80 FR 52403 - Dimethomorph; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 168 (August 31, 2015)

Page Range		52403-52408
FR Document		2015-21192
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).
Federal Register, Volume 80 Issue 168 (Monday, August 31, 2015)
[Federal Register Volume 80, Number 168 (Monday, August 31, 2015)]
[Rules and Regulations]
[Pages 52403-52408]
From the Federal Register Online  [www.thefederalregister.org]
[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 http://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 http://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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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 http://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: http://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 http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://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, http://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 http://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 http://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 http://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 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 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
Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Rules and Regulations 52403

EPA APPROVED ALBUQUERQUE/BERNALILLO COUNTY, NM REGULATIONS—Continued
State ap-
State citation Title/subject proval/effec- EPA approval date Explanation
tive date

* * * * * * *
Part 61 (20.11.61 NMAC) ............ Prevention of Significant Deterio- 5/29/2015 8/31/2015 [Insert Federal Reg-
ration. ister citation].

* * * * * * *

* * * * * FOR FURTHER INFORMATION CONTACT: must be in writing, and must be
[FR Doc. 2015–21015 Filed 8–28–15; 8:45 am] Susan Lewis, Registration Division received by the Hearing Clerk on or
BILLING CODE 6560–50–P (7505P), Office of Pesticide Programs, before October 30, 2015. Addresses for
Environmental Protection Agency, 1200 mail and hand delivery of objections
Pennsylvania Ave. NW., Washington, and hearing requests are provided in 40
ENVIRONMENTAL PROTECTION DC 20460–0001; main telephone CFR 178.25(b).
AGENCY number: (703) 305–7090; email address: In addition to filing an objection or
RDFRNotices@epa.gov. hearing request with the Hearing Clerk
40 CFR Part 180 as described in 40 CFR part 178, please
SUPPLEMENTARY INFORMATION:
[EPA–HQ–OPP–2014–0531; FRL–9932–26] submit a copy of the filing (excluding
I. General Information any Confidential Business Information
Dimethomorph; Pesticide Tolerances A. Does this action apply to me? (CBI)) for inclusion in the public docket.
Information not marked confidential
AGENCY: Environmental Protection You may be potentially affected by pursuant to 40 CFR part 2 may be
Agency (EPA). this action if you are an agricultural disclosed publicly by EPA without prior
ACTION: Final rule. producer, food manufacturer, or notice. Submit the non-CBI copy of your
pesticide manufacturer. The following objection or hearing request, identified
SUMMARY: This regulation establishes, list of North American Industrial by docket ID number EPA–HQ–OPP–
and removes tolerances for residues of Classification System (NAICS) codes is 2014–0531, by one of the following
dimethomorph in or on multiple not intended to be exhaustive, but rather methods:
commodities which are identified and provides a guide to help readers • Federal eRulemaking Portal: http://
discussed later in this document. BASF determine whether this document www.regulations.gov. Follow the online
Corporation requested these tolerances applies to them. Potentially affected instructions for submitting comments.
under the Federal Food, Drug, and entities may include: Do not submit electronically any
Cosmetic Act (FFDCA). EPA is • Crop production (NAICS code 111). information you consider to be CBI or
correcting the CAS name of • Animal production (NAICS code other information whose disclosure is
dimethomorph in 40 CFR 180.493(a), 40 112). restricted by statute.
CFR 180.493(c), and 40 CFR 180.493(d). • Food manufacturing (NAICS code • Mail: OPP Docket, Environmental
311). Protection Agency Docket Center (EPA/
DATES: This regulation is effective
• Pesticide manufacturing (NAICS DC), (28221T), 1200 Pennsylvania Ave.
August 31, 2015. Objections and
code 32532). NW., Washington, DC 20460–0001.
requests for hearings must be received
on or before October 30, 2015, and must B. How can I get electronic access to • Hand Delivery: To make special
be filed in accordance with the other related information? arrangements for hand delivery or
instructions provided in 40 CFR part delivery of boxed information, please
You may access a frequently updated follow the instructions at http://
178 (see also Unit I.C. of the electronic version of EPA’s tolerance
SUPPLEMENTARY INFORMATION).
www.epa.gov/dockets/contacts.html.
regulations at 40 CFR part 180 through Additional instructions on commenting
ADDRESSES: The docket for this action, the Government Printing Office’s e-CFR or visiting the docket, along with more
identified by docket identification (ID) site at http://www.ecfr.gov/cgi-bin/text- information about dockets generally, is
number EPA–HQ–OPP–2014–0531, is idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ available at
available at http://www.regulations.gov 40tab_02.tpl. http://www.epa.gov/dockets.
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) C. How can I file an objection or hearing II. Summary of Petitioned-for Tolerance
in the Environmental Protection Agency request? In the Federal Register of December
Docket Center (EPA/DC), West William Under FFDCA section 408(g), 21 17, 2014 (79 FR 75107) (FRL–9918–90),
Jefferson Clinton Bldg., Rm. 3334, 1301 U.S.C. 346a, any person may file an EPA issued a document pursuant to
Constitution Ave. NW., Washington, DC objection to any aspect of this regulation FFDCA section 408(d)(3), 21 U.S.C.
20460–0001. The Public Reading Room and may also request a hearing on those 346a(d)(3), announcing the filing of a
is open from 8:30 a.m. to 4:30 p.m., objections. You must file your objection pesticide petition (PP 4F8281) by BASF
Monday through Friday, excluding legal or request a hearing on this regulation Corporation, P.O. Box 13528, Research
holidays. The telephone number for the in accordance with the instructions
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Triangle Park, North Carolina, 27709.
Public Reading Room is (202) 566–1744, provided in 40 CFR part 178. To ensure The petition requested that 40 CFR
and the telephone number for the OPP proper receipt by EPA, you must 180.493 be amended by establishing
Docket is (703) 305–5805. Please review identify docket ID number EPA–HQ– tolerances for residues of the fungicide,
the visitor instructions and additional OPP–2014–0531 in the subject line on dimethomorph in or on strawberry at
information about the docket available the first page of your submission. All 1.0 parts per million (ppm) and
at http://www.epa.gov/dockets. objections and requests for a hearing removing the established tolerances for

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Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Rules and Regulations 52407

the population group receiving the population, or to infants and children establishing a tolerance on strawberry at
greatest exposure. from aggregate exposure to 0.90 ppm. EPA established the tolerance
2. Chronic risk. Using the exposure dimethomorph residues. for leafy vegetables (except brassica)
assumptions described in this unit for crop group 4 in the Federal Register on
chronic exposure, EPA has concluded IV. Other Considerations
May 4, 2012 under docket ID number
that chronic exposure to dimethomorph A. Analytical Enforcement Methodology EPA–HQ–OPP–2011–0388. In this
from food and water will utilize 26% of ruling, the tolerance for vegetable, leafy,
Adequate enforcement methodology
the cPAD for children 1 to 2 years of except brassica, group 4 was established
(high performance liquid
age, the population group receiving the at 30.0 ppm. According to 40 CFR
greatest exposure. There are no chromatography with ultraviolet
180.493, the individual tolerances for
residential uses for dimethomorph. detection (HPLC/UV) method FAMS
lettuce, head and lettuce, leaf, both at
3. Short-term risk. Short-term 002–04 and Method M 2577, a gas
10.0 ppm, were not removed. Based
aggregate exposure takes into account chromatographic (GC) method with
upon the previous explanation, EPA is
short-term residential exposure plus nitrogen phosphorus detection (NPD))
removing the tolerances for lettuce,
chronic exposure to food and water are available to enforce the tolerance
head at 10.0 ppm and lettuce, leaf at
(considered to be a background expression. 10.0 ppm.
exposure level). B. International Residue Limits EPA is correcting the CAS name of
A short-term adverse effect was dimethomorph in 40 CFR 180.493(a), 40
identified; however, dimethomorph is In making its tolerance decisions, EPA CFR 180.493(c), and 40 CFR 180.493(d).
not registered for any use patterns that seeks to harmonize U.S. tolerances with The CAS name of dimethomorph is
would result in short-term residential international standards whenever currently incorrect (currently is listed as
exposure. Short-term risk is assessed possible, consistent with U.S. food the International Union of Pure and
based on short-term residential safety standards and agricultural Applied Chemistry (IUPAC) name (E,Z)-
exposure plus chronic dietary exposure. practices. EPA considers the 4-[3-(4-chlorophenyl)-3-(3,4-
Because there is no short-term international maximum residue limits dimethoxyphenyl) acryloyl]morpholine,
residential exposure and chronic dietary (MRLs) established by the Codex and is being revised to the correct CAS
exposure has already been assessed Alimentarius Commission (Codex), as name 4-[3-(4-chlorophenyl)-3-(3,4-
under the appropriately protective required by FFDCA section 408(b)(4). dimethoxyphenyl)-1-oxo-2-propen-1-
cPAD (which is at least as protective as The Codex Alimentarius is a joint yl]morpholine)).
the POD used to assess short-term risk), United Nations Food and Agriculture
no further assessment of short-term risk Organization/World Health V. Conclusion
is necessary, and EPA relies on the Organization food standards program, Therefore, EPA is establishing a
chronic dietary risk assessment for and it is recognized as an international tolerance for residues of the fungicide,
evaluating short-term risk for food safety standards-setting dimethomorph in or on strawberry at
dimethomorph. organization in trade agreements to 0.90 ppm and removing the established
4. Intermediate-term risk. which the United States is a party. EPA tolerances for lettuce, head and lettuce
Intermediate-term aggregate exposure may establish a tolerance that is leaf at 10 ppm. EPA is correcting the
takes into account intermediate-term different from a Codex MRL; however, CAS name of dimethomorph in 40 CFR
residential exposure plus chronic FFDCA section 408(b)(4) requires that 180.493(a), 40 CFR 180.493(c), and 40
exposure to food and water (considered EPA explain the reasons for departing CFR 180.493(d) to the following
to be a background exposure level). An from the Codex level. tolerance expressions:
intermediate-term adverse effect was The Codex has established MRLs for 40 CFR 180.493(a): Tolerances are
identified; however, dimethomorph is dimethomorph in or on strawberry at established for residues of the fungicide
not registered for any use patterns that 0.05 ppm. These MRLs are different dimethomorph, 4-[3-(4-chlorophenyl)-3-
would result in intermediate-term than the tolerances established for (3,4-dimethoxyphenyl)-1-oxo-2-propen-
residential exposure. Intermediate-term dimethomorph in the United States. 1-yl]morpholine, including its
risk is assessed based on intermediate- EPA is not proposing to harmonize the metabolites and degradates, in or on the
term residential exposure plus chronic U.S. tolerance for residues in strawberry commodities in the following table.
dietary exposure. Because there is no with the Codex due to different Compliance with the tolerance levels
intermediate-term residential exposure application rates (U.S. application rate, specified in the following table is to be
and chronic dietary exposure has 219–237 gram active ingredient/hectare, determined by measuring only
already been assessed under the and Codex countries’ application rate, dimethomorph in or on the commodity.
appropriately protective cPAD (which is 150 gram active ingredient/hectare). 40 CFR 180.493(c): Tolerances with
at least as protective as the POD used to regional registrations are established for
C. Revisions to Petitioned-For
assess intermediate-term risk), no residues of the fungicide
Tolerances
further assessment of intermediate-term dimethomorph, 4-[3-(4-chlorophenyl)-3-
risk is necessary, and EPA relies on the BASF proposed a tolerance of (3,4-dimethoxyphenyl)-1-oxo-2-propen-
chronic dietary risk assessment for dimethomorph residues on strawberry 1-yl]morpholine, including its
evaluating intermediate-term risk for at 1.0 ppm. BASF and EPA used the metabolites and degradates, in or on the
dimethomorph. Organization for Economic Cooperation commodities in the following table.
5. Aggregate cancer risk for U.S. & Development (OECD) spreadsheet Compliance with the tolerance levels
population. An aggregate cancer risk calculator and both determined from the specified in the following table is to be
data set that a tolerance of 0.90 ppm was
rmajette on DSK7SPTVN1PROD with RULES

was not calculated because determined by measuring only
dimethomorph was classified as ‘‘not the recommended OECD calculator dimethomorph in or on the commodity.
likely to be carcinogenic to humans’’. spreadsheet output. However, BASF 40 CFR 180.493(d): Tolerances are
6. Determination of safety. Based on rounded that value to 1.0 ppm, while established for the indirect or
these risk assessments, EPA concludes EPA’s policy is to establish the tolerance inadvertent residues of the fungicide
that there is a reasonable certainty that at the OECD calculator output level dimethomorph, 4-[3-(4-chlorophenyl)-3-
no harm will result to the general without rounding; therefore, EPA is (3,4-dimethoxyphenyl)-1-oxo-2-propen-

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52408 Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Rules and Regulations

1-yl]morpholine, including its 1999) and Executive Order 13175, (3,4-dimethoxyphenyl)-1-oxo-2-propen-
metabolites and degradates, in or on the entitled ‘‘Consultation and Coordination 1-yl]morpholine, including its
commodities in the following table. with Indian Tribal Governments’’ (65 FR metabolites and degradates, in or on the
Compliance with the tolerance levels 67249, November 9, 2000) do not apply commodities in the following table.
specified in the following table is to be to this action. In addition, this action Compliance with the tolerance levels
determined by measuring only does not impose any enforceable duty or specified in the following table is to be
dimethomorph in or on the commodity. contain any unfunded mandate as determined by measuring only
VI. Statutory and Executive Order described under Title II of the Unfunded dimethomorph in or on the
Reviews Mandates Reform Act (UMRA) (2 U.S.C. commodities.
1501 et se.).
This action establishes tolerances This action does not involve any Parts per
Commodity
under FFDCA section 408(d) in technical standards that would require million
response to a petition submitted to the Agency consideration of voluntary
Agency. The Office of Management and consensus standards pursuant to section
Budget (OMB) has exempted these types * * * * *
12(d) of the National Technology Strawberry ............................ 0.90
of actions from review under Executive Transfer and Advancement Act
Order 12866, entitled ‘‘Regulatory (NTTAA) (15 U.S.C. 272 note). * * * * *
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action VII. Congressional Review Act
* * * * *
has been exempted from review under Pursuant to the Congressional Review (c) Tolerances with regional
Executive Order 12866, this action is Act (5 U.S.C. 801 et se.), EPA will registrations. Tolerances with regional
not subject to Executive Order 13211, submit a report containing this rule and registrations are established for residues
entitled ‘‘Actions Concerning other required information to the U.S. of the fungicide dimethomorph, 4-[3-(4-
Regulations That Significantly Affect Senate, the U.S. House of chlorophenyl)-3-(3,4-dimethoxyphenyl)-
Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller 1-oxo-2-propen-1-yl]morpholine,
FR 28355, May 22, 2001) or Executive General of the United States prior to including its metabolites and
Order 13045, entitled ‘‘Protection of publication of the rule in the Federal degradates, in or on the commodities in
Children from Environmental Health Register. This action is not a ‘‘major the following table. Compliance with
Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2). the tolerance levels specified in the
April 23, 1997). This action does not following table is to be determined by
contain any information collections List of Subjects in 40 CFR Part 180
measuring only dimethomorph in or on
subject to OMB approval under the Environmental protection, the commodity.
Paperwork Reduction Act (PRA) (44 Administrative practice and procedure,
U.S.C. 3501 et se.), nor does it require * * * * *
Agricultural commodities, Pesticides
any special considerations under (d) Indirect or inadvertent residues.
and pests, Reporting and recordkeeping
Executive Order 12898, entitled Tolerances are established for the
requirements.
‘‘Federal Actions to Address indirect or inadvertent residues of the
Dated: August 10, 2015. fungicide dimethomorph, 4-[3-(4-
Environmental Justice in Minority
Populations and Low-Income Susan Lewis, chlorophenyl)-3-(3,4-dimethoxyphenyl)-
Populations’’ (59 FR 7629, February 16, Director, Registration Division, Office of 1-oxo-2-propen-1-yl]morpholine,
1994). Pesticide Programs. including its metabolites and
Since tolerances and exemptions that Therefore, 40 CFR chapter I is degradates, in or on the commodities in
are established on the basis of a petition amended as follows: the following table. Compliance with
under FFDCA section 408(d), such as the tolerance levels specified in the
the tolerance in this final rule, do not PART 180—[AMENDED] following table is to be determined by
require the issuance of a proposed rule, measuring only dimethomorph in or on
the requirements of the Regulatory ■ 1. The authority citation for part 180 the commodity.
Flexibility Act (RFA) (5 U.S.C. 601 et continues to read as follows: * * * * *
se.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371. [FR Doc. 2015–21192 Filed 8–28–15; 8:45 am]
This action directly regulates growers, BILLING CODE 6560–50–P
■ 2. In § 180.493:
food processors, food handlers, and food
■ a. Revise the introductory text of
retailers, not States or tribes, nor does
paragraph (a).
this action alter the relationships or FEDERAL COMMUNICATIONS
■ b. Remove the entries in the table in
distribution of power and COMMISSION
paragraph (a) for ‘‘Lettuce, head’’, and
responsibilities established by Congress
‘‘Lettuce leaf’’.
in the preemption provisions of FFDCA ■ c. Add alphabetically the entry for 47 CFR Parts 2 and 5
section 408(n)(4). As such, the Agency ‘‘Strawberry’’ to the table in paragraph
has determined that this action will not [ET Docket Nos. 10–236, 06–155; FCC 15–
(a). 76]
have a substantial direct effect on States ■ d. Revise the introductory text of
or tribal governments, on the paragraphs (c) and (d). Radio Experimentation and Market
relationship between the national The additions and revisions read as Trials
government and the States or tribal follows:
governments, or on the distribution of
rmajette on DSK7SPTVN1PROD with RULES

AGENCY: Federal Communications
power and responsibilities among the § 180.493 Dimethomorph; tolerances for Commission.
various levels of government or between residues. ACTION: Final rule.
the Federal Government and Indian (a) * * *
tribes. Thus, the Agency has determined Tolerances are established for SUMMARY: This document responds to
that Executive Order 13132, entitled residues of the fungicide three petitions for reconsideration
‘‘Federalism’’ (64 FR 43255, August 10, dimethomorph, 4-[3-(4-chlorophenyl)-3- seeking to modify certain rules adopted

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Document Created: 2018-02-23 11:04:39
Document Modified: 2018-02-23 11:04:39
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
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).
Contact		Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation		80 FR 52403
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements