[Federal Register: March 18, 2009 (Volume 74, Number 51)]
[Rules and Regulations]
[Page 11494-11499]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18mr09-14]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0936; FRL-8402-8]
Pyraclostrobin; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
combined residues of pyraclostrobin and its desmethoxy metabolite in or
on sugarcane, cane and sugarcane, molasses. This action is in response
to EPA's granting of an emergency exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing
use of the pesticide on sugarcane. This regulation establishes a
maximum permissible level for residues of pyraclostrobin and its
desmethoxy metabolite in these food. The time-limited tolerances expire
and are revoked on December 31, 2011.
DATES: This regulation is effective March 18, 2009. Objections and
requests for hearings must be received on or before May 18, 2009, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0936. All documents in the
docket are listed in the docket index available in http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (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 in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Libby Pemberton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9364; e-mail address: pemberton.libby@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA),
[[Page 11495]]
21 U.S.C. 346a, 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. You must file your
objection or request a hearing on this regulation in accordance with
the instructions provided in 40 CFR part 178. To ensure proper receipt
by EPA, you must identify docket ID number EPA-HQ-OPP-2008-0936 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 May 18, 2009.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2008-0936, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing
time-limited tolerances for combined residues of the fungicide,
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
sugarcane, cane at 0.02 parts per million (ppm) and sugarcane, molasses
at 0.4 ppm. These time-limited tolerances expire and are revoked on
December 31, 2011. EPA will publish a document in the Federal Register
to remove the revoked tolerances from the CFR.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related time-limited tolerances to set binding precedents
for the application of section 408 of FFDCA and the new safety standard
to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of 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. . .
.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Pyraclostrobin on Sugarcane, cane and
Sugarcane, molasses and FFDCA Tolerances
Florida and Louisiana declared a crisis exemption under FIFRA
section 18 for the use of pyraclostrobin on sugarcane for control of
Orange Rust (Puccinia Keuhnii) and/or Brown Rust (Puccinia
melanocephala). EPA concurs that emergency conditions exist for these
States, and that the criteria for an emergency exemption are met.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of
pyraclostrobin in or on sugarcane, cane and sugarcane, molasses. In
doing so, EPA considered the safety standard in section 408(b)(2) of
FFDCA, and EPA decided that the necessary tolerance under section
408(l)(6) of FFDCA would be consistent with the safety standard and
with FIFRA section 18. Consistent with the need to move quickly on the
emergency exemption in order to address an urgent non-routine situation
and to ensure that the resulting food is safe and lawful, EPA is
issuing this tolerance without notice and opportunity for public
comment as provided in section 408(l)(6) of FFDCA. Although these time-
limited tolerances expire and are revoked on December 31, 2011, under
section 408(l)(5) of FFDCA, residues of the pesticide not in excess of
the amounts specified in the tolerance remaining in or on sugarcane,
cane and sugarcane, molasses. after that date will not be unlawful,
provided the pesticide was applied in a manner that was lawful under
FIFRA, and the residues do not exceed a level that was authorized by
these time-limited tolerances at the time of that application. EPA will
take action to revoke these time-limited tolerances earlier if any
experience with, scientific data on, or other relevant information on
this pesticide indicate that the residues are not safe.
Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
pyraclostrobin meets FIFRA's registration requirements for use on
sugarcane, cane and sugarcane, molasses or whether permanent tolerances
for this use would be appropriate. Under these circumstances, EPA does
not believe that this time-limited tolerance decision serves as a basis
for registration of pyraclostrobin by a State for special local needs
under FIFRA section 24(c). Nor does this tolerance serve as the basis
for persons in any State other than Florida and Louisiana to use this
pesticide on these crops under FIFRA section 18 absent the issuance of
an emergency exemption applicable within that State. For additional
information regarding the emergency exemption for pyraclostrobin,
contact the Agency's Registration Division at the address
[[Page 11496]]
provided under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
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. . .
.''
Consistent with the factors specified in FFDCA section
408(b)(2)(D), EPA has reviewed the available scientific data and other
relevant information in support of this action. EPA has sufficient data
to assess the hazards of and to make a determination on aggregate
exposure expected as a result of this emergency exemption request and
the time-limited tolerances for combined residues of the fungicide,
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
sugarcane, cane at 0.02 ppm and sugarcane, molasses at 0.4 ppm. EPA's
assessment of exposures and risks associated with establishing time-
limited tolerances follows.
A. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account 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. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-term,
intermediate-term, and chronic-term risks are evaluated by comparing
food, water, and residential exposure to the POD to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded. This latter value is referred to as the Level of
Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for pyraclostrobin used
for human risk assessment can be found at http://www.regulations.gov in
document Pyraclostrobin: Human Health Risk Assessment for Proposed Uses
on Oats, Oilseed Group (Canola and Flax), Plus Seed Treatment on Oats,
Canola, and Flax; Tropical Fruits (Avocado, Black Sapote, Canistel,
Mamey Sapote, Mango; Papaya, Sapodilla, and Star Apple);Increased
Tolerance on Barley; Adding Aerial Application to Turf and Ornamentals;
and Adding In-Furrow Applications to Corn, Soybean, and Sugar Beets
pages 21 to 23 in docket ID number EPA-HQ-OPP-2007-0906-0004.
B. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pyraclostrobin, EPA considered exposure under the time-
limited tolerances established by this action as well as all existing
pyraclostrobin tolerances in (40 CFR 180.582). EPA assessed 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. EPA identified such an
effect for the general population (decreased body weight gain seen
after a single oral dose in the rat acute neurotoxicity study) and for
females 13 to 49 years old (increased resorptions/litter and increased
total resorptions seen in the rabbit developmental toxicity study that
are presumed to occur after a single exposure). The aPAD for the
general population has been established at 3.0 milligrams/kilogram/day
(mg/kg/day); whereas, the aPAD for females 13 to 49 years old is
significantly lower (0.05 mg/kg/day), due to the more sensitive
endpoint on which it is based. In estimating acute dietary exposure,
EPA used food consumption information from the U.S. Department of
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII). As to residue levels in food, EPA
assumed that residues are present at tolerance levels or for some
commodities (amaranth, leafy; arugula; chrysanthemum; cress, garden;
cress, upland; dandelion, leaves; fennel; parsley, leaves; radicchio;
rhubarb; spinach; swiss chard; beans, dry; celery; lettuce, head;
lettuce, leaf; and pea, dry) at the highest residue level found in
residue field trials. One hundred percent crop treated (PCT) was
assumed for all commodities in the assessment. Default processing
factors were applied to all commodities except those for which
experimentally-derived processing factors were available: Apple juice,
grape juice, citrus juices, cottonseed oil, tomato paste, tomato puree,
wheat flour, and wheat germ.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed that residues
are present at tolerance levels in all crops except apple, broccoli,
celery, collard, grape, lettuce, citrus, pepper, mustard green and
tomato. EPA relied on anticipated residues (average residues from field
trials) for these crops. One hundred PCT was assumed for all
commodities in the assessment. Default processing factors were applied
to all commodities except those for which experimentally-derived
processing factors were available: Apple juice, grape juice, citrus
juices, tomato paste, tomato puree, wheat flour, and wheat germ.
[[Page 11497]]
iii. Cancer. Based on the results of carcinogenicity studies in
rats and mice, EPA has concluded that pyraclostrobin is ``not likely to
be carcinogenic to humans.'' Consequently, a quantitative cancer
exposure and risk assessment is not appropriate for pyraclostrobin.
iv. Anticipated residue 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 residues that have been measured in food. If EPA relies on
such information, EPA must require pursuant to FFDCA section 408(f)(1)
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. For the present action, EPA will
issue such Data Call-Ins as are required by FFDCA section 408(b)(2)(E)
and authorized under FFDCA section 408(f)(1). Data will be required to
be submitted no later than 5 years from the date of issuance of these
tolerances.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring 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 environmental
fate characteristics of pyraclostrobin. Further information regarding
EPA drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm. Based on
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS) and Screening Concentration in Ground Water (SCI/GROW) models,
the estimated environmental concentrations (EECs) of pyraclostrobin for
acute exposures are estimated to be 35.6 parts per billion (ppb) for
surface water and 0.02 ppb for ground water. The EECs for chronic
exposures are estimated to be 2.3 ppb for surface water and 0.02 ppb
for ground water. Modeled estimates of drinking water concentrations
were directly entered into the dietary exposure model. For acute
dietary risk assessment, the water concentration value of 35.6 ppb was
used to assess the contribution to drinking water. For chronic dietary
riskassessment, the water concentration value of 2.3 ppb was used to
assess the contribution to drinking 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 the following
residential non-dietary sites: Residential and recreational turf grass.
EPA assessed residential exposure using the following assumptions:
Residential and recreational turf applications are applied by
professional pest control operators (PCOs) only, and, therefore,
residential handler exposures do not occur. There is, however, a
potential for short-term and intermediate-term postapplication exposure
of adults and children entering lawn and recreation areas previously
treated with pyraclostrobin. Exposures from treated recreational sites
are expected to be similar to, or in many cases lower than, those from
treated residential turf sites; therefore, a separate exposure
assessment for recreational turf sites was not conducted. EPA assessed
exposures from the following residential turf post application
scenarios:
i. Adult and toddler post application dermal exposure from contact
with treated lawns
ii. Toddlers' incidental ingestion of pesticide residues on lawns
from hand-to-mouth transfer
iii. Toddlers' object-to-mouth transfer from mouthing of pesticide-
treated turf grass, and:
iv. Toddlers' incidental ingestion of soil from pesticide-treated
residential areas. The post application risk assessment was conducted
in accordance with the Residential Standard Operating Procedures (SOPs)
and recommended approaches of the Health Effects Division's (HED's)
Science Advisory Council for Exposure (Expo SAC).
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.''
EPA has not found pyraclostrobin to share a common mechanism of
toxicity with 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 assumed that
pyraclostrobin does not have 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 http://
www.epa.gov/pesticides/cumulative.
C. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional SF when reliable data
available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicology database for pyraclostrobin includes the rat and rabbit
developmental toxicity studies and the 2-generation reproduction
toxicity study in rats. There was no evidence of increased quantitative
or qualitative susceptibility of in utero rats or offspring following
exposure to pyraclostrobin in the rat developmental and reproduction
studies. In the rabbit developmental study, there was evidence of
increased qualitative susceptibility of in utero rabbits following
exposure to pyraclostrobin (increases in resorptions/litter and post-
implantation losses). However, this qualitative susceptibility seen in
the rabbit developmental study does not indicate a heightened risk for
infants or children because: The developmental effects were seen in the
presence of maternal toxicity; there are clear NOAELs for maternal and
developmental toxicities; and this endpoint is used in the acute
dietary reference dose (RfD) exposure assessment for females, 13 years
and older, as well as for short-term and intermediate-term dermal risk
assessments.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. This
[[Page 11498]]
determination was exhaustively discussed in a prior order concerning
pyraclostrobin, September 12, 2007 (72 FR 52108) (FRL-8144-4). In
summary, the safety factor decision is based on the following findings:
i. The toxicity database for pyraclostrobin is complete.
ii. There is no indication that pyraclostrobin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that pyraclostrobin results in increased
susceptibility in utero rats in the prenatal developmental study orin
young rats in the 2-generation reproduction study. Although there is
qualitative evidence of increased susceptibility in the prenatal
developmental study in rabbits, the Agency did not identify any
residual uncertainties after establishing toxicity endpoints and
traditional UFs to be used in the risk assessment of pyraclostrobin.
The degree of concern for prenatal toxicity is low.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues or anticipated residues derived
from reliable field trial data. Conservative ground water and surface
water modeling estimates were used. Similarly, conservative assumptions
were used to assess post-application dermal exposure of children as
well as incidental oral exposure of toddlers. These assessments will
not underestimate the exposure and risks posed by pyraclostrobin.
D. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-term, intermediate-term, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the POD to ensure that the MOE
called for by the product of all applicable UFs is not exceeded.
1. Acute risk: Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to pyraclostrobin will occupy 80% of the aPAD for (females 13-49 years)
the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
pyraclostrobin from food and water will utilize 48% of the cPAD for
(children 1-2 years,) the population group receiving the greatest
exposure. Based on the explanation in the unit regarding residential
use patterns, chronic residential exposure to residues of
pyraclostrobin is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Pyraclostrobin is currently registered for uses that could result
in short-term residential exposure and the Agency has determined that
it is appropriate to aggregate chronic food and water and short-term
exposures for pyraclostrobin. Using the exposure assumptions described
in this unit for short-term exposures, EPA has concluded that the
aggregated food, water, and residential exposures result in aggregate
MOEs of 200 for adults and 100 for children, 1 to 2 years old. The
aggregate MOE for adults is based on the residential turf scenario and
includes combined food, drinking water and post-application dermal
exposures. The aggregate MOE for children includes food, drinking
water, post-application dermal and incidental oral exposures from
entering turf are as previously treated with pyraclostrobin.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Pyraclostrobin is currently registered for uses 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. Since the endpoints and
points of departure NOAELs are identical for short-term and
intermediate-term exposures, the aggregate MOEs for intermediate-term
exposure are the same as those for short-term exposure (200 for adults
and 100 for children, 1 to 2 years old).
5. Aggregate cancer risk for U.S. population. EPA has classified
pyraclostrobin into the category ``Not Likely to be Carcinogenic to
Humans.'' Pyraclostrobin is not expected to pose a cancer risk.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to pyraclostrobin residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Two adequate enforcement methodologies (a Liquid Chromatography/
Mass Spectrometry (LC/MS/MS) method (BASF Method D9808), and a High
Performance Liquid Chromatography using Untraviolet Detection (HPLC/UV)
method (BASF Method D9904)) are available to enforce the tolerance
expression in/on plant commodities. Two more adequate methods have also
been proposed for enforcing tolerances for livestock commodities: HPLC/
UV method 439/0 and method 446 (consisting of CAS Chromatography/Mass
Spectroscopy (GC/MS) method 446/0 and LC/MS/MS method 446/1) The
methods 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
No Codex maximum residue levels have been established for residues
of pyraclostrobin in or on these commodities.
VI. Conclusion
Therefore, time-limited tolerances are established for combined
residues of the fungicide, 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 sugarcane, cane at 0.02 ppm and sugarcane, molasses at 0.4
ppm. These tolerances expire and are revoked on December 31, 2011.
VII. Statutory and Executive Order Reviews
This final rule establishes tolerances under sections 408(e) and
408(l)(6) 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
[[Page 11499]]
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). 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., 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).
Since tolerances and exemptions that are established in accordance
with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not 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).
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).
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 24, 2009.
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 alphabetically adding commodities to
the table in paragraph (b) to read as follows:
Sec. 180.582 Pyraclostrobin; tolerances for residues.
* * * * *
(b) * * *
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
* * * * *
Sugarcane, cane..................................... 0.02 December 31, 2011
Sugarcane, molasses................................. 0.4 December 31, 2011
----------------------------------------------------------------------------------------------------------------
* * * * *
[FR Doc. E9-5834 Filed 3-17-09; 8:45 am]
BILLING CODE 6560-50-S