[Federal Register Volume 68, Number 250 (Wednesday, December 31, 2003)]
[Rules and Regulations]
[Pages 75430-75438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-32007]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0377; FRL-7340-5]


Fluroxypyr; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
fluroxypyr in or on field corn, sweet corn, sorghum, range and pasture 
grass. Dow AgroSciences LLC requested this tolerance under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act of 1996 (FQPA).

DATES: This regulation is effective December 31, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0377, 
must be received on or before March 1, 2004.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703)305-6224; e-mail address: 
[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:
    [sbull] Crop production (NAICS 111), e.g., Agricultural workers; 
Greenhouse, nursery, and floriculture workers; Farmers.
    [sbull] Animal production (NAICS 112), e.g., Cattle ranchers and 
farmers, Dairy cattle farmers, Livestock farmers.
    [sbull] Food manufacturing (NAICS 311), e.g., Agricultural workers; 
Farmers; Greenhouse, nursery, and floriculture workers; Ranchers; 
Pesticide applicators.
    [sbull] Pesticide manufacturing (NAICS 32532), e.g., Agricultural 
workers; Commercial applicators; Farmers; Greenhouse, nursery, and 
floriculture workers; Residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0377. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall  2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m.,

[[Page 75431]]

Monday through Friday, excluding legal holidays. The docket telephone 
number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html/, a 
beta site currently under development. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of May 14, 2003 (68 FR 25883) (FRL-7301-3), 
EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, 
as amended by FQPA (Public Law 104-170), announcing the filing of a 
pesticide petition (PP 9F6050) by Dow AgroSciences LLC, 9330 Zionville 
Road, Indianapolis, IN 46268. That notice included a summary of the 
petition prepared by Dow AgroSciences LLC, the registrant. There were 
no comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.535 be amended by 
establishing tolerances for combined residues of the herbicide 
fluroxypyr 1-methylheptyl ester [((4-amino-3,5-dichloro-6-fluoro-2-
pyridinyl)oxy) acetic acid, 1-methylheptyl] and its metabolite 
fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy) acetic 
acid], free and conjugated, all expressed as fluroxypyr, in or on the 
following raw agricultural commodities: Sweet corn at 0.02 parts per 
million (ppm) for kernels plus cob with husk removed, and forage and 
stover at 1.0 ppm. Tolerances for residues of fluroxypyr in or on field 
corn are being proposed in support of this registration as follows: 
grain, 0.02 ppm; forage, 1.0 ppm; and stover, 0.5 ppm. Tolerances for 
residues of fluroxypyr in or on sorghum as follows: Grain, 0.02 ppm; 
forage, 2.0 ppm; and stover, 4.0 ppm. Tolerances for residues of 
fluroxypyr in or on grasses as follows: Forage, 120 ppm; hay, 160 ppm; 
and grass silage, 100 ppm. Increased tolerances are also proposed for 
fluroxypyr in or on the following animal commodities: Milk of cattle, 
goats, hogs, horses and sheep at 0.3 ppm; and kidney of cattle, goats, 
hogs, horses and sheep at 1.5 ppm.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that`` there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for tolerances for combined residues of fluroxypyr 
on or in field corn, grain at 0.02 ppm; field corn, forage at 1.0 ppm; 
field corn, stover at 0.5 ppm; on or in sweet corn, kernels plus cob 
with husks removed at 0.02 ppm; sweet corn, forage at 1.0 ppm; sweet 
corn, stover at 2.0 ppm; on or in sorghum, grain at 0.02 ppm; sorghum, 
forage at 2.0 ppm; sorghum, stover (fodder) at 4.0 ppm; on or in grass, 
forage at 120 ppm; grass, hay at 160 ppm; and a tolerance for combined 
residues of fluroxypyr on cattle, milk; goat, milk; hog, milk; horse, 
milk; and sheep, milk at 0.3 ppm; and on cattle, kidney; goat, kidney; 
hog, kidney; horse, kidney; and sheep, kidney at 1.5 ppm. EPA's 
assessment of exposures and risks associated with establishing the 
tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by fluroxypyr are 
discussed in Table 1 of this unit as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies reviewed.

                                Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity--Rats  NOAEL = 700 milligram/kilogram/day (mg/kg/
                                                                      day)
                                                                     LOAEL = 1,000 mg/kg/day based on decreased
                                                                      body weight gain & testis weight (M),
                                                                      decreased brain weight (F), and increased
                                                                      kidney weight (M/F).
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity--Mice  NOAEL = 1,342 mg/kg/day (Males)/ 1,748 mg/
                                                                      kg/day (Females)
                                                                     LOAEL not established.
----------------------------------------------------------------------------------------------------------------

[[Page 75432]]

 
870.3200                                 21/28-Day dermal toxicity   NOAEL = 1,000 mg/kg/day
                                                                     LOAEL not established
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental--    Maternal NOAEL = 300 mg/kg/day
                                          Rodents                    LOAEL = 600 mg/kg/day based on increased
                                                                      maternal deaths and decreased body weight
                                                                      gains and food consumption.
                                                                     Developmental
                                                                     NOAEL = 600 mg/kg/day
                                                                     LOAEL not established.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental--    Maternal NOAEL = 500 mg/kg/day
                                          Nonrodents                 LOAEL = 1,000 mg/kg/day based on increased
                                                                      abortions.
                                                                     Developmental
                                                                     NOAEL = 500 mg/kg/day
                                                                     LOAEL = 1,000 mg/kg/day based on increased
                                                                      abortions.
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  Parental/Systemic NOAEL = 100 mg/kg/day
                                          effects                     (Males) / 500 mg/kg/day (Females)
                                                                     LOAEL = 500 mg/kg/day (Males) / 1,000 mg/kg/
                                                                      day (Females), based on kidney effects
                                                                      (M&F) and increased deaths (F).
                                                                     Reproductive NOAEL = 750 mg/kg/day (Males)
                                                                       1,000 mg/kg/day (Females).
                                                                     LOAEL not established.
                                                                     Offspring NOAEL = 500 mg/kg/day
                                                                     LOAEL = 1,000 mg/kg/day based on decreased
                                                                      pup weight and body weight gain and
                                                                      slightly lower survival.
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity--Dogs      NOAEL = 150 mg/kg/day
                                                                     LOAEL not established.
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity--Mice       NOAEL = 300 mg/kg/day (Males/Females)
                                                                     LOAEL = 1,000 mg/kg/day based on decreased
                                                                      body weight and body weight gain (M) and
                                                                      increased kidney lesions (F).(no) evidence
                                                                      of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity--Rats       NOAEL = 100 mg/kg/day
                                                                     LOAEL = 500 mg/kg/day based on chronic
                                                                      progressive kidney glomerulonephropathy
                                                                      (M&F).(no) evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.5100                                 Bacterial reverse mutation  Negative.
----------------------------------------------------------------------------------------------------------------
870.5300                                 In vitro mammalian cell     Negative, but did not test a soluble dose.
                                          gene mutation
----------------------------------------------------------------------------------------------------------------
870.5375                                 In vitro mammalian          Negative.
                                          chromosome aberration
                                          (HL)
----------------------------------------------------------------------------------------------------------------
870.5395                                 Mammalian micronucleus      Negative.
                                          (mouse)
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and              Total recovery of the administered dose was
                                          pharmacokinetics            105%, with the principal route of
                                                                      excretion being expired 14CO2, which
                                                                      contained approximately 61% of the
                                                                      radioactivity for the fluroxypyr MHE. The
                                                                      urine contained approximately 30% and the
                                                                      feces contained 5% of the administered
                                                                      dose. At 48 hours post dose, approximately
                                                                      7% of the administered dose was recovered
                                                                      in the blood, carcass, and skin.
                                                                      Approximately 52% of the administered dose
                                                                      was absorbed and expired as 14CO2 within
                                                                      12 hours post dose, and an additional 18%
                                                                      of the administered dose was excreted in
                                                                      the urine within 12 hours post dose. Based
                                                                      on the percentage of dose in the expired
                                                                      14CO2 , urine, and tissues, approximately
                                                                      90% of the dose was absorbed. Once
                                                                      absorbed, it was extensively metabolized
                                                                      and rapidly expired as 14CO2 and
                                                                      eliminated in the urine with a half-life
                                                                      of 6 hours. Peak plasma concentrations of
                                                                      14C-radioactivity were attained by 7 hours
                                                                      post dose.
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

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

[[Page 75433]]

``special FQPA safety factor;'' and the ``default FQPA safety factor.'' 
By the term ``traditional uncertainty factor,'' EPA is referring to 
those additional uncertainty factors used prior to FQPA passage to 
account for database deficiencies. These traditional uncertainty 
factors have been incorporated by the FQPA into the additional safety 
factor for the protection of infants and children. The term ``special 
FQPA safety factor'' refers to those safety factors that are deemed 
necessary for the protection of infants and children primarily as a 
result of the FQPA. The ``default FQPA safety factor'' is the 
additional 10X safety factor that is mandated by the statute unless it 
is decided that there are reliable data to choose a different 
additional factor (potentially a traditional uncertainty factor or a 
special FQPA safety factor).
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 
100 to account for interspecies and intraspecies differences and any 
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). 
Where a special FQPA safety factor or the default FQPA safety factor is 
used, this additional factor is applied to the RfD by dividing the RfD 
by such additional factor. The acute or chronic Population Adjusted 
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this 
type of safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 X 
10-\5\), one in a million (1 X 10-\6\), or one in 
ten million (1 X 10-\7\). Under certain specific 
circumstances, MOE calculations will be used for the carcinogenic risk 
assessment. In this non-linear approach, a ``point of departure'' is 
identified below which carcinogenic effects are not expected. The point 
of departure is typically a NOAEL based on an endpoint related to 
cancer effects though it may be a different value derived from the dose 
response curve. To estimate risk, a ratio of the point of departure to 
exposure (MOEcancer = point of departure/exposures) is 
calculated.
    A summary of the toxicological endpoints for fluroxypyr used for 
human risk assessment is shown in Table 2 of this unit:

      Table 2.--Summary of Toxicological Dose and Endpoints for Fluroxypyr for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute Dietary(All populations)         NOAEL = NA               FQPA SF = NA             No appropriate endpoint
                                       UF = NA................  aPAD = acute RfD/ FQPA    to quantify single
                                       Acute RfD = NA.........   SF.                      dose exposure.
                                                                = NA...................
----------------------------------------------------------------------------------------------------------------
Chronic Dietary(All populations)       NOAEL= 100 mg/kg/day     FQPA SF = 1x             Chronic/Onco-Rat
                                       UF = 100...............  cPAD =chronic RfD/ FQPA  LOAEL = 100 mg/kg/day
                                       Chronic RfD =1 mg/kg/     SF.                      based on kidney
                                        day.                    = 1 mg/kg/day..........   effects.
----------------------------------------------------------------------------------------------------------------
Short-TermIncidental Oral (1-30 days)  NOAEL= 100 mg/kg/day     Residential LOC for MOE  Chronic/Onco-Rat
                                                                 = 100                   LOAEL = 100 mg/kg/day
                                                                Occupational = NA......   based on kidney
                                                                                          effects.
----------------------------------------------------------------------------------------------------------------
Intermediate-TermIncidental Oral (1-   NOAEL= 100 mg/kg/day     Residential LOC for MOE  Chronic/Onco-Rat
 6 months)                                                       = 100                   LOAEL = 100 mg/kg/day
                                                                Occupational = NA......   based on kidney
                                                                                          effects.
----------------------------------------------------------------------------------------------------------------
Dermal(All durations)                  Dermal (or oral) study   Residential LOC for MOE  Quantification not
                                       NOAEL=NA...............   = NA                     required since 21-Day
                                                                Occupational LOC for      dermal rabbit
                                                                 MOE = NA.               NOAEL = 1,000 mg/kg/day
                                                                                          and there is no
                                                                                          developmental toxicity
                                                                                          concern.
----------------------------------------------------------------------------------------------------------------
Inhalation(All durations)              Inhalation (or oral)     Residential LOC for MOE  Chronic/Onco-Rat
                                        study                    = 100                   LOAEL = 100 mg/kg/day
                                       NOAEL= 100 mg/kg/day...  Occupational LOC for      based on kidney
                                       (inhalation absorption    MOE = 100.               effects.
                                        rate = 100%).
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)                   Classification: ``not likely'' human carcinogen
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL =
  lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference
  dose, MOE = margin of exposure, LOC = level of concern, NA = Not Applicable


[[Page 75434]]

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.535) for the combined residues of fluroxypyr, 
in or on a variety of raw agricultural commodities. Tolerances have 
also been established for the combined residues of fluroxypyr on meat 
and milk. Risk assessments were conducted by EPA to assess dietary 
exposures from fluroxypyr in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide, if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one-day 
or single exposure.
    No adverse effect attributable to a single exposure (dose) of 
fluroxypyr was observed in the oral toxicity studies. Therefore, EPA 
did not identify an acute dietary endpoint and a quantitative acute 
dietary assessment was not performed because no acute risk is expected.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\T\), which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII), and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the chronic exposure 
assessments: 100% crop treated (PCT) and tolerance-level residues for 
fluroxypyr on all treated crops. This assessment was Tier I analysis. 
The exposures from fluroxypyr residues are below EPA's level of concern 
(<100% of the chronic population adjusted dose (cPAD)) for the general 
U.S. population (<1% of the cPAD) and all population subgroups.
    iii. Cancer. Fluroxypyr is classified as ``not likely'' a human 
carcinogen and there was no concern for its mutagenicity potential.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for fluroxypyr in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of fluroxypyr.
    The Agency used the Pesticide Root Zone Model/Exposure Analysis 
Modeling System (PRZM/EXAMS), a Tier 2 model, to estimate pesticide 
concentrations in surface water. PRZM/EXAMS incorporates an index 
reservoir environment and includes a percent crop area factor as an 
adjustment to account for the maximum percent crop coverage within a 
watershed or drainage basin. The Tier 1 Screening Concentration In 
Ground Water (SCI-GROW) model is used to predict pesticide 
concentrations in shallow ground water.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used to quantify drinking water exposure and risk as a %RfD or %PAD. 
Instead drinking water levels of comparison (DWLOCs) are calculated and 
used as a point of comparison against the model estimates of a 
pesticide's concentration in water. DWLOCs are theoretical upper limits 
on a pesticide's concentration in drinking water in light of total 
aggregate exposure to a pesticide in food, and from residential uses. 
Since DWLOCs address total aggregate exposure to fluroxypyr they are 
further discussed in the aggregate risk sections in Unit III.E.
    Based on the PRZM/EXAMS and SCI-GROW models, the EECs of fluroxypyr 
for acute exposures are estimated to be 32.9 parts per billion (ppb) 
for surface water and 0.04 ppb for ground water. The EECs for chronic 
exposures are estimated to be 3.3 ppb for surface water and 0.062 ppb 
for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Fluroxypyr is currently registered for use on the following 
residential non-dietary sites: Residential turfgrass and recreational 
sites such as golf courses and sports fields. The risk assessment was 
conducted using the following residential exposure assumptions: Adults 
and children may be exposed to fluroxypyr residues from dermal contact 
with turf during postapplication activities. Toddlers may receive 
short- and intermediate-term oral exposure from incidental ingestion 
during postapplication activities. Residential handlers may receive 
short-term dermal and inhalation exposure to fluroxypyr when mixing, 
loading and applying the formulations.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether fluroxypyr has a common mechanism of toxicity with other 
substances. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, EPA 
has not made a common mechanism of toxicity finding as to fluroxypyr 
and any other substances and fluroxypyr does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that fluroxypyr has a 
common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see the policy statements released by EPA's OPP concerning 
common mechanism determinations and procedures for cumulating effects 
from substances found to have a common mechanism on EPA's web site at 
http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1.In general. Section 408 of FFDCA provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in

[[Page 75435]]

calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10 X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of rat or rabbit fetuses following in utero 
exposure in the developmental studies with fluroxypyr. There is no 
evidence of increased susceptibility of rats in the reproduction study 
with fluroxypyr. EPA concluded there are no residual uncertainties for 
prenatal and/or postnatal exposure.
    3. Conclusion. There is a complete toxicity data base for 
fluroxypyr and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the 10X SF to protect infants and children should be removed and 
instead, a different additional safety factor of 1X should be used. The 
FQPA factor is removed because: There is no evidence (quantitative/
qualitative) of increased susceptibility following in utero exposure to 
the acid and the ester of fluroxypyr in rats and rabbits, or following 
pre and/or postnatal exposure to the acid of fluroxypyr in rats; there 
are no concerns or residual uncertainties for pre- and/or post-natal 
toxicity; there is no evidence of neurotoxicity or neuropathology in 
the available studies; the toxicological database is complete for FQPA 
assessment; the chronic dietary food exposure assessment utilizes 
tolerance level residue estimates and assumes 100% CT for all 
commodities, thus not likely to underestimate exposure/risk; the 
dietary drinking water assessment utilizes water concentration values 
generated by model and associated modeling parameters which are 
designed to provide conservative, health protective, high-end estimates 
of water concentrations which will not likely be exceeded; and the 
residential exposure assessment was conducted using standard 
assumptions which are based on carefully reviewed data.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against EECs. DWLOC values are 
not regulatory standards for drinking water. DWLOCs are theoretical 
upper limits on a pesticide's concentration in drinking water in light 
of total aggregate exposure to a pesticide in food and residential 
uses. In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water [e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)]. This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the EPA's Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. A quantitative acute risk assessment was not 
performed. No adverse effect attributable to a single exposure(dose) of 
fluroxypyr was observed in the oral toxicity studies and no acute risk 
is expected.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
fluroxypyr from food will utilize <1% of the cPAD for the U.S. 
population, <1% of the cPAD for all infants, and 1.4% of the cPAD for 
children (1-2 years old). In addition, there is potential for chronic 
dietary exposure to fluroxypyr in drinking water. After calculating 
DWLOCs and comparing them to the EECs for surface and ground water, EPA 
does not expect the aggregate exposure to exceed 100% of the cPAD, as 
shown in Table 3 of this unit. Based upon the use pattern, chronic 
(non-dietary) residential exposure to residues of fluroxypyr is not 
expected.

               Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Fluroxypyr
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                            1           <1          3.3        0.042       35,000
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old)                                  1           <1          3.3        0.042       10,000
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                                   1          1.4          3.3        0.042        9,900
----------------------------------------------------------------------------------------------------------------

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

[[Page 75436]]

short-term DWLOCs were calculated and compared to the EECs for chronic 
exposure of fluroxypyr in ground and surface water. After calculating 
DWLOCs and comparing them to the EECs for surface and ground water, EPA 
does not expect short-term aggregate exposure to exceed the Agency's 
level of concern, as shown in Table 4 of this unit:

                    Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Fluroxypyr
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                       31,000          100          3.3        0.042       35,000
----------------------------------------------------------------------------------------------------------------
Children(1-2 years old)                                4,500          100          3.3        0.042        9,800
----------------------------------------------------------------------------------------------------------------

    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Fluroxypyr is currently registered for use(s) that could result in 
intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and 
intermediate-term exposures for fluroxypyr.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food and 
residential exposures aggregated result in aggregate MOEs of 31,000 for 
the U.S. population and 4,500 for children (1-2 years old). These 
aggregate MOEs do not exceed the Agency's level of concern for 
aggregate exposure to food and residential uses. In addition, 
intermediate-term DWLOCs were calculated and compared to the EECs for 
chronic exposure of fluroxypyr in ground and surface water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect intermediate-term aggregate exposure 
to exceed the Agency's level of concern, as shown in Table 5 of this 
unit:

                Table 5.--Aggregate Risk Assessment for Intermediate-Term Exposure to Fluroxypyr
----------------------------------------------------------------------------------------------------------------
                                                             Aggregate
                                                Aggregate     Level of     Surface       Ground    Intermediate-
             Population Subgroup               MOE (Food +    Concern     Water EEC    Water EEC     Term DWLOC
                                              Residential)     (LOC)        (ppb)        (ppb)         (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                     31,000          100          3.3        0.042        35,000
----------------------------------------------------------------------------------------------------------------
Children(1-2 years old)                              4,500          100          3.3        0.042         9,800
----------------------------------------------------------------------------------------------------------------

    5. Aggregate cancer risk for U.S. population. Fluroxypyr is 
classified as a not likely human carcinogen and is not expected to pose 
a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to fluroxypyr residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

    There is neither a Codex proposal, nor Canadian or Mexican limits, 
for residues of fluroxypyr in/on field corn, sweet corn, sorghum, range 
and pasture grass. Harmonization is not an issue for this petition.

C. Conditions

    The following data are being required to confirm the results of the 
studies already reviewed by the Agency and/or to complete the database 
requirements prior to approval of an unconditional sweet corn 
registration:
    i. Additional field trials - conduct and submit four (4) additional 
field trials in Regions III (1 trial), V(1 trial), XI(1 trial), and 
XII(1 trial). Residue analysis of sweet corn field trial samples should 
avoid using the DowElanco Method ACR 90.8, due to matrix interference 
cited in PP2G04066.
    ii. Storage stability data - submit to support the sweet corn field 
trial data.
    iii. 28-Day Inhalation Toxicity Study

V. Conclusion

    Therefore, the tolerances are established for combined residues of 
fluroxypyr 1-methylheptyl ester [((4-amino-3,5-dichloro-6-fluoro-2-
pyridinyl)oxy) acetic acid, 1-methylheptyl] and its metabolite 
fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy) acetic 
acid], free and conjugated, all expressed as fluroxypyr, in or on field 
corn, grain at 0.02 ppm; field corn, forage at 1.0 ppm; field corn, 
stover at 0.5 ppm; on or in sweet corn, kernels plus cob with husks 
removed at 0.02 ppm; sweet corn, forage at 1.0 ppm; sweet corn, stover 
at 2.0 ppm; on or in sorghum, grain at 0.02 ppm; sorghum, forage at 2.0 
ppm; sorghum, stover (fodder) at 4.0 ppm; and on or in grass, forage at 
120 ppm; grass, hay at 160 ppm. Tolerances are revised for combined 
residues of fluroxypyr on cattle, milk; goat, milk;

[[Page 75437]]

hog, milk; horse, milk; and sheep, milk at 0.3 ppm; and on cattle, 
kidney; goat, kidney; hog, kidney; horse, kidney; and sheep, kidney at 
1.5 ppm.

VI. Objections and Hearing Requests

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

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0377 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before March 1, 
2004.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [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-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2003-0377, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [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).

VII. Statutory and Executive Order Reviews

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

[[Page 75438]]

consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 
104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and 
exemptions that are established on the basis of a petition under 
section 408(d) of FFDCA, such as the tolerance in this final rule, do 
not require the issuance of a proposed rule, the requirements of the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. 
In addition, the Agency has determined that this action will not have a 
substantial direct effect on States, on the relationship between the 
national government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism(64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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


    Dated: December 22, 2003.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.535 is amended by alphabetically adding new commodities 
and revising the commodities ``cattle, kidney,'' ``goat, kidney,'' 
``hog, kidney,'' ``horse, kidney,'' ``milk,'' and ``sheep, kidney'' in 
the table in paragraph (a) to read as follows:


Sec.  180.535  Fluroxypyr; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Cattle, kidney.......................................                1.5
                                * * * * *
Corn, field, forage..................................                1.0
Corn, field, grain...................................               0.02
Corn, field, stover..................................                0.5
Corn, sweet, forage..................................                1.0
Corn, sweet, kernel plus cob with husks removed......               0.02
Corn, sweet, stover..................................                2.0
                                * * * * *
Goat, kidney.........................................                1.5
                                * * * * *
Grass, forage........................................                120
Grass, hay...........................................                160
                                * * * * *
Hog, kidney..........................................                1.5
                                * * * * *
Horse, kidney........................................                1.5
                                * * * * *
Milk.................................................                0.3
                                * * * * *
Sheep, kidney........................................                1.5
                                * * * * *
Sorghum, grain, forage...............................                2.0
Sorghum, grain, grain................................               0.02
Sorghum, grain, stover...............................                4.0
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 03-32007 Filed 12-30-03; 8:45 am]
BILLING CODE 6560-50-S