[Federal Register: December 31, 2003 (Volume 68, Number 250)]
[Rules and Regulations]
[Page 75430-75438]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31de03-21]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0377; FRL-7340-5]
Fluroxypyr; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
fluroxypyr in or on field corn, sweet corn, sorghum, range and pasture
grass. Dow AgroSciences LLC requested this tolerance under the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA).
DATES: This regulation is effective December 31, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0377,
must be received on or before March 1, 2004.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703)305-6224; e-mail address:
miller.joanne@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
[sbull] Crop production (NAICS 111), e.g., Agricultural workers;
Greenhouse, nursery, and floriculture workers; Farmers.
[sbull] Animal production (NAICS 112), e.g., Cattle ranchers and
farmers, Dairy cattle farmers, Livestock farmers.
[sbull] Food manufacturing (NAICS 311), e.g., Agricultural workers;
Farmers; Greenhouse, nursery, and floriculture workers; Ranchers;
Pesticide applicators.
[sbull] Pesticide manufacturing (NAICS 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 provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0377. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m.,
[[Page 75431]]
Monday through Friday, excluding legal holidays. The docket telephone
number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.A frequently updated electronic version of 40 CFR part 180 is available at http://
http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html/, a
beta site currently under development. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of May 14, 2003 (68 FR 25883) (FRL-7301-3),
EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a,
as amended by FQPA (Public Law 104-170), announcing the filing of a
pesticide petition (PP 9F6050) by Dow AgroSciences LLC, 9330 Zionville
Road, Indianapolis, IN 46268. That notice included a summary of the
petition prepared by Dow AgroSciences LLC, the registrant. There were
no comments received in response to the notice of filing.
The petition requested that 40 CFR 180.535 be amended by
establishing tolerances for combined residues of the herbicide
fluroxypyr 1-methylheptyl ester [((4-amino-3,5-dichloro-6-fluoro-2-
pyridinyl)oxy) acetic acid, 1-methylheptyl] and its metabolite
fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy) acetic
acid], free and conjugated, all expressed as fluroxypyr, in or on the
following raw agricultural commodities: Sweet corn at 0.02 parts per
million (ppm) for kernels plus cob with husk removed, and forage and
stover at 1.0 ppm. Tolerances for residues of fluroxypyr in or on field
corn are being proposed in support of this registration as follows:
grain, 0.02 ppm; forage, 1.0 ppm; and stover, 0.5 ppm. Tolerances for
residues of fluroxypyr in or on sorghum as follows: Grain, 0.02 ppm;
forage, 2.0 ppm; and stover, 4.0 ppm. Tolerances for residues of
fluroxypyr in or on grasses as follows: Forage, 120 ppm; hay, 160 ppm;
and grass silage, 100 ppm. Increased tolerances are also proposed for
fluroxypyr in or on the following animal commodities: Milk of cattle,
goats, hogs, horses and sheep at 0.3 ppm; and kidney of cattle, goats,
hogs, horses and sheep at 1.5 ppm.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that`` there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for tolerances for combined residues of fluroxypyr
on or in field corn, grain at 0.02 ppm; field corn, forage at 1.0 ppm;
field corn, stover at 0.5 ppm; on or in sweet corn, kernels plus cob
with husks removed at 0.02 ppm; sweet corn, forage at 1.0 ppm; sweet
corn, stover at 2.0 ppm; on or in sorghum, grain at 0.02 ppm; sorghum,
forage at 2.0 ppm; sorghum, stover (fodder) at 4.0 ppm; on or in grass,
forage at 120 ppm; grass, hay at 160 ppm; and a tolerance for combined
residues of fluroxypyr on cattle, milk; goat, milk; hog, milk; horse,
milk; and sheep, milk at 0.3 ppm; and on cattle, kidney; goat, kidney;
hog, kidney; horse, kidney; and sheep, kidney at 1.5 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. The nature of the toxic effects caused by fluroxypyr are
discussed in Table 1 of this unit as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies reviewed.
Table 1.--Subchronic, Chronic, and Other Toxicity
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Guideline No. Study Type Results
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870.3100 90-Day oral toxicity--Rats NOAEL = 700 milligram/kilogram/day (mg/kg/
day)
LOAEL = 1,000 mg/kg/day based on decreased
body weight gain & testis weight (M),
decreased brain weight (F), and increased
kidney weight (M/F).
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870.3100 90-Day oral toxicity--Mice NOAEL = 1,342 mg/kg/day (Males)/ 1,748 mg/
kg/day (Females)
LOAEL not established.
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[[Page 75432]]
870.3200 21/28-Day dermal toxicity NOAEL = 1,000 mg/kg/day
LOAEL not established
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870.3700 Prenatal developmental-- Maternal NOAEL = 300 mg/kg/day
Rodents LOAEL = 600 mg/kg/day based on increased
maternal deaths and decreased body weight
gains and food consumption.
Developmental
NOAEL = 600 mg/kg/day
LOAEL not established.
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870.3700 Prenatal developmental-- Maternal NOAEL = 500 mg/kg/day
Nonrodents LOAEL = 1,000 mg/kg/day based on increased
abortions.
Developmental
NOAEL = 500 mg/kg/day
LOAEL = 1,000 mg/kg/day based on increased
abortions.
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870.3800 Reproduction and fertility Parental/Systemic NOAEL = 100 mg/kg/day
effects (Males) / 500 mg/kg/day (Females)
LOAEL = 500 mg/kg/day (Males) / 1,000 mg/kg/
day (Females), based on kidney effects
(M&F) and increased deaths (F).
Reproductive NOAEL = 750 mg/kg/day (Males)
1,000 mg/kg/day (Females).
LOAEL not established.
Offspring NOAEL = 500 mg/kg/day
LOAEL = 1,000 mg/kg/day based on decreased
pup weight and body weight gain and
slightly lower survival.
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870.4100 Chronic toxicity--Dogs NOAEL = 150 mg/kg/day
LOAEL not established.
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870.4200 Carcinogenicity--Mice NOAEL = 300 mg/kg/day (Males/Females)
LOAEL = 1,000 mg/kg/day based on decreased
body weight and body weight gain (M) and
increased kidney lesions (F).(no) evidence
of carcinogenicity
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870.4300 Carcinogenicity--Rats NOAEL = 100 mg/kg/day
LOAEL = 500 mg/kg/day based on chronic
progressive kidney glomerulonephropathy
(M&F).(no) evidence of carcinogenicity
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870.5100 Bacterial reverse mutation Negative.
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870.5300 In vitro mammalian cell Negative, but did not test a soluble dose.
gene mutation
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870.5375 In vitro mammalian Negative.
chromosome aberration
(HL)
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870.5395 Mammalian micronucleus Negative.
(mouse)
----------------------------------------------------------------------------------------------------------------
870.7485 Metabolism and Total recovery of the administered dose was
pharmacokinetics 105%, with the principal route of
excretion being expired 14CO2, which
contained approximately 61% of the
radioactivity for the fluroxypyr MHE. The
urine contained approximately 30% and the
feces contained 5% of the administered
dose. At 48 hours post dose, approximately
7% of the administered dose was recovered
in the blood, carcass, and skin.
Approximately 52% of the administered dose
was absorbed and expired as 14CO2 within
12 hours post dose, and an additional 18%
of the administered dose was excreted in
the urine within 12 hours post dose. Based
on the percentage of dose in the expired
14CO2 , urine, and tissues, approximately
90% of the dose was absorbed. Once
absorbed, it was extensively metabolized
and rapidly expired as 14CO2 and
eliminated in the urine with a half-life
of 6 hours. Peak plasma concentrations of
14C-radioactivity were attained by 7 hours
post dose.
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B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect 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. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
Three other types of safety or uncertainty factors may be used:
``Traditional uncertainty factors;'' the
[[Page 75433]]
``special FQPA safety factor;'' and the ``default FQPA safety factor.''
By the term ``traditional uncertainty factor,'' EPA is referring to
those additional uncertainty factors used prior to FQPA passage to
account for database deficiencies. These traditional uncertainty
factors have been incorporated by the FQPA into the additional safety
factor for the protection of infants and children. The term ``special
FQPA safety factor'' refers to those safety factors that are deemed
necessary for the protection of infants and children primarily as a
result of the FQPA. The ``default FQPA safety factor'' is the
additional 10X safety factor that is mandated by the statute unless it
is decided that there are reliable data to choose a different
additional factor (potentially a traditional uncertainty factor or a
special FQPA safety factor).
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of
100 to account for interspecies and intraspecies differences and any
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF).
Where a special FQPA safety factor or the default FQPA safety factor is
used, this additional factor is applied to the RfD by dividing the RfD
by such additional factor. The acute or chronic Population Adjusted
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this
type of safety factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk). An example of how such a probability risk is expressed
would be to describe the risk as one in one hundred thousand (1 X
10-\5\), one in a million (1 X 10-\6\), or one in
ten million (1 X 10-\7\). Under certain specific
circumstances, MOE calculations will be used for the carcinogenic risk
assessment. In this non-linear approach, a ``point of departure'' is
identified below which carcinogenic effects are not expected. The point
of departure is typically a NOAEL based on an endpoint related to
cancer effects though it may be a different value derived from the dose
response curve. To estimate risk, a ratio of the point of departure to
exposure (MOEcancer = point of departure/exposures) is
calculated.
A summary of the toxicological endpoints for fluroxypyr used for
human risk assessment is shown in Table 2 of this unit:
Table 2.--Summary of Toxicological Dose and Endpoints for Fluroxypyr for Use in Human Risk Assessment
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Dose Used in Risk
Assessment, Special FQPA SF and
Exposure Scenario Interspecies and Level of Concern for Study and Toxicological
Intraspecies and any Risk Assessment Effects
Traditional UF
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Acute Dietary(All populations) NOAEL = NA FQPA SF = NA No appropriate endpoint
UF = NA................ aPAD = acute RfD/ FQPA to quantify single
Acute RfD = NA......... SF. dose exposure.
= NA...................
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Chronic Dietary(All populations) NOAEL= 100 mg/kg/day FQPA SF = 1x Chronic/Onco-Rat
UF = 100............... cPAD =chronic RfD/ FQPA LOAEL = 100 mg/kg/day
Chronic RfD =1 mg/kg/ SF. based on kidney
day. = 1 mg/kg/day.......... effects.
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Short-TermIncidental Oral (1-30 days) NOAEL= 100 mg/kg/day Residential LOC for MOE Chronic/Onco-Rat
= 100 LOAEL = 100 mg/kg/day
Occupational = NA...... based on kidney
effects.
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Intermediate-TermIncidental Oral (1- NOAEL= 100 mg/kg/day Residential LOC for MOE Chronic/Onco-Rat
6 months) = 100 LOAEL = 100 mg/kg/day
Occupational = NA...... based on kidney
effects.
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Dermal(All durations) Dermal (or oral) study Residential LOC for MOE Quantification not
NOAEL=NA............... = NA required since 21-Day
Occupational LOC for dermal rabbit
MOE = NA. NOAEL = 1,000 mg/kg/day
and there is no
developmental toxicity
concern.
----------------------------------------------------------------------------------------------------------------
Inhalation(All durations) Inhalation (or oral) Residential LOC for MOE Chronic/Onco-Rat
study = 100 LOAEL = 100 mg/kg/day
NOAEL= 100 mg/kg/day... Occupational LOC for based on kidney
(inhalation absorption MOE = 100. effects.
rate = 100%).
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Classification: ``not likely'' human carcinogen
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UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL =
lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference
dose, MOE = margin of exposure, LOC = level of concern, NA = Not Applicable
[[Page 75434]]
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.535) for the combined residues of fluroxypyr,
in or on a variety of raw agricultural commodities. Tolerances have
also been established for the combined residues of fluroxypyr on meat
and milk. Risk assessments were conducted by EPA to assess dietary
exposures from fluroxypyr in food as follows:
i. Acute exposure. Acute dietary 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 one-day
or single exposure.
No adverse effect attributable to a single exposure (dose) of
fluroxypyr was observed in the oral toxicity studies. Therefore, EPA
did not identify an acute dietary endpoint and a quantitative acute
dietary assessment was not performed because no acute risk is expected.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\T\), which incorporates
food consumption data as reported by respondents in the USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to the chemical for each commodity.
The following assumptions were made for the chronic exposure
assessments: 100% crop treated (PCT) and tolerance-level residues for
fluroxypyr on all treated crops. This assessment was Tier I analysis.
The exposures from fluroxypyr residues are below EPA's level of concern
(<100% of the chronic population adjusted dose (cPAD)) for the general
U.S. population (<1% of the cPAD) and all population subgroups.
iii. Cancer. Fluroxypyr is classified as ``not likely'' a human
carcinogen and there was no concern for its mutagenicity potential.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for fluroxypyr 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 physical
characteristics of fluroxypyr.
The Agency used the Pesticide Root Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS), a Tier 2 model, to estimate pesticide
concentrations in surface water. PRZM/EXAMS incorporates an index
reservoir environment and includes a percent crop area factor as an
adjustment to account for the maximum percent crop coverage within a
watershed or drainage basin. The Tier 1 Screening Concentration In
Ground Water (SCI-GROW) model is used to predict pesticide
concentrations in shallow ground water.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a screen for sorting out pesticides for which it is
unlikely that drinking water concentrations would exceed human health
levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs), which are the model estimates of a
pesticide's concentration in water. EECs derived from these models are
used to quantify drinking water exposure and risk as a %RfD or %PAD.
Instead drinking water levels of comparison (DWLOCs) are calculated and
used as a point of comparison against the model estimates of a
pesticide's concentration in water. DWLOCs are theoretical upper limits
on a pesticide's concentration in drinking water in light of total
aggregate exposure to a pesticide in food, and from residential uses.
Since DWLOCs address total aggregate exposure to fluroxypyr they are
further discussed in the aggregate risk sections in Unit III.E.
Based on the PRZM/EXAMS and SCI-GROW models, the EECs of fluroxypyr
for acute exposures are estimated to be 32.9 parts per billion (ppb)
for surface water and 0.04 ppb for ground water. The EECs for chronic
exposures are estimated to be 3.3 ppb for surface water and 0.062 ppb
for ground water.
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).
Fluroxypyr is currently registered for use on the following
residential non-dietary sites: Residential turfgrass and recreational
sites such as golf courses and sports fields. The risk assessment was
conducted using the following residential exposure assumptions: Adults
and children may be exposed to fluroxypyr residues from dermal contact
with turf during postapplication activities. Toddlers may receive
short- and intermediate-term oral exposure from incidental ingestion
during postapplication activities. Residential handlers may receive
short-term dermal and inhalation exposure to fluroxypyr when mixing,
loading and applying the formulations.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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.''
EPA does not have, at this time, available data to determine
whether fluroxypyr has a common mechanism of toxicity with other
substances. 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 fluroxypyr
and any other substances and fluroxypyr 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 fluroxypyr has a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's OPP concerning
common mechanism determinations and procedures for cumulating effects
from substances found to have a common mechanism on EPA's web site at
http://www.epa.gov/pesticides/cumulative/.
D. Safety Factor for Infants and Children
1.In general. Section 408 of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
[[Page 75435]]
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10 X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility of rat or rabbit fetuses following in utero
exposure in the developmental studies with fluroxypyr. There is no
evidence of increased susceptibility of rats in the reproduction study
with fluroxypyr. EPA concluded there are no residual uncertainties for
prenatal and/or postnatal exposure.
3. Conclusion. There is a complete toxicity data base for
fluroxypyr and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10X SF to protect infants and children should be removed and
instead, a different additional safety factor of 1X should be used. The
FQPA factor is removed because: There is no evidence (quantitative/
qualitative) of increased susceptibility following in utero exposure to
the acid and the ester of fluroxypyr in rats and rabbits, or following
pre and/or postnatal exposure to the acid of fluroxypyr in rats; there
are no concerns or residual uncertainties for pre- and/or post-natal
toxicity; there is no evidence of neurotoxicity or neuropathology in
the available studies; the toxicological database is complete for FQPA
assessment; the chronic dietary food exposure assessment utilizes
tolerance level residue estimates and assumes 100% CT for all
commodities, thus not likely to underestimate exposure/risk; the
dietary drinking water assessment utilizes water concentration values
generated by model and associated modeling parameters which are
designed to provide conservative, health protective, high-end estimates
of water concentrations which will not likely be exceeded; and the
residential exposure assessment was conducted using standard
assumptions which are based on carefully reviewed data.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against EECs. DWLOC values are
not regulatory standards for drinking water. DWLOCs are theoretical
upper limits on a pesticide's concentration in drinking water in light
of total aggregate exposure to a pesticide in food and residential
uses. In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water [e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure)]. This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default body weights and drinking water consumption
values vary on an individual basis. This variation will be taken into
account in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. A quantitative acute risk assessment was not
performed. No adverse effect attributable to a single exposure(dose) of
fluroxypyr was observed in the oral toxicity studies and no acute risk
is expected.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
fluroxypyr from food will utilize <1% of the cPAD for the U.S.
population, <1% of the cPAD for all infants, and 1.4% of the cPAD for
children (1-2 years old). In addition, there is potential for chronic
dietary exposure to fluroxypyr in drinking water. After calculating
DWLOCs and comparing them to the EECs for surface and ground water, EPA
does not expect the aggregate exposure to exceed 100% of the cPAD, as
shown in Table 3 of this unit. Based upon the use pattern, chronic
(non-dietary) residential exposure to residues of fluroxypyr is not
expected.
Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Fluroxypyr
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 1 <1 3.3 0.042 35,000
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old) 1 <1 3.3 0.042 10,000
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old) 1 1.4 3.3 0.042 9,900
----------------------------------------------------------------------------------------------------------------
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).
Fluroxypyr is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for fluroxypyr.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of 31,000 for the U.S. population
and 4,500 for children (1-2 years old). These aggregate MOEs do not
exceed the Agency's level of concern for aggregate exposure to food and
residential uses. In addition,
[[Page 75436]]
short-term DWLOCs were calculated and compared to the EECs for chronic
exposure of fluroxypyr in ground and surface water. After calculating
DWLOCs and comparing them to the EECs for surface and ground water, EPA
does not expect short-term aggregate exposure to exceed the Agency's
level of concern, as shown in Table 4 of this unit:
Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Fluroxypyr
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 31,000 100 3.3 0.042 35,000
----------------------------------------------------------------------------------------------------------------
Children(1-2 years old) 4,500 100 3.3 0.042 9,800
----------------------------------------------------------------------------------------------------------------
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).
Fluroxypyr is currently registered for use(s) that could result in
intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and
intermediate-term exposures for fluroxypyr.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of 31,000 for
the U.S. population and 4,500 for children (1-2 years old). These
aggregate MOEs do not exceed the Agency's level of concern for
aggregate exposure to food and residential uses. In addition,
intermediate-term DWLOCs were calculated and compared to the EECs for
chronic exposure of fluroxypyr in ground and surface water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect intermediate-term aggregate exposure
to exceed the Agency's level of concern, as shown in Table 5 of this
unit:
Table 5.--Aggregate Risk Assessment for Intermediate-Term Exposure to Fluroxypyr
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Intermediate-
Population Subgroup MOE (Food + Concern Water EEC Water EEC Term DWLOC
Residential) (LOC) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 31,000 100 3.3 0.042 35,000
----------------------------------------------------------------------------------------------------------------
Children(1-2 years old) 4,500 100 3.3 0.042 9,800
----------------------------------------------------------------------------------------------------------------
5. Aggregate cancer risk for U.S. population. Fluroxypyr is
classified as a not likely human carcinogen and is not expected to pose
a cancer risk.
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, and to infants and children from aggregate
exposure to fluroxypyr residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The gas chromatography/mass selective detector (GC/MSD) enforcement
method, submitted by Dow AgroSciences LLC, has been validated for the
determination of residues of fluroxypyr and fluroxypyr 1-MHE as the
acid equivalent in plant commodities. The method for livestock
commodities has been validated for the determination of residues of
fluroxypyr and fluroxypyr 1-MHE in cow milk and liver. The proposed
plant and animal method is adequate for enforcement of tolerances in/on
field corn, sweet corn, sorghum, range and pasture grass, and animal
commodities as a result of this use.
Fluroxypyr has been tested through the FDAs Multiresidue
Methodology, Protocols C, D, and E. The results have been published in
the FDA Pesticide Analytical Manual, Volume I.
B. International Residue Limits
There is neither a Codex proposal, nor Canadian or Mexican limits,
for residues of fluroxypyr in/on field corn, sweet corn, sorghum, range
and pasture grass. Harmonization is not an issue for this petition.
C. Conditions
The following data are being required to confirm the results of the
studies already reviewed by the Agency and/or to complete the database
requirements prior to approval of an unconditional sweet corn
registration:
i. Additional field trials - conduct and submit four (4) additional
field trials in Regions III (1 trial), V(1 trial), XI(1 trial), and
XII(1 trial). Residue analysis of sweet corn field trial samples should
avoid using the DowElanco Method ACR 90.8, due to matrix interference
cited in PP2G04066.
ii. Storage stability data - submit to support the sweet corn field
trial data.
iii. 28-Day Inhalation Toxicity Study
V. Conclusion
Therefore, the tolerances are established for combined residues of
fluroxypyr 1-methylheptyl ester [((4-amino-3,5-dichloro-6-fluoro-2-
pyridinyl)oxy) acetic acid, 1-methylheptyl] and its metabolite
fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy) acetic
acid], free and conjugated, all expressed as fluroxypyr, in or on field
corn, grain at 0.02 ppm; field corn, forage at 1.0 ppm; field corn,
stover at 0.5 ppm; on or in sweet corn, kernels plus cob with husks
removed at 0.02 ppm; sweet corn, forage at 1.0 ppm; sweet corn, stover
at 2.0 ppm; on or in sorghum, grain at 0.02 ppm; sorghum, forage at 2.0
ppm; sorghum, stover (fodder) at 4.0 ppm; and on or in grass, forage at
120 ppm; grass, hay at 160 ppm. Tolerances are revised for combined
residues of fluroxypyr on cattle, milk; goat, milk;
[[Page 75437]]
hog, milk; horse, milk; and sheep, milk at 0.3 ppm; and on cattle,
kidney; goat, kidney; hog, kidney; horse, kidney; and sheep, kidney at
1.5 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2003-0377 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before March 1,
2004.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2003-0377, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.1. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary
[[Page 75438]]
consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law
104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and
exemptions that are established on the basis of a petition under
section 408(d) of FFDCA, such as the tolerance in this final rule, do
not require the issuance of a proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
In addition, the Agency has determined that this action will not have a
substantial direct effect on States, on the relationship between the
national government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism(64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: December 22, 2003.
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), 346(a) and 371.
0
2. Section 180.535 is amended by alphabetically adding new commodities
and revising the commodities ``cattle, kidney,'' ``goat, kidney,''
``hog, kidney,'' ``horse, kidney,'' ``milk,'' and ``sheep, kidney'' in
the table in paragraph (a) to read as follows:
Sec. 180.535 Fluroxypyr; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Cattle, kidney....................................... 1.5
* * * * *
Corn, field, forage.................................. 1.0
Corn, field, grain................................... 0.02
Corn, field, stover.................................. 0.5
Corn, sweet, forage.................................. 1.0
Corn, sweet, kernel plus cob with husks removed...... 0.02
Corn, sweet, stover.................................. 2.0
* * * * *
Goat, kidney......................................... 1.5
* * * * *
Grass, forage........................................ 120
Grass, hay........................................... 160
* * * * *
Hog, kidney.......................................... 1.5
* * * * *
Horse, kidney........................................ 1.5
* * * * *
Milk................................................. 0.3
* * * * *
Sheep, kidney........................................ 1.5
* * * * *
Sorghum, grain, forage............................... 2.0
Sorghum, grain, grain................................ 0.02
Sorghum, grain, stover............................... 4.0
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 03-32007 Filed 12-30-03; 8:45 am]
BILLING CODE 6560-50-S