14014 Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Rules and Regulations 

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 3, 2015. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Revise § 180.589(a)(1) as follows: 

■ a. Add in alphabetical order entries 

for ‘‘Dill, seed’’ and ‘‘Herb subgroup 

19A’’. 

■ b. Remove the entries for ‘‘Fruit, 

stone, group 12’’ and ‘‘Nut, tree, group 

14’’ and add in their place entries for 

‘‘Fruit, stone, group 12–12’’ and ‘‘Nut, 

tree, group 14–12’’, respectively. 

■ c. Remove the entry for ‘‘Pistachio.’’ 

■ d. Remove the entry for ‘‘Papya’’ and 

add in its place an entry for ‘‘Papaya.’’ 

The addition and revisions read as 

follows: 

§ 180.589 Boscalid; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

*****

* * 

Dill, seed ............................... 100 

*****

* * 

Fruit, stone, group 12–12 ..... 3.5 

*****

* * 

Herb subgroup 19A .............. 150 

Commodity Parts per 

million 

*****

* * 

Nut, tree, group 14–12 ......... 0.70 

*****

* * 

Papaya .................................. 1.5 

*****

* * 

* * * * * 

[FR Doc. 2015–06141 Filed 3–17–15; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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 


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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: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Publishing Office’s eCFR 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 


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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-observedadverse-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 nonthreshold 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

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (Females 13–49 

years of age).

No appropriate endpoint was identified including developmental toxicity studies in rats 

and rabbits.

Not applicable .......... No study selected. 

Acute dietary (General population).LOAEL = 250 mg/kg/

day UFA.

UFH = 10x ................

FQPA SFL = 10x .....

Acute RfD = 0.25 

mg/kg/day.

aPAD = 0.25 mg/kg/

day.

Acute Neurotoxicity Study. 

LOAEL = 250 mg/kg/day based on reduced motor activity in 

both sexes. 

Chronic dietary (All populations) NOAEL = 11 mg/kg/

day UFA = 10x.

UFH = 10x ................

FQPA SF = 1x .........

Chronic RfD = 0.1 

mg/kg/day.

cPAD = 0.1 mg/kg/

day.

Carcinogenicity study in rats. 

LOAEL = 46.3 mg/kg/day based on decreased body weight 

and 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 


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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 nonoccupational, 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 


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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 intermediateterm 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: 

residuemethods@epa.gov. 

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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.493 alphabetically add the 

commodity ‘‘papaya’’ to the table in 

paragraph (a) to read as follows: 

§ 180.493 Dimethomorph; tolerances for 

residues. 

(a) General. * * * 


wreier-aviles on DSK5TPTVN1PROD with RULES
Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Rules and Regulations 14019 

Commodity Parts per 

million 

* * * * * * 

Papaya 1 ............................... 1.5 

* * * * * * 

1There 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R04–OAR–2014–0610; FRL–9924–47– 

Region 4] 

Approval and Promulgation of 

Implementation Plans; Region 4 

States; 2008 Lead, 2008 Ozone and 

2010 Nitrogen Dioxide Prevention of 

Significant Deterioration Infrastructure 

Plans 

AGENCY: Environmental Protection 

Agency. 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is approving portions of 

submissions from Alabama, Florida, 

Georgia, Kentucky, Mississippi, South 

Carolina and Tennessee for inclusion 

into each State’s implementation plan. 

This action pertains to the Clean Air Act 

(CAA or Act) infrastructure 

requirements for the 2008 Lead, 2008 

Ozone and 2010 Nitrogen Dioxide (NO2) 

National Ambient Air Quality Standards 

(NAAQS). The CAA requires that each 

state adopt and submit a state 

implementation plan (SIP) for the 

implementation, maintenance, and 

enforcement of each NAAQS 

promulgated by EPA. These plans are 

commonly referred to as 

‘‘infrastructure’’ SIPs. Specifically, EPA 

is approving the portions of the 

submissions from Alabama, Florida, 

Georgia, Kentucky, Mississippi, South 

Carolina and Tennessee that relate to 

the infrastructure SIP prevention of 

significant deterioration (PSD) 

requirements. All other applicable 

infrastructure requirements for the 2008 

Lead, 2008 Ozone and 2010 NO2

NAAQS associated with these States are 

being addressed in separate 

rulemakings. 

DATES: This rule is effective on April 17, 

2015. 

ADDRESSES: EPA has established a 

docket for this action under Docket 

Identification No. EPA–R04–OAR– 

2014–0610. All documents in the docket 

are listed on the www.regulations.gov 

Web site. Although listed in the index, 

some information is not publicly 

available, i.e., Confidential Business 

Information or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically through 

www.regulations.gov or in hard copy at 

the Air Regulatory Management Section 

(formerly Regulatory Development 

Section), Air Planning and 

Implementation Branch, Air, Pesticides 

and Toxics Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street SW., 

Atlanta, Georgia 30303–8960. EPA 

requests that if at all possible, you 

contact the person listed in the FOR

FURTHER INFORMATION CONTACT section to 

schedule your inspection. The Regional 

Office’s official hours of business are 

Monday through Friday 8:30 a.m. to 

4:30 p.m., excluding Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Sean Lakeman, Air Regulatory 

Management Section, Air Planning and 

Implementation Branch, Air, Pesticides 

and Toxics Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street SW., 

Atlanta, Georgia 30303–8960. The 

telephone number is (404) 562–9043. 

Mr. Lakeman can be reached via 

electronic mail at lakeman.sean@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

By statute, SIPs meeting the 

requirements of sections 110(a)(1) and 

(2) are to be submitted by states within 

three years after promulgation of a new 

or revised NAAQS to provide for the 

implementation, maintenance, and 

enforcement of the new or revised 

NAAQS. EPA has historically referred to 

these SIP submissions made for the 

purpose of satisfying the requirements 

of CAA sections 110(a)(1) and 110(a)(2) 

as ‘‘infrastructure SIP’’ submissions. 

Sections 110(a)(1) and (2) require states 

to address basic SIP elements such as 

for monitoring, basic program 

requirements and legal authority that 

are designed to assure attainment and 

maintenance of the newly established or 

revised NAAQS. More specifically, 

section 110(a)(1) provides the 

procedural and timing requirements for 

SIPs. Section 110(a)(2) lists specific 

elements that states must meet for the 

‘‘infrastructure’’ SIP requirements 

related to a newly established or revised 

NAAQS. The contents of an 

infrastructure SIP submission may vary 

depending upon the data and analytical 

tools available to the state, as well as the 

provisions already contained in the 

state’s implementation plan at the time 

in which the state develops and submits 

the submission for a new or revised 

NAAQS. 

Through this action, EPA is approving 

the PSD requirements of sections 

110(a)(2)(C), 110(a)(2)(D)(i)(II) (prong 3) 

and 110(a)(2)(J) (hereafter ‘‘PSD 

Elements’’) for various infrastructure 

SIP submissions from the states of 

Alabama, Florida, Georgia, Kentucky, 

Mississippi, South Carolina and 

Tennessee. As described further below, 

for some of these states, EPA is 

approving the PSD Elements in the 

infrastructure SIP submissions for the 

2008 Lead, 2008 Ozone and 2010 NO2

NAAQS; whereas for other states, EPA 

is only approving the PSD Elements of 

the infrastructure SIP submissions for a 

subset of these NAAQS. All other 

applicable infrastructure requirements 

for the 2008 Lead, 2008 Ozone and 2010 

NO2 NAAQS associated with these 

States are being addressed in separate 

rulemakings. 

a. 2008 Lead NAAQS 

For the 2008 Lead NAAQS, EPA is 

only approving the PSD Elements of the 

infrastructure SIP submissions from 

Alabama (received November 4, 2011), 

Florida (received October 14, 2011), 

Georgia (received May 14, 2012), 

Kentucky (received July 17, 2012), 

Mississippi (received November 17, 

2011), and South Carolina (received 

September 20, 2011). EPA notes that the 

Agency approved the PSD Elements of 

Tennessee’s 2008 Lead infrastructure 

SIP submission on August 12, 2013 (78 

FR 48806). 

b. 2008 Ozone NAAQS 

For the 2008 Ozone NAAQS, EPA is 

only approving the PSD Elements of the 

infrastructure SIP submissions from 

Alabama (received August 20, 2012), 

Georgia (received March 6, 2012), 

Mississippi (received May 29, 2012; and 

resubmitted July 26, 2012), and South 

Carolina (received on July 17, 2012). 

EPA notes that the Agency approved the 

PSD Elements of the infrastructure SIP 

submissions for the 2008 Ozone NAAQS 

for Kentucky on March 7, 2013 (78 FR 

14691) and November 3, 2014 (79 FR 

65143), and Tennessee on March 6, 

2013 (78 FR 14450) and January 9, 2014 

(79 FR 1593). 


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