Quinclorac; Pesticide Tolerance, 55068-55073 [E7-19227]
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Federal Register / Vol. 72, No. 188 / Friday, September 28, 2007 / Rules and Regulations
EPA-APPROVED LOUISIANA REGULATIONS IN THE LOUISIANA SIP—Continued
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EPA-APPROVED LOUISIANA NONREGULATORY PROVISIONS AND QUASI-REGULATORY MEASURES
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40 CFR Part 180
3. The authority citation for part 97
continues to read as follows:
[EPA–HQ–OPP–2006–0191; FRL–8149–5]
Authority: 42 U.S.C. 7401, 7403, 7410,
7426, 7601, and 7651, et seq.
Quinclorac; Pesticide Tolerance
I
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
4. Appendix A to Subpart EE is
amended by adding an entry, in
alphabetical order, for ‘‘Louisiana’’ to
paragraph 1., to read as follows:
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Appendix A to Subpart EE of Part 97—States
With Approved State Implementation Plan
Revisions Concerning Allocations
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Louisiana
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5. Appendix A to Subpart EEEE is
amended by adding an entry, in
alphabetical order, for ‘‘Louisiana’’
under the introductory text to read as
follows:
I
Appendix A to Subpart EEEE of Part 97—
States With Approved State Implementation
Plan Revisions Concerning Allocations
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Louisiana
[FR Doc. E7–18962 Filed 9–27–07; 8:45 am]
BILLING CODE 6560–50–P
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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 https://
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
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SIP
revision
also
addresses
CAA
110(a)(2)(D)(i)—Interstate Transport. The
protection of visibility requirement will be reevaluated after submission of the regional
haze SIP.
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ENVIRONMENTAL PROTECTION
AGENCY
PART 97—[AMENDED]
Comments
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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
https://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:
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Federal Register / Vol. 72, No. 188 / Friday, September 28, 2007 / Rules and Regulations
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.
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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 https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://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
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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: https://
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-8quinoline 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,
https://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
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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 noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (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).
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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 https://
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, Interspecies and
Intraspecies and any Traditional FQPA, SF
FQPA SF and Level of
Concern for Risk Assessment
Study and Toxicological Effects
Acute dietary (Females 13–49
years of age)
NOAEL = 200 milligram/kilogram/day (mg/kg/day) UF
= 100Acute reference dose
(RfD) = 2.0 mg/kg/day
FQPA SF = 1x aPAD =
acute RfD ÷ FQPA SF =
2.0 mg/kg/day
Developmental toxicity study in rabbits LOAEL
= 600 mg/kg/day based on increased early
resorptions and postimplantation loss, decreased live fetuses, decreased fetal weight.
Chronic dietary (All populations)
NOAEL= 37.5 mg/kg/day UF
= 100Chronic RfD =0.38
mg/kg/day
FQPA SF = 1x cPAD =
chronic RfD ÷ FQPA SF
= 0.38 mg/kg/day
Dietary carcinogenicity in mice LOAEL = 150
mg/kg/day based on decreased body weight
Incidental Oral Short-term (1–
30 days) and Intermediateterm (1–6 months)
NOAEL = 70 mg/kg/day
FQPA SF = 0.38 LOC for
MOE = 100 (Residential)
Developmental toxicity study in rabbits LOAEL
= 200 mg/kg/day based on decreased maternal body weight gain and food consumption (and increased water consumption)
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) and Intermediate-term
inhalation (1–6 months)
NOAEL= 70 mg/kg/day (inhalation absorption rate =
100% relative to oral absorption)
Exposure/Scenario
Long-term inhalation (>6
months)
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.
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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.
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Developmental toxicity study in rabbits. LOAEL
= 200 mg/kg/day based on decreased maternal body weight gain and food consumption (and increased water consumption.
Not applicable. Long-term inhalation exposure is not anticipated under current use scenarios.
C. Exposure Assessment
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MOE = 100 (Residential)
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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
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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
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can be found at https://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 (SCIGROW) 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 (DEEMFCID(TM)).
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, 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 postapplication 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 handto-mouth exposures, since quincloracspecific turf transferable residue study
data are not available.
ii. Twenty percent of the application
rate has been used to calculate the dayzero 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
c 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.
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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 https://
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 preand/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:
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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, intermediateterm, 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
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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 postapplication 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 intermediateterm 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.
VerDate Aug<31>2005
18:21 Sep 27, 2007
Jkt 211001
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-dichloro8-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
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Fmt 4700
Sfmt 4700
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
E:\FR\FM\28SER1.SGM
28SER1
Federal Register / Vol. 72, No. 188 / Friday, September 28, 2007 / Rules and Regulations
on or before November 27, 2007, and
must be filed in accordance with the
instructions provided in 40 CFR part
List of Subjects in 40 CFR Part 180
178 (see also Unit I.C. of the
Environmental protection,
SUPPLEMENTARY INFORMATION ).
Administrative practice and procedure,
ADDRESSES: EPA has established a
Agricultural commodities, Pesticides
docket for this action under docket
and pests, Reporting and recordkeeping identification (ID) number EPA–HQ–
requirements.
OPP–2006–0993. To access the
electronic docket, go to https://
Dated: September 21, 2007.
www.regulations.gov, select ‘‘Advanced
Lois Rossi,
Search,’’ then ‘‘Docket Search.’’ Insert
Director, Registration Division, Office of
the docket ID number where indicated
Pesticide Programs.
and select the ‘‘Submit’’ button. Follow
I Therefore, 40 CFR chapter I is
the instructions on the regulations.gov
amended as follows:
website to view the docket index or
access available documents. All
PART 180—[AMENDED]
documents in the docket are listed in
I 1. The authority citation for part 180
the docket index available in
continues to read as follows:
regulations.gov. Although listed in the
index, some information is not publicly
Authority: 21 U.S.C. 321(q), 346a and 371.
available, e.g., Confidential Business
I 2. Section 180.463 is amended by
Information (CBI) or other information
alphabetically adding the following
whose disclosure is restricted by statute.
commodities to the table in paragraph
Certain other material, such as
(a) to read as follows:
copyrighted material, is not placed on
the Internet and will be publicly
§ 180.463 Quinclorac; tolerances for
residues.
available only in hard copy form.
Publicly available docket materials are
(a) * * *
available in the electronic docket at
https://www.regulations.gov, or, if only
Commodity
Parts per million
available in hard copy, at the OPP
Barley, grain ...................
2.0 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.
[FR Doc. E7–19227 Filed 9–27–07; 8:45 am]
to 4 p.m., Monday through Friday,
BILLING CODE 6560–50–S
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
ENVIRONMENTAL PROTECTION
FOR FURTHER INFORMATION CONTACT:
AGENCY
Joanne I. Miller, Registration Division
(7505P), Office of Pesticide Programs,
40 CFR Part 180
Environmental Protection Agency, 1200
[EPA–HQ–OPP–2006–0993; FRL–8148–4]
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
Florasulam; Pesticide Tolerance
(703) 305–6224; e-mail address:
miller.joanne@epa.gov.
AGENCY: Environmental Protection
Agency (EPA).
SUPPLEMENTARY INFORMATION:
ACTION: Final rule.
I. General Information
rwilkins on PROD1PC63 with RULES
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
SUMMARY: This regulation establishes a
tolerance for florasulam in or on barley,
grain at 0.01 ppm, barley, hay at 0.05
ppm, barley straw at 0.05 ppm, oat,
grain at 0.01 ppm, oat, forage at 0.05
ppm, oat, hay at 0.05 ppm, oat, straw at
0.05 ppm, rye, grain at 0.01 ppm, rye,
forage at 0.05 ppm, rye, straw at 0.05
ppm, wheat, grain at 0.01 ppm, wheat,
forage at 0.05 ppm, wheat, hay at 0.05
ppm, and wheat, straw at 0.05 ppm.
Dow AgroSciences LLC 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
VerDate Aug<31>2005
18:21 Sep 27, 2007
Jkt 211001
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;
PO 00000
Frm 00063
Fmt 4700
Sfmt 4700
55073
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 https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of 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–2006–0993 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–
E:\FR\FM\28SER1.SGM
28SER1
Agencies
[Federal Register Volume 72, Number 188 (Friday, September 28, 2007)]
[Rules and Regulations]
[Pages 55068-55073]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19227]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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 https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://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 https://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: https://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, https://
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 https://
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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
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 https://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 https://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.
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