Federal Register / Vol. 80, No. 213 / Wednesday, November 4, 2015 / Rules and Regulations 68257 

TENNESSEE—1997 ANNUAL PM2.5 NAAQS 

[Primary and Secondary] 

Designated area 

Designation a Classification 

Date 1 Type Date 2 Type 

Chattanooga, TN-GA-AL: 

Hamilton County ....................................................................................... 11/4/2015 Attainment ..... ........................

* * * * * * * 

a Includes Indian Country located in each county or area, except as otherwise specified. 

1This date is 90 days after January 5, 2005, unless otherwise noted. 

2This date is July 2, 2014, unless otherwise noted. 

* * * * * 

[FR Doc. 2015–28009 Filed 11–3–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0695; FRL–9934–05] 

Diethofencarb; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of diethofencarb 

in or on banana. Sumitomo Chemical 

Company requested this tolerance under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

November 4, 2015. Objections and 

requests for hearings must be received 

on or before January 4, 2016, 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–2014–0695 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. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2014–0695 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 January 4, 2016. 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– 

2014–0695, 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 


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68258 Federal Register / Vol. 80, No. 213 / Wednesday, November 4, 2015 / Rules and Regulations 

pesticide petition (PP 4E8232) by 

Sumitomo Chemical Company, LTD., 

27–1 Shinkawa 2 Chrome, Chuo-Ku, 

Tokyo 104–8260, Japan. The petition 

requested that 40 CFR part 180 be 

amended by establishing a tolerance 

without a U.S. registration for residues 

of the fungicide diethofencarb in or on 

banana at 0.09 parts per million (ppm). 

That document referenced a summary of 

the petition prepared by Sumitomo 

Chemical Company, LTD, the registrant, 

which is available in the docket, 

http://www.regulations.gov. There were 

no FFDCA-related comments received 

in response to the notice of filing. 

Based on available data, EPA is 

establishing a tolerance at a level that is 

slightly different from what was 

requested. The reason for this change is 

explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for diethofencarb 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with diethofencarb follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. The toxicology 

database is complete for diethofencarb. 

In repeated dose animal studies, the 

liver was a target organ in the rat, 

mouse, and dog. Increased liver 

pigmentation observed histologically in 

the dog, and foci of necrosis and 

hepatocellular hyperplasia in the 

mouse, were considered adverse and 

evidence of toxicity. Other target organs 

identified were the kidney 

(proteinaceous cast and regenerative 

epithelium), urinary bladder 

(submucosal lymphoid hyperplasia) and 

thyroid (follicular cell adenomas and 

carcinomas) in the rat, and the nervous 

system (changes in functional 

observational battery parameters, 

decreased motor activity, and decreased 

pupillary reflex) in the rat. The 

neurotoxicity in the rat, however, 

occurred only at high dose levels, at or 

above the limit dose, and were minimal 

in severity and there was no other 

evidence of neurotoxicity in the data 

base; therefore, there is no concern for 

neurotoxicity. There was no evidence of 

immunotoxicity in the data base, 

including the immunotoxicity study. 

Decreased body weight and food 

consumption and increased salivation 

were observed in the dog. In the prenatal developmental studies in rats and 

rabbits, increased abortions were 

observed in the rabbit only at dose 

levels near the limit dose; in the multigeneration reproduction study in rats, 

decreased body weight was seen in F2 

pups during lactation in the absence of 

parental toxicity, raising a concern for 

increased susceptibility in offspring. 

However, appropriate endpoints and 

points of departure were used to address 

the susceptibility issue and there are no 

residual pre- and/or post-natal 

uncertainties for offspring. The Agency 

has classified diethofencarb as 

‘‘suggestive evidence of 

carcinogenicity’’ based on the presence 

of thyroid tumors in male and female 

rats. There was no evidence of 

carcinogenicity in male or female mice 

at dose levels that were considered 

adequate to assess carcinogenicity. 

Additionally, there is no concern for 

mutagenicity. Quantification of human 

cancer risk is not required. The chronic 

reference dose (RfD) will adequately 

account for all chronic toxicity, 

including carcinogenicity, which could 

result from exposure to diethofencarb. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by diethofencarb as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document, 

‘‘Human Health Risk Assessment for the 

Proposed Tolerance of Diethofencarb in/ 

on Banana’’ at pp. 15–18 in docket ID 

number EPA–HQ–OPP–2014–0695. 

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 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 

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 diethofencarb used for 

human risk assessment is shown in 

Table 1 of this unit. 


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Federal Register / Vol. 80, No. 213 / Wednesday, November 4, 2015 / Rules and Regulations 68259 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR DIETHOFENCARB 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 (All Populations) A toxicity endpoint was not identified. 

Toxicological effects attributable to a single exposure (dose) were not observed in oral toxicity studies. 

Chronic dietary (All populations) NOAEL = 50 mg/kg/ 

day.

UFA = 10X 

UFH = 10X 

Chronic RfD = 0.50 

mg/kg/day 

cPAD = 0.50 mg/kg/ 

day 

Chronic Toxicity, Dog. 

LOAEL = 250 mg/kg/day based on decreased body weights 

and emesis. 

FQPA SF = 1X 

Cancer (Oral, dermal, inhalation).Classification: ‘‘suggestive evidence of carcinogenicity to humans’’ based on the rat thyroid follicular cell tumors; quantification is not required. 

NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from 

animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = 

FQPA Safety Factor. RfD = Reference Dose. cPAD = chronic Population Adjusted Dose. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to diethofencarb, EPA assessed 

dietary exposures from diethofencarb 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. 

No such effects were identified in the 

toxicological studies for diethofencarb; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the 2003–2008 U.S. Department of 

Agriculture’s (USDA’s) National Health 

and Nutrition Examination Survey, 

What We Eat in America, (NHANES/

WWEIA). The assessment assumes 

residues of diethofencarb are present at 

tolerance levels and that 100% of 

bananas are treated with diethofencarb. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that diethofencarb was 

assigned the classification ‘‘suggestive 

evidence of carcinogenicity to humans’’ 

based on the rat thyroid tumors, but 

quantification is not required. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for diethofencarb. Tolerance-level 

residues and 100 PCT were assumed for 

all food commodities. 

2. Dietary exposure from drinking 

water. An assessment of residues in 

drinking water is not required for this 

assessment because diethofencarb is not 

registered for use in the United States, 

and thus, there is no exposure to 

diethofencarb in drinking water in the 

United States. 

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). 

Diethofencarb 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 diethofencarb to 

share a common mechanism of toxicity 

with any other substances, and 

diethofencarb does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that diethofencarb 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. 

In the rat developmental study, there 

were no indications of toxicity in the 

dams or fetuses up to the limit dose. An 

acceptable (non-guideline) rabbit 

developmental toxicity study showed 

late-term abortions (considered 

evidence of both maternal and fetal 

toxicity) at dose levels near the limit 

dose (800 milligram/kilogram/day (mg/ 

kg/day) and above). In the rat 

reproduction study, offspring effects 

(decreased pup body weight in F2 males 

and females) were noted below the 

parental NOAEL, indicating increased 

quantitative susceptibility in offspring. 

However, clear NOAELs and LOAELs 

are available for all parental and 

offspring effects and endpoints and 

PODs are based on the effects in the 

offspring. 

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 

diethofencarb is complete. 

ii. There are no concerns for 

neurotoxicity and there is no need for a 

developmental neurotoxicity study or 

additional uncertainty factors (UFs) to 

account for neurotoxicity. 


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68260 Federal Register / Vol. 80, No. 213 / Wednesday, November 4, 2015 / Rules and Regulations 

iii. There is evidence that 

diethofencarb results in reproductive 

susceptibility as shown in the multigeneration reproduction study, but the 

effect is well characterized; therefore, 

there is no need to retain the 10X FQPA 

safety factor to account for effects on 

infants and children. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The Agency used tolerance-level 

residues and 100 PCT. No drinking 

water and residential exposures are 

expected as there are no U.S. 

registrations containing diethofencarb. 

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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, diethofencarb is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to diethofencarb 

from food will utilize ≤ 100% of the 

cPAD for the general U.S. population 

and all population sub-groups. The most 

highly exposed population subgroup 

was children 1–2 years old with an 

estimated risk of ≤ 1% cPAD. There are 

no residential uses for diethofencarb. 

3. Short-term and intermediate-term 

risks. 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); 

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). 

Because there are no residential uses for 

diethofencarb registered in the United 

States, no assessment of short- or 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating risk for 

diethofencarb. 

4. Aggregate cancer risk for U.S. 

population. Based on the discussion in 

Unit III.A., EPA has determined that 

diethofencarb is not expected to pose a 

cancer risk to humans. 

5. 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 

diethofencarb residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high-performance liquid 

chromatography method with tandem 

mass-spectrometry detection (HPLC/

MS/MS), PTRL West Method No. 

2348W) 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 diethofencarb. 

C. Revisions to Petitioned-For 

Tolerances 

The requested tolerance levels differ 

from those being established by EPA. 

The petitioner used the Organization for 

Economic Co-operation and 

Development Maximum Residue Limit 

(OECD MRL) methodologies and entered 

12 trials. EPA determined that 2 sets of 

trials (out of 12 total) were not 

independent. As a result, EPA entered 

10 values only into the calculator, and 

is establishing a tolerance level slightly 

higher than what was proposed. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of diethofencarb, in or on 

banana at 0.10 ppm. 

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 


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Federal Register / Vol. 80, No. 213 / Wednesday, November 4, 2015 / Rules and Regulations 68261 

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: October 21, 2015. 

Jack E. Housenger, 

Director, 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. Add § 180.688 to subpart C to read 

as follows: 

§ 180.688 Diethofencarb; tolerance for 

residue. 

(a) General. (1) Tolerances are 

established for residues of the fungicide 

diethofencarb, including its metabolites 

and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only diethofencarb (1- 

methylethyl N-(3,4- 

diethoxyphenyl)carbamate). 

Commodity Parts per 

million 

Banana * ............................... 0.10 

* There is no U.S. registration for use on this 

commodity as of November 4, 2015. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues 

[Reserved] 

[FR Doc. 2015–27891 Filed 11–3–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0034; FRL–9912–40] 

Nicosulfuron; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of nicosulfuron 

in or on sorghum, grain, forage; 

sorghum, grain, grain; and sorghum, 

grain, stover. E.I. du Pont de Nemours 

and Company requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 4, 2015. Objections and 

requests for hearings must be received 

on or before January 4, 2016, 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–2013–0034, 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–2013–0034 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 January 4, 2016. 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 


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