[Federal Register Volume 66, Number 248 (Thursday, December 27, 2001)]
[Rules and Regulations]
[Pages 66778-66786]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-31800]


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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: 
<a href="/cdn-cgi/l/email-protection#4a262b3d3964272f382f2e233e220a2f3a2b642d253c"><span class="__cf_email__" data-cfemail="14787563673a79716671707d607c547164753a737b62">[email protected]</span></a>.

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<SUP>-</SUP>\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<INF>cancer</INF> = 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/    <divide> 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 <divide>      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<Register>) 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<Register> 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 <ls-thn-eq> 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 <a href="/cdn-cgi/l/email-protection#6612090b160d0f0815480c0f0b2603160748010910"><span class="__cf_email__" data-cfemail="33475c5e43585a5d401d595a5e735643521d545c45">[email protected]</span></a>, 
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: <a href="/cdn-cgi/l/email-protection#056a757528616a666e6071456075642b626a73"><span class="__cf_email__" data-cfemail="fd928d8dd099929e969889bd988d9cd39a928b">[email protected]</span></a>. 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


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