FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Return to FAN's Pesticide Homepage

Return to Triflusulfuron Methyl Index Page


Triflusulfuron Methyl (IR-4 and Dupont). June 12, 2002. Pesticide oolerance for residues in or on Beet (sugar roots and tops) and Chicory (roots) -- all at 0.05 ppm. Final Rule. Federal Register.


http://www.epa.gov/fedrgstr/EPA-PEST/2002/June/Day-12/p14501.htm



[Federal Register: June 12, 2002 (Volume 67, Number 113)]
[Rules and Regulations]
[Page 40189-40196]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jn02-11]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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, 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, Exit Disclaimer 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  NOAEL = 3.9/3.7 (m/f) mg/kg/day
                                          in 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      NOAEL = 1,000 mg/kg/day
                                          toxicity                   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 = 
                                                                      31,000 mg/kg/day limit dose
                                                                     LOAEL = 31,000
                                                                      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 = 3115
                                                                      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 = 32,000
                                          screening battery           mg/kg/day HDT
                                                                     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&equal; 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             NOAEL = 2.44 mg/kg/day   FQPA SF = 1x             Chronic Toxicity in
 populations)                          UF = 100...............  cPAD = chronic RfD        Rats
                                       Chronic RfD = 0.024 mg/   &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 year)                                         -1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-6 years)     0.000025                &attompkins.jim@epa.gov, 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:opp-docket@epa.gov. 
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