[Federal Register Volume 67, Number 181 (Wednesday, September 18, 2002)]
[Rules and Regulations]
[Pages 58712-58725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23746]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0190; FRL-7196-7]


Triclopyr; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for combined residues 
of triclopyr and its metabolites, 3,5,6-trichloro-2-pyridinol (TCP) and 
2-methoxy-3,5,6-trichloropyridine (TMP) in or on fish and shellfish. 
Dow Agrosciences LLC requested this tolerance 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 September 18, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0190, 
must be received on or before November 18, 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 identification (ID) number OPP-
2002-0190 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Jim Tompkins, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-5697; e-mail address: 
[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, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS Codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently 
under development. To access the OPPTS Harmonized Guidelines referenced 
in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0190. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of February 25, 1998 (63 FR 9519) (FRL-
5768-4), EPA issued a notice pursuant to section 408 of FFDCA, 21 
U.S.C. 346a, as amended by FQPA (Public Law 104-

[[Page 58713]]

170), announcing the filing of a pesticide petition (PP 1F3935) by Dow 
Agrosciences LLC, 9330 Zionville Rd, Indianapolis, IN 46268-1054. This 
notice included a summary of the petition prepared by Dow Agrosciences 
LLC, the registrant. There were no comments received in response to the 
notice of filing.
    The petition requested that 40 CFR 180.417 be amended by 
establishing a tolerance for combined residues of the herbicide 
triclopyr and its metabolites, 3,5,6-trichloro-2-pyridinol (TCP) and 2-
methoxy-3,5,6-trichloropyridine (TMP), in or on fish at 3.0 parts per 
million (ppm) and shellfish at 3.5 ppm.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that`` there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for a tolerance for combined residues of triclopyr and its 
metabolites, 3,5,6-trichloro-2-pyridinol (TCP) and 2-methoxy-3,5,6-
trichloropyridine (TMP) on fish at 3.0 ppm and shellfish at 3.5 ppm. 
EPA's assessment of exposures and risks associated with establishing 
the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by triclopyr are 
discussed in the following Table 1 as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

                             Table 1.--Acute Toxicity of Various Forms of Triclopyr
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
                                Acute Toxicity of triclopyr acid, technical grade
----------------------------------------------------------------------------------------------------------------
870.1100                                 Acute oral                  Lethal dose (LD)50 = 729 milligram/kilogram
                                                                      (mg/kg) Male (M); 630 mg/kg Female (F)
                                                                     Category III
----------------------------------------
870.1200                                 Acute dermal                LD50 > 2,000 mg/kg
                                                                     Category III
----------------------------------------
870.1300                                 Acute inhalation            Not available
----------------------------------------
870.2400                                 Primary eye irritation      Not available
----------------------------------------
870.2500                                 Primary skin irritation     Not available
----------------------------------------
870.2600                                 Dermal sensitization        Not available
----------------------------------------
870.6200                                 Acute neurotoxicity         Not available
----------------------------------------
                                 Acute toxicity of triclopyr triethylamine salt
----------------------------------------------------------------------------------------------------------------
870.1100                                 Acute oral                  LD50 = 1,847 mg/kg
                                                                     (M & F) Category III
----------------------------------------
870.1200                                 Acute dermal                LD50 > 2,000 mg/kg
                                                                     Category III
----------------------------------------
870.1300                                 Acute inhalation            LC50 > 2.6 mg/liter (L)
                                                                     Category III
----------------------------------------
870.2400                                 Primary eye irritation      Corrosive
                                                                     Category I
----------------------------------------
870.2500                                 Primary skin irritation     Not irritating
                                                                     Category IV
----------------------------------------
870.2600                                 Dermal sensitization        sensitizer
----------------------------------------

[[Page 58714]]

 
870.6200                                 Acute neurotoxicity         Not available
----------------------------------------
                                  Acute toxicity of triclopyr butoxyethyl ester
----------------------------------------------------------------------------------------------------------------
870.1100                                 Acute oral                  LD50 = 803 mg/kg (M & F)
                                                                     Category III
----------------------------------------
870.1200                                 Acute dermal                LD50 > 2,000 mg/kg
                                                                     Category III
----------------------------------------
870.1300                                 Acute inhalation            LC50 > 4.8 mg/L
                                                                     Category III
----------------------------------------
870.2400                                 Primary eye irritation      Minimally irritating
                                                                     Category III
----------------------------------------
870.2500                                 Primary skin irritation     Not irritating
                                                                     Category IV
----------------------------------------
870.2600                                 Dermal sensitization        sensitizer
----------------------------------------
870.6200                                 Acute neurotoxicity         Not available
----------------------------------------------------------------------------------------------------------------



                                     Table 2.--Toxicity Profile of Triclopyr
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity        NOAEL = 5 mg/kg/day in males and females
                                          rodents with acid - rat    LOAEL = 20 mg/kg/day in males and females
                                                                      based on degeneration of the proximal
                                                                      tubules of the kidneys
----------------------------------------
870.3100                                 90-Day oral toxicity        NOAEL = 7 mg/kg/day in males and < 7 mg/kg/
                                          rodents with ester - rat    day in females
                                                                     LOAEL = 28 mg/kg/day in males, 7 mg/kg/day
                                                                      based on increased relative kidney weight
                                                                      (M) and decreased red blood cell content,
                                                                      hemoglobin content, and packed cell volume
                                                                      (F). Degeneration of the proximal tubules
                                                                      of the kidneys was seen in males at 70 and
                                                                      350 mg/kg/day and females at 350 mg/kg/day
                                                                      highest dose tested (HDT).
----------------------------------------
870.3150                                 183-Day oral toxicity non-  NOAEL <= 2.5 mg/kg/day (HDT) in males and
                                          rodents - dog               females
                                                                     LOAEL > 2.5 mg/kg/day in males and females
                                                                      based on toxicologically non-significant
                                                                      decreased rate of phenolsulfothalein (PSP)
                                                                      due to competition between triclopyr and
                                                                      PSP for renal excretion.
----------------------------------------
870.3200                                 21-Day dermal toxicity -    NOAEL = 1,000 mg/kg/day (males and females)
                                          rabbit                     LOAEL > 1,000 mg/kg/day. Decreased alkaline
                                                                      phosphatase in both sexes of rabbits at
                                                                      1,000 mg/kg/day and increased absolute and
                                                                      relative liver weight in males at 1,000 mg/
                                                                      kg/day were considered marginal and not of
                                                                      toxicological significance.
----------------------------------------
870.3700                                 Prenatal developmental      Maternal NOAEL = 100 mg/kg/day
                                          with ester - rats          Maternal LOAEL = 300 mg/kg/day based on
                                                                      mortality, clinical signs, necropsy
                                                                      findings, decreased body weight gains,
                                                                      decreased food consumption, increased
                                                                      water consumption, and increased relative
                                                                      kidney and liver weight.
                                                                     Developmental NOAEL = 100 mg/kg/day
                                                                     Developmental LOAEL = 300 mg/kg/day based
                                                                      on increased incidence of hydrocephalus,
                                                                      cleft palate, microphthalmia/anophthalmia,
                                                                      retinal folds, thin diaphragm/protrusion
                                                                      of the liver, decreased fetal weight and
                                                                      visceral and skeletal anomalies and
                                                                      variants.
----------------------------------------
870.3700                                 Prenatal developmental      Maternal NOAEL = 30 mg/kg/day
                                          with ester - rabbits       Maternal LOAEL = 100 mg/kg/day based on
                                                                      mortality
                                                                     Developmental NOAEL = 30 mg/kg/day
                                                                     Developmental LOAEL = 100 mg/kg/day based
                                                                      on decreased total live fetuses and
                                                                      increased total fetal deaths, as well as
                                                                      increased fetal and/or litter incidence of
                                                                      skeletal anomalies and variants.
----------------------------------------

[[Page 58715]]

 
870.3700                                 Prenatal developmental      Maternal NOAEL = 30 mg/kg/day
                                          with salt - rabbit         Maternal LOAEL = 100 mg/kg/day based on
                                                                      mortality, abortions, decreased body
                                                                      weight gain, decreased food efficiency,
                                                                      increased liver and kidney weight.
                                                                     Developmental NOAEL = 30 mg/kg/day
                                                                     Developmental LOAEL = 100 mg/kg/day based
                                                                      on decreased live fetuses and increased
                                                                      embryonic deaths due to abortions.
----------------------------------------
870.3700                                 Prenatal developmental      Maternal NOAEL = 100 mg/kg/day
                                          with salt - rat            Maternal LOAEL = 300 mg/kg/day based on
                                                                      mortality
                                                                     Developmental NOAEL = 100 mg/kg/day
                                                                     Developmental LOAEL = 300 mg/kg/day based
                                                                      on decreased fetal weight, increased fetal
                                                                      and litter incidence of skeletal
                                                                      anomalies, increased fetal incidence of
                                                                      unossified sternebrae.
----------------------------------------
870.3700                                 Prenatal developmental      Maternal NOAEL = < 50 mg/kg/day
                                          with acid - rat            Maternal LOAEL = 50 mg/kg/day based on
                                                                      increased clinical signs
                                                                     Developmental NOAEL = 100 mg/kg/day
                                                                     Developmental LOAEL = 200 mg/kg/day based
                                                                      on increase incidence of fetuses and
                                                                      litters with retarded ossification of
                                                                      skull bones, and two litters (one fetus
                                                                      per litter) with cleft palate and
                                                                      brachycephaly.
----------------------------------------
870.3800                                 Reproduction and fertility  Parental/Systemic NOAEL = 5 mg/kg/day in
                                          effects with acid - rat     males and in females
                                                                     Parental/Systemic LOAEL = 25 mg/kg/day in
                                                                      males and females based on increased
                                                                      incidence of proximal tubular degeneration
                                                                      in male and female P1 and P2 rats.
                                                                     Reproductive/Offspring NOAEL = 5 mg/kg/day
                                                                      in males and females
                                                                     Reproductive/Offspring LOAEL = 25 based on
                                                                      increased incidence of F2 pups with
                                                                      exencephaly and ablepharia.
----------------------------------------
870.4100a                                228-Day toxicity study -    NOAEL = 10 mg/kg/day in males and females
                                          acid - dogs                LOAEL = 20 mg/kg/day in males and females
                                                                      based on decreased body weight gain (M),
                                                                      decreased hematological parameters (M),
                                                                      changes in clinical chemistry (both
                                                                      sexes), and liver histopathology (both
                                                                      sexes).
----------------------------------------
870.4100b                                Chronic toxicity (1 year) - NOAEL <= 5 mg/kg/day in males and females
                                           acid - dogs               LOAEL > 5 mg/kg/day in males and females
                                                                      based on changes in clinical chemistry
                                                                      which are due not to toxicity, but a
                                                                      physiologic response of the dog based on
                                                                      limited ability of the dog to excrete
                                                                      organic acids at higher plasma
                                                                      concentrations.
----------------------------------------
870.4300                                 Chronic/carcinogenicity -   NOAEL = 12 mg/kg/day in males, <= 36 mg/kg/
                                          acid - rats                 day in females
                                                                     LOAEL = 36 in males, > 36 mg/kg/day in
                                                                      females based on marginal increases in
                                                                      proximal tubular degeneration at 6 months.
                                                                     Increase in adrenal gland pheochromocytoma
                                                                      in males and significant trend (< 0.05)
                                                                      for mammary gland adenocarcinomas in
                                                                      females.
----------------------------------------
870.4300                                 Carcinogenicity - acid -    NOAEL = 84 mg/kg/day in males, 109.5 mg/kg/
                                          mice                        day in females
                                                                     LOAEL = 143 mg/kg/day in males, 135 mg/kg/
                                                                      day in females based on decreased weight
                                                                      gain
                                                                     No evidence of carcinogenicity in males,
                                                                      but females had a significant trend (<
                                                                      0.05) for mammary gland adenocarcinomas
----------------------------------------
870.5265                                 Gene mutation               Triclopyr BEE was non-mutagenic when tested
                                                                      up to 5,000 [mu]g/plate or cytotoxic
                                                                      levels, in presence and absence of
                                                                      activation, in S. typhimurium strains
                                                                      TA98, TA100, TA1535 and TA1537.
----------------------------------------
870.5265                                 Gene mutation               Triclopyr acid was non-mutagenic when
                                                                      tested up to 10,000 [mu]g/plate or
                                                                      cytotoxic levels, in presence and absence
                                                                      of activation, in S. typhimurium strains
                                                                      TA98, TA100, TA1535, TA1537, and TA1538.
----------------------------------------
870.5300                                 Gene mutation               In the rec - assay, triclopyr acid produced
                                                                      no evidence of growth inhibition for the
                                                                      repair competent (H17) or repair deficient
                                                                      (M45) B. subtilis bacterial strains when
                                                                      tested up to 2,000 [mu]g/disk.
----------------------------------------
870.5300                                 Gene mutation               In the host-mediated assay, triclopyr acid
                                                                      was negative for mutagenicity at doses up
                                                                      to 70 mg/kg in ICR random bred mice when
                                                                      tested against indicator organisms
----------------------------------------
870.5395                                 In Vivo Cytogenetic assay - Triclopyr acid was negative for chromosomal
                                           rats                       aberrations in the cytogenetic assay when
                                                                      administered singly or for 5 days to
                                                                      Sprague-Dawley rats up to 70 mg/kg/day
----------------------------------------
870.5395                                 In vivo Mouse micronucleus  Triclopyr BEE was not clastogenic in the
                                                                      mouse micronucleus test up to 600 mg/kg
                                                                      (HDT)
----------------------------------------

[[Page 58716]]

 
870.5550                                 Unscheduled DNA synthesis   Triclopyr BEE did not cause DNA damage or
                                                                      inducible repair in the rat hepatocyte
                                                                      unscheduled DNA synthesis
----------------------------------------
870.5550                                 Unscheduled DNA synthesis   Triclopyr acid did not produce any evidence
                                                                      of unscheduled DNA synthesis, as
                                                                      determined by radioactive tracer
                                                                      procedures (nuclear silver grain counts),
                                                                      in rat primary hepatocyte cultures exposed
                                                                      up to cytotoxic levels.
----------------------------------------
870.5450                                 Dominant lethal assay -     Triclopyr acid was negative for the
                                          mice                        dominant lethal mutagenic effect in
                                                                      treated male rats which were fed for 9
                                                                      consecutive weeks at doses up to 70 mg/kg/
                                                                      day and mated to virgin females.
----------------------------------------
870.5450                                 Dominant lethal assay -     Triclopyr acid was negative for the
                                          rats                        dominant lethal mutagenic effect in
                                                                      treated male rats at doses up to 70 mg/kg/
                                                                      day given by oral intubation followed by
                                                                      mating to 2 untreated females per week for
                                                                      7 weeks
----------------------------------------
870.7485                                 Metabolism and              In a rat metabolism with C14-triclopyr acid
                                          pharmacokinetics - rat      at doses of 3 mg/kg (single, low dose), 3
                                                                      mg/kg x 14 days (repeated low dose) and 60
                                                                      mg/kg (high dose), triclopyr was well
                                                                      absorbed and rapidly excreted at the low
                                                                      dose or repeated low dose. At 60 mg/kg,
                                                                      excretion was decreased between 0-12 hours
                                                                      due to saturation of renal excretion
                                                                      mechanisms (attainment of zero order
                                                                      kinetics). Unmetabolized parent
                                                                      represented > 90% of the urinary
                                                                      radioactivity, with the remainder present
                                                                      as primarily TCP.
----------------------------------------
870.7500                                 Dermal penetration study    In an oral and dermal pharmacokinetics
                                          in humans                   study of triclopyr in human volunteers,
                                                                      triclopyr was administered orally and
                                                                      dermally to six human volunteers. More
                                                                      than 80% of the administered dose was
                                                                      found as unchanged triclopyr in the urine.
                                                                      An average of 1.65% of the dermally
                                                                      applied dose was recovered in the urine
                                                                      and represented dermal penetration of
                                                                      triclopyr.
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which the NOAEL from the toxicology study identified as 
appropriate for use in risk assessment is used to estimate the 
toxicological level of concern (LOC). However, the LOAEL is sometimes 
used for risk assessment if no NOAEL was achieved in the toxicology 
study selected. An uncertainty factor (UF) is applied to reflect 
uncertainties inherent in the extrapolation from laboratory animal data 
to humans and in the variations in sensitivity among members of the 
human population as well as other unknowns. An UF of 100 is routinely 
used, 10X to account for interspecies differences and 10X for 
intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor (SF) 
is retained due to concerns unique to the FQPA, this additional factor 
is applied to the RfD by dividing the RfD by such additional factor. 
The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-6 or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for triclopyr used for human risk assessment is shown in the 
following Table 3:

        Table 3.--Summary of Toxicological Dose and Endpoints for triclopyr in Human Risk Assessments\1\
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk       FQPA SF and LOC for    Study and Toxicological
          Exposure Scenario                 Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                          NOAEL = 100 mg/kg/day    FQPA SF = 1X             Developmental toxicity
General population...................  UF = 100...............  aPAD = aRfD / FQPA SF..   study with BEE- rat
                                       acute RfD = 1.0 mg/kg/   = 1.0 mg/kg/day........  LOAEL = 300 mg/kg/day
                                        day.                                              based on clinical
                                                                                          signs on GD 7
--------------------------------------

[[Page 58717]]

 
Acute dietary                          NOAEL = 5 mg/kg/day      FQPA SF = 1X             2-Generation
Females 13-50 years old..............  UF = 100...............  aPAD = aRfD / FQPA SF..   reproduction study
                                       acute RfD = 0.05 mg/kg/  = 0.05 mg/kg/day.......   with acid - rat
                                        day.                                             LOAEL = 25 mg/kg/day
                                                                                          based on increased
                                                                                          incidence of F2 pups
                                                                                          with exencephaly and
                                                                                          ablepharia
--------------------------------------
Chronic dietary                        NOAEL= 5.0 mg/kg/day     FQPA SF = 1X             2-Generation
All populations......................  UF = 100...............  cPAD = cRfD / FQPA SF..   reproduction study
                                       Chronic RfD = 0.05 mg/   = 0.05 mg/kg/day.......   with acid - rat
                                        kg/day.                                          LOAEL = 25 mg/kg/day
                                                                                          based on increased
                                                                                          incidence of proximal
                                                                                          tubular degeneration
                                                                                          in male and female P1
                                                                                          and P2 rats
--------------------------------------
Short-term incidental, oral (1-30      Oral NOAEL = 100 mg/kg/  LOC for MOE = 100        Developmental rat
 days)                                  day                                               studies with BEE and
Swimmer, residential.................                                                     TEA (co-critical)
                                                                                         LOAEL = 300 mg/kg/day
                                                                                          based on mortality
                                                                                          (both studies),
                                                                                          clinical signs (red
                                                                                          and/or green staining)
                                                                                          beginning on GD 7 (BEE
                                                                                          study) and GD 15 (TEA
                                                                                          study) and decreased
                                                                                          body weight gain on GD
                                                                                          6-20 (BEE study)
--------------------------------------
Intermediate-term incidental, oral (1- Oral NOAEL = 5.0 mg/kg/  LOC for MOE = 100        Subchronic toxicity
 6 months)                              day                                               (feeding) with acid -
Residential..........................                                                     rat
                                                                                         LOAEL = 20 mg/kg/day
                                                                                          based on histological
                                                                                          changes in the kidney
                                                                                          (degeneration of the
                                                                                          proximal renal tubule)
--------------------------------------
Short-term dermal (1-30 days)          Oral NOAEL = 5.0 mg/kg/  LOC for MOE = 100        2-Generation
(Occupational/residential)...........   day                                               reproduction study
                                       Dermal absorption = 2%.                            with acid - rat
                                                                                         LOAEL = 25 mg/kg/day
                                                                                          based on increased
                                                                                          incidence of F2 pups
                                                                                          with exencephaly and
                                                                                          ablepharia
--------------------------------------
Intermediate-term dermal (1-6 months)  Oral NOAEL = 5.0 mg/kg/  LOC for MOE = 100        2-Generation
Occupational/residential.............   day                                               reproduction study
                                       Dermal absorption = 2%.                            with acid - rat and 90-
                                                                                          day feeding study with
                                                                                          acid - rat (co-
                                                                                          critical)
                                                                                         LOAEL = 20 mg/kg/day
                                                                                          (90 day study) and 25
                                                                                          mg/kg/day (2-
                                                                                          generation rat
                                                                                          reproduction study)
                                                                                          based on histological
                                                                                          changes in the kidney
                                                                                          in both studies
                                                                                          (degeneration of the
                                                                                          proximal renal
                                                                                          tubules)
--------------------------------------
Long-term dermal (6 months-lifetime)   Oral NOAEL = 5.0 mg/kg/  LOC for MOE = 100        2-Generation
(Occupational/residential)...........   day                                               reproduction study
                                       Dermal Absorption = 2%.                            with acid - rat
                                                                                         LOAEL = 25 mg/kg/day
                                                                                          based on increased
                                                                                          incidence of proximal
                                                                                          tubular degeneration
                                                                                          in male and female P1
                                                                                          and P2 rats
--------------------------------------
Short-term inhalation (1-30 days)      Oral NOAEL = 5.0 mg/kg/  LOC for MOE = 100        2-Generation
(Occupational/residential)...........   day                                               reproduction study
                                       Inhalation absorption                              with acid - rat
                                        rate = 100%.                                     LOAEL = 25 mg/kg/day
                                                                                          based on increased
                                                                                          incidence of F2 pups
                                                                                          with exencephaly and
                                                                                          ablepharia
--------------------------------------
Intermediate-term inhalation (1-6      Oral NOAEL = 5.0 mg/kg/  LOC for MOE = 100        2-Generation
 months)                                day                                               reproduction study
Occupational/residential.............  Inhalation absorption                              with acid - rat and 90
                                        rate = 100%.                                      Day feeding study with
                                                                                          acid - rat (co-
                                                                                          critical)
                                                                                         LOAEL = 20 mg/kg/day
                                                                                          (90 day study) and 25
                                                                                          mg/kg/day (2-
                                                                                          generation rat
                                                                                          reproduction study)
                                                                                          based on histological
                                                                                          changes in the kidney
                                                                                          in both studies
                                                                                          (degeneration of the
                                                                                          proximal renal
                                                                                          tubules)
--------------------------------------

[[Page 58718]]

 
Long-term inhalation (6 months-        Oral NOAEL= 5.0 mg/kg/   LOC for MOE = 100        2-Generation
 lifetime)                              day                                               reproduction study
Occupational/residential.............  Inhalation absorption                              with acid - rat and 90
                                        rate = 100%.                                      Day feeding study with
                                                                                          acid - rat (co-
                                                                                          critical)
                                                                                         LOAEL = 20 mg/kg/day
                                                                                          (90 day study) and 25
                                                                                          mg/kg/day (2-
                                                                                          generation rat
                                                                                          reproduction study)
                                                                                          based on histological
                                                                                          changes in the kidney
                                                                                          in both studies
                                                                                          (degeneration of the
                                                                                          proximal renal
                                                                                          tubules)
--------------------------------------
Cancer (oral, dermal, inhalation)      Cancer classification    Risk Assessment not      Group D chemical
                                        (``Group D'')            required
----------------------------------------------------------------------------------------------------------------
1 UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL =
  lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference
  dose, LOC= data base for triclopyr is complete and adequate for FQPA assessment; a developmental level of
  concern, MOE = margin of exposure. The reference to the FQPA Safety Factor refers to any additional safety
  factor retained due to concerns unique to the FQPA.

    In accordance with the Agency's 1999 Guidelines for Carcinogenic 
Risk Assessment, triclopyr has been classified as a ``Group D'' 
chemical - not classifiable as to human carcinogenicity (not entirely 
negative, but yet not convincing). Although increases in the incidence 
of two tumor types was observed in the acceptable carcinogenicity 
studies (mammary gland adenocarcinomas in female mice and rats, and 
benign adrenal pheochromocytomas in male rats), the Agency determined 
that the Group D classification is appropriate because: (1) The 
increased incidence of these tumor types was only marginal; (2) 
statistical significance was not achieved by pair-wise comparisons of 
mammary gland adenocarcinomas in treated female mice to the concurrent 
controls; (3) a dose-related response in tumor incidence was not 
apparent in female rat mammary gland adenocarcinomas and in male rat 
benign adrenal pheochromocytomas following treatment with triclopyr; 
(4) no evidence of genotoxicity in a full battery of mutagenicity 
assays conducted with the triclopyr acid, triethylamine salt and the 
butoxyethyl ester was observed; and (5) data from structural analogs, 
such as chlorpyrifos, did not provide additional support for 
carcinogenicity. Experimental data on chlopyrifos demonstrated that 
this insecticide is not a carcinogen and unlike triclopyr, is more 
readily metabolized. Given the only marginal indication of carcinogenic 
potential, EPA does not expect triclopyr to pose a cancer risk to 
humans.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.417) for the combined residues of triclopyr and 
its metabolites, 3,5,6-trichloro-2-pyridinol (TCP) and 2-methoxy-3,5,6-
trichloropyridine (TMP) in or on grasses, forage and grasses, forage, 
hay; and the combined residues of triclopyr and its metabolites, 3,5,6-
trichloro-2-pyridinol (TCP) in or on rice, grain; rice, straw; eggs; 
meat, fat, and meat byproducts of cattle, goats, hogs, horses, sheep, 
and poultry. Risk assessments were conducted by EPA to assess dietary 
exposures from triclopyr 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. The Dietary Exposure Evaluation Model (DEEM[reg]) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the acute 
exposure assessments: A refined acute analysis was performed using 
anticipated residue levels for rice, fish, shellfish, and livestock 
commodities, default processing factors, and making use of percent crop 
treated (PCT) values for all commodities except fish and shellfish. A 
value of 1% was used wherever values < 1% were reported. For acute 
dietary risk, HED's LOC is > 100% aPAD. A probabilistic assessment was 
conducted, using 1,000 iterations in the Monte Carlo analysis.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEM[reg] analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1989-1992 nationwide 
CSFII and accumulated exposure to the chemical for each commodity. The 
following assumptions were made for the chronic exposure assessments: 
The chronic dietary exposure analysis made use of the same assumptions 
that went into the acute analysis described above, except that average 
anticipated residue levels were used in a deterministic analysis.
    iii. Cancer. As described above, given the only marginal evidence 
supporting triclopyr's carcinogenic potential, EPA has determined 
qualitatively, based on the weight of the evidence, that triclopyr is 
not expected to pose a cancer risk to humans and, therefore has not 
conducted a quantitative analysis.
    iv. Anticipated residue and PCT. Section 408(b)(2)(E) authorizes 
EPA to use available data and information on the anticipated residue 
levels of pesticide residues in food and the actual levels of pesticide 
chemicals that have been measured in food. If EPA relies on such 
information, EPA must require that data be provided 5 years after the 
tolerance is established, modified, or left in effect, demonstrating 
that the levels in food are not above the levels anticipated. Following 
the initial data submission, EPA is authorized to require similar data 
on a time frame it deems appropriate. As required by section 
408(b)(2)(E), EPA will issue a data call-in for information relating to 
anticipated residues to be submitted no later than 5 years from the 
date of issuance of this tolerance.
    Section 408(b)(2)(F) states that the Agency may use data on the 
actual percent of food treated for assessing chronic dietary risk only 
if the Agency can make the following findings: Condition 1, that the 
data used are reliable and provide a valid basis to show what 
percentage of the food derived from such crop is likely to

[[Page 58719]]

contain such pesticide residue; Condition 2, that the exposure estimate 
does not underestimate exposure for any significant subpopulation 
group; and Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F), EPA may require registrants to submit data on 
PCT.
    The Agency used PCT information as follows: 100% fresh-water fish 
and shellfish; 6% rice; 1% hay.
    The Agency believes that the conditions listed in Unit IV. have 
been met. With respect to Condition 1, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. EPA uses a weighted average PCT for chronic dietary 
exposure estimates. This weighted average PCT figure is derived by 
averaging State-level data for a period of up to 10 years, and 
weighting for the more robust and recent data. A weighted average of 
the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. For acute dietary exposure estimates, EPA uses an estimated 
maximum PCT. The exposure estimates resulting from this approach 
reasonably represent the highest levels to which an individual could be 
exposed, and are unlikely to underestimate an individual's acute 
dietary exposure. The Agency is reasonably certain that the percentage 
of the food treated is not likely to be an underestimation. As to 
Conditions 2 and 3, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which triclopyr may 
be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for triclopyr and its 
metabolites, 3,5,6-trichloro-2-pyridinol (TCP) in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of triclopyr and its metabolites, 3,5,6-trichloro-2-
pyridinol (TCP).
    3. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    TCP, 3,5,6-trichloro-2-pyridinol is a metabolite of triclopyr, 
chlopyrifos, and chlorpyrifos-methyl. Accordingly, EPA has assessed the 
risk of triclopyr taking into account aggregate exposure to TCP 
resulting from triclopyr, chlorpyrifos, and chlorpyrifos-methyl.

D. Safety Factor for Infants and Children

    1. In general. FFDCA section 408 provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. The toxicology data base for 
triclopyr is adequate according to the Subdivision F Guideline 
requirements for a food-use chemical. Acceptable developmental toxicity 
studies in the rat and rabbit are available, as is an acceptable 2-
generation reproduction study in the rat. In determining the degree of 
concern and residual uncertainties, the Agency examined the need for an 
additional safety factor to account for the concern. In both the 
prenatal and postnatal study in rats with triclopyr, there were clearly 
defined NOAELs and LOAELs for developmental and offspring toxicities. 
The Agency noted that although the skull malformations (exencephaly and 
ablepharia) are rare, they occurred at a dose (25 mg/kg/day) above the 
dose (5mg/kg/day) that is used for acute and chronic dietary and 
residential exposure risk assessments. The other anomalies seen in the 
rat following in utero exposure occurred even at much higher dose 
levels (LOAEL = 200 mg/kg/day). The Agency determined that it is 
unlikely that the occurrence of commonly seen developmental effects 
would go undetected or under estimated since the rare findings were 
clearly observed following both prenatal and postnatal exposures.
    3. Conclusion. There is a complete toxicity data base for triclopyr 
and exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures. The Agency has determined 
that the Special FQPA SF of 10x can be reduced to 1x because:
    i. The toxicology data base is complete for FQPA special SF 
determination;
    ii. There is no susceptibility identified following in utero 
exposure in rabbits;
    iii. There is qualitative susceptibility identified following in 
utero as well as prenatal and postnatal exposure of the rat, however, 
these effects occurred at a dose (25 mg/kg/day) above the dose (5 mg/
kg/day) that is used for acute and chronic dietary and residential 
exposure risk assessments;
    iv. The developmental neurotoxicity study is not required for this 
chemical;
    v. There are no residual uncertainties associated with the exposure 
assessments performed for the dietary food and drinking water or the 
residential pathway.
    In addition, the Agency determined that no traditional additional 
safety factor (addressing data deficiencies) is needed because: The 
Agency concluded that the toxicological data base for triclopyr is 
complete and adequate for FQPA assessment; a developmental 
neurotoxicity study was not required for triclopyr and no additional 
safety factors are needed to account for toxicology data deficiencies.
    The default FQPA SF of 10X has been retained on TCP because at this 
time, an individual analysis has not been conducted as to whether a 
different safety factor would be appropriate.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water,

[[Page 58720]]

and residential uses, the Agency calculates the drinking water levels 
of concern (DWLOCs) which are used as a point of comparison against the 
model estimates of a pesticide's concentration in water (EECs). DWLOC 
values are not regulatory standards for drinking water. DWLOCs are 
theoretical upper limits on a pesticide's concentration in drinking 
water in light of total aggregate exposure to a pesticide in food and 
residential uses. In calculating a DWLOC, the Agency determines how 
much of the acceptable exposure (i.e., the PAD) is available for 
exposure through drinking water e.g., allowable chronic water exposure 
(mg/kg/day) = cPAD - (average food + residential exposure). This 
allowable exposure through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by EPA are used to calculate DWLOCs: 2L/70 kg (adult 
male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body 
weights and drinking water consumption values vary on an individual 
basis. This variation will be taken into account in more refined 
screening-level and quantitative drinking water exposure assessments. 
Different populations will have different DWLOCs. Generally, a DWLOC is 
calculated for each type of risk assessment used: acute, short-term, 
intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Triclopyr i.--Acute risk. Using the exposure assumptions 
discussed in this unit for acute exposure, the acute dietary exposure 
from food to triclopyr and its metabolites, 3,5,6-trichloro-2-pyridinol 
(TCP) and 2-methoxy-3,5,6-trichloropyridine (TMP) will occupy 0.6% of 
the aPAD for the U.S. population, 11% of the aPAD for females 13 years 
and older, 0.8% of the aPAD for all infants and 1% of the aPAD for 
children 1-6 years old. In addition, there is potential for acute 
dietary exposure to triclopyr in drinking water. After calculating 
DWLOCs and comparing them to the EECs for surface water, EPA does not 
expect the aggregate exposure to exceed 100% of the aPAD, as shown in 
the following Table 4:

                       Table 4.--Aggregate Risk Assessment for Acute Exposure to triclopyr
----------------------------------------------------------------------------------------------------------------
                                                                             Maximum
                                                aPAD, mg/kg/  Acute Food   Acute Water    Surface       Acute
         Scenario/Population Subgroup               day       Exposure,   Exposure\1\,     Water      DWLOC\3\,
                                                              mg/kg/day     mg/kg/day   EEC\2\, ppb      ppb
----------------------------------------------------------------------------------------------------------------
U.S. Population                                         1.0     0.006245      0.993755        1,000       35,000
-----------------------------------------------
All infants (< 1 year old)                              1.0     0.000770      0.999230        1,000       10,000
-----------------------------------------------
Children (1-6 years old)                                1.0     0.009764      0.990236        1,000        9,900
-------------------------------------------------------------
Children (7-12 years old)                               1.0     0.006929      0.993071        1,000        9,900
-------------------------------------------------------------
Females (13-50 years old)                              0.05     0.005328      0.044672        1,000        1,300
-------------------------------------------------------------
Males (13-19 years old)                                 1.0     0.008638      0.991362        1,000       35,000
-------------------------------------------------------------
Males (20+ years old)                                   1.0     0.005200      0.994800        1,000       35,000
-------------------------------------------------------------
Seniors (55+ years old)                                 1.0     0.005671      0.994329        1,000       35,000
----------------------------------------------------------------------------------------------------------------
\1\ Maximum acute water exposure (mg/kg/day) = aPAD (mg/kg/day) - acute food exposure from DEEM[reg] (mg/kg/
  day).
\2\ 2Peak drinking water estimate based on proposed aquatic uses.
\3\ 3The acute DWLOCs were calculated as follows: DWLOC ([mu]/L) = maximum water exposure (mg/kg/day) x body
  weight (kg) / consumption (L/day) x 0.001 mg/[mu]g.

    ii. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to triclopyr 
and its metabolites, 3,5,6-trichloro-2-pyridinol (TCP) and 2-methoxy-
3,5,6-trichloropyridine (TMP) from food will utilize 0.2 % of the cPAD 
for the U.S. population, 0.02 % of the cPAD for all infants under 1 
year old and 0.2% of the cPAD for Children 1-6 years old. Based the use 
pattern, chronic residential exposure to residues of triclopyr is not 
expected. In addition, there is potential for chronic dietary exposure 
to triclopyr in drinking water. After calculating DWLOCs and comparing 
them to the EECs for surface water, EPA does not expect the aggregate 
exposure to exceed 100% of the cPAD, as shown in the following Table 5:

               Table 5.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to triclopyr
----------------------------------------------------------------------------------------------------------------
                                                                             Maximum
                                                               Chronic       Chronic      Surface      Chronic
         Scenario/Population Subgroup           cPAD, mg/kg/     Food         Water        Water      DWLOC\3\,
                                                    day       Exposure,   Exposure\1\,  EEC\2\, ppb      ppb
                                                              mg/kg/day     mg/kg/day
----------------------------------------------------------------------------------------------------------------
U.S. Population                                        0.05     0.000084      0.049916          390        1,700
-------------------------------------------------------------

[[Page 58721]]

 
All infants (< 1 year old)                             0.05     0.000008      0.049992          390          500
-------------------------------------------------------------
Children (1-6 years old)                               0.05     0.000105      0.049895          390          500
-------------------------------------------------------------
Children (7-12 years old)                              0.05     0.000070      0.049930          390          500
-------------------------------------------------------------
Females (13-50 years old)                              0.05     0.000082      0.049918          390        1,500
-------------------------------------------------------------
Males (13-19 years old)                                0.05     0.000096      0.049904          390        1,700
-------------------------------------------------------------
Males (20+ years old)                                  0.05     0.000091      0.049909          390        1,700
-------------------------------------------------------------
Seniors (55+ years old)                                0.05     0.000079      0.049921          390        1,700
----------------------------------------------------------------------------------------------------------------
\1\ Maximum chronic water exposure (mg/kg/day) = cPAD (mg/kg/day) - chronic food exposure from DEEM (mg/kg/day).
\2\ Chronic drinking water estimate based on aquatic uses.
\3\ The chronic DWLOCs were calculated as follows: DWLOC ([mu]/L) = maximum water exposure (mg/kg/day) x body
  weight (kg) / consumption (L/day) x 0.001 mg/[mu]g.

    iii. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Triclopyr is currently registered for use that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for triclopyr.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 477 for females 13-50 years old, 
5,950 for children 1-6 years old, 9,890 for all infants less than 1 
year old, and 11,500 for children 7-12 years old. These aggregate MOEs 
do not exceed the Agency's LOC for aggregate exposure to food and 
residential uses. In addition, short-term DWLOCs were calculated and 
compared to the EECs for chronic exposure of triclopyr in ground and 
surface water. After calculating DWLOCs and comparing them to the EECs 
for surface and ground water, EPA does not expect short-term aggregate 
exposure to exceed the Agency's LOC, as shown in the following Table 6:

                    Table 6.--Aggregate Risk Assessment for Short-Term Exposure to triclopyr
----------------------------------------------------------------------------------------------------------------
                                                                  Short Term Scenario
                                      --------------------------------------------------------------------------
              Population                             Aggregate MOE    Max Water   Surface Water     Short-Term
                                          Target       (food and     Exposure\3\  EEC\4\([mu]g/  DWLOC\5\([mu]g/
                                          MOE\1\    residential)\2\   mg/kg/day         L)              L)
----------------------------------------------------------------------------------------------------------------
All Infants (<1 year)                          100          9,890       0.989892           390           9,900
----------------------------------------------------
Children 1-6 years old                         100          5,950       0.983195           390           9,800
----------------------------------------------------
Children 7-12 years old                        100         11,500        0.99131           390           9,900
----------------------------------------------------
Females 13-50 years old\6\                     100            477       0.039518           390           1,200
----------------------------------------------------------------------------------------------------------------
\1\ Basis for the target MOE: interspecies and intraspecies uncertainty factors totaling 100.
\2\ Aggregate MOE = NOAEL / (Chronic Food Exposure + Residential Exposure. Home post application & swimming)
\3\ Maximum Water Exposure (mg/kg/day) = Target Maximum Exposure - (Food Exposure + Residential Exposure)
\4\ Chronic drinking water estimate based on aquatic uses.
\5\ DWLOC([mu]g/L) = maximum water exposure (mg/kg/day) x body weight (kg) / water consumption (L) x 10-3 mg/
  [mu]g (10 kg body weight assumed, except for Females, 13-50, 60 kg)
\6\ Although this dose/endpoint was not specifically identified for use in short-term incidental oral aggregate
  risk calculations for females 13-50, the Agency believes the use of the acute dieatry endpoint is appropraite
  to evelauate this senario.

    iv. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Triclopyr is currently registered for use(s) that could result in 
intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and 
intermediate-term exposures for triclopyr.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food and 
residential exposures aggregated result in aggregate MOEs of 142,000 
for all infants less than 1 year of age, 37,900 for children 1-6 years 
of age, and 51,500 for children 7-12 years of age. These aggregate MOEs 
do not exceed the Agency's LOC for aggregate exposure to food and 
residential uses. In addition, intermediate-term DWLOCs were calculated 
and compared to the EECs for chronic exposure of triclopyr

[[Page 58722]]

in surface water. After calculating DWLOCs and comparing them to the 
EECs for surface water, EPA does not expect intermediate-term aggregate 
exposure to exceed the Agency's LOC, as shown in the following Table 7:

                 Table 7.--Aggregate Risk Assessment for Intermediate-Term Exposure to triclopyr
----------------------------------------------------------------------------------------------------------------
                                                                 Intermediate-term Scenario
                                          ----------------------------------------------------------------------
                                                                                        Surface
                Population                  Target MOE   Aggregate MOE    Max Water      Water     Intermediate-
                                               \1\         (food and     Exposure\3\     EEC\4\    Term DWLOC\5\
                                                        residential)\2\   mg/kg/day    ([mu]g/L)     ([mu]g/L)
----------------------------------------------------------------------------------------------------------------
All Infants (< 1 year)                             100        142,000       0.049965          390           500
--------------------------------------------------------
Children 1-6 years old                             100         37,900       0.049868          390           500
--------------------------------------------------------
Children 7-12 years old                            100         51,500       0.049903          390           500
----------------------------------------------------------------------------------------------------------------
\1\ Basis for the target MOE: interspecies and intraspecies uncertainty factors totaling 100.
\2\ Aggregate MOE = NOAEL / (Chronic Food Exposure + Residential Exposure (toddler soil ingestion only))
\3\ Maximum Water Exposure (mg/kg/day) = Target Maximum Exposure - (Food Exposure + Residential Exposure
  (toddler soil ingestion only))
\4\ Chronic drinking water estimate based on aquatic uses.
\5\ DWLOC ([mu]g/L) = maximum water exposure (mg/kg/day) x body weight (kg) / water consumption (L) x 10-3 mg/
  [mu]g (10 kg body weight assumed

    v. Cancer. Given the only marginal indication of carcenogenic 
potential, EPA does not expect triclopyr to pose a cancer risk to 
humans.
    2. TCP (3,5,6-trichloro-2-pyridinol). TCP is a metabolite of 
triclopyr, chlorpyrifos, and chlorpyrifos-methyl. Thus, contributions 
from all three chemicals are needed to adequately estimate the total 
amount of TCP exposure from food, water and residential sources.
    TCP aggregate exposure risk assessments were performed for acute 
and chronic aggregate exposure (food + drinking water). TCP residential 
exposure risk assessments were not conducted because triclopyr 
residential assessments were deemed protective of TCP residential 
exposures for reasons explained below.
    Since the Agency does not have ground and surface water monitoring 
data to calculate a quantitative aggregate exposure, drinking water 
levels of concern (DWLOCs) were calculated.
    i. Acute risk. Because the aPAD for TCP is based on developmental 
toxicity effects, the only population subgroup of concern for acute 
dietary exposure is females 13-50 years old. The developmental toxicity 
study in rabbits had a developmental NOAEL = 25 mg/kg/day based on 
increased incidence of hydrocephaly and dilated ventricles seen at 100 
mg/kg/day (LOAEL).
    The Agency's LOC for acute exposure to TCP is for exposures greater 
than 100% of the aPAD of 0.025 mg/kg/day. An aggregate assessment of 
TCP resulting from uses of chlorpyrifos, chlorpyrifos-methyl, and 
triclopyr provides an acute dietary estimate for females 13-50 years 
old that utilizes 22% of the aPAD when using percent crop treated 
values for the registered uses and assuming all shellfish and 
freshwater fish contain triclopyr residues and 90% of the triclopyr 
residues are present as TCP.
    The results of the TCP acute aggregate risk analysis indicate that 
the acute aggregate dietary risk estimate for the Females 13-50 years 
old population subgroup does not exceed the Agency's LOC. The aggregate 
TCP EEC of 510 ppb is less than the DWLOC of 590 ppb. Thus, acute 
aggregate risk estimates are below the Agency's LOC. Table 8 summarizes 
the acute aggregate exposure to TCP residues.

                               Table 8.--Acute Aggregate Exposures to TCP Residues
----------------------------------------------------------------------------------------------------------------
                                                                             Maximum
                                                 Subgroup    Acute Food    Acute Water    Surface       Acute
             Scenario/Population               aPAD, mg/kg/ Exposure\1\,  Exposure\2\,     Water      DWLOC\4\,
                                                   day        mg/kg/day     mg/kg/day   EEC\3\, ppb      ppb
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                            0.025      0.005447      0.019553          510          590
----------------------------------------------------------------------------------------------------------------
\1\ Acute aggregate TCP exposure from Table 3.
\2\ Maximum acute water exposure (mg/kg/day) = aPAD (mg/kg/day) - acute food exposure from DEEM (mg/kg/day).
\3\ Peak drinking water estimate based on sum of TCP levels from chlorpyrifos/chlorpyrifos-methyl and triclopyr
  uses.
\4\ The acute DWLOC was calculated as follows: DWLOC ([mu]g/L) = maximum water exposure (mg/kg/day) x body
  weight (kg) / consumption L/day x 0.001 mg/[mu]g

    ii. Chronic risk. The Agency's LOC for chronic exposure to TCP is 
for exposures greater than 100% of the cPAD of 0.012 mg/kg/day from a 
1-year chronic dog study with a NOAEL 12 mg/kg/day based on alterations 
in clinical chemistry levels at 48 mg/kg/day (LOAEL). An aggregate 
assessment of TCP resulting from uses of chlorpyrifos, chlorpyrifos-
methyl, and triclopyr provides an chronic dietary estimate for all 
infants that utilize 0.5 % cPAD to children 1-6 years old that utilizes 
1.5% of the cPAD for TCP when using PCT values for the registered uses 
and assuming all shellfish and freshwater fish contain triclopyr 
residues and 90% of the triclopyr residues are present as TCP.
    The results of the TCP chronic aggregate risk analysis indicates 
that the chronic dietary risk estimates for all adult population 
subgroups do not exceed the Agency's LOC. The aggregate TCP EEC of 340 
ppb are less than the DWLOCs for all population adult subgroups. The 
Agency notes that the chronic aggregate risk assessment for TCP exceeds 
the Agency's LOC (the

[[Page 58723]]

chronic DWLOC) for infants and children.

                                                  Table 9.--Chronic Aggregate Exposures to TCP Residues
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                           Subgroup
      Scenario/Population Subgroup       cPAD, mg/kg/       Chronic Food        Maximum Chronic Water    Surface Water EEC\3\,    Chronic DWLOC\4\, ppb
                                             day       Exposure\1\, mg/kg/day   Exposure\2\, mg/kg/day            ppb
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population                                0.012                 0.000110                 0.011890                      340                      420
------------------------------------------------------
All infants (<1 year old)                      0.012                 0.000056                 0.011944                      340                      120
------------------------------------------------------
Children (1-6 years old)                       0.012                 0.000185                 0.011815                      340                      120
------------------------------------------------------
Children (7-12 years old)                      0.012                 0.000120                 0.011880                      340                      120
------------------------------------------------------
Females (13-50 years old)                      0.012                 0.000099                 0.011901                      340                      360
------------------------------------------------------
Males (13-19 years old)                        0.012                 0.000098                 0.011902                      340                      420
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Chronic aggregate TCP exposure from Table 5.
\2\Maximum chronic water exposure (mg/kg/day) = cPAD (mg/kg/day) - chronic food exposure from DEEM (mg/kg/day).
\3\Chronic drinking water estimate based on sum of TCP levels from chlorpyrifos/chlorpyrifos-methyl and triclopyr uses (see Table 6).
\4\The chronic DWLOCs were calculated as follows: DWLOC ([mu]g/L) = maximum water exposure (mg/kg/day) x body weight (kg) / consumption L/day x 0.001 mg/
  [mu]g

    Although the generally conservative aggregate risk assessment based 
on modeling data exceeds the Agency's LOC under the chronic exposure 
scenario for infants and children, the Agency has biomonitoring data on 
416 individuals that include all pathways and routes of exposure (food, 
water, residential, dermal, oral, and inhalation). The Agency believes 
that the biomonitoring study represents a worse case scenario since 120 
children that were monitored were from households where their residents 
had been treated with a termiticide containing chlorpyrifos. All adult 
exposures measured in studies represented less than 8% of the cPAD for 
TCP. For children 1-6 years old, 95% of the individuals had exposures 
that utilized 4.5% of the cPAD or less. The Agency feels the 
biomonitoring studies represent a worst-case scenario and that chronic 
exposure to TCP for children will be significantly lower than shown 
through biomonitoring. The Agency reached this conclusion based on the 
fact that chlorpyrifos and chlorpyrifos methyl were the main source of 
TCP compared to triclopyr. At the time of the biomonitoring study 35X 
more chlorpyrifos and chlorpyrifos methyl was being used than 
triclopyr. With the cancellation of all uses of chlorpyrifos methyl 
with the exception of the stored grain use, the post-construction use 
of chlorpyrifos as a termiticide being canceled at the end of 2002, the 
pre-construction use of chlorpyrifos as a termiticide being canceled in 
2004/2005 unless submitted data shows acceptable exposure levels (due 
to the circumstances of its application significant exposure, is not 
expected from pre-construction use of chlorpyrifos but data has been 
required to confirm this assumption), and homeowner applied 
chlorpyrifos products having been canceled, the chronic exposure to TCP 
should be significantly lower than shown through the biomonitoring.
    iii. Residential assessment. A residential assessment was not done 
for TCP. The residential uses of triclopyr are expected to result in 
exposure to levels of TCP levels that are approximately 100X less than 
the estimated triclopyr levels and the short term dermal endpoint for 
TCP is 5X higher than same endpoint for triclopyr. Residential TCP 
exposures are not expected from chlorpyrifos or chlorpyrifos-methyl. 
All chlorpyrifos-methyl uses (stored grain only) should be completely 
phased out by 2004. For chlorpyrifos, the following reductions are in 
progress: Pre-construction termiticide uses will be completely phased 
out by 2004 unless submitted data shows acceptable risks, post-
construction termiticide uses will be completely phased out by 2002, 
homeowner applied products have been canceled, and major reductions in 
professionally applied residential lawn/ornamental products are 
expected.
    3. Determination of safety for Triclopyr and TCP. Based on these 
risk assessments, EPA concludes that there is a reasonable certainty 
that no harm will result to the general population, and to infants and 
children from aggregate exposure to triclopyr and TCP.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (capillary gas chromatography with 
mass selective detection (GC/MSD)(GRM 97.02) is available to enforce 
the tolerance expression. The method may be requested from: Paul 
Golden, Analytical Chemistry Lab, Office of Pesticide Programs, 
Environmental Protection Agency, Environmental Science Center, 701 
Maples Road, Fort Meade, MD 20755-5350; telephone number: (410) 305-
2960; e-mail address: [email protected].

B. International Residue Limits

    There are no established or proposed Codex, Canadian, or Mexican 
maximum residue levels (MRLs) for triclopyr residues. Therefore, 
harmonization is not an issue at this time.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
triclopyr and its metabolites, 3,5,6-trichloro-2-pyridinol (TCP) and 2-
methoxy-3,5,6-trichloropyridine (TMP) in or on fish at 3.0 ppm and 
shellfish at 3.5 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may

[[Page 58724]]

file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. Although the procedures in those regulations require 
some modification to reflect the amendments made to the FFDCA by the 
FQPA of 1996, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) provides essentially the same process for 
persons to ``object'' to a regulation for an exemption from the 
requirement of a tolerance issued by EPA under new section 408(d), as 
was provided in the old FFDCA sections 408 and 409. However, the period 
for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2002-0190 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before November 
18, 2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm. 104, Crystal Mall  2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i ) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket ID number OPP-2002-0190, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in 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 and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104--113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(d), such as

[[Page 58725]]

the tolerance in this final rule, do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism(64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of FFDCA section 408(n)(4). 
For these same reasons, the Agency has determined that this rule does 
not have any ``tribal implications'' as described in Executive Order 
13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and record 
keeping requirements.

    Dated: September 9, 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 180.417 is amended by alphabetically adding the 
commodities ``Fish''and ``Shellfish'' to the table in paragraph (a)(1) 
to read as follows:


Sec.  180.417  Triclopyr; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Fish.................................................                3.0
                                * * * * *
Shellfish............................................                3.5
------------------------------------------------------------------------

* * * * *

[FR Doc. 02-23746 Filed 9-17-02; 8:45 am]
BILLING CODE 6560-50-S