[Federal Register: September 19, 2003 (Volume 68, Number 182)]
[Rules and Regulations]
[Page 54808-54818]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19se03-10]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0278; FRL-7326-4]
Cyprodinil; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
cyprodinil in or on brassica, head and stem, subgroup 5A; brassica,
leafy greens, subgroup 5B; carrot; herb, subgroup 19A, dried; herb,
subgroup 19A, fresh; longan; lychee; pulasan; rambutan; spanish lime;
and turnip, greens. Interregional Research Project Number 4 (IR-4)
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 September 19, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0278,
must be received on or before November 18, 2003.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address:
brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you an are
agricultural producer, food manufacturer, and pesticide manufacturer
Potentially affected entities may include, but are not limited to:
[bull] Crop production (NAICS 111)
[bull] Animal production (NAICS 112)
[bull] Food manufacturing (NAICS 311)
[bull] Pesticide manufacturing (NAICS 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System
[[Page 54809]]
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0278. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. frequently updated
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html
, a
beta site currently under development. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of April 21, 2003 (68 FR 19528) (FRL-7301-
6), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, as amended by FQPA (Public Law 104-170), announcing the filing of
pesticide petitions (PP 2E6447, 2E6461, 2E6485, 3E6529, and 3E6530) by
IR-4, 681 US Highway 1 South, New Brunswick, NJ 08902-3390.
That notice included a summary of the petitions prepared by Syngenta
Crop Protection Incorporated, the registrant.
The petitions requested that 40 CFR 180.532 be amended by
establishing tolerances for residues of the fungicide, cyprodinil, CGA
219417; 4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine, in or on the
following commodities: brassica, head and stem, subgroup 5A at 2.0
parts per million (ppm); and brassica, leafy greens, subgroup 5B at
10.0 ppm (PP 2E6485); carrot at 0.5 (PP 2E6461); herb subgroup 19A at
10.0 ppm (3E6529); longan; lychee; pulasan; rambutan; and spanish lime
at 2.0 ppm (PP 2E6447); and turnip, greens at 10.0 ppm (PP 2E6485).
Petition numbers 2E6485, 2E6461 and 3E6529 were subsequently
amended to propose tolerances for brassica, head and stem, subgroup 5A
at 1.0 ppm; and brassica, leafy greens, subgroup 5B at 10.0 ppm (PP
2E6485); carrot at 0.75 ppm (PP 2E6461); herb, subgroup 19A, dried at
15.0 ppm, and herb, subgroup 19A, fresh at 3.0 ppm (3E6529); longan;
lychee; pulasan; rambutan; and spanish lime at 2.0 ppm (PP 2E6447); and
turnip, greens at 10.0 ppm (PP 2E6485). There were no comments received
on these petitions.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that`` there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of the FFDCA, for tolerances for residues of cyprodinil, CGA
219417; 4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine on brassica,
head and stem, subgroup 5A at 1.0 ppm; brassica, leafy greens, subgroup
5B at 10.0 ppm; carrot at 0.75; herb, subgroup 19A, dried at 15.0 ppm;
herb, subgroup 19A, fresh at 3.0 ppm; longan, lychee, pulasan,
rambutan, and spanish lime at 2.0 ppm; and turnip, greens at 10.0 ppm.
EPA's assessment of exposures and risks associated with establishing
the tolerances follow.
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 cyprodinil are
discussed in the following Table 1 as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies reviewed.
[[Page 54810]]
Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
Guideline No. Study Type Results
------------------------------------------------------------------------
870.3100 90-Day oral NOAEL = 73.3/103 mg/
toxicity (mouse) kg/day, M/F
LOAEL = 257/349 mg/
kg/day, M/F, based
on
histopathological
changes in the
liver
------------------------------------------------------------------------
870.3100 90-Day oral NOAEL =3.14 mg/kg/
toxicity (rat) day
LOAEL = 19 mg/kg/
day based on
increased tubular
kidney lesions in
males
------------------------------------------------------------------------
Non-guideline 28-Day Feeding/ NOAEL = 64.8/62.2
Range mg/kg/day, M/F
Finding(rat) LOAEL = 316/299 mg/
kg/day, M/F, based
on lower body-
weight gains,
microcytosis,
increase
cholesterol and
phospholipid
levels, and
hepatocyte
hypertrophy
------------------------------------------------------------------------
Non-guideline 28-Day Gavage/ NOAEL = 10 mg/kg/
Range day
Finding(rat) LOAEL = 100 mg/kg/
day based on
increased liver
weights and
abnormalities in
liver morphology
------------------------------------------------------------------------
870.3150 90-Day oral NOAEL =210/232 mg/
toxicity (dog) kg/day, M/F
LOAEL = 560/581 mg/
kg/day, M/F, based
on lower body-
weight gains and
decreased food
consumption in
both sexes
------------------------------------------------------------------------
870.3200 21/28-Day dermal- NOAEL = 25/125 mg/
toxicity(rat) kg/day, F/M
LOAEL = 125/1000 mg/
kg/day, F/M, based
on clinical signs
(hunched posture
and/or
piloerection).
------------------------------------------------------------------------
870.3200 Carcinogenicity - NOAEL = 16.1 mg/kg/
(mouse) day
LOAEL = 212.4 mg/kg/
day based on a
dose-related
increase in the
incidence of focal
and multifocal
hyperplasia of the
exocrine pancreas
in males
No evidence of
carcinogenicity
------------------------------------------------------------------------
870.3700 Prenatal Maternal NOAEL =
developmental(rat 200 mg/kg/day
) Maternal LOAEL =
1,000 mg/kg/day
based on lower
body-weight/body-
weight gain and
reduced food
consumption
Developmental NOAEL
= 200 mg/kg/day
Developmental LOAEL
= 1,000 mg/kg/day
based on lower
mean fetal weights
and increased
incidence of
delayed
ossification
------------------------------------------------------------------------
870.3700 Prenatal Maternal NOAEL =
developmental 150 mg/kg/day
(rabbit) Maternal LOAEL =
400 mg/kg/day
based on decreased
body-weight gain
Developmental NOAEL
= 150 mg/kg/day
Developmental LOAEL
= 400 mg/kg/day
based on slight
increase of
litters showing
extra (13th) ribs
------------------------------------------------------------------------
870.3800 Reproduction and Maternal/Systemic
fertility NOAEL = 81 mg/kg/
effects(rat) day
Maternal/Systemic
LOAEL = 326 mg/kg/
day based on
decreased body
weight gain in the
F0 females during
the pre-mating
period.
Reproductive/
Developmental
NOAEL = 81 mg/kg/
day
Reproductive/
Developmental
LOAEL = 326 mg/kg/
day based on
decreased pup
weights (F1 and
F2)
------------------------------------------------------------------------
870.4300 Chronic toxicity/ NOAEL = 2.7 mg/kg/
Carcinogenicity day
(feeding)(rat) LOAEL = 35.6 mg/kg/
day based on
degenerative liver
lesions
(spongiosis
hepatis) in males
No evidence of
carcinogenicity
------------------------------------------------------------------------
870.4100 Chronic toxicity NOAEL = 65.63/67.99
(dog) mg/kg/day, M/F
LOAEL = 449.25/
446.3, M/F, mg/kg/
day based on lower
body-weight gains
and decreased food
consumption and
food efficiency
------------------------------------------------------------------------
870.5100 Gene Mutation - In a reverse gene
Bacteria mutation assay
with Salmonella
typhimurium/
Escherichia coli,
cyprodinil was
negative up to
concentrations
(>=1,250 [mu]g/
plate +/-S9) that
produced
reproducible
cytotoxicity for
the majority of
strains. Compound
insolubility was
reported at >=313
[mu]g/plate.
------------------------------------------------------------------------
870.5100 CGA 249287 Metabolite Gene In repeat gene
Mutation - mutation assays in
Bacteria bacteria, CGA
249287 was
negative for
induction of
reverse mutation
in the bacterial
cultures assayed
under the
conditions of the
experiments.
------------------------------------------------------------------------
[[Page 54811]]
870.5300 In vitro mammalian In a Chinese
cell hamster V79 cell
HGPRT forward gene
mutation assay,
cyprodinil was
negative up to
cytotoxic
concentrations
(>=96.0 [mu]g/mL
with S9) (>=24
[mu]g/mL without
S9).
------------------------------------------------------------------------
870.5375 Cytogenetics/In In an in vitro
vitro Chromosomal assay for
Aberration chromosome
aberrations in
Chinese hamster
ovary (CHO) cells,
cyprodinil gave
negative results
up to cytotoxic
concentrations
(>=50 [mu]g/mL
without S9, 18- or
42-hour cell
harvest or >=25
[mu]g/mL with S9,
18- hour cell
harvest) or to the
highest sub-
cytotoxic
concentration (50
[mu]g/mL with S9,
42-hour cell
harvest).
------------------------------------------------------------------------
870.5395 Cytogenetics/In In an in vivo bone
vivo bone marrow marrow
micronucleus micronucleus
assay, cyprodinil
was negative when
administered
orally (gavage) at
5,000 mg/kg (HDT)
to both sexes of
Tif:MAGF mice. No
signs of overt
toxicity or clear
evidence of
cytotoxicity for
the target organ
were noted at any
dose or sacrifice
time.
------------------------------------------------------------------------
870.5550 UDS In an UDS assay in
primary rat
hepatocytes,
cyprodinil was
negative up to a
cytotoxic
concentration (80
[mu]g/mL)
------------------------------------------------------------------------
870.7485 Metabolism and Single oral doses
pharmacokinetics (0.5 or 100 mg/kg
bw) of phenyl or
pyrimidyl-
radiolabelled
cyprodinil (purity
>=98%) were
administered to
Tif:RAIf(SPF)
rats, with one low-
dose group
receiving
unlabelled
cyprodinil (purity
>=99%) for 2 weeks
prior to treatment
with radiolabelled
compound.
Absorption was
very rapid with
rapid clearance. A
minimum of 75% of
the administered
dose was absorbed.
Excretion was
rapid and almost
complete, with
urine as the
principle route of
excretion (48-
68%), and >90% of
the administered
dose detected in
the urine and
feces within 48
hours. Excretion,
distribution and
metabolite
profiles were
essentially
independent of
dose level,
pretreatment, and
type of label,
although there
were some
quantitative
differences sex-
dependent
qualitative
differences in two
urinary metabolite
fractions.
------------------------------------------------------------------------
870.7485 Metabolism and Excreta and bile
pharmacokinetics from radiolabelled
cyprodinil-treated
Tif:RAIf(SPF) rats
were used to
characterize,
isolate and
identify
cyprodinil
metabolites.
Eleven metabolites
were isolated from
urine, feces and
bile, and the
metabolic pathways
in the rat were
proposed. All
urinary and
biliary
metabolites (with
the exception of
7U) were
conjugated with
glucuronic acid or
sulfonated, and
excreted.
Cyprodinil was
almost completely
metabolized by
hydroxylation of
the phenyl ring
(position 4) or
pyrimidine ring
(position 5),
followed by
conjugation. An
alternative
pathway involved
oxidation of the
phenyl ring
followed by
glucuronic acid
conjugation. A
quantitative sex
difference was
observed with
respect to
sulfonation of the
major metabolite
that formed 6U.
The monosulfate
metabolite (1U)
was predominant in
females, whereas
equal amounts of
mono- and
disulfate (6U)
conjugates were
noted in males.
Most of the
significant
metabolites in
feces were exocons
of biliary
metabolites (2U,
3U, 1G). These
were assumed to be
deconjugated in
the intestines,
partially
reabsorbed into
the general
circulation,
conjugated again,
and eliminated
renally. The major
metabolic pathways
of cyprodinil were
not significantly
influenced by the
dose, treatment
regimen, or sex of
the animal.
------------------------------------------------------------------------
870.7600 Dermal Absorption In a dermal
(rat) absorption study
with cyprodinil
formulated as
SWITCH 62.5 WG in
the rat, the
maximum systemic
absorption was
21.71% (at 24
hours). An
additional 12% of
the applied dose
(that is
potentially
available for
absorption)
remained on the
treated skin at 24
hours.
------------------------------------------------------------------------
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.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factors
(SF) is retained due to concerns unique to the FQPA, this additional
factor is applied to the RfD by dividing the RfD by such additional
factor. The acute or
[[Page 54812]]
chronic Population Adjusted Dose (aPAD or cPAD) is a modification of
the RfD to accommodate this type of FQPA SF.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as1 x 10-6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for cyprodinil used for human risk assessment is shown in the
following Table 2:
Table 2.--Summary of Toxicological Dose and Endpoints for Cyprodinil for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose used in Risk FQPA SF and Endpoint Study, Toxicological
Exposure Scenerio Assessment UF for Risk Assessment Endpoint
----------------------------------------------------------------------------------------------------------------
Acute Dietary females 13-50 years of Developmental NOAEL = Special FQPA SF* = 1X Developmental Toxicity
age 150 mg/kg/day aPAD = acute RfD / rabbit
UF = 100............... Special FQPA SF = 1.5 Developmental LOAEL =
Acute RfD = 1.5 mg/kg/ mg/kg/day. 400 mg/kg/day based on
day. slight increase of
litters showing extra
ribs (13th).
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations NOAEL= 2.7 Special FQPA SF = 1X 2-Year Chronic Toxicity/
UF = 100............... cPAD = chronic RfD / Carcinogenicity-rat
Chronic RfD = 0.03 mg/ Special FQPA SF = 0.03 LOAEL = 35.6 mg/kg/day
kg/day. mg/kg/day. based on degenerative
liver lesions
(spongiosis hepatis)
in males.
----------------------------------------------------------------------------------------------------------------
Incidental Oral Short-Term (1-30 oral NOAEL= 62 mg/kg/ LOC for MOE = 100 28-Day Feeding/Range-
days)(Residential) day (Residential, includes finding - rat
the Special FQPA SF of LOAEL = 299 mg/kg/day
1X) based on decreased
body-weight gain,
increased cholesterol
and phospholipid
levels, microcytosis,
and hepatocyte
hypertrophy.
----------------------------------------------------------------------------------------------------------------
Incidental Oral Intermediate-Term (1- oral NOAEL= 2.7 mg/kg/ LOC for MOE = 100 2-Year Chronic Toxicity/
6 months)(Residential) day (Residential, includes Carcinogenicity -rat
the Special FQPA SF of LOAEL = 35.6 mg/kg/day
1X) based on degenerative
liver lesions
(spongiosis hepatis)
in males.
----------------------------------------------------------------------------------------------------------------
Dermal Short-Term (1-30 oral NOAEL= 62 mg/kg/ LOC for MOE = 100 28-Day Feeding/Range-
days)(Residential) day (dermal absorption (Residential, includes finding - rat
rate = 30%) the Special FQPA SF of LOAEL = 299 mg/kg/day
1X) based on decreased
body-weight gain,
increased cholesterol
and phospholipid
levels, microcytosis,
and hepatocyte
hypertrophy.
----------------------------------------------------------------------------------------------------------------
Dermal Intermediate-Term(1-6 months) oral NOAEL= 2.7 mg/kg/ LOC for MOE = 100 2-Year Chronic Toxicity/
and Long-Term (26 day(dermal absorption (Residential, includes Carcinogenicity - Rat
months)(Residential) rate = 30%) the Special FQPA SF of LOAEL = 35.6 mg/kg/day
1X) based on degenerative
liver lesions
(spongiosis hepatis)
in males.
----------------------------------------------------------------------------------------------------------------
Inhalation Short-Term(1-30 days) oral NOAEL = 62 mg/kg/ LOC for MOE = 100 28-Day Feeding/Range-
(Residential) day (inhalation (Residential, includes finding - rat
absorption rate = the Special FQPA SF of LOAEL = 299 mg/kg/day
100%) 1X) based on decreased
body-weight gain,
increased cholesterol
and phospholipid
levels, microcytosis,
and hepatocyte
hypertrophy.
----------------------------------------------------------------------------------------------------------------
Inhalation Intermediate-Term(1-6 oral NOAEL = 2.7 mg/kg/ LOC for MOE = 100 2-Year Chronic Toxicity/
months) and Long-Term (26 months) day (inhalation (Residential, includes Carcinogenicity in
(Residential) absorption rate = the Special FQPA SF of Rats
100%) 1X) LOAEL = 35.6 mg/kg/day
based on degenerative
liver lesions
(spongiosis hepatis)
in males.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Classification: ``Not likely to be carcinogenic to humans''
----------------------------------------------------------------------------------------------------------------
*The reference to the special FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.
[[Page 54813]]
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.532) for the residues of cyprodinil, in or on a
variety of raw agricultural commodities: almond, hulls; almond
nutmeats; apple, wet pomace; fruit, pome; fruit, stone; grape; and
raisins. Time-limited tolerances are established (40 CFR 180.532
(a)(2)) for onion, dry bulb; onion, green; and strawberry (each set to
expire December 31, 2003). A time-limited tolerance (40 CFR 180.532
(b)) on caneberries is also set to expire December 31, 2003. Risk
assessments were conducted by EPA to assess dietary exposures from
cyprodinil in food as follows:
i. Acute exposure. In conducting this acute dietary risk assessment
EPA used the Dietary Exposure Evaluation Model software with the Food
Commodity Intake Database (DEEM-FCID[reg]) 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: An unrefined, Tier 1 acute dietary exposure assessment
(using tolerance-level residues, DEEM (version 7.76) default processing
factors and assuming 100% CT for all proposed commodities) was
conducted for the females 13- 49 years old population subgroup.
ii. Chronic exposure. In conducting this acute dietary risk
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID[reg]) 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 was made for the chronic exposure
assessment: An unrefined, Tier 1 chronic dietary exposure assessment
(using tolerance-level residues, DEEM default processing factors, and
assuming 100% CT for all proposed commodities) was conducted for the
general U.S. population and various population subgroups.
iii. Cancer. A quantitative cancer aggregate-risk assessment was
not performed because cyprodinil is not carcinogenic.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for cyprodinil 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 cyprodinil.
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone model/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. FIRST and PRZM/EXAMS incorporate an index reservoir
environment, and 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) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead, drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to cyprodinil they are further
discussed in the aggregate risk sections in Unit III.E.
Environmental fate data suggest that as cyprodinil dissipates from
the environment, it forms the transformation product CGA 249287 and
other metabolites under natural conditions. CGA 249287 was observed at
<11% of the applied parent in aerobic soil metabolism studies. It was
also one of the transformation products observed at <14% in the
terrestrial field dissipation studies.
EPA concluded that CGA 249287 is a potential concern in drinking
water. Therefore, EEC's of CGA 249287 (along with the parent) were also
simulated. The maximum application rate and relevant environmental fate
parameters for cyprodinil and its metabolite CGA 249287 were used in
the two screening models PRZM/EXAMS and SCI-GROW for EEC's in surface
water and groundwater, respectively. The outputs of the two screening
models represent estimates of the concentrations that might be found in
surface water and groundwater due to the use of cyprodinil on cabbage
and strawberry.
Table 3.--Summary of EPA's EEC's in Surface Water and Groundwater Table
----------------------------------------------------------------------------------------------------------------
Surface Water ([mu]g/L)
Chemical -------------------------------------------- Groundwater ([mu]g/L)
Acute Non-Cancer Chronic
----------------------------------------------------------------------------------------------------------------
Florida Cabbage
----------------------------------------------------------------------------------------------------------------
Cyprodinil 23.9 6.63 0.04
---------------------------------------
CGA 249287 5.29 1.42 0.12
¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬
Total 29.2 8.1 0.16
----------------------------------------------------------------------------------------------------------------
[[Page 54814]]
Florida Strawberry
----------------------------------------------------------------------------------------------------------------
Cyprodinil 26.67 5.32 0.04
---------------------------------------
CGA 249287 6.20 1.04 0.12
¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬
Total 32.9 6.4 0.16
----------------------------------------------------------------------------------------------------------------
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).
Cyprodinil is not registered for use on any sites that would result
in residential exposure. There are no registered or proposed uses of
cyprodinil which result in potential residential exposures.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether cyprodinil has a common mechanism of toxicity with other
substances. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to cyprodinil
and any other substances and cyprodinil 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 cyprodinil has a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.
D. Safety Factor for Infants and Children
1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. There are no concerns or
residual uncertainties for pre- and/or postnatal exposure.
3. Conclusion. There is a complete toxicity data base for
cyprodinil and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10X Safety factor to protect infants and children should be
reduced to 1X because:
i. The toxicological data base is complete for the assessment of
toxicity and susceptibility following pre- and/or post-natal exposures.
No clinical signs of neurotoxicity or neuropathology were observed in
the data base, and the developmental neurotoxicity study was not
required.
ii. There is no evidence of increased susceptibility of rat or
rabbit fetuses following in utero exposure in the developmental studies
with cyprodinil. There is no evidence of increased susceptibility of
young rats in the reproduction study with cyprodinil.
iii. There are no residual concerns regarding pre- or post-natal
toxicity or completeness of the toxicity or exposure data base.
iv. The dietary food exposure assessment is Tier 1, screening
level, which is based on tolerance level residues and assumes 100% of
all crops will be treated with cyprodinil. By using these screening
level assessments, actual exposures/risks will not be underestimated.
v. The dietary drinking water assessment utilizes water
concentration values generated by models and associated modeling
parameters which are designed to provide conservative, health
protective, high-end estimates of water concentrations which will not
likely be exceeded.
vi. There are currently no registered residential uses of
cyprodinil.
vii. These assessments will not underestimate the exposure/risks
posed by current or proposed uses of cyprodinil.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water [e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure)]. This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default body weights and drinking water consumption
values vary on an individual basis. This variation will be taken into
account in more refined screening-level and quantitative
[[Page 54815]]
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 groundwater are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of 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
cyprodinil will occupy 2% of the aPAD for the females 13-49 years old.
In addition, there is potential for acute dietary exposure to
cyprodinil in drinking water. For the general U.S. population, no toxic
effects of concern that could be attributed to a single exposure were
observed in the oral-toxicity studies, including the developmental
toxicity studies in rats and rabbits. Therefore, an acute RfD was not
established for this population subgroup and an acute dietary exposure
assessment was not conducted for this population subgroup. 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 the following Table 4:
Table 4.--Aggregate Risk Assessment for Acute Exposure to Cyprodinil
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old 1.5 2 32.9 0.16 44,000
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
cyprodinil from food will utilize 25% of the cPAD for the U.S.
population, 65% of the cPAD for (the most highly exposed population
subgroup) children 1-2 years old, 32% of the cPAD for all infants <1
year old, and 21% of the cPAD for females 13-49 years old. Based on the
use pattern, chronic residential exposure to residues of cyprodinil is
not expected. In addition, there is potential for chronic dietary
exposure to cyprodinil 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
the following Table 5:
Table 5.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Cyprodinil
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ %cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.03 25 8.1 0.16 790
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old) 0.03 65 8.1 0.16 100
----------------------------------------------------------------------------------------------------------------
All Infants (<1 year old) 0.03 32 8.1 0.16 200
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old) 0.03 21 8.1 0.16 710
----------------------------------------------------------------------------------------------------------------
3. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in mice and rats at doses that were judged
to be adequate to assess the carcinogenic potential, cyprodinil was
classified as ``not likely to be carcinogenic to humans.'' Therefore,
cyprodinil is not expected to pose a cancer risk to humans.
4. 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 cyprodinil residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The results of Multiresidue Method testing of cyprodinil and its
metabolite CGA-232449 have been forwarded to the Food and Drug
Administration (FDA). Cyprodinil was tested according to the FDA
Multiresidue protocols (Protocols C, D, and E), and acceptable
recoveries were obtained for cyprodinil fortified in apples at 0.50 ppm
using Protocol D. The petitioner is proposing the Method AG-631A as a
tolerance enforcement method for residues of cyprodinil in/on the
subject crops. The method includes confirmatory procedures using gas
chromatography/nitrogen/phosphorus detector (GC/NPD). The method has
successfully undergone radiovalidation using 14C-labeled
tomato samples and independent laboratory validation. In addition, the
method has been the subject of acceptable Agency petition method
validations on stone fruits and almond nutmeat and hulls. 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
Canada, Codex, and Mexico do not have maximum residue limits (MRLs)
for residues of cyprodinil in/on the proposed crops. Therefore,
harmonization is not an issue.
[[Page 54816]]
V. Conclusion
Therefore, the tolerances are established for residues of
cyprodinil, CGA 219417; 4-cyclopropyl-6-methyl-N-phenyl-2-
pyrimidinamine, in or on brassica, head and stem, subgroup 5A at 1.0
ppm; brassica, leafy greens, subgroup 5B at 10.0 ppm; carrot at 0.75
ppm; herb, subgroup 19A, dried at 15.0 ppm; herb, subgroup 19A, fresh
at 3.0 ppm; longan, lychee, pulasan, rambutan, and spanish lime at 2.0
ppm; and turnip, greens at 10.0 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d)
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2003-0278 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 November
18, 2003.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you 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 Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2003-0278, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.1. You may also send an electronic copy of
your request via e-mail to: 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 the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income
[[Page 54817]]
Populations (59 FR 7629, February 16, 1994); or OMB review or any
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Since tolerances and exemptions that are
established on the basis of a petition under section 408(d) of the
FFDCA, such as the tolerance in this final rule, do not require the
issuance of a proposed rule, the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition,
the Agency has determined that this action will not have a substantial
direct effect on States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism(64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this rule does not have any ``tribal implications''
as described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the 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 10, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
0
2. Section 180.532 is amended by adding alphabetically commodities to
the table in paragraph (a)(1) to read as follows:
Sec. 180.532 Cyprodinil; tolerances for residues.
(a) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
* * * * *
Brassica, head and stem, subgroup 5A 1.0
Brassica, leafy greens, subgroup 5B 10.0
* * * * *
Carrot 0.75
Herb, subgroup 19A, dried 15.0
Herb, subgroup 19A, fresh 3.0
* * * * *
Longan 2.0
Lychee 2.0
* * * * *
Pulasan 2.0
Rambutan 2.0
* * * * *
Spanish lime 2.0
Turnip, greens 10.0
* * * * *
----------------------------------------------------------------------------------------------------------------
[[Page 54818]]
* * * * *
[FR Doc. 03-23854 Filed 9-18-03; 8:45 am]
BILLING CODE 6560-50-S