Pyraclostrobin; Pesticide Tolerances, 17014-17021 [06-3262]
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Federal Register / Vol. 71, No. 65 / Wednesday, April 5, 2006 / Rules and Regulations
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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
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
VIII. 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
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the Comptroller General of the United
States prior to publication of this final
rule in theFederal 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: March 27, 2006.
Losi Rossi,
Director, Registration Division, Office of
Pesticide Programs.
This final rule also increases the
tolerances for almond, hulls; pea and
bean, dried shelled, except soybean,
subgroup 6C; and strawberry. BASF
Corporation requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996
(FQPA).
This regulation is effective April
5, 2006. Objections and requests for
hearings must be received on or before
June 5, 2006.
DATES:
To submit a written
objection or hearing request follow the
detailed instructions as provided in
Unit VI. of the SUPPLEMENTARY
I Therefore, 40 CFR chapter I is
INFORMATION. EPA has established a
amended as follows:
docket for this action under docket
PART 180—[AMENDED]
identification (ID) number EPA–HQ–
OPP–2004–0292. All documents in the
I 1. The authority citation for part 180
docket are listed on the regulations.gov
continues to read as follows:
website. (EDOCKET, EPA’s electronic
Authority: 21 U.S.C. 321(q), 346a and 371.
public docket and comment system was
replaced on November 25, 2005, by an
I 2. Section 180.598 is amended by
enhanced Federal-wide electronic
alphabetically adding the following
docket management and comment
commodity to the table in paragraph (a)
system located at https://
to read as follows:
www.regulations.gov. Follow the on-line
§ 180.598 Novaluron; tolerances for
instructions.) Although listed in the
residues.
index, some information is not publicly
(a) * * *
available, e.g., CBI or other information
whose disclosure is restricted by statute.
Commodity
Parts per million
Certain other material, such as
copyrighted material, is not placed on
*
*
*
*
*
the Internet and will be publicly
Brassica, head and stem,
subgroup 5A
0.50 available only in hard copy form.
Publicly available docket materials are
*
*
*
*
*
available either electronically through
regulations.gov or in hard copy at the
[FR Doc. 06–3261 Filed 4–4–06; 8:45 am]
Public Information and Records
BILLING CODE 6560–50–S
Integrity Branch(PIRIB), Rm. 119,
Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA. This Docket Facility is
ENVIRONMENTAL PROTECTION
open from 8:30 a.m. to 4 p.m., Monday
AGENCY
through Friday, excluding legal
40 CFR Part 180
holidays. The Docket telephone number
is (703) 305–5805.
[EPA–HQ–OPP–2004–0292; FRL–7772–8]
Pyraclostrobin; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for combined residues of
pyraclostrobin (carbamic acid, [2-[[[1-(4chlorophenyl)-1H-pyrazol-3yl]oxy]methyl]phenyl]methoxy-, methyl
ester) and its desmethoxy metabolite
(methyl-N-[[[1-(4-chlorophenyl)-1Hpyrazol-3yl]oxy]methyl]phenylcarbamate),
expressed as parent compound, in or on
bean, succulent, shelled; legume
vegetables group, foliage, in crop group
7; mango (import); and papaya (import).
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ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Tony Kish, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9443; e-mail address:
kish.tony@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:
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• Crop production (NAICS code 111),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
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.
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B. How Can I Access Electronic Copies
of this Document and Other Related
Information?
In addition to using regulations.gov,
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
In the Federal Register of August 27,
2004 (69 FR 52670) (FRL–7676–9), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of
three pesticide petitions by BASF
Corporation (0F6139, 2F6431, and
3F6581) of Research Triangle Park, NC
27709 and one petition (3E6774) by the
Interregional Research Project Number 4
(IR-4), 681 US Highway #1 South, North
Brunswick, NJ, 08902-3390. These
petitions requested that 40 CFR 180.582
be amended by establishing tolerances
for combined residues of the fungicide
pyraclostrobin and its desmethoxy
metabolite, expressed as parent
compound, in or on a large number of
crops. Most, but not all of the proposed
new tolerances requested in the four
petitions mentioned in this unit were
established in a final rule published in
the Federal Register of October 29, 2004
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(69 FR 63083) (FRL-7681-9). The
following tolerances were requested, but
not included in the October 29, 2004
final rule, and thus are included herein:
Bean, succulent, shelled; legume
vegetables group, foliage, in crop group
7; mango (import); and papaya (import).
Additionally, in the Federal Register
of February 15, 2006 (71 FR 7955) (FRL–
7759–4), EPA issued a notice pursuant
to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
revised pesticide petition by BASF
Corporation (5F6906) of Research
Triangle Park, NC 27709. That notice
included a summary of the pesticide
petition prepared by BASF, the
registrant. This petition requested that
40 CFR 180.582 be amended by revising
established tolerances for combined
residues of the fungicide pyraclostrobin
and its desmethoxy metabolite,
expressed as parent compound, in or on
pea and bean, dried shelled, except
soybean, subgroup 6C, and strawberry.
The October 29, 2004 final rule
previously established tolerances for
pea and bean, dried shelled, except
soybean, subgroup 6C, and for
strawberry. However, the existing 0.3
parts per million (ppm) tolerance in this
rule for pea and bean, dried shelled,
except soybean, subgroup 6C, was based
on submission of confirmatory field trial
data. These confirmatory data were
submitted and reviewed, and result in
the tolerance being increased herein
from 0.3 ppm to 0.5 ppm. Hence, a
revised notice of filing/petition was
submitted.
Furthermore, the existing 1.5 ppm
time-limited tolerance established for
strawberry in that final rule expired
December 31, 2005. Upon this
expiration, the tolerance reverted back
to the permanent 0.4 ppm tolerance.
Based on submission of recent field trial
data, the permanent strawberry
tolerance is being increased from 0.4
ppm to 1.2 ppm. Hence, a revised notice
of filing/petition was submitted. No
comments were received on the notice
of filing.
In the Federal Register of January 27,
2006, (71 FR 4579) (FRL–7758–8), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition by BASF Corporation
(5F6906) of Research Triangle Park, NC
27709. That notice included a summary
of the pesticide petition prepared by
BASF, the registrant. This petition
requested that 40 CFR 180.582 be
amended by increasing the tolerance for
combined residues of the fungicide
pyraclostrobin and its desmethoxy
metabolite, expressed as parent
compound, in or on almonds, hulls.
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Comments were received on the notice
of filing. EPA’s response to these
comments is discussed in Unit IV.C.
Section 408(b)(2)(A)(i) of 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 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 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....’’
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 FFDCA
and a complete description of the risk
assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and
Determination of Safety
Consistent with section 408(b)(2)(D)
of 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 and to make a
determination on aggregate exposure,
consistent with section 408(b)(2) of
FFDCA, for tolerances for combined
residues of pyraclostrobin and its
desmethoxy metabolite, expressed as
parent compound, on almond, hulls at
7.0 ppm; bean, succulent, shelled at 0.5
ppm; legume vegetables group, foliage,
in crop group 7, at 25 ppm; mango
(import) at 0.1 ppm; papaya (import) at
0.1 ppm; pea and bean, dried shelled,
except soybean, subgroup 6C at 0.5
ppm; and strawberry at 1.2 ppm.
EPA’s assessment of exposures and
risks associated with establishing the
tolerances follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
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considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the toxic effects caused by
pyraclostrobin as well as the noobserved-adverse-effect-levels
(NOAELs) and the lowest-observedadverse-effect-levels (LOAELs) from the
toxicity studies can be found in the
October 29, 2004 final rule.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the dose at which no adverse
effects are observed (the NOAEL) from
the toxicology study identified as
appropriate for use in risk assessment is
used to estimate the toxicological level
of concern (LOC). However, the lowest
dose at which adverse effects of concern
are identified (the LOAEL) is sometimes
used for risk assessment if no NOAEL
was achieved in the toxicology study
selected. An uncertainty factor (UF) is
applied to reflect uncertainties inherent
in the extrapolation from laboratory
animal data to humans and in the
variations in sensitivity among members
of the human population as well as
other unknowns.
The linear default risk methodology
(Q*) is the primary method currently
used by the Agency to quantify nonthreshold hazards such as cancer. The
Q* approach assumes that any amount
of exposure will lead to some degree of
cancer risk, estimates risk in terms of
the probability of occurrence of
additional cancer cases.
A summary of the toxicological
endpoints for pyraclostrobin used for
human risk assessment is discussed in
Unit III.B. of the October 29, 2004 final
rule.
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have previously
been established (40 CFR 180.582) for
the combined residues of pyraclostrobin
and its desmethoxy metabolite,
expressed as parent compound, in or on
a variety of raw agricultural
commodities. Risk assessments were
conducted by EPA to assess dietary
exposures from pyraclostrobin in food
as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1-day or single
exposure.
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The Dietary Exposure Evaluation
Model (DEEMTM) analysis evaluated the
individual food consumption as
reported by respondents in the U.S.
Department of Agriculture (USDA)
1994–1996 and 1998 Nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII) and accumulated
exposure to the chemical for each
commodity. The following assumptions
were made for the acute exposure
assessments:
Values corresponding to the HAFT
(highest average field trial), instead of
the tolerance level, were used for crops
in the leafy vegetables crop group and
for the dry shelled peas and beans
subgroup. For all other crops, residue
values corresponding to tolerance levels
were used. A 100% percent crop treated
(PCT) estimate was used for all crops.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the DEEMTM software with
the Food Commodity Intake Database
(DEEM-FCIDTM), which incorporates
food consumption data as reported by
respondents in the USDA 1994–1996
and 1998 Nationwide CSFII, and
accumulated exposure to the chemical
for each commodity. The following
assumptions were made for the chronic
exposure assessments:
Residues corresponding to tolerance
level for all crops other than apple and
pear (average values from field trials),
and PCT were used in this assessment.
iii. Cancer. The assessment assumed
residues corresponding to tolerance
level, or average residue from field trials
(apple and pear), and PCT.
iv. Anticipated residue and PCT
information. Section 408(b)(2)(E) of
FFDCA authorizes EPA to use available
data and information on the anticipated
residue levels of pesticide residues in
food and the actual levels of pesticide
chemicals that have been measured in
food. If EPA relies on such information,
EPA must pursuant to FFDCA section
408(f)(1) require that data be provided 5
years after the tolerance is established,
modified, or left in effect, demonstrating
that the levels in food are not above the
levels anticipated. Following the initial
data submission, EPA is authorized to
require similar data on a time frame it
deems appropriate. For the present
action, EPA will issue such data call-ins
for information relating to anticipated
residues as are required by FFDCA
section 408(b)(2)(E) and authorized
under FFDCA section 408(f)(1). Such
data call-ins will be required to be
submitted no later than 5 years from the
date of issuance of this tolerance.
Section 408(b)(2)(F) of FFDCA states
that the Agency may use data on the
actual percent of food treated for
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assessing chronic dietary risk only if the
Agency can make the following
findings: Condition 1, that the data used
are reliable and provide a valid basis to
show what percentage of the food
derived from such crop is likely to
contain such pesticide residue;
Condition 2, that the exposure estimate
does not underestimate exposure for any
significant subpopulation group; and
Condition 3, if data are available on
pesticide use and food consumption in
a particular area, the exposure estimate
does not understate exposure for the
population in such area. In addition, the
Agency must provide for periodic
evaluation of any estimates used. To
provide for the periodic evaluation of
the estimate of PCT as required by
FFDCA section 408(b)(2)(F), EPA may
require registrants to submit data on
PCT.
The Agency used PCT information in
Table 1 of this unit.
TABLE 1.—VALUES FOR PERCENT
CROP TREATED
Commodity
PCT
Root and Tuber Vegetables
Beet, garden
41*
Beet, sugar
55*
Carrot
31*
Potato
66*
Radish
8*
Sweet potato
2*
Yam
1*
Other root and tuber
6
Bulb Vegetables
Onion
17
Other bulbs
17
Leafy Vegetables
Celery
44*
Lettuce (leaf)
58*
Lettuce (head)
58*
Spinach
40*
Swiss chard
9*
Other leafy
5
Brassica Vegetables
Broccoli
7*
Brussels sprouts
43*
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TABLE 1.—VALUES FOR PERCENT
CROP TREATED—Continued
Commodity
TABLE 1.—VALUES FOR PERCENT
CROP TREATED—Continued
Commodity
PCT
PCT
Other stone
28
Cabbage
40*
Cauliflower
31*
Other head and stem
2
Collards
41
Kale
20*
All nuts
1
Mustard green
15*
Pistachio
6
Turnip green
15*
Other leafy
2
Berries
All berries
2
Tree Nuts
Grains
2
Corn, field
Legume Vegetables
Barley
1*
Beans, lima
24*
Corn, pop
2
Beans, snap
36*
Corn, sweet
16*
Other beans, succulent
1
Rye
2
Beans, dry
1
Wheat (triticale)
2
Peas, green or succulent
1*
Peas, dry
2*
Banana/plantain
100
Soybean (dry)
1*
Grape
16
Grape, raisin
16
Fruiting Vegetables
Miscellaneous Commodities
Pepper
18
Hop
48*
Tomato
18
Mango
100
Other fruiting
18
Papaya
100
Peanut
19
Mint
6*
Strawberry
80
Sunflower
3*
Cucurbit Vegetables
Cantaloupe
37
Cucumber
37
Other cucurbit vegetables
37
Edible Animal Tissue (Cattle, Goat, Hog,
Horse and Sheep)
Citrus Fruits
Grapefruit
6
Meat
100
Oranges
6
Meat byproduct/kidney
100
Other citrus
6
Liver
100
Fat
100
Milk
100
Pome Fruits
Apple
41*
Pears
49*
Other pome
7
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53
Peach
28
Plum
28
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Water, direct
100
Water, indirect
Stone Fruits
Cherry
Drinking Water
100
* Projected
figures.
The Agency believes that the three
conditions listed in Unit III.C.1.iv have
been met. With respect to Condition 1,
PCT estimates for existing uses are
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derived from Federal and private market
survey data, which are reliable and have
a valid basis. The Agency is reasonably
certain that the percentage of the food
treated is not likely to be an
underestimation. As to Conditions 2 and
3, regional consumption information
and consumption information for
significant subpopulations is taken into
account through EPA’s computer-based
model for evaluating the exposure of
significant subpopulations including
several regional groups. Use of this
consumption information in EPA’s risk
assessment process ensures that EPA’s
exposure estimate does not understate
exposure for any significant
subpopulation group and allows the
Agency to be reasonably certain that no
regional population is exposed to
residue levels higher than those
estimated by the Agency. Other than the
data available through national food
consumption surveys, EPA does not
have available information on the
regional consumption of food to which
pyraclostrobin may be applied in a
particular area.
EPA estimates projected percent crop
treated (PPCT) for a new pesticide use
by assuming that the PCT during the
pesticide’s initial 5 years of use on a
specific use site will not exceed the
average PCT of the dominant pesticide
(i.e., the one with the greatest PCT) on
that site over the three most recent
surveys. Comparisons are only made
among pesticides of the same pesticide
types (i.e., the dominant fungicide on
the use site is selected for comparison
with a new fungicide). The PCTs
included in the average may be each for
the same pesticide or for different
pesticides since the same or different
pesticides may dominate for each year
selected. Typically, EPA uses USDA/
National Agricultural Statistics Service
(NASS) as the source for raw PCT data
because it is publicly available and does
not have to be calculated from available
data sources. When a specific use site is
not surveyed by USDA/NASS, EPA uses
proprietary data and calculates the
estimated PCT.
This estimated PPCT, based on the
average PCT of the market leader is
appropriate for use in the chronic
dietary risk assessment. This method of
estimating a PPCT for a new use of a
registered pesticide or a new pesticide,
produces a high-end estimate that is
unlikely, in most cases, to be exceeded
during the initial 5 years of actual use.
The predominant factor that bears on
whether the estimated PPCT could be
exceeded is whether the new pesticide
use is more efficacious or controls a
broader spectrum of pests than the
dominant pesticide(s). All information
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currently available has been considered
for pyraclostrobin, and based on that
information EPA concludes that it is
unlikely that actual PCT for
pyraclostrobin will exceed the estimated
PPCT during the next 5 years.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for
pyraclostrobin 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
pyraclostrobin. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found in the October 29, 2004
final rule.
Based on the Tier II Pesticide Root
Zone Mode/Exposure Analysis
Modeling System (PRZM/EXAMS) and
Screening Concentration in
Groundwater (SCI-GROW) models, the
estimated drinking water concentrations
(EDWCs) of pyraclostrobin for acute
exposures are estimated to be 10.2 parts
per billion (ppb) for surface water and
0.02 ppb for ground water. The EDWCs
for chronic exposures are estimated to
be 0.8 ppb for surface water and 0.02
ppb for ground water.
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).
Pyraclostrobin is currently registered
for use on the following residential nondietary sites: Residential and
recreational turfgrass sites and golf
course turf. The risk assessment was
conducted using the following
residential exposure assumptions:
Residential and recreational turf
applications are applied by professional
pest control operators (PCOs) only, and
therefore, residential handler exposure
is not expected, and was not evaluated.
There is, however, a potential for
exposure to homeowners in residential
settings from entering previously treated
lawns where children might play and
adults might work or play. As a result,
risk assessments have been completed
for postapplication scenarios.
Recreational nonresidential exposures
are expected to be similar to, or in many
cases less than, those evaluated for
residential postapplication exposure
and risk; and therefore, a separate
recreational nonresidential exposure
assessment was not conducted. Refer to
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the October 29, 2004 final rule, for a
detailed discussion of residential/
recreational exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of 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
pyraclostrobin and any other substances
and pyraclostrobin 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 pyraclostrobin 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.
D. Safety Factor for Infants and
Children
1.In general. Section 408 of 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
based on reliable data that a different
margin of safety will be safe for infants
and children. Margins of safety are
incorporated into EPA risk assessments
either directly through use of a margin
of exposure (MOE) analysis or through
using uncertainty (safety) factors in
calculating a dose level that poses no
appreciable risk to humans. In applying
this provision, EPA either retains the
default value of 10X when reliable data
do not support the choice of a different
factor, or, if reliable data are available,
EPA uses a different additional safety
factor value based on the use of
traditional UFs and/or special FQPA SF,
as appropriate.
2. Prenatal and postnatal sensitivity.
There was no substantial evidence of
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increased prenatal or postnatal
susceptibility following in utero
exposure to rats. A complete discussion
can be found in the October 29, 2004
final rule.
3. Conclusion. There is an adequate
toxicity database for the selection of
doses and endpoints for use in risk
assessment for pyraclostrobin. Exposure
data are complete or are estimated based
on data that reasonably accounts for
potential exposures. EPA previously
evaluated the available studies and
established acute and chronic reference
doses (RfDs), as well as doses and
endpoints for the cancer and
occupational and residential risk
assessments. EPA has evaluated and
reevaluated the potential for increased
susceptibility of infants and children to
pyraclostrobin and has concluded that
there are reliable data to support
reducing the FQPA SF to 1X for all
potential pyraclostrobin exposure
scenarios because the toxicity and
exposure databases are adequate, there
are no residual uncertainties for pre- or
postnatal toxicity, and there is no
substantial evidence of increased
sensitivity of infants and children to
pyraclostrobin. For a detailed
discussion, refer to the October 29, 2004
final rule.
E. Aggregate Risks and Determination of
Safety
1. Acute risk. The total combined
MOEs from dietary (food + water) and
non-occupational/residential exposures,
are 100 and 160 for children 1–2 yrs,
and the general U.S. population,
respectively, and therefore are not of
concern. This aggregate exposure risk
assessment is considered a very
conservative estimate, that should not
underestimate risks, because of the
following inputs:
i. Dietary inputs primarily used
tolerance level residues.
ii. Crop specific (turf) screening level
drinking water modeling data were used
(i.e., Tier II surface water model).
iii. Maximum application rates and
minimum application intervals were
used
iv. Conservative standard operating
procedures (SOPs) and upper level
estimates of exposure were employed.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to pyraclostrobin from
food and drinking water will utilize
21% of the chronic population adjusted
dose (cPAD) for the U.S. population,
and 33% of the cPAD for children 1–2
years of age, the most highly exposed
population subgroup. Based on the use
pattern, chronic residential exposure to
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residues of pyraclostrobin is not
expected. Drinking water was
incorporated directly into the dietary
assessment using the 1 in 10 year
annual mean concentration for surface
water generated by the PRZM-EXAMS
model. EPA does not expect the
aggregate exposure to exceed 100% of
the cPAD for any population subgroup.
3. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level).
Pyraclostrobin is currently registered
for use(s) that could result in
intermediate-term residential exposure
and the Agency has determined that it
is appropriate to aggregate chronic food
and water and intermediate-term
exposures for pyraclostrobin.
Using the exposure assumptions for
intermediate-term exposures, EPA has
concluded that food and residential
exposures aggregated result in aggregate
MOEs of 100 or above for all population
subgroups. These aggregate MOEs do
not exceed the Agency’s level of
concern for aggregate exposure to food
and residential uses.
4. Aggregate cancer risk for U.S.
population. The Agency has calculated
aggregate MOEs (food and drinking
water exposure) for pyraclostrobin. In
general, acceptable study results
indicate that pyraclostrobin is unlikely
to be a carcinogen. However, the Agency
has also concluded that the
carcinogenicity data available for
pyraclostrobin are inadequate to allow
full assessment of the human
carcinogenic potential of this pesticide
because the highest dosing levels for
females in the mouse carcinogenicity
study were not great enough to produce
significant toxicological effects (that is,
the highest dose tested (HDT), is the
NOAEL for female mice in this study).
The company is performing an
additional carcinogenicity study in
female mice to remedy this deficiency.
Because neither of the rat nor mouse
cancer studies show any evidence of
carcinogenicity, a non-threshold (Q-star)
approach cannot be used to estimate
cancer risk. Instead, a regulatory MOE
has been chosen as a tool for bounding
any potential chronic dietary cancer risk
from pyraclostrobin that may exist. The
regulatory MOE is derived from the
HDT in female mice (a NOAEL of 32.8
milligram/kilogram/day (mg/kg/day)
and is 10 times higher than the NOAEL
used for chronic non-cancer risk. The
MOE for cancer is estimated to be 4,500.
It is derived from the highest dose tested
in female mice (32.8 mg/kg/day) in the
inadequate mouse oncogenicity study,
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divided by the chronic dietary exposure
(food + water) for the U.S. general
population (0.00727 mg/kg/day).
Drinking water was incorporated
directly into the dietary assessment
using the 1 in 30 annual mean
concentration for surface water
generated by the PRZM-EXAMS model.
5. 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
pyraclostrobin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(gas chromatography/mass
spectrometry) 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
The Codex Alimentarius Commission
has established maximum residue limits
(MRLS) for pyraclostrobin in or on
almond, hulls at 2.0 ppm; strawberry at
0.5 ppm; beans (dry) at 0.2 ppm; lentil
(dry) at 0.5 ppm; and peas (dry) at 0.3
ppm. The U.S. tolerances differ from the
Codex MRLS because the U.S. residue
definitions include both the parent
compound (pyraclostrobin), and its
desmethoxy metabolite, whereas the
Codex MRLS only include the parent
compound.
C. Response to Comments
Comments were received from B.
Sachau on petition 5F6906 for almond,
hulls. The comments stated general
opposition to Agency approval of
tolerances and exemptions other than
zero, for pesticides. The commenter
opposes any residue left on a treated
crop. The comments contained no
scientific data or evidence to rebut the
Agency’s conclusion that there is a
reasonable certainty that no harm will
result from aggregate exposure to
pyraclostrobin, including all anticipated
dietary exposures and other exposures
for which there is reliable information.
These same or similar comments from
this responder have been addressed by
the Agency on several prior occasions.
See the October 29, 2004 and January 7,
2005 (70 FR 1349) (FRL-7691-4) final
rules.
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17019
V. Conclusion
Therefore, the tolerances are
established for combined residues of
pyraclostrobin and its desmethoxy
metabolite, expressed as parent
compound, in or on bean, succulent,
shelled at 0.5 ppm; legume vegetables
group, foliage, in crop group 7 at 25
ppm; mango (import) at 0.1 ppm; and
papaya (import) at 0.1 ppm.
Existing tolerances are being
increased almond, hulls from 1.6 ppm
to 7.0 ppm; pea and bean, dried shelled,
except soybean, subgroup 6C, from 0.3
ppm to 0.5 ppm; strawberry from 0.4
ppm to 1.2 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as
amended by 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 FFDCA
by FQPA, EPA will continue to use
those procedures, with appropriate
adjustments, until the necessary
modifications can be made. The new
section 408(g) of 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 FFDCA, as was
provided in the old sections 408 and
409 of 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
HQ–EPA–OPP–2004–0292 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 June 5, 2006.
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
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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 VI.A., you should also send a copy
of your request to the PIRIB for its
inclusion in the official record that is
described in ADDRESSES. Mail your
copies, identified by docket ID number
HQ–EPA–OPP–2004–0292, 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.
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
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requestor would be adequate to justify
the action requested (40 CFR 178.32).
VII. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this rule has
been exempted from review under
Executive Order 12866 due to its lack of
significance, this rule is not subject to
Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any
enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104–4). Nor does it require any
special considerations under Executive
Order 12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994); or OMB review or any Agency
action under Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are
established on the basis of a petition
under section 408(d) of 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
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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
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
VIII. 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
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rule is not a ‘‘major rule’’ as defined by
5 U.S.C. 804(2).
17021
I. Background
Section 902 of the Medicare
*
*
*
*
*
Prescription Drug, Improvement, and
List of Subjects in 40 CFR Part 180
Vegetables, foliage
Modernization Act of 2003 (MMA) (Pub.
of legume, group
Environmental protection,
7 ........................
25 L. 108–173) amended section 1871(a) of
Administrative practice and procedure,
the Act and requires the Secretary, in
*
*
*
*
*
Agricultural commodities, Pesticides
consultation with the Director of the
1 There are no U.S. registrations on mango
and pests, Reporting and recordkeeping
Office of Management and Budget, to
or papaya as of April 5, 2006.
requirements.
establish and publish timelines for the
*
*
*
*
*
Dated: March 29, 2006.
publication of Medicare final
Lois Rossi,
regulations based on the previous
[FR Doc. 06–3262 Filed 4–4–06; 8:45 am]
Director, Registration Division, Office of
publication of a Medicare proposed or
BILLING CODE 6560–50–S
Pesticide Programs.
interim final regulation. Section 902 of
the MMA also states that the timelines
I Therefore, 40 CFR chapter I is
for these regulations may vary but shall
amended as follows:
DEPARTMENT OF HEALTH AND
not exceed 3 years after publication of
HUMAN SERVICES
PART 180—[AMENDED]
the preceding proposed or interim final
regulation except under exceptional
Centers for Medicare & Medicaid
I 1. The authority citation for part 180
circumstances.
Services
continues to read as follows:
This final rule finalizes provisions set
Authority: 21 U.S.C. 321(q), 346a and 371.
forth in August 26, 2005 (70 FR 50940)
42 CFR Part 410
interim final regulation.
I 2. Section 180.582 is amended by:
[CMS–3017–F]
In addition, this final rule has been
I a. Removing in the introductory text
published within the 3-year time limit
of paragraph (a)(1) the phrase ‘‘carbamic RIN 0938–AM74
imposed by section 902 of the MMA.
acid, [2-[[[1-(4-chlorophenyl)-1HMedicare Program; Conditions for
Therefore, we believe that the final rule
pyrazol-3Payment of Power Mobility Devices,
is in accordance with Congress’s intent
yl]oxy]methyl]phenyl]methoxy-, methyl
Including Power Wheelchairs and
to ensure timely publication of final
ester and its desmethoxy metabolite
Power-Operated Vehicles
regulations.
methyl 2-[[[1-(4-chlorophenyl)-1HSections 1832(a)(1) and 1861(s)(6) of
pyrazol-3-yl]oxy]methyl]phenyl
AGENCY: Centers for Medicare &
the Social Security Act (the Act)
carbamate’’ and adding in its place
Medicaid Services (CMS), HHS.
established that the provision of durable
‘‘(carbamic acid, [2-[[[1-(4ACTION: Final rule.
medical equipment (DME) is a covered
chlorophenyl)-1H-pyrazol-3benefit under Part B of the Medicare
yl]oxy]methyl]phenyl]methoxy-, methyl SUMMARY: This final rule conforms our
program. Section 1834(a)(1)(A) of the
regulations to section 302(a)(2)(E)(iv) of
ester) and its desmethoxy metabolite
Act provides that Medicare will pay for
the Medicare Prescription Drug,
(methyl-N-[[[1-(4-chlorophenyl)-1HImprovement, and Modernization Act of covered items defined in section
pyrazol-31834(a)(13) which, in turn, defines the
2003. This rule defines the term power
yl]oxy]methyl]phenylcarbamate).’’
term ‘‘covered item’’ to include DME
mobility devices (PMDs) as power
I
defined in section 1861(n). Section
wheelchairs and power operated
I b. Revising the commodities ‘‘almond,
vehicles (POVs or scooters). It sets forth 1861(n) provides that DME includes
hulls; pea and bean, dried shelled,
wheelchairs, including power-operated
revised conditions for Medicare
except soybean, subgroup; and
payment of PMDs and defines who may vehicles that may appropriately be used
strawberry’’ and adding alphabetically
as wheelchairs, that are necessary based
the remaining commodities listed below prescribe PMDs. This rule also requires
on the beneficiary’s medical and
a face-to-face examination of the
to the table in paragraph (a)(1). The
physical condition, meet safety
beneficiary by the physician or treating
amended table reads as set forth below.
I c. Removing paragraph (a)(3).
practitioner, a written prescription, and requirements prescribed by the
receipt of pertinent parts of the medical Secretary, and are used in the
§ 180.582 Pyraclostrobin; tolerances for
beneficiary’s home, including an
record by the supplier within 45 days
residues.
institution used as the beneficiary’s
after the face-to-face examination that
(a) * * *
home other than a hospital described in
the durable medical equipment
(1) * * *
section 1861(e)(1) or a skilled nursing
suppliers maintain in their records and
facility described in section 1819(a)(1)
make available to CMS or its agents
Commodity
Parts per million
of the Act. Section 414.202 of our
upon request. Finally, this rule
regulations further defines DME as
discusses CMS’ policy on
Almond, hulls ........
7.0
documentation that may be requested by equipment that can withstand repeated
*
*
*
*
*
Bean, succulent
CMS or its agents to support a Medicare use, is primarily and customarily used
to serve a medical purpose, generally is
shelled ...............
0.5 claim for payment, as well as the
*
*
*
*
*
elimination of the Certificate of Medical not useful to a person in the absence of
Mango1 .................
0.1 Necessity (CMN) for PMDs.
an illness or injury, and is appropriate
*
*
*
*
*
for use in the home. We have
Papaya1 ................
0.1 DATES: Effective Date: These regulations
interpreted the term wheelchair to
are effective on June 5, 2006.
*
*
*
*
*
include both power wheelchairs and
FOR FURTHER INFORMATION CONTACT:
Pea and bean,
power-operated vehicles (POVs or
dried shelled, exKaren Rinker, (410) 786–0189. Camille
scooters), and we collectively refer to
cept soybean,
Soondar, (410) 786–9370 for CMN
power wheelchairs and power-operated
subgroup 6C .....
0.5 issues.
vehicles as power mobility devices
*
*
*
*
*
Strawberry ............
1.2 SUPPLEMENTARY INFORMATION:
(PMDs).
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]]>Agencies
[Federal Register Volume 71, Number 65 (Wednesday, April 5, 2006)]
[Rules and Regulations]
[Pages 17014-17021]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-3262]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2004-0292; FRL-7772-8]
Pyraclostrobin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for combined residues
of pyraclostrobin (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-
3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy
metabolite (methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenylcarbamate), expressed as parent compound, in or on
bean, succulent, shelled; legume vegetables group, foliage, in crop
group 7; mango (import); and papaya (import). This final rule also
increases the tolerances for almond, hulls; pea and bean, dried
shelled, except soybean, subgroup 6C; and strawberry. BASF Corporation
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA), as amended by the Food Quality Protection Act of 1996
(FQPA).
DATES: This regulation is effective April 5, 2006. Objections and
requests for hearings must be received on or before June 5, 2006.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2004-0292. All documents in the
docket are listed on the regulations.gov website. (EDOCKET, EPA's
electronic public docket and comment system was replaced on November
25, 2005, by an enhanced Federal-wide electronic docket management and
comment system located at https://www.regulations.gov. Follow the on-
line instructions.) Although listed in the index, some information is
not publicly available, e.g., 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 through regulations.gov 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: Tony Kish, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9443; e-mail address: kish.tony@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:
[[Page 17015]]
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
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 regulations.gov, 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
In the Federal Register of August 27, 2004 (69 FR 52670) (FRL-7676-
9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of three pesticide petitions
by BASF Corporation (0F6139, 2F6431, and 3F6581) of Research Triangle
Park, NC 27709 and one petition (3E6774) by the Interregional Research
Project Number 4 (IR-4), 681 US Highway 1 South, North
Brunswick, NJ, 08902-3390. These petitions requested that 40 CFR
180.582 be amended by establishing tolerances for combined residues of
the fungicide pyraclostrobin and its desmethoxy metabolite, expressed
as parent compound, in or on a large number of crops. Most, but not all
of the proposed new tolerances requested in the four petitions
mentioned in this unit were established in a final rule published in
the Federal Register of October 29, 2004 (69 FR 63083) (FRL-7681-9).
The following tolerances were requested, but not included in the
October 29, 2004 final rule, and thus are included herein: Bean,
succulent, shelled; legume vegetables group, foliage, in crop group 7;
mango (import); and papaya (import).
Additionally, in the Federal Register of February 15, 2006 (71 FR
7955) (FRL-7759-4), EPA issued a notice pursuant to section 408(d)(3)
of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a revised
pesticide petition by BASF Corporation (5F6906) of Research Triangle
Park, NC 27709. That notice included a summary of the pesticide
petition prepared by BASF, the registrant. This petition requested that
40 CFR 180.582 be amended by revising established tolerances for
combined residues of the fungicide pyraclostrobin and its desmethoxy
metabolite, expressed as parent compound, in or on pea and bean, dried
shelled, except soybean, subgroup 6C, and strawberry.
The October 29, 2004 final rule previously established tolerances
for pea and bean, dried shelled, except soybean, subgroup 6C, and for
strawberry. However, the existing 0.3 parts per million (ppm) tolerance
in this rule for pea and bean, dried shelled, except soybean, subgroup
6C, was based on submission of confirmatory field trial data. These
confirmatory data were submitted and reviewed, and result in the
tolerance being increased herein from 0.3 ppm to 0.5 ppm. Hence, a
revised notice of filing/petition was submitted.
Furthermore, the existing 1.5 ppm time-limited tolerance
established for strawberry in that final rule expired December 31,
2005. Upon this expiration, the tolerance reverted back to the
permanent 0.4 ppm tolerance. Based on submission of recent field trial
data, the permanent strawberry tolerance is being increased from 0.4
ppm to 1.2 ppm. Hence, a revised notice of filing/petition was
submitted. No comments were received on the notice of filing.
In the Federal Register of January 27, 2006, (71 FR 4579) (FRL-
7758-8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition by
BASF Corporation (5F6906) of Research Triangle Park, NC 27709. That
notice included a summary of the pesticide petition prepared by BASF,
the registrant. This petition requested that 40 CFR 180.582 be amended
by increasing the tolerance for combined residues of the fungicide
pyraclostrobin and its desmethoxy metabolite, expressed as parent
compound, in or on almonds, hulls. Comments were received on the notice
of filing. EPA's response to these comments is discussed in Unit IV.C.
Section 408(b)(2)(A)(i) of 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 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 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....''
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 FFDCA and a complete
description of the risk assessment process, see https://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of 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 and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for tolerances for combined residues of
pyraclostrobin and its desmethoxy metabolite, expressed as parent
compound, on almond, hulls at 7.0 ppm; bean, succulent, shelled at 0.5
ppm; legume vegetables group, foliage, in crop group 7, at 25 ppm;
mango (import) at 0.1 ppm; papaya (import) at 0.1 ppm; pea and bean,
dried shelled, except soybean, subgroup 6C at 0.5 ppm; and strawberry
at 1.2 ppm.
EPA's assessment of exposures and risks associated with
establishing the tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also
[[Page 17016]]
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. Specific information on the studies received and
the nature of the toxic effects caused by pyraclostrobin as well as the
no-observed-adverse-effect-levels (NOAELs) and the lowest-observed-
adverse-effect-levels (LOAELs) from the toxicity studies can be found
in the October 29, 2004 final rule.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases.
A summary of the toxicological endpoints for pyraclostrobin used
for human risk assessment is discussed in Unit III.B. of the October
29, 2004 final rule.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have
previously been established (40 CFR 180.582) for the combined residues
of pyraclostrobin and its desmethoxy metabolite, expressed as parent
compound, in or on a variety of raw agricultural commodities. Risk
assessments were conducted by EPA to assess dietary exposures from
pyraclostrobin in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
The Dietary Exposure Evaluation Model (DEEM\TM\) analysis evaluated
the individual food consumption as reported by respondents in the U.S.
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII) and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the acute exposure assessments:
Values corresponding to the HAFT (highest average field trial),
instead of the tolerance level, were used for crops in the leafy
vegetables crop group and for the dry shelled peas and beans subgroup.
For all other crops, residue values corresponding to tolerance levels
were used. A 100% percent crop treated (PCT) estimate was used for all
crops.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEM\TM\ software with the Food Commodity
Intake Database (DEEM-FCID\TM\), which incorporates food consumption
data as reported by respondents in the USDA 1994-1996 and 1998
Nationwide CSFII, and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments:
Residues corresponding to tolerance level for all crops other than
apple and pear (average values from field trials), and PCT were used in
this assessment.
iii. Cancer. The assessment assumed residues corresponding to
tolerance level, or average residue from field trials (apple and pear),
and PCT.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide chemicals that have been measured in food. If EPA
relies on such information, EPA must pursuant to FFDCA section
408(f)(1) require that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. Following the initial
data submission, EPA is authorized to require similar data on a time
frame it deems appropriate. For the present action, EPA will issue such
data call-ins for information relating to anticipated residues as are
required by FFDCA section 408(b)(2)(E) and authorized under FFDCA
section 408(f)(1). Such data call-ins will be required to be submitted
no later than 5 years from the date of issuance of this tolerance.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if the Agency can make the following findings: Condition 1,
that the data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by FFDCA section 408(b)(2)(F), EPA may require registrants to submit
data on PCT.
The Agency used PCT information in Table 1 of this unit.
Table 1.--Values for Percent Crop Treated
------------------------------------------------------------------------
Commodity PCT
------------------------------------------------------------------------
Root and Tuber Vegetables
------------------------------------------------------------------------
Beet, garden 41\*\
------------------------------------------------------------------------
Beet, sugar 55\*\
------------------------------------------------------------------------
Carrot 31\*\
------------------------------------------------------------------------
Potato 66\*\
------------------------------------------------------------------------
Radish 8\*\
------------------------------------------------------------------------
Sweet potato 2\*\
------------------------------------------------------------------------
Yam 1\*\
------------------------------------------------------------------------
Other root and tuber 6
------------------------------------------------------------------------
Bulb Vegetables
------------------------------------------------------------------------
Onion 17
------------------------------------------------------------------------
Other bulbs 17
------------------------------------------------------------------------
Leafy Vegetables
------------------------------------------------------------------------
Celery 44\*\
------------------------------------------------------------------------
Lettuce (leaf) 58\*\
------------------------------------------------------------------------
Lettuce (head) 58\*\
------------------------------------------------------------------------
Spinach 40\*\
------------------------------------------------------------------------
Swiss chard 9\*\
------------------------------------------------------------------------
Other leafy 5
------------------------------------------------------------------------
Brassica Vegetables
------------------------------------------------------------------------
Broccoli 7\*\
------------------------------------------------------------------------
Brussels sprouts 43\*\
------------------------------------------------------------------------
[[Page 17017]]
Cabbage 40\*\
------------------------------------------------------------------------
Cauliflower 31\*\
------------------------------------------------------------------------
Other head and stem 2
------------------------------------------------------------------------
Collards 41
------------------------------------------------------------------------
Kale 20\*\
------------------------------------------------------------------------
Mustard green 15\*\
------------------------------------------------------------------------
Turnip green 15\*\
------------------------------------------------------------------------
Other leafy 2
------------------------------------------------------------------------
Legume Vegetables
------------------------------------------------------------------------
Beans, lima 24\*\
------------------------------------------------------------------------
Beans, snap 36\*\
------------------------------------------------------------------------
Other beans, succulent 1
------------------------------------------------------------------------
Beans, dry 1
------------------------------------------------------------------------
Peas, green or succulent 1\*\
------------------------------------------------------------------------
Peas, dry 2\*\
------------------------------------------------------------------------
Soybean (dry) 1\*\
------------------------------------------------------------------------
Fruiting Vegetables
------------------------------------------------------------------------
Pepper 18
------------------------------------------------------------------------
Tomato 18
------------------------------------------------------------------------
Other fruiting 18
------------------------------------------------------------------------
Cucurbit Vegetables
------------------------------------------------------------------------
Cantaloupe 37
------------------------------------------------------------------------
Cucumber 37
------------------------------------------------------------------------
Other cucurbit vegetables 37
------------------------------------------------------------------------
Citrus Fruits
------------------------------------------------------------------------
Grapefruit 6
------------------------------------------------------------------------
Oranges 6
------------------------------------------------------------------------
Other citrus 6
------------------------------------------------------------------------
Pome Fruits
------------------------------------------------------------------------
Apple 41\*\
------------------------------------------------------------------------
Pears 49\*\
------------------------------------------------------------------------
Other pome 7
------------------------------------------------------------------------
Stone Fruits
------------------------------------------------------------------------
Cherry 53
------------------------------------------------------------------------
Peach 28
------------------------------------------------------------------------
Plum 28
------------------------------------------------------------------------
Other stone 28
------------------------------------------------------------------------
Berries
------------------------------------------------------------------------
All berries 2
------------------------------------------------------------------------
Tree Nuts
------------------------------------------------------------------------
All nuts 1
------------------------------------------------------------------------
Pistachio 6
------------------------------------------------------------------------
Grains
------------------------------------------------------------------------
Barley 2
------------------------------------------------------------------------
Corn, field 1\*\
------------------------------------------------------------------------
Corn, pop 2
------------------------------------------------------------------------
Corn, sweet 16\*\
------------------------------------------------------------------------
Rye 2
------------------------------------------------------------------------
Wheat (triticale) 2
------------------------------------------------------------------------
Miscellaneous Commodities
------------------------------------------------------------------------
Banana/plantain 100
------------------------------------------------------------------------
Grape 16
------------------------------------------------------------------------
Grape, raisin 16
------------------------------------------------------------------------
Hop 48\*\
------------------------------------------------------------------------
Mango 100
------------------------------------------------------------------------
Papaya 100
------------------------------------------------------------------------
Peanut 19
------------------------------------------------------------------------
Mint 6\*\
------------------------------------------------------------------------
Strawberry 80
------------------------------------------------------------------------
Sunflower 3\*\
------------------------------------------------------------------------
Edible Animal Tissue (Cattle, Goat, Hog, Horse and Sheep)
------------------------------------------------------------------------
Meat 100
------------------------------------------------------------------------
Meat byproduct/kidney 100
------------------------------------------------------------------------
Liver 100
------------------------------------------------------------------------
Fat 100
------------------------------------------------------------------------
Milk 100
------------------------------------------------------------------------
Drinking Water
------------------------------------------------------------------------
Water, direct 100
------------------------------------------------------------------------
Water, indirect 100
------------------------------------------------------------------------
\*\ Projected figures.
The Agency believes that the three conditions listed in Unit
III.C.1.iv have been met. With respect to Condition 1, PCT estimates
for existing uses are derived from Federal and private market survey
data, which are reliable and have a valid basis. The Agency is
reasonably certain that the percentage of the food treated is not
likely to be an underestimation. As to Conditions 2 and 3, regional
consumption information and consumption information for significant
subpopulations is taken into account through EPA's computer-based model
for evaluating the exposure of significant subpopulations including
several regional groups. Use of this consumption information in EPA's
risk assessment process ensures that EPA's exposure estimate does not
understate exposure for any significant subpopulation group and allows
the Agency to be reasonably certain that no regional population is
exposed to residue levels higher than those estimated by the Agency.
Other than the data available through national food consumption
surveys, EPA does not have available information on the regional
consumption of food to which pyraclostrobin may be applied in a
particular area.
EPA estimates projected percent crop treated (PPCT) for a new
pesticide use by assuming that the PCT during the pesticide's initial 5
years of use on a specific use site will not exceed the average PCT of
the dominant pesticide (i.e., the one with the greatest PCT) on that
site over the three most recent surveys. Comparisons are only made
among pesticides of the same pesticide types (i.e., the dominant
fungicide on the use site is selected for comparison with a new
fungicide). The PCTs included in the average may be each for the same
pesticide or for different pesticides since the same or different
pesticides may dominate for each year selected. Typically, EPA uses
USDA/National Agricultural Statistics Service (NASS) as the source for
raw PCT data because it is publicly available and does not have to be
calculated from available data sources. When a specific use site is not
surveyed by USDA/NASS, EPA uses proprietary data and calculates the
estimated PCT.
This estimated PPCT, based on the average PCT of the market leader
is appropriate for use in the chronic dietary risk assessment. This
method of estimating a PPCT for a new use of a registered pesticide or
a new pesticide, produces a high-end estimate that is unlikely, in most
cases, to be exceeded during the initial 5 years of actual use. The
predominant factor that bears on whether the estimated PPCT could be
exceeded is whether the new pesticide use is more efficacious or
controls a broader spectrum of pests than the dominant pesticide(s).
All information
[[Page 17018]]
currently available has been considered for pyraclostrobin, and based
on that information EPA concludes that it is unlikely that actual PCT
for pyraclostrobin will exceed the estimated PPCT during the next 5
years.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for pyraclostrobin 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 pyraclostrobin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found in the October 29, 2004 final rule.
Based on the Tier II Pesticide Root Zone Mode/Exposure Analysis
Modeling System (PRZM/EXAMS) and Screening Concentration in Groundwater
(SCI-GROW) models, the estimated drinking water concentrations (EDWCs)
of pyraclostrobin for acute exposures are estimated to be 10.2 parts
per billion (ppb) for surface water and 0.02 ppb for ground water. The
EDWCs for chronic exposures are estimated to be 0.8 ppb for surface
water and 0.02 ppb for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Pyraclostrobin is currently registered for use on the following
residential non-dietary sites: Residential and recreational turfgrass
sites and golf course turf. The risk assessment was conducted using the
following residential exposure assumptions: Residential and
recreational turf applications are applied by professional pest control
operators (PCOs) only, and therefore, residential handler exposure is
not expected, and was not evaluated. There is, however, a potential for
exposure to homeowners in residential settings from entering previously
treated lawns where children might play and adults might work or play.
As a result, risk assessments have been completed for postapplication
scenarios. Recreational nonresidential exposures are expected to be
similar to, or in many cases less than, those evaluated for residential
postapplication exposure and risk; and therefore, a separate
recreational nonresidential exposure assessment was not conducted.
Refer to the October 29, 2004 final rule, for a detailed discussion of
residential/recreational exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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 pyraclostrobin and any
other substances and pyraclostrobin 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 pyraclostrobin
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.
D. Safety Factor for Infants and Children
1.In general. Section 408 of 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 based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
margin of exposure (MOE) analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. In applying this provision, EPA either retains the default
value of 10X when reliable data do not support the choice of a
different factor, or, if reliable data are available, EPA uses a
different additional safety factor value based on the use of
traditional UFs and/or special FQPA SF, as appropriate.
2. Prenatal and postnatal sensitivity. There was no substantial
evidence of increased prenatal or postnatal susceptibility following in
utero exposure to rats. A complete discussion can be found in the
October 29, 2004 final rule.
3. Conclusion. There is an adequate toxicity database for the
selection of doses and endpoints for use in risk assessment for
pyraclostrobin. Exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA previously
evaluated the available studies and established acute and chronic
reference doses (RfDs), as well as doses and endpoints for the cancer
and occupational and residential risk assessments. EPA has evaluated
and reevaluated the potential for increased susceptibility of infants
and children to pyraclostrobin and has concluded that there are
reliable data to support reducing the FQPA SF to 1X for all potential
pyraclostrobin exposure scenarios because the toxicity and exposure
databases are adequate, there are no residual uncertainties for pre- or
postnatal toxicity, and there is no substantial evidence of increased
sensitivity of infants and children to pyraclostrobin. For a detailed
discussion, refer to the October 29, 2004 final rule.
E. Aggregate Risks and Determination of Safety
1. Acute risk. The total combined MOEs from dietary (food + water)
and non-occupational/residential exposures, are 100 and 160 for
children 1-2 yrs, and the general U.S. population, respectively, and
therefore are not of concern. This aggregate exposure risk assessment
is considered a very conservative estimate, that should not
underestimate risks, because of the following inputs:
i. Dietary inputs primarily used tolerance level residues.
ii. Crop specific (turf) screening level drinking water modeling
data were used (i.e., Tier II surface water model).
iii. Maximum application rates and minimum application intervals
were used
iv. Conservative standard operating procedures (SOPs) and upper
level estimates of exposure were employed.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
pyraclostrobin from food and drinking water will utilize 21% of the
chronic population adjusted dose (cPAD) for the U.S. population, and
33% of the cPAD for children 1-2 years of age, the most highly exposed
population subgroup. Based on the use pattern, chronic residential
exposure to
[[Page 17019]]
residues of pyraclostrobin is not expected. Drinking water was
incorporated directly into the dietary assessment using the 1 in 10
year annual mean concentration for surface water generated by the PRZM-
EXAMS model. EPA does not expect the aggregate exposure to exceed 100%
of the cPAD for any population subgroup.
3. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Pyraclostrobin is currently registered for use(s) that could result
in intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and
intermediate-term exposures for pyraclostrobin.
Using the exposure assumptions for intermediate-term exposures, EPA
has concluded that food and residential exposures aggregated result in
aggregate MOEs of 100 or above for all population subgroups. These
aggregate MOEs do not exceed the Agency's level of concern for
aggregate exposure to food and residential uses.
4. Aggregate cancer risk for U.S. population. The Agency has
calculated aggregate MOEs (food and drinking water exposure) for
pyraclostrobin. In general, acceptable study results indicate that
pyraclostrobin is unlikely to be a carcinogen. However, the Agency has
also concluded that the carcinogenicity data available for
pyraclostrobin are inadequate to allow full assessment of the human
carcinogenic potential of this pesticide because the highest dosing
levels for females in the mouse carcinogenicity study were not great
enough to produce significant toxicological effects (that is, the
highest dose tested (HDT), is the NOAEL for female mice in this study).
The company is performing an additional carcinogenicity study in female
mice to remedy this deficiency. Because neither of the rat nor mouse
cancer studies show any evidence of carcinogenicity, a non-threshold
(Q-star) approach cannot be used to estimate cancer risk. Instead, a
regulatory MOE has been chosen as a tool for bounding any potential
chronic dietary cancer risk from pyraclostrobin that may exist. The
regulatory MOE is derived from the HDT in female mice (a NOAEL of 32.8
milligram/kilogram/day (mg/kg/day) and is 10 times higher than the
NOAEL used for chronic non-cancer risk. The MOE for cancer is estimated
to be 4,500. It is derived from the highest dose tested in female mice
(32.8 mg/kg/day) in the inadequate mouse oncogenicity study, divided by
the chronic dietary exposure (food + water) for the U.S. general
population (0.00727 mg/kg/day). Drinking water was incorporated
directly into the dietary assessment using the 1 in 30 annual mean
concentration for surface water generated by the PRZM-EXAMS model.
5. 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 pyraclostrobin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography/mass
spectrometry) 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
The Codex Alimentarius Commission has established maximum residue
limits (MRLS) for pyraclostrobin in or on almond, hulls at 2.0 ppm;
strawberry at 0.5 ppm; beans (dry) at 0.2 ppm; lentil (dry) at 0.5 ppm;
and peas (dry) at 0.3 ppm. The U.S. tolerances differ from the Codex
MRLS because the U.S. residue definitions include both the parent
compound (pyraclostrobin), and its desmethoxy metabolite, whereas the
Codex MRLS only include the parent compound.
C. Response to Comments
Comments were received from B. Sachau on petition 5F6906 for
almond, hulls. The comments stated general opposition to Agency
approval of tolerances and exemptions other than zero, for pesticides.
The commenter opposes any residue left on a treated crop. The comments
contained no scientific data or evidence to rebut the Agency's
conclusion that there is a reasonable certainty that no harm will
result from aggregate exposure to pyraclostrobin, including all
anticipated dietary exposures and other exposures for which there is
reliable information. These same or similar comments from this
responder have been addressed by the Agency on several prior occasions.
See the October 29, 2004 and January 7, 2005 (70 FR 1349) (FRL-7691-4)
final rules.
V. Conclusion
Therefore, the tolerances are established for combined residues of
pyraclostrobin and its desmethoxy metabolite, expressed as parent
compound, in or on bean, succulent, shelled at 0.5 ppm; legume
vegetables group, foliage, in crop group 7 at 25 ppm; mango (import) at
0.1 ppm; and papaya (import) at 0.1 ppm.
Existing tolerances are being increased almond, hulls from 1.6 ppm
to 7.0 ppm; pea and bean, dried shelled, except soybean, subgroup 6C,
from 0.3 ppm to 0.5 ppm; strawberry from 0.4 ppm to 1.2 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of 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 FFDCA, as was
provided in the old sections 408 and 409 of 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 HQ-EPA-OPP-2004-0292 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 June 5,
2006.
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
[[Page 17020]]
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 14\th\ 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 VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number HQ-EPA-OPP-2004-0292, 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. 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).
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of 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 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 that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VIII. 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
[[Page 17021]]
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: March 29, 2006.
Lois Rossi,
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 180.582 is amended by:
0
a. Removing in the introductory text of paragraph (a)(1) the phrase
``carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl ester and its desmethoxy
metabolite methyl 2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl carbamate'' and adding in its place ``(carbamic
acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy
metabolite (methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenylcarbamate).''
0
b. Revising the commodities ``almond, hulls; pea and bean, dried
shelled, except soybean, subgroup; and strawberry'' and adding
alphabetically the remaining commodities listed below to the table in
paragraph (a)(1). The amended table reads as set forth below.
0
c. Removing paragraph (a)(3).
Sec. 180.582 Pyraclostrobin; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Almond, hulls................................. 7.0
* * * * *
Bean, succulent shelled....................... 0.5
* * * * *
Mango\1\....................................... 0.1
* * * * *
Papaya\1\...................................... 0.1
* * * * *
Pea and bean, dried shelled, except soybean, 0.5
subgroup 6C...................................
* * * * *
Strawberry.................................... 1.2
* * * * *
Vegetables, foliage of legume, group 7......... 25
* * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations on mango or papaya as of April 5,
2006.
* * * * *
[FR Doc. 06-3262 Filed 4-4-06; 8:45 am]
BILLING CODE 6560-50-S
