[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
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Guideline No. Study Type Results
----------------------------------------------------------------------------------------------------------------
870.3100 90-Day oral toxicity in NOAEL = 2,000 mg/kg/day in both sexes;
mice LOAEL = 5,000 mg/kg/day in both sexes
based on decreased body weight in both
sexes.
----------------------------------------------------------------------------------------------------------------
870.3200 21/28-Day dermal toxicity NOAEL 1,000 mg/kg/day for both sexes.
in rabbits
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870.3250 90-Day dermal toxicity in NA\1\
rats
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870.3465 90-Day inhalation toxicity NA
in rats
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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
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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.
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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
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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.
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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
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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.
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870.5550 in vitro unscheduled DNA There was no evidence of unscheduled DNA
synthesis assay synthesis in initial or supplementary
assays.
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[[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
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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