Clopyralid; Pesticide Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: September 25, 2002 (Volume 67, Number 186)]
[Rules and Regulations]
[Page 60152-60161]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25se02-10]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0235; FRL-7198-4]

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

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SUMMARY: This regulation establishes tolerances for residues of
clopyralid in or on certain raw agricultural commodities. Interregional
Research Project Number 4 (IR-4) and Dow Agro Sciences LLC requested
these tolerances under the Federal Food, Drug, and Cosmetic Act, as
amended by the Food Quality Protection Act of 1996.

DATES: This regulation is effective September 25, 2002. Objections and
requests for hearings, identified by docket control number OPP-2002-
0235, must be received on or before November 25, 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 control number OPP-2002-0235 in
the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: 703 305-6224; and e-mail
address: miller.joanne@epamail.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

[[Page 60153]]

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 control number OPP-2002-0235. 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 ailable 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 August 14, 2002 (67 FR 52990) (FRL-7191-
7), EPA issued a notice pursuant to section 408 of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food
Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing
the filing of pesticide petitions (PP 1E6227, 1E6241, 1E6283, 1E6291,
1E6320, 1E6329, 1E6333, 1E6334, 1E6335, 1E6399, and 1E6340 ) by the
Interregional Research Project Number 4 (IR-4), P.O. Box 231, Rutgers
University, New Brunswick, NJ 08903 and PP 4F4379 from Dow Agro
Sciences LLC, Indianapolis, IN 46268. This notice included a summary of
the petition prepared by Dow Agro Sciences LLC, the registrant. There
were no comments received in response to the notice of filing.
The petitions requested that 40 CFR 180.431 be amended by
establishing tolerances for residues of the herbicide clopyralid, 3,6-
dichloro-2-pyridinecarboxylic acid, in or on the following commodities:
Flax seed at 3.0 part per million (ppm); strawberry at 1.0 ppm; hop,
dried cones at 5.0 ppm; rapeseed seed, rapeseed forage, canola seed,
mustard seed, and crambe seed at 3 ppm, and canola meat at 6.0 ppm;
spinach at 5.0 ppm; stone fruit group at 0.5 ppm; garden beet tops at
3.0 ppm and garden beet roots at 4.0 ppm; mustard greens at 5.0 ppm;
turnip roots at 1.0 ppm and turnip greens at 4.0 ppm; cranberry at 4
ppm; sweet corn, kernel plus cob with husks removed at 1.0 ppm, sweet
corn forage at 7.0 ppm, sweet corn stover at 10.0 ppm, pop corn grain
at 1.0 ppm, pop corn stover at 10.0 ppm, liver of cattle, goat, horse,
and sheep at 3.0 ppm, meat byproducts, except liver, of cattle, goat,
horse and sheep at 36.0 ppm, and milk at 0.2 ppm; and the brassica,
head and stem, subgroup at 2.0 ppm. EPA is editorially correcting the
tolerance expressions to read canola meal and turnip, tops.
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 residues of clopyralid on strawberry at
1.0 ppm; hop, dried cones, at 5.0 ppm; rapeseed seed, rapeseed forage,
mustard seed, and crambe seed at 3 ppm, canola meal and flax meal at
6.0 ppm; spinach at 5.0 ppm; stone fruit group at 0.5 ppm; prunes at
1.5 ppm, garden beet tops at 3.0 ppm and garden beet roots at 4.0 ppm;
mustard greens at 5.0 ppm; turnip roots at 1.0 ppm and turnip tops at
4.0 ppm; cranberry at 4.0 ppm; sweet corn, kernel plus cob with husks
removed at 1.0 ppm, sweet corn forage at 7.0 ppm, sweet corn stover at
10.0 ppm, pop corn grain at 1.0 ppm, pop corn stover at 10.0 ppm, liver
of cattle, goat, horse, and sheep at 3.0 ppm, meat byproducts, except
liver, of cattle, goat, horse and sheep at 36.0 ppm, and milk at 0.2
ppm; and the Brassica, head and stem, subgroup at 2.0 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 clopyralid are
discussed in the following Table 1 and Table 2 as well as the no
observed adverse effect level (NOAEL) and the lowest observed adverse
effect level (LOAEL) from the toxicity studies reviewed.

[[Page 60154]]

Table 1.--Subchronic, Chronic, and Other Toxicity of Clopyralid
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Guideline No. Study Type Results
----------------------------------------------------------------------------------------------------------------
870.3100 90-Day oral toxicity in NOAEL = 2,000 mg/kg/day in both sexes.
mice LOAEL = 5,000 mg/kg/day in both sexes based
on decreased body weight in both sexes.
----------------------------------------------------------------------------------------------------------------
870.3200 21/28-Day dermal toxicity NOAEL = 1,000 mg/kg/day for both sexes.
in rabbits
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870.3700 Prenatal developmental Maternal NOAEL = 75 mg/kg/day
toxicity in rats LOAEL = 250 mg/kg/day based on mortality,
reduced body weight gains and reduced food
consumption.
Developmental NOAEL = 250 mg/kg/day highest
dose tested (HDT).
----------------------------------------------------------------------------------------------------------------
870.3700 Prenatal developmental Maternal NOAEL = 110 mg/kg/day.
toxicity in rabbits LOAEL = 250 mg /kg/day based on mortality,
clinical signs, decreased body weight
gains, and lesions of the gastric mucosa.
Developmental NOAEL = 110 mg/kg/day.
LOAEL = 250 mg/kg/day based on decreased
fetal body weight and hydrocephalus.
----------------------------------------------------------------------------------------------------------------
870.3800 Reproduction and fertility Systemic NOAEL = 500 mg/kg/day for males
effects in rats and females
LOAEL = 1,500 mg/kg/day for males and
females based on decreased body weights,
decreased weight gain, and decreased food
consumption in both sexes and slight focal
hyperkeratotic changes in gastric squamous
mucosa in males.
Reproductive/Offspring NOAEL = 500 mg/kg/
day
LOAEL = 1,500 mg/kg/day for males and
females based on reduced pup weights in
males and increased relative liver weight
in pups of both sexes.
----------------------------------------------------------------------------------------------------------------
870.4100 Chronic toxicity dogs NOAEL = 100 mg/kg/day in males and females.
LOAEL = 320 mg/kg/day based upon reduction
in hematological parameters in both sexes,
increased absolute liver weight in males,
and vacuolated adrenal cortical cells in
females.
----------------------------------------------------------------------------------------------------------------
870.4200 Carcinogenicity mice NOAEL = 500 mg/kg/day and >=2,000 mg/kg/day
in females.
LOAEL = 2,000 mg/kg/day in males based on
decreased body weight, body weight gains,
and food efficiency. No evidence of
carcinogenicity.
----------------------------------------------------------------------------------------------------------------
870.4300 Combined Chronic Toxicity/ NOAEL = 15 mg/kg/day.
Carcinogenicity in rats LOAEL = 150 mg/kg/day based on epithelial
hyperplasia and thickening of the limiting
ridge of the stomach in both sexes.
No evidence of carcinogenicity.
----------------------------------------------------------------------------------------------------------------
870.5300 In vitro and in vivo host No evidence of induced mutant colonies over
mediated assay in background in Salmonella strains TA 1,530
bacteria bacteria and G-46 and Saccharomyces strain
D-3
----------------------------------------------------------------------------------------------------------------
870.5385 Bone marrow chromosome There was no significant increase in the
aberrations assay frequency of chromosome aberrations in
bone marrow at any dose tested.
----------------------------------------------------------------------------------------------------------------
870.5550 In vitro unscheduled DNA There was no evidence of unscheduled DNA
synthesis assay synthesis in initial or supplementary
assays.
----------------------------------------------------------------------------------------------------------------
870.5450 Dominant lethal assay in No evidence of treatment related
rats. resorptions up to 400 mg/kg/day for 5
days.
----------------------------------------------------------------------------------------------------------------
870.7485 Metabolism in rats Rapidly absorbed and excreted mainly in the
urine. Parent compound only is detected in
the excreta.
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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 lowest dose at which
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 intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to

[[Page 60155]]

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 clopyralid used for human risk assessment is shown in the
following Table 2:

Table 2.--Summary of Toxicological Dose and Endpoints for Clopyralid for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population, NOAEL = 75 mg/kg/day FQPA SF = 1X Developmental Toxicity
including infants and children) UF = 100............... aPAD = acute RfD/FQPA Study - rat
Acute RfD = 0.75 mg/kg/ SF. Maternal LOAEL = 250 mg
day. = 0.75 mg/kg/day....... ai/ kg/day based on
decreased weight gain
during gestation days
6-9
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations) NOAEL = 15 mg/kg/day FQPA SF = 1X 2-Year Chronic Toxicity/
UF = 100 Chronic RfD =. cPAD = chronic RfD/FQPA Carcinogenicity Study
0.15 mg/kg/day......... SF. rat
= 0.15 mg/kg/day....... LOAEL = 150 mg ai/kg/
day based on increased
epithelial hyperplasia
and thickening of the
limiting ridge of the
stomach in both sexes
----------------------------------------------------------------------------------------------------------------
Short-Term Incidental Oral NOAEL = 75 mg/kg/day LOC for MOE = 100 Developmental Toxicity
Study - rat
Maternal LOAEL = 250 mg
ai/ kg/day based on
decreased weight gain
during gestation days
6-9
----------------------------------------------------------------------------------------------------------------
Intermediate Term Incidental Oral NOAEL = 15 mg/kg/day LOC for MOE = 100 2-Year Chronic Toxicity/
Carcinogenicity Study
rat
LOAEL = 150 mg ai/kg/
day based on increased
epithelial hyperplasia
and thickening of the
limiting ridge of the
stomach in both sexes
----------------------------------------------------------------------------------------------------------------
Short-Term (1-7 days) and None No systemic toxicity Not Applicable (N/A)
Intermediate-Term (1 week - several was seen at the limit
months) Dermal dose (1,000 mg/kg/day)
in the 21-day dermal
toxicity study in
rabbits. This risk
assessment is not
required.
----------------------------------------------------------------------------------------------------------------
Short-Term (1-7 days) Inhalation NOAEL = 75 mg/kg/day LOC for MOE = 100 Developmental Toxicity
(inhalation absorption Study - rat
rate = 100%) Maternal LOAEL = 250 mg
ai/kg/day based on
decreased body weight
gain
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Not likely N/A Acceptable oral rat and
mouse carcinogenicity
studies; no evidence
of carcinogenic or
mutagenic potential.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.431) for the residues of clopyralid, in or on a
variety of raw agricultural commodities. Established, proposed and
increased tolerances for clopyralid are adequate for any expected
secondary residues in meat, milk, poultry and/or eggs. Risk assessments
were conducted by EPA to assess dietary exposures from clopyralid in
food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. In conducting this acute dietary risk assessment
the Dietary Exposure Evaluation Model (DEEM\TM\) 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.
Residue levels are at the recommended tolerances with the exception of
sugar beets. The empirical processing factor of 0.1x was used for
sugar-beet representing the 10-fold reduction in residues for refined
sugar. One hundred percent of all of the crops are treated with
clopyralid.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model

[[Page 60156]]

(DEEM\TM\) 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 chronic exposure assessments. Residue levels are at the
recommended tolerances with the exception of sugar beets. The empirical
processing factor of 0.1x was used for sugar-beet representing the 10-
fold reduction in residues for refined sugar. One hundred percent of
all of the crops are treated with clopyralid.
iii. Cancer. Acceptable oral rat and mouse carcinogenicity studies
show no evidence of carcinogenic or mutagenic potential. Clopyralid is
classified as not likely to be a human carcinogen.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for clopyralid 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 clopyralid.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) to estimate pesticide concentrations in surface
water and SCI-GROW, which predicts pesticide concentrations in
groundwater. In general, EPA will use GENEEC (a tier 1 model) before
using PRZM/EXAMS (a tier 2 model) for a screening-level assessment for
surface water. The GENEEC model is a subset of the PRZM/EXAMS model
that uses a specific high-end runoff scenario for pesticides. GENEEC
incorporates a farm pond scenario, while PRZM/EXAMS incorporate an
index reservoir environment in place of the previous pond scenario. The
PRZM/EXAMS model includes a percent crop area factor as an adjustment
to account for the maximum percent crop coverage within a watershed or
drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to clopyralid they are further
discussed in the aggregate risk sections in Unit III.E of this
document.
Based on the FIRST and SCI-GROW models the estimated environmental
concentrations (EECs) of clopyralid for acute exposures are estimated
to be 46 parts per billion (ppb) for surface water and 9.7 ppb for
ground water. The EECs for chronic exposures are estimated to be 18 ppb
in surface water and 9.7 ppb for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Clopyralid is currently registered for use on the following
residential non-dietary sites: Turf and ornamentals (including golf
courses). The risk assessment was conducted using the following
residential exposure assumptions: the 75 mg/kg/day NOAEL was used in
the short-term inhalation, hand-to-mouth, and episodic granular
ingestion risk assessments of the residential exposure. The
intermediate-term assessment for children's hand-to-mouth exposure was
based on the 15 mg/kg/day NOAEL chosen for incidental oral exposure. As
no dermal endpoint was selected, a dermal risk assessment was not
required for residential exposure. For residential oral and inhalation
risk assessments, the target margin of exposure (MOE) was 100 which
incorporates the removal of the FQPA Safety Factor. MOEs calculated for
residential handler's inhalation exposure and children's oral exposures
were well above the target of 100; and therefore, do not exceed the
Agency's level of concern.
4. 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.''
EPA does not have, at this time, available data to determine
whether clopyralid has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
clopyralid does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that clopyralid has a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

1. In general. 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. No increased quantitative or
qualitative susceptibility was seen following pre- and/or post-natal
exposures. In the developmental study with rats, no developmental
toxicity was seen at the HDT (250 mg/kg/day) even in the presence of
severe maternal toxicity which manifested as deaths, reduced body
weight gain and decreased food consumption. In the two generation
reproduction study, offspring toxicity, characterized as decreased pup
weight and increased liver weights, occurred only at the HDT (1,500 mg/
kg/day) which is higher than the Limit Dose (1,000 mg/kg/day). These
changes occurred in the presence of severe

[[Page 60157]]

parental toxicity (decreased body weight, body weight gain, food
consumption and slight focal hyper keratosis of the gastric mucosa). In
the developmental rabbit study, hydrocephalus was seen in eight fetuses
(3/15 litters) only at the highest dose tested (250 mg/kg/day) in the
presence of severe maternal toxicity that manifested as death,
decreases in mean body weight and lesions of the gastric mucosa; the
developmental NOAEL was 110 mg/kg/day. The available data indicate that
a developmental neurotoxicity study would have to be tested at dose
levels higher than 250 mg/kg/day because no developmental toxicity was
observed in rats at 250 mg/kg/day. In addition, the offspring NOAEL in
the two generation reproduction study was 500 mg/kg/day with a LOAEL of
1,500 mg/kg/day. Therefore, it is anticipated that in order to elicit
any fetal nervous system abnormalities in a developmental neurotoxicity
study, the selected dose levels would have to be higher than 500 mg/kg/
day. Since the dose level selections for the developmental
neurotoxicity study will be greater than 500 mg/kg/day, the resultant
NOAEL will be either comparable to, or higher than the doses currently
used in the risk assessment. The NOAEL of 75 mg/kg/day selected for the
acute RfD is seven times lower than the offspring NOAEL in the
reproduction study. The NOAEL of 15 mg/kg/day selected for the chronic
RfD and the residential exposure risk assessments is thirty three times
lower than the offspring NOAEL in the reproduction study. Therefore, a
developmental neurotoxicity study would not likely change the
regulatory doses used for overall risk assessments.
3. Conclusion. EPA determined that an additional factor to protect
infants and children was not appropriate. Several factors influenced
this decision not to require a development neurotoxicity (DNT) study:
i. Although hydrocephalus was observed at the high dose in the
developmental rabbit study, it was seen in the presence of severe
maternal toxicity;
ii. No alterations to the fetal nervous system were seen in the
developmental rat study at the same dose (250 mg/kg/day);
iii. There was no quantitative or qualitative evidence of increased
susceptibility in the two generation reproduction study;
iv. There is no concern nor are there residual uncertainties for
pre and/or post natal toxicity; and
v. Although there are no acute or subchronic neurotoxicity studies,
there is no evidence of neurotoxicity or neuropathology in adult
animals in any of the studies. EPA decided that the FQPA safety factor
should be reduced to 1 rather than the statutory default factor of 10
because the existing toxicology database, which is complete, revealed
no quantitative or qualitative evidence of increased susceptibility
following in utero exposure to rats and rabbits and/or following
prenatal/postnatal exposure to rats; and dietary (food and drinking
water) and residential exposure assessments will not underestimate the
potential exposures for infants, children, and/or women of childbearing
age from the use of clopyralid.

E. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison 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 the USEPA Office of Water 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, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
clopyralid will occupy 4% of the aPAD for the U.S. population, 2% of
the aPAD for females 13 years and older, 4% of the aPAD for all infants
(< 1 year) and 7% of the aPAD for children 1-6 years. In addition,
there is potential for acute dietary exposure to clopyralid in drinking
water. After calculating DWLOCs and comparing them to the EECs for
surface and ground water, EPA does not expect the aggregate exposure to
exceed 100% of the aPAD, as shown in the following Table 3:

Table 3.--Aggregate Risk Assessment for Acute Exposure to Clopyralid
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. Population 0.75 4 46 9.7 25,000
----------------------------------------------------------------------------------------------------------------
All Infants (< 1 year) 0.75 4 46 9.7 7,200
----------------------------------------------------------------------------------------------------------------
Children 1-6 years 0.75 7 46 9.7 7,000
----------------------------------------------------------------------------------------------------------------
Females 13-50 0.75 2 46 9.7 22,000
----------------------------------------------------------------------------------------------------------------

[[Page 60158]]

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
clopyralid from food will utilize 7% of the cPAD for the U.S.
population, 7% of the cPAD for all infants (< 1 year) and 17% of the
cPAD for children 1-6 years. Based on the use pattern, chronic
residential exposure to residues of clopyralid is not expected. In
addition, there is potential for chronic dietary exposure to clopyralid
in drinking water. After calculating DWLOCs and comparing them to the
EECs for surface and ground water, EPA does not expect the aggregate
exposure to exceed 100% of the cPAD, as shown in the following Table 4:

Table 4.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Clopyralid
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.15 7 18 9.7 4,900
----------------------------------------------------------------------------------------------------------------
All Infants (< 1 year) 0.15 7 18 9.7 1,400
----------------------------------------------------------------------------------------------------------------
Children 1-6 years 0.15 17 18 9.7 1,200
----------------------------------------------------------------------------------------------------------------
Females 13-50 0.15 5 18 9.7 4,300
----------------------------------------------------------------------------------------------------------------

3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Clopyralid 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 clopyralid.
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 7,000 (U.S. population, food and
residential), 9,600 (females 13-50, food and residential) and 2,200
(children 1-6 years old, food and residential). These aggregate MOEs do
not exceed the Agency's level of concern for aggregate exposure to food
and residential uses. In addition, short-term DWLOCs were calculated
and compared to the EECs for chronic exposure of clopyralid 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 level of concern, as shown in
the following Table 5:

Table 5.--Aggregate Risk Assessment for Short-Term Exposure to Clopyralid
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 7,000 100 18 9.7 26,000
----------------------------------------------------------------------------------------------------------------
Children 1-6 years 2,200 100 18 9.7 7,200
----------------------------------------------------------------------------------------------------------------
Females 13-50 years 9,600 100 18 9.7 22,000
----------------------------------------------------------------------------------------------------------------

4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Clopyralid 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 clopyralid.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in an aggregate MOE of 530
(children 1-6 years, food and residential). This aggregate MOE does not
exceed the Agency's level of concern for aggregate exposure to food and
residential uses. In addition, an intermediate-term DWLOC was
calculated and compared to the EECs for chronic exposure of clopyralid
in ground and surface water. After calculating the DWLOC and comparing
it to the EECs for surface and ground water, EPA does not expect
intermediate-term aggregate exposure to exceed the Agency's level of
concern, as shown in the following Table 6:

Table 6.--Aggregate Risk Assessment for Intermediate-Term Exposure to Clopyralid
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Intermediate-
Population Subgroup MOE (Food + Concern Water EEC Water + EEC Term DWLOC
Residential) (LOC) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Children 1-6 years 530 100 18 9.7 1,200
----------------------------------------------------------------------------------------------------------------

[[Page 60159]]

5. Aggregate cancer risk for U.S. population. The Agency concluded
that clopyralid was negative for carcinogenicity potential in rats and
mice and classified clopyralid as ``not likely'' to be a human
carcinogen according to EPA Draft Guidelines for Carcinogen Risk
Assessment.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to clopyralid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

An adequate residue analytical method is available for enforcement
of the proposed tolerances. This method, ACR 75.6, determines
clopyralid as the methyl ester by gas chromatography using electron
capture detection. This method has been successfully validated by EPA
and has been published in FDA's Pesticide Analytical Manual, Vol-II
(PAM II).
An adequate residue analytical method is also available for the
enforcement of the proposed tolerance on animal commodities. This
method, ACR 86.1, determines clopyralid as the methyl ester by gas
chromatography using electron capture detection. This method has been
successfully validated by EPA and has been published in FDA's Pesticide
Analytical Manual, Vol-II (PAM II).

B. International Residue Limits

There are no Codex or Mexican maximum residue limits (MRLs). Canada
has set maximum residue limits of 2.0 ppm for barley, oats, and wheat,
7.0 ppm for the milled fractions of barley, oats, and wheat (excluding
flour), 1.0 ppm for strawberries and 0.2 ppm for flax.

V. Conclusion

Therefore, tolerances are established for residues of clopyralid on
strawberry at 1.0 ppm; hop, dried cones, at 5.0 ppm; rapeseed seed,
rapeseed forage, mustard seed, and crambe seed at 3.0 ppm, canola meal
and flax meal at 6.0 ppm; spinach at 5.0 ppm; stone fruit group at 0.5
ppm; prunes at 1.5 ppm, garden beet tops at 3.0 ppm and garden beet
roots at 4.0 ppm; mustard greens at 5.0 ppm; turnip roots at 1.0 ppm
and turnip tops at 4.0 ppm; cranberry at 4.0 ppm; sweet corn, kernel
plus cob with husks removed at 1.0 ppm, sweet corn forage at 7.0 ppm,
sweet corn stover at 10.0 ppm, pop corn grain at 1.0 ppm, pop corn
stover at 10.0 ppm, liver of cattle, goat, horse, and sheep at 3.0 ppm,
meat byproducts, except liver, of cattle, goat, horse and sheep at 36.0
ppm, and milk at 0.2 ppm; and the brassica, head and stem, subgroup at
2.0 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 control number OPP-2002-0235 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
25, 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 (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. 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.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-2002-0235, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the 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.

[[Page 60160]]

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
recordkeeping requirements.

Dated: September 16, 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 180.431 is amended as follows:
i. By alphabetically adding commodities to the table in paragraph
(a);
ii. By removing tolerances for cattle, kidney; goat, kidney; horse,
kidney and sheep, kidney in the table in paragraph (a);
iii. By increasing tolerances for cattle, meat byproducts, except
liver; goat, meat byproducts, except liver; horse, meat byproducts,
except liver and sheep, meat byproducts, except liver; and milk in the
table in paragraph (a); and
iv. By removing the text from paragraph (b); and reserving
paragraph (b) with the heading.
The additions and revisions read as follows:

[[Page 60161]]

Sec. 180.431 Clopyralid; tolerances for residues.

(a) General. Tolerances are established for residues of the
herbicide clopyralid (3,6-dichloro-2-pyridinecarboxylic acid) in or on
the following commodities:

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Beet, garden, tops................................... 3.0
Beet, garden, roots.................................. 4.0
Brassica, head and stem, subgroup.................... 2.0
Canola, meal......................................... 6.0
Canola, seed......................................... 3.0
* * * * *
Cattle, liver........................................ 3.0
* * * * *
Cattle, meat byproducts, except liver................ 36.0
* * * * *
Corn, pop, grain..................................... 1.0
Corn, pop, stover.................................... 10.0
Corn, sweet, forage.................................. 7.0
Corn, sweet, kernel plus cob with husks removed...... 1.0
Corn, sweet, stover.................................. 10.0
Crambe, seed......................................... 3.0
Cranberry............................................ 4.0
* * * * *
Flax, meal........................................... 6.0
Flax, seed........................................... 3.0
Fruit, stone, group.................................. 0.5
* * * * *
Goat, liver.......................................... 3.0
* * * * *
Goat, meat byproducts, except liver.................. 36.0
* * * * *
Hop, dried cones..................................... 5.0
* * * * *
Horse, liver......................................... 3.0
* * * * *
Horse, meat byproducts, except liver................. 36.0
Milk................................................. 0.2
* * * * *
Mustard, greens...................................... 5.0
Mustard, seed........................................ 3.0
* * * * *
Plum, prune, dried................................... 1.5
* * * * *
Rapeseed, seed....................................... 3.0
Rapeseed, forage..................................... 3.0
* * * * *
Sheep, liver......................................... 3.0
* * * * *
Sheep, meat byproducts, except liver................. 36.0
* * * * *
Spinach.............................................. 5.0
Strawberry........................................... 1.0
* * * * *
Turnip, roots........................................ 1.0
Turnip, tops......................................... 4.0
* * * * *
------------------------------------------------------------------------

(b) Section 18 emergency exemptions. [Reserved]
* * * * *

[FR Doc. 02-24232 Filed 9-24-02; 8:45 am]
BILLING CODE 6560-50-S

Clopyralid; Pesticide Tolerance

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