[Federal Register Volume 67, Number 132 (Wednesday, July 10, 2002)]
[Rules and Regulations]
[Pages 45643-45650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17266]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0113; FRL-7183-2]


Halosulfuron; 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 in or on tomato. 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 tomato. This regulation establishes a maximum 
permissible level for residues of halosulfuron in this food commodity. 
The tolerance will expire and is revoked on June 30, 2005.

DATES: This regulation is effective July 10, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0113, 
must be received on or before September 9, 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 ID number OPP-2002-0113 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Barbara Madden, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-6463; e-mail address: 
[email protected].

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_00/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 ID number OPP-2002-0113. 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 5-[(4,6-dimethoxy-2-pyrimidinyl)amino] 
carbonylaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, in 
or on tomato at 0.05 part per million (ppm). This tolerance will expire 
and is revoked on June 30, 2005. EPA will publish a document in the 
Federal Register to remove the revoked tolerance from the Code of 
Federal Regulations.
    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.

[[Page 45644]]

    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.
    Recently, EPA has received objections to a tolerance it established 
for halosulfuron on a different food commodity. The objections were 
filed by the Natural Resources Defense Council (NRDC) and raised 
several issues regarding aggregate exposure estimates and the 
additional safety factor for the protection of infants and children. 
Although these objections concern separate rulemaking proceedings under 
the FFDCA, EPA has considered whether it is appropriate to establish 
the emergency exemption tolerance for halosulfuron in or on tomato 
while the objections are still pending.
    Factors taken into account by EPA included how close the Agency is 
to concluding the proceedings on the objections, the nature of the 
current action, whether NRDC's objections raised frivolous issues, and 
the extent to which the issues raised by NRDC had already been 
considered by EPA. Although NRDC's objections are not frivolous, the 
other factors all support establishing this tolerance at this time. 
First, the objections proceeding is not near to conclusion. NRDC's 
objections raise complex legal, scientific, policy, and factual matters 
and EPA has just initiated a 60 day public comment period on them. [67 
FR 41628-41635, June 19, 2002] Second, the nature of the current 
actions are extremely time-sensitive as they address emergency 
situations. Third, the issues raised by NRDC are not new matters but 
questions that have been the subject of considerable study by EPA and 
comment by stakeholders. Accordingly, EPA is proceeding with 
establishing the tolerances for halosulfuron in or on tomato.

III. Emergency Exemption for Halosulfuron on Tomato and FFDCA 
Tolerances

    Yellow (Cyperus esculentus) and purple nutsedge (Cyperus rotundus) 
are very difficult to control warm season, perennial weeds that 
reproduce by seeds and nutlets. They have high reproductive potential 
and can be very competitive with tomatoes during crop establishment. In 
addition to crop competition nutsedge plants can penetrate the plastic 
mulch used in tomato culture destroying the plastic and allowing 
entrance of other pest species.
    Halosulfuron will allow preemergence or post emergence applications 
to control emerged nutsedge plants before they can flower or form 
nutlets to propagate themselves. It can be used in the plant rows or 
between the plant rows. The alternative chemicals consist of methyl 
bromide whose production is being phased out, metam sodium, pebulate, 
and napropamide. The last three chemicals can only be applied preplant 
incorporated or preemergence and do not provide season long control of 
nutsedge. Cultivation and hand weeding only help to further distribute 
the plants and nutlets. Deep plowing can provide suppression the first 
time it is used but subsequent plowing operations bring the old tubers 
back up to germinate. The states of Florida and Georgia claim that 
yield losses of tomatoes due to purple and yellow nutsedge infestations 
can be as high as 20 to 30% compared to the next best alternative.
    EPA has authorized under FIFRA section 18 the use of halosulfuron 
on tomato for control of purple and yellow nutsedge in Florida and 
Georgia. After having reviewed the submission, 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 in or on 
tomato. 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 June 30, 2005, under FFDCA section 408(l)(5), 
residues of the pesticide not in excess of the amounts specified in the 
tolerance remaining in or on tomato 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 
meets EPA's registration requirements for use on tomato 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 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 Florida and Georgia 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, 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 and to make a determination on aggregate exposure,

[[Page 45645]]

consistent with section 408(b)(2), for a time-limited tolerance for 
residues of halosulfuron in or on tomato at 0.05 ppm. EPA's assessment 
of the dietary exposures and risks associated with establishing the 
tolerance follows.

A. Toxicological Endpoints

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by halosulfuron-methyl 
are discussed in Unit II.A. of the final rule on halosulfuron-methyl 
pesticide tolerances published in the Federal Register for September 
29, 2000 (65 FR 58424) (FRL-6746-2). A summary of the toxicological 
dose and endpoints for halosulfuron-methyl for use in this human risk 
assessment is discussed in Unit III.B. of the final rule on 
halosulfuron-methyl pesticide tolerances published in the Federal 
Register of December 26, 2001 (66 FR 66333) (FRL-6816-8).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.479) for the residues of halosulfuron, in or on 
a variety of raw agricultural commodities. The established tolerances 
include tree nuts (crop group 14); pistachio nutmeat; almond hulls; 
sugarcane; corn (sweet, kernel+cob with husks removed, field grain, 
fodder, forage, pop); rice (grain, straw); and cotton (gin by-products 
and undelinted seed). Additionally, tolerances are established (40 CFR 
180.479(a)(1)) 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) at 0.1 ppm 
in or on meat by-products of cattle, goats, hogs, horses and sheep. 
Risk assessments were conducted by EPA to assess dietary exposures from 
halosulfuron in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure. The Dietary Exposure Evaluation Model (DEEM[reg]) 
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: Tolerance level residues and 100 percent crop-
treated for all commodities.
    ii. Chronic exposure.In conducting this chronic dietary risk 
assessment the DEEM[reg] 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: 
Tolerance level residues and 100 percent crop-treated for all 
commodities.
    iii. Cancer. Halosulfuron is classified as a ``Not Likely'' human 
carcinogen. Therefore, risk assessments to assess cancer risk were not 
completed.
    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 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.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW, which predicts pesticide concentrations in ground water. In 
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS 
(a tier 2 model) for a screening-level assessment for surface water. 
The GENEEC model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. GENEEC incorporates a 
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir 
environment in place of the previous pond scenario. The PRZM/EXAMS 
model includes a percent crop 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 percent of the Reference dose 
(%RfD) or percent of population adjusted dose (%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 they are 
further discussed in the aggregate risk sections below.
    Based on the GENEEC and SCI-GROW models the EECs of halosulfuron 
for acute exposures are estimated to be 8.3 parts per billion (ppb) for 
surface water and 0.065 ppb for ground water. The EECs for chronic 
exposures are estimated to be 1.7 ppb for surface water and 0.065 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 is 
currently registered for use on the following residential non-dietary 
sites: Residential turfgrass and landscaped areas.
    Short- and intermediate-term exposure may occur for residential 
handlers and for postapplication activities. Exposure for adults is 
expected for handler and postapplication exposure. Residential post-
application dermal and oral exposure is expected for infants and 
children. Adults may be exposed through skin contact with treated 
surfaces (dermal exposure), while children may be exposed through skin 
contact as well as orally, through hand-to-mouth exposure and through 
object-to-mouth exposure (putting grass in their mouth). Exposure 
estimates for adult handlers' and children's postapplication exposure 
to halosulfuron-methyl are based on the Agency's Draft Standard 
Operating Procedures for Residential Exposure Assessments (12/18/1997) 
and its interim revisions, and data from the review of Outdoor 
Residential Exposure

[[Page 45646]]

Task Force Chemical Handler Exposure Studies. Chronic exposures for the 
residential uses are not expected based on the use pattern.
    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 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 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 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 database 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 
calculating a dose level that poses no appreciable risk to humans.
    2. Conclusion. There is a complete toxicity database for 
halosulfuron and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. The Agency has 
determined that the 10X FQPA Safety factor for enhanced sensitivity to 
infants and children can be reduced to 1X. The decision is based upon 
the following reasons: 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.
    The Agency determined that the requirement of a developmental 
neurotoxicity study in rats did not warrant an application of 
additional safety factors because: (1) The alterations observed in the 
fetal nervous system occurred in only one species (in rats and not in 
rabbits); (2) 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); (3) 
there was no evidence of clinical signs of neurotoxicity, brain weight 
changes, or neuropathology in the subchronic or chronic studies in 
rats; (4) the developmental neurotoxicity study is required only as 
confirmatory data to understand what the effect is at a high exposure 
(dose) level; (5) exposure assessments do not indicate a concern for 
potential risk to infants and children based on the results of the 
field trial studies and the very low application rate ([sim] 0.06 lbs. 
active ingredient per acre). Detectable residues are not expected in 
foods. Consequently, there is no concern that the level of 750 mg/kg/
day would be approached.

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 population adusted dose (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 EPA's 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 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 on drinking water as a part of the aggregate risk 
assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
halosulfuron will occupy 1% or less of the aPAD for all population 
subgroups in DEEM[reg] including females 13 years and older, infants 
and children. In addition, despite the potential for acute dietary 
exposure to halosulfuron in drinking water, after calculating DWLOCs 
and comparing them to conservative model EECs of halosulfuron 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:

[[Page 45647]]



                     Table 2.--Aggregate Risk Assessment for Acute Exposure to Halosulfuron
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13 years and older.....................          0.5          <1%          8.3        0.065       15,000
All infants (< 1 year old).....................          0.5           1%          8.3        0.065        5,000
Children.......................................          0.5          <1%          8.3        0.065        5,000
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
halosulfuron from food will utilize less than 1% of the chronic 
population adjusted dose (cPAD) for all population subgroups in 
DEEM[reg] including the U.S. population, infants and children. There 
are no residential uses for halosulfuron that result in chronic 
residential exposure to halosulfuron. Based on the use pattern, chronic 
residential exposure to residues of halosulfuron is not expected. In 
addition, despite the potential for chronic dietary exposure to 
halosulfuron in drinking water, after calculating DWLOCs and comparing 
them to conservative model EECs of halosulfuron 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
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population................................          0.1          <1%          1.7        0.065        3,500
All infants (<1 year old)......................          0.1          <1%          1.7        0.065        1,000
Children.......................................          0.1          <1%          1.7        0.065        1,000
----------------------------------------------------------------------------------------------------------------

    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 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.
    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 4,500 for adults for both 
handler and postapplication exposures and 2,800 for infants and 
children for dermal and incidental oral exposures. These aggregate MOEs 
do not exceed the Agency's level of concern for aggregate exposure to 
food and residential uses. In addition, short-term DWLOCs were 
calculated and compared to the EECs for chronic exposure of 
halosulfuron 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
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population...............................         4,500          100          1.7        0.065       17,000
Infants.......................................         2,800          100          1.7        0.065        4,800
Children......................................         2,800          100          1.7        0.065        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). Halosulfuron 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.
    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 
adults and 1,100 for infants and 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 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:

[[Page 45648]]



               Table 5.--Aggregate Risk Assessment for Intermediate- Term Exposure to Halosulfuron
----------------------------------------------------------------------------------------------------------------
                                                             Aggregate
                                                Aggregate     Level of     Surface       Ground    Intermediate-
             Population Subgroup               MOE (Food +    Concern     Water EEC    Water EEC     Term DWLOC
                                              Residential)     (LOC)        (ppb)        (ppb)         (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population.............................         1,700          100          1.7        0.065         3,300
Infants.....................................         1,100          100          1.7        0.065           910
Children....................................         1,100          100          1.7        0.065           910
----------------------------------------------------------------------------------------------------------------

    5. Aggregate cancer risk for U.S. population. Halosulfuron is 
classified as a ``Not Likely'' human carcinogen. Therefore, risk 
assessments to assess cancer risk were not completed.
    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 residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression. The method may be requested from: Calvin Furlow, 
PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; 
telephone number: (703) 305-5229; e-mail address: 
[email protected].

B. International Residue Limits

    There is neither a Codex proposal, nor Canadian or Mexican maximum 
residue limits, for residues of halosulfuron in or on tomatoes, 
therefore harmonization is not an issue.

C. Conditions

    A maximum of 0.094 pounds halosulfuron may be applied per acre per 
season. A total of 2 applications per season may be made. The 
preharvest interval (PHI) is 30 days.

VI. Conclusion

    Therefore, the tolerance is established for residues of 
halosulfuron, methyl 5-[(4,6- dimethoxy-2-pyrimidinyl)amino] 
carbonylaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, in 
or on tomato at 0.05 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-2002-0113 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 September 
9, 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 [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit 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-2002-0113, to: 
Public Information and Records Integrity Branch, Information Resources 
and Services Division (7502C), Office of Pesticide Programs, 
Environmental

[[Page 45649]]

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: [email protected]. 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.

    Dated: June 24, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

    2. In Sec. 180.479, paragraph (b) is amended by revising the text 
and by alphabetically adding an entry for ``Tomato'' to the table to 
read as follows:


Sec. 180.479  Halosulfuron; tolerances for residues.

* * * * *
    (b)Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of halosulfuron, methyl 5-[(4,6-dimethoxy-2-
pyrimidinyl)amino] carbonylaminosulfonyl-3-chloro-1-

[[Page 45650]]

methyl-1H-pyrazole-4-carboxylate, in connection with use of the 
pesticide under section 18 emergency exemptions granted by EPA in or on 
the following commodities:

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
                     *       *      *      *      *
Tomato........................................         0.05      6/30/05
------------------------------------------------------------------------

* * * * *
[FR Doc. 02-17266 Filed 7-9-02; 8:45 am]
BILLING CODE 6560-50-S