
Developmental 1,280 mg/kg/day
Toxicity, Rat (above the Limit
Dose of 1,000 mg/
kg/day)
Maternal LOAEL:
3,200 mg/kg/day
based on
differential
staining and
slight
enlargement of
the centrilobular
hepatocytes.
Developmental
NOAEL: >3,200 mg/
kg/day (above the
Limit Dose)
Developmental
LOAEL: >3,200 mg/
kg/day (above the
Limit Dose)
------------------------------------------------------
870.3700 Prenatal Maternal NOAEL:
Developmental 1,000 mg/kg/day
Toxicity, Rabbit (Limit Dose)
Maternal LOAEL:
3,000 mg/kg/day
based on
decreased body
weight and food
consumption.
Developmental
NOAEL: 1,000 mg/
kg/day (Limit
Dose)
Developmental
LOAEL: 3,000 mg/
kg/day based on
decreased mean
fetal weight.
------------------------------------------------------
870.3800 2-Generation Parental/Systemic
Reproductive and NOAEL: >=20.0 mg/
Fertility kg/day
Effects, Rat Parental/Systemic
LOAEL: >20.0 mg/
kg/day
Reproductive
NOAEL: >=20.0 mg/
kg/day
Reproductive
LOAEL: >20.0 mg/
kg/day
Offspring NOAEL:
>=20.0 mg/kg/day
Offspring LOAEL:
>20.0 mg/kg/day
------------------------------------------------------
870.4100 Chronic Feeding NOAEL (systemic):
Toxicity, 1.25 mg/kg/day
Nonrodent (Dog) LOAEL (systemic):
25.0 mg/kg/day
based on
increased liver
weights,
hepatocellular
enlargement, and
increased serum
cholesterol,
triglycerides,
and alkaline
phosphatase
levels.
------------------------------------------------------
870.4200 Chronic NOAEL (systemic):
Carcinogenicity 50.70 mg/kg/day
(Feeding), Mouse LOAEL (systemic):
543.0 mg/kg/day
based on
decreased body
weights and body
weight gains,
increased
incidence of
eosinophilic
areas in
hepatocytes of
males. In
females,
increased
incidence of
basophilic and/or
eosinophilic foci
or areas of
hepatocyte
alterations,
mortality with
amyloidosis as a
contributing
factor for
increased
mortality. No
evidence of
carcinogenicity.
------------------------------------------------------
870.4300 Combined Chronic NOAEL (systemic):
Feeding Toxicity/ 1.72 mg/kg/day
Carcinogenicity LOAEL (systemic):
Study, Rat 17.3 mg/kg/day
based on
increased liver
weights and liver-
to-body weight
ratios and
increased
thyroxin levels;
and centrilobular
hepatocellular
hypertrophy and
vacuolation,
focal cystic
degeneration of
hepatocytes, and
diffuse
distribution of
fat deposits in
liver (M).
Evidence of
carcinogenicity
in male rats
[thyroid tumors].
------------------------------------------------------
870.5200 Mouse Lymphoma Non-mutagenic
()
activation.
------------------------------------------------------
870.5250 Gene Mutation, Non-mutagenic
Salmonella ()
activation.
------------------------------------------------------
870.5395 In vitro Mammalian Non-mutagenic.
Cytogenetics Test
(Erythocyte
Micronucleus
Assay), Mice
------------------------------------------------------
870.5450 Rodent Dominant Non-mutagenic.
Lethal Assay, Rat
------------------------------------------------------
870.5575 Mitotic Gene Non-mutagenic and
Conversion in negative for
Saccharomyces mitotic
cerevisiae recombination.
------------------------------------------------------
870.7485 General Male and female
Metabolism, Rat rats given
clofentezine
technical at
1,000 mg/kg
manifested peak
plasma levels of
between 14 and 16
ppm at 6-8 hours
post-dosing which
then declined to
3 ppm at 24 hours
post-dosing.
Plasma half-life
was approximately
3.5 hours. Whole
body
autoradiography
of rats given a
10 mg/kg dose
indicated poor
gastrointestinal
absorption with
60-70% of the
given dose
excreted in the
feces during the
first 24 hours
and about 20%
excreted in the
urine. Major
metabolites were
3-(2'-methyl-thio-
3' hydroxy
phenyl)-6-(2'-
chloro-phenyl)-
1,2,4,5-tetrazine
and 3-,4-, and 5-
hydroxyclofentezi
ne. Both liver
and kidney had
the highest
tissue
concentration
after 72 hours.
------------------------------------------------------------------------
[[Page 11566]]
B. Toxicological Endpoints
The dose at which 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 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. An UF of 100 is routinely
used, 10x to account for interspecies differences and 10x for
intraspecies differences.
Three other types of safety or uncertainty factors may be used: The
``traditional uncertainty factor;'' the ``special FQPA safety factor;''
and the ``default FQPA safety factor.'' By the term ``traditional
uncertainty factor,'' EPA is referring to those additional uncertainty
factors used prior to FQPA passage to account for database
deficiencies. These traditional uncertainty factors have been
incorporated by the FQPA into the additional safety factor for the
protection of infants and children. The term ``special FQPA safety
factor'' refers to those safety factors that are deemed necessary for
the protection of infants and children primarily as a result of the
FQPA. The ``default FQPA safety factor'' is the additional 10x safety
factor that is mandated by the statute unless it is decided that there
are reliable data to choose a different additional factor (potentially
a ``traditional uncertainty factor'' or a ``special FQPA safety
factor'').
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of
100 to account for interspecies and intraspecies differences and any
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF).
Where a special FQPA safety factor or the default FQPA safety factor is
used, this additional factor is applied to the RfD by dividing the RfD
by such additional factor. The acute or chronic Population Adjusted
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this
type of safety factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10x
to account for interspecies differences and 10x for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk). An example of how such a probability risk is expressed
would be to describe the risk as one in one hundred thousand (1 x
10-\5\), one in a million (1 x 10-\6\), or one in
ten million (1 x 10-\7\). Under certain specific
circumstances, MOE calculations will be used for the carcinogenic risk
assessment. In this non-linear approach, a ``point of departure'' is
identified below which carcinogenic effects are not expected. The point
of departure is typically a NOAEL based on an endpoint related to
cancer effects though it may be a different value derived from the dose
response curve. To estimate risk, a ratio of the point of departure to
exposure (MOEcancer = point of departure/exposures) is
calculated.
In general, clofentezine has low acute toxicity by the oral, dermal
and inhalation routes of exposure (Categories III and IV) although mild
eye irritation has been observed in rabbits. No appropriate
toxicological endpoint (effect) attributable to a single exposure
(dose) was identified in any study including the available oral studies
in the rat and developmental studies in the rat and rabbit; therefore,
an acute RfD was not established and no risk is expected from acute
exposure. Long-term dermal exposure and risk is not expected, based on
the current use pattern. In addition, based on the overall low toxicity
of clofentezine, there is minimal concern for short-, intermediate-,
and long-term inhalation exposure and risk. A summary of the
toxicological endpoints used for the clofentezine human health risk
assessment is shown below in Table 2.
Table 2.--Summary of Toxicological Dose and Endpoints for Clofentezine 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
----------------------------------------------------------------------------------------------------------------
Chronic Dietary NOAEL= 1.25 mg/kg/day Special FQPA SF = 1x Chronic Feeding
(General U.S. Population including UF = 100............... cPAD = chronic RfD..... Toxicity, Nonrodent
infants and children). Chronic RfD =.......... Special FQPA SF = 0.013 (Dog)
0.013 mg/kg/day........ mg/kg/day. LOAEL = 25.0 mg/kg/day
....................... based on
histopathology in the
liver and elevated
serum cholesterol,
triglycerides, and
alkaline phosphatase
observed at the LOAEL.
----------------------------------------------------------------
Short-Term Dermal Oral study NOAEL = 2 mg/ LOC for MOE = 90-Day subchronic
(1 to 30 days)....................... kg/day 100 (Residential)...... feeding toxicity, Rat
(Residential)........................ (dermal absorption rate LOAEL = 20 mg/kg/day
= 1%). based on increased
cholesterol, increased
liver weights, thyroid
colloid depletion and
thyroid follicular
cell hypertrophy.
----------------------------------------------------------------
Intermediate-Term Dermal Oral study NOAEL = 2 mg/ LOC for MOE = 90-Day Subchronic
(1 to 6 months)...................... kg/day 100 (Residential)...... Feeding Toxicity, Rat
(Residential)........................ (dermal absorption rate LOAEL = 20 mg/kg/day
= 1%). based on increased
cholesterol, increased
liver weights, thyroid
colloid depletion and
thyroid follicular
cell hypertrophy.
----------------------------------------------------------------------------------------------------------------
[[Page 11567]]
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.446) for the residues of clofentezine per se,
in or on a variety of raw agricultural commodities (RACs).
Specifically, tolerances for clofentezine are established for almonds,
apples, apricots, cherries, nectarines, peaches, pears, and walnuts.
Risk assessments were conducted by EPA to assess dietary exposures from
clofentezine in food as follows:
i. Acute exposure. As discussed in Unit III.B, an acute dietary
exposure assessment was not performed because an endpoint of concern
attributable to a single oral dose was not selected for any population
subgroup (including infants and children).
ii. Chronic exposure. In conducting the chronic and cancer dietary
(food only) exposure assessments for clofentezine, EPA used the Dietary
Exposure Evaluation Model software with the Food Commodity Intake
Database (DEEM-FCID\TM\), Version 2.03, and the Lifeline\TM\Model,
Version 2.0, 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 and cancer dietary exposure assessments: The Agency has
determined that clofentezine per se and the 3-(2-chloro-4-
hydroxyphenyl)-6-(2-chlorophenyl)-1,2,4,5-tetrazine metabolite are the
residues of concern for the chronic dietary analysis. The chronic
dietary analysis for clofentezine was based on anticipated residue
levels (ARs) in the form of average field trial residue values, and the
analysis included estimates for percent crop treated (PCT).
iii. Cancer. As explained in Unit III.C.1.ii above, the Agency
assessed cancer dietary exposure for clofentezine using the same
assumptions used for chronic dietary exposure. Cancer risk is
determined for the general U.S. population only. The estimated exposure
of the general U.S. population to clofentezine is 0.000023 mg/kg/day.
iv. Anticipated residue and 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
(food only) 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:
For existing uses, the Agency used estimates of PCT for the chronic
dietary (food only) risk assessment, which was determined using USDA's
National Agricultural Statistics Service (NASS) usage data and EPA 2003
proprietary usage data (DOANE 2003). Table 3 below displays the chronic
PCT estimates used for the existing uses of clofentezine. When the PCT
for a commodity is estimated as <1%, the PCT used for risk assessment
purposes is 1%.
Table 3.--Clofentezine Estimates of Percent Crop Treated for Existing
Uses.
------------------------------------------------------------------------
Commodity Percent Crop Treated
------------------------------------------------------------------------
Almonds <1
------------------------------------------------------------------------
Apples 5
------------------------------------------------------------------------
Apricots 5
------------------------------------------------------------------------
Cherries <1
------------------------------------------------------------------------
Nectarines 10
------------------------------------------------------------------------
Peaches 5
------------------------------------------------------------------------
Pears 5
------------------------------------------------------------------------
Prunes & Plums <1
------------------------------------------------------------------------
Walnuts <1
------------------------------------------------------------------------
For the new uses, the Agency used PCT estimates for the chronic
dietary (food only) risk assessment based on ``screening level'' usage
data for agricultural crops. This information was retrieved from 1998-
2003 USDA National Agricultural Statistics Service (NASS) usage data
and EPA 2003 proprietary usage data (DOANE 2003) for the historically,
most widely used miticide for control of pests for each crop. The 2003
NASS data were compared to the DOANE 2003 data, both yielded similar
results and did not make a difference. As a result of this comparison,
the highest, most conservative PCT estimate for each crop was used for
the chronic dietary (food only) risk assessment. These highly
conservative estimates should not underestimate actual usage of
clofentezine on the new crops/sites. Some of these numbers may be based
on information that does not cover all 50 states; therefore, it is
possible that if the remaining (usually minor states for the crop) had
been included, the quantity (pounds) of active ingredient would be
slightly higher.
To further support the reliability of these PCT estimates, as a
condition of registration, the registrant will be required to agree to
report annually on the market share attained for the new uses for which
clofentezine is registered. As a condition of registration, they will
also be required to agree to mitigate dietary risk as deemed
appropriate by the Agency should the market share data raise a concern
for increased dietary risk. The Agency will then compare that market
share information with the PCT estimates used to evaluate potential
dietary risk. In those instances where percent market share is
approaching or exceeding the predicted PCT estimate used in the
Agency's risk assessment, EPA will conduct a new dietary risk
assessment to evaluate the new dietary risk. If the market share data
raise a concern for increased pesticide risk, the Agency will act to
mitigate that dietary risk and
[[Page 11568]]
could employ several approaches, including but not limited to
production caps, geographical limitations, removal of uses, or other
means deemed appropriate by the Agency. Table 4 below displays the
chronic PCT estimates used for the new uses of clofentezine. When the
PCT for a commodity is estimated as <1%, the PCT used for risk
assessment purposes is 1%.
Table 4.--Clofentezine Estimates of Percent Crop Treated for New Uses.
------------------------------------------------------------------------
Commodity Percent Crop Treated
------------------------------------------------------------------------
Grapes 13
------------------------------------------------------------------------
Persimmons <1
------------------------------------------------------------------------
The Agency believes that the three conditions listed in this Unit
have been met. With respect to Condition 1, PCT estimates are derived
from Federal and private market survey data, which are reliable and
have a valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. As to Conditions 2 and 3, regional consumption information
and consumption information for significant subpopulations is taken
into account through EPA's computer-based model for evaluating the
exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group, and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available information on the regional consumption of food to
which clofentezine may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for clofentezine 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 clofentezine.
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) to
produce estimates of pesticide concentrations in an index reservoir.
The SCI-GROW model is used to predict pesticide concentrations in
shallow ground water. For a screening-level assessment for surface
water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a
tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that
uses a specific high-end runoff scenario for pesticides. Both FIRST and
PRZM/EXAMS incorporate an index reservoir environment, and both models
include a percent crop area factor as an adjustment to account for the
maximum percent crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a screen for sorting out pesticides for which it is
unlikely that drinking water concentrations would exceed human health
levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs), which are the model estimates of a
pesticide's concentration in water. EECs derived from these models are
used to quantify drinking water exposure and risk as a %RfD or %PAD.
Instead, drinking water levels of comparison (DWLOCs) are calculated
and used as a point of comparison against the model estimates of a
pesticide's concentration in water. DWLOCs are theoretical upper limits
on a pesticide's concentration in drinking water in light of total
aggregate exposure to a pesticide in food, and from residential uses.
Since DWLOCs address total aggregate exposure to clofentezine, they are
further discussed in the aggregate risk sections in Unit III.E.
Based on the FIRST and SCI-GROW models, the EECs of clofentezine
for acute exposures are estimated to be 4.2 parts per billion (ppb) for
surface water and 0.1 ppb for ground water. The EECs for chronic
exposures are estimated to be 0.2 ppb for surface water and 0.1 ppb for
ground water.
3. From nondietary exposure. The term ``residential exposure'' is
used in this document to refer to nonoccupational, nondietary exposure
(e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Clofentezine is not
registered for use on any sites that would result in residential
exposure. Therefore, a residential exposure assessment was not
conducted.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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 clofentezine and any other
substances and clofentezine 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 clofentezine 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 OPP concerning
common mechanism determinations and procedures for cumulating effects
from substances found to have a common mechanism on EPA's web site 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 database 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
an MOE analysis or through using uncertainty (safety) factors in
calculating a dose
[[Page 11569]]
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 an
increased susceptibility of rat or rabbit fetuses/pups to in utero and/
or postnatal exposure in the developmental and reproductive toxicity
studies.
3. Conclusion. EPA has determined that there are reliable data
supporting removal of the additional 10x factor for the protection of
infants and children. This decision was based on the following
conclusions:
i. The toxicology database is complete;
ii. There is no indication of increased susceptibility of rats or
rabbit fetuses/pups [quantitatively or qualitatively] to in utero and/
or postnatal exposure to clofentezine in the developmental and
reproductive toxicity studies;
iii. A developmental neurotoxicity study (DNT) is not required;
iv. Exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures; and
v. There are currently no registered residential uses of
clofentezine.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against EECs. DWLOC values are
not regulatory standards for drinking water. A DWLOC is a theoretical
upper limit on a pesticide's concentration in drinking water in light
of total aggregate exposure to a pesticide in food, drinking water, and
through residential uses. In calculating a DWLOC, the Agency determines
how much of the acceptable exposure (i.e., the PAD) is available for
exposure through drinking water (e.g., allowable chronic water exposure
(mg/kg/day) = cPAD - (average food + residential exposure)). This
allowable exposure through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxicological endpoint, drinking
water consumption, and body weights. Default body weights and
consumption values as used by the EPA's Office of Water are used to
calculate DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult
female), and 1L/10 kg (child). Default body weights and drinking water
consumption values vary on an individual basis. This variation will be
taken into account in more refined screening-level and quantitative
drinking water exposure assessments. Different populations will have
different DWLOCs. Generally, a DWLOC is calculated for each type of
risk assessment used: Acute, short-term, intermediate-term, chronic,
and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
Human health aggregate risk assessments have been conducted for the
chronic and cancer (food + drinking water) exposure scenarios. An acute
aggregate risk assessment was not performed because an endpoint of
concern attributable to a single oral dose was not identified for any
population subgroup (including infants and children). Short-,
intermediate- and long-term aggregate risk assessments were not
performed because there are no registered or proposed residential uses
for clofentezine. All potential exposure pathways were assessed in the
aggregate risk assessment. All aggregate exposure and risk estimates do
not exceed EPA's LOC for the chronic and cancer (food + drinking water)
exposure scenarios.
1. Acute risk. As discussed in Unit III.E., clofentezine is not
expected to pose an acute risk because an endpoint of concern
attributable to a single oral dose was not identified for any
population subgroup (including infants and children).
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
clofentezine from food will utilize 0.1% of the cPAD for the general
U.S. population, 0.3% of the cPAD for all infants (<1 year old), and
0.4% of the cPAD for children (1-2 years old). There are no residential
uses for clofentezine that result in chronic residential exposure to
clofentezine. In addition, there is potential for chronic dietary
exposure to clofentezine in drinking water. After calculating DWLOCs
and comparing them to the EECs for surface and ground water, EPA does
not expect the aggregate exposure to exceed 100% of the cPAD, as shown
below in Table 5.
Table 5. --Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Clofentezine.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface Water EEC/ Ground/Water EEC/
Population/Subgroup cPAD/mg/kg/day %/cPAD/(Food) (ppb) (ppb) Chronic/DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
General U.S. population 0.013................. 0.1................... 0.2.................. 0.1.................. 450
-------------------------------------------------------------
All infants (<1 year old) 0.013................. 0.3................... 0.2.................. 0.1.................. 130
-------------------------------------------------------------
Children (1-2 years old) 0.013................. 0.4................... 0.2.................. 0.1.................. 130
-------------------------------------------------------------
Females (13-49 years old) 0.013................. 0.1................... 0.2.................. 0.1.................. 390
--------------------------------------------------------------------------------------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Clofentezine 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 LOC.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Clofentezine
is not
[[Page 11570]]
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 LOC.
5. Aggregate cancer risk for U.S. population. In conducting the
aggregate cancer risk assessment, only food and drinking water pathways
of exposure were considered. At this time, there are no uses for
clofentezine that would result in any non-occupational, non-dietary
exposure (i.e., there are no dermal or inhalation routes of exposure
that should be included in an aggregate assessment). The cancer risk
from exposure to clofentezine residues in food was calculated as 4.31 x
10-\7\. This is below EPA's level of concern for cancer risk
(risks in the range of one in a million). A DWLOC was derived for the
general U.S. population based on EPA's LOC for cancer or a risk in the
range of one in one million (using the value of 1 x 10-\6\
as a first Tier value in calculating a conservative estimate of DWLOC
that is consistent with the range of one in one million). The DWLOC is
compared to the EECs of clofentezine in surface and ground water and is
used to determine whether or not aggregate cancer exposures are likely
to result in risk estimates that exceed EPA's LOC. Table 6 below
summarizes the cancer aggregate exposure estimates to clofentezine
residues.
Table 6.--Aggregate Risk Assessment for Cancer Exposure to Clofentezine.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface
Maximum Exposure (mg/ Food Exposure (mg/kg/ Maximum Water Ground/Water EEC/ Water
Population/Subgroup kg/day) day) Exposure (mg/kg/day) Cancer DWLOC (ppb) (ppb) EEC/
(ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
General U.S. Population 2.66 x 10-\5\ 1.1 x 10-\5\ 1.56 x 10-\5\ 0.6 0.1 0.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
The EECs calculated for ground and surface water are less than
EPA's calculated cancer DWLOC. Therefore, the cancer aggregate risk
associated with the proposed use of clofentezine does not exceed EPA's
level of concern for the general U.S. population and all population
subgroups.
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 U.S. population, and to infants and children, from
aggregate exposure to clofentezine residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
A high-performance liquid chromatography (HPLC) analytical method
exists for the determination of clofentezine residues. A petition
method validation (PMV) was successfully completed by the analytical
chemistry laboratory (ACL), and the method was found acceptable. The
limit of quantitation (LOQ) and limit of detection (LOD) reported were
0.01 ppm and 0.003 ppm, respectively. The Agency concluded that the
method was suitable for enforcement purposes. The method was forwarded
to FDA for inclusion in Pesticide Analytical Manual (PAM)-Volume II.
PAM-Volume I multiresidue methods are not acceptable for tolerance
enforcement.
Adequate enforcement methodology (example --gas chromatography) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Road, Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
B. International Residue Limits
Codex MRLs exist for clofentezine on grapes. The Codex MRLs for
grapes and the U.S. tolerances established for clofentezine on grapes
by this rule are harmonized at 1.0 ppm. No Codex MRLs exist for
clofentezine on persimmons.
V. Conclusion
Therefore, tolerances are established for residues of clofentezine
per se, (3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine), in or on grapes at
1.0 ppm and persimmons at 0.05 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2005-0022 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 May 9,
2005.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th Street, NW.,
Washington, DC 20005-3419. The
[[Page 11571]]
Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A, you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2005-0022, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hea
