[Federal Register Volume 67, Number 113 (Wednesday, June 12, 2002)]
[Rules and Regulations]
[Pages 40189-40196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-14501]


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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: [email protected] or 
[email protected].

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, foodmanufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include,but are not limited to:

           Table 1.--Examples of Potentially Affected Entities
------------------------------------------------------------------------
                                                         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 forreaders regarding entities likely to be affected by this 
action. Other types of entities not listed inthe 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 actionmight 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 andOther Related Documents?

    1. Electronically. You may obtain electronic copies of 
thisdocument, and certain other related documents that might be 
available electronically, from theEPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Pageselect ``Laws 
and Regulations,'' ``Regulations and Proposed Rules,'' and then look up 
the entry for this document under the ``Federal Register--Environmental 
Documents.'' You canalso go directly to the Federal Register listings 
athttp://www.epa.gov/fedrgstr/. A frequently updated electronic version 
of 40 CFR part 180 is available athttp://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under 
development. To access the OPPTS HarmonizedGuidelines referenced in 
this document, go directly to the guidelines athttp://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official recordfor this 
action under docket ID number OPP-2002-0082. The official 
recordconsists of the documents specifically referenced in this action, 
and other information related tothis action, including any information 
claimed as Confidential Business Information (CBI). Thisofficial record 
includes the documents that are physically located in the docket, as 
well as thedocuments that are referenced in those documents. The public 
version of the official record doesnot include any information claimed 
as CBI. The public version of the official record, whichincludes 
printed, paper versions of any electronic comments submitted during an 
applicablecomment period is available for inspection in the Public 
Information and Records IntegrityBranch (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 
telephonenumber 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

[[Page 40190]]

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 thenotice 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 
forsugar beet, root at 0.05 ppm and sugar beet, top at 0.05 ppm be 
converted to permanenttolerances 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 thetolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines``safe'' to mean that ``there is a 
reasonable certainty that no harmwill result from aggregate exposure to 
the pesticide chemical residue, including all anticipateddietary 
exposures and all other exposures for which there is reliable 
information.''This includes exposure through drinking water and in 
residential settings, but does not includeoccupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration toexposure of infants and children to the pesticide 
chemical residue in establishing a tolerance andto ``ensure that there 
is a reasonable certainty that no harm will result to infants 
andchildren from aggregate exposure to the pesticide chemical 
residue....''
    EPA performs a number of analyses to determine the risks from 
aggregateexposure 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 
BifenthrinPesticide 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 scientificdata and other relevant information in support of 
this action. EPA has sufficient data to assess thehazards 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'sassessment 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 
ofmajor identifiable subgroups of consumers, including infants and 
children. The nature of thetoxic effects caused by triflusulfuron 
methyl are discussed in Table 2 of this unit, as well asthe 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        NOAEL = 6.56/7.71 (m/f) mg/kg/day
                                          rodents                     (milligram/kilogram/day)
                                         (two studies submitted)...  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     NOAEL = 3.9/3.7 (m/f) mg/kg/day
                                          nonrodents                 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  Maternal NOAEL = 120 mg/kg/day
                                          rodents                    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  Maternal NOAEL = 90 mg/kg/day
                                          nonrodents                 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.
----------------------------------------------------------------------------------------------------------------

[[Page 40191]]

 
870.3800                                 Reproduction and fertility  Parental/Systemic NOAEL = 5.81/7.75 (m/f)
                                          effects                     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 = >115 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                                 Carcino-genicity 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                                 Carcino-genicity 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                                 Other Effects               Positive effects in the presence of
870.5395...............................                               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         NOAEL = >2,000 mg/kg/day HDT
                                          screening battery          LOAEL = Not established
----------------------------------------------------------------------------------------------------------------
870.6200b                                Subchronic neurotoxicity    NOAEL = 92.7/7.1 (m/f) mg/kg/day
                                          screening battery          LOAEL = 186.2/51.6 (m/f) mg/kg/day based on
                                                                      decreased body weight and body weight
                                                                      gain.
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and              Urine major route of excretion at low doses
                                          pharmacokinetics            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    The purpose of these studies was to
                                          and in vitro mechanic       investigate the mechanism of Leydig cell
                                          studies                     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 
thetoxicology study identified as appropriate for use in risk 
assessment is used to estimate thetoxicological level of concern (LOC). 
However, the lowest dose at which adverse effects ofconcern are 
identified, the LOAEL, is sometimes used for risk assessment if no 
NOAEL wasachieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflectuncertainties inherent in the 
extrapolation from laboratory animal data to humans and in 
thevariations 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 calculatean acute or chronic reference dose (acute RfD or chronic 
RfD) where the RfD is equal to theNOAEL divided by the appropriate UF 
(RfD = NOAEL/

[[Page 40192]]

UF). Where an additional safety factor isretained due to concerns 
unique to the FQPA, this additional factor is applied to the RfD 
bydividing 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 determinethe LOC. For example, when 100 is the appropriate UF (10X 
to account for interspeciesdifferences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of theNOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated 
andcompared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used bythe Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposurewill lead to some degree of 
cancer risk. A Q* is calculated and used to estimate risk 
whichrepresents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as1 x 10-\6\ or one in a million). 
Under certain specificcircumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below whichcarcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
anendpoint related to cancer effects though it may be a different value 
derived from the doseresponse curve. To estimate risk, a ratio of the 
point of departure to exposure (MOEcancer= point of 
departure/exposures) is calculated. A summary of thetoxicological 
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
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose used in risk       FQPA SF* and LOC for   Study and toxicological
          Exposure scenario                 assessment, UF          risk assessment              effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (all population          N/A                                               No toxicological
 subgroups)                                                                               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   FQPA SF = 1x             Chronic Toxicity in
                                       UF = 100...............  cPAD = chronic RfD /...   Rats
                                       Chronic RfD = 0.024 mg/  FQPA SF = 0.024 mg/kg/   LOAEL = 30.6 mg/kg/day
                                        kg/day.                  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. Riskassessments 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 
interstitialcell 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

[[Page 40193]]

analogsstructurally related to triflusulfuron methyl, three 
sulfonylureas have been associated withcarcinogenicity in rodents. 
Primisulfuron methyl and prosulfuron are classified as Group 
Dcarcinogens (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 noevidence 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 acomprehensive 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 intoaccount 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 runoffscenario for pesticides. While both FIRST and 
PRZM/EXAMS incorporate an index reservoirenvironment, the PRZM/EXAMS 
model includes a percent crop area factor as an adjustment toaccount 
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 theremoval of 
pesticides from the source water. The primary use of these models by 
the Agency atthis stage is to provide a coarse screen for sorting out 
pesticides for which it is highly unlikely thatdrinking water 
concentrations would ever exceed human health LOCs.
    Since the models used are considered to be screening tools in the 
risk assessmentprocess, the Agency does not use estimated environmental 
concentrations (EECs) from thesemodels to quantify drinking water 
exposure and risk as a %RfD or %PAD. Instead drinking waterlevels of 
comparison (DWLOCs) are calculated and used as a point of comparison 
against themodel 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 totriflusulfuron 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, andflea 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 
whethertriflusulfuron methyl has a common mechanism of toxicity with 
other substances or how toinclude this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA hasfollowed 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 thepurposes of this tolerance action, 
therefore, EPA has not assumed that triflusulfuron methylhas 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 thecumulative 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 shallapply an 
additional 10-fold margin of safety for infants and children in the 
case of thresholdeffects to account for pre-natal and post-natal 
toxicity and the completeness of the data base ontoxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
forinfants and children. Margins of safety are incorporated into EPA 
risk assessments either directlythrough use of a MOE analysis or 
through using uncertainty (safety) factorsin 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 asabortions 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 secondgeneration. There is no indication for a developmental 
neurotoxicity study since noneuropathological or neurobehavioral 
effects in the acute or subchronic neurotoxicitystudies 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 triflusulfuronmethyl is 
complete except for a 28-day inhalation (nose only) toxicity study. 
This study is ofmarginal 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 childrenhas 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,

[[Page 40194]]

andresidential 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 notregulatory standards for 
drinking water. DWLOCs are theoretical upper limits on a 
pesticide'sconcentration in drinking water in light of total aggregate 
exposure to a pesticide in food andresidential uses. In calculating a 
DWLOC, the Agency determines how much of the acceptableexposure (i.e., 
the PAD) is available for exposure through drinking water (e.g., 
allowable chronicwater exposure (mg/kg/day) = cPAD - (average food + 
residential exposure)). This allowableexposure 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 
individualbasis. 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 drinkingwater (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 OPPconsiders the aggregate risk resulting from multiple 
exposure pathways associated with apesticide'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 indrinking 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Surface water EEC       Ground water EEC
        Population Subgroup              cPAD mg/kg/day           % cPAD (food)              (ppb)                  (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 chronicexposure 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.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure pluschronic 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 forquanification of human cancer risk, the 
chronic aggregate risk assessment is sufficientlyprotective of human 
health.
     6. Determination of safety. Based on these risk assessments, 
EPAconcludes 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 theextract 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 areconverted 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

[[Page 40195]]

filean 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 willcontinue to use those procedures, with 
appropriate adjustments, until the necessary modificationscan 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 toleranceissued 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 accordancewith the instructions provided in this unit and 
in 40 CFR part 178. To ensure proper receipt byEPA, 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 
specificprovisions 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 ahearing is requested, the requestor's contentions on such 
issues, and a summary of any evidencerelied 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 thatinformation as CBI. Information so marked will not be disclosed 
except in accordance withprocedures 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), 
EnvironmentalProtection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliveryour 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., Mondaythrough 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 AccountingOperations 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 at[email protected], 
or by mailing a request for information to Mr. Tompkins at 
RegistrationDivision (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200Pennsylvania Ave., NW., 
Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mailyour request for such a waiver to: James Hollins, 
Information Resources and Services Division(7502C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 PennsylvaniaAve., NW., 
Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection 
orhearing request with the Hearing Clerk as described in Unit VI.A., 
you should also send a copy ofyour 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: 
PublicInformation 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:[email protected]. 
Please use an ASCII file format and avoid the use of special characters 
andany form of encryption. Copies of electronic objections and hearing 
requests will also be acceptedon disks in WordPerfect 6.1/8.0 or ASCII 
file format. Do not include any CBI in your electroniccopy. You may 
also submit an electronic copy of your request at many Federal 
DepositoryLibraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that thematerial submitted shows the following: There is a 
genuine and substantial issue of fact; there is areasonable possibility 
that available evidence identified by the requestor would, if 
establishedresolve one or more of such issues in favor of the 
requestor, taking into account uncontested claimsor facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestorwould 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 apetition submitted to the Agency. The Office of 
Management and Budget (OMB) has exemptedthese types of actions from 
review under Executive Order 12866, entitled RegulatoryPlanning and 
Review (58 FR 51735, October 4, 1993). Because this rule has 
beenexempted from review under Executive Order 12866 due to its lack of 
significance, this rule is notsubject to Executive Order 13211, Actions 
Concerning Regulations ThatSignificantly 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 
thePaperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
anyenforceable duty or contain any unfunded mandate as described under 
Title II of the UnfundedMandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require anyspecial considerations under Executive 
Order 12898, entitled Federal Actions toAddress 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 SafetyRisks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standardsthat 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 areestablished on the basis of a petition under 
FFDCA section 408(d), such as the tolerance in thisfinal rule, do not

[[Page 40196]]

require the issuance of a proposed rule, the requirements of the 
RegulatoryFlexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In 
addition, theAgency has determined that this action will not have a 
substantial direct effect on States, on therelationship between the 
national government and the States, or on the distribution of power 
andresponsibilities among the various levels of government, as 
specified in Executive Order 13132,entitled Federalism (64 FR 43255, 
August 10, 1999). Executive Order 13132requires EPA to develop an 
accountable process to ensure ``meaningful and timely inputby State and 
local officials in the development of regulatory policies that have 
federalismimplications.'' ``Policies that have federalism 
implications'' isdefined in the Executive order to include regulations 
that have ``substantial direct effectson the States, on the 
relationship between the national government and the States, or on 
thedistribution of power and responsibilities among the various levels 
of government.''This final rule directly regulates growers, food 
processors, food handlers and food retailers, notStates. This action 
does not alter the relationships or distribution of power and 
responsibilitiesestablished by Congress in the preemption provisions of 
FFDCA section 408(n)(4). For these samereasons, 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 toensure ``meaningful and timely input by tribal officials in 
the development of regulatorypolicies that have tribal implications.'' 
``Policies that have tribalimplications'' is defined in the Executive 
order to include regulations that have``substantial direct effects on 
one or more Indian tribes, on the relationship between theFederal 
Government and the Indian tribes, or on the distribution of power and 
responsibilitiesbetween the Federal Government and Indian tribes.'' 
This rule will not have substantialdirect effects on tribal 
governments, on the relationship between the Federal Government 
andIndian tribes, or on the distribution of power and responsibilities 
between the Federal Governmentand Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does notapply to 
this rule.

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as addedby the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides thatbefore a rule may take effect, the agency promulgating the 
rule must submit a rule report, whichincludes a copy of the rule, to 
each House of the Congress and to the Comptroller General of theUnited 
States. EPA will submit a report containing this rule and other 
required information to theU.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United Statesprior 
to publication of this final rule in the Federal Register. This final 
ruleis 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 
theherbicide, 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]
BILLING CODE 6560-50-S