Federal Register / Vol. 78, No. 221 / Friday, November 15, 2013 / Rules and Regulations 68741 

Issued in Washington, DC, on this day of 

November 12, 2013. 

Judith Starr, 

General Counsel, Pension Benefit Guaranty 

Corporation. 

[FR Doc. 2013–27385 Filed 11–14–13; 8:45 am] 

BILLING CODE 7709–02–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0427; FRL–9392–1] 

Tebuconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of tebuconazole 

in or on the fruiting vegetable group 8– 

10 and amends the existing tolerances 

for barley grain and the cucurbit 

vegetable group 9. Interregional 

Research Project Number 4 (IR–4) 

requested this tolerance and amendment 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 15, 2013. Objections and 

requests for hearings must be received 

on or before January 14, 2014, 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–2012–0427, 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), EPA West 

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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; 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 eCFR 

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–2012–0427 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before January 14, 2014. 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– 

2012–0427, 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.htm. 

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 August 22, 

2012 (77 FR 50661) (FRL–9358–9), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 2E8012) by Interregional 

Research Project Number 4 (IR–4), 500 

College Road East, Suite 201W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.474 be 

amended by establishing tolerances for 

residues of the fungicide tebuconazole, 

alpha-[2-(4-chlorophenyl)ethyl]-alpha- 

(1,1-dimethylethyl)-1H-1,2,4-triazole-1- 

ethanol, including its metabolites and 

degradates, in or on barley, grain at 0.3 

parts per million (ppm); vegetable, 

cucurbit group 9 at 0.4 ppm; and 

vegetable, fruiting group 8–10 at 1.3 

ppm. The petition also requested the 

removal of the established tolerance, in 

or on vegetable, fruiting, group 8 at 1.3 

ppm once the proposed tolerance for 

vegetable, fruiting group 8–10 at 1.3 

ppm, has been established since the 

proposed new tolerance will supersede 

the existing tolerance. That document 

referenced a summary of the petition 

prepared by Bayer CropScience, 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 


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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 tebuconazole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with tebuconazole 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. 

Tebuconazole has low acute toxicity 

by the oral and dermal routes of 

exposure and moderate toxicity by the 

inhalation route. It is not a dermal 

sensitizer nor a dermal irritant; 

however, it is slightly to mildly 

irritating to the eye. The primary target 

organs of tebuconazole toxicity are the 

liver, the adrenals, the hematopoietic 

system, and the nervous system. Effects 

on these target organs were seen in both 

rodent and non-rodent species. In 

addition, ocular lesions were seen in 

dogs (including lenticular degeneration 

and increased cataract formation) 

following subchronic or chronic 

exposure. 

Oral administration of tebuconazole 

caused developmental toxicity in all 

species evaluated (rat, rabbit and 

mouse), with the most prominent effects 

in the nervous system. The 

developmental toxicity studies, 

including the developmental 

neurotoxicity study, demonstrated an 

increase in susceptibility in developing 

fetuses both quantitatively and 

qualitatively. 

Tebuconazole was classified as a 

Group C possible human carcinogen, 

based on an increase in the incidence of 

hepatocellular adenomas, carcinomas, 

and combined adenomas/carcinomas in 

male and female mice. This 

classification is generally used for 

chemicals with limited evidence of 

carcinogenicity in animals in the 

absence of human data. EPA has 

determined that quantification of risk 

using a non-linear approach, i.e., 

reference dose (RfD), for tebuconazole 

will adequately account for all chronic 

toxicity, including carcinogenicity, that 

could result from exposure to 

tebuconazole. That conclusion is based 

on the following considerations: (1) No 

carcinogenic response was seen in 

either sex in an acceptable rat cancer 

study; (2) the tumors found in the 

mouse are commonly seen in the mouse; 

(3) both tumors types were found only 

at the high dose, which was considered 

to be excessive for carcinogenicity 

testing based on the non-neoplastic 

findings; and (4) tebuconazole is not 

mutagenic. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by tebuconazole 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 docket ID 

number EPA–HQ–OPP–2012–0427 on 

pages 33–36 of the document titled 

‘‘Tebuconazole: Human Health Risk 

Assessment for Tolerance Increases 

Based on Submission of Condition of 

Registration Requirements for Barley 

and Cantaloupe; and Crop Group 

Expansion for Fruiting Vegetable Crop 

Group 8–10.’’ 

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://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for tebuconazole used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TEBUCONAZOLE 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 (General 

population including infants and children).

LOAEL = 8.8 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF (UFL) = 3x 

Acute RfD = 0.029 mg/

kg/day.

aPAD = 0.029 mg/kg/

day 

Developmental Neurotoxicity Study—Rat. LOAEL = 8.8 mg/kg/

day based on decreases in body weights, absolute brain 

weights, brain measurements and motor activity in offspring. 

Chronic dietary (All populations).LOAEL = 8.8 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF (UFL) = 3x 

Chronic RfD = 0.029 mg/

kg/day.

cPAD = 0.029 mg/kg/day 

Developmental Neurotoxicity Study—Rat. LOAEL = 8.8 mg/kg/

day based on decreases in body weights, absolute brain 

weights, brain measurements and motor activity in offspring. 

Incidental oral short-term 

(1 to 30 days).

LOAEL = 8.8 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF (UFL) = 3x 

LOC for MOE = 300 ...... Developmental Neurotoxicity Study—Rat. LOAEL = 8.8 mg/kg/

day based on decreases in body weights, absolute brain 

weights, brain measurements and motor activity in offspring. 


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

ASSESSMENT—Continued 

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Dermal short-term (1 to 

30 days).

Oral study LOAEL = 

8.8mg/kg/day (dermal 

absorption rate = 13%.

UFA = 10x 

UFH = 10x 

FQPA SF (UFL ) = 3x 

LOC for MOE = 300 ...... Developmental Neurotoxicity Study—Rat. LOAEL = 8.8 mg/kg/

day based on decreases in body weights, absolute brain 

weights, brain measurements and motor activity in offspring. 

Inhalation short-term (1 

to 30 days).

Oral study LOAEL = 8.8 

mg/kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF (UFL) = 3x 

LOC for MOE = 300 ...... Developmental Neurotoxicity Study—Rat. LOAEL = 8.8 mg/kg/

day based on decreases in body weights, absolute brain 

weights, brain measurements and motor activity in offspring. 

Cancer (Oral, dermal, inhalation).Classification: Group C- possible human carcinogen based on statistically significant increase in the incidence of 

hepatocellular adenoma, carcinoma, and combined adenoma/carcinomas in both sexes of NMRI mice. The chronic 

risk assessment is considered to be protective of any cancer effects; therefore, a separate 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). UFL = use of a LOAEL to extrapolate a NOAEL. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to tebuconazole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing tebuconzole tolerances in 40 

CFR 180.474. EPA assessed dietary 

exposures from tebuconazole 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 

tebuconazole. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat in America, (NHANES/WWEIA). As 

to residue levels in food, a somewhat 

refined, acute probabilistic dietary 

exposure assessment was conducted for 

all existing food uses of tebuconazole. 

EPA assumed tolerance levels residues 

for some commodities and used field 

trial and USDA PDP data for others. 

EPA also assumed 100% crop treated 

levels for most commodities and used 

percent crop treated (PCT) data for other 

commodities as described in Unit 

III.C.1.iv. below. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the food 

consumption data from the 2003–2008 

NHANES/WWEIA. As to residue levels 

in food, a somewhat refined chronic 

dietary exposure assessment was 

conducted for all existing food uses of 

tebuconazole. EPA assumed tolerance 

levels residues for some commodities 

and used field trial and USDA PDP data 

for others. EPA also assumed 100% crop 

treated levels for most commodities and 

used PCT data for other commodities as 

described in Unit III.C.1.iv. below. 

iii. Cancer. The Agency determined 

that cancer dietary risk concerns due to 

long-term consumption of tebuconazole 

residues are adequately addressed by 

the chronic dietary exposure analysis 

using the reference dose; i.e., the 

chronic dietary risk assessment is 

considered to be protective of any 

cancer effects, and therefore, a separate 

cancer dietary exposure analysis was 

not performed. 

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 CallIns 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, 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. 

For the acute assessment, the Agency 

estimated the PCT for existing uses as 

follows: 

Grapes: 25%; grape, raisin: 25%; 

nectarine: 25%; peach: 20%; peanuts: 

45%. 

For the chronic assessment, the 

Agency estimated the PCT for existing 

uses as follows: 

Grapes: 15%; grape, raisin: 15%; 

nectarine: 20%; peach: 15%; peanuts: 

35%. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 


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recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 1. 

In those cases, 1% is used as the average 

PCT and 2.5% is used as the maximum 

PCT. EPA uses a maximum PCT for 

acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency also used 2006 PCT 

information for tebuconazole on the 

following uses for the acute dietary 

assessment (apples, 44%; apricots 56%; 

cherries, (babyfood), 42%; cherries (all 

other food forms), 100%; corn, sweet, 

22%; hops 64%; plum 26%; turnip 

68%) and for the chronic dietary 

assessment (apples, 41%; apricots, 43%; 

cherries, (babyfood), 37%; cherries (all 

other food forms), 66%; corn, sweet, 

14%; hops, 64%; plum, 24%; turnip, 

44%). For further explanation of EPA’s 

process for developing these PCT 

estimates, see the 2011 final rule for 

tebuconazole tolerances (76 FR 54127) 

(August 31, 2011) and its supporting 

documents. 

Subsequently, EPA considered the 

maximum and average PCT estimates 

for tebuconazole from the most recent 

(2011) screening level usage analysis 

available. Based on that information, 

EPA concludes that its risk assessments 

do not underestimate the overall actual 

PCT for uses of tebuconazole or 

exposure from the use of tebuconazole. 

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 tebuconazole 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 tebuconazole in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

tebuconazole. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

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

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

tebuconazole for acute exposures are 

estimated to be 96.6 parts per billion 

(ppb) for surface water and 1.56 ppb for 

ground water and for chronic exposures 

are estimated to be 59 ppb for surface 

water and 1.56 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For the 

acute dietary risk assessment a 

distribution of 30-year daily surface 

water concentrations was estimated for 

the EDWCs of tebuconazole. For chronic 

dietary risk assessment, the water 

concentration of value 59 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). 

Tebuconazole is currently registered 

for the following uses that could result 

in residential exposures: Turf, flower 

gardens, trees, ornamentals, and 

pressure-treated wood. EPA assessed 

residential exposure using the following 

assumptions: For residential handlers, 

exposure is expected to be short-term. 

Intermediate-term exposures are not 

likely because of the intermittent nature 

of applications by homeowners. Dermal 

and inhalation exposures were 

combined since the same endpoint and 

point of departure (POD) is used for 

both routes of exposure. Residential 

dermal and incidental oral postapplication exposure was assessed for 

adults and children golfing, working in 

gardens, and performing physical 

activities on pressure-treated wood after 

application of tebuconazole may receive 

exposure to tebuconazole residues. Postapplication exposure is expected to be 

short-term in duration. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at 

http://www.epa.gov/pesticides/trac/

science/trac6a05.pdf. 

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.’’ 

Tebuconazole is a member of the 

triazole-containing class of pesticides, 

the conazoles. Although conazoles act 

similarly in plants by inhibiting 

ergosterol biosynthesis, there is not 

necessarily a relationship between their 

pesticidal activity and their mechanism 

of toxicity in mammals. Structural 

similarities do not constitute a common 

mechanism of toxicity. Evidence is 

needed to establish that the chemicals 

operate by the same, or essentially the 

same, sequence of major biochemical 

events. In conazoles, however, a 

variable pattern of toxicological 

responses is found; some are 

hepatotoxic and hepatocarcinogenic in 

mice. Some induce thyroid tumors in 

rats. Some induce developmental, 

reproductive, and neurological effects in 

rodents. Furthermore, the conazoles 

produce a diverse range of biochemical 

events, including altered cholesterol 

levels, stress responses, and altered 

DNA methylation. It is not clearly 

understood whether these biochemical 

events are directly connected to their 

toxicological outcomes. Thus, there is 

currently no conclusive data to indicate 

that conazoles share common 

mechanisms of toxicity and EPA is not 

following a cumulative risk approach 

based on a common mechanism of 

toxicity for the conazoles. For 

information regarding EPA’s procedures 

for cumulating effects from substances 

found to have a common mechanism of 

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

www.epa.gov/pesticides/cumulative. 

Tebuconazole is a triazole-derived 

pesticide. This class of compounds can 

form the common metabolite 1,2,4- 

triazole and two triazole conjugates 

(triazolylalanine and triazolylacetic 

acid). To support existing tolerances 

and to establish new tolerances for 


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triazole-derivative pesticides, including 

tebuconazole, EPA conducted a human 

health risk assessment for exposure to 

1,2,4-triazole, triazolylalanine, and 

triazolylacetic acid resulting from the 

use of all current and pending uses of 

any triazole-derived fungicide. The risk 

assessment is a highly conservative, 

screening-level evaluation in terms of 

hazards associated with common 

metabolites (e.g., use of a maximum 

combination of uncertainty factors) and 

potential dietary and non-dietary 

exposures (i.e., high end estimates of 

both dietary and non-dietary exposures). 

In addition, the Agency retained the 

additional 10X FQPA safety factor for 

the protection of infants and children. 

The assessment includes evaluations of 

risks for various subgroups, including 

those comprised of infants and children. 

The Agency’s complete risk assessment 

is found in the propiconazole 

reregistration docket at http://

www.regulations.gov, docket ID number 

EPA–HQ–OPP–2005–0497. 

An updated dietary exposure and risk 

analysis for the common triazole 

metabolites 1,2,4-triazole (T), 

triazolylalanine (TA), triazolylacetic 

acid (TAA), and triazolylpyruvic acid 

(TP) was conducted and completed in 

May 2013, in association with a 

registration request for several other 

triazole fungicides. That analysis 

concluded that risk estimates were 

below the Agency’s level of concern for 

all population groups. After addition of 

tolerances associated with this action to 

the exposure analyses, the increased 

tolerances for tebuconazole in/on 

barley, grain and vegetables, cucurbits, 

group 9 along with the crop group 

conversion covered by this action do not 

significantly http://www.regulations.gov 

by searching for the following titles and 

docket numbers: ‘‘Common Triazole 

Metabolites: Updated Aggregate Human 

Health Risk Assessment to Address The 

New Section 3 Registrations For Use of 

Prothioconazole on Bushberry Crop 

Subgroup 13–07B, Low Growing Berry, 

Except Strawberry, Crop Subgroup 13– 

07H, and Cucurbit Vegetables Crop 

Group 9; Use of Flutriafol on Coffee; and 

Ipconazole on Crop Group 6’’ (located in 

docket ID number EPA–HQ–OPP–2012– 

0876); ‘‘Common Triazole Metabolites: 

Updated Dietary (Food + Water) 

Exposure and Risk Assessment to 

Address the Revised Tolerance for 

Residues of Fenbuconazole in Peppers’’ 

(docket ID number EPA–HQ–OPP– 

2012–0520). 

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. 

The toxicity database for tebuconazole 

includes prenatal developmental 

toxicity studies in three species (mouse, 

rat, and rabbit), a reproductive toxicity 

study in rats, acute and subchronic 

neurotoxicity studies in rats, and a 

developmental neurotoxicity study in 

rats. The data from prenatal 

developmental toxicity studies in mice 

and a developmental neurotoxicity 

study in rats indicated an increased 

quantitative and qualitative 

susceptibility following in utero 

exposure to tebuconazole. The NOAELs/ 

LOAELs for developmental toxicity in 

these studies were found at dose levels 

less than those that induce maternal 

toxicity or in the presence of slight 

maternal toxicity. There was no 

indication of increased quantitative 

susceptibility in the rat and rabbit 

developmental toxicity studies, the 

NOAELs for developmental toxicity 

were comparable to or higher than the 

NOAELs for maternal toxicity. In all 

three species, however, there was 

indication of increased qualitative 

susceptibility. For most studies, 

minimal maternal toxicity was seen at 

the LOAEL (consisting of increases in 

hematological findings in mice, 

increased liver weights in rabbits and 

rats, and decreased body weight gain/

food consumption in rats) and did not 

increase substantially in severity at 

higher doses. However, there was more 

concern for the developmental effects at 

each LOAEL, which included increases 

in runts, increased fetal loss, and 

malformations in mice; increased 

skeletal variations in rats; and increased 

fetal loss and frank malformations in 

rabbits. Additionally, more severe 

developmental effects (including frank 

malformations) were seen at higher 

doses in mice, rats and rabbits. In the 

developmental neurotoxicity study, 

maternal toxicity was seen only at the 

high dose (decreased body weights, 

body weight gains, and food 

consumption, prolonged gestation with 

mortality, and increased number of dead 

fetuses), while offspring toxicity 

(including decreases in body weight, 

brain weight, brain measurements and 

functional activities) was seen at all 

doses. 

Available data indicated greater 

sensitivity of the developing organism 

to exposure to tebuconazole, as 

demonstrated by increases in qualitative 

sensitivity in prenatal developmental 

toxicity studies in rats, mice, and 

rabbits, and by increases in both 

qualitative and quantitative sensitivity 

in the developmental neurotoxicity 

study in rats with tebuconazole. 

However, the degree of concern is low 

because the toxic endpoints in the 

prenatal developmental toxicity studies 

were well characterized with clear 

NOAELs established and the most 

sensitive endpoint, which is found in 

the developmental neurotoxicity study, 

has been used for overall risk 

assessments. Therefore, there are no 

residual uncertainties for prenatal and/ 

or postnatal susceptibility. 

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 3x. That decision is 

based on the following findings: 

i. The toxicity database for 

tebuconazole is considered complete. 

An immunotoxicity study in rats has 

been submitted to the Agency and the 

study is currently under review. With 

preliminary evaluation, tebuconazole 

tested up to 1,000 ppm (78.4 

milligrams/kilogram/day (mg/kg/day) 

produced no immunotoxicity under the 

conditions of this study. 

ii. Tebuconazole demonstrated 

neurotoxicity in the acute neurotoxicity 

study in rats; the LOAEL of 100 mg/kg/ 

day was based on increased motor 

activity in male and female rats and 

decreased footsplay in female rats. 

Malformations indicative of nervous 

system development disruption were 

seen in developmental toxicity studies 

in mice, rats, and rabbits. Neurotoxicity 

was also seen in offspring in the 

developmental neurotoxicity study in 

rats. The LOAEL of 8.8 mg/kg/day was 

based on decreases in body weights, 

decreases in absolute brain weights, 

changes in brain morphometric 

parameters, and decreases in motor 

activity. A NOAEL could not be 

established. However, the LOAEL (8.8 

mg/kg/day) was employed as the point 

of departure in assessing the risk for all 

exposure scenarios, and the FQPA SF is 

retained as a UFL (i.e., use of a LOAEL 

to extrapolate a NOAEL). A Benchmark 

Dose (BMD) analysis of the datasets 

relevant to the adverse offspring effects 


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(decreased body weight and brain 

weight) seen at the LOAEL in the DNT 

study was conducted. All of the BMDLs 

(benchmark dose limit) modeled 

successfully on statistically significant 

effects are 1–2X lower than the LOAEL. 

The results also indicate that an 

extrapolated NOAEL is not likely to be 

10X lower than the LOAEL and that use 

of an UFL of 3X would not 

underestimate risk. Therefore, the 

analysis supports reducing the UFL from 

10X to 3X. Using an UFL of 3X in risk 

assessment (8.8 mg/kg/day ÷ 3x = 2.9 

mg/kg/day) is further supported by 

other studies in the tebuconazole 

toxicity database: Those studies with 

the lowest NOAELs were a 

developmental toxicity study in mice at 

3 mg/kg/day and a chronic toxicity 

study in dogs at 2.9 mg/kg/day, with 

effects being seen at respective LOAELs 

of 10 and 4.5 mg/kg/day. 

iii. Although there is qualitative 

evidence of increased susceptibility in 

the prenatal developmental studies in 

rats, the Agency did not identify any 

residual uncertainties after establishing 

toxicity endpoints and traditional UFs 

to be used in the risk assessment of 

tebuconazole. The degree of concern for 

residual uncertainties for prenatal and/ 

or postnatal toxicity is low. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

EPA utilized a tiered approach in 

estimating exposure to tebuconazole. 

While some refinements were 

incorporated into dietary and residential 

exposure calculations, EPA is confident 

that the aggregate risk from exposure to 

tebuconazole in food, water and 

residential pathways will not be 

underestimated. The acute and chronic 

dietary exposure assessments 

incorporated refined estimates of 

residues in food commodities from 

reliable field trial data reflecting 

maximum use conditions, recent 

monitoring data from USDA’s Pesticide 

Data Program (PDP), and relevant 

market survey data on the percentage of 

crops treated. Estimated concentrations 

of tebuconazole in drinking water were 

incorporated into the chronic dietary 

analysis as the upper bound point 

estimate and into the probabilistic acute 

dietary analysis as a distribution. For 

the residential exposure pathway 

(ornamentals, golf course turf, and 

treated wood products), potential 

exposure resulting from tebuconazole 

outdoor uses in the residential setting 

was assessed using screening-level 

inputs that assumes an adult or child 

will come in contact with turf and other 

surfaces immediately after application. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

tebuconazole will occupy 55% of the 

aPAD for children 12 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 tebuconazole 

from food and water will utilize 14% 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 tebuconazole 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). 

Tebuconazole 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 tebuconazole. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined chronic food, water, and 

short-term residential exposures result 

in aggregate MOEs of 1,500 for adult 

handlers; 400 for children 11–16 years 

old (post-application); 360 for children 

6–11 years old (post-application); 310 

for adults (post-application); and 330 for 

children 3–5 years old (postapplication). Because EPA’s level of 

concern for tebuconazole is a MOE of 

300 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, tebuconazole 

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 

tebuconazole. 

5. Aggregate cancer risk for U.S. 

population. Tebuconazole has been 

classified as a possible human 

carcinogen based on statistically 

significant increase in the incidence of 

hepatocellular adenoma, carcinoma, and 

combined adenoma/carcinomas in both 

sexes of NMRI mice. The Agency has 

determined that the chronic risk 

assessment is considered to be 

protective of any cancer effects; 

therefore, a separate quantitative cancer 

risk assessment is not required 

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 tebuconazole 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(Gas Chromatography/Nitrogen 

Phosphorus Detector (GC/NPD)) is 

available to enforce the tolerance 

expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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


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Federal Register / Vol. 78, No. 221 / Friday, November 15, 2013 / Rules and Regulations 68747 

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. 

Codex MRLs have been established 

for residues of tebuconazole in or on 

barley grain at 2 ppm. The Codex MRLs 

are based on field trials conducted in 

Europe with a maximum of two foliar 

applications and a pre-harvest interval 

(PHI) of 28 days. The U.S. tolerance of 

0.3 ppm for barley grain is based on 

field trials conducted in the U.S. and 

Canada on barley as a single application 

with a 30-day PHI. The U.S. use pattern 

has a total seasonal application rate 

25% of that of Europe. This explains the 

large difference in the recommended 

U.S. tolerance and the Codex MRL, and 

thus, harmonization is not possible. 

Codex MRLs are established on 

cucumber (0.15 ppm), summer squash 

(0.2 ppm), and melons (except 

watermelon) (0.15 ppm), which are 

crops included in EPA crop group 

vegetable, cucurbit, group 9. The Codex 

MRLs are based on field trials 

conducted in Europe with a maximum 

of four foliar applications and a PHI of 

3 days for cucumbers and squash and 7 

days for melon. The U.S. tolerance for 

vegetable, cucurbit, group 9 is based on 

field trials conducted in the U.S. on 

cucumber, summer squash, and melons 

where tebuconazole was applied three 

times with a 2–8 day PHI. A tolerance 

of 0.4 ppm is recommended for cucurbit 

vegetables using the OECD statistical 

calculation procedures. Harmonization 

cannot be achieved since Codex MRLs 

are established on individual crops 

rather than on crop groups and have 

lower MRLs. 

Codex MRLs are established for sweet 

peppers (1 ppm), and tomatoes (0.7 

ppm), which are crops included in 

EPA’s crop grouping of vegetable, 

fruiting, group 8–10. The Codex MRLs 

are based on field trials conducted in 

Europe with a maximum of three foliar 

applications and a PHI of 3–7 days. The 

U.S. tolerance (1.3 ppm) was based on 

field trials conducted in the U.S. on bell 

peppers, non-bell peppers, and tomatoes 

where tebuconazole was applied as six 

broadcast foliar applications with a 6– 

7 day PHI. Harmonization cannot be 

achieved since Codex MRLs are 

established on individual crops rather 

than on crop groups and have lower 

MRLs. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of tebuconazole, alpha-[2- 

(4-chlorophenyl)ethyl]-alpha-(1,1- 

dimethylethyl)-1H-1,2,4-triazole-1- 

ethanol, including its metabolites and 

degradates, in or on the vegetable, 

fruiting group 8–10 at 1.3 ppm. The 

existing tolerance for barley, grain is 

modified from 0.15 ppm to 0.3 ppm; 

and the existing tolerance for vegetable, 

cucurbit group 9 is modified from 0.09 

ppm to 0.4 ppm. Also, due to the 

establishment of the crop group 

tolerance for the vegetable, fruiting, 

group 8–10, the existing tolerances on 

okra and the vegetable, fruiting, group 8 

are removed as unnecessary. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: October 30, 2013. 

Lois Rossi, 

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 § 180.474, the table in paragraph 

(a) is amended by: 

■ a. Revising the entries for ‘‘Barley, 

grain’’, and ‘‘Vegetable, cucurbit, group 

9.’’ 

■ b. Removing the entries for ‘‘Okra’’ 

and ‘‘Vegetable, fruiting, group 8.’’ 


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68748 Federal Register / Vol. 78, No. 221 / Friday, November 15, 2013 / Rules and Regulations 

1 73 FR 58887 (Oct. 8, 2008) (Docket No. NHTSA– 

2008–0059). 

■ c. Adding alphabetically the 

commodity ‘‘Vegetable, fruiting, group 

8–10.’’ 

The amendments read as follows: 

§ 180.474 Tebuconazole; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

*****

Barley, grain ............................. 0.3 

*****

Vegetable, cucurbit, group 9 .... 0.4 

Vegetable, fruiting, group 8–10 1.3 

*****

* * * * * 

[FR Doc. 2013–27147 Filed 11–14–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Part 571 

[Docket No. NHTSA–2009–0189] 

RIN 2127–AL13 

Federal Motor Vehicle Safety 

Standards; Designated Seating 

Positions 

AGENCY: National Highway Traffic 

Safety Administration (NHTSA), 

Department of Transportation. 

ACTION: Final rule; response to petitions 

for reconsideration. 

SUMMARY: This document completes the 

agency’s response to petitions for 

reconsideration of an October 2008 final 

rule that amended the definition of the 

term, ‘‘designated seating position,’’ as 

used in the Federal motor vehicle safety 

standards, to facilitate the determination 

of which areas within the interior of a 

vehicle meet that definition. The final 

rule made the new definition applicable 

to vehicles manufactured on and after 

September 1, 2010. Previously, the 

agency granted petitions requesting one 

year of additional lead time until the 

new definition became applicable, 

removal the portion of the regulatory 

text stating that State tort law 

requirements are preempted, and 

technical corrections. This final rule 

addresses the remaining issues raised in 

the petitions for reconsideration and 

makes clarifying changes to the manner 

in which designated seating positions 

are measured. We are also including 

technical corrections addressing sidefacing seats and longer seating surfaces. 

DATES: The effective date of this final 

rule is December 16, 2013. 

Petitions for reconsideration must be 

received not later than December 30, 

2013. 

ADDRESSES: Petitions must be submitted 

to: Administrator, National Highway 

Traffic Safety Administration, 1200 New 

Jersey Avenue SE., Washington, DC 

20590. 

FOR FURTHER INFORMATION CONTACT: For 

non-legal issues, you may contact Louis 

Molino of the NHTSA Office of 

Crashworthiness Standards by 

telephone at (202) 366–1740, and by fax 

at (202) 493–2739. 

For legal issues, you may contact 

David Jasinski of the NHTSA Office of 

Chief Counsel by telephone at (202) 

366–2992, and by fax at (202) 366–3820. 

You may send mail to both of these 

officials at the National Highway Traffic 

Safety Administration, 1200 New Jersey 

Avenue SE., Washington, DC 20590. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

II. Petitions for Reconsideration 

III. Analysis of Petitions for Reconsideration 

A. Definition of DSP 

B. Analysis of Safety Problem 

C. Seating Surface Measuring Procedure 

1. Determination of the ‘‘Front Leading 

Surface’’ 

2. Determination of Seating Surface Width 

3. Interior Trim at the Seating Surface 

Outer Edges 

4. Seating Surface Interrupted by Interior 

Trim 

5. Voids and Seat Separation 

6. H-Point Interruptions 

7. Folding, Removable, and Adjustable 

Seats 

8. Closely Adjoining Seat Belt Buckles 

D. Calculating the Number of DSPs 

E. Consumer Information Label 

F. SAE J1100 

G. Technical Correction for Side-Facing 

Seats 

IV. Rulemaking Analyses and Notices 

I. Background 

On October 8, 2008, NHTSA 

published in the Federal Register a final 

rule (October 2008 final rule) revising 

the definition of ‘‘designated seating 

position’’ (DSP), as that term is used in 

the Federal motor vehicle safety 

standards (FMVSS), and providing a 

calculation procedure for determining 

the number of seating positions at a seat 

location.1 The revised definition 

specifies more clearly the areas within 

the interior of a vehicle that are 

regarded as being designated seating 

positions for trucks, multipurpose 

passenger vehicles, passenger cars, and 

buses. The rule also established a 

calculation procedure for determining 

the number of DSPs at a seat location for 

trucks and multipurpose passenger 

vehicles with a gross vehicle weight 

rating less than 4,536 kilograms (10,000 

pounds), passenger cars, and buses. 

The designation of a seating position 

has important safety consequences. 

Under the FMVSSs, motor vehicle 

manufacturers must meet various 

performance requirements for each 

interior location designated as a seating 

position. For example, FMVSS No. 208, 

Occupant Crash Protection, requires 

that each DSP in a light vehicle be 

provided with the appropriate occupant 

crash protection system (e.g., air bag, 

seat belts or both). Clarity in the 

definition of DSP is important for the 

purposes of that standard because if a 

vehicle has fewer DSPs than the number 

of individuals able to sit in it, one or 

more of those individuals would not be 

protected by seat belts and/or other 

crash protection systems. 

In the October 2008 final rule, the 

agency stated that the revised definition 

of ‘‘designated seating position’’ added 

clarity to the existing definition and was 

not expected to have a substantial 

impact on current vehicle designs. The 

degree to which seat designs exhibited 

the characteristics that gave rise to the 

agency’s concerns had significantly 

lessened in the fleet. Manufacturers had 

either reduced the width of the seating 

area to more accurately reflect the 

intended occupancy or had provided 

additional DSPs. 

The October 2008 final rule noted that 

the inclusion of auxiliary seats in the 

definition of ‘‘designated seating 

position’’ and the newly established 

procedure for determining the number 

of DSPs would require minor redesign 

of a small number of vehicles. To allow 

manufacturers the opportunity to make 

such redesigns, the agency provided 

approximately two years of lead time, 

such that, on September 1, 2010, all 

vehicles would need to comply with the 

new requirements. 

II. Petitions for Reconsideration 

We received ten petitions for 

reconsideration of the October 2008 

final rule. The petitioners are SAE 

International (SAE), BMW North 

America (BMW), the Alliance of 


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