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triflusulfuron methyl (Pinnacle) Pesticide Tolerance 5/02

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0082; FRL-7180-8]
 
Triflusulfuron Methyl; Pesticide Tolerance
AGENCY:  Environmental Protection Agency (EPA).
ACTION:  Final rule.
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SUMMARY:  This regulation establishes tolerances for residues of 
triflusulfuron methyl in or on beet, sugar, roots; beet, sugar, tops; 
and chicory, roots. Interregional Research Project #4 (IR-4) and E. 
I. Dupont de Nemours & Company requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act of 1996 (FQPA).
DATES:  This regulation is effective June 12, 2002. Objections and 
requests for hearings, identified by docket ID number 
OPP-2002-0082, must be received on or before August 12, 
2002.
ADDRESSES:  Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket ID number 
OPP-2002-0082 in the subject line on the first page of your 
response.
FOR FURTHER INFORMATION CONTACT:  By mail: James A. Tompkins or Hoyt 
Jamerson, Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460; telephone number: (703) 305-5697 or 
(703) 308-9368; e-mail address: tompkins.jim@epa.gov or 
jamerson.hoyt@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include,but are not limited to:
        Table 1. Examples of Potentially Affected Entities
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                                                         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 toa particular 
entity, consult the persons 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
currently under development. To access the OPPTS Harmonized Guidelines 
referenced in this document, go directly to the guidelines at http://
www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for this 
action under docket ID number OPP-2002-0082. The official 
record consists of the documents specifically referenced in this action, 
and other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The public 
version of the official record does not include any information claimed 
as CBI. The public version of the official record, which includes 
printed, paper versions of any electronic comments submitted during an 
applicable comment period is available for inspection in the Public 
Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 
#2, 1921 Jefferson Davis Hwy., Arlington, VA,from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The PIRIB 
telephone number is (703) 305-5805.
II. Background and Statutory Findings
    In the Federal Register of December 22, 1999(64 FR 71760) 
(FRL-6391-1) and August 8, 2001 (66 FR 41593) 
(FRL-6795-4), EPA issued a notice pursuant to section 408 
of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 
104-170), announcing the filing of a pesticide petition (PP) by 
IR-4 and E. I. Dupont de Nemours & Company, 681 US Highway #1 
South North Brunswick, NJ 08902-3390, and E.I. DuPont de Nemours & Company, 
DuPont Agricultural Products, Barley Mill Plaza,Wilmington, DE 19880-0038. 
This notice included a summary of the petition prepared by E.I.DuPont de Nemours, 
the registrant. There were no comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.492 be amended by 
establishing a tolerance for residues of the herbicide, triflusulfuron 
methyl, methyl 2-[[[[[4-(dimethylamino)-6-(2,2,2-trifluoroethoxy)-
1,3,5-triazin-2-yl]amino]carbonyl]amino]sulfonyl]-3-methylbenzoate, in 
or on chicory, root at 0.05 parts per million (ppm) (PP 0E6214). PP 
4F4278 proposed that the currently established time-limited tolerances 
for sugar beet, root at 0.05 ppm and sugar beet, top at 0.05 ppm be 
converted to permanent tolerances and to revise the commodities to read 
beet, sugar, roots at 0.05 ppm and beet,sugar, tops at 0.05 ppm.
    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." 
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...."
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section408 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).
III. Aggregate Risk Assessment and Determination of Safety
    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 and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA,for tolerances for residues of triflusulfuron methyl 
on chicory, root at 0.05 ppm; and to convert the time-limited 
tolerances for beet, sugar, root at 0.05 ppm and beet, sugar, top at 
0.05 to permanent tolerances. EPA's assessment of exposures and risks 
associated with establishing the tolerances follows.
A. Toxicological Profile
    EPA has evaluated the available toxicity data and considered its 
validity,completeness, and reliability as well as the relationship of 
the results of the studies to human risk.EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by triflusulfuron 
methyl are discussed in Table 2 of this unit, as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level(LOAEL) from the toxicity studies reviewed.
Table 2. Subchronic, Chronic, and Other Toxicity
Guideline No.
Study type
Results
870.3100 90–Day oral toxicity rodents
(two studies submitted)
NOAEL = 6.56/7.71 (m/f) mg/kg/day (milligram/kilogram/day)
LOAEL = 133/153 (m/f) mg/kg/day based on decreased body weight gain and food efficiency in males; increased incidence of histopathological changes (kidney and spleen) in females.
NOAEL = 6.20/7.54 (m/f) mg/kg/day
LOAEL = 127/150 (m/f) mg/kg/day; based on decreased mean body weight gain, decreased mean food consumption (f), decreased mean food efficiency, alterations in hematology parameters (m); hemosiderin in kidneys (f)
870.3150 90–Day oral toxicity in nonrodents NOAEL = 3.9/3.7 (m/f) mg/kg/day
LOAEL = 146.9/159.9 (m/f) mg/kg/day based on decreased mean body weight and body weight gain, decreased hematocrit, hemoglobin, RBC‘s, SGOT, SGPT, ALP, absolute and relative liver and testes weight; microscopic abnormalities of the liver and testes.
870.3200 21/28–Day dermal toxicity NOAEL = 1,000 mg/kg/day
LOAEL = 1,000 mg/kg/day based on limit dose.
870.3700a Pre-natal developmental in rodents Maternal NOAEL = 120 mg/kg/day
LOAEL = 350 mg/kg/day based on decreased body weight gain, decreased food consumption and lower food efficiency.
Developmental NOAEL = > 1,000 mg/kg/day limit dose
LOAEL = > 1,000 mg/kg/day.
870.3700b Pre-natal developmental in nonrodents Maternal NOAEL = 90 mg/kg/day
LOAEL = 270 mg/kg/day based on clinical signs including absent/reduced stool and stained fur, maternal death, increased abortions, decreased body weight gain, and lower-food efficiency.
Developmental NOAEL = 90 mg/kg/day
LOAEL = 270 mg/kg/day based on increased abortions.
870.3800 Reproduction and fertility effects Parental/Systemic NOAEL = 5.81/7.75 (m/f) mg/kg/day
LOAEL = 44/58 mg/kg/day based on decreased body weight, decreased body weight gain, decreased food consumption, and decreased-food efficiency.
Reproductive NOAEL = 89.5/115 (m/f) mg/kg/day based on the absence of reproductive effects at the highest dose tested (HDT).
LOAEL =  mg/kg/day.
Offspring NOAEL = 5.81/7.75 (m/f) mg/kg/day
LOAEL = 44/58 (m/f) mg/kg/day based on decreased F1 pup body weight on days 14 and 21 due to exposure via milk and in the diet.
870.4100a Chronic toxicity rodents NOAEL = 2.44 mg/kg/day
LOAEL = 30.6 mg/kg/day based on decreased body weight and body weight gain, alteration in hematology (mainly males) and increased incidences of interstitial cell hyperplasia in testes.
870.4100b Chronic toxicity dogs NOAEL = 26.9 mg/kg/day
LOAEL = 116.6 mg/kg/day based on increased liver weight, alkaline phosphatase, and hepatocellular hypertrophy.
870.4200 Carcinogenicity rats NOAEL = 2.44 mg/kg/day
LOAEL = 30.6 mg/kg/day based on decreased body weight and body weight gain, alteration in hematology (mainly males) and increased incidences of interstitial cell hyperplasia in the testes.
(Possible) evidence of carcinogenicity
870.4300 Carcinogenicity mice NOAEL = 14.6 mg/kg/day
LOAEL = 349 mg/kg/day based on increased liver weight and increased hepatic cell tumors (adenomas and/or carcinomas combined.
(Possible) evidence of carcinogenicity
870.5100 Gene Mutation No genotoxic effect in Ames assay using S. typhimurium.
(two studies)
870.5375 Cytogenetics No genotoxic effect in Chinese hampster ovary (CHO) gene mutation assay
870.5375
870.5395
Other Effects Positive effects in the presence of metabolic activation, but inconclusive in the absence of metabolic activation in a chromosomal aberration/human lymphocyte study.
Mouse micronucleus assay negative for genotoxic effects.
870.6200a Acute neurotoxicity screening battery NOAEL = > 2,000 mg/kg/day HDT
LOAEL = Not established
870.6200b Subchronic neurotoxicity screening battery NOAEL = 92.7/7.1 (m/f) mg/kg/day
LOAEL = 186.2/51.6 (m/f) mg/kg/day based on decreased body weight and body weight gain.
870.7485 Metabolism and pharmacokinetics Urine major route of excretion at low doses and the feces at high doses. N-desmethyl triflusulfuron methyl, the upper urinary metabolite composed between 25–44% of the dose at the low dose level (single and repeated). Parent was the major component in the high dose feces and liver.
870.7600 Dermal penetration No dermal absorption studies were available. A 27% absorption was calculated from a ratio of the LOAEL from a developmental and 21–day dermal toxicity studies in rabbits.
  Special studies: In vivo and in vitro mechanic studies The purpose of these studies was to investigate the mechanism of Leydig cell tumor induction in the testes of male rats. A dose-dependent decrease in aromatase enzyme activity was seen in vitro, but was inconclusive in vivo.
B. Toxicological Endpoints
    The dose at which no adverse effects are observed, the NOAEL, from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern (LOC). 
However, the lowest dose at which adverse effects of concern are 
identified, the LOAEL, is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in 
the variations in sensitivity among members of the human population as 
well as other unknowns. AnUF of 100 is routinely used, 10X to account 
for interspecies differences and 10X for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or chronic 
RfD) where the RfD is equal to the NOAEL divided by the appropriate UF 
(RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns 
unique to the FQPA, this additional factor is applied to the RfD 
by dividing the RfD by such additional factor. The acute or chronic 
Population Adjusted Dose(aPAD or cPAD) is a modification of the RfD to 
accommodate this type of FQPA safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated 
and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree of 
cancer risk. A Q* is calculated and used to estimate risk 
which represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as1 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
"point of departure" is identified below which carcinogenic 
effects are not expected. The point of departure is typically a NOAEL 
based on an endpoint related to cancer effects though it may be a 
different value derived from the dose response curve. To estimate risk, 
a ratio of the point of departure to exposure 
(MOEcancer&equal; point of departure/exposures) is 
calculated. A summary of the toxicological endpoints for triflusulfuron 
methyl used for human risk assessment is shown in Table 3 of this unit:
Table 3. Summary of Toxicological Dose and Endpoints for Triflusulfuron Methyl for Use in Human Risk
Exposure scenario
Dose used in risk assessment, UF
FQPA SF* and LOC for risk assessment
Study and toxicological effects
Acute Dietary (all population subgroups) N/A   No toxicological effects attributable to a single exposure (dose) were observed in oral toxicity studies. Therefore, an acute RfD can not be established and an acute dietary risk assessment will not be conducted for the general population.
Chronic Dietary (all populations) NOAEL = 2.44 mg/kg/day
UF = 100
Chronic RfD = 0.024 mg/kg/day
FQPA SF = 1x
cPAD = chronic RfD ÷
FQPA SF = 0.024 mg/kg/day
Chronic Toxicity in Rats
LOAEL = 30.6 mg/kg/day based on decreased body weight and body weight gain, alter. In hematology (mainly males), increased incidence of interstitial cell hyperplasia in testes.
Cancer (oral, dermal, inhalation)     Triflusulfuron methyl is classified as a Group C—possible human carcinogen chemical.
* The reference to the FQPA safety factor refers to any additional safety factor retained due to concerns unique to the FQPA.
C. Exposure Assessment
    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.492) for the residues of triflusulfuron methyl 
in or on sugar beet, root and sugar beet, top. Risk assessments were 
conducted by EPA to assess dietary exposures from triflusulfuron 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 
1-day or single exposure. There are no effects attributable to a 
single, oral dose of triflusulfuron methyl. Therefore, an acute dietary 
risk assessment was not conducted.
    ii. Chronic exposure. In conducting this chronic dietary 
riskassessment, the Dietary Exposure Evaluation Model (DEEM\TM\) 
analysisevaluated the individual food consumption as reported by 
respondents in the United States Department of Agriculture 
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 chronic exposure 
assessments: Tolerance level residues and that 100% of the crop is 
treated. Because suitable data depicting residues of triflusulfuron 
methyl in drinking were not available for incorporation into the 
dietary exposure model,the dietary exposure estimates do not include 
potential exposure from drinking water. The dietary exposure is based 
on sugar beets, because chicory was not reported as being consumed in 
the 1989-1992 CSFII. Therefore, inclusion of chicory in the 
dietary analysiswould not alter the exposure or risk estimates from 
those obtained from sugar beets. The cRfD or 0.024 mg/kg/day was 
determined where the NOAEL of 2.44 mg/kg/day is based on decreased body 
weight gain, alterations in hematology (mainly in males) and increases 
in the incidence of interstitial hyperplasia in the testes at the LOAEL 
of 30.6 mg/kg/day. A 100-fold UF for interspecies extrapolation 
and intraspecies variability was applied.
    iii. Cancer. Triflusulfuron methyl is classified as a Group 
C possible human carcinogen chemical and for the purpose of risk 
characterization the RfD approach should be used for quantification of 
human risk. This decision was based on evidence of statistically 
significant, dose related increases in the incidence of 
interstitial cell adenomas of the testes at two doses, as well as 
statistically significant positive trend for these tumors in male rats. 
The testicular interstitial cell adenomas observed in the rat 
werebenign. There was no reported increased tumor incidences of any 
type in the female ratand the dosing was adequate for assessing the 
carcinogenic potential of triflusulfuron methyl. Evidence of a hormonal 
mechanism for development of these benign tumors inrats does exist, 
however, the data were suggestive but not conclusive. Although there 
wassome evidence of clastogenic activity for triflusulfuron methyl, 
positive results were onlyseen with activation in human lymphocytes/
chromosomal aberration assay. Triflusulfuron methyl is a member of a 
class of chemicals known as sulfonylureas. Of the 12
analogs structurally related to triflusulfuron methyl, three 
sulfonylureas have been associated with carcinogenicity in rodents. 
Primisulfuron methyl and prosulfuron are classified as Group 
D carcinogens (not classifiable as to human carcinogenicity). Only 
tribenuron methyl isclassified as a Group C carcinogen (possible human 
carcinogen), however, a Q* for cancer risk assessment is not required 
because there is no evidence of genotoxicity and the increased incidence 
of mammary gland tumors is observed at doses which exceed the maximum 
tolerated dose. Therefore the RfD approach is appropriate for 
quantification of human cancer risk.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for triflusulfuron methyl 
indrinking 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 triflusulfuron methyl.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), 
to produce estimates of pesticide concentrations in an index reservoir. 
The SCI-GROW model is used topredict pesticide concentrations in 
shallow ground water. For a screening-level assessment forsurface water 
EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 
model).The FIRST model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. While both FIRST and 
PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS 
model includes a percent crop area factor as an adjustment to account 
for the maximum percent crop coverage within a watershed or drainage 
basin.
    None of these models include consideration of the impact, 
processing (mixing,dilution, or treatment) of raw water for 
distribution as drinking water would likely have on the removal of 
pesticides from the source water. The primary use of these models by 
the Agency at this stage is to provide a coarse screen for sorting out 
pesticides for which it is highly unlikely that drinking water 
concentrations would ever exceed human health LOCs.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated environmental 
concentrations (EECs) from these models to quantify drinking water 
exposure and risk as a %RfD or %PAD. Instead drinking water levels of 
comparison (DWLOCs) are calculated and used as a point of comparison 
against the model estimates of a pesticide's concentration in water. 
DWLOCs are theoretical upper limits ona pesticide's concentration in 
drinking water in light of total aggregate exposure to a pesticide 
infood, and from residential uses. Since DWLOCs address total aggregate 
exposure to triflusulfuron methyl they are further discussed in the 
aggregate risk sections in Unit III. E.
    Based on the PRZM/EXAMS and SCI-GROW models the EECs of 
triflusulfuron methyl for acute exposures areestimated to be 0.42 parts 
per billion (ppb) for surface water and 0.5 ppb for ground water. 
TheEECs for chronic exposures are estimated to be 0.005 ppb for surface 
water and 0.5 ug/L (micrograms/Liter) forground 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).
    Triflusulfuron methyl is not registered for use on any sites that 
would result inresidential exposure.
    4. Cumulative exposure to substances with a common mechanism 
oftoxicity. 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."
    EPA does not have, at this time, available data to determine 
whether triflusulfuron methyl has a common mechanism of toxicity with 
other substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
triflusulfuron 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 triflusulfuron methyl has a common 
mechanism of toxicity with other substances. For information regarding 
EPA'sefforts 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).
D. Safety Factor for Infants and Children
    1. In general. Section 408 of FFDCA provides that EPA shall apply an 
additional 10-fold 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 data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directlythrough use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Pre-natal and post-natal sensitivity. There is noquantitative or 
qualitative evidence of increased susceptibility of rat or rabbit 
fetuses to in utero exposure in the developmental studies. No 
developmental toxicity was seen at thelimit dose (1,000 mg/kg/day) in 
rats. In rabbits, developmental toxicity manifested as abortions in the 
presence of severe maternal toxicity (mortality, abortions, clinical 
signs,decreased body weight, and food efficiency). In the 
2-generation reproductive toxicity study,the effects in the 
offspring (decreased pup body weight in F1 on days 14 and 21; 
latelactation) can be attributed to the decreases in body weights seen 
in the parental animals.In addition, this decrease was seen only in the 
F1 generation but not in the second generation. There is no indication 
for a developmental neurotoxicity study since noneuropathological or 
neurobehavioral effects in the acute or subchronic neurotoxicity studies 
were observed; no alteration of the fetal nervous system was observed; 
and noevidence of neurotoxicity was found in other studies in the data 
base.
    3. Conclusion. The toxicity data base for triflusulfuron methyl is 
complete except for a 28-day inhalation (nose only) toxicity 
study. This study is of marginal value for the FFDCA determination 
because there are no residential uses oftriflusulfuron methyl. Exposure 
data are complete or are estimated based on data that reasonably 
accounts for potentialexposures. Based on these reasons, the FQPA 
Safety Factor for the protection of children has been removed (i.e. 
reduced to 1x.)
E. Aggregate Risks and Determination of Safety
    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs which are used as a 
point of comparison againstthe model estimates of a pesticide's 
concentration in water. DWLOC values are not regulatory standards for 
drinking water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food and residential uses. In calculating a 
DWLOC, the Agency determines how much of the acceptable exposure (i.e., 
the PAD) is available for exposure through drinking water (e.g., 
allowable chronic water exposure (mg/kg/day) = cPAD − (average 
food + residential exposure)). This allowable exposure through drinking 
water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption,and body weights. Default body weights and consumption 
values as used by the EPA Office of Water are used to calculate DWLOCs: 
2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10kg (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 quantitativedrinking 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 ground water are less than the 
calculatedDWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along with 
other sources of exposure for which OPP has reliable data) would not 
result in unacceptable levels of aggregate human health risk at this 
time. Because OPP considers the aggregate risk resulting from multiple 
exposure pathways associated with a pesticide's uses, levels of 
comparison in drinking water may vary as those uses change. If newuses 
are added in the future, OPP will reassess the potential impacts of 
residues of the pesticide in drinking water as a part of the aggregate 
risk assessment process.
    1. Acute risk. Because there are no effects attributable to 
asingle, oral dose of triflusulfuron methyl is not expected to pose 
anacute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
triflusulfuron methyl from food will utilize 
&1% of the cPAD for the U.S. population, 
&1% of the cPAD for infants 
&1 year, and 
&1% of the cPAD for children aged 
1-6 years and children aged 7-12 years. There are no 
residential uses for triflusulfuron methyl that result in chronic 
residential exposure to triflusulfuron methyl. After calculating DWLOCs 
and comparing them to the EECs for surface and ground water, EPA does 
not expect the aggregate exposure to exceed 100% of the cPAD, as shown 
in Table 4 of this unit:
Table 4. Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Triflusulfuron Methyl
Population Subgroup
cPAD mg/kg/day
% cPAD (food)
Surface water EEC (ppb)
Ground water EEC (ppb)
Chronic DWLOC (ppb)
U.S. Population 0.000011 < 1 0.005 0.50 840
Female (13–50 years) 0.000009 < 1 0.005 0.50 720
All infants (< 1 year) 0.000040 < 1 0.005 0.50 240
Children (1–6 years) 0.000025 < 1 0.005 0.50 240
    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).
    Triflusulfuron methyl is not registered for use on any sites that 
would result in residential exposure. Therefore, the aggregate risk is 
the sum of the risk from food and water,which do not exceed the 
Agency's LOC.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus  chronic exposure to food 
and water (considered to be a background exposure level).
    Triflusulfuron methyl is not registered for use on any sites that 
would result inresidential exposure. Therefore, the aggregate risk is 
the sum of the risk from food and water,which do not exceed the 
Agency's LOC.
    5. Aggregate cancer risk for U.S. population. Triflusulfuron methyl 
has been designated a Category C "possible human 
carcinogen" and does not require aseparate cancer risk 
assessment. Because the RfD approach was determined appropriate 
for quanification of human cancer risk, the chronic aggregate risk 
assessment is sufficiently protective of human health.
     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, andto infants and children from 
aggregate exposure to triflusulfuron methyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
    An adequate tolerance enforcement method is available in PAM II. 
The methodextracts residues of triflusulfuron methyl in a buffered 
acetonitrile solution, cleans the extract on a phenyl solid-phase 
extraction cartridge, and quantitates residues on a HPLC/UVsystem.
B. International Residue Limits
    There are no Canadian or Codex MRLs established for triflusulfuron 
methyl.
C. Conditions
    Submission of a 28-day inhalation (nose only) toxicity study 
is required as condition of registration.
V. Conclusion
    Therefore, the tolerances are established for residues of 
triflusulfuron methyl, methyl 2-[[[[[4-(dimethylamino)-6-(2,2,2-
trifluoroethoxy)-1,3,5-triazin-2-yl]amino]carbonyl]amino]sulfonyl]-3-
methylbenzoate, in or on chicory, roots at 0.05 ppm; and time-limited 
tolerances for sugar beet, root at 0.05 ppm and sugar beet, top at 0.05 
ppm are converted to permanent tolerances and redefined as beet, sugar, 
roots and beet, sugar, tops.
VI. Objections and Hearing Requests
    Under section 408(g) of 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 forhearings appear in 
40 CFR part 178. Although the procedures in those regulations require 
somemodification 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) 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 FFDCA sections 408 and 
409.However, the period for filing objections is now 60 days, rather 
than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit and 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number OPP-2002-0082 in the subject line on 
thefirst page of your submission. All requests must be in writing, and 
must be mailed or delivered tothe Hearing Clerk on or before August 12, 
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 anobjection 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 mustbe submitted for 
inclusion in the public record. Information not marked confidential may 
bedisclosed 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 HearingClerk is (202) 
260-4865.
    2. Tolerance fee payment. If you file an objection or request 
ahearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that feepursuant 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 
judgementof 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 maycontact James 
Tompkins by phone at (703) 305-5697, by e-mail 
attompkins.jim@epa.gov, or by mailing a request for information to Mr. 
Tompkins at Registration division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division(7502C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection 
or hearing request with the Hearing Clerk as described in Unit VI.A., 
you should also send a copy of your request to the PIRIB for its 
inclusion in the official record that is described in Unit I.B.2.Mail 
your copies, identified by docket ID number OPP-2002-0082, 
to: Public Information and Records Integrity Branch, Information 
Resources and Services Division (7502C),Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460. In person or by courier, bring a copy to the 
location of the PIRIBdescribed in Unit I.B.2. You may also send an 
electronic copy of your request via e-mail to:opp-docket@epa.gov. 
Please use an ASCII file format and avoid the use of special characters 
and any form of encryption. Copies of electronic objections and hearing 
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII 
file format. Do not include any CBI in your electronic copy. You may 
also submit an electronic copy of your request at many Federal 
Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable possibility 
that available evidence identified by the requestor would, if 
established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).
VII. Regulatory Assessment Requirements
    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has 
been exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001).This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under 
Executive Order 12898, entitled Federal Actions to Address Environmental 
Justice in Minority Populations and Low-Income Populations (59FR 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 section12(d) 
of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law104-113, section 12(d) (15 U.S.C. 272 note). 
Since tolerances and exemptions that a reestablished on the basis of a 
petition under FFDCA section 408(d), such as the tolerance in this final 
rule, do not require the issuance of a proposed rule, the requirements of the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In 
addition, the Agency has determined that this action will not have a 
substantial direct effect on States, on the relationship between the 
national government and the States, or on the distribution of power 
and responsibilities among the various levels of government, as 
specified in Executive Order 13132,entitled Federalism (64 FR 43255, 
August 10, 1999). Executive Order 13132 requires EPA to develop an 
accountable process to ensure "meaningful and timely input by 
State and local officials in the development of regulatory policies 
that have federalism implications." "Policies that have 
federalism implications" is defined in the Executive order to 
include regulations that have "substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government."This final rule directly regulates 
growers, food processors, food handlers and food retailers, not States. 
This action does not alter the relationships or distribution of power 
and responsibilities established by Congress in the preemption 
provisions of FFDCA section 408(n)(4). For these same reasons, the 
Agency has determined that this rule does not have any "tribal 
implications" as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249,November 6, 2000). Executive Order 13175, requires EPA to develop 
an accountable process to ensure "meaningful and timely input by 
tribal officials in the development of regulatory policies that have 
tribal implications." "Policies that have 
tribal implications" is defined in the Executive order to include 
regulations that have "substantial direct effects on one or more 
Indian tribes, on the relationship between the federal Government and 
the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian 
tribes." This rule will not have substantial direct effects on 
tribal governments, on the relationship between the Federal Government 
and Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.
VIII. Submission to Congress and the Comptroller General
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating the 
rule must submit a rule report, which includes a copy of the rule, to 
each House of the Congress and to the Comptroller General of the united 
States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a "major rule" as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.
    Dated: May 31, 2002.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:
PART 180 [AMENDED]
    1. The authority citation for part 180 continues to read as 
follows:
    Authority:  21 U.S.C. 321(q), 346(a) and 374.
    2. Section 180.492 is revised to read as follows:
Sec. 180.492  Triflusulfuron methyl; tolerances for residues.
    (a) General. Tolerances are established for residues of 
the herbicide, triflusulfuron methyl 2-[[[[[4-(dimethylamino)-6-(2,2,2-
trifluoroethoxy)-1,3,5-triazin-2-yl]amino]carbonyl]amino]sulfonyl]-3-
methylbenzoate in or on the raw agricultural commodities:
------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Beet, sugar, roots........................  0.05
Beet, sugar, tops.........................  0.05
Chicory, roots............................  0.05
------------------------------------------------------------------------
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 02-14501 Filed 6-11-02; 8:45 am]
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