[Federal Register Volume 71, Number 182 (Wednesday, September 20, 2006)]
[Rules and Regulations]
[Pages 54917-54922]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-15460]


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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: 
[email protected].

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.
    A summary of the toxicological endpoints for dithianon used for 
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
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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
----------------------------------------------------------------------------------------------------------------
                                       Acute dietary (95th Percentile)*               Chronic dietary*
                                   -----------------------------------------------------------------------------
        Population subgroup          aPAD (mg/     Exposure                 cPAD (mg/     Exposure
                                        kg)      (mg/kg/day)     % aPAD        kg)      (mg/kg/day)     % cPAD
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

[[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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
Females 13-49 years                        0.02      .013119           66        0.006     0.000369            6
----------------------------------------------------------------------------------------------------------------
* 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: 
[email protected].

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]
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