[Federal Register Volume 72, Number 188 (Friday, September 28, 2007)]
[Rules and Regulations]
[Pages 55068-55073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19227]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0191; FRL-8149-5]


Quinclorac; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
quinclorac in or on imported barley grain. BASF Corporation requested 
this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 28, 2007. Objections and 
requests for hearings must be received on or before November 27, 2007, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0191. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Hope Johnson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5410; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

[[Page 55069]]

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 those 
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, any person may file an objection 
to any aspect of this regulation and may also request a hearing on 
those objections. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2006-0191 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 as required by 40 CFR part 178 on or 
before November 27, 2007.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2006-0191, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of August 16, 2006 (71 FR 47216) (FRL-7776-
6), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
0E6114) by BASF Corporation, 26 Davis Dr., P.O. Box 13528, Research 
Triangle Park, NC 27709-3528. The petition requested that 40 CFR 
180.463 be amended by establishing a tolerance for residues of the 
herbicide quinclorac, 3,7-dichloro-8-quinoline carboxylic acid, in or 
on imported barley grain at 1.5 parts per million (ppm). That notice 
referenced a summary of the petition prepared by BASF Corporation, the 
registrant, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
determined it appropriate to establish the tolerance for residues of 
the herbicide quinclorac in or on imported barley grain at 2.0 ppm. The 
reason for these changes is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to 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....'' These provisions were added to the FFDCA by the Food 
Quality Protection Act (FQPA) of 1996.
    Consistent with section 408(b)(2)(D) of the FFDCA, and the factors 
specified in section 408(b)(2)(D) of the FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for 
tolerance for residues of quinclorac on imported barley grain at 2.0 
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 adverse effects caused by quinclorac as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule 
published in the Federal Register of March 26, 1999 (64 FR 14626) (FRL-
6069-5).

[[Page 55070]]

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which no adverse effects are observed (the 
NOAEL) in the toxicology study identified as appropriate for use in 
risk assessment. However, if a NOAEL cannot be determined, the lowest 
dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the LOC to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
risks by comparing aggregate exposure to the pesticide to the acute 
population adjusted dose (aPAD) and chronic population adjusted dose 
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all 
applicable UFs. Short-term, intermediate-term, and long-term risks are 
evaluated by comparing aggregate exposure to the LOC to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for quinclorac used for 
human risk assessment is shown in the following Table of this unit.

           Summary of Toxicological Dose and Endpoints for Quinclorac for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          FQPA SF and Level of
          Exposure/Scenario                Interspecies and         Concern for Risk     Study and Toxicological
                                         Intraspecies and any          Assessment                Effects
                                         Traditional FQPA, SF
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Acute dietary (Females 13-49 years of  NOAEL = 200 milligram/   FQPA SF = 1x aPAD =      Developmental toxicity
 age)                                   kilogram/day (mg/kg/     acute RfD / FQPA SF =    study in rabbits LOAEL
                                        day) UF = 100Acute       2.0 mg/kg/day            = 600 mg/kg/day based
                                        reference dose (RfD) =                            on increased early
                                        2.0 mg/kg/day                                     resorptions and
                                                                                          postimplantation loss,
                                                                                          decreased live
                                                                                          fetuses, decreased
                                                                                          fetal weight.
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Chronic dietary (All populations)      NOAEL= 37.5 mg/kg/day    FQPA SF = 1x cPAD =      Dietary carcinogenicity
                                        UF = 100Chronic RfD      chronic RfD / FQPA SF    in mice LOAEL = 150 mg/
                                        =0.38 mg/kg/day          = 0.38 mg/kg/day         kg/day based on
                                                                                          decreased body weight
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Incidental Oral Short-term (1-30       NOAEL = 70 mg/kg/day     FQPA SF = 0.38 LOC for   Developmental toxicity
 days) and Intermediate-term (1-6                                MOE = 100                study in rabbits LOAEL
 months)                                                         (Residential)            = 200 mg/kg/day based
                                                                                          on decreased maternal
                                                                                          body weight gain and
                                                                                          food consumption (and
                                                                                          increased water
                                                                                          consumption)
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Dermal (All durations)                 Not applicable. A dermal endpoint was not selected because an appropriate
                                        endpoint was not available (no dermal toxicity at limit dose of 1,000 mg/
                                                        kg/day in 21-day dermal toxicity study).
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Short-term inhalation (1 to 30 days)   NOAEL= 70 mg/kg/day      FQPA SF = 0.38 LOC for   Developmental toxicity
 and Intermediate-term inhalation (1-   (inhalation absorption   MOE = 100                study in rabbits.
 6 months)                              rate = 100% relative     (Residential)            LOAEL = 200 mg/kg/day
                                        to oral absorption)                               based on decreased
                                                                                          maternal body weight
                                                                                          gain and food
                                                                                          consumption (and
                                                                                          increased water
                                                                                          consumption.
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Long-term inhalation (>6 months)         Not applicable. Long-term inhalation exposure is not anticipated under
                                                                 current use scenarios.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)         Classification: ``Not classifiable as to carcinogenicity to humans''
                                        based on an equivocal increase in pancreatic acinar cell adenomas in the
                                                male rat only and no increases in female rats or in mice.
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to quinclorac, EPA considered exposure under the petitioned-
for tolerances as well as all existing quinclorac tolerances in (40 CFR 
180.463). EPA assessed dietary exposures from quinclorac in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    In estimating acute dietary exposure, EPA used food consumption 
information from the U.S. Department of Agriculture (USDA) 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, EPA assumed all foods for which 
there are tolerances were treated and contain tolerance-level residues. 
Percent crop treated and/or anticipated residues were not used.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA assumed all foods for 
which there are tolerances were treated and contain tolerance-level 
residues. Percent crop treated and/or anticipated residues were not 
used.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for quinclorac in drinking water. Because 
the Agency does not have comprehensive monitoring data, drinking water 
concentration estimates are made by reliance on simulation or modeling 
taking into account data on the environmental fate characteristics of 
quinclorac. Further information regarding EPA drinking water models 
used in pesticide exposure assessment

[[Page 55071]]

can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model /Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
quinclorac for acute exposures are estimated to be 22.9 parts per 
billion (ppb) for surface water and 29 ppb for ground water. The EDWCs 
for chronic exposures are estimated to be 14.5 ppb for surface water 
and 29 ppb for ground water. The EDWCs were directly entered into the 
dietary exposure model (DEEM-FCID(\TM\)).
    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).
    Quinclorac is currently registered for the following residential 
non-dietary sites: Ornamental plantings and turfgrass. EPA assessed 
residential post-application exposure using the following assumptions:
    i. Five percent of the application rate has been used to calculate 
the day-zero turf transferable residue (TTR) residue levels used for 
assessing risk from hand-to-mouth exposures, since quinclorac-specific 
turf transferable residue study data are not available.
    ii. Twenty percent of the application rate has been used to 
calculate the day-zero turf transferable residue (TTR) residue levels 
used for assessing risk from object-to-mouth exposures (a higher 
percent transfer has been used for object-to-mouth behaviors, because 
it involves a teething action believed to be more analogous to DFR/leaf 
wash sample collection where 20 percent is also used).
    iii. Three year old toddlers are expected to weigh 15 kilograms 
(representing an average weight from years one to six)
    iv. Hand-to-mouth exposures are based on a frequency of 20 events/
hour and a surface area per event of 20 cm2, representing 
the palmar surfaces of three fingers.
    v. Saliva extraction efficiency is 50 percent meaning that every 
time the hand goes in the mouth approximately [frac12] of the residues 
on the hand are removed.
    vi. Object-to-mouth exposures are based on 25 cm2 
surface area.
    vii. Exposures durations for turfgrass scenarios are estimated to 
be 2 hours based on information in HED's Exposure Factors Handbook.
    viii. Soil residues are contained in the top centimeter and soil 
density is 0.67 mL/gram.
    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 quinclorac and any other 
substances and quinclorac 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 quinclorac 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 
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional (``10X'') tenfold margin of safety for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the database on toxicity and 
exposure unless EPA determines based on reliable data that a different 
margin of safety will be safe for infants and children. This additional 
margin of safety is commonly referred to as the FQPA safety factor. 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 FQPA 
safety factor value based on the use of traditional UFs and/or special 
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased pre- and/or postnatal susceptibility from exposure to 
quinclorac. Offspring effects were only noted at or above maternally 
toxic dose levels.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for quinclorac is complete for the 
purposes of this action.
    ii. There is no indication that quinclorac is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is no evidence that quinclorac results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% crop treated and tolerance-level residues. Conservative ground 
and surface water modeling estimates were used. Similarly conservative 
Residential SOPs were used to assess post-application exposure to 
children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
quinclorac.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-term, intermediate-term, 
and long-term risks are evaluated by comparing aggregate exposure to 
the LOC to ensure that the MOE called for by the product of all 
applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to quinclorac will occupy <1% of the aPAD for the population group 
(females 13-49 years) receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
quinclorac from food and water will utilize 2% of the cPAD for the 
population group (children 1-2 years). Based on the current use 
patterns, chronic residential exposure to residues of quinclorac is not 
expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Quinclorac is currently registered for uses that could result in 
short-term residential post-application exposure

[[Page 55072]]

and the Agency has determined that it is appropriate to aggregate 
chronic food and water and short-term exposures for quinclorac. The 
post-application exposure scenarios from the use on turf represent the 
worst-case estimates of exposure and risk.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential 
post-application exposures aggregated result in aggregate MOEs of 3,300 
for infants (<1 year), 3,100 for children 1-2 years, and 3,200 for 
children 3-5 years. These values are greater than 100 and, therefore, 
indicate that risks are below the Agency's LOC.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Though residential post-application exposure could occur, no 
intermediate-term exposure scenarios are associated with quinclorac. 
Therefore, the aggregate risk is the sum of the risk from food and 
water and non-dietary (residential post-application exposures).
    5. Aggregate cancer risk for U.S. population. Quinclorac is 
classified as ``Group D, not classifiable as to carcinogenicity to 
humans,'' under the 1986 Agency cancer classification guidelines. 
Available carcinogenicity studies indicate that there was equivocal 
evidence of an increase in the incidince of pancreatic acniar cell 
adenomas in the male rat, but no treatment-associated in increases in 
tumors were observed in female rats or in mice. A quantification of 
cancer risk is not warrented because the chronic RfD of 0.4 mg/kg/day 
is approximately 1,200-fold lower than the dose (487 mg/kg/day) that 
induced the benign pancreatic tumors. Thus, the chronic RfD will 
adequately account for all chronic effects, including the observed 
adenomas, likely to result from exposure to quinclorac. Additionally, 
if quinclorac is evaluated under the current 2005 Guidelines for 
Carcinogen Risk Assessment, quinclorac will be classified as ``Not 
Likely to be Carcinogenic to Humans'' since only benign tumors were 
seen in only one sex and in one species.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to quinclorac residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (BASF Methods A8902 (plants) and 
268/1 (livestock)) is available to enforce the tolerance expression. 
The methods may be requested from: Chief, Analytical Chemistry Branch, 
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; 
telephone number: (410) 305-2905; e-mail address: 
[email protected].

B. International Residue Limits

    There are no Codex maximum residue limits (MRLs) established for 
quinclorac. A Canadian MRL of 2.0 ppm is established for residues of 
quinclorac in/on barley grain.

C. Changes from Notice of Filing

    BASF Corporation initially requested a tolerance of 1.5 ppm be 
established for residues of quinclorac in or on imported barley grain. 
However, based on residue trials conducted in Canada and reviewed by 
Health Canada's Pest Management Regulatory Agency (PMRA), a MRL of 2.0 
ppm was established for residues of quinclorac in or on barley grain in 
Canada. Due to trade-harmonization issues, EPA also supports a 
tolerance of 2.0 ppm for residues of quinclorac in or on imported 
barley grain.

V. Conclusion

    Therefore, the tolerance is established for residues of quinclorac, 
3,7-dichloro-8-quinoline carboxylic acid, in or on imported barley 
grain at 2.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
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, 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) or Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). 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., 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of the 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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. As such, the Agency has determined 
that this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000) do not apply to this rule. In addition, This 
rule does not 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).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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

[[Page 55073]]

a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: September 21, 2007.
Lois Rossi,
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 180.463 is amended by alphabetically adding the following 
commodities to the table in paragraph (a) to read as follows:


Sec.  180.463  Quinclorac; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Barley, grain........................................                2.0
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-19227 Filed 9-27-07; 8:45 am]
BILLING CODE 6560-50-S