Halosulfuron-methyl; Pesticide Tolerances for Emergency Exemptions

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: December 27, 2001 (Volume 66, Number 248)]
[Rules and Regulations]
[Page 66778-66786]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27de01-24]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301197; FRL-6816-1]
RIN 2070-AB78

Halosulfuron-methyl; Pesticide Tolerances for Emergency
Exemptions

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for
residues of Halosulfuron-methyl in or on asparagus. This action is in
response to EPA's granting of an emergency exemption under section 18
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
authorizing use of the pesticide on asparagus. This regulation
establishes a maximum permissible level for residues of halosulfuron-
methyl in this food commodity. The tolerance will expire and is revoked
on December 31, 2003.

DATES: This regulation is effective December 27, 2001. Objections and
requests for hearings, identified by docket control number OPP-301197,
must be received by EPA on or before February 25, 2002.

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 VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301197 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Meredith Laws, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 308-9366; and e-mail address:
laws.meredith@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected 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. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html , a beta site currently
under development.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301197. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA,
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing a tolerance for residues of the herbicide
halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidinyl)
amino]carbonylaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-
carboxylate, in or on asparagus at 2.0 parts per million (ppm). This
tolerance will expire and is revoked on 12/31/03. EPA will publish a
document in the Federal Register to remove the revoked tolerance from
the Code of Federal Regulations (CFR).

[[Page 66779]]

Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
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. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by the Food Quality Protection Act (FQPA). EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Halosulfuron-methyl on Asparagus and
FFDCA Tolerances

Washington, Idaho and Oregon requested the use of halosulfuron-
methyl to control nutsedge infesting asparagus fields. Michigan
requested the use of halosulfuron-methyl to control nutsedge and
pigweed infesting asparagus fields. In the Pacific Northwest nutsedge
has spread throughout the asparagus growing region and has been
declared a Class B noxious weed in Washington. Asparagus growers are
especially vulnerable to nutsedge because of the difficulty in
controlling a perennial monocot weed in a perennial monocot crop. The
information provided by the four applicant states indicates that
nutsedge is reducing asparagus yields and reducing the life span of the
crop. EPA agrees that heavily infested fields can have severe yield
losses. Additionally, EPA expects that yield reductions in Michigan due
to redroot pigweed could be quite high due to coverage of the crop
during the harvest period. EPA has authorized under FIFRA section 18
the use of halosulfuron-methyl on asparagus for control of nutsedge in
Washington, Idaho, Oregon and Michigan and also for control of pigweed
in Michigan. After having reviewed the submissions, EPA concurs that
emergency conditions exist for these States.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of halosulfuron-methyl in or
on asparagus. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the safety standard
and with FIFRA section 18. Consistent with the need to move quickly on
the emergency exemption in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
comment as provided in section 408(l)(6). Although this tolerance will
expire and is revoked on December 31, 2003, under FFDCA section
408(l)(5), residues of the pesticide not in excess of the amounts
specified in the tolerance remaining in or on asparagus after that date
will not be unlawful, provided the pesticide is applied in a manner
that was lawful under FIFRA, and the residues do not exceed a level
that was authorized by this tolerance at the time of that application.
EPA will take action to revoke this tolerance earlier if any experience
with, scientific data on, or other relevant information on this
pesticide indicate that the residues are not safe.
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether halosulfuron-
methyl meets EPA's registration requirements for use on asparagus or
whether a permanent tolerance for this use would be appropriate. Under
these circumstances, EPA does not believe that this tolerance serves as
a basis for registration of halosulfuron-methyl by a State for special
local needs under FIFRA section 24(c). Nor does this tolerance serve as
the basis for any State other than Washington, Idaho, Oregon and
Michigan to use this pesticide on this crop under section 18 of FIFRA
without following all provisions of EPA's regulations implementing
section 18 as identified in 40 CFR part 166. For additional information
regarding the emergency exemption for halosulfuron- methyl, contact the
Agency's Registration Division at the address provided under FOR
FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

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).
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
halosulfuron-methyl and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
residues of halosulfuron-methyl in or on asparagus at 2.0 ppm. EPA's
assessment of the dietary exposures and risks associated with
establishing the tolerance follows.

A. Toxicological Endpoints

The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological endpoint. However, the
lowest dose at which adverse effects of concern are identified (the
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved
in the toxicology study selected. An uncertainty factor (UF) is applied
to reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. An UF of 100
is routinely used, 10X to account for interspecies differences and 10X
for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference

[[Page 66780]]

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 facto 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 level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-\6\ or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOE_cancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for halosulfuron-methyl used for human risk assessment is
shown in the following Table 1:

Table 1.--Summary of Toxicological Dose and Endpoints for Halosulfuron-methyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary NOAEL = 50 mg/kg/day FQPA SF = 1x Developmental - rabbit
(Females 13+, Infants and Children).. UF = 100............... aPAD = acute RfD LOAEL = 150 mg/kg/day
Acute RfD = 0.5 mg/kg/ FQPA SF. based on decreased
day. = 0.5 mg/kg/day........ mean litter size,
increased resorptions,
and increased
postimplantation loss.
----------------------------------------------------------------------------------------------------------------
Acute dietary None No appropriate endpoint A dose and endpoint was
(Adult male)......................... was selected not identified for
this subpopulation
since there were no
toxicological effects
applicable to adult
males and attributable
to a single exposure
(dose) observed in
oral toxicity studies
including the
developmental toxicity
studies in rats and
rabbits.
----------------------------------------------------------------------------------------------------------------
Chronic dietary NOAEL= 10 mg/kg/day FQPA SF = 1x Chronic toxicity - dog
all populations...................... UF = 100............... cPAD =................. LOAEL = 40 mg/kg/day
Chronic RfD =.......... chronic RfD based on decrease in
0.1 mg/kg/day.......... FQPA SF. body weight gain and
= 0.1 mg/kg/day........ alterations in
hematology and
clinical chemistry
parameters
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1 to 7 days) Oral study NOAEL= LOC for MOE = Developmental - rabbit
(Residential)........................ 50 mg/kg/day (dermal 100 (Residential)...... LOAEL = 150 mg/kg/day
absorption rate = 75%). based on decreased
mean litter size,
increased resorptions,
and increased
postimplantation loss
----------------------------------------------------------------------------------------------------------------
Intermediate-term dermal (1 week to Oral study NOAEL= LOC for MOE = Chronic toxicity - dog
several months) 10 mg/kg/day (dermal 100 (Residential)...... LOAEL = 40 mg/kg/day
(Residential)........................ absorption rate = 75%. based on decrease in
body weight gain
during weeks 0-13
----------------------------------------------------------------------------------------------------------------
Long-term dermal (several months to Oral study NOAEL= LOC for MOE = Chronic toxicity - dog
lifetime) 10 mg/kg/day (dermal 100 (Residential)...... LOAEL = 40 mg/kg/day
(Residential)........................ absorption rate = 75% based on decrease in
when appropriate). body weight gain and
alterations
inhematology and
clinical chemistry
parameters
----------------------------------------------------------------------------------------------------------------
Inhalation (any time period) None - Low toxicity and use
(Residential)........................ pattern do not
indicate a need for
risk assessment for
this route.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) - - Classified as a ``Not-
likely'' human
carcinogen based on
the lack of evidence
of carcinogenicity in
male and female mice
and rats.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA.

B. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.479) for the residues of halosulfuron-methyl,
in or on a variety of raw agricultural commodities. The established
tolerances include tree nuts (crop group 14); sugarcane; corn rice and
cotton, and their associated commodities. Additionally, tolerances are
established for residues of halosulfuron-methyl and its metabolites
determined as 3-chloro-1-methyl-5-sulfamoylpyrazole-4-carboxylic acid
(also referred to as CSA, expressed as parent equivalents) in/on meat
by-products of cattle, goats, hogs, horses and sheep. Risk assessments
were conducted by EPA to assess dietary exposures from halosulfuron-
methyl in food as follows:

[[Page 66781]]

i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. The Dietary Exposure Evaluation Model
(DEEM) analysis evaluated the individual food consumption as
reported by respondents in the USDA 1989-1992 nationwide Continuing
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure
to the chemical for each commodity. The following assumptions were made
for the acute exposure assessments: A Tier 1 acute dietary exposure
analysis was conducted. The assumptions of the Tier 1 analysis were
tolerance level residues and 100 percent crop-treated for all
commodities for which halosulfuron-methyl tolerances are established
and for the section 18 subject crop (asparagus). Percent crop treated
and anticipated residues were not used.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEM analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992 nationwide
CSFII and accumulated exposure to the chemical for each commodity. The
following assumptions were made for the chronic exposure assessments: A
Tier 1 chronic dietary exposure analysis was conducted. The assumptions
of this Tier 1 analysis were tolerance level residues and 100 percent
crop-treated for all commodities for which halosulfuron-methyl
tolerances are established and for the subject section 18 crop
(asparagus). Percent crop treated and anticipated residues were not
used.
iii. Cancer. There is no evidence of carcinogenicity for
halosulfuron-methyl in the mouse or rat. EPA has classified
halosulfuron-methyl as a ``Not-Likely'' human carcinogen.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for halosulfuron-methyl 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 halosulfuron-methyl.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS)
to produce estimates of pesticide concentrations in an index reservoir.
The screening concentration in ground water (SCI-GROW) model is used to
predict pesticide concentrations in shallow ground water. For a
screening-level assessment for surface water EPA will generally use
FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The
FIRST model is a subset of the PRZM/EXAMS model that uses a specific
high-end runoff scenario for pesticides. While both FIRST and PRZM/
EXAMS incorporate an index reservoir environment, the PRZM/EXAMS model
includes a percent crop area factor as an adjustment to account for the
maximum percent crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to halosulfuron-methyl they are
further discussed in the aggregate risk sections below.
Based on the FIRST and SCI-GROW models the EECs of halosulfuron-
methyl for acute exposures are estimated to be 5.39 parts per billion
(ppb) for surface water and 0.049 ppb for ground water. The EECs for
chronic exposures based on FIRST and SCI-GROW models are estimated to
be 0.245 ppb for surface water and 0.049 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).
Halosulfuron-methyl is currently registered for use on the
following residential non-dietary sites: Residential turf. The risk
assessment was conducted using the following exposure assumptions:
Halosulfuron-methyl (trade name: ``Manage'') is a sulfonylurea
herbicide used for control of broadleaf weeds and nutsedge. Manage may
be broadcast applied at a rate of 0.031 to 0.062 lb ai/acre. For
residential handlers and postapplication activities, short-term to
intermediate-term exposures may occur. Chronic exposures (greater than
or equal to 6 months of continuous exposure) are not expected. Adults
may be dermally exposed after treatment to lawns, and children may be
exposed through dermal, hand-to-mouth and incidental oral sources.
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 halosulfuron-methyl 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,
halosulfuron-methyl 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 halosulfuron-methyl 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).

C. 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 prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in

[[Page 66782]]

calculating a dose level that poses no appreciable risk to humans.
2. Developmental toxicity studies. In a prenatal developmental
toxicity study in rats, the NOAEL for maternal toxicity was 250 mg/kg/
day and the LOAEL was 750 mg/kg/day based on increased incidence of
clinical observations (primarily alopecia and urine stains) and reduced
body weight gains, food consumption, and food efficiency. For
developmental toxicity, the NOAEL was 250 mg/kg/day and the LOAEL was
750 mg/kg/day based on decreased mean litter size, increased number of
resorptions (total and per litter), significantly decreased mean fetal
body weight, and increases in fetal and litter incidences of soft
tissue (primarily dilation of the lateral ventricles and other
anomalies in the development of the fetal nervous system) and skeletal
variations (anomalies or delays in ossification in the thoracic
vertebrae, sternebrae, and ribs). EPA noted that both the fetal and
litter incidences of dilated lateral ventricles of the brain were
statistically significant, and appeared to be dose related, since the
finding was also observed at the mid-dose in 2 fetuses of 2 litters.
Due to the lack of historical control data, it was not possible to
evaluate the biological significance of the low incidence of this
finding at the mid-dose level. EPA recommends that the study
developmental NOAEL and LOAEL as defined by the data evaluation record
not be revised at this time.
In a prenatal developmental toxicity study in the rabbit, the NOAEL
for maternal toxicity was 50 mg/kg/day and the LOAEL was 150 mg/kg/day
based on decreased body weight gain, food consumption, and food
efficiency. For developmental toxicity, the NOAEL was 50 mg/kg/day and
the LOAEL was 150 mg/kg/day based on decreased mean litter size,
increased number of resorptions (total and per dam) and increased
postimplantation loss. EPA notes that these developmental findings,
while not statistically significant, define a consistent pattern of
effect. The developmental NOAEL is 50 mg/kg/day based on decreased mean
litter size, increased number of resorptions (total and per dam) and
increased postimplantation loss at 150 mg/kg/day (LOAEL). EPA
recommends that this dose and effect be used for assessing acute
dietary risks for the sub-populations, Females 13+ as well as Infants
and Children. Although the endpoint is developmental toxicity occurring
in utero, and thus may not be suitable for use in risk assessment for
Infants and Children, EPA determined that it is appropriate to use for
this subpopulation (infants and children) because there is evidence of
alteration to the development of the fetal nervous system in the
developmental study in rats (see above). Thus, EPA determined that
potential effects on functional development mandate the use of this
endpoint for females of child bearing age (Females 13+) as well as for
infants and children. This endpoint is not applicable for adult males.
A dose and endpoint was not identified for this subpopulation since
there were no toxicological effects applicable to adult males and
attributable to a single exposure (dose) observed in oral toxicity
studies including the developmental toxicity studies in rats and
rabbits.
3. Reproductive toxicity study. In the 2-generation reproduction
study in rats, effects in the offspring were observed only at or above
treatment levels which resulted in evidence of parental toxicity.
4. Prenatal and postnatal sensitivity. There was no evidence of
increased susceptibility of rats or rabbits to in utero and/or
postnatal exposure to halosulfuron-methyl. In the prenatal
developmental toxicity studies in rats and rabbits and the 2-generation
reproduction study in rats, effects in the offspring were observed only
at or above treatment levels which resulted in evidence of parental
toxicity.
5. Conclusion. There is a complete toxicity data base for
halosufuron-methyl and exposure data are complete or are estimated
based on data that reasonably accounts for potential exposures. EPA
determined that the 10X safety factor to protect infants and children
should be removed. The FQPA factor is removed because there was no
indication of increased susceptibility of rats or rabbits to in utero
and/or postnatal exposure to halosulfuron-methyl. In the prenatal
developmental toxicity studies in rats and rabbits and the 2-generation
reproduction study in rats, effects in the offspring were observed only
at or above treatment levels which resulted in evidence of parental
toxicity. EPA determined that the requirement of a developmental
neurotoxicity study in rats did not warrant an application of
additional safety factors because: (a) The alterations in the fetal
nervous system occurred in only one species (in rats and not in
rabbits); (b) the fetal effects which will be investigated in the
required developmental neurotoxicity study were seen only at a dose of
750 mg/kg/day which is close to the Limit-Dose (1,000 mg/kg/day); (c)
there was no evidence of clinical signs of neurotoxicity, brain weight
changes, or neuropathology in the subchronic or chronic studies in
rats; (d) the developmental neurotoxicity study is required only as
confirmatory data to understand what the effect is at a high exposure
(dose) level.

D. 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 + chronic non-dietary, non-occupational exposure).
This allowable exposure through drinking water is used to calculate a
DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and groundwater are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to halosulfuron-methyl 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 EPA 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 halosulfuron-methyl on drinking water as a part of the aggregate
risk assessment process.

[[Page 66783]]

1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
halosulfuron-methyl will occupy < 1.0% of the aPAD for females 13 years
and older, 1.0% of the aPAD for All Infants, < 1 year old and < 1.0% of
the aPAD for Children, 1-6 years old. In addition, despite the
potential for acute dietary exposure to halosulfuron-methyl in drinking
water, after calculating DWLOCs and comparing them to conservative
model EECs of halosulfuron-methyl in surface and ground water, EPA does
not expect the aggregate exposure to exceed 100% of the aPAD, as shown
in the following Table 2:

Table 2.--Aggregate Risk Assessment for Acute Exposure to Halosulfuron-methyl
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
All infants.................................... 0.50 1.0 5.39 0.049 5,000
Females, 13-50 years........................... 0.50 <1.0 5.39 0.049 15,000
Children, 1-6 years............................ 0.50 <1.0 5.39 0.049 5,000
----------------------------------------------------------------------------------------------------------------

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
halosulfuron-methyl from food will utilize < 1.0% of the cPAD for the
U.S. population, < 1.0% of the cPAD for All infants, < 1 year old and <
1.0% of the cPAD for Children, 1-6 years old. Based on the use pattern,
chronic residential exposure to residues of halosulfuron-methyl is not
expected. In addition, despite the potential for chronic dietary
exposure to halosulfuron-methyl in drinking water, after calculating
DWLOCs and comparing them to conservative model estimated environmental
concentrations of halosulfuron-methyl in surface and ground water, EPA
does not expect the aggregate exposure to exceed 100% of the cPAD, as
shown in the following Table 3:

Table 3. --Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Halosulfuron-methyl
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population................................ 0.10 < 1.0 0.245 0.049 3,500
All Infants.................................... 0.10 < 1.0 0.245 0.049 990
Children, 1-6 years............................ 0.10 < 1.0 0.245 0.049 1,000
Females, 13-50 years........................... 0.10 < 1.0 0.245 0.049 3,000
----------------------------------------------------------------------------------------------------------------

3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Halosulfuron-methyl is currently registered for use(s) that could
result in short-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and short-
term exposures for halosulfuron-methyl. EPA concludes with reasonable
certainty that residues of halosulfuron-methyl in drinking water will
not contribute significantly to the short-term aggregate human health
risk and that the short-term aggregate exposure from halosulfuron-
methyl residues in food and drinking water will not exceed the Agency's
level of concern (MOE £ 100) for short-term aggregate
exposure by any population subgroup.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of 2,200 for females and 2,900 for
children. These aggregate MOEs do not exceed the Agency's level of
concern for aggregate exposure to food and residential uses. Short-term
dermal MOEs for residential handlers are all above 100 and do not
exceed EPA's level of concern. Non-occupational postapplication risk
was estimated for adults and children.Risk estimates for all
residential exposure scenarios and time periods result in MOEs that are
100 or greater, and therefore do not exceed EPA's level of concern. In
addition, short-term DWLOCs were calculated and compared to the EECs
for chronic exposure of halosulfuron-methyl in ground water and surface
water. After calculating DWLOCs and comparing them to the EECs for
surface and ground water, EPA does not expect short-term aggregate
exposure to exceed the Agency's level of concern, as shown in the
following Table 4:

Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Halosulfuron-methyl
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females....................................... 2,200 100 0.245 0.049 14,000
Children...................................... 2,900 100 0.245 0.049 4,800
----------------------------------------------------------------------------------------------------------------

4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level).

[[Page 66784]]

Halosulfuron-methyl is currently registered for use(s) that could
result in intermediate-term residential exposure and the Agency has
determined that it is appropriate to aggregate chronic food and water
and intermediate-term exposures for halosulfuron-methyl.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of 1,700 for
females, 2,000 for males, and 1,000 for children. These aggregate MOEs
do not exceed the Agency's level of concern for aggregate exposure to
food and residential uses. In addition, intermediate-term DWLOCs were
calculated and compared to the EECs for chronic exposure of
halosulfuron-methyl in ground water and surface water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect intermediate-term aggregate exposure
to exceed the Agency's level of concern, as shown in the following
Table 5:

Table 5.--Aggregate Risk Assessment for Intermediate- Term Exposure to Halosulfuron-methyl
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Intermediate-
Population Subgroup MOE (Food + Concern Water EEC Water EEC Term DWLOC
Residential) (LOC) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females..................................... 1,700 100 0.245 0.049 2,800
Males....................................... 2,000 100 0.245 0.049 3,300
Children.................................... 1,000 100 0.245 0.049 900
----------------------------------------------------------------------------------------------------------------

5. Aggregate cancer risk for U.S. population. Halosulfuron-methyl
is classified as a ``not likely'' human carcinogen based on a lack of
evidence of carcinogenicity in male and female mice and rats. A cancer
risk assessment is not required.
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 halosulfuron-methyl residues.

V. Other Considerations

A. Analytical Enforcement Methodology

Analytical enforcement methodology for the determination of
halosulfuron-methyl in various plant commodities has been sent to the
Food and Drug Administration for publication in the Pesticide
Analytical Methods, Volume II (PAM II). Quantitation of residues is by
gas chromotography with nitrogen specific detection (GC/TSD).

B. International Residue Limits

There are no Codex, Canadian, or Mexican maximum residue limits for
halosulfuron-methyl in/on asparagus. Therefore, harmonization is not an
issue.

VI. Conclusion

Therefore, the tolerance is established for residues of
halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidinyl)
amino]carbonylaminosulfonyl-3-chloro-1-methyl-1H- pyrazole-4-
carboxylate in or on asparagus at 2.0 ppm.

VII. Objections and Hearing Requests

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

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

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301197 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
25, 2002.
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

[[Page 66785]]

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 VII.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 the docket control number OPP-301197, 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).

VIII. Regulatory Assessment Requirements

This final rule establishes a time limited tolerance under FFDCA
section 408. The Office of Management and Budget (OMB) has exempted
these types of actions from review under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
Because this rule has been exempted from review under Executive Order
12866 due to its lack of significance, this rule is not subject to
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 exemption under FFDCA section 408, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

IX. 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.

[[Page 66786]]

Dated: December 14, 2001.
Peter Caulkins,
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 371.

2. Section 180.479 is amended by adding text to paragraph (b) to
read as follows:

Sec. 180.479 Halosulfuron; tolerances for residues.

* * * * *
(b) Section 18 emergency exemptions. A time-limited tolerance is
established for halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-
pyrimidinyl)amino]
carbonylaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-
4-carboxylate, in or on asparagus in connection with use of the
pesticide under a section 18 exemption granted by EPA. The time-limited
tolerance will expire on the date specified in the following table.

------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Asparagus......................... 2.0 12/31/03
------------------------------------------------------------------------

* * * * *
[FR Doc. 01-31800 Filed 12-26-01; 8:45 am]
BILLING CODE 6560-50-S

Halosulfuron-methyl; Pesticide Tolerances for Emergency Exemptions

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