[Federal Register: October 27, 2004 (Volume 69, Number 207)]
[Rules and Regulations]
[Page 62602-62615]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27oc04-16]
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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: larocca.george@epa.gov.
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
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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:
residuemethods@epa.gov.
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 tompkins.jim@epa.gov,
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: opp-docket@epa.gov. 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