[Federal Register Volume 70, Number 16 (Wednesday, January 26, 2005)]
[Rules and Regulations]
[Pages 3642-3649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1440]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0008; FRL-7695-2]


Fluroxypyr; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective January 26, 2005. Objections and 
requests for hearings must be received on or before March 28, 2005

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

FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; e-mail address: [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 entities may include, but are not limited to:
     Crop production (NAICS code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     Pesticide manufacturing (NAICS code 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions above. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

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

II. Background and Statutory Findings

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

[[Page 3643]]

is establishing a tolerance for combined residues of the herbicide 
fluroxypyr 1-methylheptyl ester 1-methylheptyl ((4-amino-3,5-dichloro-
6-fluoro-2-pyridinyl)oxy)acetate and its metabolite fluroxypyr [((4-
amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid], in or on 
onion at 0.02 parts per million (ppm). This tolerance will expire and 
is revoked on June 30, 2007. EPA will publish a document in the Federal 
Register to remove the revoked tolerance from the Code of Federal 
Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 of the FFDCA and the new safety standard to 
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State agency from any provision of FIFRA, if EPA determines that 
``emergency conditions exist which require such exemption.'' This 
provision was not amended by the Food Quality Protection Act of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

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

    According to the State of Colorado, due to a long string of mild 
winters, volunteer potatoes have become a more important problem. They 
are especially difficult to control in onions, and due to the 
noncompetitive nature of onions versus the large vigorous growth of 
volunteer potatoes, they result in very large yield reductions if not 
controlled. None of the currently registered herbicides for onions 
provide acceptable control of volunteer potatoes. EPA has authorized 
under FIFRA section 18 the use of fluroxypyr 1-methylheptyl ester on 
onion for control of volunteer potatoes in Colorado. After having 
reviewed the submission, EPA concurs that emergency conditions exist 
for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of fluroxypyr 1-methylheptyl 
ester in or on onion. In doing so, EPA considered the safety standard 
in section 408(b)(2) of the FFDCA, and EPA decided that the necessary 
tolerance under section 408(l)(6) of the FFDCA would be consistent with 
the safety standard and with FIFRA section 18. Consistent with the need 
to move quickly on the emergency exemption in order to address an 
urgent non-routine situation and to ensure that the resulting food is 
safe and lawful, EPA is issuing this tolerance without notice and 
opportunity for public comment as provided in section 408(l)(6) of the 
FFDCA. Although this tolerance will expire and is revoked on June 30, 
2007, under section 408(l)(5) of the FFDCA, residues of the pesticide 
not in excess of the amounts specified in the tolerance remaining in or 
on onion after that date will not be unlawful, provided the pesticide 
is applied in a manner that was lawful under FIFRA, and the residues do 
not exceed a level that was authorized by this tolerance at the time of 
that application. EPA will take action to revoke this tolerance earlier 
if any experience with, scientific data on, or other relevant 
information on this pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether fluroxypyr 1-
methylheptyl ester meets EPA's registration requirements for use on 
onion or whether a permanent tolerance for this use would be 
appropriate. Under these circumstances, EPA does not believe that this 
tolerance serves as a basis for registration of fluroxypyr 1-
methylheptyl ester by a State for special local needs under FIFRA 
section 24(c). Nor does this tolerance serve as the basis for any State 
other than Colorado to use this pesticide on this crop under section 18 
of FIFRA without following all provisions of EPA's regulations 
implementing FIFRA section 18 as identified in 40 CFR part 166. For 
additional information regarding the emergency exemption for fluroxypyr 
1-methylheptyl ester, contact the Agency's Registration Division at the 
address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of 
fluroxypyr 1-methylheptyl ester and to make a determination on 
aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for 
a time-limited tolerance for combined residues of fluroxypyr 1-
methylheptyl ester in or on onion at 0.02 ppm. EPA's assessment of the 
dietary exposures and risks associated with establishing the tolerance 
follows.

A. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological endpoint. However, the 
lowest dose at which adverse effects of concern are identified (the 
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved 
in the toxicology study selected. An uncertainty factor (UF) is applied 
to reflect uncertainties inherent in the extrapolation from laboratory 
animal data to humans and in the variations in sensitivity among 
members of the human population as well as other unknowns. An UF of 100 
is routinely used, 10X to account for interspecies differences and 10X 
for intraspecies differences.

[[Page 3644]]

    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (LOC). For example, when 100 is the 
appropriate UF (10X to account for interspecies differences and 10X for 
intraspecies differences) the LOC is 100. To estimate risk, a ratio of 
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is 
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for fluroxypyr 1-methylheptyl ester used for human risk 
assessment is shown in the following Table 1:

      Table 1.--Summary of Toxicological Dose and Endpoints for Fluroxypyr for Use in Human Risk Assessment
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                                          Dose Used in Risk       FQPA SF* and LOC for   Study and Toxicological
          Exposure Scenario                 Assessment, UF          Risk Assessment              Effects
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Acute dietary                          None                     None                     No effects were
(All populations)....................                                                     observed in oral
                                                                                          toxicity studies
                                                                                          (including
                                                                                          developmental
                                                                                          studies), which could
                                                                                          be attributed to a
                                                                                          single-dose exposure.
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Chronic dietary                        NOAEL = 100 mg/kg/day    FQPA SF = 1x             Chronic/oncogenicity -
(All populations)....................  UF = 100...............  cPAD = chronic RfD /      Rat
                                       Chronic RfD = 1 mg/kg/    FQPA SF = 1 mg/kg/day.  LOAEL = 100 mg/kg/day
                                        day.                                              based on kidney
                                                                                          effects.
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Short-term                             NOAEL = 100 mg/kg/day    Residential LOC for MOE  Chronic/oncogenicity -
Incidental oral (1-30 days)..........                            = 100                    Rat
                                                                Occupational = NA......  LOAEL = 100 mg/kg/day
                                                                                          based on kidney
                                                                                          effects.
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Intermediate-term                      NOAEL= 100 mg/kg/day     Residential LOC for MOE  Chronic/oncogenicity -
Incidental oral (1-6 months).........                            = 100                    Rat
                                                                Occupational = NA......  LOAEL = 100 mg/kg/day
                                                                                          based on kidney
                                                                                          effects.
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Dermal                                 Dermal (or oral) study   Residential LOC for MOE  Quantification not
(All durations)......................   NOAEL = NA               = NA                     required since 21-day
                                                                Occupational LOC for      dermal Rabbit
                                                                 MOE = NA.               NOAEL = 1,000 mg/kg/day
                                                                                          and there is no
                                                                                          developmental toxicity
                                                                                          concern.
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Inhalation                             Inhalation (or oral)     Residential LOC for MOE  Chronic/oncogenicity -
(All durations)......................   study NOAEL= 100 mg/kg/  = 100                    Rat
                                        day (inhalation         Occupational LOC for     LOAEL = 100 mg/kg/day
                                        absorption rate =        MOE = 100.               based on kidney
                                        100%)                                             effects.
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Cancer (oral, dermal, inhalation)            Fluroxypyr is classified as a ``not likely'' human carcinogen.
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* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.535) for the combined residues of fluroxypyr 1-
methylheptyl ester and its metabolite fluroxypyr, in or on a variety of 
raw agricultural commodities including barley, corn, grass, oats, 
sorghum, wheat, milk, and meat, kidney, meat byproducts and fat of 
cattle, goat, hog, horse, and sheep. Risk assessments were conducted by 
EPA to assess dietary exposures from fluroxypyr 1-methylheptyl ester in 
food as follows:
    i. Acute exposure. Quantitative Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a one day or single exposure. There were no toxic effects 
attributable to a single dose. Therefore, an endpoint of concern was 
not identified to quantitate acute-dietary risk to the general 
population or to the subpopulation females 13-50 years old. As a 
result, no acute risk is expected from exposure to fluroxypyr and hence 
no quantitative acute dietary risk assessment was performed.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\, version 1.3) which 
incorporates food consumption data as reported by respondents in the 
USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII) and accumulated exposure to the chemical for each

[[Page 3645]]

commodity. The following assumptions were made: an unrefined, Tier 1 
chronic-dietary exposure assessment using tolerance-level residues and 
assuming 100% crop treated (CT) for all commodities, and default 
processing factors for all commodities.
    iii. Cancer. Fluroxypyr has been classified as not likely to be 
carcinogenic to humans. Therefore, a quantitative exposure assessment 
was not conducted to assess cancer risk.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for fluroxypyr 1-methylheptyl 
ester in drinking water. Because the Agency does not have comprehensive 
monitoring data, drinking water concentration estimates are made by 
reliance on simulation or modeling taking into account data on the 
physical characteristics of fluroxypyr 1-methylheptyl ester.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW, which predicts pesticide concentrations in ground water. In 
general, EPA will use GENEEC (a Tier 1 model) before using PRZM/EXAMS 
(a Tier 2 model) for a screening-level assessment for surface water. 
The GENEEC model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. GENEEC incorporates a 
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir 
environment in place of the previous pond scenario. The PRZM/EXAMS 
model includes a percent crop area factor as an adjustment to account 
for the maximum percent crop coverage within a watershed or drainage 
basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to fluroxypyr 1-methylheptyl 
ester they are further discussed in the aggregate risk sections below.
    Based on the GENEEC and SCI-GROW models the estimated environmental 
concentrations (EECs) of fluroxypyr 1-methylheptyl ester for chronic 
exposures are estimated to be 1.6 ppb for surface water and 0.017 ppb 
for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Fluroxypyr is 
currently registered for use on the following residential non-dietary 
sites: Residential turfgrass and recreational sites such as golf 
courses and sports fields. The risk assessment was conducted using the 
following residential exposure assumptions: Adults and children may be 
exposed to fluroxypyr residues from dermal contact with turf during 
postapplication activities. Toddlers may receive short- and 
intermediate-term oral exposure from incidental ingestion during 
postapplication activities. Residential handlers may receive short-term 
dermal and inhalation exposure to fluroxypyr when mixing, loading and 
applying the formulations.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether fluroxypyr 1-methylheptyl ester has a common mechanism of 
toxicity with other substances or how to include this pesticide in a 
cumulative risk assessment. Unlike other pesticides for which EPA has 
followed a cumulative risk approach based on a common mechanism of 
toxicity, fluroxypyr 1-methylheptyl ester does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that fluroxypyr 1-
methylheptyl ester has a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see the final rule for Bifenthrin 
Pesticide Tolerances (62 FR 62961, November 26, 1997).

C. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Developmental toxicity studies. In a prenatal developmental 
study in rats the Maternal NOAEL is 300 mg/kg/day and the LOAEL is 600 
mg/kg/day based on increased maternal deaths and decreased body weight 
gains and food consumption. The Developmental NOAEL is 600 mg/kg/day 
and a LOAEL was not established.
    In a prenatal developmental study in rabbits the Maternal NOAEL is 
500 mg/kg/day and the LOAEL is 1,000 mg/kg/day based on increased 
abortions. The Developmental NOAEL is 500 mg/kg/day and the LOAEL is 
1,000 mg/kg/day based on increased abortions.
    3. Reproductive toxicity study. In a reproduction and fertility 
study the Parental/Systemic NOAEL is 100 mg/kg/day effects (Males) and 
500 mg/kg/day (Females) with a LOAEL of 500 mg/kg/day (Males) / 1,000 
mg/kg/ day (Females), based on kidney effects in males and females and 
increased deaths in females. The Reproductive NOAEL is 750 mg/kg/day 
for males and 1,000 mg/kg/day for females. A LOAEL was not established. 
Offspring NOAEL is 500 mg/kg/day and the LOAEL is 1,000 mg/kg/day based 
on decreased pup weight and body weight gain and slightly lower 
survival.
    4. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of rat or rabbit fetuses following in utero 
exposure in the

[[Page 3646]]

developmental studies with fluroxypyr. There is no evidence of 
increased susceptibility of rats in the reproduction study with 
fluroxypyr. EPA concluded there are no residual uncertainties for 
prenatal and/or postnatal exposure.
    5. Conclusion. There is a complete toxicity data base for 
fluroxypyr and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the 10X SF to protect infants and children should be removed and 
instead, a different additional safety factor of 1X should be used. The 
FQPA factor is removed because: There is no evidence (quantitative/ 
qualitative) of increased susceptibility following in utero exposure to 
the acid and the ester of fluroxypyr in rats and rabbits, or following 
pre and/or postnatal exposure to the acid of fluroxypyr in rats; there 
are no concerns or residual uncertainties for pre- and/or post-natal 
toxicity; there is no evidence of neurotoxicity or neuropathology in 
the available studies; the toxicological database is complete for FQPA 
assessment; the chronic dietary food exposure assessment utilizes 
tolerance level residue estimates and assumes 100% CT for all 
commodities, thus not likely to underestimate exposure/risk; the 
dietary drinking water assessment utilizes water concentration values 
generated by model and associated modeling parameters which are 
designed to provide conservative, health protective, high-end estimates 
of water concentrations which will not likely be exceeded; and the 
residential exposure assessment was conducted using standard 
assumptions which are based on carefully reviewed data.

D. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water [e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + chronic non-dietary, non-occupational 
exposure)]. This allowable exposure through drinking water is used to 
calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to fluroxypyr 1-methylheptyl ester in drinking water (when 
considered along with other sources of exposure for which EPA has 
reliable data) would not result in unacceptable levels of aggregate 
human health risk at this time. Because EPA considers the aggregate 
risk resulting from multiple exposure pathways associated with a 
pesticide's uses, levels of comparison in drinking water may vary as 
those uses change. If new uses are added in the future, EPA will 
reassess the potential impacts of fluroxypyr 1-methylheptyl ester on 
drinking water as a part of the aggregate risk assessment process.
    1. Acute risk. An endpoint of concern was not identified to 
quantitate acute-dietary risk to the general population or to the 
subpopulation females 13-50 years old. As a result, no acute risk is 
expected from exposure to fluroxypyr.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
fluroxypyr from food will utilize <1% of the cPAD for the U.S. 
population, <1% of the cPAD for all infants, and <2% of the cPAD for 
children (1-2 years old), the subpopulation at greatest exposure. Based 
upon the use pattern, chronic (non-dietary) residential exposure to 
residues of fluroxypyr is not expected.In addition, there is potential 
for chronic dietary exposure to fluroxypyr in drinking water. After 
calculating DWLOCs and comparing them to the EECs for surface water and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD, as shown in Table 2 of this unit.

    Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Fluroxypyr 1-methylheptyl ester
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
 
--------------------------------------------------------------
U.S. population                                            1          <1%          1.6        0.017       35,000
--------------------------------------------------------------
All infants                                                1          <1%          1.6        0.017       10,000
--------------------------------------------------------------
Children (1-2 years old)                                   1          <2%          1.6        0.017        9,900
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Fluroxypyr is currently 
registered for use that could result in short-term residential exposure 
and the Agency has determined that it is appropriate to aggregate 
chronic food and water and short-term exposures for fluroxypyr. Using 
the exposure assumptions described in this unit for short-term 
exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 31,000 for the U.S. population 
and 4,500 for children (1-2 years old). These aggregate MOEs do not 
exceed the Agency's LOC for aggregate exposure to food and residential 
uses. In addition,

[[Page 3647]]

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

         Table 3.--Aggregate Risk Assessment for Short-Term Exposure to Fluroxypyr 1-methylheptyl ester
----------------------------------------------------------------------------------------------------------------
                                                  Aggregate                  Surface       Ground
              Population Subgroup                MOE (Food +   Aggregate    Water EEC    Water EEC    Short-Term
                                                Residential)      LOC         (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                       31,000          100          1.6        0.017       35,000
--------------------------------------------------------------
Children (1-2 years old)                               4,500          100          1.6        0.017        4,500
----------------------------------------------------------------------------------------------------------------

    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Fluroxypyr is 
currently registered for use(s) that could result in intermediate-term 
residential exposure and the Agency has determined that it is 
appropriate to aggregate chronic food and water and intermediate-term 
exposures for fluroxypyr. Using the exposure assumptions described in 
this unit for intermediate-term exposures, EPA has concluded that food 
and residential exposures aggregated result in aggregate MOEs of 31,000 
for the U.S. population and 4,500 for children (1-2 years old). These 
aggregate MOEs do not exceed the Agency's LOC for aggregate exposure to 
food and residential uses. In addition, intermediate-term DWLOCs were 
calculated and compared to the EECs for chronic exposure of fluroxypyr 
in ground water and surface water. After calculating DWLOCs and 
comparing them to the EECs for surface water and ground water, EPA does 
not expect intermediate-term aggregate exposure to exceed the Agency's 
LOC, as shown in Table 4. of this unit:

      Table 4.--Aggregate Risk Assessment for Intermediate-Term Exposure to Fluroxypyr 1-methylheptyl ester
----------------------------------------------------------------------------------------------------------------
                                                  Aggregate                  Surface       Ground
              Population Subgroup                MOE (Food +   Aggregate    Water EEC    Water EEC    Short-Term
                                                Residential)      LOC         (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                       31,000          100          1.6        0.017       35,000
--------------------------------------------------------------
Children (1-2 years old)                               4,500          100          1.6        0.017        4,500
----------------------------------------------------------------------------------------------------------------

    5. Aggregate cancer risk for U.S. population. Fluroxypyr has been 
classified as not likely to be carcinogenic to humans. Therefore, 
fluroxypyr is expected to pose at most a negligible cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to fluroxypyr 1-methylheptyl ester residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    The gas chromatography/mass selective detector (GC/MSD) enforcement 
method, submitted by Dow AgroSciences LLC, has been validated for the 
determination of residues of fluroxypyr and fluroxypyr 1-MHE as the 
acid equivalent in plant commodities. The method for livestock 
commodities has been validated for the determination of residues of 
fluroxypyr and fluroxypyr 1-MHE in cow milk and liver. The proposed 
plant and animal method is adequate for enforcement of tolerances in/on 
field corn, sweet corn, sorghum, range and pasture grass, and animal 
commodities as a result of this use. Fluroxypyr has been tested through 
the FDAs Multiresidue Methodology, Protocols C, D, and E. The results 
have been published in the FDA Pesticide Analytical Manual, Volume I.

B. International Residue Limits

    There is neither a Codex proposal, nor Canadian or Mexican limits, 
for residues of fluroxypyr in/on onion. Harmonization is not an issue 
for this time-limited tolerance.

VI. Conclusion

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

VII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of the FFDCA, as was provided in the old sections 408 and 409 of the 
FFDCA. However, the period for filing objections is now 60 days, rather 
than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions

[[Page 3648]]

provided in this unit and in 40 CFR part 178. To ensure proper receipt 
by EPA, you must identify docket ID number OPP-2005-0008 in the subject 
line on the first page of your submission. All requests must be in 
writing, and must be mailed or delivered to the Hearing Clerk on or 
before March 28, 2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by the docket ID number OPP-2005-0008, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [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. Statutory and Executive Order Reviews

    This final rule establishes a time-limited tolerance under section 
408 of the FFDCA. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under section 408 of the FFDCA, such as the 
[tolerance in this final rule, do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers, and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of the 
FFDCA. For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (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

[[Page 3649]]

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

IX. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

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

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.535 is amended by alphabetically adding a commodity to 
the table in paragraph (b) to read as follows:


Sec.  180.535   Fluroxypyr 1-methylheptyl ester; tolerances for 
residues.

    (b) * * *

------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    revocation date
------------------------------------------------------------------------
                                * * * * *
Onion...........................  0.02                6/30/07
                                * * * * *
------------------------------------------------------------------------

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