[Federal Register: September 30, 2004 (Volume 69, Number 189)]
[Rules and Regulations]
[Page 58290-58299]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30se04-13]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0211; FRL-7367-4]
Cyazofamid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for the combined
residues of cyazofamid and its metabolite CCIM in or on potatoes,
tomatoes, cucurbits, and imported wine. ISK Biosciences Corporation
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective September 30, 2004. Objections and
requests for hearings must be received on or before November 29, 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
ID number OPP-2004-0211. All documents in the docket are listed in the
EDOCKET index athttp://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: Janet Whitehurst, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 305-6129; e-mail
address:whitehurst.janet@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; 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 athttp://www.epa.gpo/opptsfrs/home/guidelin.htm/
.
II. Background and Statutory Findings
In the Federal Register of May 7, 2003 (68 FR 24463) (FRL-7305-7),
EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
1F06305) by ISK Biosciences Corporation, Concord, OH. That notice
included a summary of the petition prepared by ISK Biosciences
Corporation, the registrant. There were no comments received in
response to the notice of filing.
The petition requested that 40 CFR part 180 be amended by
establishing tolerances for combined residues of the fungicide
cyazofamid, 4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-
imidazole-1-sulfonamide and its metabolite CCIM, 4-chloro-5-(4-
methylphenyl)-1H-imidazole-2-carbonitrile, expressed as cyazofamid, in
or on cucurbit vegetables (Group 9) at 0.10 parts per million (ppm),
potato at 0.01 ppm, tomato at 0.20 ppm, and grape wine at 1.0 ppm.
Following review of the residue and metabolism data, EPA has made
several minor changes to the proposed tolerances. For cucurbits and
potatoes, EPA expanded the tolerance expression to cover both
cyazofamid and its metabolite CCIM, which is also a residue of concern.
This expansion of the toleranceexpression necessitated a raising of the
tolerance level for potatoes from 0.01 ppm to 0.02 ppm. No change in
the tolerance values was needed for tomatoes. Finally, residue and
processing data for grape wine showed that residues might slightly
exceed 1.0
[[Page 58291]]
ppm; accordingly, the tolerance for grape wine was raised to 1.5 ppm.
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 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 cyazofamid
on cucurbits at 0.10 ppm, potatoes at 0.01 ppm, tomatoes at 0.2 ppm,
and wine grape at 1.0 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by cyazofamid are
discussed in Table 1 of this unit as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies reviewed.
Table 1.--Toxicity Profile of Cyazofamid [IKF-916] Technical
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Guideline No. Study Type Results
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870.3100 90-day oral toxicity in NOAEL = 29.5 [M] mg/kg/day
rats LOAEL = 295 [M] mg/kg/day based on
increased number of ``basophilic kidney
tubules,'' and increased urinary volume,
pH, and protein.
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870.3150 90-Day oral toxicity in NOAEL = 1,000 [M/F] mg/kg/day
dogs LOAEL = not observed.
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870.3200 28-Day dermal toxicity in NOAEL = 1,000 [M/F] mg/kg/day
rats LOAEL = not observed.
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870.3700 Prenatal developmental in Maternal NOAEL = 1,000 mg/kg/day
rats LOAEL = not observed
Developmental NOAEL = 100 mg/kg/day
LOAEL = 1,000 mg/kg/day based on increased
incidence of bent ribs.
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870.3700 Prenatal developmental in Maternal NOAEL = 1,000 mg/kg/day
rabbits LOAEL = not observed
Developmental NOAEL = 1,000 mg/kg/day
LOAEL = not observed
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870.3800 Reproduction and fertility Parental/Systemic NOAEL = 1,114/1,416 [M/F]
effects in rats mg/kg/day
LOAEL = not observed
Reproductive NOAEL = 1,114/1,416 [M/F] mg/
kg/day
LOAEL = not observed
Offspring NOAEL = 1,114/1,416 [M/F] mg/kg/
day
LOAEL = not observed
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870.4100 Chronic toxicity in rats NOAEL = 171/ 856 [M/F] mg/kg/day
LOAEL = not observed.
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870.4100 Chronic toxicity in dogs NOAEL = 200 [M/F] mg/kg/day
LOAEL = 1,000 [M/F] mg/kg/day based on
increased cysts in parathyroids in both
sexes and increased pituitary cysts in
females.
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870.4200 Carcinogenicity rats NOAEL = 171/ 856 [M/F] mg/kg/day
LOAEL = not observed.
No evidence of carcinogenicity
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870.4300 Carcinogenicity mice NOAEL = 94.8 [M] mg/kg/day
LOAEL = 985 [M] mg/kg/day based on
increased incidence of skin lesions
including hair loss, body sores,
dermatitis, ulceration, and acanthosis.
No evidence of carcinogenicity
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[[Page 58292]]
870.5100 Gene Mutation Negative S9 up to 5,000 [mu]g/
Bacterial reverse mutation plate by standard plate and tube
assay. preincubation (not cytotoxic but there was
precipitation at >= 1,500 [mu]g/plate.
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870.5300 Gene Mutation Negative S9 up to cytotoxic
Mammalian cell culture.... and precipitating concentration of 100
[mu]g/mL
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870.5375 Cytogenetics Negative S9 for clastogenic/
Chromosomal aberrations... aneugenic activity up to cytotoxic and
precipitating 200 [mu]g/mL
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870.5395 Cytogenetics Negative up to the highest dose tested
Micronucleus test on mouse (limit dose) 2,000 mg/kg
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870.5500 Other Effects Negative S9 up to limit of
Bacterial DNA repair test solubility at 8,000 [mu]g/disc
(Rec-assay).
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870.7485 Metabolism and There was rapid absorption (irrespective of
pharmacokinetics in rats dose tcmax = 0.25-0.5 hrs) and rapid
elimination at the low dose (t[frac12] 4.4-
5.8 hrs) while there was saturated
absorption with prolonged elimination
(t[frac12] of 7.6-11.6 hrs) at the high-
dose. The extent of absorption (as per
cent of administered dose) was highly dose-
dependent being nearly 75% at the low dose
and only about 5% at the high dose. Both
the urine and feces were major routes of
excretion at the low dose with most of the
urinary radioactivity being a metabolite
named CCBA (4-(4-chloro-2-cyanoimidazol-5-
yl)benzoic acid). The biliary elimination
was highly variable at the low dose (12-
39% of the administered low dose) and
negligible (< 2%) in the high-dose groups.
Urinary or biliary excretion in the high-
dose groups was low (each 2%) with most of
the radioactivity being CCBA. Irrespective
of the dosing regimen, most of the
recovered fecal radioactivity was
unchanged parent compound; the major fecal
metabolites were CCBA and 4-chloro-5-p-
tolylimidazole-2-carbonitrile (CCIM) each
of which being less than 5% of the
administered dose. Tissue burdens at
t[frac12], tmax, and at 168 hours post
dose indicated rapid clearance and low
tissue burdens suggesting little or no
bioaccumulation or sequestration.
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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
[[Page 58293]]
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 cyazofamid used for
human risk assessment is shown in Table 2 of this unit:
Table 2.--Summary of Toxicological Dose and Endpoints for Cyazofamid
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Special FQPA SF* and
Exposure Scenario Dose Used in Risk Level of Concern for Study and Toxicological
Assessment, UF Risk Assessment Effects
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Acute Dietary (Females 13-50 years of NOAEL = 100 mg/kg FQPA SF = 1X Rat Prenatal
age) UF = 100............... aPAD = acute RfD / FQPA Developmental Toxicity
Acute RfD = 1.0 mg/kg.. SF = 1.0 mg/kg. (MRID 45408933)
LOAEL = 1,000 mg/kg
based on developmental
toxicity findings of
increased incidence of
bent ribs.
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Acute Dietary (General population NOAEL = NA FQPA SF = NA Not Required. No
including infants and children) UF = NA................ aPAD = acute RfD / FQPA adverse effects were
Acute RfD = NA......... SF = NA. observed which could
be attributed to a
single-dose exposure.
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Chronic Dietary (All populations) NOAEL= 94.8 mg/kg/day FQPA SF = 1X 18-Month Mouse Oral
UF = 100............... cPAD = chronic RfD / Carcinogenicity (MRID
Chronic RfD = 0.95 mg/ FQPA SF = 0.95 mg/kg/ 45408932)
kg/day. day. LOAEL = 985 mg/kg/day
based on increased
skin lesions.
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Short- (1-30 days) and Intermediate- NOAEL= NA Residential LOC for MOE NA
Term (1 to 6 months) Incidental Oral No Residential Uses.... = NA
Occupational = NA......
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Short- (1-30 days) and Intermediate- Oral study NOAEL = 100 Residential LOC for MOE Rat Prenatal
Term (1 to 6 months) Dermal mg/kg/day = NA Developmental Toxicity
(dermal absorption rate Occupational LOC for (MRID 45408933)
= 37%). MOE = 100. LOAEL = 1,000 mg/kg
based on developmental
toxicity findings of
increased incidence of
bent ribs.
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Long-Term Dermal (>6 months) Oral study NOAEL = 94.8 Residential LOC for MOE 18-Month Mouse Oral
mg/kg/day = NA Carcinogenicity (MRID
(dermal absorption rate Occupational LOC for 45408932)
= 37%). MOE = 100. LOAEL = 985 mg/kg/day
based on increased
skin lesions.
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Short- (1-30 days) and Intermediate- Oral study NOAEL = 100 Residential LOC for MOE Rat Prenatal
Term (1 to 6 months) Inhalation mg/kg/day = NA Developmental Toxicity
Occupational LOC for (MRID 45408933)
MOE = 100. LOAEL = 1,000 mg/kg
based on developmental
toxicity findings of
increased incidence of
bent ribs.
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Long-Term Inhalation (>6 months) Oral study NOAEL = 94.8 Residential LOC for MOE 18-Month Mouse Oral
mg/kg/day = NA Carcinogenicity (MRID
Occupational LOC for 45408932)
MOE = 100. LOAEL = 985 mg/kg/day
based on increased
skin lesions.
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Cancer (oral, dermal, inhalation) Not Applicable NA NA
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UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no-observed-adverse-effect-level, LOAEL =
lowest-observed-adverse-effect-level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference
dose, MOE = margin of exposure, LOC = level of concern, NA = Not Applicable
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Permanent and
temporary tolerances for residues of cyazofamid and its metabolites are
not currently established. Risk assessments were conducted by EPA to
assess dietary exposures from the proposed uses of cyazofamid on food
and feed crops as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide, if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1-day or
single exposure.
In conducting the acute dietary risk assessment EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCIDTM) and LifelineTM,
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: As an acute dietary endpoint was not identified
for the general population including infants and children, the acute
dietary analysis was performed for the population subgroup females 13
to 49 years old only. The assumptions of this dietary exposure
assessment are tolerance level residues and 100% crop-treated.
At the 95th percentile of exposure, the Tier 1 acute DEEM-
FCIDTM and LifelineTM analysis gave the results
listed in Table 3. For the acute analysis, the exposure at the 95th
percentile for Females 13 to 49 years old is 0.003769 mg/kg/day for
DEEM-FCIDTM or
[[Page 58294]]
0.004013 mg/kg/day for LifelineT, which utilizes < 1% of the acute PAD
for cyazofamid for both DEEM-FCIDTM and
LifelineTM. The results of the LifelineTM and
DEEM-FCIDTM analyses are fully consistent.
A summary of the acute dietary exposure estimates for cyazofamid
and its metabolote CCIM used for human risk assessment are shown in
Table 3 of this unit:
Table 3.--Acute Dietary Exposure Estimates for Cyazofamid
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DEEM-FCIDTM LifeLineTM
aPAD (mg/kg/---------------------------------------------------
Population Subgroup day) Exposure Exposure
(mg/kg/day) %aPAD\1\ (mg/kg/day) %aPAD\1\
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Females 13-49 years old 1.0 0.003769 < 1 0.004013 < 1
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\1\ Percent Acute PAD = (Exposure / Acute PAD) x 100%.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the DEEM-FCIDTM and
LifelineTM, 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: The
assumptions of this dietary exposure assessment are tolerance level
residues and 100% crop-treated.
The Tier 1 chronic DEEM-FCIDTM and LifelineTM
analysis gave the results listed in Table 4. For the chronic analysis,
the most highly exposed population subgroup and the highest risk
estimate was for Children 1 to 2 years old. The chronic exposures for
Children 1 to 2 years old are 0.004778 mg/kg/day for DEEM-
FCIDTM) or 0.004529 mg/kg/day for LifelineTM),
which utilize <1.0% (for both DEEM-FCIDTM and Lifeline
TM) of the chronic PAD for cyazofamid. The results of the
LifelineTM and DEEM-FCIDTM analyses are fully
consistent.
A summary of the chronic dietary exposure estimates for cyazofamid
used for human risk assessment is shown in Table 4 of this unit:
Table 4.--Chronic Dietary Exposure Estimates for Cyazofamid
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DEEM-FCIDTM LifeLineTM
cPAD (mg/kg/---------------------------------------------------
Population Subgroup day) Exposure Exposure
(mg/kg/day) %cPAD\1\ (mg/kg/day) %cPAD\1\
----------------------------------------------------------------------------------------------------------------
General U.S. Population 0.95 0.001016 < 1 0.000988 < 1
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All Infants (< 1 year old) 0.95 0.001448 < 1 0.001501 < 1
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Children 1-2 years old 0.95 0.004778 < 1 0.004529 < 1
----------------------------------------------------------------------------------------------------------------
Children 3-5 years old 0.95 0.003101 < 1 0.003236 < 1
----------------------------------------------------------------------------------------------------------------
Children 6-12 years old 0.95 0.001338 < 1 0.00131 < 1
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Youth 13-19 years old 0.95 0.000567 < 1 0.000589 < 1
----------------------------------------------------------------------------------------------------------------
Adults 20-49 years old 0.95 0.000684 < 1 0.000751 < 1
----------------------------------------------------------------------------------------------------------------
Adults 50+ years old 0.95 0.000774 < 1 0.000802 < 1
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old 0.95 0.000720 < 1 0.000816 < 1
----------------------------------------------------------------------------------------------------------------
\1\ Percent Chronic PAD = (Exposure / Chronic PAD) x 100%.
iii. Cancer. A cancer dietary assessment was not conducted because
cyazofamid has been classified as ``not likely to be carcinogenic to
humans''.
iv. Anticipated residue and percent crop treated (PCT) information.
The Agency did not use anticicated residue estimates and PCT
information in the cyazofamid dietary exposure assessment.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for cyazofamid and its
metabolites 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 cyazofamid.
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 Screening Concentration in Groudwater (SCI-GROW) model
is used to predict pesticide concentrations in shallow ground water.
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. Both FIRST and PRZM/EXAMS incorporate
an index reservoir environment, and both models include 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
[[Page 58295]]
(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 percent of the
reference dose (%RfD) or percent of the population adjusted dose
(%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.
Based on the FIRST and SCI-GROW models, the EECs of cyazofamid and
its metabolites for acute exposures are estimated to be 6.436 parts per
billion (ppb) for surface water and 0.002680 ppb for ground water. The
EECs for chronic exposure is estimated to be 0.495 ppb for surface
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). Cyazofamid is not
registered for use on any sites that would result in residential
exposure.
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 cyazofamid and any other
substances and cyazofamid 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 cyazofamid has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the policy statements released by EPA's OPP concerning common mechanism
determinations and procedures for cumulating effects from substances
found to have a common mechanism on EPA's web site at http://www.epa.gov/pesticides/cumulative/
.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
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. There are no concernsor
residual uncertainties for pre- and or postnatal toxicity.
3. Conclusion. EPA determined that the 10X safety factor to protect
infants and children should be removed i.e., reduced to 1X. The FQPA
factor is removed because:
i. In the prenatal developmental toxicity study in rabbits, there
was no indication of increased susceptibility (qualitative or
quantitative) of rabbit fetuses to in utero exposure to cyazofamid. No
maternal or developmental effects were seen at any dose up to the limit
dose of 1,000 mg/kg/day.
ii. In the prenatal developmental toxicity study in rabbits, there
was no indication of increased susceptibility (qualitative or
quantitative) of rabbit fetuses to in utero exposure to cyazofamid. No
maternal or developmental effects were seen at any dose up to the limit
dose of 1,000 mg/kg/day.
iii. In the two-generation reproduction study, the highest dose
tested (>1,000 mg/kg/day) did not cause maternal systemic toxicity nor
did it elicit reproductive or offspring toxicity.
iv. The Agency concluded that the concern is low for the
quantitative susceptibility seen in the rat developmental toxicity
study and there are no residual uncertainties because:
a. The developmental effect is well identified with clear NOAEL/
LOAEL.
b. The developmental effect (increased bent ribs) is a variation
rather than a malformation.
c. The developmental effect is seen only at the limit dose of 1,000
mg/kg/day.
d. This endpoint is used to establish the acute RfD for Females 13-
49 years old.
e. The overall toxicity profile indicates that cyazofamid is not a
very toxic compound.
v. There were no indications of pre- or postnatal toxicity and no
residual uncertainties from the rabbit developmental study or the rat
two generation reproduction study.
vi. The exposure assessments are Tier 1, conservative, high-end
assessments and will not underestimate the potential dietary (food and
water) exposures.
vii. There are no proposed residential uses.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against EECs. DWLOC values are
not regulatory standards for drinking water. DWLOCs are theoretical
upper limits on a pesticide's concentration in drinking water in light
of total aggregate exposure to a pesticide in food and residential
uses. In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default
[[Page 58296]]
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
cyazofamid will occupy < 1% of the aPAD for females 13 years and older.
In addition, there is potential for acute dietary exposure to
cyazofamid 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 Cyazofamid
----------------------------------------------------------------------------------------------------------------
Ground Surface
Acute 95% Maximum Water Water Acute
Population Subgroup aPAD (mg/kg/ Food Acute Water EDWC\3\ EDWC\3\ DWLOC\4\
day) Exposure\1\ Exposure\2\ (ppb or (ppb or (ppb or
(mg/kg/day) (mg/kg/day) [mu]g/L) [mu]g/L) [mu]g/L)
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old 1.0 0.004013 1.0 0.495 6.436 3.0 x 104
----------------------------------------------------------------------------------------------------------------
\1\ The exposure from the model producing the highest exposure estimate for the population subgroup was used.
\2\ Maximum Water Exposure (mg/kg/day) = aPAD (mg/kg/day) - Dietary (Food) Exposure.
\3\ The highest level was used.
\4\ DWLOC([mu]g/L) = [maximum water exposure (mg/kg/day) x body weight (kg)] [water consumption (L) x 10-\3\ mg/
[mu]g]. A body weight of 70 kg is assumed for adults, 60 kg for females and youth, and 10 kg for children;
water consumption is assumed to be 2 L for adults and 1 L for children.
2. Chronic risk. The chronic dietary exposure analyses in this
assessment for cyazofamid result in dietary risk (food only) estimates
that are below the Agency's level of concern for chronic dietary (food
only) exposure. For the chronic analysis, the most highly exposed
population subgroup and the highest risk estimate was for children 1 to
2 years old. The chronic exposures for children 1 to 2 years old are
0.004778 mg/kg/day for DEEM-FCIDTM or 0.004529 mg/kg/day for
LifelineTM, which utilize <1.0% (for both DEEM-
FCIDTM and LifelineTM) of the chronic PAD for
cyazofamid. 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 Cyazofamid
----------------------------------------------------------------------------------------------------------------
Maximum Ground Surface
Chronic Chronic Water Water Chronic
Population Subgroup cPAD (mg/kg/ Food Water EDWC\3\ EDWC\3\ DWLOC\4\
day) Exposure\1\ Exposure\2\ (ppb or (ppb or (ppb or
(mg/kg/day) (mg/kg/day) [mu]g/L) [mu]g/L) [mu]g/L)
----------------------------------------------------------------------------------------------------------------
General U.S. Population 0.95 0.001016 0.95 NA NA 3.3 x 104
----------------------------------------------------------------------------------------------------------------
All Infants (< 1 year old) 0.95 0.001501 0.95 NA NA 9.5 x 103
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old 0.95 0.004778 0.95 NA NA 9.5 x 103
----------------------------------------------------------------------------------------------------------------
Children 3-5 years old 0.95 0.003236 0.95 NA NA 9.5 x 103
----------------------------------------------------------------------------------------------------------------
Children 6-12 years old 0.95 0.001338 0.95 0.495 8.085 9.5 x 103
----------------------------------------------------------------------------------------------------------------
Youth 13-19 years old 0.95 0.000589 0.95 NA NA 2.8 x 104
----------------------------------------------------------------------------------------------------------------
Adults 20-49 years old 0.95 0.000751 0.95 NA NA 3.3 x 104
----------------------------------------------------------------------------------------------------------------
Adults 50+ years old 0.95 0.000802 0.95 NA NA 3.3 x 104
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old 0.95 0.000816 0.95 NA NA 2.8 x 104
----------------------------------------------------------------------------------------------------------------
\1\ The exposure from the model producing the highest exposure estimate for the population subgroup was used.
\2\ Maximum Water Exposure (mg/kg/day) = cPAD (mg/kg/day) - Dietary (Food) Exposure
\3\ The highest level was used.
\4\ DWLOC([mu]g/L) = [maximum water exposure (mg/kg/day) x body weight (kg)] [water consumption (L) x 10-\3\ mg/
[mu]g]. A body weight of 70 kg is assumed for adults, 60 kg for females and youth, and 10 kg for children;
water consumption is assumed to be 2L for adults and 1L for children.
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).
[[Page 58297]]
Cyazofamid is not registered for use on any sites that would result
in residential exposure. Therefore, the aggregate risk is the sum of
the risk from food and water, which do not exceed the Agency's level of
concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Cyazofamid is not registered for use on any sites that would result
in residential exposure. Therefore, the aggregate risk is the sum of
the risk from food and water, which do not exceed the Agency's level of
concern.
5. Aggregate cancer risk for U.S. population. The Agency classified
cyazofamid as ``not likely to be carcinogenic to humans.'' Thus,
cyazofamid is not expected to pose a 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 cyazofamid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The Food and Drug Administration's (FDA's) Multi-Residue Protocol D
(without cleanup) is the acceptable enforcement method in crops. The
petitioner should provide the Agency with a single modified method for
all crops with the inclusion of the minor variations for crops as
needed.
B. International Residue Limits
There are currently no Codex, Canadian, or Mexican MRL's or
tolerances for cyazofamid on cucurbits, tomato, potato, and wine.
Therefore, international harmonization is not an issue for this
petition.
C. Conditions
The following confirmatory data are needed for wheat. Data are
listed below by guideline series.
1. Harmonized guideline 860.1300--Nature of the residue. The
metabolism studies conducted on plants (grapes, potatoes, and tomatoes)
and livestock (goats and hen) as well as the confined rotational crop
study are deemed tentatively acceptable. To fully upgrade each study,
the petitioner is required to provide information pertaining to dates
of sample collection, extraction, and final analysis. This information
is required for each study to determine actual sample storage
intervals.
The metabolic profiles in crop matrices (grape, wine; potato and
tomato) determined at the beginning and at the end of the analytical
phase were not provided. Representative chromatograms of the
radiolabeled residues taken before and after storage under frozen
conditions should be submitted. In the future, additional metabolism
data might be required if uses on additional crops are requested.
2. Harmonized guideline 860.1340--Residue analytical methods. The
petitioner has provided the proposed enforcement method entitled,
``Analytical Method for IKF-916 and CCIM in Tomato Samples'' as an
attachment to the ILV of the method. The Agency finds that the Residue
Analytical Methods used for data collection may be used as a single
analyte confirmatory method. However, the petitioner should provide the
Agency with a single modified method for all crops with the inclusion
of the minor variations for crops as needed. The FDA's Multi-Residue
Protocol D (without cleanup) is the acceptable enforcement method in
crops.
3. Harmonized guideline 860.1380--Storage stability. Storage
stability data for 18 months on the representative commodities of the
cucurbit group should be submitted to support the storage intervals and
conditions of the crop field trials.
4. Harmonized guideline 860.1850--Confined Accumulation in
rotational Crops. The submitted study is tentatively deemed adequate to
satisfy data requirements for a confined rotational crop study pending
submission of information pertaining to extraction and analysis dates
of samples from the 31-day PBI. These dates are required to determine
the actual sample storage intervals and need for additional storage
stability data. The supporting storage stability data from the current
submission indicate that the parent and its metabolites CCIM and CCBA
are relatively stable in fortified samples of carrot roots, lettuce,
and wheat forage stored frozen for up to 4 months. The identities of
the parent, CCIM, CCIM-AM, and sugars are deemed adequately identified
pending submission of representative TLC or data from TLC analyses.
5. Other data. Historical control data for dog toxicity studies.
V. Conclusion
Therefore, tolerances are established for the combined residues of
cyazofamid, 4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-
imidazole-1-sulfonamide, and its metabolite CCIM, 4-chloro-5-(4-
methylphenyl)-1H-imidazole-2-carbonitrile, expressed as cyazofamid, in
or on cucurbit vegetables (Group 9) at 0.10 ppm, potato at 0.02 ppm,
tomato at 0.20 ppm, and grape, wine at 1.5 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2004-0211 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
29, 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
[[Page 58298]]
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 14th Street, NW., Suite
350, Washington, DC. 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. 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-2004-0211 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 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
[[Page 58299]]
and pests, Reporting and recordkeeping requirements.
Dated:___________
________________
Director, 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 180.601 is added to read as follows:
Sec. 180.601 Cyazofamid; tolerances for residues.
(a) General. Tolerances are established for the combined residues
of cyazofamid, 4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-
imidazole-1-sulfonamide, and its metabolite CCIM, 4-chloro-5-(4-
methylphenyl)-1H-imidazole-2-carbonitrile, expressed as cyazofamid, in
or on the following commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cucurbit vegetables (Group 9).......................... 0.10
Grape, wine,* import................................... 1.5
Potato................................................. 0.02
Tomato................................................. 0.20
------------------------------------------------------------------------
*No domestic registrations.
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 04-21931 Filed 9-29-04; 8:45 am]
BILLING CODE 6560-50-S