7982 Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Rules and Regulations 

§ 52.1620 Identification of plan. 

* * * * * 

(e) * * * 

EPA APPROVED NONREGULATORY PROVISIONS AND QUASI-REGULATORY MEASURES IN THE NEW MEXICO SIP 

Name of SIP provision Applicable geographic 

or nonattainment area 

State 

submittal/ 

effective date 

EPA approval date Explanation 

*******

Infrastructure and Interstate 

Transport for the 2010 NO2

NAAQS.

Albuquerque-Bernalillo County .... 7/26/2013 2/17/16, [insert Federal 

Register citation].

[FR Doc. 2016–03130 Filed 2–16–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0913; FRL–9941–69] 

Fluridone; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of fluridone in or 

on cotton, undelinted seed. SePRO 

Corporation requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 17, 2016. Objections and 

requests for hearings must be received 

on or before April 18, 2016, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2014–0913, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

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

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

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

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2014–0913 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 18, 2016. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2014–0913, 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 April 6, 

2015 (80 FR 18327) (FRL–9924–00), 

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 4F8308) by 

SePRO Corporation, 11550 North 

Meridian Street, Suite 600, Carmel, IN 

46032. The petition requested that 40 

CFR part 180 be amended by 

establishing tolerances for residues of 


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Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Rules and Regulations 7983 

the herbicide fluridone, 1-methyl-3- 

phenyl-5-(3-(trifluoromethyl)phenyl)- 

4(1H)-pyridinone, in or on cotton, 

undelinted seed at 0.1 parts per million 

(ppm). That document referenced a 

summary of the petition prepared by 

SePRO Corporation, the registrant, 

which is available in the docket, 

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

no comments received in response to 

the notice of filing. 

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 fluridone 

including exposure resulting from the 

tolerance established by this action. 

EPA’s assessment of exposures and risks 

associated with fluridone 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 liver and 

kidneys were identified as the primary 

target organs based on a multitude of 

organ specific effects noted across the 

toxicity database. All model species 

exhibited indications of liver toxicity 

that were often accompanied by body 

weight effects. Mice were the most 

sensitive species examined, and dogs 

were the most tolerant. Rat sensitivity 

was comparable (chronic exposure) to or 

slightly less (subchronic exposure) than 

mice; however, rats were the only 

species to exhibit minor kidney effects 

in addition to liver and body weight 

toxicity. Progression of toxicity from 

subchronic to chronic exposures was 

not observed in mice and was limited 

(2-fold difference) in rats. No evidence 

of fetal sensitivity was observed in rats 

or rabbits. Body weight effects in the F2

rat offspring during the lactation period 

were suggestive of susceptibility in the 

young. However, this evidence is 

considered equivocal because the effects 

were isolated to the F2 offspring, body 

weight of the F2 offspring returned to 

control levels after the lactation period 

and no subsequent evidence of 

susceptibility was observed in progeny 

of the F2 generation. Furthermore, the 

offspring effects occurred at doses 2 to 

4.5 times higher than the target organ 

and body weight toxicity noted in adult 

rodents. While these effects are 

considered equivocal, susceptibility will 

be assumed to be present in the young 

in the absence of more definitive 

toxicity data. Behavioral anomalies, 

physiological effects, and locomotor 

impairment consistent with 

neurotoxicity were only observed 

following acute gavage exposure to 

doses that likely exceeded linear 

pharmacokinetics and were at least 13 

to 26 times higher than the lowest doses 

causing liver and kidney effects in 

rodents. No signs of neurotoxicity were 

identified in the rest of the toxicity 

database. Toxicity from repeated dose 

dermal exposures was limited to 

irritation effects on the skin (erythema, 

desquamation, epidermal fissures). No 

evidence of immunotoxicity, 

mutagenicity, or carcinogenicity were 

noted in the toxicity database. Fluridone 

did not demonstrate mutagenic behavior 

either in vitro or in vivo nor did 

exposure result in an increased 

incidence of tumors. The EPA 

concluded that fluridone should be 

classified as ‘‘not likely’’ to be a human 

carcinogen. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fluridone as well as 

the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in document 

Fluridone. Human Health Risk 

Assessment for Registration Review and 

to Support the Registration of the Use 

on Cotton on pages 47 thru 72 in docket 

ID number EPA–HQ–OPP–2014–0913. 

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-pesticides. 

The 2-year mouse study was used for 

the residential points of departures 

(PODs) for short- and intermediate-term 

incidental oral, dermal and inhalation 

exposure. The mouse chronic endpoint 

was considered appropriate for shortand intermediate-term fluridone 

exposures because mice were the most 

sensitive species and there was no 

progression of toxicity from subchronic 

to chronic exposure. 

The guideline dermal study was not 

used to set endpoints for the dermal 

assessment, because the study did not 

address concerns for the possible 

sensitivity in the young observed in the 

3-generation reproduction study. The 

systemic NOAEL from the dermal study 

is 384 milligram/kilogram/day (mg/kg/

day), but there is equivocal, yet 

suggestive evidence of offspring toxicity 

at 112 mg/kg/day. The NOAEL from the 

2-year mouse cancer study is 38.5 mg/ 

kg/day after accounting for route-toroute extrapolation (dermal absorption 

factor of 39%) and is therefore 

protective of the equivocal offspring 

effects. The chronic mouse oral 


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endpoint was used for the inhalation 

assessment as well, because a routespecific inhalation study was not 

available. Without a route specific 

study, inhalation exposure was assumed 

to be equivalent to oral exposure. 

A summary of the toxicological 

endpoints for fluridone used for human 

risk assessment is shown in Table 1 of 

this unit. 

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

ASSESSMENT

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (All populations) .. NOAEL = 125 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 1.25 

mg/kg/day.

aPAD = 1.25 mg/kg/

day 

Acute Neurotoxicity—Rat. 

LOAEL = 650 mg/kg/day based on decreased ambulatory 

counts and the prevalence of functional observational battery 

(FOB) anomalies in males and females. 

Chronic dietary (All populations) NOAEL= 15 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.15 

mg/kg/day.

cPAD = 0.15 mg/kg/

day 

2-year cancer study—Mouse. 

LOAEL = 50 mg/kg/day based on increased alkaline phosphatase activity and increased incidence of hepatocellular 

hyperplasia. 

Incidental oral short-term (1 to 

30 days) and intermediateterm.

NOAEL= 15 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 2-year cancer study—Mouse. 

LOAEL = 50 mg/kg/day based on increased alkaline phosphatase activity and increased incidence of hepatocellular 

hyperplasia. 

Dermal short-term (1 to 30 

days) and intermediate-term 

(1 to 6 months).

Oral study NOAEL = 

15 mg/kg/day (dermal absorption 

rate = 39%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 2-year cancer study—Mouse. 

LOAEL = 50 mg/kg/day based on increased alkaline phosphatase activity and increased incidence of hepatocellular 

hyperplasia. 

Inhalation short-term (1 to 30 

days) and intermediate-term 

(1 to 6 months).

Oral study NOAEL= 

15 mg/kg/day (inhalation absorption 

rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 2-year cancer study—Mouse. 

LOAEL = 50 mg/kg/day based on increased alkaline phosphatase activity and increased incidence of hepatocellular 

hyperplasia. 

Cancer (Oral, dermal, inhalation).Fluridone is classified as ‘‘not likely’’ to be a human carcinogen. Quantitative cancer risk assessment is not required. 

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). 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 fluridone, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

fluridone tolerances in 40 CFR 180.420. 

EPA assessed dietary exposures from 

fluridone 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 fluridone. In estimating acute dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). This 

dietary survey was conducted from 2003 

to 2008. 100 percent crop treated (PCT), 

tolerance residues, and default 

processing factors were assumed for this 

assessment. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA NHANES/WWEIA. This 

dietary survey was conducted from 2003 

to 2008. 100 PCT, tolerance residues, 

and default processing factors were 

assumed. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fluridone does not pose 

a cancer risk to humans. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for fluridone. Tolerance-level residues 

and/or 100 PCT were assumed for all 

food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening-level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fluridone in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 


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transport characteristics of fluridone. 

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 First Index Reservoir 

Screening Tool (FIRST) and Pesticide 

Root Zone Model Ground Water (PRZM 

GW), the estimated drinking water 

concentrations (EDWCs) of fluridone for 

acute exposures are estimated to be 24 

parts per billion (ppb) for surface water 

and 34 ppb for ground water. For 

chronic exposures they are estimated to 

be 21 ppb for surface water and 32 ppb 

for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 34 ppb was used 

to assess the contribution to drinking 

water. For chronic dietary risk 

assessment, the water concentration of 

value 32 ppb was used to assess the 

contribution to drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

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

indoor pest control, termiticides, and 

flea and tick control on pets). 

Fluridone is currently registered for 

the following uses that could result in 

residential exposures: From use on 

ponds (including a homeowner use), 

lakes, reservoirs, and rivers. EPA 

assessed residential exposure using the 

following assumptions: Adult 

applicators may be exposed (dermal and 

inhalation) while applying the pesticide 

to residential ponds. Residential 

handler exposure is expected to be 

short-term in duration only. 

Intermediate-term and chronic 

exposures are not likely because of the 

intermittent nature of applications by 

homeowners. There is also potential for 

residential post-application exposure 

(dermal, inhalation and incidental 

ingestion) for adults and children (3 to 

<6 years old) swimming in treated 

water. Residential post-application 

exposure is expected to be short term in 

duration only. 

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 fluridone to share 

a common mechanism of toxicity with 

any other substances, and fluridone 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that fluridone does not have a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www2.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. 

There was no evidence of qualitative 

susceptibility in fetuses in the rat and 

rabbit developmental study. Equivocal 

susceptibility was observed in the 

young from the F2 population in the 

reproductive study during the lactation 

phase (based decreased body weight); 

however, body weight of the F2

offspring returned to control levels after 

the lactation period and no evidence of 

susceptibility was observed in the F3

offspring. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1x. That decision is 

based on the following findings: 

i. The toxicity database for fluridone 

is complete. Though EPA relied on an 

oral study to assess inhalation 

exposures, a subchronic inhalation 

study is not required based on a weightof-evidence (WOE) approach that 

considered the physical/chemical 

properties of fluridone including low 

vapor pressure, low acute inhalation 

toxicity, and the large short- and 

intermediate-term inhalation MOEs 

calculated. 

ii. The combination of behavioral 

anomalies and impaired physiological 

and locomotor function in the acute 

neurotoxicity (ACN) study were 

suggestive of neurotoxicity following 

high dose acute exposure. However, the 

concern for neurotoxicity is low because 

the adverse effects in the ACN study 

were only seen at relatively high gavage 

doses (650–2000 mg/kg/day); there were 

no corresponding 

neurohistopathological findings; there 

were no indications of neurotoxicity in 

the rest of the toxicity database; and the 

endpoints selected for risk assessment 

are protective of these adverse effects. 

iii. There is no evidence that 

fluridone results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies. 

There was equivocal susceptibility 

observed in the young from the F2

population in the reproductive study 

during the lactation phase (decreased 

body weight); however, body weight of 

the F2 offspring returned to control 

levels after the lactation period, and no 

evidence of susceptibility was observed 

in the F3 offspring. The PODs selected 

to assess risk are protective of the 

equivocal susceptibility in young 

animals. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to fluridone 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 fluridone. 

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 


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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 

fluridone will occupy 1.3% of the aPAD 

for children 1–2 years 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 fluridone from 

food and water will utilize 5.5% of the 

cPAD for children 1–2 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 fluridone 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). Fluridone 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 

fluridone. Using the exposure 

assumptions described in this unit for 

short-term exposures, EPA has 

concluded the combined short-term 

food, water, and residential exposures 

result in aggregate MOEs of 1,500 for 

adults and 1,600 for children. Because 

EPA’s level of concern for fluridone is 

a MOE of 100 or below, these MOEs are 

not of concern. 

4. Intermediate-term risk. An 

intermediate-term adverse effect was 

identified; however, fluridone 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 

fluridone. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

fluridone is not expected to pose a 

cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to fluridone 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

[high performance liquid 

chromatography (HPLC) method 

(originally submitted as method AM– 

AA–CA–RO52–AA–755)] is available in 

the Pesticide Analytical Manual (PAM) 

Volume II for residues of fluridone in 

plant commodities, including cotton. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for fluridone in cotton. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of fluridone, 1-methyl-3- 

phenyl-5-(3-(trifluoromethyl)phenyl)- 

4(1H)-pyridinone, in or on cotton, 

undelinted seed at 0.1 ppm. 

Additionally, the tolerances for cotton, 

undelinted seed at 0.1 ppm in 

paragraphs (b) and (d) are removed, 

since they are superseded by this action. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 


asabaliauskas on DSK5VPTVN1PROD with RULES
Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Rules and Regulations 7987 

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 8, 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 § 180.420, is amended: 

■ i. By alphabetically adding ‘‘cotton, 

undelinted seed’’ to the table in 

paragraph (a)(2); 

■ ii. By removing and reserving the text 

of paragraph (b); 

■ iii. By removing ‘‘cotton, undelinted 

seed’’ from the table in paragraph (d). 

The addition reads as follows: 

§ 180.420 Fluridone; tolerances for 

residues. 

(a) * * * 

(2) * * * 

Commodity Parts per 

million 

* * * * * 

Cotton, undelinted seed ....... 0.1 

* * * * * 

(b) Section 18 emergency exemptions. 

[Reserved]. 

* * * * * 

[FR Doc. 2016–03220 Filed 2–16–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 745 

[EPA–HQ–OPPT–2014–0304; FRL–9941–61] 

RIN 2070–AK02 

Lead-Based Paint Programs; 

Amendment to Jurisdiction-Specific 

Certification and Accreditation 

Requirements and Renovator 

Refresher Training Requirements 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is finalizing revisions to 

the Lead Renovation, Repair, and 

Painting (RRP) rule, and the Lead-based 

Paint (LBP) Activities rule. The 

revisions are intended to improve the 

day-to-day function of these programs 

by reducing burdens to industry and 

EPA, and by clarifying language for 

training providers, while retaining the 

protections provided by the original 

rules. First, EPA is modifying the 

requirement that the renovator refresher 

training for individuals have a hands-on 

component. Second, the Agency is 

removing jurisdiction-specific 

certification and accreditation 

requirements under the LBP Activities 

program in States where EPA 

administers the program. Previously, 

this program required that training 

providers, firms and individuals seek 

certification in each jurisdiction (e.g., a 

State) where the organization or person 

wanted to work. Third, EPA is adding 

clarifying language to the requirements 

for training providers under both the 

RRP and LBP Activities programs. 

DATES: This final rule is effective 

February 17, 2016. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number HQ–OPPT–2014–0304, is 

available at http://www.regulations.gov 

or at the Office of Pollution Prevention 

and Toxics Docket (OPPT Docket), 

Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, 

DC. 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 OPPT 

Docket is (202) 566–0280. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Marc 

Edmonds, National Program Chemicals 

Division, Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: 202–566–0758; email address: 

edmonds.marc@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you operate a training 

program required to be accredited under 

40 CFR 745.225, if you are a firm or 

individual who must be certified to 

conduct lead-based paint activities in 

accordance with 40 CFR 745.226, or if 

you are an individual who must be 

certified to conduct renovation activities 

in accordance with 40 CFR 745.90. This 

rule applies only in States, territories, 

and tribal areas that do not have 

authorized programs pursuant to 40 CFR 

745.324. For further information 

regarding the authorization status of 

States, territories, and Tribes, contact 

the National Lead Information Center at 

1–800–424–LEAD (5323). 

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: 

• Building construction (NAICS code 

236), e.g., single-family housing 

construction, multi-family housing 

construction, residential remodelers. 

• Specialty trade contractors (NAICS 

code 238), e.g., plumbing, heating, and 

air-conditioning contractors, painting 

and wall covering contractors, electrical 

contractors, finish carpentry contractors, 

drywall and insulation contractors, 

siding contractors, tile and terrazzo 

contractors, glass and glazing 

contractors. 

• Real estate (NAICS code 531), e.g., 

lessors of residential buildings and 

dwellings, residential property 

managers. 

• Child day care services (NAICS 

code 624410). 

• Elementary and secondary schools 

(NAICS code 611110), e.g., elementary 

schools with kindergarten classrooms. 

• Other technical and trade schools 

(NAICS code 611519), e.g., training 

providers. 


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