[Federal Register: September 20, 2006 (Volume 71, Number 182)]
[Rules and Regulations]
[Page 54917-54922]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20se06-11]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0623; FRL-8090-5]
Dithianon; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
dithianon, (5,10-dihydro-5,10-dioxonaphtho(2,3-b)-1,4-dithiin-2,3-
dicarbonitrile in or on imported fruit, pome, group 11, and hop, dried
cones. BASF Corporation requested this tolerance 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 September 20, 2006. Objections and
requests for hearings must be received on or before November 20, 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-2006-0623. 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: Rose Mary Kearns, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-5611; e-mail address:
kearns.rosemary@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., cattle ranchers 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.
To access the
[[Page 54918]]
OPPTS Harmonized Guidelines referenced in this document, go directly to
the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm.
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-2006-0623. 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 November 20, 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-2006-0623, 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 April 12, 2006 (71 FR 19733) (FRL-7767-
7), 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
6E4781) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research
Triangle Park, N.C. 22709. The petition requested that 40 CFR part 180
be amended by establishing a tolerance for residues of the fungicide
dithianon, 5,10-dihydro-5,10-dioxonaphtho(2,3-b)-1,4-dithiin-2,3-
dicarbonitrile, in or on imported fruit, pome, group 11 at 5 parts per
million (ppm) and hop, dried cones at 100 ppm. There were no comments
received in response to the notice of filing.
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 a tolerance for residues of dithianon on fruit,
pome, group 11 at 5 parts per million and hop, dried cones at 100 ppm.
EPA's assessment of exposures and risks associated with establishing
the tolerance follows.
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 dithianon 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 either in the
docket ID number HQ-EPA-2006-0623 at http://www.regulations.gov or at
http://www.epa.gov/opprd001/factsheets.
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/factsheets/riskassess.htm or http://www.epa.gov/oppfead1/trac/science.
1/trac/science.
human risk assessment is shown in Table 1 of this unit:
[[Page 54919]]
Table 1.--Summary of Toxicological Dose and Endpoints for Dithianon for Use in Human Risk Assessment
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Dose Used in Risk
Assessment, Special FQPA SF and
Exposure/Scenario Interspecies and Level of Concern for Study and Toxicological
Intraspecies and any Risk Assessment Effects
Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-49 years of NOAEL = 20 mg/kg/day... Special FQPA SF = 1.... Developmental toxicity
age). UF = 1,000............. aPAD = acute RfD/ study in rats.
aAcute RfD = 0.02 mg/kg/ Special FQPA SF = 0.02 LOAEL = 50 mg/kg/day
day. mg/kg/day. based on post
implantation loss due
to early resorptions
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population None................... None................... Not selected.
including infants and children). No appropriate dose and
endpoint could be
identified for these
population groups.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations).... NOAEL = 6 mg/kg/day.... Special FQPA SF = 1.... Combined chronic
UF = 1,000............. cPAD = chronic RfD/ toxicity/oncogenicity
a Chronic RfD = 0.006 Special FQPA SF = study in rats.
mg/kg/day. 0.006 mg/kg/day. LOAEL = 30 mg/kg/day
based on decreased
body weight gains and
increased relative to
body kidney weights (M
and F), grossly
observed kidney
lesions in males
(irregular surfaces,
pale kidneys, cysts,
and enlarged kidneys)
and females (masses),
and non-neoplastic
lesions of the kidney
in males (tubular
nephrosis, renal
cysts, and end-stage
kidney lesions) and
females (tubular
nephrosis,
proliferative tubules,
and
glomerulonephropathy).
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) ....................... ....................... Classification:
Classification is
``Suggestive Evidence
of Carcinogenic
Potential''. The risk
assessment for chronic
effects is considered
protective of any
cancer effect.
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest
observed effect level, PAD = population adjusted dose (a = acute, c = chronic), RFD = reference dose, MOE =
margin of exposure, LOC = level of concern, N/A = Not Applicable, \a\ Additional 10x database uncertainty
factor for lack of an acceptable developmental rabbit study.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have not
been established for the residues of dithianon, in or on a variety of
raw agricultural commodities because it is a new pesticide chemical.
Risk assessments were conducted by EPA to assess dietary exposures from
dithianon 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 appropriate endpoint attributable to a single exposure for
females 13-49 years of age was identified in the toxicological studies
for dithianon, therefore, a quantitative acute dietary exposure
assessment is necessary for this population. In conducting the acute
dietary exposure assessment EPA used the Dietary Exposure Evaluation
Model software with the Food Commodity Intake Database (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 following assumptions were made for the acute
exposure assessment. This acute analysis was based on tolerance-level
residues, and an assumption of 100% crop treated.
No appropriate dose and endpoint could be identified attributable
to a single exposure for the general population, including infants and
children. Therefore, an acute dietary exposure assessment is not
necessary for these populations.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (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 following assumptions were made for the chronic exposure
assessment: This chronic analysis was based on anticipated (average)
residues and an assumption of 100% crop treated. Exposure to dithianon
would originate from food only, because the proposed tolerances would
only be established on imported commodities. With no proposed U.S.
registration, there is no expectation that dithianon residues would
occur in surface or ground water sources of drinking water.
iii. Cancer. The Agency classified dithianon as having ``Suggestive
Evidence of Carcinogenicity'', based on the presence of renal adenomas
and carcinomas in the female rat at doses that were adequate to assess
carcinogenicity. This classification is based on several weight-of-
evidence
[[Page 54920]]
considerations. First treatment-related rare kidney tumors, primarily
adenomas, were seen only at the highest dose tested (HDT) (600 ppm) in
one sex (females) and in one species (rats). The HDT was considered
adequate, but not excessive, to assess the carcinogenicity of
dithianon; however, significant renal toxicity occurred at this dose.
Second, there is no mutagenicity concern for dithianon. Finally, the
Agency concluded that the registrant's hypothesized non-genotoxic mode
of action involving nephrotoxicity and sustained regenerative
proliferation is biologically plausible. The risk assessment for
chronic effects is considered protective of any cancer effects.
2. Dietary exposure from drinking water. Since dithianon is
proposed for use only on imported pome fruit and imported hops
commodities, the sole anticipated exposure route for the U.S.
population is via dietary (food) exposure. With no proposed U.S.
registration, there is no expectation that dithianon residues would
occur in surface or ground water sources of 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).
Dithianon 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 dithianon and any other
substances and dithianon 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 dithianon 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.
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. There is no indication of
increased quantitative or qualitative susceptibility of the offspring
in the developmental and 2-generation reproduction studies. In the
developmental toxicity study in rats, reductions in maternal body
weights, body weight gains, and food consumption were seen at 50 mg/kg/
day, but a higher dose (100 mg/kg/day) was required to produce a
reduction in fetal body weights. The significant increase in post-
implantation loss due to early resorptions occurred at 50 mg/kg/day,
including dams that experienced total litter loss, is not evidence of
increased qualitative susceptibility; instead, it is likely due to
maternal toxicity. In the 2-generation reproduction study, decreased
body weights, body weight gains, and food consumption were observed in
the parents but no adverse effects were seen in the offspring up to the
HDT.
3. Conclusion. The toxicology database shows no evidence of
increased qualitative or quantitative susceptibility in the offspring.
The dietary food exposure assessment utilizes tolerance level residues
and 100% crop treated assumptions for acute risk, and average residues
from crop field trials and 100% crop treated assumptions for chronic
risk; by using these conservative assumptions, exposures/risks will not
be underestimated. There are no existing or proposed residential uses
for dithianon at this time. Nonetheless, because an acceptable rabbit
developmental study is not available, the Agency retained the 10x FQPA
safety factor, in the form of data base uncertainty factor of
(UFDB).
E. Aggregate Risks and Determination of Safety
1. Acute risk. An acute endpoint was selected for only one
population subgroup, females 13-49. Using the exposure assumptions
discussed in this unit for acute exposure, EPA has concluded that acute
exposure to dithianon from food will utilize 66% of the aPAD for
females 13 to 49 years of age.
Table 2.--Aggregate Risk Assessment for Acute and Chronic Exposure to Dithianon
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Acute dietary (95th Percentile)* Chronic dietary*
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Population subgroup aPAD (mg/ Exposure cPAD (mg/ Exposure
kg) (mg/kg/day) % aPAD kg) (mg/kg/day) % cPAD
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General U.S. Population Not Not Not 0.006 .000738 12
applicable. applicable. applicable.
----------------------------------------------------------------------------------------------------------------
All Infants < 1 year Not Not Not 0.006 0.003268 55
applicable. applicable. applicable.
----------------------------------------------------------------------------------------------------------------
Children 1-2 years Not Not Not 0.006 0.002773 46
applicable. applicable. applicable.
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[[Page 54921]]
Children 3-5 years Not Not Not 0.006 0.001995 33
applicable. applicable. applicable.
----------------------------------------------------------------------------------------------------------------
Children 6-12 years Not Not Not 0.006 0.000903 15
applicable. applicable. applicable.
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Youths 13-19 years Not Not Not 0.006 0.000313 5
applicable. applicable. applicable.
----------------------------------------------------------------------------------------------------------------
Adults 20-49 years Not Not Not 0.006 0.000583 10
applicable. applicable. applicable.
----------------------------------------------------------------------------------------------------------------
Adults 50+ years Not Not Not 0.006 0.000483 8
applicable. applicable. applicable.
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Females 13-49 years 0.02 .013119 66 0.006 0.000369 6
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* Values for the population with the highest risk are bolded.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
dithianon from food will utilize 12% of the cPAD for the U.S.
population and 55% of the cPAD for all infants less than 1 year of age.
There are no residential uses for dithianon that result in chronic
residential exposure to dithianon.
3. Short-term risk. Dithianon is not registered for use on any
sites that would result in residential exposure. Therefore, the
aggregate risk is the risk from food only, which does not exceed the
Agency's level of concern.
4. Intermediate-term risk. Dithianon is not registered for use on
any sites that would result in residential exposure and is intended
only for imported fruit, pome, group 11 and hops, dried cones.
Therefore, the aggregate risk is the risk from food only, which does
not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. In accordance with
EPA's Final Guidelines for Carcinogen Risk Assessment (March, 2005),
the Agency classified dithianon into the category ``Suggestive Evidence
of Carcinogenicity'', based on the presence of renal adenomas and
carcinomas in the female rat at doses that were adequate to assess
carcinogenicity. However, as noted in Unit.III.C.1.iii., the chronic
risk assessment is protective of any possible cancer effect.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to dithianon residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (HPLC/UV for pome fruit and HPLC/
ECD for hops) is available to enforce the tolerance expression. The
method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
Codex MRLs have been established for residues of dithianon in or on
pome fruit at 5 ppm and hops at 100 ppm; the proposed tolerances on
imported commodities are harmonized with established MRLs. There are
currently no established Canadian or Mexican MRLs for dithianon.
V. Conclusion
Therefore, a tolerance is established for residues of dithianon,
5,10-dihydro-5,10-dioxonaphtho(2,3-b)-1,4-dithiin-2,3-dicarbonitrile,
in or on imported fruit, pome, group 11 at 5 ppm and hop, dried cones
at 100 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,
[[Page 54922]]
or on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132, entitled
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: September 11, 2006.
James Jones,
Director, 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 180.621 is added to read as follows:
Sec. 180.621 Dithianon; tolerances for residues.
(a) General. Tolerances are established for residues of the
fungicide dithianon, (5,10-dihydro-5,10-dioxonaphtho(2,3-b)-1,4-
dithiin-2,3-dicarbonitrile) in or on the following commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Fruit, pome, group 11\1\....... 5
Hop, dried cones\1\............ 100
------------------------------------------------------------------------
\1\No U.S. registration as of September 5, 2006.
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E6-15460 Filed 9-19-06; 8:45 am]
BILLING CODE 6560-50-S