[Federal Register: August 31, 2005 (Volume 70, Number 168)]
[Rules and Regulations]
[Page 51615-51623]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31au05-11]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0165; FRL-7719-8]
Halosulfuron-methyl; Pesticide Tolerances for Emergency
Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
residues of halosulfuron-methyl in or on sweet potatoes. 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 sweet potatoes. This regulation
establishes a maximum permissible level for residues of halosulfuron-
methyl in this food commodity. The tolerance will expire and is revoked
on December 31, 2008.
DATES: This regulation is effective August 31, 2005. Objections and
requests for hearings must be received on or before October 31, 2005.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under docket
identification (ID) number OPP-2005-0165. All documents in the docket
are listed in the EDOCKET index at http://www.epa.gov/edocket/.
Although listed in the index, some information is not publicly
available, i.e., Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either electronically in
EDOCKET or in hard copy at the Public Information and Records Integrity
Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. Bell St.,
Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The docket telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9367; e-mail address: ertman.andrew@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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 this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180
is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
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, in or on sweet potatoes at 1.0 parts per million
(ppm). This tolerance will expire and is revoked on December 31, 2008.
EPA will publish a document in the Federal Register to remove the
revoked tolerance from the Code of Federal Regulations (CFR).
Section 408(l)(6) of 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
FIFRA section 18 related tolerances to set binding precedents for the
application of section 408 of FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of 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.''
[[Page 51616]]
Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there
is a reasonable certainty that no harm will result from aggregate
exposure to the pesticide chemical residue, including all anticipated
dietary exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
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 of 1996 (FQPA). EPA has
established regulations governing such emergency exemptions in 40 CFR
part 166.
III. Emergency Exemption for Halosulfuron-methyl on Sweet Potatoes and
FFDCA Tolerances
Several sweet potato growing States requested the use of
halosulfuron-methyl due to resistance to pesticides registered for the
control of the weed purple nutsedge in sweet potato fields. EPA has
authorized under section 18 of FIFRA the use of halosulfuron-methyl on
sweet potatoes for control of purple nutsedge in Louisiana,
Mississippi, and North Carolina. After having reviewed the submissions,
EPA concurs that emergency conditions exist for these States.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of halosulfuron-methyl in or
on sweet potatoes. In doing so, EPA considered the safety standard in
section 408(b)(2) of FFDCA, and EPA decided that the necessary
tolerance under section 408(l)(6) of FFDCA would be consistent with the
safety standard and with section 18 of FIFRA. 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) of
FFDCA. Although this tolerance will expire and is revoked on December
31, 2008, under section 408(l)(5) of FFDCA, residues of the pesticide
not in excess of the amounts specified in the tolerance remaining in or
on sweet potatoes after that date will not be unlawful, provided the
pesticide is applied in a manner that was lawful under FIFRA, and the
residues do not exceed a level that was authorized by this tolerance at
the time of that application. EPA will take action to revoke this
tolerance earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether halosulfuron-
methyl meets EPA's registration requirements for use on sweet potatoes
or whether a permanent tolerance for this use would be appropriate.
Under these circumstances, EPA does not believe that this tolerance
serves as a basis for registration of halosulfuron-methyl by a State
for special local needs under section 24(c) of FIFRA. Nor does this
tolerance serve as the basis for any State other than Louisiana,
Mississippi, and North Carolina to use this pesticide on this crop
under section 18 of FIFRA without following all provisions of EPA's
regulations implementing section 18 of FIFRA as identified in 40 CFR
part 166. For additional information regarding the emergency exemption
for halosulfuron-methyl, contact the Agency's Registration Division at
the address provided under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of FFDCA 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) of FFDCA , EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of
halosulfuron-methyl and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of FFDCA, for a time-limited
tolerance for residues of halosulfuron-methyl in or on sweet potatoes
at 1.0 ppm. EPA's assessment of the dietary exposures and risks
associated with establishing the tolerance follows.
A. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological endpoint. However, the
lowest dose at which adverse effects of concern are identified (the
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved
in the toxicology study selected. An uncertainty factor (UF) is applied
to reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. An UF of 100
is routinely used, 10X to account for interspecies differences and 10X
for intra species differences. For halosulfuron-methyl, the Agency
identified the need for a developmental neurotoxicity (DNT) study. In
the absence of a DNT study, EPA concluded that an additional database
UF of 3X is needed for all dietary and residential (non-dietary)
exposure scenarios until the data are received and evaluated. An UF of
3X (as opposed to a higher value) was viewed to be adequate because 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). Consequently, based on the available data it is
unlikely the results of the DNT would impact the overall risk
assessment.
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
(SF).
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100.
[[Page 51617]]
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 x10-\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 Table 1 of this unit:
Table 1.--Summary of Toxicological Dose and Endpoints for Halosulfuron-methyl for Use in Human Risk Assessment
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Dose milligram/
Exposure scenario kilogram/day (mg/kg/ Hazard based special Endpoint for risk
day) UF/MOE FQPA SF assessment
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Dietary risk assessments
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Acute dietary NOAEL = 50 UF = 300\a\ 1x Developmental toxicity--
Females 13-50 years of age........... Acute RfD = 0.17 mg/kg/ rabbit
day. LOAEL = 150 mg/kg/day
based on decreased
mean litter size,
increased number of
resorptions (total and
per dam) and increased
post-implantation
loss. (developmental
toxicity).
--------------------------------------
Chronic dietary NOAEL = 10 UF = 300\a\ 1x Chronic toxicity--dog
All populations...................... Chronic RfD = 0.03 mg/ LOAEL = 40 mg/kg/day
kg/day. based on decreased
body weight gains in
females.
--------------------------------------
Incidental oral NOAEL = 50 1x Developmental toxicity--
Short-term (1-30 days)............... MOE = 300.............. rabbit
Residential only..................... LOAEL = 150 mg/kg/day
based on decreased
body weight gain, food
consumption, and food
efficiency. (maternal
toxicity).
--------------------------------------
Incidental oral NOAEL = 10 1x 13 Week Subchronic
Intermediate-term (1-6 months)....... MOE = 300.............. toxicity--dog
Residential only..................... LOAEL = 40 mg/kg/day
based on decreased
body weight gain and
food efficiency in
females.
--------------------------------------
Non-dietary risk assessments
----------------------------------------------------------------------------------------------------------------
Dermal Dermal NOAEL = 100 21-Day dermal toxicity
Short-term (1-30 days)............... study--rat
LOAEL = 1,000 mg/kg/day
based on decreased
body weight gain in
males.
----------------------------------------------------------------------------------------
Residential MOE = 300
--------------------------------------
Dermal\b\ Oral NOAEL = 10 13 Week subchronic
Intermediate-term (1-6 months)....... toxicity--dog
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 1x Chronic toxicity--dog
Long-term (> 6 months)............... MOE = 300.............. LOAEL = 40 mg/kg/day
Residential.......................... based on decreased
body weight gains in
females.
--------------------------------------
Inhalation\c\ Oral NOAEL = 10 1x 13 Week subchronic
Intermediate-term (1-6 months)....... MOE = 300.............. toxicity--dog
Residential.......................... LOAEL = 40 mg/kg/day
based on decreased
body weight gain and
food efficiency in
females.
--------------------------------------
Inhalation\c\ Oral NOAEL = 10 1x Chronic toxicity--dog
Long-term (> 6 months)............... MOE = 300.............. LOAEL = 40 mg/kg/day
Residential.......................... based on decreased
body weight gains in
females.
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[[Page 51618]]
Cancer Classification: ``not likely to be carcinogenic to humans'' by the oral
route, based on no evidence from studies in rats and mice.
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\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 should be used in route-to-route extrapolation.
\c\ Absorption via the inhalation route is presumed to be equivalent to oral absorption.
B. Exposure Assessment
1. Dietary exposure from food, feed uses, and drinking water.
Tolerances have been previously established (40 CFR 180.479) for the
residues of halosulfuron-methyl, in or on a variety of raw agricultural
commodities. The established tolerances include almond hulls; corn
(sweet, kernel+cob with husks removed, field grain, fodder, forage,
pop); cotton (gin by-products and undelinted seed); pistachio nutmeat;
sugarcane; rice (grain, straw); and tree nuts (crop group 14).
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.
In conducting the acute and chronic dietary risk assessments, EPA
used the Dietary Exposure Evaluation Model (DEEM\TM\) software. Modeled
estimates of drinking water concentrations were directly entered into
the exposure model to assess the contribution from drinking water. 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 DEEM\TM\ analysis evaluated the individual food
consumption as reported by respondents in the U.S. Department of
Agriculture (USDA) 1994-1996 and 1998 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 (PCT) for all commodities for which halosulfuron-
methyl tolerances are established and for the crop. Aggregate acute
food and water exposure was determined by including modeled estimates
of drinking water concentrations in the dietary model. The Agency used
the acute water concentration (105 parts per billion (ppb)) derived
from surface water modeling results, which was significantly higher
than the modeled ground water concentration, and therefore protective
of potential exposures via ground water sources of drinking water.
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 1994-1996 and 1998
nationwide 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 PCT for all commodities
for which halosulfuron-methyl tolerances are established and for sweet
potatoes. Aggregate chronic food and water exposure was determined by
including modeled estimates of drinking water concentrations in the
dietary model. The Agency used the chronic water concentration (105
ppb) derived from surface water modeling results, which was
significantly higher than the modeled ground water concentration, and
therefore protective of potential exposures via ground water sources of
drinking water.
iii. Cancer. Halosulfuron-methyl is classified as a ``Not Likely''
human carcinogen. Therefore, risk assessments to assess cancer risk
were not conducted.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for halosulfuron-methyl in
drinking water. Because the Agency does not have comprehensive
monitoring data, drinking water concentration estimates are made by
reliance on simulation or modeling taking into account data on the
physical characteristics of halosulfuron-methyl.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS)
to produce estimates of pesticide concentrations in an index reservoir.
The Screening Concentration in Ground Water Modeling System (SCI-GROW)
model is used to predict pesticide concentrations in shallow ground
water. For a screening-level assessment for surface water EPA will
generally use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2
model). The FIRST model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. While both FIRST and
PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water.
Based on the FIRST and SCI-GROW models the estimated environmental
concentrations (EECs) of halosulfuron-methyl for acute exposures are
estimated to be 105 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). Halosulfuron-methyl
is currently registered for use on the following residential non-
dietary sites: Residential turfgrass and landscaped areas.
The short-term aggregate risk assessment estimates risks likely to
[[Page 51619]]
result from 1- to 30-day exposure to halosulfuron-methyl residues. A
short-term risk assessment is required for adults because there are
both residential handler and post-application exposure scenarios. In
addition, a short-term risk assessment is required for infants and
children because there is a residential post-application exposure
scenario. Since the same effect was identified as the endpoint across
all routes of exposure (decreased body-weight gain), MOEs are combined
to result in an aggregate MOE (using the ``1/MOE Approach''). The
Agency's level of concern for short-term exposure is an MOE of 300 or
lower. Results from the short-term risk assessment indicate that all
short-term aggregate MOEs are 3,100 or higher. Therefore, estimated
aggregate (food + water + residential) exposure to halosulfuron-methyl
are not of concern for short-term aggregate exposure.
The intermediate-term aggregate risk assessment estimates risks
likely to result from 1 to 6 months of exposure to halosulfuron-methyl
residues from food, drinking water, and residential pesticide uses. An
intermediate-term risk assessment is not required for adults because
residential handler scenarios are not expected to occur for longer than
a short-term time frame. However, an intermediate-term risk assessment
is required for infants and children because there is a residential
post-application oral exposure scenario. Since the same effect was
identified as the endpoint across all routes of exposure (decreased
body weight gain), MOEs are combined to result in an aggregate MOE
(using the ``1/MOE Approach''). High-end estimates of residential
exposure are used in the intermediate-term assessment, while average
values are used for food and drinking water exposure. The Agency's
level of concern for intermediate-term exposure is an MOE of 300 or
lower. Results from the intermediate-term risk assessment indicate that
the intermediate-term aggregate MOE is 819 for the most highly exposed
child subgroup. Therefore, estimated aggregate (food + water +
residential) exposure to halosulfuron-methyl are not of concern for
intermediate-term aggregate exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA 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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to halosulfuron-methyl and
any other substances and 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 policy statements
released by EPA's OPP concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.
C. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for pre-natal and post-natal
toxicity and the completeness of the 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 MOE analysis or
through using UFs in calculating a dose level that poses no appreciable
risk to humans.
2. Conclusion. The Agency concludes that no special FQPA SF 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 is regulating at
the NOAEL of 50 mg/kg/day for acute dietary, short-term incidental oral
and inhalation risk assessments and the NOAEL of 10 mg/kg/day for
chronic dietary and intermediate-term incidental oral, dermal, and
inhalation risk assessments. These endpoints 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).
ii. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments may be refined using
anticipated residues calculated from field trial data with any PCT
information. Conservative ground and surface water modeling estimates
have been used. The Agency's residential standard operating procedures
(SOPs) are used to assess post-application exposure to children as well
as incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by halosulfuron-methyl.
However, a 3X additional database UF will be used to address the
data deficiency for the developmental neurotoxicity study. The 3X
safety factor should be applied to all dietary and residential non-
dietary exposure scenarios. No FQPA SF is appropriate for halosulfuron-
methyl.
D. Aggregate Risks and Determination of Safety
The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs) which are used
as a point of comparison against EECs. The DWLOC values are not
regulatory standards for drinking water, but 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 the EPA's Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2 L/60 kg (adult female), and 1
L/10 kg (child). Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, 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
[[Page 51620]]
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. When new
uses are added OPP reassesses the potential impacts of residues of the
pesticide in drinking water as a part of the aggregate risk assessment
process.
More recently the Agency has used another approach to estimate
aggregate exposure through food, residential, and drinking water
pathways. In this approach, modeled surface and ground water EECs are
directly incorporated into the dietary exposure analysis, along with
food. This provides a more realistic estimate of exposure because
actual body weights and water consumption from the CSFII are used. The
combined food and water exposures are then added to estimated exposure
from residential sources to calculate aggregate risks. The resulting
exposure and risk estimates are still considered to be high end, due to
the assumptions used in developing drinking water modeling inputs. This
risk assessment for halosulfuron-methyl was conducted using this
approach.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to halosulfuron-methyl will occupy 14% for females 13-50 years of age,
the population subgroup of concern. EPA does not expect the aggregate
exposure to exceed 100% of the aPAD, as shown in Table 2 of this unit:
Table 2.--Aggregate Risk Assessment for Acute Exposure to Halosulfuron-
methyl
------------------------------------------------------------------------
% aPAD (Food and
Population subgroup aPAD (mg/kg) Water)
------------------------------------------------------------------------
Females 13 years and older 0.17 14%
------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
halosulfuron-methyl from food and water will utilize 2% or less of the
cPAD for all population subgroups in DEEM\TM\ including the U.S.
population, infants and children. There are no residential uses for
halosulfuron-methyl that result in chronic residential exposure to
halosulfuron-methyl. Based on the use pattern, chronic residential
exposure to residues of halosulfuron-methyl is not expected. EPA does
not expect the aggregate exposure to exceed 100% of the cPAD, as shown
in Table 3 of this unit:
Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to
Halosulfuron-methyl
------------------------------------------------------------------------
% cPAD (Food and
Population subgroup cPAD mg/kg/day Water)
------------------------------------------------------------------------
U.S. population 0.03 1%
-----------------------------------
-----------------------------------
-----------------------------------
-----------------------------------
-----------------------------------
------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Halosulfuron-methyl is
currently registered for use(s) that could result in short-term
residential exposure and the Agency has determined that it is
appropriate to aggregate chronic food and water and short-term
exposures for halosulfuron-methyl.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water and residential
exposures aggregated result in aggregate MOEs of 5,800 for the general
U.S. population and 3,200 for children 3-5 years old for dermal,
incidental oral, and inhalation exposures. These aggregate MOEs do not
exceed the Agency's level of concern for aggregate exposure to food and
residential uses. EPA does not expect short-term aggregate exposure to
exceed the Agency's level of concern, as shown in Table 4 of this unit:
Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Halosulfuron-methyl
----------------------------------------------------------------------------------------------------------------
Aggregate MOE (Food + Water Aggregate Level of Concern
Population subgroup + Residential) (LOC)
----------------------------------------------------------------------------------------------------------------
U.S. population 5,800 300
----------------------------------------------------------------------------------------------------------------
[[Page 51621]]
Intermediate-term risk. Intermediate-term aggregate exposure takes into
methyl.Using the exposure assumptions described in
this unit for intermediate-term exposures, EPA has
concluded that food, water and residential
exposures aggregated result in an aggregate MOE of
819 for infants and children (the population
subgroup of concern). This aggregate MOE does not
exceed the Agency's level of concern for aggregate
exposure to food, water and residential uses. EPA
does not expect intermediate-term aggregate
exposure to exceed the Agency's level of concern,
as shown in Table 5 of this unit:3,L4,i1,s15,25,25
Children 3-5 years 819 300
----------------------------------------------------------------------------------------------------------------
5. Aggregate cancer risk for U.S. population. Halosulfuron-methyl
is classified as a ``Not Likely'' human carcinogen. Therefore, risk
assessments to assess cancer risk were not conducted.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to halosulfuron-methyl residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (example--gas chromatography) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
B. International Residue Limits
There is neither a Codex proposal, nor Canadian or Mexican maximum
residue limits, for residues of halosulfuron-methyl in or on sweet
potatoes. Therefore, harmonization is not an issue.
VI. Conclusion
Therefore, the tolerance is established for residues of
halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidinyl)amino]
carbonylaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, in
or on sweet potato at 1.0 ppm.
VII. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA 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) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. 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-2005-0165 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 October
31, 2005.
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 (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW.,
Washington, DC 20005. 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) 564-6255.
2. 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 ADDRESSES. Mail your
copies, identified by the docket ID number OPP-2005-0165, 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-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. 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.
[[Page 51622]]
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. Statutory and Executive Order Reviews
This final rule establishes a time-limited tolerance under section
408 of FFDCA. 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 section 408 of FFDCA, 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 section 408(n)(4) of the FFDCA. 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. Congressional Review Act
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: August 19, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.479 is amended by revising the introductory text of
paragraph (a)(1) and by adding text to paragraph (b) to read as
follows:
Sec. 180.479 Halosulfuron-methyl; tolerances for residues.
(a) * * * (1) Tolerances are established for residues of the
herbicide halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidinyl)
amino]carbonylaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-
carboxylate, in or on the raw agricultural commodities listed in the
table in this unit.
* * * * *
(b) Section 18 emergency exemptions. Time-limited 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 connection with use of the pesticide
under FIFRA section 18 emergency exemptions granted by EPA in or on the
following commodity:
[[Page 51623]]
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
Sweet potato.................................. 1.0 12/31/08
------------------------------------------------------------------------
* * * * *
[FR Doc. 05-17204 Filed 8-30-05; 8:45 am]
BILLING CODE 6560-50-S