Federal Register / Vol. 74, No. 154 / Wednesday, August 12, 2009 / Rules and Regulations 40503 

1All sections for 7 DE Admin. Code 1144: Control 

of Stationary Generator Emissions shall be 

incorporated by reference into 40 CFR part 55 

except for all references to Carbon Dioxide (CO2). 

7 DE Admin Code 1134: Emission Banking 

and Trading Program 

Section 1.0: Program Overview (Effective 10/ 

06/1997) 

Section 2.0: Definitions (Effective 10/06/ 

1997) 

Section 3.0: Applicability (Effective 10/06/ 

1997) 

Section 4.0: Generating an Emission 

Reduction (Effective 10/06/1997) 

Section 5.0: Application for Certification of 

an Emission Reduction as an ERC 

(Effective 10/06/1997) 

Section 6.0: Source Baseline (Effective 10/06/ 

1997) 

Section 7.0: Post-Reduction Emission rate 

(Effective 10/06/1997) 

Section 8.0: Certification of an Emission 

Reduction (Effective 10/06/1997) 

Section 9.0: Trading and Use of ERCs 

(Effective 10/06/1997) 

Section 10.0: Record Keeping Requirements 

(Effective 10/06/1997) 

Section 11.0: ERC Banking System (Effective 

10/06/1997) 

Section 12.0: Fees (Effective 10/06/1997) 

Section 13.0: Enforcement (Effective 10/06/ 

1997) 

Section 14.0: Program Evaluation and 

Individual Audits (Effective 10/06/1997) 

7 DE Admin. Code 1135: Conformity of 

General Federal Actions to the State 

Implementation Plans 

Section 1.0: Purpose (Effective 08/14/1996) 

Section 2.0: Definitions (Effective 08/14/ 

1996) 

Section 3.0: Applicability (Effective 08/14/ 

1996) 

Section 4.0: Conformity Analysis (Effective 

08/14/1996) 

Section 5.0: Reporting Requirements 

(Effective 08/14/1996) 

Section 6.0: Public Participation and 

Consultation (Effective 08/14/1996) 

Section 7.0: Frequency of Conformity 

Determinations (Effective 08/14/1996) 

Section 8.0: Criteria for Determining 

Conformity of General Federal Actions 

(Effective 08/14/1996) 

Section 9.0: Procedures for Conformity 

Determinations of General Federal Actions 

(Effective 08/14/1996) 

Section 10.0: Mitigation of Air Quality 

Impacts (Effective 08/14/1996) 

Section 11.0: Savings Provisions (Effective 

08/14/1996) 

7 DE Admin. Code 1139: Nitrogen Oxides 

(NOX) Budget Trading Program 

Section 1.0: Purpose (Effective 12/11/2000) 

Section 2.0: Emission Limitation (Effective 

12/11/2000) 

Section 3.0: Applicability (Effective 12/11/ 

2000) 

Section 4.0: Definitions (Effective 12/11/ 

2000) 

Section 5.0: General Provisions (Effective 12/ 

11/2000) 

Section 6.0: NOX Authorized Account 

Representative for NOX Budget Sources 

(Effective 12/11/2000) 

Section 7.0: Permits (Effective 12/11/2000) 

Section 8.0: Monitoring and Reporting 

(Effective 12/11/2000) 

Section 9.0: NATS (Effective 12/11/2000) 

Section 10.0: NOX Allowance Transfers 

(Effective 12/11/2000) 

Section 11.0: Compliance Certification 

(Effective 12/11/2000) 

Section 12.0: End-of-Season Reconciliation 

(Effective 12/11/2000) 

Section 13.0: Failure to Meet Compliance 

Requirements (Effective 12/11/2000) 

Section 14.0: Individual Units Opt-Ins 

(Effective 12/11/2000) 

Section 15.0: General Accounts (Effective 12/ 

11/2000) 

Appendix A: Allowance Allocations to NOX

Budget Units under 3.1.1.1 and 3.1.1.2 of 

DE Admin. Code 1139 (Effective 02/11/ 

2000) 

Appendix B: 7 DE Admin. Code 1137—7 DE 

Admin. Code 1139 Program Transition 

(Effective 02/11/2000) 

7 DE Admin. Code 1140: Delaware’s 

National Low Emission Vehicle (NLEV) 

Regulation 

Section 1.0: Applicability (Effective 09/11/ 

1999) 

Section 2.0: Definitions (Effective 09/11/ 

1999) 

Section 3.0: Program Participation (Effective 

09/11/1999) 

7 DE Admin. Code 1142: Specific Emission 

Control Requirements 

Section 1.0: Control of NOX Emissions from 

Industrial Boilers (Effective 12/12/2001) 

7 DE Admin. Code 1143: Heavy Duty Diesel 

Engine Standards 

Section 1.0: On Road Heavy Duty Diesel 

Requirements for Model Years 2005 and 

2006 (Effective 02/11/2005) 

Section 2.0: On Road Heavy Duty Diesel 

Requirements for Model Year 2007 and 

Later (Effective 02/11/2005) 

7 DE Admin. Code 1144: Control of 

Stationary Generator Emissions 1

Section 1.0: General (Effective 01/11/2006) 

Section 2.0: Definitions (Effective 01/11/ 

2006) 

Section 3.0: Emissions (Effective 01/11/2006) 

Section 4.0: Operating Requirements 

(Effective 01/11/2006) 

Section 5.0: Fuel Requirements (Effective 01/ 

11/2006) 

Section 7.0: Emissions Certification, 

Compliance, and Enforcement (Effective 

01/11/2006) 

Section 8.0: Credit for Concurrent Emissions 

Reductions (Effective 01/11/2006) 

Section 9.0: DVFA Member Companies 

(Effective 01/11/2006) 

7 DE Admin. Code 1145: Excessive Idling of 

Heavy Duty Vehicles 

Section 1.0: Applicability (Effective 04/11/ 

2005) 

Section 2.0: Definitions (Effective 04/11/ 

2005) 

Section 3.0: Severability (Effective 04/11/ 

2005) 

Section 4.0: Operational Requirements for 

Heavy Duty Motor Vehicles (Effective 04/ 

11/2005) 

Section 5.0: Exemptions (Effective 04/11/ 

2005) 

Section 6.0: Enforcement and Penalty 

(Effective 04/11/2005) 

7 DE Admin. Code 1146: Electric Generating 

Unit (EGU) Multi-Pollutant Regulation 

Section 1.0: Preamble (Effective 12/11/2006) 

Section 2.0: Applicability (Effective 12/11/ 

2006) 

Section 3.0: Definitions (Effective 12/11/ 

2006) 

Section 4.0: NOX Emissions Limitations 

(Effective 12/11/2006) 

Section 5.0: SO2 Emissions Limitations 

(Effective 12/11/2006) 

Section 6.0: Mercury Emissions Limitations 

(Effective 12/11/2006) 

Section 7.0: Recordkeeping and Reporting 

(Effective 12/11/2006) 

Section 8.0: Compliance Plan (Effective 12/ 

11/2006) 

Section 9.0: Penalties (Effective 12/11/2006) 

7 DE Admin. Code 1148: Control of 

Stationary Combustion Turbine Electric 

Generating Unit Emissions 

Section 1.0: Purpose (Effective 07/11/2007) 

Section 2.0: Applicability (Effective 07/11/ 

2007) 

Section 3.0: Definitions (Effective 07/11/ 

2007) 

Section 4.0: NOX Emissions Limitations 

(Effective 07/11/2007) 

Section 5.0: Monitoring and Reporting 

(Effective 07/11/2007) 

Section 6.0: Recordkeeping (Effective 07/11/ 

2007) 

Section 7.0: Penalties (Effective 07/11/2007) 

(2) [Reserved] 

* * * * * 

[FR Doc. E9–19324 Filed 8–11–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0041; FRL–8430–5] 

Sodium Lauryl Sulfate; Exemption 

From the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of sodium lauryl 

sulfate (CAS Reg. No. 151–21–3) when 

used as a component of food contact 

sanitizing solutions applied to all food 

contact surfaces in public eating places, 

dairy-processing equipment, and foodprocessing equipment and utensils at a 

maximum level in the end-use 

concentration of 350 parts per million 

(ppm). ETI H2O submitted a petition to 

EPA under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting an 

exemption from the requirement of a 


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40504 Federal Register / Vol. 74, No. 154 / Wednesday, August 12, 2009 / Rules and Regulations 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of sodium 

lauryl sulfate. 

DATES: This regulation is effective 

August 12, 2009. Objections and 

requests for hearings must be received 

on or before October 13, 2009, 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–2008–0041. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Kerry Leifer, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8811; e-mail address: 

leifer.kerry@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 electronically 

available documents 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 cite at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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. 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 

identify docket ID number EPA–HQ– 

OPP–2008–0041 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 October 13, 2009. 

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–2008–0041, 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 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background 

In the Federal Register of February 6, 

2008 (73 FR 6964) (FRL–8350–9), EPA 

issued a notice pursuant to section 408 

(d)(3) of FFDCA, 21 U.S.C. 346a, 

announcing the filing of a pesticide 

petition (PP 7F7179) by ETI H2O, 1725 

Gillespie Way, El Cajon, CA 92020. The 

petition requested that 40 CFR 

180.940(a) be amended by establishing 

an exemption from the requirement of a 

tolerance for residues of sodium lauryl 

sulfate (CAS Reg. No. 151–21–3) as a 

component of food contact sanitizing 

solutions applied to all food contact 

surfaces in public eating places, dairyprocessing equipment, and foodprocessing equipment and utensils 

which increases the maximum level in 

the end-use concentration from 3 ppm 

to 350 ppm. That notice included a 

summary of the petition prepared by the 

petitioner. There were no comments 

received in response to the notice of 

filing. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene ploymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 


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IV. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish an exemption 

from the requirement of 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. . . .’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

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

of FFDCA, and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

exemption from the requirement of a 

tolerance for residues of sodium lauryl 

sulfate when used as a component of 

food contact sanitizing solutions 

applied to all food contact surfaces in 

public eating places, dairy-processing 

equipment, and food-processing 

equipment and utensils at a maximum 

level in the end-use concentration of 

350 ppm. EPA’s assessment of 

exposures and risks associated with 

establishing tolerances follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

The toxicology database is adequate to 

support the use of sodium lauryl sulfate 

as an inert ingredient in pesticide 

formulations as well as its use as a 

component of food contact sanitizing 

solutions. 

Sodium lauryl sulfate has low acute 

oral and dermal toxicity but is irritating 

to the skin and eye at high doses. 

Sodium lauryl sulfate is not a skin 

sensitizer. Sodium lauryl sulfate was 

negative in tests for genotoxicity. The 

repeated dose toxicity data on alkyl 

sulfates including sodium lauryl sulfate 

demonstrate effects consistent with 

surfactant-mediated irritant effects. The 

common target organs of toxicity 

following repeated-dose oral exposure 

were the forestomach in gavage studies, 

and the liver and kidneys in dietary 

studies. No evidence of neurotoxicity 

was observed in any of the available 

studies. Chronic toxicity data on sodium 

lauryl sulfate is available in limited, 

summary form. A developmental 

toxicity study with sodium lauryl 

sulfate in rats, rabbits and mice 

demonstrated developmental toxicity at 

maternally toxic doses at a dose level of 

600 milligrams/kilogram/day (mg/kg/ 

day). A 2-generation reproductive 

toxicity study conducted with a related 

chemical, a-alkyl (C12) olefin sulfonate, 

showed no treatment-related adverse 

reproductive effects. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by sodium lauryl sulfate 

as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies can be found 

at http://www.regulations.gov in the 

document Sodium Lauryl Sulfate. 

Human Health Risk Assessment to 

Support Proposed Exemption from the 

Requirement of a Tolerance When Used 

as an Inert Ingredient in Pesticide 

Formulations. pages 6–9 in docket ID 

number EPA–HQ–OPP–2008–0041. 

B. 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-term, intermediate-term, 

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 sodium lauryl sulfate used 

for human risk assessment is shown in 

the following Table. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SODIUM LAURYL SULFATE FOR USE IN HUMAN RISK

ASSESSMENT

Exposure/Scenario Point of Departure and Uncertainty/Safety Factors 

RfD, PAD, LOC for Risk Assessment Study and Toxicological Effects 

Acute dietary (all populations) An endpoint attributable to a single exposure was not seen in the database; therefore, a point of departure was not 

selected. 


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40506 Federal Register / Vol. 74, No. 154 / Wednesday, August 12, 2009 / Rules and Regulations 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SODIUM LAURYL SULFATE FOR USE IN HUMAN RISK

ASSESSMENT—Continued 

Exposure/Scenario Point of Departure and Uncertainty/Safety Factors 

RfD, PAD, LOC for Risk Assessment Study and Toxicological Effects 

Chronic dietary (all 

populations) 

NOAEL= 100 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x

Chronic RfD = 1 mg/kg/day 

cPAD = 1 mg/kg/day 

28-Day oral (gavage) toxicity study in rats 

LOAEL = 200 mg/kg/day,based on decreased 

body weight gain 

Incidental oral, dermal 

and inhalation 

(short-term and intermediate-term) 

NOAEL= 100 mg/kg/day 

Dermal absorption of 1% inhalation exposure is assumed to be equivalent to 

oral exposure 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential/occupational LOC for 

MOE = 100 

28-Day oral (gavage) toxicity study in rats LOAEL 

= 200 mg/kg/day, based on decreased body 

weight gain 

Cancer (oral, dermal, 

inhalation) 

Classification: Based on limted data sodium lauryl sulfate is not expected to be carcinogenic. 

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect 

level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = 

potential variation in sensitivity among members of the human population (intraspecies). PAD = population adjusted dose (a=acute, c=chronic). 

FQPA SF = FQPA Safety Factor. RfD = reference dose. MOE = margin of exposure. LOC = level of concern. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to sodium lauryl sulfate, EPA 

considered exposure under the 

petitioned-for exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from sodium 

lauryl sulfate in food as follows: 

i. Acute exposure. No adverse effects 

attributable to a single exposure of 

sodium lauryl sulfate were seen in the 

toxicity databases; therefore, an acute 

dietary exposure assessment for sodium 

lauryl sulfate is not necessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used food 

consumption information from the U.S. 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, no residue data were submitted 

for sodium lauryl sulfate. In the absence 

of specific residue data, EPA has 

developed an approach which uses 

surrogate information to derive upper 

bound exposure estimates for the 

subject inert ingredient. Upper bound 

exposure estimates are based on the 

highest tolerance for a given commodity 

from a list of high-use insecticides, 

herbicides, and fungicides. A complete 

description of the general approach 

taken to assess inert ingredient risks in 

the absence of residue data is found at 

http://www.regulations.gov in the 

document Alkyl Amines Polyalkoxylates 

(Cluster 4): Acute and Chronic 

Aggregate (Food and Drinking Water) 

Dietary Exposure and Risk Assessments 

for the Inerts in docket ID number EPA– 

HQ–OPP–2008–0738. 

In the dietary exposure assessment, 

the Agency assumed that the residue 

level of the inert ingredient would be no 

higher than the highest tolerance for a 

given commodity. Implicit in this 

assumption is that there would be 

similar rates of degradation (if any) 

between the active and inert ingredient 

and that the concentration of inert 

ingredient in the scenarios leading to 

these highest of tolerances would be no 

higher than the concentration of the 

active ingredient. 

In addition to dietary exposures 

resulting from use of sodium lauryl 

sulfate as an inert ingredient in 

pesticide formulation application to 

crops, a conservative dietary exposure 

estimate of residues of sodium lauryl 

sulfate in food as a result of its use as 

a component in food contact sanitizing 

solution was also performed. This 

estimate also utilizes conservative 

assumptions related to the amount of 

residues that can be transferred to foods 

as a result of use of food contact 

sanitizing products. 

The Agency believes the assumptions 

used to estimate dietary exposures lead 

to an extremely conservative assessment 

of dietary risk due to a series of 

compounded conservatisms. First, 

assuming that the level of residue for an 

inert ingredient is equal to the level of 

residue for the active ingredient will 

overstate exposure. The concentration of 

active ingredients in agricultural 

products is generally at least 50 percent 

of the product and often can be much 

higher. Further, pesticide products 

rarely have a single inert ingredient; 

rather, there is generally a combination 

of different inert ingredients used 

thereby further reducing the 

concentration of any single inert 

ingredient in the pesticide product in 

relation to that of the active ingredient. 

Second, the conservatism of this 

methodology is compounded by EPA′s 

decision to assume that, for each 

commodity, the active ingredient which 

will serve as a guide to the potential 

level of inert ingredient residues is the 

active ingredient with the highest 

tolerance level. This assumption 

overstates residue values because it 

would be highly unlikely, given the 

high number of inert ingredients, that a 

single inert ingredient or class of 

ingredients would be present at the 

level of the active ingredient in the 

highest tolerance for every commodity. 

Finally, a third compounding 

conservatism is EPA′s assumption that 

all foods contain the inert ingredient at 

the highest tolerance level. In other 

words, EPA assumed 100 percent of all 

foods are treated with the inert 

ingredient at the rate and manner 

necessary to produce the highest residue 

legally possible for an active ingredient. 

In summary, EPA chose a very 

conservative method for estimating the 

level of inert residue that could be on 

food, then used this methodology to 

choose the highest possible residue that 

could be found on food and assumed 

that all food contained this residue. No 

consideration was given to potential 

degradation between harvest and 

consumption even though monitoring 

data show that tolerance level residues 


jlentini on DSKJ8SOYB1PROD with RULES
Federal Register / Vol. 74, No. 154 / Wednesday, August 12, 2009 / Rules and Regulations 40507 

are typically one to two orders of 

magnitude higher than actual residues 

in food when distributed in commerce. 

Accordingly, although sufficient 

information to quantify actual residue 

levels in food is not available, the 

compounding of these conservative 

assumptions will lead to a significant 

exaggeration of actual exposures. EPA 

does not believe that this approach 

underestimates exposure in the absence 

of residue data. 

iii. Cancer. There is no evidence that 

sodium lauryl sulfate is carcinogenic. 

While the full study reports are not 

available, summary data on two 

carcinogenicity studies with sodium 

(C12-C15) alkyl sulfate show no increase 

in tumor incidence, nor any impact on 

tumor type at levels up to up to 1.5% 

highest dose tested (HDT) in the diet. 

Since the Agency has not identified 

any concerns for carcinogenicity 

relating to sodium lauryl sulfate, a 

cancer dietary exposure assessment was 

not performed. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for sodium lauryl sulfate. Tolerance 

level residues and/or 100% CT were 

assumed for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for sodium lauryl sulfate in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of sodium lauryl sulfate. 

Further information regarding EPA 

drinking water models used in the 

pesticide exposure assessment can be 

found at http://www.epa.gov/oppefed1/ 

models/water/index.htm. 

A screening level drinking water 

analysis, based on the Pesticide Root 

Zone Model/Exposure Analysis 

Modeling System (PRZM/EXAMS) was 

performed to calculate the estimated 

drinking water concentrations (EDWCs) 

of sodium lauryl sulfate. Modeling runs 

on four surrogate inert ingredients using 

a range of physical chemical properties 

that would bracket those of sodium 

lauryl sulfate were conducted. Modeled 

acute drinking water values ranged from 

0.001 parts per billion (ppb) to 41 ppb. 

Modeled chronic drinking water values 

ranged from 0.0002 ppb to 19 ppb. 

Further details of this drinking water 

analysis can be found at http:// 

www.regulations.gov in the document 

Sodium Lauryl Sulfate. Human Health 

Risk Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as an Inert 

Ingredients in Pesticide Formulations, 

pages 10 and 25–27 in docket ID 

number EPA–HQ–OPP–2008–0041. 

For the purpose of the screening level 

dietary risk assessment to support this 

request for an exemption from the 

requirement of a tolerance for sodium 

lauryl sulfate, a conservative drinking 

water concentration value of 100 ppb 

based on screening level modeling was 

used to assess the contribution to 

drinking water for chronic dietary risk 

assessments for the parent compounds 

and for the metabolites of concern. 

These values were directly entered into 

the dietary exposure model. 

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). Sodium 

lauryl sulfate may be used as an inert 

ingredient in pesticide products that are 

registered for specific uses that may 

result in both indoor and outdoor 

residential exposures. A screening level 

residential exposure and risk 

assessment was completed for products 

containing sodium lauryl sulfate. The 

Agency conducted an assessment to 

represent worst-case residential 

exposure by assessing sodium lauryl 

sulfate in pesticide formulations 

resulting in the highest residential 

exposures, including both residential 

handler exposures and residential postapplication exposures. Further details of 

this residential exposure and risk 

analysis can be found at http:// 

www.regulations.gov in the document 

Joint Insert Task Force (JITF) Inert 

Ingredients. Residential and 

Occupational Exposure Assessment 

Algorithms and Assumptions Appendix 

for the Human Health Risk Assessments 

to Support Proposed Exemption from 

the Requirement of a Tolerance When 

Used as Inert Ingredients in Pesticide 

Formulations, in docket ID number 

EPA–HQ–OPP–2008–0710. 

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 sodium lauryl sulfate to share a 

common mechanism of toxicity with 

any other substances, and sodium lauryl 

sulfate does not appear to produce a 

toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that sodium lauryl sulfate 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 website 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 prenatal and postnatal toxicology 

database for sodium lauryl sulfate 

includes a prenatal developmental 

toxicity study in rats, rabbits, and mice 

as well as a 2-generation reproduction 

toxicity study in rats on a closely related 

compound. There was no evidence of 

increased quantitative or qualitative 

susceptibility following in utero 

exposure of rats, rabbits or mice in the 

developmental toxicity study and no 

evidence of increased quantitative or 

qualitative susceptibility of offspring in 

the reproduction study. Developmental 

toxicity was not observed in the 

developmental toxicity study at doses 

below that which maternal toxicity was 

also observed. In the reproduction 

study, no offspring or maternal toxicity 

was observed at the highest dose tested 

(HDT) of 285 mg/kg/day. There is no 

evidence of neurotoxicity in the toxicity 

database for sodium lauryl sulfate. 

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 sodium 

lauryl sulfate is considered adequate for 

assessing the risks to infants and 

children (the available studies are 

described in Unit IV.D.2.). 

ii. No evidence of quantitative or 

qualitative increased susceptibility was 

demonstrated in the offspring in a 


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40508 Federal Register / Vol. 74, No. 154 / Wednesday, August 12, 2009 / Rules and Regulations 

developmental toxicity study in rats, 

rabbits, and mice following in utero and 

prenatal exposure or in young rats in the 

2-generation reproduction study. 

iii. There is no indication that sodium 

lauryl sulfate is a neurotoxic chemical 

and thus there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iv. The Agency has concluded that an 

additional uncertainty factor is not 

needed for the use of a subchronic study 

for a chronic exposure assessment as 

reported NOAELs in two chronic rat 

studies were at the same levels as the 

POD derived from a subchronic toxicity 

study. 

v. There are no residual uncertainties 

identified in the exposure databases. 

The food and drinking water assessment 

is not likely to underestimate exposure 

to any subpopulation, including those 

comprised of infants and children. The 

food exposure assessments are 

considered to be highly conservative as 

they are based on the use of the highest 

tolerance level from the surrogate 

pesticides for every food and the 

assumption that for all crops, 100% of 

the crop is treated as well as similarly 

conservative assumptions related to the 

transfer of residues of sodium lauryl 

sulfate into food from its use in food 

contact sanitizing solutions. EPA also 

made conservative (protective) 

assumptions in the ground water and 

surface water modeling used to assess 

exposure to sodium lauryl sulfate in 

drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children as well 

as incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by sodium lauryl sulfate. 

E. 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 SFs. 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. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing 

the estimated aggregate 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. 

1. Acute risk. There was no hazard 

attributable to a single exposure seen in 

the toxicity database for sodium lauryl 

sulfate. Therefore, sodium lauryl sulfate 

is not expected to pose an acute risk. 

2. Chronic risk. A chronic aggregate 

risk assessment takes into account 

exposure estimates from chronic dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for chronic 

exposure, the chronic dietary exposure 

from food and water to sodium lauryl 

sulfate is 19% of the cPAD for the U.S. 

population and 67% of the cPAD for 

children 1 to 2 years old, the most 

highly exposed population subgroup. 

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). 

Sodium lauryl sulfate is used in 

pesticide products that are currently 

registered for uses that could result in 

short-term residential exposure and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

sodium lauryl sulfate. Using the 

exposure assumptions described in this 

unit, EPA has concluded that the 

combined short-term aggregated food, 

water, and residential exposures result 

in aggregate MOEs of 500, for both adult 

males and females, respectively. Adult 

residential exposure combines high end 

dermal and inhalation handler indoor 

and outdoor exposure with a high end 

post application dermal exposure. EPA 

has concluded that the combined shortterm aggregated food, water, and 

residential exposures result in an 

aggregate MOE of 147 for children. 

Children′s residential exposure 

combines outdoor and indoor dermal 

and hand-to-mouth exposures. As the 

level of concern is for MOEs that are 

lower than 100, these MOEs are not of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Sodium lauryl sulfate is used in 

products currently registered for uses 

that could result in intermediate-term 

residential exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with intermediate-term 

residential exposures to sodium lauryl 

sulfate. Using the exposure assumptions 

described in this unit, EPA has 

concluded that the combined 

intermediate-term aggregated food, 

water, and residential exposures result 

in aggregate MOEs of 660 for both adult 

males and females, respectively. Adult 

residential exposure includes high end 

post application dermal exposure from 

contact with treated lawns. EPA has 

concluded that the combined 

intermediate-term aggregated food, 

water, and residential exposures result 

in an aggregate MOE of 148 for children. 

Children′s residential exposure 

combines outdoor and indoor dermal 

and hand-to-mouth exposures. As the 

level of concern is for MOEs that are 

lower than 100, these MOEs are not of 

concern. 

5. Aggregate cancer risk for U.S. 

population. The Agency has not 

identified any concerns for 

carcinogenicity relating to sodium 

lauryl sulfate. 

6. Determination of safety. Based on 

these risk assessments and the 

limitation imposed in the exemption, 

EPA concludes that, with respect to the 

exemption, there is a reasonable 

certainty that no harm will result to the 

general population, or to infants and 

children from aggregate exposure to 

residues of sodium lauryl sulfate under 

reasonably foreseeable circumstances. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

B. International Residue Limits 

The Agency is not aware of any 

country requiring a tolerance for sodium 

lauryl sulfate nor have any CODEX 

Maximum Residue Levels been 

established for any food crops at this 

time. 

VI. Conclusion 

Therefore, an exemption from the 

requirement of a tolerance is established 

for residues of sodium lauryl sulfate as 

a component of food contact sanitizing 

solutions applied to all food contact 

surfaces in public eating places, dairyprocessing equipment, and foodprocessing equipment and utensils at a 

maximum level in the end-use 

concentration of 350 ppm. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemtpion from the requirement of a 

tolerance under section 408(d) of 

FFDCA in response to a petition 

submitted to the Agency. The Office of 

Management and Budget (OMB) has 


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Federal Register / Vol. 74, No. 154 / Wednesday, August 12, 2009 / Rules and Regulations 40509 

exempted these types of actions from 

review under Executive Order 12866, 

entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993). 

Because this final rule has been 

exempted from review under Executive 

Order 12866, this final rule is not 

subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the exemption 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 6, 2009. 

G. Jeffrey Herndon, 

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 §180.940(a), the table is amended 

by revising the following entry to read 

as follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) *** 

Pesticide chemical CAS Reg. No. Limits 

* * * * * * * 

Sulfuric acid monododecyl ester, sodium salt (sodium lauryl sulfate). 151–21–3 When ready for use, the end-use concentration is not to exceed 350 ppm. 

* * * * * * * 

* * * * * 

[FR Doc. E9–19314 Filed 8–11–09 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0129; FRL–8426–3] 

Carbon Black; Exemption from the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of carbon black 

(CAS Reg. No. 1333–86–4) under 40 

CFR 180.920 when used as an inert 

ingredient (colorant) in pesticide 

formulations applied to seeds used to 

grow agricultural and horticultural 

crops. Becker Underwood, Inc. 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of carbon black. 

DATES: This regulation is effective 

August 12, 2009. Objections and 

requests for hearings must be received 

on or before October 13, 2009, 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–2009–0129. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 


jlentini on DSKJ8SOYB1PROD with RULES