Federal Register / Vol. 76, No. 167 / Monday, August 29, 2011 / Rules and Regulations 53641 

appropriate circuit by October 28, 2011. 

Filing a petition for reconsideration by 

the Administrator of this final rule does 

not affect the finality of this action for 

the purposes of judicial review nor does 

it extend the time within which a 

petition for judicial review may be filed, 

and shall not postpone the effectiveness 

of such rule or action. This action may 

not be challenged later in proceedings to 

enforce its requirements (see section 

307(b)(2)). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen dioxide, Ozone, Particulate 

matter, Reporting and recordkeeping 

requirements, Volatile organic 

compounds. 

Dated: August 8, 2011. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

Part 52, Chapter I, Title 40 of the Code 

of Federal Regulations is amended as 

follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for Part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart F—California 

■ 2. Section 52.220, is amended by 

adding paragraph (c)(388)(i)(B) to read 

as follows: 

§ 52.220 Identification of plan. 

* * * * * 

(c) * * * 

(388) * * * 

(i) * * * 

(B) San Joaquin Valley Air Pollution 

Control District. 

(1) Rule 4354, ‘‘Glass Melting 

Furnaces,’’ amended on September 16, 

2010. 

* * * * * 

[FR Doc. 2011–21940 Filed 8–26–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0583; FRL–8885–1] 

Tetraconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of tetraconazole 

in or on multiple commodities which 

are identified and discussed later in this 

document. In addition, EPA is removing 

the existing grape tolerance because 

grape is now covered under the newly 

established tolerance for small fruit vine 

climbing, except fuzzy kiwifruit, 

subgroup 13–07F. The Interregional 

Research Project Number 4 (IR–4) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

August 29, 2011. Objections and 

requests for hearings must be received 

on or before October 28, 2011, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0583. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Sidney Jackson, Registration Divison, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; e-mail address: 

jackson.sidney@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. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

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://ecfr.gpoaccess.gov/cgi/t/ 

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

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2010–0583 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 October 28, 2011. 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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0583, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 


Emcdonald on DSK2BSOYB1PROD with RULES
53642 Federal Register / Vol. 76, No. 167 / Monday, August 29, 2011 / Rules and Regulations 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of September 

8, 2010 (75 FR 54629) (FRL–8843–3) 

and December 15, 2010 (75 FR 78240) 

(FRL–8853–1), EPA issued notices 

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

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

filing of pesticide petitions (PP) 0E7735 

by Interregional Research Project 

Number 4 (IR–4), IR–4 Project 

Headquarters, 500 College Road East, 

Suite 201 W, Princeton, NJ 08450, and 

(PP) 0F7737 by Isagro S.p.A., 430 Davis 

Drive, Suite 240, Morrisville, NC 27560, 

respectively. The petitions requested 

that 40 CFR 180.557 be amended by 

establishing tolerances for residues of 

the fungicide tetraconazole, 1-[2-(2,4- 

dichlorophenyl)-3-(1,1,2,2- 

tetrafluoroethoxyl)propyl]-1H-1,2,4- 

triazole, in or on small fruit vine 

climbing, except fuzzy kiwifruit, 

subgroup 13–07F at 0.20 parts per 

million (ppm); and low growing berry, 

subgroup 13–07G at 0.25 ppm (0E7735), 

and corn, field, forage; corn field, grain; 

corn, field, stover; corn pop, grain; and 

corn, pop, stover at 1.0, 0.01, 1.5, 0.01 

and 1.5 ppm, respectively (0F7737). 

Each notice referenced a summary of the 

petition prepared by Isagro, USA, the 

registrant, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notices of filing. Based 

upon review of all available data 

supporting the petitions, EPA made the 

following modifications: 

1. Revised the tolerance expression in 

§ 180.557(a), and corrected commodities 

name. 

2. Revised proposed tolerance levels 

for corn, field, forage; corn, field, stover; 

and corn, pop, stover. 

3. EPA is also revising established 

tolerance levels for milk; milk, fat; 

poultry, meat by-products, and fat, liver, 

and meat by-products of cattle, goat, 

horse and sheep based on the proposed 

tolerances and revisions to existing feed 

commodity tolerances. 

4. EPA is removing the existing grape 

tolerance because grape is covered 

under the newly established tolerance 

for small fruit vine climbing, except 

fuzzy kiwifruit, subgroup 13–07F. 

The reasons for these changes are 

explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. * * *’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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 tetraconazole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with tetraconazole 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. 

Tetraconazole has low acute toxicity 

via the oral, dermal, and inhalation 

routes. It is a slight eye irritant, but is 

not a dermal irritant or a dermal 

sensitizer. The liver and kidney are the 

primary target organs of tetraconazole in 

mice, rats and dogs. Toxicity in these 

organs occurred following 28-day, 90- 

day, and 1- to 2-year oral exposures. 

For chronic durations, the dog was 

the most sensitive species, followed by 

the mouse, and then the rat. Chronic 

toxicity in the dog included increased 

absolute and relative kidney weights 

and histopathological changes in the 

male kidney (cortical tubular 

hypertrophy) which were observed at 

the mid-dose. At the high dose, liver 

effects were observed in both sexes. In 

the mouse, effects included increased 

liver weights, hepatocellular 

vacuolization in both sexes, and 

increased kidney weights in males. In 

rats, several effects not related to liver 

and kidney toxicity were observed. 

These included histopathological 

changes of the bone, pale and thickened 

incisors, decreased absolute and relative 

adrenal and pituitary weights in males, 

and decreased body weight (at terminal 

sacrifice) in females. Centrilobular 

hepatocyte hypertrophy was observed in 

the high-dose groups for both sexes in 

this study. 

Oral rat and rabbit prenatal 

developmental studies showed no 

increased quantitative susceptibility of 

the fetus to tetraconazole exposure in 

utero. In the developmental toxicity 

study in rats, the maternal toxicity was 

manifested as decreased body weight 

gain, food consumption, increased water 

intake, increased liver and kidney 

weights. There were developmental 

effects in rats which suggested 

qualitative susceptibility. They 

consisted of increased incidences of 

supernumerary ribs, and increased 

incidences of hydroureter and 

hydronephrosis, which exceeded the 

high end value of the historical control 

range. No developmental toxicity was 

seen in the rabbit study. The sole 

maternal effect in this rabbit study was 

decreased body weight gain which 

occurred at the highest dose tested. 

A 2-generation rat reproduction study 

also revealed no increased quantitative 

susceptibility in offspring. Parental 

toxicity resulted in increased mortality 

in females of the P and F1 generations 

at the mid dose. This increase in 

mortality had a higher incidence at the 

highest dose tested. Effects in parental 

animals that survived the duration of 

the study were consistent with other 

studies in the database including 

decreased body-weight gain and food 

consumption during pre-mating, 

increased relative liver and kidney 

weights, and hepatocellular 

hypertrophy in males and females at the 

lowest-observed adverse-effect levels 

(LOAELs). 

There were signs of neurotoxicity in 

the acute neurotoxicity study. There is 


Emcdonald on DSK2BSOYB1PROD with RULES
Federal Register / Vol. 76, No. 167 / Monday, August 29, 2011 / Rules and Regulations 53643 

no evidence of neurotoxicity in any of 

the other studies in the toxicity database 

for tetraconazole. In the absence of 

specific immunotoxicity studies, EPA 

has evaluated the available 

tetraconazole toxicity database to 

determine whether an additional 

database uncertainty factor (UFDB) is 

needed to account for potential 

immunotoxicity. No evidence of 

immunotoxicity was found. 

There were no systemic effects 

observed in the 21-day dermal toxicity 

study up to the highest dose used. In the 

28-day inhalation study in rats, toxicity 

was observed at the lowest 

concentration/dose. At the highest 

concentration tested, there were 

treatment-related increases in absolute 

lung weights in both sexes. There were 

also treatment-related increases in 

absolute and relative liver weights in 

males. In the kidney, there were 

treatment-related increases in absolute 

and relative kidney and adrenal gland 

weights in females. In females there was 

a treatment-related statisticallysignificant increase in circulating 

globulins at the mid and high 

concentrations. Finally in the kidney, at 

the highest concentration tested, there 

was a 50% increase in the incidence of 

tubular hyaline droplets with features 

characteristic of a-2 microglobulin. This 

was observed only in males, and this 

effect is not considered relevant to 

humans. 

Tetraconazole did not show evidence 

of mutagenicity in in vitro or in vivo 

studies. Carcinogenicity studies with 

tetraconazole resulted in an increased 

incidence of combined benign and 

malignant liver tumors in mice of both 

sexes. In contrast to mice, no tumors 

were noted in male or female rats after 

long-term dietary administration of 

tetraconazole. The Agency classified 

tetraconazole as ‘‘likely to be 

carcinogenic to humans’’ by the oral 

route based on the occurrence of liver 

tumors in male and female mice. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by tetraconazole as well 

as the no-observed-adverse-effect level 

(NOAEL) and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Tetraconazole: Human-Health Risk 

Assessment for Proposed Uses of Small 

Fruit Vine Climbing Subgroup 13–07F, 

Low-Growing Berry Subgroup 13–07G, 

and Field Corn and Popcorn’’ dated 

April 14, 2011 at pages 38–47 in docket 

ID number EPA–HQ–OPP–2010–0583– 

0004. 

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 tetraconazole used for 

human risk assessment is shown in the 

following Table. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TETRACONAZOLE FOR USE IN DIETARY AND NONOCCUPATIONAL HUMAN HEALTH RISK ASSESSMENT

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary (Females 13–50 

years of age).

NOAEL = 22.5 milligrams/kilograms/day (mg/kg/day).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.225 mg/kg/day ......

aPAD = 0.225 mg/kg/day 

Developmental toxicity study in 

rats Developmental LOAEL = 

100 mg/kg/day based on increased incidence of small 

fetuses, supernumerary ribs, 

and hydroureter and hydronephrosis. 

Acute dietary (General population 

including infants and children).

NOAEL = 50 mg/kg/day ...............

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.5 mg/kg/day ..........

aPAD = 0.5 mg/kg/day 

Acute neurotoxicity (rat) LOAEL = 

200 mg/kg/day based on decreased motor activity on day 0 

in both sexes, and clinical signs 

in females including hunched 

posture, decreased defecation, 

and/or red or yellow material on 

various body surfaces. 

Chronic dietary (All populations) .... NOAEL= 0.73 mg/kg/day ..............

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.0073 mg/kg/day

cPAD = 0.0073 mg/kg/day 

Chronic oral toxicity (dog) Developmental LOAEL = 100 mg/kg/ 

day based on absolute and relative kidney weights and 

histopathological changes in the 

male kidney. 

Cancer (Oral, dermal, inhalation) .. Classification: ‘‘Likely to be Carcinogenic to Humans’’ and report cancer slope factor (Q1*) of 2.3 x 10¥2

mg/kg/day derived from the male mouse liver benign and/or malignant combined tumor rates. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference 

dose. MOE = margin of exposure. LOC = level of concern. 


Emcdonald on DSK2BSOYB1PROD with RULES
53644 Federal Register / Vol. 76, No. 167 / Monday, August 29, 2011 / Rules and Regulations 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to tetraconazole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing tetraconazole tolerances in 40 

CFR 180.557. EPA assessed dietary 

exposures from tetraconazole 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 tetraconazole. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA assumed 

tolerance level residues and 100 percent 

crop treated (PCT) for all existing and 

proposed uses. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, the 

chronic analysis (food and water) was 

refined through the incorporation of 

empirical processing factors, average 

field trial residues, average residues 

from the feeding studies, and PCT 

estimates for sugar beet, peanut, field 

corn and soybean. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. If quantitative cancer risk 

assessment is appropriate, cancer risk 

may be quantified using a linear or 

nonlinear approach. If sufficient 

information on the carcinogenic mode 

of action is available, a threshold or 

non-linear approach is used and a 

cancer RfD is calculated based on an 

earlier noncancer key event. If 

carcinogenic mode of action data are not 

available, or if the mode of action data 

determine a mutagenic mode of action, 

a default linear cancer slope factor 

approach is utilized. Based on the data 

summarized in Unit III.A., EPA has 

concluded that tetraconazole should be 

classified as ‘‘Likely to be Carcinogenic 

to Humans’’ and a linear approach has 

been used to quantify cancer risk. The 

cancer analysis (food and water) was 

refined through the incorporation of 

empirical processing factors, average 

field trial residues, average residues 

from the feeding studies, and projected 

PCT estimates for sugar beet, field corn, 

peanut, and soybean. 

iv. Percent crop treated (PCT) 

information. 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. 

The Agency estimated the PCT uses as 

follows: sugarbeet—70%; and peanut— 

77%. 

In most cases, EPA uses available data 

from the 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 

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 estimated the PCT for as 

follows: field corn—9% and soybean at 

5%. 

EPA estimates of the PCT for 

proposed new uses of tetraconazole 

represent the upper bound of use 

expected during the pesticide’s initial 

5 years of registration. Because soybean 

has not been registered for 5 years, the 

Agency has treated it as a new use for 

analyzing PCT. The PCT for new uses 

for use in the chronic dietary 

assessment is calculated as the average 

PCT of the market leader or leaders (i.e., 

the pesticides with the greatest PCT) on 

that site over the three most recent years 

of available data. Comparisons are only 

made among pesticides of the same 

pesticide type (e.g., the market leader 

for fungicides on the use site is selected 

for comparison with a new fungicide). 

The market leader included in the 

estimation may not be the same for each 

year since different pesticides may 

dominate at different times. 

To evaluate whether the PCT estimate 

for tetraconazole could be exceeded, 

EPA considered whether there may be 

unusually high pest pressure, as 

indicated in emergency exemption 

requests for tetraconazole; the pest 

spectrum of the new pesticide in 

comparison with the market leaders and 

whether the market leaders are well 

established for that use; and whether 

pest resistance issues with past market 

leaders provide tetraconazole with 

significant market potential. Given 

currently available information, EPA 

concludes that it is unlikely that actual 

PCT for tetraconazole will exceed the 

estimated PCT for new uses during the 

next 5 years. 

The Agency believes that the three 

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

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which tetraconazole 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 tetraconazole in drinking water. 


Emcdonald on DSK2BSOYB1PROD with RULES
Federal Register / Vol. 76, No. 167 / Monday, August 29, 2011 / Rules and Regulations 53645 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

tetraconazole. 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 (PRZM ver. 3.12.2) and Exposure 

Analysis Modeling System (EXAMS ver. 

2.98.04.06) and Screening Concentration 

in Ground Water (SCI–GROW) models, 

ver. 2.3, the estimated drinking water 

concentrations (EDWCs) of 

tetraconazole for acute exposures are 

estimated to be 10.45 parts per billion 

(ppb) for surface water and 0.40 ppb for 

ground water. Chronic exposures for 

non-cancer assessments are estimated to 

be 4.68 ppb for surface water and 0.40 

ppb for ground water. Chronic 

exposures for cancer assessments are 

estimated to be 3.29 ppb for surface 

water and 0.40 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 10.45 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 4.68 ppb was used to assess the 

contribution to drinking water. For 

cancer dietary risk assessment, the 

water concentration of value 3.29 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). 

Tetraconazole is not registered for any 

specific use patterns that would result 

in residential exposure. 

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.’’ 

Tetraconazole is a member of the 

triazole-containing class of pesticides. 

Although conazoles act similarly in 

plants (fungi) 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 (EPA, 2002). 

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 

evidence 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. 

Triazole-derived pesticides can form 

the common metabolite T and two 

triazole conjugates (TA and TAA). To 

support existing tolerances and to 

establish new tolerances for triazolederivative pesticides, including 

tetraconazole, EPA conducted a humanhealth risk assessment for exposure to T, 

TA, and TAA 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 SF 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 

Identification (ID) Number EPA–HQ– 

OPP–2005–0497, and an update to 

assess the addition of the commodities 

included in this action may be found in 

docket ID EPA–HQ–OPP–2010–0583 in 

the document titled ‘‘Common Triazole 

Metabolites, Updated Aggregate HumanHealth Risk Assessment to address 

tolerance petitions for Tetraconazole’’. 

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. 

There are no residual uncertainties for 

pre- and post-natal toxicity. There is no 

evidence of increased quantitative 

susceptibility of rat or rabbit fetuses to 

in utero exposure to tetraconazole. 

There is evidence of increased 

qualitative susceptibility to fetuses in 

the rat prenatal developmental toxicity 

(increased incidences of supernumary 

ribs, and hydroureter and 

hydronephrosis). The level of concern is 

low however because: 

i. The fetal effects were seen at the 

same dose as the maternal effects. 

ii. A clear NOAEL was established. 

iii. The developmental NOAEL from 

the study in rats is being used as the 

POD for the acute dietary endpoint 

(females 13–49 years of age). 

iv. There were no developmental 

effects in the rabbit study. There is also 

no evidence of increased quantitative or 

qualitative susceptibility to offspring in 

the 2-generation reproduction study. 

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: The 

toxicity database for tetraconazole is 

complete. The EPA has recently 

received an immunotoxicity study for 

tetraconazole. Preliminary review of the 

study shows no evidence of 

immunotoxicity and does not impact 

the selection of endpoints. EPA believes 

the existing data are sufficient for 

endpoint selection for exposure/risk 

assessment scenarios and for evaluation 

of the requirements under the FQPA, 

and an additional safety factor does not 

need to be applied. 

i. There were effects indicative of 

neurotoxicity (motor activity effects) in 

the acute neurotoxicity study in rats. 

However, the level of concern is low for 

the following reasons: 


Emcdonald on DSK2BSOYB1PROD with RULES
53646 Federal Register / Vol. 76, No. 167 / Monday, August 29, 2011 / Rules and Regulations 

• A clear NOAEL was established 

which is being used in endpoint 

selection. 

• Comparison of the LOAELs from 

the acute neurotoxicity and chronic dog 

studies reveal a ∼70-fold difference 

between the effects from the two 

studies, with the chronic effects being 

the more sensitive of the two. 

• Neither of the more severe 

endpoints indicative of neurotoxicity 

(changes in brain weight or 

histopathological changes in the brain 

or nerve processes) were observed in the 

acute neurotoxicity study. Additionally, 

the EPA has recently received a 

subchronic neurotoxicity study for 

tetraconazole. A preliminary review of 

this study shows no signs of 

neurotoxicity. Furthermore, 

neurotoxicity was not seen in any other 

study in the toxicity database for 

tetraconazole. Therefore, there is no 

need for a developmental neurotoxicity 

study or additional UFs to account for 

neurotoxicity. 

ii. There is no evidence that 

tetraconazole results in increased 

quantitative susceptibility in in utero 

rats or rabbits in the prenatal 

developmental studies or in young rats 

in the 2-generation reproduction study. 

There is evidence of increased 

qualitative susceptibility to fetuses in 

the rat prenatal developmental toxicity 

(increased incidences of supernumary 

ribs, and hydroureter and 

hydronephrosis). The level of concern is 

low however because: 

• The fetal effects were seen at the 

same dose as the maternal effects. 

• A clear NOAEL was established. 

• The developmental NOAEL from 

the study in rats is being used as the 

POD for the acute dietary endpoint 

(females 13–49 years of age). 

• There were no developmental 

effects in the rabbit study. There is also 

no evidence of increased quantitative or 

qualitative susceptibility to offspring in 

the 2-generation reproduction study. 

iii. There are no residual uncertainties 

identified for pre- and post-natal 

toxicity in the exposure databases. 

Tolerance-level residues, 100% crop 

treated, and modeled water estimates 

were incorporated into the acute dietary 

exposure analysis. Therefore, the acute 

analysis is highly conservative. The 

chronic and cancer dietary exposure 

analyses utilized empirical processing 

factors, average field trial residues, 

average residues from the feeding 

studies, percent crop treated estimates, 

and modeled drinking water estimates. 

A critical commodity analysis for the 

chronic/cancer runs indicated that more 

than half of the exposure was derived 

from water. The models upon which the 

water estimates were based incorporate 

conservative (protective) assumptions 

with actual concentrations likely to be 

significantly lower. As a result, it can be 

concluded that the chronic/cancer risk 

estimates provided in this document do 

not underestimate the risks posed by 

tetraconazole. 

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 

tetraconazole will occupy 1.8% of the 

aPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to tetraconazole 

from food and water will utilize 5% of 

the cPAD for all infants < 1 year old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for tetraconazole. 

3. Short-term risk and intermediateterm risks. Short-term and intermediateterm aggregate risk takes into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

A short-term and intermediate-term 

adverse effect was identified; however, 

tetraconazole is not registered for any 

use patterns that would result in shortterm or intermediate-term residential 

exposure. Short-term and intermediateterm risk is assessed based on shortterm and intermediate-term residential 

exposure plus chronic dietary exposure. 

Because there is no short-term and 

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 short-term and intermediate-term 

risk), no further assessment of shortterm and intermediate-term risk is 

necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating short-term and intermediateterm risk for tetraconazole. 

4. Aggregate cancer risk for U.S. 

population. Using the exposure 

assumptions described in Unit 

III.C.1.iii., EPA has concluded the 

cancer risk from food and water for all 

existing and proposed tetraconazole 

uses will result in a lifetime cancer risk 

of 3 × 10¥6. A critical commodity 

analysis for the cancer/chronic risk 

assessment indicated that water was the 

major contributor to the estimated 

cancer risk (63% of total exposure). The 

drinking water estimate incorporated 

into the cancer dietary assessment was 

based on models which make 

conservative (protective) assumptions to 

derive a concentration in ground and 

surface water. Actual concentrations are 

likely to be significantly lower. EPA 

generally considers cancer risks in the 

range of 10¥6 or less to be negligible. 

The precision which can be assumed for 

cancer risk estimates is best described 

by rounding to the nearest integral order 

of magnitude on the log scale; for 

example, risks falling between 3 × 10¥7

and 3 × 10¥6 are expressed as risks in 

the range of 10¥6. Considering the 

precision with which cancer hazard can 

be estimated, the conservativeness of 

low-dose linear extrapolation, and the 

rounding procedure described above in 

this unit, cancer risk should generally 

not be assumed to exceed the 

benchmark level of concern of the range 

of 10¥6 until the calculated risk exceeds 

approximately 3 × 10¥6. This is 

particularly the case where some 

conservatism is maintained in the 

exposure assessment. 

5. 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 tetraconazole 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

is available to enforce the tolerance 

expression currently established for 

tetraconazole plant and livestock 

tolerances. As part of the corn petition, 

Isagro submitted adequate method 

validation and independent laboratory 

validation (ILV) data which indicate 

that the QuEChERS multi-residue 

method L 00.00–115 is capable of 

quantifying tetraconazole residues in or 

on a variety of fruit, cereal grain, root, 

oilseed, and livestock commodities 

(note that mean recoveries in or on 

wheat straw were 50–70%). Based on 

these data and since the extraction 


Emcdonald on DSK2BSOYB1PROD with RULES
Federal Register / Vol. 76, No. 167 / Monday, August 29, 2011 / Rules and Regulations 53647 

solvent employed in the QuEChERS 

method is similar to the extraction 

solvent employed in the radiovalidated 

enforcement methods, the Agency 

concludes that the QuEChERS method 

is adequate for enforcement of 

established tolerances. 

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 U.N. 

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 no Canadian or Codex 

maximum residue limits (MRLs) 

established for tetraconazole. 

C. Revisions to Petitioned-For 

Tolerances 

After completing review of the current 

tetraconazole database and utilizing the 

Agency’s tolerance spreadsheet (see 

Guidance for Setting Tolerances Based 

on Field Trial Data SOP (August 2009 

version)), EPA revised, added or deleted 

tolerances, or otherwise modified the 

tolerance levels proposed in the notices 

of filing. EPA is removing the existing 

grape tolerance because grape is covered 

under the newly established tolerance 

for small fruit vine climbing, except 

fuzzy kiwifruit, subgroup 13–07F. The 

Agency corrected listings of certain 

commodity names and replaced them 

with the preferred commodity terms. In 

addition, the Agency revised existing 

tolerance levels for tetraconazole 

residues in or on certain livestock 

commodities and established the 

following tolerances: Cattle, fat at 0.15 

ppm; cattle, liver at 1.5 ppm; cattle, 

meat by-products, except liver at 0.15 

ppm; goat, fat at 0.15 ppm; goat, liver at 

1.50 ppm; goat, meat by-product, except 

liver at 0.15 ppm; horse, fat at 0.15 ppm; 

horse, liver at 1.50 ppm; horse, meat byproducts, except liver at 0.15 ppm; milk 

at 0.03 ppm; milk, fat at 0.75 ppm; 

poultry, meat by-products at 0.05 ppm; 

sheep, fat at 0.15 ppm; sheep, liver at 

1.50 ppm; and sheep, meat by-products, 

except liver at 0.15 ppm. Using 

resources defined above in this section, 

the Agency revised tolerance levels for 

livestock commodities because of 

increased livestock dietary exposure as 

a result of newly established corn 

tolerances and to take into account all 

tetraconazole residues in animal feed 

commodities. 

Finally, the Agency is modifying the 

tolerance expression for tetraconazole to 

clarify that, as provided in FFDCA 

section 408(a)(3), the tolerance covers 

metabolites and degradates of 

tetraconazole not specifically 

mentioned; and that compliance with 

the specified tolerance levels is to be 

determined by measuring only the 

specific compounds mentioned in the 

tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of tetraconazole, including 

its metabolites and degradates, in or on 

the commodities listed in the Table 

below under § 180.557. Compliance 

with the following tolerance levels is to 

be determined by measuring only 

tetraconazole (1-[2-(2,4-dichlorophenyl)- 

3-(1,1,2,2-tetrafluoroethoxy)propyl]-1H1,2,4-triazole). 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to petitions submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104–4). 

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), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 


Emcdonald on DSK2BSOYB1PROD with RULES
53648 Federal Register / Vol. 76, No. 167 / Monday, August 29, 2011 / Rules and Regulations 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 18, 2011. 

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. Section 180.557 is amended by: 

■ i. Revising the introductory text in 

paragraph (a); 

■ ii. Removing the commodity ‘‘Grape’’ 

from the table in paragraph (a); 

■ iii. Revising the tolerance level for 

these commodities: ‘‘Cattle, fat’’ ‘‘Cattle, 

liver’’ ‘‘Cattle, meat byproducts, except 

liver’’ ‘‘Goat, fat’’ ‘‘Goat, liver’’ ‘‘Goat, 

meat byproducts, except liver’’ ‘‘Horse, 

fat’’ ‘‘Horse, liver’’ ‘‘Horse, meat 

byproducts, except liver’’ ‘‘Milk’’ ‘‘Milk, 

fat’’ ‘‘Poultry, meat byproducts’’ ‘‘Sheep, 

fat’’ ‘‘Sheep, liver’’ and ‘‘Sheep, meat 

byproducts, except liver’’ in the table in 

paragraph (a); and 

■ iv. Alphabetically adding the 

following commodities: ‘‘Corn, field, 

forage’’ ‘‘Corn, field, grain’’ ‘‘Corn, field, 

stover’’ ‘‘Corn, pop, grain’’ ‘‘Corn, pop 

stover’’ ‘‘Low growing berry subgroup 

13–07G, except cranberry;’’ and ‘‘Small 

fruit vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F’’ to the table 

in paragraph (a) to read as follows: 

§ 180.557 Tetraconazole; Tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of tetraconazole, 

including its metabolites and 

degradates, in or on the commodities 

listed below. Compliance with the 

following tolerance levels is to be 

determined by measuring only 

tetraconazole (1-[2-(2,4-dichlorophenyl)- 

3-(1,1,2,2-tetrafluoroethoxy)propyl]-1H1,2,4-triazole), in or on the following 

commodities. 

Commodity Parts per 

million 

*****

Cattle, fat .................................... 0 .15 

Cattle, liver .................................. 1 .50 

Commodity Parts per 

million 

*****

Cattle, meat byproducts, except 

liver .......................................... 0 .15 

Corn, field, forage ....................... 1 .1 

Corn, field, grain ......................... 0 .01 

Corn, field, stover ....................... 1 .7 

Corn, pop, grain .......................... 0 .01 

Corn, pop, stover ........................ 1 .7 

Goat, fat ...................................... 0 .15 

Goat, liver ................................... 1 .50 

*****

Goat, meat byproducts, except 

liver .......................................... 0 .15 

Horse, fat .................................... 0 .15 

Horse, liver ................................. 1 .50 

*****

Horse, meat byproducts, except 

liver .......................................... 0 .15 

Low growing berry subgroup 13– 

07G, except cranberry ............ 0 .25 

Milk ............................................. 0 .03 

Milk, fat ....................................... 0 .75 

*****

Poultry, meat byproducts ............ 0 .05 

*****

Sheep, fat ................................... 0 .15 

Sheep, liver ................................. 1 .50 

*****

Sheep, meat byproducts, except 

liver .......................................... 0 .15 

Small fruit vine climbing, except 

fuzzy kiwifruit, subgroup 13– 

07F .......................................... 0 .20 

*****

* * * * * 

[FR Doc. 2011–21947 Filed 8–26–11; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Part 571 

[Docket No. NHTSA–2008–0149] 

RIN 2127–AK25 

Federal Motor Vehicle Safety 

Standards: Occupant Crash Protection 

AGENCY: National Highway Traffic 

Safety Administration (NHTSA), 

Department of Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: This final rule amends the 

Federal motor vehicle safety standard 

(FMVSS) on occupant crash protection 

to remove the sunset of a requirement 

that a vehicle’s lap belt must be 

lockable, without the use of special 

tools, to tightly secure a child restraint 

system (CRS). We refer to this as the 

‘‘lockability’’ requirement. Under the 

current standard, the lockability 

requirement ceases to apply to seating 

positions that are equipped with a child 

restraint anchorage system (commonly 

referred to as a ‘‘LATCH’’ system) on 

vehicles manufactured on or after 

September 1, 2012. Because data 

indicate that motorists are still using 

lockable belts to install CRSs even in 

seating positions with LATCH, there is 

a continuing need for the lockability 

requirement even in seating positions 

with LATCH. Thus, this final rule 

ensures that the lockability requirement 

continues in effect for all seating 

positions past September 1, 2012. 

DATES: Effective date: The final rule is 

effective December 27, 2011. Petitions 

for reconsideration of the final rule must 

be received not later than October 13, 

2011. 

ADDRESSES: Any petitions for 

reconsideration should refer to the 

docket number of this document and be 

submitted to: Administrator, National 

Highway Traffic Safety Administration, 

U.S. Department of Transportation, 1200 

New Jersey Avenue, SE., West Building, 

Washington, DC 20590. 

FOR FURTHER INFORMATION CONTACT: For 

non-legal issues, you may call Ms. Carla 

Rush, Office of Crashworthiness 

Standards, Light Duty Vehicle Division 

(Phone: 202–366–4583; fax: 202–493– 

2739). For legal issues, you may call Mr. 

Thomas Healy, Office of the Chief 

Counsel (Phone: 202–366–2992; fax: 

202–366–3820). You may send mail to 

these officials at: National Highway 

Traffic Safety Administration, 1200 New 

Jersey Avenue, SE., Washington, DC 

20590. 

SUPPLEMENTARY INFORMATION: This final 

rule amends FMVSS No. 208 to retain 

the lockability requirement, which is 

slated to sunset September 1, 2012. The 

agency is issuing this final rule because 

data indicate that motorists are still 

using vehicle belts to a large degree to 

attach CRSs to the vehicle seats. The 

NPRM preceding this final rule was 

published September 12, 2008 (73 FR 

52939, Docket No. NHTSA–2008–0149). 

I. Background 

On October 13, 1993, NHTSA 

amended FMVSS No. 208, Occupant 

Crash Protection, to require all 

passenger cars, trucks, buses, and 


Emcdonald on DSK2BSOYB1PROD with RULES