[Federal Register Volume 65, Number 136 (Friday, July 14, 2000)]
[Rules and Regulations]
[Pages 43704-43713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17619]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301013; FRL-6593-1]
RIN 2070-AB78


Pyridaben; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
pyridaben [2-tert-butyl-5-(4-tert-butylbenzylthio)-4-choropyridazin-
3(2H)-one] in or on citrus; citrus pulp, dried; citrus oil; apple; 
apple pomace, wet; pear; tree nuts; almond hulls; pistachio; peach (and 
nectarine); plum; prune; grape; and cranberry. Time-limited tolerances 
are established for residues of pyridaben on apricot and cherry (sweet 
and tart) which will expire and are revoked on June 30, 2004. This 
regulation also establishes tolerances for residues of pyridaben and 
its metabolites PB-7 and PB-9 in or on the following ruminant 
commodities: milk, and milk-by-product, fat, and meat of cattle, goat, 
hog, and sheep. BASF Corporation and the Interregional Research Project 
Number 4 (IR-4) requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act, as amended by the Food Quality Protection Act 
(FQPA) of 1996.

DATES: This regulation is effective July 14, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301013, 
must be received by EPA on or before September 12, 2000.

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-301013 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Melody A. Banks, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; 
telephone

[[Page 43705]]

number: 703-305-5413; 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            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'' 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/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301013. 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 January 9, 1998 (63 FR 1457) (FRL-5762-
6) and February 13, 1998 (63 FR 7414) (FRL-5768-9), EPA issued a notice 
pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act 
of 1996 (FQPA) (Public Law 104-170) announcing the filing of a 
pesticide petition (PP 7F4881) for a tolerance by BASF Corporation, 
Agricultural Products, P.O. Box 13528, Research Triangle Park, NC 
27709. This notice included a summary of the petition prepared by BASF 
Corporation, Agricultural Products. Also, in the Federal Register of 
December 22, 1999 (64 FR 71767) (FRL-6396-2), EPA issued a notice 
pursuant to section 408 of the FFDCA, 21 U.S.C. 346a as amended by the 
FQPA (Public Law 104-170) announcing the filing of a pesticide petition 
(PP 9E6002) for a tolerance by IR-4, Center for Minor Crop Pest 
Management, North Brunswick, NJ 08902-3390. There were no comments 
received in response to either notice of filing.
    The petition requested that 40 CFR 180.494 be amended by 
establishing a tolerance for residues of pyridaben [2-tert-butyl-5-(4-
tert-butylbenzylthio-4-choropyridazin-3(2H)-one], in or on the 
following crops and crop groups: peach and nectarine at 2.4 ppm; plum 
and prune (fresh) at 0.7 ppm; prune (dried) at 2.2 ppm; cherry and 
apricot at 0.05 ppm; grape at 1.4 ppm; and tree nut crops at 0.05 ppm. 
IR-4 proposed a tolerance for cranberry at 0.50 ppm in support of 
regional registration. Registration for use on cranberry will be 
geographically limited based on the available residue data to the 
states of Maine, New Jersey, Rhode Island, Massachusetts, New York, 
Connecticut, New Hampshire, Vermont, and Delaware. Persons seeking 
broader registration should contact the appropriate EPA product manager 
concerning additional residue data required to expand the use area.
    Time-limited tolerances currently exist in 40 CFR 180.494 for 
pyridaben on apple, pear, almond, and citrus. After further 
reassessment of the data base in lieu of additional data submitted by 
the petitioner for tolerances originally established for pyridaben on 
the forementioned commodities, BASF petitioned EPA to reestablish 
tolerances for pyridaben on apple and pear. As a result of additionally 
submitted crop field trial data, EPA is proposing that the tolerances 
be adjusted as follows: apple from 0.6 ppm to 0.5 ppm and pear from 
0.75 ppm to 0.6 ppm; tolerances for citrus and almond will remain the 
same. Currently, a separate tolerance exists in 40 CFR 180.494(a) for 
pyridaben on almond. Since the crop group, tree nuts, includes almond, 
the existing almond tolerance is being removed. However, the existing 
tolerance for almond hulls at 4.0 ppm will remain the same.
    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

[[Page 43706]]

certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for a tolerance for residues of pyridaben in or on peach at 
2.5 ppm; nectarine at 2.5 ppm; plum at 0.75 ppm; cherry, sweet at 0.05 
ppm; cherry, tart at 0.05 ppm; apricot at 0.05 ppm; crop group 14, tree 
nuts at 0.05 ppm; pistachio at 0.05 ppm; grape at 1.5 ppm; prune at 2.5 
ppm; and cranberry at 0.5 ppm. EPA's assessment of the dietary 
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 pyridaben are 
discussed in this unit.
    Pyridaben belongs to the pyridazinone class of pesticides. Other 
active ingredients that belong to this class of pesticides include 
pyrazon and norflurazon. EPA does not currently have data available to 
determine with certainty whether pyridaben has a common mechanism of 
toxicity with any other substances. For the purposes of this human 
health risk assessment, EPA has not assumed that pyridaben has a common 
mechanism of toxicity with other pesticides.
    In general, the acute toxicology studies conducted on technical 
grade pyridaben demonstrate that it has moderate to mild toxic effects. 
It was classified as Toxicity Category III based upon the acute oral 
LD50 of 1,100 milligrams/kilograms (mg/kg) in male rats and 
570 mg/kg in female rats. The dermal LD50, in rabbits was 
greater than or equal to 2,000 mg/kg (Toxicity Category III) and the 
inhalation LC50 was 0.66/0.64 milligram/liter (mg/L) in 
male/female rats, respectively (Toxicity Cateogry III). The eye 
irritation study (rabbits) produced slight ocular irritation (Toxicity 
Cateogry III). Pyridaben was not a dermal irritant (Toxicity Cateogry 
IV) or sensitizer.
    There are guideline acute and subchronic neurotoxicity studies. The 
neurological symptoms in the available neurotoxicity studies and some 
of the other studies, were seen only at relatively high doses. The 
neurotoxic effects (piloerection, hypocricturty, tremors, partially 
closed eyes) were weak, sporadic, transient and/or non-reproducible 
with no neuropathological effects. In a 90-day rat study, plasma 
cholinesterase enzyme (ChE) was statistically-significantly inhibited 
in the females at the highest dose tested (HDT) of 350 ppm (25.71 mg/
kg/day for males or 27.68 mg/kg/day for females). Based on these 
neurotoxic effects, EPA has required that a developmental neurotoxicity 
study be submitted. There are developmental toxicity studies in rats 
and rabbits (by the oral or dermal routes), and a multi-generation 
reproduction study in rats. The developmental and reproduction toxicity 
studies showed no effect on reproduction and no increased 
susceptibility of rats or rabbits to in utero and/or postnatal exposure 
to pyridaben as demonstrated by a higher developmental lowest observed 
adverse effect level (LOAEL) than those observed to produce maternal 
toxicity.
    The most common toxicity endpoint across the various studies and 
tested species was decreased body weight/decreased body weight gain 
followed by decreased feed consumption and/or feed efficiency. These 
effects were observed in 13-week feeding studies in mice, rats, and 
dogs, in a 21-day dermal toxicity study in rats, in a 28-day inhalation 
toxicity study in rats, in a 13-week neurotoxicity study in rats, in 1-
year feeding studies in dogs, in a 78-week feeding/carcinogenicity 
study in mice, in developmental toxicity studies in rats and rabbits, 
in a 2-generation reproduction study in rats, and in a 2-year feeding/
carcinogenicity study in rats. It is noteworthy that the LOAELs were 
always based on decreases in body weight gain/decreases in body weight 
or decreases in food consumption. Other effects were sporadic and 
involved changes in certain clinical chemistry values or increases or 
decreases in organ weights. There is no evidence of increased 
susceptibility of infants and children to any of these endpoints.
    In an acceptable rat metabolism study by the oral route, pyridaben 
was mainly eliminated in feces where 80-97% of the administered dose 
was excreted regardless of dose or site of label (pyridazinone or 
benzyl ring). Nearly 20% of the excreted residue in the feces was 
unmetabolized parent compound and there was some evidence of 
glucuronide conjugate(s) in the bile. The plasma levels following a 
single low oral dose (3 mg/kg) peaked at 2-3 hours while peak levels at 
the high dose (30 mg/kg) were at approximately 24 hours post-dose due, 
at least in part, to enterohepatic circulation where nearly 22-30% of 
an administered radioactive dose is excreted in bile within a period of 
24 hours. Residual radioactivity was at or near background levels for 
most tissues by 72 to 168 hours. Generally, there seemed to be 
increased distribution to fat over time and, compared to other tissues, 
fat seemed to have relatively more residual radioactivity. Several 
metabolites, totaling up to 20-30, were resolved in urine and feces and 
some were structurally identified.

B. Toxicological Endpoints

    1. Acute toxicity. An acute reference dose (RfD) of 0.13 mg/kg/day 
NOAEL = 13 mg/kg/day, uncertainty factor (UF) = 100 for use in 
assessing acute dietary risk for females 13 years and older. This acute 
RfD is based upon the developmental toxicity study with rats in which 
developmental effects (decreased fetal body weight and increased 
delayed bone ossification) were observed at the development LOAEL of 30 
mg/kg/day. The acute population adjusted dose (PAD) = acute RfD/FQPA 
factor (1x) = 0.13 mg/kg/day for females 13 years older.
    An acute RfD of 0.50 mg/kg/day (NOAEL = 50 mg/kg/day, UF = 100) was 
selected for use in assessing acute dietary risk for the general 
population. This acute RfD is based upon the acute oral neurotoxicity 
study with rats in which the following effects were observed at the 
LOAEL of 100 mg/kg/day: clinical signs of toxicity, decreased food 
consumption, and decreased body weight gain. The acute PAD = acute RfD/
FQPA factor (1x) = 0.5 mg/kg/day for the U.S. population.
    2. Short-term and intermediate-term toxicity. A NOAEL of 100 mg/kg/
day was selected based on a 21-day dermal toxicity study in rats that 
resulted in decreased body weight gain in female rats at 300 mg/kg/day 
(LOAEL). A margin of exposure (MOE) of 100 or

[[Page 43707]]

greater is adequate since the FQPA factor was reduced to 1X.
    EPA concluded that for short-term and intermediate-term aggregate 
exposure risk assessment the MOEs cannot be combined since the 
toxicological endpoints were different via the oral, dermal, and 
inhalation routes (i.e., no common endpoint of concern).
    3. Long-term dermal toxicity. A long-term dermal endpoint was not 
selected as the use pattern does not indicate a potential for long-term 
exposure.
    4. Chronic toxicity. A chronic RfD of 0.005 mg/kg/day (NOAEL =  
0.50 mg/kg/day; UF = 100) was selected for use in assessing chronic 
dietary risk. This chronic RfD is based on the chronic toxicity study 
in dogs, in which the following effects were observed at the LOAEL of 
0.5 mg/kg/day: increased incidence of clinical signs in both sexes and 
decreased body weight gain in females. An additional uncertainty factor 
(3x, for not establishing a NOAEL) was not applied to the chronic RfD 
because the toxic response observed was very minimal and was considered 
to be a threshold effect. The 100x UF for use in assessing chronic 
dietary risk was considered to be adequate. The chronic cPAD = chronic 
RfD/FQPA factor (1x) = 0.005 mg/kg/day.
    5. Carcinogenicity. Based on the lack of evidence of 
carcinogenicity in acceptable studies in male and female rats and mice, 
pyridaben was classified as a ``not likely'' human carcinogen based 
upon the proposed EPA Weight-of-the-Evidence Categories. Also, there 
was no indication that pyridaben is mutagenic in acceptable in vitro 
and in vivo studies.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.494) for the residues of pyridaben, in or on a variety of raw 
agricultural commodities. Pyridaben is currently registered for use on 
almond, apple, citrus fruit, and pear. Time-limited tolerances are 
established in conjunction with these uses. Additionally, a time-
limited tolerance for pyridaben in/on cranberries is established in 
conjunction with a section 18 request. BASF Corporation has proposed to 
make the tolerances for pyridaben in/on citrus fruit and pear 
permanent. Additionally, in today's action, tolerances will be 
established for pyridaben in/on tree nuts, pistachio, peach, nectarine, 
plum, prune, apricot, cherry, grape, and cranberry.
    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.
    i. Acute exposure and risk. 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.
    EPA used the Dietary Exposure Evaluation Model (DEEM ) software for 
conducting a Tier 1 acute dietary (food only) risk analysis. DEEM is a 
dietary exposure analysis system developed by Novigen Sciences, Inc. 
that is used to estimate exposure to a pesticide chemical in foods 
comprising the diets of the U.S. population, including population 
subgroups. DEEM contains food consumption data as reported by 
respondents in the Department of Agriculture (USDA) Continuing Surveys 
of Food Intake by Individuals conducted in 1989-1992. The assumptions 
of the Tier 1 acute dietary exposure analysis are tolerance level 
residues and 100 percent crop-treated estimates. The tolerance levels 
were adjusted to account for organosoluble residue content.
    The acute DEEM analysis indicates the resulting dietary food 
exposures (at the 95th percentile) occupy up to 19% of the acute PAD 
for population subgroups exclusive to females 13 years and older. The 
highest exposed subgroup for females 13 years and older is females 
(13+/nursing). The analysis also shows that the resulting dietary food 
exposures (at the 95th percentile) occupy up to 18% of the 
acute PAD for population subgroups not specific to females 13 years and 
older. The highest exposed subgroup for population subgroups not 
specific to females 13 years and older is all infants ( 1-year).
    ii. Chronic exposure and risk. EPA used DEEM software for 
conducting a Tier 2 chronic (non-cancer) dietary (food only) risk 
analysis. The assumptions of the Tier 2 chronic dietary exposure 
analysis are anticipated residue estimates and 100% crop-treated 
estimates. The chronic DEEM analysis indicates that the most highly 
exposed population subgroup is non-nursing infants which occupy up to 
64% of the chronic PAD.
    2. From drinking water. The Agency currently lacks sufficient 
water-related exposure data from monitoring to complete a quantitative 
drinking water exposure analysis and risk assessment for pyridaben. 
Therefore, the Agency is presently relying on computer-generated 
Estimated Environmental Concentrations (EECs). GENEEC and/or PRZM/EXAMS 
(both produce estimates of pesticide concentration in a farm pond) are 
used to generate EECs for surface water and SCI-GROW (an empirical 
model based upon actual monitoring data collected for a number of 
pesticides that serve as benchmarks) predicts EECs in ground water. 
These models take into account the use patterns and the environmental 
profile of a pesticide, but do not include consideration of the impact 
that processing 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 assessing whether a pesticide is likely to be present 
in drinking water at concentrations which would exceed human health 
levels of concern.
    For any given pesticide, the SCI-GROW model generates a single EEC 
value of pesticide concentration in ground water. That EEC is used in 
assessments of both acute and chronic dietary risk. It is not unusual 
for the ground water EEC to be significantly lower than the surface 
water EECs. The GENEEC model generates several time-based EECs of 
pesticide concentration in surface water, ranging from 0-days (peak) to 
56-days (average). The GENEEC peak EEC is used in assessments of acute 
dietary risk; the GENEEC 56-day (average) EEC is used in assessments of 
chronic (non-cancer and cancer) dietary risk. PRZM/EXAMS provides 
longer duration (up to 36 years) values of pesticide concentration in 
surface water and is mainly used when a refined EEC is needed.
    A drinking water level of comparison (DWLOC) is the concentration 
of a pesticide in drinking water that would be acceptable as a 
theoretical upper limit in light of total aggregate exposure to that 
pesticide from food, water, and residential uses. EPA uses DWLOCs 
internally in the risk assessment process as a surrogate measure of 
potential exposure associated with pesticide exposure through drinking 
water. In the absence of monitoring data for a pesticide, the DWLOC is 
used as a point of comparison against the conservative

[[Page 43708]]

EECs provided by computer modeling (SCI-GROW, GENEEC  PRZM/EXAMS).
    EPA back-calculates DWLOCs by a two-step process: exposure food + 
(if applicable) residential is subtracted from the PAD to obtain the 
maximum acceptable exposure allowed in drinking water; DWLOCs are then 
calculated using that value and default body weight and drinking water 
consumption figures. In assessing human health risk, DWLOCs are 
compared to EECs. When EECs are less than DWLOCs, HED considers the 
aggregate risk from food + water + (if applicable) residential 
exposures to be acceptable.
    EPA conducted its Tier II screening-level assessments using the 
simulation models SCI-GROW and PRZM/EXAMS to generate EECs for ground 
and surface water, respectively. The modeling was conducted based on 
the environmental profile and the maximum seasonal application rate 
proposed for pyridaben (0.5 lbs active ingredient (ai/acre) x 2 
applications/acre/year on apples). The EECs are summarized in Table 1 
below.

         Table 1.--Estimated Environmental Concentrations (EECs)
------------------------------------------------------------------------
                                     PRZM/EXAMS 3
   SCI-GROW 1 (g/L) 2      (g/L)
-----------------------------------------------------
0.006 (acute & chronic)           0.215 (peak)        0.020 (long-term
                                                       mean)
------------------------------------------------------------------------
\1\ SCI-GROW (Screening Concentration in Ground Water) is an empirical
  model for predicting pesticide levels in ground water. The value from
  SCI-GROW is considered an upper bound concentration estimate.
\2\ g/L = parts per billion (ppb).
\3\ PRZM (Pesticide Root Zone Model--simulates the transport of a
  pesticide off the agricultural field) and EXAMS (Exposure Analysis
  Modeling System--simulates fate and transport of a pesticide in
  surface water. PRZM/EXAMS can substantially overestimate true
  pesticide concentrations in drinking water.

    i. Acute exposure and risk. Drinking Water Levels of Comparison 
(DWLOCs). The DWLOCs value are shown in Table 2. For each population 
subgroup listed, the acute PAD and the acute dietary (food only) 
exposure for that subgroup were used to calculate the acute DWLOC for 
the subgroup, using the formulas in footnotes 1 and 2 of Table 2.

                                                       Table 2.--DWLOCs for Acute Dietary Exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Max. Water
       Population Subgroup         Acute PAD (mg/kg/  Food Exposure (mg/   Exposure (mg/kg/    SCI-GROW (g/
                                         day)               kg/day)             day) 1              m>g/L)        EEC (g/L)       L) 2,3,4
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population (all seasons)     0.50                0.023               0.48                0.006               0.215               1.6 x 104
---------------------------------------------------------------------------------------------                    ---------------------
Females 13+ 5                     0.13                0.024               0.11                                                        3.2 x 103
---------------------------------------------------------------------------------------------                    ---------------------
Infants/Children 5                0.50                0.091               0.41                                                        4.1 x 103
---------------------------------------------------------------------------------------------                    ---------------------
Other 5                           0.50                0.029               0.47                                                        1.6 x 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Maximum Water Exposure (mg/kg/day) = Acute PAD (mg/kg/day)--Acute Food Exposure + Acute Residential Exposure (mg/kg/day). Pyridaben has no
  registered residential uses.
\2\ DWLOC (g/L) = Maximum Water Exposure (mg/kg/day) x body wt (kg) (10-3 mg/g) x water consumed daily (L/day). /L = ppb.
\3\ Default body weights are: general U.S. Population, 70 kg; males (13+ years old), 70 kg; females (13+ years old), 60 kg; other adult populations, 70
  kg; and, all infants/children, 10 kg.
\4\ Default daily drinking rates are 2 L/day for adults and 1 L/day for children.
\5\ Within each of these subgroups, the subpopulation with the highest (acute) food exposure was selected; namely, females (13+/nursing); all infants (
  1-year); and, the non-Hispanic other, respectively.

    ii. Chronic exposure and risk.--Chronic (Non-Cancer) Dietary 
(Drinking Water) Exposure--Drinking water levels of comparison 
(DWLOCs). The DWLOC value are shown in Table 3. For each population 
subgroup listed, the chronic PAD (0.005 mg/kg/day) and the chronic 
dietary (food only) exposure for that subgroup were used to calculate 
the chronic DWLOC for the subgroup, using the formulas in footnotes 1 
and 2 of Table 3.

                                               Table 3.--DWLOCs for Chronic (Non-Cancer) Dietary Exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Max. Water
       Population Subgroup        Chronic PAD (mg/kg/ Food Exposure (mg/   Exposure (mg/kg/   SCI- GROW (g/
                                         day)               kg/day)             day) 1              m>g/L)        EEC (g/L)       L) 2,3,4
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population (48 contiguous    0.0050              0.00073             0.0043              0.006               0.020               1.4 x 102
 States, all seasons)
---------------------------------
---------------------------------
---------------------------------

[[Page 43709]]

 
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Maximum Water Exposure (mg/kg/day) = Chronic PAD (mg/kg/day)--Chronic Food Exposure + Chronic Residential Exposure (mg/kg/day). Pyridaben has no
  registered residential uses.
\2\ DWLOC (g/L) = Maximum Water Exposure (mg/kg/day) x body weightt (kg) (10-3 mg/g) x water consumed daily (L/day). g/L =
  ppb.
\3\ HED default body weights are: General U.S. population, 70 kg; males (13+ years old), 70 kg; females (13+ years old), 60 kg; other adult populations,
  70 kg; and, all infants/children, 10 kg.
\4\ HED default daily drinking rates are 2 L/day for adults and 1 L/day for children.
\5\ Within each of these subgroups, the subpopulation with the highest (chronic) food exposure was selected; namely, females (13+/nursing); non-nursing
  infants ( 1-year); and the Pacific Region, respectively.

    3. From non-dietary exposure. At present, there are no registered 
or proposed residential uses of pyridaben. Thus, a residential exposure 
assessment is not required. There is a potential for occupational 
exposure to pyridaben during mixing, loading, and application 
activities. However, risks from these routes of exposure are considered 
negligible.
    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 pyridaben 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, 
pyridaben 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 pyridaben has a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Aggregate Risks and Determination of Safety for U.S. Population and 
Infants and Children.

    1. Acute risk. Acute aggregate risk is the sum of exposures 
resulting from acute dietary food + acute drinking water. This acute 
aggregate risk assessment was conducted for all population subgroups, 
and the acute PAD of 0.13 mg/kg/day is applied to all population 
subgroups exclusive to females 13 years and older and the acute PAD of 
0.50 mg/kg/day is applied to all other population subgroups.
    EPA used DEEM software for conducting a Tier 1 acute dietary (food 
only) risk analysis. The assumptions of the Tier 1 dietary exposure 
analysis are tolerance level residues and 100% crop-treated estimates. 
The tolerance levels were adjusted to account for organosoluble residue 
content.
    The resulting dietary food exposures (at the 95th 
percentile) occupy up to 19% of the acute PAD for population subgroups 
exclusive to females 13 years and older (females (13+/nursing)). The 
resulting dietary food exposures (at the 95th percentile) 
occupy up to 18% of the acute PAD for population subgroups not specific 
to females 13 years and older (all infants ( 1-year)).
    The EECs for assessing acute aggregate dietary risk are 0.006 ppb 
(in ground water, based on SCI-GROW) and 0.215 ppb (in surface water, 
based on the PRZM/EXAMS). The back-calculated DWLOCs (Table 2) for 
assessing acute aggregate dietary risk range from 3.2 x 103 
ppb for the most highly exposed population subgroup (females 13 years 
and older/nursing) to 1.6 x 104 ppb for the U.S. population 
(all seasons) and non-Hispanic others.
    The SCI-GROW and PRZM/EXAMS acute EECs are less than the Agency's 
level of comparison (the DWLOC value for each population subgroup) for 
pyridaben residues in drinking water as a contribution to acute 
aggregate exposure. EPA thus concludes with reasonable certainty that 
residues of pyridaben in drinking water will not contribute 
significantly to the aggregate acute human health risk and that the 
acute aggregate exposure from pyridaben residues in food and drinking 
water will not exceed the Agency's level of concern (100% of the acute 
PAD) for acute dietary aggregate exposure by any population subgroup. 
EPA generally has no concern for exposures below 100% of the acute PAD, 
because it is a level at or below which daily aggregate dietary 
exposure over a lifetime will not pose appreciable risks to the health 
and safety of any population subgroup. This risk assessment is 
considered high confidence, conservative, and very protective of human 
health.
    2. Chronic risk. Chronic (non-cancer) aggregate risk is the sum of 
exposures resulting from chronic dietary food + chronic drinking water 
+ chronic residential uses. Pyridaben has no registered residential 
uses. Therefore, this risk assessment is the aggregate of chronic 
dietary food + chronic drinking water exposures only. This chronic 
aggregate risk assessment was conducted for all population subgroups, 
and the chronic PAD is applied to all population subgroups.
    EPA used DEEM software for conducting a Tier 2 chronic (non-cancer) 
dietary (food) exposed analysis. Tier 2 assumptions are anticipated 
residue levels and 100% crop-treated estimates.
    The resulting dietary food exposures occupy up to 64% of the 
chronic PAD for the most highly exposed population subgroup, non-
nursing infants. These results should be viewed as conservative (health 
protective) risk estimates. Refinements such as use of percent crop-
treated information and/or additional refinements of the anticipated 
residue estimates would yield even lower estimates of chronic dietary 
exposure.
    The EECs for assessing chronic aggregate dietary risk are 0.006 ppb 
(in ground water, based on SCI-GROW) and 0.020 ppb (in surface water, 
based on the PRZM/EXAMS). The back-calculated DWLOCs for assessing 
chronic aggregate dietary risk range from 18 ppb for the most highly 
exposed population subgroup (non-nursing infants,  1-year old) to 1.4 x 
102 ppb for the U.S. population (48 contiguous States--all 
seasons).
    The SCI-GROW and PRZM/EXAMS chronic EECs are less than the Agency's

[[Page 43710]]

level of comparison (the DWLOC value for each population subgroup) for 
pyridaben residues in drinking water as a contribution to chronic 
aggregate exposure. EPA thus, concludes with reasonable certainty that 
residues of pyridaben in drinking water will not contribute 
significantly to the aggregate chronic human health risk and that the 
chronic aggregate exposure from pyridaben residues in food and drinking 
water will not exceed the Agency's level of concern (100% of the 
chronic PAD) for chronic dietary aggregate exposure by any population 
subgroup. EPA generally has no concern for exposures below 100% of the 
chronic PAD, because it is a level at or below which daily aggregate 
dietary exposure over a lifetime will not pose appreciable risks to the 
health and safety of any population subgroup. This risk assessment is 
considered high confidence, conservative, and very protective of human 
health.
    Cancer aggregate risk is based on the sum of exposures resulting 
from chronic dietary food + chronic drinking water + chronic 
residential uses. Pyridaben is classified as a ``not likely'' human 
carcinogen based upon the proposed EPA Weight-of-the-Evidence 
Categories. Thus, pyridaben does not pose a cancer risk.
    3. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to pyridaben residues.

E. Aggregate Risks and Determination of Safety 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 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 MOE analysis 
or through using UF in calculating a dose level that poses no 
appreciable risk to humans. EPA believes that reliable data support 
using the standard UF (usually 100 for combined interspecies and 
intraspecies variability) and not the additional tenfold MOE/UF when 
EPA has a complete data base under existing guidelines and when the 
severity of the effect in infants or children or the potency or unusual 
toxic properties of a compound do not raise concerns regarding the 
adequacy of the standard MOE/safety factor.
    ii. Conclusion. There is a complete toxicity data base for 
pyridaben 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 
removed. The FQPA factor is removed because:
    a. The toxicity data base is complete for the assessment of the 
effects following in utero and /or postnatal exposure to pyridaben.
    b. The toxicity data provided no indication of quantitative or 
qualitative increased susceptibility of rats or rabbits to in utero 
and/or postnatal exposure.
    c. Although a developmental neurotoxicity study is required, this 
requirement is not based on criteria reflecting some special concern 
for developing fetuses or the young which are generally used for 
requiring a developmental neurotoxicity study and retention of the FQPA 
safety factor; and, therefore, does not warrant retention of the FQPA 
safety factor.
    d. The exposure assessments will not underestimate the potential 
dietary (food and water) exposures for infants and children from the 
use of pyridaben (currently no residential exposure is expected).
    2. Acute risk. The resulting dietary food exposures (at the 
95th percentile) occupy up to 19% of the acute PAD for 
population subgroups exclusive to females 13 years and older (females 
(13+/nursing). The resulting dietary food exposures (at the 
95th percentile) occupy up to 18% of the acute PAD for 
population subgroups not specific to females 13 years and older (all 
infants  1-year).
    The EECs for assessing acute aggregate dietary risk are 0.006 ppb 
(in ground water, based on SCI-GROW) and 0.215 ppb (in surface water, 
based on the PRZM/EXAMS). The back-calculated DWLOCs for assessing 
acute aggregate dietary risk range from 3.2 x 103 ppb for 
the most highly exposed population subgroup (females 13 years and 
older/nursing) to 1.6 x 104 ppb for the U.S. population (all 
seasons) and non-Hispanic others.
    3. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to pyridaben from food 
will utilize 64% of the RfD for infants and children. EPA generally has 
no concern for exposures below 100% of the RfD because the RfD 
represents the level at or below which daily aggregate dietary exposure 
over a lifetime will not pose appreciable risks to human health. 
Despite the potential for exposure to pyridaben in drinking water and 
from non-dietary, non-occupational exposure, EPA does not expect the 
aggregate exposure to exceed 100% of the RfD.
    4. Short-term or intermediate-term risk. These aggregate risk 
assessments take into account chronic dietary exposure from food and 
water (considered to be a background exposure level) plus (short-term, 
intermediate-term, or long-term, as applicable) indoor and outdoor 
residential exposure. Since pyridaben is not registered for residential 
uses, short-term and intermediate-term, and long-term aggregate risk is 
captured by the assessment for aggregate chronic risk.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to pyridaben residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

    1. Nature of residues in plants. EPA concludes that the tolerance 
expression for plant commodities will include pyridaben only and that 
all organosoluble residues may be presumed to be of comparable toxicity 
to the parent. Thus, the risk assessment for human dietary consumption 
of pyridaben-treated plant commodities will include all organosoluble 
residues. EPA has calculated a ratio of pyridaben to organosoluble 
residues based upon the low dose pyridaben apple and orange metabolism 
studies. These studies were chosen because they approximate the 
proposed use of pyridaben on citrus and apples. For dietary exposure 
analysis, tolerance levels of pyridaben in/on plant commodities will be 
multiplied by the ratio of organosoluble residues to pyridaben.
    2. Nature of residues in animals. EPA concludes that the tolerance 
expression for ruminant commodities will include pyridaben and its 
metabolites PB-7 and PB-9 and that all organosoluble residues may be 
presumed to be of comparable toxicity to the parent. Thus, the risk 
assessment for human consumption of ruminant commodities will also 
include all organosoluble residues. For liver, EPA will calculate a 
ratio of pyridaben, PB-7 and PB-9 residues to organosoluble residues 
based upon the ruminant metabolism study. For milk and other tissues, 
best estimates of residues of concern for risk assessment may need to 
be based on total organosoluble residues in the goat metabolism study. 
Dietary exposure of

[[Page 43711]]

poultry to pyridaben residues is not expected as a result of the 
proposed uses.
    3. Enforcement analytical methods--Plants--Apple, pear, peach, 
plum, cherry, apricot, grape, pistachio and tree nuts. BASF Method 
D9312A: For solid samples, residues of pyridaben are extracted by 
blending the sample with a solution of acetone/water (8:2 v/v). For 
juice, residues are extracted by mixing the sample with 80% acetone/
water (v/v). Following filtration to remove the sample material, the 
solvent is exchanged to water and an aliquot of the extract is applied 
to a mini-C18 silica gel column. Residues are eluted with 80% methanol/
water (v/v) and the solvent is exchanged to toluene for analysis. 
Residues of pyridaben are quantified by analysis of the sample extracts 
by gas chromatography (GLC) utilizing an electron capture detector 
(63Ni--ECD) and a fused silica column. The method has been validated to 
a quantification limit of 0.05 p.m. This method has been independently 
validated for use with apple and pear commodities as per PR Notice 88-
5.
    BASF Method D9312 has been adequately validated in both apples and 
almonds. The submitted method is adequate for the enforcement of the 
proposed tolerances for residues of pyridaben in/on apples, pears, and 
almonds. This method has been validated by EPA and was submitted to the 
Food and Drug Administration (FDA) for inclusion in PAM, Volume II.
    4. Citrus BASF Method D9309B BASF Method D9309B is briefly 
described as follows: whole fruit are homogenized and then blended with 
acetone:water. Sodium chloride is added to the extract and the residues 
are partitioned into dichloromethane, dried by evaporation, dissolved 
in DCM:hexane (3:7, v/v) and cleaned up on a silica gel column eluted 
with DCM:hexane (11:9, v/v). The samples are then dried, dissolved in 
toluene, and analyzed by GC/ECD. This method has been independently 
validated for use with citrus commodities as per PR Notice 88-5. The 
submitted method is adequate for enforcement of permanent tolerances 
for residues of pyridaben in/on citrus and will be forwarded to the 
Food and Drug Administration for publication in PAM Vol. II.
    5. Enforcement analytical method--Animals--BASF Method D9405 for 
animal matrices. BASF Method D9405 is briefly described as follows: 
macerate animal tissue with acetone/water and milk with acetone. Filter 
and wash the sample with the same solvent. Methylate a portion of the 
extract with diazomethane. After adding water, load the methylated 
sample onto a octadecylsilane column and elute with methanol/water. The 
sample is then evaporated to dryness, dissolved in acetonitrile and 
analyzed by GC/ECD. This method has been independently validated for 
use with milk and liver commodities as per PR Notice 88-5. BASF Method 
D9405 has been validated in both liver and milk.

B. International Residue Limits

    There are no established or proposed Codex, Canadian or Mexican 
limits for residues of pyridaben in/on plant commodities or for 
pyridaben and its metabolites (PB-7 and PB-9) in/on livestock 
commodities. Therefore, no compatibility issues exist with regard to 
the proposed U.S. tolerances discussed in this risk assessment.

V. Conclusion

    Therefore, the tolerance is established for residues of pyridaben, 
in or on peach at 2.5 ppm; nectarine at 2.5 ppm; plum at 0.75 ppm; 
cherry, sweet at 0.05 ppm; cherry, tart at 0.05 ppm; apricot at 0.05 
ppm; crop group, 14, tree nuts at 0.05 ppm; almond hulls at 4.4 ppm; 
pistachio at 0.05 ppm; grape at 1.5 ppm; prune at 2.5 ppm; cranberry at 
0.5 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-301013 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 September 
12, 2000.
    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 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

[[Page 43712]]

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-301013, 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 file format 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). 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 prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments (63 FR 27655, May 19, 1998); special considerations as 
required by Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or require 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).

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: June 28,2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

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


    2. Section 180.494 is revised to read as follows:


Sec. 180.494  Pyridaben; tolerance for residues.

    (a) General. Tolerances are established for residues of the 
insecticide pyridaben [2-tert-butyl-5-(4-tert-butylbenzylthio)-4-
chloropyridazin-3(2H)-one] on the following plants, and of the 
insecticide pyridaben and its metabolites (2-tert-butyl-5-(4-(1-
carboxy-1-methylethyl)benzylthio)-4-chloropyridazin-3(2H)-one] and (2-
tert-butyl-5-[4(-1,1-dimethyl-2-hypdroxyethyl)benzylthio-4-
chloropyridazinn-3(2H)-one) on animals, as indicated in the following 
table.

[[Page 43713]]



 
----------------------------------------------------------------------------------------------------------------
                Commodity                          Parts per million              Revocation/expiration date
----------------------------------------------------------------------------------------------------------------
Almond hulls............................                                 4.0                                None
Apple...................................                                 0.5                                None
Apple, wet pomace.......................                                0.75                                None
Apricot.................................                                0.05                             6/30/04
Cattle, fat.............................                                0.05                                None
Cattle, meat............................                                0.05                                None
Cattle, meat by-products................                                0.05                                None
Cherry, sweet...........................                                0.05                             6/30/04
Cherry, tart............................                                0.05                             6/30/04
Citrus, crop group......................                                0.05                                None
Citrus, dried pulp......................                                 1.5                                None
Citrus, oil.............................                                10.0                                None
Goat, fat...............................                                 0.0                                None
Goat, meat..............................                                0.05                                None
Goat meat by-products...................                                0.05                                None
Grape...................................                                 1.5                                None
Hog, fat................................                                0.05                                None
Hog, meat...............................                                0.05                                None
Hog meat by-products....................                                0.05                                None
Horse, fat..............................                                0.05                                None
Horse meat..............................                                0.05                                None
Horse meat by-products..................                                0.05                                None
Milk....................................                                0.01                                None
Nectarine...............................                                 2.5                                None
Nut, tree crop group....................                                0.05                                None
Peach...................................                                 2.5                                None
Pear....................................                                0.75                                None
Pistachio...............................                                0.05                                None
Plum....................................                                 2.5                                None
Prune...................................                                 2.5                                None
Sheep, fat..............................                                0.05                                None
Sheep, meat.............................                                0.05                                None
Sheep, meat by-product..................                                0.05                                None
----------------------------------------------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with 
regional registration, as defined in Sec. 180.1(n) are established for 
residues of the insecticide pyridaben [2-tert-butyl-5(4-tert-
butylbenzylthio)-4-chloropyridazin-3(2H)-one] in or on the following 
raw agricultural commodity:

 
----------------------------------------------------------------------------------------------------------------
                Commodity                          Parts per million                    Expiration Date
----------------------------------------------------------------------------------------------------------------
Cranberry...............................                                 0.5                                None
----------------------------------------------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 00-17619 Filed 7-13-00; 8:45 am]
BILLING CODE 6560-50-F