[Federal Register Volume 66, Number 88 (Monday, May 7, 2001)]
[Rules and Regulations]
[Pages 22930-22936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11414]



[[Page 22930]]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301122; FRL-6781-4]
RIN 2070-AB78


Forchlorfenuron; Time-Limited Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

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: [email protected].

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 (MOEcancer = 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: 
[email protected].

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 [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 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: [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).

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