80 FR 14014 - Dimethomorph; Pesticide Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 52 (March 18, 2015)

Page Range		14014-14019
FR Document		2015-06106
This regulation establishes a tolerance for residues of dimethomorph in or on papaya at 1.5 parts per million (ppm). BASF Corporation requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA) to cover residues of dimethomorph in papaya imported into the United States; there are currently no U.S. registrations for pesticides containing dimethomorph that are used on papaya.
Federal Register, Volume 80 Issue 52 (Wednesday, March 18, 2015)
[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Rules and Regulations]
[Pages 14014-14019]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-06106]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0483; FRL-9923-59]


Dimethomorph; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
dimethomorph in or on papaya at 1.5 parts per million (ppm). BASF 
Corporation requested this tolerance under the Federal Food, Drug, and 
Cosmetic Act (FFDCA) to cover residues of dimethomorph in papaya 
imported into the United States; there are currently no U.S. 
registrations for pesticides containing dimethomorph that are used on 
papaya.

DATES: This regulation is effective March 18, 2015. Objections and 
requests for hearings must be received on or before May 18, 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-2014-0483, 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

[[Page 14015]]

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 
Publishing 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-2014-0483 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 
May 18, 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-2014-0483, 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 
3E8218) by BASF Corporation, P.O. Box, 13528, Research Triangle Park, 
North Carolina 27709. The petition requested that 40 CFR part 180 be 
amended by establishing a tolerance for residues of the fungicide 
dimethomorph, in or on papaya at 1.5 ppm. That document referenced a 
summary of the petition prepared by BASF Corporation, the registrant, 
which is available in the docket, http://www.regulations.gov. No 
comments were received on the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with 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.
    Dimethomorph has low acute toxicity by the oral, dermal, or 
inhalation route of exposure. It is not an eye or skin irritant, and is 
not a skin sensitizer. There is no evidence that dimethomorph is a 
developmental, reproductive, carcinogenic, mutagenic or immunotoxic 
chemical. Dimethomorph is classified as ``not likely to be carcinogenic 
to humans'' based upon lack of evidence of carcinogenicity in rats and 
mice.
    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

[[Page 14016]]

no-observed-adverse-effect-level's (NOAEL) 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 doses lower than that causing parental toxicity.
    In an acute neurotoxicity study, functional observational battery 
(FOB) findings and reduced motor activity were observed. However, these 
findings were considered an impairment of the overall condition of the 
animals following treatment, rather than direct neurotoxic effects of 
the dimethomorph exposure. No neurotoxic effects were observed in the 
subchronic neurotoxicity study in rats and there is no evidence of 
neurotoxicity throughout the dimethomorph toxicity database. There was 
no evidence of immunotoxicity in the immunotoxicity study.
    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 document Dimethomorph: 
Human Health Risk Assessment to Support Establishment of a Tolerance 
Without U.S. Registration for Papaya on page 9 within the docket ID 
number EPA-HQ-OPP-2014-0483.

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 the NOAEL and the LOAEL at which adverse 
effects of concern are identified. Uncertainty/safety factors (U/SF) 
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 the Table of this unit.

  Table--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 13-49       No appropriate        Not applicable.....  No study selected.
 years of age).                     endpoint was
                                    identified
                                    including
                                    developmental
                                    toxicity studies in
                                    rats and rabbits.
----------------------------------------------------------------------------------------------------------------
Acute dietary (General             LOAEL = 250 mg/kg/    Acute RfD = 0.25 mg/ Acute Neurotoxicity Study.
 population).                       day UFA.              kg/day.             LOAEL = 250 mg/kg/day based on
                                   UFH = 10x...........  aPAD = 0.25 mg/kg/    reduced motor activity in both
                                   FQPA SFL = 10x......   day.                 sexes.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 11 mg/kg/day  Chronic RfD = 0.1    Carcinogenicity study in rats.
                                    UFA = 10x.            mg/kg/day.          LOAEL = 46.3 mg/kg/day based on
                                   UFH = 10x...........  cPAD = 0.1 mg/kg/     decreased body weight and
                                   FQPA SF = 1x........   day.                 increases in liver lesions in
                                                                               female rats.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``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. NOAEL = no-observed-adverse-effect-level. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation
  from animal to human (interspecies). 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) Nationwide Health and Nutrition Examination Survey, 
What We Eat In America (NHANES/WWEIA) conducted from 2003-2008. As to 
residue levels in food, EPA made the following assumptions for the 
acute exposure assessment: tolerance-level residues for all 
commodities, 100 percent crop treated (PCT) for all commodities and 
Dietary Exposure Evaluation Model (DEEM) (ver. 7.81) default processing 
factors or empirical processing factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data

[[Page 14017]]

from the USDA's (NHANES/WWEIA) conducted from 2003-2008 as well. As to 
residue levels in food, EPA made the following assumptions for the 
chronic exposure assessment: Tolerance-level residues for all 
commodities, 100 PCT for all commodities and DEEM (ver. 7.81) default 
processing factors or empirical processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that dimethomorph should be classified as ``not likely'' to 
be a human carcinogen based upon lack of evidence of carcinogenicity in 
rats and mice. Therefore a cancer risk assessment was not necessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for dimethomorph. Tolerance level residues and/or 
100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The drinking water 
concentrations have not changed since the last assessment. The Agency 
utilized a maximum application rate of 1.4 pound active ingredient/
acre/season (lb ai/A/season) for broccoli (which is the use with the 
most exposure and highest PCT area). The groundwater value was 
generated using the Screening Concentration in Groundwater (SCI-GROW) 
Model and the surface water values were generated using a Tier 1 
broccoli model. The surface water estimate was used for both acute and 
chronic assessment (81.1 parts per billion (ppb) for acute and 24.7 ppb 
for chronic) because these values were higher than the groundwater 
value. Since the current petition is for a tolerance in/on imported 
papaya, an assessment of the impacts of that use on drinking water was 
not required.
    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 Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. The available data did not 
provide evidence of increased sensitivity in the offspring based on the 
results from developmental studies conducted with rats and rabbits as 
well as a 2-generation reproduction study conducted with rats. There 
were no toxic effects observed in either the rat developmental toxicity 
or the rat 2-generation reproductive toxicity studies at doses that 
were lower than doses which produced toxic effects in the parents. 
Additionally, no developmental toxicity was demonstrated in the rabbit 
developmental toxicity study.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for dimethomorph is complete.
    ii. The available data do not support a determination that 
dimethomorph is a neurotoxic chemical and there is no need for a 
developmental neurotoxicity study or additional UFs to account for 
neurotoxicity.
    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 unrefined acute and chronic dietary risk assessments 
used tolerance level residues, included modeled drinking water 
estimates, assumed 100 PCT, and incorporated DEEM default processing 
factors. EPA made conservative (protective) assumptions in the 
groundwater 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 3-5 years old, 
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 25% of the cPAD for 
children 1-2 years 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). Because no 
short-term adverse effect was identified, dimethomorph is not expected 
to pose a short-term risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered

[[Page 14018]]

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. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, dimethomorph is not expected to pose a cancer risk 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

    FAMS-002-04 which utilizes high performance liquid chromatography 
with ultraviolet detection (HPLC/UV) is available to enforce the 
tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email 
address: [email protected].

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 not established a MRL for residues of dimethomorph 
in/on papaya.

V. Conclusion

    Therefore, tolerances are established for residues of dimethomorph, 
in or on papaya at 1.5 ppm. While no pesticides containing dimethomorph 
have been registered in the United States for use on papaya, this 
tolerance allows importation of papaya containing permissible residues 
of dimethomorph under the FFDCA.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance 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 seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under 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 
seq.), 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 seq.).
    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 seq.), 
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: March 9, 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 alphabetically add the commodity ``papaya'' to the 
table in paragraph (a) to read as follows:


Sec.  180.493  Dimethomorph; tolerances for residues.

    (a) General. * * *

[[Page 14019]]



------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                  * * *                            * * *
Papaya \1\..............................................             1.5
 
                                  * * *                            * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of January 20, 2015.

* * * * *
[FR Doc. 2015-06106 Filed 3-17-15; 8:45 am]
 BILLING CODE 6560-50-P
14014 Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Rules and Regulations

October 4, 1993). Because this action VII. Congressional Review Act Parts per
Commodity
has been exempted from review under Pursuant to the Congressional Review million
Executive Order 12866, this action is Act (5 U.S.C. 801 et seq.), EPA will
not subject to Executive Order 13211, submit a report containing this rule and
entitled ‘‘Actions Concerning * * * * *
other required information to the U.S. * *
Regulations That Significantly Affect Senate, the U.S. House of
Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller Nut, tree, group 14–12 ......... 0.70
FR 28355, May 22, 2001) or Executive General of the United States prior to
Order 13045, entitled ‘‘Protection of publication of the rule in the Federal
Children from Environmental Health * * * * *
Register. This action is not a ‘‘major
Risks and Safety Risks’’ (62 FR 19885, * *
rule’’ as defined by 5 U.S.C. 804(2).
April 23, 1997). This action does not
List of Subjects in 40 CFR Part 180 Papaya .................................. 1.5
contain any information collections
subject to OMB approval under the Environmental protection,
Paperwork Reduction Act (PRA) (44 Administrative practice and procedure, * * * * *
U.S.C. 3501 et seq.), nor does it require Agricultural commodities, Pesticides * *
any special considerations under and pests, Reporting and recordkeeping
Executive Order 12898, entitled requirements. * * * * *
‘‘Federal Actions to Address Dated: March 3, 2015.
[FR Doc. 2015–06141 Filed 3–17–15; 8:45 am]
Environmental Justice in Minority BILLING CODE 6560–50–P
Susan Lewis,
Populations and Low-Income
Director, Registration Division, Office of
Populations’’ (59 FR 7629, February 16,
Pesticide Programs. ENVIRONMENTAL PROTECTION
1994).
Since tolerances and exemptions that Therefore, 40 CFR chapter I is AGENCY
are established on the basis of a petition amended as follows:
under FFDCA section 408(d), such as 40 CFR Part 180
PART 180—[AMENDED]
the tolerance in this final rule, do not [EPA–HQ–OPP–2014–0483; FRL–9923–59]
require the issuance of a proposed rule, ■ 1. The authority citation for part 180
the requirements of the Regulatory continues to read as follows: Dimethomorph; Pesticide Tolerance
Flexibility Act (RFA) (5 U.S.C. 601 et
Authority: 21 U.S.C. 321(q), 346a and 371. AGENCY: Environmental Protection
seq.), do not apply.
■ 2. Revise § 180.589(a)(1) as follows: Agency (EPA).
This action directly regulates growers,
food processors, food handlers, and food ■ a. Add in alphabetical order entries ACTION: Final rule.
retailers, not States or tribes, nor does for ‘‘Dill, seed’’ and ‘‘Herb subgroup
19A’’. SUMMARY: This regulation establishes a
this action alter the relationships or tolerance for residues of dimethomorph
■ b. Remove the entries for ‘‘Fruit,
distribution of power and in or on papaya at 1.5 parts per million
responsibilities established by Congress stone, group 12’’ and ‘‘Nut, tree, group
14’’ and add in their place entries for (ppm). BASF Corporation requested this
in the preemption provisions of FFDCA tolerance under the Federal Food, Drug,
section 408(n)(4). As such, the Agency ‘‘Fruit, stone, group 12–12’’ and ‘‘Nut,
tree, group 14–12’’, respectively. and Cosmetic Act (FFDCA) to cover
has determined that this action will not residues of dimethomorph in papaya
■ c. Remove the entry for ‘‘Pistachio.’’
have a substantial direct effect on States ■ d. Remove the entry for ‘‘Papya’’ and imported into the United States; there
or tribal governments, on the add in its place an entry for ‘‘Papaya.’’ are currently no U.S. registrations for
relationship between the national The addition and revisions read as pesticides containing dimethomorph
government and the States or tribal follows: that are used on papaya.
governments, or on the distribution of
DATES: This regulation is effective
power and responsibilities among the § 180.589 Boscalid; tolerances for
various levels of government or between residues. March 18, 2015. Objections and requests
the Federal Government and Indian (a) * * * for hearings must be received on or
tribes. Thus, the Agency has determined (1) * * * before May 18, 2015, and must be filed
that Executive Order 13132, entitled in accordance with the instructions
‘‘Federalism’’ (64 FR 43255, August 10, Parts per provided in 40 CFR part 178 (see also
Commodity
1999) and Executive Order 13175,
million Unit I.C. of the SUPPLEMENTARY
INFORMATION).
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR * * * * * ADDRESSES: The docket for this action,
67249, November 9, 2000) do not apply * * identified by docket identification (ID)
to this action. In addition, this action number EPA–HQ–OPP–2014–0483, is
does not impose any enforceable duty or Dill, seed ............................... 100 available at
contain any unfunded mandate as http://www.regulations.gov or at the
described under Title II of the Unfunded * * * * * Office of Pesticide Programs Regulatory
Mandates Reform Act (UMRA) (2 U.S.C. * * Public Docket (OPP Docket) in the
1501 et seq.). Environmental Protection Agency
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This action does not involve any Fruit, stone, group 12–12 ..... 3.5 Docket Center (EPA/DC), West William
technical standards that would require Jefferson Clinton Bldg., Rm. 3334, 1301
Agency consideration of voluntary Constitution Ave. NW., Washington, DC
* * * * *
consensus standards pursuant to section * *
20460–0001. The Public Reading Room
12(d) of the National Technology is open from 8:30 a.m. to 4:30 p.m.,
Transfer and Advancement Act Herb subgroup 19A .............. 150 Monday through Friday, excluding legal
(NTTAA) (15 U.S.C. 272 note). holidays. The telephone number for the

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14018 Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Rules and Regulations

to be a background exposure level). An different from a Codex MRL; however, have a substantial direct effect on States
intermediate-term adverse effect was FFDCA section 408(b)(4) requires that or tribal governments, on the
identified; however, dimethomorph is EPA explain the reasons for departing relationship between the national
not registered for any use patterns that from the Codex level. government and the States or tribal
would result in intermediate-term The Codex has not established a MRL governments, or on the distribution of
residential exposure. Intermediate-term for residues of dimethomorph in/on power and responsibilities among the
risk is assessed based on intermediate- papaya. various levels of government or between
term residential exposure plus chronic V. Conclusion the Federal Government and Indian
dietary exposure. Because there is no tribes. Thus, the Agency has determined
intermediate-term residential exposure Therefore, tolerances are established that Executive Order 13132, entitled
and chronic dietary exposure has for residues of dimethomorph, in or on ‘‘Federalism’’ (64 FR 43255, August 10,
already been assessed under the papaya at 1.5 ppm. While no pesticides 1999) and Executive Order 13175,
appropriately protective cPAD (which is containing dimethomorph have been entitled ‘‘Consultation and Coordination
at least as protective as the POD used to registered in the United States for use with Indian Tribal Governments’’ (65 FR
assess intermediate-term risk), no on papaya, this tolerance allows 67249, November 9, 2000) do not apply
further assessment of intermediate-term importation of papaya containing to this action. In addition, this action
risk is necessary, and EPA relies on the permissible residues of dimethomorph does not impose any enforceable duty or
chronic dietary risk assessment for under the FFDCA. contain any unfunded mandate as
evaluating intermediate-term risk for VI. Statutory and Executive Order described under Title II of the Unfunded
dimethomorph. Reviews Mandates Reform Act (UMRA) (2 U.S.C.
5. Aggregate cancer risk for U.S. This action establishes a tolerance 1501 et seq.).
population. Based on the lack of under FFDCA section 408(d) in This action does not involve any
evidence of carcinogenicity in two response to a petition submitted to the technical standards that would require
adequate rodent carcinogenicity studies, Agency. The Office of Management and Agency consideration of voluntary
dimethomorph is not expected to pose Budget (OMB) has exempted these types consensus standards pursuant to section
a cancer risk to humans. of actions from review under Executive 12(d) of the National Technology
6. Determination of safety. Based on Order 12866, entitled ‘‘Regulatory Transfer and Advancement Act
these risk assessments, EPA concludes Planning and Review’’ (58 FR 51735, (NTTAA) (15 U.S.C. 272 note).
that there is a reasonable certainty that October 4, 1993). Because this action
no harm will result to the general VII. Congressional Review Act
has been exempted from review under
population, or to infants and children Executive Order 12866, this action is Pursuant to the Congressional Review
from aggregate exposure to not subject to Executive Order 13211, Act (5 U.S.C. 801 et seq.), EPA will
dimethomorph residues. entitled ‘‘Actions Concerning submit a report containing this rule and
IV. Other Considerations Regulations That Significantly Affect other required information to the U.S.
Energy Supply, Distribution, or Use’’ (66 Senate, the U.S. House of
A. Analytical Enforcement Methodology FR 28355, May 22, 2001) or Executive Representatives, and the Comptroller
FAMS–002–04 which utilizes high Order 13045, entitled ‘‘Protection of General of the United States prior to
performance liquid chromatography Children from Environmental Health publication of the rule in the Federal
with ultraviolet detection (HPLC/UV) is Risks and Safety Risks’’ (62 FR 19885, Register. This action is not a ‘‘major
available to enforce the tolerance April 23, 1997). This action does not rule’’ as defined by 5 U.S.C. 804(2).
expression. The method may be contain any information collections
requested from: Chief, Analytical List of Subjects in 40 CFR Part 180
subject to OMB approval under the
Chemistry Branch, Environmental Paperwork Reduction Act (PRA) (44 Environmental protection,
Science Center, 701 Mapes Rd., Ft. U.S.C. 3501 et seq.), nor does it require Administrative practice and procedure,
Meade, MD 20755–5350; telephone any special considerations under Agricultural commodities, Pesticides
number: (410) 305–2905; email address: Executive Order 12898, entitled and pests, Reporting and recordkeeping
residuemethods@epa.gov. ‘‘Federal Actions to Address requirements.
Environmental Justice in Minority
B. International Residue Limits Dated: March 9, 2015.
Populations and Low-Income
In making its tolerance decisions, EPA Susan Lewis,
Populations’’ (59 FR 7629, February 16,
seeks to harmonize U.S. tolerances with 1994). Director, Registration Division, Office of
international standards whenever Since tolerances and exemptions that Pesticide Programs.
possible, consistent with U.S. food are established on the basis of a petition Therefore, 40 CFR chapter I is
safety standards and agricultural under FFDCA section 408(d), such as amended as follows:
practices. EPA considers the the tolerance in this final rule, do not
international maximum residue limits require the issuance of a proposed rule, PART 180—[AMENDED]
(MRLs) established by the Codex the requirements of the Regulatory
Alimentarius Commission (Codex), as Flexibility Act (RFA) (5 U.S.C. 601 et ■ 1. The authority citation for part 180
required by FFDCA section 408(b)(4). seq.), do not apply. continues to read as follows:
The Codex Alimentarius is a joint This action directly regulates growers, Authority: 21 U.S.C. 321(q), 346a and 371.
United Nations Food and Agriculture food processors, food handlers, and food
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Organization/World Health retailers, not States or tribes, nor does ■ 2. In § 180.493 alphabetically add the
Organization food standards program, this action alter the relationships or commodity ‘‘papaya’’ to the table in
and it is recognized as an international distribution of power and paragraph (a) to read as follows:
food safety standards-setting responsibilities established by Congress
organization in trade agreements to in the preemption provisions of FFDCA § 180.493 Dimethomorph; tolerances for
residues.
which the United States is a party. EPA section 408(n)(4). As such, the Agency
may establish a tolerance that is has determined that this action will not (a) General. * * *

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Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Rules and Regulations 14019

Parts per 2014–0610. All documents in the docket related to a newly established or revised
Commodity million are listed on the www.regulations.gov NAAQS. The contents of an
Web site. Although listed in the index, infrastructure SIP submission may vary
some information is not publicly depending upon the data and analytical
* * * * * * available, i.e., Confidential Business
Papaya 1 ............................... 1.5 tools available to the state, as well as the
Information or other information whose provisions already contained in the
* * * * * * disclosure is restricted by statute. state’s implementation plan at the time
Certain other material, such as in which the state develops and submits
1 There are no U.S. registrations as of Janu-
copyrighted material, is not placed on the submission for a new or revised
ary 20, 2015.
the Internet and will be publicly NAAQS.
* * * * * available only in hard copy form.
[FR Doc. 2015–06106 Filed 3–17–15; 8:45 am] Publicly available docket materials are Through this action, EPA is approving
BILLING CODE 6560–50–P available either electronically through the PSD requirements of sections
www.regulations.gov or in hard copy at 110(a)(2)(C), 110(a)(2)(D)(i)(II) (prong 3)
the Air Regulatory Management Section and 110(a)(2)(J) (hereafter ‘‘PSD
ENVIRONMENTAL PROTECTION (formerly Regulatory Development Elements’’) for various infrastructure
AGENCY Section), Air Planning and SIP submissions from the states of
Implementation Branch, Air, Pesticides Alabama, Florida, Georgia, Kentucky,
40 CFR Part 52 Mississippi, South Carolina and
and Toxics Management Division, U.S.
[EPA–R04–OAR–2014–0610; FRL–9924–47– Environmental Protection Agency, Tennessee. As described further below,
Region 4] Region 4, 61 Forsyth Street SW., for some of these states, EPA is
Atlanta, Georgia 30303–8960. EPA approving the PSD Elements in the
Approval and Promulgation of requests that if at all possible, you infrastructure SIP submissions for the
Implementation Plans; Region 4 contact the person listed in the FOR 2008 Lead, 2008 Ozone and 2010 NO2
States; 2008 Lead, 2008 Ozone and NAAQS; whereas for other states, EPA
FURTHER INFORMATION CONTACT section to
2010 Nitrogen Dioxide Prevention of is only approving the PSD Elements of
schedule your inspection. The Regional
Significant Deterioration Infrastructure the infrastructure SIP submissions for a
Office’s official hours of business are
Plans
Monday through Friday 8:30 a.m. to subset of these NAAQS. All other
AGENCY: Environmental Protection 4:30 p.m., excluding Federal holidays. applicable infrastructure requirements
Agency. FOR FURTHER INFORMATION CONTACT: for the 2008 Lead, 2008 Ozone and 2010
ACTION: Final rule. Sean Lakeman, Air Regulatory NO2 NAAQS associated with these
Management Section, Air Planning and States are being addressed in separate
SUMMARY: The Environmental Protection Implementation Branch, Air, Pesticides rulemakings.
Agency (EPA) is approving portions of and Toxics Management Division, U.S.
submissions from Alabama, Florida, a. 2008 Lead NAAQS
Environmental Protection Agency,
Georgia, Kentucky, Mississippi, South Region 4, 61 Forsyth Street SW.,
Carolina and Tennessee for inclusion For the 2008 Lead NAAQS, EPA is
Atlanta, Georgia 30303–8960. The only approving the PSD Elements of the
into each State’s implementation plan. telephone number is (404) 562–9043.
This action pertains to the Clean Air Act Mr. Lakeman can be reached via infrastructure SIP submissions from
(CAA or Act) infrastructure Alabama (received November 4, 2011),
electronic mail at lakeman.sean@ Florida (received October 14, 2011),
requirements for the 2008 Lead, 2008 epa.gov.
Ozone and 2010 Nitrogen Dioxide (NO2) Georgia (received May 14, 2012),
National Ambient Air Quality Standards SUPPLEMENTARY INFORMATION: Kentucky (received July 17, 2012),
(NAAQS). The CAA requires that each I. Background Mississippi (received November 17,
state adopt and submit a state 2011), and South Carolina (received
By statute, SIPs meeting the September 20, 2011). EPA notes that the
implementation plan (SIP) for the
requirements of sections 110(a)(1) and Agency approved the PSD Elements of
implementation, maintenance, and
(2) are to be submitted by states within Tennessee’s 2008 Lead infrastructure
enforcement of each NAAQS
three years after promulgation of a new SIP submission on August 12, 2013 (78
promulgated by EPA. These plans are
or revised NAAQS to provide for the FR 48806).
commonly referred to as
implementation, maintenance, and
‘‘infrastructure’’ SIPs. Specifically, EPA
enforcement of the new or revised b. 2008 Ozone NAAQS
is approving the portions of the
NAAQS. EPA has historically referred to
submissions from Alabama, Florida, For the 2008 Ozone NAAQS, EPA is
these SIP submissions made for the
Georgia, Kentucky, Mississippi, South only approving the PSD Elements of the
purpose of satisfying the requirements
Carolina and Tennessee that relate to infrastructure SIP submissions from
of CAA sections 110(a)(1) and 110(a)(2)
the infrastructure SIP prevention of Alabama (received August 20, 2012),
as ‘‘infrastructure SIP’’ submissions.
significant deterioration (PSD) Georgia (received March 6, 2012),
Sections 110(a)(1) and (2) require states
requirements. All other applicable Mississippi (received May 29, 2012; and
to address basic SIP elements such as
infrastructure requirements for the 2008 resubmitted July 26, 2012), and South
for monitoring, basic program
Lead, 2008 Ozone and 2010 NO2 Carolina (received on July 17, 2012).
requirements and legal authority that
NAAQS associated with these States are EPA notes that the Agency approved the
are designed to assure attainment and
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being addressed in separate PSD Elements of the infrastructure SIP
maintenance of the newly established or
rulemakings. submissions for the 2008 Ozone NAAQS
revised NAAQS. More specifically,
DATES: This rule is effective on April 17, section 110(a)(1) provides the for Kentucky on March 7, 2013 (78 FR
2015. procedural and timing requirements for 14691) and November 3, 2014 (79 FR
ADDRESSES: EPA has established a SIPs. Section 110(a)(2) lists specific 65143), and Tennessee on March 6,
docket for this action under Docket elements that states must meet for the 2013 (78 FR 14450) and January 9, 2014
Identification No. EPA–R04–OAR– ‘‘infrastructure’’ SIP requirements (79 FR 1593).

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Document Created: 2018-02-21 09:39:51
Document Modified: 2018-02-21 09:39:51
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 March 18, 2015. Objections and requests for hearings must be received on or before May 18, 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 14014
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements