FR Doc 02-30472

[Federal Register: December 4, 2002 (Volume 67, Number 233)]
[Rules and Regulations]
[Page 72104-72110]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04de02-9]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0005; FRL-7279-5]

Pyrithiobac Sodium (sodium 2-chloro-6-[(4,6-dimethoxypyrimidin-2-
yl)thio]benzoate); Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
pyrithiobac sodium (sodium 2-chloro-6-[(4,6-dimethoxypyrimidin-2-
yl)thio]benzoate) in or on cotton, undelinted seed and cotton gin
byproducts. DuPont Agricultural Products, Wilmington, DE requested this
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act (FQPA) of 1996.

DATES: This regulation is effective December 4, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0005,
must be received on or before February 3, 2003.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number OPP-2002-0005 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: James A. Tompkins, Product
Manager (PM) 25, Registration Division 7505C, Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 305-5697; e-mail address:
tompkins.jim@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------

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

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

1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2002-0005. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. A frequently updated
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/4
0cfr180--00.html, a
beta site currently under development. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.

II. Background and Statutory Findings

In the Federal Register of September 24, 1997 (62 FR 49979) (FRL-
5745-8), EPA issued a notice pursuant to section 408 of the FFDCA, 21
U.S.C. 346a, as amended by the FQPA of 1996 (Public Law 104-170),
announcing the filing of a pesticide petition PP 4F4391 by DuPont
Agricultural Products, Wilmington, DE. This notice included a summary
of the petition prepared by DuPont Agricultural Products, the
registrant. There were no comments received in response to the notice
of filing.
The petition requested that 40 CFR 180.487 be amended by
establishing a tolerance for residues of the herbicide pyrithiobac
sodium, (sodium 2-chloro-6-[(4,6-dimethoxypyrimidin-2-
yl)thio]benzoate), in or on cotton, undelinted seed at 0.02 parts per
million (ppm) and cotton gin byproducts at 0.1 ppm. The Registrant
subsequently amended the petition by

[[Page 72105]]

increasing the tolerance request for cotton gin byproducts to 0.15 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances November 26, 1997, (62 FR 62961) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for a tolerance for residues of pyrithiobac sodium on
cotton, undelinted seed at 0.02 ppm and cotton gin byproducts at 0.15
ppm. EPA's assessment of exposures and risks associated with
establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by pyrithiobac sodium
are discussed below. This discussion refers to the no observed effect
level (NOEL) and the lowest observed effect level (LOEL) from the
toxicity studies reviewed rather than the no observed adverse effect
level (NOAEL) and the lowest observed adverse effect level (LOAEL)
because the toxicity studies for pyrithiobac sodium were reviewed prior
to adoption in 1998 of the NOAEL/LOAEL terminology by EPA's Office of
Pesticide Programs (OPP) and its Health Effects Division (HED). At the
time of the switch to the revised terminology, HED noted that the new
terminology was unlikely to have any substantive effect on its hazard
evaluations: ``In a practical sense, the terms NOEL and NOAEL have been
used interchangeably in OPP. As a general rule, OPP would consider as
appropriate for hazard identification and risk assessment only those
effects which are adverse or potentially adverse. This inclusion of the
term NOAEL should not change any of our hazard endpoints for regulation
but add to the quality of the risk assessment.'' HED Standard Operating
Procedure (SOP) 98.3
1. A rat acute oral study with a LD50 of 3,300
milligrams/kilogram (mg/kg) for males and a LD50 of 3,200
mg/kg for females.
2. A 90-day rat feeding study with a NOAEL of 50 parts per million
(ppm) (3.25 mg/kg/day for males and 4.14 mg/kg/day for females) and a
LOAEL of 500 ppm (31.8 mg/kg/day for males and 40.5 mg/kg/day for
females based on decrease body weight gains and increased rate of
hepatic beta-oxidation in males.
3. A 90-day mouse feeding study with a NOAEL of 500 ppm (83.1 mg/
kg/day for males and 112 mg/kg/day for females) and a LOAEL of 1,500
ppm (263 mg/kg/day for males and 384 mg/kg/day for females) based on
increased liver weight and an increased incidence of hepatocellular
hypertrophy in males and decreased neutrophil count in females.
4. A 3-month dog feeding study with a NOAEL of 5,000 ppm (165 mg/
kg/day) and a LOAEL of 20,000 ppm (626 mg/kg/day), based on decrease
red blood cell count, hemoglobin, and hematocrit in females and
increased liver weight in both sexes.
5. A 21-day rat dermal study with a Dermal Irritation NOAEL of 50
mg/kg/day and, a Dermal Irritation LOAEL of 500 mg/kg/day based on
increased incidence of erythema and edema, and with a Systemic Dermal
NOAEL of 500 mg/kg/day and a Systemic Dermal LOAEL of 1,200 mg/kg/day
based on body weight gain inhibition.
6. A 90-day rat neurotoxicity screening battery with a Systemic
NOAEL of 7,000 ppm (466 mg/kg/day for males and 588 mg/kg/day for
females) and a Systemic LOAEL of 20,000 ppm (1,376 mg/kg/day for males
and 1,609 mg/kg/day for females), based on deceased hind grip strength
and increased foot spay in males, and a Neurotoxicity NOAEL of 20,000
ppm highest dose tested (HDT).
7. A 78-week dietary carcinogenicity study in mice with a NOAEL of
1,500 ppm 217 mg/kg/day (males) and 319 mg/kg/day (females) and a LOAEL
of 5,000 ppm 745 mg/kg/day (males) and 1,101 mg/kg/day (females) based
on decreased body weight gain in both sexes, treatment related increase
in the incidence of foci/focus of hepatocellular alternation in males,
and increased incidence of glomerulonephropathy (murine) in both sexes,
and an increased incidence of infarct in the kidney and keratopathy of
the eyes. There was evidence of carcinogenicity based on significant
differences in the pair-wise comparisons of hepatocellular adenomas and
combined adenoma/carcinoma in the 150 ppm and 1,500 ppm dose groups
(but not at the high dose of 5,000 ppm) with the controls. The
carcinogenic effects observed are discussed below.
8. A 23-month rat chronic toxicity/carcinogenicity study with a
Systemic NOAEL of 1,500 ppm (58.7 mg/kg/day) for males and 5,000 ppm
(278 mg/kg/day) for females, and with a Systemic LOAEL of 5,000 ppm
(200 mg/kg/day) for males and 15,000 ppm (918 mg/kg/day) for females,
based on deceased body weight, body weight gain and food efficiency for
females, the increased incidence of eye lesions in both sexes, mild
changes in hematology and urinalysis in both sexes, clinical signs
suggestive of urinary tract dysfunction in males and females, increased
incidence of focal cystic degeneration in the liver in males, increased
rate of hepatic peroxisomal beta-oxidation in males and an increased
incidence of inflammatory and degenerative lesions in the kidney in
females. There was evidence of carcinogenicity based on significant
dose-related increasing trend in kidney tubular combined adenoma/
carcinoma in male rats and a significant dose related increasing trend
in kidney tubular bilateral and/or unilateral adenomas in females. The
carcinogenic effects observed are discussed further below.
9. A 1-year dog chronic toxicity study with a NOAEL of 5,000 ppm
(143 mg/kg/day for males and 166 mg/kg/day for females) and a LOAEL of
20,000 ppm (580 mg/kg/day for males and 647 mg/kg/day for females)
based on decreases in body weight gain, increase thyroid

[[Page 72106]]

and liver weights, and microscopic findings in the liver and kidneys.
10. A 2-generation reproduction study in rats with a NOAEL for
maternal toxicity of 1,500 ppm (103 mg/kg/day) and a maternal LOAEL of
7,500 ppm (508 mg/kg/day), based on decreased body weight, body weight
gain and food efficiency. The NOAEL for paternal toxicity is 1,500 ppm
(86 mg/kg/day), while the LOAEL is 7,500 ppm (439 mg/kg/day), based on
decreased body weight, body weight gain and food efficiency. The NOAEL
for reproductive effects can be set at 7,500 ppm (508 mg/kg/day), the
LOAEL at 20,000 ppm (1,551 mg/kg/day), based on decreased pup body
weight. The NOAEL for effects on offspring is 7,500 ppm (508 mg/kg/
day), and the LOAEL at 20,000 ppm (1,551 mg/kg/day), based on decreased
pup body weight.
11. A 13-day dosing (gestation days 7-19) developmental toxicity
study in rabbits with a maternal NOAEL of 300 mg/kg and a maternal
LOAEL of 1,000 mg/kg based on deaths, decreased body weight gain and
feed consumption, and an increase in early resorptions. There is
developmental toxicity observed at 1,000 mg/kg based on decreased fetal
body weights.
12. A 10-day dosing (gestation days 7-16) developmental toxicity
study in rats wth a maternal NOAEL of 200 mg/kg and maternal LOAEL of
600 mg/kg due to increased incidence of peritoneal staining. The
developmental NOAEL is 600 mg/kg and the developmental LOAEL is 1,800
mg/kg based on the increased incidence of skeletal variations.
13. No evidence of gene mutation was observed in a test for
induction of forward mutations at the hypoxanthine guanine
phophoribosyl transferase (HGPRT) locus in Chinese hamster ovary cells.
No evidence was observed for inducing reverse gene mutation in two
independent assays with Salmonella typhimurium with and without
mammalian metabolic activation. Pyrithiobac sodium was negative for the
induction of micronuclei in the bone marrow cells of mice, and negative
for induction of unscheduled DNA synthesis in rat primary hepatocytes.
Pyrithiobac sodium was positive for inducing chromosome aberrations
assay in human lymphocytes.
14. A rat metabolism study showed that radio labeled pyrithiobac
sodium is excreted in urine and feces with >90% being eliminated within
48 hours. A sex difference was observed in the excretion and
biotransformation. Females excreted a greater amount of the radiolabel
in the urine than males following all regimens, with a corresponding
lower amount being eliminated in the feces compared to the males.

B. Toxicological Endpoints

The dose at which the NOAEL from the toxicology study identified as
appropriate for use in risk assessment is used to estimate the
toxicological level of concern (LOC). However, the LOAEL at which
effects of concern are identified is sometimes used for risk assessment
if no NOAEL was achieved in the toxicology study selected. An
uncertainty factor (UF) is applied to reflect uncertainties inherent in
the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10⁶ or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for pyrithiobac sodium used for human risk assessment is as
follows:
1. Acute toxicity. EPA has concluded that no endpoint exists to
suggest any evidence of significant toxicity from 1-day or single-event
exposure.
2. Short-term and intermediate-term toxicity. EPA has concluded
that available evidence does not indicate any evidence of significant
toxicity from short-term and intermediate-term exposure.
3. Chronic toxicity. EPA has established the RfD for pyrithiobac
sodium at 0.587 mg/kg/day. This RfD is based on the systemic NOAEL of
58.7 mg/kg/day for males in the rat chronic feeding study with a 100-
fold safety factor to account for interspecies extrapolation and
intraspecies variability.
4. Carcinogenicity. EPA has concluded that the available data
provide limited evidence of the carcinogenicity of pyrithiobac sodium
in mice and rats and has classified pyrithiobac sodium as a Group C
(possible human carcinogen with limited evidence of carcinogenicity in
animals) in accordance with Agency guidelines, published in the Federal
Register of (September 24, 1986, 51 FR 33992) and recommended that for
the purpose of risk characterization a low dose extrapolation model
should be applied to the experimental animal tumor data for
quantification for human risk (Q^1*). This decision was based
on liver adenomas, carcinomas and combined adenoma/carcinomas in the
male mouse and rare kidney tubular adenomas, carcinomas and combined
adenoma/carcinomas in male rats. The unit risk, Q^1* (mg/kg/
day)-1, of pyrithiobac sodium is 1.05 x 10-3 (mg/kg/day)-1 in human
equivalents based on male kidney tumors.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Permanent tolerances
have been requested to replace the time limited tolerance in/on
cottonseed 40 CFR 180.487 at 0.02 ppm, and a new tolerance for the
residues of pyrithiobac sodium, in or on cotton gin byproducts at 0.1
ppm. The requested tolerance for cotton gin byproducts has been amended
to 0.15 ppm based on the results of the submitted field residue trials,
and cottonseed was changed to cotton, undelinted seed. Processing
studies for cotton have shown that

[[Page 72107]]

pyrithiobac sodium does not concentrate in cottonseed processed food/
feed commodities. No requested tolerances were necessary for meat,
milk, and eggs because detectible residues are not expected in these
commodities from this use on cotton. Risk assessments were conducted by
EPA to assess dietary exposures from pyrithiobac sodium in food as
follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1-day or
single exposure. EPA has concluded that no endpoint exists to suggest
any evidence of significant toxicity from one-day or single-event
exposure; therefore, an acute exposure assessment is not applicable.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM^TM
analysis evaluated the individual food consumption as reported by
respondents in the Department of Argiculture (USDA) 1989-1992
nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and
accumulated exposure to the chemical for each commodity. EPA assumed
that all commodities for which tolerances exist and all cotton food
commodities had pyrithiobac sodium residues at the appropriate
tolerance level.
iii. Cancer. The cancer exposure assessment relied upon the same
data and assumptions as the chronic exposure assessment.
iv. Anticipated residue and percent crop treated (PCT) information.
Tolerance level residues and treatment of 100% of the crop was assumed.
Anticipated residues and PCT information was not used.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for pyrithiobac sodium in
drinking water. Because the Agency does not have comprehensive
monitoring data, drinking water concentration estimates are made by
reliance on simulation or modeling taking into account data on the
physical characteristics of pyrithiobac sodium.
The Agency uses the GENEEC or the PRZM/EXAMS to estimate pesticide
concentrations in surface water and SCI-GROW, which predicts pesticide
concentrations in ground water. In general, EPA will use GENEEC (a tier
1 model) before using PRZM/EXAMS (a tier 2 model) for a screening-level
assessment for surface water. The GENEEC model is a subset of the PRZM/
EXAMS model that uses a specific high-end runoff scenario for
pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS
incorporate an index reservoir environment in place of the previous
pond scenario. The PRZM/EXAMS model includes a percent crop (PC) area
factor as an adjustment to account for the maximum PC coverage within a
watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to pyrithiobac sodium they are
further discussed in the aggregate risk sections in Unit E.
Based on the GENEEC and SCI-GROW models the EECs of pyrithiobac
sodium for chronic exposures are estimated to be 7.76 parts per billion
(ppb) for surface water and 0.778 ppb for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Pyrithiobac sodium is not registered for use on any sites that
would result in residential exposure.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether pyrithiobac sodium 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,
pyrithiobac sodium 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 pyrithiobac sodium 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
(November 26, 1997, 62 FR 62961).

D. Safety Factor for Infants and Children

1. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for pre-natal and post-natal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
2. Pre-natal and post-natal sensitivity. In a preliminary review,
EPA concluded that data do not indicate that there is a significant
potential for reproductive or developmental effects from pyrithiobac
sodium as tested.
3. Conclusion. There is a complete toxicity data base for
pyrithiobac sodium and exposure data are complete or are estimated
based on data that reasonably accounts for potential exposures.
Pyrithiobac sodium has not been formally reviewed by the Agency
regarding the need to retain the additional 10X safety factor for the
protection of infants and children. Thus, despite the completeness of
the database and the lack of any indication of significant potential
for reproductive or developmental effects, EPA has retained the
additional 10X safety factor until a full review can be completed.
Retention of the additional safety factor yields a

[[Page 72108]]

cPAD for pyrithiobac sodium of 0.0587 mg/kg/day.

E. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by EPA Office of Water are used to calculate DWLOCs: 2L/
70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child).
Default body weights and drinking water consumption values vary on an
individual basis. This variation will be taken into account in more
refined screening-level and quantitative drinking water exposure
assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
Pyrithiobac sodium is not registered for use on any sites that
would result in residential exposure. Therefore, the aggregate risk is
the sum of the risk from food and water.
1. Acute risk. EPA has concluded that no endpoint exists to suggest
any evidence of significant toxicity from acute exposures from the use
of pyrithiobac sodium on cotton.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
pyrithiobac sodium from food and water will utilize less than 0.2% of
the cPAD for the U.S. population, and less than 0.2% of the cPAD for
children 1 to 6 years at greatest exposure to both food and water.
There are no residential uses for pyrithiobac sodium that result in
chronic residential exposure to pyrithiobac sodium. EPA generally has
no concern for exposures below 100% of the cPAD because the cPAD
represents the level at or below which aggregate dietary exposure over
a lifetime will not pose appreciable risks to human health. Due to the
low exposure for the U.S. population (less than 0.2%) and for children
1 to 6 years (less than 0.2%) for both food and water, the calculated
DWLOC is approximately equal to the cPAD.
3. Short-term risk. EPA has concluded that no endpoint exists to
suggest any evidence of significant toxicity from short-term exposures
from the use of pyrithiobac sodium on cotton.
4. Intermediate-term risk. EPA has concluded that no endpoint
exists to suggest any evidence of significant toxicity from
intermediate-term exposures from the use of pyrithiobac sodium on
cotton.
5. Aggregate cancer risk for U.S. population. Based on the upper
bound potency factor (Q*1) of 1.05 x 10-3 (mg/kg/day)-1, the aggregate
upper bound lifetime cancer risk from the use of pyrithiobac sodium on
cotton from worst case estimates of residues in food and drinking water
is 2.3 x 10-7.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to pyrithiobac sodium residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology high performance liquid
chromotography using ultra-violent detection (HPLC-UV) with column
switching) is available to enforce the tolerance expression. The method
may be requested from: Paul Golden, U.S. Environmental Protection
Agency, Office of Pesticide Programs, BEAD, ACB, Environmental Science
Center, 701 Mapes Road Fort Meade, MD 20755-5350; Telephone (410) 305-
2960.

B. International Residue Limits

There are no established Codex maximum residue levels (MRLs) for
pyrithiobac sodium on cottonseed. An established Mexican tolerance for
pyrithiobac sodium on cottonseed is identical to the U.S. tolerance.
Compatibility of tolerance levels is not an issue at this time.

C. Conditions

There are no conditions. Adequate residue data has been submitted
to support the tolerances established in this Federal Register Notice.

V. Conclusion

Therefore, the tolerance is established for residues of pyrithiobac
sodium, (sodium 2-chloro-6-[(4,6-dimethoxypyrimidin-2-
yl)thio]benzoate), in or on cotton, undelinted seed at 0.02 ppm and
cotton gin byproducts at 0.15 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2002-0005 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before February
3, 2003.

[[Page 72109]]

1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket ID number OPP-2002-0005, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

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

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Regulatory Assessment Requirements

This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitledRegulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this rule does not have

[[Page 72110]]

any ``tribal implications'' as described in Executive Order 13175,
entitled Consultation and Coordination with Indian Tribal Governments
(65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government andIndian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.

VIII. Submission to Congress and the Comptroller General

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

List of Subjects in 40 CFR Part 180

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

Dated: November 8, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

Authority: 21 U.S.C. 321(q), 346(a) and 374.

2. Section 180.487 paragraph (a) is revised to read as follows:

Sec. 180.487 Pyrithiobac sodium; tolerances for residues.

(a) General. Tolerances are established for residues of the
herbicide, pyrithiobac sodium, (sodium 2-chloro-6-[(4,6-
dimethoxypyrimidin-2-yl)thio]benzoate), resulting from the application
of the pesticide chemical in or on the following foods/feeds:

----------------------------------------------------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
Cotton gin byproducts................................. 0.15
Cotton, undelinted seed............................... 0.02
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 02-30472 Filed 12-3-02; 8:45 am]

BILLING CODE 6560-50-S