Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Rules and Regulations 7541 

PENNSYLVANIA—1997 ANNUAL PM2.5 NAAQS 

[Primary and secondary] 

Designated area 

Designation a Classification 

Date 1 Type Date 2 Type 

Harrisburg-Lebanon-Carlisle, PA: 

Cumberland County ........................................................................... 12/08/14 Attainment.

Dauphin County ................................................................................. 12/08/14 Attainment.

Lebanon County ................................................................................. 12/08/14 Attainment.

* * * * * * * 

York, PA: 

York County ....................................................................................... 12/08/14 Attainment.

* * * * * * * 

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

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

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

* * * * * 

PENNSYLVANIA—2006 24-HOUR PM2.5 NAAQS 

[Primary and secondary] 

Designated area 

Designation a Classification 

Date 1 Type Date 2 Type 

*******

Harrisburg-Lebanon-Carlisle-York, PA: 

Cumberland County ........................................................................... 12/08/14 Attainment.

Dauphin County ................................................................................. 12/08/14 Attainment.

Lebanon County ................................................................................. 12/08/14 Attainment.

York County ....................................................................................... 12/08/14 Attainment.

*******

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

1This date is 30 days after November 13, 2009, unless otherwise noted. 

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

* * * * * 

[FR Doc. 2015–02857 Filed 2–10–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0768; FRL–9921–89] 

Pendimethalin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pendimethalin 

in or on multiple commodities which 

are identified and discussed later in this 

document. In addition, this regulation 

removes existing tolerances on fruit, 

citrus, group 10; fruit, pome, group 11; 

fruit, stone, group 12; garlic; leek; onion, 

bulb; onion, green; onion, welsh; 

shallot; strawberry; sunflower seed; and 

vegetable, fruiting, group 8, which are 

superseded by this action. Interregional 

Research Project Number 4 (IR–4) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

February 11, 2015. Objections and 

requests for hearings must be received 

on or before April 13, 2015, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0768, 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 


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7542 Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Rules and Regulations 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2013–0768 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 13, 2015. 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– 

2013–0768, 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 Friday, 

February 21, 2014 (79 FR 9870) (FRL– 

9904–98), EPA issued a document 

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

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

of a pesticide petition (PP 3E8212) by 

IR–4, IR–4 Project Headquarters, 500 

College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.361 be 

amended by establishing tolerances for 

residues of the herbicide pendimethalin, 

[N-(1-ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine], and its metabolite, 

4-[(1-ethylpropyl)amino]-2-methyl-3,5- 

dinitrobenzyl alcohol, calculated as the 

stoichiometric equivalent of 

pendimethalin, in or on berry, low 

growing subgroup 13–07G at 0.1 parts 

per million (ppm); fruit, citrus, group 

10–10 at 0.1 ppm; fruit, pome, group 

11–10 at 0.1 ppm; fruit, stone, group 12– 

12 at 0.1 ppm; hops, dried cones at 0.1 

ppm; onion, bulb subgroup 3–07A at 0.1 

ppm; onion, green subgroup 3–07B at 

0.2 ppm; sunflower, subgroup 20B at 0.1 

ppm; and vegetable, fruiting, group 8–10 

at 0.1 ppm. That document referenced a 

summary of the petition prepared by 

BASF 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 pendimethalin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with pendimethalin follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity database 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. 

Pendimethalin has low acute toxicity 

by the oral, dermal, or inhalation route 

of exposure. It is not an eye or skin 

irritant, and is not a skin sensitizer. The 

target organ is the thyroid. Thyroid 

toxicity in chronic and subchronic rat 

and mouse studies was manifested as 

alterations in thyroid hormones 

(decreased total T4, and T3, increased 

percent of free T4 and T3), increased 

thyroid weight, and microscopic thyroid 

lesions (including increased thyroid 

follicular cell height, follicular cell 

hyperplasia, as well as follicular cell 

adenomas). Due to these effects, the 

Agency required that a developmental 

thyroid assay be conducted to evaluate 

the impact of pendimethalin on thyroid 

hormones, structure, and/or thyroid 

hormone homeostasis during 

development. A developmental thyroid 

study was submitted and demonstrated 

that there is no potential thyroid 

toxicity following pre- and/or post-natal 

exposure to pendimethalin. 

The points of departure (PODs) used 

for the chronic and short-term risk 

assessments were based on a 92-day 

thyroid function study in rats, a 56-day 

thyroid study in rats, and a 14-day intra 

thyroid metabolism study in rats. Due to 

several important quantitative dynamic 

differences between rats and humans 

with respect to thyroid function, the 

interspecies uncertainty factor (UF), 

which used to account for animal to 

human differences in toxicokinetics and 

toxicodynamics, was reduced to 3X for 


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the chronic and short-term risk 

assessments. A 10X interspecies UF was 

used in the acute risk assessment 

because the POD was based on an acute 

neurotoxicity study, not a thyroid study. 

Although a subchronic inhalation study 

was not available in the database, EPA 

determined that one is not needed at 

this time based on the following: 

1. All relevant hazard and exposure 

information, including its low acute 

inhalation toxicity. 

2. Its physical/chemical properties, 

including its low volatility. 

3. The use of an oral POD that results 

in occupational and residential 

inhalation margin of exposure (MOE) (in 

the case of pendimethalin MOE = 30 

based on thyroid POD). 

There is no evidence that 

pendimethalin is a developmental, 

reproductive, neurotoxic, or 

immunotoxic chemical. There is no 

evidence of increased qualitative or 

quantitative susceptibility in the young. 

EPA classified pendimethalin as a 

‘‘Group C’’, possible human carcinogen 

based on a statistically significant 

increased trend and pair-wise 

comparison between the high-dose 

group and controls for thyroid follicular 

cell adenomas in male and female rats. 

A non-quantitative approach (i.e., nonlinear, reference dose (RfD) approach) 

was used to assess cancer risk since 

mode-of-action studies are available to 

demonstrate that the thyroid tumors are 

due to a thyroid-pituitary imbalance, 

and also since pendimethalin was 

shown to be non-mutagenic in 

mammalian somatic cells and germ 

cells. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by pendimethalin as well 

as the no-observed-adverse-effect-level 

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

toxicity studies are discussed in the 

final rule published in the Federal 

Register of August 29, 2012 (77 FR 

52240) (FRL–9360–5) and in 

‘‘Pendimethalin: Human Health Risk 

Assessment to Support New Use on 

Hops and Crop Subgroup Conversions/ 

Expansions for Low Growing Berry 

Subgroup 13–07G, Onion, Bulb 

Subgroup 3–07A, Onion, Green 

Subgroup 3–07B, and Sunflower 

Subgroup 20B; Crop Group Expansions 

for Citrus Fruit, Group 10, Pome Fruit, 

Group 11, Stone Fruit, Group 12, and 

Fruiting Vegetable, Group 8,’’ in docket 

ID number EPA–HQ–OPP–2013–0768. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological POD and levels of concern 

to use in evaluating the risk posed by 

human exposure to the pesticide. For 

hazards that have a threshold below 

which there is no appreciable risk, the 

toxicological POD is used as the basis 

for derivation of reference values for 

risk assessment. PODs are developed 

based on a careful analysis of the doses 

in each toxicological study to determine 

the dose at which the NOAEL and the 

LOAEL are identified. Uncertainty/

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

RfD—and a safe MOE. For nonthreshold risks, the Agency assumes 

that any amount of exposure will lead 

to some degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for pendimethalin used for 

human risk assessment is discussed in 

the final rule published in the Federal 

Register on Wednesday, August 29, 

2012 (77 FR 52240) (FRL–9360–5) 

establishing tolerances for residues of 

pendimethalin and its metabolite in or 

on various commodities. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to pendimethalin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing pendimethalin tolerances in 40 

CFR 180.361. EPA assessed dietary 

exposures from pendimethalin 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 

pendimethalin. In conducting the acute 

dietary exposure assessment for 

pendimethalin, EPA used the Dietary 

Exposure Evaluation Model software 

with the Food Commodity Intake 

Database (DEEM–FCID) Version 3.16. 

This software uses 2003–2008 food 

consumption data from the U.S. 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). The 

deterministic acute analysis is based on 

tolerance-level residues; 100 percent 

crop treated (PCT) assumptions for all of 

the pendimethalin use commodities in 

this assessment and DEEMTM default 

processing factors or empirical 

processing factors where available. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the DEEM–FCID, Version 3.16 

software with 2003–2008 food 

consumption data from the USDA’s 

NHANES/WWEIA. The deterministic 

unrefined chronic analysis is based on 

tolerance-level residues; 100 PCT 

assumptions for all of the 

pendimethalin use commodities in this 

assessment and DEEMTM default 

processing factors or empirical 

processing factors where available. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to pendimethalin. Cancer 

risk was assessed using the same 

exposure estimates as discussed in Unit 

III.C.1.ii., chronic exposure. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for 

pendimethalin. Tolerance-level 

residues, default processing factors and 

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 pendimethalin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

pendimethalin. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS—New York 

grape scenario) and Screening 

Concentration in Ground Water (SCI– 

GROW) models the estimated drinking 

water concentrations (EDWCs) of 

pendimethalin for acute exposures are 

estimated to be 77.7 parts per billion 

(ppb) for surface water and 0.036 ppb 

for ground water; and for chronic 

exposures are estimated to be 6.0 ppb 

for surface water and 0.036 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 77.7 ppb was 

used to assess the contribution to 


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drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 6.0 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). 

Pendimethalin is currently registered 

for the following uses that could result 

in residential exposures: Turf, home 

gardens, and ornamentals. EPA assessed 

residential exposure using the following 

assumptions: For handlers, it is 

assumed that most residential use will 

result in short-term (1 to 30 days) 

duration dermal and inhalation 

exposures. Residential handlers are 

assumed to be adults wearing shortsleeved shirts, short pants, shoes and 

socks during application of 

pendimethalin. 

Residential post-application exposure 

is also assumed to be short-term (1–30 

days) in duration, resulting from the 

following exposure scenarios: 

Gardening: Adults (dermal) and 

children 6<11 years old (dermal); 

physical activities on turf: Adults 

(dermal) and children 1–2 years old 

(dermal and incidental oral); mowing 

turf: Adults (dermal) and children 

11<16 years old (dermal); and exposure 

to golf courses during golfing: Adults 

(dermal), children 11<16 years old 

(dermal), and children 6<11 years old 

(dermal). 

EPA did not combine exposure 

resulting from adult handler and postapplication exposure resulting from 

treated gardens, lawns, and/or golfing 

because of the conservative assumptions 

and inputs within each estimated 

exposure scenario. The Agency believes 

that combining exposures resulting from 

handler and post-application activities 

would result in an overestimate of adult 

exposure. EPA selected the most 

conservative adult residential scenario 

(adult dermal post-application exposure 

from gardening) as the contributing 

source of residential exposure to be 

combined with the dietary exposure for 

the aggregate assessment. 

The children’s oral exposure is based 

on post-application hand-to-mouth 

exposures. To include exposure from 

object-to-mouth and soil ingestion in 

addition to hand-to-mouth would 

overestimate the potential for oral 

exposure. However, there is the 

potential for co-occurrence of dermal 

and oral exposure, since the 

toxicological effects from the dermal 

and oral routes of exposure are the 

same. As a result, the children’s 

aggregate assessment combines postapplication dermal and oral exposure 

along with dietary exposure from food 

and water. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

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

pesticides/science/residential-exposuresop.html. 

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 pendimethalin to 

share a common mechanism of toxicity 

with any other substances, and 

pendimethalin does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that pendimethalin does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

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

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Federal 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 indication of pre- and/or 

post-natal qualitative or quantitative 

increased susceptibility in the 

developmental studies in rats and 

rabbits or the 2-generation reproduction 

studies in rats. A developmental thyroid 

toxicity study demonstrated that there is 

no potential thyroid toxicity following 

pre- and/or post-natal exposure to 

pendimethalin. 

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 

pendimethalin is complete. 

ii. There is no indication that 

pendimethalin is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

pendimethalin results in increased 

susceptibility in utero rats or rabbits in 

the prenatal developmental studies or in 

young rats in the 2-generation 

reproduction study. In addition, a 

developmental thyroid toxicity study 

demonstrated that there is no potential 

thyroid toxicity following pre- and/or 

post-natal exposure to pendimethalin. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT, 

tolerance-level residues and default 

processing factors. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

pendimethalin in drinking water. EPA 

used similarly conservative assumptions 

to assess post-application exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by pendimethalin. 

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 population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). For 

linear cancer risks, EPA calculates the 

lifetime probability of acquiring cancer 

given the estimated aggregate exposure. 

Short-, intermediate-, and chronic-term 

risks are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

pendimethalin will occupy 1.7% of the 

aPAD for all infants less than 1 year old, 

the population group receiving the 

greatest exposure. Aggregate acute risk 

is by definition considered to include 


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exposure to food and drinking water 

only. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to pendimethalin 

from food and water will utilize 1.7% 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 

(dermal and inhalation) to residues of 

pendimethalin 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). 

Pendimethalin 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 pendimethalin. 

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 130 for adults and 93 for 

children 1–2 years old, the two 

population subgroups receiving the 

greatest combined dietary and nondietary exposure. Because EPA’s level of 

concern for pendimethalin is a MOE of 

30 or below, these MOEs 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, pendimethalin 

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. Therefore, an 

intermediate-term aggregate assessment 

is not required. 

5. Aggregate cancer risk for U.S. 

population. As discussed in Unit III.A., 

EPA has determined that an RfD 

approach based on the chronic point of 

departure is appropriate for evaluating 

cancer risk. As there are not chronic 

aggregate risks of concern, there are no 

cancer aggregate risk concerns. 

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 

pendimethalin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement analytical 

methodologies are available to enforce 

the proposed tolerances. BASF Method 

D1005 is adequate to enforce the 

proposed tolerance for hops. 

Additionally, the FDA PESTDATA 

database pesticide analytical manual 

(PAM Volume II, Appendix I) lists four 

gas chromatograph with electron 

capture detection (GC/ECD) methods for 

the determination of pendimethalin 

residues of concern in plant 

commodities. These GC/ECD methods 

are suitable to enforce the tolerances 

associated with the crop conversions. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

There are currently no established 

Codex MRLs for the residues of 

pendimethalin. 

V. Conclusion 

Therefore, tolerances are established 

for residues of the herbicide 

pendimethalin in or on berry, low 

growing subgroup 13–07G at 0.1 ppm; 

fruit, citrus, group 10–10 at 0.1 ppm; 

fruit, pome, group 11–10 at 0.1 ppm; 

fruit, stone, group 12–12 at 0.1 ppm; 

hops, dried cones at 0.1 ppm; onion, 

bulb subgroup 3–07A at 0.1 ppm; onion, 

green subgroup 3–07B at 0.2 ppm; 

sunflower, subgroup 20B at 0.1 ppm; 

and vegetable, fruiting, group 8–10 at 

0.1 ppm. Compliance with these 

tolerances will be determined by 

measuring only pendamethalin [N-(1- 

ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine], and its metabolite, 

4-[(1-ethylpropyl)amino]-2-methyl-3,5- 

dinitrobenzyl alcohol, calculated as the 

stoichiometric equivalent of 

pendimethalin. In addition, this 

regulation removes existing tolerances 

under 40 CFR 180.361 on 

pendimethalin in or on fruit, citrus, 

group 10 at 0.1 ppm; fruit, pome, group 

11 at 0.1 ppm; fruit, stone, group 12 at 

0.1 ppm; garlic at 0.1 ppm; leek at 0.20 

ppm; onion, bulb at 0.1 ppm; onion, 

green at 0.20 ppm; onion, welsh at 0.20 

ppm; shallot at 0.20 ppm; strawberry at 

0.10 ppm; sunflower seed at 0.10 ppm; 

and vegetable, fruiting, group 8 at 0.10 

ppm, as 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 tolerances in this final rule, 

do not require the issuance of a 


wreier-aviles on DSK5TPTVN1PROD with RULES
7546 Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Rules and Regulations 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

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

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

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

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 30, 2015. 

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 § 180.361: 

■ a. Remove the entries for ‘‘fruit, citrus, 

group 10 at 0.1 ppm; fruit, pome, group 

11 at 0.1 ppm; fruit, stone, group 12 at 

0.1 ppm; garlic at 0.1 ppm; leek at 0.20 

ppm; onion, bulb at 0.1 ppm; onion, 

green at 0.20 ppm; onion, welsh at 0.20 

ppm; shallot at 0.20 ppm; strawberry at 

0.10 ppm; sunflower seed at 0.10 ppm; 

and vegetable, fruiting, group 8 at 0.10 

ppm,’’ from the table in paragraph (a). 

■ b. Add alphabetically the 

commodities to the table in paragraph 

(a). 

The additions read as follows: 

§ 180.361 Pendimethalin; tolerance for 

residues. 

(a) General. * * * 

Commodity Parts per 

million 

*******

Berry, low growing subgroup 13–07G ................................................................................................................................................. 0.1 

*******

Fruit, citrus, group 10–10 .................................................................................................................................................................... 0.1 

Fruit, pome, group 11–10 .................................................................................................................................................................... 0.1 

* * * * * * * 

Fruit, stone, group 12–12 .................................................................................................................................................................... 0.1 

* * * * * * * 

Hop, dried cones ................................................................................................................................................................................. 0.1 

* * * * * * * 

Onion, bulb subgroup 3–07A ............................................................................................................................................................... 0.1 

Onion, green subgroup 3–07B ............................................................................................................................................................ 0.2 

* * * * * * * 

Sunflower subgroup 20B ..................................................................................................................................................................... 0.1 

* * * * * * * 

Vegetable, fruiting, group 8–10 ........................................................................................................................................................... 0.1 

*******

* * * * * 

[FR Doc. 2015–02705 Filed 2–10–15; 8:45 am] 

BILLING CODE 6560–50–P 


wreier-aviles on DSK5TPTVN1PROD with RULES
Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Rules and Regulations 7547 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 1, 43 and 63 

[IB Docket No. 04–112; FCC 13–6] 

Reporting Requirements for U.S. 

Providers of International 

Telecommunications Services 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: In this document, the Federal 

Communications Commission 

(Commission) announces that the Office 

of Management and Budget (OMB) has 

approved, for a period of three years, the 

information collection associated with 

the Commission’s Second Report and 

Order, IB Docket No. 04–112, FCC 13– 

6. This document is consistent with the 

Second Report and Order, which stated 

that the Commission would publish a 

document in the Federal Register 

announcing OMB approval and the 

effective date of the requirements. 

DATES: 47 CFR 1.767(l)(2), 43.61, 43.62, 

43.82, 63.10(c)(2) and (4), 63.21(d) and 

63.22(e), published at 78 FR 15615, 

March 12, 2013 are effective on 

February 11, 2015. 

FOR FURTHER INFORMATION CONTACT: For 

additional information contact Cathy 

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

418–2918. 

SUPPLEMENTARY INFORMATION: This 

document announces that, on February 

5, 2015, OMB approved the information 

collection requirements contained in the 

Commission’s Second Report and 

Order, FCC 13–6, published at 78 FR 

15615, March 12, 2013. The OMB 

Control Number is 3060–1156. The 

Commission publishes this document as 

an announcement of the effective date of 

the requirements. If you have any 

comments on the burden estimates 

listed below, or how the Commission 

can improve the collections and reduce 

any burdens caused thereby, please 

contact Cathy Williams, Federal 

Communications Commission, Room 1– 

C823, 445 12th Street SW., Washington, 

DC 20554. Please include the OMB 

Control Number, 3060–1165, in your 

correspondence. The Commission will 

also accept your comments via email at 

PRA@fcc.gov. 

To request materials in accessible 

formats for people with disabilities 

(Braille, large print, electronic files, 

audio format), send an email to fcc504@

fcc.gov or call the Consumer and 

Governmental Affairs Bureau at (202) 

418–0530 (voice), (202) 418–0432 

(TTY). 

Synopsis 

As required by the Paperwork 

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

the FCC is notifying the public that it 

received OMB approval on February 5, 

2015, for the new information collection 

requirements contained in FCC 13–6. 

Under 5 CFR part 1320, an agency 

may not conduct or sponsor a collection 

of information unless it displays a 

current, valid OMB Control Number. 

No person shall be subject to any 

penalty for failing to comply with a 

collection of information subject to the 

Paperwork Reduction Act that does not 

display a current, valid OMB Control 

Number. The OMB Control Number is 

3060–1156. 

The foregoing notice is required by 

the Paperwork Reduction Act of 1995, 

Public Law 104–13, October 1, 1995, 

and 44 U.S.C. 3507. 

The total annual reporting burdens 

and costs for the respondents are as 

follows: 

OMB Control Number: 3060–1156. 

OMB Approval Date: February 5, 

2015. 

OMB Expiration Date: February 28, 

2018. 

Title: 47 CFR 43.62 Annual Reporting 

Requirements for U.S. Providers of 

International Services and Circuits. 

Form Number: N/A. 

Respondents: Business or other forprofit entities. 

Number of Respondents and 

Responses: 2,328 respondents; 2,328 

responses. 

Estimated Time per Response: 2–151 

hours. 

Frequency of Response: Annual 

reporting requirement. 

Obligation to Respond: Required to 

obtain or retain benefits. The statutory 

authority for this information collection 

is contained under Sections 1, 4(i)–4(j), 

11, 201–205, 211, 214, 219, 220, 303(r), 

309 and 403 of the Communications Act 

of 1934, as amended, 47 U.S.C. 151, 

154(i)–154(j), 161, 201–205, 211, 214, 

219–220, 303(r), 309, 403. 

Total Annual Burden: 14,606 hours. 

Total Annual Cost: $2,400. 

Privacy Act Impact Assessment: No 

impact(s). 

Nature and Extent of Confidentiality: 

In general, there is no need for 

confidentiality with this collection of 

information. The Commission, however, 

will allow filing entities to seek 

confidential treatment of their data. 

Needs and Uses: The Federal 

Communications Commission 

(Commission) received approval from 

the Office of Management and Budget 

(OMB) for a revision of OMB Control 

No. 3060–1156. The purpose of the 

revision was to obtain OMB approval of 

the annual reporting requirements 

stipulated under 47 CFR 43.62 which 

requires that entities providing 

international services file annual circuit 

capacity reports and annual traffic and 

revenue reports, in a format set out in 

a Filing Manual. 

Federal Communications Commission. 

Marlene H. Dortch, 

Secretary, Office of the Secretary, Office of 

the Managing Director. 

[FR Doc. 2015–02853 Filed 2–10–15; 8:45 am] 

BILLING CODE 6712–01–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 635 

[Docket No. 120328229–4949–02] 

RIN 0648–XD672 

Atlantic Highly Migratory Species; 

Atlantic Bluefin Tuna Fisheries 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; annual 

adjustment of Atlantic bluefin tuna 

Purse Seine and Reserve category 

quotas. 

SUMMARY: NMFS is adjusting the 

Atlantic bluefin tuna (BFT) Purse Seine 

and Reserve category quotas for 2015, 

based on regulations implementing 

Amendment 7 to the 2006 Consolidated 

Highly Migratory Species Fishery 

Management Plan. 

DATES: Effective February 10, 2015 

through December 31, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Sarah McLaughlin or Brad McHale, 

978–281–9260. 

SUPPLEMENTARY INFORMATION: 

Regulations implemented under the 

authority of the Atlantic Tunas 

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

seq.) and the Magnuson-Stevens Fishery 

Conservation and Management Act 

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

et seq.) governing the harvest of BFT by 

persons and vessels subject to U.S. 

jurisdiction are found at 50 CFR part 

635. Section 635.27 divides the U.S. 

BFT quota recommended by the 


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