[Federal Register Volume 66, Number 8 (Thursday, January 11, 2001)]
[Rules and Regulations]
[Pages 2308-2316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-745]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301099; FRL-6762-5]
RIN 2070-AB78


Clopyralid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends tolerances for residues of clopyralid 
(3,6-dichloro-2-pyridinecarboxylic acid) in or on sugar beet roots and 
sugar beet tops. In addition, this regulation establishes a tolerance 
for sugar beet molasses. Finally, the established tolerances for barley 
forage and milled fractions of barley, oats and wheat are being added 
back to the tolerance expression for clopyralid after being 
inadvertently deleted. Dow AgroSciences LLC requested this tolerance 
under the Federal Food, Drug, and Cosmetic Act, as amended by the Food 
Quality Protection Act of 1996.

DATES: This regulation is effective January 11, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301099, 
must be received by EPA on or before March 12, 2001.

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-301099 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 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/. 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-301099. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of February 9, 1999 (64 FR 6351) (FRL-6058-
3), 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 a pesticide petition (PP 8F3600) for tolerance by Dow 
AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268. This 
notice included a summary of the petition prepared by Dow AgroSciences 
LLC, the registrant. There were no comments received in response to the 
notice of filing.
    The petition requested that 40 CFR 180.431 be amended by 
establishing tolerances for residues of the herbicide clopyralid (3,6-
dichloro-2-pyridinecarboxylic acid) in or on sugar beet roots at 2.0 
parts per million (ppm), sugar beet tops at 3.0 ppm, and sugar beet 
molasses at 16.0 ppm.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that`` there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate

[[Page 2309]]

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 tolerances for residues of clopyralid (3,6-dichloro-2-
pyridinecarboxylic acid) on sugar beet roots at 2.0 ppm, sugar beet 
tops at 3.0 ppm, and sugar beet molasses at 10.0 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 as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

                                Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             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
----------------------------------------------------------------------------------------------------------------
870.3250                                 90-Day dermal toxicity in   NA\1\
                                          rats
----------------------------------------------------------------------------------------------------------------
870.3465                                 90-Day inhalation toxicity  NA
                                          in rats
----------------------------------------------------------------------------------------------------------------
870.3700a                                Prenatal developmental      Maternal NOAEL = 75 mg/kg/day; LOAEL = 250
                                          toxicity in rats            mg/kg/day based on mortality, reduced body
                                                                      weight gains and reduced food consumption;
                                                                      Developmental NOAEL 250 mg/kg/day
----------------------------------------------------------------------------------------------------------------
870.3700b                                Prenatal developmental      Maternal NOAEL = 110 mg/kg/day; LOAEL = 250
                                          toxicity in rabbits         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  Parental/Systemic NOAEL = 500 mg/kg/day for
                                          effects in rats             males 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 for males and females; 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.
----------------------------------------------------------------------------------------------------------------
870.4100b                                Chronic toxicity in 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.
----------------------------------------------------------------------------------------------------------------
870.4300                                 Combined Chronic Toxicity/  NOAEL = 15 mg/kg/day in males and females;
                                          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
----------------------------------------------------------------------------------------------------------------
870.4200b                                Carcinogenicity in mice     NOAEL = 500 mg/kg/day in males 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.
----------------------------------------------------------------------------------------------------------------
870.5300                                 in vitro and in vivo host   No evidence of induced mutant colonies over
                                          mediated assay in           background in Salmonellastrains TA 1,530
                                          bacteria                    and G-46 and Saccharomycesstrain 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.
----------------------------------------------------------------------------------------------------------------

[[Page 2310]]

 
870.5450                                 dominant lethal assay in    No evidence of treatment related
                                          rats.                       resorptions up to 400 mg/kg/day for 5
                                                                      days.
----------------------------------------------------------------------------------------------------------------
870.6200a                                Acute neurotoxicity         NA
                                          screening battery in rats
----------------------------------------------------------------------------------------------------------------
870.6200b                                Subchronic neurotoxicity    NA
                                          screening battery in rats
----------------------------------------------------------------------------------------------------------------
870.6300                                 Developmental               NA
                                          neurotoxicity in rats
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism in rats          Rapidly absorbed and excreted mainly in the
                                                                      urine. Parent compound only is detected in
                                                                      the excreta.
----------------------------------------------------------------------------------------------------------------
870.7600                                 Dermal penetration          NA
----------------------------------------------------------------------------------------------------------------
\1\Not Applicable

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (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 adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor 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 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 ai/kg/     FQPA SF = 3X; aPAD =     Developmental Toxicity
 including infants and children         day; UF = 100; Acute     acute RfD/FQPA SF =      Study - rat; Maternal
                                        RfD = 0.75 mg ai/ kg/    0.25 mg/kg/day           LOAEL = 250 mg ai/kg/
                                        day                                               day based on decreased
                                                                                          weight gain during
                                                                                          gestation days 6-9.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL= 15 mg ai/kg/day;  FQPA SF = 3X; cPAD =     2-Year Chronic Toxicity/
                                        UF = 100; Chronic RfD    chronic RfD/FQPA SF =    Carcinogenicity Study
                                        = 0.15 mg/kg/day         0.05 mg/kg/day            rat; LOAEL = 150 mg
                                                                                          ai/kg/day based on
                                                                                          increased epithelial
                                                                                          hyperplasia and
                                                                                          thickening of the
                                                                                          limiting ridge of the
                                                                                          stomach in both sexes.
----------------------------------------------------------------------------------------------------------------

[[Page 2311]]

 
Short-Term (1-7 days) and              none                     No systemic toxicity     NA
 Intermediate-Term (1 week - several                             was seen at the limit
 months) Dermal (Occupational/                                   dose (1,000 mg/kg/day)
 Residential).                                                   in the 21-day dermal
                                                                 toxicity study in
                                                                 rabbits. This risk
                                                                 assessment is not
                                                                 required.
----------------------------------------------------------------------------------------------------------------
Short-Term (1-7 days) and              NOAEL= 75 mg ai/kg/day   LOC for MOE = 100        Developmental Toxicity
 Intermediate-Term (1 week - several    (inhalation absorption   (Occupational); LOC      Study - rat; Maternal
 months) Inhalation (Occupational/      rate = 100%)             for MOE = 300            LOAEL = 250 mg ai/kg/
 Residential)                                                    (Residential)            day based on decreased
                                                                                          body weight gain
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      ``not likely''           NA                       Acceptable oral rat and
                                                                                          mouse carcinogenicity
                                                                                          studies; no evidence
                                                                                          of carcinogenic or
                                                                                          mutagenic potential.
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest
  observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic), RfD = reference dose,
  MOE = margin of exposure, LOC = level of concern.
*The reference to the FQPA Safety Factor refers to any additional safety factor retained of 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. Risk assessments were 
conducted by EPA to assess dietary exposures from clopyralid (3,6-
dichloro-2-pyridinecarboxylic acid) 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. The Dietary Exposure Evaluation Model 
(DEEM) 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: For all commodities, 100% crop 
treated was assumed and those residues will be at the level of the 
tolerance (with one exception: refined sugar from sugar-beet). The 
above assumptions result in an overestimate of human dietary exposure. 
All Section 18 tolerances (canola, cranberries, flax seed, peaches, and 
nectarines) are included in this dietary risk assessment. With the 
exception of sugar beets, default processing factors were used for 
processed commodities. The empirical processing factor of 0.1X was used 
for sugar-beet representing the 10-fold reduction in residues for 
refined sugar. The aPAD for the U.S. population is 0.25 mg/kg/day. For 
acute dietary risk estimates, the level of concern is >100% aPAD. The 
population subgroup with the highest dietary exposure from food is 
children 1-6 years. The percentage of dietary exposure for this 
subgroup is 13% of the aPAD. The acute dietary risk estimates from 
residues in food which result from the established and proposed uses of 
clopyralid are below the level of concern for the U.S. population and 
all population subgroups.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM\\) 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: For all commodities, 100% crop treated was assumed and 
those residues will be at the level of the tolerance (with one 
exception: refined sugar from sugar-beet). The empirical processing 
factor of 0.1X was used for sugar-beet representing the 10-fold 
reduction in residues for refined sugar. The cPAD for the general U.S. 
population and all subgroups is 0.05 mg/kg/day. For chronic dietary 
risk estimates, the Agency's level of concern is greater than 100% of 
the cPAD. The subgroup with the highest chronic dietary exposure from 
food is children 1-6 years. The percentage of dietary exposure for this 
subgroup is 34% of the cPAD. The chronic dietary risk estimates from 
residues in food resulting from the established and proposed uses of 
clopyralid are below the Agency's level of concern for the U.S. 
population and all population subgroups.
    iii. Cancer. The Agency concluded that clopyralid was negative for 
carcinogenic potential in mice and rats and classified clopyralid as 
``not likely'' to be a human carcinogen. Therefore, a cancer dietary 
exposure analysis was not performed.
    iv. Anticipated residue and percent crop treated information. 
Section 408(b)(2)(E) authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate. As required by section 408(b)(2)(E), EPA will 
issue a data call-in for information relating to anticipated residues 
to be submitted no later than 5 years from the date of issuance of this 
tolerance.
    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,

[[Page 2312]]

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/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 below.
    Based on the GENEEC and SCI-GROW models the estimated environmental 
concentrations (EECs) of clopyralid for acute exposures are estimated 
to be 27.0 parts per billion (ppb) for surface water and 9.7 ppb for 
ground water. The EECs for chronic exposures are estimated to be 9 ppb 
for surface water, (based on a 56-day concentration of 27 ppb and a 3x 
adjustment factor allowed by Agency policy for 56-day GENEEC values) 
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 inhalation, short-term, and intermediate-term hand-to-mouth, and 
episodic granular ingestion risk assessments of the residential 
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 
300, which incorporates the FQPA Safety Factor of 3x. MOEs calculated 
for residential handler's inhalation exposure and children's oral 
exposures were well above the target of 300; 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 margin of exposure 
(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 rabbit and rat developmental toxicity studies, the 
effects seen in fetuses are at dose levels equal to or greater than 
doses where maternal toxicity is seen. In a 2-generation reproductive 
toxicity study in rats, the effects seen in offspring were at dose 
levels equal to or greater than doses where parental toxicity is seen.
    3. Conclusion. EPA determined that an additional factor to protect 
infants and children was appropriate because of a data gap for a 
developmental neurotoxicity study in rats. This study was required due 
to the concern for malformations (hydrocephalus) seen in the prenatal 
developmental toxicity study in rabbits; EPA decided on an additional 
factor of 3 rather than the statutory default factor of 10 because the 
existing toxicology database, which is complete except for the newly 
required developmental neurotoxicity study, 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

[[Page 2313]]

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 groundwater 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 8% of the aPAD for the U.S. population, 5% of 
the aPAD for females 13-50 years, 9% of the aPAD for all infants <1 
year and 13% of the aPAD for children between 1 and 6 years old. 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)
----------------------------------------------------------------------------------------------------------------
U.S. Population................................         0.25            8            9          9.7        8,100
All infants (< 1 year).........................         0.25            9            9          9.7        2,300
Children 1-6 years.............................         0.25           13            9          9.7        2,200
Females 13-50 years............................         0.25            5            9          9.7        7,200
----------------------------------------------------------------------------------------------------------------

    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 14% of the cPAD for the U.S. 
population, 11% of the cPAD for all infants < 1 year and 34% of the 
cPAD for children between 1 and 6 years old. 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................................         0.05           14            9          9.7        1,500
All infants (< 1 year).........................         0.05           11            9          9.7          450
Children 1-6 years.............................         0.05           34            9          9.7          330
Females 13-50 years............................         0.05           11            9          9.7        1,300
----------------------------------------------------------------------------------------------------------------

    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 10,000 (U.S. population, food 
and residential), 14,000 (females 13-50, food and residential) and 
3,100 (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:

[[Page 2314]]



                    Table 5.--Aggregate Risk Assessment for Short-Term Exposure to Clopyralid
----------------------------------------------------------------------------------------------------------------
                                                  Aggregate    Aggregate
                                                MOE  (Food +    Level of     Surface       Ground     Short-Term
              Population Subgroup                               Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population...............................        10,000          300            9          9.7        8,500
Females 13-50.................................        14,000          300            9          9.7        7,300
Children 1-6 years............................         3,100          300            9          9.7        2,300
----------------------------------------------------------------------------------------------------------------

    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 aggregate MOEs of 10,000 
(U.S. Population, food only), 14,000 (females 13-50, food only) and 
3,800 (children 1-6 years, 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, intermediate-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 
intermediate-term aggregate exposure to exceed the Agency's level of 
concern, as shown in the following Table 6:

           Table 6.--Aggregate Aggregate Risk Assessment for Intermediate-Term Exposure to Clopyralid
----------------------------------------------------------------------------------------------------------------
                                                Aggregate    Aggregate
                                              MOE  (Food +    Level of     Surface       Ground    Intermediate-
             Population Subgroup                              Concern     Water EEC    Water EEC     Term DWLOC
                                              Residential)     (LOC)        (ppb)        (ppb)         (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population.............................        10,000          300            9          9.7         8,500
Females 13-50...............................        14,000          300            9          9.7         7,300
Children 1-6 years..........................         3,800          300            9          9.7         2,300
----------------------------------------------------------------------------------------------------------------

    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. Therefore, a cancer risk assessment was not performed.
    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 the 
Biological and Economic Analysis Division's (BEAD) Analytical Chemistry 
Branch 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 BEAD's Analytical Chemistry Branch 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 a maximum residue limit of 2.0 ppm for barley, oats, and wheat, 
and 7.0 ppm for the milled fractions of barley, oats, and wheat 
(excluding flour).

C. Conditions

    A revised label is needed to specify (1) a 48-hour restricted entry 
interval, and (2) whether plantback intervals for crops not listed in 
the crop rotation table will be 10.5 months or whether rotation to 
crops not listed will be prohibited. As a condition of registration, 
the registrant also needs to submit a developmental neurotoxicity study 
(870.6300) because neuropathology or central nervous system 
malformations were seen in the rabbit developmental toxicity study.

V. Conclusion

    Therefore, tolerances are amended for residues of clopyralid (3,6-
dichloro-2-pyridinecarboxylic acid), in or on sugar beet roots at 2.0 
ppm and sugar beet tops at 3.0. In addition, a tolerance is established 
for residues of clopyralid in or on sugar beet molasses at 10 ppm. 
Finally, the established tolerances for barley forage at 9 ppm and 
milled fractions (except flour) of barley, oats and wheat at 12 ppm are 
being added back to the tolerance expression for clopyralid after being 
inadvertently deleted.

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

[[Page 2315]]

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-301099 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 March 12, 
2001.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. 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 (202) 260-4865.
    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-301099, 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. 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). 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 prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments (63 FR 27655, May 19, 1998); special considerations as 
required by Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or require 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

[[Page 2316]]

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).

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: December 26, 2000.

James Jones,

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 371.


    2. Section 180.431 is amended by removing the entries for ``sugar 
beet roots'' and ``sugar beet tops'' and alphabetically adding 
commodities to the table in paragraph (a) to read as follows:


Sec. 180.431  Clopyralid; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                   *      *      *      *      *
Barley, forage.............................................          9.0
                   *      *      *      *      *
Barley, milled fractions (except flour)....................           12
                   *      *      *      *      *
Beet, sugar, molasses......................................           10
Beet, sugar, roots.........................................          2.0
Beet, sugar, tops..........................................          3.0
                   *      *      *      *      *
Oats, milled fractions (except flour)......................           12
                   *      *      *      *      *
Wheat, milled fractions (except flour).....................           12
------------------------------------------------------------------------

* * * * *

[FR Doc. 01-745 Filed 1-10-01; 8:45 am]
BILLING CODE 6560-50-S