38962 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 

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 tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of 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: July 21, 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 §180.920, 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 

*******

Methyl poly(oxyethylene)C8–C18 alkylammonium 

chlorides where the poly(oxyethylene) content is 

n=2–15 and where C8–C18 alkyl is linear and may be 

saturated or unsaturated (CAS Reg. Nos. 3010–24– 

0, 18448–65–2, 70750–47–9, 22340–01–8, 67784– 

77–4, 64755–05–1, 61791–10–4, 28724–32–5, 

28880–55–9, 68187–69–9, 68607–27–2, 60687–90– 

3. 

Concentration in formulated end use products not to 

exceed 10% by weight in herbicide products and 5% 

by weight in all other pesticide products. 

Surfactants, related adjuvants of surfactants 

*******

[FR Doc. E9–18348 Filed 8–4–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0099; FRL–8428–6] 

Sodium Alkyl Naphthalenesulfonate; 

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 alkyl 

naphthalenesulfonate, herein referred to 

in this document as SANS, when used 

as an inert ingredient at a maximum of 

30% by weight in pesticide 

formulations for pre-harvest and postharvest uses, as well as, for application 

to animals. The Joint Inerts Task Force 

(JITF), Cluster Support Team Number 

10, 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 SANS. 

DATES: This regulation is effective 

August 5, 2009. Objections and requests 

for hearings must be received on or 

before October 5, 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–2009–0099. All documents in the 

docket are listed in the docket index 


srobinson on DSKHWCL6B1PROD with RULES
Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 38963 

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 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–2009–0099 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 

October 5, 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–2009–0099, 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 April 15, 

2009 (74 FR 17487) (FRL–8409–7), 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 9E7524) by The 

Joint Inerts Task Force (JITF), Cluster 

Support Team 10 (CST 10), c/o CropLife 

America, 1156 15th Street, NW., Suite 

400, Washington, DC 20005. The 

petition requested that 40 CFR 180.910 

and 40 CFR 180.930 be amended by 

establishing exemptions from the 

requirement of a tolerance for residues 

of the inert ingredient sodium alkyl 

naphthalenesulfonate (SANS). That 

notice referenced a summary of the 

petition prepared by JITF (CST 10), the 

petitioner, which is available to the 

public in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

modified the exemptions requested by 

adding a use limitation of not more than 

30% by weight in pesticide 

formulations applied pre-and postharvest and in pesticide formulations 

applied to animals. This limitation is 

based on the Agency’s risk assessment 

which can be found at http:// 

www.regulations.gov in document 

Sodium Alkyl Naphthalenesulfonate 

(SANS) – JITF CST 10 Inert Ingredients). 

Human Health Risk Assessment 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–2009–0099. 

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 

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

expiration date for the tolerance 

exemptions subject to revocation was 

August 9, 2008, which was later 

extended to August 9, 2009 by a final 

rule published in the Federal Register 

of August 4, 2008 (73 FR 45312) (FRL– 

8372–7) 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. 


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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 

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 SANS, when 

used as an inert ingredient in pesticide 

formulations for pre-harvest and postharvest uses, as well as for application 

to animals provided that the 

concentration of the SANS inerts is 

limited to no more than 30% by weight 

in pesticide formulations. 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 representative test compounds for 

the SANS cluster group include (1) an 

aqueous mixture containing 80% 3- 

butyl-naphthalene- 1 sulfonate (CAS 

Reg. No. 25638–17–9) and 20% sodium 

di-3, 6-dibutyl naphthalene-1-sulfonate 

(CAS Reg. No. 25417–20–3); (2) a 

complex mixture from a boiling 

distillate from petroleum catalytic 

reformer fractionator residue that 

includes C9-rich C8-C10-alkyl-sodium 

naphthalenesulfonate (CAS Reg. No. 

908356–16–1); and (3) 

naphthalenesulfonic acid, sodium salt, 

isopropylate (CAS Reg. No. 68442–09– 

1), which is a mixture containing 

sodium diisopropyl and triisopropyl-2- 

naphthalenesulfonates in a 40:60 ratio, 

with 6% of mono-isopropyl-2- 

naphthalenesulfonates. The existing 

toxicology database for the SANS inerts 

consists of an OPPTS Harmonized 

Guideline 870.3650 (combined repeated 

dose toxicity study with the 

reproduction/developmental toxicity 

screening studies in rats) on each of the 

representative SANS, and several 

publicly-available studies on acute 

toxicity. These data are adequate to 

apply to the SANS inerts when used as 

inert ingredients in pesticide 

formulations and to characterize the 

potential toxic effects of these 

surfactants. 

The sodium alkyl 

naphthalenesulfonates have low acute 

oral and inhalation toxicity but are 

irritating to the skin and eye. No 

mutagenicity data are available. The 

OPPTS Harmonized Guideline 870.3650 

combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening tests on three 

representative surfactants demonstrate 

local irritation effects on the 

forestomach/stomach, reduced bodyweight gain during mating (males), and/ 

or decrease in thymus weight and 

thymus atrophy and microscopic lesions 

in the kidney (females) in the parental 

animals. No evidence of neurotoxicity 

was observed in any of the studies. 

There was evidence of increased 

susceptibility to the offspring of rats 

following prenatal or postnatal exposure 

to naphthalenesulfonic acid, sodium 

salt, isopropylate. Increased postimplantation and postnatal losses and 

reduced pup body weights were 

observed at 120 and 288 milligrams/ 

kilograms/day (mg/kg/day), whereas 

maternal toxicity was observed only at 

288 mg/kg/day, as evidenced by 

mortality, and increase in liver enzymes 

and creatinine, increased kidney weight, 

and histopathological lesions in the 

kidney (tubular cell necrosis), stomach 

(inflammatory submucosal infiltrates 

and mucosal ulceration) and liver 

(hepatic fatty change). Based on the fact 

that there is a clear NOAEL for the pup 

effects, the point of departure is based 

on this endpoint (increased postimplantation and postnatal losses and 

reduced pup weight) and is protective of 

the effects seen in the study, and 

because of the highly conservative 

inputs used in both the hazard and 

exposure assessments, there is no 

residual concern for this finding. 

No evidence of increased 

susceptibility was observed following 

prenatal or postnatal exposure to the 

other representative inerts. Following 

exposure to an aqueous mixture 

containing 3-butyl-naphthalene-1 

sulfonate and sodium di-3, 6-dibutyl 

naphthalene-1-sulfonate, parental 

toxicity manifested as microscopic 

forestomach lesions, and developmental 

toxicity manifested as decreased pup 

body weight (↓7-8%). No other 

developmental effects or reproductive 

effects were observed, and there was no 

evidence of neurotoxicity in the adult 

animal. Following exposure to a 

complex mixture from a boiling 

distillate from petroleum catalytic 

reformer fractionator residue that 

includes C9–rich C8-C10-alkyl-sodium 

naphthalenesulfonate, parental toxicity 

manifested as decreased body-weight 

gain during premating (males), 

decreased testes weight, increased 

incidence of hematopoiesis in the liver 

(females), and an increased incidence of 

erosion in the glandular stomach (both 

sexes) at the limit dose. No 

developmental or reproductive effects 

were observed, and there was no 


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Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 38965 

evidence of neurotoxicity in the adult 

animal at the limit dose. 

The SANS metabolism and 

elimination are contingent on both the 

nature of the alkyl groups and the 

nature and extent of naphthalene ring 

substituents. The Agency’s August 1998 

‘‘Toxicological Review of Naphthalene 

(CAS Reg. No. 91–20–3)’’ states that the 

in vivo and in vitro metabolism of the 

parent unsubstituted naphthalene has 

been studied extensively in mammalian 

systems. Without a functional group for 

conjugation, it is expected that the 

majority of absorbed unsubstituted 

naphthalene is eliminated and will 

proceed through microsome cytochrome 

P-450 oxygenases to 1- and 2-napthols. 

However, in the case of the CST 10 

SANS surfactants, in addition to 

microsome cytochrome P-450 

oxygenases, the 1- or 2-sulfonic acid 

sodium salt moieties on the naphthalene 

ring may provide a handle by which 

these compounds can be readily 

conjugated and eliminated. 

There is no evidence that the SANS 

inerts are carcinogenic. The Agency 

used a qualitative structure activity 

relationship (SAR) database, DEREK 

Version 11, to determine if there were 

structural alerts. No structural alerts 

were identified. In addition, there was 

little concern that any of the postulated 

metabolites would have greater toxicity 

than the parent compounds. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by the SANS, as well as, 

the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in document 

Sodium Alkyl Naphthalenesulfonate 

(SANS) – JITF CST 10 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 9-13 and 46-53 in 

docket ID number EPA–HQ–OPP–2009– 

0099. 

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-, 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 SANS used for human 

health risk assessment is shown in the 

following Table 1. 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SANS FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/Scenario Point of Departure and Uncertainty/Safety Factors 

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

Acute dietary (all populations) No appropriate endpoints identified for acute dietary assessment. 

Chronic dietary (all populations) NOAEL = 50 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.5 mg/kg/day 

cPAD = 0.5 mg/kg/day 

OPPTS Harmonized Guideline 

870.3650 

Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity 

Screen in Rats 

LOAEL = 120 mg/kg/day, based 

on increased postnatal loss, reduced viability, decreased birth 

index 

Incidental Oral, (Short- and Intermediate-Term), Dermal and Inhalation (Short, Intermediate-, 

and Long-term) 

NOAEL = 50 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

(5% dermal absorption; inhalation 

hazard assumed to be equivalent to oral hazard) 

Residential LOC for MOE = 100 OPPTS Harmonized Guideline 

870.3650 

Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity 

Screen in Rats 

LOAEL = 120 mg/kg/day, based 

on increased postnatal loss, reduced viability, decreased birth 

index. 


srobinson on DSKHWCL6B1PROD with RULES
38966 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SANS FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/Scenario Point of Departure and Uncertainty/Safety Factors 

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

Cancer (oral, dermal, inhalation) Classification: No animal toxicity data available for an assessment. Based on SAR analysis, SANS are 

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. N/A = not applicable. 

C. Exposure Assessment 

Very limited information is available 

for the sodium alkyl 

naphthalenesulfonates (SANS) with 

respect to plant and animal metabolism 

or environmental degradation. The 

Agency relied collectively on 

information provided on the 

representative chemical structures, the 

submitted physicochemical data, 

structure-activity relationship 

information, as well as information on 

other surfactants and chemicals of 

similar size and functionality to 

determine the residues of concern for 

these inert ingredients. Based on SAR 

analysis the SANS inerts are unlikely to 

degrade in the environment to 

compounds that are more toxic than the 

parent compounds; therefore, the parent 

compounds SANS are the residues of 

concern. 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to SANS, EPA considered 

exposure under the petitioned-for 

exemptions from the requirement of a 

tolerance. EPA assessed dietary 

exposures from SANS in food as 

follows: 

i. Acute exposure. No adverse effects 

attributable to a single exposure of 

SANS was seen in the toxicity 

databases. Therefore, an acute dietary 

risk assessment for SANS 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 SANS. 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 contained in the 

memorandum entitled Alkyl Amines 

Polyalkoxylates (Cluster 4): Acute and 

Chronic Aggregate (Food and Drinking 

Water) Dietary Exposure and Risk 

Assessments for the Inerts (D361707, S. 

Piper, 2/25/09) and can be found at 

http://www.regulations.gov 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. 

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 concentrations 

of active ingredient 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 which 

additionally reduces the concentration 

of any single inert ingredient in the 

pesticide product in relation to that of 

the active ingredient. In the case of 

SANS, EPA made a specific adjustment 

to the dietary exposure assessment to 

account for the use limitations of the 

amount of SANS that may be in 

formulations (no more than 30% by 

weight in pesticide formulations) and 

assumed that the SANS are present at 

the maximum limitations rather than at 

equal quantities with the active 

ingredient. This remains a very 

conservative assumption because 

surfactants are generally used at levels 

far below this percentage. 

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 

what level of inert residue 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 shows that tolerance level residues 

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. The Agency used a 

qualitative structure activity 

relationship (SAR) database, DEREK11, 

to determine if there were structural 


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alerts suggestive of carcinogenicity. No 

structural alerts for carcinogenicity were 

identified. SANS are not expected to be 

carcinogenic. Therefore, a cancer dietary 

exposure assessment is not necessary to 

assess cancer risk. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for SANS. 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 SANS in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of SANS. 

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 SANS. Modeling runs on four 

surrogate inert ingredients using a range 

of physical chemical properties that 

would bracket those of SANS 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 Alkyl Naphthalenesulfonate 

(SANS) – JITF CST 10 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 14-15 and 56-58 in 

docket ID number EPA–HQ–OPP–2009– 

0099. 

For the purpose of the screening level 

dietary risk assessment to support this 

request for an exemption from the 

requirement of a tolerance for SANS, 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). SANS 

may be used as inert ingredients 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 

SANS as inert ingredients. In this 

assessment, representative scenarios 

based on end-use product application 

methods and labeled application rates 

were selected. The SANS may be used 

as inert ingredients in pesticide 

formulations that are used in and 

around the home. Additionally, uses are 

possible in household cleaning 

products. For each of the use scenarios, 

the Agency assessed residential handler 

(applicator) inhalation and dermal 

exposure for indoor and outdoor 

scenarios with high exposure potential 

(i.e., exposure scenarios with high end 

unit exposure values) to serve as a 

screening assessment for all potential 

residential pesticides containing SANS. 

Similarly, residential post application 

dermal and oral exposure assessments 

were also performed utilizing high end 

indoor and outdoor exposure scenarios. 

Further details of this residential 

exposure and risk analysis can be found 

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

memorandum entitled 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 (D364751, 5/7/09, Lloyd/ 

LaMay 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 the SANS to share 

a common mechanism of toxicity with 

any other substances, and the SANS do 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that the 

SANS 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. 

2. Prenatal and postnatal sensitivity. 

The representative test compounds for 

the SANS cluster group includes: 

i. An aqueous mixture containing 

80% 3-butyl-naphthalene-1 sulfonate 

(CAS Reg. No. 25638–17–9) and 20% 

sodium di-3, 6-dibutyl naphthalene-1- 

sulfonate (CAS Reg. No. 25417–20–3); 

ii. A complex mixture from a boiling 

distillate from petroleum catalytic 

reformer fractionator residue that 

includes C9-rich C8-C10-alkyl-sodium 

naphthalenesulfonate (CAS Reg. No. 

908356–16–1); and 

iii. Naphthalenesulfonic acid, sodium 

salt, isopropylate (CAS Reg. No. 68442– 

09–1), which is a mixture containing 

sodium diisopropyl and triisopropyl-2- 

naphthalenesulfonates in a 40:60 ratio, 

with 6% of mono-isopropyl-2- 

naphthalenesulfonates. The existing 

toxicology database for the SANS inerts 

consists of an OPPTS Harmonized 

Guideline 870.3650 combined repeated 

dose toxicity study with the 

reproduction/developmental toxicity 

screening studies in rats on each of the 

representative SANS. 

In the case of the SANS inerts, there 

was no increased susceptibility to the 

offspring of rats following prenatal and 

postnatal exposure in two of the three 

OPPTS Harmonized Guideline 870.3650 

studies. There were no developmental 

effects at any dose level up to the limit 

dose following exposure to (CAS Reg. 

No. 908356–16–1). In that study, 

maternal toxicity was manifested as 

mortality, an increase in liver enzymes 

and creatinine, increased kidney weight, 

and histopathological lesions in the 

kidney (tubular cell necrosis), stomach 

(inflammatory submucosal infiltrates 


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and mucosal ulceration), and liver 

(hepatic fatty change) at 1,000 mg/kg/ 

day. Following exposure to (CAS Reg. 

No. 25638–17–9) and (CAS Reg. No. 

25417–20–3), developmental toxicity 

(decreased pup body weight; ↓7-8%) 

was observed at the same dose level 

where maternal/paternal toxicity was 

observed, as evidenced by microscopic 

lesions in the stomach at 540 mg/kg/ 

day. 

Developmental toxicity was observed 

following exposure to (CAS Reg. No. 

68442–09–1) at a dose level where no 

significant effects were observed in the 

parental animals. Offspring effects 

included increases in post-implantation 

loss and postnatal loss and lower pup 

body weights at dose levels of 120 and 

288 mg/kg/day. Parental toxicity was 

observed at 288 mg/kg/day, as 

evidenced by mortality, increased 

kidney weight and histopathological 

lesions in the kidney (tubular cell 

necrosis), stomach (inflammatory 

submucosal infiltrates and mucosal 

ulceration), and liver (hepatic fatty 

change), and increase in liver enzymes 

and creatinine in females. Based on the 

fact that there is a clear NOAEL (50 mg/ 

kg/day), the point of departure is based 

on this endpoint (increased postnatal 

loss, decreased pup viability, reduced 

birth index) and is protective of the 

effects seen in the study, and because of 

the highly conservative inputs used in 

both the hazard and exposure 

assessments, there is no residual 

concern for this finding. 

3. Conclusion. 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: 

i. The toxicity database for SANS is 

considered adequate for assessing the 

risks to infants and children (the 

available studies are described in unit 

IV.D.2.). The Agency noted changes in 

thymus weight and thymus atrophy. 

However, these were determined to be 

non-specific changes not indicative of 

immunotoxicity. In addition, no blood 

parameters were affected. Furthermore, 

these compounds do not belong to a 

class of chemicals that would be 

expected to be immunotoxic. Therefore, 

the Agency does not believe that an 

additional uncertainty factor (UFdb) for 

database uncertainties needs to be 

applied. In addition, this effect was not 

observed in the pups. 

ii. No increased susceptibility of the 

offspring or reproductive toxicity was 

demonstrated in the OPPTS 

Harmonized Guideline 870.3650 

reproductive/developmental toxicity 

studies in rats following prenatal and 

postnatal exposure to two of the three 

representative compounds (540 and 

1,000 mg/kg/day). Increased 

susceptibility was demonstrated in the 

rat offspring following prenatal and 

postnatal exposure to one of the three 

representative compounds. Decreased 

pup body weight, increased pup 

mortality, and a lower viability index 

were observed (120 and 288 mg/kg/day) 

at a dose level where no parental 

toxicity was observed. A clear NOAEL 

was established for these effects, and the 

point of departure is based on this 

endpoint. Reproductive toxicity was 

observed following exposure to one of 

the representative inerts (120 and 288 

mg/kg/day), as evidenced by the 

reduction in birth index. A clear 

NOAEL was established for this effect 

and the point of departure for risk 

assessment is significantly below the 

NOAEL for this effect. The selected 

point of departure for the dietary, 

dermal and inhalation risk assessments 

is protective of these offspring effects, 

thus there are no residual concerns. 

iii. There is no indication that SANS 

are neurotoxic chemicals and thus there 

is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iv. While there is no chronic toxicity 

data, the Agency has concluded that an 

additional uncertainty factor is not 

needed for the use of a subchronic study 

for a chronic exposure assessment 

because the adverse effects observed in 

the available toxicity studies are 

attributable to the irritant nature of 

surfactants and would not be expected 

to increase in severity from subchronic 

to chronic exposure scenarios. Based on 

the lack of progression of severity of 

effects with time, along with the 

considerable similarities of effects 

across the species tested, the 

observation that the vast majority of the 

effects observed are related to local 

irritation and corrosive effects, and the 

highly conservative nature of the 

exposure assessment, EPA concludes 

that an additional UF for extrapolation 

from subchronic toxicity study to a 

chronic exposure scenario is not 

needed. 

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 100% crop 

treated is assumed for all crops. EPA 

also made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to SANS in drinking water. EPA used 

similarly conservative assumptions to 

assess post-application exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by SANS. 

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. 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.There was no hazard 

attributable to a single exposure seen in 

the toxicity database for SANS. 

Therefore, the SANS are 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, and the use limitations of not 

more than 30% by weight in pesticide 

formulations, the chronic dietary 

exposure from food and water to SANS 

is 23% of the cPAD for the U.S. 

population and 75% 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). 

SANS are used as inert ingredients 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 

SANS. Using the exposure assumptions 

described in this unit, EPA has 

concluded that the combined short-term 

food, water, and residential exposures 

aggregated result in aggregate MOEs of 


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120 for both adult males and females, 

respectively. Adult residential exposure 

combines high end dermal and 

inhalation handler exposure with a high 

end post application dermal exposure. 

EPA has concluded that the combined 

short-term aggregated food, water, and 

residential exposures result in an 

aggregate MOE of 120 for children. 

Children’s residential exposure 

combines 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). 

SANS are 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 SANS. 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 520 for both 

adult males and females, respectively. 

Adult residential exposure includes 

high end post application dermal 

exposures. EPA has concluded that the 

combined intermediate-term aggregated 

food, water, and residential exposures 

result in an aggregate MOE of 130 for 

children. Children’s residential 

exposure combines dermal and hand-tomouth 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 SANS. 

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 residues of 

SANS. 

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 SANS 

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 alkyl 

naphthalenesulfonates when used as 

inert ingredients applied to crops preharvest and post-harvest, and to animals 

at a maximum of 30% by weight in 

pesticide formulations. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the requirement of 

tolerances 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, 

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: July 29, 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 § 180.910, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 


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38970 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

* * * * * * * 

Sodium alkyl naphthalenesulfonates (CAS Reg. Nos. 68909–83–1, 68909–84–2, 

68909–82–0, 27213–90–7, 26264–58–4, 27178–87–6, 111163–74–7, 908356–16–1, 

25417–20–3, 25638–17–9, 145578–88–7, 1322–93–6, 1323–19–9, 7403–47–6, 

68442–09–1, 127646–44–0, 908356–18–3).

Limited to no more than 

30% by weight in pesticide end-use products.

Surfactants, related adjuvants of surfactants 

* * * * * * * 

■ 4. In § 180.930, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

* * * * * * * 

Sodium alkyl naphthalenesulfonates (CAS Reg. Nos. 68909–83–1, 68909–84–2, 

68909–82–0, 27213–90–7, 26264–58–4, 27178–87–6, 111163–74–7, 908356–16–1, 

25417–20–3, 25638–17–9, 145578–88–7, 1322–93–6, 1323–19–9, 7403–47–6, 

68442–09–1, 127646–44–0, 908356–18–3).

Limited to no more than 

30% by weight in pesticide end-use products.

Surfactants, related adjuvants of surfactants 

* * * * * * * 

[FR Doc. E9–18702 Filed 8–4–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0881; FRL–8429–1] 

Pasteuria usgae; Temporary Exemption 

From the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

temporary exemption from the 

requirement of a tolerance for residues 

of the microbial pesticide, Pasteuria 

usgae, on strawberries when applied/ 

used as a nematicide in accordance with 

the terms of Experimental Use Permit 

(EUP) 85004-EUP-1. MacIntosh and 

Associates, Incorporated, 1203 Hartford 

Avenue, Saint Paul, MN 55116–1622 

(on behalf of Pasteuria Bioscience, 

Incorporated, 12085 Research Drive, 

Suite 185, Alachua, FL 32615) 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting the temporary 

tolerance exemption. This regulation 

eliminates the need to establish a 

maximum permissible level for residues 

of Pasteuria usgae in or on strawberries. 

The temporary tolerance exemption 

expires on December 31, 2010. 

DATES: This regulation is effective 

August 5, 2009. Objections and requests 

for hearings must be received on or 

before October 5, 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–2008–0881. 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: 

Jeannine Kausch, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8920; e-mail address: 

kausch.jeannine@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. 


srobinson on DSKHWCL6B1PROD with RULES