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Triclopyr (Garlon) - Pesticide Tolerance 9/02

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0190; FRL-7196-7]

Triclopyr; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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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:
tompkins.jim@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          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-
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
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 rodents
with acid - rat
NOAEL = 5 mg/kg/day in males and females
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 rodents
with ester - rat
NOAEL = 7 mg/kg/day in males and < 7 mg/kg/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 nonrodents
- dog
NOAEL = 2.5 mg/kg/day (HDT) in males and 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 - rabbit NOAEL = 1,000 mg/kg/day (males and females)
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
with ester - rats
Maternal NOAEL = 100 mg/kg/day
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
with ester - rabbits
Maternal NOAEL = 30 mg/kg/day
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.
870.3700 Prenatal developmental
with salt - rabbit
Maternal NOAEL = 30 mg/kg/day
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
with salt - rat
Maternal NOAEL = 100 mg/kg/day
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
with acid - rat
Maternal NOAEL = < 50 mg/kg/day
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
effects with acid - rat
Parental/Systemic NOAEL = 5 mg/kg/day in 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 -
acid - dogs
NOAEL = 10 mg/kg/day in males and females
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) -
acid - dogs
NOAEL = 5 mg/kg/day in males and females
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 -
acid - rats
NOAEL = 12 mg/kg/day in males, = 36 mg/kg/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 -
mice
NOAEL = 84 mg/kg/day in males, 109.5 mg/kg/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 µg/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 µg/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 µg/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 - rats Triclopyr acid was negative for chromosomal 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)
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 - mice Triclopyr acid was negative for the 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 - rats Triclopyr acid was negative for the 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 pharmacokinetics
- rat
In a rat metabolism with C14-triclopyr acid 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 humans
In an oral and dermal pharmacokinetics 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 (MOE-cancer = 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 Assessments1
Exposure Scenario
Dose Used in Risk Assessment,
UF
FQPA SF and LOC for Risk Assessment
Study and Toxicological Effects
Acute dietary
General population
NOAEL = 100 mg/kg/day
UF = 100
acute RfD = 1.0 mg/kg/day
FQPA SF = 1X
aPAD = aRfD ÷ FQPA SF
= 1.0 mg/kg/day
Developmental toxicity study with BEE- rat
LOAEL = 300 mg/kg/day based on clinical
signs on GD 7
Acute dietary
Females 13–50 years old
NOAEL = 5 mg/kg/day
UF = 100
acute RfD = 0.05 mg/kg/day
FQPA SF = 1X
aPAD = aRfD ÷ FQPA SF
= 0.05 mg/kg/day
2–Generation reproduction study with acid -
rat
LOAEL = 25 mg/kg/day based on increased
incidence of F2 pups with exencephaly
and ablepharia
Chronic dietary
All populations
NOAEL= 5.0 mg/kg/day
UF = 100
Chronic RfD = 0.05 mg/kg/
day
FQPA SF = 1X
cPAD = cRfD ÷ FQPA SF
= 0.05 mg/kg/day
2–Generation reproduction study 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 incidental, oral (1–
30 days)
Swimmer, residential
Oral NOAEL = 100 mg/kg/
day
LOC for MOE = 100 Developmental rat studies with BEE and
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 (1–6 months)
Residential
Oral NOAEL = 5.0 mg/kg/day LOC for MOE = 100 Subchronic toxicity (feeding) with acid - 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)
(Occupational/residential)
Oral NOAEL = 5.0 mg/kg/day
Dermal absorption = 2%
LOC for MOE = 100 2–Generation reproduction study 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)
Occupational/residential
Oral NOAEL = 5.0 mg/kg/day
Dermal absorption = 2%
LOC for MOE = 100 2–Generation reproduction study 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 monthslifetime)
(Occupational/residential)
Oral NOAEL = 5.0 mg/kg/day
Dermal Absorption = 2%
LOC for MOE = 100 2–Generation reproduction study 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)
(Occupational/residential)
Oral NOAEL = 5.0 mg/kg/day
Inhalation absorption rate =
100%
LOC for MOE = 100 2–Generation reproduction study with acid -
rat
LOAEL = 25 mg/kg/day based on increased
incidence of F2 pups with exencephaly
and ablepharia
Intermediate-term inhalation
(1–6 months)
Occupational/residential
Oral NOAEL = 5.0 mg/kg/day
Inhalation absorption rate =
100%
LOC for MOE = 100 2–Generation reproduction study 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 inhalation (6
months-lifetime)
Occupational/residential
Oral NOAEL= 5.0 mg/kg/day
Inhalation absorption rate =
100%
LOC for MOE = 100 2–Generation reproduction study 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)
Cancer (oral, dermal, inhalation) Cancer classification ("Group D") Risk Assessment not required Group D chemical
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
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, 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
Scenario/Population Subgroup
aPAD, mg/
kg/day
Acute Food
Exposure,
mg/kg/day
Maximum
Acute Water
Exposure1,
mg/kg/day
Surface
Water
EEC2, ppb
Acute
DWLOC3,
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. (mg/kg/day).
2 2Peak drinking water estimate based on proposed aquatic uses.
3 3The acute DWLOCs were calculated as follows: DWLOC (µ/L) = maximum water exposure (mg/kg/day) x body weight (kg) ÷ consumption
L/day) x 0.001 mg/µg.
    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
Scenario/Population Subgroup
cPAD, mg/
kg/day
Chronic Food
Exposure,
mg/kg/day
Maximum
Chronic Water
Exposure1,
mg/kg/day
Surface
Water
EEC2, ppb
Chronic
DWLOC3,
ppb
U.S. Population 0.05 0.000008 0.049992 390 500
All infants (< 1 year old) 0.05 0.000770 0.999230 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 (µ/L) = maximum water exposure (mg/kg/day) x body weight (kg) ÷ consumption
(L/day) x 0.001 mg/µg.
    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
Population
Short Term Scenario
Target
MOE1
Aggregate
MOE (food
and residential)
2
Max Water
Exposure3
mg/kg/day
Surface
Water
EEC4 (µg/L)
Short-Term
DWLOC5 (µg/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 old6 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(µg/L) = maximum water exposure (mg/kg/day) x body weight (kg) ÷ water consumption (L) x 10–3 mg/µg (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 dietary endpoint is appropriate to evelauate this scenario.
    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
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
Population
Intermediate-term Scenario
Target
MOE1
Aggregate
MOE (food
and residential)
2
Max Water
Exposure3
mg/kg/day
Surface
Water
EEC4 (µg/L)
Intermediate-Term
DWLOC5 (µg/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 (µg/L) = maximum water exposure (mg/kg/day) x body weight (kg) ÷ water consumption (L) x 10–3 mg/µg (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
Scenario/Population
Subgroup
aPAD, mg/
kg/day
Acute Food
Exposure1,
mg/kg/day
Maximum
Acute Water
Exposure2,
mg/kg/day
Surface
Water
EEC3, ppb
Acute
DWLOC4,
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 (µg/L) = maximum water exposure (mg/kg/day) x body weight (kg) ÷ consumption L/
day x 0.001 mg/µg
    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 chronic DWLOC) for infants and children.
Table 9.--Chronic Aggregate Exposures to TCP Residues
Scenario/Population Subgroup
Subgroup
cPAD, mg/
kg/day
Chronic Food
Exposure1,
mg/kg/day
Maximum
Chronic Water
Exposure2,
mg/kg/day
Surface
Water
EEC3, ppb
Chronic
DWLOC4,
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 (µg/L) = maximum water exposure (mg/kg/day) x body weight (kg) ÷ consumption
L/day x 0.001 mg/µg
    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: golden.paul@epa.gov.

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 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 tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
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: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (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
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]