[Federal Register Volume 66, Number 172 (Wednesday, September 5, 2001)]
[Rules and Regulations]
[Pages 46390-46397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22282]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301165; FRL-6798-6]
RIN 2070-AB78


Pyriproxyfen; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a time-limited tolerance for the 
combined residues of pyriproxyfen in or on succulent beans. This action 
is in response to EPA's granting of an emergency exemption under 
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act 
authorizing use of the pesticide on succulent beans. This regulation 
establishes a maximum permissible level for residues of pyriproxyfen in 
this food commodity. The tolerance will expire and is revoked on June 
30, 2003.

DATES: This regulation is effective September 5, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301165, 
must be received by EPA on or before November 5, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301165 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-9367; and e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

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

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to theFederal Register listings 
at http://www.epa.gov/fedrgstr/. 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-301165. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing a tolerance for combined residues of the 
insect growth regulator pyriproxyfen, [2-[1-methyl-2-(4-
phenoxyphenoxy)ethoxy]pyridine], in or on succulent beans at 0.10 part 
per million (ppm). This tolerance will expire and is revoked on June 
30, 2003. EPA will publish a document in the Federal Register to remove 
the revoked tolerance from the Code of Federal Regulations.

[[Page 46391]]

    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to 
establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    Section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from 
any provision of FIFRA, if EPA determines that ``emergency conditions 
exist which require such exemption.'' This provision was not amended by 
the Food Quality Protection Act (FQPA). EPA has established regulations 
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Pyriproxyfen on Succulent Beans and 
FFDCA Tolerances

    The silverleaf whitefly (SLW) is a relatively new pest, and has 
caused severe economic damage to various commodities nationwide. The 
larval instars and adults feed on the sap of bean plants, resulting in 
honeydew production which serves as a medium for fungal disease 
development, which hampers photosynthesis and renders pods 
unmarketable. Additionally, in late 1992, bean golden mosaic virus 
(BGMV) was first detected, although it's distribution was limited for 
several years. This virus is transmitted by the SLW. Recently, BGMV has 
become a more serious problem, believed to be the result of season-long 
build-up of the disease. This shift is a significant new development 
making BGMV a major pest in legume production in Florida. This trend is 
expected to continue unless an effective insecticide is available to 
control the SLW. EPA has authorized under FIFRA section 18 the use of 
pyriproxyfen on succulent beans for control of silverleaf whitefly in 
Florida. After having reviewed the submission, EPA concurs that 
emergency conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of pyriproxyfen in or on 
succulent beans. In doing so, EPA considered the safety standard in 
FFDCA section 408(b)(2), and EPA decided that the necessary tolerance 
under FFDCA section 408(l)(6) would be consistent with the safety 
standard and with FIFRA section 18. Consistent with the need to move 
quickly on the emergency exemption in order to address an urgent non-
routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment as provided in section 408(l)(6). Although this 
tolerance will expire and is revoked on June 30, 2003, under FFDCA 
section 408(l)(5), residues of the pesticide not in excess of the 
amounts specified in the tolerance remaining in or on succulent beans 
after that date will not be unlawful, provided the pesticide is applied 
in a manner that was lawful under FIFRA, and the residues do not exceed 
a level that was authorized by this tolerance at the time of that 
application. EPA will take action to revoke this tolerance earlier if 
any experience with, scientific data on, or other relevant information 
on this pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether pyriproxyfen 
meets EPA's registration requirements for use on succulent beans or 
whether a permanent tolerance for this use would be appropriate. Under 
these circumstances, EPA does not believe that this tolerance serves as 
a basis for registration of pyriproxyfen by a State for special local 
needs under FIFRA section 24(c). Nor does this tolerance serve as the 
basis for any State other than Florida to use this pesticide on this 
crop under section 18 of FIFRA without following all provisions of 
EPA's regulations implementing section 18 as identified in 40 CFR part 
166. For additional information regarding the emergency exemption for 
pyriproxyfen, contact the Agency's Registration Division at the address 
provided underFOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of 
pyriproxyfen and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a time-limited tolerance for 
combined residues of pyriproxyfen in or on succulent beans at 0.10 ppm. 
EPA's assessment of the dietary exposures and risks associated with 
establishing the tolerance follows.

A. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological endpoint. However, the 
lowest dose at which adverse effects of concern are identified (the 
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved 
in the toxicology study selected. An uncertainty factor (UF) is applied 
to reflect uncertainties inherent in the extrapolation from laboratory 
animal data to humans and in the variations in sensitivity among 
members of the human population as well as other unknowns. An UF of 100 
is routinely used, 10X to account for interspecies differences and 10X 
for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is

[[Page 46392]]

retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (LOC). For example, when 100 is the 
appropriate UF (10X to account for interspecies differences and 10X for 
intraspecies differences) the LOC is 100. To estimate risk, a ratio of 
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is 
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x10-6 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 pyriproxyfen used for human risk assessment is shown in 
the following Table 1:

     Table 1.--Summary of Toxicological Dose and Endpoints for Pyriproxyfen for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk      FQPA SF* and Endpoint   Study and Toxicological
          Exposure Scenario                Assessment, UF1        for Risk Assessment            Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary all populations          not applicable           not applicable           There were no effects
                                                                                          that could be
                                                                                          attributed to a single
                                                                                          exposure (dose) in
                                                                                          oral toxicity studies
                                                                                          including the
                                                                                          developmental toxicity
                                                                                          studies in rats and
                                                                                          rabbits.
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations        NOAEL= 35.1 mg/kg/day    FQPA SF = 1              Combined/chronic
                                       UF = 100...............  cPAD = 0.35............   toxicity - rat LOAEL =
                                       Chronic RfD = 0.35 mg/   1 = 0.35 mg/kg/day.....   182.7 mg/kg/day based
                                        kg/day.                                           on decreased weight
                                                                                          gain in female rats.
----------------------------------------------------------------------------------------------------------------
Short-term dermal and inhalation (1-7  not applicable           not applicable
 days) and intermediate-term dermal
 and inhalation (1 week - several
 months)
(Occupational/Residential)...........
----------------------------------------------------------------------------------------------------------------
Long-term dermal (several months -     35.1 mg/kg/day           LOC for MOE = 100        Combined/chronic
 lifetime)2                                                     (Residential)..........   toxicity - rat LOAEL =
(Occupational/Residential)...........                                                     182.7 mg/kg/day based
                                                                                          on decreased weight
                                                                                          gain in female rats.
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (several months - 35.1 mg/kg/day           LOC for MOE = 100        Combined/chronic
  lifetime)2                                                    (Residential)..........   toxicity - rat LOAEL =
(Occupational/Residential)...........                                                     182.7 mg/kg/day based
                                                                                          on decreased weight
                                                                                          gain in female rats.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      ``Group E'' human        not applicable           There is no evidence of
                                        carcinogen                                        carcinogenic
                                                                                          potential. Therefore,
                                                                                          a cancer risk
                                                                                          assessment is not
                                                                                          required.
----------------------------------------------------------------------------------------------------------------
1UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest
  observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose,
  LOC = level of concern, MOE = margin of exposure.
2Appropriate route-to-route extrapolation should be performed for these risk assessments. Exposure values using
  absorption factors of 10% for dermal and 100% for inhalation (default value) should be converted to equivalent
  oral doses and compared to the oral NOAEL.
 
*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.510) for the combined residues of pyriproxyfen, 
in or on a variety of raw agricultural commodities. Section 18 
emergency exemptions for use in/on cotton, citrus, almonds, and stone 
fruits have been approved. Section 3 permanent tolerances have been 
granted for cotton, citrus fruits, pome fruits, tree nuts, fruiting 
vegetables, and all foods in food handling establishments. Risk 
assessments were conducted by EPA to assess dietary exposures from 
pyriproxyfen 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. The acute dietary assessment is not required for 
pyriproxyfen because there were no effects that could be attributed to 
a single exposure (dose) in oral toxicity studies including the 
developmental toxicity studies in rats and rabbits.
    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:

[[Page 46393]]

Tolerance level residues and 100% crop treated.
    iii. Cancer. Pyriproxyfen has been classified as a Group E 
carcinogen; there is no evidence of carcinogenic potential. Therefore, 
a cancer risk assessment is not required.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for pyriproxyfen 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 pyriproxyfen.
    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 
Screening Concentrations in Ground Water (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 pyriproxyfen they are 
further discussed in the aggregate risk sections below.
    Based on the PRZM/EXAMS and SCI-GROW models the EECs of 
pyriproxyfen for chronic exposures are estimated to be 0.11 ppb for 
surface water and 0.006 ppb for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Pyriproxyfen is 
currently registered for use on the following residential non-dietary 
sites: Residential (indoor, non-food) products for flea and tick 
control. Formulations include contact sprays, emulsifiable 
concentrates, and impregnated materials (pet collars). With the 
exception of the pet collar uses, consumer use of pyriproxyfen 
typically results in short-term, intermittent exposures. Hence, chronic 
residential postapplication exposure and risk assessments were 
conducted to estimate the potential risks from pet collar uses.
    The risk assessment was conducted using the following assumptions: 
Application rate of 0.58 mg ai/day (product label), average body weight 
for a 1 to 6 year old child of 10 kg, the active ingredient dissipates 
uniformly through 365 days (the label instructs to change the collar 
once a year), and 1% of the active ingredient is available for dermal 
and inhalation exposure per day. The assessment also assumes an 
absorption rate of 100%. This is a conservative assumption since the 
dermal absorption was estimated to be 10%.
    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 pyriproxyfen 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, 
pyriproxyfen 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 pyriproxyfen has a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

C. Safety Factor for Infants and Children

    1. In general. FFDCA section 408 provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a margin of exposure 
(MOE) analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans.
    2. Developmental toxicity studies. In the developmental study in 
rats, the maternal (systemic) NOAEL was 100 mg/kg/day, based on 
decreased body weight, body weight gain, food consumption and increased 
water consumption at the LOAEL of 300 mg/kg/day. The developmental 
(fetal) NOAEL was 300 mg/kg/day, based on increased skeletal variations 
and unspecified visceral variations at the LOAEL of 1,000 mg/kg/day.
    In the developmental toxicity study in rabbits, the maternal 
(systemic) NOAEL was 100 mg/kg/day, based on abortions, soft stools, 
emaciation, decreased activity and bradypnea at the LOAEL of 300 mg/kg/
day. The developmental (pup) NOAEL was 300 mg/kg/day, based on 
decreased viable litters at the LOAEL of 1,000 mg/kg/day.
    3. Reproductive toxicity study. In the 2-generation reproductive 
toxicity study in rats, the maternal (systemic) NOAEL was 87/96 mg/kg/
day for M/F, based on decreased body weights, body weight gains, and 
increased liver weight associated with histopathological findings in 
the liver at the LOAEL of 453/498 mg/kg/day for M/F. The developmental 
(pup) NOAEL was 87/96 mg/kg/day, based on decreased body weight on 
lactation days 14 and 21 at the LOAEL of 453/498 mg/kg/day. The

[[Page 46394]]

reproductive NOAEL was 453/498 mg/kg/day HDT.
    4. Prenatal and postnatal sensitivity. The toxicological data base 
for evaluating prenatal and postnatal toxicity for pyriproxyfen is 
complete with respect to current data requirements. There are no 
prenatal or postnatal toxicity comparisons for infants and children, 
based on the results of the rat and rabbit developmental toxicity 
studies and the 2-generation rat reproductive toxicity study.
    5. Conclusion. Based on the above, the Agency concludes that 
reliable data support use of a 100-fold margin of exposure/uncertainty 
factor, rather than the standard 1,000-fold margin/factor, to protect 
infants and children.

D. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water EECs. DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + chronic non-dietary, non-occupational exposure). 
This allowable exposure through drinking water is used to calculate a 
DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to pyriproxyfen 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 
pyriproxyfen on drinking water as a part of the aggregate risk 
assessment process.
    1. Acute risk. The acute dietary assessment is not required for 
pyriproxyfen because there were no effects that could be attributed to 
a single exposure (dose) in oral toxicity studies including the 
developmental toxicity studies in rats and rabbits.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
pyriproxyfen from food will utilize 0.9% of the cPAD for the U.S. 
population, 1.6% of the cPAD for all infants <1 year old and 2.6% of 
the cPAD for children 1-6 years old. Chronic residential exposure to 
pyriproxyfen from pet collars is estimated to increase total 
pyriproxyfen exposure to infants and children only marginally. In 
addition, despite the potential for chronic dietary exposure to 
pyriproxyfen in drinking water, after calculating DWLOCs and comparing 
them to conservative model estimated environmental concentrations of 
pyriproxyfen in surface and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the cPAD, as shown in the 
following Table 2:

              Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Pyriproxyfen
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population all seasons                             0.35          0.9         0.11        0.006        12000
----------------------------------------------------------------------------------------------------------------
All infants (<1 year)                                   0.35          1.6         0.11        0.006         3400
----------------------------------------------------------------------------------------------------------------
Children (1-6 years)                                    0.35          2.6         0.11        0.006         3400
----------------------------------------------------------------------------------------------------------------
Children (7-12 years)                                   0.35          1.5         0.11        0.006         3400
----------------------------------------------------------------------------------------------------------------
Females (13-50 years)                                   0.35          0.7         0.11        0.006        10000
----------------------------------------------------------------------------------------------------------------
Males (13-19 years)                                     0.35          0.9         0.11        0.006        12000
----------------------------------------------------------------------------------------------------------------
Males (20+ years)                                       0.35          0.6         0.11        0.006        12000
----------------------------------------------------------------------------------------------------------------
Seniors (55+)                                           0.35          0.6         0.11        0.006        12000
----------------------------------------------------------------------------------------------------------------

    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). A short-term 
residential exposure assessment is not required for pyriproxyfen due to 
the lack of significant toxicological effects observed.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account non-dietary, non-occupational exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). An intermediate-term residential exposure assessment is not 
required for pyriproxyfen due to the lack of significant toxicological 
effects observed.
    5. Aggregate cancer risk for U.S. population. Pyriproxyfen has been 
classified as a Group E carcinogen; there is no evidence of 
carcinogenic potential.

[[Page 46395]]

 Therefore, a cancer risk assessment is not required.
    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 pyriproxyfen residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (example - gas chromotography) is 
available to enforce the tolerance expression. 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 Maximum Residue Limits 
(MRL) for pyriproxyfen on succulent beans.

VI. Conclusion

    Therefore, the tolerance is established for combined residues of 
pyriproxyfen in or on succulent beans at 0.10 ppm.

VII. Objections and Hearing Requests

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

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301165 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before November 
5, 2001.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by the docket control number OPP-301165, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VIII. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under FFDCA 
section 408. The Office of Management and Budget (OMB) has exempted 
these types of actions from review under Executive Order 12866, 
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). 
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

[[Page 46396]]

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 FIFRA section 18 
petition under FFDCA section 408, such as the tolerances in this final 
rule, do not require the issuance of a proposed rule, the requirements 
of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not 
apply. In addition, the Agency has determined that this action will not 
have a substantial direct effect on States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government, as 
specified in Executive Order 13132, entitled Federalism(64 FR 43255, 
August 10, 1999). Executive Order 13132 requires EPA to develop an 
accountable process to ensure ``meaningful and timely input by State 
and local officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

IX. Submission to Congress and the Comptroller General

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

List of Subjects in 40 CFR Part 180

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


    Dated: August 21, 2001.
Donald R. Stubbs,

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.


    2. Section 180.510 is amended by alphabetically adding the 
commodity bean, succulent to the table in paragraph (b) to read as 
follows:


Sec. 180.510  Pyriproxyfen; tolerances for residues.

* * * * *
    (b)*  *  *  

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   Revocation Date
------------------------------------------------------------------------
              *        *        *        *        *
Bean, succulent...................               0.10            6/30/03
              *        *        *        *        *
------------------------------------------------------------------------


[[Page 46397]]

* * * * *

[FR Doc. 01-22282 Filed 9-4-01; 8:45am]
BILLING CODE 6560-50-S