Quinclorac; Pesticide Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: September 28, 2007 (Volume 72, Number 188)]
[Rules and Regulations]
[Page 55068-55073]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28se07-13]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0191; FRL-8149-5]

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: johnson.hope@epa.gov.

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
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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).
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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:
residuemethods@epa.gov.

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.

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

PART 180--[AMENDED]

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

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

• 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

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Quinclorac; Pesticide Tolerance

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