51732 Federal Register / Vol. 80, No. 165 / Wednesday, August 26, 2015 / Rules and Regulations 

Executive Order 13211: Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use 

Because it is not a ‘‘significant 

regulatory action’’ under Executive 

Order 12866 or a ‘‘significant energy 

action,’’ this action is also not subject to 

Executive Order 13211, ‘‘Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001). 

National Technology Transfer 

Advancement Act 

In reviewing state submissions, EPA’s 

role is to approve state choices, 

provided that they meet the criteria of 

the CAA. In this context, in the absence 

of a prior existing requirement for the 

state to use voluntary consensus 

standards (VCS), EPA has no authority 

to disapprove a state submission for 

failure to use VCS. It would thus be 

inconsistent with applicable law for 

EPA, when it reviews a state 

submission, to use VCS in place of a 

state submission that otherwise satisfies 

the provisions of the CAA. Thus, the 

requirements of section 12(d) of the 

National Technology Transfer and 

Advancement Act of 1995 (15 U.S.C. 

272 note) do not apply. 

Executive Order 12898: Federal Actions 

To Address Environmental Justice in 

Minority Populations and Low-Income 

Populations 

Executive Order 12898 (59 FR 7629 

(Feb. 16, 1994)) establishes Federal 

executive policy on environmental 

justice. Its main provision directs 

Federal agencies, to the greatest extent 

practicable and permitted by law, to 

make environmental justice part of their 

mission by identifying and addressing, 

as appropriate, disproportionately high 

and adverse human health or 

environmental effects of their programs, 

policies, and activities on minority 

populations and low-income 

populations in the United States. 

EPA lacks the discretionary authority 

to address environmental justice in this 

action. In reviewing SIP submissions, 

EPA’s role is to approve or disapprove 

state choices, based on the criteria of the 

CAA. Accordingly, this action merely 

disapproves certain state requirements 

for inclusion into the SIP under section 

110 and subchapter I, part D of the CAA 

and will not in-and-of itself create any 

new requirements. Accordingly, it does 

not provide EPA with the discretionary 

authority to address, as appropriate, 

disproportionate human health or 

environmental effects, using practicable 

and legally permissible methods, under 

Executive Order 12898. 

Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by October 26, 2015. Filing a 

petition for reconsideration by the 

Administrator of this final rule does not 

affect the finality of this rule for the 

purposes of judicial review nor does it 

extend the time within which a petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. This action may not 

be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Ozone, Particulate matter. 

Dated: August 14, 2015. 

Susan Hedman, 

Regional Administrator, Region 5. 

40 CFR part 52 is amended as follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

■ 2. Section 52.745 is amended by 

revising paragraphs (c) and (e) to read as 

follows: 

§ 52.745 Section 110(a)(2) infrastructure 

requirements. 

* * * * * 

(c) Approval and Disapproval—In an 

August 9, 2011, submittal, and 

supplemented on August 25, 2011, and 

June 27, 2012, Illinois certified that the 

State has satisfied the infrastructure SIP 

requirements of section 110(a)(2)(A) 

through (H), and (J) through (M) for the 

2006 24-hour PM2.5 NAAQS. EPA is 

approving Illinois’ submission 

addressing the infrastructure SIP 

requirements of section 110(a)(2)(A), 

(B), (C) with respect to enforcement, 

(D)(i)(II) with respect to visibility 

protection, (D)(ii), (E) except for state 

board requirements, (F) through (H), (J) 

except for prevention of significant 

deterioration (PSD), and (K) through 

(M). EPA is not taking action on (D)(i)(I). 

EPA is disapproving the state board 

requirements of (E)(ii). EPA is 

disapproving Illinois’ submission 

addressing PSD in (C), (D)(i)(II), and the 

PSD portion of (J). Although EPA is 

disapproving portions of Illinois’ 

submission addressing PSD, Illinois 

continues to implement the Federally 

promulgated rules for this purpose as 

they pertain to (C), (D)(i)(II), and the 

PSD portion of (J). 

* * * * * 

(e) Approval and Disapproval—In a 

December 31, 2012, submittal, Illinois 

certified that the State has satisfied the 

infrastructure SIP requirements of 

section 110(a)(2)(A) through (H), and (J) 

through (M) for the 2008 ozone NAAQS 

except for 110(a)(2)(D)(i)(I). EPA is 

approving Illinois’ submission 

addressing the infrastructure SIP 

requirements of section 110(a)(2)(A), 

(B), (C) with respect to enforcement, 

(D)(i)(II) with respect to visibility 

protection, (D)(ii), (E) except for state 

board requirements, (F) through (H), (J) 

except for prevention of significant 

deterioration (PSD), and (K) through 

(M). EPA is disapproving the state board 

requirements of (E)(ii). EPA is 

disapproving Illinois’ submission 

addressing PSD in (C), (D)(i)(II), and the 

PSD portion of (J). Although EPA is 

disapproving portions of Illinois’ 

submission addressing PSD, Illinois 

continues to implement the Federally 

promulgated rules for this purpose as 

they pertain to (C), (D)(i)(II), and the 

PSD portion of (J). 

* * * * * 

[FR Doc. 2015–21010 Filed 8–25–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0470; FRL–9929–61] 

Difenoconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 


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Federal Register / Vol. 80, No. 165 / Wednesday, August 26, 2015 / Rules and Regulations 51733 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

difenoconazole in or on artichoke, 

globe; ginseng; fruit, stone, group 12–12; 

and nut, tree, group 14–12. This 

regulation additionally removes existing 

tolerances in or on fruit, stone, group 

12; nut, tree, group 14; and pistachio. 

Interregional Research Project Number 4 

(IR–4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

August 26, 2015. Objections and 

requests for hearings must be received 

on or before October 26, 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–2014–0470, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&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–2014–0470 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before October 26, 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– 

2014–0470, 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 September 

5, 2014 (79 FR 53009) (FRL–9914–98), 

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 4E8274) by IR–4, 

500 College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the fungicide 

difenoconazole, 1-[2-[2-chloro-4-(4- 

chlorophenoxy)phenyl]-4-methyl-1,3- 

dioxolan-2-ylmethyl]-1H–1,2,4-triazole, 

in or on ginseng at 0.50 parts per 

million (ppm); artichoke, globe at 1.5 

ppm; fruit, stone, group 12–12 at 2.5 

ppm; and nut, tree, group 14–12 at 0.03 

ppm. That document referenced a 

summary of the petition prepared on 

behalf of IR–4 by Syngenta Crop 

Protection, LLC, the registrant, which is 

available in the docket, http://

www.regulations.gov. Comments were 

received on the notice of filing. EPA’s 

response to these comments is 

discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerance in or on ginseng. 

The reason for this change is explained 

in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with 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 


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51734 Federal Register / Vol. 80, No. 165 / Wednesday, August 26, 2015 / Rules and Regulations 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for difenoconazole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with difenoconazole 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. 

Subchronic and chronic studies with 

difenoconazole in mice and rats showed 

decreased body weights, decreased body 

weight gains and effects on the liver 

(e.g. hepatocellular hypertrophy, liver 

necrosis, fatty changes in the liver). No 

systemic toxicity was observed at the 

limit dose in the most recently 

submitted rat dermal toxicity study. 

The available toxicity studies 

indicated no increased susceptibility of 

rats or rabbits from in utero or postnatal 

exposure to difenoconazole. In prenatal 

developmental toxicity studies in rats 

and rabbits and in the 2-generation 

reproduction study in rats, fetal and 

offspring toxicity, when observed, 

occurred at equivalent or higher doses 

than in the maternal and parental 

animals. 

In a rat developmental toxicity study, 

developmental effects were observed at 

doses higher than those which caused 

maternal toxicity. Developmental effects 

in the rat included increased incidence 

of ossification of the thoracic vertebrae 

and thyroid, decreased number of 

sternal centers of ossification, increased 

number of ribs and thoracic vertebrae, 

and decreased number of lumbar 

vertebrae. In the rabbit study, 

developmental effects (increases in postimplantation loss and resorptions and 

decreases in fetal body weight) were 

also seen at maternally toxic doses 

(decreased body weight gain and food 

consumption). In the 2-generation 

reproduction study in rats, toxicity to 

the fetuses and offspring, when 

observed, occurred at equivalent or 

higher doses than in the maternal and 

parental animals. 

In an acute neurotoxicity study in 

rats, reduced fore-limb grip strength was 

observed on day one in males at the 

lowest-observed-adverse-effect-level 

(LOAEL), and clinical signs of 

neurotoxicity were observed in females 

only at the highest dose tested. In a 

subchronic neurotoxicity study in rats, 

decreased hind limb strength was 

observed in males only at the mid- and 

high-doses. The effects observed in 

acute and subchronic neurotoxicity 

studies were considered transient. 

Although there is some evidence that 

difenoconazole affects antibody levels at 

doses that cause systemic toxicity, there 

are no indications in the available 

studies that organs associated with 

immune function, such as the thymus 

and spleen, are affected by 

difenoconazole. 

EPA is using the nonlinear reference 

dose (RfD) approach to assess cancer 

risk. Difenoconazole is not mutagenic, 

and no evidence of carcinogenicity was 

seen in rats. 

Evidence for carcinogenicity was seen 

in mice (liver tumors), but statistically 

significant carcinoma tumors were only 

induced at excessively-high doses. 

Adenomas (benign tumors) and liver 

necrosis only were seen at 300 ppm (46 

and 58 milligram/kilogram/day (mg/kg/ 

day) in males and females, respectively). 

Based on excessive toxicity observed at 

the two highest doses in the mouse 

carcinogenicity study, the presence of 

only benign tumors and necrosis at the 

mid-dose, the absence of tumors at the 

study’s lower doses, and the absence of 

genotoxic effects, EPA has concluded 

that the chronic point of departure 

(POD) from the chronic mouse study 

will be protective of any cancer effects. 

The POD from this study is the noobserved-adverse-effect-level (NOAEL) 

of 30 ppm (4.7 and 5.6 mg/kg/day in 

males and females, respectively), which 

was chosen based upon only those 

biological endpoints which were 

relevant to tumor development (i.e., 

hepatocellular hypertrophy, liver 

necrosis, fatty changes in the liver and 

bile stasis). EPA has concluded that a 

nonlinear RfD approach is appropriate 

for assessing cancer risk to 

difenoconazole and a separate 

quantitative cancer exposure assessment 

is unnecessary since the chronic dietary 

risk estimate will be protective of 

potential cancer risk. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by difenoconazole as well 

as the NOAEL and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in document, 

‘‘Difenoconazole: Human Health Risk 

Assessment for Proposed New Foliar 

Uses on Globe Artichoke, Ginseng and 

Greenhouse Grown Cucumbers and 

Conversion of the Established Foliar 

Uses/Tolerances for Stone Fruit Group 

12 and Tree Nut Crop Group 14 to Stone 

Fruit Group 12–12 and Tree Nut Group 

14–12.’’ at pp. 36–43 in docket ID 

number EPA–HQ–OPP–2014–0470. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological 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 are identified. Uncertainty/

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or an 

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 difenoconazole used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of April 2, 2015 (80 

FR 17697) (FRL–9923–82). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to difenoconazole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing difenoconazole tolerances in 40 

CFR 180.475. EPA assessed dietary 

exposures from difenoconazole 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 

difenoconazole. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). As to 

residue levels in food, EPA assumed 


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tolerance level residues and 100 percent 

crop treated (PCT) information. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA NHANES/WWEIA. As 

to residue levels in food, EPA used 

USDA Pesticide Data Program (PDP) 

monitoring data, average field trial 

residues for some commodities, 

tolerance level residues for the 

remaining commodities, average PCT for 

some commodities, and 100 PCT for the 

remaining commodities. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or nonlinear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or nonlinear approach is 

used and a cancer RfD is calculated 

based on an earlier noncancer key event. 

If carcinogenic mode of action data are 

not available, or if the mode of action 

data determines a mutagenic mode of 

action, a default linear cancer slope 

factor approach is utilized. 

Based on the data summarized in Unit 

III.A., EPA has concluded that a 

nonlinear RfD approach is appropriate 

for assessing cancer risk to 

difenoconazole. Therefore, a separate 

quantitative cancer exposure assessment 

is unnecessary since the chronic dietary 

risk estimate will be protective of 

potential cancer risk. 

iv. Anticipated residue and PCT 

information. Section 408(b)(2)(E) of 

FFDCA authorizes EPA to use available 

data and information on the anticipated 

residue levels of pesticide residues in 

food and the actual levels of pesticide 

residues that have been measured in 

food. If EPA relies on such information, 

EPA must require pursuant to FFDCA 

section 408(f)(1) that data be provided 5 

years after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

408(b)(2)(E) and authorized under 

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

For the chronic dietary exposure 

analysis, the Agency estimated the PCT 

for existing uses as follows: 

Almond, 5%; cabbage, 2.5%; 

cucumber, 5%; garlic, 5%; grape, 5%; 

grapefruit, 2.5%; onion, 5%; orange, 

2.5%; peach, 1%; pecan, 2.5%; pepper, 

2.5%; pistachio, 2.5%; pumpkin, 2.5%; 

squash, 5%; strawberry, 2.5%; sugar 

beet, 15%; tangerine, 2.5%; tomato, 

25%; walnut, 2.5%; watermelon, 5%; 

and wheat, 10%. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which difenoconazole may be applied 

in a particular area. 

2. Dietary exposure from drinking 

water. The drinking water assessment 

was performed using a total toxic 

residue method, which considers both 

parent difenoconazole and its major 

metabolite, CGA 205375, in surface and 

groundwater. Therefore, the Agency 

used screening level water exposure 

models in the dietary exposure analysis 

and risk assessment for difenoconazole 

and its major metabolite in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of difenoconazole and 

CGA 205375. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/

oppefed1/models/water/index.htm. 

Based on Surface Water Concentration 

Calculator (SWCC), Screening 

Concentration in Ground Water (SCI– 

GROW), and Pesticide Root Zone Model 

Ground Water (PRZM GW) models, the 

combined estimated drinking water 

concentrations (EDWCs) of 

difenoconazole and CGA 205375 are 

estimated to be 20.0 parts per billion 

(ppb) for surface water and 1.77 ppb for 

ground water. For chronic exposure 

assessments, EDWCs are estimated to be 

13.6 ppb for surface water; EDWCs were 

not detected for ground water for 

chronic assessments. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 20.0 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 13.6 ppb was used to assess the 

contribution to drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 


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indoor pest control, termiticides, and 

flea and tick control on pets). 

Difenoconazole is currently registered 

for the following uses that could result 

in residential exposures: Treatment of 

ornamental plants in commercial and 

residential landscapes and interior 

plantscapes. EPA assessed residential 

exposure using the following 

assumptions: For residential handlers, 

adult short-term dermal and inhalation 

exposure is expected from mixing, 

loading, and applying difenoconazole 

on ornamentals (gardens and trees). For 

residential post-application exposures, 

short-term dermal exposure is expected 

for both adults and children from postapplication activities in treated 

residential landscapes. 

The scenarios used in the aggregate 

assessment were those that resulted in 

the highest exposures. The highest 

exposures consist of the short-term 

dermal exposure to adults from postapplication activities in treated gardens 

and short-term dermal exposure to 

children 6 to 11 years old from postapplication activities in treated gardens. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

science/residential-exposure-sop.html. 

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.’’ 

Difenoconazole is a member of the 

triazole-containing class of pesticides. 

Although conazoles act similarly in 

plants (fungi) by inhibiting ergosterol 

biosynthesis, there is not necessarily a 

relationship between their pesticidal 

activity and their mechanism of toxicity 

in mammals. Structural similarities do 

not constitute a common mechanism of 

toxicity. Evidence is needed to establish 

that the chemicals operate by the same, 

or essentially the same, sequence of 

major biochemical events (EPA, 2002). 

This document may be found at EPA’s 

Web site at http://www.epa.gov/

oppfead1/trac/science/

cumulativeguidance.pdf. 

In conazoles, however, a variable 

pattern of toxicological responses is 

found; some are hepatotoxic and 

hepatocarcinogenic in mice. Some 

induce thyroid tumors in rats. Some 

induce developmental, reproductive, 

and neurological effects in rodents. 

Furthermore, the conazoles produce a 

diverse range of biochemical events 

including altered cholesterol levels, 

stress responses, and altered DNA 

methylation. It is not clearly understood 

whether these biochemical events are 

directly connected to their toxicological 

outcomes. Thus, there is currently no 

evidence to indicate that conazoles 

share common mechanisms of toxicity 

and EPA is not following a cumulative 

risk approach based on a common 

mechanism of toxicity for the conazoles. 

For information regarding EPA’s 

procedures for cumulating effects from 

substances found to have a common 

mechanism of toxicity, see EPA’s Web 

site at http://www.epa.gov/pesticides/

cumulative. 

Difenoconazole is a triazole-derived 

pesticide. This class of compounds can 

form the common metabolite 1,2,4- 

triazole and two triazole conjugates 

(triazolylalanine and triazolylacetic 

acid). To support existing tolerances 

and to establish new tolerances for 

triazole-derivative pesticides, including 

difenoconazole, EPA conducted a 

human health risk assessment for 

exposure to 1,2,4-triazole, 

triazolylalanine, and triazolylacetic acid 

resulting from the use of all current and 

pending uses of any triazole-derived 

fungicide. The risk assessment is a 

highly conservative, screening-level 

evaluation in terms of hazards 

associated with common metabolites 

(e.g., use of a maximum combination of 

uncertainty factors) and potential 

dietary and non-dietary exposures (i.e., 

high end estimates of both dietary and 

non-dietary exposures). In addition, the 

Agency retained the additional 10X 

Food Quality Protection Act Safety 

Factor (FQPA SF) for the protection of 

infants and children. The assessment 

includes evaluations of risks for various 

subgroups, including those comprised 

of infants and children. 

The Agency’s complete risk 

assessment may be found in the 

propiconazole reregistration docket at 

http://www.regulations.gov, docket ID 

Number EPA–HQ–OPP–2005–0497. The 

Agency’s latest complete risk 

assessment for the triazole-containing 

metabolites was finalized on April 9, 

2015 and is entitled, ‘‘Common Triazole 

Metabolites: Updated Dietary (Food + 

Water) Exposure and Risk Assessment 

to Address The New Section 3 

Registrations For Use of Propiconazole 

on Tea, Dill, Mustard Greens, Radish, 

and Watercress; Use of Difenoconazole 

on Globe Artichoke, Ginseng and 

Greenhouse Grown Cucumbers and 

Conversion of the Established Foliar 

Uses/Tolerances for Stone Fruit and 

Tree Nut Crop Groups to Fruit, Stone, 

Group 12–12 and the Nut, Tree, Group 

14–12.; and Use of Flutriafol on Hops.’’ 

The assessment may be found in the 

propiconazole reregistration docket at 

http://www.regulations.gov, docket ID 

number EPA–HQ–OPP–2014–0470. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA 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 prenatal and postnatal toxicology 

database for difenoconazole includes rat 

and rabbit prenatal developmental 

toxicity studies and a 2-generation 

reproduction toxicity study in rats. The 

available Agency guideline studies 

indicated no increased qualitative or 

quantitative susceptibility of rats or 

rabbits to in utero and/or postnatal 

exposure to difenoconazole. In the 

prenatal developmental toxicity studies 

in rats and rabbits and the 2-generation 

reproduction study in rats, toxicity to 

the fetuses/offspring, when observed, 

occurred at equivalent or higher doses 

than in the maternal/parental animals. 

In a rat developmental toxicity study 

developmental effects were observed at 

doses higher than those which caused 

maternal toxicity. In the rabbit study, 

developmental effects (increases in postimplantation loss and resorptions and 

decreases in fetal body weight) were 

also seen at maternally toxic doses 

(decreased body weight gain and food 

consumption). In the 2-generation 

reproduction study in rats, toxicity to 

the fetuses/offspring, when observed, 

occurred at equivalent or higher doses 

than in the maternal/parental animals. 

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 

difenoconazole is complete. 

ii. There are no clear signs of 

neurotoxicity following acute, 

subchronic, or chronic exposure in 

multiple species in the difenoconazole 


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Federal Register / Vol. 80, No. 165 / Wednesday, August 26, 2015 / Rules and Regulations 51737 

study database. The effects observed in 

acute and subchronic neurotoxicity 

studies are transient, and the doseresponse is well characterized with 

identified NOAELs. Based on the 

toxicity profile, and lack of concern for 

neurotoxicity, there is no need for a 

developmental neurotoxicity study or 

additional uncertainty factors (UFs) to 

account for neurotoxicity. 

iii. There is no evidence that 

difenoconazole results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary risk assessment utilized 

tolerance level residues and 100 PCT for 

the acute assessment; the chronic 

assessment was refined by using USDA 

PDP monitoring data, average field trial 

residues for some commodities, 

tolerance level residues for remaining 

commodities, and average PCT for some 

commodities. These assumptions will 

not underestimate dietary exposure to 

difenoconazole. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to difenoconazole in 

drinking water. EPA used similarly 

conservative assumptions to assess 

postapplication exposure of children. 

These assessments will not 

underestimate the exposure and risks 

posed by difenoconazole. 

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 

difenoconazole will occupy 49% of the 

aPAD for all infants less than 1 year 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 difenoconazole 

from food and water will utilize 89% of 

the cPAD for children 1 to 2 years old, 

the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

difenoconazole is not expected. 

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). Difenoconazole is 

currently registered for uses that could 

result in short-term residential 

exposure, and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to difenoconazole. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 170 for adults and 190 for 

children. Because EPA’s level of 

concern for difenoconazole is a MOE of 

100 or below, these MOEs are not of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). An 

intermediate-term adverse effect was 

identified; however, difenoconazole 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 

difenoconazole. 

5. Aggregate cancer risk for U.S. 

population. Based on the data 

summarized in Unit III.A., the chronic 

dietary risk assessment is protective of 

any potential cancer effects. Based on 

the results of that assessment, EPA 

concludes that difenoconazole 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 

difenoconazole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

gas chromatography with nitrogen 

phosphorus detection (GC/NPD) method 

AG–575B, is available for the 

determination of residues of 

difenoconazole per se in or on plant 

commodities. Liquid chromatography 

with tandem mass spectrometry (LC/

MS/MS) method REM 147.07b is 

available for the determination of 

residues of difenoconazole and CGA– 

205375 in livestock commodities. 

Adequate confirmatory methods are also 

available. 

The methods 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 

in or on artichoke, globe. Codex has 

established the following MRLs for 

difenoconazole: Ginseng at 0.08 ppm; 

dried and red ginseng at 0.2 ppm; 

ginseng extracts at 0.6 ppm; cherry and 

plum, including prune at 0.2 ppm; 

nectarine and peach at 0.5 ppm; and 

tree nut at 0.03 ppm. The MRL for tree 

nut at 0.03 ppm is the same as the 

tolerance being established for 

difenoconazole in the United States for 

nut, tree, group 14–12 at 0.03 ppm. 

Based on the data reviewed in 

conjunction with this action, 

harmonization with Codex MRLs is not 

possible for ginseng and stone fruit 


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51738 Federal Register / Vol. 80, No. 165 / Wednesday, August 26, 2015 / Rules and Regulations 

commodities (including cherry, 

nectarine, peach, plum, and prune). The 

data supporting the EPA petition 

support the establishment of tolerance 

levels that are higher than the 

established Codex MRLs. The U.S. 

tolerances are being recommended by 

EPA are as follows: Ginseng at 1.0 ppm; 

and fruit, stone, group 12–12 at 2.5 

ppm. 

C. Response to Comments 

Several comments were received in 

response to the notice of filing. All but 

one were concerned with potential 

environmental impacts, and were not 

specifically related to the 

difenoconazole action. EPA notes that 

these comments address potential 

environmental concerns; however, the 

safety standard for approving tolerances 

under section 408 of the FFDCA focuses 

on potential harms to human health and 

does not permit consideration of effects 

on the environment. 

One additional comment was received 

that did not specifically address the 

difenoconazole action, but that raised 

concerns about the toxicity of pesticides 

and requested that no tolerance be 

established. The Agency understands 

the commenter’s concerns and 

recognizes that some individuals believe 

that pesticides should be banned on 

agricultural crops. However, the existing 

legal framework provided by Section 

408 of the FFDCA states that tolerances 

may be set when persons seeking such 

tolerances or exemptions have 

demonstrated that the pesticide meets 

the safety standard imposed by that 

statute. This citizen’s comment appears 

to be directed at the underlying statute 

and not EPA’s implementation of it; the 

citizen has made no contention that 

EPA has acted in violation of the 

statutory framework. EPA has found 

that there is a reasonable certainty of no 

harm to humans after considering the 

toxicological studies and the exposure 

levels of humans to difenoconazole. 

D. Revisions to Petitioned-for 

Tolerances 

Based on the data supporting the 

petition, EPA determined that the 

proposed tolerance in or on ginseng at 

0.50 ppm should be established at 1.0 

ppm. Residues of difenoconazole 

appeared to increase significantly with 

a pre-harvest interval (PHI) longer than 

the proposed 0-day PHI. Average pertrial residues increased by a factor of as 

much as 2.3x between the 0- and 21-day 

PHIs and based on this finding, EPA 

determined that average per-trial 

residues of difenoconazole for trials 

reflecting a 0-day PHI should be 

adjusted by a factor of 2.3x to account 

for the maximum demonstrated increase 

in difenoconazole residues resulting 

from PHIs longer than the proposed 0- 

day PHI. Therefore, the adjusted 

residues were used in the Organization 

for Economic Cooperation and 

Development (OECD) tolerance 

calculation procedures, resulting in the 

recommend tolerance in or on ginseng 

at 1.0 ppm. 

V. Conclusion 

Therefore, tolerances are established 

for residues of difenoconazole, 1-[2-[2- 

chloro-4-(4-chlorophenoxy)phenyl]-4- 

methyl-1,3-dioxolan-2-ylmethyl]-1H– 

1,2,4-triazole, in or on artichoke, globe 

at 1.5 ppm; ginseng at 1.0 ppm; fruit, 

stone, group 12–12 at 2.5 ppm; and nut, 

tree, group 14–12 at 0.03 ppm. 

Additionally, this regulation removes 

the established tolerances for residues of 

difenoconazole in or on fruits, stone 

group 12 at 2.5 ppm; nut, tree, group 14 

at 0.03 ppm; and pistachio at 0.03 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et 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: August 13, 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 § 180.475: 


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Federal Register / Vol. 80, No. 165 / Wednesday, August 26, 2015 / Rules and Regulations 51739 

■ a. Remove the entries ‘‘Fruits, stone, 

group 12’’; ‘‘Nut, tree, group 14’’; and 

‘‘Pistachio’’ from the table in paragraph 

(a)(1). 

■ b. Add alphabetically the following 

commodities to the table in paragraph 

(a)(1). 

The amendments read as follows: 

§ 180.475 Difenoconazole; tolerances for 

residues. 

(a)(1) * * * 

Commodity Parts per 

million 

* * * * * 

Artichoke, globe ...................... 1 .5 

* * * * * 

Fruit, stone, group 12–12 ....... 2 .5 

Ginseng .................................. 1 .0 

* * * * * 

Nut, tree, group 14–12 ........... 0 .03 

* * * * * 

* * * * * 

[FR Doc. 2015–21078 Filed 8–25–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF DEFENSE 

Defense Acquisition Regulations 

System 

48 CFR Parts 202, 204, 212, 239, and 

252 

[Docket No. DARS–2015–0039] 

RIN 0750–AI61 

Defense Federal Acquisition 

Regulation Supplement: Network 

Penetration Reporting and Contracting 

for Cloud Services (DFARS Case 2013– 

D018) 

AGENCY: Defense Acquisition 

Regulations System, Department of 

Defense (DoD). 

ACTION: Interim rule. 

SUMMARY: DoD is issuing an interim rule 

amending the Defense Federal 

Acquisition Regulation Supplement 

(DFARS) to implement a section of the 

National Defense Authorization Act for 

Fiscal Year 2013 and a section of the 

National Defense Authorization Act for 

Fiscal Year 2015, both of which require 

contractor reporting on network 

penetrations. Additionally, this rule 

implements DoD policy on the purchase 

of cloud computing services. 

DATES: Effective August 26, 2015. 

Comment date: Comments on the 

interim rule should be submitted in 

writing to the address shown below on 

or before October 26, 2015 to be 

considered in the formation of a final 

rule. 

ADDRESSES: Submit comments 

identified by DFARS Case 2013–D018, 

using any of the following methods: 

Æ Regulations.gov: http://

www.regulations.gov. Submit comments 

via the Federal eRulemaking portal by 

entering ‘‘DFARS Case 2013–D018’’ 

under the heading ‘‘Enter keyword or 

ID’’ and selecting ‘‘Search.’’ Select the 

link ‘‘Submit a Comment’’ that 

corresponds with ‘‘DFARS Case 2013– 

D018.’’ Follow the instructions provided 

at the ‘‘Submit a Comment’’ screen. 

Please include your name, company 

name (if any), and ‘‘DFARS Case 2013– 

D018’’ on your attached document. 

Æ Email: osd.dfars@mail.mil. Include 

DFARS Case 2013–D018 in the subject 

line of the message. 

Æ Fax: 571–372–6094. 

Æ Mail: Defense Acquisition 

Regulations System, Attn: Mr. Dustin 

Pitsch, OUSD(AT&L)DPAP/DARS, 

Room 3B941, 3060 Defense Pentagon, 

Washington, DC 20301–3060. 

Comments received generally will be 

posted without change to http://

www.regulations.gov, including any 

personal information provided. To 

confirm receipt of your comment(s), 

please check www.regulations.gov, 

approximately two to three days after 

submission to verify posting (except 

allow 30 days for posting of comments 

submitted by mail). 

FOR FURTHER INFORMATION CONTACT: Mr. 

Dustin Pitsch, OUSD(AT&L)DPAP/

DARS, telephone 571–372–6090. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This interim rule requires contractors 

and subcontractors to report cyber 

incidents that result in an actual or 

potentially adverse effect on a covered 

contractor information system or 

covered defense information residing 

therein, or on a contractor’s ability to 

provide operationally critical support. 

DoD is working to establish a single 

reporting mechanism for DoD contractor 

reporting of cyber incidents on 

unclassified information systems. This 

rule is intended to streamline the 

reporting process for DoD contractors 

and minimize duplicative reporting 

processes. Cyber incidents involving 

classified information on classified 

contractor systems will continue to be 

reported in accordance with the 

National Industrial Security Program 

Operating Manual (see DoD–M 5220.22 

available at http://www.dtic.mil/whs/

directives/corres/pdf/522022m.pdf). 

The rule revises the DFARS to 

implement section 941 of the National 

Defense Authorization Act (NDAA) for 

Fiscal Year (FY) 2013 (Pub. L. 112–239) 

and section 1632 of the NDAA for FY 

2015. Section 941 of the NDAA for FY 

2013 requires cleared defense 

contractors to report penetrations of 

networks and information systems and 

allows DoD personnel access to 

equipment and information to assess the 

impact of reported penetrations. Section 

1632 of the NDAA for FY 2015 requires 

that a contractor designated as 

operationally critical must report each 

time a cyber incident occurs on that 

contractor’s network or information 

systems. 

In addition, this rule also implements 

DoD policies and procedures for use 

when contracting for cloud computing 

services. The DoD Chief Information 

Officer (CIO) issued a memo on 

December 15, 2014, entitled ‘‘Updated 

Guidance on the Acquisition and Use of 

Commercial Cloud Computing Services’’ 

to clarify DoD guidance when acquiring 

commercial cloud services (See memo 

here: http://iase.disa.mil/cloud_

security/Pages/docs.aspx). The DoD CIO 

also released a Cloud Computing 

Security Requirements Guide (SRG) 

Version 1, Release 1 on January 13, 

2015, for cloud service providers to 

comply with when providing the DoD 

with cloud services (See SRG here: 

http://iase.disa.mil/cloud_security/

Pages/index.aspx). This rule 

implements these new policies 

developed within the DoD CIO memo 

and the SRG in the DFARS to ensure 

uniform application when contracting 

for cloud services across the DoD. The 

combination of the two statutes as well 

as the cloud computing policy will 

serve to increase the cyber security 

requirements placed on DoD 

information in contractor systems and 

will help the DoD to mitigate the risks 

related to compromised information as 

well as gather information for future 

improvements in cyber security policy. 

II. Discussion and Analysis 

To implement section 941 of the 

NDAA for FY 2013 and section 1632 of 

the NDAA for FY 2015, an existing 

DFARS subpart and clause have been 

utilized and expanded upon, and a new 

provision and clause added. A new 

subpart, provision, and clause are added 

for the implementation of cloud 

contracting policies. 

(1) DFARS subpart 204.73 is modified 

to expand safeguarding and reporting 

policy to require protection of covered 

defense information, which includes 

controlled technical information, export 

controlled information, critical 


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