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/ 2002
/ September
/ Friday, September 20, 2002
[Federal Register: September 20, 2002 (Volume 67, Number 183)]
[Rules and Regulations]
[Page 59182-59193]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20se02-13]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0243; FRL-7200-8]
Halosulfuron-methyl; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidinyl)amino]
carbonyaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate in or
on asparagus; vegetables, fruiting (except cucurbits), group; bean,
dry, seed and bean, snap, succulent. Gowan Company and Interregional
Research Project Number 4 (IR-4) requested these tolerances under the
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality
Protection Act of 1996.
DATES: This regulation is effective September 20, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0243,
must be received on or before November 19, 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 VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number OPP-2002-0243 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: James A. Tompkins and Hoyt
Jamerson, Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: (703) 305-5687 and (703)
308-9368, respectively; e-mail address: tompkins.jim@epa.gov and
jamerson.hoyt@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112............... Animal production
311............... Food manufacturing
32532............. Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. 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 theFederal 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-2002-0243. 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, Crystal 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
In the Federal Register of June 3, 2002 (67 FR 38276) (FRL-7179-2),
EPA issued a notice pursuant to section 408 of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food
Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing
the filing of a pesticide petition (PP 1E6322) by Interregional
Research Project Number 4(IR-4), 681 U.S. Highway 1 South, North
Brunswick, New Jersey 08902-3390. In addition to the Federal Register
of August 31, 2001 (66 FR 45993) (FRL-6796-1), EPA issued a notice
pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act
(FFDCA) 21 U.S.C. 346a, as amended by the FQPA announcing the filing of
pesticide petitions 0F6169 and 1F6229) by Gowan Company, P.O. Box 5569;
Yuma, AZ 85366. These notices included a summary of the petitions
prepared by Gowan Company, the registrant. There were no comments
received in response to these notices of filing.
[[Page 59183]]
The petitions requested that 40 CFR 180.479(a) be amended by
establishing tolerances for residues of the herbicide halosulfuron-
methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidinyl)amino]
carbonyaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, in or
on vegetables, fruiting (except cucurbits), group at 0.05 part per
million (ppm) (PP 0F6169), asparagus at 0.8 ppm (1F6229); and dry bean
and succulent snap bean at 0.05 ppm (1E6322). The tolerance in or on
asparagus at 0.8 ppm established by the current action will replace the
time limited tolerance for asparagus established under Sec. 180.479(b)
in the Federal Register of December 27, 2001 (66 FR 66778) (FRL-6816-
1).
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances in the Federal Register of November 26, 1997 (62 FR 62961)
(FRL-5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for a tolerance for residues of halosulfuron-methyl on
asparagus at 0.8 ppm; bean, dry, seed at 0.05 ppm; bean, snap,
succulent at 0.05 ppm and vegetables, fruiting (except cucurbits),
group at 0.05 ppm. EPA's assessment of exposures and risks associated
with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by halosulfuron-methyl
are discussed in Unit II.A. of the final rule on halosulfuron-methyl
pesticide tolerances in the Federal Register of September 29, 2000 (65
FR 58424) (FRL-6746-2).
B. 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 level of concern
(LOC). 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 dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-\6\ or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = 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 Toxicological Dose and Endpoints for Halosulfuron-methyl for Use In Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose (mg/kg/day) UF/ Hazard Based Special Endpoint for Risk
Exposure Scenario MOE FQPA Safety Factor Assessment
----------------------------------------------------------------------------------------------------------------
Dietary Risk Assessments
----------------------------------------------------------------------------------------------------------------
Acute Dietary (females 13-50 years of NOAEL = 50 1x Developmental Toxicity
age) Rabbit
[[Page 59184]]
UF = 300\a\ LOAEL = 150 mg/kg/day
based on decreased
mean litter size,
increased number of
resorptions (total and
per dam) and increased
postimplantation loss
(developmental
toxicity)
Acute RfD = 0.17 mg/kg/
day
-----------------------------------------------------------------------------------------
Acute Dietary NOAEL = N/A N/A No appropriate dose/
endpoint selected.
general population including infants UF = N/A
and children
Acute RfD = N/A
-----------------------------------------------------------------------------------------
Chronic Dietary NOAEL = 10 1x Chronic Toxicity - Dog
all populations UF = 300\a\ LOAEL = 40 mg/kg/day
based on decreased
body weight gains in
females
Chronic RfD = 0.03 mg/
kg/day
-----------------------------------------------------------------------------------------
Incidental Oral NOAEL = 50 1x Developmental Toxicity-
Rabbit
Short-Term (1-30 Days) UF = 300\a\ LOAEL = 150 mg/kg/day
based on decreased
body weight gain, food
consumption, and food
efficiency. (maternal
toxicity)
Residential Only MOE = 300
-----------------------------------------------------------------------------------------
Incidental Oral NOAEL = 10 1x 13 Week Subchronic
Toxicity - Dog
Intermediate-Term (1-6 Months) UF = 300\a\ LOAEL = 40 mg/kg/day
based on decreased
body weight gain and
food efficiency in
females
Residential Only MOE = 300
-----------------------------------------------------------------------------------------
Non-Dietary Risk Assessments
----------------------------------------------------------------------------------------------------------------
Dermal Dermal NOAEL = 100 21-Day Dermal Toxicity
Study - Rat
Short-Term (1-30 days) LOAEL = 1000 mg/kg/day
based on decreased
body weight gain in
males
Residential MOE = 300 1x
-----------------------------------------------------------------------------------------
Dermal\b\ Oral NOAEL = 10 13 Week Subchronic
Toxicity - Dog
Intermediate-Term (1-6 Months) LOAEL = 40 mg/kg/day
based on decreased
body weight gain and
food efficiency in
females.
Residential MOE = 300 1x
-----------------------------------------------------------------------------------------
Dermal\b\ Oral NOAEL= 10 Chronic Toxicity - Dog
Long-Term (>6 Months) LOAEL = 40 mg/kg/day
based on decreased
body weight gains in
females
Residential MOE = 300 1x
-----------------------------------------------------------------------------------------
Inhalation\c\ Oral NOAEL = 50 Developmental Toxicity-
Rabbit
Short-Term (1-30 days) LOAEL = 150 mg/kg/day
based on decreased
body weight gain, food
consumption, and food
efficiency. (Maternal
toxicity)
Residential MOE = 300 1x
-----------------------------------------------------------------------------------------
Inhalation\c\ Oral NOAEL = 10 13 Week Subchronic
Toxicity - Dog
Intermediate-Term (1-6 Months) LOAEL = 40 mg/kg/day
based on decreased
body weight gain and
food efficiency in
females
Residential MOE = 300 1x
-----------------------------------------------------------------------------------------
Inhalation\c\ Oral NOAEL = 10 Chronic Toxicity - Dog
Long-Term (>6 Months) LOAEL = 40 mg/kg/day
based on decreased
body weight gains in
females
Residential MOE = 300 1x
-----------------------------------------------------------------------------------------
Cancer Classification: ``not likely to be carcinogenic to humans'' by the oral
route, based on no evidence of carcinogenicity from studies in rats and
mice
----------------------------------------------------------------------------------------------------------------
\*a\ = UFDB = 300 (10x for inter-species extrapolation and 10 x for intra- species variability, 3x for lack of
DNT).
\b\ = A 75% dermal absorption factor was used for route to route extrapolation.
\c\ = Absorption via inhalation route is presumed to be equivalent to oral absorption.
[[Page 59185]]
C. 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. Additionally,
tolerances for residues of halosulfuron-methyl and its metabolites
determined as 3-chloro-1-methyl-5-sulfamoylpyrazole-4-carboxylic acid
(CSA, expressed as parent equivalents) are established at 0.1 ppm 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:
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\TM\)
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: 100% of the crops with halosulfuron-methyl
tolerances (both established and proposed) are treated and that all
commodities contain tolerance level residues when consumed.
The acute dietary exposure estimates are provided for females 13-50
years old only. No appropriate endpoint attributable to a single
exposure was identified for the general U.S. population including
infants, children and adult males. This assessment concludes that the
acute dietary exposure estimates are below the Agency's level of
concern (<100% aPAD) at the 95th exposure percentile for females 13-50
(<1% of the aPAD). The results are presented in the following Table 2.
Table 2.--Acute Dietary Exposure Estimates at the 95th Percentile of
Exposure
------------------------------------------------------------------------
Exposure
Population Subgroup (mg/kg/day) % aPAD
------------------------------------------------------------------------
Females 13-50 years old 0.00068 <1
------------------------------------------------------------------------
ii. Chronic Exposure. In conducting this chronic dietary risk
assessment, the DEEM\TM\ 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:
100% of the crops treated with halosulfuron-methyl tolerances (both
established and proposed) are treated and that all commodities contain
tolerance level residues when consumed.
The tier 1 chronic dietary exposure assessment was conducted for
all supported halosulfuron-methyl food uses. The chronic dietary
exposure estimates are presented for the general U.S. population
including infants, children and adult males in the following Table 3.
This assessment concludes that the chronic dietary exposure estimates
are below the Agency's level of concern (<100% cPAD) for the general
U.S. population (<1% of the cPAD). The most highly exposed population
subgroup is all infants <1 year old at 2.4% of the cPAD.
Table 3.--Results of Chronic Dietary Exposure Analysis
------------------------------------------------------------------------
Exposure
Population Subgroup (mg/kg/day) % cPAD
------------------------------------------------------------------------
U.S. Population (total) 0.00028 <1
All Infants (<1 year) 0.00071 2.4
Children 1-6 years 0.00052 1.7
Children 7-12 years 0.00039 1.3
Females 13-50 0.00023 <1
Males 13-19 0.00027 <1
Males 20+ years 0.00023 <1
Seniors 55+ 0.00024 <1
------------------------------------------------------------------------
iii. Cancer. 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 is not expected.
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 SCI-GROW model is used to predict pesticide concentrations in
shallow groundwater. For a screening-level assessment for surface water
EPA will 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 Unit III.E.
Based on the FIRST and SCI-GROW models the estimated environmental
concentrations (EECs) of halosulfuron-methyl for acute exposures are
estimated to be 105 parts per billion (ppb) for surface water and 0.065
ppb for ground water. The EECs for chronic exposures are estimated to
be 105 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).
[[Page 59186]]
Halosulfuron-methyl is currently registered for use on the
following residential non-dietary sites: Application to commercial and
residential turf and on other non-crop sites including airports,
cemeteries, fallow areas, golf courses, landscaped areas, public
recreation areas, residential property, road sides, school grounds, sod
or turf seed farms, sports fields, landscaped areas with established
woody ornamentals and other similar use sites. Application may be by
commercial applicator or homeowner. The risk assessment was conducted
using the following residential exposure assumptions: No chemical-
specific exposure data for handler activities were submitted to the
Agency in support of the registered lawn uses. The Agency`s Draft
Standard Operating Procedures (SOPs) for Residential Exposure
Assessments, and Recommended Revisions (Policy Number 11, revised Feb.
22, 2001), were used as the basis for the residential handler exposure
calculations. The handler exposure data used in this assessment are
from the Outdoor Residential Exposure Task Force (ORETF). The task
force recently submitted proprietary data to the Agency on hose-end
sprayers, push-type granular spreaders, and handgun sprayers. The ORETF
data were used in this assessment in place of PHED data for the garden
hose-end sprayer scenario. The ORETF data were designed to replace the
present PHED data with higher-confidence, higher quality data that
contain more replicates than the PHED data for those scenarios.
Table 4 shows the assumptions and exposure calculations for this
scenario. For short-term exposure and risk for residential lawn
applicators (``handlers''), the resulting dermal MOE is 21,000 and the
inhalation MOE is 7,000,000. The Total MOE of 20,000 for residential
handlers is well above the target MOE of 300, and therefore, does not
trigger the Agency's level of concern.
Table 4.--Short-Term Handler Exposure and Risk Estimates for Residential Lawn Applicators
--------------------------------------------------------------------------------------------------------------------------------------------------------
PHED Scenario Selected from Draft Acres ORETF Unit Daily
SOP for Residential Exposure Exposure Route Application Rate Treated Exposure Absorption Dose\1\ (mg/ Short-Term Total
Assessments (lb ai/A) (acres/day) (mg/lb ai) Factor kg/day) MOE\2\ MOE\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Garden Hose End Sprayer/Liquid Dermal 0.062 0.5 11 1.0 0.0043 21,000 20,000
Open Pour (Mix, Load, and Apply)
Inhalation 0.062 0.5 0.016 1.0 0.0000071 7,000,000 20,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Daily Dose =[Application Rate (lb ai/A) x Acres Treated (A/day) x Unit Exposure (mg/lb ai handled) x Absorption Factor]/Body Weight (70 kg)
\2\ MOE = NOAEL/Daily Dose; where dermal NOAEL = 100 mg/kg/day, and inhalation NOAEL = 10
\3\ Total MOE = 1 / [(1/dermal MOE) + (1/inhalation MOE)]
The following postapplication exposure scenarios resulting from
lawn treatment were assessed: (1) Toddlers' incidental ingestion of
pesticide residues on lawns from hand-to-mouth transfer, (2) object-to-
mouth transfer from mouthing of pesticide-treated turfgrass, (3)
incidental ingestion of soil from pesticide-treated residential areas,
and (4) children's and adult's postapplication dermal exposure.
Postapplication exposures from various activities following lawn
treatment are considered to be the most common and significant in
residential settings. The exposure via incidental ingestion of other
plant material may occur but is considered negligible.
The exposure estimates are based on some upper-percentile (i.e.,
maximum application rate, initial amount of transferrable residue and
duration of exposure) and some central tendency (i.e., surface area,
hand-to-mouth activity, and body weight) assumptions and are considered
to be representative of high-end exposures. The uncertainties
associated with this assessment stem from the use of an assumed amount
of pesticide available from turf, and assumptions regarding transfer of
chemical residues and hand-to mouth activity. The estimated exposures
are believed to be reasonable high-end estimates based on observations
from chemical-specific field studies and professional judgement.
The exposure and risk estimates for the residential exposure
scenarios are assessed for the day of application (day ``0'') because
it is assumed that toddlers could contact the lawn immediately after
application. Both short-term and intermediate-term oral and dermal
exposure are expected, but inhalation exposure is expected to be
negligible. Risk from short-term and intermediate-term incidental
ingestion by toddlers is assessed by comparing these exposures to the
NOAELs of 50 mg/kg/day and 10 mg/kg/day, respectively. Dermal
postapplication risk was assessed by comparing the exposures to the
NOAELs of 100 mg/kg/day and 10 mg/kg/day, respectively. The results of
the exposure calculations are presented in the following Tables 5
through 8.
Table 5.--Postapplication Dermal Exposure and Risk From Treated Lawns
--------------------------------------------------------------------------------------------------------------------------------------------------------
Short- / Daily Dose\2\ (mg/kg/day) Dermal MOE\3\
Application Dislodgeable Intermediate-Term -------------------------------------------------------
Subgroup Exposed Rate (lb ai/ Foliar Dermal Transfer Body Wt
A) Residue\1\ Coefficient (kg) Short-term Intermediate- Short-term Intermediate-
(ug/cm\2\) (cm\2\/hr) term term
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 0.062 0.035 14,500/7,300 70 0.014 0.0054 7,000 1,800
Children 0.062 0.035 5,200/2,600 15 0.024 0.0090 4,200 1,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Dislodgeable Foliar Residue\Postapplication day zero\ (ug/cm\2\) = Application rate (lb ai/A) x Fraction of ai Retained on the Foliage (0.05) x [(1-
Fraction of Residue That Dissipates Daily (0.1)]\Postapplication day\ x 4.54E+8 []g/Lb x 2.47E-8 A/cm\2\ (11.2)
\2\ Daily Dose = [Dislodgeable Foliar Residue x Absorption Factor (1 for short-term, 0.75 for intermediate-term) x 0.001 mg/ug x Dermal Transfer
Coefficient x Exposure Time (2 hrs/day)]/Body weight
[[Page 59187]]
\3\ Dermal MOE = Dermal NOAEL/Daily Dose; where short-term NOAEL = 100 mg/kg/day, and intermediate-term NOAEL = 10 mg/kg/day
Table 6.--Postapplication Oral Hand-to-Mouth Exposure and Risk for Children from Treated Lawns
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Fraction of ai Dislodgeable Short-term/ Daily Dose\2\ (mg/kg/day) Oral MOE\3\
Appl. Rate (lb ai/A) Retained on the Saliva Extraction Foliar Residue\1\ Hand Surface Area Intermediate-term Body Weight (kg) -------------------------------------------------------------------------------
Foliage Factor (ug/cm\2\) (cm\2\/event) Freq. (events/hr) Short-term Intermediate-term Short-term Intermediate-term
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
0.062 0.05 50% 0.035 20 20/9.5 15 0.00093 0.00044 54,000 23,000
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Dislodgeable Foliar Residue\Postapplication day\ (ug/cm\2\)=Application rate (lb ai/A) x Fraction of ai Retained on the Foliage x (1- Fraction of Residue That Dissipates Daily, 0.10)\Postapplication day\ x 4.54E+8 []g/lb x 24.7E-9 A/cm\2\ (11.2138)
\2\ Daily Dose = (Dislodgeable Foliar Residue (ug/cm\2\) x Hand Surface Area (cm\2\/event) x Extraction factor x Frequency (events/hr) x 0.001 mg/ug x Exposure time (2 hrs/day)]/[Body Weight (kg)]
\3\ Oral MOE = Oral NOAEL/Daily Dose; where Short-term NOAEL = 50 mg/kg/day, and Intermediate-term NOAEL = 10 mg/kg/day
Table 7.--Postapplication Oral Object-to-Mouth (Turfgrass) Exposure and Risk for Children from Treated Lawns
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fraction of Oral MOE\3\
ai Retained Grass Ingestion Rate Body Weight Daily Dose\2\ (mg/-------------------------------------
Application Rate (lb ai/A) on the Residue\1\ (cm\2\/day) (kg) kg/day)
Foliage ug/cm\2\) Short-term Intermediate-term
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.062 0.20 0.031 25 15 0.00023 220,000 43,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Grass residue\Postapplication day\ (ug/cm\2\) = Application rate (lb ai/A) x Fraction of ai Retained on the Foliage x (1- Fraction of Residue That
Dissipates Daily)\Postapplication day\ x 4.54E+8 []g/lb x 24.7E-9 A/cm\2\
\2\ Daily Dose = [Grass reside (ug/cm\2\) x Ingestion rate (cm\2\/day) x 0.001 mg/ug] / [Body Weight (kg)]]
\3\ Oral MOE = Oral NOAEL/Daily Dose; where Short-term NOAEL = 50 mg/kg/day, and Intermediate-term NOAEL = 10 mg/kg/day
Table 8.--Postapplication Incidental Soil Ingestion Exposure and Risk for Children from Treated Lawns
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fraction of ai Soil Daily Oral MOE\3\
Appl. Rate (lb ai/A) Retained in the Residue\1\ Ingestion Rate Body Weight Dose\2\ (mg/-------------------------------------
Soil (ug/g) (mg/day) (kg) kg/day) Short-term Intermediate-term
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.062 1 0.47 100 15 3.1E-06 16,000,000 3,200,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Soil residue \Postapplication day\ (ug/cm\2\) = Application rate (lb ai/A) x Fraction of ai Retained on the Foliage x (1- Fraction of Residue That
Dissipates Daily) \Postapplication day\ x 4.54E+8 []g/lb x 24.7E-9 A/cm\2\ x 0.67 cm\3\/g soil
\2\ Daily Dose = [Soil reside (ug/g) x Ingestion rate (mg/day) x 0.000001 g/ug] / [Body Weight (kg)]]
\3\ Oral MOE = Oral NOAEL/Daily Dose; where Short-term NOAEL = 50 mg/kg/day, and Intermediate-term NOAEL = 10 mg/kg/day
Both short-term and intermediate-term MOEs for each scenario are
above the target MOE of 300, and are not of concern.
When a common effect (i.e., decreased body weight gain) is observed
in those studies selected for the endpoints for all routes of exposure;
MOEs are to be combined where appropriate. Aggregate residential risk
was assessed for adults and children (Tables 9 and 10). For children,
short-term and intermediate-term aggregate risk was assessed based on
postapplication dermal and oral exposure. For adults, short-term
aggregate residential risk was assessed based on exposure through
application (handler) and postapplication dermal exposure. Intermediate
aggregate risk for adults was not assessed because the application of
halosulfuron-methyl is not expected to occur for more than 30 days. The
Total MOEs resulting from the combined MOEs for both adults and
children, are also above the target MOE of 300, and are not of concern.
Table 9.--Adult's Aggregate Exposure and Risk Estimates from Residential Lawns
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acres PHED Unit Short-term
Adult's Scenario Exposure Route Rate (lb ai/ Treated Exposure Daily Dose Short-term Total Short-
acre) (acres/day) (mg/lb ai) (mg/kg/day) MOE term MOE
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. Mix/load and broadcast application of dermal 0.062 0.5 30 0.0043 21,000 5,200
liquid formulation (garden hose-end
sprayer)
inhalation 0.062 0.5 0.016 0.0000071 7,000,000 5,200
-----------------------------------------------------------------------------------------
2. Postapplication exposure dermal 0.062 N/A N/A 0.014 7,000 5,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 59188]]
Table 10.--Children's Aggregate Exposure and Risk Estimates from Residential Lawns
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children's Short-Term Intermediate Total
TTR/GR/SR0 (ug/cm\2\ or g)\1\ ScenariosExposure PDR\0-norm\ PDR\0-norm\ Short-Term Intermediate-Term Total Short- Intermedite-
Route (mg/kg/day) (mg/kg/day) MOE MOE Term MOE term MOE
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) Dermal contact 0.035 0.024 0.0090 4,200 1,100 3,800 1,000
(2) Hand-to-mouth 0.035 0.00093 0.00044 54,000 23,000 3,800 1,000
(3) Mouth grass 0.14 0.00023 0.00023 220,000 43,000 3,800 1,000
(4) Soil ingestion 0.047 3.1E-6 3.1E-6 16,000,000 3,2000,000 3,800 1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ TTR=turf transferable residue on the ``0''; GR=gras residue on the day ``0''; SR0=soil residue on the day ``0.''
\2\ PDR 0-norm = potential doe rate on day ``0.''
Halosulfuron-methyl may be used on turf at recreational use sites,
and, therefore may result in postapplication exposure to adults and
children involved in recreational activities. Exposures to adults and
children from the use of halosulfuron-methyl at recreational use sites
are assumed to be the same as those assessed for residential use sites,
and therefore, a separate recreational exposure assessment was not
included. Refer to section 4.4 of this risk assessment for details on
assumptions, input variables and risk estimates for residential use
sites. Residential turf exposure assessment results in what are
considered upper bound risk estimates. Therefore, it is not expected
that the upper bound residential exposure scenario would occur on the
same day as an upper bound recreational exposure scenario. Exposure
from these two exposure scenarios are not aggregated. Rather, the
residential risk estimate should serve as an upper bound for both
residential and recreational exposure.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether 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 in
the Federal Register of November 26, 1997 (62 FR 62961) (FRL-5754-7).
D. Safety Factor for Infants and Children
1.In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for 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 MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility of young rats in the reproduction study with
halosulfuron-methyl. Although there is qualitative evidence of
increased susceptibility in the prenatal developmental studies in rats
and rabbits, the Agency did not identify any residual uncertainties
after establishing toxicity endpoints and traditional uncertainty
factors to be used in the risk assessment of halosulfuron-methyl.
3. Conclusion. There is a complete toxicity data base for
halosulfuron-methyl except for a developmental neurotoxicity study and
exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures. EPA determined that, based
on reliable data, an additional database uncertainty factor of 3X is
necessary to protect the safety of infants and children in assessing
halosulfuron-methyl exposures and risks. This factor is necessary to
address a data deficiency for the developmental neurotoxicity study.
The additional uncertainty factor of 3X is incorporated into the
numerical expression for the acute and chronic RfD and PAD (aPAD and
cPAD) and applied to all dietary and residential (non-dietary) exposure
scenarios. For residential assessments, an MOE of 300 (10X for
interspecies extrapolation, 10X for intraspecies variation, and the
additional database uncertainty factor of 3X) is required.
No Special FQPA Safety Factor is necessary to protect the safety of
infants and children in assessing halosulfuron-methyl exposure and
risks because:
i. There is no evidence of increased susceptibility of young rats
in the reproduction study with halosulfuron-methyl. Although there is
qualitative evidence of increased susceptibility in the prenatal
developmental studies in rats and rabbits, the Agency did not identify
any residual uncertainties after establishing toxicity endpoints and
traditional uncertainty factors to be used in the risk assessment of
halosulfuron-methyl.
ii. There are no residual uncertainties identified in the exposure
databases. The dietary (food and drinking water) exposure assessments
will not underestimate the exposure (postapplication exposure to
children as well as incidental oral exposure to toddlers) and risks
posed by halosulfuron-methyl.
Recently, EPA has received objections to a tolerance it established
for residues of halosulfuron-methyl in or on the melon subgroup (66 FR
66786, December 26, 2001) and an emergency exemption for asparagus (66
FR 66778, December 27, 2001). 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. NRDC's objections raise complex
legal, scientific, policy, and factual matters and EPA has initiated a
public comment period on them in the Federal Register of June 19, 2002
(67 FR 41628) (FRL-7167-7), which ends on September 17, 2002. Although
that proceeding remains ongoing, prior to
[[Page 59189]]
acting on this current tolerance action, EPA reviewed the halosulfuron-
specific objections raised by NRDC and has addressed them below.
In reference to NRDC`s statements that the Agency erred by not
retaining the additional 10X children's safety factor in light of the
data gap for developmental neurotoxicity study, the Agency re-reviewed
its determination that a different safety factor, 3X, would be safe for
infants and children. Taking into account the lack of the developmental
neurotoxicity study, EPA concluded that an additional traditional
Database Uncertainty Factor of 3X is needed for all dietary and
residential (non-dietary) exposure scenarios until the data are
received and evaluated. An uncertainty factor of 3X (as opposed to a
higher value) was viewed to be adequate because the doses selected for
dietary and non-dietary risk assessments would address the concerns for
the alterations of the fetal nervous system seen in the developmental
toxicity study in rats and provide a large margin of safety in regard
to any uncertainty arising from the lack of a developmental
neurotoxicity study. The NOAEL of 50 mg/kg/day (used for acute dietary,
short-term incidental oral and inhalation risk assessments) and the
NOAEL of 10 mg/kg/day (used for chronic dietary and intermediate-term
incidental oral, dermal and inhalation risk assessments) are 5X and 25X
lower, respectively, than the NOAEL of 250 mg/kg/day in the rat
developmental study where alterations of the fetal nervous system were
seen at 750 mg/kg/day (LOAEL). It was these alterations of the fetal
nervous system seen at 750 mg/kg/day in the rat developmental study
that caused EPA to require submission of a developmental neurotoxicity
study. Thus, in combination with the 3X database uncertainty factor,
the doses selected for risk assessment provide a 15X (acute) and 75X
(chronic) margin of safety with regard to observed developmental
neurotoxic effects. Consequently, based on the available data, use of a
3X factor instead of a 10X factor will provide an adequate margin of
safety for the protection of infants and children.
NRDC also claimed that there were several other data gaps
necessitating retention of the additional 10X safety factor for the
protection of infants and children. NRDC claimed that no cancer risk
assessment or short-term or intermediate-term residential risk
assessments had been conducted. NRDC's allegations in this regard are
contradicted by the Federal Register notice establishing the
halosulfuron-methyl tolerances. EPA did assess the cancer risk posed by
halosulfuron-methyl and concluded that ``no cancer risk is expected
from exposure to halosulfuron-methyl.'' (66 FR 66333, 66338, December
26, 2001). This conclusion was based on EPA's qualitative conclusion
that halosulfuron-methyl is not likely to be a human carcinogen. Id.
Having concluded that, as a qualitative matter, halosulfuron-methyl is
not likely to be a human carcinogen EPA did not perform a quantitative
cancer risk assessment, as such risk assessment would not be
scientifically justified. EPA's statement earlier in the Federal
Register notice regarding not conducting a cancer risk assessment
referred to the fact that a quantitative assessment was unnecessary.
Id. at 66336. Short-term and intermediate-term risk residential risk
assessments were performed and considered by the Agency. Id. at 66337-
66338.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by USEPA Office of Water are used to calculate DWLOCs
21/70 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, the Office of Pesticide Programs (OPP) concludes
with reasonable certainty that exposures to the pesticide in drinking
water (when considered along with other sources of exposure for which
OPP has reliable data) would not result in unacceptable levels of
aggregate human health risk at this time. Because OPP considers the
aggregate risk resulting from multiple exposure pathways associated
with a pesticide's uses, levels of comparison in drinking water may
vary as those uses change. If new uses are added in the future, OPP
will reassess the potential impacts of residues of the pesticide in
drinking water as a part of the aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in Unit
III.C., Exposure Assessment, for acute exposure, the acute dietary
exposure from food to halosulfuron-methyl will occupy <1% of the aPAD
for females 13 years and older. The acute dietary exposure estimates
are provided for females 13-50 years old only. No appropriate endpoint
attributable to a single exposure was identified for the general U.S.
population including infants, children, and adult males. In addition,
there is potential for acute dietary exposure to halosulfuron-methyl in
drinking water. After calculating DWLOCs and comparing them to the EECs
for surface and ground water, EPA does not expect the aggregate
exposure to exceed 100% of the aPAD, as shown in the following Table
11:
Table 11.--Aggregate Risk Assessment for Acute Exposure to Halosulfuron-methyl
--------------------------------------------------------------------------------------------------------------------------------------------------------
Food Exposure (mg/ Surface Water EEC Ground Water EEC
Population Subgroup aPAD (mg/kg) kg/day) (ppb) (ppb) Acute DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 13-50 years old 0.17 0.00068 105 0.065 5100
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 59190]]
2. Chronic risk. Using the exposure assumptions described in Unit
III.C., Exposure Assessment, for chronic exposure, EPA has concluded
that exposure to halosulfuron-methyl from food will utilize <1% of the
cPAD for the U.S. population, 2.4% of the cPAD for all infants <1 year
old and 1.7% of the cPAD for children 1-6 years . Based the use
pattern, chronic residential exposure to residues of halosulfuron-
methyl is not expected. In addition, there is potential for chronic
dietary exposure to halosulfuron-methyl in drinking water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in the following Table 12:
Table 12.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Halosulfuron-methyl
--------------------------------------------------------------------------------------------------------------------------------------------------------
Food Exposure (mg/ Surface Water EEC Ground Water EEC Chronic DWLOC
Population Subgroup cPAD mg/kg/day kg/day) (ppb) (ppb) (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population 0.03 0.00028 105 0.065 1,000
All infants (<1 year old) 0.03 0.00071 105 0.065 300
Females 13-50 years old 0.03 0.00023 105 0.065 900
Males 13-19 years old 0.03 0.00027 105 0.065 1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
here3. 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 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.
Using the exposure assumptions described in Unit III.C., Exposure
Assessment, for short-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of 5200 for
adults from exposure to residential lawns including MOEs of 21,000 for
dermal, 7,000,000 for inhalation and 7,000 for postkapplication dermal;
3800 for children from exposure to residential lawns including MOEs of
4,200 for dermal contact, 54,000 for hand-to-mouth, 220,000 for
mouthing grass, and 16,000,000 for soil ingestion. 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-methyl in ground 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 13:
Table 13.--Aggregate Risk Assessment for Short-Term Exposure to halosulfuron-methyl
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aggregate MOE
Population Subgroup (Food + Aggregate Level Surface Water EEC Ground Water EEC Short-Term DWLOC
Residential) of Concern (LOC) (ppb) (ppb) (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population 5300 300 105 0.065 5500
Females 13-50 years old 4700 300 105 0.065 4700
All infants (<1 year old) 3600 300 105 0.065 1500
Males 13-19 years old 5400 300 105 0.065 5500
--------------------------------------------------------------------------------------------------------------------------------------------------------
4. Intermediate-term risk. Intermediate-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 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 Unit III.C., Exposure
Assessment, for intermediate-term exposures, EPA has concluded that
food and residential exposures aggregated result in aggregate MOEs of
1,000 for children from residential lawns including MOEs of 1100 for
dermal contact, 23,000 for hand-to-mouth, 43,000 for mouthing grass,
and 3,200,000 for soil ingestion. 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 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 14:
Table 14.--Aggregate Risk Assessment for Intermediate-Term Exposure to Halosulfuron-methyl
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aggregate MOE
Population Subgroup (Food + Aggregate Level Surface Water EEC Ground Water EEC Intermediate-Term
Residential) of Concern (LOC) (ppb) (ppb) DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
All infants (<1 year) 960 300 105 0.065 230
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 59191]]
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.
Accordingly, exposure to halosulfuron-methyl is not expected to pose a
cancer risk to humans.
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.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate analytical enforcement method is available to enforce
the proposed tolerance for residues of halosulfuron-methyl in or on
asparagus; vegetables, fruiting (except cucurbits), group; bean, dry,
seed and bean, snap succulent. The method used to validate residues of
halosulfuron-methyl is the ``Analytical Method for the Determination of
MON 12000 in Raw Agricultural Commodities and Processed Fractions,''
RES-109-97-4, which has been approved by the Agency for enforcement of
tolerances for halosulfuron-methyl per se in plant commodities and has
been sent to FDA for publication in PAM II. The method limit of
quantification (LOQ) was 0.05 ppm.
An adequate analytical method is available to enforce the
established tolerances for secondary residues in livestock commodities.
The Agency-approved analytical method for livestock commodities is
Monsanto method RES-046-93. The method quantifies halosulfuron-methyl
and the 3-chlorosulfonamide acid metabolite expressed as parent
equivalents. The limit of quantitation is 0.01 ppm.
Adequate enforcement methodology (example: gas chromotography) is
available to enforce the tolerance expression. The method may be
requested from: Paul Golden, Analytical Chemistry Lab. Office of
Pesticide Programs, Environmental Protection Agency, Environmental
Science Center, 701 Maples Road, Fort Mead, MD 20755-5350; telephone
number: (410) 305-2960; e-mail address: golden.paul@epa.gov.
B. International Residue Limits
No Codex, Canadian, or Mexican maximum residue levels (MRL) have
been established for residues of halosulfuron-methyl in/on asparagus,
bean, dry, seed, and bean, snap, succulent, tomatoes, and bell or non-
bell peppers. International harmonization is therefore not an issue.
V. Conclusion
Therefore, the tolerances are 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 0.8 ppm; vegetables, fruiting (except cucurbits),
group at 0.05 ppm; bean, dry, seed at 0.05 ppm and bean, snap,
succulent at 0.05 ppm. Paragraph (b) of Sec. 180.479 is removed and
reserved since the tolerance established in this document for asparagus
at 0.8 ppm replaces the tolerance for asparagus and the tolerance for
tomato is removed because the vegetables, fruiting (except cucurbits),
group at 0.05 ppm includes tomatoes.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2002-0243 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 November
19, 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 (1900C),
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. 104, Crystal Mall 2, 1921
Jefferson Davis Hwy, Arlington, VA. 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
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its
[[Page 59192]]
inclusion in the official record that is described in Unit I.B.2. Mail
your copies, identified by docket ID number OPP-2002-0243, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, 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
petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of FFDCA section 408(n)(4). For these same reasons, the
Agency has determined that this rule does not have 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.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 12, 2002.
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 as follows:
i. By revising the section heading and alphabetically adding the
following
[[Page 59193]]
commodities to the table in paragraph (a)(2).
ii. The text of paragraph (b) is removed and reserved.
Sec. 180.479 Halosulfuron-methyl; tolerances for residues.
(a) General. * * *
(2) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Asparagus.................................................. 0.8
Bean, dry, seed............................................ 0.05
Bean, snap, succulent...................................... 0.05
* * * * *
Vegetables, fruiting (except cucurbits), group............. 0.05
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. 02-23995 Filed 9-19-02; 8:45 am]
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