Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Rules and Regulations 81799 

the regulatory change effective in the 

CFR. 

Issued: December 14, 2020. 

Kimberly D. Bose, 

Secretary. 

[FR Doc. 2020–27797 Filed 12–16–20; 8:45 am] 

BILLING CODE 6717–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2018–0053; FRL–10016–42] 

Broflanilide; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of broflanilide in 

or on multiple commodities that are 

identified and discussed later in this 

document. BASF Corporation requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 17, 2020. Objections and 

requests for hearings must be received 

on or before February 16, 2021, 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–2018–0053, 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. 

Due to the public health concerns 

related to COVID–19, the EPA Docket 

Center (EPA/DC) and Reading Room is 

closed to visitors with limited 

exceptions. The staff continues to 

provide remote customer service via 

email, phone, and webform. For the 

latest status information on EPA/DC 

services and docket access, visit https:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Marietta Echeverria, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; main 

telephone number: (703) 305–7090; 

email address: RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Publishing Office’s eCFR site at http://www.ecfr.gov/cgi-bin/ 

text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2018–0053 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 

February 16, 2021. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2018–0053, 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 24, 

2018 (83 FR 34968) (FRL–9980–31), 

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 7F8646) by BASF 

Corporation, 26 Davis Dr., P.O. Box 

13528, Research Triangle Park, NC 

27709. The petition requested to 

establish tolerances in 40 CFR part 180 

for residues of the insecticide, 

broflanilide, including its metabolites 

and degradates, in or on grain, cereal, 

except rice, group 15; amaranth grain; 

quinoa, grain; spelt, grain; canihua, 

grain; chia, grain; cram-cram, grain; 

huauzontle, grain; teff, grain; and corn, 

sweet, kernel plus cob with husks 

removed at 0.01 parts per million (ppm); 

and vegetables, tuberous and corm, 

subgroup 1C at 0.04 ppm. Tolerances 

were also requested for cattle, meat; 

goat, meat; horse, meat; sheep, meat at 

0.01 ppm; milk, fat and poultry, fat at 

0.02 ppm; and cattle, fat; sheep, fat; and 

goat, fat at 0.05 ppm. Additionally, 

tolerances were requested for grain, 

cereal, forage, fodder and straw, group 

16, except rice; quinoa, hay; teff, hay; 

and corn, sweet, stover; corn, sweet, 

forage at 0.01 ppm; corn, field, milled 

products at 0.015 ppm; and potato, wet 

peel at 0.1 ppm. In addition, BASF 

proposed to establish a tolerance of 0.01 

ppm for residues of broflanilide in or on 

all food items in food handling 

establishments where food and food 

products are held, processed, prepared 

and/or served. That document 

referenced a summary of the petition 

prepared by BASF, the registrant, which 

81800 Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Rules and Regulations 

is available in the docket, http://

www.regulations.gov. A comment was 

received on the notice of filing. EPA’s 

response to this comment is discussed 

in Unit IV.C. 

In the Federal Register of June 24, 

2020 (85 FR 37806) (FRL–10010–82), 

EPA issued a second notice amending 

the previous NOF published in the 

Federal Register on July 24, 2018, by 

announcing additional commodities for 

which the petitioner was seeking 

tolerances. BASF requested to establish 

a tolerance in 40 CFR part 180 for 

residues of the insecticide, broflanilide, 

including its metabolites and 

degradates, in or on amaranth, stover; 

quinoa, forage; quinoa, straw; teff, 

forage; and teff, straw at 0.01 ppm. 

(EPA’s notice inadvertently listed 

amaranth, grain, which had already 

been identified in the July 2018 notice, 

instead of amaranth, stover, but BASF’s 

petition included a request for 

amaranth, stover.) BASF also requested 

tolerances for food items (animal origin) 

for hog, meat; poultry, meat; eggs; cattle, 

meat byproducts; goat, meat byproducts; 

hog, meat byproducts; horse, meat 

byproducts; poultry, meat byproducts; 

sheep, meat byproducts; hog, fat; and 

horse, fat at 0.02 ppm. No comments 

were received in response to this notice. 

Based upon review of the data 

supporting the petition, EPA is 

establishing some tolerances at different 

levels than were petitioned for. The 

reason for these changes is explained in 

Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for broflanilide 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with broflanilide 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 target organs of broflanilide 

toxicity are the adrenal glands (rats, 

mice, and dogs) and ovaries (rats and 

mice). Adrenal effects include increased 

adrenal weights, increased incidence of 

adrenal cortex vacuolation, and adrenal 

cortex hypertrophy in both sexes. 

Ovarian effects include increased 

incidence of ovarian interstitial gland 

vacuolation. 

There were no parental or 

developmental effects reported up to the 

limit dose tested (1000 mg/kg/day) in 

the developmental studies in rats and 

rabbits. In the reproduction study in 

rats, increased adrenal weights with 

corroborative histopathological findings 

(increased vacuolation and diffuse 

hypertrophy in the adrenal gland cortex) 

were observed in parental rats of both 

sexes and generations. Offspring 

showed decreased pup weights in F1 

and F2 pups, which occurred at a higher 

dose level than the observed adverse 

effects in parental rats. Reproductive 

parameters showed increased ovarian 

weights and increased incidence of 

vacuolation of interstitial gland in the 

ovary at a higher dose level than the 

adverse effects in parental rats. There 

were no effects on fertility or other 

measured reproductive parameters. 

There is no evidence of neurotoxicity 

in acute or subchronic neurotoxicity 

studies and broflanilide is not an 

immunotoxic chemical. In the 

subchronic inhalation study, there was 

an increase in absolute and relative 

adrenal weight and increased incidence 

of adrenal vacuolation in both sexes and 

increased incidence of ovarian 

vacuolation. 

In the chronic toxicity/carcinogenicity 

study in rats, there were treatmentrelated increases in Leydig cell 

adenomas in male rats, and in luteomas 

and granulosa cell tumors in the ovaries, 

as well as in uterine adenocarcinomas, 

and adrenal cortex carcinomas in female 

rats. No treatment-related increase in 

tumor incidences was observed in mice. 

All mutagenicity studies were negative 

for both the parent and major 

metabolites (DM–8007, S(PFP–OH)- 

8007, DC–8007, DC–DM–8007, MFBA, 

AB-oxa, S9Br-OH)-8007). 

Specific information on the studies 

received and the nature of the adverse 

effects caused by broflanilide 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 the document 

titled ‘‘Broflanilide: New Active 

Ingredient Human Health Risk 

Assessment’’ (hereinafter ‘‘Broflanilide 

Human Health Risk Assessment’’) on 

pages 42–58 in docket ID number EPA– 

HQ–OPP–2018–0053. 

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://

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticide. 

A summary of the toxicological 

endpoints for broflanilide used for 

human risk assessment can be found in 

the Broflanilide Human Health Risk 

Assessment. 

Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Rules and Regulations 81801 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to broflanilide, EPA 

considered exposure under the 

petitioned-for tolerances. EPA assessed 

dietary exposures from broflanilide 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 broflanilide; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the 2003–2008 food 

consumption data from the U.S. 

Department of Agriculture’s National 

Health and Nutrition Examination 

Survey, What We Eat in America 

(NHANES/WWEIA). As to residue levels 

in food, for all commodities in the 

Dietary Exposure Evaluation Model 

software with the Food Commodity 

Intake Database (DEEM–FCID), EPA 

used tolerance-level residues, highest 

average field trials (HAFT) residue 

values, anticipated residues, 100 

percent crop treated (PCT), and default 

processing factors resulting from 

agricultural uses, and the food handling 

establishment (FHE) values (1⁄2 FHE 

LOQ tolerance and 4.65% FHE 

treatment). 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that broflanilide should be 

classified as ‘‘Likely to be Carcinogenic 

to Humans’’ and a linear approach has 

been used to quantify cancer risk. The 

cancer risk assessment used the same 

assumptions as the chronic assessment. 

iv. Anticipated residue and PCT 

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

FFDCA authorizes EPA to use available 

data and information on the anticipated 

residue levels of pesticide residues in 

food and the actual levels of pesticide 

residues that have been measured in 

food. If EPA relies on such information, 

EPA must require pursuant to FFDCA 

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

years after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

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

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

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

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

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area and the exposure 

estimate does not understate exposure 

for the population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

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

EPA may require registrants to submit 

data on PCT. 

The chronic and cancer assessments 

assumed 100 PCT for agricultural uses 

and the treatment value of 4.65% for 

FHE uses. 

EPA estimates the percent of 

commodities treated in Food Handling 

Establishments (FHE) for new uses of 

active ingredients based on the best 

available information. This includes 

survey information on pesticide usage 

related to the number of facilities being 

treated, product forms used (e.g., liquids 

and aerosols), and treatment schedule 

by FHE segments (e.g., warehouse, food 

processor, distributor, and restaurant). 

EPA also incorporated the best available 

information related to the transfer of 

commodities between various segments 

of food handling establishments and the 

percent of food consumed by location, 

either in the home or outside the home. 

All information currently available 

has been considered and EPA has 

concluded that for any active ingredient, 

including broflanilide, there is at most 

a 4.65% likelihood that a food 

commodity could contain potential 

residues resulting from one or more 

treatments while in the food handling 

establishment channel of trade. Similar 

to estimates of agricultural use, this 

estimate should be reconsidered in 5 

years. 

The Agency believes that the three 

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

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which broflanilide may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for broflanilide alone as well as for the 

combined residues of concern (ROC), 

broflanilide and DC–8007 in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of broflanilide and the 

ROC, broflanilide and DC–8007. Further 

information regarding EPA drinking 

water models used in pesticide 

exposure assessment can be found at 

http://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. 

Based on the Pesticide in Water 

Calculator (PWC) model and using the 

Total Residue (TR) method for the 

ROCs, the estimated drinking water 

concentrations (EDWCs) of broflanilide 

and DC–8007 for chronic exposures for 

non-cancer assessments are estimated to 

be 0.9 ppb for surface water and for 

chronic exposures for cancer 

assessments are estimated to be 0.7 ppb 

for surface water. Since breakthrough of 

broflanilide into groundwater is 

incomplete after 100 years of 

simulation, post-breakthrough EDWCs 

are negligible. Due to the high 

Freundlich adsorption coefficient (KF) 

of broflanilide, peak EDWCs in 

groundwater were negligible as well. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For the 

chronic dietary risk assessment, the 

water concentration value of 0.9 ppb 

was used to assess the contribution to 

drinking water. For the cancer dietary 

risk assessment, the water concentration 

value of 0.7 ppb was used to assess the 

contribution to drinking water. 

81802 Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Rules and Regulations 

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). 

There are several proposed residential 

uses for broflanilide. These uses 

include, but are not limited to, 

insecticide treatments in and around 

homes, apartments, schools, picnic 

areas, hospitals, and nursing homes. In 

addition, there are several proposed 

termiticide products that may be used 

around the exterior of homes, 

apartments, schools, and other 

residential use sites. EPA assessed 

residential exposure using the following 

assumptions: 

• Residential handler: Although there 

is one proposed broflanilide product 

label with residential use sites (e.g., 

homes, apartments, mobile homes), this 

product is formulated as a ready-to-use 

pressurized can, which, once dispensed, 

rapidly expands to generate a dry foam. 

One ounce (weight) of the product is 

being dispensed in approximately 5 

seconds, and the ready-to-use 

pressurized can produces about 1 quart 

of foam. Based on the areas to which it 

is applied (i.e., with actuators in voids, 

cracks, and other places where insects 

harbor), dermal exposure is expected to 

be negligible. In addition, considering 

the low vapor pressure of broflanilide 

(6.7×10¥11 mmHg) and formulation into 

foam, inhalation exposure is also 

expected to be negligible. Therefore, 

neither a quantitative non-cancer nor 

cancer residential handler exposure and 

risk assessment was conducted. 

• Post-application exposure: There is 

the potential for short-term postapplication exposure for individuals 

exposed as a result of being in an 

environment that has been previously 

treated with broflanilide. Due to a lack 

of dermal hazard for broflanilide, a 

dermal non-cancer assessment was not 

conducted. The quantitative non-cancer 

exposure and risk assessment for 

residential short-term post-application 

exposures is based on the following 

maximum application rate scenarios: 

Inhalation and incidental oral exposure 

from indoor crack and crevice, banded, 

and spot applications. 

The PODs for the oral and inhalation 

routes are based on the same effects: 

Therefore, oral and inhalation routes 

can be combined. Since the LOCs for 

both incidental oral and inhalation are 

different (100 and 30), the aggregate risk 

index (ARI) approach was used: 

Aggregate Risk Index (ARI) = 1 ÷ 

[(Incidental Oral LOC ÷ Incidental 

Oral MOE) + (Inhalation LOC ÷ 

Inhalation MOE)]. 

Although a non-cancer dermal risk 

assessment was not performed due to 

the lack of an adverse effect in the noncancer dermal study, a dermal cancer 

exposure and risk assessment was 

performed because dermal exposure 

does contribute to the overall cancer 

risk for broflanilide. 

Post-application cancer risk estimates 

for adults were calculated using a linear 

low-dose extrapolation approach in 

which a Lifetime Average Daily Dose 

(LADD) is first calculated and then 

compared with a Q1 * that has been 

calculated for broflanilide based on dose 

response data in the appropriate 

toxicology study (Q1* = 2.48 × 10¥3

(mg/kg/day)¥1). 

The residential exposure scenario 

used in the adult non-cancer aggregate 

assessment is short-term postapplication inhalation exposure 

following an indoor surface directed 

spot application. The residential 

exposure scenario used in the noncancer aggregate assessment of children 

1 to less than 2 years old is the 

combined inhalation and hand-tomouth exposures from short-term postapplication exposure to indoor 

perimeter/spot coarse and pin stream 

surface spray applications on carpet. 

The residential exposure scenario 

used in the adult cancer aggregate 

assessment is post-application dermal 

and inhalation exposure following an 

indoor surface directed perimeter/spot 

application. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www2.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.’’ 

EPA has not found broflanilide to 

share a common mechanism of toxicity 

with any other substances, and 

broflanilide does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that broflanilide 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 website at http:// 

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-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 

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. 

Broflanilide did not demonstrate any 

evidence of increased qualitative or 

quantitative susceptibility in the rat and 

rabbit developmental toxicity studies or 

the 2-generation rat reproduction study. 

In the rabbit and rat developmental 

toxicity studies, there were no 

developmental effects up to the limit 

dose tested (1000 mg/kg/day). In the 

reproduction study in rats, decreased 

pup weights in F1 and F2 pups occurred 

at a higher dose levels than the dose 

with adverse parental findings. 

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 

broflanilide is complete. 

ii. Acute and subchronic 

neurotoxicity studies showed no 

evidence of neurotoxicity in male or 

female rats. There was no other 

evidence in any species tested to 

indicate neurotoxicity potential. 

Therefore, there is no concern for acute 

or subchronic neurotoxicity resulting 

from exposure to broflanilide. 

iii. There is no evidence that 

broflanilide 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 

Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Rules and Regulations 81803 

were performed based on 100 PCT for 

agricultural uses, a treatment value of 

4.65% for FHE uses, and some 

anticipated residue data. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to broflanilide 

in drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children as well 

as incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by broflanilide. 

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, broflanilide 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 broflanilide 

from food and water will utilize less 

than 1% of the cPAD for children 1 to 

2 years old, the population group 

receiving the greatest exposure. Based 

on the explanation in Unit III.C.3., 

regarding residential use patterns, 

chronic residential exposure to residues 

of broflanilide 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). 

Broflanilide is proposed 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 broflanilide. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

ARIs of 320 for adults and 4.4 for 

children 1 to <2 years old. Because 

EPA’s level of concern for broflanilide is 

an ARI of 1 or below, 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). 

An intermediate-term adverse effect 

was identified; however, broflanilide is 

not registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

broflanilide. 

5. Aggregate cancer risk for U.S. 

population. A cancer aggregate risk 

assessment was completed for the 

proposed residential and dietary uses of 

broflanilide using the linear slope factor 

(Q1 *) of 2.48 × 10¥3. The assessment 

incorporates the adult post-application 

dermal and inhalation exposure 

following an indoor surface directed 

perimeter/spot application. The 

residential assessment is a conservative 

calculation which assumes 12 

retreatments a year as allowed by the 

label at the maximum rate proposed, 

365 days of exposure in the residential 

setting, and 10% dissipation of residues 

per day. The cancer dietary exposure 

estimate for adults 20–49 years old, the 

most highly-exposed adult population 

subgroup, assumed 100% crop treated 

for agricultural uses and the FHE 

treatment value of 4.65% for FHE uses. 

The resulting aggregate cancer risk 

estimate is 1 × 10¥6. 

EPA generally considers cancer risks 

(expressed as the probability of an 

increased cancer case) in the range of 1 

in 1 million (or 1 × 10¥6) or less to be 

negligible. Accordingly, EPA has 

concluded the aggregate cancer risk for 

all broflanilide uses fall within the 

range of 1 × 10¥6 and are thus 

negligible. 

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 broflanilide 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

The petitioner proposed a multiresidue method, BASF method D1417/ 

01, based on QuEChERS (quick, easy, 

cheap, effective, rugged, safe) for the 

determination of broflanilide residues in 

plant matrices. This method has been 

proven to be suitable for the 

determination of residues of broflanilide 

in plant matrices. 

BASF method D1604/01 is proposed 

as the enforcement method for the 

determination of residues of broflanilide 

and DM–8007 in livestock commodities 

by LC–MS/MS. This method has been 

proven to be suitable for the 

determination of residues of broflanilide 

and DM–8007 in livestock matrices. 

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. 

Broflanilide is a new active ingredient 

and no MRLs have yet been established 

by Codex. 

C. Response to Comments 

One comment was received in 

response to the Notice of Filing. The 

comment stated in part that ‘‘the notice 

of the application for these uses does 

not contain any information about 

human toxicity, water solubility, 

granular transmissibility, or other 

information which could help evaluate 

the risk of higher levels of use of 

81804 Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Rules and Regulations 

broflanilide’’ and that ‘‘perhaps EPA 

should reissue the notice with attached 

information on toxicity and 

transmission levels.’’ A supporting 

document summarizing the information 

on the residue chemistry, toxicological 

profile, as well as an estimate of the 

aggregate exposure expected was 

available in the docket at the time the 

notice was published. The NOF 

published on July 24, 2018, referred to 

the docket and noted that the summary 

was available. That document provided 

information to help evaluate the risks of 

broflanilide. 

D. Revisions to Petitioned-For 

Tolerances 

EPA is establishing the tolerance in/ 

on potato, wet peel at 0.08 ppm rather 

than the petitioned-for tolerance of 0.1 

ppm. The Agency’s practice is to use the 

HAFT value from the field trials and the 

median processing factor. Based on 

these data, the appropriate tolerance for 

potato, wet peel is 0.08 ppm. 

EPA is not establishing a separate 

tolerance for corn, sweet, kernel plus 

cob with husks removed because it is 

covered under grain, cereal, group 15, 

except rice. Similarly, separate 

tolerances for corn, sweet, stover; and 

corn, sweet forage are not being 

established because they are covered 

under grain, cereal, forage, fodder, and 

straw, group 16, except rice. 

EPA is including the livestock 

metabolite DM–8007 as a residue of 

concern for tolerance enforcement and 

risk assessment. Therefore, the tolerance 

expression for livestock commodities is 

being revised to include the metabolite 

DM–8007. 

EPA is establishing a tolerance for 

residues in milk at 0.02 ppm to 

harmonize with Canadian livestock 

LOQ MRLs. The tolerance of 0.02 ppm 

for residues in milk is higher than the 

anticipated residues in milk fat; 

therefore, although the available data 

support a tolerance for residues in milk 

fat at 0.01 ppm, a separate milk fat 

tolerance is not necessary at this time. 

Lastly, the commodity definitions for 

the FHE use, egg and crop group 16 are 

being modified to be consistent with 

Agency nomenclature. 

V. Conclusion 

Therefore, tolerances are established 

for residues of broflanilide, including its 

metabolites and degradates, in or on the 

following plant commodities: 

Amaranth, grain, grain at 0.01 ppm; 

Amaranth, grain, stover at 0.01 ppm; 

Can ̃ihua, grain at 0.01 ppm; Chia, grain 

at 0.01 ppm; Corn, field, milled 

byproducts at 0.015 ppm; Cram-cram, 

grain at 0.01 ppm; Grain, cereal, group 

15, except rice at 0.01 ppm; Food and 

feed commodities (other than those 

covered by a higher tolerance) at 0.01 

ppm; Grain, cereal, forage, fodder, and 

straw, group 16, except rice at 0.01 ppm; 

Huauzontle, grain at 0.01 ppm; Potato, 

wet peel at 0.08 ppm; Quinoa, forage at 

0.01 ppm; Quinoa, grain at 0.01 ppm; 

Quinoa, hay at 0.01 ppm; Quinoa, straw 

at 0.01 ppm; Spelt, grain at 0.01 ppm; 

Teff, forage at 0.01 ppm; Teff, grain at 

0.01 ppm; Teff, hay at 0.01 ppm; Teff, 

straw at 0.01 ppm; and Vegetable, 

tuberous and corm, subgroup 1C at 0.04 

ppm. 

Tolerances are also established for 

residues of broflanilide, including its 

metabolites and degradates, in or on the 

following livestock commodities: Cattle, 

fat at 0.02 ppm; Cattle, meat at 0.02 

ppm; Cattle, meat byproducts at 0.02 

ppm; Egg at 0.02 ppm; Goat, fat at 0.02 

ppm; Goat, meat at 0.02 ppm; Goat, 

meat byproducts at 0.02 ppm; Hog, fat 

at 0.02 ppm; Hog, meat at 0.02 ppm; 

Hog, meat byproducts at 0.02 ppm; 

Horse, fat at 0.02 ppm; Horse, meat at 

0.02 ppm; Horse, meat byproducts at 

0.02 ppm; Milk at 0.02 ppm; Poultry, fat 

at 0.02 ppm; Poultry, meat at 0.02 ppm; 

Poultry, meat byproducts at 0.02 ppm; 

Sheep, fat at 0.02 ppm; Sheep, meat at 

0.02 ppm; and Sheep, meat byproducts 

at 0.02 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997), nor is it considered a 

regulatory action under Executive Order 

13771, entitled ‘‘Reducing Regulations 

and Controlling Regulatory Costs’’ (82 

FR 9339, February 3, 2017). 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. 

Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Rules and Regulations 81805 

Dated: November 30, 2020. 

Edward Messina, 

Acting Director, Office of Pesticide Programs. 

Therefore, for the reasons stated in the 

preamble, EPA is amending 40 CFR 

chapter I as follows: 

PART 180—TOLERANCES AND 

EXEMPTIONS FOR PESTICIDE 

CHEMICAL RESIDUES IN FOOD 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Add § 180.714 to subpart C to read 

as follows: 

§ 180.714 Broflanilide; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of broflanilide, 

including its metabolites and 

degradates, in or on the commodities to 

Table 1 of this section. Compliance with 

the tolerance levels specified in Table 1 

is to be determined by measuring only 

broflanilide, 3-(benzoylmethylamino)-N- 

[2-bromo-4-[1,2,2,2-tetrafluoro-1- 

(trifluoromethyl)ethyl]-6- 

(trifluoromethyl)phenyl]-2- 

fluorobenzamide, in or on the 

commodity. 

TABLE 1 TO PARAGRAPH (a)(1) 

Commodity Parts per 

million 

Amaranth, grain, grain ................ 0.01 

Amaranth, grain, stover .............. 0.01 

Can ̃ihua, grain ............................ 0.01 

Chia, grain .................................. 0.01 

Corn, field, milled byproducts ..... 0.015 

Cram-cram, grain ........................ 0.01 

Grain, cereal, group 15, except 

rice .......................................... 0.01 

Food and feed commodities 

(other than those covered by a 

higher tolerance) ..................... 0.01 

Grain, cereal, forage, fodder, 

and straw, group 16, except 

rice .......................................... 0.01 

Huauzontle, grain ....................... 0.01 

Potato, wet peel .......................... 0.08 

Quinoa, forage ............................ 0.01 

Quinoa, grain .............................. 0.01 

Quinoa, hay ................................ 0.01 

Quinoa, straw ............................. 0.01 

Spelt, grain ................................. 0.01 

Teff, forage ................................. 0.01 

Teff, grain ................................... 0.01 

Teff, hay ...................................... 0.01 

Teff, straw ................................... 0.01 

Vegetable, tuberous and corm, 

subgroup 1C ........................... 0.04 

(2) Tolerances are established for 

residues of broflanilide, including its 

metabolites and degradates, in or on the 

commodities to Table 2 of this section. 

Compliance with the tolerance levels 

specified in Table 2 is to be determined 

by measuring the sum of broflanilide, 3- 

(benzoylmethylamino)-N-[2-bromo-4- 

[1,2,2,2-tetrafluoro-1- 

(trifluoromethyl)ethyl]-6- 

(trifluoromethyl)phenyl]-2- 

fluorobenzamide, and its metabolite 3- 

benzamido-N-[2-bromo-4- 

(perfluoropropan-2-yl)-6- 

(trifluoromethyl)phenyl]-2- 

fluorobenzamide, calculated as the 

stoichiometric equivalent of 

broflanilide, in or on the commodity. 

TABLE 2 TO PARAGRAPH (A)(2) 

Commodity Parts per 

million 

Cattle, fat .................................... 0.02 

Cattle, meat ................................ 0.02 

Cattle, meat byproducts ............. 0.02 

Egg ............................................. 0.02 

Goat, fat ...................................... 0.02 

Goat, meat .................................. 0.02 

Goat, meat byproducts ............... 0.02 

Hog, fat ....................................... 0.02 

Hog, meat ................................... 0.02 

Hog, meat byproducts ................ 0.02 

Horse, fat .................................... 0.02 

Horse, meat ................................ 0.02 

Horse, meat byproducts ............. 0.02 

Milk ............................................. 0.02 

Poultry, fat .................................. 0.02 

Poultry, meat .............................. 0.02 

Poultry, meat byproducts ............ 0.02 

Sheep, fat ................................... 0.02 

Sheep, meat ............................... 0.02 

Sheep, meat byproducts ............ 0.02 

(b)–(d) [Reserved] 

[FR Doc. 2020–27906 Filed 12–16–20; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 76 

[MB Docket Nos. 20–70, 17–105, 11–131; 

FCC 20–162; FRS 17261] 

Review Procedures; Modernization of 

Media Regulation Initiative; Program 

Carriage Rules 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the 

Commission revises the rules governing 

the resolution of program carriage 

disputes between video programming 

vendors and multichannel video 

programming distributors (MVPDs) and 

parallel procedural rules, which govern 

program access, open video system 

(OVS), and good-faith retransmission 

consent complaints. Specifically, the 

document amends the third prong of the 

statute of limitations for filing program 

carriage complaints so that it no longer 

undermines the fundamental purpose of 

a statute of limitations. To harmonize 

the rules, the document similarly 

amends the statutes of limitations for 

filing program access, OVS, and goodfaith retransmission consent complaints. 

The document also revises the effective 

date and review procedures for initial 

decisions issued by an administrative 

law judge (ALJ) in program carriage, 

program access, and OVS proceedings to 

make them consistent with the 

Commission’s generally applicable 

procedures and adopts an aspirational 

shot clock to encourage quick resolution 

of appeals of such decisions. The 

Commission concludes that these 

changes will help to ensure a clear and 

expeditious program access, program 

carriage, retransmission consent, and 

OVS complaint process for potential 

complainants and defendants. 

DATES: Effective January 19, 2021. 

FOR FURTHER INFORMATION CONTACT: For 

additional information on this 

proceeding, contact John Cobb, 

John.Cobb@fcc.gov, of the Policy 

Division, Media Bureau, (202) 418– 

2120. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Report 

and Order, MB Docket Nos. 20–70, 17– 

105, 11–131; FCC 20–162, adopted and 

released on November 18, 2020. The full 

text of this document is available via 

ECFS (http://www.fcc.gov/cgb/ecfs/). 

(Documents will be available 

electronically in ASCII, Word, and/or 

Adobe Acrobat.) To request these 

documents in accessible formats 

(computer diskettes, large print, audio 

recording, and Braille), send an email to 

fcc504@fcc.gov or call the Commission’s 

Consumer and Governmental Affairs 

Bureau at (202) 418–0530 (voice), (202) 

418–0432 (TTY). 

Synopsis 

In this Report and Order (Order), we 

adopt proposed changes to the rules 

governing the resolution of program 

carriage disputes between video 

programming vendors and multichannel 

video programming distributors 

(MVPDs) and parallel procedural rules 

in part 76 of our rules, which govern 

program access, open video system 

(OVS), and good-faith retransmission 

consent complaints. Specifically, we 

amend the third prong of the statute of 

limitations for filing program carriage 

complaints so that it no longer 

undermines the fundamental purpose of 

a statute of limitations. To harmonize 

our rules, we similarly amend the 

statutes of limitations for filing program