[Federal Register Volume 68, Number 187 (Friday, September 26, 2003)]
[Rules and Regulations]
[Pages 55503-55513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24371]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0304]; FRL-7325-8]


Thiacloprid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of thiacloprid ([3-[(6-chloro-3-pridinyl)methyl]-2-
thiazolidinylidene]cyanamide) and metabolites retaining the 
thiazolidine ring intact, measured and expressed in terms of 
thiacloprid, per se, in or on apple, wet pomace; cotton, undelinted 
seed; cotton, gin by-products; fruit, pome group 11; fat, meat, liver, 
kidney and meat by-products of cattle, sheep, goat and horse; and milk. 
Bayer CropScience requested these tolerances 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 September 26, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0304], 
must be received on or before November 25, 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: Marilyn Mautz, Registration Division, 
7505C, Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone 
number: 703 305-6785; 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] Crop production ( NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 32532)]
    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 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-2003-0304. 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

[[Page 55504]]

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 7, 2003 (68 FR 24458) (FRL-7303-7), 
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 9F6060) by Bayer CropScience, P.O. Box 12014, 2 
T.W. Alexander Dr., Research Triangle Park, NC 27709. That notice 
included a summary of the petition prepared by Bayer CropScience, the 
registrant. There were no comments received in response to the notice 
of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the insecticide, thiacloprid, 
in or on apple, wet pomace; cattle, meat and meat byproducts; cotton, 
gin byproducts; cotton, undelinted seed; fruit, pome, group 11; and 
milk at 0.6; 0.2; 11.0; 1.0; 0.3; and 0.1 parts per million (ppm), 
respectively. Upon review and evaluation of the data submitted in 
support of the petition, the Agency determined that the residues of 
concern are thiacloprid plus metabolites retaining the thiazolidine 
ring intact. Excluded from the residues of concern are metabolites such 
as 6-nicotinic acid (6-CNA) for which the thiazolidine ring is broken. 
These metabolites are excluded based on the finding that the toxic 
effects of thiacloprid are considered to be associated with the entire 
thiacloprid molecule (with both the thiazolidine ring and the 
chloropyridine ring intact). Because metabolism and degradation studies 
have shown that the thiazolidine ring is less stable than the 
chloropyridine ring, it is understood that metabolites retaining the 
thiazolidine ring also retain the chloropyridine ring intact. 
Metabolites retaining the thiazolidine ring generally constitute most 
of the residue in foods and feeds. The petition was subsequently 
revised to:
    1. Request that 40 CFR part 180 be amended by establishing 
tolerances for the insecticide thiacloprid in or on the commodities: 
Meat, meat byproducts, liver, fat, and kidney of sheep, goat and horse; 
liver; fat and kidney of cattle; and
    2. Lowering the previously proposed tolerance levels for the food 
commodities, cattle, meat from 0.2 ppm to 0.03 ppm; cattle, meat 
byproducts from 0.2 ppm to 0.05 ppm; cotton, undelinted seed from 1.0 
ppm to 0.02 ppm and milk from 0.1 ppm to 0.03 ppm based on measurement 
of thiacloprid per se rather than measurement of the common moiety, 6-
nicotinic acid (6-CNA) upon which the original proposed tolerances were 
based; as summarized in Table 1 of this unit.

        Table 1--Proposed Tolerance Levels for Food Commodities.
------------------------------------------------------------------------
                                                       Revised, Measured
            Commodity             Original, Measured    as Thiacloprid
                                    as 6-CNA (ppm)           (ppm)
------------------------------------------------------------------------
Apple, wet pomace                 0.6                 0.6
------------------------------------------------------------------------
Cattle, meat                      0.2                 0.03
------------------------------------------------------------------------
Cattle, meat byproducts           0.2                 0.05
------------------------------------------------------------------------
Cotton, gin byproducts            11.0                11.0
------------------------------------------------------------------------
Cotton, undelinted seed           1.0                 0.02
------------------------------------------------------------------------
Cattle, sheep, goat and horse                         0.02
 fat
------------------------------------------------------------------------
Cattle, sheep, goat and horse                         0.05
 kidney
------------------------------------------------------------------------
Cattle, sheep, goat and horse                         0.15
 liver
------------------------------------------------------------------------
Fruit, pome, group 11             0.3                 0.3
------------------------------------------------------------------------
Milk                              0.1                 0.03
------------------------------------------------------------------------
Sheep, goat and horse meat                            0.03
------------------------------------------------------------------------
Sheep, goat and horse meat                            0.05
 byproducts
------------------------------------------------------------------------

    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 tolerances for combined residues of 
thiacloprid and metabolites

[[Page 55505]]

retaining the thiazolidine ring intact, measured and expressed in terms 
of thiacloprid, per se on apple, wet pomace; cattle, sheep, goat and 
horse meat; meat byproducts; liver; kidney; and fat; cotton, undelinted 
seed; cotton, gin byproducts; fruit, pome, group 11; and milk at 0.6; 
0.03; 0.05; 0.15; 0.05; 0.02; 0.02; 11.0; 0.3; and 0.03 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 thiacloprid are 
discussed in Table 2 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.

                                Table 2.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity         NOAEL = rats: males, 7.3 mg/kg/day ;
                                          rodents                     females, 7.6 mg/kg/day; mice, females,
                                                                      27.3 mg/kg/day ; males 102.6 milligram/
                                                                      kilogram/day (mg/kg/day)
                                                                     LOAEL = rats: males,28.6 mg/kg/day;
                                                                      females, 35.6 mg/kg/day; mice: females,
                                                                      27.2 mg/kg/day; males, 542.4 mg/kg/day
                                                                      based on rats: decreased body weight
                                                                      throughout treatment: mice: females based
                                                                      on adrenal X-zone changes. males based on
                                                                      liver effects (weight and hypertrophy).
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day oral toxicity in     NOAEL = males. 8.5, females, 8.9 mg/kg/day
                                          nonrodents                 LOAEL = [sim]34.9 mg/kg/day based on mainly
                                                                      liver enzyme changes, thyroid hormone
                                                                      level (T4) and binding capacity changes
                                                                      and prostatic weight change and prostatic
                                                                      hypertrophy.
----------------------------------------------------------------------------------------------------------------
870.3200                                 21/28-Day dermal toxicity   NOAEL = females, 300 mg/kg/day
                                                                     LOAEL = 1,000 mg/kg/day based on liver and
                                                                      thyroid effects and clinical signs.
----------------------------------------------------------------------------------------------------------------
870.3465                                 28 Day inhalation toxicity  NOAEL = 0.542 mg/kg/day
                                                                     LOAEL = 4.93 mg/kg/day based on [liver
                                                                      effects (hypertrophy and increased N-DEM).
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   Maternal NOAEL = 10 mg/kg/day
                                          rodents                    LOAEL = 50 mg/kg/day based on decreased
                                                                      body weights, body weight gains, food
                                                                      consumption, increased urination, and
                                                                      changes in water consumption.
                                                                     Developmental NOAEL = 10 mg/kg/day
                                                                     LOAEL = 50 mg/kg/day based on increased
                                                                      resorptions (complete and late), skeletal
                                                                      retardations, variations (wavy ribs and
                                                                      asymmetrical sternebrae), and
                                                                      malformations (dysplastic humerus, radius,
                                                                      and scapulae) and on decreased fetal
                                                                      weights
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   Maternal NOAEL = 2 mg/kg/day
                                          nonrodents                 LOAEL = 10 mg/kg/day based on decreased
                                                                      body weight gains, food consumption, and
                                                                      fecal output.
                                                                     Developmental NOAEL = 2 mg/kg/day
                                                                     LOAEL = 10 mg/kg/day based on decreased
                                                                      fetal weights
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  Parental/Systemic NOAEL = males, 3.5 mg/kg/
                                          effects                     day
                                                                     LOAEL = 21 mg/kg/day based on increased
                                                                      liver and thyroid weights and on
                                                                      hepatocytomegaly, liver necrosis, and
                                                                      thyroid follicular cell hypertrophy.
                                                                     Reproductive NOAEL = females, 4 .2 mg/kg/
                                                                      day
                                                                     LOAEL = 26 mg/kg/day based on dystocia
                                                                     Offspring NOAEL = females, 4.2 mg/kg/day
                                                                     LOAEL = females, 21 mg/kg/day based on
                                                                      decreased pup weight during lactation.
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity dogs       No firm LOAEL was established for this
                                                                      chronic feeding study with dogs; 1,000 ppm
                                                                      highest dose tested (HDT). There were no
                                                                      effects that were of sufficient magnitude
                                                                      or consistency to justify that they were
                                                                      definite responses to treatment. Certain
                                                                      effects noted in the subchronic dog study
                                                                      on the prostate and other male organs and
                                                                      an apparent effect on uterine weight in
                                                                      the subchronic dog study were not seen in
                                                                      this chronic study. This may be because
                                                                      the dogs in this study had reached
                                                                      maturity
----------------------------------------------------------------------------------------------------------------
870.4300                                 Combined chronic feeding/   NOAEL = males, 1.2 mg/kg/day ; females, 1.6
                                          cacinogenicity rats         mg/kg/day
                                                                     LOAEL = males, 2.5 mg/kg/day; females, 3.3
                                                                      mg/kg/day based on [liver toxicity
                                                                      (hepatocellular hypertrophy and
                                                                      cytoplasmic change and increased enzyme
                                                                      activity), thyroid follicular epithelial
                                                                      hypertrophy in males and oculotoxicity
                                                                      (retinal atrophy) in females
                                                                     Evidence of carcinogenicity based on
                                                                      increased incidence of thyroid follicular
                                                                      cell adenomas in males and possibly also
                                                                      in females and increased incidence of
                                                                      uterine tumors (adenocarcinomas)
----------------------------------------------------------------------------------------------------------------

[[Page 55506]]

 
870.4200                                 Carcinogenicity mice        NOAEL = males,5.7 mg/kg/day; females: 10.9
                                                                      mg/kg/day
                                                                     LOAEL = males, 234.1mg/kg/day; females,
                                                                      475.3 mg/kg/day based on liver toxicity
                                                                      and microscopic lymph node changes in both
                                                                      sexes and increased X-zone vacuolization
                                                                      of the adrenal glands in female mice
                                                                     Evidence of carcinogenicity based on
                                                                      increased incidence of ovarian luteomas
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene Mutation               Negative in a battery of tests
----------------------------------------------------------------------------------------------------------------
870.5300                                 Gene Mutation               Negative in a battery of tests
----------------------------------------------------------------------------------------------------------------
870.5375                                 Cytogenetics                Negative in battery of tests
----------------------------------------------------------------------------------------------------------------
870.5395                                 Cytogenetics                Negative in battery of tests
----------------------------------------------------------------------------------------------------------------
870.5500                                 Cytogenetics                Negative in battery of tests
----------------------------------------------------------------------------------------------------------------
870.5550                                 Other Effects               Negative
----------------------------------------------------------------------------------------------------------------
870.6200                                 Acute neurotoxicity         NOAEL = males, 11 mg/kg bodyweight (bw);
                                          screening battery           females, 3.1 mg/kg/day LOAEL = males, 22
                                                                      mg/kg bw; females, 11 mg/kg/day
                                                                     In females, based on reductions in motor
                                                                      and locomotor activity.; in males, (based
                                                                      on FOB observations of slight tremors and
                                                                      ptosis of the eyelids on the day of
                                                                      treatment)
----------------------------------------------------------------------------------------------------------------
870.6200                                 Subchronic neurotoxicity    NOAEL = males , 24.2 mg/kg/day; females,
                                          screening battery           27.9 mg/kg/day
                                                                     LOAEL = males, 101 mg/kg/day; females, 115
                                                                      mg/kg/day based on decreased body weight
                                                                      gains and food consumption in both sexes
                                                                      and decreased hindlimb grip strength in
                                                                      males.
----------------------------------------------------------------------------------------------------------------
870.6300                                 Developmental               Maternal NOAEL = 4.4 mg/kg/day
                                          neurotoxicity              LOAEL = 25.6 mg/kg/day based on decreased
                                                                      body weight gain and food consumption
                                                                      during early gestation (gestation day (GD)
                                                                      0-6.
                                                                     Offspring NOAEL = Tentative Offspring , 4.4
                                                                      mg/kg/day
                                                                     LOAEL = Tentative Offspring, 25.6 mg/kg/day
                                                                      based on decreased pre-weaning and post-
                                                                      weaning body weights in both sexes and
                                                                      delayed sexual maturation in the males,
                                                                      and altered performance in passive
                                                                      avoidance testing.
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and              Thiacloprid is rapidly absorbed and is
                                          pharmacokinetics            rapidly excreted after the following
                                                                      metabolic processes, with little remaining
                                                                      in the tissues. The metabolic processes
                                                                      were summarized as:
                                                                     1. Hyroxylation of the thiazolidine ring
                                                                      and subsequent glucuronidation (as shown
                                                                      by metabolite PIZ 1270),
                                                                      2. Hydroxylation of the cyanamide moiety
                                                                      (metabolite KNO 1891),
                                                                     3. Opening of the thiazolidine ring (e.g.,
                                                                      metabolites KNO2672, PIZ1297F/WAK 6935),
                                                                     4. Formation of an oxazole ring (metabolite
                                                                      PIZ 1253),
                                                                     5. Oxidation and subsequent methylation of
                                                                      the thiazolidine ring (e.g., PIZ 1297E and
                                                                      PIZ 1269X), and
                                                                     6. Oxidative cleavage of the methylene
                                                                      bridge (PIZ 1243). Only minor gender-
                                                                      related quantitative differences in
                                                                      metabolite profiles were observed.
----------------------------------------------------------------------------------------------------------------
870.7600                                 Dermal penetration          A 5% dermal absorption value is appropriate
                                                                      for estimating the risk resulting from
                                                                      dermal exposure to Thiacloprid formulated
                                                                      as a 40.4% liquid formulation (SC 480).
                                                                      This 5% value is also appropriate for
                                                                      other liquid thiacloprid formulations that
                                                                      are similar to the SC 480 liquid
                                                                      formulation product tested and for aqueous
                                                                      dilutions of most thiacloprid
                                                                      formulations.
----------------------------------------------------------------------------------------------------------------

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. As 
explained in Unit III.D.3., EPA determined that the FQPA SF be reduced 
to 3X.
    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

[[Page 55507]]

(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.
    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 thiacloprid used for human risk assessment is shown in 
Table 3 of this unit:

     Table 3.--Summary of Toxicological Dose and Endpoints for Thiacloprid for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                  Special FQPA SF* and
          Exposure Scenario               Dose Used in Risk       Level of Concern for   Study and Toxicological
                                            Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (All population groups)  NOAEL = 3.1 mg/kg        Special FQPA SF = 1      Acute Neurotoxicity -
                                       UF = 300*..............  aPAD = acute RfD/FQPA     rats
                                       Acute RfD = 0.01 mg/kg.   SF.                     LOAEL = 11 mg/kg/day
                                                                = 0.01 mg/kg...........   based on decreased
                                                                                          motor activity in
                                                                                          females.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL= 1.2 mg/kg/day     Special FQPA SF = 1      Chronic feeding in
                                       UF = 300*..............  cPAD = chronic RfD/       rats.
                                       Chronic RfD = 0.004 mg/   FQPA SF.                LOAEL = 2.5 mg/kg/day
                                        kg/day.                 = 0.004 mg/kg/day......   based on hepatic
                                                                                          hypertrophy and
                                                                                          cytoplasmic change and
                                                                                          thyroid hypertrophy
                                                                                          and retinal
                                                                                          degeneration.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)      Q1* (mg/kg/day)-\1\ =    Classified as a likely human carcinogen based on
                                        4.06 x 10-\2\             thyroid tumors and uterine tumors in rats and
                                                                              ovary tumors in mice
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level,
  PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose
* 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. There are no 
tolerances established for residues of thiacloprid. Risk assessments 
were conducted by EPA to assess dietary exposures from thiacloprid 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. The Dietary Exposure Evaluation Model (DEEM\TM\) 
analysis evaluated the individual food consumption as reported by 
respondents in the 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 acute exposure assessments: A moderately refined, Tier 3 acute 
dietary exposure assessment, which incorporated field trial data, 
estimates of % market share, and empirical processing factors, was 
conducted for the general U.S. population and various population 
subgroups. Monitoring data are not available for thiacloprid as it is a 
new chemical. EPA estimated exposure at the 99.9th exposure percentile.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis 
evaluated the individual food consumption as reported by respondents in 
the 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 partially refined, Tier 3 chronic dietary 
exposure assessment, which incorporated field trial data, empirical 
processing factors, and projected percent crop treated estimates, was 
conducted for the general U.S. population and various population 
subgroups. Monitoring data are not available for thiacloprid as it is a 
new chemical.
    iii. Cancer. A cancer assessment was performed using the same 
assumptions as the chronic assessment in Unit III.C.1. ii. The cancer 
dietary exposure estimate for the general U.S. population is 1.3 x 
10-\6\.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate. As required by section 408(b)(2)(E) of the FFDCA, 
EPA will issue a data call-in for information relating to anticipated 
residues to be submitted no later than 5 years from the date of 
issuance of this tolerance.
    Section 408(b)(2)(F) of the FFDCA states that the Agency may use 
data on the actual percent of food treated for assessing chronic 
dietary risk only if the Agency can make the following findings: 
Condition 1, that the data used are reliable and provide a valid basis 
to show what percentage of the food derived from such crop is likely to 
contain such pesticide residue; Condition 2, that the exposure estimate 
does not underestimate exposure for any significant subpopulation 
group; and

[[Page 55508]]

Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to 
submit data on PCT.
    The Agency used PCT information for both the acute and chronic 
dietary risk assessment as follows:
    A routine acute and chronic dietary exposure analysis for 
thiacloprid was based on 61% of apple crop treated, 51% of pear crop 
treated and 1% of cotton crop treated.
    The Agency believes that the three conditions previously discussed 
have been met. With respect to Condition 1, EPA finds that the PCT 
information described in the preceding paragraph for thiacloprid used 
on these crops is reliable and has a valid basis. The PCT estimates are 
based on use of existing alternate insecticides against insects that 
thiacloprid will control. As per Agency practice, the PCT estimates are 
what the Agency expects to be likely upper bound market penetrations 
for various crop/pest niches. Maximal percent crop treated estimates 
were projected for apples, pears, and cotton. The Agency is reasonably 
certain that the percentage of the food treated is not likely to be an 
underestimation. As to Conditions 2 and 3, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available information on the regional consumption of food to 
which thiacloprid may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for thiacloprid 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 thiacloprid.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), 
to produce estimates of pesticide concentrations in an index reservoir. 
The SCI-GROW model is used to predict pesticide concentrations in 
shallow groundwater. For a screening-level assessment for surface water 
EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 
model). The FIRST model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. While both FIRST and 
PRZM/EXAMS incorporate an index reservoir environment, 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.
    The Tier II screening model, PRZM/EXAMS, was used to estimate 
residues of thiacloprid and one of its major degradates, YRC 2984 amide 
in surface water. The SCI-GROW model was used to estimate the ground 
water residues.
    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 thiacloprid they are further 
discussed in the aggregate risk sections in Unit III.E.
    Based on the PRZM/EXAMS and SCI-GROW models the estimated 
environmental concentrations (EECs) of thiacloprid and one of its major 
degratates, YRC 2894 amide for acute exposures are estimated to be 10.2 
parts per billion (ppb) for surface water and 0.06 ppb for ground 
water. The EECs for chronic exposures are estimated to be 2.36 ppb for 
surface water and 0.06 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).
    Thiacloprid is not registered or proposed for use on any sites that 
would result in residential exposure.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Cumulative effects from 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 thiacloprid has a common mechanism of toxicity with other 
substances. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, EPA 
has not made a common mechanism of toxicity finding as to thiacloprid 
and any other substances and thiacloprid does not appear to produce a 
toxic metabolite produced by other substances. Thiacloprid does produce 
6-CNA, a metabolite also produced by another registered 
chloronicotinoid pesticide. However, the limiting toxic endpoints used 
in this assessment for thiacloprid are not based upon the toxicity of 
6-CNA. For the purposes of this tolerance action, therefore, EPA has 
not assumed that thiacloprid 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 policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

[[Page 55509]]

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.
    2. Prenatal and postnatal sensitivity. Developmental studies did 
not show either qualitative or quantitative susceptibility. There is no 
increase in quantitative susceptibility demonstrated in the rat 
developmental neurotoxicity, rabbit developmental or rat reproduction 
studies. There is an apparent qualitative increase in susceptibility in 
the rat developmental toxicity study as indicated by increases in 
resorptions, increases in skeletal variations and retardations and 
malformations, and decreases in fetal body weight that occurred at the 
same dose showing a decrease in maternal body weight, but the concern 
is low since:
    i. There is a well characterized dose response with a clear NOAEL 
and LOAEL;
    ii. The fetal effects were noted in the presence of maternal 
toxicity; and
    iii. There are no residual uncertainties.
    3. Conclusion. In evaluating whether to retain the 10X SF to 
protect infants and children or to select a different safety factor, 
EPA considered the following factors:
    i. There are no special concerns regarding pre- or post-natal 
toxicity exposure;
    ii. The exposure databases ( food and drinking water) are complete 
and/or employ conservative assumptions;
    iii. There is no residential exposure;
    iv. The risk assessments cover or approximate all the metabolites 
and degradates of concern;
    v. The assessments do not underestimate the potential risk for 
infants and children; and
    vi. The toxicity database is complete except that there is a lack 
of morphometric assessments for the low- and mid-dose group animals in 
the developmental neurotoxicity study (DNT).
    Although the lack of morphometric assessments in the DNT raised 
some uncertainty, EPA determined that there were sufficient reliable 
data to select an additional safety factor of 3X instead of 10X. The 
FQPA safety factor of 3X is in the form of a database uncertainty 
factor of 3X. A 3X factor was judged to be adequate because the dose 
selected for overall risk assessments is already based on the most 
sensitive end points for acute (i.e. clinical signs indicative of 
neurotoxicity) and chronic (i.e. liver and thyroid effects) dietary and 
non-dietary exposure scenarios, and the available data indicate that 
the full characterization of brain morphometrics from the DNT study 
would not be expected to lower the dose used for risk assessments by 
more than 3-fold.
    To elaborate, since the magnitude (4-14%) of the morphometric 
histopathology changes seen in the offspring at the highest dose (40.8 
mg/kg/day) in the developmental neurotoxicity study were considered to 
be at or near the limit of detection for differences in morphometric 
measurements, it is unlikely that measurable morphometric changes will 
be seen at lower doses. Any possible slight effects at lower doses are 
highly unlikely to change the regulatory level. The actual doses used 
to establish the acute RfD (3.1 mg/kg/day) and the chronic RfD (1.2 mg/
kg/day) are 13 and 34 fold lower, respectively, than the 40.8 mg/kg/day 
dose where the effects of minimal magnitude were seen. Applying the 3 X 
factor further renders the adjusted doses 39 and 102-fold lower than 
the dose level where the effects of minimal magnitude were seen. 
Morever, even if the slight morphometric changes are seen at the mid, 
and even the low, dose of the DNT, a RfD calculated on such findings is 
highly unlikely to be lower than current acute and chronic RfDs 
adjusted by 3X given that the effects seen at the high dose were 
marginal. Therefore it is concluded that 3X is adequate to account for 
any possible morphometric effects that may be noted in the lower doses 
for which the additional readings are being sought.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water [e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)]. This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2 liter (L)/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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
thiacloprid will occupy 20% of the aPAD for the U.S. population, 8.5 % 
of the aPAD for females 13 years and older, 51 % of the aPAD for all 
infants and 47 % of the aPAD for children 1-2 years old. In addition, 
there is potential for acute dietary exposure to thiacloprid 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 aPAD, as shown in Table 4 of this unit:

[[Page 55510]]



                      Table 4.--Aggregate Risk Assessment for Acute Exposure to Thiacloprid
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. population                                 0.01           20         10.2         0.06          281
----------------------------------------------------------------------------------------------------------------
All infants < 1 year old                                0.01           51         10.2         0.06           49
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old                                  0.01           47         10.2         0.06           53
----------------------------------------------------------------------------------------------------------------
Children 3-5 years old                                  0.01           33         10.2         0.06           67
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old                                 0.01          8.5         10.2         0.06          274
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
thiacloprid from food will utilize <1.0 % of the cPAD for the U.S. 
population, 4.4 % of the cPAD for all infants and 4.2% of the cPAD for 
children 1-2 years old . There are no residential uses for thiacloprid 
that result in chronic residential exposure to thiacloprid. In 
addition, there is potential for chronic dietary exposure to 
thiacloprid 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 5 of 
this unit:

              Table 5.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Thiacloprid
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                        0.004         <1.0         2.36         0.06          139
----------------------------------------------------------------------------------------------------------------
All Infants < 1 year old                               0.004          4.4         2.36         0.06           38
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old                                 0.004          4.2         2.36         0.06           38
----------------------------------------------------------------------------------------------------------------
Children 3-5 years old                                 0.004          2.9         2.36         0.06           38
----------------------------------------------------------------------------------------------------------------
Children 6-12 years old                                0.004          1.3         2.36         0.06           39
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old                                0.004         <1.0         2.36         0.06          120
----------------------------------------------------------------------------------------------------------------

    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).
    Thiacloprid is not registered or proposed for use on any sites that 
would result in residential exposure. Therefore, the aggregate risk is 
the sum of the risk from food and water, which do not exceed the 
Agency's level of concern.
    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).
    Thiacloprid is not registered or proposed for use on any sites that 
would result in residential exposure. Therefore, the aggregate risk is 
the sum of the risk from food and water, which do not exceed the 
Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. In accordance with 
the EPA Draft Guidelines for Carcinogen Risk Assessment: (July 1999), 
thiacloprid was classified into the category Likely to be Carcinogenic 
to Humans. A linear low-dose extrapolation approach is applied to the 
quantifications of risk to be estimated, based upon male rat thyroid, 
rat uterine, and mouse ovarian tumors. The data did not support a mode 
of action. The Q1* is 4.06 x 10-\2\ in human equivalents 
based on the rat uterine adenoma, adenocarcinoma and/or adenosquamous 
carcinoma combined tumor rates.
    The dietary cancer risk from residues in food is 1.3X 
10-\6\. A cancer DWLOC is calculated only for the general 
U.S. Population. For this population the calculated DWLOC of 1.5ug/L is 
the same as the calculated EEC of 1.5 ug/L.
    DWLOC = 3 X 10-\6\/Q1* - average food 
exposure (mg/kg/day)]*bwt* 1,000 ug/mg/Water consumption (liter/day)
    DWLOC (US Pop.) = 1.5 ug/L. Since the surface water EEC for cancer 
is 1.5 ug/L the risk cup is exactly filled to 3 X 10-\6\.
    For risk management purposes, EPA considers a cancer risk to be 
greater than negligible when it exceeds the range of 1 in 1 million. 
EPA has generally treated cancer risks up to 3 in 1 million as within 
the range of 1 in 1 million.
    EPA believes that the lifetime exposure will be result in 
negligible cancer risk for the following reason:
    The cancer risk from the food uses alone is 1.3 x 
10-\6\.The dietary risk is based on residue data derived 
from the average of field trials. It is not unusual in the Agency's 
experience for field trial data to be an order of magnitude above 
actual monitoring. Since thiacloprid is a new chemical, actual 
monitoring data are not yet available. It is likely that the actual 
risk contribution from food will be much lower than current data 
indicate, which would result in a larger DWLOCcancer.
    Thus, EPA does not expect that the general population would be 
exposed to levels that would exceed a neglible cancer risk over a 
lifetime.
    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

[[Page 55511]]

population, and to infants and children from aggregate exposure to 
thiacloprid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The petitioner proposed a high performance liquid chromatography 
mass spectrometry (HPLC/MS/MS) method for determining thiacloprid, YRC-
2894 amide and 4-hydroxy-YRC2894 amide in plants which has been found 
to be appropriate for use in the enforcement of the plant tolerances 
associated with this petition. The available radiovalidation and 
metabolism data supports this method. An adequate Independent Lab 
Validation (ILV) has been provided for the method and adequate 
confirmatory ions were also identified in the ILV.
    The petitioner has proposed a HPLC/MS/MS method for determining 
thiacloprid in livestock tissues which has been found to be appropriate 
for use in the enforcement of the animal tissue tolerances associated 
with this petition. Existing radiovalidation and metabolism data 
supports this method as well as does an ILV. Mass spectrometry provides 
an adequate confirmatory method. This conclusion is based upon the 
successful use of mass spectrometry as a confirmatory method for 
thiacloprid in plants, the similarity between the HPLC/MS/MS methods 
for thiacloprid in plants and animals, and the Agency's familiarity 
with mass spectrometry in general. As a condition of registration, the 
registrant will be required to submit a description of the procedures 
for the use of mass spectrometry for thiacloprid in animals.
    Thiacloprid, parent only, has been tested through the FDA PAM I 
multi-residue protocol. Upon request, the methods will be available 
prior to the harvest from: Chief, 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 established Codex, Canadian or Mexican maximum residue 
limits (MRLs) for thiacloprid.

C. Conditions

    The following information must be submitted as a condition for 
product registrations related to these tolerances: The registrant will 
be required to submit a description of the procedures for the use of 
mass spectrometry for thiacloprid in animals.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
thiacloprid and metabolites retaining the thiazolidine ring intact, 
measured and expressed as thiacloprid, per se, in or on apple, wet 
pomace at 0.6 ppm; cattle, sheep, goat, and horse meat at 0.03 ppm; 
cattle, sheep, goat and horse meat byproducts at 0.05 ppm; cattle, 
sheep, goat, and horse liver at 0.15 ppm; cattle, sheep, goat, and 
horse kidney at 0.05 ppm; and cattle sheep, goat, and horse fat at 0.02 
ppm; cotton, undelinted seed at 0.02 ppm; cotton, gin byproducts at 
11.0 ppm; fruit, pome, group 11 at 0.3 ppm; and milk at 0.03 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, 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-2003-0304 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before November 
25, 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 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-
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

[[Page 55512]]

copies, identified by docket ID number OPP-2003-0304, 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 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: September 16, 2003.
James Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.594 is added to read as follows:


Sec.  180.594  Thiacloprid; tolerances for residues.

    (a) General. Tolerances for combined residues of the insecticide 
thiacloprid

[[Page 55513]]

([3-[(6-chloro-3-pyridinyl)methyl]-2-thiazolidinylidene] cyanamide) and 
metabolites retaining the thiazolidine ring intact, measured and 
expressed in terms of thiacloprid, per se, in or on the following 
commodities:

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Apple, wet pomace..............................                     0.60
Cattle, fat....................................                    0.020
Cattle, kidney.................................                    0.050
Cattle, liver..................................                     0.15
Cattle, meat...................................                    0.030
Cattle, meat byproducts........................                    0.050
Cotton, gin byproducts.........................                     11.0
Cotton, undelinted seed........................                    0.020
Fruit, pome, group 11..........................                     0.30
Goat, fat......................................                    0.020
Goat, kidney...................................                    0.050
Goat, liver....................................                     0.15
Goat, meat.....................................                    0.030
Goat, meat byproducts..........................                    0.050
Horse, fat.....................................                    0.020
Horse, kidney..................................                    0.050
Horse, liver...................................                     0.15
Horse, meat....................................                    0.030
Horse, meat byproducts.........................                    0.050
Milk...........................................                    0.030
Sheep, fat.....................................                    0.020
Sheep, kidney..................................                    0.050
Sheep, liver...................................                     0.15
Sheep, meat....................................                    0.030
Sheep, meat byproducts.........................                    0.050
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 03-24371 Filed 9-25-03; 8:45 am]
BILLING CODE 6560-50-S