[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]
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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.
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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: opp-docket@epa.gov. 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:
perreault.peg@epa.gov.
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="">-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="">1* 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="">-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,="">tompkins.jim@epa.gov. 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:
opp-docket@epa.gov.
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
