[Federal Register Volume 72, Number 89 (Wednesday, May 9, 2007)]
[Rules and Regulations]
[Pages 26317-26322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8954]



[[Page 26317]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0237; FRL-8127-3]


Fenpyroximate; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
combined residues of fenpyroximate in or on honey. 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 in managed beehives. This regulation 
establishes a maximum permissible level for residues of fenpyroximate 
in this food commodity. The tolerance expires and is revoked on 
December 31, 2010.

DATES: This regulation is effective May 9, 2007. Objections and 
requests for hearings must be received on or before July 9, 2007, 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-2007-0237. 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 web site 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 (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Stacey Groce, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-2505; e-mail address: <a href="/cdn-cgi/l/email-protection#9ff8edf0fcfab1ecebfefcfae6dffaeffeb1f8f0e9"><span class="__cf_email__" data-cfemail="7b1c0914181e55080f1a181e023b1e0b1a551c140d">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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 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-
2007-0237 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 July 9, 2007.
    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-2007-0237 by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> 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 the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing a time-limited tolerance for combined 
residues of the miticide fenpyroximate in or on honey at 0.10 parts per 
million (ppm). This 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 Code of Federal Regulations (CFR).
    Section 408(l)(6) of the FFDCA requires EPA to establish a 
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

[[Page 26318]]

exemption granted by EPA under section 18 of FIFRA. Such tolerances can 
be established without providing notice or period for public comment. 
EPA does not intend for its actions on section 18 related tolerances to 
set binding precedents for the application of section 408 of the FFDCA 
and the new safety standard to other tolerances and exemptions. Section 
408(e) of the FFDCA allows EPA to establish a tolerance or an exemption 
from the requirement of a tolerance on its own initiative, i.e., 
without having received any petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by the Food Quality Protection Act of 1996 (FQPA). EPA has 
established regulations governing such emergency exemptions in 40 CFR 
part 166.

III. Emergency Exemption for Fenpyroximate on Honey and FFDCA 
Tolerances

    The varroa mite, (Varroa jacobsoni), is an ectoparasite of 
honeybees. It was first detected in the continental United States in 
1979 and is currently the most important pest of honey bee colonies. 
The feeding of varroa mites has a number of effects on the bee from 
damaging tissue to shortening the bee's life span as an adult. Further, 
the mites vector disease viruses and heavy levels of parasitism 
increase bee mortality and weaken colonies. Fluvalinate is currently 
registered for the control of varroa mites; however, populations of 
varroa mites have developed resistance to fluvalinate. The applicants 
for this use pattern assert that the continued survival of managed bee 
colonies is critical to the production of many agricultural crops and 
it is becoming increasingly difficult to control varroa mites due to 
pesticide resistance. EPA has authorized under FIFRA section 18 the use 
of fenpyroximate on honey for control of varroa mites in Nebraska, 
North Dakota, New York, Idaho, Oregon, and Washington States. In 
addition, EPA has authorized under the FIFRA section 18 crisis 
provision the use of fenpyroximate in beehives for control of varroa 
mites in Texas. After having reviewed the submission, EPA concurs that 
emergency conditions exist for these States.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of fenpyroximate in or on 
honey. In doing so, EPA considered the safety standard in section 
408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance 
under section 408(l)(6) of the FFDCA would be consistent with the 
safety standard and with FIFRA section 18. Consistent with the need to 
move quickly on the emergency exemption in order to address an urgent 
non-routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this time-limited tolerance without notice and 
opportunity for public comment as provided in section 408(l)(6) of the 
FFDCA. Although this time-limited tolerance expires and is revoked on 
December 31, 2010, under section 408(l)(5) of the FFDCA, residues of 
the pesticide not in excess of the amounts specified in the tolerance 
remaining in or on honey after that date will not be unlawful, provided 
the pesticide is applied in a manner that was lawful under FIFRA, and 
the residues do not exceed a level that was authorized by this time-
limited tolerance at the time of that application. EPA will take action 
to revoke this tolerance earlier if any experience with, scientific 
data on, or other relevant information on this pesticide indicate that 
the residues are not safe.
    Because this time-limited tolerance is being approved under 
emergency conditions, EPA has not made any decisions about whether 
fenpyroximate meets EPA's registration requirements for use on honey or 
whether a permanent tolerance for this use would be appropriate. Under 
these circumstances, EPA does not believe that this tolerance serves as 
a basis for registration of fenpyroximate by a State for special local 
needs under FIFRA section 24(c). Nor does this time-limited tolerance 
serve as the basis for any States other than Idaho, Nebraska, 
Minnesota, New York, North Dakota, Texas, and Washington States to use 
this pesticide on bee hives under section 18 of FIFRA without following 
all provisions of EPA's regulations implementing FIFRA section 18 as 
identified in 40 CFR part 166. For additional information regarding the 
emergency exemption for fenpyroximate contact the Agency's Registration 
Division at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of 
fenpyroximate and to make a determination on aggregate exposure, 
consistent with section 408(b)(2) of the FFDCA, for a time-limited 
tolerance for combined residues of fenpyroximate in or on honey at 0.10 
ppm. EPA's assessment of the dietary exposures and risks associated 
with establishing the tolerance follows.

A. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological endpoint. However, the 
lowest dose at which adverse effects of concern are identified (the 
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved 
in the toxicology study selected. An uncertainty factor (UF) is applied 
to reflect uncertainties inherent in the extrapolation from laboratory 
animal data to humans and in the variations in sensitivity among 
members of the human population as well as other unknowns. An UF of 100 
is routinely used, 10X to account for interspecies differences and 10X 
for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the

[[Page 26319]]

FQPA, this additional factor is applied to the RfD by dividing the RfD 
by such additional factor. The acute or chronic Population Adjusted 
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this 
type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (LOC). For example, when 100 is the 
appropriate UF (10X to account for interspecies differences and 10X for 
intraspecies differences) the LOC is 100. To estimate risk, a ratio of 
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is 
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 X 10\6\ or one in a million). Under 
certain specific circumstances, MOE calculations will be used for the 
carcinogenic risk assessment. In this non-linear approach, a ``point of 
departure'' is identified below which carcinogenic effects are not 
expected. The point of departure is typically a NOAEL based on an 
endpoint related to cancer effects though it may be a different value 
derived from the dose response curve. To estimate risk, a ratio of the 
point of departure to exposure (MOE<INF>cancer</INF> = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for fenpyroximate used for human risk assessment is discussed 
in Table 1 on page 5 of the Fenpyroximate Human Health Risk Assessment 
dated December 4, 2006: Section 18 Request for Use in Bee Hives, and 
can be located by searching for docket ID number EPA-HQ-OPP-2007-0237. 
Double-click on the document to view the referenced information.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.566) for the combined residues of the miticide 
fenpyroximate in or on a variety of raw agricultural commodities. 
Tolerances have also been established for fenpyroximate and its 
metabolites (E)-4-[(1,3-dimethyl-5-phenoxypyrazol-4-yl)-methylene 
aminooxymethyl] benzoic acid and (E)-1,1-dimethylethyl-2-hydroxyethyl 
4-[[[[(1,3-dimethyl-5-phenoxy-1 H-pyrazol-4-yl) methylene] 
amino]oxy]methyl]benzoate, calculated as the parent compound at 0.015 
ppm in milk, and the fat, meat, and meat byproducts (excluding liver 
and kidney) of cattle, goat, horse, and sheep at 0.03 ppm. Risk 
assessments were conducted by EPA to assess dietary exposures from 
fenpyroximate in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1-day or 
single exposure. The Dietary Exposure Evaluation Model (DEEM-FCID\TM\) 
version 2.02 analysis evaluated the individual food consumption as 
reported by respondents in the USDA 1994-1996 and 1998 nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII) and 
accumulated exposure to the chemical for each commodity. The following 
assumptions were made for the acute exposure assessments: An unrefined 
Tier I acute dietary-exposure assessment was conducted for females 13-
49 years old. The unrefined Tier I acute dietary analyses assumed that 
fenpyroximate residues were present in all commodities at tolerance 
levels and that 100% of all commodities (registered and proposed uses) 
are treated. Adequate processing data on apples, grapes, oranges, and 
mint are available. Modified processing factors based on these data 
were used for apple juice, pear juice, grape juice, raisins, citrus 
juice (orange, grapefruit, lemon, lime) and mint oils (peppermint and 
spearmint). The DEEM-FCID\TM\ default processing factors were used for 
all other processing commodities.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEM-FCID\TM\ version 2.02 analysis evaluated the 
individual food consumption as reported by respondents in the USDA 
1994-1996 and 1998 nationwide CSFII and accumulated exposure to the 
chemical for each commodity. The following assumptions were made for 
the chronic exposure assessments: An unrefined Tier I chronic dietary-
exposure assessment was conducted for the general U.S. population and 
various sub-populations. The unrefined Tier I chronic dietary analyses 
assumed that fenpyroximate residues were present in all commodities at 
tolerance levels and that 100% of all commodities (registered and 
proposed uses) are treated. Adequate processing data on apples, grapes, 
oranges, and mint are available. Modified processing factors based on 
these data were used for apple juice, pear juice, grape juice, raisins, 
citrus juice (orange, grapefruit, lemon, lime) and mint oils 
(peppermint and spearmint). The DEEM-FCID\TM\ default processing 
factors were used for all other processing commodities.
    iii. Cancer. Fenpyroximate is classified as ``not likely'' to be a 
human carcinogen. Therefore a cancer risk assessment was not performed.
    2. Dietary exposure from drinking water. The Agency determined that 
in addition to the parent compound, known as fenpyroximate, M-1, the z 
isomer of fenpyroximate, and the M-3 metabolite should be included in 
the drinking water assessment for fenpyroximate based on their 
structural similarity. Some surface water and ground water 
contamination may occur based on the proposed application rates and the 
environmental fate properties of fenpyroximate. However, the risk of 
water contamination from the parent compound is relatively low, based 
on its high sorption potential. Unlike the parent compound, sorption of 
the M-3 metabolite is much less, and it may move into water resources 
more readily. Fenpyroximate and M-1 are not expected to persist under 
terrestrial environmental conditions, with metabolism as the primary 
route of dissipation. Hydrolysis and photodegradation on soil are not 
expected to be significant routes of dissipation, but photodegradation 
in water could be significant assuming clear, well-mixed, shallow water 
bodies.
    Based on Tier II screening-level surface water modeling for 
drinking water, the Agency estimated concentrations in surface water to 
be used for acute, chronic non-cancer, and cancer exposure assessment. 
Tier II surface water concentrations for parent fenpyroximate and M-1 
were calculated using the Pesticide Root Zone Model/Exposure Analysis 
Modeling System (PRZM-EXAMS) shell. The acute and chronic non-cancer 
concentrations for Georgia (GA) pecan (highest exposure) are 12.9 and 
1.8 microgram/Liter (ug/L), respectively. EPA used the Screening 
Concentration Ground Water (SCI-GROW2) model to estimate a ground water 
concentration of 0.059 parts per billion (ppb). These results for both 
surface water and ground water are consistent with the fate and 
transport properties of fenpyroximate.
    Modeled estimates of drinking water concentrations were 
incorporated directly into the dietary assessment using the estimated 
drinking water concentrations (EDWC) for surface water generated by the 
PRZM-EXAMS model. For the acute assessment, the peak concentration of 
12.9 ppb was used to assess the contribution to drinking water; for the 
chronic assessment, the annual mean value of 1.8 ppb was used

[[Page 26320]]

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). Fenpyroximate is not 
registered for use on any sites that would result in residential 
exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to fenpyroximate and any 
other substances and fenpyroximate does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that fenpyroximate has 
a common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see the policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

C. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans. In applying this provision, 
EPA either retains the default value of 10X when reliable data do not 
support the choice of a different factor, or, if reliable data are 
available, EPA uses a different additional safety factor value based on 
the use of traditional uncertainty factors and/or special FQPA safety 
factors, as appropriate.
    2. Prenatal and postnatal sensitivity. The rat and rabbit 
developmental toxicity studies were tested at doses that produced 
minimal maternal toxicity. These doses were supported partly by range 
finding data. The 2-generation reproductive toxicity study indicated 
that maternal (decreased body weight) and offspring toxicity (decreased 
lactational weight gain) occurred at the same dose, suggesting no 
evidence of increased sensitivity or susceptibility. Reproductive 
parameters were not affected in this 2-generation reproduction study. 
There are no neurotoxicity studies other than a negative delayed acute 
neurotoxicity study in the hen. There was no indication of 
neurotoxicity present in any of the existing subchronic or chronic 
toxicity studies. The toxicology database is complete for FQPA purposes 
and there are no residual uncertainties for prenatal/postnatal 
toxicity.
    3. Conclusion. There is a complete toxicity database for 
fenpyroximate and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the 10X safety factor to protect infants and children should be 
changed to 1X for the following reasons:
    i. There are no concerns or residual uncertainties for prenatal or 
postnatal toxicity.
    ii. The toxicological database is complete for the assessment of 
toxicity and susceptibility following prenatal and/or postnatal 
exposures. No clinical signs of neurotoxicity or neuropathology were 
observed in the database.
    iii. There are no residual concerns regarding completeness of the 
exposure database.
    iv. The dietary food exposure assessment is an unrefined, Tier I, 
acute and chronic analyses, which assumed that fenpyroximate residues 
were present in all commodities at tolerance levels and that 100% of 
all commodities (registered and proposed uses) were treated with 
fenpyroximate. By using these screening level assessments, actual 
exposures /risks will not be underestimated.
    v. The dietary drinking water assessment utilizes water 
concentration values generated by models and associated modeling 
parameters which are designed to provide conservative, health 
protective, high-end estimates of water concentrations that will not 
likely be exceeded.
    vi. There are currently no registered or proposed residential uses 
of fenpyroximate.

D. Aggregate Risks and Determination of Safety

    The Agency currently has two ways to estimate total aggregate 
exposure to a pesticide from food, drinking water, and residential 
uses. First, a screening assessment can be used, in which the Agency 
calculates drinking water levels of comparison (DWLOCs), which are used 
as a point of comparison against estimated drinking water 
concentrations (EDWCs). The DWLOC values are not regulatory standards 
for drinking water, but are theoretical upper limits on a pesticide's 
concentration in drinking water in light of total aggregate exposure to 
a pesticide in food and residential uses. More information on the use 
of DWLOCs in dietary aggregate risk assessments can be found at http:/
www.epa.gov/oppfead1/trac/science/screeningsop.pdf.
    More recently, the Agency has used another approach to estimate 
aggregate exposure through food, residential and drinking water 
pathways. In this approach, modeled surface water and ground water 
EDWCs are directly incorporated into the dietary exposure analysis, 
along with food. This approach provides a more realistic estimate of 
exposure because actual body weights and water exposures are then added 
to estimated and water consumption form the CSFII are used. The 
combined food and water exposures are then added to estimated exposure 
from residential sources to calculate aggregate risks. The resulting 
exposure and risk estimates are still considered to be high end, due to 
the assumptions used in developing drinking water modeling inputs. The 
risk assessment for fenpyroximate used in this tolerance document uses 
this approach of incorporating water exposure directly into the dietary 
exposure analysis.
    There are no registered or proposed uses of fenpyroximate, which 
result in residential exposures, so the aggregate exposure assessment 
required by FFDCA section 408(b)(2)(D)(vi) consists solely of dietary 
(food + drinking water) exposures.
    Aggregate exposure risk assessments were conducted by incorporating 
the drinking water concentrations directly into the dietary exposure 
assessment for the acute and chronic aggregate exposures (food + 
drinking water). These aggregate exposures do not exceed the Agency's 
level of concern since they were less than 100% of the respective 
population adjusted doses (PADs).

[[Page 26321]]

    1. Acute risk. An unrefined acute dietary-exposure assessment was 
conducted for females 13 to 49 years old. Since an effect of concern 
attributable to a single dose in toxicity studies was not identified 
for the general U.S. population, an acute dietary-exposure assessment 
was not performed for this population. Using the exposure assumptions 
discussed in this unit for acute exposure, the acute dietary exposure 
from food and water to fenpyroximate will occupy 6.8% of the acute 
population adjusted dose (aPAD) for females 13 years and older. EPA 
does not expect the aggregate exposure to exceed 100% of the aPAD.
    2. Chronic risk. Using the exposure assumptions discussed in this 
unit for chronic exposure, EPA has concluded that exposure to 
fenpyroximate from food and water will utilize 9.8% of the chronic 
population adjusted dose (cPAD) for the U.S. population, 20% of the 
cPAD for all infants, 1 year old, and 34% of the cPAD for children 1 to 
2 years old. There are no residential uses for fenpyroximate which 
result in chronic residential exposure to fenpyroximate. Therefore, EPA 
does not expect the aggregate exposure to exceed 100% of the cPAD.
    3. Aggregate cancer risk for U.S. population. A cancer aggregate-
risk assessment was not performed because fenpyroximate has been 
classified as not likely to be carcinogenic to humans.
    4. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to fenpyroximate residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology and high-performance liquid 
chromatography/mass spectrometry/mass spectrometry (HPLC/MS/MS) is 
available to enforce the tolerance expression. The methods may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address:<a href="/cdn-cgi/l/email-protection#ddafb8aeb4b9a8b8b0b8a9b5b2b9ae9db8adbcf3bab2ab"><span class="__cf_email__" data-cfemail="40322533292435252d2534282f2433002530216e272f36">[email protected]</span></a>.

B. International Residue Limits

    There are no Codex, Canadian, or Mexican maximum residue limits 
(MRLs) for the residues of fenpyroximate in honey. Therefore, there are 
no international harmonization concerns at this time.

VI. Conclusion

    Therefore, the time-limited tolerance is established for combined 
residues of fenpyroximate, (E)-1,1-dimethylethyl 4-[[[(E)-[(1,3-
dimethyl-5-phenoxy-1H-pyrazol-4-yl)methylene] 
amino]oxy]methyl]benzoate, in or on honey at 0.10 ppm. This tolerance 
expires and is revoked on December 31, 2010.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866, this rule is not 
subject to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001) 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 on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    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 6, 
2000) do not apply to this rule. In addition, This 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: April 26, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.566 is amended by adding text and a table to paragraph 
(b) to read as follows:


Sec.  180.566  Fenpyroximate; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemption. Time-limited tolerance is 
established for the combined residues of fenpyroximate, (E)-1,1-
dimethylethyl 4-

[[Page 26322]]

[[[(E)-[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl) methylene] amino]oxy] 
methyl]benzoate in or on honey at 0.10 ppm. This tolerance expires and 
is revoked on the date specified in the following table.

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
Honey.............................           0.10 ppm         12/31/2010
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-8954 Filed 5-8-07; 8:45 am]
BILLING CODE 6560-50-S


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