Federal Register / Vol. 79, No. 29 / Wednesday, February 12, 2014 / Rules and Regulations 8301 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 27, 2014. 

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 § 180.132, revise the introductory 

text of paragraph (a) and revise the entry 

for ‘‘Strawberry’’ in the table in 

paragraph (a) to read as follows: 

§ 180.132 Thiram; tolerances for residues. 

(a) General. Tolerances for residues of 

the fungicide thiram (tetramethyl 

thiuram disulfide), including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified is to be determined by 

measuring only thiram. 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

* * * * * 

Strawberry ........ 20 None. 

* * * * * 

[FR Doc. 2014–03074 Filed 2–11–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0791; FRL–9905–22] 

Linuron; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of linuron in or 

on multiple commodities which are 

identified and discussed later in this 

document. This regulation additionally 

removes a tolerance with regional 

registrations in or on parsley leaves, as 

it will be superseded by a tolerance 

without regional registrations. IR–4 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

February 12, 2014. Objections and 

requests for hearings must be received 

on or before April 14, 2014, and must 

be filed in accordance with 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–2012–0791, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s 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–2012–0791 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before April 14, 2014. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 


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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– 

2012–0791, 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 November 

7, 2012 (77 FR 66781) (FRL–9367–5), 

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 2E8083) by IR–4, 

500 College Road East, Suite 201 W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.184 be 

amended by establishing tolerances for 

residues of the herbicide linuron, 3-(3,4- 

dichlorophenyl)-1-methoxy-1- 

methylurea), and its metabolites, in or 

on cilantro, dried leaves at 27 parts per 

million (ppm); cilantro, fresh leaves at 

3 ppm; dillweed, dried leaves at 7.1 

ppm; dillweed, fresh leaves at 1.5 ppm; 

dill oil at 4.8 ppm; dill seed at 0.3 ppm; 

horseradish at 0.050 ppm; parsley, dried 

leaves at 8.3 ppm; parsley leaves at 3 

ppm; and pea, dry, seed at 0.08 ppm. 

The petition additionally requested to 

delete the regional tolerance in 40 CFR 

180.184(c) for residues of linuron in or 

on parsley, leaves at 0.25 ppm upon 

approval of the requested tolerances for 

parsley leaves. That document 

referenced a summary of the petition 

prepared on behalf of IR–4 by Syngenta 

Crop Protection, LLC, the registrant, 

which is available in the docket, 

http://www.regulations.gov. Comments 

were received on the notice of filing. 

EPA’s response to these comments is 

discussed in Unit IV.C. 

Subsequent to the publication of the 

November 7, 2012 Federal Register 

notice, the petitioner submitted a 

second petition, in which it requested 

again the same tolerances noticed in the 

November 7, 2012 Federal Register 

document and added a new request for 

a tolerance for residues of linuron and 

its metabolites in or on coriander seed 

at 0.01 ppm. So, in the Federal Register 

of July 19, 2013 (78 FR 43115) (FRL– 

9392–9), EPA issued another document 

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

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

of a pesticide petition (PP 2E8083) by 

IR–4, seeking tolerances for 

commodities as noted in the November 

7, 2012 document as well as a tolerance 

for coriander seed at 0.01 ppm. That 

document referenced a summary of the 

petition prepared on behalf of IR–4 by 

Syngenta Crop Protection, LLC, the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the tolerances for several proposed 

commodities. The Agency has also 

determined that the tolerance 

expression should be revised for all 

commodities. The reasons for these 

changes are explained in Unit IV.D. 

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 linuron including 

exposure resulting from the tolerances 

established by this action. EPA’s 

assessment of exposures and risks 

associated with linuron 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. 

With repeated dosing in test animals, 

linuron produces two primary effects: 

(1) Changes in the hematopoetic system 

in rats, mice, and dogs and; (2) changes 

in the male reproductive system in 

developing rats. Lowest observed 

adverse effect levels (LOAELs) for 

hematological effects produced by 

linuron were substantially lower than 

LOAELs for reproductive effects. Dogs 

were shown to be most sensitive to the 

hematological effects, including 

hemolytic anemia characterized by 

slightly reduced hemoglobin, 

hematocrit, and erythrocyte counts 

accompanied by hemosiderin 

deposition in liver Kupffer cells. 

Secondary erythropogenic activity 

(erythroid hyperplasia of bone marrow) 

was also found. Systemic toxicity 

observed in mice included increased 

methemoglobin formation, vacuolation 

and hemosiderosis of the spleen, and 

decreased erythrocyte counts. In the 

chronic rat study, microscopic 

observations consistent with hemolysis 

(hemosiderin in Kupffer cells and 

increased hemosiderosis in bone 

marrow, spleen, and/or mesenteric 

lymph nodes) were found. 

The rat developmental study showed 

increased post-implantation loss, fetal 

resorptions, decreased litter size, and 

decreased fetal body weight. In the 

rabbit developmental toxicity study, an 

increased incidence of fetuses with 

skeletal skull variations was found. In 

the 2-generation reproductive toxicity 

study, rats exposed to linuron during 

both development and adulthood had 

gross lesions of the testes (including 

reduction in size); abnormally soft and 

small epididymides, deformities of the 

epididymides, decreased pup survival, 

decreased weanling body weights, 

decreased liver and kidney weights; and 

increased incidence of offspring liver 

atrophy. 


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The developmental effects on the 

reproductive system seen in the 

guideline studies are consistent with 

those reported in the published 

literature, though it should be noted that 

most of the literature studies employed 

dose levels of 100 milligrams/kilogram 

(mg/kg) or greater. The available data 

indicate that linuron inhibits 

transcriptional activity of 

dihydrotestosterone (DHT), human 

androgen receptor (hAR) in vitro, and 

steroidogenic enzymes. Additional 

findings indicate that linuron exposure 

decreases anogenital distance; may 

increase retention of areole/nipples in 

male rat offspring following in utero 

exposure; increases luteinizing hormone 

(LH) levels in F0 and F1 male rats; 

reduces the size of androgen dependent 

tissues such as seminal vesicles, 

epididymis, and ventral prostate; and 

demonstrates a weak affinity for 

androgen receptors, which may decrease 

fetal testosterone synthesis (Refs 1, 2, 3, 

and 4). At this time, linuron has not 

been demonstrated to be an estrogen 

receptor antagonist (Ref 5). It should be 

emphasized that the toxicity endpoints 

based on the hematological effects for 

chronic exposures were derived from 

the chronic oral toxicity study in dogs. 

The point of departure (POD) for 

hematological effects was approximately 

40X lower than the LOAEL that caused 

the testicular effects seen in the rat 

reproduction toxicity study. 

In rat and mouse carcinogenicity 

studies, linuron induced interstitial cell 

adenomas in the testes of rats and 

hepatocellular adenomas in mice. In a 

special study with aged rats, linuron 

induced hyperplasia and adenomas of 

the testes within 6 to 12 months. 

However, EPA has concluded that 

quantification of cancer risk is not 

necessary because both interstitial cell 

adenomas and hepatocellular adenomas 

were benign and show no progression 

towards malignancy. In addition, 

linuron was not mutagenic in bacteria or 

in cultured mammalian cells. There was 

also no indication of a clastogenic effect 

up to toxic doses in vivo. Finally, the 

cRFD is a NOAEL of 0.77 mg/kg/day, 

which would be protective of any 

tumors caused by linuron in the rat and 

mouse carcinogenicity study at higher 

doses. 

At the highest dose tested, the acute 

neurotoxicity study demonstrated that 

linuron produced changes in the 

parameters of the field observation 

battery (FOB). These changes included 

rats holding their heads low, crusty 

deposits on the nose, impaired mobility, 

ataxia, low arousal, decreased rearing, 

no reaction to tail pinch or startle, 

decreased righting reflex, reduced or no 

hindlimb extensor strength, decreased 

grip strength in both hindlimbs and 

forelimbs, reduced rotarod performance, 

decreased hindlimb footsplay, and 

increased catalepsy. At the lowestobserved-adverse-effect-level (LOAEL), 

linuron produced decreases in motor 

activity and rearing. No compoundrelated changes in neurohistopathology 

were observed at any of the tested dose 

levels. In addition, linuron did not show 

any signs of immunotoxicity in the 

submitted immunotoxicity study up to 

the highest dose tested. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by linuron 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: 

‘‘Linuron: Section 3 Human Health Risk 

Assessment for Proposed Use on 

Coriander, Dill, Horseradish, Parsley, 

Celeriac, Rhubarb, and Pea (Dry).’’ at 

pages 33–38 in docket ID number EPA– 

HQ–OPP–2012–0791. References for the 

published toxicity studies cited in this 

section may be found Unit VI. 

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 linuron used 

for human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR LINURON 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 = 12 mg/

kg/day 

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Acute RfD = 0.12 

mg/kg/day 

aPAD = 0.12 mg/

kg/day 

Rat Developmental Toxicity. 

LOAEL = 50 mg/kg/day based on increased post-implantation loss and fetal/litter resorptions. 

Acute dietary (General population including infants and children).NOAEL = 20 mg/

kg/day.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Acute RfD = 0.2 

mg/kg/day.

aPAD = 0.2 mg/kg/

day 

Acute Neurotoxicity Study (Rat). 

LOAEL = 100 mg/kg based on decreases in rearing and in 

motor activity. 

Chronic dietary (All populations) ............ NOAEL= 0.77 mg/

kg/day.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Chronic RfD = 

0.0077 mg/kg/

day.

cPAD = 0.0077 

mg/kg/day 

Chronic Oral Dog Study. 

LOAEL = 3.5 mg/kg/day based on hematological effects 

(increased met- and sulf-hemoglobin levels). 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR LINURON 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) ........... Quantification of human cancer risk is not necessary for reasons stated in Unit III.A. 

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

milligrams/kilogram/day. 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 linuron, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing linuron 

tolerances in 40 CFR 180.184. EPA 

assessed dietary exposures from linuron 

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 linuron. In estimating acute dietary 

exposure, EPA used Dietary Exposure 

Evaluation Model software with the 

Food Commodity Intake Database 

(DEEM–FCID) Version 3.16, which uses 

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) from 

2003 through 2008. As to residue levels 

in food, EPA utilized tolerance-level 

residues, DEEM (Ver. 7.81) default 

processing factors as necessary, and 100 

percent crop treated (PCT) for all 

commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment. EPA used the food 

consumption data from the USDA’s 

2003–2008 NHANES/WWEIA. As to 

residue levels in food, EPA used 

tolerance-level residues for all 

commodities, and DEEM default 

processing factors. The Agency utilized 

average PCT estimates, when available, 

and 100 PCT for all other commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that a cancer exposure 

assessment is not necessary. 

iv. Anticipated residue and 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 average 

PCT for existing uses for use in the 

chronic dietary assessment as follows: 

Asparagus, 25%; carrots, 85%; celery, 

25%; corn, 1.0%; cotton, 1.0%; 

potatoes, 5.0%; sorghum, 1.0%; 

soybeans, 1.0%; sweet corn, 1.0%; and 

wheat, 1.0%. 

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 

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 linuron 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 linuron in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of linuron. 

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 Pesticide 

Root Zone Model Ground Water (PRZM 

GW), the estimated drinking water 

concentrations (EDWCs) of linuron for 

surface water are estimated to be 89.05 

parts per billion (ppb) for acute 

exposures and 48.69 ppb for chronic 

exposures for non-cancer assessments. 

The EDWCs of linuron for groundwater 

are estimated to be 48.8 ppb for acute 


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and chronic exposures for non-cancer 

assessments. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 89.05 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 48.8 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). Linuron 

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.’’ EPA has not 

found linuron to share a common 

mechanism of toxicity with any other 

substances, and linuron does not appear 

to produce a toxic metabolite produced 

by other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that linuron 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. 

The following acceptable studies are 

available to assess the prenatal and 

postnatal sensitivity to linuron: rat and 

rabbit developmental toxicity studies, a 

2-generation rat reproductive toxicity 

study, and a 3-generation rat 

reproductive toxicity study. There is no 

qualitative or quantitative evidence of 

increased susceptibility of rabbits in the 

developmental study; developmental 

effects were seen at a dose higher than 

those causing maternal toxicity. In the 

rat developmental study, increases in 

post-implantation losses and increases 

in fetal resorptions/litter were seen at a 

dose that caused decreases in maternal 

body weight and food consumption. 

Since increases in resorptions were 

marginal and there was no change in the 

number of live fetuses to corroborate the 

increases in post-implantation losses, 

these effects were not indicative of 

qualitative evidence of susceptibility. 

There was no quantitative evidence of 

susceptibility in either the 2-generation 

or the 3-generation reproduction 

studies. In the 2-generation study, 

reduced body weight gains of pups were 

seen at the same dose that caused 

decreases in parental body weights. In 

the 3-generation study, offspring effects 

including deceased pup survival and 

pup body weight were seen a dose (44 

mg/kg/day) higher than the dose that 

caused decreases in body weight gain in 

the parental animals (9 mg/kg/day). 

However, when reproductive effects 

were examined, testicular atrophy was 

seen at the same dose (45 mg/kg/day) in 

both studies. In both studies, while the 

F0 males were not affected, testicular 

lesions and reduced fertility were seen 

in the F1 males. This effect in the F1 

males is an indication of qualitative 

evidence of susceptibility. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for linuron is 

complete. 

ii. In an acute neurotoxicity study, 

FOB findings of impaired mobility, 

alterations in gait, lack of coordination, 

lowered body temperature, no reaction 

to stimuli, low arousal, and decreases in 

motor activity were seen at the time of 

peak effect (7 hours post dosing) on 

study day 0. These observations were 

mostly seen in the 500 mg/kg group and 

no pathological changes were found in 

nervous system tissues. A clear NOAEL 

(20 mg/kg/day) was established, and 

this NOAEL was approximately 2–26X 

greater than most PODs selected for risk 

assessment. The nervous system was not 

a target organ for linuron. The 

requirement of a subchronic 

neurotoxicity study was waived by the 

Agency because the target systems for 

linuron toxicity are the hematopoietic 

and endocrine systems and not the 

nervous system as shown by all 

available/required toxicity studies. 

There is no need for a developmental 

neurotoxicity study because linuron 

affects testes and hematological 

parameters but did not produce an 

increased susceptibility in young rats. 

Therefore, the concern for neurotoxicity 

is low, and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that linuron 

results in increased susceptibility in in 

utero rats or rabbits in the prenatal 

developmental studies. While increased 

qualitative susceptibility was identified 

from the reproductive findings in the 2- 

generation and 3-generation rat toxicity 

studies, clear NOAELs were established 

for the effects on the reproductive 

system. Furthermore, the point of 

departure (POD) selected for assessment 

of chronic effects, is approximately 40X 

lower than the LOAEL that caused the 

testicular effects seen in the rat 

reproduction toxicity study; therefore, 

EPA considers the PODs for risk 

assessment to be protective of the effects 

seen on the male reproductive system 

and an additional safety factor to 

account for this qualitative 

susceptibility is not necessary. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on tolerance-level 

residues, 100 PCT for the acute 

assessment and average PCT for 

available commodities in the chronic 

dietary assessment. EPA made 

conservative (protective) assumptions in 

the ground-water and surface water 

modeling used to assess exposure to 

linuron in drinking water. These 

assessments will not underestimate the 

exposure and risks posed by linuron. 

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 


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8306 Federal Register / Vol. 79, No. 29 / Wednesday, February 12, 2014 / Rules and Regulations 

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 linuron 

will occupy 10% of the aPAD for all 

infants less than 1 year old, the most 

highly exposed U.S. population 

subgroup; and 5.7% of the aPAD for 

females 13–49 years old. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to linuron from 

food and water will utilize 60% of the 

cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for linuron. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Short- and 

intermediate-term adverse effects were 

identified; however, linuron is not 

registered for any use patterns that 

would result in short- or intermediateterm residential exposure. Short- and 

intermediate-term risk is assessed based 

on short- and intermediate-term 

residential exposure plus chronic 

dietary exposure. Because there are no 

short- or intermediate-term residential 

exposures 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- or intermediate-term risks), 

no further assessments of short- or 

intermediate-term risk are necessary, 

and EPA relies on the chronic dietary 

risk assessment for evaluating the shortand intermediate-term risks for linuron. 

4. Aggregate cancer risk for U.S. 

population. Based on the discussion of 

carcinogenicity for linuron in Unit 

III.A., EPA has concluded that the cPAD 

is protective of possible cancer effects. 

Given the results of the chronic risk 

assessment, EPA has concluded that 

linuron does not pose a cancer risk. 

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 linuron 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

Method ABC–68406–M, is available to 

enforce the tolerance expression. This 

method involves reflux of crop samples 

in strong base to hydrolyze residues of 

linuron and its metabolites to 3,4-DCA, 

which is analyzed using gas 

chromatography/mass spectrometry 

(GC/MS). 

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 linuron. 

C. Response to Comments 

EPA received one comment to the 

notice of filing from November 7, 2012 

which opposed the use of linuron on 

any food. The commenter expressed a 

general opposition to the use of ‘‘toxic 

chemicals’’ on food and further noted 

that ‘‘red blood cells are harmed in 

animals from this toxic chemical.’’ The 

Agency understands the commenter’s 

concerns and recognizes that some 

individuals believe that certain 

pesticide chemicals should not be 

permitted in our food. However, the 

existing legal framework provided by 

section 408 of the FFDCA states that 

tolerances may be set when the 

pesticide meets the safety standard 

imposed by that statute. The Agency is 

required by Section 408 of the FFDCA 

to estimate the risk of the potential 

exposure to these residues. EPA has 

concluded, based on data submitted in 

support of the petition and other 

reliable data, that there is a reasonable 

certainty that no harm will result from 

aggregate human exposure to linuron 

residues from these uses. The points of 

departure selected for risk assessment 

are protective of any effects on the 

hematopoietic system, including red 

blood cells. Additionally, testing 

requirements for pesticide tolerances 

have been specified by rulemaking after 

allowing for notice and comment by the 

public and peer review by appropriate 

scientific bodies. See 40 CFR part 158 

for further information. 

D. Revisions to Petitioned-for 

Tolerances 

Based on the data supporting the 

petition, EPA has revised the proposed 

tolerances for several commodities, as 

follows: Cilantro, dried leaves from 27 

ppm to 10 ppm; dillweed, dried leaves 

from 7.1 ppm to 5.0 ppm; dill, seed from 

0.3 ppm to 0.5 ppm; dill, oil from 4.8 

ppm to 2.0 ppm; parsley, leaves from 

3.0 ppm to 4.0 ppm; parsley, dried 

leaves from 8.3 ppm to 9.0 ppm; and 

pea, dry, seed from 0.08 ppm to 0.09 

ppm. The Agency revised the cilantro, 

fresh leaves; dillweed, fresh leaves, and 

pea, dry seed tolerance levels based on 

analysis of the residue field trial data 

using the Organization for Economic 

Cooperation and Development (OECD) 

tolerance calculation procedures. Due to 

a limited number of field trials, EPA 

used the formula of 5X the mean in 

order to establish tolerance levels for 

coriander, seed; dill, seed; and parsley, 

leaves. Finally, for the dried herbs 

(cilantro, dillweed, and parsley) and dill 

oil, the formula of the highest average 

field trial (HAFT), multiplied by the 

concentration factor was used to 

calculate the recommended tolerance 

levels for these commodities. These 

concentration factors were derived from 

dividing the average dried or oil 

commodity residue by the average fresh 

commodity residue. Based on this 

calculation method, all four tolerance 

levels were decreased. 

Finally, the Agency has revised the 

tolerance expression to clarify (1) that, 

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

the tolerance covers metabolites and 

degradates of linuron not specifically 

mentioned; and (2) that compliance 

with the specified tolerance levels is to 

be determined by measuring only 

residues of linuron convertible to 3,4- 

dichloroaniline. 

V. Conclusion 

Therefore, tolerances are established 

for residues of linuron, 3-(3,4- 

dichlorophenyl)-1-methoxy-1- 

methylurea), and its metabolites, in or 

on cilantro, fresh leaves at 3.0 ppm; 

cilantro, dried leaves at 10 ppm; 

coriander, seed at 0.01 ppm; dillweed, 

fresh leaves at 1.5 ppm; dillweed, dried 


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Federal Register / Vol. 79, No. 29 / Wednesday, February 12, 2014 / Rules and Regulations 8307 

leaves at 5.0 ppm; dill, seed at 0.5 ppm; 

dill, oil at 2.0 ppm; horseradish at 0.05 

ppm; parsley, leaves at 4.0 ppm; 

parsley, dried leaves at 9.0 ppm; and 

pea, dry, seed at 0.09 ppm. The 

regulation additionally removes the 

tolerance in or on parsley, leaves at 0.25 

ppm from 40 CFR 180.184(c). 

VI. References 

The following literature was 

referenced in the preamble of this 

document. 

1. Gray, L; Wolf, C; Lambright, C; Mann, P; 

Price, M; Cooper, R; Ostby, J. 1999. 

Administration of potentially 

antiandrogenic pesticides (procymidone, 

linuron, iprodione, chlozolinate, p,p’- 

DDE, and ketoconazole) and toxic 

substances (dibutyl- and diethylhexyl 

phthalate, PCB 169, and ethane 

dimethane sulphonate) during sexual 

differentiation produces diverse profiles 

of reproductive malformations in the 

male rat. Toxicol Ind Health, 15 (1– 

2):94–118. 

2. Hotchkiss, A; Parks-Saldutti, L; Ostby, J; 

Lambright, C; Furr, J; Vandenbergh, J; & 

Gray, L. 2004. A mixture of the 

‘‘antiandrogens’’ linuron and butyl 

benzyl phthalate alters sexual 

differentiation of the male rats in a 

cumulative fashion. Biol.of Reprod 

71:1852–1861. 

3. Lambright, C; Ostby, J; Bobseine, K; 

Wilson, V; Hotchkiss, A; Mann, PC; 

Gray, L. 2000. Cellular and molecular 

mechanisms of action of linuron: an 

antiandrogenic herbicide that produces 

reproductive malformations in male rats. 

Toxicol Sci. 56(2):389–99. 

4. McIntyre, B; Barlow, N; Wallace, D; 

Maness, S; Gaido, K; Foster, P. 2000. 

Effects of in utero exposure to linuron on 

androgen-dependent reproductive 

development in the male Crl:CD(SD)BR 

rat. Toxicol Appl Pharmacol. 167(2):87– 

9. 

5. Vinggaard, A., Breinholt, V., and Larsen, 

J. 1999. Screening of selected pesticides 

for oestrogen receptor activation in vitro. 

Food Addit Contam. 16(12):533–542. 

VII. 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 tolerances 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). 

VIII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 24, 2014. 

Daniel J. Rosenblatt, 

Acting 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 § 180.184: 

■ a. Revise the introductory text in 

paragraph (a). 

■ b. Add ‘‘Cilantro, dried leaves’’, 

Cilantro, fresh leaves’’, ‘‘Coriander, 

seed’’, ‘‘Dill, oil’’, ‘‘Dill, seed’’, 

‘‘Dillweed, dried leaves’’, Dillweed, 

fresh leaves’’, Horseradish’’, ‘‘Parsley, 

dried leaves’’, ‘‘Parsley, leaves’’, and 

‘‘Pea, dry, seed’’ to the table in 

paragraph (a). 

■ c. Revise the introductory text in 

paragraph (b). 

■ d. Revise the introductory text in 

paragraph (c). 

■ e. Remove ‘‘Parsley, leaves’’ from the 

table in paragraph (c). 

The amendments read as follows: 

§ 180.184 Linuron; tolerance for residues. 

(a) General. Tolerances are 

established for residues of the herbicide 

linuron (3-(3,4-dichlorophenyl)-1- 

methoxy-1-methylurea), including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only those linuron residues 

convertible to 3,4-dichloroaniline, 

calculated as the stoichiometric 

equivalent of linuron, in or on the 

commodity: 

Commodity Parts per 

million 

* * * * * 

Cilantro, dried leaves .......... 10 

Cilantro, fresh leaves .......... 3 .0 

Coriander, seed .................. 0 .01 

* * * * * 

Dill, oil ................................. 2 .0 

Dill, seed ............................. 0 .5 

Dillweed, dried leaves ........ 5 .0 

Dillweed, fresh leaves ........ 1 .5 


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8308 Federal Register / Vol. 79, No. 29 / Wednesday, February 12, 2014 / Rules and Regulations 

Commodity Parts per 

million 

* * * * * 

Horseradish ........................ 0 .05 

* * * * * 

Parsley, dried leaves .......... 9 .0 

Parsley, leaves ................... 4 .0 

* * * * * 

Pea, dry, seed .................... 0 .09 

* * * * * 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances are established 

for residues of the herbicide linuron [3- 

(3,4-dichlorophenyl)-1-methoxy-1- 

methylurea], including its metabolites 

and degradates, in or on the 

commodities in the table below, 

resulting from use of the pesticide 

pursuant to FIFRA section 18 

emergency exemptions. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

only those linuron residues convertible 

to 3.4-dichloroaniline, calculated as the 

stoichiometric equivalent of linuron, in 

or on the commodity. The tolerance 

expires and is revoked on the date 

specified in the table. 

* * * * * 

(c) Tolerances with regional 

registrations. Tolerances with regional 

registrations, as defined in § 180.1(l), are 

established for residues of the herbicide 

linuron (3-(3,4-dichlorophenyl)-1- 

methoxy-1-methylurea), including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only those linuron residues 

convertible to 3,4-dichloroaniline, 

calculated as the stoichiometric 

equivalent of linuron, in or on the 

commodity. 

* * * * * 

[FR Doc. 2014–03077 Filed 2–11–14; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 25 

[IB Docket No. 12–267; FCC 13–111] 

Comprehensive Review of Licensing 

and Operating Rules for Satellite 

Services 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: The Federal Communications 

Commission (FCC) has adopted many 

changes in its rules, which governs 

licensing and operation of space stations 

and earth stations. Collectively, the 

changes adopted in this document will 

streamline the Commission’s 

regulations, fostering more rapid 

deployment of services to the public, 

greater investment, and new 

innovations in satellite services. 

DATES: The rules in this document 

contain information collection 

requirements that have not been 

approved by Office of Management and 

Budget. The Commission will publish a 

document in the Federal Register 

announcing such OMB approval, the 

effective date of all of the rule 

amendments adopted in the Report and 

Order, and the approval date of the 

incorporation by reference of a certain 

publication listed in the rule. 

FOR FURTHER INFORMATION CONTACT: 

William Bell (202) 418–0741, Satellite 

Division, International Bureau, Federal 

Communications Commission, 

Washington, DC 20554. For additional 

information concerning the information 

collection(s) contained in this 

document, contact Leslie Smith at 202– 

418–0217, or via the Internet at 

Leslie.Smith@fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Report 

and Order in IB Docket No. 12–267, FCC 

13–111, adopted and released on August 

9, 2013. The full text of the Report and 

Order is available for public inspection 

and copying during regular business 

hours at the FCC Reference Information 

Center, Portals II, 445 12th Street SW., 

Room CY–A257, Washington, DC 20554. 

This document may also be purchased 

from the Commission’s duplicating 

contractor, Best Copy and Printing, Inc., 

Portals II, 445 12th Street SW., Room 

CY–B402, Washington, DC 20554, 

telephone 202–488–5300, facsimile 

202–488–5563, or via email FCC@

BCPIWEB.com. The full text may also be 

downloaded at http://apps.fcc.gov/ecfs/ 

document/view?id=7520937207 http://

www.fcc.gov. Alternative formats are 

available to person with disabilities by 

sending an email to fcc504@fcc.gov or 

calling the Consider & Governmental 

Affairs Bureau at 202–418–0530 (voice), 

or 202–418–0432 (tty). 

Synopsis 

1. In September 2012, the 

Commission issued a Notice of 

Proposed Rulemaking (NPRM), 77 FR 

67172, November 8, 2012 proposing 

extensive changes in part 25 of its rules, 

which governs licensing and operation 

of space stations and earth stations for 

the provision of satellite communication 

services. Sixteen parties filed comments 

in response to the NPRM and 10 parties 

filed reply comments. In this Report and 

Order, we adopt most of the changes 

proposed previously and discuss 

recommendations for further changes. In 

all, we revise over 150 rule provisions 

in part 25 to better reflect evolving 

technology; eliminate unnecessary 

information filing requirements for 

licensees and applicants; eliminate 

unnecessary technical restrictions; 

reorganize existing requirements; 

eliminate redundancy and unnecessary 

verbiage; clarify vague, confusing, or 

ambiguous provisions; resolve 

inconsistencies; and codify existing 

policies to improve transparency. These 

changes will better enable the 

Commission to assess the interference 

potential of proposed operations; afford 

more operational flexibility for satellite 

licensees; enable applicants and 

licensees to conserve time, effort, and 

expense in preparing applications and 

reports; ease administrative burdens for 

the Commission; and make the rules 

easier to understand. 

Paperwork Reduction Act 

2. This document contains new or 

modified information collection 

requirements subject to the Paperwork 

Reduction Act of 1995 (PRA), Public 

Law 104–13. It will be submitted to the 

Office of Management and Budget 

(OMB) for review under Section 3507(d) 

of the PRA. OMB, the general public, 

and other Federal agencies are invited to 

comment on the new or modified 

information collection requirements 

contained in this proceeding. 

3. Pursuant to the Small Business 

Paperwork Relief Act of 2002, Public 

Law 107–198, see 44 U.S.C. 3506(c)(4), 

we previously sought specific comment 

on how the Commission might further 

reduce the information collection 

burden for small business concerns with 

fewer than 25 employees. We received 

no comments on this issue. We have 

assessed the effects of the revisions 

adopted that might impose information 

collection burdens on small business 

concerns, and find that the impact on 

businesses with fewer than 25 

employees will be an overall reduction 

in burden. The amendments adopted in 

this Report and Order eliminate 

unnecessary information filing 

requirements for licensees and 

applicants; eliminate unnecessary 

technical restrictions and enable 

applicants and licensees to conserve 

time, effort, and expense in preparing 

applications and reports. Overall, these 

changes may have a greater positive 


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