[Federal Register Volume 74, Number 41 (Wednesday, March 4, 2009)]
[Rules and Regulations]
[Pages 9351-9356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4370]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0258; FRL-8401-6]


Dimethomorph; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
dimethomorph in or on ginseng and turnip, greens. Additionally, it 
establishes tolerances with regional registrations in or on beans, 
lima, succulent and grape. This regulation also deletes the existing 
grape import tolerance, as a regional tolerance supersedes it. Finally, 
it increases the existing tolerance level for potato, wet peel and re-
establishes the tolerance for potato. The Interregional Research 
Project Number 4 (IR-4) requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 4, 2009. Objections and 
requests for hearings must be received on or before May 4, 2009, 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-2008-0258. 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: Laura Nollen, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7390; e-mail address: <a href="/cdn-cgi/l/email-protection#701e1f1c1c151e5e1c11050211301500115e171f06"><span class="__cf_email__" data-cfemail="731d1c1f1f161d5d1f12060112331603125d141c05">[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).

[[Page 9352]]

    <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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents 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 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 
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 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-2008-0258 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 May 4, 2009.
    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-2008-0258, 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 May 16, 2008 (73 FR 28461) (FRL-8361-6), 
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 8E7314) 
by Interregional Research Project (IR-4), 500 College Rd. East, Suite 
201 W., Princeton, NJ 08540. The petition requested that 40 CFR 180.493 
be amended by establishing tolerances for residues of the fungicide 
dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-
oxo-2-propenyl]morpholine, in or on beans, lima at 0.60 parts per 
million (ppm); ginseng at 0.85 ppm; grape at 3.5 ppm; grape, raisin at 
6.0 ppm; and turnip, greens at 20.0 ppm. In the Federal Register of 
October 8, 2008 (73 FR 58962) (FRL-8383-7), EPA issued a notice 
pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), 
announcing the filing of an amendment to the pesticide petition (PP 
8E7314) by IR-4, which requested that 40 CFR 180.493 be amended for 
residues of the fungicide dimethomorph by increasing the tolerance in 
or on potato, wet peel from 0.15 ppm to 0.20 ppm, and re-establishing 
the tolerance in or on potato at 0.05 ppm. These notices referenced a 
summary of the petition prepared on behalf of IR-4 by BASF Corporation, 
the registrant, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the 
notices of filing.
    Based upon review of the data supporting the petition, EPA has 
determined that the proposed tolerance level for ginseng should be 
increased. EPA has additionally determined that the proposed tolerances 
for beans, lima and grape should be established as regional tolerances, 
and that the import tolerance for grape, raisin should remain. The 
reasons for these changes are explained in Unit IV.D.

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 
tolerances for residues of dimethomorph on beans, lima at 0.60 ppm; 
ginseng at 0.90 ppm; grape at 3.5 ppm; grape, raisin at 6.0 ppm; potato 
at 0.05 ppm; potato, wet peel at 0.20 ppm; and turnip, greens at 20 
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 existing dimethomorph data indicate that it possesses 
relatively low toxicity. No appropriate toxicological endpoints 
attributable to a single exposure were identified in oral studies. 
Consequently, it was determined that there was no basis for selecting a 
dose

[[Page 9353]]

and endpoint for an acute reference dose (aRfD).
    In the dimethomorph rat chronic dietary feeding study, there were 
significant body weight decrements, and liver effects in female rats. 
Available data for dimethomorph do not show potential for immunotoxic 
nor neurotoxic effects. Neither the subchronic nor chronic toxicity 
studies in rats or dogs, nor the developmental toxicity studies 
indicated that the nervous system was affected by treatment with 
dimethomorph.
    Based on the toxicity profile for dimethomorph, a developmental 
neurotoxicity (DNT) study in rats is not required. In a carcinogenicity 
study in rat, there was no evidence of increased incidence of any 
neopolasms at any doses. In a carcinogenicity study in mice, there was 
no dose-related decrease in survival, or in any parameter examined on 
necropsy. At the maximum dose required by the test guidelines for a 
dietary oncogenicity study, there was no evidence of carcinogenicity. 
Therefore, the EPA classified dimethomorph as ``not likely to be 
carcinogenic to humans.''
    The toxicology data on dimethomorph provides no indication of 
enhanced sensitivity of infants and children, based on the results from 
developmental studies conducted with rats and rabbits, as well as a 2-
generation reproduction study conducted with rats. There were no toxic 
effects observed in either the rat developmental toxicity, or the rat 
2-generation reproductive toxicity studies, that were observed at lower 
doses than those which produced toxic effects in the parents. No 
developmental toxicity was demonstrated in the rabbit developmental 
toxicity study.
    Specific information on the studies received and the nature of the 
adverse effects caused by dimethomorph as well as the no-observed-
adverse-effect-level and the lowest-observed-adverse-effect-level from 
the toxicity studies can be found at http://www.regulations.gov in 
document ``Dimethomorph. Human Health Risk Assessment for the Proposed 
Food/Feed Use of the Fungicide (Associated with Section 3 Registration) 
on Succulent Lima Beans, Ginseng, Grapes and Turnip Tops'' at pages 46-
49 in docket ID number EPA-HQ-OPP-2008-0258.

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 no 
adverse effects are observed (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-term, 
intermediate-term, 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 dimethomorph used for 
human risk assessment can be found at http://www.regulations.gov in 
document ``Dimethomorph. Human Health Risk Assessment for the Proposed 
Food/Feed Use of the Fungicide (Associated with Section 3 Registration) 
on Succulent Lima Beans, Ginseng, Grapes and Turnip Tops'' at pages 17-
18 in docket ID number EPA-HQ-OPP-2008-0258.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to dimethomorph, EPA considered exposure under the petitioned-
for tolerances as well as all existing dimethomorph tolerances in (40 
CFR 180.493). EPA assessed dietary exposures from dimethomorph 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 in the toxicological studies for 
dimethomorph; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the U.S. Department 
of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys 
of Food Intake by Individuals (CSFII). As to residue levels in food, 
EPA used tolerance-level residues, the Dietary Exposure Evaluation 
Model (DEEM) default processing factors, and assumed 100 percent crop 
treated (PCT) for all proposed commodities.
    iii. Cancer. Based on the results of the carcinogenicity studies in 
rats and mice, dimethomorph has been classified as ``not likely to be 
carcinogenic to humans;'' therefore, a quantitative exposure assessment 
to evaluate cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for dimethomorph. Tolerance level residues and/or 100 PCT were assumed 
for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for dimethomorph in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of dimethomorph. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    The First Index Reservoir Screening Tool (FIRST) Tier 1 model was 
used to estimate concentrations for dimethomorph in surface water. The 
Tier 1 Screening Concentration in Ground Water (SCI-GROW) model was 
utilized to predict concentrations in ground water. The Tier 1 Generic 
Estimated Environmental Concentration (GENEEC) model, from a previous 
drinking water assessment, calculated another estimated drinking water 
concentration (EDWC) for dimethomorph in surface water. The EDWCs of 
dimethomorph for acute exposures are estimated to be 81.1 parts per 
billion (ppb) for surface water and 0.264 ppb for ground water. For 
chronic exposures, the non-cancer assessments are estimated to be 24.7 
ppb for surface water, 28.5 ppb for a previously

[[Page 9354]]

determined surface water assessment, and 0.264 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the most conservative water concentration of value 28.5 
ppb, from GENEEC modeling, was used to assess the contribution to 
drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Dimethomorph 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 dimethomorph to share a common mechanism of 
toxicity with any other substances, and dimethomorph does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
dimethomorph 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 Food Quality 
Protection Act (FQPA) safety factor (SF). In applying this provision, 
EPA either retains the default value of 10X, or uses a different 
additional SF when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. The toxicology data on 
dimethomorph provides no indication of enhanced sensitivity of infants 
and children, based on the results from developmental studies conducted 
with rats and rabbits, as well as a 2-generation reproduction study 
conducted with rats. There were no toxic effects observed in either the 
rat developmental toxicity, or the rat 2-generation reproductive 
toxicity studies, that were observed at lower doses than those which 
produced toxic effects in the parents. Further, clear NOAELs were 
observed for all effects observed in fetuses. These NOAELs are well 
above the NOAEL used as a point of departure in assessing the safety of 
dimethomorph. No developmental toxicity was demonstrated in the rabbit 
developmental toxicity study. Additionally, there is no evidence of 
neurotoxicity.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for dimethomorph is complete except for 
the immunotoxicity, acute neurotoxicity, and subchronic neurotoxicity 
studies. Recent changes to 40 CFR part 158 make acute and subchronic 
neurotoxicity testing (OPPTS Guideline 870.6200), and immunotoxicity 
testing (OPPTS Guideline 870.7800) required for pesticide registration. 
The available data for dimethomorph do not show potential for 
immunotoxic or neurotoxic effects. Therefore, EPA does not believe that 
conducting OPPTS Guideline 870.6200 neurotoxicity and OPPTS Guideline 
870.7800 immunotoxicity studies will result in a NOAEL lower than the 
NOAEL of 11 milligram/kilogram/day (mg/kg/day) already set for 
dimethomorph. Consequently, an additional database uncertainty factor 
(UF) does not need to be applied.
    ii. There is no indication that dimethomorph is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. The developmental and reproductive toxicity data did not 
indicate increased quantitative or qualitative susceptibility of rats 
or rabbits to in utero and/or postnatal exposure to dimethomorph. There 
are no residual concerns regarding developmental effects in the young.
    iv. There are no residual uncertainties identified in the exposure 
databases. Dietary food exposure assessments were performed based on 
100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to dimethomorph in drinking water. These assessments 
will not underestimate the exposure and risks posed by dimethomorph.

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-term, intermediate-term, 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. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. No acute dietary endpoint was identified for any 
segment of the U.S. population. Therefore, dimethomorph is not expected 
to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
dimethomorph from food and water will utilize 20% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for dimethomorph to consider.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account short-term and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Dimethomorph is not registered for any use patterns that would 
result in residential exposure. Therefore, the short-term and 
intermediate-term aggregate risk is the sum of the risk from exposure 
to dimethomorph through food and water and will not be greater than the 
chronic aggregate risk.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in mice and rats at doses that were judged 
to be adequate to assess the carcinogenic potential, dimethomorph was 
classified

[[Page 9355]]

as ``not likely to be carcinogenic to humans.'' Therefore, dimethomorph 
is not expected to pose a cancer risk to humans.
    5. 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 dimethomorph residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (High-Performance Liquid 
Chromatography using Ultraviolet detection (HPLC/UV) Method, (FAMS) 
002-04) 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: 
<a href="/cdn-cgi/l/email-protection#275542544e4352424a42534f4843546742574609404851"><span class="__cf_email__" data-cfemail="8af8eff9e3eeffefe7effee2e5eef9caeffaeba4ede5fc">[email protected]</span></a>.

B. International Residue Limits

    There are no Canadian or Mexican maximum residue limits (MRLs) 
established for residues of dimethomorph in crops associated with this 
review. Codex MRLs have been finalized in grapes and grape, raisins at 
2 and 5 ppm, respectively. However, the proposed tolerances in grape 
and grape, raisin (3.5 and 6.0 ppm, respectively) cannot be harmonized 
with the Codex MRLs on these commodities because field trial data shows 
residue levels for grape that are higher than 2 ppm.

C. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petition, EPA revised 
the proposed tolerance for ginseng, from 0.85 ppm to 0.90 ppm. EPA 
revised the proposed tolerance based on analysis of the residue field 
trial data using the Agency's Tolerance Spreadsheet in accordance with 
the Agency's Guidance for Setting Pesticide Tolerances Based on Field 
Trial Data. EPA also changed the commodity term from ``bean, lima'' to 
``bean, lima, succulent'' because field trial data for dry lima beans 
was not submitted. Use on lima beans is restricted to those varieties 
intended for harvest as succulent seed. Use on lima beans is also 
restricted to areas east of the Rocky Mountains, and will therefore be 
established as a regional tolerance under paragraph (c) Tolerances with 
regional registrations in Sec. 180.493. The proposed tolerance for 
grape will also be restricted to a regional tolerance under 
Sec. 180.493(c), since data were submitted to support use of 
dimethomorph on grapes grown east of the Rocky Mountains. Since grapes 
processed for raisin production are only grown west of the Rock 
Mountains, the import tolerance for raisins will remain, and a 
tolerance for raisin under Sec.  180.493(c) will not be established.

V. Conclusion

    Therefore, tolerances are established for residues of dimethomorph 
(E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-
propenyl]morpholine, in or on ginseng at 0.90 ppm and turnip, greens at 
20.0 ppm. Tolerances with regional registrations are established in or 
on bean, lima, succulent at 0.6 ppm and grape at 3.5 ppm. This 
regulation also deletes the existing tolerance for use in or on grape, 
as the regional tolerance supersedes it. Finally, it increases the 
existing import tolerance level for potato, wet peel from 0.15 to 0.20 
ppm and re-establishes the tolerance for potato at 0.05 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to petitions 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 tolerances 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 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.



[[Page 9356]]


    Dated: February 12, 2009.
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 180.493 is amended as follows:

0
i. In paragraph (a), by revising the introductory text; in the table by 
removing the entry ``Grape,'' by revising the entry ``Potato, wet 
peel'' and Footnote 1, and by alphabetically adding the following 
commodities to the table to read as follows:

0
ii. By revising paragraph (c) to read as follows:


Sec.  180.493  Dimethomorph; tolerances for residues.

     (a) General. Tolerances are established for the residues of the 
fungicide dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-
dimethoxyphenyl)-1-oxo-2-propenyl]morpholine, in or on the following 
commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Ginseng....................................................         0.90
Grape, raisin\1\...........................................          6.0
                                * * * * *
Potato.....................................................         0.05
Potato, wet peel...........................................         0.20
                                * * * * *
Turnip, greens.............................................         20.0
                               * * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of March 4, 2009, for the use of
  dimethomorph on grapes grown for raisin production.

* * * * *
    (c) Tolerances with regional registrations. Tolerances with 
regional registrations are established for residues of the fungicide 
dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-
oxo-2-propenyl]morpholine, in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Bean, lima, succulent......................................         0.60
Grape......................................................          3.5
------------------------------------------------------------------------

* * * * *
[FR Doc. E9-4370 Filed 3-3-09; 8:45 am]
BILLING CODE 6560-50-S


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