Acetic acid, [(5-chloro-8-quinolinyl) oxy]-, 1-methylhexyl ester (Cloquintocet-mexyl); Pesticide Tolerance, 74679-74688 [05-24097]
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PART 165—REGULATED NAVIGATION
AREAS AND LIMITED ACCESS AREAS
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David P. Pekoske,
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[FR Doc. 05–24135 Filed 12–15–05; 8:45 am]
BILLING CODE 4910–15–P
Authority: 33 U.S.C. 1226 and 1231; 46
U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33
CFR 1.05–1(g), 6.04–1, 6.04–6, and 160.5;
Pub. L. 107–295, 116 Stat. 2064; Department
of Homeland Security Delegation No. 0170.1.
ENVIRONMENTAL PROTECTION
AGENCY
2. From 6 a.m. on November 29, 2005
until 11:59 p.m. on May 31, 2006, add
temporary § 165.T01–106 to read as
follows:
40 CFR Part 60
§ 165.T01–106 Regulated Navigation Area,
East Rockaway Inlet to Atlantic Beach
Bridge, Nassau County, Long Island, New
York.
CFR Correction
I
(a) Location. The following area is
established as a Regulated Navigation
Area: All waters of East Rockaway Inlet
in an area bounded by lines drawn from
the approximate position of the Silver
Point breakwater buoy (LLN 31500) at
40°34′56″ N, 073°45′19″ W, running
north to a point of land on the
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Standards of Performance for New
Stationary Sources
In title 40 of the Code of Federal
Regulations, Part 60 (§ 60.1 to End),
revised as of July 1, 2005, on page 167,
in § 60.41c, correct the definition of
‘‘Annual capacity factor’’ to read as
follows:
§ 60.41c
Definitions.
*
*
*
*
*
Annual capacity factor means the
ratio between the actual heat input to a
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steam generating unit from an
individual fuel or combination of fuels
during a period of 12 consecutive
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design heat input capacity. In the case
of steam generating units that are rented
or leased, the actual heat input shall be
determined based on the combined heat
input from all operations of the affected
facility during a period of 12
consecutive calendar months.
*
*
*
*
*
[FR Doc. 05–55521 Filed 12–15–05; 8:45 am]
BILLING CODE 1505–01–D
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2005–0234; FRL–7753–4]
Acetic acid, [(5-chloro-8-quinolinyl)
oxy]-, 1-methylhexyl ester
(Cloquintocet-mexyl); Pesticide
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: EPA is granting in part, and
denying in part, pesticide petition PP
4E6831 submitted by Syngenta Crop
Protection, Inc. that requested certain
amendments to 40 CFR 180.560 for
acetic acid [(5-chloro-8-quinolinyl) oxy], 1-methylhexyl ester; cloquintocetmexyl; CAS Reg. No. 99607–70–2] and
its acid metabolite (5-chloro-8quinolinoxyacetic acid). EPA issued a
notice pursuant to section 408(d)(3) of
FFDCA, 21 U.S.C. 346a(d)(3) in the
Federal Register of June 2, 2004 (69 FR
31116) (FRL–7357–8) announcing the
filing of this petition requesting that the
tolerance expressions under § 180.560
for wheat forage and hay be increased,
the addition of tolerances for barley
commodities (grain, hay, and straw),
and the inclusion of a reference to the
active ingredient pinoxaden. Although
EPA finds it is safe to add a reference
to pinoxaden and tolerances for barley
(grain, hay, and straw) to this tolerance
regulation, EPA does not agree that
grounds exist to increase the tolerance
expressions for wheat forage and hay.
Thus, EPA is granting Syngenta’s
petition in as far as it seeks to add the
reference pinoxaden and tolerances for
barley (grain, hay, and straw) but is
denying the request to increase the
tolerance expressions for wheat forage
and hay.
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Federal Register / Vol. 70, No. 241 / Friday, December 16, 2005 / Rules and Regulations
This final rule is effective
December 16, 2005. Objections and
requests for hearings must be received
on or before February 14, 2006.
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 EPA–HQ–
OPP–2005–0234. All documents in the
docket are listed on the https://
www.regulations.gov Web site.
(EDOCKET, EPA’s electronic public
docket and comment system was
replaced on November 25, 2005, by an
enhanced federal-wide electronic docket
management and comment system
located at https://www.regulations.gov.
Follow the on-line instructions.)
Although listed in the index, some
information is not publicly available,
i.e., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically in
EDOCKET or in hard copy at the Public
Information and Records Integrity
Branch (PIRIB), Rm. 119, Crystal Mall
#2, 1801 S. Bell St., Arlington, VA. This
docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays. The docket
telephone number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT: R.
Tracy Ward, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number: 703
308–9361; e-mail address:
ward.tracyh@epa.gov.
DATES:
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).
• Animal production (NAICS 112).
• Food manufacturing (NAICS 311).
• Pesticide manufacturing (NAICS
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
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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 at https://www.epa.gpo/
opptsfrs/home/guidelin.htm/.
II. Background and Statutory Findings
In the Federal Register of June 22,
2004 (69 FR 31116) (FRL–7357–8), 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 4E6831) by
Syngenta Crop Protection, Inc., P.O. Box
18300, Greensboro, North Carolina,
27419–8300. This notice included a
summary of the petition prepared by
Syngenta Crop Protection, Inc., the
petitioner. The petition requested that
40 CFR 180.560 for combined residues
of the inert ingredient herbicide safener
acetic acid, [(5-chloro-8-quinolinyl)
oxy]-, 1-methylhexyl ester and its acid
metabolite (5-chloro-8quinolinoxyacetic acid) be amended by:
1. Increasing the tolerance
expressions in or on wheat, forage to
0.20 ppm and wheat, hay to 0.50 ppm,
2. Adding tolerance expressions for
barley, grain, hay and straw at 0.10
ppm, and
3. By adding a reference to the active
ingredient pinoxaden.
For ease of reading this document,
acetic acid, [(5-chloro-8-quinolinyl)
oxy]-, 1-methylhexyl ester will be
referred to as cloquintocet-mexyl. The
Chemical Abstracts Service (CAS)
Registry Number of cloquintocet-mexyl
is 99607–70–2 and the CAS name is
acetic acid, [(5-chloro-8-quinolinyl)
oxy]-, 1-methylhexyl ester (9 CI).
One comment was received on the
notice of filing from a private citizen
questioning whether the Agency was
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going to use the most current and up-todate information and data available
when writing the final rule. In
developing the final rule, EPA did
evaluate the information and data
submitted by the petitioner as well as
more recent information that was
available to the Agency.
In the final rule that EPA used to
establish the existing tolerances under
40 CFR 180.560 (Federal Register of
June 22, 2000 (65 FR 38757; FRL–
6592-4; PP7E4920), EPA determined
that additional data (for plant and
livestock metabolism, plant analytical
methods, multiresidue methods, storage
stability, crop field trials, processing
studies, and rotational crops) were
required before a permanent registration
for cloquintocet-mexyl in or on wheat
commodities could be established.
Syngenta submitted data in response to
the previous risk assessment.
Assessments of human exposures and
risks were conducted for acute and
chronic dietary risk, exposure and risk
to cloquintocet-mexyl residues in water,
residential exposure and risk, aggregate
risk, and exposure and risk to workers.
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue....’’
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. For
further discussion of the regulatory
requirements of section 408 of the
FFDCA and a complete description of
the risk assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and
Determination of Safety
Consistent with section 408(b)(2)(D)
of FFDCA, EPA has reviewed the
available scientific data and other
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relevant information in support of this
action. EPA has sufficient data to assess
the hazards of and to make a
determination on aggregate exposure,
consistent with section 408(b)(2) of
FFDCA, for a tolerance for combined
residues of cloquintocet-mexyl and its
acid metabolite on wheat, grain and
straw at 0.10 ppm; wheat, forage at 0.20
ppm; wheat, hay at 0.50 ppm; barley,
grain at 0.01 ppm; and barley, hay and
straw at 0.10 ppm. EPA’s assessment of
exposures and risks associated with
establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the toxic effects caused by
cloquintocet-mexyl as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
are described in this section.
1. Acute toxicity. The acute toxicity
data (see Table 1) indicated that
cloquintocet-mexyl (CGA 185072) has
low acute oral, dermal, and inhalation
toxicity (Acute Toxicity Category III)
and is slightly irritating to eyes. It is not
a skin irritant. However, it is a skin
sensitizer.
TABLE 1.—ACUTE TOXICITY DATA ON
CLOQUINTOCET-MEXYL
GDLN
Study Type
Results
81–1
Acute Oral-Rat
LD50>2,000
mg/kg (M&F)
81–1
Acute OralMouse
LD50>2,000
mg/kg (M&F)
81–2
Acute DermalRat
LD50> 2,000
mg/kg
81–3
Acute Inhalation-Rat
LC50>0.935 µg/
L
81–4
Primary Eye Irritation-Rabbit
Slight eye irritant
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TABLE 1.—ACUTE TOXICITY DATA ON
CLOQUINTOCET-MEXYL—Continued
GDLN
Study Type
Results
81–5
Primary Skin
IrritationRabbit
Non-irritant
81–6
Dermal SensitizationGuinea pig
Skin sensitizer
2. Subchronic and chronic toxicity.
Available toxicity studies are described
in Table 2.
i. Systemic toxicity. The primary
target organs for subchronic exposure of
cloquintocet-mexyl (CGA 185072) are
the liver and the renal system. In a 90day feeding study in rats, increased
incidence of urinary bladder
hyperplasia and increased serum
bilirubin were observed in males at
doses ≥ 1,000 ppm (equivalent to 64 mg/
kg/day). This observation was supported
by a 28-day oral gavage study in rats
where renal papillary necrosis and
inflammation with fibrosis were
observed at doses ≥ 100 mg/kg/day. In
a 28-day dermal toxicity study in rats,
mottled or reddish livers accompanied
by histopathological changes including
necrosis and fibrosis were observed in
two of five females exposed to 1,000
mg/kg/day of cloquintocet-mexyl (CGA
185072). In a 90-day feeding study in
dogs, liver toxicity was evidenced by
observations of liver necrosis and
perivascular inflammatory cell
infiltration. In the one-year dog study,
increased relative liver weight and
increased chronic interstitial nephritis
were observed. It is notable that in the
two-year chronic toxicity study in rats,
no renal or liver toxicity was reported;
however, there was an increase in
lymphoid hyperplasia of the thymus in
male rats and an increase in thyroid
follicular epithelial hyperplasia in
female rats at 73 mg/kg/day.
ii. Developmental/reproductive
toxicity. There was no evidence of
developmental or reproductive toxicity
for cloquintocet-mexyl. The data
demonstrate no increased sensitivity of
rats or rabbits to in utero or early postnatal exposure to cloquintocet-mexyl
(CGA 185072). NOAELs for maternal/
parental toxicity were either less than or
equal to the NOAELs for fetal or
reproductive toxicity.
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iii. Carcinogenicity. In accordance
with the EPA Proposed EPA Weight-ofthe-Evidence Categories, August 1999
cloquintocet-mexyl was classified as not
likely to be a human carcinogen.
Carcinogenicity studies in rats and mice
did not show increased incidence of
spontaneous tumor formation. With
negative mutagenic test battery, it is
suggested that cloquintocet-mexyl (CGA
185072) is not likely to be a human
carcinogen.
iv. Mutagenicity. Studies indicate that
cloquintocet-mexyl is not mutagenic in
bacteria (Salmonella typhimurium or
Escherichia coli) or cultured
mammalian cells (Chinese hamster V79
lung fibroblasts). There is also no
evidence of clastogenicity either in vitro
or in vivo. Similarly, cloquintocet-mexyl
did not induce unscheduled DNA
synthesis (UDS) in primary rat
hepatocytes.
v. Neurotoxicity. There is no evidence
of neurotoxicity based on observations
in toxicity studies. Acute and
subchronic neurotoxicity studies are not
available for cloquintocet-mexyl;
additional neurotoxicity testing is not
being required at this time.
vi. Metabolism. Metabolism studies in
rats indicated that approximately 40%
of the administered dose of
cloquintocet-mexyl was absorbed
through the gastrointestinal tract and
subsequently excreted via the urine.
Fecal excretion accounted for
approximately 60% of the administered
dose. The chemical was rapidly
eliminated (more than 80% of the
administered dose) via feces and urine
within 48 hours post-dosing. Sex,
dosing regime, and dose levels had little
effect on the excretion pattern.
Excretion patterns were similar between
the biliary cannulated and noncannulated animals indicating that there
was no enterohepatic circulation of the
chemical. Three days after
administration, tissue radioactivity
accounted for less than 0.3% of the
administered dose (or was nondetectable) and was not detectable in
the expired air. At day three postdosing, most tissue residues of
radioactivity were below the limit of
detection. The major metabolic pathway
of cloquintocet-mexyl was ester
hydrolysis to yield 5-chloro-8quinolinoxy acetic acid, the major
metabolite in the fecal and urinary
pools.
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TABLE 2.—TOXICITY PROFILE SUMMARY TABLE FOR CLOQUINTOCET-MEXYL
Guideline No.
Study Type
Results
870.3100
28-Day oral in rodents
NOAEL = 10 mg/kg/day
LOAEL = 100 mg/kg/day based on microscopic kidney lesions
870.3100
28-Day oral in rodents.
NOAEL = 10 mg/kg/day (females only)
LOAEL = 400 mg/kg/day based on transient decrease in body weight
gain, microscopic alterations of the pituitary and thyroid and possibly
increased SGPT.
870.3100
13 week oral in rodents
NOAEL = M: 150 ppm (9.7 mg/kg), F= 6,000 ppm (=407 mg/kg/day).
LOAEL = M - 1,000 ppm (6.9 mg/kg); F ≥ 6,000 ppm (≥ 407 mg/kg/
day), based on urinary bladder hyperplasia, kidney hydronephrosis
and increased serum bilirubin in males.
870.3150
90-Day oral in non-rodent
NOAEL = 100 ppm (M: 2.9 mg/kg/day; F: 3.3 mg/kg/day).
LOAEL = 1,000 ppm (M and F: 30.2 mg /kg/day) based on
perivascular mixed inflammatory cell infiltrates and multicellular
multifocal necrosis of the liver and thymic atrophy
870.3200
28-Day dermal toxicity
NOAEL = 200 mg/kg/day
LOAEL = 1,000 mg/kg/day based on mottled or reddish livers accompanied by histopathological changes including necrosis and fibrosis
870.3700
Prenatal developmental in rodent
Maternal NOAEL = 100 mg/kg/day
LOAEL = 400 mg/kg/day based on clinical signs and decrease in body
weight gain and food consumption.
Developmental NOAEL = 100 mg/kg/day
LOAEL = 400 mg/kg/day based on the higher incidence of skeletal
variants and decrease in fetal body weights in the high dose group.
870.3700
Prenatal developmental in nonrodent
Maternal NOAEL = 60 mg/kg/day
Maternal LOAEL = 300 mg/kg/day based on maternal toxicity (death)
in the high dose group only.
Developmental NOAEL = 300 mg/kg/day
Developmental LOAEL ≥ 300 mg/kg/day
870.3800
2 Generation Reproduction
Parental/Systemic NOAEL = 5,000 ppm (M: 370.7; F: 442.8 mg/kg/
day)
Parental/Systemic LOAEL =10,000 ppm (M: 721.7 ; F: 846.9 mg/kg/
day), based on decreased body weight, deceased food consumption, and pathological changes in the kidney (dilated renal pelvis,
nephrolith, hydronephrosis, urethral constrictions) and urinary bladder (cytoliths, hyperemia, cystitis and urothelial hyperplasia).
Reproductive NOAEL = 10,000 ppm (721.7 mg/kg/day).
Reproductive LOAEL ≥ 10,000 ppm (721.7 mg/kg/day)
Developmental NOAEL = 5,000 ppm (442.8 mg/kg/day)
Developmental LOAEL = 10,000 (846.9 mg/kg/day) based on decreased pup weight and dilated renal pelvis.
870.4100
Chronic toxicity in nonrodent
NOAEL = 1500 ppm (M: 43, F: 45 mg/kg/day)
LOAEL = 15,000/10,000 ppm (M: 196 F:216 mg/kg/day) based on decreased body weight/weight gain and food consumption, anemia, increased serum iron, protein alterations, bone marrow hypoplasia
and possibly decreased testes/prostate weights and interstitial nephritis.
870.4200
Carcinogenicity in mice
NOAEL = 1,000 ppm (M: 111; F: 102 mg/kg/day)
LOAEL = 5,000 ppm (M: 583; F: 520 mg/kg/day) based on decreased
body weight/weight gain in both sexes, urinary bladder lesions
(chronic inflammation, ulceration, calculus and submucosa edema)
in males and possibly slightly increased water consumption in both
sexes.
Negative for oncogenicity.
870.4300
Combined chronic/oncogenicity in
rat
NOAEL = F: 100 ppm (4.3 mg/kg/day) M: 1,000 ppm (36.4 mg/kg/day)
LOAEL = F: 1,000 ppm (41.2 mg/kg/day); M: 2,000 ppm ( 81.5 mg/kg/
day) based on increased incidence of thyroid follicular epithelial
hyperplasia in females and based on lymphoid hyperplasia of the
thymus in males.
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74683
TABLE 2.—TOXICITY PROFILE SUMMARY TABLE FOR CLOQUINTOCET-MEXYL—Continued
Guideline No.
Study Type
Results
870.5100
Gene Mutation
Testing up to 5,000 µg/plate with or without S9 microsomes produced
no evidence that CGA 185072 technical induced a mutagenic effect
in any strain.
Negative mutagen
870.5200
Gene Mutation
There was no evidence mutagenic effect at any dose (up to 500 µg/
plate) with or without S9 activation.
Negative mutagen.
870.5315
Human Lymphocytes in vitro
Human lymphocytes were exposed in vitro up to 75 µg/mL with or
without S9 activation showed no evidence that CGA 185072 induced
a cytogenetic effects. at any dose.
Negative mutagen.
870.5395
Micronucleus Test
Chinese hamsters dosed from 625 to 2,500 mg/kg showed no evidence that CGA 185072 induced a clastogenic or aneugenic effect
in either sex at any dose or sacrifice time.
Negative mutagen.
870.5550
DNA Repair Human Fibroblasts
Cultured human fibrocytes were exposed in vitro to up to 60 µg/mL for
5 hrs. and scored for silver grains in the nucleus. There was no evidence that CGA 185072 technical in the absence of S9 activation induced a genotoxic response.
870.5550
DNA Repair Rat Hepatocytes
Primary rat hepatocytes expose to 200 µg/mL for 16-18 hour and
scored for nuclear grains showed no evidence that CGA 185072
technical induced a genotoxic response.
Negative mutagen.
870.7485
Metabolism and pharmacokinetics
Absorption after a single low oral dose (50 mg/kg bw), was between
40.2% (males) and 35.6% (females).
The major metabolite in the 0 to 24 hour fecal and urinary pools was
determined to be quinolinoxy acetic acid, reference material CGA
153433, accounting for approximately 95% of the recovered radioactivity.
870.7485
Metabolism and pharmacokinetics
The major metabolic pathway of CGA 185072 was determined to be
hydrolysis of the ester group, resulting in the formation of 5-chloro-8quinolinoxy acetic acid. The major metabolic pathway was not significantly affected by sex, dose level or dosing regime.
B. Toxicological Endpoints
A summary of the toxicological
endpoints for cloquintocet-mexyl used
for human risk assessment is shown
below in Table 3.
1. Acute dietary exposure. An acute
reference dose (RfD) was selected for the
subpopulation of females 13-50 years
old. This acute RfD of 1 mg/kg/day is
based on the no-observable-adverseeffect-level (NOAEL) of 100 mg/kg/day
selected from a developmental toxicity
in rats (MRID 44387429) where an
increased incidence of skeletal variants
and decreased fetal body weight was
observed at 400 mg/kg/day. [The
NOAEL of 100 mg/kg/day is divided by
uncertainty factors (UF) for inter-species
extrapolation (10x) and intra-species
variability (10x).] Based on the
conservative assumption that
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developmental toxicity could occur
following a single exposure to a
pregnant female, this endpoint is
appropriate for acute risk assessment for
females 13-50 years old.
An acute RfD for the general
population was not identified. Based on
the available toxicology data, toxic
effects observed in oral toxicity studies
could not be attributed to a single dose
(exposure) for population subgroups
other than females 13-50 years old. No
acute or subchronic neurotoxicity
studies are available for cloquintocetmexyl at this time. No other neurotoxic
effects were observed in available
toxicity studies. It is also noteworthy
that the acute oral LD50 for male and
female rats for technical grade
cloquintocet-mexyl (98% a.i.) is <2,000
mg/kg (Toxicity Category III).
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2. Chronic dietary exposure. The
Agency selected a chronic RfD of 0.04
mg/kg/day (NOAEL = 4.3 mg/kg/day;
Uncertainty Factor = 100). This chronic
RfD is based on a two year combined
chronic/oncogenicity study in rats
(MRID 44387431). In this study, the
NOAEL of 4.3 mg/kg/day was based on
increased incidence of thyroid follicular
epithelial hyperplasia in females at 41.2
mg/kg/day (lowest-observable-adverseeffect-level; LOAEL). The Uncertainty
Factor accounts for both interspecies
extrapolation (10X) and intraspecies
variability (10X). This study is
considered an appropriate study for
assessment of chronic dietary risk
because the endpoint is based on
chronic effects observed in thyroid
pathology.
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TABLE 3.—SUMMARY OF TOXICOLOGY ENDPOINT SELECTIONS FOR CLOQUINTOCET-MEXYL
EXPOSURE SCENARIO/STUDY
Acute Dietary(For females
mental toxicity study in rats
DOSE (mg/kg/day)
13+)/Develop-
ENDPOINT
NOAEL=100
(UF=100)
Higher incidence of skeletal variants and decrease in fetal body weights in the high
dose group at 400 mg/kg/day (LOAEL).
Acute RfD (females 13+) = 1.0 mg/kg/day
Acute Dietary(For general population)
Based on available data, a suitable endpoint
was not identified for general population
because there were no effects observed in
oral toxicity studies appropriate to this population that could be attributed to a single
dose exposure.
Acute RfD (general population) = Not applicable
Chronic Dietary/Chronic/Oncogenicity Toxicity
-Rat
NOAEL=4.3
(UF=100)
Observation of thyroid hyperplasia in females
at 41.2 mg/kg/day (LOAEL).
Chronic RfD = Chronic PAD = 0.04 mg/kg/
day
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Acute and chronic dietary
exposure assessments were conducted
using the Dietary Exposure Evaluation
Model software with the Food
Commodity Intake Database (DEEMFCIDTM, Version 2.02), which
incorporates consumption data from
USDA’s Continuing Surveys of Food
Intakes by Individuals (CSFII), 1994–
1996 and 1998. The 1994–96, and 98
data are based on the reported
consumption of more than 20,000
individuals over two non-consecutive
survey days. Foods as consumed (e.g.,
apple pie) are linked to EPA-defined
food commodities (e.g. apples, peeled
fruit - cooked; fresh or N/S; baked; or
wheat flour - cooked; fresh or N/S,
baked) using publicly available recipe
translation files developed jointly by
USDA/ARS and EPA. For chronic
exposure assessment, consumption data
are averaged for the entire U.S.
population and within population
subgroups, but for acute exposure
assessment are retained as individual
consumption events. Based on analysis
of the 1994–96, and 98 CSFII
consumption data, which took into
account dietary patterns and survey
respondents, the Agency concluded that
it is most appropriate to report risk for
the following population subgroups: the
general U.S. population, all infants (<1
year old), children 1-2, children 3-5,
children 6-12, youth 13-19, adults 2049, females 13-49, and adults 50+ years
old.
Established and recommended
tolerances were used in acute and
chronic dietary assessments. Percent
crop treated data were not applied.
DEEMTM default concentration factors
were used.
i. Acute exposure. The acute food
exposure analysis for cloquintocetmexyl is a Tier 1 assessment because no
additional data were used to refine the
analysis. One hundred percent of
proposed and registered crops are
assumed treated with cloquintocetmexyl (100% CT) and tolerance-level
residues were used in the analysis. The
acute dietary endpoint (incidence of
skeletal variants and decrease in fetal
body weights) is only applicable to the
population subgroup females 13-49
years old. An acute dietary endpoint for
the general population including infants
and children was not identified. The
highest estimate for acute drinking
water exposure, 0.186 ppb, was used in
the analysis. The estimated dietary
exposure for females 13-49 years old is
0.000347 mg/kg/day, which occupies
less than 1% of the aPAD and does not
exceed EPA’s level of concern.
ii. Chronic exposure. The chronic
dietary exposure analysis for
cloquintocet-mexyl is a Tier 1
assessment because no additional data
were used to refine the analysis. One
hundred percent of proposed and
registered crops are assumed treated
with cloquintocet-mexyl (100% CT) and
tolerance-level residues were used in
the analysis. The chronic dietary
endpoint applies to all population
subgroups including infants and
children. The highest estimate for
chronic drinking water exposure, 0.005
ppb, was used in the analysis. A listing
of the subgroups are reported below in
Table 4.
The results of the chronic dietary
analysis estimates exposure for the
general U.S. population, all infants < 1
year, children 6-12 years, youths 13-19
years, and adults 20+ years to be < 1%
of the cPAD. The estimated dietary
exposure for children 1-2 and 3-5 years
occupies 1% of the cPAD. Risk
estimates for all population subgroups
are below EPA’s level of concern (100%
of the cPAD).
TABLE 4.—RESULTS OF CHRONIC DIETARY EXPOSURE ANALYSIS
Population Subgroup
cPAD (mg/kg/day)
Exposure (mg/kg/day)
% cPAD
General U.S. Population
0.04
0.000180
<1
All Infants (< 1 year old)
0.04
0.000077
<1
Children 1-2 years old
0.04
0.000403
1
Children 3-5 years old
0.04
0.000411
1
Children 6-12 years old
0.04
0.000289
<1
Youth 13-19 years old
0.04
0.000176
<1
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74685
TABLE 4.—RESULTS OF CHRONIC DIETARY EXPOSURE ANALYSIS—Continued
Population Subgroup
cPAD (mg/kg/day)
Exposure (mg/kg/day)
% cPAD
Adults 20-49 years old
0.04
0.000153
<1
Adults 50+ years old
0.04
0.000120
<1
Females 13-49 years old
0.04
0.000137
<1
iii. Cancer. In August 1999, EPA
classified cloquintocet-mexyl as not
likely to be a human carcinogen. Due to
the classification, no quantitative cancer
exposure assessment was performed.
2. Dietary exposure from drinking
water. The mobility of cloquintocetmexyl (as measured by its binding to
soils) varies from low in a moderate
organic soil to essentially immobile in a
high organic soil. The persistence of
cloquintocet-mexyl in soil is very low.
Therefore, based upon the its low
persistence and low mobility, the
leaching potential of cloquintocet-mexyl
should be negligible. The results of the
aerobic aquatic metabolism studies
indicate that cloquintocet-mexyl will
rapidly degrade in aerobic ground and
surface waters that have adequate
microbial activity. The results of the
direct photolysis (DT50 of several
hours) indicate that cloquintocet-mexyl
is also susceptible to rapid rates of
direct photolysis in clear shallow water.
However, based on the results of the
abiotic hydrolysis study (half-lives of
4.4 yr. at pH 5, 134 days at pH 7 and
6.6 days at pH 9), it may be substantially
more persistent in aerobic waters with
low microbial activity. Data are not
currently available to assess its
persistence in anaerobic waters.
The Agency currently lacks sufficient
water-related exposure data from
monitoring to complete a quantitative
drinking water exposure analysis and
risk assessment for cloquintocet-mexyl.
Therefore, the Agency is presently
relying on computer-generated
estimated environmental concentrations
(EECs). GENEEC is a model used to
generate EECs for surface water based
on estimates of safener concentration in
a farm pond. SCI-GROW is an empirical
model based upon actual monitoring
data collected for a number of pesticides
which serve as benchmarks and has
been used to predict EECs in ground
water. The highest EECs from the
current and proposed uses were the
GENEEC estimates acute (peak) and
chronic (56-year mean) concentrations
of cloquintocet-mexyl and CGA–153433
in water at 0.186 ppb and 0.005 ppb,
respectively.
3. From non-dietary exposure. The
term residential exposure is used in this
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document to refer to non-occupational,
non-dietary exposure (e.g., for lawn and
garden pest control, indoor pest control,
termiticides, and flea and tick control
on pets).
Residential uses are not proposed in
this petition and there are no residential
uses registered for products in which
cloquintocet-mexyl serves as a safener,
and therefore, a residential exposure
assessment is not required.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of the FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider available
information concerning the cumulative
effects of a particular pesticide’s
residues and other substances that have
a common mechanism of toxicity.
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
cloquintocet-mexyl and any other
substances, and cloquintocet-mexyl
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 cloquintocet-mexyl has a
common mechanism of toxicity with
other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see the policy statements
released by EPA’s Office of Pesticide
Programs concerning common
mechanism determinations and
procedures for cumulating effects from
substances found to have a common
mechanism on EPA’s 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 data base on
toxicity and exposure unless EPA
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determines based on reliable data that a
different margin of safety will be safe for
infants and children. Margins of safety
are incorporated into EPA risk
assessments either directly through use
of a MOE analysis or through using
uncertainty (safety) factors in
calculating a dose level that poses no
appreciable risk to humans. In applying
this provision, EPA either retains the
default value of 10X when reliable data
do not support the choice of a different
factor, or, if reliable data are available,
EPA uses a different additional safety
factor value based on the use of
traditional uncertainty factors and/or
special FQPA safety factors, as
appropriate.
2. Conclusions. EPA concluded that
the FQPA safety factor could be
removed for cloquintocet-mexyl for the
following reasons. The toxicology
database is complete for cloquintocetmexyl. There is no indication of
quantitative or qualitative increased
susceptibility of rats or rabbits to in
utero and/or postnatal exposure to
cloquintocet-mexyl in the available
toxicity data, and EPA determined that
a developmental neurotoxicity study is
not required for cloquintocet-mexyl.
The dietary (food and drinking water)
exposure assessments will not
underestimate the potential exposures
for infants and children from the use of
cloquintocet-mexyl (currently there are
no proposed residential uses and
therefore non-occupational exposure is
not expected).
E. Aggregate Risks and Determination of
Safety
1. Acute risk. The aggregate acute risk
estimates include exposure to residues
of cloquintocet-mexyl in food and
water, and does not include dermal,
inhalation or incidental oral exposure.
Since the dietary exposure assessment
already includes the highest acute
exposure from the drinking water
modeling data, no further calculations
are necessary. The food and water
exposure estimates for females 13-49 yrs
old is <1% aPAD. The acute risk
estimate for females 13-49 years,
resulting from aggregate exposure to
cloquintocet-mexyl in food and drinking
water is below EPA’s level of concern.
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2. Short- and intermediate-term
aggregate risk (food + drinking water +
residential). These aggregate risk
assessments take into account chronic
dietary exposure from food and water
(considered to be a background
exposure level) plus (short- and/or
intermediate-term, as applicable) indoor
and outdoor residential exposures.
EPA selected doses and toxicological
endpoints for assessments of short- and
intermediate-term dermal and
inhalation risk. However, since there are
no residential uses for cloquintocetmexyl (either established or pending) at
this time, these risk assessments are not
needed.
3. Chronic aggregate risk. The
aggregate chronic risk assessment takes
into account average exposure estimates
from dietary consumption of
cloquintocet-mexyl (food and drinking
water) and residential uses. Since there
are no residential uses for cloquintocetmexyl (either established or pending) at
this time, the aggregate chronic
assessment included exposures from
food and drinking water only. Since the
dietary exposure assessment already
includes the highest chronic exposure
from the drinking water modeling data,
no further calculations are necessary.
The general U.S. population and all
population subgroups have exposure
and risk estimates which are below the
Agency’s level of concern (i.e., the
percentages of the chronic population
adjusted doses (cPADs) are all below
100%). The exposure to the U.S.
population is <1% cPAD and the most
highly exposed subgroup, children 3-5
yrs old is 1% cPAD. Therefore, chronic
risk estimates resulting from aggregate
exposure to cloquintocet-mexyl in food
and drinking water are below the
Agency’s level of concern from all
population subgroups.
4. Cancer aggregate risk. EPA has
concluded cloquintocet-mexyl is
unlikely to pose a cancer risk.
5. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, and to infants and children
from aggregate exposure to cloquintocetmexyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
1. Residue Analytical Methods.
Adequate enforcement methods are
available for enforcement of the
proposed/existing tolerances on wheat
and barley. The two enforcement
methods are the HPLC/UV method REM
138.01 for determination of
cloquintocet-mexyl (parent) and the
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HPLC/UV Method REM 138.10 for
determination of the metabolite CGA–
153433. Adequate EPA petition method
validations have been conducted on
wheat grain, straw, and forage for the
two enforcement methods. Both
methods have been forwarded to FDA
for publication in Pesticide Analytical
Manual, Vol. II. The validated LOQs for
Method REM 138.01 are 0.05 ppm for
wheat forage, hay, and straw, and 0.02
ppm for wheat grain, processed
commodities, and aspirated grain
fractions. The validated LOQ for
Method REM 138.10 is 0.05 ppm for all
wheat commodities.
Syngenta submitted analytical
Methods REM 199.02, REM 199.03, and
117-01 for analysis of residues of CGA–
153433, the metabolite of cloquintocetmexyl, in cereal grain matrices. Method
REM 199.02 was used to determine
residues of CGA–153433 in barley grain,
hay, and straw in one barley field trial
study (MRID 46203205) and in wheat
field trials conducted in Canada (MRID
46302206). Method 117–01 was used to
determine residues of CGA–153433 in
barley grain, hay, and straw in one
barley field trial study (MRID 46203204)
and in the barley grain and processed
commodities in the processing study
(MRID 46203204). All three methods
possessed the same extraction
procedure consisting of acid hydrolysis
(1N HCl) by boiling under reflux for two
hours. The acid hydrolysis is intended
to convert the parent cloquintocetmexyl (CGA–185072) to the acid
metabolite, CGA–153433; however,
validation/recovery data for CGA–
185072 was not provided. The three
methods are adequate for data gathering
methods for cloquintocet-mexyl in
cereal grain commodities.
Method REM 117–01 (MRID
46203138) is also proposed as an
enforcement method. To be an
enforcement method for cloquintocetmexyl, EPA’s analytical chemistry
laboratory (ACB/BEAD) would have to
validate the Method 117–01 for
cloquintocet-mexyl (CGA–185072) and
its metabolite CGA–153433 in cereal
matrices and radiovalidation data for
the method would have to be submitted.
This is not a deficiency for these
actions.
2. Multiresidue Methods.
Cloquintocet-mexyl and CGA–153433
were tested through the FDA
multiresidue methods according to the
decision tree and protocols in the
Pesticide Analytical Manual, Volume I,
Appendix II. Cloquintocet-mexyl was
tested per Protocols C, D, and E;
recovery was variable using protocol D,
and the test substance was not
recovered using Protocol E. CGA-153433
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was tested per Protocols B and C; the
compound was not recovered using
Protocol B, and based on the results of
Protocol C testing, no further testing was
required for this compound. The
submitted multiresidue methods data
have been forwarded to FDA.
B. International Residue Limits
There are no Codex tolerances
established for cloquintocet mexyl.
Australia has established maximum
residue limits (MRLs) for cloquintocetmexyl on wheat and barley at 0.1 ppm.
V. Conclusion
EPA has reviewed the data and
information submitted by the petitioner
in support of the establishment of
tolerances for the combined residues of
cloquintocet-mexyl and its acid
metabolite (5-chloro-8quinolinoxyacetic acid) in or on wheat
(grain, straw, forage, and hay) and
barley (grain, hay, and straw) as
required in the Federal Register of June
22, 2000 (65 FR 38757; FRL–6592–4).
The residue data show that residues
are not expected to exceed 0.01 ppm in
barley grain (LOQ) and 0.05 ppm in
barley hay and straw. The Agency will
establish permanent tolerances for the
combined residues of cloquintocetmexyl (acetic acid, [(5-chloro-8quniolinyl)oxy]-, 1-methylhexyl
ester)(CAS Reg. No. 99607–70–2) and its
acid metabolite (5-chloro-8quinlinoxyacetic acid), in/on barley
(straw, hay and grain) at 0.1 ppm.
The available data indicate that no
revisions to the current tolerance levels
of 0.1 ppm on wheat, forage and wheat,
hay are needed. EPA does not agree that
grounds exist to increase the tolerance
expressions for wheat forage and hay
because residues of cloquintocet-mexyl
will not exceed 0.1 ppm.
EPA established tolerances for the
combined residues of pinoxaden in or
on barley and wheat in the Federal
Register on July 27, 2005 (70 FR 43313)
(FRL–7725–5). Therefore, EPA is
granting Syngenta’s petition to allow the
use of the safener cloquintocet-mexyl
with pinoxaden in a 1:4 ratio of safener
to active ingredient in or on wheat
(grain, straw, forage, and hay) and
barley (grain, hay, and straw).
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
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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
EPA–HQ–OPP–2005–0234 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 February 14, 2006.
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 issue(s) on which a hearing
is requested, the requestor’s contentions
on such issues, and a summary of any
evidence relied upon by the objector (40
CFR 178.27). Information submitted in
connection with an objection or hearing
request may be claimed confidential by
marking any part or all of that
information as CBI. Information so
marked will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2. A copy of the
information that does not contain CBI
must be submitted for inclusion in the
public record. Information not marked
confidential may be disclosed publicly
by EPA without prior notice.
Mail your written request to: Office of
the Hearing Clerk (1900L),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001. You may also deliver
your request to the Office of the Hearing
Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of
the Hearing Clerk is open from 8 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Office of the Hearing
Clerk is (202) 564–6255.
2. Copies for the Docket. In addition
to filing an objection or hearing request
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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
EPA–HQ–OPP–2005–0234, to: Public
Information and Records Integrity
Branch, Information Technology and
Resource Management Division (7502C),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., 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 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
issue(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 a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this rule has
been exempted from review under
Executive Order 12866 due to its lack of
significance, this rule is not subject to
Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any
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74687
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. The Agency hereby
certifies that this rule will not have
significant negative economic impact on
a substantial number of small entities.
In addition, the Agency has determined
that this action will not have a
substantial direct effect on States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this rule
E:\FR\FM\16DER1.SGM
16DER1
74688
Federal Register / Vol. 70, No. 241 / Friday, December 16, 2005 / Rules and Regulations
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. 801et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of this final
rule in the Federal Register. This final
rule is not a ‘‘major rule’’ as defined by
5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: December 6, 2005.
Donald R. Stubbs,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—AMENDED
1. The authority citation for part 180
continues to read as follows:
I
VerDate Aug<31>2005
16:21 Dec 15, 2005
Jkt 208001
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.560 is amended by
revising paragraph (a) to read as follows:
I
§ 180.560 Cloquintocet-mexyl; tolerances
for residues.
(a) General. Tolerances are
established for the combined residues of
cloquintocet-mexyl (acetic acid, [(5chloro-8-quniolinyl)oxy]-, 1methylhexyl ester)(CAS No. 99607–70–
2) and its acid metabolite (5-chloro-8quinlinoxyacetic acid) when used as an
inert ingredient (safener) in pesticide
formulations containing the active
ingredients pinoxaden (wheat or barley)
or clodinafop-propargyl (wheat only) in
a 1:4 ratio of safener to active ingredient
in or on the following food
commodities:
Commodity
Parts per million
Barley, grain ...................
Barley, hay ......................
Barley, straw ...................
Wheat, forage .................
Wheat, grain ...................
Wheat, hay .....................
Wheat, straw ...................
*
*
*
*
0.1
0.1
0.1
0.1
0.1
0.1
0.1
*
[FR Doc. 05–24097 Filed 12–15–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2005–0276; FRL–7746–5]
Bifenazate; Pesticide Tolerances for
Emergency Exemptions
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
time-limited tolerances for combined
residues of bifenazate in or on tart
cherries and soybeans. This action is in
response to EPA’s granting of emergency
exemptions under section 18 of the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) authorizing
use of the pesticide on tart cherries and
soybeans. This regulation establishes
maximum permissible levels for
residues of bifenazate in these food
commodities. The tolerance will expire
and is revoked on December 31, 2009.
DATES: This regulation is effective
December 16, 2005. Objections and
requests for hearings must be received
on or before February 14, 2006.
ADDRESSES: To submit a written
objection or hearing request follow the
PO 00000
Frm 00050
Fmt 4700
Sfmt 4700
detailed instructions as provided in
Unit VII. of the SUPPLEMENTARY
INFORMATION. EPA has established a
docket for this action under Docket
identification (ID) number EPA–HQ–
OPP–2005–0276. All documents in the
docket are listed on the
www.regulations.gov web site.
(EDOCKET, EPA’s electronic public
docket and comment system was
replaced on November 25, 2005, by an
enhanced federal-wide electronic docket
management and comment system
located at https://www.regulations.gov/.
Follow the on-line instructions.)
Although listed in the index, some
information is not publicly available,
i.e., CBI or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically in
EDOCKET or in hard copy at the Public
Information and Records Integrity
Branch (PIRIB), Rm. 119, Crystal Mall
#2, 1801 S. Bell St., Arlington, VA. This
docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays. The docket
telephone number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Marcel Howard, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–6784; e-mail
address:howard.marcel@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS code 111)
• Animal production (NAICS code
112)
• Food manufacturing (NAICS code
311)
• Pesticide manufacturing (NAICS
code 32532)
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
E:\FR\FM\16DER1.SGM
16DER1
]]>Agencies
[Federal Register Volume 70, Number 241 (Friday, December 16, 2005)]
[Rules and Regulations]
[Pages 74679-74688]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-24097]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0234; FRL-7753-4]
Acetic acid, [(5-chloro-8-quinolinyl) oxy]-, 1-methylhexyl ester
(Cloquintocet-mexyl); Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is granting in part, and denying in part, pesticide
petition PP 4E6831 submitted by Syngenta Crop Protection, Inc. that
requested certain amendments to 40 CFR 180.560 for acetic acid [(5-
chloro-8-quinolinyl) oxy]-, 1-methylhexyl ester; cloquintocet-mexyl;
CAS Reg. No. 99607-70-2] and its acid metabolite (5-chloro-8-
quinolinoxyacetic acid). EPA issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3) in the Federal Register of
June 2, 2004 (69 FR 31116) (FRL-7357-8) announcing the filing of this
petition requesting that the tolerance expressions under Sec. 180.560
for wheat forage and hay be increased, the addition of tolerances for
barley commodities (grain, hay, and straw), and the inclusion of a
reference to the active ingredient pinoxaden. Although EPA finds it is
safe to add a reference to pinoxaden and tolerances for barley (grain,
hay, and straw) to this tolerance regulation, EPA does not agree that
grounds exist to increase the tolerance expressions for wheat forage
and hay. Thus, EPA is granting Syngenta's petition in as far as it
seeks to add the reference pinoxaden and tolerances for barley (grain,
hay, and straw) but is denying the request to increase the tolerance
expressions for wheat forage and hay.
[[Page 74680]]
DATES: This final rule is effective December 16, 2005. Objections and
requests for hearings must be received on or before February 14, 2006.
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 EPA-HQ-OPP-2005-0234. All documents in the
docket are listed on the https://www.regulations.gov Web site. (EDOCKET,
EPA's electronic public docket and comment system was replaced on
November 25, 2005, by an enhanced federal-wide electronic docket
management and comment system located at https://www.regulations.gov.
Follow the on-line instructions.) Although listed in the index, some
information is not publicly available, i.e., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
electronically in EDOCKET or in hard copy at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
docket telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: R. Tracy Ward, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: 703 308-9361; e-mail address: ward.tracyh@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).
Animal production (NAICS 112).
Food manufacturing (NAICS 311).
Pesticide manufacturing (NAICS 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (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 at https://www.epa.gpo/opptsfrs/home/guidelin.htm/.
II. Background and Statutory Findings
In the Federal Register of June 22, 2004 (69 FR 31116) (FRL-7357-
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
4E6831) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro,
North Carolina, 27419-8300. This notice included a summary of the
petition prepared by Syngenta Crop Protection, Inc., the petitioner.
The petition requested that 40 CFR 180.560 for combined residues of the
inert ingredient herbicide safener acetic acid, [(5-chloro-8-
quinolinyl) oxy]-, 1-methylhexyl ester and its acid metabolite (5-
chloro-8-quinolinoxyacetic acid) be amended by:
1. Increasing the tolerance expressions in or on wheat, forage to
0.20 ppm and wheat, hay to 0.50 ppm,
2. Adding tolerance expressions for barley, grain, hay and straw at
0.10 ppm, and
3. By adding a reference to the active ingredient pinoxaden.
For ease of reading this document, acetic acid, [(5-chloro-8-
quinolinyl) oxy]-, 1-methylhexyl ester will be referred to as
cloquintocet-mexyl. The Chemical Abstracts Service (CAS) Registry
Number of cloquintocet-mexyl is 99607-70-2 and the CAS name is acetic
acid, [(5-chloro-8-quinolinyl) oxy]-, 1-methylhexyl ester (9 CI).
One comment was received on the notice of filing from a private
citizen questioning whether the Agency was going to use the most
current and up-to-date information and data available when writing the
final rule. In developing the final rule, EPA did evaluate the
information and data submitted by the petitioner as well as more recent
information that was available to the Agency.
In the final rule that EPA used to establish the existing
tolerances under 40 CFR 180.560 (Federal Register of June 22, 2000 (65
FR 38757; FRL-6592[dash]4; PP7E4920), EPA determined that additional
data (for plant and livestock metabolism, plant analytical methods,
multiresidue methods, storage stability, crop field trials, processing
studies, and rotational crops) were required before a permanent
registration for cloquintocet-mexyl in or on wheat commodities could be
established. Syngenta submitted data in response to the previous risk
assessment. Assessments of human exposures and risks were conducted for
acute and chronic dietary risk, exposure and risk to cloquintocet-mexyl
residues in water, residential exposure and risk, aggregate risk, and
exposure and risk to workers.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see https://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other
[[Page 74681]]
relevant information in support of this action. EPA has sufficient data
to assess the hazards of and to make a determination on aggregate
exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance
for combined residues of cloquintocet-mexyl and its acid metabolite on
wheat, grain and straw at 0.10 ppm; wheat, forage at 0.20 ppm; wheat,
hay at 0.50 ppm; barley, grain at 0.01 ppm; and barley, hay and straw
at 0.10 ppm. EPA's assessment of exposures and risks associated with
establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by cloquintocet-mexyl as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are described in this
section.
1. Acute toxicity. The acute toxicity data (see Table 1) indicated
that cloquintocet-mexyl (CGA 185072) has low acute oral, dermal, and
inhalation toxicity (Acute Toxicity Category III) and is slightly
irritating to eyes. It is not a skin irritant. However, it is a skin
sensitizer.
Table 1.--Acute Toxicity Data on Cloquintocet-mexyl
------------------------------------------------------------------------
GDLN Study Type Results
------------------------------------------------------------------------
81-1 Acute Oral-Rat LD50>2,000 mg/kg
(M&F)
---------------------------------
81-1 Acute Oral-Mouse LD50>2,000 mg/kg
(M&F)
---------------------------------
81-2 Acute Dermal-Rat LD50> 2,000 mg/kg
---------------------------------
81-3 Acute Inhalation- LC50>0.935 [mu]g/L
Rat
---------------------------------
81-4 Primary Eye Slight eye
Irritation-Rabbit irritant
---------------------------------
81-5 Primary Skin Non-irritant
Irritation-Rabbit
---------------------------------
81-6 Dermal Skin sensitizer
Sensitization-
Guinea pig
------------------------------------------------------------------------
2. Subchronic and chronic toxicity. Available toxicity studies are
described in Table 2.
i. Systemic toxicity. The primary target organs for subchronic
exposure of cloquintocet-mexyl (CGA 185072) are the liver and the renal
system. In a 90-day feeding study in rats, increased incidence of
urinary bladder hyperplasia and increased serum bilirubin were observed
in males at doses >= 1,000 ppm (equivalent to 64 mg/kg/day). This
observation was supported by a 28-day oral gavage study in rats where
renal papillary necrosis and inflammation with fibrosis were observed
at doses >= 100 mg/kg/day. In a 28-day dermal toxicity study in rats,
mottled or reddish livers accompanied by histopathological changes
including necrosis and fibrosis were observed in two of five females
exposed to 1,000 mg/kg/day of cloquintocet-mexyl (CGA 185072). In a 90-
day feeding study in dogs, liver toxicity was evidenced by observations
of liver necrosis and perivascular inflammatory cell infiltration. In
the one-year dog study, increased relative liver weight and increased
chronic interstitial nephritis were observed. It is notable that in the
two-year chronic toxicity study in rats, no renal or liver toxicity was
reported; however, there was an increase in lymphoid hyperplasia of the
thymus in male rats and an increase in thyroid follicular epithelial
hyperplasia in female rats at 73 mg/kg/day.
ii. Developmental/reproductive toxicity. There was no evidence of
developmental or reproductive toxicity for cloquintocet-mexyl. The data
demonstrate no increased sensitivity of rats or rabbits to in utero or
early post-natal exposure to cloquintocet-mexyl (CGA 185072). NOAELs
for maternal/parental toxicity were either less than or equal to the
NOAELs for fetal or reproductive toxicity.
iii. Carcinogenicity. In accordance with the EPA Proposed EPA
Weight-of-the-Evidence Categories, August 1999 cloquintocet-mexyl was
classified as not likely to be a human carcinogen. Carcinogenicity
studies in rats and mice did not show increased incidence of
spontaneous tumor formation. With negative mutagenic test battery, it
is suggested that cloquintocet-mexyl (CGA 185072) is not likely to be a
human carcinogen.
iv. Mutagenicity. Studies indicate that cloquintocet-mexyl is not
mutagenic in bacteria (Salmonella typhimurium or Escherichia coli) or
cultured mammalian cells (Chinese hamster V79 lung fibroblasts). There
is also no evidence of clastogenicity either in vitro or in vivo.
Similarly, cloquintocet-mexyl did not induce unscheduled DNA synthesis
(UDS) in primary rat hepatocytes.
v. Neurotoxicity. There is no evidence of neurotoxicity based on
observations in toxicity studies. Acute and subchronic neurotoxicity
studies are not available for cloquintocet-mexyl; additional
neurotoxicity testing is not being required at this time.
vi. Metabolism. Metabolism studies in rats indicated that
approximately 40% of the administered dose of cloquintocet-mexyl was
absorbed through the gastrointestinal tract and subsequently excreted
via the urine. Fecal excretion accounted for approximately 60% of the
administered dose. The chemical was rapidly eliminated (more than 80%
of the administered dose) via feces and urine within 48 hours post-
dosing. Sex, dosing regime, and dose levels had little effect on the
excretion pattern. Excretion patterns were similar between the biliary
cannulated and non-cannulated animals indicating that there was no
enterohepatic circulation of the chemical. Three days after
administration, tissue radioactivity accounted for less than 0.3% of
the administered dose (or was non-detectable) and was not detectable in
the expired air. At day three post-dosing, most tissue residues of
radioactivity were below the limit of detection. The major metabolic
pathway of cloquintocet-mexyl was ester hydrolysis to yield 5-chloro-8-
quinolinoxy acetic acid, the major metabolite in the fecal and urinary
pools.
[[Page 74682]]
Table 2.--Toxicity Profile Summary Table for Cloquintocet-mexyl
------------------------------------------------------------------------
Guideline No. Study Type Results
------------------------------------------------------------------------
870.3100 28-Day oral in NOAEL = 10 mg/kg/
rodents day
LOAEL = 100 mg/kg/
day based on
microscopic kidney
lesions
--------------------------------
870.3100 28-Day oral in NOAEL = 10 mg/kg/
rodents. day (females only)
LOAEL = 400 mg/kg/
day based on
transient decrease
in body weight
gain, microscopic
alterations of the
pituitary and
thyroid and
possibly increased
SGPT.
--------------------------------
870.3100 13 week oral in NOAEL = M: 150 ppm
rodents (9.7 mg/kg), F=
6,000 ppm (=407 mg/
kg/day).
LOAEL = M - 1,000
ppm (6.9 mg/kg); F
>= 6,000 ppm (>=
407 mg/kg/day),
based on urinary
bladder
hyperplasia,
kidney
hydronephrosis and
increased serum
bilirubin in
males.
--------------------------------
870.3150 90-Day oral in non- NOAEL = 100 ppm (M:
rodent 2.9 mg/kg/day; F:
3.3 mg/kg/day).
LOAEL = 1,000 ppm
(M and F: 30.2 mg
kg/day) based on
perivascular mixed
inflammatory cell
infiltrates and
multicellular
multifocal
necrosis of the
liver and thymic
atrophy
--------------------------------
870.3200 28-Day dermal NOAEL = 200 mg/kg/
toxicity day
LOAEL = 1,000 mg/kg/
day based on
mottled or reddish
livers accompanied
by
histopathological
changes including
necrosis and
fibrosis
--------------------------------
870.3700 Prenatal Maternal NOAEL =
developmental in 100 mg/kg/day
rodent LOAEL = 400 mg/kg/
day based on
clinical signs and
decrease in body
weight gain and
food consumption.
Developmental NOAEL
= 100 mg/kg/day
LOAEL = 400 mg/kg/
day based on the
higher incidence
of skeletal
variants and
decrease in fetal
body weights in
the high dose
group.
--------------------------------
870.3700 Prenatal Maternal NOAEL = 60
developmental in mg/kg/day
nonrodent Maternal LOAEL =
300 mg/kg/day
based on maternal
toxicity (death)
in the high dose
group only.
Developmental NOAEL
= 300 mg/kg/day
Developmental LOAEL
>= 300 mg/kg/day
--------------------------------
870.3800 2 Generation Parental/Systemic
Reproduction NOAEL = 5,000 ppm
(M: 370.7; F:
442.8 mg/kg/day)
Parental/Systemic
LOAEL =10,000 ppm
(M: 721.7 ; F:
846.9 mg/kg/day),
based on decreased
body weight,
deceased food
consumption, and
pathological
changes in the
kidney (dilated
renal pelvis,
nephrolith,
hydronephrosis,
urethral
constrictions) and
urinary bladder
(cytoliths,
hyperemia,
cystitis and
urothelial
hyperplasia).
Reproductive NOAEL
= 10,000 ppm
(721.7 mg/kg/day).
Reproductive LOAEL
>= 10,000 ppm
(721.7 mg/kg/day)
Developmental NOAEL
= 5,000 ppm (442.8
mg/kg/day)
Developmental LOAEL
= 10,000 (846.9 mg/
kg/day) based on
decreased pup
weight and dilated
renal pelvis.
--------------------------------
870.4100 Chronic toxicity NOAEL = 1500 ppm
in nonrodent (M: 43, F: 45 mg/
kg/day)
LOAEL = 15,000/
10,000 ppm (M: 196
F:216 mg/kg/day)
based on decreased
body weight/weight
gain and food
consumption,
anemia, increased
serum iron,
protein
alterations, bone
marrow hypoplasia
and possibly
decreased testes/
prostate weights
and interstitial
nephritis.
--------------------------------
870.4200 Carcinogenicity in NOAEL = 1,000 ppm
mice (M: 111; F: 102 mg/
kg/day)
LOAEL = 5,000 ppm
(M: 583; F: 520 mg/
kg/day) based on
decreased body
weight/weight gain
in both sexes,
urinary bladder
lesions (chronic
inflammation,
ulceration,
calculus and
submucosa edema)
in males and
possibly slightly
increased water
consumption in
both sexes.
Negative for
oncogenicity.
--------------------------------
870.4300 Combined chronic/ NOAEL = F: 100 ppm
oncogenicity in (4.3 mg/kg/day) M:
rat 1,000 ppm (36.4 mg/
kg/day)
LOAEL = F: 1,000
ppm (41.2 mg/kg/
day); M: 2,000 ppm
( 81.5 mg/kg/day)
based on increased
incidence of
thyroid follicular
epithelial
hyperplasia in
females and based
on lymphoid
hyperplasia of the
thymus in males.
--------------------------------
[[Page 74683]]
870.5100 Gene Mutation Testing up to 5,000
[mu]g/plate with
or without S9
microsomes
produced no
evidence that CGA
185072 technical
induced a
mutagenic effect
in any strain.
Negative mutagen
--------------------------------
870.5200 Gene Mutation There was no
evidence mutagenic
effect at any dose
(up to 500 [mu]g/
plate) with or
without S9
activation.
Negative mutagen.
--------------------------------
870.5315 Human Lymphocytes Human lymphocytes
in vitro were exposed in
vitro up to 75
[mu]g/mL with or
without S9
activation showed
no evidence that
CGA 185072 induced
a cytogenetic
effects. at any
dose.
Negative mutagen.
--------------------------------
870.5395 Micronucleus Test Chinese hamsters
dosed from 625 to
2,500 mg/kg showed
no evidence that
CGA 185072 induced
a clastogenic or
aneugenic effect
in either sex at
any dose or
sacrifice time.
Negative mutagen.
--------------------------------
870.5550 DNA Repair Human Cultured human
Fibroblasts fibrocytes were
exposed in vitro
to up to 60 [mu]g/
mL for 5 hrs. and
scored for silver
grains in the
nucleus. There was
no evidence that
CGA 185072
technical in the
absence of S9
activation induced
a genotoxic
response.
--------------------------------
870.5550 DNA Repair Rat Primary rat
Hepatocytes hepatocytes expose
to 200 [mu]g/mL
for 16-18 hour and
scored for nuclear
grains showed no
evidence that CGA
185072 technical
induced a
genotoxic
response.
Negative mutagen.
--------------------------------
870.7485 Metabolism and Absorption after a
pharmacokinetics single low oral
dose (50 mg/kg
bw), was between
40.2% (males) and
35.6% (females).
The major
metabolite in the
0 to 24 hour fecal
and urinary pools
was determined to
be quinolinoxy
acetic acid,
reference material
CGA 153433,
accounting for
approximately 95%
of the recovered
radioactivity.
--------------------------------
870.7485 Metabolism and The major metabolic
pharmacokinetics pathway of CGA
185072 was
determined to be
hydrolysis of the
ester group,
resulting in the
formation of 5-
chloro-8-
quinolinoxy acetic
acid. The major
metabolic pathway
was not
significantly
affected by sex,
dose level or
dosing regime.
------------------------------------------------------------------------
B. Toxicological Endpoints
A summary of the toxicological endpoints for cloquintocet-mexyl
used for human risk assessment is shown below in Table 3.
1. Acute dietary exposure. An acute reference dose (RfD) was
selected for the subpopulation of females 13-50 years old. This acute
RfD of 1 mg/kg/day is based on the no-observable-adverse-effect-level
(NOAEL) of 100 mg/kg/day selected from a developmental toxicity in rats
(MRID 44387429) where an increased incidence of skeletal variants and
decreased fetal body weight was observed at 400 mg/kg/day. [The NOAEL
of 100 mg/kg/day is divided by uncertainty factors (UF) for inter-
species extrapolation (10x) and intra-species variability (10x).] Based
on the conservative assumption that developmental toxicity could occur
following a single exposure to a pregnant female, this endpoint is
appropriate for acute risk assessment for females 13-50 years old.
An acute RfD for the general population was not identified. Based
on the available toxicology data, toxic effects observed in oral
toxicity studies could not be attributed to a single dose (exposure)
for population subgroups other than females 13-50 years old. No acute
or subchronic neurotoxicity studies are available for cloquintocet-
mexyl at this time. No other neurotoxic effects were observed in
available toxicity studies. It is also noteworthy that the acute oral
LD50 for male and female rats for technical grade
cloquintocet-mexyl (98% a.i.) is <2,000 mg/kg (Toxicity Category III).
2. Chronic dietary exposure. The Agency selected a chronic RfD of
0.04 mg/kg/day (NOAEL = 4.3 mg/kg/day; Uncertainty Factor = 100). This
chronic RfD is based on a two year combined chronic/oncogenicity study
in rats (MRID 44387431). In this study, the NOAEL of 4.3 mg/kg/day was
based on increased incidence of thyroid follicular epithelial
hyperplasia in females at 41.2 mg/kg/day (lowest-observable-adverse-
effect-level; LOAEL). The Uncertainty Factor accounts for both
interspecies extrapolation (10X) and intraspecies variability (10X).
This study is considered an appropriate study for assessment of chronic
dietary risk because the endpoint is based on chronic effects observed
in thyroid pathology.
[[Page 74684]]
Table 3.--Summary of Toxicology Endpoint Selections for Cloquintocet-
mexyl
------------------------------------------------------------------------
EXPOSURE SCENARIO/STUDY DOSE (mg/kg/day) ENDPOINT
------------------------------------------------------------------------
Acute Dietary(For females 13+)/ NOAEL=100 Higher incidence
Developmental toxicity study in (UF=100).......... of skeletal
rats variants and
decrease in fetal
body weights in
the high dose
group at 400 mg/
kg/day (LOAEL).
Acute RfD (females
13+) = 1.0 mg/kg/
day
---------------------------------
Acute Dietary(For general Based on available Acute RfD (general
population) data, a suitable population) = Not
endpoint was not applicable
identified for
general
population
because there
were no effects
observed in oral
toxicity studies
appropriate to
this population
that could be
attributed to a
single dose
exposure.
---------------------------------
Chronic Dietary/Chronic/ NOAEL=4.3 Observation of
Oncogenicity Toxicity -Rat (UF=100).......... thyroid
hyperplasia in
females at 41.2
mg/kg/day
(LOAEL).
Chronic RfD =
Chronic PAD =
0.04 mg/kg/day
------------------------------------------------------------------------
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Acute and chronic
dietary exposure assessments were conducted using the Dietary Exposure
Evaluation Model software with the Food Commodity Intake Database
(DEEM-FCID\TM\, Version 2.02), which incorporates consumption data from
USDA's Continuing Surveys of Food Intakes by Individuals (CSFII), 1994-
1996 and 1998. The 1994-96, and 98 data are based on the reported
consumption of more than 20,000 individuals over two non-consecutive
survey days. Foods as consumed (e.g., apple pie) are linked to EPA-
defined food commodities (e.g. apples, peeled fruit - cooked; fresh or
N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using
publicly available recipe translation files developed jointly by USDA/
ARS and EPA. For chronic exposure assessment, consumption data are
averaged for the entire U.S. population and within population
subgroups, but for acute exposure assessment are retained as individual
consumption events. Based on analysis of the 1994-96, and 98 CSFII
consumption data, which took into account dietary patterns and survey
respondents, the Agency concluded that it is most appropriate to report
risk for the following population subgroups: the general U.S.
population, all infants (<1 year old), children 1-2, children 3-5,
children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+
years old.
Established and recommended tolerances were used in acute and
chronic dietary assessments. Percent crop treated data were not
applied. DEEM\TM\ default concentration factors were used.
i. Acute exposure. The acute food exposure analysis for
cloquintocet-mexyl is a Tier 1 assessment because no additional data
were used to refine the analysis. One hundred percent of proposed and
registered crops are assumed treated with cloquintocet-mexyl (100% CT)
and tolerance-level residues were used in the analysis. The acute
dietary endpoint (incidence of skeletal variants and decrease in fetal
body weights) is only applicable to the population subgroup females 13-
49 years old. An acute dietary endpoint for the general population
including infants and children was not identified. The highest estimate
for acute drinking water exposure, 0.186 ppb, was used in the analysis.
The estimated dietary exposure for females 13-49 years old is 0.000347
mg/kg/day, which occupies less than 1% of the aPAD and does not exceed
EPA's level of concern.
ii. Chronic exposure. The chronic dietary exposure analysis for
cloquintocet-mexyl is a Tier 1 assessment because no additional data
were used to refine the analysis. One hundred percent of proposed and
registered crops are assumed treated with cloquintocet-mexyl (100% CT)
and tolerance-level residues were used in the analysis. The chronic
dietary endpoint applies to all population subgroups including infants
and children. The highest estimate for chronic drinking water exposure,
0.005 ppb, was used in the analysis. A listing of the subgroups are
reported below in Table 4.
The results of the chronic dietary analysis estimates exposure for
the general U.S. population, all infants < 1 year, children 6-12 years,
youths 13-19 years, and adults 20+ years to be < 1% of the cPAD. The
estimated dietary exposure for children 1-2 and 3-5 years occupies 1%
of the cPAD. Risk estimates for all population subgroups are below
EPA's level of concern (100% of the cPAD).
Table 4.--Results of Chronic Dietary Exposure Analysis
----------------------------------------------------------------------------------------------------------------
Population Subgroup cPAD (mg/kg/day) Exposure (mg/kg/day) % cPAD
----------------------------------------------------------------------------------------------------------------
General U.S. Population 0.04 0.000180 <1
--------------------------------------------------
All Infants (< 1 year old) 0.04 0.000077 <1
--------------------------------------------------
Children 1-2 years old 0.04 0.000403 1
--------------------------------------------------
Children 3-5 years old 0.04 0.000411 1
--------------------------------------------------
Children 6-12 years old 0.04 0.000289 <1
--------------------------------------------------
Youth 13-19 years old 0.04 0.000176 <1
--------------------------------------------------
[[Page 74685]]
Adults 20-49 years old 0.04 0.000153 <1
--------------------------------------------------
Adults 50+ years old 0.04 0.000120 <1
--------------------------------------------------
Females 13-49 years old 0.04 0.000137 <1
----------------------------------------------------------------------------------------------------------------
iii. Cancer. In August 1999, EPA classified cloquintocet-mexyl as
not likely to be a human carcinogen. Due to the classification, no
quantitative cancer exposure assessment was performed.
2. Dietary exposure from drinking water. The mobility of
cloquintocet-mexyl (as measured by its binding to soils) varies from
low in a moderate organic soil to essentially immobile in a high
organic soil. The persistence of cloquintocet-mexyl in soil is very
low. Therefore, based upon the its low persistence and low mobility,
the leaching potential of cloquintocet-mexyl should be negligible. The
results of the aerobic aquatic metabolism studies indicate that
cloquintocet-mexyl will rapidly degrade in aerobic ground and surface
waters that have adequate microbial activity. The results of the direct
photolysis (DT50 of several hours) indicate that cloquintocet-mexyl is
also susceptible to rapid rates of direct photolysis in clear shallow
water. However, based on the results of the abiotic hydrolysis study
(half-lives of 4.4 yr. at pH 5, 134 days at pH 7 and 6.6 days at pH 9),
it may be substantially more persistent in aerobic waters with low
microbial activity. Data are not currently available to assess its
persistence in anaerobic waters.
The Agency currently lacks sufficient water-related exposure data
from monitoring to complete a quantitative drinking water exposure
analysis and risk assessment for cloquintocet-mexyl. Therefore, the
Agency is presently relying on computer-generated estimated
environmental concentrations (EECs). GENEEC is a model used to generate
EECs for surface water based on estimates of safener concentration in a
farm pond. SCI-GROW is an empirical model based upon actual monitoring
data collected for a number of pesticides which serve as benchmarks and
has been used to predict EECs in ground water. The highest EECs from
the current and proposed uses were the GENEEC estimates acute (peak)
and chronic (56-year mean) concentrations of cloquintocet-mexyl and
CGA-153433 in water at 0.186 ppb and 0.005 ppb, respectively.
3. From non-dietary exposure. The term residential exposure is used
in this document to refer to non-occupational, non-dietary exposure
(e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Residential uses are not proposed in this petition and there are no
residential uses registered for products in which cloquintocet-mexyl
serves as a safener, and therefore, a residential exposure assessment
is not required.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider available information concerning the cumulative effects
of a particular pesticide's residues and other substances that have a
common mechanism of toxicity.
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to cloquintocet-mexyl and any
other substances, and cloquintocet-mexyl 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 cloquintocet-
mexyl has a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's 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 data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Conclusions. EPA concluded that the FQPA safety factor could be
removed for cloquintocet-mexyl for the following reasons. The
toxicology database is complete for cloquintocet-mexyl. There is no
indication of quantitative or qualitative increased susceptibility of
rats or rabbits to in utero and/or postnatal exposure to cloquintocet-
mexyl in the available toxicity data, and EPA determined that a
developmental neurotoxicity study is not required for cloquintocet-
mexyl. The dietary (food and drinking water) exposure assessments will
not underestimate the potential exposures for infants and children from
the use of cloquintocet-mexyl (currently there are no proposed
residential uses and therefore non-occupational exposure is not
expected).
E. Aggregate Risks and Determination of Safety
1. Acute risk. The aggregate acute risk estimates include exposure
to residues of cloquintocet-mexyl in food and water, and does not
include dermal, inhalation or incidental oral exposure. Since the
dietary exposure assessment already includes the highest acute exposure
from the drinking water modeling data, no further calculations are
necessary. The food and water exposure estimates for females 13-49 yrs
old is <1% aPAD. The acute risk estimate for females 13-49 years,
resulting from aggregate exposure to cloquintocet-mexyl in food and
drinking water is below EPA's level of concern.
[[Page 74686]]
2. Short- and intermediate-term aggregate risk (food + drinking
water + residential). These aggregate risk assessments take into
account chronic dietary exposure from food and water (considered to be
a background exposure level) plus (short- and/or intermediate-term, as
applicable) indoor and outdoor residential exposures.
EPA selected doses and toxicological endpoints for assessments of
short- and intermediate-term dermal and inhalation risk. However, since
there are no residential uses for cloquintocet-mexyl (either
established or pending) at this time, these risk assessments are not
needed.
3. Chronic aggregate risk. The aggregate chronic risk assessment
takes into account average exposure estimates from dietary consumption
of cloquintocet-mexyl (food and drinking water) and residential uses.
Since there are no residential uses for cloquintocet-mexyl (either
established or pending) at this time, the aggregate chronic assessment
included exposures from food and drinking water only. Since the dietary
exposure assessment already includes the highest chronic exposure from
the drinking water modeling data, no further calculations are
necessary. The general U.S. population and all population subgroups
have exposure and risk estimates which are below the Agency's level of
concern (i.e., the percentages of the chronic population adjusted doses
(cPADs) are all below 100%). The exposure to the U.S. population is <1%
cPAD and the most highly exposed subgroup, children 3-5 yrs old is 1%
cPAD. Therefore, chronic risk estimates resulting from aggregate
exposure to cloquintocet-mexyl in food and drinking water are below the
Agency's level of concern from all population subgroups.
4. Cancer aggregate risk. EPA has concluded cloquintocet-mexyl is
unlikely to pose a cancer risk.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to cloquintocet-mexyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
1. Residue Analytical Methods. Adequate enforcement methods are
available for enforcement of the proposed/existing tolerances on wheat
and barley. The two enforcement methods are the HPLC/UV method REM
138.01 for determination of cloquintocet-mexyl (parent) and the HPLC/UV
Method REM 138.10 for determination of the metabolite CGA-153433.
Adequate EPA petition method validations have been conducted on wheat
grain, straw, and forage for the two enforcement methods. Both methods
have been forwarded to FDA for publication in Pesticide Analytical
Manual, Vol. II. The validated LOQs for Method REM 138.01 are 0.05 ppm
for wheat forage, hay, and straw, and 0.02 ppm for wheat grain,
processed commodities, and aspirated grain fractions. The validated LOQ
for Method REM 138.10 is 0.05 ppm for all wheat commodities.
Syngenta submitted analytical Methods REM 199.02, REM 199.03, and
117-01 for analysis of residues of CGA-153433, the metabolite of
cloquintocet-mexyl, in cereal grain matrices. Method REM 199.02 was
used to determine residues of CGA-153433 in barley grain, hay, and
straw in one barley field trial study (MRID 46203205) and in wheat
field trials conducted in Canada (MRID 46302206). Method 117-01 was
used to determine residues of CGA-153433 in barley grain, hay, and
straw in one barley field trial study (MRID 46203204) and in the barley
grain and processed commodities in the processing study (MRID
46203204). All three methods possessed the same extraction procedure
consisting of acid hydrolysis (1N HCl) by boiling under reflux for two
hours. The acid hydrolysis is intended to convert the parent
cloquintocet-mexyl (CGA-185072) to the acid metabolite, CGA-153433;
however, validation/recovery data for CGA-185072 was not provided. The
three methods are adequate for data gathering methods for cloquintocet-
mexyl in cereal grain commodities.
Method REM 117-01 (MRID 46203138) is also proposed as an
enforcement method. To be an enforcement method for cloquintocet-mexyl,
EPA's analytical chemistry laboratory (ACB/BEAD) would have to validate
the Method 117-01 for cloquintocet-mexyl (CGA-185072) and its
metabolite CGA-153433 in cereal matrices and radiovalidation data for
the method would have to be submitted. This is not a deficiency for
these actions.
2. Multiresidue Methods. Cloquintocet-mexyl and CGA-153433 were
tested through the FDA multiresidue methods according to the decision
tree and protocols in the Pesticide Analytical Manual, Volume I,
Appendix II. Cloquintocet-mexyl was tested per Protocols C, D, and E;
recovery was variable using protocol D, and the test substance was not
recovered using Protocol E. CGA[dash]153433 was tested per Protocols B
and C; the compound was not recovered using Protocol B, and based on
the results of Protocol C testing, no further testing was required for
this compound. The submitted multiresidue methods data have been
forwarded to FDA.
B. International Residue Limits
There are no Codex tolerances established for cloquintocet mexyl.
Australia has established maximum residue limits (MRLs) for
cloquintocet-mexyl on wheat and barley at 0.1 ppm.
V. Conclusion
EPA has reviewed the data and information submitted by the
petitioner in support of the establishment of tolerances for the
combined residues of cloquintocet-mexyl and its acid metabolite (5-
chloro-8-quinolinoxyacetic acid) in or on wheat (grain, straw, forage,
and hay) and barley (grain, hay, and straw) as required in the Federal
Register of June 22, 2000 (65 FR 38757; FRL-6592-4).
The residue data show that residues are not expected to exceed 0.01
ppm in barley grain (LOQ) and 0.05 ppm in barley hay and straw. The
Agency will establish permanent tolerances for the combined residues of
cloquintocet-mexyl (acetic acid, [(5-chloro-8-quniolinyl)oxy]-, 1-
methylhexyl ester)(CAS Reg. No. 99607-70-2) and its acid metabolite (5-
chloro-8-quinlinoxyacetic acid), in/on barley (straw, hay and grain) at
0.1 ppm.
The available data indicate that no revisions to the current
tolerance levels of 0.1 ppm on wheat, forage and wheat, hay are needed.
EPA does not agree that grounds exist to increase the tolerance
expressions for wheat forage and hay because residues of cloquintocet-
mexyl will not exceed 0.1 ppm.
EPA established tolerances for the combined residues of pinoxaden
in or on barley and wheat in the Federal Register on July 27, 2005 (70
FR 43313) (FRL-7725-5). Therefore, EPA is granting Syngenta's petition
to allow the use of the safener cloquintocet-mexyl with pinoxaden in a
1:4 ratio of safener to active ingredient in or on wheat (grain, straw,
forage, and hay) and barley (grain, hay, and straw).
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
[[Page 74687]]
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 EPA-HQ-OPP-2005-0234 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 February
14, 2006.
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 issue(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 14\th\ St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit 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 EPA-HQ-OPP-2005-0234, to: Public
Information and Records Integrity Branch, Information Technology and
Resource Management Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., 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
