[Federal Register: July 23, 2008 (Volume 73, Number 142)]
[Rules and Regulations]
[Page 42713-42718]
[DOCID:fr23jy08-7]

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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.

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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 http://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 http://
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<PHONE_NUMBER>.

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:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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 an electronic copy of this Federal
Register document through the electronic docket 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 pilot e-CFR site 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), 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: 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'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<PHONE_NUMBER>.

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

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 http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for fludioxonil used for
human risk assessment can be found at http://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

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 http://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 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. 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

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:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
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,

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


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 April 13, 2006 OFFICE OF PREVENTION PESTICIDES AND TOXIC SUBSTANCES Memorandum SUBJECT: Biological and Economic Analysis of Dichlorvos for Pet Collars FROM: Don Atwood, Entomologist Biological Analysis Branch Biological and Economic Analysis Division ( 7503C)

THRU: Arnet Jones, Chief Biological Analysis Branch Tim Kiely, Acting Chief Economic Analysis Branch Biological and Economic Analysis Division ( 7503C)

TO: Dayton Eckerson/ Eric Olson, Chemical Review Manager Reregistration Branch 1 Special Review and Reregistration Division ( 7508C)

PRP REVIEW DATE: March 31, 2006 SUMMARY Flea/ Tick collars only represent 20% of the total pet pest control market. Recent trends, 1997 2001, indicate market movement away from pest collars towards rub in/ spot on products and veterinarian medications. Numerous alternative active ingredients are currently marketed as pest collars for flea and tick control. Taking into account the availability of alternative insecticides, both pest collar and other, and the changing trend in residential flea and tick control, BEAD concludes that their would be no biological impact from the absence of dichlorvos in the pest collar market. As dichlorvos is not currently marketed as a flea/ tick collar product, no economic analysis was conducted in the course of this assessment. 2 I. SCOPE AND LIMITATIONS OF ASSESSMENT The scope of this assessment is at the national level. The scope of this analysis includes an examination of impacts associated with no longer allowing the use of dichlorvos in flea and tick colars. This mitigation scenario reflects the health risks as identified by the Health Effects Division of the Office of Pesticide Programs.

There are limits to this assessment. The primary limit is the lack of data associated with dichlorvos use in flea and tick collars. Although registered for this use, no products containing dichlorvos are currently marketed. The lack of usage and economic data makes the benefit analysis rely chiefly on alternative insecticides.

BEAD assessment is based on the best professional judgement of BEAD analysts when estimates are not available from other sources. BEAD has relied largely on state pesticide recommendations and proprietary usage data. In the absence of efficacy data, is assumed that the recommended alternative insecticides are efficacious against the target pests.

II. INSECTICIDE USAGE FOR FLEA / TICK CONTROL ON DOGS AND CATS Usage data for dichlorvos to kill fleas and ticks on dogs and cats is not available. However, usage data is available for other currently marketed pet products. Insecticidal flea/ tick treatments for pets is available as collars, on animal sprays, shampoos, dips, powder, liquid rubin spot on, and veterinarian medication. Use of insecticides is greatest on dogs and for flea control, each accounting for approximately 70% of revenues. Flea/ tick collars , veterinary medication, and shampoo all have similar usage patterns by dog owners, approximately 20% of product use. Usage pattern for cat owners is similar to that with dogs but with liquid rub in/ spot on replacing shampoos. Pet collars for flea and tick control amounts to less than 10% of all total flea/ tick control revenues. However, trends indicate a greater number of pet owners, both dog and cat, switching away from collars. In addition, revenues generated by liquid rub in/ spot on products increased by more than 350% between 1997 and 2000.

III. INSECTICIDES AVAILABLE FOR FLEA/ TICK CONTROL ON PETS Flea control is best achieved with a simultaneous, coordinated effort involving strict sanitation, pet treatment and premise treatment ( both indoors & outdoors).

A. INSECTICIDE ALTERNATIVES 1. Collars  There is a great variety of flea/ tick collars available to pet owners. Control can extend from 4 12 months depending on the active ingredient. Collars represent less than 10% of total revenues for flea/ tick control. The 3 leading active ingredients include propoxur, carbaryl, and naled. Other active ingredients in flea/ tick collars include; tetachorvinphos + methoprene, d limonene + linalool, rotenone, allethrin, methoprene, permethrin ( dog use only), and amitraz ( dog use only).

2. Sprays  Sprays are one of the most common flea/ tick control products available. The most common active ingredient in use for sprays is pyrethrum. Numerous collars may also include an insect growth regulator ( IGR) such as methoprene in combination with pyrethrum to provide adult flea and tick control as well as larval flea control.

3. Shampoos  As with sprays, most shampoos are based on pyrethrum as the active ingredient. There has been a move away from shampoo use for flea/ tick control for both dogs and cats ( though more pronounced for cats). A few natural products are also marketed as shampoos containing dlimonen a citrus extract, for flea/ tick control.

4. Dips  Dips are no longer widely used by pest owners even though they are highly effective. This is largely due to the fact that they are hard to use and are messy. Most dips provide immediate control with residual activity of up to 7 days. The leading active ingredients for use in dips are permethrin and pyrethrum.

5. Powders  As with dips, powders for flea/ tick control only have limited use as the difficult to apply and are unattractive on the pet's coat. Active ingredients most commonly used in powders are carbaryl and pyrethrum.

6. Rub in/ Spot on  Use of rub in/ spot ons has increased by over 350% in the last 3 years. This market has grown specifically at the expense of the more traditional treatments. Rub in/ Spot ons account for the second largest sales revenue for the flea and tick market, less than 15%. The active ingredients most commonly used in rub in/ spot on treatments are fipronil and imidacloprid.

7. Veterinarian medications  Since 1997, veterinarian medications to control fleas and ticks has increased by approximately 7% annually. Veterinarian medications account for over 60% of sales revenue. Active ingredients commonly found in veterinarian medications include lufenuron, selamectin, and nitenpyram.

IV. ALTERNATIVE NONCHEMICAL CONTROL OF FLEAS AND TICKS No alternative nonchemical controls are available that would provide acceptable control of 4 fleas and ticks. Control must include pet treatment, premise treatment, and sanitation. Insecticides are an integral part residential flea/ tick control program.

V. BIOLOGICAL IMPORTANCE OF DICHLORVOS FOR FLEA/ TICK CONTROL No biological impact would be expected in the absence of dichlorvos for use in flea/ tick collars on pets. Flea collars only represent 20% of total pet insecticide use and only account for 10% of total pet insecticide revenues. The recent trend for pet pest control products has been away from collars and towards rub in/ spot on products and veterinarian medications. Due to the large number of active ingredients currently available in flea/ tick collars and the move toward other pet treatment methods, the absence of dichlorvos from the flea/ tick collar market will have no biological impact.

VI. ECONOMIC IMPORTANCE OF DICHLORVOS FOR FLEA/ TICK CONTROL As dichlorvos currently has no market for pet collars, no economic impacts are expected.

VII. REFERENCES 1. EPA Proprietary Data. 2001.

2. Pet Products to Control Pests. 2001. FDA http:// www. fda. gov/ fdac/ features/ 2001/ petchart. html 3. Veterinary Prescribed Products . Ohio State University. Extension Bulletin 586 http:// ohioline. osu. edu/ b586/ b586_ 5. html 4. Fighting Fleas and Ticks. 1996. FDA. http:// www. fda. gov/ fdac/ features/ 696_ flea. html