Clopyralid; Pesticide Tolerances for Emergency Exemptions

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

[Federal Register: September 27, 2000 (Volume 65, Number 188)]
[Rules and Regulations]
[Page 57949-57956]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27se00-8]

[[Page 57949]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301043; FRL-6741-9]
RIN 2070-AB78

Clopyralid; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for
residues of clopyralid in or on peaches and nectarines. This action is
in response to EPA's granting of an emergency exemption under section
18 of the Federal Insecticide, Fungicide, and Rodenticide Act
authorizing use of the pesticide on peaches and nectarines. This
regulation establishes a maximum permissible level for residues of
clopyralid in these food commodities. The tolerances will expire and
are revoked on December 31, 2002.

DATES: This regulation is effective September 27, 2000. Objections and
requests for hearings, identified by docket control number OPP-301043
must be received by EPA on or before November 27, 2000.

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 VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301043 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Barbara Madden, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-6463; and e-mail address:
madden.barbara@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially 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 theFederal Register listings at http://
www.epa.gov/fedrgstr/.
2.In person. The Agency has established an official record for this
action under docket control number OPP-301043. 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, (CM #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

EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing tolerances for residues of the herbicide
clopyralid, 3,6-dichloro-2-pyridinecarboxylic acid, in or on peaches
and nectarines at 0.50 part per million (ppm). These tolerances will
expire and are revoked on December 31, 2002. EPA will publish a
document in the Federal Register to remove the revoked tolerances from
the Code of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
Section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from
any provision of FIFRA, if EPA determines that

[[Page 57950]]

``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act (FQPA).
EPA has established regulations governing such emergency exemptions in
40 CFR part 166.

III. Emergency Exemption for Clopyralid on Peaches and Nectarines
and FFDCA Tolerances

Plum pox virus was introduced to the United States in 1999 and has
recently been found in Pennsylvania. This disease is a major threat to
stone fruit production, and Delaware and New Jersey are requesting an
emergency exemption for use of clopyralid since removal of broadleaf
weeds that are alternate hosts for the virus, or are refugia for the
green peach aphid, the vector of this virus, will enhance the
effectiveness of imidacloprid which has already been exempted under
section 18 of FIFRA for use to combat the aphid vector directly.
The registered alternative herbicides are not optimal for control
of the weeds that clopyralid is being requested for. Most are for
preemergence use on bare ground, and will not affect perennial weeds
such as clover, Canada thistle, and asters. Some are non-selective and
will kill the sod between tree rows, resulting in unacceptable erosion.
Only 2,4-D is useful for some weeds, but for others, gives only partial
control. While the use of imidacloprid to control the vectors is the
major tool to contain or eradicate plum pox virus, an herbicide like
clopyralid will enhance the effectiveness of imidacloprid by reducing
the population of insects needing to be controlled, and the population
of weeds that can serve as alternate hosts for the virus. EPA has
authorized under FIFRA section 18 the use of clopyralid on peaches and
nectarines for control of weeds that serve as alternate hosts for plum
pox virus or are refugia for the green peach aphid in Delaware and New
Jersey. After having reviewed the submission, EPA concurs that
emergency conditions exist for these States.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of clopyralid in or on
peaches and nectarines. In doing so, EPA considered the safety standard
in FFDCA section 408(b)(2), and EPA decided that the necessary
tolerance under FFDCA section 408(l)(6) would be consistent with the
safety standard and with FIFRA section 18. Consistent with the need to
move quickly on the emergency exemption in order to address an urgent
non-routine situation and to ensure that the resulting food is safe and
lawful, EPA is issuing this tolerance without notice and opportunity
for public comment as provided in section 408(l)(6). Although these
tolerances will expire and are revoked on December 31, 2002, under
FFDCA section 408(l)(5), residues of the pesticide not in excess of the
amounts specified in the tolerance remaining in or on peaches and
nectarines after that date will not be unlawful, provided the pesticide
is applied in a manner that was lawful under FIFRA, and the residues do
not exceed a level that was authorized by these tolerances at the time
of that application. EPA will take action to revoke these tolerances
earlier if any experience with, scientific data on, or other relevant
information on this pesticide indicate that the residues are not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether clopyralid
meets EPA's registration requirements for use on peaches and nectarines
or whether permanent tolerances for these uses would be appropriate.
Under these circumstances, EPA does not believe that these tolerances
serve as a basis for registration of clopyralid by a State for special
local needs under FIFRA section 24(c). Nor do these tolerances serve as
the basis for any State other than Delaware and New Jersey to use this
pesticide on this crop under section 18 of FIFRA without following all
provisions of EPA's regulations implementing section 18 as identified
in 40 CFR part 166. For additional information regarding the emergency
exemption for clopyralid, contact the Agency's Registration Division at
the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

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).
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
clopyralid and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for time-limited tolerances for
residues of clopyralid in or on peaches and nectarines at 0.50 ppm.
EPA's assessment of the dietary exposures and risks associated with
establishing the tolerance follows.

A. 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 endpoint. 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 intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD=NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (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

[[Page 57951]]

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. The doses and toxicological
endpoints selected and the LOC for margins of exposure for various
exposure senarios are summarized in the following Table 1:

Table 1.--Summary of Toxicological Dose and Endpoints for Clopyralid for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and level of
Exposure scenario Dose used in risk concern for risk Study and toxicological
assessment, UF assessment effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population NOAEL = 75 mg/kg/day; FQPA SF = 3x; aPAD = Developmental toxicity
including females 13-50 years of UF = 100; Acute RfD = acute RfD study in rats LOAEL =
age, infants and children 0.75 mg/kg/day FQPA SF = 0.25 mg/kg/ 250 mg/kg/day based on
day decreased weight gain
and food consumption
during days 6-9 of
gestation. These
effects in the maternal
animal are believed to
be due to one or a few
doses given at the
initiation of the
dosing period (days 6-
15).
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations NOAEL = 15 mg/kg/day; FQPA SF = 3x; cPAD = Chronic Oral Toxicity /
UF = 100; Chronic RfD chronic RfD Carcinogenicity Study
= 0.15 mg/kg/day FQPA SF = 0.05 mg/kg/ in Rats LOAEL = 150 mg/
day kg/day based on
histopathologic
findings in the stomach
(epithelial hyperplasia
and thickening of the
limiting ridge).
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1 to 7 days) none none none
(Residential)
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal (1 week to none none none
several months) (Residential)
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (several months to none none none
lifetime) (Residential)
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 7 days) inhalation (or oral) LOC for MOE = 300 Developmental study in
(Residential) study NOAEL = 75 mg/kg/ (Residential) rats LOAEL = 250 mg/kg/
day (inhalation day based on decreased
absorption rate = weight gain and food
100%) consumption during days
6-9 of gestation.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 week inhalation (or oral) LOC for MOE = 300 Developmental study in
to several months) (Residential) study NOAEL = 75 mg/kg/ (Residential) rats LOAEL = 250 mg/kg/
day (inhalation day based on decreased
absorption rate = weight gain and food
100%) consumption during days
6-9 of gestation.
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (several months none none none
to lifetime) (Residential)
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) none none Clopyralid is negative
for carcinogenicity in
feeding studies in rats
and mice at doses above
the limit dose and has
been classified as
``not likely'' to be a
human carcinogen.
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA.

B. 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. Tolerances currently exist for
residues of clopyralid on asparagus, barley, field corn, mint, oats,
sugar beet tops, wheat, meat, milk and eggs. Additionally, time-limited
tolerances for canola, cranberries and flax have been established. Risk
assessments were conducted by EPA to assess dietary exposures from
clopyralid in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1-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: 100% crop treated was assumed for all crops and
residues were assumed to be at tolerance level.
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 CSFII and accumulated
exposure to the chemical for each commodity. The following assumptions
were made for the chronic exposure assessments: 100% crop treated was
assumed for all crops and residues were assumed to be at tolerance
level.

[[Page 57952]]

iii. Cancer. Clopyralid has been classified as ``not likely'' to be
a human carcinogen. Therefore, an exposure assessment to address cancer
risk is not required.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for clopyralid in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of clopyralid.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
screening concentration in ground water (SCI-GROW), which predicts
pesticide concentrations in ground water. 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 EECs of clopyralid for
acute exposures are estimated to be 27 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 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. Applications can be made 1-2 times per
year at rates up to 0.5 lb acid equivalent (ae) per acre. The current
registered labels permit homeowners to mix/load/apply both liquid and
granular formulations. The risk assessment was conducted using the
following exposure assumptions: residential handlers may receive short-
term dermal and inhalation exposure to clopyralid when mixing, loading
and applying; adults and children may be exposed to clopyralid from
dermal contact with residues when contacting foliage during post-
application activities; and toddlers may also receive short-term oral
exposure from hand-to-mouth ingestion during post-application
activities.
No chemical-specific exposure or residue dissipation data for
handler or post-application activities were submitted to the Agency in
support of the registered lawn uses. Therefore, the Agency's Draft
Standard Operating Procedures for Residential Exposure Assessments were
used as the basis for all handler exposure calculations. The post-
application risk assessment is based on generic assumptions as
specified by the newly proposed Residential SOPs and recommended
approaches by the Agency's Exposure Science Advisory Committee
(ExpoSAC). Changes to the Residential SOPs have been proposed that
alter the residential post-application scenario assumptions. The
proposed assumptions are expected to better represent residential
exposure and are still considered to be high-end, screening level
assumptions. Agency management has authorized the use of the revised
residential SOPs that were presented to the FIFRA SAP in September
1999. Therefore, the revised residential SOPs were used to calculate
exposure estimates for the clorpyralid turf and ornamental uses.
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).

C. Safety Factor for Infants and Children

1. Safety factor for infants and children --i. In general. FFDCA
section 408 provides that EPA shall apply an additional tenfold margin
of safety for infants and children in the case of threshold effects to
account for prenatal and postnatal toxicity and the completeness of the
data base on toxicity and exposure unless EPA determines that a
different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA risk assessments either
directly through use of a MOE analysis or through using uncertainty
(safety) factors in calculating a dose level that poses no appreciable
risk to humans.
ii. Developmental toxicity studies. In the developmental study in
rats, the maternal toxicity LOAEL is 250 mg/kg/day based on death,
reduced body weight gains, and reduced food consumption, and the
maternal toxicity NOAEL is 75 mg/kg/day. The developmental toxicity
NOAEL is greater than or equal to 250 mg/kg/day.
In the developmental toxicity study in rabbits, the maternal NOAEL
is 110 mg/kg/day based on death, clinical signs,

[[Page 57953]]

reduced body weight, and gastric lesions at the LOAEL of 250 mg/kg/day.
The developmental NOAEL is also 110 mg/kg/day based on hydrocephalus (8
fetuses in 3 litters) at the LOAEL of 250 mg/kg/day.
iii. Reproductive toxicity study. In the 2-generation reproductive
toxicity study in rats, the systemic toxicity NOAEL is 500 mg/kg/day.
This endpoint is based on decreased body weights, body weight gains,
and food consumption in the F0 and F1 males and
females and slight focal hyperkeratotic changes in the gastric squamous
mucosa of 1 of 30 F0 males and 2 of 30 F1 males
at the LOAEL of 1,500 mg/kg/day. The reproductive toxicity NOAEL is 500
mg/kg bw/day. This endpoint is based on the decreased day 28 body
weight of male pups of both litters of the F1 generation and
the increased relative liver weight of F1a pups (both sexes)
and F1b males of the F1 generation at the LOAEL of 1,500 mg/
kg/day.
iv. Prenatal and postnatal sensitivity. There is no evidence of
qualitative or quantitative susceptibility following in utero exposure
to rats or rabbits in the prenatal developmental studies or in the
offspring following pre/postnatal exposure in the two generation rat
reproduction toxicity study.
v. Conclusion. The FQPA 10x Safety Factor was reduced to 3x. This
reduction was made because there is no quantitative or qualitative
evidence of increased susceptibility following in utero exposure to
rats and rabbits and/or following prenatal/postnatal exposure to rats.
Additionally, the dietary (food and drinking water) and non-
occupational exposure assessments will not underestimate the potential
exposures for infants, children, and/or women of childbearing age.
However, there was neuropathology in fetuses (hydrocephalus) in the
rabbit developmental study. This study was considered a ``weak
trigger'' for the requirement of a developmental neurotoxicity study.
Therefore, the FQPA Safety Factor is 3x.

D. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD--(average food+ chronic non-dietary, non-occupational 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 clopyralid 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
clopyralid on 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 years and older, 9% of the aPAD for all infants
less than 1 year old (the infant subpopulation at greatest exposure)
and 13% of the aPAD for children 1-6 years old (the children
subpopulation at greatest exposure). In addition, despite the potential
for acute dietary exposure to clopyralid in drinking water, after
calculating DWLOCs and comparing them to conservative model estimated
environmental concentrations of clopyralid in surface and ground water,
EPA does not expect the aggregate exposure to exceed 100% of the aPAD,
as shown in the following Table 2:

Table 2.--Aggregate Risk Assessment for Acute Exposure to Clorpyralid
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface water EEC Ground water EEC
Population subgroup aPAD (mg/kg) % aPAD (Food) (ppb) (ppb) Acute DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population 0.25 8% 27 9.7 8100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females, 13 years & older 0.25 5% 27 9.7 7100
--------------------------------------------------------------------------------------------------------------------------------------------------------
All Infants (less than 1 year) 0.25 9% 27 9.7 2300
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 0.25 13% 27 9.7 2200
--------------------------------------------------------------------------------------------------------------------------------------------------------

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, 10% of the cPAD for all infants less than 1 year old (the
infant subpopulation at greatest exposure) and 34% of the aPAD for
children 1-6 years old (the children's subpopulation at greatest
exposure). Though there are residential uses for clopyralid, based on
the use pattern, chronic residential exposure is not expected. In
addition, despite the potential for chronic dietary exposure to
clopyralid in drinking water, after calculating the DWLOCs and
comparing them to conservative model EECs of clopyralid in surface and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in the following Table 3:

[[Page 57954]]

Table 3.-- Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Clopyralid
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface water EEC Ground water EEC Chronic DWLOC
Population subgroup cPAD mg/kg/day % cPAD (Food) (ppb) (ppb) (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population 0.05 14% 9 9.7 1500
Children, 1-6 years old 0.05 34 9 9.7 330
--------------------------------------------------------------------------------------------------------------------------------------------------------
All Infants, less than 1 year old 0.05 10 9 9.7 450
--------------------------------------------------------------------------------------------------------------------------------------------------------

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(s) 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. A short-term aggregate risk assessment was conducted for
adults because there is potential for inhalation exposure to the
residential handler. In addition, a short-term risk assessment was
conducted for infants and children because of the potential for
residential post-application oral exposure. Since no short-term dermal
endpoint was identified, even though there is potential for short-term
dermal exposures, no short-term dermal aggregate risk assessment was
conducted.
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 for inhalation exposure
for adults, and 2,300 for children 1-6 years old and 2,400 for all
infants less than 1 year old for post-application oral exposure. 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 water 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 is shown in the following
Table 4:

Table 4. -- 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 8500
Children (1-6 years) 3,100 300 9 9.7 2300
----------------------------------------------------------------------------------------------------------------
All Infants (less than 1 year) 6,200 300 9 9.7 2400
----------------------------------------------------------------------------------------------------------------

4. Intermediate-term risk.
Intermediate-term aggregate exposure takes into account non-
dietary, non-occupational exposure plus chronic exposure to food and
water (considered to be a background exposure level). Intermediate-term
exposure is considered to be exposures that last for 1 week to several
months. Though clopyralid is registered for use on turf and
ornamentals, only 1-2 applications can be made. Therefore,
intermediate-term exposure is not expected. Therefore, the short-term
aggregate risk estimate discussed above, is considered protective of
the aggregate exposure from non-dietary, non-occupational uses.
5. Aggregate cancer risk for U.S. population. Clopyralid has been
classified as ``not likely'' to be a human carcinogen. Therefore, an
aggregate risk assessment to address cancer risk is not required.
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.

V. Other Considerations

A. Analytical Enforcement Methodology

An adequate analytical method is available for enforcement of the
proposed time-limited tolerance for peaches and nectarines. This method
(ACR 79.5, Dow Chemical) is a Gas Chromatography method using a Hall
electrolytic conductivity detector. The method has been validated for
use on wheat and barley and has been submitted to FDA for publication
in PAM II. The method may be requested from: Calvin Furlow, PRRIB, IRSD
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number:
(703) 305-5229; e-mail address: furlow.calvin@epa.gov.

B. International Residue Limits

There are no CODEX, Canadian, or Mexican Maximum Residue Limits
(MRL) for clopyralid on peaches or nectarines. International
harmonization is therefore not an issue for these section 18 requests.

C. Conditions

No more than 0.375 lb clopyralid can be applied per acre per year.
A 60-day preharvest interval (PHI) will be observed.

VI. Conclusion

Therefore, the tolerances are established for residues of
clopyralid, 3,6-dichloro-2-pyridinecarboxylic acid, in or on peaches
and nectarines at 0.50 ppm.

VII. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will

[[Page 57955]]

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--301043 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before November
27, 2000.
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 tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.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 the docket control number OPP-301043, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 file format 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).

VIII. Regulatory Assessment Requirements

This final rule establishes time limited tolerances under FFDCA
section 408. 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 FIFRA
section 18 exemption under FFDCA section 408, such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input

[[Page 57956]]

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).

IX. Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: September 8, 2000

Peter Caulkins,

Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

1. The authority citation for part 180 continues to read as
follows:

Authority: 21 U.S.C. 321(q), 346(a) and 371.

2. Section 180.431 is amended by alphabetically adding commodities
to the table in paragraph (b) to read as follows:

Sec. 180.431 Clopyralid; tolerances for residues.

* * * * *
(b) * * *

------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
* * * * *
Nectarine 0.50 12/31/02
Peach 0.50 12/31/02
------------------------------------------------------------------------

* * * * *

[FR Doc. 00-24320 Filed 9-26-00; 8:45 am]
BILLING CODE 6560-50-S

Clopyralid; Pesticide Tolerances for Emergency Exemptions

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