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Fluroxypyr 1-Methylheptyl Ester. September 17, 2001. Pesticide Tolerances for Emergency Exemptions. Final Rule. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2001/September/Day-17/p23092.htm
[Federal Register: September 17, 2001 (Volume 66, Number 180)]
[Rules and Regulations]
[Page 47964-47971]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se01-4]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301164; FRL-6798-5]
RIN 2070-AB78
Fluroxypyr 1-Methylheptyl Ester; Pesticide Tolerances for
Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for the
combined residues of fluroxypyr 1-methylheptyl ester and its metabolite
fluroxypyr, free and conjugated, all expressed as fluroxypyr in or on
grass, forage and grass, hay and modifies the existing permanent
tolerances for milk and for kidney of cattle, goat, hog, horse, and
sheep. This action is in response to EPA's granting of an emergency
exemption under section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act authorizing use of the pesticide on pastures and
rangeland. This regulation establishes maximum permissible levels for
residues of fluroxypyr 1-methylheptyl ester and its metabolite
fluroxypyr, free and conjugated, all expressed as fluroxypyr in these
food commodities. The tolerances will expire and are revoked on June
30, 2003.
DATES: This regulation is effective September 17, 2001. Objections and
requests for hearings, identified by docket control number OPP-301164,
must be received by EPA on or before November 16, 2001.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301164 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 308-9367, and e-mail address:
ertman.andrew@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 categories and entities may include, but are not
limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
.............................. 112 Animal production
311 Food manufacturing
.............................. 32532 Pesticide
manufacturing
------------------------------------------------------------------------
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 the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
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 Additional Information, Including Copies of This
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently
under development.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301164. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA,
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The PIRIB telephone number is (703) 305-5805.
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, is establishing tolerances for the combined residues of
the herbicide fluroxypyr 1-methylheptyl ester and its metabolite
fluroxypyr, free and
[[Page 47965]]
conjugated, all expressed as fluroxypyr, in or on grass, forage at 120
part per million (ppm), grass, hay at 160 ppm, and modifying the
permanent tolerances for milk from 0.1 ppm to 0.30 ppm and for kidney
(cattle, goat, hog, horse, and sheep) from 0.5 ppm to 1.5 ppm. These
tolerances will expire and are revoked on June 30, 2003. EPA will
publish a document in the Federal Register to remove the revoked
tolerances 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 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) 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)
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 Federal Insecticide, Fungicide, and Rodenticide
Act (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 (FQPA). EPA has established regulations
governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Fluroxypyr on Pastures and Rangeland
and FFDCA Tolerances
Sericea lespedeza (also known as Chinese bush clover) is a
perennial legume native to Asia that was introduced into the United
States in 1896 for use as forage for livestock and as an erosion
control plant. It was first recognized as a potential weed problem in
southeast Kansas in the early 1980s. The Kansas Legislature made
sericea lespedeza a statewide noxious weed effective July 1, 2000. It
is the first federally listed crop to be declared a noxious weed.
While sericea lespedeza remains a relatively important forage crop
in several southeastern states, it has become an invasive weed in tall
grass and high plains prairie lands. Sericea aggressively competes with
native prairie plants, and can result in a substantial reduction of
native grasses and broadleaf plants. Researchers at Emporia State
University (Emporia, Kansas) found that the number of grass and forb
species in severely infested fields in east-central Kansas declined by
66% and 74% respectively. In a Kansas State University study, native
grass production was reduced by as much as 80% when compared to non-
infested areas. In addition, sericea lespedeza develops high tannin
levels under the low rainfall conditions that exist in Kansas and
becomes unpalatable to cattle as it matures. EPA has authorized under
FIFRA section 18 the use of fluroxypyr on pastures and rangeland for
control of sericea lespedeza in Kansas. 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 in or on grass
forage and hay and their associated commodities. In doing so, EPA
considered the safety standard in FFDCA section 408(b)(2), and EPA
decided that the necessary tolerances under FFDCA section 408(l)(6)
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 these tolerances
without notice and opportunity for public comment as provided in
section 408(l)(6). Although these tolerances will expire and are
revoked on June 30, 2003, under FFDCA section 408(l)(5), residues of
the pesticide not in excess of the amounts specified in the tolerance
remaining in or on grass forage and hay and their associated
commodities 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 these tolerances
at the time of that application. EPA will take action to revoke these
tolerances earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
Because these tolerances is being approved under emergency
conditions, EPA has not made any decisions about whether fluroxypyr
meets EPA's registration requirements for use on pastures and rangeland
or whether permanent tolerances for this use would be appropriate.
Under these circumstances, EPA does not believe that these tolerances
serve as a basis for registration of fluroxypyr by a State for special
local needs under FIFRA section 24(c). Nor do these tolerances serve as
the basis for any State other than Kansas to use this pesticide on this
crop under section 18 of FIFRA without following all provisions of
EPA's regulations implementing section 18 as identified in 40 CFR part
166. For additional information regarding the emergency exemption for
fluroxypyr, 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 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), 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 and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for time-limited tolerances for
combined residues of fluroxypyr 1-methylheptyl ester and its metabolite
fluroxypyr, free and conjugated, all expressed as fluroxypyr, in or on
grass, forage at 120 ppm, grass, hay at 160 ppm, and modifying the
permanent tolerances for milk from 0.1 ppm to 0.30 ppm and for
[[Page 47966]]
kidney (cattle, goat, hog, horse, and sheep) from 0.5 ppm to 1.5 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.
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 safety factor.
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 x 10-6 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 (MOE cancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for fluroxypyr used for human risk assessment is shown in the
following Table 1:
Table 1. -- Summary of Toxicological Dose and Endpoints for Fluroxypyr for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk FQPA SF and Endpoint/ Study and Toxicological
Exposure Scenario Assessment, UF LOC for Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary females 13-50 years of Developmental FQPA SF = 3x Developmental rabbit
age NOAEL = 100 mg/kg/day.. aPAD = acute RfD....... Developmental LOAEL =
UF = 100............... FQPA SF = 0.33 mg/kg/ 250 mg/kg/day, based
Acute RfD = 1.0 mg/kg/ day. on increased
day. postimplantation loss.
----------------------------------------------------------------------------------------------------------------
Acute dietary general population A dose and endpoint were not selected for this population group because
including infants and children there were no effects observed in oral toxicology studies including
maternal toxicity in the developmental toxicity studies in rats and
rabbits that are attributable to a single exposure (dose). A risk
assessment is not required for this population subgroup.
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations NOAEL = 50 mg/kg/day FQPA SF = 1X 28-day dog range-
UF = 100............... cPAD = cRfD =.......... finding feeding study
Chronic RfD = 0.50 mg/ FQPA SF = 0.50 mg/kg/ LOAEL = 150 mg/kg/day
kg/day. day. based on
histopathological
lesions in the
kidneys, decreased
testes weights, and
increased adrenal
weights in both sexes.
----------------------------------------------------------------------------------------------------------------
Incidental, Oral: Since there are no residential uses, toxicology endpoints were not
Short-term (1-7 days),............... proposed/selected for any exposure scenarios.
Intermediate-term (1 week - several
months),.
Long-term (several months - lifetime)
(Residential)........................
----------------------------------------------------------------------------------------------------------------
Dermal1 and Inhalation2, Oral NOAEL= 100 mg/kg/ LOC for MOE = 100 Developmental rabbit
Short-term (1-7days)................. day (Occupational)......... study
(Occupational/Residential)........... Developmental LOAEL =
250 mg/kg/day, based
on increased
postimplantation loss.
----------------------------------------------------------------------------------------------------------------
Dermal1 and Inhalation 2: Oral NOAEL= 100 mg/kg/ LOC for MOE = 100 Developmental rabbit
Intermediate-term (1 week-several day (Occupational)......... study
months). Developmental LOAEL =
(Occupational/Residential)........... 250 mg/kg/day, based
on increased
postimplantation loss.
----------------------------------------------------------------------------------------------------------------
1 Since an oral NOAEL was selected, a dermal absorption factor of 100% (default value) should be used in route-
to-route extrapolation.
2 Since an oral NOAEL was selected, an inhalation absorption factor of 100% (default value) should be used in
route-to-route extrapolation.
[[Page 47967]]
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,
in or on a variety of raw agricultural commodities, including meat,
milk, poultry and eggs. 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. The Dietary Exposure Evaluation Model (DEEM)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1989-1992 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 acute
exposure assessments: For the acute analysis, published and proposed
tolerances level residues were used. Default concentration factors and
100% CT was assumed for all commodities.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEM analysis evaluated the individual food consumption
as reported by respondents in the USDA 1989-1992 nationwide CSFII and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the chronic exposure assessments: For the
chronic analysis, published and proposed tolerances level residues were
used. Default concentration factors and 100% CT was assumed for all
commodities.
iii. Cancer. The Agency has classified fluroxypyr as ``not likely''
to be a human carcinogen, therefore this risk assessment is not
required.
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 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
Screening Concentrations in Ground Water (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 they are further
discussed in the aggregate risk sections below.
Based on the GENEEC and SCI-GROW models the EECs of fluroxypyr for
acute exposures are estimated to be 7.6 parts per billion (ppb) for
surface water and 0.017 ppb for ground water. The EECs 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 not registered for use on any sites that would result
in residential exposure.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' aggregate exposure 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 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 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 final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
C. Safety Factor for Infants and Children
1. In general. FFDCA section 408 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 margin of exposure
(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 the developmental study in
rats, the maternal (systemic) NOAEL was 125 milligrams/kilograms/day
(mg/kg/day), based on clinical signs at the LOAEL of 250 mg/kg/day. The
developmental (fetal) NOAEL was 250 mg/kg/day, based on reduced
ossification at the LOAEL of 500 mg/kg/day.
In the developmental toxicity study in rabbits, the maternal
(systemic) NOAEL was 250 mg/kg/day, based on maternal deaths at the
LOAEL of 400 mg/kg/day.
[[Page 47968]]
The developmental (pup) NOAEL was 125 mg/kg/day, based on increased
postimplantation loss at the LOAEL of 250 mg/kg/day.
3. Reproductive toxicity study. In the 2-generation reproductive
toxicity study in rats, the maternal (systemic) NOAEL was 100 mg/kg/
day, based on increased kidney weights and kidney histopathology at the
LOAEL of 500 mg/kg/day. The developmental (pup) NOAEL was 500 mg/kg/
day, based on decreased body weight at the LOAEL of 1,000 mg/kg/day.
The reproductive NOAEL was 1,000 mg/kg/day (HDT).
4. Prenatal and postnatal sensitivity. The toxicological data base
for evaluating prenatal and postnatal toxicity for fluroxypyr is
complete with respect to current data requirements. Based on the
results of the rabbit developmental toxicity study for fluroxypyr there
does appear to be an extra sensitivity for prenatal effects.
5. Conclusion. Based on the above, EPA concludes that reliable data
support use of a 300 fold margin of exposure/uncertainty factor, rather
than the standard 1,000 fold margin/factor, to protect infants and
children.
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 US EPA Office of Water are used to calculate
DWLOCs: 2Liter/70 kilogram (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 fluroxypyr 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
fluroxypyr on drinking water as a part of the aggregate risk assessment
process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
fluroxypyr will occupy 1.5% of the aPAD for females 13-50 years old,
the only population sub-group of concern. A dose and endpoint were not
selected for the U.S. population, including infants and children
because there were no effects observed in oral toxicology studies
including maternal toxicity in the developmental toxicity studies in
rats and rabbits that are attributable to a single exposure (dose).
Therefore, a risk assessment is not required for this population
subgroup.
In addition, despite the potential for acute dietary exposure to
fluroxypyr in drinking water, after calculating DWLOCs and comparing
them to conservative model estimated environmental concentrations of
fluroxypyr in surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, as shown in the
following Table 2:
Table 2. -- Aggregate Risk Assessment for Acute Exposure to Fluroxypyr
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ %aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 0.33 1.5 7.6 0.017 9,700
----------------------------------------------------------------------------------------------------------------
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 0.6% of the cPAD for the U.S.
population, 0.9% of the cPAD for all infants < 1 year old and 2.1% of
the cPAD for children 1-6 years old. There are no residential uses for
fluroxypyr that result in chronic residential exposure to fluroxypyr.
In addition, despite the potential for chronic dietary exposure to
fluroxypyr in drinking water, after calculating DWLOCs and comparing
them to conservative model estimated environmental concentrations of
fluroxypyr in surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the cPAD, as shown in the
following Table 3:
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 (48 contiguous states) 0.50 0.6 1.6 0.017 17,000
----------------------------------------------------------------------------------------------------------------
All infants (< 1 year old) 0.50 0.9 1.6 0.017 5,000
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 0.50 2.1 1.6 0.017 4,900
----------------------------------------------------------------------------------------------------------------
[[Page 47969]]
Children (7-12 years old) 0.50 1.1 1.6 0.017 4,900
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 0.50 0.4 1.6 0.017 15,000
----------------------------------------------------------------------------------------------------------------
Males (13-19 years old) 0.50 0.7 1.6 0.017 17,000
----------------------------------------------------------------------------------------------------------------
Males (20+ years old) 0.50 0.4 1.6 0.017 17,000
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years old) 0.50 0.4 1.6 0.017 17,000
----------------------------------------------------------------------------------------------------------------
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 not registered for use on any sites that would result
in residential exposure. Therefore, the aggregate risk is the sum of
the risk from food and water, which were previously addressed.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Fluroxypyr is not registered for use on any sites that would result
in residential exposure. Therefore, the aggregate risk is the sum of
the risk from food and water, which were previously addressed.
5. Aggregate cancer risk for U.S. population. The Agency has
classified fluroxypyr as ``not likely'' to be a human carcinogen,
therefore this risk assessment is not required.
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.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (example - gas chromotography) is
available to enforce the tolerance expression. The method may be
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.
B. International Residue Limits
There are no CODEX, Canadian, or Mexican Maximum Residue Limits
(MRLs) for fluroxypyr on grass.
VI. Conclusion
Therefore, tolerances are established for the combined residues of
fluroxypyr 1-methylheptyl ester and its metabolite fluroxypyr, free and
conjugated, all expressed as fluroxypyr, in or on grass, forage at 120
part per million (ppm), grass, hay at 160 ppm, and the permanent
tolerances are modified for milk from 0.1 ppm to 0.30 ppm and for
kidney (cattle, goat, hog, horse, and sheep) from 0.5 ppm to 1.5 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 of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409.
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 control number OPP-301164 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 November
16, 2001.
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 (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. 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) 260-4865.
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
[[Page 47970]]
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.
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.
3. 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 Unit I.B.2. Mail your
copies, identified by the docket control number OPP -301164, 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.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. 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. Regulatory Assessment Requirements
This final rule establishes time-limited tolerances under FFDCA
section 408. 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 prior consultation as specified by Executive Order
13084, entitled Consultation and Coordination with Indian Tribal
Governments (63 FR 27655, May 19, 1998); special considerations as
required by Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or require 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 FFDCA
section 408, such as the tolerances 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 FFDCA section 408(n)(4). 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.
IX. Submission to Congress and the Comptroller General
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,
[[Page 47971]]
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: August 30, 2001.
James Jones,
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), 346(a) and 371.
2. Section 180.535 is amended by alphabetically adding the
following commodities to the table in paragraph (b) to read as follows:
Sec. 180.535 Fluroxypyr 1-methylheptyl ester; tolerances for residues.
* * * * *
(b)* * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
* * * * *
Grass, forage..................... 120 6/30/03
Grass hay......................... 160 6/30/03
Kidney, cattle.................... 1.5 6/30/03
Kidney, goat...................... 1.5 6/30/03
Kidney, hog....................... 1.5 6/30/03
Kidney, horse..................... 1.5 6/30/03
Kidney, sheep..................... 1.5 6/30/03
Milk.............................. 0.30 6/30/03
------------------------------------------------------------------------
* * * * *
[FR Doc. 01-23092 Filed 9-14-01; 8:45am]
BILLING CODE 6560-50-S
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Last Updated: Sep 17 15:01:00 2001
URL: http://www.epa.gov/fedrgstr/EPA-PEST/2001/September/Day-17/p23092.htm