Browse by Year
/ 2002
/ July
/ Wednesday, July 10, 2002
[Federal Register: July 10, 2002 (Volume 67, Number 132)]
[Rules and Regulations]
[Page 45643-45650]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10jy02-11]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0113; FRL-7183-2]
Halosulfuron; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a time-limited tolerance for
residues of halosulfuron in or on tomato. This action is in response to
EPA's granting of an emergency exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing
use of the pesticide on tomato. This regulation establishes a maximum
permissible level for residues of halosulfuron in this food commodity.
The tolerance will expire and is revoked on June 30, 2005.
DATES: This regulation is effective July 10, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0113,
must be received on or before September 9, 2002.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number OPP-2002-0113 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Barbara Madden, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-6463; e-mail address:
Madden.Barbara@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected categories and entities may include, but are not
limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS Codes Potentially
Affected Entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of This
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml--00/Title--40/40cfr180--00.html, a beta site currently
under development.
2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0113. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Mall 2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305--
5805.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing a tolerance for residues of the herbicide
halosulfuron, methyl 5-[(4,6-dimethoxy-2-pyrimidinyl)amino]
carbonylaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, in
or on tomato at 0.05 part per million (ppm). This tolerance will expire
and is revoked on June 30, 2005. EPA will publish a document in the
Federal Register to remove the revoked tolerance from the Code of
Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
[[Page 45644]]
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by the Food Quality Protection Act (FQPA). EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
Recently, EPA has received objections to a tolerance it established
for halosulfuron on a different food commodity. The objections were
filed by the Natural Resources Defense Council (NRDC) and raised
several issues regarding aggregate exposure estimates and the
additional safety factor for the protection of infants and children.
Although these objections concern separate rulemaking proceedings under
the FFDCA, EPA has considered whether it is appropriate to establish
the emergency exemption tolerance for halosulfuron in or on tomato
while the objections are still pending.
Factors taken into account by EPA included how close the Agency is
to concluding the proceedings on the objections, the nature of the
current action, whether NRDC's objections raised frivolous issues, and
the extent to which the issues raised by NRDC had already been
considered by EPA. Although NRDC's objections are not frivolous, the
other factors all support establishing this tolerance at this time.
First, the objections proceeding is not near to conclusion. NRDC's
objections raise complex legal, scientific, policy, and factual matters
and EPA has just initiated a 60 day public comment period on them. [67
FR 41628-41635, June 19, 2002] Second, the nature of the current
actions are extremely time-sensitive as they address emergency
situations. Third, the issues raised by NRDC are not new matters but
questions that have been the subject of considerable study by EPA and
comment by stakeholders. Accordingly, EPA is proceeding with
establishing the tolerances for halosulfuron in or on tomato.
III. Emergency Exemption for Halosulfuron on Tomato and FFDCA
Tolerances
Yellow (Cyperus esculentus) and purple nutsedge (Cyperus rotundus)
are very difficult to control warm season, perennial weeds that
reproduce by seeds and nutlets. They have high reproductive potential
and can be very competitive with tomatoes during crop establishment. In
addition to crop competition nutsedge plants can penetrate the plastic
mulch used in tomato culture destroying the plastic and allowing
entrance of other pest species.
Halosulfuron will allow preemergence or post emergence applications
to control emerged nutsedge plants before they can flower or form
nutlets to propagate themselves. It can be used in the plant rows or
between the plant rows. The alternative chemicals consist of methyl
bromide whose production is being phased out, metam sodium, pebulate,
and napropamide. The last three chemicals can only be applied preplant
incorporated or preemergence and do not provide season long control of
nutsedge. Cultivation and hand weeding only help to further distribute
the plants and nutlets. Deep plowing can provide suppression the first
time it is used but subsequent plowing operations bring the old tubers
back up to germinate. The states of Florida and Georgia claim that
yield losses of tomatoes due to purple and yellow nutsedge infestations
can be as high as 20 to 30% compared to the next best alternative.
EPA has authorized under FIFRA section 18 the use of halosulfuron
on tomato for control of purple and yellow nutsedge in Florida and
Georgia. After having reviewed the submission, EPA concurs that
emergency conditions exist for these States.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of halosulfuron in or on
tomato. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the safety standard
and with FIFRA section 18. Consistent with the need to move quickly on
the emergency exemption in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
comment as provided in section 408(l)(6). Although this tolerance will
expire and is revoked on June 30, 2005, under FFDCA section 408(l)(5),
residues of the pesticide not in excess of the amounts specified in the
tolerance remaining in or on tomato after that date will not be
unlawful, provided the pesticide is applied in a manner that was lawful
under FIFRA, and the residues do not exceed a level that was authorized
by this tolerance at the time of that application. EPA will take action
to revoke this tolerance earlier if any experience with, scientific
data on, or other relevant information on this pesticide indicate that
the residues are not safe.
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether halosulfuron
meets EPA's registration requirements for use on tomato or whether a
permanent tolerance for this use would be appropriate. Under these
circumstances, EPA does not believe that this tolerance serves as a
basis for registration of halosulfuron by a State for special local
needs under FIFRA section 24(c). Nor does this tolerance serve as the
basis for any State other than Florida and Georgia to use this
pesticide on this crop under section 18 of FIFRA without following all
provisions of EPA's regulations implementing section 18 as identified
in 40 CFR part 166. For additional information regarding the emergency
exemption for halosulfuron, contact the Agency's Registration Division
at the address provided under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
halosulfuron and to make a determination on aggregate exposure,
[[Page 45645]]
consistent with section 408(b)(2), for a time-limited tolerance for
residues of halosulfuron in or on tomato at 0.05 ppm. EPA's assessment
of the dietary exposures and risks associated with establishing the
tolerance follows.
A. Toxicological Endpoints
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by halosulfuron-methyl
are discussed in Unit II.A. of the final rule on halosulfuron-methyl
pesticide tolerances published in the Federal Register for September
29, 2000 (65 FR 58424) (FRL-6746-2). A summary of the toxicological
dose and endpoints for halosulfuron-methyl for use in this human risk
assessment is discussed in Unit III.B. of the final rule on
halosulfuron-methyl pesticide tolerances published in the Federal
Register of December 26, 2001 (66 FR 66333) (FRL-6816-8).
B. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.479) for the residues of halosulfuron, in or on
a variety of raw agricultural commodities. The established tolerances
include tree nuts (crop group 14); pistachio nutmeat; almond hulls;
sugarcane; corn (sweet, kernel+cob with husks removed, field grain,
fodder, forage, pop); rice (grain, straw); and cotton (gin by-products
and undelinted seed). Additionally, tolerances are established (40 CFR
180.479(a)(1)) for residues of halosulfuron-methyl and its metabolites
determined as 3-chloro-1-methyl-5-sulfamoylpyrazole-4-carboxylic acid
(also referred to as CSA, expressed as parent equivalents) at 0.1 ppm
in or on meat by-products of cattle, goats, hogs, horses and sheep.
Risk assessments were conducted by EPA to assess dietary exposures from
halosulfuron in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. The Dietary Exposure Evaluation Model (DEEM[reg])
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The following assumptions were made for the acute
exposure assessments: Tolerance level residues and 100 percent crop-
treated for all commodities.
ii. Chronic exposure.In conducting this chronic dietary risk
assessment the DEEM[reg] analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992 nationwide
CSFII and accumulated exposure to the chemical for each commodity. The
following assumptions were made for the chronic exposure assessments:
Tolerance level residues and 100 percent crop-treated for all
commodities.
iii. Cancer. Halosulfuron is classified as a ``Not Likely'' human
carcinogen. Therefore, risk assessments to assess cancer risk were not
completed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for halosulfuron in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of halosulfuron.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in ground water. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. The PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a percent of the Reference dose
(%RfD) or percent of population adjusted dose (%PAD). Instead, drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to halosulfuron they are
further discussed in the aggregate risk sections below.
Based on the GENEEC and SCI-GROW models the EECs of halosulfuron
for acute exposures are estimated to be 8.3 parts per billion (ppb) for
surface water and 0.065 ppb for ground water. The EECs for chronic
exposures are estimated to be 1.7 ppb for surface water and 0.065 ppb
for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Halosulfuron is
currently registered for use on the following residential non-dietary
sites: Residential turfgrass and landscaped areas.
Short- and intermediate-term exposure may occur for residential
handlers and for postapplication activities. Exposure for adults is
expected for handler and postapplication exposure. Residential post-
application dermal and oral exposure is expected for infants and
children. Adults may be exposed through skin contact with treated
surfaces (dermal exposure), while children may be exposed through skin
contact as well as orally, through hand-to-mouth exposure and through
object-to-mouth exposure (putting grass in their mouth). Exposure
estimates for adult handlers' and children's postapplication exposure
to halosulfuron-methyl are based on the Agency's Draft Standard
Operating Procedures for Residential Exposure Assessments (12/18/1997)
and its interim revisions, and data from the review of Outdoor
Residential Exposure
[[Page 45646]]
Task Force Chemical Handler Exposure Studies. Chronic exposures for the
residential uses are not expected based on the use pattern.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether halosulfuron has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
halosulfuron does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that halosulfuron has a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
C. Safety Factor for Infants and Children
1. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
2. Conclusion. There is a complete toxicity database for
halosulfuron and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. The Agency has
determined that the 10X FQPA Safety factor for enhanced sensitivity to
infants and children can be reduced to 1X. The decision is based upon
the following reasons: There was no indication of increased
susceptibility of rats or rabbits to in utero and/or postnatal exposure
to halosulfuron-methyl. In the prenatal developmental toxicity studies
in rats and rabbits and the 2-generation reproduction study in rats,
effects in the offspring were observed only at or above treatment
levels which resulted in evidence of parental toxicity.
The Agency determined that the requirement of a developmental
neurotoxicity study in rats did not warrant an application of
additional safety factors because: (1) The alterations observed in the
fetal nervous system occurred in only one species (in rats and not in
rabbits); (2) the fetal effects which will be investigated in the
required developmental neurotoxicity study were seen only at a dose of
750 mg/kg/day which is close to the Limit-Dose (1,000 mg/kg/day); (3)
there was no evidence of clinical signs of neurotoxicity, brain weight
changes, or neuropathology in the subchronic or chronic studies in
rats; (4) the developmental neurotoxicity study is required only as
confirmatory data to understand what the effect is at a high exposure
(dose) level; (5) exposure assessments do not indicate a concern for
potential risk to infants and children based on the results of the
field trial studies and the very low application rate ([sim] 0.06 lbs.
active ingredient per acre). Detectable residues are not expected in
foods. Consequently, there is no concern that the level of 750 mg/kg/
day would be approached.
D. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the population adusted dose (PAD)) is
available for exposure through drinking water [e.g., allowable chronic
water exposure (mg/kg/day) = cPAD - (average food + chronic non-
dietary, non-occupational exposure)]. This allowable exposure through
drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and groundwater are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to halosulfuron in drinking water (when considered along with
other sources of exposure for which EPA has reliable data) would not
result in unacceptable levels of aggregate human health risk at this
time. Because EPA considers the aggregate risk resulting from multiple
exposure pathways associated with a pesticide's uses, levels of
comparison in drinking water may vary as those uses change. If new uses
are added in the future, EPA will reassess the potential impacts of
halosulfuron on drinking water as a part of the aggregate risk
assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
halosulfuron will occupy 1% or less of the aPAD for all population
subgroups in DEEM[reg] including females 13 years and older, infants
and children. In addition, despite the potential for acute dietary
exposure to halosulfuron in drinking water, after calculating DWLOCs
and comparing them to conservative model EECs of halosulfuron in
surface and ground water, EPA does not expect the aggregate exposure to
exceed 100% of the aPAD, as shown in the following Table 2:
[[Page 45647]]
Table 2.--Aggregate Risk Assessment for Acute Exposure to Halosulfuron
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13 years and older..................... 0.5 <1% 8.3 0.065 15,000
All infants (< 1 year old)..................... 0.5 1% 8.3 0.065 5,000
Children....................................... 0.5 <1% 8.3 0.065 5,000
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
halosulfuron from food will utilize less than 1% of the chronic
population adjusted dose (cPAD) for all population subgroups in
DEEM[reg] including the U.S. population, infants and children. There
are no residential uses for halosulfuron that result in chronic
residential exposure to halosulfuron. Based on the use pattern, chronic
residential exposure to residues of halosulfuron is not expected. In
addition, despite the potential for chronic dietary exposure to
halosulfuron in drinking water, after calculating DWLOCs and comparing
them to conservative model EECs of halosulfuron in surface and ground
water, EPA does not expect the aggregate exposure to exceed 100% of the
cPAD, as shown in the following Table 3:
Table 3.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to halosulfuron
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population................................ 0.1 <1% 1.7 0.065 3,500
All infants (<1 year old)...................... 0.1 <1% 1.7 0.065 1,000
Children....................................... 0.1 <1% 1.7 0.065 1,000
----------------------------------------------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Halosulfuron is
currently registered for use(s) that could result in short-term
residential exposure and the Agency has determined that it is
appropriate to aggregate chronic food and water and short-term
exposures for halosulfuron.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of 4,500 for adults for both
handler and postapplication exposures and 2,800 for infants and
children for dermal and incidental oral exposures. These aggregate MOEs
do not exceed the Agency's level of concern for aggregate exposure to
food and residential uses. In addition, short-term DWLOCs were
calculated and compared to the EECs for chronic exposure of
halosulfuron in ground water and surface water. After calculating
DWLOCs and comparing them to the EECs for surface and ground water, EPA
does not expect short-term aggregate exposure to exceed the Agency's
level of concern, as shown in the following Table 4:
Table 4.--Aggregate Risk Assessment for Short-Term Exposure to halosulfuron
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population............................... 4,500 100 1.7 0.065 17,000
Infants....................................... 2,800 100 1.7 0.065 4,800
Children...................................... 2,800 100 1.7 0.065 4,800
----------------------------------------------------------------------------------------------------------------
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Halosulfuron is currently registered for use(s) that could
result in intermediate-term residential exposure and the Agency has
determined that it is appropriate to aggregate chronic food and water
and intermediate-term exposures for halosulfuron.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of 1,700 for
adults and 1,100 for infants and children. These aggregate MOEs do not
exceed the Agency's level of concern for aggregate exposure to food and
residential uses. In addition, intermediate-term DWLOCs were calculated
and compared to the EECs for chronic exposure of halosulfuron in ground
water and surface water. After calculating DWLOCs and comparing them to
the EECs for surface and ground water, EPA does not expect
intermediate-term aggregate exposure to exceed the Agency's level of
concern, as shown in the following Table 5:
[[Page 45648]]
Table 5.--Aggregate Risk Assessment for Intermediate- Term Exposure to Halosulfuron
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Intermediate-
Population Subgroup MOE (Food + Concern Water EEC Water EEC Term DWLOC
Residential) (LOC) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population............................. 1,700 100 1.7 0.065 3,300
Infants..................................... 1,100 100 1.7 0.065 910
Children.................................... 1,100 100 1.7 0.065 910
----------------------------------------------------------------------------------------------------------------
5. Aggregate cancer risk for U.S. population. Halosulfuron is
classified as a ``Not Likely'' human carcinogen. Therefore, risk
assessments to assess cancer risk were not completed.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to halosulfuron residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology is available to enforce the
tolerance expression. The method may be requested from: Calvin Furlow,
PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460;
telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.
B. International Residue Limits
There is neither a Codex proposal, nor Canadian or Mexican maximum
residue limits, for residues of halosulfuron in or on tomatoes,
therefore harmonization is not an issue.
C. Conditions
A maximum of 0.094 pounds halosulfuron may be applied per acre per
season. A total of 2 applications per season may be made. The
preharvest interval (PHI) is 30 days.
VI. Conclusion
Therefore, the tolerance is established for residues of
halosulfuron, methyl 5-[(4,6- dimethoxy-2-pyrimidinyl)amino]
carbonylaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, in
or on tomato at 0.05 ppm.
VII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-2002-0113 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before September
9, 2002.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at 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 VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by the docket control number OPP-2002-0113, to:
Public Information and Records Integrity Branch, Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental
[[Page 45649]]
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. Regulatory Assessment Requirements
This final rule establishes a time limited tolerance under FFDCA
section 408. The Office of Management and Budget (OMB) has exempted
these types of actions from review under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
Because this rule has been exempted from review under Executive Order
12866 due to its lack of significance, this rule is not subject to
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 exemption under FFDCA section 408, such as the [tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers, and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
IX. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 24, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 374.
2. In Sec. 180.479, paragraph (b) is amended by revising the text
and by alphabetically adding an entry for ``Tomato'' to the table to
read as follows:
Sec. 180.479 Halosulfuron; tolerances for residues.
* * * * *
(b)Section 18 emergency exemptions. Time-limited tolerances are
established for residues of halosulfuron, methyl 5-[(4,6-dimethoxy-2-
pyrimidinyl)amino] carbonylaminosulfonyl-3-chloro-1-
[[Page 45650]]
methyl-1H-pyrazole-4-carboxylate, in connection with use of the
pesticide under section 18 emergency exemptions granted by EPA in or on
the following commodities:
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
* * * * *
Tomato........................................ 0.05 6/30/05
------------------------------------------------------------------------
* * * * *
[FR Doc. 02-17266 Filed 7-9-02; 8:45 am]
BILLING CODE 6560-50-S
Browse by Year
/ 2002
/ July
/ Wednesday, July 10, 2002
Debt Consolidation - Arizona Pools - Internet Marketing - Loans
|
|
