[Federal Register Volume 66, Number 50 (Wednesday, March 14, 2001)]
[Rules and Regulations]
[Pages 14852-14861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6330]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301103; FRL-6766-6]
RIN 2070-AB78


Pyriproxyfen; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for residues of the 
insecticide, pyriproxyfen [2-[1-methyl-2-(4-
phenoxyphenoxy)ethoxy]pyridine] in or on all food items in food 
handling establishments where food and food products are held, 
processed and/or prepared at 0.1 ppm. McLaughlin Gormley King Company 
requested this tolerance under the Federal Food, Drug, and Cosmetic 
Act, as amended by the Food Quality Protection Act of 1996.

DATES: This regulation is effective March 14, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301103, 
must be received by EPA on or before May 14, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301103 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Joseph Tavano, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-6411; 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

[[Page 14853]]

categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                 Examples of Potentially
             Categories                 NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                    111  Crop production
                                            112  Animal production
                                            311  Food manufacturing
                                          32532  Pesticide manufacturing
------------------------------------------------------------------------

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

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

    1. Electronically.You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'', ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40tab_00.html, a 
beta site currently under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301103. 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 February 29, 2000 (65 FR 16608) (FRL-
6493-8), 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) for tolerance by 
McLaughlin Gormley king Company, 8810 Tenth Avenue North, Minneapolis, 
MN 55427-4372. This notice included a summary of the petition prepared 
by McLaughlin Gormley King Company, 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)ethoxy]pyridine], in or on food 
commodities at 0.5 part per million (ppm).
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (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 pyriproxyfen on all food 
items in food handling establishments where food and food products are 
held, processedand/or prepared at 0.1 ppm. EPA's assessment of 
exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile

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

[[Page 14854]]



                               Table 1.-- Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity        NOAEL = 23.49 mg/kg/day in males and 27.68
                                          rodents                     mg/kg/day in females
                                                                     LOAEL = 117.79 mg/kg/day in males and
                                                                      141.28 mg/kg/day in females based on
                                                                      higher mean total cholesterol and
                                                                      phospholipids, decreased mean RBCs,
                                                                      hematocrit and hemoglobin counts and
                                                                      increased relative liver weight.
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day oral toxicity in     NOAEL = 100 mg/kg/day
                                          dogs
                                                                     LOAEL = 300 mg/kg/day based on increased
                                                                      absolute and relative liver weight in
                                                                      males and hepatocellular hypertrophy in
                                                                      females. These findings were also observed
                                                                      at 1000 mg/kg/day and may represent
                                                                      adaptive changes at both 300 mg/kg/day and
                                                                      the limit dose of 1000 mg/kg/day .
----------------------------------------------------------------------------------------------------------------
870.3200                                 21-Day dermal toxicity in   NOAEL = >1,000 mg/kg/day for systemic
                                          rats                        effects limit dose.
                                                                     LOAEL = for systemic effects was not
                                                                      established in this study. No dermal or
                                                                      systemic toxicity at the limit dose.
----------------------------------------------------------------------------------------------------------------
870.3700a                                Prenatal developmental in   Maternal NOAEL = 100 mg/kg/day
                                          rats
                                                                     LOAEL = 300 mg/kg/day based on increased
                                                                      incidences in mortality and clinical signs
                                                                      at 1,000 mg/kg/day with decreases in food
                                                                      consumption, body weight, and body weight
                                                                      gain together with increases in water
                                                                      consumption at 300 and 1,000 mg/kg/day .
                                                                     Developmental NOAEL = 300 mg/kg/day
                                                                     LOAEL = 1,000 mg/kg/day based on increased
                                                                      incidences of skeletal variations and
                                                                      unspecified visceral variations at 1,000
                                                                      mg/kg/day.
----------------------------------------------------------------------------------------------------------------
870.3700b                                Prenatal developmental in   Maternal NOAEL = 100 mg/kg/day
                                          rabbits
                                                                     LOAEL = 300 mg/kg/day based on based on
                                                                      premature delivery/abortions, soft stools,
                                                                      emaciation, decreased activity and
                                                                      bradypnea.
                                                                     Developmental NOAEL = 300 mg/kg/day
                                                                     LOAEL: only 4 litters examined at 1,000 mg/
                                                                      kg/day [HDT] without effects.
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  Parental/Systemic NOAEL = 1,000 mg/kg/day
                                          effects
                                                                     LOAEL = 5,000 mg/kg/day based on based on
                                                                      decreased body weight, weight gain and
                                                                      food consumption in both sexes and both
                                                                      generations. Increased liver weight in
                                                                      both sexes of the F1 generation and liver
                                                                      and kidney histopathology in F1 males.
                                                                     Reproductive NOAEL = 5,000 ppm [HDT].
                                                                     Offspring NOAEL = 1,000 ppm.
                                                                     LOAEL = 5,000 ppm based on decreased pup
                                                                      body weight on lactation days 14 and 21.
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity dogs       NOAEL = 100 mg/kg/day
                                                                     LOAEL = 300 mg/kg/day based on based on
                                                                      decreased weight gain, increased absolute
                                                                      and relative liver weight, mild anemia,
                                                                      increased cholesterol and triglycerides in
                                                                      both sexes and slight anemia in males.
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity mice        NOAEL = 600 ppm
----------------------------------------------------------------------------------------------------------------
                                                                     LOAEL = 3,000 ppm based on renal lesions in
                                                                      both sexes. No statistically significant
                                                                      increase in tumor incidence relative to
                                                                      controls were observed in either sex at
                                                                      any dose up to 3,000 ppm [HDT].
870.4300                                 2-Year Chronic Feeding/     NOAEL = 35.1 mg/kg/day for females and >138
                                          Oncogenicity rats           mg/kg/day for males. LOAEL = 182.7 mg/kg/
                                                                      day for females based on decrease of 16.9%
                                                                      in body weight gain at 3,000 ppm. No
                                                                      evidence of carcinogenic response.
----------------------------------------------------------------------------------------------------------------
870.5100 and 870.5265                    Gene Mutation Assay(Ames    Negative for induction of gene mutation
                                          Test)/Reverse Mutation      measured as the reversion to histidine
                                                                      protrophy of 5 S. typhimurium strains and
                                                                      E. Coli WP2 uvra at doses from 10 to 5,000
                                                                      g/plate with and without S-9
                                                                      activation. The highest dose was
                                                                      insoluble.
----------------------------------------------------------------------------------------------------------------
870.5300                                 Gene Mutation Assay          Negative for mutagenicity in Chinese
                                          Mammalian Cells             hamster V79 cells with and without
                                                                      metabolic activation up to cytotoxic doses
                                                                      [300 g/mL].
----------------------------------------------------------------------------------------------------------------
870.5380                                 Structural Chromosomal      Nonclastogenic in Chinese hamster ovary
                                          Aberration Assay In vivo    cells both with and without S-9 activation
                                          cytogenetics                up to cytotoxic doses [300 g/mL].
----------------------------------------------------------------------------------------------------------------

[[Page 14855]]

 
870.5550                                 Other Genotoxicity Assays   Did not induce an increase in unscheduled
                                          (Unscheduled DNA            DNA synthesis both with and without
                                          Synthesis in HeLa cells)    activation in HeLa cells exposed up to
                                                                      insoluble doses ranging to 6.4 g/
                                                                      mL [without activation] and 51.2 g/mL [with activation].
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism                  Rats were orally dosed with 14C-labeled
                                                                      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 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.
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

    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 LOAEL is sometimes used for risk assessment 
if no NOAEL was achieved in the toxicology study selected. An 
uncertainty factor (UF) is applied to reflect uncertainties inherent in 
the extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1  x  10-\6\ or one in a 
million). Under certain specific circumstances, MOE calculations will 
be used for the carcinogenic risk assessment. In this non-linear 
approach, a ``point of departure'' is identified below which 
carcinogenic effects are not expected. The point of departure is 
typically a NOAEL based on an endpoint related to cancer effects though 
it may be a different value derived from the dose response curve. To 
estimate risk, a ratio of the point of departure to exposure 
(MOEcancer = point of departure/exposures) is calculated. A 
summary of the toxicological endpoints for pyriproxyfen used for human 
risk assessment is shown in the following Table 2:

    Table 2.-- Summary of Toxicological Dose and Endpoints for pyriproxyfen for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population       Not Applicable           Not Applicable           There were no effects
 including infants and children                                                           that could be
                                                                                          attributed to a single
                                                                                          exposure (dose) in
                                                                                          oral toxicity studies
                                                                                          including the
                                                                                          developmental toxicity
                                                                                          studies in rats and
                                                                                          rabbits.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL = 35.1 mg/kg/day;  FQPA SF = 1; cPAD =      Combined/chronic
                                        UF = 100; Chronic RfD    0.35/1 = 0.35 mg/kg/     toxicity - rat: LOAEL
                                        = 0.35 mg/kg/day         day                      = 182.7 mg/kg/day
                                                                                          based on decreased
                                                                                          weight gain in female
                                                                                          rats.
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (several months to    NOAEL= 35.1 mg/kg/day    LOC for MOE = 100        Combined/chronic
 lifetime) (Residential)                                                                  toxicity - rat: LOAEL
                                                                                          = 182.7 mg/kg/day
                                                                                          based on decreased
                                                                                          weight gain in female
                                                                                          rats.
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (several months   NOAEL= 35.1 mg/kg/day    LOC for MOE = 100        Combined/chronic
 to lifetime) (Residential)                                                               toxicity - rat: LOAEL
                                                                                          = 182.7 mg/kg/day
                                                                                          based on decreased
                                                                                          weight gain in female
                                                                                          rats.
----------------------------------------------------------------------------------------------------------------

[[Page 14856]]

 
Cancer (oral, dermal, inhalation)      ``Group E'' human        Not Applicable           There is no evidence of
                                        carcinogen                                        carcinogenic
                                                                                          potential. Therefore,
                                                                                          a cancer risk
                                                                                          assessment is not
                                                                                          required.
----------------------------------------------------------------------------------------------------------------
\*\ The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns
  unique to the FQPA.

C. Exposure Assessment

    1.  Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.510 (a) for the residues of pyriproxyfen, in or 
on the following raw agricultural commodities: pome fruits (crop group 
11) (0.2 ppm), citrus fruits (crop group 10) (0.3 ppm), fruiting 
vegetables (except cucurbits) (crop group 8) (0.2 ppm), tree nuts (crop 
group 14) (0.02 ppm), cotton seed (0.05 ppm), cotton gin byproducts 
(2.0 ppm), almond hulls (2.0 ppm), citrus oil (20 ppm), and citrus 
pulp, dried (2.0 ppm). In todays action tolerances will be established 
for the residues of pyriproxyfen in or on all foods at 0.10 ppm as a 
result of the proposed use of pyriproxyfen in food handling 
establishments. Risk assessments were conducted by EPA to assess 
dietary exposures from pyriproxyfen in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure. An acute dose and endpoint was not selected for any 
population subgroup for pyriproxyfen. No effects that could be 
attributed to a single exposure (dose) were observed in oral toxicity 
studies including the developmental toxicity studies in rats and 
rabbits. A dose and endpoint were not identified for acute dietary risk 
assessment; therefore, the Agency concludes that there is a reasonable 
certainty of no harm from acute dietary exposure.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. A conservative analysis was conducted using 
published and recommended tolerance level residues and 100% crop 
treated assumptions for all commodities. No anticipated residues or 
percent crop treated estimates were used. The residue levels of all 
food commodities, except those with existing tolerances, were set at 
0.1 ppm. For commodities with tolerances greater than 0.1 ppm, existing 
tolerance level residues were employed. The cPAD for all population 
subgroups is 0.35 mg/kg/day. For chronic dietary risk estimates, HED's 
level of concern is for exposures >100% cPAD. Dietary exposure 
estimates for the U.S. population and other representative subgroups 
are presented in the following table 3:

 Table 3.--Summary of Results from Chronic DEEM Analysis of Pyriproxyfen
------------------------------------------------------------------------
                                                   Exposure
                    Subgroups                       (mg/kg/     %cPAD
                                                     day)
------------------------------------------------------------------------
U.S. Population (48 states)                        0.003258          0.9
------------------------------------------------------------------------
All infants (< 1 year)                             0.005538          1.6
------------------------------------------------------------------------
Children (1-6 years)                               0.008956          2.6
------------------------------------------------------------------------
Children (7-12 years)                              0.005229          1.5
------------------------------------------------------------------------
Females 13-50 yrs                                  0.002323          0.7
------------------------------------------------------------------------
Males 13-19 yrs                                    0.003158          0.9
------------------------------------------------------------------------
Males 20+ yrs                                      0.002228          0.6
------------------------------------------------------------------------
Seniors 55+                                        0.002233          0.6
------------------------------------------------------------------------

The population subgroups listed include those subgroups having 
sufficient numbers of survey respondents in the CSFII food consumption 
survey to be considered statistically reliable. The results show that 
chronic dietary exposure to pyriproxyfen residues from all existing and 
proposed uses do not exceed HED's level of concern of 100% cPAD. 
Refinement of residue estimates using %CT corrections and anticipated 
residue estimates would result in even lower residue estimates.
    2. Dietary exposure from drinking water. The Agency uses the 
Generic Estimated Environmental Concentration (GENEEC) or the Pesticide 
Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate 
pesticide concentrations in surface water and SCI-GROW, which predicts 
pesticide concentrations in groundwater. In general, EPA will use 
GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a 
screening-level assessment for surface water. The GENEEC model is a 
subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. GENEEC incorporates a farm pond scenario, 
while PRZM/EXAMS incorporate an index reservoir environment in place of 
the previous pond scenario. The PRZM/EXAMS model includes a percent 
crop area factor as an adjustment to account for the maximum percent 
crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to pyriproxyfen they are 
further discussed in the aggregate risk sections below.

[[Page 14857]]

    Based on the PRZM/EXAMS and SCI-GROW models the estimated 
environmental concentrations (EECs) of pyriproxyfen for acute exposures 
are estimated to be 0.11 parts per billion (ppb) for surface water and 
0.006 ppb for ground water. The EECs for chronic exposures are 
estimated to be 0.11 ppb for surface water and 0.006 ppb for ground 
water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Pyriproxyfen is currently registered for use in residential non-
dietary sites for flea and tick control. Formulations include contact 
sprays, emulsifiable concentrates, and impregnated materials (pet 
collars). With the exception of the pet collar uses, consumer use of 
pyriproxyfen typically results in short-term, intermittent exposures. 
Hence, chronic residential post-application exposure and risk 
assessments were conducted to estimate the potential risks from pet 
collar uses. The risk assessment was conducted using the following 
assumptions: application rate of 0.58 mg ai/day (product label), 
average body weight for a 1 to 6 year old child of 10 kg, the active 
ingredient dissipates uniformly through 365 days (the label instructs 
to change the collar once a year), and 1% of the active ingredient is 
available for dermal and inhalation exposure per day (assumption from 
Draft HED Standard Operating Procedures (SOPs) for Residential Exposure 
Assessments, 18-DEC-1997). The assessment also assumes an absorption 
rate of 100%. This is a conservative assumption since the dermal 
absorption was estimated to be 10% (HED Hazard Identification 
Assessment Review Committee, 24-OCT-1997). The following Table 4 shows 
residential exposure and risk Assessment for homeowner use of pet 
collars:

 Table 4.--Residential Exposure and Risk Assessment for Homeowner Use of
                               Pet Collars
------------------------------------------------------------------------
                                                     Average
                                                    Potential
                                       Application     Dose     Chronic
         Population Subgroup           Rate\1\ mg/   Rate\2\      Term
                                           day       (mg/kg/     MOE\3\
                                                       day)
------------------------------------------------------------------------
Children                                   0.58      0.00058      61,000
------------------------------------------------------------------------
Adults                                     0.58      0.000081   430,000
------------------------------------------------------------------------
\1\Product label: Reg. No. 2382-149 (0.5% pyriproxyfen, ovisterilant pet
  collar). Application rate = 42 gm collar  x  0.5% a.i./collar  x
  1,000 mg/1 gm  x  1/365 days. Collar to be replaced once a year.
\2\Potential Dose Rate (PDR) = Application rate  x  fraction of ai
  available for exposure (1%)  x  absorption rate(100%)  x  1/(10 or
  71.8 kg bw for children or adults, respectively) (Draft HED Standard
  Operating Procedures (SOPs) for Residential Exposure Assessments, 18-
  DEC-1997).
\3\Dermal and Inhalation NOAEL = 35.1 mg/kg/day; MOE = NOAEL/Exposure;
  Adequate MOE = 100.

The estimated chronic term MOE is 61,000 for children, and 430,000 for 
adults. The risk estimates indicate that potential risks from pet 
collar uses do not exceed HED's level of concern (MOEs < 100).
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether pyriproxyfen has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
pyriproxyfen does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that pyriproxyfen has a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. Safety factor for infants and children--i. In general. FFDCA 
section 408 provides that EPA shall apply an additional tenfold margin 
of safety for infants and children in the case of threshold effects to 
account for prenatal and postnatal toxicity and the completeness of the 
data base on toxicity and exposure unless EPA determines that a 
different margin of safety will be safe for infants and children. 
Margins of safety are incorporated into EPA risk assessments either 
directly through use of a margin of exposure (MOE) analysis or through 
using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk to humans.
    ii. Prenatal and postnatal sensitivity. The oral perinatal and 
prenatal data demonstrated no indication of increased sensitivity of 
rats or rabbits to in utero and postnatal exposure to pyriproxyfen.
    iii. Conclusion. The 10X safety factor to protect infants and 
children was reduced to 1x because (1) the toxicology data base is 
complete; (2) there is no indication of increased susceptibility of 
rats or rabbit fetuses to in utero and/or postnatal exposure in the 
developmental and reproductive toxicity studies; (3) a developmental 
neurotoxicity study is not required; (4) food exposure estimates are 
unrefined (assuming tolerance level residues and 100% CT) and likely 
result in an overestimate of the actual dietary exposure; (5) EFED 
models are used for ground and surface source drinking water exposure 
assessments resulting in conservative estimates of actual dietary 
exposures; and (6) the Draft Standard Operating Procedures for 
Residential Exposure Assessments have been used as the basis for all 
calculations which normally rely on one or more upper-percentile 
assumptions and are considered to be protective.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is

[[Page 14858]]

available for exposure through drinking water [e.g., allowable chronic 
water exposure (mg/kg/day) = cPAD - (average food + residential 
exposure)]. This allowable exposure through drinking water is used to 
calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and 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 dose and endpoint was not 
identified. Thus the risk from acute aggregate exposure is considered 
to be negligible.
    2. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has calculated that the maximum percentage of the 
cPAD that will be utilized by dietary (food) exposure to residues of 
pyriproxyfen is 2.6% percent for children (1-6 years). Chronic 
residential exposure to pyriproxyfen from pet collars is estimated to 
increase total pyriproxyfen exposure to infants and children only 
marginally. Despite the potential for exposure to pyriproxyfen in 
drinking water, EPA does not expect the aggregate exposure to exceed 
100% of the cPAD.
EPA bases this determination on a comparison of estimated 
concentrations of pyriproxyfen in surface and ground water to 
calculated drinking water levels of comparison. The estimates of 
pyriproxyfen in surface and ground water are derived from water quality 
models that use conservative assumptions regarding the pesticide 
transport from the point of application to surface and ground water. 
Because EPA considers the aggregate risk resulting from multiple 
exposure pathways associated with the pesticide's uses, levels of 
comparison in drinking water may vary as those uses change. If new uses 
are added in the future, EPA will reassess the potential impact of 
pyriproxyfen in food and drinking water as part of the aggregate 
chronic risk assessment process.
    The following table 5 summarizes the quantitative aspects of the 
aggregate risk assessment for chronic exposure to pyriproxyfen. For 
chronic exposure to pyriproxyfen in surface and ground water, the 
DWLOCs are 12,000 g/L for U.S. population and 3,400 
g/L for children (1-6 years). Estimated average concentrations 
of pyriproxyfen in surface and ground water are 0.11 ppb and 0.006 ppb, 
respectively. The estimated average concentrations of pyriproxyfen in 
surface and ground water are less than EPA's level of concern for 
pyriproxyfen in drinking water as a contribution to chronic aggregate 
exposure. Therefore, taking into account present uses and uses proposed 
in this action, EPA concludes that there is a reasonable certainty that 
no harm will result to any population subgroup from chronic aggregate 
exposure to pyriproxyfen residues.

Table 5.--Aggregate Risk Assessment for Chronic Exposure to Pyriproxyfen
------------------------------------------------------------------------
                              cPAD            Surface  Ground
                               mg/  Exposure   Water    Water   Chronic
     Population Subgroup       kg/   mg/kg/     EEC      EEC     DWLOC
                               day     day     (ppb)    (ppb)    (ppb)
------------------------------------------------------------------------
U.S. population - all         0.35  0.003258    0.11    0.006      12000
 seasons
------------------------------------------------------------------------
All Infants (<1 year)         0.35  0.005538    0.11    0.006       3400
------------------------------------------------------------------------
Children (1-6 years)          0.35  0.008956    0.11    0.006      3,400
------------------------------------------------------------------------
Children (7-12 years)         0.35  0.005229    0.11    0.006      3,400
------------------------------------------------------------------------
Females (13-50 years)         0.35  0.002323    0.11    0.006     10,000
------------------------------------------------------------------------
Males (13-19 years)           0.35  0.003158    0.11    0.006     12,000
------------------------------------------------------------------------
Males (20+ years)             0.35  0.002228    0.11    0.006     12,000
------------------------------------------------------------------------
Seniors (55+)                 0.35  0.002233    0.11    0.006     12,000
------------------------------------------------------------------------

    3. Short-term risk. Pyriproxyfen is not expected to pose a short-
term risk due to the lack of significant toxicological effects 
observed.
    4. Intermediate-term risk. Pyriproxyfen is not expected to pose an 
intermediate-term risk due to the lack of significant toxicological 
effects observed.
     5. Aggregate cancer risk for U.S. population. Pyriproxyfen is 
classified as Category E: not carcinogenic in two acceptable animal 
studies and is, therefore, not expected to pose a cancer risk to 
humans.
     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.

[[Page 14859]]

IV. Other Considerations

A. Analytical Enforcement Methodology

    Previously, the Agency successfully validated gas chromatography 
(GC) methods for pyriproxyfen on cotton seed and on pome fruits, citrus 
fruits, fruiting vegetables, and tree nuts. Biological Test Center 
(BTC) conducted an Independent Laboratory Validation (ILV) of the 
proposed enforcement method for tolerances of pyriproxyfen on four 
representative foods using high performance liquid chromatography 
(HPLC) with ultraviolet (UV) detection. Sugar, flour, lettuce and 
butter were selected to represent high sugar content foods, dry foods, 
high water content foods, and fatty foods, respectively. The limit of 
quantitation (LOQ) was 0.1 ppm for all foods except butter, which was 
0.5 ppm. Sugar, flour, and lettuce samples were fortified at 0.1 and 
0.5 ppm. Average recoveries ranged from 89% to 97% for these food 
samples. Butter was fortified at 0.5 and 2.4 ppm and gave an average 
recovery of 68%. Some modifications to the analytical method were 
necessary for the butter samples. With incorporation of these 
modifications, EPA considers the ILV of the pyriproxyfen 
(Nylar) analytical method for food commodities to be 
successful.
    Agency validation of the HPLC method on flour, candy, lettuce, and 
butter, and of the GC method on liver was requested and completed. EPA 
concludes these methods are adequate as analytical enforcement methods 
pending revision of the methods as requested by the Agency laboratory.
    Valent submitted data from a study performed by Corning Hazleton 
Inc. describing the testing of pyriproxyfen through the Food and Drug 
Administration (FDA) Multiresidue Methods Protocols A, C, D, E, and F 
found in the Pesticide Analytical Manual Volume I (PAM I), Appendix II. 
This study was previously reviewed in a memo dated 06-MAY-1997. 
Pyriproxyfen was recovered from fortified apple and cotton samples 
through protocols A, C, D, E, and F. The metabolite PYPAC was tested 
with protocols A, B, C, and D. The multiresidue methods will serve as 
confirmatory methods for residues of pyriproxyfen. The multiresidue 
recovery data were sent to the FDA for inclusion in PAM I.
    The methods may be requested from: Calvin Furlow, PRRIB, IRSD 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: 
(703) 305-5229; e-mail address: [email protected].

B. International Residue Limits

    There are no CODEX, Canadian, or Mexican tolerances for 
pyriproxyfen residues in or on any food items or raw agricultural 
commodities (RACs). Maximum residue limits (MRLs) have been proposed 
for cotton seed, citrus, meat, and edible offal; however, there is no 
certainty these proposed levels will become official. Therefore, 
international harmonization is not an issue at this time.

C. Conditions

     As a condition of the registration a revised analytical method for 
foods must be submitted.

V. Conclusion

    Therefore, a tolerance is established for residues of pyriproxyfen 
[2-[1-methyl-2-(4-phenoxyphenoxy)ethoxy]pyridine], in or on all foods 
at 0.10 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-301103 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 14, 
2001.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issue(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.

[[Page 14860]]

    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-301103, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issue(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 special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4).
    For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.''

VIII. Submission to Congress and the Comptroller General

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

List of Subjects in 40 CFR Part 180

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

    Dated: February 28, 2001.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

    2. Section 180.510(a) is amended by designating the text following 
the heading ``General'' as paragraph (a)(1), and by adding paragraph 
(a)(2) to read as follows:

[[Page 14861]]

Sec. 180.510  Pyriproxyfen; tolerances for residues.

    (a) General. (1) * * *
    (2) A tolerance of 0.10 parts per million is established for all 
foods as a result of the proposed use of NYLAR in food handling 
establishments where food and food products are held, prepared, 
processed or served. Application is limited to space, general surface, 
spot, and/or crack and crevice treatment in food handling 
establishments where food and food products are held, processed, 
prepared and served. Space and general surface application may be used 
only when the facility is not in operation provided exposed food is 
covered or removed from the area being treated prior to application. 
Spot, and/or crack and crevice treatment may be used while the facility 
is in operation provided exposed food is covered or removed from the 
area being treated prior to application. Food contact surfaces should 
be thoroughly washed with an effective cleaning compound and rinced 
with potable water after use of the product. To assure safe use of this 
additive, its label and labeling shall conform to that registered with 
the U.S. Environmental Protection Agency, and shall be used in 
accordance with such label and labeling.
* * * * *
[FR Doc. 01-6330 Filed 3-13-01; 8:45 am]
BILLING CODE 6560-50-S