[Federal Register Volume 69, Number 207 (Wednesday, October 27, 2004)]
[Rules and Regulations]
[Pages 62602-62615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24040]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0331; FRL-7683-5]


Deltamethrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of deltamethrin, isomers trans-deltamethrin and [alpha]-R-deltamethrin 
in or on almond hulls; apples, wet pomace; artichoke, globe; barley, 
bran; cattle, fat; cattle, meat; cattle, meat byproducts; corn, field, 
forage; corn, field, refined oil; corn, field, stover; corn, pop, 
stover; corn, sweet, forage; corn, sweet, kernel + cob with husks 
removed; corn, sweet, stover; egg; fruit, pome, group 11; goat, fat; 
goat, meat; goat, meat byproducts; grain, aspirated fractions; grain, 
cereal, group 15, except sweet corn; hog, fat; horse, fat; horse, meat; 
horse, meat byproducts; lychee (import tolerance); milk, fat 
(reflecting 0.02 ppm in whole milk); nut, tree, group 14; onion, dry 
bulb; onion, green; poultry, fat; poultry, meat; poultry, meat 
byproducts; radish tops; rapeseed; rice, hulls; rye, bran; sheep, fat; 
sheep, meat; sheep, meat byproducts; sorghum, grain forage; sorghum, 
grain stover; soybean, seed; soybean, hulls; starfruit (import 
tolerance); sunflower seeds; vegetable, cucurbit, group 9; vegetable, 
fruiting, group 8; vegetable, root, except sugar beet, subgroup IB; 
vegetable, tuberous and corm, subgroup; IC; wheat, bran. Bayer Crop 
Science LP, formerly Aventis CropScience, requested these tolerances 
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 October 27, 2004. Objections and 
requests for hearings must be received on or before December 27, 2004.

ADDRESSES:  To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP -2004-0331. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: George LaRocca, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone 
number: (703) 305-6100; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers;

[[Page 62603]]

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 Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/.

 II. Background and Statutory Findings

    In the Federal Register of November 7, 2001 (66 FR 56298) (FRL-
6808-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
1E6232) (PP 0F6080) by Bayer Crop Science LP, formerly Aventis 
CropScience, P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle 
Park, NC 27709. The petition requested that 40 CFR 180.435 be amended 
by establishing a tolerance for residues of the insecticide 
deltamethrin, in or on almond hulls; apples, wet pomace; artichokes; 
brassica, head and stem crop subgroup 5A, excluding cabbage; bulb 
vegetables ; cabbage (w/wrapper leaves); cabbage (w/o wrapper leaves); 
carambola (star fruit); corn, field grain; corn, forage (field); corn, 
fodder/stover (field); corn, refined oil; corn, flour; corn, meal; 
corn, milled by products; cucurbit vegetables; eggs; fruiting 
vegetables; leafy vegetables; lichi fruit; milk, fat (reflecting 0.02 
ppm in whole milk); mustard greens; pome fruit; poultry, fat; poultry, 
mbyp; poultry, meat; prunes; rapeseed (including canola and crambe); 
root vegetable, except sugarbeet (subgroup 1B): roots; ruminant fat; 
ruminant mbyp; ruminant meat; sorghum, forage; sorghum, fodder/stover; 
sorghum, grain; soybeans; stone fruit; sunflower seeds; tree nuts; 
tuberous and corm vegetables subgroup 1C, excluding artichokes; wheat 
gluten (post harvest); wheat, grain (post harvest); wheat, grain dust 
(post harvest) at 1.2, 1.2, 0.5, 0.50, 1.5, 1.5, 0.15, 0.2, 0.06, 0.7, 
7.0, 0.6, 0.18, 0.12, 0.18, 0.06, 0.02, 0.25, 4.5, 0.2, 0.1, 4.5, 0.2, 
0.05, 0.02, 0.02, 2.4, 0.12, 0.15, 0.04, 0.02, 0.02, 0.5, 2.0, 0.5, 
0.05, 0.6, 0.05, 4.0, 0.1, 0.04, 1.4, 2.0, and 2.7 parts per million 
(ppm) respectively . The registrant originally filed petition PP 1E6232 
with the Agency, proposing the establishment of regulations for 
residues of deltamethrin, an insecticide, in or on various food 
commodities. The petition (PP 1E6232) requested the establishment of 
proposed tolerances for deltamethrin in/on almond hull, three crop 
subgroups and rapeseed, and import tolerances for two tropical fruits, 
as petitioned through the Minor Crop Pest Management program (IR-4). 
Petition (PP 1E6232) was superceded, at the request of the registrant, 
by petition (PP 0F6080), including additional tolerances for the above 
listed crops, and the proposed commodities described in the previous 
petition (PP 1E6232). The Notice of Filing of November 7, 2001 ( 66 FR 
56298) (FRL-6808-5) identified an inclusive summary of both petitions 
prepared by Bayer Crop Science LP formerly Aventis CropScience, the 
registrant. There were no comments received in response to the notice 
of filing.
    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 a tolerance for combined residues of 
deltamethrin, isomers trans-deltamethrin and [alpha]-R-deltamethrin in 
or on the commodities listed in Unit II. 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 deltamethrin is 
discussed in Tables 1 and 2 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.

[[Page 62604]]



                                Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-day oral toxicity--      NOAEL = 1.0 and 10 milligrams/kilogram/day
                                          rodents                     (mg/kg/day) for males and females
                                                                      respectively
                                                                     LOAEL = 2.5 mg/kg/day for males based on
                                                                      decreased body weight for males, females
                                                                      was not established.
----------------------------------------
870.3150                                 90-Day oral toxicity--      NOAEL = 1.0 mg/kg/day males and females
                                          nonrodents                 LOAEL = 2.5 mg/kg/day based on central
                                                                      nervous system effects diarrhea, vomiting
                                                                      and decreased body weight gain for males
                                                                      and females.
----------------------------------------
870.3200                                 21/28-Day dermal toxicity    NOAEL > 1,000 mg/kg/day for males and
                                          rat                         females (limit dose)
                                                                     Dermal NOAEL was not established.
                                                                     Signs of local irritation seen at all
                                                                      doses.
----------------------------------------
870.3250                                 90-Day dermal toxicity      NA
----------------------------------------
870.3465                                 21-Day inhalation toxicity  NOAEL = 3.0 mg/kg/day males and females.
                                          rat                        LOAEL = 9.6 mg/kg/day based on decreased
                                                                      weight gain, nervous system stimulation
                                                                      and skin irritation for males and females
----------------------------------------
870.3700                                 Prenatal developmental--    Maternal NOAEL = 3.3 mg/kg/day
                                          rodents                    Maternal LOAEL = 7.0 mg/kg/day based on
                                                                      decreased body weights and body weight
                                                                      gains and clinical signs of toxicity
                                                                     Developmental NOAEL = greater than 11.0 mg/
                                                                      kg/day
                                                                     Developmental LOAEL = none observed
----------------------------------------
870.3700                                 Prenatal developmental--    Maternal NOAEL >= 10 mg/kg/day
                                          mouse                      Maternal LOAEL = not observed
                                                                     Developmental NOAEL = 0.1 mg/kg/day
                                                                     Developmental LOAEL = 1.0 mg/kg/day based
                                                                      on decreased fetal weight, and delayed
                                                                      ossification of the sternebrae and paws
----------------------------------------
870.3800                                 Reproduction and fertility  Parental/Systemic NOAEL = 5.4 and 6.1 mg/kg/
                                          effects                     day for males and females respectively.
                                                                     Parental/Systemic LOAEL = 21.2 and 23.5 mg/
                                                                      kg/day for males and females respectively.
                                                                      Based on increased mortality and clinical
                                                                      signs, decreased body weights, body weight
                                                                      gains, and absolute food consumption, and
                                                                      gross pathological findings in both sexes.
                                                                     Reproductive NOAEL = 21.2 mg/kg/day for
                                                                      males and females.
                                                                     Reproductive LOAEL = [not established]
                                                                     Offspring NOAEL = 5.8 and 6.7 mg/kg/day for
                                                                      males and females respectively.
                                                                     Offspring LOAEL = 24.9 and 27.2 mg/kg/day
                                                                      for males and females respectiveley. Based
                                                                      on increased mortality and clinical signs,
                                                                      decreased body weights, body weight gains,
                                                                      and absolute food consumption, and gross
                                                                      pathological findings in both sexes.
----------------------------------------
870.4100                                 Chronic toxicity--rodents   Same as Chronic Toxicity/Carcinogenicity-
                                                                      rat see below (870.4300)
----------------------------------------
870.4100                                 Chronic toxicity--dogs      NOAEL = 1.0 mg/kg/day males and females.
                                                                     LOAEL = 10.0 mg/kg/day males and females.
                                                                      Based on reduced body weight gain, chewing
                                                                      and scratching of extremities, and liquid
                                                                      feces.
----------------------------------------
870.4200                                 Carcinogenicity--rats       No evidence of carcinogenicity
                                                                     Same as chronic toxicity/carcinogenicity-
                                                                      rat see below (870.4300).
----------------------------------------
870.4300                                 Carcinogenicity--mice       NOAEL = 2,000 mg/kg/day (HDT)
                                                                     LOAEL = not established
                                                                     No evidence of carcinogenicity, HDT assumed
                                                                      to be adequate to characterize the
                                                                      carcinogenic potential based on a 12-week
                                                                      toxicity study in mice showing death and
                                                                      body weight differences (13% decrease) at
                                                                      3,000 ppm.
----------------------------------------
870.4300                                 Chronic/Carcinogenicity-    NOAEL = >50 ppm (HDT) for males and
                                          rat                         females.
                                                                     LOAEL was not determined
                                                                     No evidence of carcinogenicity
----------------------------------------
870.5100                                 Bacterial reverse mutation  There was no evidence of an induced
                                          test-S. typhimurium         mutagenic effect up to cytotoxic
                                                                      concentrations >=38 micro grams/mL -S9;
                                                                      150 [mu]g/mL +S9). Levels >=75 micrograms/
                                                                      mL were insoluble.
----------------------------------------

[[Page 62605]]

 
870.5375                                 In vitro mammalian          There was no evidence of an induced
                                          chromosome aberration       mutagenic effect up to cytotoxic
                                          test- Chinese hamster       concentrations (>=38 micrograms/mL -S9;
                                          ovary (CHO) cells           150 micrograms/mL +S9). Levels >=75
                                                                      micrograms/mL were insoluble.
----------------------------------------
870.5550                                 Other Genotoxicity          There was no evidence of DNA repair/damage
                                         Bacterial DNA damage/        up to the limit dose ( (5,000 micrograms/
                                          repair-E. coli.             well +/-S9). Compound precipitation seen
                                                                      at >=200 micrograms/well.
----------------------------------------
870.5550                                 Other Genotoxicity          There was no evidence that unscheduled DNA
                                         Unscheduled DNA synthesis    synthesis was induced up to insoluble
                                          in primary rat              concentrations (>=130 micrograms/mL).
                                          hepatocytes.
----------------------------------------
870.6200                                 Acute neurotoxicity         NOAEL = 5 mg/kg/day
                                          screening battery rats     LOAEL = 15 mg/kg/day based on salivation,
                                                                      soiled fur, impaired motility, no reaction
                                                                      to approach or touch response in the
                                                                      functional observation battery (FOB)
----------------------------------------
870.6200                                 Subchronic neurotoxicity    NOAEL = 14 and 16 mg/kg/day for males and
                                          screening battery           females respectively.
                                                                     LOAEL = 54 and 58 mg/kg/day for males and
                                                                      females respectivley.. Based on mortality,
                                                                      clinical signs, FOB findings, and
                                                                      decreased body weights, body weight gains,
                                                                      and food consumption.
----------------------------------------
870.6300                                 Developmental               NA
                                          neurotoxicity
----------------------------------------
870.7485                                 Metabolism and              The test material was relatively well
                                          pharmacokinetics - rats     absorbed. Excretion was almost complete
                                                                      within 48 hours. Approximately 36-59% of
                                                                      the dose was found in feces and an
                                                                      approximately equal amount in urine.
                                                                      Absorbed deltamethrin was cleaved by
                                                                      hydrolysis at the ester site followed by
                                                                      rapid sulfate and glucuronide conjugation.
----------------------------------------
870.7600                                 Dermal penetration          NA
----------------------------------------
                                         Special studies             There were no special studies
----------------------------------------------------------------------------------------------------------------


                            Table 2.--Non-guideline Toxicity Studies and Literature.
----------------------------------------------------------------------------------------------------------------
               Study Type                                  Results                             Citation
----------------------------------------------------------------------------------------------------------------
Acute Motor Function Oral-male rat       Vehicle: Corn oil                            Crofton et al., (1995)
                                         ED50 5.1 mg/kg.............................
                                         LOAEL 3.0 mg/kg (based on reduced motor
                                          function).
                                         NOAEL 1.0 mg/kg............................
                                         Vehicle: Methylcellulose...................
                                         ED50 >1,000 mg/kg..........................
                                         LOAEL 300 mg/kg (based on reduced motor
                                          function).
                                         NOAEL 100 mg/kg............................
----------------------------------------
Acute Motor Function Oral- male rat      Vehicle: Corn oil                            Crofton and Reiter, (1984)
                                         LOAEL 2.0 mg/kg (based on reduced motor
                                          function).
                                         NOAEL Not established......................
----------------------------------------
Acute Locomotor Activity Oral- male rat  Vehicle: Corn oil                            Gilbert et al., (1990)
                                         LOAEL 3.0 mg/kg (based on reduced locomotor
                                          activity).
                                         NOAEL 1.0 mg/kg............................
----------------------------------------
Acute Acoustic Startle Response (ASR)    Vehicle: Corn oil                            Sheets et al., (1994)
 Oral-rats                               21-day old rats:...........................
                                         LOAEL 1 mg/kg..............................
                                         NOAEL Not established......................
                                         Adults:....................................
                                         LOAEL 2 mg/kg..............................
                                         NOAEL Not established......................
                                         At the ED50 (4 mg/kg), the brain
                                          concentration of deltamethrin was [ap]2-
                                          fold higher in weanlings than in adults.
----------------------------------------

[[Page 62606]]

 
Acute Behavioral Tests Oral - Mice       Vehicle: 20% Fat Emulsion at 0.7 mg/kg       Eriksson and Fredriksson,
                                          (only dose tested)                           (1991)
                                         17- day old mice...........................
                                         No significant changes.....................
                                         4-month old mice...........................
                                         Significant changes in locomotion, rearing
                                          and activity and a significant decrease in
                                          3HQNB binding sites in the cerebral
                                          cortex..
----------------------------------------
Prenatal developmental--rodents          Maternal NOAEL = 1.0 mg/kg/day               Non-guideline
                                         Maternal LOAEL = 7.0 mg/kg/day based on
                                          slightly reduced body weights.
                                         Developmental NOAEL = 1.0 mg/kg/day........
                                         Developmental LOAEL = 10 mg/kg/day based on
                                          delayed ossification of the sternebrae.
----------------------------------------
Prenatal developmental--nonrodents       Maternal NOAEL = 100 mg/kg/day               Non-guideline
                                         Maternal LOAEL = not established...........
                                         Developmental NOAEL = 25 mg/kg/day.........
                                         Developmental LOAEL = 100 mg/kg/day based
                                          on increases in the incidences of delayed
                                          ossification and skeletal variations.
----------------------------------------
Prenatal developmental--nonrodents       Maternal NOAEL = 10 mg/kg/day                Non-guideline
                                         Maternal LOAEL = 32 mg/kg/day based on
                                          decreased bodyweight gain between GD 6 and
                                          21..
                                         Developmental NOAEL = >32 mg/kg/day........
                                         Developmental LOAEL = not established......
----------------------------------------------------------------------------------------------------------------

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 ``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 deltamethrin used for 
human risk assessment is shown in Table 3 of this unit:

[[Page 62607]]



                         Table 3.--Summary of Toxicological Dose and Endpoints for Deltamethrin for Use in Human Risk Assessment
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Dose Used in Risk
                                                                Assessment, Interspecies and  Special FQPA SF and Level of     Study and Toxicological
                       Exposure Scenario                            Intraspecies and any       Concern for Risk Assessment             Effects
                                                                       Traditional UF
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute Dietary (General Population and Females 13-49 years of           NOAEL = 1.0 mg/kg/day          Special FQPA SF = 3X  Neurotoxicity-Motor Activity
 age)                                                                               UF = 100     aPAD = acute RfD/ Special        (Crofton et al., 1995)
                                                                  Acute RfD = 0.01 mg/kg/day    FQPA SF = 0.0033 mg/kg/day   LOAEL = 3.0 mg/kg/day based
                                                                                                                               on reduced motor activity
---------------------------------------------------------------
Chronic Dietary (All populations)                                       NOAEL= 1.0 mg/kg/day          Special FQPA SF = 3X             Chronic Dog Study
                                                                                    UF = 100    cPAD = chronic RfD/Special    LOAEL = 10 mg/kg/day based
                                                                Chronic RfD = 0.01 mg/kg/day    FQPA SF = 0.0033 mg/kg/day         on clinical signs and
                                                                                                                                reduced body weight gain
---------------------------------------------------------------
Incidental Oral Short and Intermediate Term                            NOAEL = 1.0 mg/kg/day             LOC for MOE = 300       Same as chronic dietary
                                                                                    UF = 100
---------------------------------------------------------------
Dermal All Durations                                                                                                           Not required: No systemic
                                                                                                                                 toxicity via the dermal
                                                                                                                             route was seen at the limit
                                                                                                                             dose; there was no evidence
                                                                                                                             of cumulative toxicity; and
                                                                                                                                     physical and dermal
                                                                                                                                 properties indicate low
                                                                                                                                      dermal absorption.
---------------------------------------------------------------
Inhalation All Durations (Residential)                                 NOAEL = 1.0 mg/kg/day             LOC for MOE = 300      Same as chronic dietary.
                                                                             UF = 100= 100%)                 (Residential)
---------------------------------------------------------------
Cancer (oral, dermal, inhalation)                                                                                             Classification: Not likely
                                                                                                                               to be a human carcinogen.
--------------------------------------------------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.435) for the combined residues of deltamethrin, 
isomers trans-deltamethrin and [alpha]-R-deltamethrin, in or on a 
variety of raw agricultural commodities, including additional meat, 
milk, poultry and egg tolerances. Risk assessments were conducted by 
EPA to assess dietary exposures from combined residues of deltamethrin, 
isomers trans-deltamethrin and [alpha]-R-deltamethrin, and tralomethrin 
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.
    In conducting the acute dietary risk assessment EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCID\TM\), 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 acute exposure assessments: The 
acute dietary exposure analysis was a refined probabilistic one. The 
analysis was refined through the use of projected market share 
estimates from Agency analysis and anticipated residues (ARs) based on 
field trial values. At the 99.9th percentile of exposure, the risk 
estimate for the general U.S. population is 39% of the acute population 
adjusted dose (aPAD). The most highly exposed population subgroup is 
All Infants, which utilizes 65% of the aPAD.
    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\TM\), 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: Chronic exposure analysis was refined through the use of 
projected market share estimates from Agency analysis and the 
anticipated residues (ARs) are based on field trial values. The U.S. 
population and all population subgroups have exposure and risk 
estimates that are below the Agency's level of concern. The general 
U.S. population utilizes 3.0% of the chronic PAD (cPAD). The most 
highly exposed subgroup, Children 1-2 years, utilizes 7.6% of the cPAD.
    iii. Cancer. Deltamethrin is classified by the Agency as not likely 
to be carcinogenic in humans.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate.
    Section 408(b)(2)(F) of the FFDCA states that the Agency may use 
data on the actual percent of food treated for assessing chronic 
dietary risk only if the Agency can make the following findings: 
Condition 1, that the data used are reliable and provide a valid basis 
to

[[Page 62608]]

show what percentage of the food derived from such crop is likely to 
contain such pesticide residue; Condition 2, that the exposure estimate 
does not underestimate exposure for any significant subpopulation 
group; and Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of %CT as required 
by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to 
submit data on %CT.
    The Agency used PCT information as follows:
    For existing uses of deltamethrin and tralomethrin, the Agency used 
estimates of PCT for the acute and chronic exposure assessments which 
were determined using Doanes Market Survey Data (1996-2001). The 
following deltamethrin PCT data estimates were used for both the acute 
and chronic dietary exposure assessments: Cotton (14), tomato (19). The 
following tralomethrin PCT data estimates were used for both the acute 
and chronic dietary exposure assessments: Broccoli (6.0), lettuce, head 
(15), lettuce, leaf (22), and soybean (1.0). Tralomethrin is also 
registered for use on cotton and sunflower. For cotton, the 
deltamethrin PCT value is higher; therefore, the deltamethrin value was 
used in the assessment. There is a proposed use for deltamethrin on 
sunflower, and the projected market share value is higher than the PCT 
value for tralomethrin. As a result, the projected market share value 
for deltamethrin was used in the assessment. Since deltamethrin and 
tralomethrin are essentially the same chemical, it was assumed that 
both pesticides would not be used on the same crop.
    The Agency believes that the three conditions listed in Unit 
III.C.1.iv. have been met. With respect to Condition 1, PCT estimates 
are derived from market survey data, which are reliable and have a 
valid basis.
    The Agency used maximum PCT for both acute and chronic dietary 
exposure estimates. A maximum PCT is unlikely to underestimate exposure 
to an individual because of the fact that an individual is unlikely to 
be exposed to more than the maximum PCT either on an acute basis or 
over a lifetime. For acute assessments, the Agency incorporates PCT 
information by creating a residue distribution file which includes the 
measured residue values from field trials, and zero residue values 
added to account for the percent of crop not treated. This approach is 
used only for non-blended or partially blended commodities as defined 
under EPA SOP99.6. For blended commodities, a single-point estimate is 
created from the residue value multiplied by the upper bound PCT. The 
Agency is reasonably certain that the percentage of the food treated is 
not likely to be an underestimation.
    For the new uses, the Agency used PCT estimates for both the acute 
and chronic exposure assessments based on market share projections as 
follows: Almond (28 %); apple (38 %); canola (1.0 %); cantaloupe (11 
%); carrot (22 %); corn (5.0 %); cucumber (10 %); garlic (1.0 %); onion 
(2.0 %); pear (23 %); pepper (12 %); potato (7.0 %); soybean (1.0 %); 
squash (2.0 %); sunflower (9.0 %); and walnut (5.0%). The following 
methods were used to estimate market share for the new uses: The Agency 
reviewed the proposed new uses for deltamethrin, identified practicable 
alternatives based on the primary target pest for each use site, and 
estimated a likely upper-bound for the percent crop treated. The Agency 
has determined that the alternatives are viable based on the best 
available EPA data, and assumes they will control the insect pests 
identified on the proposed label. The Agency believes that the 
projected market share estimates are upper-bound estimates because it 
summed the current market share of all chemicals that are currently 
being used to control the target pest on a particular crop. By doing 
so, the Agency has made the assumption that deltamethrin will replace 
all other insecticides that are currently being used on that crop to 
control the primary target pest that deltamethrin will be used to 
control. Furthermore, the Agency has made the assumption that 
deltamethrin will replace all competing insecticides on all of the 
crops for which projected market share data were used. In addition, the 
Agency has made the assumption that for many of the crops in the 
dietary analysis, 100% of the crop would be treated. For the stored 
grains, the PCT estimates are derived from usage data for 
chlorpyriphos-methyl, historically the most widely used insecticide for 
control of insect pests in stored grains. The estimates are as follows: 
Wheat, oats, and barley (avg: 8.0 %, max: 9.0 %); field corn and pop 
corn (avg: 3.0 %, max: 6.0 %); sweet corn (avg: 2.1 %, max: 3.5 %); 
sorghum (avg: 3.2 %, max: 3.7 %); and rice (avg: 2.9 %, max: 3.1 %). 
For all other new uses, it was assumed that 100% of the crop would be 
treated.
    The Agency believes that the three conditions previously discussed 
have been met regarding PCT estimates for the new deltamethrin 
registrations. With respect to Condition 1, EPA finds that the PCT 
information described in Unit II.C.1.iv. for deltamethrin on almonds, 
apples, canola, cantaloupe, carrots, corn, cucumbers, garlic, onions, 
pears, peppers, potatoes, soybeans, squash, sunflowers, walnuts, and 
stored cereal grains is derived from market survey data, which are 
reliable and have a valid basis. For almonds, apples, canola, 
cantaloupe, carrots, corn, cucumbers, garlic, onions, pears, peppers, 
potatoes, soybeans, squash, sunflowers, and walnuts, the PCT estimates 
are based on current market share data for all alternative insecticides 
used to control the primary target pest, and the generous assumption 
that deltamethrin will replace all of the competing insecticides used 
to control that target pest. For stored grains, the estimate is derived 
from usage data for chlorpyrifos-methyl, historically the most widely 
used insecticide for control of insect pests in stored grains. These 
estimates should not underestimate actual usage of deltamethrin on the 
new crops/sites.
    As to Conditions 2 and 3, regional consumption information and 
consumption information for significant subpopulations is taken into 
account through EPA's computer-based model for evaluating the exposure 
of significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which deltamethrin 
may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for deltamethrin 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 deltamethrin.

[[Page 62609]]

    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), 
to produce estimates of pesticide concentrations in an index reservoir. 
The SCI-GROW model is used to predict pesticide concentrations in 
shallow groundwater. For a screening-level assessment for surface water 
EPA will use FIRST, a tier 1 model, before using PRZM/EXAMS, a tier 2 
model. The FIRST model is a subset of the PRZM/EXAMS model that uses a 
specific high end runoff scenario for pesticides. While both FIRST and 
PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS 
model includes a percent crop area factor as an adjustment to account 
for the maximum percent crop coverage within a watershed or drainage 
basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a 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 deltamethrin they are 
further discussed in the aggregate risk sections in Unit III.E.
    Based on FIRST and SCI-GROW models, the EECs of deltamethrin for 
acute exposures are estimated to be 0.20 parts per billion (ppb) for 
surface water and 0.006 ppb for ground water. The EECs for chronic 
exposures are estimated to be 0.067 ppb for surface water and 0.006 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).
    Deltamethrin is currently registered for use on lawns, turf, golf 
courses, sod farms, ornamental gardens, perimeter treatment, indoor 
broadcast, spot, and crack and crevice surface treatment, and pet 
collars. The end use products are formulated as ready-to-use sprays, 
granular, dust, wettable powders and liquids to be applied by 
commercial applicators and/or homeowners depending on the product. 
These uses include a wide range of application methods including hose-
end sprayers, push-type spreader, shaker can, aerosol can, low/high 
pressure hand wands, injection, airless sprayers, injection syringe, 
and paint brush/roller used to treat indoors and outdoors.
    No dermal endpoint was selected because no systemic toxicity via 
the dermal route was seen at the limit dose and therefore a dermal risk 
assessment for handlers was not required. All inhalation MOEs for 
residential handlers exposure ranged from 3,300 to 1,800,000 and 
therefore did not exceed the Agency's level of concern.
    Based on the use pattern of residential products, duration of 
postapplication exposure is expected to be short term. As indicated 
previously no dermal endpoint was selected and therefore no risk from 
dermal exposure is expected. The Agency concluded that use of an indoor 
fogger would result in the worst case scenario for assessing 
postapplication inhalation exposure. The postapplication inhalation 
MOEs following use of a fogger were greater than the targeted MOE and 
therefore the risks were not of concern. Fogger postapplication risks 
are protective of inhalation risks from other indoor products. 
Furthermore the vapor pressure of deltamethrin is very low (1.5 x 
10-\8\ mm Hg at 25[deg]) and therefore postapplication 
inhalation exposure is expected to be minimal for indoor uses.
    The following postapplication incidental oral scenarios following 
application to lawns and indoor surfaces (carpet versus hardwood or 
vinyl floors) were assessed:
    i. Short-term oral hand-to-mouth exposure to toddlers and children 
from indoor use ;
    ii. Short-term oral object to mouth exposure to toddlers and 
children from ingestion of pesticide treated turf; and
    iii. Short-term oral exposure to toddlers and children following 
soil ingestion.
Since the FQPA safety factor for the protection of children and infants 
was reduced to 3X, a target MOE value of 300 has been identified for 
residential assessments. MOE values greater than 300 are not considered 
to be of concern to the Agency. MOE estimates are based on the NOAEL 
dose level of 1 mg/kg/day established for short-term oral risk 
assessment.

                        Table 4.--Summary of Short-term Residential Postapplication MOEs.
----------------------------------------------------------------------------------------------------------------
            Exposure Scenario                    Oral Dose (mg/kg/day                      Oral MOE
----------------------------------------------------------------------------------------------------------------
Hand-to-Mouth (Indoor Use)                                            0.0028                                 340
-----------------------------------------
Object-to-Mouth (Turf)                                               0.00049                               2,000
-----------------------------------------
Soil Ingestion (Turf)                                              0.0000065                             150,000
----------------------------------------------------------------------------------------------------------------
Note: Episodic incidental ingestion of granules and paint chips was also assessed and was not considered to be
  of concern to the Agency.

    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.''
    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 deltamethrin and any other 
substances and deltamethrin 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 deltamethrin has 
a common mechanism of toxicity with other substances. For information

[[Page 62610]]

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 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
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. The toxicology data base for 
deltamethrin for an FQPA assessment includes developmental toxicity 
studies in rats, rabbits and mice, a two-generation reproduction 
toxicity study in rats, acute and subchronic neurotoxicity studies in 
rats, and studies from the open literature indicating increased 
susceptibility and neurotoxicity.
    Signs of neurotoxicity were seen in guideline acute and subchronic 
neurotoxicity studies in rats, including salivation, soiled fur, 
impaired mobility, no reaction to approach and no reaction to touch 
response observed in the functional observation battery (FOB) in the 
acute study, and mortality, clinical signs of toxicity, FOB findings, 
and decreased body weights, body weight gains, and food consumption in 
the subchronic study. In addition, similar signs of neurotoxicity were 
observed in several literature studies conducted in rats and mice.
    Acceptable developmental toxicity studies in rats and rabbits 
indicated no evidence of developmental toxicity. In 3 non-guideline 
multi-species developmental toxicity studies, there is concern for 
developmental effects that occurred in either the absence of or in the 
presence of mild maternal toxicity in three species (mice, rats and 
rabbits). In mice, an increase in delayed ossification in the fetuses 
was seen in the absence of maternal toxicity at the highest dose 
tested. In rats, increased delayed ossification was seen in the 
presence of decreased body weight in the dams. In rabbits, increased 
fetal death and decreased fetal body weight were seen in the absenceof 
maternal toxicity at the highest dose tested.
    There is qualitative evidence of increased susceptibility only at 
the highest dose tested in the two-generation toxicity study in rats. 
Effects were seen in the adults of the F1 generation. These effects 
were not seen in the P generation or in the F1 rats when they were 
pups. These effects included increased death, clinical findings (i.e. 
impaired righting reflexes, hyperactivity, splayed limbs, vocalization, 
and excessive salivation) and cerebral congestion and/or blood clots at 
the highest dose tested. Evidence for age-related sensitivity was seen 
in a published literature study in which the brain concentration of 
deltamethrin in weanling rats was higher than in adult rats.
    Based on clinical signs indicative of neurotoxicity observed in 
adult animals, concern for the effects seen in the two-generation 
reproduction study and structural-activity relationship concerns, a 
developmental neurotoxicity study (DNT) has been required for 
deltamethrin. The study protocol indicates that the proposed lowest 
dose in the study is 1 mg/kg/day, which is equivalent to the NOAELs 
currently selected for dietary and non-dietary risk assessment.
    3. Conclusion. The hazard-based FQPA Safety Factor has been reduced 
to 3x for all population subgroups including those comprised of infants 
and children.
    Previously, the Agency determined that the overall FQPA Safety 
Factor should be retained at 10x due to the lack of an acceptable pre-
natal toxicity study in rabbits; the lack of the required developmental 
neurotoxicity (DNT) study; an overall degree of concern for the 
qualitative and quantitative evidence of increased susceptibility 
observed in mice; and residual uncertainties for pre/post-natal 
toxicity. The default 10x factor encompassed the database uncertainty 
factor and the Special FQPA Safety Factor.
    The Agency has since received and reviewed an acceptable pre-natal 
developmental toxicity study in rabbits which does not show evidence 
(quantitative or qualitative) of increased susceptibility. A dose 
analysis indicated no need for a database uncertainty factor for the 
lack of a DNT since this study is not expected to lower the doses 
currently used for the overall risk assessment. Therefore, there is no 
need for a database uncertainty factor. However, the Special FQPA 
Safety Factor is needed since there is still a concern for the 
qualitative evidence of increased susceptibility observed in mice. A 
Special FQPA Safety Factor of 3X (as opposed to a 10X) was determined 
to be adequate based on the following weight-of-evidence 
considerations.
    i. The endpoint of concern for risk assessment is already based on 
the most sensitive endpoint (i.e., clinical signs indicative of 
neurotoxicity),
    ii. In the acute and subchronic neurotoxicity studies, no damage to 
the neurological system (e.g., neuropathology or alterations in brain 
weight) was seen, and there was no evidence of malformations or 
variations of the central nervous system of the fetuses in the pre-
natal studies or to offspring in the post-natal study,
    iii. The generally accepted mechanism of action for pyrethroids, 
sodium channel disruption, has not been traditionally associated with 
developmental neuropathology, and
    iv. A dose that was four-fold higher than the dose used for risk 
assessment was required to cause the two-fold difference in brain 
concentration of deltamethrin in weanling rats.
    The NOAEL of 1.0 mg/kg/day currently used for overall risk 
assessment is protected by a safety factor of 3X which yields an 
extrapolated dose of 0.3 mg/kg/day. This dose is an order of magnitude 
lower than the dose that caused the two-fold decrease in brain 
concentrations of deltamethrin in the weanling rats. Therefore, a half-
log reduction (3X) in the Special FQPA Safety Factor is considered to 
be sufficiently protective of the concerns for the qualitative 
susceptibility seen in mice.

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

[[Page 62611]]

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 
youth 13-19), 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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
deltamethrin will occupy 39% of the aPAD for the U.S. population, 28% 
of the aPAD for females 13 to 49, 65% of the aPAD for All Infants (< 1 
year old), and 60% of the aPAD for Children 1-2 years old. In addition, 
there is potential for acute dietary exposure to deltamethrin 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 aPAD, as shown in Table 5 of this unit:

                     Table 5.--Aggregate Risk Assessment for Acute Exposure to Deltamethrin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                  Exposure      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                   (mg/kg)       (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. Population                             0.001305           39         0.20        0.006           71
------------------------------------------------
All Infants (< 1 year old)                          0.002175           65         0.20        0.006           12
------------------------------------------------
Children 1-2 years old                              0.001992           60         0.20        0.006           13
------------------------------------------------
Children 3-5 years old                              0.002135           64         0.20        0.006           12
------------------------------------------------
Children 6-12 years old                             0.001555           47         0.20        0.006           18
------------------------------------------------
Youth 13-19 years old                               0.001010           30         0.20        0.006           70
------------------------------------------------
Adults 20-49 years old                              0.000830           25         0.20        0.006           88
------------------------------------------------
Adults 50+ years old                                0.000836           25         0.20        0.006           87
------------------------------------------------
Females 13-49 years old                             0.000937           28         0.20        0.006           72
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
deltamethrin from food will utilize 3 % of the cPAD for the U.S. 
population, 7.6 % of the cPAD for Children 1-2 years old. Based on the 
use pattern, chronic residential exposure to residues of deltamethrin 
is not expected. In addition, there is potential for chronic dietary 
exposure to deltamethrin 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 6 of this unit:

              Table 6.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Deltamethrin
 
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                Exposure mg/    % cPAD     Water EEC    Water EEC     Chronic
                                                    kg/day       (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                     0.000099          3.0        0.067        0.006          110
------------------------------------------------
All Infants (< 1 year old)                          0.000157          4.7        0.067        0.006           32
------------------------------------------------
Children 1-2 years old                              0.000252          7.6        0.067        0.006           31
------------------------------------------------
Children 3-5 years old                              0.000238          7.1        0.067        0.006           31
------------------------------------------------
Children 6-12 Years                                 0.000149          4.5        0.067        0.006           32
------------------------------------------------

[[Page 62612]]

 
Youth 13-19 Years                                   0.000086          2.6        0.067        0.006           97
------------------------------------------------
Adults 20-49 Years                                  0.000076          2.3        0.067        0.006          110
------------------------------------------------
Adults 50+ Years                                    0.000078          2.3        0.067        0.006          110
------------------------------------------------
Females 13-49                                       0.000077          2.3        0.067        0.006           98
----------------------------------------------------------------------------------------------------------------

    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).
    Deltamethrin 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 deltamethrin.
    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 2600 for the U.S. Population, 
2700 for Females 13-49, 338 for all infants <1 year old, 328 for 
Children 1-2 years old, and 329 for Children 3-5 years old. These 
aggregated MOEs include average exposure from deltamethrin residues in 
food as well as inhalation exposure of adults; oral (hand-to-mouth) 
exposure of infants and children from the residential uses of 
deltamethrin resulting from spot, and crack and crevice use and surface 
treatments to carpet and vinyl surfaces. These aggregate MOEs do not 
exceed the Agency's level of concern for aggregate exposure to food and 
residential uses. In addition, short-term DWLOCs were calculated and 
compared to the EECs for chronic exposure of deltamethrin 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 7 
of this unit:

                   Table 7.--Aggregate Risk Assessment for Short-Term Exposure to Deltamethrin
----------------------------------------------------------------------------------------------------------------
                                                               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                                        2,600          300        0.067        0.006          100
-----------------------------------------------
Females 13-49                                          2,700          300        0.067        0.006           89
-----------------------------------------------
All infants (<1 year)                                    338          300        0.067        0.006          3.8
-----------------------------------------------
Children 1-2                                             328          300        0.067        0.006          2.8
-----------------------------------------------
Children 3-5                                             329          300        0.067        0.006          3.0
----------------------------------------------------------------------------------------------------------------

    4. Intermediate-term risk. Intermediate term residential exposures 
are not anticipated from the registered and proposed uses of 
deltamethrin, therefore, an intermediate term risks are not expected.
    5. Aggregate cancer risk for U.S. population. Deltamethrin is 
classified by the Agency as not likely to be carcinogenic in humans, 
therefore, deltamethrin 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 deltamethrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate analytical methods based on gas chromatography (GC) with 
electron capture detection (ECD) are available for enforcing tolerances 
for residues of deltamethrin. These methods are used for the 
determination of cis-deltamethrin, trans-deltamethrin, and alpha-R-
deltamethrin in various raw agricultural, animal-derived, and processed 
commodities. In addition, cis-deltamethrin is completely recovered and 
its trans isomer is partially recovered by one of the multiresidue 
methods utilized by the Food and Drug Administration for monitoring of 
pesticide residues. 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

    Codex Maximum Residue Limits (MRL's) are established on a variety 
of commodities for residues of deltamethrin in terms of the cis-isomer 
only. This definition is not compatible with the U.S. tolerances, which 
also include the trans and alpha-R isomers. However, the cis-isomer is 
consistently present at much higher levels than the other two isomers 
in crop field trials. Thus, in numerical terms there is not a 
significant difference in the tolerance definitions. Therefore, the 
Agency concludes that it is reasonable to harmonize U.S. tolerance 
levels numerically with Codex MRL's where feasible. The commodities for 
which the

[[Page 62613]]

U.S. tolerances have been raised for harmonization purposes are meat 
byproducts of cattle, goats, horses, and sheep (to match the 0.05 ppm 
Codex MRL for edible mammalian offal); cereal grains; soybean seed (0.1 
ppm Codex MRL for legume vegetables); sunflower seed (0.1 ppm Codex MRL 
on oilseeds); cucurbit vegetables; and wheat bran. The U.S. tolerances 
on barley bran and rye bran have also been increased since they are 
based on the data for wheat bran. The data for dry bulb onions in the 
U.S. support setting the tolerance at the same level as the Codex bulb 
vegetable tolerance. The following U.S. tolerances can not be 
harmonized numerically with Codex MRL's due to residues being higher 
from the requested uses in the U.S. or the tolerances being based on 
the sum of the analytical method limits of quantitation for the three 
deltamethrin isomers (versus only the cis-isomer included in Codex 
MRL's): globe artichoke; meat of cattle, goats, horses, and sheep; 
stover of field corn, pop corn, sweet corn, and grain sorghum; eggs; 
pome fruit; green onion; poultry meat and meat byproducts; rapeseed; 
fruiting vegetables; root vegetables; and tuberous and corm vegetables.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
deltamethrin, isomers trans-deltamethrin and [alpha]-R-deltamethrin, in 
or on almond hulls; apples, wet pomace; artichoke, globe; barley, bran; 
cattle, fat; cattle, meat; cattle, meat byproducts; corn, field, 
forage; corn, field, refined oil; corn, field, stover; corn, pop, 
stover; corn, sweet, forage; corn, sweet, kernel + cob with husks 
removed; corn, sweet, stover; egg; fruit, pome, group 11; goat, fat; 
goat, meat; goat, meat byproducts; grain, aspirated fractions; grain, 
cereal, group 15, except sweet corn; hog, fat; horse, fat; horse, meat; 
horse, meat byproducts; lychee (import tolerance); milk, fat 
(reflecting 0.02 ppm in whole milk); nut, tree, group 14; onion, dry 
bulb; onion, green; poultry, fat; poultry, meat; poultry, meat 
byproducts; radish tops; rapeseed; rice, hulls; rye, bran; sheep, fat; 
sheep, meat; sheep, meat byproducts; sorghum, grain forage; sorghum, 
grain stover; soybean, seed; soybean, hulls; starfruit (import 
tolerance); sunflower seeds; vegetable, cucurbit, group 9; vegetable, 
fruiting, group 8; vegetable, root, except sugar beet, subgroup IB; 
vegetable, tuberous and corm, subgroup; IC; wheat, bran at 2.5, 1.0, 
0.5, 5.0, 0.05, 0.02, 0.05, 0.7, 2.5, 5.0, 5.0, 10, 0.03, 15, 0.02, 
0.2, 0.05, 0.02, 0.05, 65, 1.0, 0.05, 0.05, 0.02, 0.05, 0.2, 0.1, 0.1, 
0.1, 1.5, 0.05, 0.02, 0.02, 4.0, 0.2, 2.5, 5.0, 0.05, 0.02, 0.05, 0.5, 
1.0, 0.1, 0.2, 0.2, 0.1, 0.2, 0.3, 0.2, 0.04, 5.0 parts per million 
(ppm) respectively .
    At the request of the registrant (Bayer Crop Science LP, formerly 
Aventis CropScience, P.O. Box 12014, 2 T.W. Alexander Drive, Research 
Triangle Park, NC 27709]) the following crop tolerances were 
voluntarily withdrawn from the original petition: head & stem brassica 
vegetables, leafy vegetables and stone fruits.

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-2004-0331 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 December 
27, 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 (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. 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 ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2004-0331, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection

[[Page 62614]]

Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In 
person or by courier, bring a copy to the location of the PIRIB 
described in ADDRESSES. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

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 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: September 30, 2004.
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), 346a and 371.

0
2. Section 180.435 is amended by alphabetically adding commodities to 
the table in paragraph (a)(1) to read as follows:


Sec.  180.435  Deltamethrin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Almond hulls.........................................                2.5
Apples, wet pomace...................................                1.0
Artichoke, globe.....................................                0.5

[[Page 62615]]

 
Barley, bran.........................................                5.0
Cattle, fat..........................................               0.05
Cattle, meat.........................................               0.02
Cattle, meat byproducts..............................               0.05
Corn, field, forage..................................                0.7
Corn, field, refined oil.............................                2.5
Corn, field, stover..................................                5.0
Corn, pop, stover....................................                5.0
Corn, sweet, forage..................................                 10
Corn, sweet, kernel + cob with husks removed.........               0.03
Corn, sweet, stover..................................                 15
                                * * * * *
Egg..................................................               0.02
Fruit, pome, Group 11................................                0.2
Goat, fat............................................               0.05
Goat, meat...........................................               0.02
Goat, meat byproducts................................               0.05
Grain, aspirated fractions...........................                 65
Grain, cereal, Group 15, except sweet corn...........                1.0
Hog, fat.............................................               0.05
Horse, fat...........................................               0.05
Horse, meat..........................................               0.02
Horse, meat byproducts...............................               0.05
Lychee*..............................................                0.2
Milk, fat (reflecting 0.02 ppm in whole milk)........                0.1
Nut, tree, Group 14..................................                0.1
Onion, dry bulb......................................                0.1
Onion, green.........................................                1.5
Poultry, fat.........................................               0.05
Poultry, meat........................................               0.02
Poultry, meat byproducts.............................               0.02
Radish tops..........................................                4.0
Rapeseed.............................................                0.2
Rice, hulls..........................................                2.5
Rye, bran............................................                5.0
Sheep, fat...........................................               0.05
Sheep, meat..........................................               0.02
Sheep, meat byproducts...............................               0.05
Sorghum, grain forage................................                0.5
Sorghum, grain stover................................                1.0
Soybean, seed........................................                0.1
Soybean, hulls.......................................                0.2
Starfruit*...........................................                0.2
Sunflower seed.......................................                0.1
                                * * * * *
Vegetable, cucurbit, Group 9.........................                0.2
Vegetable, fruiting, Group 8.........................                0.3
Vegetable, root, except sugar beet, Subgroup IB......                0.2
Vegetable, tuberous and corm, Subgroup IC............               0.04
Wheat, bran..........................................                5.0
------------------------------------------------------------------------
*There are no U.S. registrations for use of deltamethrin on starfruit
  and lychee.

* * * * *

[FR Doc. 04-24040 Filed 10-26-04; 8:45 am]
BILLING CODE 6560-50-S