[Federal Register Volume 64, Number 74 (Monday, April 19, 1999)]
[Rules and Regulations]
[Pages 19042-19050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9710]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300843; FRL-6075-6]
RIN 2070-AB78


Clofentezine; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for residues of 
clofentezine in or on apples and apple pomace. AgrEvo USA 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 April 19, 1999. Objections and 
requests for hearings must be received by EPA on or before June 18, 
1999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300843], must be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. Fees accompanying objections and hearing 
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: 
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and 
hearing requests filed with the Hearing Clerk identified by the docket 
control number, [OPP-300843], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 119, Crystal 
Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: [email protected]. Copies of objections and hearing requests 
must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Copies of objections and hearing 
requests will also be accepted on disks in WordPerfect 5.1/6.1 file 
format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket control 
number [OPP-300843]. No Confidential Business Information (CBI) should 
be submitted through e-mail. Electronic copies of objections and 
hearing requests on this rule may be filed online at many Federal 
Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Peg Perreault, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail address: Rm. 209, Crystal Mall 
#2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-5417, e-mail: 
[email protected].

 SUPPLEMENTARY INFORMATION: In the Federal Register of January 28, 1999 
(64 FR 4414) (FRL-6056-3), 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) (Pub. L. 104-
170) announcing the filing of a pesticide petition (PP) for tolerance 
by AgrEvo USA Company, Little Falls Centre One, 2711 Centerville Road, 
Wilmington, DE 19808. This notice included a summary of the petition 
prepared by AgrEvo USA Company, the registrant. There were no comments 
received in response to the notice of filing.
    The petition requested that 40 CFR 180.446(b) be amended by 
establishing a tolerance for residues of the insecticide clofentezine, 
in or on apples at 0.5 parts per million (ppm) and apple pomace at 3.0 
ppm.

I. Background and Statutory Findings

    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).

II. 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 
clofentezine (3,6-bis(chlorophenyl)-1,2,4,5-tetrazine) and to make a 
determination on aggregate exposure, consistent with section 408(b)(2), 
for a tolerance for residues of clofentezine on apples at 0.5 ppm and 
apple pomace at 3.0 ppm. EPA's assessment of the dietary exposures and 
risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by clofentezine are 
discussed in this unit.
    1. Acute toxicity. Technical clofentezine has a relatively low 
degree of acute toxicity by the oral, dermal, and inhalation routes of 
exposure (Toxicity Category III for oral, dermal and inhalation 
toxicity). The acute oral LD50

[[Page 19043]]

of clofentezine was determined to be > 5,200 milligrams per kilogram 
(mg/kg) in rats and mice, > 3,200 mg/kg in hamsters, and > 2,000 mg/kg 
in beagle dogs. The acute rat dermal LD50 was > 2,100 mg/kg. 
Clofentezine is considered to be a mild eye irritant (Toxicity Category 
IV) and practically non-irritating to the skin (Toxicity Category IV), 
but is considered to be a weak skin sensitizer based on a guinea pig 
maximization assay.
     The end-use product APOLLO SC Ovicide/Miticide (42% a.i.) is 
classified as Toxicity Category IV for oral toxicity and skin 
irritation, and as Toxicity Category III for dermal toxicity and eye 
irritation. APOLLO SC is considered slightly irritating to eyes and 
skin.
    2. Subchronic toxicity.  In a 90-day feeding study, clofentezine 
was administered to rats at dietary concentrations of 0, 40, 400 and 
4,000 ppm. Elevated cholesterol levels, increased liver weights, 
increased liver-to-body-weight ratios, and centrilobular hepatocyte 
enlargement were noted at 400 and/or 4,000 ppm. In addition, there was 
a depletion of thyroid colloid in all dose groups and follicular cell 
hypertrophy in mid- and high dose male rats. Although present in 
females, the thyroid effects were less marked. All thyroid effects were 
reversible after the recovery period. The NOAEL for this study was 
considered to be 40 ppm (2.8 milligrams per kilograms per day (mg/kg/
day)).
    Clofentezine was administered to beagle dogs for 90 days at dietary 
concentrations of 0, 3,200, 8,000 and 20,000 ppm. Increased liver 
weights were noted at all dose levels but no histopathological changes 
or any other treatment-related effects were observed.
    3.  Chronic toxicity.  In a 12-month feeding study, clofentezine 
was administered to beagle dogs at dietary concentrations of 0, 50, 
1,000 and 20,000 ppm. Treatment related effects were noted in dogs in 
the mid- (1,000 ppm) and high dose (20,000 ppm) groups. These effects 
included liver changes with hepatocyte enlargement concurrent with 
eosinophilic cytoplasm, increased liver weight (both sexes), increased 
thyroid weight (high dose males only), and increased adrenal weight 
(high dose females only). Also in the mid- and high dose groups 
elevated serum cholesterol and triglycerides were noted. There was a 
statistically significant increase in alkaline phosphatase in both 
sexes at the high dose primarily during the early part of the study and 
again at term in high dose males and mid- and high dose females. The 
NOAEL for this study was considered to be 50 ppm (1.25 mg/
kg/day1).
    4. Chronic toxicity/Carcinogenicity. In a 27-month feeding study, 
clofentezine was administered to rats at dietary concentrations of 0, 
10, 40 and 400 ppm. Treatment related effects were noted in the liver 
and thyroid at 400 ppm (primarily in males). These effects are 
discussed below. The NOAEL for this study was considered to be 40 ppm 
( cents2 mg/kg/day).
    In both the chronic (27-month) and the subchronic (1 and 3 month) 
feeding studies in rats, conducted with doses of clofentezine ranging 
from 0.43 to 1,500 mg/kg/day, non-neoplastic compound related effects 
were noted. Liver was the primary target organ with secondary effects 
to the thyroid and perturbations of the general metabolism. The 
induction of the liver enzyme, uridine-diphosphate-glucuronyl-
transferase (UDPGT) and the subsequent increase in the metabolism and 
the excretion of the thyroid hormone thyroxine (T4) reduced 
the availability of T4 required for the general metabolism 
and the maintenance of homeostasis. The decreased levels of plasma 
T4 resulted in the stimulation of the thyroid by the 
pituitary gland to raise the plasma T4 levels. Thyroid 
changes in the form of colloid depletion, thyroid follicular cell 
hypertrophy and hyperplasia were observed as a means to regain the 
homeostasis. Body weights and body weight gains were decreased whereas 
liver weights were increased and hepatocellular enlargement was 
reported along with other observations on the liver. Increases in 
plasma cholesterol and triglyceride levels were also recorded with 
these effects supported by the liver and thyroid pathology. Cessation 
of dosing accompanied by a recovery period allowed for the attainment 
of normal physiological levels of T4 and a reversal of the 
above noted changes.
    Tumors of the thyroid were only recorded in male rats during 
chronic treatment indicating a sensitivity for this species and sex. 
The mode of action appears to be one of endocrine disruption and 
follows the generally recognized adaptive physiology of decreased 
plasma thyroxine levels followed by a positive feedback to the 
pituitary which then signals the thyroid to produce more thyroxine to 
raise the plasma thyroxine levels and regain the homeostasis. 
Structural changes in the thyroid in the manner of hypertrophy and 
hyperplasia of the thyroid cells then results. However, a chronic over 
stimulation of the thyroid from an inability to regain the normal 
levels of plasma thyroxine results in the transformation of cells at 
some unknown time point from a controlled state of hypertrophy and 
hyperplasia to an uncontrolled state of hyperplasia with the result of 
thyroid follicular cell tumor formation.
    EPA has classified clofentezine as a likely human carcinogen 
[classification of C]. The doses in the rat study were, however, 
considered to be below the maximum tolerated dose (MTD) based on the 
results in the subchronic studies as well as little evidence of 
toxicity even at the high dose tested. It was concluded that a new 
study was not required but may be required at some future date to 
support the appropriate characterization and quantification of 
potential risks associated with the use of clofentezine. Biologically 
or statistically significant tumors were not observed in female rats 
and clofentezine was not carcinogenic to mice when administered for 2 
years at dietary concentrations of 0, 50, 500 and 5,000 ppm. The NOAEL 
for the mouse study was 500 ppm (50.7 mg/kg/day). Mice were also much 
less sensitive to the effects of clofentezine as seen in the 
comparative values of the NOAELS. However the liver was also the target 
organ in the mouse as seen by histological changes. Decreases in body 
weight and body weight gain were also reported in mice. Non-neoplastic 
changes in the mouse thyroid were not remarkable. Increased mortality 
was observed in female mice at the highest dose tested with amyloidosis 
considered to be a contributing factor.
    5. Reproductive toxicity. A 2-generation reproduction study in rats 
was conducted at dietary concentrations of 0, 4, 40 and 400 ppm (0, 
0.2, 2, and 20 mg/kg/day). Systemic effects observed at 400 ppm were 
limited to minimal centrilobular hepatocyte hypertrophy in adult male 
rats. The parental NOAEL was considered to be at or above 400 ppm (20 
mg/kg/day). There were no reproductive effects and no effects on 
offspring observed at any dose level. The reproductive NOAEL was 
considered to be at or above 400 ppm (20 mg/kg/day).
    6.  Developmental toxicity. In a rat developmental toxicity study, 
clofentezine was administered by gavage to female rats at dose levels 
of 0, 320, 1,280 and 3,200 mg/kg/day for days 7 through 20 of 
gestation. In dams, there was differential staining and slight 
enlargement of the centrilobular hepatocytes at 3,200 mg/kg/day. The 
maternal NOAEL was considered to be 1,280 mg/kg/day (above the limit 
test of 1,000 mg/kg/day). There were no developmental effects on 
offspring at any dose level. The developmental

[[Page 19044]]

NOAEL was considered to be at or above 3,200 mg/kg/day.
    In a rabbit developmental toxicity study, clofentezine was 
administered by gavage to female rabbits at dose levels of 0, 250, 
1,000 and 3,000 mg/kg/day for days 7 through 29 of gestation Evidence 
of maternal toxicity included body weight reduction throughout 
treatment and decreased maternal food consumption at the 3,000 mg/kg/
day dose level. The maternal NOAEL was considered to be 1,000 mg/kg/
day. Evidence of developmental toxicity included a reduced mean fetal 
weight reduction of 13% which occurred at 3,000 mg/kg/day. The 
developmental NOAEL was considered to be 1,000 mg/kg/day.
    7. Mutagenicity. No evidence of mutagenicity was noted in a battery 
of in vitro and in vivo studies. Studies submitted included Ames 
Salmonella and mouse lymphoma gene mutation assays, a mouse 
micronucleus assay, a rat dominant lethal assay, and a gene conversion 
and mitotic recombination assay in yeast.
    8.  Metabolism. Male and female rats given clofentezine technical 
at 1,000 mg/kg manifested peak plasma levels of between 14 and 16 ppm 
at 6-8 hours post dosing which then declined to 3 ppm at 24 hours post 
dosing. Plasma half life was approximately 3.5 hours. Whole body 
autoradiography of rats given a 10 mg/kg dose indicated poor 
gastrointestinal absorption with 60-70% of the given dose excreted in 
the feces during the first 24 hours and about 20% excreted in the 
urine. Major metabolites were 3-(2'-methyl-thio-3' hydroxy phenyl)-6-
(2'-chloro-phenyl)-1,2,4,5-tetrazine and 3-,4-, and 5-
hydroxyclofentezine. Both liver and kidney had the highest tissue 
concentration after 72 hours.

B. Toxicological Endpoints

    1. Acute toxicity. An acute RfD was not established. No appropriate 
toxicological endpoint attributable to a single exposure was identified 
in the available toxicology studies, including the rat and the rabbit 
developmental studies. The study data indicate that clofentezine does 
not directly affect the thyroid. It induces uridine diphosphate 
glucuronyl transferase (UDPGT) activity in the liver, the enzyme 
associated with conjugation of thyroxine (T4 with glucuronic 
acid prior to the excretion of the hormone. This allows the hormone to 
be excreted and indicates an increased excretion rate of the hormone. 
There is also weak evidence that clofentezine increases biliary flow 
and biliary excretion of T4. Increased excretion of 
T4 reduces circulating T4 in the blood. The 
reduction in circulating thyroid hormone is detected by the pituitary, 
which in turn stimulates the thyroid to generate more thyroid hormone 
through cell enlargement (hypertrophy) and an increase in the cell 
numbers (hyperplasia). This is a well recognized and normal adaptive 
mechanism reacting to decreased thyroid hormone levels resulting in the 
reestablishment of the homeostasis process and is not considered to be 
an adverse effect after a single exposure.
    2. Short- and intermediate-term toxicity. Short- and intermediate- 
term dermal endpoints were selected from a 90-day rat feeding study. 
The NOAEL of 2 mg/kg/day and the LOAEL of 20 mg/kg/day were based on 
increased cholesterol, increased liver weights, thyroid colloid 
depletion and thyroid follicular cell hypertrophy. An inhalation 
endpoint was not identified. Short and intermediate term risk 
assessments would be required for the dermal route of exposure; 
however, since there are no proposed residential uses of clofentezine 
that will result in post-application residential exposure, a risk 
assessment for residential non-dietary (dermal) exposure is not 
required. An inhalation risk assessment is not required based on the 
label specified maximum of one application per year per crop, the low 
toxicity of the chemical, and the low maximum application rate of 8 
ounces per acre.
    3. Chronic toxicity. EPA has established the Chronic RfD for 
clofentezine (3,6-bis(chlorophenyl)-1,2,4,5-tetrazine) at 0.013 mg/kg/
day. This Reference Dose (RfD) for dietary exposure is based on a 
chronic dog feeding study in which liver changes and elevated serum 
cholesterol, triglycerides, and alkaline phosphatase were seen at 25.0 
mg/kg/day (LOAEL). The NOAEL in this study was 1.25 mg/kg/day. An 
uncertainty factor (UF) of 100 was applied to the NOAEL to account for 
both inter-species extrapolation (10) and intra-species variability 
(10). The chronic RfD applies to all populations.
    4. Carcinogenicity. EPA has classified clofentezine as a likely 
human carcinogen (classification of C). Clofentezine causes thyroid 
tumors only in male rats as a result of chronic over stimulation of the 
thyroid. This leads to failure to elevate T4 to 
physiologically normal levels and regain homeostasis as noted above in 
the toxicological profile section. The cancer risk was quantified using 
a linear low dose extrapolation method resulting in a Q* of 0.0376 (mg/
kg/day)-1 (based upon male rat thyroid follicular cell 
adenoma and/or carcinoma combined tumor rates).

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.446(b)) for the residues of clofentezine, in or on a variety of 
raw agricultural commodities and in meat at 0.05 ppm and milk at 0.01 
ppm. Risk assessments were conducted by EPA to assess food exposures 
from clofentezine (3,6-bis(chlorophenyl)-1,2,4,5-tetrazine) as follows:
    Section 408(b)(2)(E) authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate. As required by section 408(b)(2)(E), EPA will 
issue a data call-in for information relating to anticipated residues 
to be submitted no later than 5 years from the date of issuance of this 
tolerance.
    Section 408(b)(2)(F) states that the Agency may use data on the 
actual percent of food treated (PCT) for assessing chronic dietary risk 
only if the Agency can make the following findings: 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; that the exposure estimate does not underestimate exposure for 
any significant subpopulation group; and 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 percent of crop treated as required by the section 408(b)(2)(F), EPA 
may require registrants to submit data on PCT.
    The Agency used PCT information to conduct a routine chronic 
dietary exposure analysis for clofentezine based on likely maximum 
percent of crop treated as follows: 24% apples, 0% apricots, 6% 
cherries, 30% nectarines, 12.2% peaches, 16% pears, 1.4% plums and 
prunes, 9.2% almonds, 7.4% walnuts (walnuts were not included in the 
dietary exposure analysis).
    The Agency believes that the three conditions, discussed in section 
408

[[Page 19045]]

(b)(2)(F) in this unit concerning the Agency's responsibilities in 
assessing chronic dietary risk findings, have been met. The PCT 
estimates are derived from Federal and private market survey data, 
which are reliable and have a valid basis. Typically, a range of 
estimates are supplied and the upper end of this range is assumed for 
the exposure assessment. By using this upper end estimate of the PCT, 
the Agency is reasonably certain that the percentage of the food 
treated is not likely to be underestimated. The 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 clofentezine may be applied in a particular area.
    i. Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a 1-day or single exposure. As previously stated, an Acute RfD was 
not established for clofentezine as no appropriate toxicological 
endpoint attributable to a single exposure was identified in the 
available toxicology studies, including the rat and the rabbit 
developmental studies. Therefore, an acute risk assessment was not 
conducted.
    ii. Chronic exposure and risk. The chronic dietary risk assessment 
for clofentezine from food sources was conducted using the Chronic RfD 
of 0.013 mg/kg bwt/day. EPA determined that the Uncertainty Factor (UF) 
of 100 used to calculate the Chronic RfD is adequate for the protection 
of the general U.S. population including infants and children from 
exposure to clofentezine and that FQPA Safety Factor should be removed 
(refer to unit II.E. of this preamble for a detailed discussion 
concerning the FQPA Safety Factor with respect to clofentezine). As 
indicated below, the results of the chronic dietary exposure analysis 
indicate an acceptable chronic dietary exposure of 100% or less of the 
Chronic RfD for all population subgroups.
    A Dietary Exposure Evaluation Model (DEEMTM) analysis 
for clofentezine was performed in order to provide an estimate of the 
food exposure and associated risk for clofentezine resulting from 
existing tolerances and the proposed tolerance level for apples. The 
DEEMTM analysis evaluated the individual food consumption as 
reported by respondents in the USDA 1989-91 Nationwide Continuing 
Surveys for Food Intake by Individuals (CSFII) and accumulated exposure 
to the chemical for each commodity. The chronic and cancer DEEM 
analysis for clofentezine estimated the food exposure using ARs and PCT 
data for all commodities except walnuts. The chronic DEEMTM 
analysis used mean consumption (3 day average). EPA's level of concern 
for the analysis is 100% RfD. A summary of the food exposures for the 
U.S. general population and other subgroups is presented in the 
following Table 1. The other subgroups included in Table 1 represent 
the highest food exposures for their respective subgroups (i.e., 
children, females, and the other general population subgroup higher 
than U.S. population).

      Table 1.--Summary of Food Exposure and Risk for Clofentezine
------------------------------------------------------------------------
                                                           Exposure
                        Subgroups                           (mg/kg/   %
                                                             day)    RfD
------------------------------------------------------------------------
U.S. Population (48 states)..............................  0.000022  0.2
Non-Hispanic Other Than Black or White...................  0.000025  0.2
Non-Nursing Infants (< 1 year old).......................  0.00018   1.4
Females (13+ years, nursing).............................  0.000029  0.2
------------------------------------------------------------------------

The chronic food risk does not exceed the Agency's level of concern.
    iii. Cancer risk. The upper bound cancer risk for the U.S. 
population subgroup was calculated to be 8.4  x 10-7 (based 
on a Q1* value of 0.0376 (mg/kg/day)-1). EPA's 
level of concern for the cancer risk are risks in the range of 1  x  
10-6. The cancer risk is below the Agency's current level of 
concern.
    2. From drinking water. EPA does not have sufficient ground or 
surface water monitoring data available to perform a quantitative risk 
assessment for clofentezine at this time. However, EPA determined 
estimated drinking water environmental concentrations (DWECs) in ground 
and surface water using available environmental fate data and the 
screening model for ground water (SCI-GROW) and the generic expected 
environmental concentration (GENEEC) model for surface water. The DWEC 
of clofentezine in ground water was estimated to be 0.04 ppb using SCI-
GROW, and the DWECs for surface water were estimated to be 6.5 ppb 
(acute DWEC) and 0.3 ppb (chronic DWEC) using GENEEC. EPA policy allows 
the 90/56-day GENECC value to be divided by 3 to obtain a value for 
chronic risk assessment calculations. Therefore, a surface water 
estimate of 0.1 ppb was used in the chronic risk assessment.
    i. Acute exposure and risk. Acute exposure and risk assessments are 
performed for a pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1-day or 
single exposure. As previously stated, an Acute RfD was not established 
for clofentezine as no appropriate toxicological endpoint attributable 
to a single exposure was identified in the available toxicology 
studies, including the rat and the rabbit developmental studies. 
Therefore, an acute risk assessment was not conducted.
    ii. Chronic exposure and chronic and cancer risk. EPA uses the 
Drinking Water Level of Comparison (DWLOC) as a theoretical upper limit 
on a pesticide's concentration in drinking water when considering total 
aggregate exposure to a pesticide in food, drinking water, and through 
residential uses. DWLOCs are not regulatory standards for drinking 
water; however, EPA uses DWLOCs in the risk assessment process as a 
surrogate measure of potential exposure from drinking water. In the 
absence of monitoring data for pesticides, it is used as a point of 
comparison against conservative model estimates of a pesticide's 
concentration in water.
    EPA has calculated DWLOCs for both chronic and cancer risks. The 
results are listed in the following Tables 2 and 3.

[[Page 19046]]



                    Table 2.-- Summary of DWLOC Calculations - Chronic (Non-Cancer Scenario)
----------------------------------------------------------------------------------------------------------------
                                                                       Chronic (Non-Cancer) Scenario
                                                         -------------------------------------------------------
                                                                            Maximum
                 Population Subgroup\1\                    RfD     Food      Water
                                                          mg/kg/ Exposure  Exposure  SCI-GROW  GENEEC    DWLOC
                                                           day    mg/kg/    mg/kg/   (ppb)\3\   (ppb)    (ppb)
                                                                    day     day\2\
----------------------------------------------------------------------------------------------------------------
U.S. Population.........................................  0.013  0.000022   0.01298    0.04      0.1         454
Non-Hispanic other than black or white..................  0.013  0.000025   0.01298    0.04      0.1         454
Non-Nursing Infants (< 1 yr old)........................  0.013  0.00018    0.01282    0.04      0.1         128
Females (13+/nursing)...................................  0.013  0.000029   0.01297    0.04      0.1         389
----------------------------------------------------------------------------------------------------------------
\1\ Population subgroups chosen were U.S. population (70 kg. body weight assumed), the Non-Hispanic subgroup (70
  kg body weight assumed) which has higher dietary exposure than the U.S. population, the infant/child subgroup
  with the highest food exposure (10 kg. body weight assumed), and the female subgroup with the highest food
  exposure (60 kg. body weight assumed).
\2\ Maximum Water Exposure (mg/kg/day) = RfD (mg/kg/day) - TMRC from DRES (mg/kg/day).
\3\ The crop producing the highest level was used.


                      Table 3.-- Summary of DWLOC Calculations - Chronic (Cancer Scenario)
----------------------------------------------------------------------------------------------------------------
                                                                        Chronic (Cancer) Scenario
                                                        --------------------------------------------------------
                                                                            Maximum
                 Population Subgroup\1\                            Food      Water
                                                           Q1*   Exposure  Exposure  SCI-GROW  GENEEC    DWLOC
                                                                  mg/kg/    mg/kg/   (ppb)\3\   (ppb)    (ppb)
                                                                    day     day\2\
----------------------------------------------------------------------------------------------------------------
U.S. Population........................................  0.0376  0.000022  0.000004    0.04      0.1        0.16
----------------------------------------------------------------------------------------------------------------
\1\ Because there is a Q*, the U.S. population is the population of concern.
\2\ Maximum Water Exposure (mg/kg/day) = RfD (mg/kg/day) - TMRC from DRES (mg/kg/day).
\3\ The crop producing the highest level was used.

    To calculate the DWLOC for chronic (non-cancer) exposure relative 
to a chronic toxicity endpoint, the chronic dietary food exposure (from 
DEEM) was subtracted from the RfD to obtain the acceptable chronic 
(non-cancer) exposure to clofentezine in drinking water. To calculate 
the DWLOC for chronic exposures relative to a carcinogenic toxicity 
endpoint, the chronic (cancer) dietary food exposure was subtracted 
from the ratio of the negligible cancer risk to the Q* to 
obtain the acceptable chronic (cancer) exposure to clofentezine in 
drinking water. DWLOCs were then calculated using default body weights 
and drinking water consumption figures.
    The estimated average concentration of clofentezine in surface 
water is 0.1 ppb. This value is less than EPA's DWLOCs for clofentezine 
as a contribution to both chronic and cancer aggregate exposures (454 
ppb and 0.16 ppb, respectively). Therefore, taking into account the 
present uses and the proposed new use, EPA concludes with reasonable 
certainty that residues of clofentezine in drinking water (when 
considered along with other sources of exposure for which EPA has 
reliable data) will not result in unacceptable levels of aggregate 
human health risk. Because EPA considers the aggregate risk resulting 
from multiple exposure pathways associated with a pesticide's uses, 
DWLOCs may vary as those uses change. If additional new uses are 
proposed in the future, EPA will reassess the potential impacts of 
clofentezine on drinking water as a part of the aggregate risk 
assessment process.
    3. From non-dietary exposure. Clofentezine is not registered for 
residential non-food use sites. Because there are no proposed 
residential uses of clofentezine that will result in post-application 
residential exposure, risk assessments for residential non-dietary 
exposure are not required.
    4. Cumulative exposure to substances with 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 clofentezine 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, 
clofentezine 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 clofentezine has a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

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

    Because there are no proposed residential uses of clofentezine that 
will result in post-application residential exposure, aggregate 
exposure risk assessment will be limited to food and water only. The 
aggregate chronic and acute risk estimate will be based on the exposure 
from food and water only for the most highly exposed population 
subgroups and the general population as appropriate. The aggregate 
cancer risk estimate will be based on the exposure from food and water 
exposure for the U.S. general population.
    1. Acute risk. As explained previously, no toxicological endpoint 
attributable to a single exposure was identified, and therefore, EPA 
concludes

[[Page 19047]]

that clofentazine does not pose any significant acute risk.
    2. Chronic risk. Using the Theoretical Maximum Residue Contribution 
(TMRC) exposure assumptions described in this unit, EPA has concluded 
that aggregate exposure to clofentezine from food will utilize 0.2 
percent of the RfD for the U.S. population. The major identifiable 
subgroup with the highest aggregate exposure is non-nursing infants, < 
1 year old (1.4% of the RfD), discussed below. EPA generally has no 
concern for exposures below 100% of the RfD because the RfD represents 
the level at or below which daily aggregate dietary exposure over a 
lifetime will not pose appreciable risks to human health. Despite the 
potential for exposure to clofentezine in drinking water, EPA does not 
expect the aggregate exposure to exceed 100% of the RfD. EPA concludes 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to clofentezine residues.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account chronic dietary food and water 
(considered to be a background exposure level) plus indoor and outdoor 
residential exposure. Since there are currently no residential uses or 
exposure scenarios for clofentezine, no short- and intermediate-term 
aggregate risk is expected.
    4. Aggregate cancer risk for U.S. population. Clofentezine has been 
classified as a category C carcinogen as a result of three Cancer Peer 
Reviews. The upper bound cancer risk for the U.S. population subgroup 
was calculated to be 8.4  x  10-7 (based on a Q1* 
value of 0.0376 (mg/kg/day)-1). The cancer risk is below the 
Agency's current level of concern. The estimated average concentrations 
of clofentezine in surface and ground water are less than EPA's DWLOC 
for clofentezine as a contribution to cancer aggregate exposure. 
Therefore, EPA concludes with reasonable certainty that residues of 
clofentezine in drinking water do not contribute significantly to the 
aggregate cancer human health risk at the present time considering the 
present uses and uses proposed in this action.
EPA bases this determination on a comparison of estimated 
concentrations of clofentezine in surface waters and ground waters to 
DWLOCs for clofentezine. The estimates of clofentezine in surface and 
ground waters 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 a pesticide's uses, DWLOCs may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impact of 
clofentezine on drinking water as a part of the aggregate cancer risk 
assessment process.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to clofentezine residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children--i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of clofentezine, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a 2-generation 
reproduction study in the rat. The developmental toxicity studies are 
designed to evaluate adverse effects on the developing organism 
resulting from maternal pesticide exposure gestation. Reproduction 
studies provide information relating to effects from exposure to the 
pesticide on the reproductive capability of mating animals and data on 
systemic toxicity.
    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 pre- and post-natal toxicity and the 
completeness of the database 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. EPA believes that reliable data support 
using the standard uncertainty factor (usually 100 for combined inter- 
and intra-species variability) and not the additional tenfold MOE/
uncertainty factor when EPA has a complete data base under existing 
guidelines and when the severity of the effect in infants or children 
or the potency or unusual toxic properties of a compound do not raise 
concerns regarding the adequacy of the standard MOE/safety factor.
    There are no data gaps in the consideration of FQPA safety factor. 
The available studies showed no evidence of an increased susceptibility 
of fetus/pups in the developmental toxicity or reproductive studies. 
There was no evidence of neurotoxicity in any of the available 
toxicology studies. There were no exposure or toxicity data gaps 
critical to the assessment of the potential hazard to infants and 
children. The 10x factor for infants and children was removed as there 
were no developmental effects on offspring in developmental rat and 
rabbit studies at or above the limit dose of 1.0 gram/kg/day and there 
were no reproductive or pre- or post-developmental effects in a two-
generation study. Clofentezine is not related to any known neurotoxic 
agent and there is no evidence in the subchronic or chronic studies 
that this chemical causes neurotoxic effects. Based on the current data 
set no developmental neurotoxicity study was required.
    In conclusion, the FQPA safety factor was removed since: (1) The 
toxicology database 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) 
EPA screening models are used for ground and surface source drinking 
water exposure assessments resulting in estimates that are upper-bound 
concentrations; and (5) there are currently no registered residential 
uses of clofentezine.
    2. Acute risk. As explained previously, no toxicological endpoint 
attributable to a single exposure was identified, and therefore, EPA 
concludes that clofentazine does not pose any significant acute risk.
    3. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to clofentezine from 
food will utilize 1.4 percent of the RfD for infants and children. EPA 
generally has no concern for exposures below 100% of the RfD because 
the RfD represents the level at or below which daily aggregate dietary 
exposure over a lifetime will not pose appreciable risks to human 
health. Despite the potential for exposure to clofentezine in drinking 
water, EPA does not expect the aggregate exposure to exceed 100% of the 
RfD.
    4. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to clofentezine 
residues.

III. Other Considerations

A. Metabolism In Plants and Animals

    The nature of the residue in both plants and animals is adequately 
understood. In plants, the only residue

[[Page 19048]]

of concern is the parent, clofentezine. In animals, the residues of 
concern are the combined residues of the parent, clofentezine, and the 
4-hydroxyclofentezine metabolite.
    1. Plants. Apple metabolism studies with radiolabeled clofentezine 
were conducted. C14-Clofentezine was applied to apples at 
doses equivalent to 1.5X and 12X the maximum proposed rate. The fruit 
were harvested at maturity (25 and 64 days after treatments). The 
apples were separated into peel and flesh, and each was analyzed for 
clofentezine residues. Sixty-five to 84% of the extractable activity 
was the parent compound, 4% was 2-chlorobenzonitrile, and 8.5% was a 
combination of several minor polar components (no single component was 
greater than 4% of the activity). Approximately 90 to 96% of the TRR 
remained in the peel. About 4 to 11% was fiber bound, and the remainder 
was solvent-extractable activity. In plants, the only residue of 
concern is the parent, clofentezine.
    2. Animals. A bovine metabolism study was conducted. 
14C-clofentezine was orally administered to a lactating cow 
at a rate of 2.21 mg/kg/day over a 3-day period. In milk samples 
radioactivity showed up within 8 hours and by 26 hours reached 
approximately 0.20 ppm 14C-clofentezine. The residues ranged 
from 0.144 to 0.175 ppm over the following 3 days. The dominant 
metabolite was 4-hydroxyclofentezine 75% of the TRR, the remaining 25% 
of the TRR was not identified. Analysis of the liver, kidneys, renal 
fat, subcutaneous fat, and muscle showed 14C-clofentezine 
equivalents of 0.76, 0.36, 0.26, and 0.02 ppm, respectively. Free or 
unbound 4-hydroxyclofentezine comprised of 67, 83, and 90% of the 
liver, kidney, and fat residue. The residues of concern are the 
combined residues of the parent and the 4-hydroxyclofentezine 
metabolite.

B. Analytical Enforcement Methodology

     A HPLC analytical method for the determination of clofentezine 
residues in/on apples was submitted with PP 3F3392. A PMV was 
successfully completed by ACL, and the method was found acceptable. The 
Limit of Quantitation (LOQ) and Minimum Detection Limit (MDL) were 
determined to be 0.01 ppm and 0.003 ppm, respectively. EPA concluded 
that the method was suitable for enforcement purposes. The method was 
forwarded to FDA for inclusion in PAM-II.

C. Magnitude of Residues

    EPA previously determined that existing meat/milk tolerances would 
be adequate to support a proposed 10 ppm tolerance for apple pomace (PP 
9F3705). No increases in the established meat/milk tolerances are 
required to support the recommended tolerance of 3.0 ppm for apple 
pomace.
    Apple pomace does not constitute a significant portion of the 
poultry diet; therefore, poultry feeding studies and tolerances have 
not been required.
    Data from a crop field trial study indicated that residues ranged 
from < 0.01 to 0.44 ppm. Therefore, the proposed tolerance level for 
apples, 0.5 ppm, is appropriate.
     Processed residue data showed that clofentazine can concentrate by 
a factor of 5.8 in wet pomace. The appropriate tolerance level for 
pomace is thus 3.0 ppm (5.8 x 0.44 ppm = 2.5 ppm, rounded up to 3.0).

D. International Residue Limits

    There is a Codex MRL of 0.5 ppm for the parent compound 
clofentezine on pome fruit at 0.5 ppm. A Canadian tolerance of 0.5 ppm 
has been established for clofentezine and the 2-chlorobenzoyl 
metabolite on apples. Tolerance compatibility problems do not exist 
with respect to the Codex MRL, but do exist with respect to the 
Canadian MRL. As EPA has concluded the submitted residue chemistry data 
support tolerances based on the parent only, it is not appropriate to 
harmonize the proposed tolerance for residues of clofentezine in/on 
apples with the Canadian MRL.

IV. Conclusion

    Therefore, the tolerance is established for residues of 
clofentezine in or on apples at 0.5 ppm and apple pomace at 3.0 ppm.

V. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation as was provided in 
the old section 408 and in section 409. However, the period for filing 
objections is 60 days, rather than 30 days. EPA currently has 
procedural regulations which govern the submission of objections and 
hearing requests. These regulations will require some modification to 
reflect the new law. However, until those modifications can be made, 
EPA will continue to use those procedural regulations with appropriate 
adjustments to reflect the new law.
    Any person may, by June 18, 1999, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given under the ``ADDRESSES'' section (40 
CFR 178.20). A copy of the objections and/or hearing requests filed 
with the Hearing Clerk should be submitted to the OPP docket for this 
regulation. The objections submitted must specify the provisions of the 
regulation deemed objectionable and the grounds for the objections (40 
CFR 178.25). Each objection must be accompanied by the fee prescribed 
by 40 CFR 180.33(i). 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 tolerance objection fee waivers, 
contact James Tompkins, Registration Division (7505C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, (703) 305-5697, [email protected]. Requests for 
waiver of tolerance objection fees should be sent to James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460.
    If a hearing is requested, the objections must include a statement 
of the factual issues on which a hearing is requested, the requestor's 
contentions on such issues, and a summary of any evidence relied upon 
by the requestor (40 CFR 178.27). A request for a hearing will be 
granted if the Administrator determines that the material submitted 
shows the following: There is 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 in the 
manner sought by the requestor would be adequate to justify the action 
requested (40 CFR 178.32). 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.

[[Page 19049]]

VI. Public Record and Electronic Submissions

     EPA has established a record for this regulation under docket 
control number [OPP-300843] (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Room 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
     Objections and hearing requests may be sent by e-mail directly to 
EPA at:

     [email protected].

     E-mailed objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption.
     The official record for this regulation, as well as the public 
version, as described in this unit will be kept in paper form. 
Accordingly, EPA will transfer any copies of objections and hearing 
requests received electronically into printed, paper form as they are 
received and will place the paper copies in the official record which 
will also include all comments submitted directly in writing. The 
official record is the paper record maintained at the Virginia address 
in ``ADDRESSES'' at the beginning of this document.

VII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    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). 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) (Pub. L. 104-4). Nor does 
it require any prior consultation as specficed by Executive Order 
12875, entitled Enhancing the Intergovernmental Partnership (58 FR 
58093, October 28, 1993), or special considerations as required by 
Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), or require OMB review in 
accordance with Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997).
    In addition, 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. Nevertheless, the Agency previously 
assessed whether establishing tolerances, exemptions from tolerances, 
raising tolerance levels or expanding exemptions might adversely impact 
small entities and concluded, as a generic matter, that there is no 
adverse economic impact. The factual basis for the Agency's generic 
certification for tolerance actions published on May 4, 1981 (46 FR 
24950), and was provided to the Chief Counsel for Advocacy of the Small 
Business Administration.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local or tribal government, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments. If the mandate is unfunded, EPA 
must provide to OMB a description of the extent of EPA's prior 
consultation with representatives of affected State, local, and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local, and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's rule does not create an unfunded Federal mandate on State, 
local, or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide OMB, in a separately identified 
section of the preamble to the rule, a description of the extent of 
EPA's prior consultation with representatives of affected tribal 
governments, a summary of the nature of their concerns, and a statement 
supporting the need to issue the regulation. In addition, Executive 
Order 13084 requires EPA to develop an effective process permitting 
elected officials and other representatives of Indian tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory policies on matters that significantly or uniquely affect 
their communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do 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 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 the rule in the Federal Register. This 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.



[[Page 19050]]


    Dated: April 8, 1999.

James Jones,

Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

     2. Section 180.446 is amended as follows:
    a. By adding a paragraph heading to paragraph (a).
    b. By redesignating paragraphs (b) and (c) as paragraphs (a)(1) and 
(a)(2), respectively.
    c. By amending newly designated paragraph (a)(1) by adding 
alphabetically to the table the commodity ``apple pomace'' and revising 
the tolerance for ``apples''.
    d. By adding and reserving with paragraph headings new paragraphs 
(b), (c) and (d).
    The added and revised portions read as follows:


Sec. 180.446  Clofentezine; tolerances for residues.

    (a) General. *  *  *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
 
                          *    *    *    *    *
Apple pomace.........................................                3.0
Apples...............................................                0.5
                          *    *    *    *    *
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 99-9710 Filed 4-16-99; 8:45 am]
BILLING CODE 6560-50-F