[Federal Register Volume 70, Number 241 (Friday, December 16, 2005)]
[Rules and Regulations]
[Pages 74679-74688]
From the Federal Register Online via the Government Publishing 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 http://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 http://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: [email protected].

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 (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines at http://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 http://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 http://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: [email protected]. 
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 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

[[Page 74688]]

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.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.560 is amended by revising paragraph (a) to read as 
follows:


Sec.  180.560  Cloquintocet-mexyl; tolerances for residues.

    (a) General. Tolerances are established for the combined residues 
of cloquintocet-mexyl (acetic acid, [(5-chloro-8-quniolinyl)oxy]-, 1-
methylhexyl ester)(CAS No. 99607-70-2) and its acid metabolite (5-
chloro-8-quinlinoxyacetic 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........................................                0.1
Barley, hay..........................................                0.1
Barley, straw........................................                0.1
Wheat, forage........................................                0.1
Wheat, grain.........................................                0.1
Wheat, hay...........................................                0.1
Wheat, straw.........................................                0.1
------------------------------------------------------------------------

* * * * *

[FR Doc. 05-24097 Filed 12-15-05; 8:45 am]
BILLING CODE 6560-50-S