[Federal Register: August 23, 2006 (Volume 71, Number 163)]
[Rules and Regulations]
[Page 49364-49368]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23au06-17]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0216; FRL-8087-6]
Fenpyroximate; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for combined residues
of fenpyroximate and its z-isomer in or on hop, dried cones; almond
hulls; nut, tree, group 14; pistachio; fruit, citrus, group 10; citrus,
dried pulp; citrus, oil; peppermint, tops; and spearmint, tops.
Interregional Project Number 4 (IR-4) requested these tolerances under
the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the
Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective August 23, 2006. Objections and
requests for hearings must be received on or before October 23, 2006,
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-2006-0216. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: 703-308-3194; e-mail address:
brothers.shaja@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 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattleranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
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 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-2006-0216 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 October 23, 2006.
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-2006-0216, 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
Building), 2777 S. Crystal Drive, 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 telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of August 10, 2005 (70 FR 46444) (FRL-7729-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5E6943) by IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ
08902-3390. The petition requested that 40 CFR 180.566 be amended by
establishing tolerances for combined residues of the insecticide/
miticide fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-
phenoxy-1H-pyrazol-4-yl) methylene]amino]oxy]methyl]benzoate and its Z-
isomer, (Z)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-
4-yl)methylene]amino]oxy] methyl]benzoate, in or on almond hulls at 1.8
parts per million (ppm); nut, tree, group 14 at 0.1 ppm; pistachio at
0.1 ppm; fruit, citrus, group 10; citrus at 0.4 ppm, fruit, citrus,
dried pulp at 2.5
[[Page 49365]]
ppm; citrus, oil at 15 ppm; hop at 4.5 ppm; peppermint, tops at 3.0
ppm; and spearmint, tops at 3.0 ppm. That notice included a summary of
the petition prepared by Nichino America, the registrant. Comments were
received on the notice of filing. EPA's response to these comments is
discussed in Unit IV.C. below.
Following review of the residue chemistry data, EPA determined that
the commodity terms and tolerance levels should be revised to the
following: Almond, hulls at 3.0 ppm; hop, dried cones at 10 ppm ; nut,
tree, group 14 at 0.10 ppm; pistachio at 0.10 ppm; fruit, citrus, group
10 at 0.60 ppm; fruit, citrus, dried pulp revised to read citrus,
dried, pulp at 2.5 ppm; citrus, oil at 10 ppm; peppermint, tops at 7.0
ppm; and spearmint, tops at 7.0 ppm.
Time-limited tolerances for grape, wine and hop (currently revised
to hop, dried cones) have expired under 40 CFR 180.566(a)(1). Permanent
tolerances have been established for these commodities; therefore,
grape, wine and hop, dried cones will be added to 40 CFR 180.566(a)(2).
The petitioner for hop, dried cones has requested a domestic
registration; therefore, footnote 1 to the table in Sec. 180.566(a)(2)
which reads ``There are no U.S. registration on hops'' has been
removed. In addition, registrations for citrus fruits, hops, mint, tree
nuts (including pistachio) have been deemed as conditional and are
contingent upon submission of required additional data.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of 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
.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for tolerances for combined residues of
fenpyroximate and its z-isomer on almond, hulls at 3.0 ppm; hop, dried
cones at 10 ppm; nut, tree, group 14 at 0.10 ppm; pistachio at 0.10
ppm; fruit, citrus, group 10 at 0.60 ppm; citrus, dried, pulp at 2.5
ppm; citrus, oil at 10 ppm; peppermint, tops at 7.0 ppm; and spearmint,
tops at 7.0 ppm. EPA's assessment of exposures and risks associated
with establishing the tolerances follow.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by fenpyroximate as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov
, Docket No. EPA-HQ-OPP-2004-0174-0001, pages 2-4.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides/health/human.htm.
A summary of the toxicological endpoints for fenpyroximate used for
human risk assessment is discussed at http://www.regulations.gov,
Docket No. EPA-HQ-OPP- 2005-0216-0001; pages 14-15.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established in 40 CFR 180.566(a)(2) for the combined residues of
fenpyroximate and its z-isomer, in or on a variety of raw agricultural
commodities. Risk assessments were conducted by EPA to assess dietary
exposures from fenpyroximate in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a one-day or single exposure.
An unrefined, Tier I acute dietary-exposure assessment was
conducted for females 13 to 49 years old. The unrefined, Tier I acute
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 and lime)
and mint oils (peppermint and spearmint). The Dietary Exposure
Evaluation Model (DEEMTM) default processing factors were
used for all other processed commodities.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Data base (DEEM-FCID\TM\), which incorporates
food consumption data 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
[[Page 49366]]
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 population subgroups. The
unrefined, Tier I chronic 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 and lime) and mint oils (peppermint and spearmint).
DEEM\TM\ default processing factors were used for all other processed
commodities.
iii. Cancer. Fenpyroximate is classified as ``not likely to be a
human carcinogen.'' Therefore, a cancer dietary exposure assessment was
not performed.
2. Dietary exposure from drinking water. The Agency determined in
addition to the parent compound (M-1), the M-3 metabolite should be
included in the drinking water assessment for fenpyroximate. Based on
the proposed application rates and the environmental fate properties of
fenpyroximate, some surface and ground water contamination may occur.
However, the risk of water contamination from parent compound is
relatively low, based on its high sorption potential. Unlike parent
compound, the sorption of the M-3 metabolite is much less, and it may
move into water resources more readily. Environmental fate data
indicate that parent and its Z-isomer are stable to photolysis in soil
and immobile in soil. Major degradates formed in the aqueous layer were
M-3 (50%), M-8 (36%), M-16 (4-hydroxymethylbenzoic acid, 58%) and M-11
(25 to 30%), and M-3 (>10%), M-11 (25 to 30%) and M8 (16 to 19%) in the
soil. However, data from a field dissipation study showed M3 (32%)
being the only significant degradate found in the field. Based on the
structural similarity between parent and M-3, the Agency concluded that
parent and M-3 be included in the risk assessment.
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-3
were calculated using the Pesticide Root Zone Model/Exposure Analysis
Modeling System (PRZM-EXAMS). The acute, and chronic non-cancer
concentrations for GA pecan (highest exposure) are 12.9 and 1.8
microgram/liter, respectively. EPA used the Screening Concentration in
Ground Water model (SCI-GROW2) to estimate a groundwater 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 directly
entered into the dietary exposure model (DEEM-FCID). For the acute
assessment, the peak concentration of 12.9 ppb was used to access the
contribution to drinking water; for the chronic assessment, the annual
mean value of 1.8 ppb was used to access 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 Web site at
http://www.epa.gov/pesticides/cumulative/.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
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 at best. These doses were supported partly by
range finding data. The two 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 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 data base is complete for FQPA
purposes and that there are no residual uncertainties for prenatal/
postnatal toxicity.
3. Conclusion. There is a complete toxicity data base for
fenpyroximate and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10X SF 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 data base is complete for the assessment of
toxicity and susceptibility following prenatal and/or postnatal
exposures. No clinical
[[Page 49367]]
signs of neurotoxicity or neuropathology were observed in the data
base.
iii. There are no residual concerns regarding completeness of the
exposure data base.
iv. The dietary food exposure assessment is Tier I, screening
level, which is based on tolerance level residues and assumes 100% of
all crops will be 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 which will not
likely be exceeded.
vi. There are currently no registered or proposed residential uses
of fenpyroximate.
E. Aggregate Risks and Determination of Safety
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 described in this
unit for chronic exposure, EPA has concluded that exposure to
fenpyroximate from food and water will utilize 9.8% of the chronic
adjusted population 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 that
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. Fenpyroximate has
been classified as not likely to be carcinogenic to humans. Therefore,
fenpryroximate is expected to pose at most a negligible cancer risk.
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.
IV. Other Considerations
A. Analytical Enforcement Methodology
An enforcement method has been developed which involves extraction
of fenpyroximate from crops with acetone, filtration, partitioning and
cleanup, and analysis by gas chromatography using a nitrogen/
phosphorous detector. This method allows detection of residues at or
above the proposed tolerances. The method has undergone independent
laboratory validation.
B. International Residue Limits
Codex maximum residue limits (MRLs) are established for residues of
fenpyroximate per se in/on apple, grapes, hops, oranges, and cattle
commodities. The Codex MRLs differ from the proposed and established
tolerances for all commodities except hops. Harmonization with the
other Codex MRLs is not possible because the U.S. tolerance expressions
include additional metabolites/isomers. There are currently no
established Canadian or Mexican MRLs.
C. Response to Comments
Comments were received from a private citizen in Florham Park, New
Jersey. The comments were in response to the notice of filing published
in the Federal Register of August 10, 2005 (70 FR 46444) (FRL-7729-3).
The commenter opposes the establishment of any food tolerances (greater
than zero) and exemptions. However, under the existing legal framework
provided by section 408 of the FFDCA, EPA is authorized to establish
pesticide tolerances or exemptions where persons seeking such
tolerances or exemptions have demonstrated that the pesticide meets the
safety standard imposed by that statute. The commenter also believes
IR-4 and Rutgers University are profiteering, and expressed concerns
about the Agency's partnership with IR-4. This comment was earlier
addressed in the Federal Register of June 30, 2005 (70 FR 37683) (FRL-
7718-3).
V. Conclusion
Therefore, the tolerances are established for combined residues of
fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-
pyrazol-4-yl) methylene] amino]oxy]methyl]benzoate and its Z-isomer,
(Z)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene] amino]oxy]methyl]benzoate, in or on almond, hulls at 3.0
ppm; hop, dried cones at 10 ppm; nut, tree, group 14 at 0.10 ppm;
pistachio at 0.10 ppm; fruit, citrus, group 10 at 0.60 ppm; citrus,
dried, pulp at 2.5 ppm; citrus, oil at 10 ppm; peppermint, tops at 7.0
ppm; and spearmint, tops at 7.0 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
[[Page 49368]]
Federalism (64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of FFDCA. For these same reasons, the
Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
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: August 11, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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2. Section 180.566 is amended by removing paragraph (a)(1), by
redesignating paragraph (a)(2) as paragraph (a)(1), by revising the
table in newly redesignated paragraph (a)(1), and by redesignating
paragraphs (a)(3) and (a)(4) as paragraphs (a)(2) and (a)(3),
respectively, to read as follows:
Sec. 180.566 Fenpyroximate; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond, hulls........................................... 3.0
Citrus, dried pulp...................................... 2.5
Citrus, oil............................................. 10
Cotton, gin byproducts.................................. 10
Cotton undelinted seed.................................. 0.10
Fruit, citrus, group 10................................. 0.60
Fruit, pome, group 11................................... 0.40
Grape................................................... 1.0
Hop, dried cones........................................ 10
Nut, tree, group 14..................................... 0.10
Peppermint, tops........................................ 7.0
Pistachio............................................... 0.10
Spearmint, tops......................................... 7.0
------------------------------------------------------------------------
* * * * *
[FR Doc. E6-13761 Filed 8-22-06; 8:45 am]
BILLING CODE 6560-50-S