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Fluroxypyr 1-methylheptyl ester
Fluoroxypyr

 http://www.epa.gov/fedrgstr/EPA-PEST/2005/January/Day-26/p1440.htm

Fluroxypyr; Pesticide Tolerances for Emergency
Exemptions  [Federal Register: January 26, 2005 (Volume 70, Number 16)]
[Rules and Regulations]
[Page 3642-3649]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ja05-15]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0008; FRL-7695-2]

Fluroxypyr; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of fluroxypyr 1-methylheptyl ester and its metabolite
fluroxypyr in or on onion. This action is in response to EPA's granting
of an emergency exemption under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide
on onion. This regulation establishes a maximum permissible level for
residues of fluroxypyr 1-methylheptyl ester and its metabolite
fluroxypyr in this food commodity. The tolerance will expire and is
revoked on June 30, 2007.

DATES: This regulation is effective January 26, 2005. Objections and
requests for hearings must be received on or before March 28, 2005
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number OPP-2005-0008. All documents in the docket
are listed in the EDOCKET index at http://www.epa.gov/edocket . Although
listed in the index, some information is not publicly available, i.e.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed on
the Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S.
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The docket
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6463; e-mail address: madden.barbara@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:
• Crop production (NAICS code 111)
• Animal production (NAICS code 112)
• Food manufacturing (NAICS code 311)
• Pesticide manufacturing (NAICS code 32532)

This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions above. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET ( http://www.epa.gov/edocket/ ), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/ . A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .

II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a,

[[Page 3643]]

is establishing a tolerance for combined residues of the herbicide
fluroxypyr 1-methylheptyl ester 1-methylheptyl ((4-amino-3,5-dichloro-
6-fluoro-2-pyridinyl)oxy)acetate and its metabolite fluroxypyr [((4-
amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid], in or on
onion at 0.02 parts per million (ppm). This tolerance will expire and
is revoked on June 30, 2007. EPA will publish a document in the Federal
Register to remove the revoked tolerance from the Code of Federal
Regulations.

Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
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. . .
.''
Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.

III. Emergency Exemption for Fluroxypyr 1-methylheptyl ester on onion
and FFDCA Tolerances

According to the State of Colorado, due to a long string of mild
winters, volunteer potatoes have become a more important problem. They
are especially difficult to control in onions, and due to the
noncompetitive nature of onions versus the large vigorous growth of
volunteer potatoes, they result in very large yield reductions if not
controlled. None of the currently registered herbicides for onions
provide acceptable control of volunteer potatoes. EPA has authorized
under FIFRA section 18 the use of fluroxypyr 1-methylheptyl ester on
onion for control of volunteer potatoes in Colorado. After having
reviewed the submission, EPA concurs that emergency conditions exist
for this State.

As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of fluroxypyr 1-methylheptyl
ester in or on onion. In doing so, EPA considered the safety standard
in section 408(b)(2) of the FFDCA, and EPA decided that the necessary
tolerance under section 408(l)(6) of the FFDCA would be consistent with
the safety standard and with FIFRA section 18. Consistent with the need
to move quickly on the emergency exemption in order to address an
urgent non-routine situation and to ensure that the resulting food is
safe and lawful, EPA is issuing this tolerance without notice and
opportunity for public comment as provided in section 408(l)(6) of the
FFDCA. Although this tolerance will expire and is revoked on June 30,
2007, under section 408(l)(5) of the FFDCA, residues of the pesticide
not in excess of the amounts specified in the tolerance remaining in or
on onion after that date will not be unlawful, provided the pesticide
is applied in a manner that was lawful under FIFRA, and the residues do
not exceed a level that was authorized by this tolerance at the time of
that application. EPA will take action to revoke this tolerance earlier
if any experience with, scientific data on, or other relevant
information on this pesticide indicate that the residues are not safe.

Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether fluroxypyr 1-
methylheptyl ester meets EPA's registration requirements for use on
onion or whether a permanent tolerance for this use would be
appropriate. Under these circumstances, EPA does not believe that this
tolerance serves as a basis for registration of fluroxypyr 1-
methylheptyl ester by a State for special local needs under FIFRA
section 24(c). Nor does this tolerance serve as the basis for any State
other than Colorado to use this pesticide on this crop under section 18
of FIFRA without following all provisions of EPA's regulations
implementing FIFRA section 18 as identified in 40 CFR part 166. For
additional information regarding the emergency exemption for fluroxypyr
1-methylheptyl ester, contact the Agency's Registration Division at the
address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

Consistent with 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
fluroxypyr 1-methylheptyl ester and to make a determination on
aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for
a time-limited tolerance for combined residues of fluroxypyr 1-
methylheptyl ester in or on onion at 0.02 ppm. EPA's assessment of the
dietary exposures and risks associated with establishing the tolerance
follows.

A. 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 endpoint. 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.

[[Page 3644]]

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 the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, 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 FQPA SF.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (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 is expressed as 1 x10-\6\ or one in a million).
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 1-methylheptyl ester used for human risk
assessment is shown in the following Table 1:

B. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.535) for the combined residues of fluroxypyr 1-
methylheptyl ester and its metabolite fluroxypyr, in or on a variety of
raw agricultural commodities including barley, corn, grass, oats,
sorghum, wheat, milk, and meat, kidney, meat byproducts and fat of
cattle, goat, hog, horse, and sheep. Risk assessments were conducted by
EPA to assess dietary exposures from fluroxypyr 1-methylheptyl ester in
food as follows:

i. Acute exposure. Quantitative 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. There were no toxic effects
attributable to a single dose. Therefore, an endpoint of concern was
not identified to quantitate acute-dietary risk to the general
population or to the subpopulation females 13-50 years old. As a
result, no acute risk is expected from exposure to fluroxypyr and hence
no quantitative acute dietary risk assessment was performed.

ii. Chronic exposure. In conducting this chronic dietary risk
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\TM\, version 1.3) 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

[[Page 3645]]

commodity. The following assumptions were made: an unrefined, Tier 1
chronic-dietary exposure assessment using tolerance-level residues and
assuming 100% crop treated (CT) for all commodities, and default
processing factors for all commodities.

iii. Cancer. Fluroxypyr has been classified as not likely to be
carcinogenic to humans. Therefore, a quantitative exposure assessment
was not conducted to assess cancer risk.

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 1-methylheptyl
ester 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 1-methylheptyl ester.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in ground water. In
general, EPA will use GENEEC (a Tier 1 model) before using PRZM/EXAMS
(a Tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. The PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage basin.
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 coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever 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) from these models 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 1-methylheptyl
ester they are further discussed in the aggregate risk sections below.
Based on the GENEEC and SCI-GROW models the estimated environmental
concentrations (EECs) of fluroxypyr 1-methylheptyl ester for chronic
exposures are estimated to be 1.6 ppb for surface water and 0.017 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 exposure to 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.''
EPA does not have, at this time, available data to determine
whether fluroxypyr 1-methylheptyl ester has a common mechanism of
toxicity with other substances or how to include this pesticide in a
cumulative risk assessment. Unlike other pesticides for which EPA has
followed a cumulative risk approach based on a common mechanism of
toxicity, fluroxypyr 1-methylheptyl ester 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 1-
methylheptyl ester 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 final rule for Bifenthrin
Pesticide Tolerances (62 FR 62961, November 26, 1997).

C. Safety Factor for Infants and Children

1. In general. Section 408 of the 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 that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.

2. Developmental toxicity studies. In a prenatal developmental
study in rats the Maternal NOAEL is 300 mg/kg/day and the LOAEL is 600
mg/kg/day based on increased maternal deaths and decreased body weight
gains and food consumption. The Developmental NOAEL is 600 mg/kg/day
and a LOAEL was not established.
In a prenatal developmental study in rabbits the Maternal NOAEL is
500 mg/kg/day and the LOAEL is 1,000 mg/kg/day based on increased
abortions. The Developmental NOAEL is 500 mg/kg/day and the LOAEL is
1,000 mg/kg/day based on increased abortions.

3. Reproductive toxicity study. In a reproduction and fertility
study the Parental/Systemic NOAEL is 100 mg/kg/day effects (Males) and
500 mg/kg/day (Females) with a LOAEL of 500 mg/kg/day (Males) / 1,000
mg/kg/ day (Females), based on kidney effects in males and females and
increased deaths in females. The Reproductive NOAEL is 750 mg/kg/day
for males and 1,000 mg/kg/day for females. A LOAEL was not established.
Offspring NOAEL is 500 mg/kg/day and the LOAEL is 1,000 mg/kg/day based
on decreased pup weight and body weight gain and slightly lower survival.

4. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility of rat or rabbit fetuses following in utero
exposure in the

[[Page 3646]]

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.

5. 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.

D. 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 the model estimates of
a pesticide's concentration in water (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 + chronic non-dietary, non-occupational
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 USEPA 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, EPA concludes with reasonable certainty that
exposures to fluroxypyr 1-methylheptyl ester in drinking water (when
considered along with other sources of exposure for which EPA has
reliable data) would not result in unacceptable levels of aggregate
human health risk at this time. Because EPA 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, EPA will
reassess the potential impacts of fluroxypyr 1-methylheptyl ester on
drinking water as a part of the aggregate risk assessment process.

1. Acute risk. An endpoint of concern was not identified to
quantitate acute-dietary risk to the general population or to the
subpopulation females 13-50 years old. As a result, no acute risk is
expected from exposure to fluroxypyr.

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 < 2% of the cPAD for
children (1-2 years old), the subpopulation at greatest exposure. Based
upon the use pattern, chronic (non-dietary) residential exposure to
residues of fluroxypyr is not expected.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 water and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in Table 2 of this unit.

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 LOC for aggregate exposure to food and residential
uses. In addition,

[[Page 3647]]

short-term DWLOCs were calculated and compared to the EECs for chronic
exposure of fluroxypyr in ground water and surface water. After
calculating DWLOCs and comparing them to the EECs for surface water and
ground water, EPA does not expect short-term aggregate exposure to
exceed the Agency's LOC, as shown in Table 3.

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 LOC 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 water and surface water. After calculating DWLOCs and
comparing them to the EECs for surface water and ground water, EPA does
not expect intermediate-term aggregate exposure to exceed the Agency's
LOC, as shown in Table 4. of this unit:

5. Aggregate cancer risk for U.S. population. Fluroxypyr has been
classified as not likely to be carcinogenic to humans. Therefore,
fluroxypyr is expected to pose at most a negligible 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 1-methylheptyl ester residues.

V. 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 onion. Harmonization is not an issue
for this time-limited tolerance.

VI. Conclusion
Therefore, the tolerance is established for combined residues of
fluroxypyr 1-methylheptyl ester, fluroxypyr 1-methylheptyl ester [1-
methylheptyl ((4-amino-3,5-dichloro-6-fluoro-2pyridinyl)oxy)acetate and
its metabolite fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-
pyridinyl)oxy)acetic acid], in or on onion at 0.02 ppm.

VII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the 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
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the 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 the FFDCA, as was provided in the old sections 408 and 409 of the
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

[[Page 3648]]

provided in this unit and in 40 CFR part 178. To ensure proper receipt
by EPA, you must identify docket ID number OPP-2005-0008 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 28, 2005.

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 (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.

2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by the docket ID number OPP-2005-0008, 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 ADDRESSES. 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).

VIII. Statutory and Executive Order Reviews
This final rule establishes a time-limited tolerance under section
408 of the FFDCA. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this rule is not subject
to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 exemption under section 408 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. 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 the
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 (59 FR 22951, 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

[[Page 3649]]

specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.

IX. 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: January 14, 2005.
Betty Shackleford,
Acting Director, Registration Division, Office of Pesticide Programs.

• Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
• 1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
• 2. Section 180.535 is amended by alphabetically adding a commodity to
the table in paragraph (b) to read as follows:
Sec. 180.535 Fluroxypyr 1-methylheptyl ester; tolerances for residues.
(b) * * *

* * * * *
[FR Doc. 05-1440 Filed 1-25-05; 8:45 am]
BILLING CODE 6560-50-S