51722 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations 

shoreline to shoreline, bounded on the 

west by a line running north to south 

from points along the shoreline at 

38°52′50′′ N/077°03′25′′ W, thence to 

38°52′49′′ N/077°03′25′′ W; and bounded 

on the east by a line running northwest 

to southeast from points along the 

shoreline at 38°52′34′′ N/077°02′48′′ W, 

thence to 38°52′32′′ N/077°02′46′′ W 

(Datum NAD 1983). 

(c) Regulations. (1) The general 

regulations governing security zones 

found in § 165.33 of this part apply to 

the security zone described in paragraph 

(b) of this section. 

(2) Entry into or remaining in this 

zone is prohibited unless authorized by 

the Captain of the Port Baltimore or his 

designated representative. Except for 

public vessels and vessels at berth, 

mooring or at anchor, all vessels in this 

zone are to depart the security zone. 

(3) Persons desiring to transit the area 

of the security zone must first obtain 

authorization from the Captain of the 

Port Baltimore. To seek permission to 

transit the area, the Captain of the Port 

Baltimore can be contacted at telephone 

number (410) 576–2693. The Coast 

Guard vessels enforcing this section can 

be contacted on Marine Band Radio, 

VHF-FM channel 16 (156.8 MHz). Upon 

being hailed by a U.S. Coast Guard 

vessel by siren, radio, flashing light, or 

other means, the operator of a vessel 

shall proceed as directed. If permission 

is granted, all persons and vessels must 

comply with the instructions of the 

Captain of the Port Baltimore and 

proceed at the minimum speed 

necessary to maintain a safe course 

while within the zone. 

(d) Enforcement. The U.S. Coast 

Guard may be assisted in the patrol and 

enforcement of the zone by Federal, 

State, and local agencies. 

(e) Enforcement period. This section 

will be enforced from 6 a.m. through 11 

a.m. on September 11, 2008. 

Dated: August 28, 2008. 

Brian D. Kelley, 

Captain, U.S. Coast Guard, Captain of the 

Port, Baltimore, Maryland. 

[FR Doc. E8–20659 Filed 9–4–08; 8:45 am] 

BILLING CODE 4910–15–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0491; FRL–8379–6] 

Linuron; Pesticide Tolerance for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited tolerance for combined 

residues of linuron and its metabolites 

in or on lentils. This action is in 

response to EPA’s granting of an 

emergency exemption under section 18 

of the Federal Insecticide, Fungicide, 

and Rodenticide Act (FIFRA) 

authorizing use of the pesticide on 

lentils. This regulation establishes a 

maximum permissible level for residues 

of linuron in the food commodity, 

lentils. The time-limited tolerance 

expires and is revoked on December 31, 

2011. 

DATES: This regulation is effective 

September 5, 2008. Objections and 

requests for hearings must be received 

on or before November 4, 2008, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2008–0491. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

regulations.gov. Although listed in the 

index, some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either in the electronic docket 

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

available in hard copy, at the Office of 

Pesticide Programs (OPP) Regulatory 

Public Docket in Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. The hours of 

operation of this Docket Facility are 

from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The Docket Facility telephone 

number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Andrea Conrath, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9356; e-mail address: 

conrath.andrea@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

as amended by the Food Quality 

Protection Act of 1996 (FQPA), any 

person may file an objection to any 

aspect of this regulation and may also 

request a hearing on those objections. 

The EPA procedural regulations which 

govern the submission of objections and 

requests for hearings appear in 40 CFR 

part 178. 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 


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identify docket ID number EPA–HQ–

OPP–2008–0491 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before November 4, 2008. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2008–0491, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with sections 408(e) and 

408(l)(6) of FFDCA, 21 U.S.C. 346a(e) 

and 346a(1)(6), is establishing a timelimited tolerance for combined residues 

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

dichlorophenyl)-1-methoxy-1- 

methylurea) and its metabolites 

convertible to 3,4-dichloroaniline, 

calculated as linuron, in or on lentils at 

0.1 parts per million (ppm). This timelimited tolerance expires and is revoked 

on December 31, 2011. EPA will publish 

a document in the Federal Register to 

remove the revoked tolerance from the 

CFR. 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under section 18 of FIFRA. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on section 18 related timelimited tolerances to set binding 

precedents for the application of section 

408 of FFDCA and the new safety 

standard to other tolerances and 

exemptions. Section 408(e) of FFDCA 

allows EPA to establish a tolerance or an 

exemption from the requirement of a 

tolerance on its own initiative, i.e., 

without having received any petition 

from an outside party. 

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. . . .’’

Section 18 of FIFRA authorizes EPA 

to exempt any Federal or State agency 

from any provision of FIFRA, if EPA 

determines that ‘‘emergency conditions 

exist which require such exemption.’’

EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemptions for Linuron 

on Lentils and FFDCA Tolerance 

The applicants from Idaho and 

Washington petitioned for an emergency 

exemption, stating that the development 

of herbicide-resistant biotypes of prickly 

lettuce and mayweed chamomile has 

led to an emergency situation. After 

having reviewed the submissions, EPA 

determined that emergency conditions 

exist for these States, and that the 

criteria for an emergency exemption are 

met. EPA has authorized under FIFRA 

section 18 the use of linuron on lentils 

for control of mayweed chamomile and 

prickly lettuce in Idaho and 

Washington. 

As part of its evaluation of the 

emergency exemption applications, EPA 

assessed the potential risks presented by 

residues of linuron in or on lentils. In 

doing so, EPA considered the safety 

standard in section 408(b)(2) of FFDCA, 

and EPA decided that the necessary 

tolerance under section 408(l)(6) of 

FFDCA would be consistent with the 

safety standard and with FIFRA section 

18. Consistent with the need to move 

quickly on the emergency exemption in 

order to address an urgent non-routine 

situation and to ensure that the resulting 

food is safe and lawful, EPA is issuing 

this tolerance without notice and 

opportunity for public comment as 

provided in section 408(l)(6) of FFDCA. 

Although this time-limited tolerance 

expires and is revoked on December 31, 

2011, under section 408(l)(5) of FFDCA, 

residues of the pesticide not in excess 

of the amount specified in the tolerance 

remaining in or on lentils after that date 

will not be unlawful, provided the 

pesticide was applied in a manner that 

was lawful under FIFRA, and the 

residues do not exceed a level that was 

authorized by this time-limited 

tolerance at the time of that application. 

EPA will take action to revoke this timelimited tolerance earlier if any 

experience with, scientific data on, or 

other relevant information on this 

pesticide indicate that the residues are 

not safe. 

Because this time-limited tolerance is 

being approved under emergency 

conditions, EPA has not made any 

decisions about whether linuron meets 

FIFRA’s registration requirements for 

use on lentils or whether a permanent 

tolerance for this use would be 

appropriate. Under these circumstances, 

EPA does not believe that this timelimited tolerance decision serves as a 

basis for registration of linuron by a 

State for special local needs under 

FIFRA section 24(c). Nor does this 

tolerance serve as the basis for persons 

in any State other than Idaho and 

Washington to use this pesticide on this 

crop under FIFRA section 18 absent the 

issuance of an emergency exemption 

applicable within that State. For 

additional information regarding the 

emergency exemption for linuron, 

contact the Agency’s Registration 

Division at the address provided under 

FOR FURTHER INFORMATION CONTACT. 

IV. 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 


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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 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 expected as a result 

of this emergency exemption request 

and the time-limited tolerance for 

combined residues of linuron on lentils 

at 0.1 ppm. EPA’s assessment of 

exposures and risks associated with 

establishing the time-limited tolerance 

follows. 

A. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

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 greater than that 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 can be found at http:// 

www.regulations.gov in the document 

Linuron Human Health Risk Assessment 

to Support a Section 18 Emergency 

Exemption for Use on Lentils in 

Washington and Idaho, page 6 in docket 

ID number EPA–HQ–OPP–2008–0491. 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to linuron, EPA considered 

exposure under the time-limited 

tolerance established by this action 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. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, for blended 

commodities, an average of the field 

trial data corrected for the maximum 

percent of crop treated (PCT) was used 

in the assessment. For non-blended or 

partially-blended commodities, all 

values from the field trials were 

included along with the use of 

maximum PCT. For the new use on 

lentils, field trial values were included 

and 100 PCT was assumed. For all 

commodities, residues reported at or 

below the analytical method limit of 

quantitation (LOQ) were incorporated 

into the assessment at the LOQ level. 

Concentration/reduction factors were 

incorporated for some commodities 

based on empirical data; for all other 

processed commodities, default 

processing factors were used. A single 

high end modeled peak surface water 

estimated drinking water concentration 

(EDWC) of 38 ppb was used as a point 

estimate for drinking water, and directly 

incorporated into the assessment. There 

were no significant toxicological effects 

attributable to a single exposure (dose) 

for the general population or any other 

population subgroups other than the 

population subgroup of females 13–49 

years old. Therefore, only this subgroup 

was included in this assessment. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. For the chronic assessment, an 

average of the field trial data and PCT 

information were used to derive 

anticipated residue values. For the new 

use on lentils, the average of the field 

trial data was used and 100 PCT was 

assumed. Concentration/reduction 

factors were incorporated for some 

commodities based on empirical data; 

for all other processed commodities, 

default processing factors were used. 

The annual mean surface water estimate 

of 18 ppb was used as a chronic 

exposure estimate for drinking water 

and was directly incorporated into the 

dietary assessment. 

iii. Cancer. Linuron has been 

classified as Group C chemical and 

quantification of human cancer risk is 

not required; therefore a cancer dietary 

risk assessment was not conducted. 

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 


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required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

For the acute assessment the 

maximum PCT was used as follows: 

sorghum and soybean at 2.5%, and 

wheat and lentils at 100%. For the 

chronic assessment, the average PCT 

was used as follows: sorghum and 

soybean at 1%, and wheat and lentils at 

100%. Although usage on wheat is 

likely negligible, since there were no 

usage data reported for this crop, a 

default of 100 PCT was used for both 

acute and chronic assessments, which is 

likely an overestimate. 

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 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.B.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. 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 Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentration (EDWC) of linuron 

for acute exposures is estimated to be 38 

ppb for surface water. For chronic 

exposures for non-cancer assessments 

the EDWC is estimated to be 18 ppb for 

surface water. Groundwater sources 

were not included in this assessment, as 

the EDWCs for this water source are 

minimal in comparison to surface water 

(0.7 ppb for both acute and chronic 

concentrations). Modeled estimates of 

drinking water concentrations were 

directly entered into the dietary 

exposure model. 

For acute dietary risk assessment, the 

water concentration value of 38 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration 

value of 18 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 the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

C. 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 SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

The data from the multi-generation 

reproduction study in rats show that 

linuron has weak affinity for androgen 

receptors and causes dose-related 

alterations in androgen-dependent 

reproductive organ development in 

male rats. While there is evidence of 

increased susceptibility seen in rats, the 

anti-androgenic effects of linuron are 

well established and there is a clear 

NOAEL for the effects. Further, the 

toxicity endpoint selected for risk 

assessment is protective of both the 

hematological effects seen (increased 

methemoglobin levels, selected as the 

chronic endpoint) as well as the antiandrogenic effects of linuron. EPA has 

determined that the available linuron 

database is adequate for assessing the 

potentially increased susceptibility of 

the young to linuron exposure and the 

possible need for a FQPA safety factor 

to protect the young from the effects of 

linuron. 

3. Conclusion. EPA concludes that the 

FQPA safety factor of 10X is not 

warranted, and it is reduced to 1X for 

the following reasons: 

EPA has determined that reliable data 

show that 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: 


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i. The toxicity database for 

understanding the toxicity of linuron is 

complete. 

ii. The information on linuron’s 

effects on differentiating male 

reproductive system (antiandrogenic 

action) is well established, and the dose 

levels where these effects occur are 

known. A clear NOAEL was established 

for the effects on the reproductive 

system. At this time, the point of 

departure for risk assessment purposes 

is protective of the linuron’s action on 

this target tissue (differentiating male 

reproductive system) as well as the 

hematological effects described in Unit 

IV.C.2. 

iii. The linuron database does not 

show any neurotoxicity in all the 

submitted and published studies at 

doses as high as 100 mg/kg. The current 

developmental neurotoxicity (DNT) 

study focuses on the neurobehavioral 

and brain histological changes and will 

not provide additional information for 

understanding the toxicity of linuron; 

therefore, this study is no longer 

required. 

iv. Exposure estimates are unlikely to 

underestimate risk. 

v. There are no residual uncertainties 

identified in the exposure databases. For 

estimation of exposure, the analysis 

incorporated PCT estimates, which are 

derived from Federal and private market 

survey data, which are reliable and have 

a valid basis. EPA believes that using 

these estimates will not underestimate 

the exposure and risks. EPA made 

conservative (protective) assumptions in 

the ground 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. 

D. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate UFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. There were no significant 

toxicological effects attributable to a 

single exposure (dose) for the general 

population other than the population 

subgroup Females 13–49 Years Old; 

therefore only this population subgroup 

was included in this assessment. Using 

the exposure assumptions discussed in 

this unit for acute exposure, the acute 

dietary exposure from food and water to 

linuron will occupy 6.0% of the aPAD 

at the 99.9th percentile of exposure 

distribution 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 22% of the 

cPAD for All Infants, the population 

subgroup receiving the greatest 

exposure. There are no residential uses 

for linuron. For the general U.S. 

population the existing and new uses 

for linuron resulted in an estimated 

chronic dietary exposure and risk 

equivalent to 7% of the cPAD. 

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). Linuron is not 

registered for any use patterns that 

would result in residential exposure. 

Therefore, the short-term aggregate risk 

is the sum of the risk from exposure to 

linuron through food and water and will 

not be greater than the chronic aggregate 

risk. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

non-dietary, non-occupational exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Linuron is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Therefore, the 

intermediate-term aggregate risk is the 

sum of the risk from exposure to linuron 

through food and water, which has 

already been addressed, and will not be 

greater than the chronic aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. Linuron has been classified 

as Group C carcinogen and 

quantification of human cancer risk is 

not required. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children, 

from aggregate exposure to linuron 

residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

The Pesticide Analytical Manual 

(PAM) Vol. II lists a colorimetric 

method (Method I) and a paper 

chromatographic method (Method II) for 

the enforcement of tolerances for 

linuron residues. Residues of diuron 

may interfere in Method I. A modified 

version of Method I (H. L. Pease, Journal 

of Agric. and Food Chem., 1962, Vol. 10, 

p. 279), which includes a cellulose 

column step to separate linuron from 

diuron, has been used for tolerance 

enforcement purposes. Both these 

methods determine linuron and all 

metabolites hydrolyzable to 3,4- 

dichloroaniline and have limits of 

detection of 0.05 ppm and are adequate 

to enforce the tolerance expression. 

B. International Residue Limits 

There are no Codex MRLs for linuron 

on lentils. 

VI. Conclusion 

Therefore, a time-limited tolerance is 

established for combined residues of 

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

methoxy-1-methylurea) and its 

metabolites convertible to 3,4- 

dichloroaniline, calculated as linuron, 

in or on lentil at 0.1 ppm. This tolerance 

expires and is revoked on December 31, 

2011. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under sections 408(e) and 408(l)(6) of 

FFDCA 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, 

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 


hsrobinson on PROD1PC76 with RULES
Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations 51727 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established in accordance with 

sections 408(e) and 408(l)(6) of FFDCA, 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VIII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 22, 2008. 

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 § 180.184 revise paragraph (b) to 

read as follows: 

§ 180.184 Linuron; tolerances for residues. 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

combined residues of the herbicide 

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

methoxy-1-methylurea) and its 

metabolites convertible to 3,4- 

dichloroaniline, calculated as linuron, 

in or on the specified agricultural 

commodities, resulting from use of the 

pesticide pursuant to FIFRA section 18 

emergency exemptions. The tolerance 

expires and is revoked on the date 

specified in the table. 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

Lentil 0.1 12/31/2011 

[FR Doc. E8–20627 Filed 9–4–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0549; FRL–8378–2] 

Chlorantraniliprole; Pesticide 

Tolerances for Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

chlorantraniliprole in or on various 

sweet corn commodities and in milk. 

This action is in response to EPA’s 

granting of emergency exemptions 

under section 18 of the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA) authorizing use of the 

pesticide on sweet corn. This regulation 

establishes maximum permissible levels 

for residues of chlorantraniliprole in or 

on these food commodities. The timelimited tolerances expire and are 

revoked on December 31, 2011. 

DATES: This regulation is effective 

September 5, 2008. Objections and 

requests for hearings must be received 

on or before November 4, 2008, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2008–0549. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

regulations.gov. Although listed in the 

index, some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either in the electronic docket 

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

available in hard copy, at the Office of 

Pesticide Programs (OPP) Regulatory 

Public Docket in Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. The hours of 

operation of this Docket Facility are 

from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The Docket Facility telephone 

number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Marcel Howard, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6784; e-mail address: 

howard.marcel@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 


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