[Federal Register Volume 68, Number 45 (Friday, March 7, 2003)]
[Rules and Regulations]
[Pages 10972-10982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5478]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0345; FRL-7289-6]


Pyriproxyfen; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
pyriproxyfen in or on Brassica, head and stem, subgroup 5A, Brassica, 
leafy greens, subgroup 5B, vegetable, cucurbit group 9, olives and 
olive oil. Valent U.S.A. Corporation requested this tolerance under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective March 7, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0345, 
must be received on or before May 6, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Joseph M. Tavano, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6411; 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 entities may include, but are not limited to:
    [sbull] Industry (NAICS 111), Crop production.
    [sbull] Industry (NAICS 112), Animal production.
    [sbull] Industry (NAICS 311), Food manufacturing
    [sbull] Industry (NAICS 32532), Pesticide manufacturing
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be

[[Page 10973]]

affected by this action. Other types of entities not listed in this 
unit could also be affected. The North American Industrial 
Classification System (NAICS) codes have been provided to assist you 
and others in determining whether this action might apply to certain 
entities. If you have any 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 Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2002-0345 The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal 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. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of May 29, 2002 (67 FR 37426-37432) (FRL-
7178-3), EPA issued a notice pursuant to section 408 of FFDCA, 21 
U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the 
filing of a pesticide petition PP 2F6385 by Valent U.S.A. Corporation, 
1333 North California Blvd., Suite 600, P.O. Box 8025, Walnut Creek, CA 
94596-8025. That notice included a summary of the petition prepared by 
Valent U.S.A. Corporation. the registrant. There were no comments 
received in response to the notice of filing.
    The petition requested that 40 CFR 180.510 be amended by 
establishing a tolerance for residues of the insecticide, pyriproxyfen, 
2-[1-methyl-2-(4-phenoxyphenoxy)ethoxypyridine, in or on Brassica leafy 
vegetables (Crop Group 5); vegetable, cucurbit (Crop Group 9); olive 
and olive, oil at 2.5, 0.1, 1.0, and 3.0 parts per million (ppm) 
respectively.
    Based on the residue data submitted, EPA has determined that the 
following changes to the requested tolerances listed in this document 
are necessary. A lower tolerance of 2.0 ppm is required for olive, oil. 
Brassica vegetables are devided into two subgroups. A tolerance of 0.70 
is required for Brassica, head and stem, subgroup 5A. A tolerance of 
2.0 ppm is required for Brassica, leafy greens, subgroup 5B.
    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) of the FFDCA 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) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA 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) of the FFDCA, 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) of the FFDCA, for a tolerance for residues of pyriproxyfen on 
Brassica, head and stem, subgroup 5A; Brassica, leafy greens, subgroup 
5B; Vegetable, cucurbit (Group 9); olive and olive, oil at 0.70, 2.0, 
0.10, 1.0, and 2.0 ppm, respectively. EPA's assessment of exposures and 
risks associated with establishing the tolerance follows.

A. Toxicological Profile

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

[[Page 10974]]



                              Table 1.--Toxicity Profile of Pyriproxyfen Technical
----------------------------------------------------------------------------------------------------------------
                                                MRID No. (year)/
        Guideline No./Study Type             Classification /Doses                      Results
----------------------------------------------------------------------------------------------------------------
870.3100                                  43210504 (1990) Acceptable/  NOAEL = 149.4 mg/kg/day in males (M),
90-Day oral toxicity rodents-- mouse....   guideline                    196.5 mg/kg/day in females (F)
                                          0; 200; 1,000; 5,000; or     LOAEL = 838.1 mg/kg/day (M), 963.9 mg/kg/
                                           10,000 ppm.                  day (F) based on pathological changes in
                                          M: 0, 28.2, 149.4, 838.1,     the kidney, increased absolute and
                                           or 2,034.5 milligram/        relative (to body) liver weight,
                                           kilogram/day (mg/kg/day).    decreased red blood cell parameters
                                          F: 0, 37.9, 196.5, 963.9,     (both sexes), and decreased body weight
                                           or 2,345.3 mg/kg/day.        gain (M)
-----------------------------------------
870.3100                                  41321716 (1989) Acceptable/  NOAEL = 23.49 mg/kg/day (M), 27.68 mg/kg/
90-Day oral toxicity rodents--rat.......   guideline                    day (F)
                                          0; 400; 2,000; 5,000; or     LOAEL = 117.79 mg/kg/day (M), 141.28
                                           10,000 ppm.                  based on increased total cholesterol and
                                          M: 0, 23.49, 117.79,          phospholipids (M),decreased red blood
                                           309.05, or 641.81 mg/kg/     cell, hematocrit, and hemoglobin counts,
                                           day.                         increased relative (to body) liver
                                          F: 0, 27.68, 141.28,          weight (M), and negative trend in red
                                           356.30, or 783.96 mg/kg/     blood cell volume (F)
                                           day.
-----------------------------------------
870.3150                                  42178307 (1988) Acceptable/  NOAEL = 100 mg/kg/day (M) and (F)
90-Day oral toxicity non-rodents--dog...   guideline                   LOAEL = 300 mg/kg/day (M) and (F) based
                                          0, 100, 300, or 1,000 mg/kg/  on increased absolute and relative (to
                                           day.                         body) liver weight (both sexes), and
                                                                        hepatocyte enlargement (F)
-----------------------------------------
870.3200                                  43994102 (1993) Acceptable/  NOAEL = 1,000 mg/kg/day (M) and (F)
21-Day dermal toxicity--rat.............   guideline                   LOAEL = not established
                                          0, 100, 300, or 1,000 mg/kg/
                                           day.
-----------------------------------------
870.3265                                  42178308 (1988)              NOAEL = 0.482 mg/L (M) and (F)
28-Day inhalation toxicity--rat.........   Supplementary               LOAEL = 1.000 mg/L based on salivation
                                          0, 269, 482, or 1,000 mg/     (both sexes), sporadic decreased body
                                           meter cubed (m\3\).          weight (M), and increased lactate
                                          0, 0.269, 0.482, or 1.000     dehydrogenase (M)
                                           mg/liter (L).
-----------------------------------------
870.3700a                                 44985002 (1988) Acceptable/  Parental NOAEL = 100 mg/kg/day
Prenatal developmental--rats (non-         nonguideline                Parental LOAEL = 300 mg/kg/day based on
 guideline).                              0, 100, 300, 500, or 1,000    clinical signs, decreased body weight
                                           mg/kg/day.                   gains, increased water consumption (both
                                                                        sexes) and increased food consumption,
                                                                        changes in organ weights, and gross
                                                                        pathological changes (M)
                                                                       Developmental NOAEL = 1,000 mg/kg/day
                                                                        highest dose tested (HDT)
-----------------------------------------
870.3700a                                 44985001 (1988) Acceptable/  Maternal NOAEL = 100 mg/kg/day
Prenatal developmental--rats (non-         nonguideline                Maternal LOAEL = 300 mg/kg/day based on
 guideline).                              0, 30, 100, 300, or 500 mg/   clinical signs, decreased body weight
                                           kg/day.                      gains, and decreased food consumption
                                                                       Developmental NOAEL = 100 mg/kg/day
                                                                       Developmental LOAEL = 300 mg/kg/day based
                                                                        on decreased body weight and increased
                                                                        incidence of dilation of the renal
                                                                        pelvis.
-----------------------------------------
870.3700b Prenatal developmental--rabbit  41321720, 42178311,          Maternal NOAEL = 100 mg/kg/day
                                           43215401, 43215402,         Maternal LOAEL = 300 mg/kg/day based on
                                           43215403 (1989) Acceptable/  premature delivery/abortions, soft
                                           guideline                    stools, emaciation, lusterless fur,
                                          0, 100, 300, or 1,000 mg/kg/  decreased activity, and bradypnea.
                                           day.                        Developmental NOAEL = 300 mg/kg/day
                                                                       Developmental LOAEL = 1,000 mg/kg/day
                                                                        based on decreased viable litters
                                                                        available for evaluation
-----------------------------------------
870.3700a                                 42178312 (1988) Acceptable/  Maternal NOAEL = 100 mg/kg/day
Prenatal developmental--rat.............   guideline                   Maternal LOAEL = 300 mg/kg/day based on
                                          0, 100, 300, or 1,000 mg/kg/  decreased body weight, body weight gain,
                                           day.                         and food consumption and increased water
                                                                        consumption .
                                                                       Developmental NOAEL = 300 mg/kg/day
                                                                       Developmental LOAEL = 1,000 mg/kg/day
                                                                        based on increased incidence of skeletal
                                                                        variations at gestation day 21 and
                                                                        unspecified visceral variations at
                                                                        postnatal day (PND) 56.
-----------------------------------------
870.3800                                  42178313 (1991) Acceptable/  Parental/Systemic NOAEL = 87 mg/kg/day
Reproduction and fertility effects-- rat   guideline                    (M), 96 mg/kg/day (F)
                                          0; 200; 1,000; or 5,000 ppm  Parental/Systemic LOAEL = 453 mg/kg/day
                                          M: 0, 18, 87, or 453 mg/kg/   (M), 498 mg/kg/day (F) based on
                                           day.                         decreased body weight, body weight gain,
                                          F: 0, 20, 96, or 498 mg/kg/   and food consumption (both sexes) and
                                           day.                         increased liver weight (both sexes) and
                                                                        histopathological lesions of liver and
                                                                        kidneys (M)
                                                                       Reproductive NOAEL = 453 mg/kg/day (M),
                                                                        498 mg/kg/day (F)
                                                                       Reproductive LOAEL = not established.
                                                                       Offspring NOAEL = 87 mg/kg/day (M), 96 mg/
                                                                        kg/day (F)
                                                                       Offspring LOAEL = 453 mg/kg/day (M), 498
                                                                        mg/kg/day (F) based on decreased body
                                                                        weight on lactation days 14 and 21
-----------------------------------------

[[Page 10975]]

 
870.4100b                                 42178309 (1991) Acceptable/  NOAEL = 100 mg/kg/day (M) and (F)
Chronic toxicity--dogs..................   guideline                   LOAEL = 300 mg/kg/day (M), 300 mg/kg/day
                                          0, 30, 100, 300, or 1,000     (F) based on decreased body weight gain
                                           mg/kg/day.                   and increased relative liver weight
                                                                        (both sexes) and increased cholesterol
                                                                        and triglycerides and decreased red cell
                                                                        counts and hemoglobin in males
-----------------------------------------
870.4300                                  42178314, 43210501,          NOAEL = 138 mg/kg/day (M), 35.1 mg/kg/day
Chronic/Carcinogenicity--rats...........   43210502, 43210503 (1991)    (F)
                                           Acceptable/guideline        LOAEL = not established in males, 182.7
                                          0, 120, 600, or 3,000 ppm..   mg/kg/day (F) based on decreases in body
                                          M: 0, 5.42, 27.31, or 138.0   weight gain
                                           mg/kg/day.                  No evidence of carcinogenicity
                                          F: 0, 7.04, 35.1, or 182.7
                                           mg/kg/day.
-----------------------------------------
870.4200                                  42178310 (1991) Acceptable/  NOAEL = 84 mg/kg/day (M), 109.5 mg/kg/day
Carcinogenicity--mice...................   guideline                    (F)
                                          0, 120, 600, or 3,000 ppm..  LOAEL = 420 mg/kg/day (M), 547 mg/kg/day
                                          M: 0, 16.8, 84.0, or 420 mg/  (F) based on renal lesions (M) and (F)
                                           kg/day.                     No evidence of carcinogenicity
                                          F: 0, 21.9, 109.5, or 547
                                           mg/kg/day.
-----------------------------------------
870.5265                                  44503506 (1995) Acceptable/  Non-mutagenic when tested up to 5,000
Gene mutation...........................   guideline                    micrograms (mg)/plate or cytotoxic
                                                                        levels, in presence and absence of
                                                                        activation; in S. typhimurium strains
                                                                        TA98, TA100, TA1535, and TA1537; and in
                                                                        E.coli strain WP2uvra with 2-OH-PY
                                                                        (metabolite of pyriproxyfen).
-----------------------------------------
870.5265                                  44503507 (1993) Acceptable/  Non-mutagenic when tested up to 5,000 mg/
Gene mutation...........................   guideline                    plate or cytotoxic levels, in presence
                                                                        and absence of activation; in S.
                                                                        typhimurium strains TA98, TA100, TA1535,
                                                                        and TA1537; and in E.coli strain WP2uvra
                                                                        with 4'--OH-PY, 5'--OH-PYR, DPH-PYR,
                                                                        POPA, and PYPAC (metabolites of
                                                                        pyriproxyfen).
-----------------------------------------
870.5265                                  44503508 (1995) Acceptable/  Non-mutagenic when tested up to 5,000 mg/
Gene mutation...........................   guideline                    plate or cytotoxic levels, in presence
                                                                        and absence of activation; in S.
                                                                        typhimurium strains TA98, TA100, TA1535,
                                                                        and TA1537; and in E.coli strain WP2uvra
                                                                        with 2,5-OH-PY (metabolite of
                                                                        pyriproxyfen).
-----------------------------------------
870.5265                                  42178315 (1988) Acceptable/  Non-mutagenic when tested up to 5,000 mg/
Gene mutation...........................   guideline                    plate or cytotoxic levels, in presence
                                                                        and absence of activation; in S.
                                                                        typhimurium strains TA98, TA100, TA1535,
                                                                        TA1537, and TA1538; and in E.coli strain
                                                                        WP2uvra with 2-OH-PY (pyriproxyfen
                                                                        technical).
-----------------------------------------
870.5300                                  42178316 (1990) Acceptable/  Non-mutagenic at the HGPRT locus in
Gene mutation...........................   guideline                    Chinese hamster lung V79 cells tested up
                                                                        to cytotoxic concentrations or limit of
                                                                        solubility, in presence and absence of
                                                                        activation.
-----------------------------------------
870.5375                                  41321722 (1989) Acceptable/  Did not induce structural chromosome
Chromosome aberration...................   guideline                    aberration in Chinese hamster ovary
                                                                        (CHO) cell cultures in the absence or
                                                                        presence of activation.
-----------------------------------------
870.5550                                  42178317 (1988) Acceptable/  There was no evidence that unscheduled
Unscheduled DNA synthesis...............   guideline                    DNA synthesis, as determined by
                                                                        radioactive tracer procedures (nuclear
                                                                        silver grain counts) was induced in HeLa
                                                                        cells exposed up to cytotoxic levels,
                                                                        both in the presence or absence of S-9.
-----------------------------------------
870.7485Metabolism and pharmacokinetics-- 42178318 (1988) Acceptable/  Rats were orally dosed with \14\C-labeled
  rat                                      guideline                    pyriproxyfen at 2 or 1,000 mg/kg and at
                                                                        repeated oral doses (14 daily doses) of
                                                                        unlabeled pyriproxyfen at 2 mg/kg
                                                                        followed by administration of a single
                                                                        oral dose of labeled pyriproxyfen at 2
                                                                        mg/kg. Most radioactivity was excreted
                                                                        in the feces (81-92%) and urine (5-12%)
                                                                        over a 7 day collection period. Expired
                                                                        air containing CO2 was not detected.
                                                                        Tissue radioactivity levels were very
                                                                        low (less than 0.3%) except for fat.
                                                                        Examination of urine, feces, liver,
                                                                        kidney, bile, and blood metabolites
                                                                        yielded numerous (> 20) identified
                                                                        metabolites when compared to synthetic
                                                                        standards. The major biotransformation
                                                                        reactions of pyriproxyfen include:
                                                                       1. Oxidation of the 4'-- position of the
                                                                        terminal phenyl group.
                                                                       2. Oxidation at the 5'--position of
                                                                        pyridine.
                                                                       3. Cleavage of the ether linkage and
                                                                        conjugation of the resultant phenols
                                                                        with sulfuric acid.
----------------------------------------------------------------------------------------------------------------


[[Page 10976]]

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for 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 factors 
(SF) is retained due to concerns unique to the FQPA, this additional 
factor is applied to the RfD by dividing the RfD by such additional 
factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is 
a modification of the RfD to accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    A summary of the toxicological endpoints for pyriproxyfen used for 
human risk assessment is shown in Table 2 of this unit:

     Table 2.--Summary of Toxicological Dose and Endpoints for pyriproxyfen for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk       FQPA SF and LOC for    Study and Toxicological
          Exposure Scenario                 Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary                          None                     None                     An appropriate endpoint
females 13-50 years old and general                                                       attributable to a
 population.                                                                              single oral dose was
                                                                                          not available in the
                                                                                          data base, including
                                                                                          maternal toxicity in
                                                                                          the developmental
                                                                                          toxicity studies.
--------------------------------------
Chronic Dietary                        NOAEL= 35.1 mg/kg/day    FQPA SF = 1X             Subchronic toxicity and
all populations......................  UF = 100...............  cPAD = cRfD / FQPA SF =   chronic toxicity
                                       Chronic RfD = 0.35 mg/    0.35 mg/kg/day.          (feeding)--rat
                                        kg/day.                                          (co-critical)
                                                                                         LOAEL = 141.28 mg/kg/
                                                                                          day based on decreased
                                                                                          body weight and
                                                                                          clinical pathology
                                                                                          results.
--------------------------------------
Short-Term Incidental, Oral (1-30      Oral Maternal NOAEL =    LOC for MOE = 100        Rat developmental
 days)                                  100 mg/kg/day                                     toxicity study
Residential..........................                                                    Maternal LOAEL = 300 mg/
                                                                                          kg/day based on
                                                                                          decreased body weight,
                                                                                          body weight gain, and
                                                                                          food consumption, and
                                                                                          increased water
                                                                                          consumption
--------------------------------------
Intermediate-Term Incidental, Oral (1- Oral NOAEL = 35.1 mg/kg/ LOC for MOE = 100        Subchronic toxicity and
 6 months)                              day                                               chronic toxicity
Residential..........................                                                     (feeding)--rat
                                                                                         (co-critical)
                                                                                         LOAEL = 141.28 mg/kg/
                                                                                          day based on decreased
                                                                                          body weight and
                                                                                          clinical pathology
                                                                                          results.
--------------------------------------
Short-, and Intermediate-Term Dermal   None                     None                     Based on the systemic
 (1-30 days and 1-6 months)                                                               toxicity NOAEL of
(Occupational/Residential)...........                                                     1,000 mg/kg/day (limit
                                                                                          dose) in the 21 day
                                                                                          dermal toxicity study
                                                                                          in rats,
                                                                                          quantification of
                                                                                          dermal risks is not
                                                                                          required. In addition,
                                                                                          no developmental
                                                                                          concerns (toxicity)
                                                                                          were seen in either
                                                                                          rats or rabbits.
--------------------------------------
Long-Term Dermal (6 months-lifetime)   Oral NOAEL= 35.1 mg/kg/  LOC for MOE = 100        Subchronic and chronic
(Occupational/Residential)...........   day (dermal absorption                            toxicity (feeding)--
                                        rate = 30%)                                       rat
                                                                                         (co-critical)
                                                                                         LOAEL = 141.28 mg/kg/
                                                                                          day based decreased
                                                                                          body weight and
                                                                                          clinical pathology
                                                                                          results
--------------------------------------
Short-, and Intermediate-Term          None                     None                     Based on the absence of
 Inhalation (1-30 days and 1-6                                                            significant toxicity
 months)                                                                                  at the LOAEL of 1.0 mg/
(Occupational/Residential)...........                                                     L (limit dose), the
                                                                                          quantification of
                                                                                          inhalation risks is
                                                                                          not required. In
                                                                                          addition, no
                                                                                          developmental concerns
                                                                                          (toxicity) were seen
                                                                                          in either rats or
                                                                                          rabbits.
--------------------------------------
Long-Term Inhalation (6 months-        Oral study NOAEL= 35.1   LOC for MOE = 100        Subchronic and chronic
 lifetime)                              mg/kg/day                                         toxicity (feeding)--
(Occupational/Residential)...........  (inhalation absorption                             rat
                                        rate = 100%).                                    (co-critical)
                                                                                         LOAEL = 141.28 mg/kg/
                                                                                          day based on decreased
                                                                                          body weight and
                                                                                          clinical pathology
                                                                                          results
--------------------------------------

[[Page 10977]]

 
Cancer (oral, dermal, inhalation)      Cancer classification    Risk Assessment not      No evidence of
                                        (``Group E'')            required                 carcinogenicity
----------------------------------------------------------------------------------------------------------------
\1\ UF = uncertainty factor, FQPA SF = Food Quality Protection Act 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
\*\ The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.510) for the residues of pyriproxyfen, in or on 
a variety of raw agricultural commodities. 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. An aRfD for females 13-50 years old and the general 
population, including infants and children, was not selected because an 
acute oral endpoint attributed to a single-dose exposure could not be 
identified in any of the toxicology data base, including maternal 
toxicity in the developmental toxicity studies. Thus, the risk from 
acute exposure is considered negligible.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model software with the Food 
Commodity Intake Database (DEEM-FCID\TM\), version 1.3 analysis 
evaluated the individual food consumption as reported by respondents in 
the United States Department of Agricluture (USDA) 1994-1996 and 1998 
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:
    a. A tier 1 (assumptions: Tolerance level residues and 100 percent 
crop treated (PCT) was conducted.
    b. The established tolerances of 40 CFR 180.510 and the new 
tolerances established in this document were included in the analysis.
    c. Anticipated residues and PCT were not used in this analysis.
    d. The processing factors applied were the DEEM default values.
    For chronic dietary risk, EPA's level of concern is >100% cPAD. 
Dietary exposure estimates for representative population subgroups are 
presented in Table 3 of this unit. The results of the chronic analysis 
indicate that the estimated chronic dietary risk associated with the 
existing and EPA-recommended uses of pyriproxyfen is below EPA's level 
of concern.

     Table 3.--Summary of Results from Chronic DEEM\TM\ Analysis of
                              Pyriproxyfen
------------------------------------------------------------------------
                                                  Exposure
                   Subgroup                     (mg/kg/day)     % cPAD
------------------------------------------------------------------------
U.S. Population (total)                            0.003836          1.1
-----------------------------------------------
All Infants (< 1 year old)                         0.006852          2.0
-----------------------------------------------
Children 1-2 years old                             0.013707          3.9
-----------------------------------------------
Children 3-5 years old                             0.010107          2.9
-----------------------------------------------
Children 6-12 years old                            0.005969          1.7
-----------------------------------------------
Youth 13-19 years old                              0.003389          1.0
-----------------------------------------------
Adults 20-49 years old                             0.002658          0.8
-----------------------------------------------
Females 13-49 years old                            0.002702          0.8
-----------------------------------------------
Adults 50+ years old                               0.002676          0.8
------------------------------------------------------------------------


    iii. Cancer. In accordance with the Agency's 1986 Guidelines for 
Carcinogenic Risk Assessment, the RfD/Peer Review Committee classified 
pyriproxyfen as a ``Group E'' chemical-negative for carcinogenicity to 
humans. This classification is based on the lack of evidence of 
carcinogenicity in mice and rats.
    iv. Anticipated residue and PCT information. Anticipated residues 
and PCT information was not used in the Agency's assessment.
    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 
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.

[[Page 10978]]

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 in Unit III.E.
    Pyriproxyfen is relatively long-lived in soil and water, with 
variable half-lives of approximately 2 weeks to 2 months. Pyriproxyfen 
is immobile, as indicated by the relative mobility scheme in Dragun 
(1998) for five soils and one sediment. The registrant determined the 
half-lives, 6.8 and 9 days, respectively, for the phenyl-label and 
pyridyl-label portions of pyriproxyfen. Since there is only one value, 
the longest half-life (9 days) was multiplied by 3 using EFED input 
guidance. Thus, the aerobic soil half-life in the modeling assessment 
was 27 days.
    EPA determined that the residue of concern in water is pyriproxyfen 
per se. Drinking water estimates include surface water EDWCs based on 
the linked PRZM/EXAMS models and the SCI-GROW groundwater regression 
model, which was developed from studies with different hydrology and 
study conditions. Both models assumed a maximum seasonal application 
rate of 0.11 lb active ingredient (ai)/acre (A), 3 times per year 
(citrus and stone fruit).
    Based on the PRZM/EXAMS model the EECs of pyriproxyfen for surface 
water was estimated to be 2.15 parts per billion (ppb) for the peak 
concentration, and 0.40 ppb for the long term average. Based on the 
SCI-GROW model the EECs of pyriproxyfen for groundwater was estimated 
to be 0.006 ppb for both the acute and chronic exposure.
    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: Flea and tick control (home environment 
and pet treatments) as well as products for ant and roach control 
(indoor and outdoor applications). Formulations include carpet powders, 
foggers, aerosol sprays, liquids (shampoos, sprays, and pipettes for 
pet treatments), granules, bait (indoor and outdoor), and impregnated 
materials (pet collars). There is a potential for short-term dermal and 
inhalation exposures to pet owners and homeowners who apply products 
containing pyriproxyfen (handlers); however, EPA did not select short-
term dermal or inhalation endpoints. Therefore, due to the lack of 
toxicity observed in animal testing, no residential pet owner/homeowner 
handler risk of concern is expected.
    Toddlers could potentially be exposed to pyriproxyfen residues on 
treated carpets, floors, furniture, and pets. There is potential for 
exposure expected for the following scenarios:
    i. Hand-to-mouth. Short-, intermediate-, and long-term hand-to-
mouth exposures by toddlers from treated carpets, flooring (note the 
efficacy of carpet powders is approximately 365 days).
    ii. Hand-to-mouth. Short- and intermediate-term hand-to-mouth 
exposures by toddlers from petting treated animals (shampoos, sprays, 
spot-on treatments, and collars). Long-term hand-to-mouth exposures by 
toddlers from petting treated animals (pet collars; note efficacy of 
pet collars up to 395 days).
    iii. Dermal. Long-term dermal exposures from treated carpets, 
flooring, and pets (note that treated furniture is included in the 
carpet/flooring assessment). Due to the lack of toxicity observed in 
animal testing, the Agency did not select any short- or intermediate-
term dermal endpoints and no dermal risk of concern for these durations 
is expected. A long-term dermal assessment is included, since EPA 
selected a long-term dermal endpoint.
    iv. Ingestion of granules or bait by toddlers (acute, episodic 
event). For the granular ingestion scenario, it should be noted that 
the Agency believes that if a toddler were to be exposed to a pellet/
granular formulation (i.e., ant bait), the event is most likely to be 
``episodic,'' that is, a one-time occurrence and not likely to be 
repeated. It is not likely that a toddler would repeatedly locate and 
ingest very small, sand colored granules. For pyriproxyfen, EPA did not 
select an acute dietary endpoint, since an appropriate endpoint could 
not be attributed to a single-oral dose; therefore, no acute dietary 
risk of concern is expected.
    Exposure and risk estimates from post-application exposure to 
indoor crack and crevice treatments are not presented in this 
assessment, as indoor broadcast treatments (i.e., carpet powders and 
sprays) are anticipated to have a higher exposure potential. 
Additionally, the Agency acknowledges that pet owners could retreat the 
home environment and/or the pet near the end of the efficacy period 
identified on the product labels. However, there are no chemical-
specific residue data for pyriproxyfen to determine the dissipation 
rate of residues or whether residues may be additive upon retreatment. 
Therefore, a tier 1 assessment was performed based on day 0 residues 
without accounting for daily residue dissipation. EPA anticipates that 
this assessment is protective as pyriproxyfen residues would be 
expected to dissipate from day 0 residue values.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA 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).

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA 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 MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.

[[Page 10979]]

    2. Prenatal and postnatal sensitivity. Based on the available data, 
there is no quantitative and qualitative evidence of increased 
susceptibility observed following in utero pyriproxyfen exposure to 
rats and rabbits or following pre/postnatal exposure in the 2-
generation reproduction study.
    3. Conclusion. There is a complete toxicity data base for 
pyriproxyfen and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the 10X safety factor to protect infants and children should be 
reduced to 1X because there was no evidence of prenatal or postnatal 
extra sensitivity or increased susceptibility in developmental studies 
in rats and rabbits, and in reproduction studies in rats. Likewise, 
there was no quantitative or qualitative evidence of increased 
susceptibility to rat or rabbit fetuses identified in the guideline 
prenatal developmental toxicity studies for rats and rabbits. 
Additionally, in the two non-guideline studies that evaluated perinatal 
and prenatal development, there was no evidence of quantitative or 
qualitative increased susceptibility. In one study, when pregnant rats 
were treated from gestation day 17 to lactation day 20, the resulting 
toxicity was comparable between adults (clinical signs, decreased body 
weight gain and food consumption) and offspring (decreased body weight 
and dilation of the renal pelvis) at the same dose. In the other study, 
when rats were exposed to pyriproxyfen prior to and in the early stages 
of pregnancy, no developmental toxicity was seen at the limit dose. 
Lastly, in the reproduction toxicity study, offspring toxicity 
(decreased body weight on pups during lactation days 14 to 21) occurred 
only in the presence of decreases in body weight in parental animals at 
the same dose level (i.e., comparable toxicity in adults and 
offspring).

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's estimated environmental concentration in water (EECs). 
DWLOC values are not regulatory standards for drinking water. DWLOCs 
are theoretical upper limits on a pesticide's concentration in drinking 
water in light of total aggregate exposure to a pesticide in food and 
residential uses. In calculating a DWLOC, the Agency determines how 
much of the acceptable exposure (i.e., the PAD) is available for 
exposure through drinking water (e.g., allowable chronic water exposure 
(mg/kg/day) = cPAD - (average food + residential exposure)). This 
allowable exposure through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the EPA Office of Water are used to calculate DWLOCs: 
2 L/70 kg (adult male), 2 L/60 kg (adult female), and 1 L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. An acute dietary RfD for females 13-49 and the 
general U.S. population, including infants and children, was not 
selected because an acute oral endpoint attributable to a single-dose 
exposure could not be identified in the toxicology data base, including 
maternal toxicity in the developmental toxicity studies. No acute 
dietary risk is expected.
    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 1.1% of the cPAD for the U.S. 
population, 2.0% of the cPAD for all infant,s and 3.9% of the cPAD for 
children 1-2 years old. Pyriproxyfen is the active ingredient in many 
registered residential products for flea and tick control on pets and 
in the home for ant and roach control for indoor and outdoor 
applications. Based on the use pattern, the residential assessment was 
performed for toddlers since they are anticipated to have the higher 
chronic residential exposure to residues of pyriproxyfen. The total 
chronic food and residential aggregate MOEs range from 850 to 13,000. 
As these MOEs are greater than 100, the chronic aggregate risk does not 
exceed EPA's level of concern. In addition, there is potential for 
chronic dietary exposure to pyriproxyfen in drinking water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD, as shown in Table 4 of this unit:

              Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Pyriproxyfen
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
        Population Subgroup           Aggegate MOE  (Food +    Target MOE   Water EEC    Water EEC     Chronic
                                           Residential)                       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                        9,200          100         0.40        0.006       12,000
====================================
All infants                                            1,000          100         0.40        0.006        3,200
====================================
Children 1-2 years old                                   860          100         0.40        0.006        3,100
====================================
 Children 3-5 years old                                  940          100         0.40        0.006       10,000
----------------------------------------------------------------------------------------------------------------



[[Page 10980]]

    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).
    Pyriproxyfen is currently registered for use that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for pyriproxyfen.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 26,000 for the U.S. population, 
1,800 for all infants(<1 year old), and 1,600 for children (1-2 years 
old). These aggregate MOEs do not exceed the Agency's level of concern 
for aggregate exposure to food and residential uses. In addition, 
short-term DWLOCs were calculated and compared to the EECs for chronic 
exposure of pyriproxyfen in ground and surface water. After calculating 
DWLOCs and comparing them to the EECs for surface and ground water, EPA 
does not expect short-term aggregate exposure to exceed the Agency's 
level of concern, as shown in Table 5 of this unit:

                   Table 5.--Aggregate Risk Assessment for Short-Term Exposure to Pyriproxyfen
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
        Population Subgroup           Aggregate MOE  (Food +   Target MOE   Water EEC    Water EEC    Short-Term
                                           Residential)                       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                       26,000          100         0.40        0.006       35,000
====================================
All infants (<1 year old                               1,800          100         0.40        0.006        9,400
====================================
Children (1-2 years old)                               1,600          100         0.40        0.006        9,400
====================================
Females (13-49 years old)                             37,000           00         0.40        0.006       30,000
----------------------------------------------------------------------------------------------------------------


    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Pyriproxyfen is currently registered for use(s) that could result 
in intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and 
intermediate-term exposures for pyriproxyfen.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food and 
residential exposures aggregated result in aggregate MOEs of 9,200 for 
the U.S. population, 650 for all infants (<1 year old, and 580 for 
children (1-2 years old). These aggregate MOEs do not exceed the 
Agency's level of concern for aggregate exposure to food and 
residential uses. In addition, intermediate-term DWLOCs were calculated 
and compared to the EECs for chronic exposure of pyriproxyfen in ground 
and surface water. After calculating DWLOCs and comparing them to the 
EECs for surface and ground water, EPA does not expect intermediate-
term aggregate exposure to exceed the Agency's level of concern, as 
shown in Table 6 of this unit:

               Table 6.--Aggregate Risk Assessment for Intermediate-Term Exposure to Pyriproxyfen
----------------------------------------------------------------------------------------------------------------
                                                                           Surface       Ground    Intermediate-
       Population Subgroup          Aggregate MOE  (Food +   Target MOE   Water EEC    Water EEC     Term DWLOC
                                         Residential)                       (ppb)        (ppb)         (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                      9,200          100         0.40        0.006        12,000
----------------------------------
All infants (<1 year old)                              650          100         0.40        0.006         3,000
----------------------------------
Children (1-2 years old)                               580          100         0.40        0.006         3,000
----------------------------------
Females (13-49 years old)                           13,000          100         0.40        0.006        10,000
----------------------------------------------------------------------------------------------------------------


    5. Aggregate cancer risk for U.S. population. There was no evidence 
of carcinogenicity in a 78-week mouse feeding study and a 2-year rat 
feeding study. Pyriproxyfen was classified as a ``Group E'' chemical 
(no evidence of carcinogenicity to humans) by the Agency based on the 
absence of evidence of carcinogenicity in male and female rats as well 
as in male and female mice.
    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.

IV. Other Considerations

A. Analytical Enforcement Methodology

    In conjunction with the residue studies on cabbage, cauliflower, 
mustard greens, cantaloupe, cucumber, summer squash, olive, okra, and 
sugar apple, the petitioner submitted adequate concurrent recovery data 
for a gas chromatography/nitrogen phosphorous detector (GC/NPD) method 
(RM-33P-1-3a) used to determine residues of pyriproxyfen in/on these 
crops. The method has undergone an adequate radiovalidation, 
independent laboratory validation (ILV) trial, petition method 
validation (PMV) trial, and has been forwarded to the Food and Drug 
Administration (FDA) for inclusion in Pesticide Analytical Method (PAM) 
Vol. II (DP Barcode D257337, W. Donovan, 7/1/99). HED concludes that 
the GC/NPD method RM-33P-1-3a is adequate for enforcement of the 
recommended

[[Page 10981]]

tolerance levels for residues of pyriproxyfen per se in/on Brassica 
leafy vegetables, cucurbit vegetables, olive, okra, sugar apple, 
cherimoya, atemoya, custard apple, ilama, soursop, birba, fig, avocado, 
papaya, star apple, black sapote, mango, sapodilla, canistel, and mamey 
sapote. As tolerances for residues of pyriproxyfen in livestock 
commodities are not required at this time, enforcement methodology for 
determining residues in livestock are not required.
    MRM testing data have previously been provided (PP6F04737, 
DP Barcode D228556, J. Garbus, 5/6/97) for pyriproxyfen. Pyriproxyfen 
was recovered from fortified apple and cotton samples through protocols 
A, C, D, E, and F. The results have been forwarded to FDA.
    Adequate enforcement methodology (example--gas chromotography) is 
available to enforce the tolerance expression. The method may be 
requested from: Francis Griffith, Analytical Chemistry Branch, 
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; 
telephone number: (410) 305-2905; e-mail address: 
[email protected].

B. International Residue Limits

    There are no Codex, Canadian, or Mexican maximum residue limits 
(MRLs) for residues of pyriproxyfen in/on any of the crops involved in 
the proposed new uses. Therefore, international harmonization is not an 
issue at this time.

V. Conclusion

    Therefore, the tolerances are established for residues of 
pyriproxyfen, [2-[1-methyl-2-(4-phenoxyphenoxy)ethoxy]pyridine], in or 
on Brassica, head and stem, subgroup 5A; Brassica, leafy greens, 
subgroup 5B; vegetable, cucurbit, group 9; olive and olive, oil at 
0.70, 2.0, 0.10, 1.0, and 2.0 ppm.respectively.

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, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA 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) 
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. 
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 ID number OPP-2002-0345 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 May 6, 
2003.
    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 (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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 
(703) 603-0061.
    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 telephone at (703) 305-5697, by e-mail at 
[email protected], or by mailing a request for information to: Mr. 
Tompkins, Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001.
    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 20460-0001.
    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.1. Mail your 
copies, identified by docket ID number OPP-2002-0345, 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-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. 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

[[Page 10982]]

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. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, 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 section 408(n)(4) of the FFDCA. 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.

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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


    Dated: February 24, 2003.
Debra Edwards,
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 commodities 
to the table in paragraph (a)(1) to read as follows:


Sec.  180.510  Pyriproxyfen; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Brassica, head and stem, subgroup 5A.......................         0.70
Brassica, leafy greens, subgroup 5B........................          2.0
                                * * * * *
Olive......................................................          1.0
Olive, oil.................................................          2.0
                                * * * * *
Vegetable, cucurbit, group 9...............................         0.10
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 03-5478 Filed 3-6-03; 8:45 am]
BILLING CODE 6560-50-S