38924 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 

Express Mail Contract 3 (MC2009–15 and 

CP2009–21) 

Express Mail & Priority Mail Contract 1 

(MC2009–6 and CP2009–7) 

Express Mail & Priority Mail Contract 2 

(MC2009–12 and CP2009–14) 

Express Mail & Priority Mail Contract 3 

(MC2009–13 and CP2009–17) 

Express Mail & Priority Mail Contract 4 

(MC2009–17 and CP2009–24) 

Express Mail & Priority Mail Contract 5 

(MC2009–18 and CP2009–25) 

Express Mail & Priority Mail Contract 6 

(MC2009–31 and CP2009–42) 

Express Mail & Priority Mail Contract 7 

(MC2009–32 and CP2009–43) 

Parcel Return Service Contract 1 (MC2009– 

1 and CP2009–2) 

Priority Mail Contract 1 (MC2008–8 and 

CP2008–26) 

Priority Mail Contract 2 (MC2009–2 and 

CP2009–3) 

Priority Mail Contract 3 (MC2009–4 and 

CP2009–5) 

Priority Mail Contract 4 (MC2009–5 and 

CP2009–6) 

Priority Mail Contract 5 (MC2009–21 and 

CP2009–26) 

Priority Mail Contract 6 (MC2009–25 and 

CP2009–30) 

Priority Mail Contract 7 (MC2009–25 and 

CP2009–31) 

Priority Mail Contract 8 (MC2009–25 and 

CP2009–32) 

Priority Mail Contract 9 (MC2009–25 and 

CP2009–33) 

Priority Mail Contract 10 (MC2009–25 and 

CP2009–34) 

Priority Mail Contract 11 (MC2009–27 and 

CP2009–37) 

Priority Mail Contract 12 (MC2009–28 and 

CP2009–38) 

Priority Mail Contract 13 (MC2009–29 and 

CP2009–39) 

Priority Mail Contract 14 (MC2009–30 and 

CP2009–40) 

Outbound International 

Global Direct Contracts (MC2009–9, 

CP2009–10, and CP2009–11) 

Global Expedited Package Services (GEPS) 

Contracts 

GEPS 1 (CP2008–5, CP2008–11, CP2008– 

12, and CP2008–13, CP2008–18, 

CP2008–19, CP2008–20, CP2008–21, 

CP2008–22, CP2008–23, and CP2008–24) 

Global Plus Contracts 

Global Plus 1 (CP2008–9 and CP2008–10) 

Global Plus 2 (MC2008–7, CP2008–16 and 

CP2008–17) 

Inbound International 

Inbound Direct Entry Contracts With 

Foreign Postal Administrations 

(MC2008–6, CP2008–14 and CP2008–15) 

International Business Reply Service 

Competitive Contract 1 (MC2009–14 and 

CP2009–20) 

Competitive Product Descriptions 

Express Mail 

[Reserved for Group Description] 

Express Mail 

[Reserved for Product Description] 

Outbound International Expedited Services 

[Reserved for Product Description] 

Inbound International Expedited Services 

[Reserved for Product Description] 

Priority 

[Reserved for Product Description] 

Priority Mail 

[Reserved for Product Description] 

Outbound Priority Mail International 

[Reserved for Product Description] 

Inbound Air Parcel Post 

[Reserved for Product Description] 

Parcel Select 

[Reserved for Group Description] 

Parcel Return Service 

[Reserved for Group Description] 

International 

[Reserved for Group Description] 

International Priority Airlift (IPA) 

[Reserved for Product Description] 

International Surface Airlift (ISAL) 

[Reserved for Product Description] 

International Direct Sacks—M-Bags 

[Reserved for Product Description] 

Global Customized Shipping Services 

[Reserved for Product Description] 

International Money Transfer Service 

[Reserved for Product Description] 

Inbound Surface Parcel Post (at non-UPU 

rates) 

[Reserved for Product Description] 

International Ancillary Services 

[Reserved for Product Description] 

International Certificate of Mailing 

[Reserved for Product Description] 

International Registered Mail 

[Reserved for Product Description] 

International Return Receipt 

[Reserved for Product Description] 

International Restricted Delivery 

[Reserved for Product Description] 

International Insurance 

[Reserved for Product Description] 

Negotiated Service Agreements 

[Reserved for Group Description] 

Domestic 

[Reserved for Product Description] 

Outbound International 

[Reserved for Group Description] 

Part C—Glossary of Terms and Conditions 

[Reserved] 

Part D—Country Price Lists for International 

Mail [Reserved] 

[FR Doc. E9–18737 Filed 8–4–09; 8:45 am] 

BILLING CODE 7710–FW–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0889; FRL–8430–2] 

Amine Salts of Alkyl (C8-C24) 

Benzenesulfonic Acid 

(Dimethylaminopropylamine, 

Isopropylamine, Mono-, Di-, and 

Triethanolamine); 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 amine salts of 

alkyl (C8-C24) benzenesulfonic acid 

(dimethylaminopropylamine, isopro

pylamine, mono-, di-, and triethano

lamine) when used as an inert 

ingredient in pesticide formulations 

applied to growing crops and applied to 

animals. The Joint Inerts Task Force, 

Cluster Support Team Number 8, 

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 amine salts of alkyl (C8- 

C24) benzenesulfonic acid (dimethyl

aminopropylamine, isopropylamine, 

mono-, di-, and triethanolamine). 

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–2008–0889. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Kerry Leifer, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8811; e-mail address: 

leifer.kerry@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 


srobinson on DSKHWCL6B1PROD with RULES
Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 38925 

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.gov/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–2008–0889 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 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–2008–0889, 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 March 25, 

2009 (74 FR 12856) (FRL–8399–4), 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 8E7472) by The 

Joint Inerts Task Force (JITF), Cluster 

Support Team 8 (CST 8), c/o CropLife 

America, 1156 15th Street, NW., Suite 

400, Washington, DC 20005. The 

petition requested that 40 CFR 180.920 

and 40 CFR 180.930 be amended by 

establishing exemptions from the 

requirement of a tolerance for residues 

of the inert ingredient amine salts of 

alkyl (C8-C24) benzenesulfonic acid 

(dimethylaminopro-pylamine, isopro

pylamine, mono-, di-, and triethanol

amine) (herein referred to in this 

document as ASABSA) including CAS 

Reg. Nos. 68953–97–9, 26545–53–9, 

877677–48–0, 319926–68–6, 90194–53– 

9, 55470–69–4, 68910–32–7, 26264–05– 

1, 157966–96–6, 68584–24–7, 68648– 

81–7, 68649–00–3, 68953–93–5, 90218– 

35–2, 27323–41–7, 68584–25–8, 68648– 

96–4, 68411–31–4, 90194–42–6, and 

1093628–27–3, when used as an inert 

ingredient in pesticide formulations 

applied to growing crops under 40 CFR 

180.920 and applied to animals under 

40 CFR 180.930. That notice referenced 

a summary of the petition prepared by 

The JITF, CST 8, 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 exemption requested by 

limiting the diethanolamine salt of alkyl 

(C8-C24) benzenesulfonic acid (CAS Reg. 

Nos. 26545–53–9 and 68953–97–9) to a 

maximum of 7% by weight in pesticide 

formulations intended for application to 

growing crops and to animals. This 

limitation is based on the Agency’s risk 

assessment which can be found at 

http://www.regulations.gov in 

documents ‘‘Dimethylaminopro

pylamine, Isopropylamine, Ethanol

amine and Triethanolamine Salts of 

Alkyl (C8-C24) Benzenesulfonic Acid 

(JITF CST 8 Inert Ingredients). Human 

Health Risk Assessment to Support 

Proposed Exemption from the 

Requirement of a Tolerance When Used 

as Inert Ingredients in Pesticide 

Formulations and Diethanolamine Salt 

of Alkyl (C8-C24) Benzenesulfonic Acid 

(DEA - JITF CST 8 Inert Ingredient). 

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–2008–0889. 

This petition was submitted in 

response to a final rule that was 

published in the Federal Register of 

August 9, 2006 (71 FR 45415) (FRL– 

8084–1) in which the Agency revoked, 

under section 408(e)(1) of 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 in the 

Federal Register of August 4, 2008 (73 

FR 45317) (FRL–8373–6) 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; 


srobinson on DSKHWCL6B1PROD with RULES
38926 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 

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 ASABSA when 

used as inert ingredients in pesticide 

formulations applied to growing crops 

and to 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. 

Amine salts of alkyl (C8-C24) benzene

sulfonic acid readily and fully 

dissociate to the corresponding amine 

and alkyl (C8-C24) benzenesulfonic acid 

constituents, therefore the hazard 

assessment conducted to support the 

requested exemption from the 

requirement of a tolerance for ASABSA 

is primarily based on the hazard 

assessment for each of the constituents, 

specifically each associated amine (i.e., 

dimethylaminopropylamine, isopro

pylamine, ethanolamine, diethanolamine and triethanolamine) and alkyl 

(C8-C24) benzenesulfonic acid. 

The hazard profile and endpoints for 

risk assessment for alkylbenzene 

sulfonic acid have previously been 

addressed as part of the tolerance 

reassessment for tolerance exemptions 

for alkyl (C8-C24) benzenesulfonic acid 

and its ammonium, calcium, 

magnesium, potassium, sodium, and 

zinc salts http://www.epa.gov/ 

opprd001/inerts/alkylc8.pdf. The 

toxicology database for these alkyl

benzene sulfonates consists almost 

entirely of published literature, and is 

essentially complete and of acceptable 

quality to assess the potential hazard to 

humans. The alkylbenzene sulfonates 

are readily absorbed following oral 

ingestion, but not following dermal 

exposure. Following oral exposure, they 

are readily metabolized, excreted fairly 

rapidly, and do not accumulate in any 

tissues. Available acute toxicity data 

show that alkylbenzene sulfonates are 

not highly acutely toxic, are irritating to 

the eye and skin, and are not skin 

sensitizers. Subchronic and chronic 

exposures show that the liver, kidney 

and intestinal tract (following oral 

exposures) are the major target organs of 

toxicity. Both in vitro and in vivo 

genotoxicity data show that 

alkylbenzene sulfonates are not 

genotoxic. The alkylbenzene sulfonates 

did not cause reproductive or 

developmental toxicity in acceptable 

studies. Early (pre Good Laboratory 

Practice standards) carcinogenicity 

studies indicate that alkylbenzene 

sulfonates do not cause an increase in 

tumor incidence. 

The existing toxicology database for 

the dimethylaminopropylamine, 

isopropylamine, ethanolamine and 

triethanolamine salt of alkyl (C8-C24) 

benzenesulfonic acid consists of an 

OPPTS Harmonized Test Guideline 

870.3550 study and acute, subchronic, 

chronic, carcinogenicity, 

developmental, and mutagenicity 

studies on the individual amines. In 

addition, the petitioner submitted an 

OPPTS Harmonized Test Guideline 

870.3650 combined repeated dose 

toxicity study with the reproduction/ 

developmental toxicity screening tests 

on isopropylamine dodecylbenzene 

sulfonate. The Agency considered these 

data in its evaluation of amine toxicity. 

While the test compound for the study 

is effectively a mixture of the amine and 

the acid, the study findings do provide 

some insight into the potential toxicity 

of the amine constituent. 

A summary of the toxicological data 

considered as part of this action is given 

below: 

1. Isopropylamine dodecylbenzene 

sulfonate (CAS No. 26264–05–1). In an 

oral gavage OPPTS Harmonized Test 

Guideline 870.3650 combined repeated 

dose toxicity study with the 

reproduction/developmental toxicity 

screening tests, the parental LOAEL was 

320 milligrams/kilograms/day (mg/kg/ 

day) (highest dose tested, (HDT)) based 

on excessive salivation (both sexes), 

soft/liquid feces (males), lesions of the 

forestomach (both sexes). No 

reproductive or developmental toxicity 

or neurotoxicity was observed. The 

NOAEL was 80 mg/kg/day. 

2. Ethanolamine (CAS No. 141–43–5). 

Ethanolamine is not acutely toxic in rats 

by the oral route of exposure but 

appears to be very acutely toxic by the 

dermal route of exposure, although this 

may be a species-specific effect in the 

rabbit. It is a skin sensitizer and is 

corrosive to the eye and skin. There is 

no evidence of mutagenicity in the 

Ames, Saccharomyces cerevisiae gene 

conversion, mouse micronucleus, cell 

transformation, and SCE human 

lymphocytes tests. In a dermal rat 

developmental toxicity study conducted 

with ethanolamine, no maternal or 

developmental toxicity was observed at 

225 mg/kg/day (HDT). Also in a dermal 

rabbit developmental toxicity study, no 

maternal or developmental toxicity was 

observed at 75 mg/kg/day (HDT). In an 

oral rat developmental toxicity study, 

the maternal LOAEL was 450 mg/kg/day 

(HDT) based on decreased body weights 

during the latter part of gestation and 

throughout lactation. The 

developmental LOAEL was 450 mg/kg/ 

day based on decrease body weights in 

female fetuses on postnatal day (PND) 1 

and 4. The maternal/developmental 

NOAEL was 120 mg/kg/day. 

3. Triethanolamine (CAS No. 102–71– 

6). In acute toxicity studies, 

triethanolamine is mildly to moderately 

toxic by the oral and dermal routes of 


srobinson on DSKHWCL6B1PROD with RULES
Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 38927 

exposure. It is not irritating in eye and 

skin irritation studies, and it is not a 

skin sensitizer. There is no evidence of 

mutagenicity in the Ames, mouse 

micronucleus, sex-linked recessive 

lethal, and Chinese hamster ovary 

(CHO) cell cytogenetics tests. In a 14– 

day inhalation study in rat, the NOAEL 

was 0.25 milligram/liter (mg/L) 

(approximate oral equivalent dose of 75 

mg/kg/day) and the LOAEL was 0.5 mg/ 

L based on increased kidney weights of 

males and females. In an oral mouse 

developmental toxicity study (ChernoffKavlock screening test), no maternal or 

developmental toxicity was observed at 

1,125 mg/kg/day (only dose tested). In a 

13–week dermal study in rat, the 

NOAEL was 1,000 mg/kg/day and the 

LOAEL was 2,000 mg/kg/day (HDT) 

based on reduced body gain and clinical 

observations (irritation, scaliness, and 

crustiness of the skin at the site of 

application). In a 13–week dermal study 

in mouse, the NOAEL was 2,000 mg/kg/ 

day and the LOAEL was 4,000 mg/kg/ 

day (HDT) based on clinical 

observations (irritation, scaliness, and 

discoloration of the skin at the site of 

application). 

4. Isopropylamine (CAS No. 75–31–0). 

In acute toxicity studies, 

isopropylamine is moderately acutely 

toxic in rats by the oral route of 

exposure, but is less toxic by the dermal 

route and is not toxic by the inhalation 

route of exposure. Rabbits appear to be 

more sensitive than rats showing 

significantly greater acute toxicity by 

the dermal route. Isopropylamine is not 

a skin sensitizer. There is no evidence 

of mutagenicity in the Ames, 

chromosomal aberrations in human 

lymphocytes and unscheduled DNA 

synthesis in rat hepatocytes tests. In a 

28–day inhalation study, SpragueDawley rats were exposed to inhalation 

dosage levels of 0, 0.1, 0.5, and 1.35 mg/ 

L for 6 hours/day for 5 days/week. The 

NOAEL was 0.1 mg/L and the LOAEL 

was 0.5 mg/L based on microscopic 

ocular and nasal lesions. In a 

developmental study, Sprague-Dawley 

rats were exposed to inhalation dosage 

levels of 0, 0.1, 0.5, and 1.0 mg/L for 6 

hours/day from gestation day (GD) 6 

through 15. The maternal toxicity was 

observed at 1.0 mg/L (HDT) based on 

decreased body weight and body weight 

gain. At this dose, no developmental 

toxicity was observed. 

5. Dimethylaminopropylamine (CAS 

No. 109–55–7). 

Dimethylaminopropylamine is mild to 

moderately toxic by the oral and 

inhalation routes of exposure, but it is 

not a skin sensitizer. There is no 

evidence of mutagenicity in the Ames 

and mouse micronucleus tests. 

Following a 28–day gavage study in 

Wistar rats, mortality (4/5 females) and 

clinical signs (males: irregular 

respiration and respiratory sounds; 

females: decreased spontaneous activity, 

stilted gait, swollen abdomen, and 

impaired respiration) were observed at 

250 mg/kg/day (HDT). In an OPPTS 

Harmonized Test Guideline 870.3550 

reproduction and developmental 

toxicity screening test in SpragueDawley rats, parental toxicity was 

observed at 200 mg/kg/day (HDT) based 

on decreased body weight gain and 

clinical signs (respiratory sounds and 

piloerection). Reproductive and 

developmental toxicity were not 

observed at any dose level. 

6. Diethanolamine (CAS No. 11–42– 

2). The existing toxicology database for 

diethanolamine (DEA) consists of 

several subchronic oral and dermal 

toxicity studies in rats and mice, 

carcinogenicity studies in rats and mice, 

oral and dermal developmental toxicity 

studies in rats and rabbits, and acute 

and mutagenicity data. Following repeat 

oral exposure to DEA, the kidney, liver, 

and blood are the major target organs. 

Repeat oral exposure via drinking water 

resulted in a microcytic anemia that 

does not involve the bone marrow in 

rats at 97 mg/kg/day in males and 57 

mg/kg/day in females. Increased kidney 

weights were associated with renal 

tubular cell necrosis, decreased renal 

function, increased incidences or 

severity of nephropathy, and/or 

mineralization in rats at 97 mg/kg/day 

(males) and 57 mg/kg/day (females) and 

in mice at 104 mg/kg/day (lowest dose 

tested, (LDT)) in males and 142 mg/kg/ 

day (LDT) in females. Increased liver 

weights were associated with 

cytoplasmic vacuolization and 

degeneration of centrilobular 

hepatocytes in rats and hypertrophy, 

individual cell necrosis or foci of 

necrotic hepatocytes in mice. Doserelated decreases in testis and 

epididymis weights were associated 

with testicular degeneration, decreased 

sperm motility, and decreased sperm 

count in male rats at 97 mg/kg/day. 

Similar kidney and liver effects were 

observed following repeat dermal 

exposure at dose levels of 32/mg/kg/day 

in rats and 80 mg/kg/day in mice. 

Demyelination in the brain (medulla 

oblongata) and spinal cord was observed 

in rats of both sexes following oral and 

dermal exposure at dose levels as low as 

250 mg/kg/day, with the female being 

more sensitive. Mortality and 

neurological symptoms (tremors, 

stiffness, and ataxia progressing to 

paresis and paralysis) have been 

reported following exposure via overthe-counter oral flea treatment (53% 

DEA) of dogs and cats, however, there 

are no registered pet care use products 

containing the DEA salt form of 

ASABSA. 

Developmental toxicity was observed 

in rats following both oral and dermal 

exposure to the maternal animal during 

gestation days (GD) 6-15. Maternal 

toxicity, as evidenced by decreased 

body weight/gain and food consumption 

and/or increased kidney weight, was 

observed at the same dose levels (125 

mg/kg/day) as the developmental effects 

[an increase in postnatal mortality (PND 

0 through 4), an increase in 

postimplantation loss, and reduced pup 

body weight following oral exposure. 

An increased incidence of skeletal 

variations was observed following 

dermal exposure at 1500 mg/kg/day 

(HDT) ]. Developmental toxicity was not 

observed in rabbits following oral or 

dermal exposure of the maternal animal 

during GD 6 through 18. 

7. Metabolism. The alkyl (C8-C24) 

benzenesulfonic acid amine salts 

undergo rapid dissociation in vivo to 

form an alkyl (C8-C24) benzenesulfonic 

acid and an amine. The two entities 

would be absorbed and metabolized 

independently. The alkyl (C8-C24) 

benzenesulfonic acid should be readily 

conjugated and rapidly excreted with 

little alkyl aromatic chain degradation 

(JITF Submission, 2008, pages 11 and 

21). Primary, secondary or tertiary 

amines should undergo oxidative amine 

metabolism followed by excretion. 

Primary aliphatic amines 

(ethanolamine, isopropylamine) are 

oxidized to aldehydes/ketones and or 

acid (glycolic acid or acetone) with 

release of ammonia. The glycolic acid 

may further oxidized and or conjugated 

and excreted. The acetone could be 

excreted through respiration or further 

oxidized to methylglyoxyl and then 

excreted. Secondary aliphatic amines 

(dimethylaminopropylamine and 

diethanolamine) may follow various 

oxidative patterns and some are 

excreted unchanged. Small molecular 

weight amines may be exhaled via 

respiration. Tertiary aliphatic amines 

(triethanolamine) may be oxidized to 

amine oxides, which may be excreted in 

the urine or deaminated with the 

eventual resultant being release of 

glycolic acid which may be further 

oxidized and or conjugated and 

excreted. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by ASABSA and its 

constituents as well as the no-observedadverse-effect-level (NOAEL) and the 

lowest-observed-adverse-effect-level 

(LOAEL) from the toxicity studies can 


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38928 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 

be found at http://www.regulations.gov 

in documents 

‘‘Dimethylaminopropylamine, 

Isopropylamine, Ethanolamine and 

Triethanolamine Salts of Alkyl (C8-C24) 

Benzenesulfonic Acid (JITF CST 8 Inert 

Ingredients). Human Health Risk 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as Inert 

Ingredients in Pesticide Formulations 

and Diethanolamine Salt of Alkyl (C8- 

C24) Benzenesulfonic Acid (DEA - JITF 

CST 8 Inert Ingredient). 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– 

2008–0889 and at http://www.epa.gov/ 

opprd001/inerts/alkylc8.pdf. 

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 ASABSA used for human 

health risk is shown in the following 

Table 1. 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ASABSA 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) An effect attributable to a single exposure was not identified. 

Chronic dietary (all populations) dimethyl

aminopropylamine, isopropylamine, ethanolamine, 

and triethanolamine salts of alkyl (C8-C24) benzenesulfonic acid. 

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 

28–day oral (gavage) toxicity study in rats with 

dimethylaminopropylamine 

NOAEL = 50 mg/kg 

LOAEL = 250 mg/kg based on mortality (4/5 females) and clinical signs (males: irregular respiration and respiratory sounds; females: decreased spontaneous activity, stilted gait, swollen 

abdomen, impaired respiration) OECD SIDS. 

UNEP Publication and BUA Report, October 

1996 plus weight of evidence of three studies 

with alkylbenzene sulfonates: 

1) Rat reproduction study LOAEL = 250 mg/kg/day 

based on decreased Day 21 female pup body 

weight (Buehler, E. et al. 1971. Tox. Appl. 

Pharmacol.18:83-91) 

2) 9–month drinking water rat study 

LOAEL = 145 mg/kg/day based on decreased body 

weight gain, and serum/ biochemical and enzymatic changes in the liver andkidney (Yoneyama 

et al. 1976 Ann. Rep. Tokyo Metrop. Res.Lab. 

Public Health 27(2):105-112) 

3) 6–month rat dietary study 

LOAEL = 114 mg/kg/day (0.2%) based on increased caecum weight and slight kidney damage (Yoneyama et al 1972 Ann. Rep. Tokyo 

Metrop. Res. Lab. Public Health 24:409-440) 


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Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 38929 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ASABSA 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 

Chronic dietary (all populations) diethanolamine salt 

of alkyl (C8-C24) benzenesulfonic acid 

NOAEL = 48 

mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 

10x 

Chronic RfD = 

0.5 mg/kg/ 

day 

cPAD = 0.05 

mg/kg/day 

Subchronic (13–week) oral toxicity study in rats 

(NTP, 1992) 

Female LOAEL = 124 mg/kg/day demyelination of 

the brain and spinal cord 

Male LOAEL = 97 mg/kg/day, based on decreased 

testis and epididymis weight associated with degeneration of seminiferous epithelium, decreased 

numbers of spermatogenic cells, reduced size of 

seminiferous tubules, decreased sperm, sperm 

motility, and sperm count 

Incidental Oral and Inhalation short-term (1 to 30 

days) and intermediate-term (1 to 6 months) dimethylaminopropylamine, isopropylamine, ethanol

amine, and triethanolamine salts of alkyl (C8-C24) 

benzenesulfonic acid. 

NOAEL = 50 

mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

inhalation toxicity is assumed to be 

equivalent to 

oral toxicity 

Residential 

LOC for 

MOE = 100 

28–day oral (gavage) toxicity study in rats with dim

ethylaminopropylamine 

NOAEL = 50 mg/kg 

LOAEL = 250 mg/kg based on mortality (4/5 females) and clinical signs (males: irregular respiration and respiratory sounds; females: decreased spontaneous activity, stilted gait, swollen 

abdomen, impaired respiration) OECD SIDS. 

UNEP Publication and BUA Report, October 

1996 plus weight of evidence of three studies 

with alkylbenzene sulfonates: 

1) Rat reproduction study LOAEL = 250 mg/kg/day 

based on decreased Day 21 female pup body 

weight (Buehler, E. et al. 1971. Tox. Appl. 

Pharmacol.18:83-91) 

2) 9–month drinking water rat study LOAEL = 145 

mg/kg/day based on decreased body weight 

gain, and serum/ biochemical and enzymatic 

changes in the liver andkidney (Yoneyama et al. 

1976 Ann. Rep. Tokyo Metrop. Res. Lab. Public 

Health 27(2):105-112) 

3) 6–month rat dietary study LOAEL = 114 mg/kg/ 

day (0.2%) based on increased caecum weight 

and slight kidney damage (Yoneyama et al 1972 

Ann. Rep. Tokyo Metrop. Res. Lab. Public Health 

24:409-440) 

Incidental Oral and Inhalation short-term (1 to 30 

days) and intermediate-term (1 to 6 months)-- 

diethanolamine salt of alkyl (C8-C24) 

benzenesulfonic acid. 

NOAEL = 48 

mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 

10x 

inhalation toxicity is assumed to be 

equivalent to 

oral toxicity 

Residential 

LOC for 

MOE = 1,000 

Subchronic (13–week) oral toxicity study in rats 

(NTP, 1992) 

Female LOAEL = 124 mg/kg/day based on 

demyelination of the brain and spinal cord 

Male LOAEL = 97 mg/kg/day, based on decreased 

testis and epididymis weight associated with degeneration of seminiferous epithelium, decreased 

numbers of spermatogenic cells, reduced size of 

seminiferous tubules, decreased sperm, sperm 

motility, and sperm count 

Dermal (short- and intermediate-term) -- dimethy

laminopropylamine, isopropylamine, ethano

lamine, and triethanolamine salts of alkyl (C8-C24) 

benzenesulfonic acid. 

No systemic toxicity observed in available dermal toxicity study. Low potential for dermal absorption to ionized amine. No quantitative risk assessment required 

Dermal (short- and intermediate-term) — 

diethanolamine salt of alkyl (C8-C24) benzenesulfonic acid 

NOAEL = 125 

mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 

10x 

Residential 

LOC for 

MOE = 1,000 


srobinson on DSKHWCL6B1PROD with RULES
38930 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ASABSA 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: Based on SAR analysis, ASABSA is not expected to be carcinogenic. No 

evidence of carcinogenicity in the available data or SAR analysis for alkyl benzene

sulfonates, dimethylaminopropylamine, isopropylamine, ethanolamine, and triethano

lamine. No concern for diethanolamine based on SAR analysis, limited evidence in experimental animals; not classifiable as to its carcinogenicity to humans 

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 ASABSA with respect to plant and 

animal metabolism or environmental 

degradation. The Agency relied 

collectively on information provided on 

the representative chemical structures, 

the generic cluster structures, the 

modeled physicochemical information, 

as well as the structure-activity 

relationship information. Additionally, 

information on other surfactants and 

chemicals of similar size and 

functionality was considered to 

determine the residues of concern for 

these inert ingredients. ASABSA are 

likely to be fully dissociated in solution. 

If dissociated amine counter ion or 

alkylbenzenesulfonic acid residues on 

plants and livestock undergo any 

metabolism or hydrolysis, they will 

likely result as highly polar or 

conjugated residues, which would not 

be of concern. 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to ASABSA, EPA considered 

exposure under the petitioned-for 

exemptions from the requirement of a 

tolerance. EPA assessed dietary 

exposures from ASABSA in food as 

follows: 

i. Acute exposure. No adverse effects 

attributable to a single exposure of 

ASABSA were seen in the toxicity 

databases. Therefore, an acute dietary 

risk assessment for ASABSA is not 

necessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

for ASABSA, 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 ASABSA. 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 can be found at http:// 

www.regulations.gov in the document 

‘‘Alkyl Amines Polyalkoxylates (Cluster 

4): Acute and Chronic Aggregate (Food 

and Drinking Water) Dietary Exposure 

and Risk Assessments for the Inerts’’, in 

docket ID number EPA–HQ–OPP–2008– 

0738. 

In the dietary exposure assessment, 

the Agency assumed that the residue 

level of the inert ingredient would be no 

higher than the highest tolerance for a 

given commodity. Implicit in this 

assumption is that there would be 

similar rates of degradation (if any) 

between the active and inert ingredient 

and that the concentration of inert 

ingredient in the scenarios leading to 

these highest of tolerances would be no 

higher than the concentration of the 

active ingredient. 

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 are 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 

relative to that of the active ingredient. 

EPA made a specific adjustment to the 

dietary exposure assessment to account 

for the use limitations of the amount of 

diethanolamine salts of alkyl (C8-C24) 

benzenesulfonic acid that may be in 

formulations (no more than 7%, which 

corresponds to a concentration of 2% 

diethanolamine) and assumed that the 

diethanolamine salts of alkyl (C8-C24) 

benzenesulfonic acid are 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 these percentages. For 

example, EPA examined several of the 

pesticide products associated with the 

tolerance/commodity combination 

which are the driver of the risk 

assessment and found that these 

products did not contain surfactants at 

levels greater than 2.25% and that none 

of the surfactants were diethanolamine 

salts of alkyl (C8-C24) benzenesulfonic 

acid. 

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. 


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In summary, EPA chose a very 

conservative method for estimating 

what level of inert residue could be on 

food, and 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 

alerts suggestive of carcinogenicity. No 

structural alerts for carcinogenicity were 

identified. Additionally, there is not 

evidence of carcinogenicity of the 

ASABSA amine or alkylbenzenesulfonic 

acid constituents. 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 ASABSA. Tolerance level residues 

and/or 100% crop treated 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 ASABSA in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of ASABSA. 

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 ASABSA. Modeling runs on four 

surrogate inert ingredients using a range 

of physical chemical properties that 

would bracket those of ASABSA 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 documents 

‘‘Dimethylaminopropylamine, 

Isopropylamine, Ethanolamine and 

Triethanolamine Salts of Alkyl (C8-C24) 

Benzenesulfonic Acid (JITF CST 8 Inert 

Ingredients). Human Health Risk 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as Inert 

Ingredients in Pesticide Formulations 

and Diethanolamine Salt of Alkyl (C8- 

C24) Benzenesulfonic Acid (DEA - JITF 

CST 8 Inert Ingredient). 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– 

2008–0889. 

For the purpose of the screening level 

dietary risk assessment to support this 

request for an exemption from the 

requirement of a tolerance for ASABSA, 

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). ASABSA 

may be used as inert ingredients in 

pesticide products that are registered for 

specific uses that may result in outdoor 

residential exposures. A screening level 

residential exposure and risk 

assessment was completed for pesticide 

products containing ASABSA as inert 

ingredients. In this assessment, 

representative scenarios, based on enduse product application methods and 

labeled application rates, were selected. 

For each of the use scenarios, the 

Agency assessed residential handler 

(applicator) inhalation and dermal 

exposure for use 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 ASABSA. 

Similarly, residential postapplication 

dermal and oral exposure assessments 

were also performed utilizing high-end 

exposure scenarios. Further details of 

this residential exposure and risk 

analysis can be found at http:// 

www.regulations.gov in the document 

‘‘JITF Inert Ingredients. Residential and 

Occupational Exposure Assessment 

Algorithms and Assumptions Appendix 

for the Human Health Risk Assessments 

to Support Proposed Exemption from 

the Requirement of a Tolerance When 

Used as Inert Ingredients in Pesticide 

Formulations,’’ in docket ID number 

EPA–HQ–OPP–2008–0710. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found ASABSA to share 

a common mechanism of toxicity with 

any other substances, and ASABSA do 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

ASABSA 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.—i. Dimethylaminopropylamine, isopropylamine, ethanol

amine, and triethanolamine salts of 

alkyl (C8-C24) benzenesulfonic acid. The 

available mammalian toxicology 

database for dimethylaminopro

pylamine, isopropylamine, 

ethanolamine, and triethanolamine salts 

of alkyl (C8-C24) benzenesulfonic is 

complete with respect to assessing the 

increased susceptibility to infants and 


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children as required by FQPA for the 

dimethylaminopropylamine, isopro

pylamine, ethanolamine and triethanolamine salts of alkyl (C8-C24) benzene

sulfonic acid. There was no increased 

susceptibility to the offspring of rats 

following prenatal and postnatal 

exposure in the OPPTS Harmonized 

Test Guidelines 870.3550 and 870.3650 

reproductive/developmental screening 

studies, and developmental effects 

studies. 

There was no increased susceptibility 

to the offspring of rats following 

prenatal and postnatal exposure in the 

OPPTS Harmonized Test Guideline 

870.3650 study with isopropylamine 

dodecylbenzene sulfonate. 

Developmental toxicity was not 

observed, whereas parental toxicity was 

manifested as excessive salivation in 

both sexes, soft feces in males, and 

lesions of the forestomach in both sexes. 

No increased susceptibility was 

observed in offspring of rats following 

exposure in the OPPTS Harmonized 

Test Guideline 870.3550 study with 

dimethylaminopropylamine. 

Developmental toxicity was not 

observed, whereas parental toxicity was 

manifested as decreased body-weight 

gain and clinical signs. Susceptibility 

was not demonstrated in the offspring in 

a rat developmental toxicity study with 

isopropylamine following inhalation 

exposure. Developmental toxicity was 

not observed, whereas parental toxicity 

was manifested as decreased body 

weight and body-weight gain. In 

developmental toxicity studies with 

ethanolamine following dermal (rat and 

rabbit) exposure, developmental and 

maternal toxicity were not observed. In 

a developmental toxicity study, 

increased susceptibility to the offspring 

was not observed following oral 

exposure to ethanolamine. 

Developmental toxicity was observed 

(decreased body weight in female 

fetuses on PND 1-4) at the same dose 

level where maternal toxicity was 

observed (decreased body weight during 

the latter part of gestation and 

throughout lactation). Since a clear 

NOAEL of 120 mg/kg/day was identified 

for offspring effects, and the selected 

point of departure of 50 mg/kg/day 

(mortality and clinical signs) for the 

dietary and inhalation risk assessments 

is protective of the offspring effects, 

there are no residual concerns. 

There is no evidence in the available 

toxicity studies or scientific literature to 

indicate neurotoxic effects of these 

amines in laboratory animals. The 

clinical signs observed in females in the 

28–day study with 

dimethylaminopropylamine (stilted gait 

and decreased spontaneous activity are 

considered agonal in nature. 

The prenatal developmental and 

reproduction studies with alkylbenzene 

sulfonates showed no qualitative or 

quantitative evidence of increased 

susceptibility. Several reproduction and 

many developmental studies have been 

performed with alkylbenzene sulfonates 

in a number of animal species. In the 

developmental studies, whenever 

toxicity was observed in adults, it was 

generally for mild effects (slight body 

weight changes, intestinal disturbances) 

except for severe dermal irritation 

effects in dermal developmental studies. 

Any developmental toxicity observed in 

these same studies included minor 

increases in visceral/skeletal anomalies 

and some fetal losses; but only at 

maternally toxic doses. In one 

reproduction study, there were slight 

changes in hematology and 

histopathology (both within historical 

control ranges) and slight decreases in 

body weight in the offspring at the 

highest dose of 250 mg/kg/day (at which 

there were no effects on the parental 

generation). There were no effects in 

either the parents or offspring in the 

other two alkyl benzensulfonate 

reproductive toxicity studies at the high 

dose tested of 70 and 170 mg/kg/day, 

respectively. 

ii. Diethanolamine salt of alkyl (C8- 

C24) benzenesulfonic acid (DEA). There 

is no OPPTS Harmonized Test 

Guideline 870.3650 combined repeated 

dose toxicity study with the 

reproduction/developmental toxicity 

screening test available on DEA. The 

toxicology database on DEA consists of 

open literature studies that include oral 

and dermal exposure developmental 

toxicity studies in rats and a dermal 

exposure developmental toxicity study 

in rabbits. There are no reproductive 

toxicity or neurotoxicity studies 

available on DEA. 

No evidence of increased 

susceptibility to the offspring of rats or 

rabbits following prenatal dermal 

exposure was located. There was 

qualitative prenatal susceptibility in the 

rat oral developmental toxicity study. 

The developmental findings with a 

NOAEL of 50 mg/kg/day were wellcharacterized and included increased 

developmental sensitivity in the form of 

increased postnatal day (PND) 0 through 

4 mortality and post implantation loss, 

and reduced pup body weight at 125 

mg/kg/day (developmental LOAEL). The 

maternal toxicity NOAEL/LOAEL of 50/ 

125 mg/kg/day was based on increased 

absolute liver weight. Developmental 

toxicity was demonstrated in the rat 

following dermal exposure to the 

maternal animal during gestation days 

(GD) 6 through 15, as evidenced by 

increased incidence of skeletal 

variations at 1500 mg/kg/day (HDT). 

The NOAEL for developmental toxicity 

was 500 mg/kg/day; the LOAEL for 

maternal toxicity was 150 mg/kg (LDT) 

based on microcytic anemia with 

abnormal red blooc cell morphology. 

The degree of concern for the increased 

qualitative susceptibility seen in the 

oral developmental toxicity study in rats 

(prenatal exposure) is low since a clear 

NOAEL/LOAEL was established for oral 

developmental toxicity and since a more 

sensitive endpoint of concern (48 mg/ 

kg/day, the NOAEL from the rat 

subchronic toxicity study) has been 

utilized in assessing the risks from 

incidential and chronic oral exposure to 

the diethanolamine salt of alkyl (C8- 

C24) benzenesulfonic acid. 

Demyelination has been observed in 

the brain (medulla) and spinal cord of 

rats following oral and dermal exposure, 

and decreased testis and epididymis 

weights associated with degeneration of 

seminiferous epithelium, decreased 

numbers of spermatogenic cells, 

reduced size of seminiferous tubules, 

decreased sperm; decreased sperm 

motility and sperm count have been 

observed in male rats following oral 

exposure. 

DEA is structurally related to the 

essential nutrient choline, and choline 

deficiency during pregnancy has been 

shown to reduce neurogenesis and 

increase apoptosis in rat and mouse 

fetal hippocampus. In the open 

literature, DEA has been shown to alter 

neurogenesis and induce apoptosis in 

fetal mouse hippocampus following 

dermal exposure of the maternal animal 

to DEA during pregnancy. 

The existing toxicology database is 

not adequate for assessing the 

sensitivity of infants and children to 

DEA exposure because a reproduction 

study is not available and in light of the 

findings in adult animals 

(demyelination in the brain and spinal 

cord and degeneration of the 

seminiferous tubules of the testis) that 

suggest the potential for developmental, 

reproductive, and/or 

neurodevelopmental toxicity in the 

young animal. The particular findings in 

the parental animals lead to 

uncertainties for the offspring. There is 

a concern for neurodevelopment since 

this is not addressed in the currently 

available database. 

3. Conclusion.—i. Dimethylaminopro

pylamine, isopropylamine, ethanol

amine, and triethanolamine salts of 

alkyl (C8-C24) benzenesulfonic acid. EPA 

has determined that reliable data show 

that the safety of infants and children 

would be adequately protected if the 


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Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 38933 

FQPA SF were reduced to 1X. That 

decision is based on the following 

findings: 

a. The toxicity database for dimethyl

aminopropylamine, isopropylamine, 

ethanolamine, and triethanolamine salts 

of alkyl (C8-C24) benzenesulfonic acid is 

considered adequate for assessing the 

risks to infants and children to dimethyl

aminopropylamine, isopropylamine, 

ethanolamine and triethanolamine salts 

of alkyl (C8-C24) benzenesulfonic acid 

exposures (the available studies are 

described in Unit IV.D.2.). 

b. No susceptibility was demonstrated 

in the offspring in the OPPTS 

Harmonized Guideline 870.3650 

combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening test in rats with 

isopropylamine dodecylbenzene 

sulfonate following prenatal and 

postnatal exposure. 

c. No susceptibility was demonstrated 

in the offspring in the OPPTS 

Harmonized Guideline 870.3550 

reproduction/developmental toxicity 

screening test with 

dimethylaminopropylamine following 

prenatal and postnatal exposure. 

d. No susceptibility was demonstrated 

in the offspring in an inhalation 

developmental toxicity study with 

isopropylamine. 

e. The prenatal developmental and 

reproduction studies with alkylbenzene 

sulfonates showed no qualitative or 

quantitative evidence of increased 

susceptibility. Slight changes in 

hematology and histopathology (both 

within historical control ranges) and 

slight decreases in body weight in the 

offspring at the highest dose of 250 mg/ 

kg/day (at which there were no effects 

on the parental generation) were seen 

with alkylbenzenesulfonate in one 

reproduction study, however there were 

no effects in either the parents or 

offspring in the other two alkyl 

benzensulfonate reproductive toxicity 

studies at the high dose tested of 70 mg/ 

kg/day and 170 mg/kg/day, respectively. 

Since the selected point of departure of 

50 mg/kg/day (mortality and clinical 

signs) for the dietary and inhalation risk 

assessments is protective of the 

offspring effects, there are no residual 

concerns. 

f. No susceptibility was demonstrated 

in the offspring in dermal (rat and 

rabbit) and oral (rat) developmental 

toxicity studies with ethanolamine. 

Developmental toxicity was observed 

following oral exposure with 

ethanolamine at the same dose level 

where maternal toxicity was observed. 

Since a clear NOAEL of 120 mg/kg/day 

was identified for offspring effects, and 

the selected point of departure of 50 mg/ 

kg/day (mortality and clinical signs) for 

the dietary and inhalation risk 

assessments is protective of the 

offspring effects, there are no residual 

concerns. 

g. No evidence of neurotoxicity was 

demonstrated in the database for 

alkylbenzene sulfonates, 

dimethylaminopropylamine, 

isopropylamine, ethanolamine, and 

triethanolamine and isopropylamine 

salt of dodecylbenzenesulfonic acid and 

thus there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

h. 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 PCT 

is assumed for all crops. EPA also made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to ASABSA 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 ASABSA. 

ii. Diethanolamine salts of alkyl (C8- 

C24) benzenesulfonic acid. EPA has 

determined that the FQPA SF should be 

retained. That decision is based on the 

following findings: 

a. Although no increased 

susceptibility was demonstrated in the 

offspring in the available dermal studies 

in rats and rabbits following prenatal 

exposure to DEA, and the degree of 

concern is low for the increased 

qualitative susceptibility seen in the 

oral developmental toxicity study in 

rats, considering the limited data in the 

literature on DEA, which indicate a 

potential for developmental and/or 

reproductive and/or developmental 

neurotoxicity effects, the toxicology 

database for DEA is not considered 

adequate for assessing the sensitivity of 

infants and children to DEA when used 

as an inert ingredient (the available 

studies are described in Unit IV.D.2.). 

b. There are no neurotoxicity studies 

available on DEA. 

c. There are no reproductive toxicity 

studies available on DEA. 

d. There are no developmental 

toxicity studies available on DEA that 

assess neurodevelopment. 

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 ASABSA. 

Therefore, ASABSA 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, including the limitation of 

use of diethanolamine salts of alkyl (C8- 

C24) benzenesulfonic acid to not more 

than 7% of the pesticide product, the 

chronic dietary exposure from food and 

water to dimethylaminopropylamine, 

isopropylamine, ethanolamine and 

triethanolamine salts of alkyl (C8-C24) 

benzenesulfonic acid, 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. The chronic dietary exposure 

from food and water to diethanolamine 

salts of alkyl (C8-C24) benzenesulfonic 

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

population and 56% 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). 

ASABSA 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 

ASABSA. Using the exposure 

assumptions described in this unit, EPA 

has concluded that the combined shortVerDate Nov<24>2008 16:20 Aug 04, 2009 Jkt 217001 PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 E:\FR\FM\05AUR1.SGM 05AUR1

srobinson on DSKHWCL6B1PROD with RULES
38934 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 

term aggregated food, water, and 

residential exposures result in aggregate 

MOEs of 220 and 260 for adult males 

and females, respectively. Adult 

residential exposure combines high end 

outdoor dermal and inhalation handler 

exposure with a high end post 

application dermal exposure from 

contact with treated lawns. EPA has 

concluded the combined short-term 

aggregated food, water, and residential 

exposures result in an aggregate MOE of 

110 for children. Children’s residential 

exposure includes total exposures 

associated with contact with treated 

lawns (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). 

ASABSA are used as inert ingredients 

in pesticide products that 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 ASABSA. 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 540 and 570 for 

adult males and females, respectively. 

Adult residential exposure includes 

high end post application dermal 

exposure from contact with treated 

lawns. EPA has concluded that the 

combined intermediate-term aggregated 

food, water, and residential exposures 

result in an aggregate MOE of 110 for 

children. Children’s residential 

exposure includes total exposures 

associated with contact with treated 

lawns (dermal and hand-to-mouth 

exposures). As the level of concern is for 

MOEs that are lower than 100, these 

MOEs are not of concern. 

5. Aggregate cancer risk for U.S. 

population. The Agency has not 

identified any concerns for 

carcinogenicity relating to ASABSA. 

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 

ASABSA. 

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 

ASABSA 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 

dimethylaminopropylamine, 

isopropylamine, ethanolamine, and 

triethanolamine salts of alkyl (C8-C24) 

benzenesulfonic acid when used as an 

inert ingredient in pesticide 

formulations applied to growing crops 

under 40 CFR 180.920 and to animals 

under 40 CFR 180.930 and to 

diethanolamine salts of alkyl (C8-C24) 

benzenesulfonic acid when used as an 

inert ingredient at levels not to exceed 

7% by weight in pesticide formulations 

applied to growing crops under 40 CFR 

180.920 and to animals under 40 CFR 

180.930. 

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). 


srobinson on DSKHWCL6B1PROD with RULES
Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 38935 

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 30, 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 asfollows: 

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: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

* * * * * * * 

Diethanolamine salts of alkyl (C8-C24) benzenesulfonic acid (CAS Reg. Nos. 26545–53– 

9 and 68953–97–9).

Not to exceed 7% of pesticide formulation.Surfactants, related adjuvants of surfactants 

* * * * * * * 

Dimethylaminopropylamine, isopropylamine, ethanolamine, and triethanolamine salts of 

alkyl (C8-C24) benzenesulfonic acid (CAS Reg. Nos. 26264–05–1, 27323–41–7, 

55470–69–4, 68411–31–4, 68584–24–7, 68584–25–8, 68648–81–7, 68648–96–4, 

68649–00–3, 68910–32–7, 68953–93–5, 90194–42–6, 90194–53–9, 90218–35–2, 

157966–96–6, 319926–68–6, 877677–48–0, 1093628–27–3).

Surfactants, related adjuvants of surfactants 

* * * * * * * 

■ 3. In §180.930, the table is amended 

by adding alphabetically the following 

inert ingredients: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

* * * * * * * 

Diethanolamine salts of alkyl (C8-C24) benzenesulfonic acid (CAS Reg. Nos. 26545–53– 

9 and 68953–97–9).

Not to exceed 7% of pesticide formulation.Surfactants, related adjuvants of surfactants 

* * * * * * * 

Dimethylaminopropylamine, isopropylamine, ethanolamine, and triethanolamine salts of 

alkyl (C8-C24) benzenesulfonic acid (CAS Reg. Nos. 26264–05–1, 27323–41–7, 

55470–69–4, 68411–31–4, 68584–24–7, 68584–25–8, 68648–81–7, 68648–96–4, 

68649–00–3, 68910–32–7, 68953–93–5, 90194–42–6, 90194–53–9, 90218–35–2, 

157966–96–6, 319926–68–6, 877677–48–0, 1093628–27–3).

Surfactants, related adjuvants of surfactants 

* * * * * * * 

[FR Doc. E9–18698 Filed 8–4–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0145; FRL–8430–1] 

Alkyl Alcohol Alkoxylates; 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 a-alkyl-whydroxypoly (oxypropylene) and/or 

poly (oxyethylene) polymers where the 

alkyl chain contains a minimum of six 

carbons when used as an inert 

ingredient in pesticide formulations. 

The Joint Inerts Task Force (JITF), 

Cluster Support Team Number 1, 

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 a-alkyl-w-hydroxypoly 

(oxypropylene) and/or poly 

(oxyethylene) polymers where the alkyl 

chain contains a minimum of six 

carbons. 

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–2009–0145. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Kerry Leifer, Registration Division 

(7505P), Office of Pesticide Programs, 


srobinson on DSKHWCL6B1PROD with RULES