Forchlorfenuron; Time-Limited Pesticide Tolerance

[Federal Register: May 7, 2001 (Volume 66, Number 88)]
[Rules and Regulations]
[Page 22930-22936]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07my01-12]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301122; FRL-6781-4]RIN 2070-AB78

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

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SUMMARY: This regulation establishes a time-limited tolerance
forresidues of Forchlorfenuron; N-(2-chloro-4-pyridinyl)-N '-phenylurea
in or on almond, apple, blueberry, cranberry, fig, grapes, kiwifruit,
olive, pear, and plums (fresh). Siemer & Associates Incorporated, agent
for KIM-C1, LLC requested this tolerance under the Federal Food, Drug,
and Cosmetic Act, as amended by the Food Quality Protection Act of
1996. The tolerance will expire on April 1, 2004.

DATES: This regulation is effective May 7, 2001. Objections and
requests for hearings, identified by docket control number OPP-301122
must be received by EPA on or before July 6, 2001.

ADDRESSES: Written objections and hearing requests may besubmitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301122 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: 703-305-7740; and e-mail
address: giles-parker.cynthia@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
Examples of Potentially
Categories NAICS 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 ``FederalRegister--Environmental
Documents.'' You can also godirectly 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. A frequently updated
electronic version of 40 CFR part 180 is available at
http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a
beta site currently under development.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301122. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

In the Federal Register of July 28, 1998 (63 FR 40273)(FRL-5799-3),
EPA issued a notice pursuant to section 408 of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality
Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the
filing of a pesticide petition (PP 7G4906) for tolerance by KIM-C1,
LLC, 6333 East Liberty Avenue, Fresno, California 93727. This notice
included a summary of the petition prepared by KIM-C1, the registrant.
The petition requested that 40 CFR part 180 be amended by
establishing a time-limited tolerance for residues of the plant growth
regulator N-(2-chloro-4-pyridinyl)-N '-phenylurea, in or on almond,
apple, blueberry, cranberry, fig, grapes, kiwifruit, olive, pear, and
plums (fresh) at 0.01 part per million (ppm). The tolerance will expire
on April 1, 2004.
One comment was received in response to the Notice of Filing. The
comment was received on December 7, 2000 as a letter dated December 1,
2000 from Mr. Robert Bianco, Desert Grape Growers League of California.
The League requested that the Agency reduce the number of table grape
acres, investigate allegations regarding taste, and that the
Experimental Use Permit be crop destruct. In response to the first
issue, it is noted that the registrant has subsequently submitted a
revised testing program that incorporates a reduced number of table
grape acres. Regarding the issue of requiring a crop destruct condition
on the grapes treated in the Experimental Use Permit due to a
difference in taste of the harvested grapes, the Agency has determined
that requiring a crop destruct condition may be imposed only in
response to concerns relating to human health.
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

[[Page 22931]]

residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) requires EPA to give special consideration to
exposure of infants and children to the pesticide chemical residue in
establishing a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for a tolerance for residues of N-(2-chloro-4-pyridinyl)-N
'-phenylurea on almond, apple, blueberry, cranberry, fig, grapes,
kiwifruit, olive, pear, and plums (fresh) at 0.01 ppm. EPA's assessment
of exposures and risks associated with establishing the tolerance
follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by N-(2-chloro-4-
pyridinyl)-N '-phenylurea are discussed in the following Table 1 as
well as the no observed adverse effect level (NOAEL) and the lowest
observed adverse effect level (LOAEL) from the toxicity studies
reviewed.

Table 1.-- Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
Guideline No. Study Type Results
----------------------------------------------------------------------------------------------------------------
870.3100 90-Day oral toxicity NOAEL = M*400; F*=84 mg/kg/day; LOAEL =
rodents M*=not determined, F=428 mg/kg/day based
on decrease BW*, BW gain & food
efficiency.
----------------------------------------------------------------------------------------------------------------
870.3150 90-Day oral toxicity in NOAEL = M=1608; F=19.1 mg/kg/day; LOAEL =
nonrodents M=162.4; F=188.7 mg/kg/day based on
decreases (10%) in BW gain, FC & food
efficiency.
----------------------------------------------------------------------------------------------------------------
870.3700a Prenatal developmental in Maternal NOAEL = 200 mg/kg/day; LOAEL = 400
rodents mg/kg/day based on increased incidence of
alopecia; decrease in BW & BW gains.
Developmental NOAEL = 200 mg/kg/day; LOAEL
= 400 mg/kg/day based on decreased mean
fetalBW.
----------------------------------------------------------------------------------------------------------------
870.3700b Prenatal developmental in Maternal NOAEL = 100 mg/kg/day; LOAEL = not
nonrodents determined. Developmental NOAEL = 100 mg/
kg/day; LOAEL = not determined.
----------------------------------------------------------------------------------------------------------------
870.3800 Reproduction and fertility Parental/Systemic NOAEL = M=11/13;F=13/15
effects mg/kg/day; LOAEL = 144-202 mg/kg/day based
on decreasedFC F0 & F1; clinical signs of
toxicity & lower BW in F1M& F and growth
retardation in F1 & F2 pups. Reproductive
NOAEL = M144/168; F=169/202 mg/kg/day;
LOAEL = 544-926 mg/kg/day based on
increased pup mortality (F1a, F1b and
F2a), emaciation in F1b, anddecrease in F1
pups litter.
----------------------------------------------------------------------------------------------------------------
870.4300 Carcinogenicity mice NOAEL = M=7; F=9 mg/kg/day; LOAEL = M=93;
F=122 mg/kg/day based on reduced BW & BW
gain & FC; kidney toxicity (M=suppurative
inflammation, F = non-suppurative
interstitial nephritis. no evidence of
carcinogenicity.
----------------------------------------------------------------------------------------------------------------
\*\M=Male; F=Female; BW=Body Weight; FC=Food Consumption

B. Toxicological Endpoints

The dose at which no adverse effects are observed (the NOAEL) from
thetoxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety 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
todetermine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-\6\ or one in a
million). Under certain specific circumstances, MOE calculations will
be used for the carcinogenic risk

[[Page 22932]]

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 N-(2-chloro-4-
pyridinyl)-N '-phenylurea used for human risk assessment is shown in
the following Table 2:

Table 2.-- Summary of Toxicological Dose and Endpoints for N-(2-chloro-4-pyridinyl)-N'-phenylurea for Use in
Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk FQPA SF\*\ and Level of
Exposure Scenario Assessment, UF (mg/kg/ Concern for Risk Study and Toxicological
day) Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary........................ ..................... None................... .......................
----------------------------------------------------------------------------------------------------------------
Chronic Dietary...................... NOAEL = 7.0............ Decreases in body 2-year rat feeding
weight, body weight study
gain and food
consumption as well as
effects on the kidney
at the LOAEL of 93 and
122 mg/kg/day for
males and females,
respectively. The risk
assessment is
required..
................................... UF = 100; FQPA = 10X... Chronic RfD=0.07 mg/kg/ .......................
day cPAD=0.007 mg/kg/
day Apply to all
population subgroups.
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal.................... NOAEL=200.............. Decreases in maternal developmental rat study
body weights and body
weight gains as well
as decrease in mean
fetal body weights..
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal............. NOAEL=17............... Based on decreases in 90-day feeding study in
body weight gain and dogs
food consumption..
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal..................... ..................... None................... ....................
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation................ NOAEL=200.............. Same as short-term developmental rat study
dermal..
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation......... NOAEL=17............... Same as intermediate- 90-day feeding study in
term dermal.. dogs
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation................. ..................... None................... .......................
----------------------------------------------------------------------------------------------------------------
Cancer............................... ..................... Not yet classified..... .......................
----------------------------------------------------------------------------------------------------------------
\*\ The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns
unique to the FQPA.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Risk assessments were
conducted by EPA to assess dietary exposures from N-(2-chloro-4-
pyridinyl)-N '-phenylurea 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 acute exposure assessment is unnecessary because
no toxicological endpoint was selected.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM)
analysisevaluated 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: This chronic dietary DEEM analysis was
a Tier 1 (assumptions: time-limited tolerance level residues of the
subject commodities and 100% crop treated). The DEEM default
concentration factors were used for the processed commodities of all
the subject crops. The resulting dietary food exposures occupy 1.5% of
the cPAD for the most highly exposed population subgroup, non-nursing
infants. These results should be viewed as conservative (health
protective) risk estimates. Refinements such as the use of percent
crop-treated information (this is a limited acreage EUP use) and/or
anticipated residue values would yield lower estimates of chronic
dietary exposure.
iii. Cancer. No concern for cancer risks were identified. Data from
available studies do not indicate a treatment-related tumor problem and
cancer risk endpoints have not been identified.
2. Dietary exposure from drinking water. The Agency lackssufficient
monitoring exposure data to complete a comprehensive dietary exposure
analysis and risk assessment for N-(2-chloro-4-pyridinyl)-N '-
phenylurea 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

[[Page 22933]]

characteristics of N-(2-chloro-4-pyridinyl)-N '-phenylurea.
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
groundwater. 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 N-(2-chloro-4-pyridinyl)-N
'-phenylurea they are further discussed in the aggregate risk sections
below.
Based on the GENEEC and SCI-GROW models the EECs of N-(2-chloro-4-
pyridinyl)-N '-phenylurea for acute and chronic exposures are estimated
to be 4.7 parts per billion (ppb) (peak and 56-day average) for surface
water and 26 ppb (acute and chronic) 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).
N-(2-Chloro-4-pyridinyl)-N '-phenylurea is not registered for use
on any sites that would result in residential exposure.
4. Cumulative exposure to substances with a common mechanismof
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 N-(2-chloro-4-pyridinyl)-N '-phenylurea 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, N-(2-chloro-4-pyridinyl)-N '-phenylurea 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
N-(2-chloro-4-pyridinyl)-N '-phenylurea 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).

D. Safety Factor for Infants and Children

1. Safety factor for infants and children--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. Conclusion. There is an adequate toxicity databasefor N-(2-
chloro-pyridinyl)-N '-phenylurea for this EUP and exposure data are
complete or are estimated based on data that reasonably accounts for
potential exposures. For the purposes of the experimental use permit
only, the FQPA safety factor will be retained (10X) and applied to all
groups for assessing chronic dietary risk.

E. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking
waterconsumption, 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 groundwater are less than the
calculated DWLOCs, the Office of Pesticide Programs (OPP) concludes
with reasonable certainty that exposures to the pesticide in drinking
water (when considered along with other sources of exposure for which
OPP has reliable data) would not result in unacceptable levels of
aggregate human health risk at this time. Because OPP considers the
aggregate risk resulting from multiple exposure pathways associated
with a pesticide's uses, levels of comparison in drinking water may
vary as those uses change. If new uses are added in the future, OPP
will reassess the potential

[[Page 22934]]

impacts of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Not applicable; no acute dietary endpointwas
identified.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to N-(2-
chloro-4-pyridinyl)-N '-phenylurea from food will utilize 0.3% of the
cPAD for the U.S. population, 1.5% of the cPAD for non-nursing infants
and 1.0% of the cPAD for children (1-6 years). There are no residential
uses for N-(2-chloro-4-pyridinyl)-N '-phenylurea that result in chronic
residential exposure to N-(2-chloro-4-pyridinyl)-N '-phenylurea. In
addition, there is potential for chronic dietary exposure to N-(2-
chloro-4-pyridinyl)-N '-phenylurea in drinking water. After calculating
DWLOCs and comparing them to the EECs for surface and ground water, EPA
does not expect the aggregate exposure to exceed 100% of the cPAD, as
shown in the following Table 3:

Table 3.-- Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to N-(2-Chloro-4-pyridinyl)-N '-
phenylurea
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population (total) 0.007 0.3 4.7 26 240
----------------------------------------------------------------------------------------------------------------
Females (13-50 years) 0.007 0.1 4.7 26 210
----------------------------------------------------------------------------------------------------------------
Infants/Children 0.007 0.4-1.5 4.7 26 70
----------------------------------------------------------------------------------------------------------------
Other 0.007 0.3 4.7 26 240
----------------------------------------------------------------------------------------------------------------

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).
N-(2-Chloro-4-pyridinyl)-N '-phenylurea is not registered for use
on any sites that would result in residential exposure. Therefore, the
aggregate risk is the sum of the risk from food and water, which do not
exceed the Agency's level of concern.
4. Intermediate-term risk. Intermediate-termaggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
N-(2-Chloro-4-pyridinyl)-N '-phenylurea is not registered for use
on any sites that would result in residential exposure. Therefore, the
aggregate risk is the sum of the risk from food and water, which do not
exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. No concern for
cancer risks were identified. Data from available studies do not
indicate a treatment-related tumor problem and cancer risk endpoints
have not been identified.
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 N-(2-chloro-4-pyridinyl)-N '-phenylurea residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

1. Plants. The proposed enforcement method is a high performance
liquid chromatography using ultraviolet detection (HPLC/UV) procedure
which measures parent N-(2-chloro-4-pyridinyl)-N '-phenylurea. For the
purpose of the Experimental Use Permit, the method has been adequately
validated. The limit of quantitation (LOQ) is 0.01 ppm and the limit of
detection is 0.003 ppm.
2. Animals. Depending on the results of a ruminant metabolism
study, an enforcement method for the regulated residue in animal
commodities may be required to support a Section 3 registration with
permanent tolerances.
Adequate enforcement methodology is available to enforce the
toleranceexpression. The method may be requested from: Calvin Furlow,
PIRIB, IRSD (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.

B. International Residue Limits

There are no Codex, Canadian, or Mexican IRLs for N-(2-chloro-4-
pyridinyl)-N '-phenylurea.

C. Conditions

There are no conditions for the registration.

V. Conclusion

Therefore, the time-limited tolerance is established for residues
of N-(2-chloro-4-pyridinyl)-N '-phenylurea in or on almond, apple,
blueberry, cranberry, fig, grapes, kiwifruit, olive, pear, and plums
(fresh) at 0.01 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
personmay 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-301122 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 July 6,
2001.
1. Filing the request. Your objection must specify thespecific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR

[[Page 22935]]

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 orrequest 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 inthe
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 VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-301122, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Regulatory Assessment Requirements

This final rule establishes a tolerance under FFDCA section 408(d)
inresponse to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).Nor does
it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4).
For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations

[[Page 22936]]

that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.''

VIII. Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., asadded 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
recordkeepingrequirements.

Dated: April 30, 2001.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180-- [AMENDED]
1. The authority citation for part 180 continues to read as
follows:

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

2. Section 180.569 is added to read as follows:

Sec. 180.569 Forchlorfenuron; tolerances for residues.

(a) General. Time-limited tolerances are established forresidues of
the plant growth regulator forchlorfenuron; N-(2-chloro-4-pyridinyl)-N
'-phenylurea in or on the food commodities:

------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Almond.......................... 0.01 4/1/04
Apple........................... 0.01 4/1/04
Blueberry....................... 0.01 4/1/04
Cranberry....................... 0.01 4/1/04
Fig............................. 0.01 4/1/04
Grape........................... 0.01 4/1/04
Kiwifruit....................... 0.01 4/1/04
Olive........................... 0.01 4/1/04
Pear............................ 0.01 4/1/04
Plum (fresh).................... 0.01 4/1/04
------------------------------------------------------------------------

(b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional restrictions. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 01-11414 Filed 5-4-01; 8:45 am]
BILLING CODE 6560-50-S

Forchlorfenuron; Time-Limited Pesticide Tolerance

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