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Cyhalofop-butyl (DOW). June 4. 2002. 5-Year pesticide tolerance for combined residues of cyhalofop (cyhalofop-butyl plus cyhalofop-acid) and the di-acid metabolite in or on rice grain and rice straw. Final Rule. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2002/June/Day-04/p13982.htm
[Federal Register: June 4, 2002 (Volume 67, Number 107)]
[Rules and Regulations]
[Page 38407-38418]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04jn02-17]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0087; FRL-7178-5]
Cyhalofop-butyl; Time-Limited Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of cyhalofop (cyhalofop-butyl plus cyhalofop-acid)
and the di-acid metabolite in or on rice grain and rice straw. Dow
AgroSciences, LLC requested this tolerance under the Federal Food,
Drug, and Cosmetic Act, as amended by the Food Quality Protection Act
of 1996. The tolerance will expire on June 1, 2007.
DATES: This regulation is effective June 4, 2002. Objections and
requests for hearings, identified by docket ID number
OPP-2002-0087, must be received on or before August 5,
2002.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number
OPP-2002-0087 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: (703) 305-6224; and
e-mail address: miller.joanne@epamail.epa.gov
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112............... Animal production
311............... Food manufacturing
32532............. Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
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 Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select "Laws and
Regulations," "Regulations and Proposed Rules,"and
then look up the entry for this document under the "Federal
Register Environmental Documents." You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/. A
frequently updated electronic version of 40 CFR part 180 is available
at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/
Title_40/40cfr180_00.html, a beta site currently under
development. To access the OPPTS Harmonized Guidelines referenced in
this document, go directly to the guidelines at http://www.epa.gov/
opptsfrs/home/guidelin.htm.
2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0087. The
official record consists of the documents specifically referenced in
this action, and other information related to this action, including
any information claimed as Confidential Business Information (CBI).
This official record includes the documents that are physically located
in the docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703)
305-5805.
II. Background and Statutory Findings
In the Federal Register of April 25, 2001 (66 FR 20808)
(FRL-6774-7), EPA issued a notice pursuant to section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as
amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law
104-
[[Page 38408]]
170), announcing the filing of a pesticide petition (PP 0F6089) by Dow
AgroSciences, LLC, 9330 Zionsville Road, Indianapolis, IN 46268. This
notice included a summary of the petition prepared by Dow AgroSciences,
LLC, theregistrant. 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 herbicide
cyhalofop-butyl (cyhalofop-butyl, cyhalofop-acid and cyhalofop-diacid)
in or on rice grain, rice hull, rice bran and polished rice at 0.03
parts per million (ppm) and rice straw at 8.0 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) 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) 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 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), 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), for a tolerance for combined residues of cyhalofop
(cyhalofop-butyl plus cyhalofop acid) and the di-acid metabolite in or
on rice grain at 0.03 ppm and rice straw at 8.0 ppm. Tolerances are not
required for rice processed fractions or for animal commodities. 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 cyhalofop-butyl are
discussed in the following Table 1 and Table 2 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. Acute Toxicity of Cyhalofop-butyl Technical
------------------------------------------------------------------------
Guideline No. Study Type Results
------------------------------------------------------------------------
870.1100 Acute Oral (Rat) LD50 &3
5000 mg/kg
(limit test)
There was no
evidence of
toxicity.
Toxicity Category
IV
------------------------------------------------------------------------
870.1100 Acute Oral (Mice) LD50 &
35000 mg/kg
(limit test)
There was no
evidence of
toxicity.
Toxicity Category
IV
------------------------------------------------------------------------
870.1200 Acute Dermal (Rat) LD50 &
35000 mg/kg (2.5
x the limit dose)
Chromodacryorrhea
was observed in 2/
5 males on day 2
only. Delayed
weight gain was
observed in all
rats, with the
females being
most affected.
There was no
dermal
irritation.
Toxicity Category
IV
------------------------------------------------------------------------
870.1300 Acute Inhalation LC50 &
35.63 mg/L (2.8 x
the limit
concentration)
Bradypnea was
noted in all rats
with recovery
within two hours
following
exposure.
Abnormal
respiratory
sounds were noted
in all rats after
exposure with
recovery by day
1. Reddish
adhesive
materials in the
nasorostral and
periocular
regions were
noted from all
test rats after
exposure with
recovery by day
2. No gross
abnormalities.
Two control rats
had reddish
adhesive
materials in the
nasorostral
region after
exposure with
recovery within
two hours.
Toxicity Category
IV
------------------------------------------------------------------------
870.2400 Primary Eye Minimally
Irritation - irritating
Rabbit Toxicity Category
IV
------------------------------------------------------------------------
870.2500 Primary Skin Essentially
Irritation - nonirritating
Rabbit Toxicity Category
IV
------------------------------------------------------------------------
870.2600 Dermal Not a dermal
Sensitization - sensitizer
Guinea Pig
------------------------------------------------------------------------
[[Page 38409]]
Table 2. Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
Guideline No. Study Type Results
----------------------------------------------------------------------------------------------------------------
870.3100 Subchronic (4 and 13 Week) NOAEL (male)3
Feeding (Rat) 400 mg/kg/day (Highest Dose Tested
[HDT]
in male)
NOAEL (female) = 400 mg/kg/day
LOAEL (female) = 800 mg/kg/day
(HDT in female) based on perineal soiling
and reduced body weights and body weight
gain.
----------------------------------------------------------------------------------------------------------------
870.3100 Subchronic Feeding (Rat) NOAEL = 60.5/65.3 mg/kg/day,M/F
LOAEL = 189.5/199.6 mg/kg/day, M/F (HDT)
based on kidney toxicity (lipofuscin
pigment deposition in proximal tubule
cells) in both sexes, and possible liver
toxicity (hepatocyte eosinophilic
granules) in males.
----------------------------------------------------------------------------------------------------------------
870.3100 Subchronic Feeding (Mice) NOAEL (male)3
30 mg/kg/day (HDT in male)
NOAEL (female)3
100 mg/kg/day (HDT in female)
----------------------------------------------------------------------------------------------------------------
870.3100 Subchronic Feeding (Mice) NOAEL (male)
337.5 mg/kg/day (HDT)
NOAEL (female) = 4.3 mg/kg/day
LOAEL (female) = 14.1 mg/kg/daybased on
enlarged kidneys (20% absolute and
relative) accompanied by swelling of the
proximal tubule cells (4/12 mice).
----------------------------------------------------------------------------------------------------------------
870.3150 Subchronic Feeding (Dog) NOAEL = 14.7 / 15.6 mg/kg/day, M/F
LOAEL = 75.2 / 79.4 mg/kg/day, M/F (HDT)
based on brown and/or atrophied thymuses,
and decreased thymus weight.
----------------------------------------------------------------------------------------------------------------
870.3200 21-Day Dermal (Rat) Systemic NOAEL
31000 mg/kg/day (limit dose)
Dermal NOAEL 3
1000 mg/kg/day (limit dose)
----------------------------------------------------------------------------------------------------------------
870.3700 Gavage Developmental Maternal NOAEL =1000 mg/kg/day (limit dose)
Toxicity (Rat) Developmental NOAEL 3
1000 mg/kg/day (limit dose)
----------------------------------------------------------------------------------------------------------------
870.3700 Gavage Developmental Maternal NOAEL = 40 mg/kg/day
Toxicity (Rabbit) Maternal LOAEL = 200 mg/kg/day based on
maternal death
Developmental NOAEL 3
1000 mg/kg/day (limit dose)
----------------------------------------------------------------------------------------------------------------
870.3800 Feeding Reproductive Systemic NOAEL (males) = 100 ppm (4.85-
Toxicity (Rat) 13.75 mg/kg/day)
Systemic LOAEL (males) = 1000 ppm (50.0-
138.7 mg/kg/day) based on kidney lesions
(slight tubular cell swelling) in F0 and
F1 male rats.
Systemic NOAEL (females)
31000 ppm (69.2-147.7 mg/kg/
day, HDT)
Reproductive NOAEL 3
1000 ppm (50.1-138.7 mg/kg/day for
males; 69.2-147.7 mg/kg/day for females)
Offspring NOAEL 3
1000 ppm (50-147.7 mg/kg/day)
----------------------------------------------------------------------------------------------------------------
870.4100 Chronic Feeding Toxicity NOAEL 346.7 /
(Dog) 45.9 mg/kg/day; M/F (HDT)
----------------------------------------------------------------------------------------------------------------
870.4200 Carcinogenicity Feeding NOAEL = 0.99 mg/kg/day
(Mouse) LOAEL = 10.06 / 10.28 mg/kg/day, M/F (HDT)
based on effects on the kidney including
tubular dilatation, chronic
glomerulonephritis, and hyaline casts in
females, and hyperplasia of the stomach
mucosal epithelium in males. There was no
evidence of carcinogenic potential under
the conditions of this study. Dosing was
too low to elicit frank toxicity and
inadequate to assess carcinogenic
potential.
----------------------------------------------------------------------------------------------------------------
870.4300 Chronic Feeding Toxicity / NOAEL = 0.823 mg/kg/day in males and 2.475
Carcinogenicity (Rat) mg/kg/day in females
LOAEL = 3.44 mg/kg/day (HDT in males),
24.97 mg/kg/day (HDT in females) based on
the early and increased deposition of the
pigments lipofuscin and hemosiderin in the
renal proximal tubular cells of both
sexes, and renal mineralization in female
rats. There were no treatment-related
increases in tumor incidence, compared to
controls. Dosing was too low to elicit
frank toxicity and inadequate to assess
carcinogenic potential.
----------------------------------------------------------------------------------------------------------------
870.5100 Bacterial Reverse Gene Negative in Salmonella TA strains and E.
Mutation Test (Ames coli WP2 uvrA.
Assay)
----------------------------------------------------------------------------------------------------------------
870.5300 Gene Mutation in Mouse Negative
----------------------------------------------------------------------------------------------------------------
870.5375 In Vitro Cheomosomal Polyploidy was induced when CHL (V79) cells
Aberration in Chinese were treated for 48 hours in the absence
Hamster Lung of S9, but there was no clastogenic effect
on DNA.
----------------------------------------------------------------------------------------------------------------
[[Page 38410]]
870.5395 In Vivo Mammalian Negative
Cytogenetics -
Micronucleus Assay in
Mouse Bone Marrow Cells
----------------------------------------------------------------------------------------------------------------
870.5550 Unscheduled DNA Synthesis Negative
in Rat Hepatocytes
----------------------------------------------------------------------------------------------------------------
870.6200 Gavage Acute Neurotoxicity NOAEL 32000 mg/
(Rat) kg (limit dose) based on the absence of
clinical signs, a lack of effects on FOB
parameters and motor activity, and the
absence of neuropathologic lesions.
----------------------------------------------------------------------------------------------------------------
870.6200 Feeding Subchronic NOAEL 375 male/
Neurotoxicity (Rat) 3250 female
mg/kg/day (HDT) based on the absence of
clinical signs, lack of effects on FOB
parameters and motor activity, and absence
of neuropathologic lesions.
----------------------------------------------------------------------------------------------------------------
Special Study Pharmacology - Mice and Mice: A single I.P. dose of 1250 or 5000 mg/
Rabbits kg was lethal to all male and female mice
within 24 hours. Death occurred as early
as three hours at 5000 mg/kg and was
preceded by behavioral and motor function
abnormalities (e.g., alterations in
alertness, visual placing, spontaneous
activity, incoordination, decreased muscle
tone, and compromised autonomic reflexes),
some of which appeared as early as 30
minutes postdosing. Male and female mice
responded similarly.
NOAEL = 78.1 mg/kg
LOAEL = 313 mg/kg (based on minimal effects
including decreased spontaneous activity,
minor alterations in muscle tone, and
minor changes in autonomic functions such
as slight hyperthermia, and slightly
decreasedrespiratory rate).
LD31250 mg/kg
Rabbits: One of three rabbits gavaged at
5000 mg/kg showed decreased spontaneous
activity, prostration, decreased muscle
tone, compromised autonomic reflexes, and
decreased respiratory and heart rate at
one day after dosing, and died on Day 4.
There were no clinically significant
findings in the remaining rabbits of the
5000 mg/kg dose group or any lower dose
groups, and no significant effects on EKGs
or blood pressure in any dosed rabbits.
NOAEL = 2500 mg/kg
LOAEL = 5000 mg/kg (based on the response
of one of three test subjects including
decreased spontaneous activity,
prostration, decreased muscle tone,
compromised autonomic reflexes, decreased
respiratory and heart rate at one day
after dosing, and death on day 4).
----------------------------------------------------------------------------------------------------------------
870.7485 Absorption, Metabolism, No treatment-related adverse effects were
and Excretion (Dog) reported. Approximately 50% of a single
gavage dose was absorbed over several
hours. Blood and plasma radioactivity
peaked after 1-2 hours.
Clearance from plasma and blood was
not especially rapid but nearly complete at
48 hours. Over 168 hours, excretion was
42.5-43.9% in the urine, and 48.6-50.6% in
the feces. Tissue distribution was not
measured. The test article appears to be
metabolized primarily by hydrolysis to R-
(+)-2-[4-cyano-2-
fluorophenoxy)phenoxy]propanoic acid which
was found in both the urine and feces.
Several other metabolites were also
formed, each representing
35% of the administered dose.
No parent compound was found in the urine,
and only minimal amounts were detected in
the feces.
----------------------------------------------------------------------------------------------------------------
870.7485 Metabolism and Absorption of gavaged test article was 93-
Pharmacokinetics (Rat) 100%, and urinary excretion was the major
route of elimination regardless of dose,
label position, or gender. Over 168-hours,
84-100% of the radioactivity was
eliminated in urine, with 86-90%
eliminated within 24 hours. Fecal
excretion was 3
5%. There was no elimination via
expired air. Over a 24-hour period,
biliary elimination accounted for 1.7 %
and 20.1% of the administered dose in
males and females, respectively, in the
low-dose [a-14C]XRD-537 BE
group, and 17.0% (males) and 11.6%
(females) of the administered dose in the
[b14C]XRD-537 BE low-dose
group.
The greatest radioactivity levels were
found in liver, kidneys, plasma, whole
blood, heart, lung, and stomach, with the
highest tissue levels being found in the
liver and kidney at 2 hours. Most tissue
levels accounted for
;1% of the administered dose. Due to
rapid excretion,tissue/organ levels
declined to near detection limits by 24
hours in all dose groups.
[[Page 38411]]
There was a biphasic pattern for both
labels with no substantial differences in
pharmacokinetic indices (Cmax, tcmax, t1/
2, AUC). Time-to-maximum plasma
concentration (tcmax of 0.5 to 4 hrs)
elimination half-times (t1/2) reflected
the relatively rapid absorption. Females
had somewhat shorter tcmax and lower Cmax
values suggestive of saturated absorption
processes. The acid metabolite (R-(+)-2-[4-
(4-cyano-2-fluoro-
phenoxy)phenoxy]propanoic acid) was the
most prominent plasma fraction (~90-
94% of the dose for males and ~75-81%
for females regardless of dose).
No parent compound or other metabolites
were detected. The acid metabolite was the
most common product in urine and feces 71-
87% (urine) and 46-75% (feces) of the
administered dose.
----------------------------------------------------------------------------------------------------------------
870.7600 Dermal Penetration (Rat) Dermal absorption was ~25-34% for the
spray formulation and ~11-16% for the
EF-1218 formulation following a 24 hour
dermal dosing. Within 48 hours, excretion
was 385% in
the urine and 3
1% in the feces, which is consistent
with metabolism to water soluble
metabolites and subsequent urinary
excretion.
Levels tested: Four Fischer 344 rats were
dermally dosed for 24 hours with \14\C-
labeled DE-537 n-butyl ester and
nonlabeled DE-537 n-butyl ester in two
formulations 200 mg/mL test article in
EF1218 (Clincher EDC with which DE-537 n-
butyl ester is normally formulated) and a
spray solution at 0.005, 1.0, or 1.8 mg/
cm\2\.
----------------------------------------------------------------------------------------------------------------
Special Study Hepatocellular In a subchronic oral toxicity study in rats
Proliferation in Rats (MRID 45000413), satellite rats dosed for
4 weeks had hepatocellular hypertrophy and
focal necrosis at all dose levels.
Although multiple necrotic foci
accompanied by inflammatory cells were
graded very slight, and were not
considered dose-related, this study was
performed to explore these findings.
An initial dramatic increase in DNA
synthesis during the first week of
treatment was followed by hepatocellular
hypertrophy at subsequent observations.
This was the reason for enlarged livers
observed in XRD-537nBu-treated rats.
Levels tested: 0, 3.0, 25, 100, or 400 mg/
kg/day in the diet with sacrifices at 1,
2, 4, and 13 weeks. One week prior to
sacrifice, 10 µL BrdU/hour was
administered via an ALZET osmotic pump
implanted subcutaneously. BrdU is a DNA
stain used to quantify hepatocellular
proliferation.
----------------------------------------------------------------------------------------------------------------
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 intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA 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 is expressed as 1 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 cyhalofop-butyl used for human risk
assessment is shown in the following Table 3:
Table 3. Summary of Toxicological Dose and Endpoints for Cyhalofop-Butyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Exposure Scenario Dose (mg/kg/day) Endpoint Study
----------------------------------------------------------------------------------------------------------------
Acute Dietary An appropriate endpoint attributable to a single dose was not identified.
An acute RfD was not established.
----------------------------------------------------------------------------------------------------------------
[[Page 38412]]
Chronic Dietary NOAEL (Female) = 0.99 Kidney effects in Carcinogenicity in Mice
FQPA SF = 1............ females including MRID 45000418
tubular dilatation,
chronic
glomerulonephritis,
and hyaline casts at
the LOAEL of 10.06 /
10.28 mg/kg/day, M/F.
--------------------------------------------------------------------------
Chronic RfD = NOAEL/UF = 0.99 mg/kg/day/100 »0.01 mg/
kg/day
Chronic PAD = cRfD/FQPA SF = 0.01 mg/kg/day/1 = 0.01 mg/kg/day
----------------------------------------------------------------------------------------------------------------
Incidental Oral, Short-Term NOAEL (Female) = 4.3 Enlarged kidneys in Subchronic Feeding in
(1-30 days) FQPA SF = 1............ females accompanied by Mice
swelling of the MRID 45014706
proximal tubule cells
in 4/12 mice at the
LOAEL of 14.1 mg/kg/
day.
LOC = 100..............
--------------------------------------
Incidental Oral, Intermediate-
Term (1-6 months)
----------------------------------------------------------------------------------------------------------------
Dermal, Short-Term (1-30 No hazard has been identified to support quantification ofrisk. No
days) systemic effects were observed in the 21-day dermal study in therat at
doses up to 1000 mg/kg/day (limit dose). In addition, no developmental
effects were observed in the developmental toxicity studies.
--------------------------------------
Dermal, Intermediate-Term
(1-6 months)
----------------------------------------------------------------------------------------------------------------
Dermal, Long-Term\a\( NOAEL (Female) = 0.99 Kidney effects in Carcinogenicity in Mice
36 months) FQPA SF = 1............ females including MRID 45000418
tubular dilatation,
chronic
glomerulonephritis,
and hyaline casts at
the LOAEL of 10.06 /
10.28 mg/kg/day, M/F.
LOC = 100..............
----------------------------------------------------------------------------------------------------------------
Inhalation, Short- NOAEL (Female) = 4.3 Enlarged kidneys in Subchronic Feeding in
Term\b\(1-30 days) FQPA SF = 1............ Enlarged kidneys in Mice
swelling of the MRID 45014706
proximal tubule cells
in 4/12 mice at the
LOAEL of 14.1 mg/kg/
day.
LOC = 100..............
--------------------------------------
Inhalation, Intermediate-
Term\b\(1-6 months)
----------------------------------------------------------------------------------------------------------------
Inhalation, Long- NOAEL (Female) = 0.99 Kidney effects in Carcinogenicity in Mice
Term\b\(3 FQPA SF = 1............ females including MRID 45000418
6 months) tubular dilatation,
chronic
glomerulonephritis,
and hyaline casts at
the LOAEL of 10.06 /
10.28 mg/kg/day, M/F.
Target MOE = 100.......
----------------------------------------------------------------------------------------------------------------
Cancer This herbicide has not been classified. The rat and mouse carcinogenicity
studies are identified as data gaps. Since the doses tested in these
studies were too low to assess the carcinogenic potential of cyhalofop-
butyl, the cancer dietary risk assessment was conducted using the
potency factor (Q1*) of 2.3 x 10-\1\ for the structural analog diclofop-
methyl.
----------------------------------------------------------------------------------------------------------------
\a\Since an oral endpoint was identified, a 34% dermal absorption factor should be used in route-to-route
extrapolations.
\b\Since an oral endpoint was identified, a default oral: inhalation absorption factor of 1 should be used in
route-to-route extrapolations.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. No tolerances have
previously been established for the combined residues of cyhalofop-
butyl, in or on raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from cyhalofop-butyl in
food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-
[[Page 38413]]
use pesticide if a toxicological study has indicated the possibility of
an effect of concern occurring as a result of a one day or single
exposure. No toxicological endpoint attributable to a single exposure
was identified in the available toxicology studies. No appropriate
study available show any acute dietary effects of concern.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis
evaluated the individual food consumption as reported by respondents in
the USDA insert 1989-1992 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: Residue levels are at the recommended tolerances
for rice and 100% of the crop rice is treated with cyhalofop-butyl. All
sub-populations had dietary exposure values which represented <1% of
the cPAD.
iii. Cancer. The cancer dietary risk assessment was conducted using
the potency factor (Q1*) of 2.3 x 10-\1\ for the structural
analog diclofop-methyl since the dose levels in the rat and mouse
carcinogenicity studies were too low to assess the carcinogenic
potential of cyhalofop-butyl. In cancer studies with diclofop-methyl
there are tumors at doses similar to those doses which caused no tumors
in the cyhalofop-butyl studies. Hypothetical rat and mouse Q1* values
were calculated on the assumption that tumor incidence might rapidly
escalate at doses greater than those actually used in the submitted
studies. When a hypothetical Q1* was calculated for cyhalofop-butyl by
assigning increased tumors at doses above those actually tested, the
results came out slightly less potent than the Q1* for diclofop-methyl
. For risk assessment purposes the diclofop-methyl Q1* will not
underestimate any possible cancer risk. A refined (Tier 3)
deterministic cancer risk assessment was conducted. Inputs to the
dietary exposure assessment included the anticipated residues of 0.0066
ppm for rice grain from field trials and estimates that a maximum of
17.6% of rice will be treated with cyhalofop-butyl. Based on the
anticipated residue and the percent of the crop treated, the refined
dietary cancer risk from residues in food is 6.2 x 10 -\8\.
Section 408(b)(2)(E) authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. As required by section 408(b)(2)(E), EPA will
issue a data call-in for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance.
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated for assessing chronic dietary risk only
if the Agency can make the following findings: Condition 1, that the
data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of percent crop
treated (PCT) as required by section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency used percent crop treated (PCT) information in Table 4
and Table 5 as follows.
Table 4. Southern States Estimated Percent Rice Crop Treated
--------------------------------------------------------------------------------------------------------------------------------------------------------
Year 2002 2003 2004 2005 2006
--------------------------------------------------------------------------------------------------------------------------------------------------------
EPA Estimate 2 4.3 4.3 5.02 5.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 5. California Estimated Percent Rice Crop Treated
--------------------------------------------------------------------------------------------------------------------------------------------------------
Year 2002 2003 2004 2005 2006
--------------------------------------------------------------------------------------------------------------------------------------------------------
EPA Estimate 6.7 12.7 13.2 15.6 17.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
The Agency believes that the three conditions have been met. With
respect to Condition 1, PCT estimates are derived from Federal and
private market survey data, which are reliable and have a valid basis.
The market share was for cyhalofop-butyl on rice was projected based on
current percent of crop treated with the existing alternative controls.
The Agency is reasonably certain that the percentage of the food
treated is not likely to be an underestimation. More importantly, EPA
has taken steps to ensure this market share projection is not exceeded
by imposing, as a condition of registration for cyhalofop-butyl under
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C.
136 et seq., a production limit corresponding to the projection. As to
Conditions 2 and 3, regional consumption information and consumption
information for significant sub-populations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant sub-populations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant sub-population group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which cyhalofop-
butyl may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for cyhalofop-butyl in drinking
water. Because the Agency does not have comprehensive monitoring data,
[[Page 38414]]
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of cyhalofop-butyl.
The GENEEC model is not adequate for predicting the estimated
environmental concentrations (EECs) for pesticide applications to rice.
The Agency developed a model using available chemical and physical
property data, to calculate the EECs for the use of cyhalofop-butyl on
rice. The model was based on a hypothetical rice paddy, 1 hectare in
size, flooded to a depth of 10 cm, with a sediment interaction zone of
1 cm. Based on these dimensions there are one million liters of water
and 100 cubic meters of active sediment in the paddy. The sediment is
assumed to weigh 135,000 kg based on a bulk density of 1.35g/cc. This
model was used for both dry and water seeded rice.
The peak drinking water concentrations for the Gulf Coast and
California are 137 and 36 ppb, respectively. The resulting chronic EECs
(annual averages in Index Reservoir) are 14.2 and 3.7 ppb,
respectively. The peak drinking water concentration for the Mississippi
Valley is 119 ppb, and the chronic EEC annual average is 12.4 ppb. If
the (normal) release is on day 78 (90 days from seedling), the peak is
25 ppb and the annual average is 2.6 ppb.
Based on this model and the SCI-GROW model the estimated
environmental concentrations (EECs) of for acute exposures are estimated
to be: In a water-seeded paddy 36 parts per billion (ppb) , and in a
dry-seeded paddy 25 ppb for surface water and 0.16 ug/L ppb for ground
water. The EECs for chronic exposures are estimated to be 3.7 ppb for
water-seeded rice and 2.6 ppb for dry-seeded rice.
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 coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since 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 cyhalofop-butyl they are
further discussed in the aggregate risk sections.
Because EECs calculated using the above models exceeded the DWLOC
regarding potential cancer risk, EPA undertook a further analysis of
this estimate. It was determined that there was not sufficient reliable
data to further refine these estimates. Therefore, the Agency required
that the FIFRA label for cyhalofop-butyl mandate a holding time of
seven days before the treated paddy water may be released to the
environment. This 7-day holding time will result in the
concentration of cyhalofop-butyl, expressed as an annual average (conc/
365), falling below 0.15 ppb.
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).
Cyhalofop-butyl is not registered for use on any sites that would
result in residential exposure.
4. Cumulative exposure to substances with a common mechanism
oftoxicity. Section 408(b)(2)(D)(v) 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 cyhalofop-butyl has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
cyhalofop-butyl 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 cyhalofop-butyl has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961,
November 26, 1997) (FRL-5754-7).
D. Safety Factor for Infants and Children
1.In general. FFDCA section 408 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 andchildren. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(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 is no indication of
quantitative or qualitative increased susceptibility of rats or rabbits
to in utero or postnatal exposure.
3. Conclusion. There is a complete toxicity data base for
cyhalofop-butyl and exposure data are complete or are estimated based
on data that reasonably accounts for potential exposures. EPA
determined that the 10X safety factor should be reduced to 1x in
assessing the risk posed by this chemical because: (1) There is no
indication of quantitative or qualitative increased susceptibility; (2)
a developmental neurotoxicity study (DNT) is not required; (3) the
dietary food and drinking water exposure assessments will not
underestimate the potential exposures for infants and children; (4)
there currently no registered or proposed residential (non-
occupational) uses of cyhalofop-butyl, and (5) the database pertaining
to threshold effects on infants and children is complete.
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
[[Page 38415]]
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: 2L/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 andquantitative 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
calculatedDWLOCs, 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 apesticide'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. An appropriate endpoint attributable to a single
dose was not identified. Therefore, cyhalofop-butyl is not expected to
pose an acute risk.
2. Chronic risk. For all population subgroups, the chronic DWLOC is
greater than the chronic surface EEC, and there is no expectation of
migration of cyhalofop-butyl residues to ground water, therefore,
aggregate chronic (non cancer) exposure to cyhalofop-butyl is not
expected to exceed the Agency's level of concern. There are no
residential uses for cyhalofop-butyl that result in chronic residential
exposure to cyhalofop-butyl. The DWLOCs for chronic risk are shown in
Table 6 as follows:
Table 6. Chronic DWLOC Calculations
----------------------------------------------------------------------------------------------------------------
Chronic Scenario
-----------------------------------------------------------------------------
Max Chronic Chronic
Population Subgroup\1\ cPAD mg/kg/ Chronic Water Exp Ground Surface DWLOC
day Food Exp mg/ mg/kg/ Water EEC Water EEC (μg/L)\4/
kg/day\2\ day\3\ (units) (units)\4\ 5\
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.01 0.000007 0.009993 14.2 350
----------------------------------------------------------------------------------------------------------------
All Infants 0.01 0.000028 0.009972 14.2 100
----------------------------------------------------------------------------------------------------------------
Children (1-6 years) 0.01 0.000015 0.009985 14.2 100
----------------------------------------------------------------------------------------------------------------
Children (7-12 years) 0.01 0.000009 0.009991 14.2 100
----------------------------------------------------------------------------------------------------------------
Females (13-50 years) 0.01 0.000005 0.009995 14.2 300
----------------------------------------------------------------------------------------------------------------
Males (13-19 years) 0.01 0.000005 0.009995 14.2 350
----------------------------------------------------------------------------------------------------------------
Males (20+ years) 0.01 0.000006 0.009994 14.2 350
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years) 0.01 0.000004 0.009996 14.2 350
----------------------------------------------------------------------------------------------------------------
Non-hispanic/non-white/non- 0.01 0.000018 0.009982 14.2 350
black
----------------------------------------------------------------------------------------------------------------
\1\The Non-hispanic/non-white/non-black population was included in this table because it has the highest adult
dietary exposure level. Body weights used to calculate the DWLOCs are 70 kg for adult males; 60 kg for adult
females, and 10 kg for children &12 years.
\2\The chronic food exposure levels are for rice, the sole crop being considered for registration.
\3\Maximum Chronic Water Exposure (mg/kg/day) = [Chronic PAD (mg/kg/day) - Chronic Dietary Exposure (mg/kg/day)]
\4\This table presents the surface water EECs without taking into account the further reduction achieved by the
mandated holding period. Even absent the holding period the predicted levels are well within the DWLOCs.
\5\Chronic DWLOC( µg/L) = [maximum chronic water exposure (mg/kg/day) x body weight (kg)]/[water consumption
(L/day)x 10-\3\ mg/ g]
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).
Cyhalofop-butyl 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).
Cyhalofop-butyl 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. Cyhalofop-butyl is
not registered for use on any sites that would result in residential
exposure. The cancer dietary risk assessment was conducted using the
potency factor (Q1*) of 2.3 x 10-\1\ for the structural
analog diclofop-methyl since the dose levels in the rat and mouse
carcinogenicity studies were too low to assess the carcinogenic
potential of cyhalofop-butyl. In cancer studies with diclofop-methyl
there are tumors at doses similar to those doses which resulted in no
tumors in the cyhalofop-butyl studies. Hypothetical rat and mouse Q1*
values were calculated on the assumption that tumor incidence might
rapidly escalate at doses greater than those actually used in the
submitted studies. These hypothetical Q1*s came out slightly less
potent than the Q1* for diclofop-methyl. Thus, given that no data with
cyhalofop-butyl
[[Page 38416]]
has indicated carcinogenic potential, use of the diclofop-methyl Q1*
will produce a conservative (health-protective) estimate of cancer
risk. Based on the anticipated residue and the percent of the crop
treated, the refined dietary cancer risk from residues in food is 6.2 x
10 -\8\. The cancer DWLOC for the general population is
shown in the table below. With a water holding time of 7 days, the
concentration of cyhalofop-butyl residues in paddy water, expressed as
an annual average (concentration/365) will be less than 0.15 µg/L.
Since this value is below the calculated cancer DWLOC of 0.44 µg/L,
aggregate cancer risk to cyhalofop-butyl is not expected to exceed
EPA's level of concern.
Table 7. Cancer DWLOC Calculations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Target Max Chronic Food Max Water
Population Q* Negligible Risk Exposure\2\ mg/kg/ Exposure mg/kg/ Exposure\3\ mg/kg/ Cancer
Level\1\ day day day DWLOC\4\(µ/L)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population 0.23 3 x 10-\6\ 1.3 x 10-\5\ 3 x 10-\7\ 1.27 x 10-\5\ 0.44
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\EPA has traditionally regarded risks in the range of the probability of one in one million as negligible, with risks as high as three in one million
considered as falling within that range.
\2\ Target Maximum Exposure (mg/kg/day) = [negligible risk/Q*]
\3\ Maximum Water Exposure (mg/kg/day) = Target Maximum Exposure - Chronic Food Exposure (Note: There are no residential uses for this chemical.)
\4\ Cancer DWLOC(µg/L) = [maximum water exposure (mg/kg/day) x body weight (kg)]/[water consumption (L) x 10-\3\ mg/µg]\2\ Body weight (kg) = 70
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 cyhalofop-butyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (example gas chromatography)
is available to enforce the tolerance expression. The method may be
requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 305-5229; e-mail
address: furlow.calvin@epa.gov.
B. International Residue Limits
There are no CODEX, Canadian, or Mexican tolerances/Maximum Residue
Levelsfor cyhalofop-butyl residues. Thus, harmonization is not an issue
at this time.
C. Conditions
The following data gaps must be fulfilled: Subacute (28-day)
inhalation toxicity study, a carcinogenicity study in rats, and a
carcinogenicity study in mice.
V. Conclusion
Therefore, time limited tolerances are established for combined
residues of cyhalofop (cyhalofop-butyl plus cyhalofop-acid) and the di-
acid metabolite in or on rice grain at 0.03 ppm and rice straw 8.0 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 of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408
and 409. 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-2002-0087 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
August 5, 2002.
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 (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. 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 theHearing Clerk is (202)
260-4865.
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 maycontact James
Tompkins by phone at (703) 305-5697, by e-mail
attompkins.jim@epa.gov, or by mailing a request for information to Mr.
Tompkins
[[Page 38417]]
at Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
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.
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.2. Mail your
copies, identified by docket ID number OPP-2002-0087, 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. In person or by courier, bring a copy to the
location of the PIRIB described in Unit I.B.2. 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. Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d)
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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 ormore
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
therelationship 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. Submission to Congress and the Comptroller General
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.
[[Page 38418]]
Dated: May 23, 2002.
James Jones,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180 [AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 374.
2. Part 180 is amended by adding Sec. 180.579 to read as
follows:
Sec. 180.579 Cyhalofop-butyl; tolerances for residues.
(a) General. Time-limited tolerances are established for combined
residues of cyhalofop (cyhalofop-butyl, R-(+)-n-butyl-2-(4(4-cyano-2-
fluorophenoxy)-phenoxy)propionate, plus cyhalofop acid, R-(+)-2-(4(4-
cyano-2-fluorophenoxy)-phenoxy)propionic acid) and the di-acid
metabolite, (2R)-4-[4-(1-carboxyethoxy)phenoxy]-3-fluorobenzoic acid,
from the application of the herbicide cyhalofop-butyl in or on the
following raw agricultural commodities:
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Rice, grain 0.03 6/1/2007
Rice, straw 8.0 6/1/2007
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 02-13982 Filed 6-3-02; 8:45 am]
BILLING CODE 6560-50-S