51382 Federal Register / Vol. 75, No. 161 / Friday, August 20, 2010 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0131; FRL–8836–5] 

Alkyl Alcohol Alkoxylate Phosphate 

Derivatives; 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 alkyl alcohol 

alkoxylate phosphate derivatives 

(AAAPD) when used under 40 CFR part 

910 as an inert ingredient—surfactant 

and related adjuvants of surfactants for 

pre- and post-harvest uses and 

application to animals in pesticide 

formulations under 40 CFR part 930, 

limited to a maximum of 30% by weight 

in end-use products. The Joint Inerts 

Task Force (JITF), Cluster Support Team 

Number 2 (CST 2) submitted a petition 

to EPA under the Federal Food, Drug, 

and Cosmetic Act (FFDCA), requesting 

establishment of an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of AAAPDs. 

DATES: This regulation is effective 

August 20, 2010. Objections and 

requests for hearings must be received 

on or before October 19, 2010, 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–2009–0131. 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: Lisa 

Austin, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7894; e-mail address: 

austin.lisa@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR cite at http:// 

www.gpoaccess.gov/ecfr. To access the 

OPPTS harmonized test guidelines 

referenced in this document 

electronically, please go to http:// 

www.epa.gov/oppts and select ‘‘Test 

Methods and Guidelines.’’ 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. The EPA procedural 

regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0131 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before October 19, 2010. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2009–0131, 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. Petition for Exemption 

In the Federal Register of February 4, 

2010 (75 FR 5793) (FRL–8807–5), EPA 

issued a notice pursuant to section 408 

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

the filing of a pesticide petition (PP 

9E7628) by the Joint Inerts Task Force, 

Cluster Support Team 2 (CST 2), c/o 

CropLife America, 1156 15th Street, 

NW., Suite 400, Washington, DC 20005. 

The petition requested that 40 CFR 

180.910 and 40 CFR 180.930 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of AAAPDs when used as an 

inert ingredient surfactant and related 

adjuvants of surfactants in pesticide 

formulations applied to growing crops, 

raw agricultural commodities and foodproducing animals limited to a 

maximum of 30% by weight in end-use 


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Federal Register / Vol. 75, No. 161 / Friday, August 20, 2010 / Rules and Regulations 51383 

products for the a-alkyl (minimum C6

linear or branched, saturated and or 

unsaturated)-w-hydroxypolyoxyethylene 

polymer with or without 

polyoxypropylene, mixture of di- and 

monohydrogen phosphate esters and the 

corresponding ammonium, calcium, 

magnesium, monoethanolamine, 

potassium, sodium and zinc salts of the 

phosphate esters; minimum oxyethylene 

content averages 2 moles; minimum 

oxypropylene content is 0 moles, 

including: Poly(oxy-1 ,2-ethanediyl), atridecyl- w -hydroxy-, phosphate (9046– 

01–9); Poly(oxy-1 ,2-ethanediyl), adodecyl-w-hydroxy-, phosphate (39464– 

66–9); Poly(oxy-1 ,2-ethanediyl), ahexadecyl-w-hydroxy-, phosphate 

(50643–20–4); Poly(oxy-1 ,2-ethanediyl), 

a-decyl-w-hydroxy-, phosphate (52019– 

36–0); Poly(oxy-1 ,2-ethanediyl), ahydro-w-hydroxy-, mono-C12–15-alkyl 

ethers, phosphates (68071–35–2); 

Polyphosphoric acids, esters with 

polyethylene glycol decyl ether (68458– 

48–0); Poly(oxy-1 ,2-ethanediyl), ahydro-w-hydroxy-, mono-C10–14-alkyl 

ethers, phosphates (68585–36–4); 

Poly(oxy-1,2-ethanediyl), a-hydro-whydroxy-, mono-C12–15-branched alkyl 

ethers, phosphates (68815–11–2); 

Poly(oxy-1 ,2-ethanediyl), a-hydro-whydroxy-, mono-C10–12-alkyl ethers, 

phosphates (68908–64–5); Poly(oxy-1 ,2- 

ethanediyl), a-hydro-w-hydroxy-, monoC12–14-aIkyl ethers, phosphates (68511– 

37–5); Poly(oxy-1 ,2-ethanediyl), ahydro-w-hydroxy-, mono-C8–10-alkyl 

ethers, phosphates (68130–47–2); 

Poly(oxy-1 ,2-ethanediyl), a-dodecyl-whydroxy-, phosphate, sodium salt 

(42612–52–2); Poly(oxy-1 ,2-ethanediyl), 

a-dodecyl-w-hydroxy-, phosphate, 

potassium salt (58318–92–6); Poly(oxy1 ,2-ethanediyl), a-hexadecyl-w– 

hydroxy-, phosphate, potassium salt 

(60267–55–2); Poly(oxy-1 ,2-ethanediyl), 

a-decyl- w hydroxy-, phosphate, 

potassium salt (68070–99–5); Poly(oxy1,2-ethanediyl), a-tridecyl-w-hydroxy-, 

phosphate, potassium salt (68186–36– 

7); Poly(oxy1,2-ethanediyl), a-decyl-whydroxy-, phosphate, sodium salt 

(68186–37–8); Poly(oxy-1,2-ethanediyl), 

a-hydro-w-hydroxy-, mono-C12–15-alkyl 

ethers, phosphates, sodium salts 

(68610–65–1); Poly(oxy-1 ,2-ethanediyl), 

a-isodecyl- w-hydroxy-, phosphate, 

potassium salt (68071–17–0); (branched 

C10) Poly(oxy-1,2-ethanediyl), aphosphono-w-[(2- propylheptyl)oxy]-, 

potassium salt (1:2) (936100–29–7); 

(branched C10) Poly(oxy-1,2-ethanediyl), 

a-phosphono-w-[(2-propylheptyl)oxy]-, 

sodium salt (1:2) (936100–30–0); 

Poly(oxy-1,2- ethanediyl), a-isotridecylw-hydroxy-, phosphate (73038–25–2); 

Poly(oxy-1 ,2- ethanediyl), a-hydro-whydroxy-, mono-C11–14-isoalkyl ethers, 

C13-rich, phosphates (78330–24–2); 

Poly(oxy-1 ,2-ethanediyl),a-hydro-whydroxy-, mono(C10-rich C9–11-isoalkyl) 

ethers, phosphates (154518–39–5); 

Poly(oxy-1 ,2-ethanediyl), a-hydro-whydroxy-, mono-C12–14-sec-alkyl ethers, 

phosphates (317833–96–8); Poly(oxy-1 

,2-ethanediyl), a-isodecyl-w-hydroxy-, 

phosphate (108818–88–8); Poly(oxy-1, 

2- ethanediyl), a-phosphono-w-[(2- 

propylheptyl)oxy] (873662–29–4); 

Poly(oxy-1, 2-ethanediyl), a-dodecyl-whydroxy-, phosphate, 

monoethanolamine salt (61837–79–4); 

Poly(oxy-1 ,2-ethanediyl), a-tridecyl-whydroxy-, phosphate monoethanolamine 

salt (68311–02–4); Poly(oxy-1,2- 

ethanediyl), a-decyl-w-hydroxy-, 

phosphate, monoethanolamine salt 

(68425–73–0); Oxirane, methyl-, 

polymer with oxirane, phosphate 

(37280–82–3); Oxirane, methyl-, 

polymer with oxirane, mono-C10–16-alkyl 

ethers, phosphates (68649–29–6); 

Oxirane, methyl-, polymer with oxirane, 

phosphate, potassium salt (67711–84– 

6); and Oxirane, methyl-, polymer with 

oxirane, mono-C10–16-alkyl ethers, 

phosphates, potassium salt (68891–13– 

4). That notice referenced a summary of 

the petition prepared by The Joint Inerts 

Task Force (JITF), Cluster Support Team 

Number 2 (CST 2), the petitioner, which 

is available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene 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(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for 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 establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

Consistent with section 408(c)(2)(A) 

of FFDCA, and the factors specified in 

FFDCA section 408(c)(2)(B), 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 AAAPDs 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with AAAPDs follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

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 


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sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the adverse effects caused 

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

lowest-observed-adverse-effect-level 

(LOAEL) from the toxicity studies are 

discussed in this unit. 

The AAAPDs are not acutely toxic by 

the oral and dermal routes of exposure 

under normal use conditions; however, 

concentrated materials are generally 

moderate to severe eye and skin irritants 

and may be skin sensitizers. Following 

subchronic exposure to rats, 

gastrointestinal irritation (increased 

incidences of hyperplasia, submucosal 

edema, and ulceration) was observed, 

but no specific target organ toxicity or 

neurotoxicity was seen. No 

neurotoxicological effects were detected 

in a functional observational battery or 

a motor activity assessment. No 

reproductive effects were noted in the 

database. There was a qualitative 

increase in susceptibility to pups seen 

in a rat developmental/reproductive 

toxicity screening study; however, 

effects were seen only in one study and 

were in the presence of maternal 

toxicity. Further, a clear NOAEL was 

established for the developmental 

effects and this NOAEL is significantly 

higher than the toxicological points of 

departure selected for risk assessment. 

There are no carcinogenicity concerns 

based on structure activity modeling. 

Points of departure for chronic dietary, 

incidental oral, inhalation, and dermal 

exposure were selected from a 2– 

generation reproduction and fertility 

effects study in rats. The endpoint was 

decreased absolute and relative liver 

weights and increased incidence in the 

number of animals with minimal 

hepatocyte necrosis in males. 

Sufficient data were provided on the 

chemical identity of the AAAPDs; 

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 (SAR) 

information, as well as information on 

other surfactants and chemicals of 

similar size and functionality to 

determine the residues of concern for 

the AAAPDs. The Agency has 

concluded that since metabolites and 

environmental degradates are not likely 

to be more toxic than the parent 

compounds, a risk assessment based on 

the parent compounds is not likely to 

underestimate risk. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by the AAAPSDs as well 

as the NOAEL and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

‘‘Alkyl Alcohol Alkoxylate Phosphate 

and Sulfate Derivatives (AAAPDs and 

AAASDs-JITF CST 2 Inert Ingredients). 

Human Health Risk Assessment to 

Support Proposed Exemption from the 

Requirement of a Tolerance When Used 

as Inert Ingredients in Pesticide,’’ pp. 

11–17 in docket ID number EPA–HQ– 

OPP–2009–0131. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors (U/SF) are used in 

conjunction with the POD to calculate a 

safe exposure level – generally referred 

to as a population-adjusted dose (PAD) 

or a reference dose (RfD) – and a safe 

margin of exposure (MOE). For nonthreshold 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 

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 AAADPs used for human 

risk assessment is discussed in Unit IV. 

of the final rule published in the 

Federal Register of July 29, 2009 (74 FR 

37571) (FRL–8424–6). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to AAAPDs, EPA considered 

exposure under the proposed exemption 

from the requirement of a tolerance. 

EPA assessed dietary exposures from 

AAAPDs in food as follows: 

i. Acute and chronic exposure. In 

conducting the acute and chronic 

dietary exposure assessments, EPA used 

food consumption information from the 

United States 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 AAAPDs. 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 ingredients. 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 dietary exposure and 

risk assessment can be found at http:// 

www.regulations.gov in ‘‘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 

in relation to that of the active 

ingredient. In the case of AAAPDs, EPA 

made a specific adjustment to the 

dietary exposure assessment to account 

for the use limitations of the amount of 

AAAPDs that may be in formulations (to 

no more than 30% and assumed that the 

AAAPDs are present at the maximum 

limitation rather than at equal quantities 

with the active ingredient. This remains 


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a very conservative assumption because 

surfactants are generally used at levels 

far below this percentage. 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 

AAAPDs. 

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. 

ii. 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 Agency has not 

identified any concerns for 

carcinogenicity relating to the inerts 

AAAPDs. Therefore a cancer dietary 

exposure assessment is not necessary to 

assess cancer risk. 

iii. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for AAAPDs. Tolerance level residues 

and/or 100 PCT were assumed for all 

food commodities. 

2. Dietary exposure from drinking 

water. For the purpose of the screening 

level dietary risk assessment to support 

this request for an exemption from the 

requirement of a tolerance for AAAPDs, 

a conservative drinking water 

concentration value of 100 parts per 

billion (ppb) based on screening level 

modeling was used to assess the 

contribution to drinking water for the 

chronic dietary risk assessments for 

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., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

AAAPDs are used as inert ingredients 

in pesticide products that are registered 

for specific uses that could result in 

indoor residential exposures and may 

have uses as inert ingredients in 

pesticide products that may result in 

outdoor residential exposures. 

A screening level residential exposure 

and risk assessment was completed for 

products containing AAAPDs 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 AAAPDs. 

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 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 AAAPDs to share 

a common mechanism of toxicity with 

any other substances, and AAAPDs do 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

AAAPDs 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 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

The toxicity database consists of 

Harmonized Test Guideline OPPTS 

870.3650 (combined repeated dose 

toxicity study with the reproduction/ 

developmental toxicity screening test) 

studies in rats conducted with 

representative AAAPDs, as well as a 2– 

generation rat reproduction toxicity 

(Harmonized Test Guideline OPPTS 

870.3800) study and a rat 

developmental toxicity study conducted 

with a representative AAASD. 

In one Harmonized Test Guideline 

OPPTS 870.3650 study conducted with 

a representative AAAPD, no increased 

susceptibility to the offspring of rats 

following prenatal and postnatal 


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51386 Federal Register / Vol. 75, No. 161 / Friday, August 20, 2010 / Rules and Regulations 

exposure was observed. In a second 

Harmonized Test Guideline OPPTS 

870.3650 study conducted with another 

representative AAAPD, there was 

evidence of increased qualitative 

susceptibility as indicated by the 

increased number of stillborn pups and 

pups dying within lactation day (LD) 4/ 

5 and clinical observations (coldness to 

the touch, discolored heads, and a lack 

of nesting behavior) at 800 milligrams/ 

kilogram/day (mg/kg/day) where lesions 

in the forestomach and thymus atrophy 

was observed in the parental animals. 

However, this qualitative susceptibility 

seen in the Harmonized Test Guideline 

OPPTS 870.3650 study does not 

indicate a heightened risk for infants 

and children because a clear NOAEL 

(200 mg/kg/day) was established for 

developmental effects and an additional 

margin of safety is provided since the 

point of departure selected from the 2– 

generation rat reproduction study for 

chronic exposure is 87 mg/kg/day. 

In a rat developmental study with 

AAASD, no maternal or developmental 

toxicity was observed at the limit dose. 

In the 2–generation reproduction study 

with AAASD, the only significant 

effects observed were liver effects 

characterized by dose-related decrease 

in absolute and relative liver weight and 

an increased incidence in the number of 

animals with ‘minimal’’ hepatocyte 

necrosis in males. No treatment-related 

effects were observed on reproduction 

or in the offspring. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for AAAPDs 

is considered adequate for assessing the 

risks to infants and children (the 

available studies are described in Unit 

IV.D.2.). 

ii. There is no indication that 

AAAPDs are neurotoxic chemicals and 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. Although increased qualitative 

susceptibility was demonstrated in the 

offspring in a reproductive/ 

developmental screening test portion of 

an Harmonized Test Guideline OPPTS 

870.3650 study with another AAAPD, 

the Agency did not identify any residual 

uncertainties after establishing toxicity 

endpoints and traditional UFs to be 

used in the risk assessment of the 

AAAPDs. 

iv. 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 AAAPDs in 

drinking water. EPA used similarly 

conservative assumptions to assess 

postapplication exposure of children as 

well as incidental oral exposure of 

toddlers. These assessments will not 

underestimate the exposure and risks 

posed by AAAPDs. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer 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 appropriate 

PODs to ensure that an adequate MOE 

exists. 

In conducting this aggregate risk 

assessment, the Agency has 

incorporated the petitioner’s requested 

use limitations of AAAPDs as inert 

ingredients in pesticide product 

formulations into its exposure 

assessment. Specifically the petition 

includes a use limitation of AAAPDs at 

not more than 30% by weight in 

pesticide formulations. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, AAAPDs are not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to AAAPDs from 

food and water will utilize 43% of the 

cPAD for children 1–2 yrs old, the 

population group receiving the greatest 

exposure. 

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). 

AAAPDs are currently used as an 

inert ingredient in pesticide products 

that are 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 AAAPDs. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 130 and 140, for adult males 

and females respectively, for a 

combined high-end dermal and 

inhalation handler exposure with a 

high-end postapplication dermal 

exposure and an aggregate MOE of 110 

for children for a combined turf dermal 

exposure with hand-to-mouth exposure. 

Because EPA’s level of concern for 

AAAPDs is a MOE of 100 or below, 

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). 

AAAPDs are currently used as an 

inert ingredient in pesticide products 

that are 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 AAAPDs. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in aggregate MOEs of 270 and 280, for 

adult males and females respectively, 

for a combined high-end dermal and 

inhalation handler exposure with a 

high-end postapplication dermal 

exposure and an MOE of 110 for 

children for a combined high-end 

dermal exposure with hand-to-mouth 

exposure. Because EPA’s level of 

concern for AAAPDs are a MOE of 100 

or below, these MOEs are not of 

concern. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack 

ofstructural alerts for carcinogenicity, 

AAAPDs are not expected to pose a 

cancer risk to humans. 

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 AAAPDs 

residues. 


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Federal Register / Vol. 75, No. 161 / Friday, August 20, 2010 / Rules and Regulations 51387 

V. Other Considerations 

A. Analytical Enforcement Methodology 

EPA is establishing a limitation on the 

amount of AAAPDs that may be used in 

pesticide formulations. That limitation 

will be enforced through the pesticide 

registration process under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA), 7 U.S.C. 136 et seq. EPA 

will not register any pesticide for sale or 

distribution that contains greater than 

30% of AAAPDs by weight in the enduse pesticide formulation. 

B. International Residue Limits 

The Agency is not aware of any 

country requiring a tolerance for nor 

have any CODEX Maximum Residue 

Levels been established for any food 

crops at this time. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 and 40 CFR 

180.930 for AAAPDs when used as an 

inert ingredient (surfactants, related 

adjuvants of surfactants) in pesticide 

formulations applied to raw agricultural 

commodities, growing crops, and 

animals. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VIII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 10, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.910, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * 

a-alkyl (minimum C6 linear or branched, saturated and or unsaturated)-w-hydroxypolyoxyethylene polymer with or without 

polyoxypropylene, mixture of di- and monohydrogen phosphate 

esters and the corresponding ammonium, calcium, magnesium, 

monoethanolamine, potassium, sodium and zinc salts of the phosphate esters; minimum oxyethylene content averages 2 moles; minimum oxypropylene content is 0 moles (CAS Reg. Nos. 9046–01–9, 

39464–66–9, 50643–20–4, 52019–36–0, 68071–35–2, 68458–48–0, 

68585–36–4, 68815–11–2, 68908–64–5, 68511–37–5, 68130–47–2, 

42612–52–2, 58318–92–6, 60267–55–2, 68070–99–5, 68186–36–7, 

68186–37–8, 68610–65–1, 68071–17–0, 936100–29–7, 936100– 

30–0, 73038–25–2, 78330–24–2, 154518–39–5, 317833–96–8, 

108818–88–8, 873662–29–4, 61837–79–4, 68311–02–4, 68425– 

73–0, 37280–82–3, 68649–29–6, 67711–84–6, 68891–13–4. 

Not to exceed 30% of pesticide 

formulation 

Surfactants, related adjuvants of 

surfactants 


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51388 Federal Register / Vol. 75, No. 161 / Friday, August 20, 2010 / Rules and Regulations 

Inert ingredients Limits Uses 

* * * * * 

* * * * * ■ 3. In § 180.930, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * 

a-alkyl (minimum C6 linear or branched, saturated and or unsaturated)-w-hydroxypolyoxyethylene polymer with or without 

polyoxypropylene, mixture of di- and monohydrogen phosphate 

esters and the corresponding ammonium, calcium, magnesium, 

monoethanolamine, potassium, sodium and zinc salts of the phosphate esters; minimum oxyethylene content averages 2 moles; minimum oxypropylene content is 0 moles (CAS Reg. Nos. 9046–01–9, 

39464–66–9, 50643–20–4, 52019–36–0, 68071–35–2, 68458–48–0, 

68585–36–4, 68815–11–2, 68908–64–5, 68511–37–5, 68130–47–2, 

42612–52–2, 58318–92–6, 60267–55–2, 68070–99–5, 68186–36–7, 

68186–37–8, 68610–65–1, 68071–17–0, 936100–29–7, 936100– 

30–0, 73038–25–2, 78330–24–2, 154518–39–5, 317833–96–8, 

108818–88–8, 873662–29–4, 61837–79–4, 68311–02–4, 68425– 

73–0, 37280–82–3, 68649–29–6, 67711–84–6, 68891–13–4. 

Not to exceed 30% of pesticide 

formulation 

Surfactants, related adjuvants of 

surfactants 

* * * * * 

* * * * * 

[FR Doc. 2010–20708 Filed 8–19–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2002–0185; FRL–8838–3] 

2-methyl-1,3-propanediol; 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 2-methyl-1,3- 

propanediol (CAS Reg. No. 2163-42-0) 

when used as an inert ingredient in 

pesticide formulations applied to 

growing crops and raw agricultural 

commodities after harvest, and when 

used as an inert ingredient solvent and/ 

or surfactant in pesticide formulations 

applied to animals (used for food). 

Lyondell Chemical Company submitted 

a petition to EPA under the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

requesting establishment of an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 2- 

methyl-1,3-propanediol. 

DATES: This regulation is effective 

August 20, 2010. Objections and 

requests for hearings must be received 

on or before October 19, 2010, 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–2002–0185. 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: Keri 

Grinstead, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8373; e-mail address: 

grinstead.keri@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 


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