[Federal Register Volume 67, Number 32 (Friday, February 15, 2002)]
[Rules and Regulations]
[Pages 7085-7092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3773]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301213; FRL-6821-7]
RIN 2070-AB78


Diflubenzuron; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of diflubenzuron and its metabolites 4-chloroaniline and 4-
chlorophenylurea in or on pear. IR-4 requested this tolerance under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act (FQPA) of 1996.

DATES: This regulation is effective February 15, 2002. Objections and 
requests for hearings, identified by docket control number OPP-301213, 
must be received by EPA on or before April 16, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301213 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-3194; 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
           Categories                 NAICS Codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301213. 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 December 14, 2001 (66 FR 64823) (FRL-
6813-2), EPA issued a notice pursuant to section 408 of the FFDCA, 21 
U.S.C. 346a as

[[Page 7086]]

amended by the FQPA of 1996 (Public Law 104-170) announcing the filing 
of a pesticide petition (PP) for tolerance by the Interregional 
Research Project Number 4 (IR-4), 681 U.S. Highway #1 South, North 
Brunswick, NJ 08902. This notice included a summary of the petition 
prepared by Uniroyal Chemical Company, the registrant. There were no 
comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.377 be amended by 
establishing a tolerance for combined residues of the insecticide 
diflubenzuron, N-[[(4-chlorophenyl)amino carbonyl]-2,6-
difluorobenzamide] and its metabolites 4-chloroaniline (PCA) and 4-
chlorophenylurea (CPU), in or on pear at 0.50 part per million (ppm).
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances November 26, 1997 (62 FR 62961) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for a tolerance for combined residues of diflubenzuron, N-
[[(4-chlorophenyl)amino]carbonyl]-2,6-difluorobenzamide and its 
metabolites PCA and CPU on pear at 0.50 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 diflubenzuron and 
its metabolites, CPU and PCA have been fully described in the 
Reregistration Eligibility Decision (RED) document (EPA 738-R-97-008, 
August 1997).

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for 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 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary 
method currently used by the Agency to quantify carcinogenic risk. The 
(Q*) approach assumes that any amount of exposure will lead 
to some degree of cancer risk. A (Q*) is calculated and used 
to estimate risk which represents a probability of occurrence of 
additional cancer cases (e.g., risk is expressed as 1 x 10-6 
or one in a million). Under certain specific circumstances, MOE 
calculations will be used for the carcinogenic risk assessment. In this 
non-linear approach, a ``point of departure'' is identified below which 
carcinogenic effects are not expected. The point of departure is 
typically a NOAEL based on an endpoint related to cancer effects though 
it may be a different value derived from the dose response curve. To 
estimate risk, a ratio of the point of departure to exposure 
(MOEcancer = point of departure/exposures) is calculated. A 
summary of the toxicological endpoints for diflubenzuron used for human 
risk assessment is shown in the following Table 1:

  Table 1.--Summary of Toxicological Dose and Endpoints for Diflubenzuron and Metabolites for Use in Human Risk
                                                   Assessment
 
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (general population      Not applicable           Not applicable           No appropriate endpoint
 including infants and children)                                                          attributable to a
                                                                                          single exposure was
                                                                                          identified in oral
                                                                                          studies. Therefore, a
                                                                                          risk assessment is
                                                                                          unnecessary.
----------------------------------------------------------------------------------------------------------------

[[Page 7087]]

 
Chronic dietary (all populations)      NOAEL = 2 milligrams/    FQPA SF =1X              Chronic toxicity study-
                                        kilograms/day (mg/kg/   cPAD = chronic RfD.....   dog
                                        day)                    FQPA SF = 0.02 mg/kg/    LOAEL = 10 mg/kg/day
                                       UF = 100...............   day.                     based on
                                       Chronic RfD = 0.02 mg/                             methemoglobinemia and
                                        kg/day.                                           sulfhemoglobinemia
----------------------------------------------------------------------------------------------------------------
Short, intermediate, and long-term     Not applicable           Not applicable           These endpoints were
 dermal (1 to 30 days)                                                                    not evaluated. There
(Residential)........................                                                     are no registered uses
                                                                                          of diflubenzuron which
                                                                                          result in significant
                                                                                          residential exposure.
----------------------------------------------------------------------------------------------------------------
Short, intermediate, and long-term     Not applicable           Not applicable           These endpoints were
 dermal (1-6 months)                                                                      not evaluated. There
(Residential)........................                                                     are no registered uses
                                                                                          of diflubenzuron which
                                                                                          result in significant
                                                                                          residential exposure.
----------------------------------------------------------------------------------------------------------------
Short, intermediate, and long-term     Not applicable           Not applicable           These endpoints were
 incidental oral (1-6 months)                                                             not evaluated. There
(Residential)........................                                                     are no registered uses
                                                                                          of diflubenzuron which
                                                                                          result in significant
                                                                                          residential exposure.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Diflubenzuron ``Group    Not aplicable            Acceptable oral rat and
                                        E'' evidence of non-                              mouse carcinogenicity
                                        carcinogenicity for                               studies; no evidence
                                        humans                                            of carcinogenic or
                                                                                          mutagenic potential.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      PCA ``Group B2''         1 X 10-6                 PCA tested positive for
                                        probably human                                    splenic tumors in male
                                        carcinogen Q1* 1.12 x                             rats and and
                                        10-1 (mg/kg/day)                                  heptocellular adenomas/
                                                                                          carcinomas in male
                                                                                          mice in a National
                                                                                          Toxicology Program
                                                                                          (NTP) study.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      CPU Q1* based on         1 X 10-6                 CPU is structurally
                                        monuron a structural                              related to monuron
                                        analog and the Q1*                                (N,N-dimethyl-CPU), a
                                        1.52 x 10-2                                       compound producing
                                                                                          tumors of kidney and
                                                                                          liver in male rats.
----------------------------------------------------------------------------------------------------------------
* 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. Tolerances have been 
established (40 CFR 180.377) for the combined residues of 
diflubenzuron. Permanent tolerances are established for residues of the 
insecticide diflubenzuron in or on the following raw agricultural 
commodities (RACs): Artichoke at 6.0 ppm; cottonseed at 0.2 ppm; 
grapefruit at 0.5 ppm; mushroom at 0.2 ppm; orange at 0.5 ppm; rice 
grain at 0.02 ppm; soybean at 0.05 ppm; tangerine at 0.5 ppm; walnuts 
at 0.1 ppm; fat, mbyp, and meat of cattle, goats, hogs, horses, sheep 
at 0.05 ppm; milk at 0.05 ppm; poultry fat, mbyp, meat at 0.05 ppm; and 
eggs at 0.05 ppm 40 CFR 180.377(a)(1). There are also tolerances with 
regional registration established in or on pasture grass at 1 ppm and 
range grass at 3 ppm 180.377(c). Risk assessments were conducted by EPA 
to assess dietary exposures from diflubenzuron 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 1 day or 
single exposure. No acute endpoints were identified for diflubenzuron; 
therefore, an acute dietary exposure analysis was not performed.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment, the Dietary Exposure Evaluation Model (DEEMTM) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the chronic 
exposure assessments: For the chronic analysis, anticipated residue 
information based on field trial data, and percent of crop treated 
(%CT) information for some commodities were used (Tier 3). A value of 
1% was used for %CT values <1%. CPU is the major degradate found in 
water and mushrooms and is a significant metabolite in milk. EPA has 
concluded that the residues of concern are diflubenzuron and 
metabolites PCA and CPU.
    iii. Cancer. Based on the submitted metabolism studies, there are 
two possible sources for dietary exposure to PCA and CPU: residues in 
mushrooms and residues in milk and liver. EPA used the results from 
metabolism studies to determine the percent of total radioactive 
residue present as PCA + CPU in mushrooms, milk and liver. For milk and 
liver, anticipated residues were calculated from the results of the 
ruminant feeding study using tolerance level residues in animal feed 
items and adjusting for percent of crop treated. The total levels of 
PCA + CPU were estimated by multiplying the ratio of (PCA + CPU)/
diflubenzuron by the diflubenzuron consumption from DEEM.

[[Page 7088]]

    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
authorizes EPA to use available data and information on the anticipated 
residue levels of pesticide residues in food and the actual levels of 
pesticide chemicals that have been measured in food. If EPA relies on 
such information, EPA must require that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. Following the initial data submission, EPA is authorized 
to require similar data on a time frame it deems appropriate. As 
required by section 408(b)(2)(E), EPA will issue a Data Call-In for 
information relating to anticipated residues to be submitted no later 
than 5 years from the date of issuance of this tolerance.
    Section 408(b)(2)(F) states that the Agency may use data on the 
actual percent of food treated for assessing chronic dietary risk only 
if the Agency can make the following findings: Condition 1, that the 
data used are reliable and provide a valid basis to show what 
percentage of the food derived from such crop is likely to contain such 
pesticide residue; Condition 2, that the exposure estimate does not 
underestimate exposure for any significant subpopulation group; and 
Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F), EPA may require registrants to submit data on 
PCT.
    The Agency used maximum PCT information as follows:
    Artichoke 100%, cotton 2%, grapefruit 8%, mushroom 31%, oranges 2%, 
pears 100%, rice 100%, soybeans 1%, tangerines 4%, walnuts 5%.
    The Agency believes that the three conditions listed above have 
been met. With respect to Condition 1, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. EPA uses a weighted average PCT for chronic dietary 
exposure estimates. This weighted average PCT figure is derived by 
averaging State-level data for a period of up to 10 years, and 
weighting for the more robust and recent data. A weighted average of 
the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. For acute dietary exposure estimates, EPA uses an estimated 
maximum PCT. The exposure estimates resulting from this approach 
reasonably represent the highest levels to which an individual could be 
exposed, and are unlikely to underestimate an individual's acute 
dietary exposure. The Agency is reasonably certain that the percentage 
of the food treated is not likely to be an underestimated. As to 
Conditions 2 and 3, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which diflubenzuron 
may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for diflubenzuron in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of diflubenzuron.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW, which predicts pesticide concentrations in ground water. In 
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS 
(a tier 2 model) for a screening-level assessment for surface water. 
The GENEEC model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. GENEEC incorporates a 
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir 
environment in place of the previous pond scenario. The PRZM/EXAMS 
model includes a percent crop (PT) 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 diflubenzuron, they are 
further discussed in the aggregate risk sections below.
    EPA has determined that PCA is only a minor metabolite of 
diflubenzuron in the environment. Drinking water will thus not be 
considered in the risk assessment for PCA.
    Ground water. Based on the SCI-GROW model, EECs of diflubenzuron in 
shallow ground water sources are not expected to exceed 0.0023 parts 
per billion (ppb). Estimated concentrations of CPU in shallow ground 
water sources are not expected to exceed 0.065 ppb. These 
concentrations can be considered as both the acute and chronic values.
    Surface water. Based on Tier II PRZM-EXAM modeling using the index 
reservoir (IR) scenario and the PC area adjustment factor, the 36-year 
average annual mean concentration of diflubenzuron in surface water 
sources is not expected to exceed 0.09 ppb. EECs of CPU in surface 
water sources are not expected to exceed 0.23 ppb.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).

[[Page 7089]]

    Diflubenzuron is currently registered for use on the following 
residential non-dietary sites: Outdoor residential and recreational 
areas. Although there are no registered homeowner uses, there is 
potential for professional applications to outdoor residential and 
recreational areas to control mosquitos, moths, and other insects. 
However, the potential for post-application residential exposures are 
expected to be limited. Due to the low dermal absorption rate (0.5%) of 
diflubenzuron, and since it is only applied to the tree canopy, minimal 
bystander contact is expected. Therefore, residential post-application 
exposure was not quanitiatively evaluated.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether diflubenzuron 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, 
diflubenzuron 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 diflubenzuron 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 November 26, 1997 (62 FR 62961) 
(FRL-5754-7).

D. Safety Factor for Infants and Children

    1. Safety factor for infants and children--i. 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.
    ii. Prenatal and postnatal sensitivity. There is no indication of 
quantitative or qualitative increased susceptibility of rats or rats to 
in utero or postnatal exposure.
    iii. Conclusion. There is a complete toxicity data base for 
diflubenzuron and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the 10X safety factor to protect infants and children should be 
reduced to 1X. The FQPA 10X safety factor is removed because: (1) There 
is no indication of quantitative or qualitative increased 
susceptibility of rats or rats to in utero or postnatal exposure; (2) a 
developmental neurotoxicity study (DNT) with diflubenzuron is not 
required; (3) food and drinking water exposure assessments will not 
underestimate the potential exposure for infants and children; and (4) 
there are currently no registered or proposed residential (non-
occupational) uses of diflubenzuron.

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 water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to 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 impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. An acute risk assessment was not performed because 
an acute dietary endpoint was not identified and therefore, 
diflubenzuron is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
diflubenzuron from food will utilize <1% of the cPAD for the U.S. 
population, 5% of the cPAD for all infants (<1 year old and <1% of the 
cPAD for children (1-6 years old). Based the use pattern, chronic 
residential exposure to residues of diflubenzuron is not expected. In 
addition, there is potential for chronic dietary exposure to 
diflubenzuron 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 2:

[[Page 7090]]



                                 Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Diflubenzuron
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Surface Water EEC       Ground Water EEC
        Population Subgroup              cPAD mg/kg/day           %cPAD (Food)               (ppb)                  (ppb)           Chronic DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population                      0.02                    <1                      0.09                   0.0023                 700
--------------------------------------------------------------------------------------------------------------------------------------------------------
All infants (<1 year old)            0.02                    5                       0.09                   0.0023                 190
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-6 years old)             0.02                    <1                      0.09                   0.0023                 200
--------------------------------------------------------------------------------------------------------------------------------------------------------

    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term risk assessments were not performed since an acute 
dietary endpoint was not identified and there are no registered or 
proposed non-food uses resulting in significant residential exposure.
    4. Aggregate cancer risk for U.S. population. Cancer aggregate risk 
assessments were not performed for diflubenzuron and PCA. Diflubenzuron 
is not a carcinogen and PCA is not a significant metabolite in drinking 
water. The potential cancer risk from dietary (food only), exposure to 
residues of PCA is 4.7 x 10-7, which is negligible. The 
results of the cancer analysis for CPU indicate that the estimated 
cancer dietary (food only) risk from CPU 3.8 x 10-8 
associated with the proposed use of diflubenzuron is below the Agency's 
level of concern. In addition, there is potential for chronic dietary 
exposure to CPU in drinking water. After calculating DWLOCs and 
comparing them to the EECs for surface and ground water, EPA does not 
expect the aggregate cancer risk to exceed EPA's level of concern, as 
shown in the following Table 3:

                         Table 3.--Aggregate Cancer Risk Assessment for Exposure to CPU
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                Residential   Cancer Risk     Ground      Surface       Cancer
                  Population                      Exposure     (food and    water EEC    Water EEC   DWLOC (ppb)
                                                             residential)     (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                           0    3.8 x 10-8        0.065         0.23          2.2
----------------------------------------------------------------------------------------------------------------

    5. 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 diflubenzuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate methods are available for the analysis of diflubenzuron in 
pears. Three enforcement methods for diflubenzuron are published in the 
Pesticide Analytical Method Volume II (PAM II) as Methods I, II, and 
III. Method II is a GC/ECD method that can separately determine 
residues of diflubenzuron, CPU, and PCA in eggs, milk, and livestock 
tissues. All three methods have undergone a successful petition method 
validation and are acceptable for enforcement purposes.

B. International Residue Limits

    The Codex Alimentarius has established a maximum residue limit, 
expressed in terms of diflubenzuron. Therefore, as the U.S. residue 
definition includes CPU and PCA, compatibility is not possible with the 
tolerance for pear.

C. Conditions

    EPA recommends that an unconditional registration of dimilin may be 
considered upon submission of a successful Agency petition method 
validation of analytical enforcement methods for PCA (4-chloroaniline) 
and CPU (4-chlorophenylurea) in crops. However, the agency concludes 
there are no residue chemistry or toxicology data requirements that 
would preclude the establishment of a conditional registration and 
permanant tolerance for the combined residues of diflubenzuron, N-[[(4-
chlorophenyl)amino]carbonyl]-2,6-difluorobenzamide and its metabolites 
4-chloroaniline and 4-chlorophenylurea in/on pears at 0.05 ppm.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
diflubenzuron, N-[[(4-chlorophenyl)amino carbonyl]-2,6-
difluorobenzamide] and its metabolites 4-chloroaniline and 4-
chlorophenylurea, in or on pears at 0.50 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301213 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 April 16, 
2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions

[[Page 7091]]

on such issues, and a summary of any evidence relied upon by the 
objector (40 CFR 178.27). Information submitted in connection with an 
objection or hearing request may be claimed confidential by marking any 
part or all of that information as CBI. Information so marked will not 
be disclosed except in accordance with procedures set forth in 40 CFR 
part 2. A copy of the information that does not contain CBI must be 
submitted for inclusion in the public record. Information not marked 
confidential may be disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit 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-301213, 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) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of

[[Page 7092]]

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

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: February 1, 2002.
Peter Caulkins,
Acting 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.


Sec. 180.377  Diflubenzuron; tolerances for residues.

    2. Section 180.377 is amended by revising paragraph (a)(2) to read 
as follows:

    (a) * * *
    (2) Tolerances are established for combined residues of the 
insecticide diflubenzuron and its metabolites 4-chlorophenlyurea and 4-
chloroaniline in or on the following food commodities:

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Pear                                                                                                        0.50
Rice, grain                                                                                                 0.02
Rice, straw                                                                                                  0.8
----------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. 02-3773 Filed 2-14-02; 8:45 am]
BILLING CODE 6560-50-S