[Federal Register Volume 68, Number 83 (Wednesday, April 30, 2003)]
[Rules and Regulations]
[Pages 23038-23046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10263]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0077; FRL-7297-9]


Mefenpyr-Diethyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for the combined 
residues of mefenpyr-diethyl also known chemically as 1-(2,4-
dichlorophenyl)-4,5-dihydro-5-methyl-1H-pyrazole-3,5-dicarboxylic acid, 
diethyl ester in or on wheat and barley commodities. Bayer CropScience 
formerly doing business as Aventis CropScience and/or AgrEvo Company 
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 April 30, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0077, 
must be received on or before June 30, 2003.

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: Bipin Gandhi, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone 
number: (703) 308-8380; 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] Industry (NAICS 111), e.g., crop production
    [sbull] Industry (NAICS 112), e.g., animal production
    [sbull] Industry (NAICS 311), e.g., food manufacturing
    [sbull] Industry (NAICS 32532), e.g., pesticide manufacturing
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in 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-2003-0077. 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., 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.

[[Page 23039]]

    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 September 26, 1997 (62 FR 50610) (FRL-
5740-2), 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 7F4850) by AgrEvo. Since 1997, by a 
series of mergers, AgrEvo became Aventis Crop Science and then Bayer 
CropScience. That notice included a summary of the petition prepared by 
AgrEvo, now doing business as Bayer CropScience, 2 T.W. Alexander Dr., 
Research Triangle Park, NC 27709. There were no comments received in 
response to the notice of filing.
    The petition requested that 40 CFR 180.509 be amended by 
establishing permanent tolerances for the combined residues of the 
herbicide safener, mefenpyr-diethyl, 1-(2,4-dichlorophenyl)-4,5-
dihydro-5-methyl-1H-pyrazole-3,5-dicarboxylic acid, diethyl ester, in 
or on wheat and barley commodities.
    In the Federal Register of August 8, 1997 (62 FR 42678) (FRL-5731-
7), EPA, on its own initiative, pursuant to section 408(e) and (1)(6) 
of the FFDCA, established time-limited tolerances for the inert 
ingredient herbicide safener, mefenpyr-diethyl, and its 2,4-
dichlorophenyl-pyrazoline metabolites in or on wheat grain and wheat 
straw. This action was 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 mefenpyr-diethyl on wheat 
grain and wheat straw in North Dakota and Montana.
    Similarly, mefenpyr-diethyl time-limited tolerances were 
established by the Agency in the Federal Register of September 9, 1998 
(63 FR 48116) (FRL-6024-7), in or on barley grain, barley hay, barley 
straw, and the processed by-products of barley grain: pearled barley, 
bran and flour. This action was in response to EPA's granting of an 
emergency exemption under FIFRA section 18 authorizing use of mefenpyr-
diethyl on barley in North Dakota.
    These time-limited tolerances have been extended as the petitioner 
has continued data generation. (See the Federal Register of May 6, 1998 
(63 FR 24939) (FRL-5788-1); the Federal Register of November 22, 1999 
(64 FR 63711) (FRL-6385-5); and the Federal Register of December 14, 
2001 (66 FR 64768) (FRL-6814-2)). The extensions of these time-limited 
tolerances were consistent with the safety standard (FFDCA section 
408(b)(2)) and FIFRA section 18. Currently, the time-limited tolerances 
under 40 CFR 180.509(b) expire on December 31, 2003. As the permanent 
tolerances are established, these emergency exemption time-limited 
tolerances are no longer necessary and will be revoked.
    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. . . 
.''
    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).

III. Aggregate Risk Assessment and Determination of Safety

    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 and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of the FFDCA, for tolerances for combined residues of 
mefenpyr-diethyl on wheat and barley commodities. EPA's assessment of 
exposures and risks associated with establishing the tolerances 
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 mefenpyr-diethyl 
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                         Subchronic feeding  NOAEL = 89.3/105.4
                                  studies in mouse    mg/kg/day
                                                      (milligram/
                                                      kilogram/day),
                                                      male and female (M/
                                                      F)
                                                      LOAEL = 449.0/
                                                      523.5 mg/kg/day (M/
                                                      F) based on
                                                      decreased body and
                                                      kidney weight,
                                                      increased liver
                                                      weight and
                                                      hepatocyte
                                                      hypertrophy in
                                                      males; decreased
                                                      bilirubin and
                                                      increased lactic
                                                      acid dehydrogenase
                                                      values in females
------------------------------------------------------------------------

[[Page 23040]]

 
870.3100                         Subchronic feeding  NOAEL = 206.7/223.0
                                  studies in rats     mg/kg/day (M/F)
                                                     LOAEL = 660.6/708.9
                                                      mg/kg/day(M/F)
                                                      based on decreased
                                                      body weight (bwt)
                                                      gains; decreased
                                                      erythrocyte
                                                      counts, hemoglobin
                                                      and hematocrit
                                                      values; and
                                                      increased
                                                      reticulocyte
                                                      counts and mean
                                                      corpuscular volume
------------------------------------------------------------------------
870.3150                         Subchronic feeding- NOAEL = 80.5/81.2
                                  dogs                mg/kg/day (M/F)
                                                      LOAEL = 341.0/
                                                      336.1 mg/kg/day (M/
                                                      F) based on
                                                      increased absolute
                                                      and relative liver
                                                      weights and
                                                      alkaline
                                                      phosphatase
                                                      activities in both
                                                      sexes; focal liver
                                                      lesions in
                                                      females; slight
                                                      anemia in both
                                                      sexes; decrease in
                                                      mean bwt and bwt
                                                      gain in females
                                                      and decreased food
                                                      consumption in
                                                      both sexes
------------------------------------------------------------------------
870.3200                         28-Day dermal        NOAEL = 1,000 mg/
                                  toxicity (rat)      kg/day highest
                                                      dose tested (HDT)
                                                      LOAEL was not
                                                      determined, but
                                                      would be greater
                                                      than the NOAEL
------------------------------------------------------------------------
870.3700                         Developmental       Maternal NOAEL <
                                  toxicity in         1,000 mg/kg/day
                                  rodents (rat)      Maternal LOAEL =
                                                      1,000 mg/kg/day
                                                      based on decrease
                                                      in body weight
                                                      gain and food
                                                      efficiency during
                                                      the first week of
                                                      treatment and on
                                                      increase in
                                                      absolute and
                                                      relative spleen
                                                      weights
                                                     Developmental NOAEL
                                                      = 1,000 mg/kg/day
                                                     Developmental LOAEL
                                                      = Not determined
                                                      but would be
                                                      greater than the
                                                      NOAEL. Note that
                                                      only one dose was
                                                      tested
------------------------------------------------------------------------
870.3700                         Postnatal           Maternal NOAEL <
                                  developmental       1,000 mg/kg/day
                                  toxicity in        Maternal NOAEL =
                                  rodents (rat)       1,000 mg/kg/day
                                                      based on decrease
                                                      in bwt gain and
                                                      food efficiency
                                                      during the first
                                                      week of treatment
                                                     Developmental NOAEL
                                                      < 1,000 mg/kg/day
                                                     Developmental LOAEL
                                                      = 1,000 mg/kg/day
                                                      based on marginal
                                                      decreases in fetal
                                                      bwt and bwt gain
                                                      during lactation.
                                                      Note that only one
                                                      dose was tested
------------------------------------------------------------------------
870.3700                         Developmental       Maternal NOAEL= 100
                                  Toxicity in         mg/kg/day
                                  nonrodents          Maternal LOAEL =
                                  (rabbit)            250 mg/kg/day
                                                      based on higher
                                                      rate of abortions
                                                      and marginal
                                                      decreases in body-
                                                      weight gain, food
                                                      efficiency index
                                                      and food
                                                      consumption
                                                      Developmental
                                                      NOAEL = 100 mg/kg/
                                                      day
                                                      LOAEL = 250 mg/kg/
                                                      day based on
                                                      higher rate of
                                                      abortions
------------------------------------------------------------------------
870.3800                         Reproduction and    Parental-Offspring/
                                  fertility effects   Systemic NOAEL =
                                                      57.3/76.0 mg/kg/
                                                      day (M/F)
                                                      Parental-Offspring/
                                                      Systemic LOAEL=
                                                      306.0/392.0 mg/kg/
                                                      day (M/F) based on
                                                      decrease mean bwt
                                                      and mean bwt gain
                                                      in parents and
                                                      offspring and an
                                                      increase in mean
                                                      spleen weight an
                                                      increase in the
                                                      severity (but not
                                                      in the incidence)
                                                      of splenic
                                                      extramedullary
                                                      hematopoiesis in
                                                      females.
                                                      Reproductive NOAEL
                                                      = 306.0/392.0 mg/
                                                      kg/day (M/F): HDT
                                                      Reproductive LOAEL
                                                      was not determined
                                                      but would be
                                                      greater than the
                                                      NOAEL
------------------------------------------------------------------------
870.4100                         Chronic-feeding     NOAEL = 51.4/57.6
                                  toxicity-dogs       mg/kg/day (M/F)
                                                      LOAEL = 260.2/
                                                      282.2 mg/kg/day (M/
                                                      F) based on high
                                                      ALP levels and
                                                      increased absolute
                                                      and relative liver
                                                      weights in both
                                                      sexes and grade 1
                                                      (minimal)
                                                      intrahepatic
                                                      cholestasis in the
                                                      liver: 2/sex
------------------------------------------------------------------------
870.4300                         Chronic Toxicity-   NOAEL = 48.5/60.0
                                  Carcinogenicity     mg/kg/day (M/F)
                                  rats                LOAEL = 251.6/
                                                      318.0 mg/kg/day (M/
                                                      F) based on
                                                      significant
                                                      increases in
                                                      reticulocyte
                                                      counts
------------------------------------------------------------------------
870.4300                         Carcinogenicity     NOAEL = 350.8/463.4
                                  mice                mg/kg/day (M/F)
                                                      LOAEL = (M/F) not
                                                      determined,
                                                      however, study
                                                      considered
                                                      adequate for
                                                      carcinogenicity
                                                      based on results
                                                      of subchronic
                                                      study
------------------------------------------------------------------------
870.5265                         Gene Mutation       Non-mutagenic with
                                  Salmonella and E.   or without
                                  Coli                activation
------------------------------------------------------------------------
870.5300                         Gene Mutation       Non-mutagenic with
                                  HGPRT with V79      or without
                                  cells               activation
------------------------------------------------------------------------
870.5375                         Chinese Hamster     No clastogenic
                                  Lung Fibroblast     response with or
                                  Assay               without activation
------------------------------------------------------------------------

[[Page 23041]]

 
870.5395                         Micronucleus Assay  No clastogenic
                                                      response at any
                                                      dose or sacrifice
                                                      time
------------------------------------------------------------------------
870.5550                         Unschedule DNA      No clear evidence
                                  synthesis           of genotoxicity.
                                                      However, study not
                                                      acceptable
------------------------------------------------------------------------
870.7485                         Metabolism and      Single dose of 1 or
                                  pharmacokinetics    100 mg/kg bwt:
                                                      Urinary excretion
                                                       76-88% of
                                                      administered
                                                      radioactivity with
                                                      59-72% excreted
                                                      within first 24
                                                      hours. Fecal
                                                      excretion ranged
                                                      from 13-32%. 83-
                                                      91% of
                                                      administered dose
                                                      excreted (urine
                                                      and feces) by 24
                                                      hours and 91 to >
                                                      99% excreted by 48
                                                      hours. At least 68-
                                                      88% of
                                                      administered dose
                                                      absorbed. Recovery
                                                      in tissues/animal:
                                                      0.24% of
                                                      administered
                                                      radioactivity
                                                      (range: 0.07 -
                                                      0.51%). General
                                                      order of
                                                      concentration
                                                      plasma > whole
                                                      blood > lungs >
                                                      subcutaneous fat >
                                                      heart > kidneys >
                                                      retroperitoneal
                                                      fat > liver >
                                                      gonads > pancreas
                                                      > skeletal muscle.
                                                      No volatile
                                                      radioactivity
                                                      detected 0-24
                                                      hours after
                                                      dosing. Between
                                                      100-106% of
                                                      administered
                                                      radioactivity
                                                      recovered.
                                                      Single dose of 1
                                                      or 100 mg/kg bwt:
                                                      Radioactivity
                                                      rapidly excreted:
                                                      total of 78-92%
                                                      excreted by 48
                                                      hours. Renal
                                                      excretion
                                                      predominant route
                                                      of elimination (65-
                                                      72% by 48 hours),
                                                      indicating that at
                                                      least 65-72% of
                                                      the administered
                                                      dose was absorbed.
                                                      None of test
                                                      material found in
                                                      its original form
                                                      in urine. Three
                                                      metabolites
                                                      identified in
                                                      urine: 13-26% of
                                                      the radioactivity
                                                      was recovered in
                                                      the feces by 48
                                                      hours. The same
                                                      three metabolites
                                                      identified in
                                                      urine were also
                                                      present in the
                                                      feces: Proposed
                                                      metabolic steps:
                                                      Consecutive
                                                      hydrolysis
                                                      (saponification)
                                                      of the two
                                                      carboxylic acid
                                                      ester groups and a
                                                      decarboxylation of
                                                      one of the
                                                      carboxylic groups,
                                                      resulting in an
                                                      aromatization of
                                                      the pyrazoline
                                                      ring.
                                                      Enterohepatic
                                                      circulation is
                                                      unlikely to play a
                                                      major role. In
                                                      males, there
                                                      appears to be
                                                      either lower
                                                      intestinal
                                                      absorption or a
                                                      higher biliary
                                                      excretion when
                                                      compared to
                                                      females.
------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which the NOAEL from the toxicology study identified as 
appropriate for use in risk assessment is used to estimate the 
toxicological level of concern (LOC). An uncertainty factor (UF) is 
applied to reflect uncertainties inherent in the extrapolation from 
laboratory animal data to humans and in the variations in sensitivity 
among members of the human population as well as other unknowns. An UF 
of 100 is routinely used, 10X to account for interspecies differences 
and 10X for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor (SF) 
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 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.
    A summary of the toxicological endpoints for mefenpyr-diethyl used 
for human risk assessment is discussed in this unit: The Agency has 
determined that there is no acute toxicological concern. No appropriate 
endpoint was identified from oral toxicity studies including the 
developmental toxicity studies in rats and rabbits. No short-term or 
intermediate-term dermal or systemic toxicity was observed up to 1,000 
mg/kg/day and no development effects were observed in the developmental 
rat study at 1,000 mg/kg/day. Therefore, no endpoint was identified for 
risk assessment for the short- and intermediate-term risk assessments. 
Based on the current use-pattern (i.e. one application per season) 
long-term exposure via the dermal route is not expected. Therefore, a 
long-term dermal end-point was not identified. Similarly, no endpoint 
was identified for carcinogenicity since this chemical is not 
classified as a human carcinogen.
    For chronic dietary risk assessment the NOAEL of 57.3 mg/kg/day in 
a 2-generation reproduction toxicity study was identified as an 
appropriate end point. Taking into account the UF of 100, the chronic 
RfD is 0.57 mg/kg/day (NOAEL 57.3/ UF 100 = 0.57). The Agency has used 
a FQPA Factor of 1 and therefore, the chronic population adjusted dose 
(PAD) is 0.57 mg/kg/day (RfD 0.57/FQPA 1 = 0.57) for mefenpyr-diethyl.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
previously established (40 CFR 180.509(b)) under FIFRA section 18, the 
Emergency Exemption Program, for the combined residues of mefenpyr-
diethyl. To establish permanent tolerances, risk assessments were 
conducted by EPA to assess dietary exposures from mefenpyr-diethyl 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 1-day or 
single exposure.
    An acute dietary risk assessment was not performed because no 
appropriate acute toxicological endpoint could be identified in any of 
the oral toxicity studies including the developmental studies in rats 
and rabbits.
    ii. Chronic exposure. The chronic dietary exposure assessment was 
conducted using the Dietary Exposure Evaluation Model software with the

[[Page 23042]]

Food Commodity Intake Database (DEEM-FCID[reg], Version 1.3), which 
incorporates consumption data from USDA's Continuing Survey of Food 
Intakes by Individuals (CSFII), 1994-1996 and 1998. The 1994-96 and 
1998 data are based on the reported consumption of more than 20,000 
individuals over two non-consecutive survey days. Foods ``as consumed'' 
(e.g., apple pie) are linked to EPA-defined food commodities (e.g. 
apples, peeled fruit - cooked; fresh or not specified (N/S); baked; or 
wheat flour - cooked; fresh or N/S, baked) using publicly available 
recipe translation files developed jointly by USDA/ARS and EPA. 
Consumption data are averaged for the entire U.S. population and within 
population subgroups for chronic exposure assessment, but are retained 
as individual consumption events for acute exposure assessment.
    For chronic exposure and risk assessment, an estimate of the 
residue level in each food or food-form (e.g., orange or orange juice) 
on the food commodity residue list is multiplied by the average daily 
consumption estimate for that food/food form. The resulting residue 
consumption estimate for each food/food form is summed with the residue 
consumption estimates for all other food/food forms on the commodity 
residue list to arrive at the total average estimated exposure. 
Exposure is expressed in mg/kg bwt/day and as a percent of the cPAD. 
This procedure is performed for each population subgroup.
    The DEEM-FCID[reg] analyses estimate the dietary exposure of the 
U.S. population and various population subgroups. The analysis assumed 
tolerance-level residues. No processing studies were required due to 
the fact that field trials conducted at exaggerated rate (greater than 
5X) showed no detectable residues in wheat and barley grains. 
Therefore, no tolerance is needed for processed commodities. A default 
processing factor of 1.92 was used for dried beef in this dietary 
exposure analysis. No other commodities in this analysis used DEEM 
default processing factors. No percent crop treated or anticipated 
residues were used.
    iii. Cancer. The Agency has determined that mefenpyr-diethyl is 
``not likely to be a human carcinogen.'' This was based on weight-of-
the-evidence from negative rat and mouse carcinogenicity studies as 
well as negative mutagenicity studies. Therefore, a carcinogenic 
dietary assessment was not performed.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for mefenpyr-diethyl 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 mefenpyr-diethyl.
    The Agency used the FQPA Index Reservoir Screening Tool (FIRST) to 
produce estimates of pesticide concentrations in an index reservoir. 
The screening concentration in ground water (SCI-GROW2) model is used 
to predict pesticide concentrations in shallow ground water. FIRST is a 
tier 1 model that uses a specific high-end runoff scenario for 
pesticides. It incorporates an index reservoir environment, but does 
include a percent crop area factor as an adjustment to account for the 
maximum percent crop coverage within a watershed or drainage basin.
    Neither FIRST nor SCI-GROW2 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 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 FIRST and SCI-GROW2 is considered to be a screening tool 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 mefenpyr-diethyl, they are 
further discussed in the aggregate risk sections see Unit III.E.
    The EECs for a single application of mefenpyr-diethyl at an 
exaggerated rate of 0.090 kg/hectare (ha) (0.080 lb/acre) results in 
the peak and chronic concentrations of combined parent and metabolites 
of 5 parts per billion (ppb) and 3 ppb, respectively for surface water 
and 4 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). Mefenpyr-diethyl is 
not registered for use on any sites that would result in residential 
exposure.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) 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 mefenpyr-diethyl 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, 
mefenpyr-diethyl 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 mefenpyr-diethyl 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).

D. 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. Prenatal and postnatal sensitivity. In the prenatal 
developmental toxicity study in rats, no evidence of developmental 
toxicity was seen, even in the presence of maternal toxicity. In the 
developmental toxicity study in

[[Page 23043]]

rabbits, developmental toxicity was seen in the presence of maternal 
toxicity. A higher rate of abortions occurred at the highest dose level 
tested (250 mg/kg/day). An examination of the individual litter data 
provided no evidence as to whether or not the higher rate was due to 
maternal toxicity or developmental toxicity. Therefore, both the 
maternal and developmental NOAELs and LOAELs were based on this effect. 
In the 2-generation reproduction study and in the postnatal 
developmental toxicity study in rats, effects in the offspring were 
observed only at or above treatment levels which caused parental 
toxicity. Developmental (Offspring) effects in these two studies 
consisted of decreases in bwt and bwt gain of the pups in the presence 
of either decreased bwt and bwt gain or hematopoietic effects in the 
parents. There does not appear to be any increased susceptibility in 
rats or rabbits to in utero and/or postnatal exposure to mefenpyr-
diethyl. Developmental effects were only observed at levels which were 
parentally toxic.
    3. Conclusion. There is a complete toxicity data base for mefenpyr-
diethyl and exposure data are complete or are estimated based on data 
that reasonably accounts for potential exposures. EPA determined that 
the 10X safety factor to protect infants and children should be 
removed. The FQPA factor is removed (i.e., reduced to 1) because there 
is no indication of increased susceptibility to infants and children, 
dietary exposure estimates are likely to result in an overestimate of 
the actual exposure, estimates for ground and surface source drinking 
water exposure are upper-bound concentrations and there are currently 
no registered residential uses and thus, this type of exposure to 
infants and children is not expected.

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 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 + 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 bwts. Default bwts and consumption values as used by 
EPA are used to calculate DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 
kg (adult female), and 1L/10 kg (child). Default bwts 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 the pesticide in drinking water (when considered along 
with other sources of exposure for which the Agency has reliable data) 
would not result in unacceptable levels of aggregate human health risk 
at this time. Because the Agency 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, the Agency 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. No acute endpoint was identified, therefore, no 
acute risk is expected.
    2. Chronic risk. EPA has concluded that exposure to mefenpyr-
diethyl from food will utilize less than 1% of the cPAD for the U.S. 
population and all population subgroups. (Table 2). There are no 
residential uses for mefenpyr-diethyl that result in chronic 
residential exposure to mefenpyr-diethyl. The following table 
represents the results of the Tier 1 chronic dietary (food only) 
exposure analysis for mefenpyr-diethyl proposed uses on barley and 
wheat.

 Table 2.--Exposure and risk estimates for dietary (food only) exposure
                          to mefenpyr-diethyl.
------------------------------------------------------------------------
                                                 Estimated
                                                  Dietary
              Population Subgroup                Exposure,      % cPAD
                                                 mg/kg bwt/
                                                    day
------------------------------------------------------------------------
U.S. population                                    0.000113          <1%
------------------------------------------------------------------------
All infants (< 1 year)                             0.000068          <1%
------------------------------------------------------------------------
Children (1-2 years)                               0.000295          <1%
------------------------------------------------------------------------
Children (3-5 years)                               0.000273          <1%
------------------------------------------------------------------------
Children (6-12 years)                              0.000186          <1%
------------------------------------------------------------------------
Youth (13-19 years)                                0.000107          <1%
------------------------------------------------------------------------
Adults (20-49 years)                               0.000091          <1%
------------------------------------------------------------------------
Females (13-49 years)                              0.000082          <1%
------------------------------------------------------------------------
Adults (50+ years)                                 0.000074          <1%
------------------------------------------------------------------------

    This exposure analysis and cPAD represents a conservative estimate 
of dietary (food only) exposure and risk from the use of mefenpyr-
diethyl on barley and wheat. Further refinement, through the use of 
anticipated residues, percent-of-crop treated estimates and/or 
monitoring data, would result in a reduction in the exposure estimates 
and the associated risk. However, in this analysis, even without 
further refinement, the risk estimate for all population subgroups is 
less than 1% of the cPAD. This is below the Agency's level of concern 
(100% of the cPAD) for the general U.S. population and all population 
subgroups.
    However, there is potential for chronic dietary exposure to 
mefenpyr-diethyl in drinking water. The EECs for surface water and 
ground water are less than the DWLOC. Thus, EPA does not expect the 
aggregate exposure to exceed 100% of the cPAD, as shown in Table 3 
below.

[[Page 23044]]



            Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Mefenpyr-Diethyl
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD (mg/kg/    % cPAD     Water EEC    Water EEC     Chronic
                                                     day)        (food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                         0.57     0.000113            3            4       20,000
---------------------------------------------------------------------------
All infants (< 1 year old)                              0.57      0.00007            3            4        5,700
---------------------------------------------------------------------------
Children (1-2 years old)                                0.57     0.000295            3            4        5,700
---------------------------------------------------------------------------
Females (13-49 years old)                               0.57      0.00008            3            4       17,000
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk and intermediate-term risk. Mefenpyr-diethyl is 
not registered for use on any sites that would result in residential 
exposure.
    4. Aggregate cancer risk for U.S. population. Mefenpyr-diethyl is 
not classified as a human carcinogen and thus is not expected to pose a 
cancer risk.
    5. 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 mefenpyr-diethyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The petitioner has submitted an analytical method for mefenpyr-
diethyl and its metabolites in wheat and barley using Gas 
Chromatography with a Mass Selective Detection (GC/MSD). This 
enforcement method has been reviewed by the Agency and fulfills the 
guidelines.
    The petitioner also submitted an analytical method for mefenpyr-
diethyl and its metabolites in Beef Liver also using GC/MSD. The 
petitioner also submitted an Independent Laboratory Validation of the 
method.
    Adequate enforcement methodology GC/MSD is available to enforce the 
tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address: [email protected].

B. International Residue Limits

    There are no CODEX, Canadian or Mexican limits for residues of 
mefenpyr-diethyl in wheat and barley. However, Italy has established an 
MRL (maximum residue limit) of 0.05 ppm in wheat grain for residues of 
mefenpyr-diethyl and its metabolites which is consistent with the wheat 
grain tolerance established today.

C. Conditions

    Based on the residue uptake results of the confined rotational 
studies at 90 gram/hectare (0.80 lb/acre) residue uptakes, the Agency 
would usually establish a 30-day plantback interval for leafy, 
fruiting, and root vegetables, and 12-month plantback interval for all 
other crops other than wheat and barley, which can be replanted at any 
time. However, at this time, the petitioner has indicated that the 
application rate will not exceed 30 gram/hectare or 0.0267 lb/acre. 
Given this reduction to one-third of the application rate used in the 
study, the Agency believes that a 30-day plantback interval is 
appropriate for all crops except cereal grains and grasses. The plant 
back interval for cereal grains and grasses, except wheat and barley, 
(which can be replanted at any time) is 12-months.

V. Conclusion

    Therefore, tolerances are established for the combined residues of 
mefenpyr-diethyl, 1-(2,4-dichlorophenyl)-4,5-dihydro-5-methyl-1H-
pyrazole-3,5-dicarboxylic acid, diethyl ester, in or on wheat and 
barley commodities.

VI. 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 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 provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0077 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 June 30, 
2003.
    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

[[Page 23045]]

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-2003-0077, 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 the 
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 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 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 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

[[Page 23046]]

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: April 17, 2003.
Peter Caulkins,
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), 346(a) and 371.

0
2. Section 180.509 is revised to read as follows:


Sec.  180.509  Mefenpyr-diethyl; tolerance for residues.

    (a) General. Tolerances are established for residues of the 
herbicide safener mefenpyr-diethyl (1-(2,4-dichlorophenyl)-4,5-dihydro-
5-methyl-1H-pyrazole-3,5-dicarboxylic acid, diethyl ester) and its 2,4-
dichlorophenyl-pyrazoline metabolites at a rate of 0.0267 pound safener 
per acre per growing season in or on following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, grain..............................................         0.05
Barley, hay................................................          0.2
Barley, straw..............................................          0.5
Cattle, meat byproducts....................................          0.1
Goat, meat byproducts......................................          0.1
Hog, meat byproducts.......................................          0.1
Horse, meat byproducts.....................................          0.1
Sheep, meat byproducts.....................................          0.1
Wheat, forage..............................................          0.2
Wheat, grain...............................................         0.05
Wheat, hay.................................................          0.2
Wheat, straw...............................................          0.5
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 03-10263 Filed 4-29-03; 8:45 am]
BILLING CODE 6560-50-S