Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 37571 

[FR Doc. E9–17945 Filed 7–28–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0131; FRL–8424–6] 

Alkyl Alcohol Alkoxylate Phosphate 

and Sulfate Derivatives; Exemption 

From the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

exemptions from the requirement of a 

tolerance for residues of alkyl alcohol 

alkoxylate phosphate derivatives when 

used as inert ingredients in growing 

crops under 40 CFR 180.920 and for 

residues of alkyl alcohol alkoxylate 

sulfate derivatives when used as inert 

ingredients in pesticide formulations 

applied to growing crops, raw 

agricultural commodities after harvest, 

and animals under 40 CFR 180.910 and 

40 CFR 180.930. 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 

an exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of alkyl 

alcohol alkoxylate phosphate and 

sulfate derivatives. 

DATES: This regulation is effective July 

29, 2009. Objections and requests for 

hearings must be received on or before 

September 28, 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–2009–0131. 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: 

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 part180 through 

the Government Printing Office’s e-CFR 

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

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gov/opptsfrs/home/ 

guidelin.htm. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0131 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before September 28, 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–2009–0131, 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. Background 

In the Federal Register of April 15, 

2009 (74 FR 17487) (FRL–8409–7), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 9E7533) by JITF, 

CST 2, c/o CropLife America, 1156 15th

St., NW., Suite 400, Washington, DC 

20005, The petition requested that 40 

CFR 180.910, 40 CFR 180.920, and 40 

CFR 180.930 be amended by 

establishing exemptions from the 


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requirement of a tolerance for residues 

of various alkyl alcohol alkoxylate 

phosphate and sulfate derivatives when 

used as inert ingredients in pesticide 

formulations applied to raw agricultural 

commodities, growing crops, and 

animals. The petition specifically 

requested the establishment of an 

exemption from the requirement of a 

tolerance under 40 CFR 180.920 for 

residues of a-alkyl (minimum C6 linear, 

branched, saturated and/or 

unsaturated)-w-hydroxypolyoxyethylene 

polymer with or without 

polyoxypropylene, mixture of di- and 

monohydrogen phosphateesters and the 

corresponding ammonium, calcium, 

magnesium, monoethanolamine, 

potassium, sodium, and zinc salts of the 

phosphate esters; minimum oxyethylene 

content is 2 moles; minimum 

oxypropylene content is 0 moles 

(Chemical Abstract Service Registry 

numbers (CAS 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); and the establishment of 

an exemption from the requirement of a 

tolerance under 40 CFR 180.910 and 40 

CFR 180.930 for residues of a-alkyl(C6- 

C15)-w-hydroxypoly(oxyethylene)sulfate, 

and its ammonium, calcium, 

magnesium, potassium, sodium, and 

zinc salts, poly(oxyethylene) content 

averages 2–4 moles (CAS Nos. 9004–82– 

4, 68585–34–2, 68891–38–3, 9004–84–6, 

13150–00–0, 26183–44–8, 68611–55–2, 

68511–39–7, 3088–31–1, 9004–82–4, 

25446–78–0, 32612–48–9, 50602–06–7, 

62755–21–9, 68424–50–0, 73665–22–2). 

For ease of reading, the alkyl alcohol 

alkoxylate phosphate and sulfate 

derivatives are referred to throughout 

this document as AAAPDs and AAASDs 

respectively, and collectively as 

AAAPSDs. That notice referenced a 

summary of the petition prepared by 

JITF, CST 2, 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, which also included a 

limitation of the concentration of alkyl 

alcohol alkoxylate phosphate and 

sulfate derivatives to not exceed 30% by 

weight of the pesticide formulation, was 

submitted in response to a final rule of 

August 9, 2006 (71 FR 45415) (FRL– 

8084–1) in which the Agency revoked, 

under FFDCA section 408(e)(1) 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 document 

published in the Federal Register issue 

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

8372–7) to allow for data to be 

submitted to support the establishment 

of tolerance exemptions for these inert 

ingredients prior to the effective date of 

the tolerance exemption revocation. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement of a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide chemical residues. 

First, EPA determines the toxicity of 

pesticide chemicals. Second, EPA 

examines exposure to the pesticide 

chemical through food, drinking water, 

and through other exposures that occur 

as a result of the pesticide chemical use 

in residential settings. 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

exemption from the requirement of a 

tolerance for residues of AAAPSDs 

when used as inert ingredients in 

pesticide formulations applied to 

growing crops, raw agricultural 

commodities and food-producing 

animals. EPA’s assessment of exposures 

and risks associated with establishing 

tolerances follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

The AAAPSDs 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 no-observedadverse-effect-level (NOAEL) was 


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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 AAAPSDs; 

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 AAAPSDs. 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 lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in 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, pages 

11–17 in docket ID number EPA–HQ– 

OPP–2009–0131. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a benchmark dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the level of concern (LOC). 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk. Thus, 

the Agency estimates risk in terms of the 

probability of an occurrence of the 

adverse effect greater than that expected 

in a lifetime. For more information on 

the general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

process, see http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for AAAPSDs used for human 

risk assessment is shown in Table 1 of 

this unit. 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR AAAPSDS FOR USE IN HUMAN 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 

Chronic dietary 

(all populations) 

NOAEL= 87 millgrams/kilograms/day (mg/kg/ 

day) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.87 

mg/kg/day 

cPAD = 0.87 mg/kg/ 

day 

Reproduction/fertility effects in male rats (Master Record Identification number (MRID) 

47060903)) 

LOAEL = 223 mg/kg/day based on a dose-related decrease in absolute and relative liver 

weight and an increased incidence in the 

number of animals with ‘‘minimal’’ 

hepatocyte necrosis in males in the highdose group compared to control group 

Incidental oral shortterm 

(1 to 30 days) and 

intermediate-term 

(1 to 6 months) 

NOAEL= 87 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Reproduction/fertility effects in male rats (MRID 

47060903) 

LOAEL = 223 mg/kg/day based on a dose-related decrease in absolute and relative liver 

weight and an increased incidence in the 

number of animals with ‘‘minimal’’ 

hepatocyte necrosis in males in the highdose group compared to control group 


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

ASSESSMENT—Continued 

Exposure/Scenario Point of Departure and Uncertainty/ 

Safety Factors 

RfD, PAD, LOC for 

Risk Assessment Study and Toxicological Effects 

Dermal and inhalation 

(all durations) 

Oral study NOAEL = 87 mg/kg/day (dermal absorption rate = 5% (inhalation absorption 

rate = 100%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Reproduction/fertility effects in male rats (MRID 

47060903) 

LOAEL = 223 mg/kg/day based on a dose-related decrease in absolute and relative liver 

weight and an increased incidence in the 

number of animals with ‘‘minimal’’ 

hepatocyte necrosis in males in the highdose group compared to control group. 

Cancer 

(oral, dermal, inhalation) 

Classification: No animal toxicity data available for an assessment; based on SAR analysis, AAAPSDs are not expected to be carcinogenic. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin 

of exposure. LOC = level of concern. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to AAAPSDs, EPA considered 

exposure under the petitioned-for 

exemptions from the requirement of a 

tolerance. EPA assessed dietary 

exposures from AAAPSDs 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 AAAPSDs. 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 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% 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 comparison with 

the active ingredient. In the case of 

AAAPSDs, EPA made a specific 

adjustment to the dietary exposure 

assessment to account for the use 

limitations of the amount of AAAPSDs 

that may be in formulations (no more 

than 30%) and assumed that the 

AAAPSDs are at the maximum 

limitations rather than at equal 

quantities with the active ingredient. 

This remains a very conservative 

assumption because surfactants are 

generally used at levels far below these 

percentages. For example, EPA 

examined several of the pesticide 

products associated with the tolerance/ 

commodity combination which are the 

driver of the risk assessment and found 

that these products did not contain 

surfactants at levels greater than 2.25% 

and that none of the surfactants were 

AAAPSDs. 

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% 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 

sum, EPA chose a very conservative 

method for estimating what level of 

inert residue could be on food, and then 

used this methodology to choose the 

highest possible residue that could be 

found on food and assumed that all food 

contained this residue. No consideration 

was given to potential degradation 

between harvest and consumption even 

though monitoring data shows that 

tolerance level residues are typically 

one to two orders of magnitude higher 

than actual residues in food when 

distributed in commerce. 

Accordingly, although sufficient 

information to quantify actual residue 

levels in food is not available, the 

compounding of these conservative 

assumptions will lead to a significant 

exaggeration of actual exposures. EPA 

does not believe that this approach 

underestimates exposure in the absence 

of residue data. 

ii. Cancer. The Agency used a 

qualitative SAR database, DEREK11, to 

determine if there were structural alerts 

for potential carcinogenicity of a 


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representative AAAPSD. No structural 

alerts for carcinogenicity were identified 

and the AAAPSDs are not expected to 

be carcinogenic. Therefore a 

quantitative cancer exposure assessment 

is not necessary to assess cancer risk. 

iii. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue or PCT 

information in the dietary assessment 

for AAAPSDs. Tolerance level residues 

or 100 PCT 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 AAAPSDs in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of AAAPSDs. 

Further information regarding EPA 

drinking water models used in 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 AAAPSDs. Modeling runs on four 

surrogate inert ingredients using a range 

of physical chemical properties that 

would bracket those of the AAAPSDs 

were conducted. Modeled acute 

drinking water values ranged from 0.001 

parts per billion (ppb) to 41 ppb. 

Modeled chronic drinking water values 

ranged from 0.0002 ppb to 19 ppb. 

Further details of this drinking water 

analysis can be found at http:// 

www.regulations.gov in document Alkyl 

Amine Polyalkoxylates (JITF CST 4 Inert 

Ingredients). Human Health Risk 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as Inert 

Ingredients in Pesticide Formulations, 

pages 18 and 70–72 in docket ID 

number EPA–HQ–OPP–2008–0738. 

For the purpose of the screening level 

dietary risk assessment to support this 

request for an exemption from the 

requirement of a tolerance for 

AAAPSDs, a conservative drinking 

water concentration value of 100 ppb 

based on screening level modeling was 

used to assess the contribution to 

drinking water for both the acute and 

chronic dietary risk assessments. 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). AAAPSDs 

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 AAAPSDs 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 AAAPSDs. 

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 AAAPSDs to share 

a common mechanism of toxicity with 

any other substances, and AAAPSDs do 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

AAAPSDs 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 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 OPPTS 

Harmonized Guideline 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 (OPPTS 

Harmonized Guideline 870.3800) study 

and a rat developmental toxicity study 

conducted with a representative 

AAASD. 

In an OPPTS Harmonized Guideline 

870.3650 study conducted with a 

representative AAAPD, no increased 

susceptibility to the offspring of rats 

following prenatal and postnatal 

exposure was observed. In a second 

OPPTS Harmonized Guideline 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 mg/kg/day 

where lesions in the forestomach and 

thymus atrophy was observed in the 

parental animals. However, this 

qualitative susceptibility seen in the 

OPPTS Harmonized Guideline 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 


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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. 

There are no residual uncertainties 

identified in the exposure databases. 

The food exposure assessments are 

considered to be conservative. The food 

and drinking water assessment is not 

likely to underestimate exposure to any 

subpopulation, including those 

comprised of infants and children. 

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 AAAPSDs 

is considered adequate for assessing the 

risks to infants and children (the 

available studies are described in Unit 

IV.D.2.). 

ii. No susceptibility was demonstrated 

in the offspring in the reproductive/ 

developmental screening test portion of 

an OPPTS Harmonized Guideline 

870.3650 study with one AAAPD 

following prenatal and postnatal 

exposure at 800 mg/kg/day. 

iii. Although increased qualitative 

susceptibility was demonstrated in the 

offspring in a reproductive/ 

developmental screening test portion of 

an OPPTS Harmonized Guideline 

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 

AAAPSDs. 

iv. There is no indication that 

AAAPSDs are neurotoxic chemicals and 

thus there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

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 PCT 

is assumed for all crops. EPA also made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to AAAPSDs 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 AAAPSDs. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

In conducting this aggregate risk 

assessment, the Agency has 

incorporated the petitioner’s requested 

use limitations of AAAPSDs as inert 

ingredients in pesticide product 

formulations into its exposure 

assessment. Specifically the petition 

includes a use limitation of AAAPSDs at 

not more than 30% by weight in 

pesticide formulations. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. No adverse effects attributable to 

a single exposure to the AAAPSDs were 

seen in the toxicity databases, therefore, 

AAAPSDs are not expected to pose an 

acute risk. 

2. Chronic risk. A chronic aggregate 

risk assessment takes into account 

exposure estimates from chronic dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for chronic 

exposure, and the use limitations of not 

more than 30% by weight in pesticide 

formulations, the chronic dietary 

exposure from food and water to 

AAAPSDs is 13% of the cPAD for the 

U.S. population and 43% of the cPAD 

for children 1–2 yrs old, the most highly 

exposed population subgroup. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

AAAPSDs 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 AAAPSDs. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures aggregated 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. 

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). 

AAAPSDs 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 AAAPSDs. 

Using the exposure assumptions 

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

combined intermediate-term food, 

water, and residential exposures 

aggregated 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-tomouth exposure. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

structural alerts for carcinogenicity, 

AAAPSDs 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 residues of 

AAAPSDs. 

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. 


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B. International Residue Limits 

The Agency is not aware of any 

country requiring a tolerance for 

AAAPSDs nor have any CODEX 

Maximum Residue Levels been 

established for any food crops at this 

time. 

VI. Conclusion 

Therefore, exemptions from the 

requirement of a tolerance are 

established for residues of AAAPDs 

when used as inert ingredients in 

pesticide formulations applied to 

growing crops only under 40 CFR 

180.920 and residues of AAASDs when 

used as inert ingredients in raw 

agricultural commodities, growing 

crops, and animals under 40 CFR 

180.910, 40 CFR 180.920, and 40 CFR 

180.930. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes 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 tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VIII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: July 20, 2009. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.910, 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(C6–C15)-w-hydroxypoly(oxyethylene)sulfate, and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts, poly(oxyethylene) content averages 2–4 

moles (CAS Reg. Nos. 3088–31–1, 9004–82–4, 9004–84–6, 13150–00–0, 25446– 

78–0, 26183–44–8, 32612–48–9, 50602–06–7, 62755–21–9, 68424–50–0, 68511– 

39–7, 68585–34–2, 68611–55–2, 68891–38–3, 73665–22–2).

Not to exceed 30% of 

pesticide formulation.

Surfactants, related adjuvants of surfactants 

* * * * * 

■ 3. In § 180.920, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 


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Inert ingredients Limits Uses 

* * * * * 

a-Alkyl (minimum C6 linear, branched, saturated and/or unsaturated)-whydroxypolyoxyethylene 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 is 2 moles; minimum oxypropylene content is 0 moles 

(CAS Reg. Nos. 9046–01–9, 37280–82–3, 39464–66–9, 42612–52–2, 50643–20–4, 

52019–36–0, 58318–92–6, 60267–55–2, 61837–79–4, 67711–84–6, 68070–99–5, 

68071–35–2, 68071–17–0, 68130–47–2, 68186–37–8, 68186–36–7, 68311–02–4, 

68425–73–0, 68458–48–0, 68511–37–5, 68610–65–1, 68585–36–4, 68649–29–6, 

68815–11–2, 68908–64–5, 68891–13–4, 73038–25–2, 78330–24–2, 108818–88–8, 

154518–39–5, 317833–96–8, 873662–29–4, 936100–29–7, 936100–30–0).

Not to exceed 30% of 

pesticide formulation.

Surfactants, related adjuvants of surfactants 

* * * * * 

■ 4. In § 180.930, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * 

a-Alkyl(C6-C15)-w-hydroxypoly(oxyethylene)sulfate, and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts, poly(oxyethylene) content averages 2–4 

moles (CAS Reg. Nos. 3088–31–1, 9004–82–4, 9004–84–6, 13150–00–0, 25446– 

78–0, 26183–44–8, 32612–48–9, 50602–06–7, 62755–21–9, 68424–50–0, 68511– 

39–7, 68585–34–2, 68611–55–2, 68891–38–3, 73665–22–2).

Not to exceed 30% of 

pesticide formulation.

Surfactants, related adjuvants of surfactants 

* * * * * 

[FR Doc. E9–18033 Filed 7–28–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0046; FRL–8428–9] 

N-alkyl (C8-C18) Primary Amines and 

Acetate Salts; 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 N-alkyl (C8-C18) 

primary amines and acetate salts where 

the alkyl group is linear and may be 

saturated and/or unsaturated, herein 

referred to in this document as 

NAPAAS, when used as inert 

ingredients for pre-harvest uses under 

40 CFR 180.920 at a maximum 

concentration in formulated end-use 

products of 10% by weight in herbicide 

products, 4% by weight in insecticide 

products, and 4% by weight in 

fungicide products. The Joint Inerts 

Task Force (JITF), Cluster Support Team 

Number 25 (CST 25), 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 NAPAAS. 

DATES: This regulation is effective July 

29, 2009. Objections and requests for 

hearings must be received on or before 

September 28, 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–2009–0046. 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 


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