[Federal Register Volume 66, Number 188 (Thursday, September 27, 2001)]
[Rules and Regulations]
[Pages 49308-49316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-24198]


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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: [email protected].

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 
(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 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      Carcinogenicity in mice
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: [email protected].

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 [email protected], 
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: [email protected]. 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]]

    (c) Tolerances with regional registration. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

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