[Federal Register Volume 75, Number 22 (Wednesday, February 3, 2010)]
[Rules and Regulations]
[Pages 5518-5522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-2145]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0460; FRL-8808-8]


Dithianon; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
dithianon in or on grapes that are imported. BASF requested this 
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 3, 2010. Objections and 
requests for hearings must be received on or before April 5, 2010, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-0460 All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available 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 Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Rose 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: <a href="/cdn-cgi/l/email-protection#d0bbb5b1a2bea3fea2bfa3b5bdb1a2a990b5a0b1feb7bfa6"><span class="__cf_email__" data-cfemail="fd96989c8f938ed38f928e98909c8f84bd988d9cd39a928b">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide 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 Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr. To 
access the OPPTS harmonized test guidelines referenced in this document 
electronically, please go to http://www.epa.gov/oppts and select ``Test 
Methods & Guidelines'' on the left-side navigation menu.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2007-0460 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 as required by 40 CFR part 178 
on or before April 5, 2010.
    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 this copy, identified by docket ID number 
EPA-HQ-OPP-2007-0460, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of November 4, 2009 (74 FR 57170) (FRL-
8797-7), 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 
6E7103) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research 
Triangle Park, NC 27709-3528. The petition requested that 40 CFR 
180.621 be amended by establishing a tolerance for residues of the 
fungicide dithianon, 5,10-dihydro-5-10-dioxonaptho(2,3-b)-1,4-dithiin-
2,3-

[[Page 5519]]

dicarbonitrile, in or on grapes at 3 parts per million (ppm). That 
notice referenced a summary of the petition prepared by BASF, the 
registrant, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in 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 for the petitioned-for 
tolerance, for residues of dithianon on grape at 3 ppm. EPA's 
assessment of exposures and risks associated with establishing 
tolerances 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.
    The acute toxicity is mild via the oral route. The toxicologically 
significant adverse effects of dithianon are similar across species. In 
studies with shorter durations of exposure, including the subchronic 
dog and rat studies, the developmental toxicity study in rats, and the 
2-generation reproduction rat study, decreases in body weight, body 
weight gain, and/or food consumption were noted in adults. However, 
with continued exposure, as in the chronic and/or carcinogenicity 
studies in the rat, mouse, and dog, the kidney is the target organ for 
toxicity. Signs of renal toxicity include increased absolute and/or 
relative kidney weights in the rat, mouse, and dog; non-neoplastic 
kidney lesions in mice and rats; and renal adenomas and carcinomas in 
female rats. Post-implantation loss due to early resorptions was 
observed in the developmental rat study.
    The available toxicology database does not show any indication of 
increased qualitative or quantitative susceptibility of the offspring. 
Dithianon did not cause reproductive or developmental toxicity in the 
2-generation reproduction study. In the developmental rat study, 
decreased fetal weights were observed only at a dose higher than that 
which produced similar maternal effects. The developmental toxicity 
study in rabbits was classified unacceptable/guideline.
    Carcinogenicity studies in rats and mice do not raise a concern as 
to carcinogenicity. The only treatment-related tumors, rare kidney 
tumors, (primarily adenomas), were seen only at the highest dose tested 
(30 milligram/kilogram/day (mg/kg/day)) in one sex (females) and in one 
species (rats). The highest dose tested was considered adequate, but 
not excessive, to assess the carcinogenicity of dithianon; however, 
significant renal toxicity occurred at this dose, which may have 
contributed to the tumor formulation. Although the Agency concluded 
that there was not a sufficient or cohesive dataset at the time to 
fully support a mode of action, it is biologically plausible that the 
tumors were caused by a non-genotoxic mode of action involving 
hephrotoxicity and sustained regenerative proliferation. Further, 
dithianon is not mutagenic. Dithianon produced positive results in an 
acceptable chromosomal aberration assay that was conducted in vitro 
using Chinese hamster lung fibroblasts (V79 cells); in contrast, a 
forward gene mutation assay tested in this same cell line was negative. 
A second forward gene mutation assay with V79 cells was also negative, 
but it was classified unacceptable due to inadequate cytotoxicity at 
the highest concentration tested. Negative responses were seen in 
bacteria (two acceptable reverse gene mutation assays in Salmonella), 
Wistar rat systems (an acceptable in vivo cytogenetic assay and an 
acceptable in vitro UDS assay), and NMRI mice (an unacceptable in vivo 
micronucleus assay).
    Specific information on the studies received and the nature of the 
adverse 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 at http://www.regulations.gov in the document ``Dithianon-Human Health Risk 
Assessment for Proposed Tolerance on Imported Grapes,'' at pages 9-12 
in docket ID number EPA-HQ-OPP-2007-0460.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which the 
NOAEL in the toxicology study identified as appropriate for use in risk 
assessment. However, if a NOAEL cannot be determined, the lowest dose 
at which adverse effects of concern are identified (the LOAEL) or a 
benchmark dose (BMD) approach is sometimes used for risk assessment. 
Uncertainty/safety factors (UFs) are used in conjunction with the POD 
to take into account uncertainties inherent in the extrapolation from 
laboratory animal data to humans and in the variations in sensitivity 
among members of the human population as well as other unknowns. Safety 
is assessed for acute and chronic dietary risks by comparing aggregate 
food and water exposure to the pesticide to the acute population 
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The 
aPAD and cPAD are calculated by dividing the POD by all applicable UFs. 
Aggregate short-, intermediate-, and chronic-term risks are evaluated 
by comparing food, water, and residential exposure to the POD to ensure 
that the margin of exposure (MOE) called for by the product of all 
applicable UFs is not exceeded. This latter value is referred to as the 
level of concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for dithianon used for 
human

[[Page 5520]]

risk assessment can be found at http://www.regulations.gov in the 
document ``Dithianon -- Human Health Risk Assessment for Proposed 
Tolerance on Imported Grapes,'' at pages 20-24 in docket ID number EPA-
HQ-OPP-2007-0460.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to dithianon, EPA considered exposure under the petitioned-for 
tolerances as well as all existing dithianon tolerances in (40 CFR 
180.621). EPA assessed 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 1-day or single exposure.
    No such effects were identified applicable to the general 
population in the toxicological studies for dithianon; therefore, a 
quantitative acute dietary exposure assessment is unnecessary. However 
an endpoint was identified for females 13-49 years of age. In 
conducting the acute dietary exposure assessment EPA used the Dietary 
Exposure Evaluation Model-Food Commodity Intake Database (DEEM-FCID, 
version 2.03). EPA assumed that dithianon is used on all crops covered 
by tolerances and that all treated crops bear tolerance-level residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM-FCID, version 2.03. EPA assumed that 
dithianon is used on all crops covered by tolerances and that all 
treated crops bear average values from crop residue field trials.
    iii. Cancer. For the reasons explained in Unit III.A., EPA has 
concluded that dithianon does not pose a cancer risk and therefore an 
exposure assessment for the purpose of evaluating cancer risk is 
unnecessary.
    iv. Anticipated residue information. Section 408(b)(2)(E) of FFDCA 
authorizes EPA to use available data and information on the anticipated 
residue levels of pesticide residues in food and the actual levels of 
pesticide residues that have been measured in food. If EPA relies on 
such information, EPA must require pursuant to FFDCA section 408(f)(1) 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. For the present action, EPA will 
issue such data call-ins as are required by FFDCA section 408(b)(2)(E) 
and authorized under FFDCA section 408(f)(1). Data will be required to 
be submitted no later than 5 years from the date of issuance of these 
tolerances.
    2. Dietary exposure from drinking water. Current and proposed 
tolerances for dithianon are intended to support imported commodities 
only and there are no existing or proposed U.S. registrations. 
Therefore, 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 any specific use patterns that 
would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found dithianon to share a common mechanism of toxicity 
with 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 assumed that dithianon does not 
have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA SF. In 
applying this provision, EPA either retains the default value of 10X, 
or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There is no indication of 
increased quantitative or qualitative susceptibility of rats to in 
utero and/or postnatal exposure to dithianon.
    3. Conclusion. The FQPA Safety Factor will be retained at 10X as a 
database uncertainty factor for acute and chronic assessments. The 
primary reason for retaining the FQPA safety factor is residual 
uncertainty concerning lack of an acceptable rabbit development study. 
In deciding to retain the safety factor EPA also took into account the 
following considerations:
    i. Immunotoxicity testing is required as a result of changes made 
to the pesticide data requirements in December 2007. Although a study 
has not yet been submitted, there is no evidence of immunotoxicity in 
any study in the toxicity database for dithianon and the Agency does 
not believe that conducting an immunotoxicity study will result in a 
lower POD than that currently used for overall risk assessment. 
Therefore, a database uncertainty factor (UFDB ) is not needed to 
account for the lack of this study.
    ii. Acute and subchronic neurotoxicity testing is required as a 
result of changes made to the pesticide data requirements in December 
2007. Although these studies have not yet been submitted, there is no 
evidence of neurotoxicity in any study in the toxicity database for 
dithianon and the Agency does not believe that conducting these studies 
will result in a lower POD than that currently used for overall risk 
assessment. Therefore, a UFDB is not needed to account for the lack of 
this study. For the same reason, EPA has determined that there is no 
need for a developmental neurotoxicity study.
    iii. There is no evidence that dithianon results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental study or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues for the acute analysis and 
reliable data on average field trial residues in the chronic analysis. 
The exposure assessments will not understate exposure to dithianon.

[[Page 5521]]

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to dithianon will occupy 79% of the aPAD for (females 13-49 years of 
age at the 95th percentile of exposure) the population group receiving 
the greatest exposure.
    2. Chronic risk. The exposure for all populations assessed are 
below the level of concern. The exposure for the general U.S. 
population is at 18% of cPAD. The most highly exposed sub-group is 
children ( 1-2 years old), whose exposure is at 63% of the cPAD. This 
assessment is slightly refined with use of average residue values and 
empirical processing factors, but is still highly conservative with the 
assumption of 100% CT. There are no residential uses for dithianon.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Dithianon is not registered for any use patterns that would result 
in residential exposure. Therefore, the short-term aggregate risk is 
the sum of the risk from exposure to dithianon through food and water 
and will not be greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Dithianon is not registered for any use patterns that would result 
in intermediate-term residential exposure. Therefore, the intermediate-
term aggregate risk is the sum of the risk from exposure to dithianon 
through food and water, which has already been addressed, and will not 
be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. As described in Unit 
III.A. above, dithianon is not expected to pose a cancer risk.
    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, or to infants and children from aggregate 
exposure to dithianon residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate methodology LC/MS/MS method (BASF 244882) is available 
for enforcing the proposed tolerance on grapes. Adequate multi-residue 
method testing data are available for dithianon and these data have 
been forwarded to the FDA for evaluation. The data indicate that FDA 
multi-residue methods are not suitable for determining residues of 
dithianon.

B. International Residue Limits

    There are currently no established Canadian or Mexican maximum 
residue limits (MRLs) for dithianon on grapes. There are no 
harmonization concerns with MRL's on grapes established by Codex and 
the European Union because the grape tolerance being established is 
equivalent to these MRLs both in terms of residue expression and 
residue level.

C. Revisions to Petitioned-For Tolerances

    EPA has revised the dithianon tolerance expression to clarify the 
chemical moieties that are covered by the tolerances and specify how 
compliance with the tolerances is to be measured. The revised tolerance 
expression makes clear that the tolerances cover residues of dithianon 
and its metabolites and degradates but that compliance with tolerance 
levels will be determined by measuring only dithianon, (5,10-dihydro-
5,10-dioxonaphtho(2-3-b)-1,4-dithiin-2,3-dicarbonitrile), in or on the 
commodities that have an established tolerance level. EPA has 
determined that it is reasonable to make this change final without 
prior proposal and opportunity for comment, because public comment is 
not necessary, in that the change has no substantive effect on the 
tolerance, but rather is merely intended to clarify the existing 
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of dithianon, 
5,10-dihydro-5,10-dioxonaphtho(2,3-b)-1,4-dithiin-2,3-dicarbonitrile, 
in or on grapes at 3 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final

[[Page 5522]]

rule does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: January 25, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.621 is revised to read as follows:


Sec.  180.621  Dithianon; tolerances for residues.

    (a) General. Tolerances are established for residues of dithianon, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below 
is to be determined by measuring only dithianon, 5, 10-dihydro-5,10-
dioxonaphtho(2,3-b)-1,4-dithiin-2,3-dicarbonitrile.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Fruit, pome, group 11\1\................................               5
Grape \2\...............................................               3
Hop, dried cones\1\.....................................             100
 
------------------------------------------------------------------------
\1\No U.S. registration as of September 5, 2006.
\2\No U.S. registration as of January 29, 2010.

    (b)Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2010-2145 Filed 2-2-10; 8:45 am]
BILLING CODE 6560-50-S


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