[Federal Register Volume 67, Number 186 (Wednesday, September 25, 2002)]
[Rules and Regulations]
[Pages 60152-60161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24232]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0235; FRL-7198-4]


Clopyralid; Pesticide Tolerance

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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                  Crop production
                                  112...............  Animal production
                                  311...............  Food manufacturing
                                  32532.............  Pesticide
                                                       manufacturing
------------------------------------------------------------------------

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

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

    1. Electronically.You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and

[[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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

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 (MOEcancer = 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 [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    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: [email protected]. 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