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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68262 Federal Register / Vol. 80, No. 213 / Wednesday, November 4, 2015 / Rules and Regulations 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0034, 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 July 19, 

2013 (78 FR 43117) (FRL–9392–9), 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 2F8132) by E.I. du Pont de 

Nemours and Company, 1007 Market 

Street, Wilmington, DE 19898. The 

petition requested that 40 CFR 180.454 

be amended by establishing tolerances 

for residues of the herbicide 

nicosulfuron, 3-pyridinecarboxamide, 2- 

((((4,6-dimethoxypyrimidin-2- 

yl)aminocarbonyl)aminosulfonyl))-N,Ndimethyl, in or on sorghum, forage at 

0.4 parts per million (ppm); sorghum, 

grain at 0.8 ppm; and sorghum, stover 

at 0.05 ppm. That document referenced 

a summary of the petition prepared by 

E.I. du Pont de Nemours and Company, 

the registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed commodity definitions, 

revised the proposed tolerance level for 

‘‘sorghum, grain, forage’’, and corrected 

the typographical error in the chemical 

name of nicosulfuron in the tolerance 

expression. Also, EPA has removed the 

expired emergency exemption 

tolerances for Bermuda grass, forage and 

Bermuda grass, hay. The reasons for 

these changes are explained in Unit 

IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for nicosulfuron 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with nicosulfuron 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. 

Nicosulfuron has low acute toxicity 

by oral, dermal, and inhalation routes of 

exposure. It is moderately irritating to 

the eye, non-irritating to the skin, and 

is not a skin sensitizer. In repeated dose 

studies by the oral route, nicosulfuron is 

minimally toxic, and rodents are 

particularly insensitive to its effects. 

Chronic dietary administrations to rats 

and mice did not produce any adverse 

effects at the highest dose tested (HDT). 

Chronic dietary administration to dogs 

produced mild effects (increased 

relative liver and kidney weights of 

males) at the HDT. 

Nicosulfuron showed no 

developmental effects in rats, and no 

adverse effects were observed in the rat 

reproductive study. In the rabbit 

developmental study, abortions 

occurred at the doses that caused other 

maternal toxicity effects. There are no 

indications of neurotoxic or 

immunotoxic effects elicited by 

nicosulfuron in animal studies; this 

includes recently submitted acute and 

subchronic neurotoxicity studies and an 

immunotoxicity study. There is no 

evidence of mutagenicity. 

Nicosulfuron is classified as ‘‘Not 

Likely to be Carcinogenic to Humans’’ 

based on lack of evidence of 

carcinogenicity in rats and mice studies 

and lack of mutagenic effects in the in 

vitro and in vivo genotoxicity studies. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by nicosulfuron 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 

‘‘Nicosulfuron: Human Health Risk 

Assessment for Proposed Use on ALS 

Inhibitor Tolerant Sorghum,’’ pp. 24–27 

in docket ID number EPA–HQ–OPP– 

2013–0034. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 


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www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for nicosulfuron used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR NICOSULFURON 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 

Chronic dietary (All populations) NOAEL= 125 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 1.25 

mg/kg/day.

cPAD = 1.25 mg/kg/ 

day 

Chronic oral toxicity—Dog. 

LOAEL = 500 mg/kg/day based on increased relative liver and 

kidney weights in males. 

Supported by rabbit developmental toxicity study (NOAEL = 

100 mg/kg/day, LOAEL = 500 mg/kg/day). 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day = milligram/kilogram/day. 

NOAEL = no-observed-adverse-effect-level. cPAD = chronic population adjusted dose. RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to nicosulfuron, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing nicosulfuron tolerances in 40 

CFR 180.454. EPA assessed dietary 

exposures from nicosulfuron 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 nicosulfuron; 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 USDA’s 2003–2008 National 

Health and Nutrition Examination 

Survey, What We Eat in America 

(NHANES/WWEIA). As to residue levels 

in food, EPA assumed that nicosulfuron 

residues were present at tolerance levels 

in all commodities for which tolerances 

have been established or proposed, and 

that 100% of those crops were treated 

with nicosulfuron. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that nicosulfuron does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for nicosulfuron. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening-level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for nicosulfuron in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

nicosulfuron. 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 the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Pesticide 

Root Zone Model Ground Water 

(PRZM–GW), the estimated drinking 

water concentrations (EDWCs) of 

nicosulfuron for chronic exposures for 

non-cancer assessments are estimated to 

be 2.8 ppb for surface water and 19.2 

ppb for ground water. Based on the 

Screening Concentration in Ground 

Water (SCI–GROW) model, the EDWC of 

nicosulfuron for chronic exposures for 

non-cancer assessments are estimated to 

be 1.42 ppb. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration value of 19.2 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, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Nicosulfuron 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 nicosulfuron to 

share a common mechanism of toxicity 

with any other substances, and 

nicosulfuron does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that nicosulfuron does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

No evidence of increased sensitivity or 

susceptibility in the developing or 

young animal was observed in the 

current database. No treatment-related 


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effects were seen for maternal or 

developmental toxicity up to and 

including the HDT in the rat prenatal 

developmental study, and no adverse 

effects were noted in the rat 

reproductive study. Although increases 

in abortions and post-implantation 

losses were observed in the rabbit 

developmental study, those effects 

occurred at the same doses as other 

maternal toxicity, indicating that they 

were a secondary effect of maternal 

toxicity, rather than a developmental or 

reproductive effect. 

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 

nicosulfuron is complete. 

ii. There is no indication that 

nicosulfuron is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

nicosulfuron results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to nicosulfuron 

in drinking water. These assessments 

will not underestimate the exposure and 

risks posed by nicosulfuron. 

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, nicosulfuron 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 nicosulfuron 

from food and water will utilize <1% of 

the cPAD for the general U.S. 

population and all population 

subgroups including infants and 

children. There are no residential uses 

for nicosulfuron. 

3. Short- and intermediate-term risks. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Because there are no 

residential uses, no short- or 

intermediate-term aggregate risk 

assessments were conducted. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

nicosulfuron 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 nicosulfuron 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(Method DuPont-32277, a high 

performance liquid chromatography 

with tandem mass spectroscopy (HPLC/ 

MS/MS)) 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 MRLs 

for nicosulfuron. 

C. Revisions to Petitioned-For 

Tolerances 

The Agency is revising the proposed 

commodity definitions of ‘‘sorghum, 

forage’’ to ‘‘sorghum, grain, forage’’; 

‘‘sorghum, grain’’ to ‘‘sorghum, grain, 

grain’’; and ‘‘sorghum, stover’’ to 

‘‘sorghum, grain, stover’’ for consistency 

with EPA’s Food and Feed Commodity 

Vocabulary. The proposed tolerance 

level of 0.4 ppm for ‘‘sorghum, forage’’ 

is revised to 0.3 ppm for ‘‘sorghum, 

grain, forage’’ based on analysis of the 

residue field trial data using the 

Organization for the Economic 

Cooperation and Development’s 

tolerance calculation procedure. The 

tolerance expression is revised to 

correct the typographical error in the 

chemical name for nicosulfuron. 

V. Conclusion 

Therefore, tolerances are established 

for residues of nicosulfuron, 2-[[[[(4,6- 

dimethoxy-2-pyrimidinyl)amino] 

carbonyl]amino]sulfonyl]-N,N-dimethyl3-pyridinecarboxamide, including its 

metabolites and degradates, in or on 

sorghum, grain, forage at 0.3 ppm; 

sorghum, grain, grain at 0.8 ppm; and 

sorghum, grain, stover at 0.05 ppm. 

In addition, as a housekeeping 

measure, the Agency is removing the 

expired emergency exemption 

tolerances on ‘‘Bermuda grass, forage’’ 

and ‘‘Bermuda grass, hay’’. The 

tolerances expired on December 31, 

2011. 

VI. Statutory and Executive Order 

Reviews 

This final rule 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 final rule 

has been exempted from review under 

Executive Order 12866, this final rule 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 


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Federal Register / Vol. 80, No. 213 / Wednesday, November 4, 2015 / Rules and Regulations 68265 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule 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 final rule 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 final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(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 of 1995 

(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. 

G. Jeffrey Herndon, 

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 § 180.454, revise paragraph (a) 

introductory text and add alphabetically 

the following commodities to the table 

and revise paragraph (b) to read as 

follows: 

§ 180.454 Nicosulfuron; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the herbicide 

nicosulfuron, including its metabolites 

and degradates, in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only 

nicosulfuron, 2-[[[[(4,6-dimethoxy-2-

pyrimidinyl)amino]carbonyl]amino]

sulfonyl]-N,N-dimethyl-3-pyridine

carboxamide. 

Commodity Parts per 

million 

* * * * * 

Sorghum, grain, forage ............. 0.3 

Sorghum, grain, grain ............... 0.8 

Sorghum, grain, stover ............. 0.05 

(b) Section 18 emergency exemptions. 

[Reserved] 

* * * * * 

[FR Doc. 2015–27887 Filed 11–3–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 635 

[Docket No. 150121066–5717–02] 

RIN 0648–XE242 

Atlantic Highly Migratory Species; 

Atlantic Bluefin Tuna Fisheries 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; inseason quota 

transfer. 

SUMMARY: NMFS is transferring 35 

metric tons (mt) of Atlantic bluefin tuna 

(BFT) quota from the Harpoon category 

and 65 mt from the Reserve category to 

the General category for the remainder 

of the 2015 fishing year. This transfer 

results in adjusted quotas of 566.7 mt, 

43.6 mt and 82.1 mt for the General, 

Harpoon, and Reserve categories, 

respectively. This action is based on 

consideration of the regulatory 

determination criteria regarding 

inseason adjustments and applies to 

Atlantic tunas General category 

(commercial) permitted vessels and 

Highly Migratory Species (HMS) 

Charter/Headboat category permitted 

vessels when fishing commercially for 

BFT. 

DATES: Effective October 30, 2015 

through December 31, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Sarah McLaughlin or Brad McHale, 

978–281–9260. 

SUPPLEMENTARY INFORMATION: 

Regulations implemented under the 

authority of the Atlantic Tunas 

Convention Act (ATCA; 16 U.S.C. 971 et 

seq.) and the Magnuson-Stevens Fishery 

Conservation and Management Act 

(Magnuson-Stevens Act; 16 U.S.C. 1801 

et seq.) governing the harvest of BFT by 

persons and vessels subject to U.S. 

jurisdiction are found at 50 CFR part 

635. Section 635.27 subdivides the U.S. 

BFT quota recommended by the 

International Commission for the 

Conservation of Atlantic Tunas (ICCAT) 

among the various domestic fishing 

categories, per the allocations 

established in the 2006 Consolidated 

Highly Migratory Species Fishery 

Management Plan (2006 Consolidated 

HMS FMP) (71 FR 58058, October 2, 

2006), as amended by the recently 

published Amendment 7 to the 2006 

Consolidated HMS FMP (Amendment 7) 

(79 FR 71510, December 2, 2014). NMFS 


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