[Federal Register Volume 66, Number 180 (Monday, September 17, 2001)]
[Rules and Regulations]
[Pages 47964-47971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23092]


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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: 
[email protected].

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: 
[email protected].

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 [email protected], 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: [email protected]. 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