Cyhalofop-butyl. Sept 27, 2001. Pesticide tolerances for Emergency Exemptions. Final Rule. Federal Register.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Cyhalofop-butyl. September 27, 2001. Pesticide Tolerances for Emergency Exemptions. Final Rule. Federal Register.

http://www.epa.gov/fedrgstr/EPA-PEST/2001/September/Day-27/p24198.htm

[Federal Register: September 27, 2001 (Volume 66, Number 188)]
[Rules and Regulations]
[Page 49308-49316]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27se01-25]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301167; FRL-6800-2]
RIN 2070-AB78

Cyhalofop-butyl; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for
combined residues of cyhalofop-butyl plus the cyhalofop-acid and di-
acid metabolites in or on rice grain and rice straw. This action is in
response to EPA's granting of an emergency exemption under section 18
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
authorizing use of the pesticide on rice. This regulation establishes a
maximum permissible level for residues of cyhalofop-butyl plus the
cyhalofop-acid and di-acid metabolites in this food commodity. These
tolerances will expire and are revoked on June 30, 2002.

DATES: This regulation is effective September 27, 2001. Objections and
requests for hearings, identified by docket control number OPP-301167,
must be received by EPA on or before November 26, 2001.

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 VII. of the SUPPLEMENTARY
INFORMATION: To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301167 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Barbara Madden, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone

[[Page 49309]]

number: (703) 305-6463; and e-mail address: madden.barbara@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 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/. 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 control number OPP-301167. 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, 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

EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing a tolerance for combined residues of the
herbicide cyhalofop-butyl, 2-[4-(4-cyano-2-fluorophenoxy)phenoxyl]-
propanoic acid, butyl ester (R) plus the cyhalofop-acid and di-acid
metabolites, in or on rice grain at 0.03 part per million (ppm) and
rice straw at 8.0 ppm. These tolerances will expire and are revoked on
June 30, 2002. EPA will publish a document in the Federal Register to
remove the revoked tolerance from the Code of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
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. . . .''
Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act (FQPA).
EPA has established regulations governing such emergency exemptions in
40 CFR part 166.

III. Emergency Exemption for Cyhalofop-butyl on Rice and FFDCA
Tolerances

Weeds cause economic damage by competing with rice plants for soil,
nutrients and sunlight, and by interfering with harvesting equipment.
Bearded sprangletop is one of the most important grass weeds in
California rice. The California Rice Research Board surveyed growers in
1999, and found that more than half reported an increasing trend in
sprangletop infestation, while only 4% thought the weed was decreasing.
The remainder called the weed populations ``variable'' or ``stable.''
As for impacts on yield, the University of California Cooperative
Extension Service in 1999 conducted trials to investigate a link
between sprangletop infestations and yield loss. The UC found that a
50% sprangletop cover results in yield losses ranging from 20% to as
high as 60%.
In 2000, Rice Researchers, Inc. measured yield impacts of
sprangletop at levels of infestation ranging from 1-3 plants per square
meter to 25-30 plants per square meter. In three replications it was
shown that yields were impacted as much as 25%.
The following conditions give rise to sprangletop infestations in
California leading to yield losses: (1) thiobencarb cannot be applied
to soils with Delayed Phytotoxicity Syndrome (DPS); (2) water
management practices (BMPs) necessary for the protection or promotion
of the rice that incidentally lead to heavier weed infestations; and
(3) the lack of

[[Page 49310]]

suitable herbicides that are effective under all conditions.
EPA has authorized under FIFRA section 18 the use of cyhalofop-
butyl on rice for control of Bearded sprangletop in California. After
having reviewed the submission, EPA concurs that emergency conditions
exist for this State.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of cyhalofop-butyl in or on
rice. In doing so, EPA considered the safety standard in FFDCA section
408(b)(2), and EPA decided that the necessary tolerance under FFDCA
section 408(l)(6) would be consistent with the safety standard and with
FIFRA section 18. Consistent with the need to move quickly on the
emergency exemption in order to address an urgent non-routine situation
and to ensure that the resulting food is safe and lawful, EPA is
issuing these tolerances without notice and opportunity for public
comment as provided in section 408(l)(6). Although these tolerances
will expire and are revoked on June 30, 2002, under FFDCA section
408(l)(5), residues of the pesticide not in excess of the amounts
specified in the tolerance remaining in or on rice grain or rice straw
after that date will not be unlawful, provided the pesticide is applied
in a manner that was lawful under FIFRA, and the residues do not exceed
a level that was authorized by this tolerance at the time of that
application. EPA will take action to revoke this tolerance earlier if
any experience with, scientific data on, or other relevant information
on this pesticide indicate that the residues are not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether cyhalofop-
butyl meets EPA's registration requirements for use on rice or whether
a permanent tolerance for this use would be appropriate. Under these
circumstances, EPA does not believe that these tolerances serve as a
basis for registration of cyhalofop-butyl by a State for special local
needs under FIFRA section 24(c). Nor do these tolerances serve as the
basis for any State other than California to use this pesticide on this
crop under section 18 of FIFRA without following all provisions of
EPA's regulations implementing section 18 as identified in 40 CFR part
166. For additional information regarding the emergency exemption for
cyhalofop-butyl, contact the Agency's Registration Division at the
address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

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).
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
cyhalofop-butyl and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for time-limited tolerances for
combined residues of cyhalofop-butyl plus the cyhalofop-acid and di-
acid metabolites in or on rice grain at 0.03 ppm and rice straw at 8.0
ppm. EPA's assessment of the dietary exposures and risks associated
with establishing the tolerances follows.

A. 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 endpoint. 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 level of concern (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
(MOE_cancer = 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 1.

[[Page 49311]]

Table 1.--Summary of Toxicological Dose and Endpoints for Cyhalofop-butyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary females 13-50 years of None None An appropriate endpoint
age and the general population attributable to a
including infants and children single exposure (dose)
was not identified in
any study including
the acute
neurotoxicity study or
developmental toxicity
studies. No systemic
effects were observed
in the acute
neurotoxicity study in
rats at 2,000 mg/kg
(limit dose), and no
developmental effects
were observed in the
developmental toxicity
studies.
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations NOAEL = 0.99 mg/kg/day FQPA SF = 10 Carcinogenicity in mice
UF = 100............... cPAD = chronic RfD LOAEL = 10.06 mg/kg/day
Chronic RfD = 0.01 mg/ FQPA SF. based on kidney
kg/day. = 0.001 mg/kg/day...... effects in females
including tubular
dilatation, chronic
glomerulonephritis,
and hyaline casts.
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1 to 30 days) and None None No hazard has been
intermediate-term dermal (1-6 identified to support
months) (residential) quantification of
risk. No systemic
effects were observed
in the 21-day dermal
study in the rat at
doses up to 1,000 mg/
kg/day (limit dose).
In addition, no
developmental effects
were observed in the
developmental studies.
----------------------------------------------------------------------------------------------------------------
Long-term dermal (greater than 6 oral study LOC for MOE = 1,000 Carcinogenicity in mice
months) (residential) NOAEL= 0.99 mg/kg/day (residential) LOAEL = 10.06 mg/kg/day
(dermal absorption based on kidney
rate = 34% when effects in females
appropriate). including tubular
dilatation, chronic
glomerulonephritis,
and hyaline casts.
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 30 days) inhalation (or oral) LOC for MOE = 1,000 Subchronic feeding
and intermediate-term inhalation (1- study (residential) study in mice
6 months) (residential) NOAEL= 4.3 mg/kg/day LOAEL = 14.1 mg/kg/day
(inhalation absorption based on enlarged
rate = 100%). kidneys in females
accompanied by
swelling of the
proximal tubule cells.
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (greater than 6
months) (residential)
Inhalation (or oral) study LOC for MOE = 1,000 Long-term inhalation (greater than 6
months) (residential)
NOAEL = 1.0 mg/kg/day (inhalation (residential) LOAEL = 10.06 mg/kg/day
absorption rate = 100%). based on kidney
effects in females
including tubular
dilatation, chronic
glomerulonephritis,
and hyaline casts..
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) None None At the doses tested,
there were no
treatment-related
increase in tumor
incidence when
compared to controls.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA.

B. Exposure Assessment

1. Dietary exposure from food and feed uses. Cyhalofop-butyl is a
new chemical, this is the first tolerance established for the combined
residues of cyhalofop-butyl plus the cyhalofop-acid and di-acid
metabolites, in or on a raw agricultural commodity (rice grain and rice
straw). 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-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. An appropriate endpoint attributable to a single
exposure (dose) was not identified in any study including the acute
neurotoxicity study or developmental toxicity studies. Therefore, acute
dietary risk assessments were not conducted.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the

[[Page 49312]]

Dietary Exposure Evaluation Model (DEEMTM) analysis
evaluated the individual food consumption as reported by respondents in
the USDA 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: Use of 100% crop treated and tolerance level residues.
iii. Cancer. The Agency has not yet classified cyhalofop-butyl for
cancer. A combined chronic toxicity/carcinogenicity study in rats and a
carcinogenicity study in mice were conducted to assess the carcinogenic
potential of cyhalofop-butyl. At the doses tested, there was no
treatment-related increase in tumor incidence when compared to
controls.
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,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of cyhalofop-butyl.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in ground water. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. The PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a 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 below.
Based on the GENEEC and SCI-GROW models the estimated environmental
concentrations (EECs) of cyhalofop-butyl for chronic exposures are
estimated to be 4 parts per billion (ppb) for surface water and 0.016
ppb for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). 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 of
toxicity. 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).

C. 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 and children. 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. Developmental toxicity studies. In a developmental toxicity
study in rats the maternal toxicity NOAEL is 1,000 mg/kg/day (limit
dose). At the 1,000 mg/kg/day treatment level, the liver to body weight
ratio and the liver to adjusted body weight ratio were both increased
(106-107% of controls; p <0.01), and there were slight, non-statistical
increases in the mean absolute liver weights of all treated groups;
however, these increases can be attributed to enzyme induction as an
adaptive response to a xenobiotic agent rather than a treatment-related
adverse effect. There were no treatment-related effects observed at 25
and 250 mg/kg/day. The developmental toxicity NOAEL is greater than or
equal to 1,000 mg/kg/day (limit dose).
In a developmental toxicity study in rabbits the maternal LOAEL is
200 mg/kg/day based on maternal death. The maternal NOAEL is 40 mg/kg/
day. The developmental NOAEL is greater than or equal to 1,000 mg/kg/
day (limit test).
3. Reproductive toxicity study. In a 2-generation reproduction
study in rats no treatment-related deaths, clinical signs, body weight
changes, or food consumption differences were observed for parental
male or female rats in either generation administered any dose of the
test material. No effects were observed for F0 or F1 females during
gestation or lactation. The Reproductive NOAEL is greater than or equal
to 1,000 ppm (50.1-138.7 mg/kg/day for males; 69.2-147.7 mg/kg/day for
females, highest dose tested (HDT)) and the Offspring NOAEL is greater
than or equal to 1,000 ppm (50-147.7 mg/kg/day, HDT).
4. Neurotoxicity studies. In an acute neurotoxicity study in rats
the NOAEL is greater than or equal to 2,000 mg/kg

[[Page 49313]]

(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 following gavage dosing.
In a subchronic neurotoxicity study in rats the NOAEL is greater
than or equal to 75 mg/kg/day HDT in males and greater than or equal to
250 mg/kg/day (HDT) in females based on the absence of clinical signs,
lack of effects on FOB parameters and motor activity, and absence of
neuropathologic lesions.
5. Conclusion. There is no evidence of quantitatively or
qualitatively increased susceptibility in the developmental toxicity
studies in rats and rabbits, or in the two generation reproductive
toxicity study in rats. However, cyhalofop-butyl has not been evaluated
by the Agency's FQPA Safety Factor Committee. Therefore, for the
purposes of this emergency exemption, the FQPA safety factor of 10X, to
protect infants and children has been retained for all dietary and
residential risk assessments.

D. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g.,allowable chronic water exposure (mg/kg/day) = cPAD
- (average food + chronic non-dietary, non-occupational 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 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 cyhalofop-butyl 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 cyhalofop-butyl on drinking water as a part of the aggregate risk
assessment process.
1. Acute risk. An appropriate endpoint attributable to a single
exposure (dose) was not identified in any study including the acute
neurotoxicity study or developmental toxicity studies. Therefore, acute
dietary risk assessments were not conducted.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
cyhalofop-butyl from food will utilize less than 1% of the cPAD for the
U.S. population, 4% of the cPAD for non-nursing infants (infant
subpopulation at greatest exposure) and 2% of the cPAD for children 1-6
years old (children subpopulation at greatest exposure. There are no
residential uses for cyhalofop-butyl. In addition, despite the
potential for chronic dietary exposure to cyhalofop-butyl in drinking
water, after calculating DWLOCs and comparing them to conservative
model estimated environmental concentrations of cyhalofop-butyl in
surface and ground water, EPA does not expect the aggregate exposure to
exceed 100% of the cPAD, as shown in the following Table 2:

Table 2. --Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Cyhalofop-butyl
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface water EEC Ground water EEC
Population subgroup cPAD mg/kg/day %cPAD (Food) (ppb) (ppb) Chronic DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population 0.001 1% 4 0.016 35
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1-6 years old 0.001 2% 4 0.016 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Non-nursing infants 0.001 4% 4 0.016 5
--------------------------------------------------------------------------------------------------------------------------------------------------------

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 were previously addressed.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational 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 were previously
addressed.
5. Aggregate cancer risk for U.S. population. The Agency has not
yet classified cyhalofop-butyl for cancer. A combined chronic toxicity/
carcinogenicity study in rats and a carcinogenicity study in mice were
conducted to assess the carcinogenic potential of cyhalofop-butyl. At
the doses tested, there was no treatment-related increase in tumor
incidence when compared to controls. Therefore, a risk assessment to
estimate risk from cancer was not conducted.
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.

V. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology is available to enforce the
tolerance

[[Page 49314]]

expression. The method may be requested from: Calvin Furlow, PRRIB,
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 is neither a Codex proposal, nor Canadian or Mexican limits,
for residues of cyhalofop-butyl and its metabolite in or on rice.
Therefore, harmonization is not an issue for this use.

VI. Conclusion

Therefore, the tolerance is established for combined residues of
cyhalofop-butyl, 2-[4-(4-cyano-2-fluorophenoxy)phenoxyl]propanoic acid,
butyl ester (R) plus the cyhalofop-acid and di-acid metabolites in or
on rice grain at 0.03 ppm and rice straw at 8.0 ppm.

VII. 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 control number OPP-301167 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
26, 2001.
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 the Hearing 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 may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
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 VII.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 the docket control number OPP-301167, 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).

VIII. Regulatory Assessment Requirements

This final rule establishes time-limited tolerances under FFDCA
section 408. 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

[[Page 49315]]

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 other 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 FIFRA section 18 exemption under FFDCA section 408, such as
the tolerances 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 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.

IX. 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.

Dated: August 29, 2001.
Anne E. Lindsey,
Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[ADDED]

1. The authority citation for part 180 continues to read as
follows:

Authority: 21 U.S.C. 321(q), 346(a) and 371.

Sec. 180.576 Cyhalofop-butyl, tolerances for residues.

2. Section 180.576 is added to read as follows:
(a) General. [Reserved]
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for combined residues of cyhalofop-butyl, 2-[4-(4-cyano-2-
fluorophenoxy)phenoxyl]propanoic acid, butyl ester (R), plus the
cyhalofop-acid and di-acid metabolites in connection with use of the
pesticide under section 18 emergency exemptions granted by the EPA. The
tolerances will expire and are revoked on the dates specified in the
following table.

----------------------------------------------------------------------------------------------------------------
Commodity Parts per million Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
* * * * *
Rice, grain.............................. 0.03........................ 6/30/02
Rice, straw.............................. 8.0......................... 6/30/02
----------------------------------------------------------------------------------------------------------------

[[Page 49316]]

[FR Doc. 01-24198 Filed 9-26-01; 8:45 am]
BILLING CODE 6560-50-S

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Last Updated: Sep 27 15:50:54 2001
URL: http://www.epa.gov/fedrgstr/EPA-PEST/2001/September/Day-27/p24198.htm