Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations 46267 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established an 

MRL for CPPA. 

VIII. Conclusion 

EPA concludes that there is a 

reasonable certainty that no harm will 

result to the U.S. population, including 

infants and children, from aggregate 

exposure to residues of CPPA. 

Therefore, EPA is establishing an 

exemption from the requirement of a 

tolerance for residues of CPPA in or on 

all food commodities when applied as a 

plant growth regulator and used in 

accordance with good agricultural 

practices. 

IX. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the requirement of a 

tolerance 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 exemption from the requirement of 

a 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). 

X. 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: July 9, 2013. 

Steven Bradbury, 

Director, 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. Add § 180.1321to subpart D to read 

as follows: 

§ 180.1321 Complex Polymeric 

Polyhydroxy Acids; exemption from the 

requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for the 

residues of complex polymeric 

polyhydroxy acids in or on all food 

commodities when applied as a plant 

growth regulator and used in 

accordance with good agricultural 

practices. 

[FR Doc. 2013–18185 Filed 7–30–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0304; FRL–9393–5] 

Trifluralin; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of trifluralin in or 

on the oilseed crop group 20. 

Interregional Research Project Number 4 

(IR–4) requested this tolerance under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective July 

31, 2013. Objections and requests for 

hearings must be received on or before 

September 30, 2013, 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–2012–0304, 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 


ehiers on DSK2VPTVN1PROD with RULES
46268 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations 

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 e-CFR 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2012–0304 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 September 30, 2013. 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– 

2012–0304, 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 July 25, 

2012 (77 FR 43562) (FRL–9353–6), 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 2E8011) by IR–4, 500 

College Road East, Suite 201W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.207 be 

amended by establishing tolerances for 

residues of the herbicide trifluralin, 

(alpha, alpha, alpha-trifluoro-2,6- 

dinitro-N,N-dipropyl-p-toluidine), in or 

on oilseed, crop group 20 at 0.05 parts 

per million (ppm). That document 

referenced a summary of the petition 

prepared by Dow AgroSciences, the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for trifluralin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with trifluralin follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

The kidney and the liver are the 

principal target organs for trifluralin in 

rats and dogs. In subchronic oral studies 

liver effects include increased liver 

weights and changes in clinical 

chemistry parameters. Kidney effects 

include decreased kidney weights, 

kidney and bladder tumors, increased 

blood urea nitrogen (BUN), increases in 

total protein, aspartate aminotransferase 

(AST) and lactate dehydrogenase (LDH) 

in the urine. Also, protein 

electrophoresis of urine samples 

showed a1-globulin and a2-globulin. 

Kidney effects also included tubular 

hyaline casts, minimal cortical tubular 


ehiers on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations 46269 

epithelial regeneration, observed 

microscopically, and an increased 

incidence of progressive glomerulonephritis. In dogs exposed to trifluralin 

for 1 year, multifocal cortical tubular 

cytoplasmic pigment deposition was 

noted in the kidneys of both sexes. In 

the subchronic studies, blood effects 

such as lower hemoglobin levels and 

changes in clinical chemistry were 

reported in rats. 

There was qualitative evidence of 

increased susceptibility in the rat 

developmental toxicity study, where 

fetal developmental effects (increased 

resorptions and wavy ribs) occurred in 

the presence of less severe maternal 

effects (decreases in body weight gain, 

clinical signs, and changes in organ 

weights). Also qualitatively, there is an 

indication of increased sensitivity in the 

2-generation reproduction study in the 

rat in that offspring effects (decreased 

fetal, neonatal and litter viability) were 

observed at a dose level where there was 

less severe maternal toxicity (decreased 

body weight, body weight gain and food 

consumption). 

In male rats, trifluralin was associated 

with increased incidence of thyroid 

follicular cell combined adenoma, 

papillary adenoma, cystadenoma, and 

carcinoma tumors. Based on the 

available data, trifluralin has been 

classified as a possible human 

carcinogen. Extensive testing showed, 

however, that trifluralin is neither 

mutagenic nor genotoxic, and does not 

inhibit the polymerization of 

microtubules in mammalian cells. It is 

also not a neurotoxicant and does not 

appear to be an immunotoxicant. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by trifluralin as well as 

the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in the document 

titled ‘‘Trifluralin: Human Health Risk 

Assessment for the Establishment of 

Tolerances on Oilseed Crop Group 20’’ 

pages 43–55 in docket ID number EPA– 

HQ–OPP–2012–0304. 

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 trifluralin used for human 

risk assessment is shown in the 

following Table. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TRIFLURALIN 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 (Females 13–49 

years of age).

NOAEL = 100 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 1.0 mg/ 

kg/day.

aPAD = 1.0 mg/kg/ 

day 

Developmental Toxicity Study Rat. 

LOAEL = 500 mg/kg/day, based on reduced ossification of the 

vertebrae and ribs; thickened, wavy or bent ribs; and increased total litter resorptions. 

Acute dietary (General population including infants and 

children).

No endpoints identified from the available developmental toxicity studies (rat and rabbit) were appropriate for 

an acute dietary assessment for trifluralin in the general population, including infants and children. 

Chronic dietary (All populations) NOAEL= 2.4 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.024 

mg/kg/day.

cPAD = 0.024 mg/ 

kg/day 

Chronic (capsule) Toxicity—Dog. 

LOAEL = 40 mg/kg/day, based on increased frequency of abnormal stool, decreased body weights and body weight 

gains, and decreased erythrocytes and hemoglobin and increased thrombocytes (males). 

Incidental oral short-term (1 to 

30 days).

NOAEL= 10 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 2-generation Reproduction Study in Rats. 

LOAEL = 32.5 mg/kg/day, based on decreased pup weights in 

both generations and increased relative to body liver weights 

in the F2b females. 

Inhalation short-term (1 to 30 

days).

Inhalation study 

NOAEL = 300 mg/ 

kg/day (inhalation 

absorption rate = 

100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 30-Day Inhalation Study—Rat. 

LOAEL = 1000 mg/m3 (270 mg/kg/day), based on increased 

methemoglobin and bilirubin in females and the incidence of 

dyspnea and rufflerd fur in males and females. 


ehiers on DSK2VPTVN1PROD with RULES
46270 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TRIFLURALIN 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 

Cancer (Oral, dermal, inhalation).Classification: Possible Human Carcinogen Q1 * = 2.96 × 10¥3 (mg/kg/day)¥1

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to trifluralin, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

trifluralin tolerances in 40 CFR 180.207. 

EPA assessed dietary exposures from 

trifluralin 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 

trifluralin. In estimating acute dietary 

exposure, EPA used 2003–2008 food 

consumption data from the U.S. 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). As to 

residue levels in food, EPA conducted 

an unrefined assessment using tolerance 

level residues, 100 percent crop treated 

(PCT), and default Dietary Exposure 

Evaluation Model (DEEM) processing 

factors. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used 2003–2008 food consumption 

data from the USDA’s NHANES/ 

WWEIA. As to residue levels in food, 

the chronic dietary exposure and risk 

estimates are somewhat refined and 

assumed tolerance level residues, PCT 

data for some existing uses, and DEEM 

default processing factors. Pesticide 

Data Program (PDP) monitoring data 

were used for carrot, orange, orange 

juice, pepper, potato, and tomato. 

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 

nonlinear 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 determines 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 

trifluralin should be classified as a 

possible human carcinogen and a linear 

approach has been used to quantify 

cancer risk since no mode of action data 

are available. 

The aggregate cancer risk assessment 

for the general U.S. population takes 

into account exposure estimates from 

dietary consumption of trifluralin from 

food, residential and drinking water 

sources. Exposures from residential uses 

are based on the lifetime average daily 

dose and assume an exposure period of 

5 days per year and 50 years of exposure 

in a lifetime. Dietary exposure 

assumptions were quantified using the 

same estimates as discussed in Unit 

III.C.1.ii., Chronic exposure. 

iv. Anticipated residue and PCT 

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

FFDCA authorizes EPA to use available 

data and information on the anticipated 

residue levels of pesticide residues in 

food and the actual levels of pesticide 

residues that have been measured in 

food. If EPA relies on such information, 

EPA must require pursuant to FFDCA 

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

years after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

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

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

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

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

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, 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 average 

PCT for existing uses as follows: 

Almonds: 1%; asparagus: 20%; 

barley: 1%; green bean: 25%; broccoli: 

10%; cabbage: 40%; canola: 2.5%; 

cantaloupe: 25%; carrot: 40%; 

cauliflower: 10%; celery: 2.5%; corn: 

1%; cotton: 30%; cucumber: 2.5%; dry 

bean/pea: 10%; garlic: 5%; grapefruit: 

1%; grape: 2.5%; honeydew: 20%; 

lemon: 1%; onion: 2.5%; orange: 1%; 

peach: 1%; peanut: 5%; pecan: 1%; 

pepper: 25%; pistachio: 2.5%; potato: 

2.5%; pumpkin: 5%; sorghum: 1%; 

soybean: 5%; squash: 5%; sugarbeet: 

2.5%; sugarcane: 5%; sunflower: 10%; 

tomato: 60%; walnut: 1%; watermelon: 

10%; and wheat: 1%. 

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 

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 

one. 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 


ehiers on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations 46271 

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 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 trifluralin 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 trifluralin in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of trifluralin. 

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 

trifluralin and its major degradates TR– 

4 (a,a,a-trifluoro-5-nitro-N4,N4- 

dipropyl-toluene-3,4-diamine), TR–6 (5- 

trifluoromethyl-3-nitro-1,2- 

benzenediamine) and TR–15 (2-ethyl-7- 

nitro-5-(trifluoromethyl) benzimidazole) 

(the residues of concern in drinking 

water) for acute exposures are estimated 

to be 23.83 parts per billion (ppb) for 

surface water and 0.0275 ppb for ground 

water. For chronic exposures for noncancer assessments they are estimated to 

be 1.97 ppb for surface water and 0.0275 

ppb for ground water. And for cancer 

assessments are estimated to be 1.59 

ppb for surface water and 0.0275 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 23.83 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 1.97 ppb was used to assess the 

contribution to drinking water. And for 

cancer dietary risk assessment, the 

water concentration of value 1.59 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). 

Trifluralin is currently registered for 

the following uses that could result in 

residential exposures including 

vegetable gardens, turf, and 

ornamentals. EPA assessed residential 

exposure using the following 

assumptions: EPA evaluated residential 

handler inhalation exposures, which are 

considered short-term in duration. The 

handler assessment did not consider 

dermal exposures because a dermal 

endpoint was not identified; in three 

dermal toxicity studies (21/28 days in 

rabbits; 21/28 days in rats; and 31-days 

in rats), trifluralin was tested up to the 

limit dose (1000 mg/kg/day) and caused 

no systemic toxicity. Handler exposure 

scenarios evaluated include the 

following: 

• Loading/applying granulars with a 

push-type spreader; 

• loading/applying granulars using a 

spoon, measuring scoop, shaker can, or 

via hand; 

• mixing/loading/applying liquids 

with a hose-end sprayer; 

• mixing/loading/applying liquids 

with low pressure handwand sprayer; 

• mixing/loading/applying liquids 

with backpack sprayer; and applying 

trifluralin impregnated fabric squares to 

soil. 

In terms of cancer risk, the Agency 

considers all exposure to trifluralin, 

including the dermal and inhalation 

exposure expected for homeowners, to 

have an associated carcinogenic risk. 

Carcinogenic risk for homeowner 

applicators was assessed based on the 

application methods outlined above. An 

upper-end assumption was made that 

the users assessed will apply trifluralin 

each season, as labeled, with an 

assumed exposure period of 5 days per 

year for 50 years of their life. Specific 

methods (or scenarios) of application 

(spreader, sprayer, etc.) were assessed to 

demonstrate the full range of exposure 

due to method and area treated, 

although users are not expected to use 

one method for 50 years. Carcinogenic 

risk for homeowner applicators was 

assessed by combining dermal exposure 

(adjusted for an estimated 3% 

absorption based on ethalfluralin data) 

and inhalation exposure (100% 

absorption), calculating this exposure 

on a per day basis (‘‘Lifetime Average 

Daily Dose’’, in mg/kg/day), and then 

quantifying risk by multiplying the 

updated upper-bound carcinogenic 

potency factor (Q1*) of 2.96 × 10¥3 (mg/ 

kg/day)¥1 by the combined exposure 

estimate. 

There is the potential for postapplication exposure for individuals 

exposed as a result of being in an 

environment (vegetable garden, golf 

course turf, turf) that has been 

previously treated with trifluralin. All 

residential exposures are considered to 

be short-term in duration (1–30 days). 

No acute dietary or short-term dermal 

points of departure have been selected 

for trifluralin; therefore; only incidental 

oral post-application non-cancer risk 

estimates for children 1<2 years old 

were evaluated. This lifestage is not the 

only lifestage that could be potentially 

exposed for these post-application 

scenarios; however, the assessment of 

this lifestage is health protective for the 

exposures and risk estimates for any 

other potentially exposed lifestage. Noncancer post-application scenarios 

assessed are as follows: Incidental oral 

(hand to mouth, object to mouth, and 

soil ingestion) exposure from granular 

applications to turf. 

Estimated post-application cancer risk 

for the general U.S. population includes 

infants and children; therefore, in 

accordance with Agency policy, a 

children’s cancer risk estimate was not 

reported separately. For postapplication cancer risk, the only adult 

post-application residential scenarios 

that are applicable are the following: 

• Dermal exposure to residues on 

lawns 

• Dermal exposure to golf course turf 

• Dermal exposure in home vegetable 

gardens. 

There may be post-application 

residential exposure scenarios for 

trifluralin which could be combined for 

purposes of an aggregate exposure 

assessment. Combinations for 

residential exposure scenarios should 

have a reasonable probability of 

occurring on a single day and the pest 

that an individual is attempting to 


ehiers on DSK2VPTVN1PROD with RULES
46272 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations 

control must be considered. It is 

reasonable that an adult may treat their 

turf and garden on the same day. 

The worst case residential exposure 

for use in the adult non-cancer aggregate 

assessment reflects residential handler 

inhalation exposure from applying 

granules by hand to pre-plant 

ornamentals. 

The worst case residential exposure 

for use in the children 1<2 years old 

non-cancer aggregate assessment reflects 

hand-to-mouth short-term postapplication exposures from granular 

application to residential turf. 

And lastly, the worst case residential 

exposure for use in the cancer aggregate 

assessment reflects dermal and 

inhalation exposure from loading/ 

applying granules with a belly grinder 

to pre-plant ornamentals. 

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.’’ 

EPA has not found trifluralin to share 

a common mechanism of toxicity with 

any other substances, and trifluralin 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that trifluralin does not have a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

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

cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

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 was qualitative evidence of 

increased susceptibility in the rat 

developmental toxicity study, where 

fetal developmental effects (increased 

resorptions and wavy ribs) occurred in 

the presence of less severe maternal 

effects (decreases in body weight gain, 

clinical signs, and changes in organ 

weights). Also qualitatively, there is an 

indication of increased sensitivity in the 

2-generation reproduction study in the 

rat in that offspring effects (decreased 

fetal, neonatal and litter viability) were 

observed at a dose level where there was 

less severe maternal toxicity (decreased 

body weight, body weight gain and food 

consumption). 

3. Conclusion. EPA has determined 

that the safety of infants and children 

would be adequately protected if the 

FQPA SF were reduced to 1X. This 

determination is based on the following 

findings: 

i. The toxicity database for trifluralin 

is complete except for immunotoxicity 

testing. In the absence of specific 

immunotoxicity studies, EPA has 

evaluated the available trifluralin 

toxicity data to determine whether an 

additional uncertainty factor is needed 

to account or potential immunotoxicity. 

There are no indications in the available 

studies that organs associated with 

immune function, such as the thymus, 

are affected by trifluralin and trifluralin 

does not belong to a class of chemicals 

(e.g., the organotins, heavy metals, or 

halogenated aromatic hydrocarbons) 

that would be expected to be 

immunotoxic. Based on the above 

considerations in this unit, EPA does 

not believe that conducting the 

immunotoxicity study will result in a 

dose less than the point of departure 

already used in this risk assessment, 

and an additional database uncertainty 

factor (UF) for potential immunotoxicity 

does not need to be applied. 

ii. There is no indication that 

trifluralin is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. Although qualitative evidence of 

increased susceptibility was seen in the 

rat developmental toxicity study, and an 

indication of increased sensitivity in the 

2-generation reproduction study in the 

rat in that offspring effects, the concern 

for these effects is low for the following 

reasons: (1) The dose response was well 

characterized; (2) the developmental 

effects were seen in the presence of 

maternal toxicity; (3) clear NOAELs/ 

LOAELs were established for maternal 

and developmental toxicities; and (4) for 

the rats in the 2-generation reproduction 

study, the effects were seen at a highdose level (295 milligrams/kilogram/day 

(mg/kg/day) for males and 337 mg/kg/ 

day for females). Furthermore, offspring 

viability was not adversely affected in 

the two other 2-generation studies with 

trifluralin at dose levels up to 100 and 

148 mg/kg/day. Finally, there are no 

residual uncertainties for pre-natal and 

post-natal toxicity since the doses 

selected for overall risk assessment are 

protective of the effects seen in these 

studies. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute dietary food exposure 

assessment for females 13–49, the 

population identified as having 

potential acute exposure, was performed 

based on 100 PCT and tolerance-level 

residues. The chronic dietary exposure 

and risk estimates are somewhat refined 

and assumed tolerance level residues, 

some PCT data, and DEEM default 

processing factors. Pesticide Data 

Program (PDP) monitoring data were 

used for carrot, orange, orange juice, 

pepper, potato, and tomato. These 

refinements are based on reliable data 

and will not underestimate the exposure 

and risk to any population subgroups. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to trifluralin in drinking water. EPA 

used similarly conservative assumptions 

to assess post-application incidental 

oral exposure of toddlers. These 

assessments will not underestimate the 

exposure and risks posed by trifluralin. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). For 

linear cancer risks, EPA calculates the 

lifetime probability of acquiring cancer 

given the estimated aggregate exposure. 

Short-, intermediate-term, and chronicterm 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 

trifluralin will occupy less than 1% of 

the aPAD for females 13–49 years old, 


ehiers on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations 46273 

the only population subgroup of 

concern. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to trifluralin from 

food and water will utilize less than 1% 

of the cPAD for all population groups. 

Based on the explanation in Unit 

III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of trifluralin 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). 

Trifluralin 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 trifluralin. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 25,000 for adults and 26,000 

for children. Because EPA’s level of 

concern for trifluralin is a MOE of 100 

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, trifluralin 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 

trifluralin. 

5. Aggregate cancer risk for U.S. 

population. The aggregate cancer risk 

estimate from trifluralin residues in 

food, drinking water, and residential 

exposure is 1 × 10¥6. EPA generally 

considers cancer risks (expressed as the 

probability of an increased cancer case) 

in the range of 1 in 1 million (or 1 × 

10¥6) or less to be negligible. 

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 trifluralin 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography (GC) with electron 

capture detection (ECD)) 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). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for trifluralin for the crops addressed in 

this document. 

C. Revisions to Petitioned-For 

Tolerances 

PA has revised the tolerance 

expression to clarify (1) that, as 

provided in FFDCA section 408(a)(3), 

the tolerance covers metabolites and 

degradates of trifluralin not specifically 

mentioned; and (2) 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 trifluralin, including its 

metabolites and degradates, in or on 

oilseed, crop group 20 at 0.05 ppm. 

Compliance with the tolerance level is 

to be determined by only trifluralin 

a,a,a-trifluoro-2,6-dinitro-N,N-dipropylp-toluidine, in or on the oilseed, crop 

group 20. 

Also, due to the establishment of the 

tolerance on oilseed, crop group 20, the 

existing tolerances for rapeseed, seed; 

flax, seed; mustard, seed; sunflower, 

seed; safflower, seed; and cotton 

undelinted seed 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 


ehiers on DSK2VPTVN1PROD with RULES
46274 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations 

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: July 25, 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 § 180.207: 

■ a. Revise the introductory text of 

paragraph (a). 

■ b. Remove the commodities cotton 

undelinted seed; flax, seed; mustard, 

seed; rapeseed, seed; safflower, seed; 

and sunflower, seed in the table in 

paragraph (a). 

■ c. Add alphabetically the following 

commodity to the table in paragraph (a). 

The amendment read as follows: 

§ 180.207 Trifluralin; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of trifluralin, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

following table is to be determined by 

only trifluralin a,a,a-trifluoro-2,6- 

dinitro-N,N-dipropyl-p-toluidine, in or 

on the commodity. 

Commodity Parts per 

million 

* * * * * 

Oilseed, crop group 20 ............... 0.05 

* * * * * 

* * * * * 

[FR Doc. 2013–18420 Filed 7–30–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0439 and EPA–HQ– 

OPP–2012–0514; FRL–9393–6] 

Pyroxasulfone; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pyroxasulfone 

in or on multiple commodities which 

are identified and discussed later in this 

document. K–I Chemical U.S.A., Inc. 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective July 

31, 2013. Objections and requests for 

hearings must be received on or before 

September 30, 2013, 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–2012–0439 and 

EPA–HQ–OPP–2012–0514, 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, 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 e-CFR 

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

40tab_02.tpl. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2012–0439 and EPA–HQ–OPP– 

2012–0514 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 September 30, 2013. Addresses 

for mail and hand delivery of objections 


ehiers on DSK2VPTVN1PROD with RULES