Boscalid; Pesticide Tolerances for Emergency Exemptions, 55286-55293 [05-18830]
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Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations
was published on December 17, 1997
(62 FR 66020), and was provided to the
Chief Counsel for Advocacy of the Small
Business Administration. Taking into
account this analysis, and available
information concerning the pesticides
listed in this rule, the Agency hereby
certifies that this final rule will not have
a significant economic impact on a
substantial number of small entities.
Specifically, as per the 1997 notice, EPA
has reviewed its available data on
imports and foreign pesticide usage and
concludes that there is a reasonable
international supply of food not treated
with canceled pesticides. Furthermore,
for the pesticides named in this final
rule, the Agency knows of no
extraordinary circumstances that exist
as to the present revocations that would
change EPA’s previous analysis. In
addition, the Agency has determined
that this action will not have a
substantial direct effect on States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive Order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this rule
does not have any ‘‘tribal implications’’
as described in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
Executive Order to include regulations
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that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
VI. Congressional Review Act
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 12, 2005
James Jones,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—AMENDED
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In section 180.133, paragraph (a) is
revised to read as follows:
I
§ 180.133 Lindane; tolerances for
residues.
(a) General. Tolerances are
established for residues of the
insecticide lindane (gamma isomer of
1,2,3,4,5,6-hexachlorocyclohexane) in or
on raw agricultural commodities as
follows:
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Parts per
million
Commodity
Broccoli .............
Brussels sprouts
Cabbage ...........
Cattle, fat ..........
Cauliflower ........
Goat, fat ............
Hog, fat .............
Horse, fat ..........
Sheep, fat .........
*
*
*
Expiration/
Revocation
Date
1.0
1.0
1.0
7.0
1.0
7.0
4.0
7.0
7.0
*
4/26/07
4/26/07
4/26/07
None
4/26/07
None
None
None
None
*
[FR Doc. 05–18829 Filed 9–20–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2005–0259; FRL–7737–9]
Boscalid; Pesticide Tolerances for
Emergency Exemptions
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes a
time-limited tolerance for residues of
boscalid, 3-pyridinecarboxamide, 2chloro-N-(4′-chloro[1,1′-biphenyl]-2-yl)
in or on tangerines. This action is in
response to EPA’s granting of an
emergency exemption under section 18
of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA)
authorizing use of the pesticide on
mandarin oranges and mandarin
hybrids. ‘‘Tangerines’’ is the accepted
regulatory term used for these crops and
a tolerance on tangerines covers both
mandarin oranges and mandarin
hybrids. This regulation establishes a
maximum permissible level for residues
of boscalid in this food commodity. The
tolerance will expire and is revoked on
December 31, 2008.
DATES: This regulation is effective
September 21, 2005. Objections and
requests for hearings must be received
on or before November 21, 2005.
ADDRESSES: To submit a written
objection or hearing request follow the
detailed instructions as provided in
Unit VII. of the SUPPLEMENTARY
INFORMATION. EPA has established a
docket for this action under Docket
identification (ID) number OPP–2005–
0259. All documents in the docket are
listed in the EDOCKET index at https://
www.epa.gov/edocket. Although listed
in the index, some information is not
publicly available, i.e., CBI or other
information whose disclosure is
restricted by statute. Certain other
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material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either
electronically in EDOCKET or in hard
copy at the Public Information and
Records Integrity Branch (PIRIB), Rm.
119, Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA. This docket facility is
open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The docket telephone number
is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Andrew Ertman, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9367; e-mail address: Sec–18–
Mailbox@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 entities may include, but are
not limited to:
• Crop production (NAICS code 111)
• Animal production (NAICS code
112)
• Food manufacturing (NAICS code
311)
• Pesticide manufacturing (NAICS
code 32532)
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 this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document and Other Related
Information?
In addition to using EDOCKET (https://
www.epa.gov/edocket/), you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of
40 CFR part 180 is available on E-CFR
Beta Site Two at https://
www.gpoaccess.gov/ecfr/.
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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 a tolerance for residues of
the fungicide boscalid, 3pyridinecarboxamide, 2-chloro-N-(4′chloro[1,1′-biphenyl]-2-yl) in or on
tangerines at 2.0 parts per million
(ppm). This tolerance will expire and is
revoked on December 31, 2008. EPA
will publish a document in the Federal
Register to remove the revoked
tolerance 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 of the FFDCA
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) of the FFDCA
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) of the FFDCA 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 FIFRA authorizes
EPA to exempt any Federal or State
agency from any provision of FIFRA, if
EPA determines that ‘‘emergency
conditions exist which require such
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55287
exemption.’’ This provision was not
amended by the Food Quality Protection
Act of 1996 (FQPA). EPA has
established regulations governing such
emergency exemptions in 40 CFR part
166.
III. Emergency Exemption for Boscalid
on Mandarin Oranges and Mandarin
Hybrids and FFDCA Tolerances
The state of California requested the
use of boscalid (pre-mixed with the
chemical pyraclostrobin as the product
Pristine) on mandarin oranges and
mandarine hybrids (termed ‘‘tangerines’’
for regulatory purposes) to control
Alternaria alternata. The applicant
reported that only two fungicides are
registered for use to control this
pathogen and that neither provide
commercially acceptable disease
control. It was also stated that crop
yields have been declining since 1999
because of Alternaria alternata. EPA has
authorized under FIFRA section 18 the
use of boscalid (pre-mixed with
pyraclostrobin as the product Pristine)
on mandarins and mandarin hybrids for
control of Alternaria alternata in
California. After having reviewed the
submission, EPA concurs that
emergency conditions exist for this
State.
As part of its assessment of this
emergency exemption, EPA assessed the
potential risks presented by residues of
boscalid in or on tangerines. In doing so,
EPA considered the safety standard in
section 408(b)(2) of the FFDCA, and
EPA decided that the necessary
tolerance under section 408(l)(6) of the
FFDCA 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) of the
FFDCA. Although this tolerance will
expire and is revoked on December 31,
2008, under section 408(l)(5) of the
FFDCA, residues of the pesticide not in
excess of the amounts specified in the
tolerance remaining in or on tangerines
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 this tolerance at
the time of that application. EPA will
take action to revoke this tolerance
earlier if any experience with, scientific
data on, or other relevant information
on this pesticide indicate that the
residues are not safe.
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Because this tolerance is being
approved under emergency conditions,
EPA has not made any decisions about
whether boscalid meets EPA’s
registration requirements for use on
tangerines or whether a permanent
tolerance for this use would be
appropriate. Under these circumstances,
EPA does not believe that this tolerance
serves as a basis for registration of
boscalid by a State for special local
needs under FIFRA section 24(c). Nor
does this tolerance serve as the basis for
any State other than California to use
this pesticide on this crop under section
18 of FIFRA without following all
provisions of EPA’s regulations
implementing FIFRA section 18 as
identified in 40 CFR part 166. For
additional information regarding the
emergency exemption for boscalid,
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 of the
FFDCA and a complete description of
the risk assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
Consistent with section 408(b)(2)(D)
of the FFDCA, 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 boscalid and to make a
determination on aggregate exposure,
consistent with section 408(b)(2) of the
FFDCA, for a time-limited tolerance for
residues of the fungicide boscalid, 3pyridinecarboxamide, 2-chloro-N-(4′chloro[1,1′-biphenyl]-2-yl) in or on
tangerines at 2.0 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 (SF).
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
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 boscalid used for human risk
assessment is shown in the following
Table 1:
TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR BOSCALID FOR USE IN HUMAN RISK ASSESSMENT
Dose Used in Risk Assessment,
UF
Exposure Scenario
Special FQPA SF and Level of
Concern for Risk Assessment
Study and Toxicological Effects
Acute Dietary
No appropriate endpoint identified
N/A
N/A
Chronic Dietary (All populations)
NOAEL= 21.8
UF = 100
Chronic RfD = 0.218 mg/kg/day ..
FQPA SF = 1
cPAD = chronic RfD/FQPA SF =
0.218 mg/kg/day.
Chronic rat, carcinogenicity rat
and 1–year dog studies
LOAEL = 57–58 mg/kg/day
based on liver and thyroid effects
Incidental Oral (Short and intermediate term residential only)
NOAEL= 21.8 mg/kg/day
Residential LOC for MOE = 100
Chronic rat, carcinogenicity rat
and 1–year dog studies
LOAEL = 57–58 mg/kg/day
based on liver and thyroid effects
Dermal (All Durations)
Oral study NOAEL=21.8 mg/kg/
day (dermal absorption rate =
15%)
Residential LOC for MOE = 100≤
Chronic rat, carcinogenicity rat
and 1–year dog studies
LOAEL = 57–58 mg/kg/day
based on liver and thyroid effects
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55289
TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR BOSCALID FOR USE IN HUMAN RISK ASSESSMENT—
Continued
Dose Used in Risk Assessment,
UF
Inhalation (All Durations)
Cancer (oral, dermal, inhalation)
*
Special FQPA SF and Level of
Concern for Risk Assessment
Oral study NOAEL= 21.8 mg/kg/
day (inhalation absorption rate
= 100%)
Exposure Scenario
Residential LOC for MOE = 100
Study and Toxicological Effects
Chronic rat, carcinogenicity rat
and 1–year dog studies
LOAEL = 57–58 mg/kg/day
based on liver and thyroid effects
Classification: ‘‘Suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic
potential.’’
The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.
B. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have been
established for residues of boscalid, 3pyridinecarboxamide, 2-chloro-N-(4′chloro[1,1′-biphenyl]-2-yl) in or on a
wide variety of crops and animal
commodities. Tolerances on primary
crops range from 0.05 ppm on the
Tuberous and Corm Vegetable Crop
Subgroup (1C) to 30 ppm on peppermint
and spearmint tops. Tolerances on
rotational crops range from 0.05 ppm on
several commodities to 8.0 ppm on
grasses. Animal commodity tolerances
range from 0.02 ppm for eggs to 0.35
ppm for the meat byproducts of cattle,
goats, horses, and sheep. Boscalid is a
member of the carboxamide (anilide)
class of compounds. In target crops and
rotational crops, parent boscalid is the
only residue of concern for both
tolerance expression and risk
assessment. In animal commodities,
parent boscalid, a hydroxy metabolite,
and the glucuronide of the hydroxy
metabolite are the residues of concern
for tolerance expression and risk
assessment. In drinking water, parent
boscalid is the only residue of concern
for risk assessment. Risk assessments
were conducted by EPA to assess
dietary exposures from boscalid in food
as follows:
i. Acute exposure. Acute dietary risk
assessments are performed for a fooduse 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. As there were no
toxic effects attributable to a single dose,
an endpoint of concern was not
identified to quantitate acute-dietary
risk to the general population or to the
subpopulation females 13–50 years old.
Therefore, there is no acute reference
dose (aRfD) or acute populationadjusted dose (aPAD) for the general
population or females 13–50 years old.
An acute aggregate risk assessment is
not needed.
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ii. Chronic exposure. In conducting
this chronic dietary risk assessment the
Dietary Exposure Evaluation Model
(DEEMTM) analysis evaluated the
individual food consumption as
reported by respondents in the USDA–
1994–1996 and 1998 nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII) and accumulated
exposure to the chemical for each
commodity. The chronic dietary
exposure analysis was based on
tolerance level residues and 100% crop
treated assumptions. DEEM (Version
7.81) default processing factors were
used for some commodities.
iii. Cancer. The Agency classified
boscalid as having ‘‘suggestive evidence
of carcinogenicity, but not sufficient to
assess human carcinogenic potential.’’
The quantification of human cancer risk
was therefore not conducted.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for
boscalid 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 boscalid.
The Agency uses the First Index
Reservoir Screening Tool (FIRST) or the
Pesticide Root Zone/Exposure Analysis
Modeling System (PRZM/EXAMS) to
produce estimates of pesticide
concentrations in an index reservoir.
The screening concentration in
groundwater (SCI-GROW) model is used
to predict pesticide concentrations in
shallow groundwater. For a screeninglevel assessment for surface water EPA
will generally use FIRST (a tier 1 model)
before using PRZM/EXAMS (a tier 2
model). The FIRST model is a subset of
the PRZM/EXAMS model that uses a
specific high-end runoff scenario for
pesticides. While both FIRST and
PRZM/EXAMS incorporate an index
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reservoir environment, 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 percent of
reference dose (%RfD) or percent of
population adjusted dose (%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 boscalid they
are further discussed in the aggregate
risk sections below.
Based on the FIRST and SCI-GROW
models the EECs of boscalid for chronic
exposures are estimated to be 26 parts
per billion (ppb) for surface water and
0.6 ppb for groundwater.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
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Boscalid is currently registered for use
on golf courses. The boscalid label
specifies that this product is intended
for golf course use only, and not for use
on residential turfgrass or turfgrass
being grown for sale or other
commercial use such as sod production.
Although the label does not indicate
that the product is applied by licensed
or commercial applicators, it is
acknowledged that the homeowner will
not be applying the product to golf
courses. Therefore, a risk assessment for
residential handler exposure is not
required. Boscalid is not packaged or
marketed for home orchard use and,
therefore, that use is not assessed.
It has been determined that the
potential exists for exposure to boscalid
from entering areas previously treated
with the fungicide. Based on the above
discussion, there is only one potential
non-occupational post-application
scenario associated with boscalid for
which risk needs to be assessed: adults
and youths golfing. Duration of
exposure is anticipated to be short-term.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of the FFDCA
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.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
boscalid and any other substances and
boscalid 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 boscalid 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 policy statements released by
EPA’s Office of Pesticide Programs
concerning common mechanism
determinations and procedures for
cumulating effects from substances
found to have a common mechanism on
EPA’s website at https://www.epa.gov/
pesticides/cumulative/.
C. Safety Factor for Infants and Children
1. In general. Section 408 of the
FFDCA provides that EPA shall apply
an additional tenfold margin of safety
for infants and children in the case of
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threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
that a different margin of safety will be
safe for infants and children. Margins of
safety are incorporated into EPA risk
assessments either directly through use
of a MOE analysis or through using
uncertainty (safety) factors in
calculating a dose level that poses no
appreciable risk to humans.
2. Prenatal and postnatal sensitivity.
A complete discussion of the prenatal/
postnatal sensitivity study was
discussed in a final rule dated July 30,
2003 (68 FR 44640) (FRL–7319–6). No
new information has been received to
change this information.
At that time, the Agency concluded
that there are no residual uncertainties
for pre- and post-natal toxicity as the
degree of concern is low for the
susceptibility seen in the available
studies, and the dose and endpoints
selected for the overall risk assessments
will address the concerns for the body
weight effects seen in the offspring.
Although the dose selected for overall
risk assessments (21.8 mg/kg/day) is
higher than the NOAELs in the 2generation reproduction study (10.1 mg/
kg/day) and the developmental
neurotoxicity study (14 mg/kg/day),
these differences are considered to be an
artifact of the dose selection process in
these studies. For example, there is a
tenfold difference between the LOAEL
(106.8 mg/kg/day) and the NOAEL (10.1
mg/kg/day) in the 2-generation
reproduction study. A similar pattern
was seen with regard to the
developmental neurotoxicity study,
where there is also a tenfold difference
between the LOAEL (147 mg/kg/day)
and the NOAEL (14 mg/kg/day). There
is only a 2- to 3-fold difference between
the LOAEL (57 mg/kg/day) and the
NOAEL (21.8 mg/kg/day) in the critical
study used for risk assessment. Because
the gap between the NOAEL and LOAEL
in the 2-generation reproduction and
developmental neurotoxicity studies
was large and the effects at the LOAELs
were minimal, the true NOAEL was
probably considerably higher.
Therefore, the selection of the NOAEL
of 21.8 mg/kg/day from the 1–year dog
study is conservative and appropriate
for the overall risk assessments. In
addition, the endpoints for risk
assessment are based on thyroid effects
seen in multiple species (mice, rats and
dogs) and after various exposure
durations (subchronic and chronic
exposures) which were not observed at
the LOAELs in either the 2-generation
reproduction or the developmental
neurotoxicity studies. Based on these
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Fmt 4700
Sfmt 4700
data, the Agency concluded that there
are no residual uncertainties for preand post-natal toxicity.
3. Conclusion. There is a complete
toxicity database for boscalid and
exposure data are complete or are
estimated based on data that reasonably
accounts for potential exposures. There
is no evidence of susceptibility
following in utero exposure to rats and
there is low concern and no residual
uncertainties in the developmental
toxicity study in rabbits, in the 2generation reproduction study or in the
developmental neurotoxicity study after
establishing toxicity endpoints and
traditional uncertainty factors to be used
in the risk assessment. Based on these
data and conclusions, EPA reduced the
FQPA safety factor to 1X.
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, nonoccupational 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: 2 liter
(L)/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, the Office of Pesticide
Programs (OPP) concludes with
reasonable certainty that exposures to
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boscalid 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 boscalid on drinking water as
infants (<1 year old) and 26% of the
cPAD for children 1 to 2 years old.
There are no residential uses for
boscalid that result in chronic
residential exposure to boscalid. In
addition, despite the potential for
chronic dietary exposure to boscalid in
drinking water, after calculating
DWLOCs and comparing them to
conservative model of boscalid in
surface and ground water, EPA does not
expect the aggregate exposure to exceed
100% of the cPAD, as shown in Table
2 of this unit:
a part of the aggregate risk assessment
process.
1. Acute risk. As there were no toxic
effects attributable to a single dose of
boscalid, an endpoint of concern was
not identified to quantitate acute dietary
risk. As a result, an acute aggregate risk
assessment is not needed.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to boscalid from food will
utilize 7% of the cPAD for the U.S.
population, 16% of the cPAD for all
TABLE 2.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO BOSCALID
cPAD mg/
kg/day
Population Subgroup
Surface
Water
EDWC
(ppb)
% cPAD
(Food)
Ground
Water
EDWC
(ppb)
Chronic
DWLOC
(ppb)
U.S. Population
0.218
7
26
0.63
7,100
All Infants (<1 year old)
0.218
16
26
0.63
1,800
Children 1–2 years
0.218
26
26
0.63
1,600
Females 13–49
0.218
5
26
0.63
6,200
3. Short-term risk. The short-term
aggregate risk assessment takes into
account average exposure estimates
from dietary consumption of boscalid
(food and drinking water) and nonoccupational uses (golf courses).
Postapplication exposures from the
proposed use on golf courses is
considered short-term, and applies to
adults and youths. Therefore, a short-
term aggregate risk assessment was
conducted. Since all endpoints are from
the same study, exposures from
different routes can be aggregated. Table
3 summarizes the results. The MOE
from food and non-occupational uses is
1,400, and the calculated short-term
DWLOC is 6,100 ppb. Compared to the
surface and groundwater EDWCs, the
DWLOCs are considerably greater.
Therefore, short-term aggregate risk does
not exceed EPA’s level of concern. The
MOE and DWLOC are considered to be
representative for youth because youth
and adults possess similar body surface
area to weight ratios, and because the
dietary exposure for youth (13–19 years
old) is less than that of the general U.S.
population.
TABLE 3.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO BOSCALID
Short-Term Scenario
Population
U.S
NOAEL
mg/kg/
day
21.8
Target
MOE
Max Exposure
mg/kg/
day
100
0.218
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account non-dietary, nonoccupational exposure plus chronic
exposure to food and water (considered
to be a background exposure level). As
no intermediate-term non-occupational
exposures to boscalid are anticipated, an
intermediate-term aggregate risk
assessment is not needed.
5. Aggregate cancer risk for U.S.
population. EPA’s review of toxicity
data has resulted in a classification of
boscalid as having ‘‘suggestive evidence
of carcinogenicity, but not sufficient to
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14:27 Sep 20, 2005
Jkt 205001
Average
Food Exposure mg/kg/
day
Residential Exposure mg/
kg/day
Aggregate
MOE
(food and
residential)
Max
Water Exposure
mg/kg/
day
0.014631
0.0008
1,400
0.2026
assess human carcinogenic potential.’’
Thus, a quantification of human cancer
risk has not been 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 boscalid
residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(example—gas chromatography) is
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Frm 00067
Fmt 4700
Sfmt 4700
Ground
Water
EDWC
(ppb)
0.6
Surface
Water
EDWC
(ppb)
26
ShortTerm
DWLOC
(ppb)
6,100
available to enforce the tolerance
expression. The method may be
requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail
address:residuemethods@epa.gov.
B. International Residue Limits
There is neither a Codex proposal, nor
a Canadian or Mexican maximum
residue limit for residues of boscalid on
tangerines. Therefore harmonization is
not an issue.
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VI. Conclusion
Therefore, the tolerance is established
for residues of the fungicide boscalid, 3pyridinecarboxamide, 2-chloro-N-(4′chloro[1,1′-biphenyl]-2-yl) in or on
tangerines at 2.0 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, EPA will continue
to use those procedures, with
appropriate adjustments, until the
necessary modifications can be made.
The new section 408(g) of the FFDCA
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) of the FFDCA, as was
provided in the old sections 408 and
409 of the FFDCA. 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 ID number
OPP–2005–0259 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 21, 2005.
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 issue(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
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14:27 Sep 20, 2005
Jkt 205001
confidential may be disclosed publicly
by EPA without prior notice.
Mail your written request to: Office of
the Hearing Clerk (1900L),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001. You may also deliver
your request to the Office of the Hearing
Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. 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) 564–6255.
2.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 ADDRESSES. Mail your
copies, identified by the docket ID
number OPP–2005–0259, to: Public
Information and Records Integrity
Branch, Information Technology and
Resource Management Division (7502C),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001. In person or by courier,
bring a copy to the location of the PIRIB
described in ADDRESSES. 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 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
issue(s) in the manner sought by the
requestor would be adequate to justify
the action requested (40 CFR 178.32).
VIII. Statutory and Executive Order
Reviews
This final rule establishes a timelimited tolerance under section 408 of
the FFDCA. The Office of Management
and Budget (OMB) has exempted these
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Fmt 4700
Sfmt 4700
types of actions from review under
Executive Order 12866, entitled
Regulatory Planning and Review (58 FR
51735, October 4, 1993). Because this
rule has been exempted from review
under Executive Order 12866 due to its
lack of significance, this rule is not
subject to Executive Order 13211,
Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any
enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104–4). Nor does it require any
special considerations under Executive
Order 12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994); or OMB review or any Agency
action under Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are
established on the basis of a FIFRA
section 18 exemption under section 408
of the FFDCA, such as the tolerance in
this final rule, do not require the
issuance of a proposed rule, the
requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the
Agency has determined that this action
will not have a substantial direct effect
on States, on the relationship between
the national government and the States,
or on the distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
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Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations
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 section 408(n)(4) of the
FFDCA. For these same reasons, the
Agency has determined that this rule
does not have any ‘‘tribal implications’’
as described in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
Executive order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
IX. Congressional Review Act
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
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14:27 Sep 20, 2005
Jkt 205001
and pests, Reporting and recordkeeping
requirements.
Dated: September 13, 2005
Meredith F. Laws,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.589 is amended by
adding text to paragraph (b) after the
paragraph heading to read as follows:
I
§ 180.589 Boscalid; tolerances for
residues.
*
*
*
*
*
(b) * * * Time-limited tolerances are
established for residues of the fungicide
boscalid, 3-pyridinecarboxamide, 2chloro-N-(4′-chloro[1,1 ′-biphenyl]-2-yl)
in connection with use of the pesticide
under section 18 emergency exemptions
granted by EPA. These tolerances will
expire and are revoked on the dates
specified in the following table:
Parts per
million
Commodity
Tangerine ..........
*
*
*
2.0
*
Expiration/
Revocation
Date
12/31/08
*
[FR Doc. 05–18830 Filed 9–20–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
I. General Information
[OPP–2005–0069; FRL–7737–3]
Inert Ingredients; Revocation of 34
Pesticide Tolerance Exemptions for 31
Chemicals
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: EPA is revoking 34
exemptions from the requirement of a
tolerance that are associated with 31
inert ingredients because these
substances are no longer contained in
active Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) pesticide
product registrations. These ingredients
are subject to reassessment by August
2006 under section 408(q) of the Federal
Food, Drug, and Cosmetic Act (FFDCA),
as amended by the Food Quality
Protection Act of 1996 (FQPA). The 34
Frm 00069
Fmt 4700
tolerance exemptions are considered
‘‘reassessed’’ for purposes of FFDCA’s
section 408(q).
DATES: This regulation is effective
September 21, 2005. Objections and
requests for hearings must be received
on or before November 21, 2005.
ADDRESSES: To submit a written
objection or hearing request follow the
detailed instructions as provided in
Unit XI. of the SUPPLEMENTARY
INFORMATION. EPA has established a
docket for this action under docket
identification (ID) number OPP–2005–
0069. All documents in the docket are
listed in the EDOCKET index at https://
www.epa.gov/edocket. Although listed
in the index, some information is not
publicly available, i.e., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either
electronically in EDOCKET or in hard
copy at the Public Information and
Records Integrity Branch (PIRIB), Rm.
119, Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA. This docket facility is
open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The docket telephone number
is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Karen Angulo, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 306–0404; e-mail address:
angulo.karen@epa.gov.
SUPPLEMENTARY INFORMATION:
40 CFR Part 180
PO 00000
55293
Sfmt 4700
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 entities may include, but are
not limited to:
• Crop production (NAICS code 111)
• Animal production (NAICS code
112)
• Food manufacturing (NAICS code
311)
• Pesticide manufacturing (NAICS
code 32532)
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 this unit could also
be affected. The North American
Industrial Classification System
E:\FR\FM\21SER1.SGM
21SER1
]]>Agencies
[Federal Register Volume 70, Number 182 (Wednesday, September 21, 2005)]
[Rules and Regulations]
[Pages 55286-55293]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18830]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0259; FRL-7737-9]
Boscalid; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a time-limited tolerance for
residues of boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-
chloro[1,1'-biphenyl]-2-yl) in or on tangerines. This action is in
response to EPA's granting of an emergency exemption under section 18
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
authorizing use of the pesticide on mandarin oranges and mandarin
hybrids. ``Tangerines'' is the accepted regulatory term used for these
crops and a tolerance on tangerines covers both mandarin oranges and
mandarin hybrids. This regulation establishes a maximum permissible
level for residues of boscalid in this food commodity. The tolerance
will expire and is revoked on December 31, 2008.
DATES: This regulation is effective September 21, 2005. Objections and
requests for hearings must be received on or before November 21, 2005.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number OPP-2005-0259. All documents in the docket
are listed in the EDOCKET index at https://www.epa.gov/edocket. Although
listed in the index, some information is not publicly available, i.e.,
CBI or other information whose disclosure is restricted by statute.
Certain other
[[Page 55287]]
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either electronically in
EDOCKET or in hard copy at the Public Information and Records Integrity
Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. Bell St.,
Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The docket telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9367; e-mail address: Sec-18-Mailbox@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 entities may include, but are not limited to:
Crop production (NAICS code 111)
Animal production (NAICS code 112)
Food manufacturing (NAICS code 311)
Pesticide manufacturing (NAICS code 32532)
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 this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (https://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available on E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.
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 a tolerance for residues of the fungicide
boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-
2-yl) in or on tangerines at 2.0 parts per million (ppm). This
tolerance will expire and is revoked on December 31, 2008. EPA will
publish a document in the Federal Register to remove the revoked
tolerance 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 of the FFDCA 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) of the FFDCA 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) of the FFDCA 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 FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.
III. Emergency Exemption for Boscalid on Mandarin Oranges and Mandarin
Hybrids and FFDCA Tolerances
The state of California requested the use of boscalid (pre-mixed
with the chemical pyraclostrobin as the product Pristine) on mandarin
oranges and mandarine hybrids (termed ``tangerines'' for regulatory
purposes) to control Alternaria alternata. The applicant reported that
only two fungicides are registered for use to control this pathogen and
that neither provide commercially acceptable disease control. It was
also stated that crop yields have been declining since 1999 because of
Alternaria alternata. EPA has authorized under FIFRA section 18 the use
of boscalid (pre-mixed with pyraclostrobin as the product Pristine) on
mandarins and mandarin hybrids for control of Alternaria alternata in
California. After having reviewed the submission, EPA concurs that
emergency conditions exist for this State.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of boscalid in or on
tangerines. In doing so, EPA considered the safety standard in section
408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance
under section 408(l)(6) of the FFDCA 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) of the FFDCA.
Although this tolerance will expire and is revoked on December 31,
2008, under section 408(l)(5) of the FFDCA, residues of the pesticide
not in excess of the amounts specified in the tolerance remaining in or
on tangerines 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 this tolerance at
the time of that application. EPA will take action to revoke this
tolerance earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
[[Page 55288]]
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether boscalid meets
EPA's registration requirements for use on tangerines or whether a
permanent tolerance for this use would be appropriate. Under these
circumstances, EPA does not believe that this tolerance serves as a
basis for registration of boscalid by a State for special local needs
under FIFRA section 24(c). Nor does this tolerance serve as the basis
for any State other than California to use this pesticide on this crop
under section 18 of FIFRA without following all provisions of EPA's
regulations implementing FIFRA section 18 as identified in 40 CFR part
166. For additional information regarding the emergency exemption for
boscalid, 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 of the FFDCA and a complete
description of the risk assessment process, see https://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
Consistent with section 408(b)(2)(D) of the FFDCA, 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
boscalid and to make a determination on aggregate exposure, consistent
with section 408(b)(2) of the FFDCA, for a time-limited tolerance for
residues of the fungicide boscalid, 3-pyridinecarboxamide, 2-chloro-N-
(4'-chloro[1,1'-biphenyl]-2-yl) in or on tangerines at 2.0 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
(SF).
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 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 boscalid used for human risk assessment is shown in the
following Table 1:
Table 1.--Summary of Toxicological Dose and Endpoints for Boscalid for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Special FQPA SF and
Exposure Scenario Dose Used in Risk Level of Concern for Study and Toxicological
Assessment, UF Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary No appropriate endpoint N/A N/A
identified
--------------------------------------
Chronic Dietary (All populations) NOAEL= 21.8 FQPA SF = 1 Chronic rat,
UF = 100............... cPAD = chronic RfD/FQPA carcinogenicity rat
Chronic RfD = 0.218 mg/ SF = 0.218 mg/kg/day. and 1-year dog studies
kg/day. LOAEL = 57-58 mg/kg/day
based on liver and
thyroid effects
--------------------------------------
Incidental Oral (Short and NOAEL= 21.8 mg/kg/day Residential LOC for MOE Chronic rat,
intermediate term residential only) = 100 carcinogenicity rat
and 1-year dog studies
LOAEL = 57-58 mg/kg/day
based on liver and
thyroid effects
--------------------------------------
Dermal (All Durations) Oral study NOAEL=21.8 Residential LOC for MOE Chronic rat,
mg/kg/day (dermal = 100> carcinogenicity rat
absorption rate = 15%) and 1-year dog studies
LOAEL = 57-58 mg/kg/day
based on liver and
thyroid effects
--------------------------------------
[[Page 55289]]
Inhalation (All Durations) Oral study NOAEL= 21.8 Residential LOC for MOE Chronic rat,
mg/kg/day (inhalation = 100 carcinogenicity rat
absorption rate = and 1-year dog studies
100%) LOAEL = 57-58 mg/kg/day
based on liver and
thyroid effects
--------------------------------------
Cancer (oral, dermal, inhalation) Classification: ``Suggestive evidence of carcinogenicity, but not
sufficient to assess human carcinogenic potential.''
----------------------------------------------------------------------------------------------------------------
\*\ The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.
B. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established for residues of boscalid, 3-pyridinecarboxamide, 2-chloro-
N-(4'-chloro[1,1'-biphenyl]-2-yl) in or on a wide variety of crops and
animal commodities. Tolerances on primary crops range from 0.05 ppm on
the Tuberous and Corm Vegetable Crop Subgroup (1C) to 30 ppm on
peppermint and spearmint tops. Tolerances on rotational crops range
from 0.05 ppm on several commodities to 8.0 ppm on grasses. Animal
commodity tolerances range from 0.02 ppm for eggs to 0.35 ppm for the
meat byproducts of cattle, goats, horses, and sheep. Boscalid is a
member of the carboxamide (anilide) class of compounds. In target crops
and rotational crops, parent boscalid is the only residue of concern
for both tolerance expression and risk assessment. In animal
commodities, parent boscalid, a hydroxy metabolite, and the glucuronide
of the hydroxy metabolite are the residues of concern for tolerance
expression and risk assessment. In drinking water, parent boscalid is
the only residue of concern for risk assessment. Risk assessments were
conducted by EPA to assess dietary exposures from boscalid 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. As there were no toxic effects attributable to a
single dose, an endpoint of concern was not identified to quantitate
acute-dietary risk to the general population or to the subpopulation
females 13-50 years old. Therefore, there is no acute reference dose
(aRfD) or acute population-adjusted dose (aPAD) for the general
population or females 13-50 years old. An acute aggregate risk
assessment is not needed.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEMTM)
analysis evaluated the individual food consumption as reported by
respondents in the USDA-1994-1996 and 1998 nationwide Continuing
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure
to the chemical for each commodity. The chronic dietary exposure
analysis was based on tolerance level residues and 100% crop treated
assumptions. DEEM (Version 7.81) default processing factors were used
for some commodities.
iii. Cancer. The Agency classified boscalid as having ``suggestive
evidence of carcinogenicity, but not sufficient to assess human
carcinogenic potential.'' The quantification of human cancer risk was
therefore not conducted.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for boscalid 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 boscalid.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS)
to produce estimates of pesticide concentrations in an index reservoir.
The screening concentration in groundwater (SCI-GROW) model is used to
predict pesticide concentrations in shallow groundwater. For a
screening-level assessment for surface water EPA will generally use
FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The
FIRST model is a subset of the PRZM/EXAMS model that uses a specific
high-end runoff scenario for pesticides. While both FIRST and PRZM/
EXAMS incorporate an index reservoir environment, 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 percent of reference dose (%RfD)
or percent of population adjusted dose (%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 boscalid they are further discussed in the
aggregate risk sections below.
Based on the FIRST and SCI-GROW models the EECs of boscalid for
chronic exposures are estimated to be 26 parts per billion (ppb) for
surface water and 0.6 ppb for groundwater.
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).
[[Page 55290]]
Boscalid is currently registered for use on golf courses. The
boscalid label specifies that this product is intended for golf course
use only, and not for use on residential turfgrass or turfgrass being
grown for sale or other commercial use such as sod production. Although
the label does not indicate that the product is applied by licensed or
commercial applicators, it is acknowledged that the homeowner will not
be applying the product to golf courses. Therefore, a risk assessment
for residential handler exposure is not required. Boscalid is not
packaged or marketed for home orchard use and, therefore, that use is
not assessed.
It has been determined that the potential exists for exposure to
boscalid from entering areas previously treated with the fungicide.
Based on the above discussion, there is only one potential non-
occupational post-application scenario associated with boscalid for
which risk needs to be assessed: adults and youths golfing. Duration of
exposure is anticipated to be short-term.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA 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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to boscalid and any other
substances and boscalid 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 boscalid 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 policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at https://www.epa.gov/pesticides/cumulative/.
C. Safety Factor for Infants and Children
1. In general. Section 408 of the FFDCA 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 database on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. A complete discussion of the
prenatal/postnatal sensitivity study was discussed in a final rule
dated July 30, 2003 (68 FR 44640) (FRL-7319-6). No new information has
been received to change this information.
At that time, the Agency concluded that there are no residual
uncertainties for pre- and post-natal toxicity as the degree of concern
is low for the susceptibility seen in the available studies, and the
dose and endpoints selected for the overall risk assessments will
address the concerns for the body weight effects seen in the offspring.
Although the dose selected for overall risk assessments (21.8 mg/kg/
day) is higher than the NOAELs in the 2-generation reproduction study
(10.1 mg/kg/day) and the developmental neurotoxicity study (14 mg/kg/
day), these differences are considered to be an artifact of the dose
selection process in these studies. For example, there is a tenfold
difference between the LOAEL (106.8 mg/kg/day) and the NOAEL (10.1 mg/
kg/day) in the 2-generation reproduction study. A similar pattern was
seen with regard to the developmental neurotoxicity study, where there
is also a tenfold difference between the LOAEL (147 mg/kg/day) and the
NOAEL (14 mg/kg/day). There is only a 2- to 3-fold difference between
the LOAEL (57 mg/kg/day) and the NOAEL (21.8 mg/kg/day) in the critical
study used for risk assessment. Because the gap between the NOAEL and
LOAEL in the 2-generation reproduction and developmental neurotoxicity
studies was large and the effects at the LOAELs were minimal, the true
NOAEL was probably considerably higher. Therefore, the selection of the
NOAEL of 21.8 mg/kg/day from the 1-year dog study is conservative and
appropriate for the overall risk assessments. In addition, the
endpoints for risk assessment are based on thyroid effects seen in
multiple species (mice, rats and dogs) and after various exposure
durations (subchronic and chronic exposures) which were not observed at
the LOAELs in either the 2-generation reproduction or the developmental
neurotoxicity studies. Based on these data, the Agency concluded that
there are no residual uncertainties for pre- and post-natal toxicity.
3. Conclusion. There is a complete toxicity database for boscalid
and exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures. There is no evidence of
susceptibility following in utero exposure to rats and there is low
concern and no residual uncertainties in the developmental toxicity
study in rabbits, in the 2-generation reproduction study or in the
developmental neurotoxicity study after establishing toxicity endpoints
and traditional uncertainty factors to be used in the risk assessment.
Based on these data and conclusions, EPA reduced the FQPA safety factor
to 1X.
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: 2 liter (L)/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, the Office of Pesticide Programs (OPP) concludes
with reasonable certainty that exposures to
[[Page 55291]]
boscalid 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
boscalid on drinking water as a part of the aggregate risk assessment
process.
1. Acute risk. As there were no toxic effects attributable to a
single dose of boscalid, an endpoint of concern was not identified to
quantitate acute dietary risk. As a result, an acute aggregate risk
assessment is not needed.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to boscalid
from food will utilize 7% of the cPAD for the U.S. population, 16% of
the cPAD for all infants (<1 year old) and 26% of the cPAD for children
1 to 2 years old. There are no residential uses for boscalid that
result in chronic residential exposure to boscalid. In addition,
despite the potential for chronic dietary exposure to boscalid in
drinking water, after calculating DWLOCs and comparing them to
conservative model of boscalid in surface and ground water, EPA does
not expect the aggregate exposure to exceed 100% of the cPAD, as shown
in Table 2 of this unit:
Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Boscalid
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EDWC Water EDWC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.218 7 26 0.63 7,100
------------------------------------------------
All Infants (<1 year old) 0.218 16 26 0.63 1,800
------------------------------------------------
Children 1-2 years 0.218 26 26 0.63 1,600
------------------------------------------------
Females 13-49 0.218 5 26 0.63 6,200
----------------------------------------------------------------------------------------------------------------
3. Short-term risk. The short-term aggregate risk assessment takes
into account average exposure estimates from dietary consumption of
boscalid (food and drinking water) and non-occupational uses (golf
courses). Postapplication exposures from the proposed use on golf
courses is considered short-term, and applies to adults and youths.
Therefore, a short-term aggregate risk assessment was conducted. Since
all endpoints are from the same study, exposures from different routes
can be aggregated. Table 3 summarizes the results. The MOE from food
and non-occupational uses is 1,400, and the calculated short-term DWLOC
is 6,100 ppb. Compared to the surface and groundwater EDWCs, the DWLOCs
are considerably greater. Therefore, short-term aggregate risk does not
exceed EPA's level of concern. The MOE and DWLOC are considered to be
representative for youth because youth and adults possess similar body
surface area to weight ratios, and because the dietary exposure for
youth (13-19 years old) is less than that of the general U.S.
population.
Table 3.--Aggregate Risk Assessment for Short-Term Exposure to Boscalid
--------------------------------------------------------------------------------------------------------------------------------------------------------
Short-Term Scenario
--------------------------------------------------------------------------------------------------------------------
Average Aggregate Ground Surface Short-
Population NOAEL mg/ Target Max Food Residential MOE (food Max Water Water Water Term
kg/day MOE Exposure Exposure mg/ Exposure mg/ and Exposure EDWC EDWC DWLOC
mg/kg/day kg/day kg/day residential) mg/kg/day (ppb) (ppb) (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S 21.8 100 0.218 0.014631 0.0008 1,400 0.2026 0.6 26 6,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
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). As no intermediate-term non-occupational exposures to boscalid
are anticipated, an intermediate-term aggregate risk assessment is not
needed.
5. Aggregate cancer risk for U.S. population. EPA's review of
toxicity data has resulted in a classification of boscalid as having
``suggestive evidence of carcinogenicity, but not sufficient to assess
human carcinogenic potential.'' Thus, a quantification of human cancer
risk has not been 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 boscalid residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (example--gas chromatography) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address:residuemethods@epa.gov.
B. International Residue Limits
There is neither a Codex proposal, nor a Canadian or Mexican
maximum residue limit for residues of boscalid on tangerines. Therefore
harmonization is not an issue.
[[Page 55292]]
VI. Conclusion
Therefore, the tolerance is established for residues of the
fungicide boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-
biphenyl]-2-yl) in or on tangerines at 2.0 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, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA 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)
of the FFDCA, as was provided in the old sections 408 and 409 of the
FFDCA. 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 ID number OPP-2005-0259 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
21, 2005.
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 issue(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 (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St.,
NW., Washington, DC 20005. 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) 564-6255.
2.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 ADDRESSES. Mail your
copies, identified by the docket ID number OPP-2005-0259, to: Public
Information and Records Integrity Branch, Information Technology and
Resource Management Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. In person or by courier, bring a copy to the
location of the PIRIB described in ADDRESSES. 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 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 issue(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. Statutory and Executive Order Reviews
This final rule establishes a time-limited tolerance under section
408 of the FFDCA. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this rule is not subject
to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 exemption under section 408 of the FFDCA, such as the
tolerance in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
[[Page 55293]]
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 section 408(n)(4) of the
FFDCA. For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.
IX. Congressional Review Act
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 13, 2005
Meredith F. Laws,
Acting Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.589 is amended by adding text to paragraph (b) after the
paragraph heading to read as follows:
Sec. 180.589 Boscalid; tolerances for residues.
* * * * *
(b) * * * Time-limited tolerances are established for residues of
the fungicide boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-
chloro[1,1 '-biphenyl]-2-yl) in connection with use of the pesticide
under section 18 emergency exemptions granted by EPA. These tolerances
will expire and are revoked on the dates specified in the following
table:
------------------------------------------------------------------------
Expiration/
Commodity Parts per Revocation
million Date
------------------------------------------------------------------------
Tangerine..................................... 2.0 12/31/08
------------------------------------------------------------------------
* * * * *
[FR Doc. 05-18830 Filed 9-20-05; 8:45 am]
BILLING CODE 6560-50-S
