Fludioxonil; Pesticide Tolerance for Emergency Exemption, 42713-42718 [E8-16876]
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Federal Register / Vol. 73, No. 142 / Wednesday, July 23, 2008 / Rules and Regulations
Lois D. Lehman-Mckeeman, Ph.D.,
Distinguished Research Fellow, Discovery
Toxicology, Bristol-Myers Squibb
Company, Princeton, NJ
Appendix 1—United States
Environmental Protection Agency
Human Studies Review Board
Chair
Celia B. Fisher, Ph.D. Marie Ward Doty
Professor of Psychology, Director, Center
for Ethics Education, Fordham University,
Department of Psychology, Bronx, NY
Vice Chair
Robert Nelson, M.D., Ph.D., Associate
Professor of Anesthesiology and Critical
Care, Department of Anesthesiology and
Critical Care, University of Pennsylvania
School of Medicine, The Children’s
Hospital of Philadelphia, Philadelphia, PA
William S. Brimijoin, Ph.D., Chair and
Professor, Molecular Pharmacology and
Experimental Therapeutics, Mayo
Foundation, Rochester, MN
Members
David C. Bellinger, Ph.D., Professor of
Neurology, Harvard Medical School
Professor in the Department of
Environmental Health, Harvard School of
Public Health Children’s Hospital, Boston,
MA
Alicia Carriquiry, Ph.D., Professor,
Department of Statistics, Iowa State
University Snedecor Hall, Ames, IA
Gary L. Chadwick, PharmD, MPH, CIP,
Associate Provost, Director, Office for
Human Subjects Protection, University of
Rochester, Rochester, NY
Janice Chambers, Ph.D., D.A.B.T., William L.
Giles Distinguished Professor, Director,
Center for Environmental Health Sciences,
College of Veterinary Medicine,
Mississippi State University, Wise Center,
Mississippi State, MS
Richard Fenske, Ph.D., MPH, Professor,
Department of Environmental and
Occupational Health Sciences, University
of Washington, Seattle, WA
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Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: July 11, 2008.
Debra Edwards,
Director, Office of Pesticide Programs.
[FR Doc. E8–16617 Filed 7–22–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0302; FRL–8369–5]
Environmental Protection
Agency (EPA).
ACTION: Final rule.
Kannan Krishnan, Ph.D., Professor,
´
´
Departement de sante environnementale et
´
´
sante au travail, Faculte de medicine,
´
´
´
Universite de Montreal, Montreal, Canada
KyungMann Kim, Ph.D., CCRP, Professor and
Associate Chair, Department of
Biostatistics and Medical Informatics,
School of Medicine and Public Health,
University of Wisconsin-Madison,
Madison, WI
Michael D. Lebowitz, Ph.D., FCCP, Professor
of Public Health and Medicine. University
of Arizona, Tucson, AZ
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List of Subjects in 40 CFR Part 180
AGENCY:
Suzanne C. Fitzpatrick, Ph.D., DABT, Senior
Science Policy Analyst, Office of the
Commissioner, Office of Science and
Health Coordination, U.S. Food and Drug
Administration, Rockville, MD
16:31 Jul 22, 2008
Sean M. Philpott, Ph.D., Research Scientist,
David Axelrod Institute, Wadsworth Center
for Laboratories and Research, New York
State Department of Health, Albany, NY
Fludioxonil; Pesticide Tolerance for
Emergency Exemption
Susan S. Fish, PharmD, MPH, Professor,
Biostatistics and Epidemiology, Boston
University School of Public Health, CoDirector, MA in Clinical Investigation
Boston University School of Medicine,
Boston, MA
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Jerry A. Menikoff, M.D., Associate Professor
of Law, Ethics and Medicine, Director of
the Institute for Bioethics, Law and Public
Policy, University of Kansas Medical
Center, Kansas City, KS
This regulation establishes a
time-limited tolerance for residues of
fludioxonil in or on carambola
(starfruit). 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 carambola. This
regulation establishes a maximum
permissible level for residues of
fludioxonil in starfruit. The time-limited
tolerance expires and is revoked on
December 31, 2010.
DATES: This regulation is effective July
23, 2008. Objections and requests for
hearings must be received on or before
September 22, 2008, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
SUMMARY:
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Unit I.C. of the SUPPLEMENTARY
INFORMATION.
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2008–0302. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
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 either in the electronic docket
at https://www.regulations.gov, or, if only
available in hard copy, at the Office of
Pesticide Programs (OPP) Regulatory
Public Docket in Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are
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:
Andrea Conrath, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9356; e-mail address:
conrath.andrea@epa.gov.
ADDRESSES:
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
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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?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.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. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s pilot e-CFR site at https://
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),
as amended by the Food Quality
Protection Act of 1996 (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. 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–2008–0302 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 September 22, 2008.
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–2008–0302, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
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16:31 Jul 22, 2008
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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’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 a timelimited tolerance for residues of the
fungicide fludioxonil, (4-(2,2-difluoro1,3-benzodioxol-4-yl)-1H-pyrrole-3carbonitrile), in or on carambola at 10
parts per million (ppm). This timelimited tolerance expires and is revoked
on December 31, 2010. EPA will publish
a document in the Federal Register to
remove the revoked tolerance 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 timelimited 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
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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
Fludioxonil on Carambola and FFDCA
Tolerances
The disease, Dothiorella fruit rot is a
recent phenomenon in Florida and was
documented as a major problem for
citrus growers during the 2006–07
season. The current practice of dipping
carambola in chlorine solution to
remove other fungal pathogens has been
ineffective in controlling Dothiorella
fruit rot, and there are no other
appropriate practices or materials
available. The industry is also
particularly vulnerable since it is still
recovering from the 2005 hurricane
season and the 2006–07 spring drought
which delayed flowering and fruiting. A
postharvest dip of fludioxonil has
demonstrated effective management of
Dothiorella fruit rot. Losses suffered
were expected to be significant if
fludioxonil were not available for postharvest treatment as requested. After
having reviewed the submission, EPA
determined that emergency conditions
exist for this State, and that the criteria
for an emergency exemption are met.
EPA has authorized under FIFRA
section 18 the use of fludioxonil on
carambola for control of Dothiorella
fruit rot in Florida.
As part of its evaluation of the
emergency exemption application, EPA
assessed the potential risks presented by
residues of fludioxonil in or on
carambola. 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
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408(l)(6) of FFDCA. Although this timelimited tolerance expires and is revoked
on December 31, 2010, under section
408(l)(5) of FFDCA, residues of the
pesticide not in excess of the amount
specified in the tolerance remaining in
or on carambola 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
this time-limited tolerance at the time of
that application. EPA will take action to
revoke this time-limited tolerance
earlier if any experience with, scientific
data on, or other relevant information
on this pesticide indicate that the
residues are not safe.
Because this time-limited tolerance is
being approved under emergency
conditions, EPA has not made any
decisions about whether fludioxonil
meets FIFRA’s registration requirements
for use on carambola or whether a
permanent tolerance 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
fludioxonil 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
to use this pesticide on this crop under
FIFRA section 18 absent the issuance of
an emergency exemption applicable
within that State. For additional
information regarding the emergency
exemption for fludioxonil, contact the
Agency’s Registration Division at the
address provided under FOR FURTHER
INFORMATION CONTACT.
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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
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16:31 Jul 22, 2008
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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 tolerance for
residues of fludioxonil on carambola at
10 ppm. EPA’s assessment of exposures
and risks associated with establishing
the time-limited tolerance 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 https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
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A summary of the toxicological
endpoints for fludioxonil used for
human risk assessment can be found at
https://www.regulations.gov in document
Fludioxonil. ‘‘Human Health Risk
Assessment for a Section 18 Emergency
Tolerance on Starfruit’’ at page 35 in
docket ID number EPA–HQ–OPP–2008–
0302.
B. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to fludioxonil, EPA considered
exposure under the time-limited
tolerance established by this action as
well as all existing fludioxonil
tolerances in 40 CFR 180.516. EPA
assessed dietary exposures from
fludioxonil in food as follows:
i. Acute exposure. In estimating acute
dietary exposure, EPA used food
consumption information from the
United States Department of Agriculture
(USDA) 1994–1996 and 1998
Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII). As to
residue levels in food, an acute dietary
assessment assuming tolerance-level
residues for all commodities with
existing and proposed tolerances and
default 100% crop treated (CT)
information was conducted for the
population subgroup females 13 to 49
years old. The estimated peak drinking
water concentration of 132 parts per
billion (ppb) was directly incorporated
into the acute risk assessment. There
were no appropriate toxicological effects
attributable to a single exposure (dose)
for the general population or any other
population subgroups; therefore these
population subgroups were not
included in this assessment. For food
and drinking water, the exposure to
females 13 to 49 yrs old (the most
sensitive population subgroup) was 0.14
milligrams/kilogram/day (mg/kg/day),
which utilized 14% of the aPAD at the
95th percentile of exposure distribution.
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 tolerance-level residues for
most commodities and 100% CT.
Anticipated residue values for apple,
grapefruit, lemon, lime, orange, and
pear were generated from field trials.
Anticipated residues were also
determined from processing studies for
apple, grapefruit, lemon, lime and
orange juices. The mean drinking water
estimate of 49 ppb was directly
incorporated into the chronic
assessment. For the U.S. population the
exposure for food and water utilized
47% of the cPAD. The chronic dietary
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risk estimate for the highest reported
exposed population subgroup, children
1 to 2 years old, is 86% of the cPAD.
iii. Cancer. Fludioxonil is classified as
a ‘‘Group D’’ chemical - not classifiable
as to human carcinogenicity. Therefore
a cancer dietary assessment was not
performed.
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 used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for fludioxonil in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of fludioxonil.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www.epa.gov/oppefed1/models/
water/index.htm.
Based on the First Index Reservoir
Screening Tool (FIRST), and Screening
Concentration in Ground Water (SCIGROW) models, the estimated drinking
water concentrations (EDWCs) of
fludioxonil for acute exposure is
estimated to be 132 ppb (peak
concentration), and for chronic (noncancer) exposures, 49 ppm (mean
concentration), both levels for surface
water concentrations. Ground water
sources were not included in this
assessment, as the EDWCs for this water
source are minimal in comparison to
surface water (0.11 ppb for both acute
and chronic concentrations).
Modeled estimates of drinking water
concentrations were entered directly
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 132 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration
value of 49 ppb was used to assess the
contribution to drinking water.
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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).
Fludioxonil is currently registered for
residential turf use, restricted to
commercial applicators only. Since
there are no short-term or intermediateterm dermal toxicity endpoints, only a
toddler post-application assessment for
incidental ingestion exposures to treated
lawns was included (for all children/
infant subgroups). The combined shortterm oral exposure risk estimate, which
includes hand-to-mouth, object-tomouth and soil ingestion pathways, was
determined to be 0.013 mg/kg body
weight (bw)/day, while the
intermediate-term was determined to be
0.0074 mg/kg bw/day. The MOEs for
combined non-dietary oral exposures
were 770 for short-term exposures and
450 for intermediate-term exposures.
These do not exceed the EPA’s LOC for
residential exposures (MOEs < 100).
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 fludioxonil to
share a common mechanism of toxicity
with any other substances, and
fludioxonil does not appear to produce
a toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that fludioxonil 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 https://
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
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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.
There was no quantitative or qualitative
evidence of increased susceptibility
following in utero exposure of rats and
rabbits or following pre-natal/post-natal
exposure of rats. In rats, there was an
increase in the number of fetuses and
litters with dilated renal pelvis and
dilated ureter. This finding was
considered to be related to maternal
toxicity rather than an indication of
increased susceptibility. Therefore, it is
concluded that there is no evidence of
increased susceptibility in rats. In rats,
developmental effects occurred in the
presence of maternal effects. In rabbits,
no developmental toxicity was seen up
to the highest dose tested which
demonstrated maternal toxicity. In the
2–generation rat reproduction study,
offspring toxicity was seen at the dose
that produced parental toxicity. The
maternal toxicity was manifested as
increased clinical signs, decreased body
weight, body weight gain and food
consumption. Fetal toxicity was
manifested as decreased weight gain in
pups. Since maternal and fetal toxicity
were comparable, it was concluded that
there is no increased susceptibility in
the 2–generation reproduction study.
3. Conclusion. EPA has determined
that reliable data show that the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for fludioxonil
is complete.
ii. There is no indication that
fludioxonil 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
fludioxonil results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2–generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
Anticipated residue values for apple,
grapefruit, lemon, lime, orange, and
pear were generated from field trials.
Anticipated residues were also
determined from processing studies for
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apple, grapefruit, lemon, lime and
orange juices. Data supporting the citrus
crop group tolerance were used to
estimate residues for carambola. These
data are reliable and will not
underestimate the exposure and risk.
EPA made conservative (protective)
assumptions in the ground and surface
water modeling used to assess exposure
to fludioxonil in drinking water. EPA
used similarly conservative assumptions
to assess postapplication exposure of
children as well as incidental oral
exposure of toddlers. These assessments
will not underestimate the exposure and
risks posed by fludioxonil.
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. Shortterm, intermediate-term, and chronicterm 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. Since the acute
aggregate risk assessment includes
exposure from food and water only, and
the acute dietary analysis that was
performed included both, no further
calculations are necessary. An acute
dietary assessment was conducted for
the population subgroup females 13 to
49 years old. There were no appropriate
toxicological effects attributable to a
single exposure (dose) for the general
population or other population
subgroups; therefore only the subgroup
of females 13 to 49 years old was
included in this assessment. Using the
exposure assumptions discussed in this
unit for acute exposure, the acute
aggregate exposure from food and water
to fludioxonil will occupy 14% of the
aPAD for Females 13 to 49 years old.
2. Chronic risk. Based on the
explanation in the unit regarding
residential use patterns, chronic
residential exposure to residues of
fludioxonil is not expected.
Consequently, the chronic aggregate risk
assessment includes exposure from food
and water only. Because the chronic
dietary analysis that was performed
included both food and water, no
further calculations are necessary for an
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aggregate chronic risk assessment. Using
the exposure assumptions described in
this unit for chronic exposure, EPA has
concluded that chronic exposure to
fludioxonil from food and water will
utilize 86% of the cPAD for children 1
to 2 years old the population group
receiving the greatest exposure. For the
U.S. population the exposure for food
and water utilized 47% of the cPAD.
3. Short-term and Intermediate-term
risk. Short-term and intermediate-term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Fludioxonil is currently registered for
uses that could result in short- and
intermediate-term residential exposure
and the Agency has determined that it
is appropriate to aggregate chronic
exposure through food and water with
short- and intermediate-term residential
exposures to fludioxonil.
Using the exposure assumptions
described in this unit for short- and
intermediate-term exposures, EPA has
concluded that combined short- and
intermediate-term food, water, and
residential exposures aggregated result
in aggregate MOEs for the most highly
exposed subgroup, Infants <1 year old,
of 320 for short-term exposures and 130
for intermediate-term exposures. These
do not exceed the level of concern for
residential exposures (MOEs < 100).
4. Aggregate cancer risk for U.S.
population. Fludioxonil is classified as
a ‘‘Group D’’ chemical - not classifiable
as to human carcinogenicity. Therefore
a cancer aggregate assessment was not
performed.
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, or to infants and children,
from aggregate exposure to fludioxonil
residues.
V. Other Considerations
A. Analytical Enforcement Methodology
The methods used in previous field
trial studies were similar to a method
validated by the Analytical Chemistry
Branch (ACB). Since adequate method
validation and concurrent recoveries
were attained in the field trial studies,
EPA concludes that the ACB validated
method is appropriate for enforcement.
Adequate enforcement methodology
(high performance liquid
chromatography method AG–597B) is
available to enforce the tolerance
expression. The method may be
requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
PO 00000
Frm 00047
Fmt 4700
Sfmt 4700
42717
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no CODEX maximum
residue levels for fludioxonil residues
on carambola.
VI. Conclusion
Therefore, a time-limited tolerance is
established for residues of fludioxonil,
(4-(2,2-difluoro-1,3-benzodioxol-4-yl)1H-pyrrole-3-carbonitrile), in or on
starfruit at 10 ppm. This tolerance
expires and is revoked on December 31,
2010.
VII. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under sections 408(e) and 408(l)(6) of
FFDCA. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final 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) 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 a
FIFRA section 18 exemption under
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,
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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: July 9, 2008.
Donald R. Stubbs,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.516 is amended by
revising the table in paragraph (b) to
read as follows:
I
§ 180.516 Fludioxonil; tolerances for
residues.
*
*
(b)
Commodity
*
*
*
*
*
*
[FR Doc. E8–16876 Filed 7–22–08; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
45 CFR Part 263
RIN 0970–AC15
Cost Allocation Methodology
Applicable to the Temporary
Assistance for Needy Families
Program
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This rule is effective
July 23, 2008.
FOR FURTHER INFORMATION CONTACT:
SUMMARY: This final rule applies to the
Temporary Assistance for Needy
Families (TANF) program and requires
States, the District of Columbia and the
Territories (hereinafter referred to as the
‘‘States’’) to use the ‘‘benefiting
program’’ cost allocation methodology
in U.S. Office of Management and
Budget (OMB) Circular A–87 (2 CFR
part 225). It is the judgment and
determination of HHS/ACF that the
‘‘benefiting program’’ cost allocation
methodology is the appropriate
VerDate Aug<31>2005
methodology for the proper use of
Federal TANF funds. The Personal
Responsibility and Work Opportunity
Reconciliation Act (PRWORA) of 1996
gave federally-recognized Tribes the
opportunity to operate their own Tribal
TANF programs. Federally-recognized
Indian tribes operating approved Tribal
TANF programs have always followed
the ‘‘benefiting program’’ cost allocation
methodology in accordance with OMB
Circular A–87 (2 CFR part 225) and the
applicable regulatory provisions at 45
CFR 286.45(c) and (d). This final rule
contains no substantive changes to the
proposed rule published on September
27, 2006.
EFFECTIVE DATE:
Administration for Children
and Families (ACF), Department of
Health and Human Services (HHS).
ACTION: Final rule.
AGENCY:
Robert Shelbourne, Director, State
TANF Policy Division at (202) 401–
5150, rshelbourne@acf.hhs.gov.
On
September 27, 2006, ACF published a
Notice of Proposed Rulemaking (NPRM)
to add section 263.14 to 45 CFR part
263, requiring a State or Territory to use
a benefiting program cost allocation
methodology consistent with the general
requirements of OMB Circular A–87 to
allocate TANF costs. We provided a 60day comment period that ended on
November 27, 2006. We offered the
public the opportunity to submit
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00048
*
*
Parts per million
Starfruit ........................................................................................................................................................
*
*
*
Fmt 4700
Sfmt 4700
10
Expiration/revocation date
12/31/10
comments by surface mail, e-mail, or
electronically via our Web site.
Comment Overview
After accounting for duplication, we
received one comment on the NPRM.
We have summarized the public
comment and our response to it in
Section II of the preamble to this final
rule.
Table of Contents
I. Statutory Authority
II. Background
III. Discussion of Regulatory Provisions
IV. Paperwork Reduction Act of 1995
V. Regulatory Flexibility Analysis
VI. Regulatory Impact Analysis
VII. Unfunded Mandates Reform Act of 1995
VIII. Congressional Review
IX. Assessment of Federal Regulation and
Policies on Families
X. Executive Order 13132
I. Statutory Authority
We are issuing this regulation under
the authority granted to the Secretary of
Health and Human Services (HHS) by
42 U.S.C. 1302(a). Section 1302(a)
authorizes the Secretary to make and
publish such rules as may be necessary
for the efficient administration of
functions with which he is charged
under the Social Security Act.
42 U.S.C. 617 limits the authority of
the Federal government to regulate State
conduct or enforce the TANF provisions
of the Social Security Act, except as
expressly provided. We interpret this
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]]>Agencies
[Federal Register Volume 73, Number 142 (Wednesday, July 23, 2008)]
[Rules and Regulations]
[Pages 42713-42718]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-16876]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0302; FRL-8369-5]
Fludioxonil; Pesticide Tolerance for Emergency Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a time-limited tolerance for
residues of fludioxonil in or on carambola (starfruit). 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 carambola. This regulation
establishes a maximum permissible level for residues of fludioxonil in
starfruit. The time-limited tolerance expires and is revoked on
December 31, 2010.
DATES: This regulation is effective July 23, 2008. Objections and
requests for hearings must be received on or before September 22, 2008,
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-2008-0302. To access the
electronic docket, go to https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in 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 either in the electronic docket at https://
www.regulations.gov, or, if only available in hard copy, at the Office
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are 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: Andrea Conrath, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9356; e-mail address: conrath.andrea@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
[[Page 42714]]
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 an electronic copy of this Federal
Register document through the electronic docket at https://
www.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. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at https://
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), as amended by the Food Quality Protection Act of 1996 (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. 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-2008-0302 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 September 22, 2008.
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-2008-0302, by one of the following methods:
Federal eRulemaking Portal: https://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'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 a
time-limited tolerance for residues of the fungicide fludioxonil, (4-
(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile), in or
on carambola at 10 parts per million (ppm). This time-limited tolerance
expires and is revoked on December 31, 2010. EPA will publish a
document in the Federal Register to remove the revoked tolerance 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 Fludioxonil on Carambola and FFDCA
Tolerances
The disease, Dothiorella fruit rot is a recent phenomenon in
Florida and was documented as a major problem for citrus growers during
the 2006-07 season. The current practice of dipping carambola in
chlorine solution to remove other fungal pathogens has been ineffective
in controlling Dothiorella fruit rot, and there are no other
appropriate practices or materials available. The industry is also
particularly vulnerable since it is still recovering from the 2005
hurricane season and the 2006-07 spring drought which delayed flowering
and fruiting. A postharvest dip of fludioxonil has demonstrated
effective management of Dothiorella fruit rot. Losses suffered were
expected to be significant if fludioxonil were not available for post-
harvest treatment as requested. After having reviewed the submission,
EPA determined that emergency conditions exist for this State, and that
the criteria for an emergency exemption are met. EPA has authorized
under FIFRA section 18 the use of fludioxonil on carambola for control
of Dothiorella fruit rot in Florida.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of fludioxonil
in or on carambola. 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
[[Page 42715]]
408(l)(6) of FFDCA. Although this time-limited tolerance expires and is
revoked on December 31, 2010, under section 408(l)(5) of FFDCA,
residues of the pesticide not in excess of the amount specified in the
tolerance remaining in or on carambola 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 this time-limited tolerance at the time of that
application. EPA will take action to revoke this time-limited tolerance
earlier if any experience with, scientific data on, or other relevant
information on this pesticide indicate that the residues are not safe.
Because this time-limited tolerance is being approved under
emergency conditions, EPA has not made any decisions about whether
fludioxonil meets FIFRA's registration requirements for use on
carambola or whether a permanent tolerance 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
fludioxonil 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 to use this pesticide on this crop under FIFRA
section 18 absent the issuance of an emergency exemption applicable
within that State. For additional information regarding the emergency
exemption for fludioxonil, contact the Agency's Registration Division
at the address 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 tolerance for residues of fludioxonil on carambola at
10 ppm. EPA's assessment of exposures and risks associated with
establishing the time-limited tolerance 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 https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for fludioxonil used for
human risk assessment can be found at https://www.regulations.gov in
document Fludioxonil. ``Human Health Risk Assessment for a Section 18
Emergency Tolerance on Starfruit'' at page 35 in docket ID number EPA-
HQ-OPP-2008-0302.
B. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fludioxonil, EPA considered exposure under the time-limited
tolerance established by this action as well as all existing
fludioxonil tolerances in 40 CFR 180.516. EPA assessed dietary
exposures from fludioxonil in food as follows:
i. Acute exposure. In estimating acute dietary exposure, EPA used
food consumption information from the United States Department of
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII). As to residue levels in food, an
acute dietary assessment assuming tolerance-level residues for all
commodities with existing and proposed tolerances and default 100% crop
treated (CT) information was conducted for the population subgroup
females 13 to 49 years old. The estimated peak drinking water
concentration of 132 parts per billion (ppb) was directly incorporated
into the acute risk assessment. There were no appropriate toxicological
effects attributable to a single exposure (dose) for the general
population or any other population subgroups; therefore these
population subgroups were not included in this assessment. For food and
drinking water, the exposure to females 13 to 49 yrs old (the most
sensitive population subgroup) was 0.14 milligrams/kilogram/day (mg/kg/
day), which utilized 14% of the aPAD at the 95th percentile of exposure
distribution.
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 tolerance-
level residues for most commodities and 100% CT. Anticipated residue
values for apple, grapefruit, lemon, lime, orange, and pear were
generated from field trials. Anticipated residues were also determined
from processing studies for apple, grapefruit, lemon, lime and orange
juices. The mean drinking water estimate of 49 ppb was directly
incorporated into the chronic assessment. For the U.S. population the
exposure for food and water utilized 47% of the cPAD. The chronic
dietary
[[Page 42716]]
risk estimate for the highest reported exposed population subgroup,
children 1 to 2 years old, is 86% of the cPAD.
iii. Cancer. Fludioxonil is classified as a ``Group D'' chemical -
not classifiable as to human carcinogenicity. Therefore a cancer
dietary assessment was not performed.
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 used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fludioxonil in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fludioxonil. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the First Index Reservoir Screening Tool (FIRST), and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of fludioxonil for
acute exposure is estimated to be 132 ppb (peak concentration), and for
chronic (non-cancer) exposures, 49 ppm (mean concentration), both
levels for surface water concentrations. Ground water sources were not
included in this assessment, as the EDWCs for this water source are
minimal in comparison to surface water (0.11 ppb for both acute and
chronic concentrations).
Modeled estimates of drinking water concentrations were entered
directly into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 132 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration value of 49 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).
Fludioxonil is currently registered for residential turf use,
restricted to commercial applicators only. Since there are no short-
term or intermediate-term dermal toxicity endpoints, only a toddler
post-application assessment for incidental ingestion exposures to
treated lawns was included (for all children/infant subgroups). The
combined short-term oral exposure risk estimate, which includes hand-
to-mouth, object-to-mouth and soil ingestion pathways, was determined
to be 0.013 mg/kg body weight (bw)/day, while the intermediate-term was
determined to be 0.0074 mg/kg bw/day. The MOEs for combined non-dietary
oral exposures were 770 for short-term exposures and 450 for
intermediate-term exposures. These do not exceed the EPA's LOC for
residential exposures (MOEs < 100).
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 fludioxonil to share a common mechanism of
toxicity with any other substances, and fludioxonil does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
fludioxonil 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 https://
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. There was no quantitative or
qualitative evidence of increased susceptibility following in utero
exposure of rats and rabbits or following pre-natal/post-natal exposure
of rats. In rats, there was an increase in the number of fetuses and
litters with dilated renal pelvis and dilated ureter. This finding was
considered to be related to maternal toxicity rather than an indication
of increased susceptibility. Therefore, it is concluded that there is
no evidence of increased susceptibility in rats. In rats, developmental
effects occurred in the presence of maternal effects. In rabbits, no
developmental toxicity was seen up to the highest dose tested which
demonstrated maternal toxicity. In the 2-generation rat reproduction
study, offspring toxicity was seen at the dose that produced parental
toxicity. The maternal toxicity was manifested as increased clinical
signs, decreased body weight, body weight gain and food consumption.
Fetal toxicity was manifested as decreased weight gain in pups. Since
maternal and fetal toxicity were comparable, it was concluded that
there is no increased susceptibility in the 2-generation reproduction
study.
3. Conclusion. EPA has determined that reliable data show that the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for fludioxonil is complete.
ii. There is no indication that fludioxonil 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 fludioxonil results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. Anticipated residue values for apple, grapefruit, lemon,
lime, orange, and pear were generated from field trials. Anticipated
residues were also determined from processing studies for
[[Page 42717]]
apple, grapefruit, lemon, lime and orange juices. Data supporting the
citrus crop group tolerance were used to estimate residues for
carambola. These data are reliable and will not underestimate the
exposure and risk. EPA made conservative (protective) assumptions in
the ground and surface water modeling used to assess exposure to
fludioxonil in drinking water. EPA used similarly conservative
assumptions to assess postapplication exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by fludioxonil.
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. Since the acute aggregate risk assessment includes
exposure from food and water only, and the acute dietary analysis that
was performed included both, no further calculations are necessary. An
acute dietary assessment was conducted for the population subgroup
females 13 to 49 years old. There were no appropriate toxicological
effects attributable to a single exposure (dose) for the general
population or other population subgroups; therefore only the subgroup
of females 13 to 49 years old was included in this assessment. Using
the exposure assumptions discussed in this unit for acute exposure, the
acute aggregate exposure from food and water to fludioxonil will occupy
14% of the aPAD for Females 13 to 49 years old.
2. Chronic risk. Based on the explanation in the unit regarding
residential use patterns, chronic residential exposure to residues of
fludioxonil is not expected. Consequently, the chronic aggregate risk
assessment includes exposure from food and water only. Because the
chronic dietary analysis that was performed included both food and
water, no further calculations are necessary for an aggregate chronic
risk assessment. Using the exposure assumptions described in this unit
for chronic exposure, EPA has concluded that chronic exposure to
fludioxonil from food and water will utilize 86% of the cPAD for
children 1 to 2 years old the population group receiving the greatest
exposure. For the U.S. population the exposure for food and water
utilized 47% of the cPAD.
3. Short-term and Intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
Fludioxonil is currently registered for uses that could result in
short- and intermediate-term residential exposure and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with short- and intermediate-term residential exposures
to fludioxonil.
Using the exposure assumptions described in this unit for short-
and intermediate-term exposures, EPA has concluded that combined short-
and intermediate-term food, water, and residential exposures aggregated
result in aggregate MOEs for the most highly exposed subgroup, Infants
<1 year old, of 320 for short-term exposures and 130 for intermediate-
term exposures. These do not exceed the level of concern for
residential exposures (MOEs < 100).
4. Aggregate cancer risk for U.S. population. Fludioxonil is
classified as a ``Group D'' chemical - not classifiable as to human
carcinogenicity. Therefore a cancer aggregate assessment was not
performed.
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, or to infants and children, from aggregate
exposure to fludioxonil residues.
V. Other Considerations
A. Analytical Enforcement Methodology
The methods used in previous field trial studies were similar to a
method validated by the Analytical Chemistry Branch (ACB). Since
adequate method validation and concurrent recoveries were attained in
the field trial studies, EPA concludes that the ACB validated method is
appropriate for enforcement.
Adequate enforcement methodology (high performance liquid
chromatography method AG-597B) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no CODEX maximum residue levels for fludioxonil residues
on carambola.
VI. Conclusion
Therefore, a time-limited tolerance is established for residues of
fludioxonil, (4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-
carbonitrile), in or on starfruit at 10 ppm. This tolerance expires and
is revoked on December 31, 2010.
VII. Statutory and Executive Order Reviews
This final rule establishes tolerances under sections 408(e) and
408(l)(6) of FFDCA. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this final rule has been exempted from review under
Executive Order 12866, this final 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) 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 a FIFRA section 18 exemption under 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,
[[Page 42718]]
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: July 9, 2008.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.516 is amended by revising the table in paragraph (b) to
read as follows:
Sec. 180.516 Fludioxonil; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Starfruit......................... 10 12/31/10
------------------------------------------------------------------------
* * * * *
[FR Doc. E8-16876 Filed 7-22-08; 8:45 am]
BILLING CODE 6560-50-S
