Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Rules and Regulations 9353 

(7) The panel members to be utilized (see 

Section 10.1.3) along with their 

qualifications. 

(8) An example certificate of successful 

course completion. 

10.1.1 A trainee must verify completion 

of at least 12 hours of field observation prior 

to attending the Method 303 certification 

course. Trainees shall observe the operation 

of a coke oven battery as it pertains to 

Method 303, including topside operations, 

and shall also practice conducting Method 

303 or similar methods. During the field 

observations, trainees unfamiliar with coke 

battery operations shall receive instruction 

from an experienced coke oven observer who 

is familiar with Method 303 or similar 

methods and with the operation of coke 

batteries. 

10.1.2 The classroom instruction shall 

familiarize the trainees with Method 303 

through lecture, written training materials, 

and a Method 303 demonstration video. 

Successful completion of the classroom 

portion of the Method 303 training course 

shall be demonstrated by a perfect score on 

the initial certification test. Those attending 

the course for third-year recertification must 

complete one of the recertification tests 

selected at random. 

10.1.3 All trainees must demonstrate 

proficiency in the application of Method 303 

to a panel of three certified Method 303 

observers, including an ability to differentiate 

coke oven emissions from condensing water 

vapor and smoldering coal. The panel 

members will be EPA, state or local agency 

personnel, or industry contractors listed in 

59 FR 11960 (March 15, 1994) or qualified as 

part of the training provider approval process 

of Section 10.1 of this method. 

Each panel member shall have at least 120 

days experience in reading visible emissions 

from coke ovens. The visible emissions 

inspections that will satisfy the experience 

requirement must be inspections of coke 

oven battery fugitive emissions from the 

emission points subject to emission 

standards under subpart L of this part (i.e., 

coke oven doors, topside port lids, offtake 

system(s), and charging operations), using 

either Method 303 or predecessor state or 

local test methods. A ‘‘day’s experience’’ for 

a particular inspection is a day on which one 

complete inspection was performed for that 

emission point under Method 303 or a 

predecessor state or local method. A ‘‘day’s 

experience’’ does not mean 8 or 10 hours 

performing inspections, or any particular 

time expressed in minutes or hours that may 

have been spent performing them. Thus, it 

would be possible for an individual to 

qualify as a Method 303 panel member for 

some emission points, but not others (e.g., an 

individual might satisfy the experience 

requirement for coke oven doors, but not 

topside port lids). Until November 15, 1994, 

the EPA may waive the certification 

requirement (but not the experience 

requirement) for panel members. The 

composition of the panel shall be approved 

by the EPA. 

The panel shall observe the trainee in a 

series of training runs and a series of 

certification runs. There shall be a minimum 

of 1 training run for doors, topside port lids, 

and offtake systems, and a minimum of 5 

training runs (i.e., 5 charges) for charging. 

During training runs, the panel can advise 

the trainee on proper procedures. There shall 

be a minimum of 3 certification runs for 

doors, topside port lids, and offtake systems, 

and a minimum of 15 certification runs for 

charging (i.e., 15 charges). The certification 

runs shall be unassisted. Following the 

certification test runs, the panel shall 

approve or disapprove certification based on 

the trainee’s performance during the 

certification runs. To obtain certification, the 

trainee shall demonstrate to the satisfaction 

of the panel a high degree of proficiency in 

performing Method 303. To aid in evaluating 

the trainee’s performance, a checklist, 

approved by the EPA, will be used by the 

panel members. 

10.1.4 Those successfully completing the 

initial certification or third-year 

recertification requirements shall receive a 

certificate showing certification as a Method 

303 observer and the beginning and ending 

dates of the certification period. 

10.1.5 The training provider will submit 

to the EPA or its designee the following 

information for each trainee successfully 

completing initial certification or third-year 

recertification training: Name, employer, 

address, telephone, cell and/or fax numbers, 

email address, beginning and ending dates of 

certification, and whether training was for 3- 

year certification or 1-year recertification. 

This information must be submitted within 

30 days of the course completion. 

10.1.6 The training provider will 

maintain the following records, to be made 

available to EPA or its designee on request 

(within 30 days of a request): 

(a) A file for each Method 303 observer 

containing the signed certification checklists, 

certification forms and test results for their 

initial certification, and any subsequent 

third-year recertifications. Initial certification 

records must also include documentation 

showing successful completion of the 

training prerequisites. Testing results from 

any interim recertifications must also be 

included, along with any relevant 

communications. 

(b) A searchable master electronic database 

of all persons for whom initial certification, 

third-year recertification or interim 

recertification has been provided. 

Information contained therein must include: 

The observer’s name, employer, address, 

telephone, cell and fax numbers and email 

address, along with the beginning and ending 

dates for each successfully completed initial, 

third-year and interim recertification. 

10.1.7 Failure by the training provider to 

submit example training course materials 

and/or requested training records to the 

Administrator may result in suspension of 

the approval of the provider and course. 

10.2 Observer Certification/

Recertification. The coke oven observer 

certification is valid for 1 year. The observer 

shall recertify annually by reviewing the 

training material, viewing the training video 

and answering all of the questions on the 

recertification test correctly. Every 3 years, an 

observer shall be required to pass the 

proficiency test in Section 10.1.3 in order to 

be certified. The years between proficiency 

tests are referred to as interim years. 

* * * * * 

[FR Doc. 2016–03757 Filed 2–24–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0314 and EPA–HQ– 

OPP–2014–0489; FRL–9941–87] 

Triclopyr; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

tolerances for residues of triclopyr in 

milk and livestock commodities which 

are identified and discussed later in this 

document, and amends the tolerance 

expressions to include triclopyr choline 

salt. Dow AgroSciences, LLC requested 

these tolerance changes under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

February 25, 2016. Objections and 

requests for hearings must be received 

on or before April 25, 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 dockets for this action, 

identified by docket identification (ID) 

numbers EPA–HQ–OPP–2014–0314 and 

EPA–HQ–OPP–2014–0489, are 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: 


rmajette on DSK2TPTVN1PROD with RULES
9354 Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Rules and Regulations 

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/test-guidelines-pesticidesand-toxic-substances. 

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 by docket ID numbers EPA– 

HQ–OPP–2014–0314 and EPA–HQ– 

OPP–2014–0489 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 April 25, 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 numbers EPA–HQ–OPP– 

2014–0314 and EPA–HQ–OPP–2014– 

0489, 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 Wednesday, 

November 25, 2015 (80 FR 73695) (FRL– 

9937–14), EPA issued a document 

pursuant to FFDCA section 408(d)(3), 21 

U.S.C. 346a(d)(3), announcing the filing 

of a revised pesticide petition (PP 

4F8249) by Dow AgroSciences, LLC, 

9330 Zionsville Rd., Indianapolis, IN 

46268–1054. The revised petition 

requested that 40 CFR part 180.417(a)(1) 

be amended by establishing a tolerance 

for residues of the herbicide triclopyr, 

[(3,5,6-trichloro-2-pyridinyl)oxy] acetic 

acid, in or on the raw agricultural 

commodity milk, fat at 0.7 parts per 

million (ppm); and increasing the 

tolerance in or on milk from 0.01 ppm 

to 0.6 ppm. The petition also requested 

that 40 CFR part 180.417(a)(2) be 

amended by establishing tolerances for 

residues of triclopyr, [(3,5,6-trichloro-2- 

pyridinyl)oxy] acetic acid and its 

metabolite 3,5,6-trichloro-2-pyridinol 

(TCP), calculated as the stoichiometric 

equivalent of triclopyr, in or on the raw 

agricultural commodities of cattle, goat, 

hog, horse, and sheep meat byproducts 

at 0.7 ppm; by increasing tolerances in 

cattle, goat, hog, horse, and sheep fat 

from 0.05 ppm to 0.09 ppm; and 

increasing tolerances in cattle, goat, hog, 

horse, and sheep meat from 0.05 ppm to 

0.08 ppm. 

In the Federal Register of Friday, 

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 4F8279) by 

Dow AgroSciences, LLC, 9330 

Zionsville Rd., Indianapolis, IN 46268– 

1054. The petition requested that 40 

CFR part 180.417(a)(1) and 180.417(a)(2) 

be amended to include residues of the 

herbicide triclopyr choline salt as 

triclopyr, [(3,5,6-trichloro-2- 

pyridinyl)oxy] acetic acid, including its 

metabolites and degradates, in or on the 

raw agricultural commodities listed. 

The documents referenced summaries 

of the petitions prepared by Dow 

AgroSciences, LLC, the registrant, 

which are available in the dockets at 

http://www.regulations.gov. The 

petition summary for PP 4F8249 is 

located in docket number EPA–HQ– 

OPP–2014–0314, and the petition 

summary for PP 4F8279 is located in 

docket number EPA–HQ–OPP–2014– 

0489. Several comments were received 

on the notices of filing. EPA’s response 

to those comments are discussed in Unit 

IV.D. 

Based upon review of the data 

supporting the petitions, EPA has (1) 

determined that a tolerance for milk fat 

is not required; (2) increased the 

proposed tolerances for the fat and meat 

of cattle, goat, hog, horse, and sheep; (3) 

decreased the proposed tolerances for 

the meat byproducts of cattle, goat, hog, 

horse, and sheep; and (4) determined 

that the current tolerances for kidney, 

liver, and meat byproducts except 

kidney and liver of cattle, goat, hog, 

horse, and sheep are not required. 

EPA is also revising the tolerance 

expressions to correct the nomenclature 

of the chemical name, clarify the 

chemical moieties that are covered by 

the tolerances, and specify how 

compliance will be measured. 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 


rmajette on DSK2TPTVN1PROD with RULES
Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Rules and Regulations 9355 

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 triclopyr 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with triclopyr 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 bioequivalence of the three 

chemical forms of triclopyr (acid, 

triethylamine salt, and butoxyethyl 

ester) has been addressed through a 

variety of special studies with the salt 

and ester forms, including data on 

comparative disposition, plasma halflife, tissue distribution, and hydrolytic 

cleavage. Those studies were found to 

adequately address the issue of 

bioequivalence amongst these forms of 

triclopyr. Additionally, the currently 

available information supports the 

bioequivalence of triclopyr and triclopyr 

choline salt. Therefore, studies 

conducted with any one form of 

triclopyr have been used to support the 

toxicology database for triclopyr as a 

whole. 

Triclopyr has been classified as 

having low acute toxicity via the oral, 

dermal, and inhalation routes. It is 

minimally-irritating (butoxyethyl ester) 

to corrosive (triethylamine salt) to the 

eye. It is a dermal sensitizer but not a 

dermal irritant. 

Overall, effects in the triclopyr 

database were indicative of kidney and 

liver toxicity in rats and dogs, 

respectively. The primary effect 

observed in rats was degeneration of the 

proximal tubule of the kidney, which 

was seen at approximately the same 

dose in the subchronic oral and 2- 

generation reproduction toxicity 

studies. Body-weight decreases in rats 

were observed in the subchronic 

neurotoxicity and immunotoxicity 

studies at doses approximately ten times 

higher than doses resulting in kidney 

effects. In dogs, liver toxicity was 

evidenced by increased liver enzymes, 

increased liver weights, and liver 

histopathology at a similar dose as 

kidney effects in the rat. Changes in 

hematological parameters (decreased 

packed-cell volume, decreased 

hemoglobin, and decreased red blood 

cell count) were also observed in dogs 

at the same dose. 

There is evidence of increased 

qualitative susceptibility to offspring 

from triclopyr exposure in the rat 2- 

generation reproduction study, based on 

increased incidence of rare pup 

malformations observed in the presence 

of parental toxicity. There is also 

potential qualitative susceptibility in 

the rat developmental toxicity study; 

however, the evidence was not as 

conclusive as the reproduction toxicity 

study. Concern is low since effects are 

well-characterized with clearly 

established no-observed adverse-effect 

level/lowest-observed adverse-effect 

level (NOAEL/LOAEL) values, effects 

were seen in the presence of parental 

toxicity, and selected endpoints are 

protective of the observed effects. 

Triclopyr has been classified as a 

‘‘Group D Chemical—unable to be 

classified as to human carcinogenicity.’’ 

Although there was marginal evidence 

of carcinogenicity in animal studies 

(adrenal tumors in male rats and 

mammary gland tumors in female rats 

and mice), EPA has determined that the 

chronic reference dose (cRfD) will 

adequately account for all chronic 

effects, including carcinogenicity, likely 

to result from exposure to triclopyr. The 

Agency reached this conclusion 

employing a weight-of-evidence (WOE) 

approach after considering the following 

factors: (1) A lack of statistical 

significance at the high dose in pairwise tests for all the tumors of concern; 

(2) for the adrenal tumors, there was a 

lack of dose-response and any preneoplastic lesions in the adrenal glands, 

along with evidence that the tumors 

were mainly benign; (3) for the 

mammary gland tumors, incidence in 

the concurrent control mice was at the 

low end of the historical control range; 

and (4) the chronic RfD is 

approximately 700-fold lower than the 

dose that induced the mammary gland 

tumors in female rats. 

Acceptable subchronic neurotoxicity 

and immunotoxicity studies have been 

submitted and show no evidence of 

neurotoxicity or immunotoxicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by triclopyr as well as the 

NOAEL and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in document, 

‘‘Triclopyr. Human Health Risk 

Assessment for Petition to Amend 

Tolerance Expressions to Include 

Triclopyr Choline Salt; and Petition to 

Remove Grazing Restrictions for Dairy 

Cattle’’ on pp. 13–15 in docket ID 

numbers EPA–HQ–OPP–2014–0314 and 

EPA–HQ–OPP–2014–0489. 

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 a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

A summary of the toxicological 

endpoints for triclopyr used for human 

health risk assessment is shown in 

Table 1 of this unit. 


rmajette on DSK2TPTVN1PROD with RULES
9356 Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Rules and Regulations 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TRICLOPYR FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/Scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary (Females 13–49 years of age) ... NOAEL = 5 mg/kg/day ...........

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.05 mg/kg/day ..

aPAD = 0.05 mg/kg/day .........

2-Generation Rat Reproduction Study with Triclopyr 

Acid 

LOAEL = 25 mg/kg/day based 

on increased incidence of 

rare malformations 

(exencephaly and ablepharia). 

Acute dietary (General population including infants and children).NOAEL = 100 mg/kg/day .......

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 1.0 mg/kg/day ....

aPAD = 1.0 mg/kg/day ...........

Developmental Rat Toxicity 

Study with Triclopyr BEE 

LOAEL = 300 mg/kg/day 

based on maternal mortality. Additional effects 

seen at this dose included 

clinical signs, necropsy findings, decreased food and 

water consumption, and increased kidney and liver 

weights. 

Chronic dietary (All populations) ...................... NOAEL= 5 mg/kg/day ............

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.05 mg/kg/day 

cPAD = 0.05 mg/kg/day .........

2-Generation Rat Reproduction Study with Triclopyr 

Acid 

LOAEL = 25 mg/kg/day based 

on degeneration of the 

proximal renal tubules. 

Incidental oral short-term (1 to 30 days) and 

intermediate-term (1 to 6 months).

NOAEL= 5 mg/kg/day ............

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ............... Subchronic Oral Rat Toxicity 

Study with Triclopyr Acid 

LOAEL = 20 mg/kg/day based 

on degeneration of the 

proximal renal tubules. 

Inhalation short-term (1 to 30 days) and intermediate-term (1 to 6 months).Inhalation (or oral) study ........

NOAEL= 5 mg/kg/day (inhalation absorption rate = 

100%) 

UFA = 10x 

UFH = 10x 

FQPA SF/UFDB = 10x 

LOC for MOE = 1000 ............. Subchronic Oral Rat Toxicity 

Study with Triclopyr Acid 

LOAEL = 20 mg/kg/day based 

on degeneration of the 

proximal renal tubules. 

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

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other data deficiency. 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 triclopyr, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

triclopyr tolerances in 40 CFR 180.417. 

EPA assessed dietary exposures from 

triclopyr 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 triclopyr. In estimating acute dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA). As 

to residue levels in food, EPA assumed 

that triclopyr 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 triclopyr. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2003–2008 NHANES/

WWEIA. As to residue levels in food, 

EPA assumed that triclopyr residues 

were present at tolerance levels in all 

commodities for which tolerances have 

been established or proposed except 

milk, and that 100% of those crops were 

treated with triclopyr. An average 

anticipated residue (AR) calculated from 

a livestock feeding study was used for 

all milk commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

determined that the chronic RfD will 

adequately account for all chronic 

effects, including carcinogenicity, that 

are likely to result from triclopyr 

exposure. 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 PCT information in the dietary 

assessment for triclopyr. However, EPA 

did use anticipated residue information 

for milk commodities in the chronic 

dietary assessment. Tolerance-level 

residues and 100 PCT were assumed for 

all other food commodities. 

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 


rmajette on DSK2TPTVN1PROD with RULES
Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Rules and Regulations 9357 

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. 

2. Dietary exposure from drinking 

water. EPA calculated and required 

setback distances from the application 

site to the functional potable water 

intake in order to maintain average 

drinking water concentration levels 

below 400 parts per billion (ppb). Since 

potable water intakes are required to be 

turned off until triclopyr concentration 

levels are below 400 ppb, EPA has 

determined that for acute and chronic 

dietary risk assessments, the water 

concentration value of 400 ppb is 

appropriate to use 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). 

Triclopyr is currently registered for 

the following uses that could result in 

residential exposures: Aquatic and turf 

areas. EPA assessed residential exposure 

using the following assumptions: 

Handler inhalation exposure from spot 

applications to turf for adults, postapplication inhalation and ingestion 

exposures of water from swimming for 

children 3 to <6 years old, and postapplication incidental oral exposure to 

turf for children 1 to <2 years old. The 

dermal route of exposure is not 

quantitatively assessed because there is 

no dermal hazard. Short-term 

residential handler exposure, and shortand intermediate-term residential postapplication exposures are expected. 

Chronic exposures are not expected. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticidescience-and-assessing-pesticide-risks/

standard-operating-proceduresresidential-pesticide. 

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.’’ 

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

triclopyr and any other substances. 

3,5,6-trichloro-2-pyridinol, commonly 

known as TCP, is a metabolite of 

triclopyr, chlorpyrifos, and chlorpyrifosmethyl. Risk assessment of TCP was 

conducted in 2002, and the previous 

conclusions that the acute and chronic 

dietary aggregate exposure estimates are 

below EPA’s level of concern (LOC) are 

still valid since the tolerances changes 

will not have a noticeable effect on 

dietary exposures to TCP. 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/pesticide-scienceand-assessing-pesticide-risks/

cumulative-assessment-risk-pesticides. 

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. 

As summarized in Unit III.A., there is 

evidence of increased qualitative 

susceptibility to offspring from triclopyr 

exposure in the 2-generation 

reproduction toxicity study and 

potential qualitative susceptibility in 

the rat developmental toxicity study. 

However, the concern is low since 

effects are well-characterized with 

clearly established NOAEL/LOAEL 

values, effects were seen in the presence 

of parental toxicity, and selected 

endpoints, which are protective of the 

effects in adult animals, are protective 

of the observed effects. 

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, with the exception 

for inhalation exposures where the 

FQPA SF is retained at 10X. These 

decisions are based on the following 

findings: 

i. The toxicity database for triclopyr is 

adequate for characterizing triclopyr 

toxicity and quantification of hazard 

exposures. For assessing risks associated 

with inhalation exposures, the FQPA SF 

is retained at 10X to incorporate the 

database uncertainty factor (UFDB) to 

account for the lack of a subchronic 

inhalation toxicity study. 

ii. There is no indication that 

triclopyr is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is evidence of increased 

qualitative susceptibility to offspring 

from triclopyr exposure. However, the 

concern is low since effects are wellcharacterized with clearly established 

NOAEL/LOAEL values, effects were 

seen in the presence of parental toxicity, 

and selected endpoints, which are 

protective of the effects in adult 

animals, are protective of the observed 

effects. 

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 for all crops 

except milk commodities and drinking 

water in which anticipated residues 

were used. EPA used conservative 

assumptions to assess post-application 

exposure of children as well as 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by triclopyr. 

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 

triclopyr will occupy 53% of the aPAD 

for females 13–49 years old, and 8% of 

the aPAD for all infants less than 1 year 


rmajette on DSK2TPTVN1PROD with RULES
9358 Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Rules and Regulations 

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 triclopyr from 

food and water will utilize 46% of the 

cPAD for all infants less than 1 year 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 

triclopyr 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). Triclopyr 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 

triclopyr. 

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 an 

aggregate MOE of 120 for children 1 to 

<2 years old (dietary exposure with 

post-application incidental oral 

exposure from turf use). Because EPA’s 

level of concern for triclopyr is a MOE 

of 100 or below, this MOE is not of 

concern. 

For adults and children 3 to <6 years 

old, an aggregate risk index (ARI) is 

used since the POD for the oral and 

inhalation routes of exposure are the 

same, but the LOC values for oral 

(MOE<100) and inhalation (MOE<1000) 

exposures are different. The ARIs are 3.6 

for children 3 to <6 years old (dietary 

exposure with post-application 

inhalation and ingestion from aquatic 

use), and 1.4 for adults (dietary 

exposure with handler inhalation 

exposure from turf use). Since EPA’s 

level of concern is an ARI below 1, these 

ARIs 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). 

Although triclopyr is currently 

registered for uses that could result in 

intermediate-term residential exposure, 

EPA determined that a quantified 

intermediate-term aggregate assessment 

is unnecessary since the short- and 

intermediate-term PODs are the same 

and the short-term aggregate provides a 

worst-case estimate of residential 

exposure and is therefore protective of 

the longer-term exposures. 

5. Aggregate cancer risk for U.S. 

population. As summarized in Unit 

III.A., EPA has determined that an 

aggregate exposure risk assessment for 

cancer risk is not required based on 

WOE conclusions on the marginal 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies 

and the use of the chronic RfD which 

will adequately account for any 

potential carcinogenic effects. 

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 triclopyr 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodologies 

(Methods ACR 77.2 and ACR 77.4, using 

gas chromatography with electroncapture detection (GC/ECD); Method 

GRM 97.02 using gas chromatography 

with mass-spectrometry detection (GC/

MS)) are available to enforce the 

tolerance expression. The Food and 

Drug Administration (FDA) PESTDATA 

database dated 1/94 (Pesticide 

Analytical Manual (PAM) Vol. I, 

Appendix I) indicates that triclopyr is 

completely recovered (>80%) using 

multi-residue method PAM Vol. I 

Section 402. Data pertaining to multiresidue methods testing of triclopyr and 

its metabolites through Protocols B, C, 

D, and E have been submitted and 

forwarded to FDA. 

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 any MRL for triclopyr. 

C. Revisions to Petitioned-for Tolerances 

Based on the available residue 

chemistry data, EPA has determined 

that a tolerance for milk fat is not 

required. Also, EPA is increasing the 

proposed tolerances for fat (0.09 ppm) 

and meat (0.08 ppm) of cattle, goat, hog, 

horse, and sheep to 0.10 ppm, and 

decreasing the proposed tolerances for 

meat byproducts of cattle, goat, hog, 

horse, and sheep from 0.7 ppm to 0.50 

ppm in order to harmonize with 

established Canadian MRLs. The current 

tolerances for kidney (0.5 ppm), liver 

(0.5 ppm), and meat byproducts except 

kidney and liver (0.05 ppm) of cattle, 

goat, hog, horse, and sheep are being 

removed and replaced by establishing 

tolerances for meat byproducts of cattle, 

goat, hog, horse, and sheep at 0.50 ppm. 

EPA is also revising the chemical 

name of triclopyr in the tolerance 

expressions to reflect the preferred 

Chemical Abstract Service (CAS) 

nomenclature. Lastly, in accordance 

with Agency guidance on tolerance 

expressions, the tolerance expressions 

for triclopyr are revised by clarifying 

that the tolerances cover ‘‘residues of 

the herbicide triclopyr, including its 

metabolites and degradates as well as 

how residues of triclopyr are to be 

measured.’’ 

D. Response to Comments 

Several comments were received in 

both dockets, EPA–HQ–OPP–2014–0314 

and EPA–HQ–OPP–2014–0489, 

containing general comments 

disapproving of the use and EPA’s 

approval of pesticides, and two similar 

comments stating that triclopyr should 

be banned due to its toxic effects on 

aquatic animals and its soil half-life. 

EPA understands these commenters’ 

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. These 

comments appear to be directed at the 

underlying statute and not EPA’s 

implementation of it; the commenters 

have made no contention that EPA has 

acted in violation of the statutory 

framework. In addition, some of the 


rmajette on DSK2TPTVN1PROD with RULES
Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Rules and Regulations 9359 

comments stated that triclopyr’s 

negative effects are detrimental to 

human health. EPA has concluded that 

there is a reasonable certainty of no 

harm to humans after considering the 

toxicological studies and the exposure 

levels of humans to triclopyr. 

V. Conclusion 

Therefore, tolerances are established 

for residues of triclopyr, 2-[(3,5,6- 

trichloro-2-pyridinyl)oxy]acetic acid, in 

or on cattle, meat byproducts at 0.50 

ppm; goat, meat byproducts at 0.50 

ppm; hog, meat byproducts at 0.50 ppm; 

horse, meat byproducts at 0.50 ppm; 

sheep, meat byproducts at 0.50 ppm; 

amended for milk at 0.60 ppm; cattle, fat 

at 0.10 ppm; cattle, meat at 0.10 ppm; 

goat, fat at 0.10 ppm; goat, meat at 0.10 

ppm; hog, fat at 0.10 ppm; hog, meat at 

0.10 ppm; horse, fat at 0.10 ppm; horse, 

meat at 0.10 ppm; sheep, fat at 0.10 

ppm; and sheep, meat at 0.10 ppm. 

The following livestock tolerances for 

‘‘kidney,’’ ‘‘liver,’’ and ‘‘meat 

byproducts, except kidney and liver’’ 

are removed since these commodities 

will be combined under the ‘‘meat 

byproducts’’ tolerances: Cattle, kidney 

at 0.5 ppm; cattle, liver at 0.5 ppm; 

cattle, meat byproducts, except kidney 

and liver at 0.05 ppm; goat, kidney at 

0.5 ppm; goat, liver at 0.5 ppm; goat, 

meat byproducts, except kidney and 

liver at 0.05 ppm; hog, kidney at 0.5 

ppm; hog, liver at 0.5 ppm; hog, meat 

byproducts, except kidney and liver at 

0.05 ppm; horse, kidney at 0.5 ppm; 

horse, liver at 0.5 ppm; horse, meat 

byproducts, except kidney and liver at 

0.05 ppm; sheep, kidney at 0.5 ppm; 

sheep, liver at 0.5 ppm; and sheep, meat 

byproducts, except kidney and liver at 

0.05 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action amends and establishes 

tolerances under FFDCA section 408(d) 

in response to petitions 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 tolerances 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: February 11, 2016. 

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 § 180.417, revise paragraph (a)(1) 

introductory text, the commodity 

‘‘Milk,’’ in the table in paragraph (a)(1) 

and paragraph (a) (2) to read as follows: 

§ 180.417 Triclopyr; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the herbicide 

triclopyr, including its metabolites and 

degradates, in or on the commodities in 

the table below resulting from the 

application of the butoxyethyl ester of 

triclopyr, triethylamine salt of triclopyr, 

or choline salt of triclopyr. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

only triclopyr, 2-[(3,5,6-trichloro-2- 

pyridinyl)oxy]acetic acid. 

Commodity Parts per 

million 

* * * * * 

Milk ........................................... 0.60 

* * * * * 

(2) Tolerances are established for 

residues of the herbicide triclopyr, 

including its metabolites and 

degradates, in or on the commodities in 

the table below resulting from the 

application of the butoxyethyl ester of 

triclopyr, triethylamine salt of triclopyr, 

or choline salt of triclopyr. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

the combined residues of triclopyr, 2- 

[(3,5,6-trichloro-2-pyridinyl)oxy]acetic 

acid, and its metabolite 3,5,6-trichloro2-pyridinol (TCP), calculated as the 

stoichiometric equivalent of triclopyr. 

Commodity Parts per 

million 

Cattle, fat .................................. 0.10 

Cattle, meat .............................. 0.10 

Cattle, meat byproducts ........... 0.50 


rmajette on DSK2TPTVN1PROD with RULES
9360 Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Rules and Regulations 

Commodity Parts per 

million 

Goat, fat .................................... 0.10 

Goat, meat ................................ 0.10 

Goat, meat byproducts ............. 0.50 

Hog, fat ..................................... 0.10 

Hog, meat ................................. 0.10 

Hog, meat byproducts .............. 0.50 

Horse, fat .................................. 0.10 

Horse, meat .............................. 0.10 

Horse, meat byproducts ........... 0.50 

Sheep, fat ................................. 0.10 

Sheep, meat ............................. 0.10 

Sheep, meat byproducts .......... 0.50 

* * * * * 

[FR Doc. 2016–03910 Filed 2–24–16; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 76 

[MB Docket No. 15–71; FCC 15–111] 

Television Market Modification; 

Statutory Implementation 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: In this document, the 

Commission announces that the Office 

of Management and Budget (OMB) has 

approved, for a period of three years, the 

information collection associated with 

the Commission’s Report and Order, 

Television Market Modification; 

Statutory Implementation. This 

document is consistent with the Report 

and Order, which stated that the 

Commission would publish a document 

in the Federal Register announcing 

OMB approval and the effective date of 

the rules. 

DATES: The amendments to 47 CFR 

76.59(a) and (b), published at 80 FR 

59635, October 2, 2015, are effective 

February 25, 2016. 

FOR FURTHER INFORMATION CONTACT: For 

additional information contact Cathy 

Williams, Cathy.Williams@fcc.gov, (202) 

418–2918. 

SUPPLEMENTARY INFORMATION: This 

document announces that, on February 

18, 2016 and February 19, 2016, OMB 

approved the information collection 

requirements contained in the 

Commission’s Report and Order, FCC 

15–111, published at 80 FR 59635, 

October 2, 2015. The OMB Control 

Numbers are 3060–0546 and 3060–0980. 

The Commission publishes this notice 

as an announcement of the effective 

date of the rules. If you have any 

comments on the burden estimates 

listed below, or how the Commission 

can improve the collections and reduce 

any burdens caused thereby, please 

contact Cathy Williams, Federal 

Communications Commission, Room 1– 

C823, 445 12th Street SW., Washington, 

DC 20554. Please include the OMB 

Control Numbers, 3060–0546 and 3060– 

0980, in your correspondence. The 

Commission will also accept your 

comments via the Internet if you send 

them to PRA@fcc.gov. 

To request materials in accessible 

formats for people with disabilities 

(Braille, large print, electronic files, 

audio format), send an email to fcc504@

fcc.gov or call the Consumer and 

Governmental Affairs Bureau at (202) 

418–0530 (voice), (202) 418–0432 

(TTY). 

Synopsis 

As required by the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507), 

the FCC is notifying the public that it 

received OMB approval on February 18, 

2016 and February 19, 2016, for the new 

information collection requirements 

contained in the Commission’s rules at 

47 CFR 76.59(a)–(b) and 76.66(d)(6). 

Under 5 CFR 1320, an agency may not 

conduct or sponsor a collection of 

information unless it displays a current, 

valid OMB Control Number. 

No person shall be subject to any 

penalty for failing to comply with a 

collection of information subject to the 

Paperwork Reduction Act that does not 

display a current, valid OMB Control 

Number. The OMB Control Numbers are 

3060–0546 and 3060–0980. 

The foregoing notice is required by 

the Paperwork Reduction Act of 1995, 

Public Law 104–13, October 1, 1995, 

and 44 U.S.C. 3507. 

The total annual reporting burdens 

and costs for the respondents are as 

follows: 

OMB Control Number: 3060–0546. 

OMB Approval Date: February 18, 

2016. 

OMB Expiration Date: February 28, 

2019. 

Title: Section 76.59 Definition of 

Markets for Purposes of the Cable 

Television Mandatory Television 

Broadcast Signal Carriage Rules. 

Form Number: N/A. 

Type of Review: Revision of a 

currently approved collection. 

Respondents: Business and other forprofit entities. 

Number of Respondents and 

Responses: 180 respondents and 200 

responses. 

Estimated Time per Response: 0.5 to 

40 hours. 

Frequency of Response: On occasion 

reporting requirement; Third party 

disclosure requirement; Recordkeeping 

requirement. 

Total Annual Burden: 1,486 hours. 

Total Annual Costs: $1,387,950. 

Obligation to Respond: Required to 

obtain or retain benefits. The statutory 

authority for this collection is contained 

in 47 U.S.C. 151, 154(i), 303(r), 338 and 

534. 

Nature and Extent of Confidentiality: 

There is no need for confidentiality with 

this collection of information. 

Privacy Impact Assessment(s): No 

impact(s). 

Needs and Uses: On September 2, 

2015, the Commission released a Report 

and Order (Order), FCC 15–111, in MB 

Docket No. 15–71, adopting satellite 

television market modification rules to 

implement Section 102 of the Satellite 

Television Extension and Localism Act 

(STELA) Reauthorization Act of 2014 

(STELAR). The STELAR amended the 

Communications Act and the Copyright 

Act to give the Commission authority to 

modify a commercial television 

broadcast station’s local television 

market—defined by The Nielsen 

Company’s Designated Market Area 

(DMA) in which it is located—to 

include additional communities or 

exclude communities for purposes of 

better effectuating satellite carriage 

rights. The Commission previously had 

the authority to modify a station’s 

market only in the cable carriage 

context. Market modification allows the 

Commission to modify the local 

television market of a particular 

commercial television broadcast station 

to enable commercial television 

stations, cable operators and satellite 

carriers to better serve the interests of 

local communities. Market modification 

provides a means to avoid rigid 

adherence to DMA designations and to 

promote consumer access to in-state and 

other relevant television programming. 

Section 338(l) of the Communications 

Act (the satellite market modification 

provision) and Section 614(h)(1)(C) of 

the Communications Act (the 

corresponding cable provision) permit 

the Commission to add communities to 

or delete communities from a station’s 

local television market following a 

written request. Furthermore, the 

Commission may determine that 

particular communities are part of more 

than one television market. 

Section 76.59(a) of the Commission’s 

Rules authorizes the filing of market 

modification petitions and governs who 

may file such a petition. With respect to 

cable market modification petitions, a 

commercial TV broadcast station and 

cable system operator may file a market 

modification petition to modify the 

local television market of a particular 


rmajette on DSK2TPTVN1PROD with RULES