Dimethomorph; Pesticide Tolerances, 52403-52408 [2015-21192]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 80, Number 168 (Monday, August 31, 2015)]
[Rules and Regulations]
[Pages 52403-52408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21192]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0531; FRL-9932-26]


Dimethomorph; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes, and removes tolerances for 
residues of dimethomorph in or on multiple commodities which are 
identified and discussed later in this document. BASF Corporation 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA). EPA is correcting the CAS name of dimethomorph in 40 CFR 
180.493(a), 40 CFR 180.493(c), and 40 CFR 180.493(d).

DATES: This regulation is effective August 31, 2015. Objections and 
requests for hearings must be received on or before October 30, 2015, 
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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2014-0531, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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 site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 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-2014-0531 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
October 30, 2015. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    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 (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2014-0531, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of December 17, 2014 (79 FR 75107) (FRL-
9918-90), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
4F8281) by BASF Corporation, P.O. Box 13528, Research Triangle Park, 
North Carolina, 27709. The petition requested that 40 CFR 180.493 be 
amended by establishing tolerances for residues of the fungicide, 
dimethomorph in or on strawberry at 1.0 parts per million (ppm) and 
removing the established tolerances for

[[Page 52404]]

lettuce, head and lettuce, leaf at 10 ppm. That document referenced a 
summary of the petition prepared by BASF, the registrant, which is 
available in the docket, https://www.regulations.gov. No comments were 
received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the tolerance for residues of dimethomorph in or strawberry to 
0.90 ppm and is correcting the CAS name of dimethomorph in 40 CFR 
180.493(a), 40 CFR 180.493(c), and 40 CFR 180.493(d) to the following 
introductory tolerance expression text: 40 CFR 180.493(a): Tolerances 
are established for residues of the fungicide dimethomorph, 4-[3-(4-
chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propen-1-yl]morpholine, 
including its metabolites and degradates, in or on the commodities in 
the following table. Compliance with the tolerance levels specified in 
the following table is to be determined by measuring only dimethomorph 
in or on the commodity. 40 CFR 180.493(c): Tolerances with regional 
registrations are established for residues of the fungicide 
dimethomorph, 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-
propen-1-yl]morpholine, including its metabolites and degradates, in or 
on the commodities in the following table. Compliance with the 
tolerance levels specified in the following table is to be determined 
by measuring only dimethomorph in or on the commodity. 40 CFR 
180.493(d): Tolerances are established for the indirect or inadvertent 
residues of the fungicide dimethomorph, 4-[3-(4-chlorophenyl)-3-(3,4-
dimethoxyphenyl)-1-oxo-2-propen-1-yl]morpholine, including its 
metabolites and degradates, in or on the commodities in the following 
table. Compliance with the tolerance levels specified in the following 
table is to be determined by measuring only dimethomorph in or on the 
commodity.
    The reason for these changes are explained in Unit IV.C.

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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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 dimethomorph including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with dimethomorph 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 target organ for dimethomorph is the liver in rats and 
dogs. No biologically significant effect was observed in the rat 
subchronic oral toxicity study while decreased body weight and 
increased incidence of arteritis in male rats and decreased body 
weights and increased incidence of ``ground-glass'' foci in livers of 
female rats were observed in the rat chronic toxicity study. In the dog 
subchronic oral toxicity study, decreased absolute and relative 
prostate weights, and slight liver effects were observed. No toxicity 
was observed at the limit dose in the rat 28-day dermal toxicity study. 
The developmental toxicity studies showed no increased sensitivity to 
offspring of either rats or rabbits as demonstrated by the no-observed-
adverse-effect-levels (NOAELs) equal to or higher than those producing 
toxicity in the maternal animals. Likewise, in the 2-generation 
reproduction study, there was no toxicity to the offspring at any dose 
lower than that causing parental toxicity. There is no evidence that 
dimethomorph is a developmental, or reproductive toxicant, and it is 
not neurotoxic or immunotoxic.
    The Agency classified dimethomorph as ``not likely to be 
carcinogenic to humans'' based upon lack of evidence of carcinogenicity 
in rats and mice and no evidence of mutagenicity. A quantitative cancer 
risk assessment is not necessary. Dimethomorph has low acute toxicity 
by the oral, dermal, or inhalation route of exposure (Toxicity Category 
III or IV). It is not an eye or skin irritant, and is not a skin 
sensitizer.
    Specific information on the studies received and the nature of the 
adverse effects caused by dimethomorph as well as the NOAEL and the 
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 
can be found at https://www.regulations.gov in the document titled 
``Dimethomorph: Human Health Risk Assessment to Support Establishment 
of a Permanent Tolerance for Residues in/on Strawberry'' at pages 29-32 
in docket ID number EPA-HQ-OPP-2014-0531.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). 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 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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for dimethomorph used for 
human risk assessment is shown in Table 1 of this unit.

[[Page 52405]]



 Table 1--Summary of Toxicological Doses and Endpoints for Dimethomorph for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50       N/A (No appropriate   N/A................  N/A.
 years of age).                     endpoint was
                                    identified
                                    including
                                    developmental
                                    toxicity studies in
                                    rats and rabbits.).
Acute dietary (General population  LOAEL = 250 mg/kg/    Acute RfD = 0.25 mg/ Acute neurotoxicity study in rats.
 including infants and children).   day.                  kg/day.             MRID 48980106.
                                   UFA = 10x...........  aPAD = 0.25 mg/kg/   LOAEL = 250 mg/kg/day based on
                                   UFH = 10x...........   day.                 reduced motor activity and
                                   FQPA SF/UFL = 10x...                        impairment of gait and rearing in
                                                                               both sexes.
Chronic dietary (All populations)  POD = 11 mg/kg/day..  Chronic RfD = 0.11   Co-critical chronic and
                                   UFA = 10x...........   mg/kg/day.           carcinogenicity studies in rats
                                   UFH = 10x...........  cPAD= 0.11 mg/kg/     MRID 42233912, 42233916.
                                   FQPA SF = 1x........   day.                LOAEL = 46.3 mg/kg/day, based on
                                                                               decreased body weight and
                                                                               increases in liver lesions in
                                                                               female rats.
Incidental oral short-term.......  NOAEL= 15 mg/kg/day.  LOC for MOE = 100..  Subchronic feeding study in dogs.
                                   UFA = 10x...........                       MRID 42233908.
                                   UFH = 10x...........                       LOAEL = 43 mg/kg/day based on
                                   FQPA SF = 1x........                        decreased absolute and relative
                                                                               prostate weights.
Dermal short- and intermediate-    N/A (No toxicity was  N/A................  N/A.
 term.                              observed at the
                                    limit dose in a 28-
                                    day dermal toxicity
                                    study.
                                   No quantitative risk
                                    assessment is
                                    necessary since no
                                    dermal or
                                    developmental
                                    toxicity concern.).
Inhalation short- and              Oral, NOAEL = 15 mg/  LOC for MOE = 1000.  Subchronic feeding study in dogs.
 intermediate-term.                 kg/day (inhalation                        MRID 42233908.
                                    absorption factor =                       LOAEL = 43 mg/kg/day based on
                                    100%).                                     decreased absolute and relative
                                   UFA = 10x...........                        prostate weights.
                                   UFH = 10x...........
                                   UFDB = 10x..........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)   Classification: This chemical is classified as ``not likely'' to be a human
                                                                     carcinogen.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UFA = extrapolation from
  animal to human (interspecies). UFDB = to account for the absence of data or other data deficiency. UFH =
  potential variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL
  to extrapolate a NOAEL.

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. Such effects were identified 
for dimethomorph. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) National Health and Nutrition Examination Survey, 
What We Eat in America (NHANES/WEIA) 2003-2008. The acute analysis 
assumed 100% crop treated (CT), Dietary Exposure Evaluation Model 
software with the Food Commodity Intake Database (DEEM-FCID) Version 
3.16 default processing factors, and tolerance-level residues for all 
foods. Drinking water was incorporated directly into the dietary 
assessment using the surface water concentration and the FIRST (Food 
Quality Protection Act (FQPA) Index Reservoir Screening Tool) model.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/WEIA 
2003-2008. The chronic analysis assumed 100% CT, DEEM-FCID Version 3.16 
default processing factors, and tolerance-level residues for all foods. 
Drinking water was incorporated directly into the dietary assessment 
using the surface water concentration and the FIRST model.

[[Page 52406]]

    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that dimethomorph does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use any anticipated residue or PCT information in the 
dietary assessment for dimethomorph.
    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 https://www.epa.gov/oppefed1/models/water/index.htm.
    Based on FIRST model for surface water and Pesticide Root Zone 
Model Ground Water (PRZM GW) for ground water, the estimated drinking 
water concentrations (EDWCs) of dimethomorph for acute exposures for 
non-cancer assessments are estimated to be 81.1 parts per billion (ppb) 
for surface water and 20.1 ppb for ground water; and for chronic 
exposures for non-cancer assessments are estimated to be 24.7 ppb for 
surface water and 18.8 ppb (post breakthrough avg. ppb) and 14.6 ppb 
(simulation avg. ppb) for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    For acute dietary risk assessment, the water concentration of 81.1 
ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of 
24.7 ppb 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 Web site at https://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 Safety 
Factor (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. The toxicology data on 
dimethomorph provides no indication of enhanced sensitivity of infants 
and children based on the results from rat or rabbit developmental 
studies as well as a 2-generation rat reproduction study.
    3. Conclusion. EPA has determined the 10X FQPA SF be retained for 
acute dietary exposure scenario for extrapolation of a NOAEL from a 
LOAEL. For other exposure scenarios, the FQPA SF is reduced to 1x since 
there is no evidence of increased qualitative or quantitative 
susceptibility in the young and exposure estimates are unlikely to 
underestimate risk.
    The above decision is based on the following findings:
    i. Although the toxicity database of dimethomorph is incomplete 
because a subchronic inhalation study is not available, the available 
toxicity database of dimethomorph, including developmental toxicity 
studies in rats and rabbits, a 2-generation reproduction study in rats, 
acute and subchronic neurotoxicity study in rats, is adequate to 
characterize developmental and reproductive effects and to assess the 
qualitative or quantitative susceptibility in the young.
    ii. In an acute neurotoxicity study, functional observational 
battery (FOB) findings and reduced motor activity were observed at >= 
250 mg/kg on day 0 only. These findings were considered an impairment 
of the overall condition of the animals following a single gavage dose, 
rather than a direct neurotoxic effect of dimethomorph based on the 
absence of any neurohistopathological changes in the treated animals 
and the transient nature of the observed FOB and neurobehavioral 
assessments. In support of this conclusion, no neurotoxic effects were 
observed in rats fed dimethomorph up to the highest dose tested at 
2,400 ppm (178/204 mg/kg/day for males/females, respectively) in a 90-
day neurotoxicity study. Additionally, the toxicology database does not 
reveal evidence of neurotoxic clinical signs, changes in brain weight, 
or histopathology of the nervous system in any study with dimethomorph.
    iii. There is no evidence that dimethomorph results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies 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. 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 dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to dimethomorph will occupy 39% of the aPAD for children 3 to 5 years 
of age,

[[Page 52407]]

the population group receiving the greatest exposure.
    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 26% of the cPAD for 
children 1 to 2 years of age, the population group receiving the 
greatest exposure. There are no residential uses for dimethomorph.
    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).
    A short-term adverse effect was identified; however, dimethomorph 
is not registered for any use patterns that would result in short-term 
residential exposure. Short-term risk is assessed based on short-term 
residential exposure plus chronic dietary exposure. Because there is no 
short-term residential exposure and chronic dietary exposure has 
already been assessed under the appropriately protective cPAD (which is 
at least as protective as the POD used to assess short-term risk), no 
further assessment of short-term risk is necessary, and EPA relies on 
the chronic dietary risk assessment for evaluating short-term risk for 
dimethomorph.
    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). An intermediate-term adverse effect was identified; however, 
dimethomorph is not registered for any use patterns that would result 
in intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
dimethomorph.
    5. Aggregate cancer risk for U.S. population. An aggregate cancer 
risk was not calculated because dimethomorph was classified as ``not 
likely to be carcinogenic to humans''.
    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 dimethomorph residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid 
chromatography with ultraviolet detection (HPLC/UV) method FAMS 002-04 
and Method M 2577, a gas chromatographic (GC) method with nitrogen 
phosphorus detection (NPD)) are available to enforce the tolerance 
expression.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has established MRLs for dimethomorph in or on strawberry 
at 0.05 ppm. These MRLs are different than the tolerances established 
for dimethomorph in the United States. EPA is not proposing to 
harmonize the U.S. tolerance for residues in strawberry with the Codex 
due to different application rates (U.S. application rate, 219-237 gram 
active ingredient/hectare, and Codex countries' application rate, 150 
gram active ingredient/hectare).

C. Revisions to Petitioned-For Tolerances

    BASF proposed a tolerance of dimethomorph residues on strawberry at 
1.0 ppm. BASF and EPA used the Organization for Economic Cooperation & 
Development (OECD) spreadsheet calculator and both determined from the 
data set that a tolerance of 0.90 ppm was the recommended OECD 
calculator spreadsheet output. However, BASF rounded that value to 1.0 
ppm, while EPA's policy is to establish the tolerance at the OECD 
calculator output level without rounding; therefore, EPA is 
establishing a tolerance on strawberry at 0.90 ppm. EPA established the 
tolerance for leafy vegetables (except brassica) crop group 4 in the 
Federal Register on May 4, 2012 under docket ID number EPA-HQ-OPP-2011-
0388. In this ruling, the tolerance for vegetable, leafy, except 
brassica, group 4 was established at 30.0 ppm. According to 40 CFR 
180.493, the individual tolerances for lettuce, head and lettuce, leaf, 
both at 10.0 ppm, were not removed. Based upon the previous 
explanation, EPA is removing the tolerances for lettuce, head at 10.0 
ppm and lettuce, leaf at 10.0 ppm.
    EPA is correcting the CAS name of dimethomorph in 40 CFR 
180.493(a), 40 CFR 180.493(c), and 40 CFR 180.493(d). The CAS name of 
dimethomorph is currently incorrect (currently is listed as the 
International Union of Pure and Applied Chemistry (IUPAC) name (E,Z)-4-
[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl) acryloyl]morpholine, and is 
being revised to the correct CAS name 4-[3-(4-chlorophenyl)-3-(3,4-
dimethoxyphenyl)-1-oxo-2-propen-1-yl]morpholine)).

V. Conclusion

    Therefore, EPA is establishing a tolerance for residues of the 
fungicide, dimethomorph in or on strawberry at 0.90 ppm and removing 
the established tolerances for lettuce, head and lettuce leaf at 10 
ppm. EPA is correcting the CAS name of dimethomorph in 40 CFR 
180.493(a), 40 CFR 180.493(c), and 40 CFR 180.493(d) to the following 
tolerance expressions:
    40 CFR 180.493(a): Tolerances are established for residues of the 
fungicide dimethomorph, 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-
1-oxo-2-propen-1-yl]morpholine, including its metabolites and 
degradates, in or on the commodities in the following table. Compliance 
with the tolerance levels specified in the following table is to be 
determined by measuring only dimethomorph in or on the commodity.
    40 CFR 180.493(c): Tolerances with regional registrations are 
established for residues of the fungicide dimethomorph, 4-[3-(4-
chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propen-1-yl]morpholine, 
including its metabolites and degradates, in or on the commodities in 
the following table. Compliance with the tolerance levels specified in 
the following table is to be determined by measuring only dimethomorph 
in or on the commodity.
    40 CFR 180.493(d): Tolerances are established for the indirect or 
inadvertent residues of the fungicide dimethomorph, 4-[3-(4-
chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propen-

[[Page 52408]]

1-yl]morpholine, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance 
levels specified in the following table is to be determined by 
measuring only dimethomorph in or on the commodity.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) 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 action has been 
exempted from review under Executive Order 12866, this action 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 action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et se.), 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 FFDCA section 408(d), 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 
se.), do not apply.
    This action 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 FFDCA section 408(n)(4). 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et se.).
    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 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et se.), 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 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: August 10, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    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. In Sec.  180.493:
0
a. Revise the introductory text of paragraph (a).
0
b. Remove the entries in the table in paragraph (a) for ``Lettuce, 
head'', and ``Lettuce leaf''.
0
c. Add alphabetically the entry for ``Strawberry'' to the table in 
paragraph (a).
0
d. Revise the introductory text of paragraphs (c) and (d).
    The additions and revisions read as follows:


Sec.  180.493  Dimethomorph; tolerances for residues.

    (a) * * *
    Tolerances are established for residues of the fungicide 
dimethomorph, 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-
propen-1-yl]morpholine, including its metabolites and degradates, in or 
on the commodities in the following table. Compliance with the 
tolerance levels specified in the following table is to be determined 
by measuring only dimethomorph in or on the commodities.

------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Strawberry.............................................            0.90
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (c) Tolerances with regional registrations. Tolerances with 
regional registrations are established for residues of the fungicide 
dimethomorph, 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-
propen-1-yl]morpholine, including its metabolites and degradates, in or 
on the commodities in the following table. Compliance with the 
tolerance levels specified in the following table is to be determined 
by measuring only dimethomorph in or on the commodity.
* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established 
for the indirect or inadvertent residues of the fungicide dimethomorph, 
4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propen-1-
yl]morpholine, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance 
levels specified in the following table is to be determined by 
measuring only dimethomorph in or on the commodity.
* * * * *
[FR Doc. 2015-21192 Filed 8-28-15; 8:45 am]
 BILLING CODE 6560-50-P