Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations 32433 

regulatory activities unless the agency 

provides Congress, through the Office of 

Management and Budget, with an 

explanation of why using these 

standards would be inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedures; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This rule does not use technical 

standards. Therefore, we did not 

consider the use of voluntary consensus 

standards. 

Environment 

We have analyzed this rule under 

Department of Homeland Security 

Management Directive 023–01 and 

Commandant Instruction M16475.lD, 

which guide the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have concluded this action is one of a 

category of actions which do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule is categorically 

excluded, under figure 2–1, paragraph 

(34)(h), of the Instruction. This rule 

involves implementation of regulations 

within 33 CFR part 100 that apply to 

organized marine events on the 

navigable waters of the United States 

that may have potential for negative 

impact on the safety or other interests of 

waterway users and shore side activities 

in the event area. The category of water 

activities includes but is not limited to 

sail boat regattas, boat parades, power 

boat racing, swimming events, crew 

racing, and sailboard racing. 

Under figure 2–1, paragraph (34)(h), 

of the Instruction, an environmental 

analysis checklist and a categorical 

exclusion determination are not 

required for this rule. 

List of Subjects in 33 CFR Part 100 

Marine safety, Navigation (water), 

Reporting and recordkeeping 

requirements, Waterways. 

■ For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 100 as follows: 

PART 100—SAFETY OF LIFE ON 

NAVIGABLE WATERS 

■ 1. The authority citation for part 100 

continues to read as follows: 

Authority: 33 U.S.C. 1233. 

■ 2. In the Table to § 100.501: 

■ a. Suspend line No. 41 from July 12, 

2009 to July 31, 2009; and 

■ b. From 9 a.m. to 5:30 p.m., on July 

12, 2009, add line No. 63. 

The addition reads as follows: 

§ 100.501. Special Local Regulations; 

Marine Events in the Fifth Coast Guard 

District. 

* * * * * 

Table to § 100.501.—All coordinates 

listed in the Table to § 100.501 reference 

Datum NAD 1983. 

COAST GUARD SECTOR HAMPTON ROADS—COTP ZONE

Number Date Event Sponsor Location 

* * * * * * * 

63 ......... July 12, 2009 Watermen’s Heritage 

Festival Workboat 

Races.

Watermen’s Museum of 

Yorktown, VA.

The waters of the York River, Yorktown, Virginia, 

bounded on the west by a line drawn along longitude 076°31′25′′ W, bounded on the east by a 

line drawn along longitude 076°30′55′′ W, 

bounded on the south by the shoreline and 

bounded on the north by a line drawn parallel 

and 400 yards north of the southern shoreline. 

Dated: June 24, 2009. 

Fred M. Rosa, Jr., 

Rear Admiral, U.S. Coast Guard, Commander, 

Fifth Coast Guard District. 

[FR Doc. E9–16063 Filed 7–2–09; 4:15 pm] 

BILLING CODE 4910–15–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0739; FRL–8423–3] 

Sodium 1,4-Dialkyl Sulfosuccinates; 

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 1,4- 

dialkyl sulfosuccinates including 

sodium 1,4-dihexyl sulfosuccinate (CAS 

Reg. No. 3006–15–3); sodium 1,4– 

diisobutyl sulfosuccinate (CAS Reg. No. 

127–39–9); and sodium 1,4–dipentyl 

sulfosuccinate (CAS Reg. No. 922–80–5) 

when used as inert ingredients in 

pesticide formulations applied to 

growing crops. The Joint Inerts Task 

Force (JITF), Cluster Support Team 

Number 13 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 sodium 

1,4–dialkyl sulfosuccinates. 

DATES: This regulation is effective July 

8, 2009. Objections and requests for 

hearings must be received on or before 

September 8, 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–2008–0739. 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 


sroberts on DSKD5P82C1PROD with RULES
32434 Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations 

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 those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I 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 EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http://

www.epa.gpo/opptsfrs/home/ 

guidelin.htm. 

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. 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–2008–0739 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 

as required by 40 CFR part 178 on or 

before September 8, 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 this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0738, 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 December 3, 

2008 (73 FR 73640) (FRL–8390–4), EPA 

issued a notice pursuant to section 

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

346a(d)(3), announcing the filing of a 

pesticide petition (PP 8E7423) by The 

Joint Inerts Task Force (JITF), Cluster 

Support Team Number 23 (CST 13), c/ 

o CropLife America, 1156 15th Street, 

N.W., Suite 400, Washington, DC 20005. 

The petition was subsequently 

redesignated as PP 8E7422. The petition 

requested that 40 CFR 180.920 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of the inert ingredients sodium 

1,4-dialkyl sulfosuccinates including 

sodium 1,4-dihexyl sulfosuccinate (CAS 

Reg. No. 3006–15–3); sodium 1,4- 

diisobutyl sulfosuccinate (CAS Reg. No. 

127–39–9); and sodium 1,4-dipentyl 

sulfosuccinate (CAS Reg. No. 922–80–5) 

(these substances are also collectively 

referred to throughout this document as 

SDSS). That notice referenced a 

summary of the petition prepared by the 

JITF CST 13, the petitioner which is 

available to the public in the docket, 

http://www.regulations.gov. There were 

no substantive comments received in 

response to the notice of filing. 

This petition was submitted in 

response to a final rule of August 9, 

2006, (71 FR 45415) (FRL–8084–1) in 

which the Agency revoked, under 

section 408(e)(1) of the Federal Food, 

Drug, and Cosmetic Act (FFDCA), the 

existing exemptions from the 

requirement of a tolerance for residues 

of certain inert ingredients because of 

insufficient data to make the 

determination of safety required by 

FFDCA section 408(b)(2). The expiration 

date for the tolerance exemptions 

subject to revocation was August 9, 

2008, which was later extended to 

August 9, 2009 (73 FR 45317) to allow 

for data to be submitted to support the 

establishment of tolerance exemptions 

for these inert ingredients prior to the 

effective date of the tolerance exemption 

revocation. 

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 polymers 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. 

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 


sroberts on DSKD5P82C1PROD with RULES
Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations 32435 

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 1,4- 

dialkyl sulfosuccinates when used as 

inert ingredients in pesticide 

formulations applied to growing crops 

or food-producing animals. 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. 

Sodium 1,4-dialkyl sulfosuccinates 

have moderate to low acute oral toxicity 

and low dermal acute toxicity. There 

was no hazard identified in a combined 

repeat dose rat reproductive/ 

developmental screening study at the 

limit dose of 1,000 milligrams/kilogram/ 

day (mg/kg/day) to either parental 

animals or their offspring. There is no 

concern for neurotoxicity, 

immunotoxicity or carcinogenicity for 

SDSS. 

Specific information on the studies 

received and the nature of any observed 

effects caused by the sodium 1,4-dialkyl 

sulfosuccinates as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found at http:// 

www.regulations.gov in document 

‘‘Sodium 1,4-Dialkyl Sulfosuccinates 

(JITF CST 13 Inert Ingredients). Human 

Health Risk Assessment to Support 

Proposed Exemption from the 

Requirement of a Tolerance When Used 

as Inert Ingredients in Pesticide 

Formulations’’ pages 6–8 in docket ID 

number EPA–HQ–OPP–2008–0739. 

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. 

There was no hazard identified in a 

combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening test in rats with SDSS 

at the limit dose of 1,000 milligrams/ 

kilogram/day (mg/kg/day) to either 

parental animals or their offspring. 

Thus, due to their low potential hazard 

and the lack of a hazard endpoint, the 

Agency has determined that a 

quantitative risk assessment using safety 

factors applied to a point of departure 

protective of an identified hazard 

endpoint is not appropriate. 

No mutagenicity, genotoxicity or 

chronic toxicity data have been located 

for any of the sodium 1,4-dialkyl 

sulfosuccinates. However, no structural 

alerts for genotoxicity or carcinogenicity 

were identified in a qualitative structure 

activity relationship (SAR) database, 

DEREK Version 11. In addition, data for 

similar compounds showed they are not 

mutagenic or carcinogenic. The primary 

alcohol mammalian metabolites of SDSS 

have been shown to be negative in the 

in vitro Ames test. Furthermore, a 

structurally similar compound that is 

also used as an inert ingredient, sodium 

dioctyl sulfosuccinate (CAS Reg. No. 

577–11–7) was not mutagenic, or 

carcinogenic in a chronic rat study or a 

tumor promotion study. Based on the 

above, sodium 1,4-dialkyl 

sulfosuccinates are not expected to be 

carcinogenic. 

C. Exposure Assessment 

1. Dietary exposure (from food and 

feed uses and drinking water). Since an 

endpoint for risk assessment was not 

identified, an exposure assessment for 

SDSS was not conducted. Any possible 

dietary exposure SDSS from their use as 

inert ingredients in pesticide products 

would be through consumption of food 

to which pesticide products containing 

SDSS have been applied and through 

drinking water (from runoff). 

2. 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). Since an 

endpoint for risk assessment was not 

identified, a quantitative residential 

exposure assessment for SDSS was not 

conducted. Residential exposures to 

SDSS may occur as a result of the use 

of pesticide products containing SDSS 

as inert ingredients (such as 


sroberts on DSKD5P82C1PROD with RULES
32436 Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations 

antimicrobial hard surface cleaners) as 

well as from other, nonpesticidal, 

residential use products containing 

SDSS. 

3. 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 SDSS to share a 

common mechanism of toxicity with 

any other substances, and sodium 1,4- 

dialkyl sulfosuccinates do not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that sodium 1,4-dialkyl 

sulfosuccinates do 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. 

The toxicity database for SDSS is 

adequate for FQPA assessment and the 

potential exposure is adequately 

characterized given the low toxicity of 

the chemical. There was no hazard 

identified in a combined repeat dose rat 

reproductive/developmental screening 

study at the limit dose of 1,000 mg/kg/ 

day to either parental animals or their 

offspring. There is no concern for 

neurotoxicity, immunotoxicity or 

carcinogenicity for the sodium 1,4- 

dialkyl sulfosuccinates. 

Based on this information, there is no 

concern, at this time, for increased 

sensitivity to infants and children to 

sodium 1,4-dialkyl sulfosuccinates 

when used as inert ingredients in 

pesticide formulations applied to 

growing crops and a safety factor 

analysis has not been used to assess 

risk. For the same reason, EPA has 

determined that an additional safety 

factor is not needed to protect the safety 

of infants and children. 

E. Aggregate Risks and Determination of 

Safety 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be demonstrated that 

the risks from aggregate exposure to 

pesticide chemical residues under 

reasonably foreseeable circumstances 

will pose no appreciable risks to human 

health. In order to determine the risks 

from aggregate exposure to pesticide 

inert ingredients, the Agency considers 

the toxicity of the inert ingredient in 

conjunction with possible exposure to 

residues of the inert ingredient through 

food, drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. If 

EPA is able to determine that a finite 

tolerance is not necessary to ensure that 

there is a reasonable certainty that no 

harm will result from aggregate 

exposure to the inert ingredient, an 

exemption from the requirement of a 

tolerance may be established. 

Since an endpoint for risk assessment 

was not identified, a quantitative dietary 

risk assessment for sodium 1,4-dialkyl 

sulfosuccinates was not conducted. 

Given the lack of concern for hazard 

posed by SDSS, EPA concludes that 

there are no dietary risks of concern as 

a result of exposure to SDSS in food and 

water. Similarly, based on the lack of 

concern for hazard posed by the SDSS 

inert ingredients, the Agency concludes 

that there are no non-dietary/nonoccupational (residential) risks of 

concern for these inert ingredients. The 

Agency has not identified any concerns 

for carcinogenicity relating to sodium 

1,4-dialkyl sulfosuccinates. 

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 

residues of sodium 1,4-dialkyl 

sulfosuccinates. 

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 

1,4-dialkyl sulfosuccinates 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 1,4-dialkyl 

sulfosuccinates when used inert 

ingredients in pesticide formulations 

applied to growing crops or to animals. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes exemptions 

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 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 exemptions 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, 


sroberts on DSKD5P82C1PROD with RULES
Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations 32437 

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: June 25, 2009. 

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 § 180.920, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

***** * *

Sodium 1,4-dihexyl sulfosuccinate (CAS Reg. No. 3006–15– 

3).

..................................................... Surfactants, related adjuvants of surfactants 

***** * *

Sodium 1,4-diisobutyl sulfosuccinate (CAS Reg. No. 127– 

39–9).

..................................................... Surfactants, related adjuvants of surfactants 

***** * *

Sodium 1,4-dipentyl sulfosuccinate (CAS Reg. No. 922–80– 

5).

..................................................... Surfactants, related adjuvants of surfactants 

***** * *

* * * * * 

[FR Doc. E9–16086 Filed 7–7–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0140; FRL–8417–4] 

d-Phenothrin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of the insecticide 

d-phenothrin [(3- 

phenoxyphenyl)methyl] 2,2-Dimethyl-3- 

(2-methyl-1- 

propenyl)cyclopropanecarboxylate in or 

on all food/feed crops at 0.01 parts per 

million (ppm) following wide-area 

mosquito adulticide applications. 

McLaughlin Gormley King Company 

requested these tolerances under the 

Federal Food, Drug and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective July 

8, 2009. Objections and requests for 

hearings must be received on or before 

September 8, 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–2008–0140. 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 Room S– 

4400, One Potomac Yard (South 

Building), 2777 S. Crystal Dr., 

Arlington, VA 22202–4501. 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: 

Carmen Rodia, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Avenue, NW., 

Washington, DC 20460–0001; telephone 

number: (703) 306–0327; fax number: 

(703) 308–0029; e-mail address: 

rodia.carmen@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to, those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 


sroberts on DSKD5P82C1PROD with RULES