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
38936 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 

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–2009–0145 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–2009–0145, 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 

of FFDCA, 21 U.S.C. 346a, announcing 

the receipt of a pesticide petition (PP 

[9E7534]) filed by The Joint Inerts Task 

Force, Cluster Support Team 1 (CST 1), 

c/o CropLife America, 1156 15th Street, 

NW., Suite 400, Washington, DC 20005. 

The petition requested that 40 CFR 

180.910, 40 CFR 180.930, 40 CFR 

180.940a, and 40 CFR 180.960 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of a group of substances known 

as a-alkyl-w-hydroxypoly 

(oxypropylene) and/or poly 

(oxyethylene) polymers where the alkyl 

chain contains a minimum of 6 carbons, 

herein referred to in this document as 

AAA. AAAs are used as inert 

ingredients in pesticide products. That 

notice referenced a summary of the 

petition prepared by The Joint Inerts 

Task Force (JITF), Cluster Support Team 

Number 1 (CST 1)], 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. 

This petition was submitted in 

response to a final rule of August 9, 

2006, (71 FR 45415) in which the 

Agency revoked, under section 408(e)(1) 

of the Federal Food, Drug, and Cosmetic 

Act (FFDCA), the existing exemptions 

from the requirement of a tolerance for 

residues of certain inert ingredients 

because of insufficient data to make the 

determination of safety required by 

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

date for the tolerance exemptions 

subject to revocation was August 9, 

2008, which was later extended to 

August 9, 2009 by a final rule published 

in the Federal Register of August 4, 

2008 (73 FR 45312) 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. 

Depending on the degree of 

alkoxylation, each of the AAA 

substances included in the petition can 

vary in number average molecular 

weight from a range of approximately 

260 to 4,000. In the case where the 

minimum number average molecular 

weight of an AAA is 1,100 or more, the 

petition’s basis of support for the 

establishment of an exemption from the 

requirement of a tolerance under 40 CFR 

180.960 is the fact that such high 

molecular weight AAAs would meet the 

criteria for a low-risk polymer as 

defined in 40 CFR 723.250. For the 

remaining AAAs (i.e., the ones with 

molecular weights between 260 and 

1,100), the petition seeks to establish 

tolerance exemptions for all AAAs 

under 40 CFR 180.910, 40 CFR 180.930, 

and 40 CFR 180.940(a). Therefore, in its 

consideration of the petition the Agency 

has conducted an assessment specific to 

the establishment of an exemption from 

the requirement of a tolerance for the 

lower weight AAAs under 40 CFR 

180.910, 40 CFR 180.930, and 40 CFR 

180.940(a) as well as an assessment 

specific to the establishment of an 

exemption from the requirement of a 

tolerance under 40 CFR 180.960 for the 

‘‘high molecular weight’’ AAAs. 

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 


srobinson on DSKHWCL6B1PROD with RULES
Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 38937 

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 residue of AAAs when 

used as an inert ingredient in pesticide 

formulations applied pre- and postharvest, applied to livestock, and used 

in antimicrobial formulations, and as a 

low risk polymer as defined in 40 CFR 

723.250. 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. 

1. For lower weight AAAs under 40 

CFR 180.910, 40 CFR 180.930, and 40 

CFR 180.940a. The available toxicology 

database includes acute studies, 

subchronic (rat and dog) studies, a 

mutagenicity study, three OPPTS 

Harmonized Guideline 870.3650 

combined repeated dose toxicity studies 

with the reproduction/developmental 

toxicity screening tests, an OPPTS 

Harmonized Guideline 870.3550 

reproduction/developmental toxicity 

screening test, an OPPTS harmonized 

Test Guideline 870.3800 reproduction 

and fertility effects study, and 

reproduction and developmental effects 

studies. 

The AAAs are not acutely toxic by the 

oral and dermal routes of exposure 

under normal use conditions. 

Concentrated materials are generally 

moderate to severe eye and skin irritants 

and may be skin sensitizers. There is no 

evidence of mutagenicity in the Ames 

assay (bacterial strains). 

Following subchronic exposure to rats 

and dogs, decreases in body weight and 

food consumption were observed, but 

no specific target organ toxicity or 

neurotoxicity was seen. No effects were 

detected in a functional observational 

battery (FOB) or motor activity 

assessment. In a 90–day dermal toxicity 

study with AAA surfactant, no systemic 

toxicity was observed at doses up to 125 

mg/kg/day (the highest dose tested). In 

an OPPTS Harmonized Guideline 

870.3650 study with the AAA surfactant 

CAS No. 9004–98–2, parental toxicity 

observed at 110 mg/kg/day included 

decreased absolute and relative thymus 

weight, decreased body weight gain and 

decreased food consumption in females, 

and clinical signs in both sexes. These 

clinical signs are indicative of local 

irritation effects rather than systemic 

effects and thus were not used as a basis 

for evaluating the safety of the AAA 

surfactants. No reproductive or 

developmental/offspring toxicity was 

observed. In the second OPPTS 

Harmonized Guideline 870.3650 study 

with the AAA surfactant CAS 103818– 

93–5, parental systemic toxicity was 

observed at 300 mg/kg/day (HDT), based 

on decreased body weight gain (in 

males) and clinical signs (orange/red 

perioral staining and moderate 

salivation) in both sexes. No 

reproductive or developmental/ 

offspring toxicity was observed. In the 

third OPPTS Harmonized Guideline 

870.3650 study with the AAA surfactant 

CAS RN 64366–70–7, parental systemic 

toxicity was observed at 500 mg/kg/day 

(HDT), based on decreased body weight 

in males. No reproductive or 

developmental/offspring toxicity was 

observed. 

In an OPPTS Harmonized Test 

Guideline 870.3550 reproduction/ 

developmental toxicity screening test 

with the AAA surfactant CAS No. 

84133–50–6, parental toxicity was 

observed at 470 mg/kg/day based on 

clinical signs (ptosis and hypoactivity), 

decreased absolute body weight, body 

weight gain, and food consumption. 

Reproductive toxicity was observed, as 

evidenced by the microscopic changes 

in the testes and epididymides 

(testicular atrophy, increased 

intraluminal exfoliated spermatogenic 

cells in epididymides, and dilated 

seminiferous tubules). Developmental/ 

offspring toxicity was observed at 470 

mg/kg/day (the highest dose tested), 

based on decreased litter size and 

increased postimplantation loss. 

In a reproduction and developmental 

effects study with the AAA surfactant 

CAS 68951–67–7, the only significant 

effects observed in female rats were 

decreased body weight and body weight 

gain during premating at 400.8 mg/kg/ 

day. At this maternally toxic dose, 

offspring toxicity observed was 

decreased body weight on lactation day 

(LD) 21 (both sexes in F1A, F1B, F2A, and 

F2B). No treatment-related effects were 

observed on reproductive parameters. 

In an OPPTS Harmonized Test 

Guideline 870.3800 reproduction and 

fertility effects study with AAA 

surfactant CAS 68951–67–7, clinical 

signs observed at 250 mg/kg/day were 

increased incidences of lachrymation, 

incidences of unkemptness, hunched 

posture, chromodacryorrhea and 

periocular swelling in F0 and F1 

females. These effects may be attributed 

to local irritant effects. No treatmentrelated effects were observed on 

reproduction or the offspring at 250 mg/ 

kg/day (HDT). 

It is generally accepted that increased 

ethoxylation decreases lipophilicity 

resulting in decreased absorption and 

decreased toxicity. The lower molecular 

weight AAAs would be expected to be 

absorbed and distributed more readily 

than higher molecular weight AAAs and 


srobinson on DSKHWCL6B1PROD with RULES
38938 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 

therefore to potentially be more toxic. 

The representative ethoxylated 

compounds tested have the lowest 

weight percent ethoxylation and lowest 

molecular weight of the series and are 

potentially the most bioavailable of the 

series. Although metabolism data are 

not available, the major metabolic 

pathway for AAA surfactants is 

expected to include the hydrolysis of 

ether linkage to the corresponding alkyl 

alcohol and polyalkoxylate (POE or 

POE/POP) group which subsequently 

undergoes oxidative degradation and/or 

excretion. 

There is no evidence that the AAA 

surfactants 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 about any of the 

postulated metabolites having greater 

toxicity than the parent compounds. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by AAA, 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 

Alkyl Alcohol Alkoxylates (AAA - JITF 

CST 1 Inert Ingredient). Human Health 

Risk Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as an Inert 

Ingredient in Pesticide Formulations at 

pp 13–20 and pp 61–75 in docket ID 

number EPA–HQ–OPP–2009–0145. 

2. For the high molecular weight 

AAAs under 40 CFR 180.960. In the case 

of certain chemical substances that are 

defined as polymers, the Agency has 

established a set of criteria to identify 

categories of polymers expected to 

present minimal or no risk. The 

definition of a polymer is given in 40 

CFR 723.250(b) and the exclusion 

criteria for identifying these low-risk 

polymers are described in 40 CFR 

723.250(d). The high molecular weight 

AAAs conform to the definition of a 

polymer given in 40 CFR 723.250(b) and 

meet the following criteria that are used 

to identify low-risk polymers. 

i. The polymer is not a cationic 

polymer nor is it reasonably anticipated 

to become a cationic polymer in a 

natural aquatic environment. 

ii. The polymer does contain as an 

integral part of its composition the 

atomic elements carbon, hydrogen, and 

oxygen. 

iii. The polymer does not contain as 

an integral part of its composition, 

except as impurities, any element other 

than those listed in 40 CFR 

723.250(d)(2)(ii). 

iv. The polymer is neither designed 

nor can it be reasonably anticipated to 

substantially degrade, decompose, or 

depolymerize. 

v. The polymer is manufactured or 

imported from monomers and/or 

reactants that are already included on 

the TSCA Chemical Substance 

Inventory or manufactured under an 

applicable TSCA section 5 exemption. 

vi. The polymer is not a water 

absorbing polymer with a number 

average molecular weight (MW) greater 

than or equal to 10,000 daltons. 

Additionally, the polymers also meet 

as required the following exemption 

criteria specified in 40 CFR 723.250(e). 

The polymer’s number average MW of 

1,100 daltons is greater than 1,000 and 

less than 10,000 daltons. The polymer 

contains less than 10% oligomeric 

material below MW 500 and less than 

25% oligomeric material below MW 

1,000, and the polymer does not contain 

any reactive functional groups. 

Thus, the high molecular weight 

AAAs meet the criteria for a polymer to 

be considered low risk under 40 CFR 

723.250. Generally, polymers of this size 

would be poorly absorbed by all routes 

of exposure, including through the 

intact gastrointestinal tract or through 

intact human skin, and therefore, no 

mammalian toxicity is anticipated from 

dietary, inhalation, or dermal exposure 

to the high molecular weight AAAs. 

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. 

1. For the lower weight AAAs under 

40 CFR 180.910, 40 CFR 180.930, and 40 

CFR 180.940a. A summary of the 

toxicological endpoints for the AAAs 

used for human heatlh risk assessment 

is shown in the following Table. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR THE AAAS 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 endpoint was identified for acute dietary assessment. 


srobinson on DSKHWCL6B1PROD with RULES
Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 38939 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR THE AAAS 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) NOAEL= 168 

mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 

1.68 mg/kg/ 

day 

cPAD = 1.68 

mg/kg/day 

OPPTS harmonized Test Guideline 870.3550 reproduction/developmental toxicity screening test MRID 47676801 (2009) LOAEL 

= 470 mg/kg/day based on one maternal death (GD 22), decreased body weight, body weight gain, and food consumption, 

increased clinical signs (ptosis and hypoactivity), and microscopic changes of the testes and epididymides (testicular atrophy, increased intraluminal exfoliated spermatogenic cells in 

epididymides, and dilated seminiferous tubules) in parental animals, decreased litter size, and increased postimplantation loss. 

Incidental Oral and Inhalation (all 

durations) 

NOAEL= 168 

mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC 

for MOE = 

100 

OPPTS harmonized Test Guideline 870.3550 reproduction/developmental toxicity screening test MRID 47676801 (2009) LOAEL 

= 470 mg/kg/day based on one maternal death (GD 22), decreased body weight, body weight gain, and food consumption, 

increased clinical signs (ptosis and hypoactivity), and microscopic changes of the testes and epididymides (testicular atrophy, increased intraluminal exfoliated spermatogenic cells in 

epididymides, and dilated seminiferous tubules) in parental animals, decreased litter size, and increased postimplantation loss. 

Dermal (all durations) NOAEL= 168 

mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC 

for MOE = 

100 

OPPTS harmonized Test Guideline 870.3550 reproduction/developmental toxicity screening test MRID 47676801 (2009) Oral 

LOAEL = 470 mg/kg/day based on one maternal death (GD 22), 

decreased body weight, body weight gain, and food consumption, increased clinical signs (ptosis and hypoactivity), and microscopic changes of the testes and epididymides (testicular atrophy, increased intraluminal exfoliated spermatogenic cells in 

epididymides, and dilated seminiferous tubules) in parental animals, decreased litter size, and increased postimplantation loss. 

The final dose used to quantify dermal risk must correct for 50% 

dermal absorption, and should be multiplied by 3 to take into account the differences in rat and human skin penetration. The resulting dose = 1,000 mg/kg/day 

Cancer (oral, dermal, inhalation) Classification: Based on SAR analysis, AAA surfactrants 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. 

2. For the high molecular weight 

AAAs under 40 CFR 180.960. Since the 

high molecular weight AAAs conform to 

the criteria that identify a low risk 

polymer, and are not likely to be 

absorbed significantly by any route of 

exposure, there are no concerns for risks 

associated with any potential exposure 

scenarios that are reasonably 

foreseeable. Thus, due to their low 

potential hazard, it was determined that 

a quantitative risk assessment using 

safety factors applied to a point of 

departure protective of an identified 

hazard endpoint is not appropriate for 

the high molecular weight AAAs, and 

an exposure assessment is not 

necessary. For the same reason, an 

additional safety factor to protect infants 

and children is not needed. 

C. Exposure Assessment 

Sufficient data were provided on the 

chemical identity of the AAAs; 

however, limited data are available on 

the metabolism and environmental 

degradation of these compounds. 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. The Agency has 

concluded that a risk assessment based 

on toxicity data for the parent 

compounds is not likely to 

underestimate risk. 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to the lower weight AAAs, 

EPA considered exposure under the 

petitioned-for exemptions from the 

requirement of a tolerance. EPA 

assessed dietary exposures from the 

lower weight AAAs in food as follows: 

i. Acute exposure. No adverse effects 

attributable to a single exposure of the 

AAAs was seen in the toxicity 

databases. Therefore, acute dietary risk 

assessments for the AAAs are 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 the AAAs. In the absence of specific 

residue data, EPA has developed an 

approach which uses surrogate 


srobinson on DSKHWCL6B1PROD with RULES
38940 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 

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. 

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 

alerts suggestive of carcinogenicity. No 

structural alerts for carcinogenicity were 

identified. The AAAs 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 the AAAs. 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 the AAAs in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of the AAAs. 

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 the AAAs. Modeling runs on four 

surrogate inert ingredients using a range 

of physical chemical properties that 

would bracket those of the AAAs were 

conducted. Modeled acute drinking 

water values ranged from 0.001 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 

Alkyl Alcohol Alkoxylates (AAA - JITF 

CST 1 Inert Ingredient). Human Health 

Risk Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as an Inert 

Ingredient in Pesticide Formulations at 

pp 20–21 and 77–79 in docket ID 

number EPA–HQ–OPP–2009–0145. 

For the purpose of the screening level 

dietary risk assessment to support this 

request for an exemption from the 

requirement of a tolerance for the AAAs, 

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 compound. 

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). The AAAs 

may be used in 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 the 

AAAs as inert ingredients. In this 

assessment, representative scenarios, 

based on end-use product application 

methods and labeled application rates, 

were selected. The AAAs may be used 

as inert ingredients in pesticide 

formulations that are used in and 

around the home. Additionally, these 

inerts may be used in pesticide products 

applied to pets as aerosol sprays 

intended for flea control on carpeted 

surfaces and bedding, or in shampoo 

products applied to pets. Lastly, these 

inerts may be present in home cleaning 

products or paint products. 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 the 

AAAs. Similarly, the Agency conducted 

an assessment to represent worst-case 

residential exposure by assessing post 

application exposures and risks from 

AAAs in pesticide formulations 


srobinson on DSKHWCL6B1PROD with RULES
Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 38941 

(outdoor scenarios), AAAs in 

disinfectant-type uses (indoor 

scenarios), AAAs in shampoo pet 

treatments (pet product scenarios) and 

AAAs in paint products (paint product 

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 AAAs to share a 

common mechanism of toxicity with 

any other substances, and the AAAs 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 

AAAs 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. 

In the case of the lower weight AAA 

surfactants, there was no evidence of 

increased susceptibility to the offspring 

of rats following prenatal and postnatal 

exposure in the reproductive/ 

developmental screening studies on 

several representative AAA surfactants. 

Decreased litter size and increased 

postimplantation loss were observed in 

one OPPTS Harmonized Guideline 

870.3550 reproduction/developmental 

toxicity screening study at 470 mg/kg/ 

day where maternal/paternal toxicity 

was manifested as one maternal death 

(GD 22), decreased body weight, bodyweight gain and food consumption and 

clinical signs (ptosis and hypoactivity) 

and microscopic changes in the testes 

(atrophy) and epididymides (increased 

intraluminal exfoliated spermatogenic 

cells) and dilated seminiferous tubules 

at the same dose (470 mg/kg/day). The 

maternal and offspring toxicity NOAEL 

was 168 mg/kg/day. The offspring 

toxicity in the OPPTS Harmonized Test 

Guideline 870.3650 study was 

manifested in the presence of more 

severe maternal toxicity (deaths), 

therefore, EPA concluded that there is 

no evidence of increased susceptibility 

in this study. In addition, there was no 

evidence of increased susceptibility in 

other submitted studies. 

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 for the lower weight 

AAAs. (As discussed earlier, given the 

low toxicological concerns with the 

high weight AAAs, a safety factor 

analysis is unnecessary). That decision 

as to the lower weight AAAs is based on 

the following findings: 

i. The toxicity database for the AAAs 

is considered adequate for assessing the 

risks to infants and children. The 

toxicity database consists of three 

OPPTS Harmonized Test Guideline 

870.3650 combined repeated dose 

toxicity studies with the reproduction/ 

developmental toxicity screening tests, 

an OPPTS Harmonized Test Guidelinge 

870.3550 reproduction/developmental 

toxicity screening test study, an OPPTS 

Harmonized Test Guideline 870.3800 

reproduction and fertility effects study, 

and reproduction and developmental 

effects studies. The Agency noted 

changes in thymus weight. However, the 

thymus/lymph node effects are 

considered secondary effects caused by 

an overall stress response to the irritant 

properties of this chemical, and 

therefore, not an immunological 

response. In addition, no blood 

parameters were affected in the 

database. Furthermore, these 

compounds do not belong to a class of 

chemicals that would be expected to be 

immunotoxic. Also, in an OPPTS 

Harmonized Test Guideline 870.3550 

study, testicular effects, such as, 

testicular atrophy, microscopic changes 

in the testes, epididymides and dilated 

seminiferous tubules were observed in 

male rats at the highest dose tested (470 

mg/kg/day). However, none of the 

reproductive parameters (pregnancy 

rate) were affected in this study. In 

addition, there were no effects observed 

on reproductive parameters in the 

OPPTS Harmonized Test Guideline 

870.3800 reproduction and fertility 

effects study. Furthermore, there was no 

histological findings in the testes in that 

study. Based on the weight of the 

evidence for immunotoxoicity and 

reproductive toxicity, there is no need 

to add additional uncertainty factors. 

ii. EPA concluded that there is no 

evidence of qualitative or quantitative 

increased susceptivility in the available 

database. Therefore, there is no concern 

for increased susceptibility to infants 

and children. 

iii. There is no indication that the 

AAAs are neurotoxic chemicals and 

thus there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity 

iv. Although the chronic point of 

departure was selected from a 

subchronic study, longer-term studies 

are available that support the NOAEL 

selected. No additional uncertainty 

factor is needed for extrapolating from 

subchronic to chronic exposure. 

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 the AAAs 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 the AAAs. 

E. Aggregate Risks and Determination of 

Safety 

1. For the lower weight AAAs under 

40 CFR 180.910, 40 CFR 180.930, and 40 

CFR 180.940a. EPA determines whether 


srobinson on DSKHWCL6B1PROD with RULES
38942 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 

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. 

i. Acute risk. There was no hazard 

attributable to a single exposure seen in 

the toxicity database for the AAAs. 

Therefore, the AAAs are not expected to 

pose an acute risk. 

ii. Chronic risk. A chronic aggregate 

risk assessment takes into account 

exposure estimates from chronic dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for chronic 

exposure the chronic dietary exposure 

from food and water to the AAAs is 

11% of the cPAD for the U.S. 

population and 37% of the cPAD for 

children 1 to 2 years old, the most 

highly exposed population subgroup. 

iii. 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). 

AAAs 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 the 

AAAs. EPA has concluded that the 

combined short-term aggregated food, 

water, and residential exposures result 

in aggregate MOEs of 110 for both adult 

males and females. Adult residential 

exposure combines high end indoor 

inhalation handler exposure with a 

high-end post application to pet 

exposures. 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 combined pet exposures. As the 

level of concern is for MOEs that are 

lower than 100, these MOEs are not of 

concern. 

iv. 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). 

The AAAs 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 the AAAs. EPA 

has concluded that the combined 

intermediate-term aggregated food, 

water, and residential exposures result 

in aggregate MOEs of 230 for both adult 

males and females, respectively. Adult 

residential exposure includes high-end 

post application dermal exposure from 

contact with treated pets. 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 combined pet exposure. As the 

level of concern is for MOEs that are 

lower than 100, these MOEs are not of 

concern. 

v. Aggregate cancer risk for U.S. 

population. The Agency has not 

identified any concerns for 

carcinogenicity relating to the AAAs. 

vi. 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 

the lower weight AAAs. 

2. For the high molecular weight 

AAAs under 40 CFR 180.960. Since 

AAA conforms to the criteria that 

identify a low-risk polymer, there are no 

concerns for risks associated with any 

potential exposure scenarios that are 

reasonably foreseeable. Therefore, 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 the high molecular weight 

AAAs. 

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 the 

AAAs 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 the lower molecular 

weight a-alkyl-w-hydroxypoly 

(oxypropylene) and/or poly 

(oxyethylene) polymers where the alkyl 

chain contains a minimum of 6 carbons 

when used as an inert ingredient in 

pesticide formulations applied pre- and 

post-harvest, applied to livestock, and 

used in antimicrobial formulations 

under 40 CFR 180.910, 40 CFR 180.930, 

and 40 CFR 180.940(a). In addition, an 

exemption from the requirement of a 

tolerance is established for residues of 

the larger molecular weight compounds 

of a-alkyl-w-hydroxypoly 

(oxypropylene) and/or poly 

(oxyethylene) polymers where the alkyl 

chain contains a minimum of 6 carbons 

under 40 CFR 180.960. 

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, 


srobinson on DSKHWCL6B1PROD with RULES
Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 38943 

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: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * * * 

a-alkyl-w-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl 

chain contains a minimum of six carbons (CAS Reg. Nos. 9002–92–0, 9004–95–9, 

9005–00–9, 26183–52–8, 34398–01–1, 52292–17–8, 66455–14–9, 66455–15–0, 

68002–97–1, 68131–39–5, 68131–40–8, 68154–96–1, 68213–23–0, 68439–45–2, 

68439–46–3, 68526–94–3, 68439–50–9, 68439–49–6, 68551–12–2, 68951–67–7, 

71243–46–4, 97043–91–9, 9043–30–5, 60828–78–6, 61827–42–7, 24938–91–8, 

68439–54–3, 69011–36–5, 78330–20–8, 78330–21–9, 106232–83–1, 127036–24–2, 

160875–66–1, 9004–98–2, 68920–66–1, 61804–34–0, 61791–28–4, 71060–57–6, 

26468–86–0, 31726–34–8, 52609–19–5, 61791–20–6, 68155–01–1, 69013–19–0, 

69364–63–2, 70879–83–3, 78330–19–5, 97953–22–5, 157627–86–6, 34398–05–5, 

72905–87–4, 84133–50–6, 61702–78–1, 27306–79–2, 169107–21–5, 61791–13–7, 

39587–22–9, 85422–93–1; 68154–98–3, 61725–89–1, 68002–96–0, 68154–97–2, 

68439–51–0, 68551–13–3, 68603–25–8, 68937–66–6, 68987–81–5, 69227–21–0, 

70750–27–5, 103818–93–5, 166736–08–9, 120313–48–6, 68213–24–1, 68458–88–8, 

68551–14–4, 69013–18–9, 69227–22–1, 72854–13–8, 73049–34–0, 78330–23–1, 

37311–02–7, 64366–70–7, 37251–67–5, 9087–53–0, 196823–11–7, 57679–21–7, 

111905–54–5, 61827–84–7, 172588–43–1) 

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. 

* * * * * 


srobinson on DSKHWCL6B1PROD with RULES
38944 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 

Inert Ingredients Limits Uses 

* * * * * * * 

a-alkyl-w-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl 

chain contains a minimum of six carbons (CAS Reg. Nos. 9002–92–0, 9004–95–9, 9005– 

00–9, 26183–52–8, 34398–01–1, 52292–17–8, 66455–14–9, 66455–15–0, 68002–97–1, 

68131–39–5, 68131–40–8, 68154–96–1, 68213–23–0, 68439–45–2, 68439–46–3, 68526– 

94–3, 68439–50–9, 68439–49–6, 68551–12–2, 68951–67–7, 71243–46–4, 97043–91–9, 

9043–30–5, 60828–78–6, 61827–42–7, 24938–91–8, 68439–54–3, 69011–36–5, 78330– 

20–8, 78330–21–9, 106232–83–1, 127036–24–2, 160875–66–1, 9004–98–2, 68920–66–1, 

61804–34–0, 61791–28–4, 71060–57–6, 26468–86–0, 31726–34–8, 52609–19–5, 61791– 

20–6, 68155–01–1, 69013–19–0, 69364–63–2, 70879–83–3, 78330–19–5, 97953–22–5, 

157627–86–6, 34398–05–5, 72905–87–4, 84133–50–6, 61702–78–1, 27306–79–2, 

169107–21–5, 61791–13–7, 39587–22–9, 85422–93–1; 68154–98–3, 61725–89–1, 

68002–96–0, 68154–97–2, 68439–51–0, 68551–13–3, 68603–25–8, 68937–66–6, 68987– 

81–5, 69227–21–0, 70750–27–5, 103818–93–5, 166736–08–9, 120313–48–6, 68213–24– 

1, 68458–88–8, 68551–14–4, 69013–18–9, 69227–22–1, 72854–13–8, 73049–34–0, 

78330–23–1, 37311–02–7, 64366–70–7, 37251–67–5, 9087–53–0, 196823–11–7, 57679– 

21–7, 111905–54–5, 61827–84–7, 172588–43–1) 

Surfactants, related adjuvants of 

surfactants 

* * * * * * * 

■ 4. Section §180.940 is amended by 

alphabetically adding the following 

entry to the table in paragraph (a): 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

Pesticide Chemical CAS Reg. No. Limits 

* * * * * * * 

a-alkyl-w-hydroxypoly (oxypropylene) and/or 

poly (oxyethylene) polymers where the alkyl 

chain contains a minimum of six carbons.

9002–92–0, 9004–95–9, 9005–00–9, 26183–52–8, 34398–01–1, 

52292–17–8, 66455–14–9, 66455–15–0, 68002–97–1, 68131– 

39–5, 68131–40–8, 68154–96–1, 68213–23–0, 68439–45–2, 

68439–46–3, 68526–94–3, 68439–50–9, 68439–49–6, 68551– 

12–2, 68951–67–7, 71243–46–4, 97043–91–9, 9043–30–5, 

60828–78–6, 61827–42–7, 24938–91–8, 68439–54–3, 69011– 

36–5, 78330–20–8, 78330–21–9, 106232–83–1, 127036–24–2, 

160875–66–1, 9004–98–2, 68920–66–1, 61804–34–0, 61791– 

28–4, 71060–57–6, 26468–86–0, 31726–34–8, 52609–19–5, 

61791–20–6, 68155–01–1, 69013–19–0, 69364–63–2, 70879– 

83–3, 78330–19–5, 97953–22–5, 157627–86–6, 34398–05–5, 

72905–87–4, 84133–50–6, 61702–78–1, 27306–79–2, 169107– 

21–5, 61791–13–7, 39587–22–9, 85422–93–1; 68154–98–3, 

61725–89–1, 68002–96–0, 68154–97–2, 68439–51–0, 68551– 

13–3, 68603–25–8, 68937–66–6, 68987–81–5, 69227–21–0, 

70750–27–5, 103818–93–5, 166736–08–9, 120313–48–6, 

68213–24–1, 68458–88–8, 68551–14–4, 69013–18–9, 69227– 

22–1, 72854–13–8, 73049–34–0, 78330–23–1, 37311–02–7, 

64366–70–7, 37251–67–5, 9087–53–0, 196823–11–7, 57679– 

21–7, 111905–54–5, 61827–84–7, 172588–43–1) 

* * * * * * * 

■ 5. In §180.960, the table is amended 

by adding alphabetically the following 

polymers: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

* * * * * 

Polymer CAS No. 

* * * * * 

a-alkyl-w-hydroxypoly 

(oxypropylene) and/or 

poly (oxyethylene) polymers where the alkyl 

chain contains a minimum of six carbons, 

minimum number average molecular weight (in 

amu) 1,100. 

9002–92–0, 9004–95–9, 9005–00–9, 26183–52–8, 34398–01–1, 52292–17–8, 66455–14–9, 66455–15–0, 68002– 

97–1, 68131–39–5, 68131–40–8, 68154–96–1, 68213–23–0, 68439–45–2, 68439–46–3, 68526–94–3, 68439–50– 

9, 68439–49–6, 68551–12–2, 68951–67–7, 71243–46–4, 97043–91–9, 9043–30–5, 60828–78–6, 61827–42–7, 

24938–91–8, 68439–54–3, 69011–36–5, 78330–20–8, 78330–21–9, 106232–83–1, 127036–24–2, 160875–66–1, 

9004–98–2, 68920–66–1, 61804–34–0, 61791–28–4, 71060–57–6, 26468–86–0, 31726–34–8, 52609–19–5, 

61791–20–6, 68155–01–1, 69013–19–0, 69364–63–2, 70879–83–3, 78330–19–5, 97953–22–5, 157627–86–6, 

34398–05–5, 72905–87–4, 84133–50–6, 61702–78–1, 27306–79–2, 169107–21–5, 61791–13–7, 39587–22–9, 

85422–93–1; 68154–98–3, 61725–89–1, 68002–96–0, 68154–97–2, 68439–51–0, 68551–13–3, 68603–25–8, 

68937–66–6, 68987–81–5, 69227–21–0, 70750–27–5, 103818–93–5, 166736–08–9, 120313–48–6, 68213–24–1, 

68458–88–8, 68551–14–4, 69013–18–9, 69227–22–1, 72854–13–8, 73049–34–0, 78330–23–1, 37311–02–7, 

64366–70–7, 37251–67–5, 9087–53–0, 196823–11–7, 57679–21–7, 111905–54–5, 61827–84–7, 172588–43–1 

* * * * * 


srobinson on DSKHWCL6B1PROD with RULES
Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 38945 

[FR Doc. E9–18706 Filed 8–4–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0944; FRL–8429–4] 

Polyoxyethylene polyoxypropylene 

mono(di-sec-butylphenyl) ether; 

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 

Polyoxyethylene polyoxypropylene 

mono(di-sec-butylphenyl) ether when 

used as an inert ingredient in herbicide 

formulations only, for pre-harvest uses 

and at no more than 30% by weight in 

herbicide formulations intended for 

application to turf. The Joint Inerts Task 

Force (JITF), Cluster Support Team 

Number 20, 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 

Polyoxyethylene polyoxypropylene 

mono(di-sec-butylphenyl) ether. 

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–2008–0944. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Kerry Leifer, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8811; e-mail address: 

leifer.kerry@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e–CFR 

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

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gpo/opptsfrs/home/ 

guidelin.htm. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0944 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–2008–0944, 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 8E7494) by The 

Joint Inerts Task Force (JITF), Cluster 

Support Team 20 (CST 20), c/o CropLife 

America, 1156 15th Street, NW., Suite 

400, Washington, DC 20005. The 

petition requested that 40 CFR 180.920 

be amended by establishing exemptions 

from the requirement of a tolerance for 

residues of the inert ingredient 


srobinson on DSKHWCL6B1PROD with RULES