Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 38945 

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

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0944; FRL–8429–4] 

Polyoxyethylene polyoxypropylene 

mono(di-sec-butylphenyl) ether; 

Exemption from the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of 

Polyoxyethylene polyoxypropylene 

mono(di-sec-butylphenyl) ether when 

used as an inert ingredient in herbicide 

formulations only, for pre-harvest uses 

and at no more than 30% by weight in 

herbicide formulations intended for 

application to turf. The Joint Inerts Task 

Force (JITF), Cluster Support Team 

Number 20, submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 

Polyoxyethylene polyoxypropylene 

mono(di-sec-butylphenyl) ether. 

DATES: This regulation is effective 

August 5, 2009. Objections and requests 

for hearings must be received on or 

before October 5, 2009, and must be 

filed in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0944. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Kerry Leifer, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8811; e-mail address: 

leifer.kerry@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e–CFR 

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

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gpo/opptsfrs/home/ 

guidelin.htm. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0944 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before October 5, 2009. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0944, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background 

In the Federal Register of March 25, 

2009 (74 FR 12856) (FRL–8399–4), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 8E7494) by The 

Joint Inerts Task Force (JITF), Cluster 

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

America, 1156 15th Street, NW., Suite 

400, Washington, DC 20005. The 

petition requested that 40 CFR 180.920 

be amended by establishing exemptions 

from the requirement of a tolerance for 

residues of the inert ingredient 


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38946 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 

Polyoxyethylene polyoxypropylene 

mono(di-sec-butylphenyl) ether, herein 

referred to in this document as POE/ 

POP mono(di-sec-butylphenyl) ether, 

when used as an inert ingredient in 

herbicide formulations for pre-harvest 

uses under 40 CFR 180.920. That notice 

referenced a summary of the petition 

prepared by The JITF, CST 20, the 

petitioner, which is available to the 

public in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

modified the exemption requested by 

limiting POE/POP mono(di-secbutylphenyl) to a maximum of 30% by 

weight in the herbicide formulations 

intended for application to turf. This 

limitation is based on the Agency’s risk 

assessment which can be found at 

http://www.regulations.gov in document 

Polyoxyethylene Polyoxypropylene 

Mono(di-sec-Butylphenyl) Ether (JITF 

CST 20 Inert Ingredients). Human 

Health Risk Assessment to Support 

Proposed Exemption from the 

Requirement of a Tolerance When Used 

as Inert Ingredients in Pesticide 

Formulations in docket ID number 

EPA–HQ–OPP–2008–0944. 

This petition was submitted in 

response to a final rule of August 9, 

2006, (71 FR 45415) in which the 

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

of the Federal Food, Drug, and Cosmetic 

Act (FFDCA), the existing exemptions 

from the requirement of a tolerance for 

residues of certain inert ingredients 

because of insufficient data to make the 

determination of safety required by 

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

date for the tolerance exemptions 

subject to revocation was August 9, 

2008, which was later extended to 

August 9, 2009 by a final rule published 

in the Federal Register of August 4, 

2008 (73 FR 45312) to allow for data to 

be submitted to support the 

establishment of tolerance exemptions 

for these inert ingredients prior to the 

effective date of the tolerance exemption 

revocation. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

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

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish an exemption 

from the requirement of a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

exemption from the requirement of a 

tolerance for residue of POE/POP 

mono(di-sec-butylphenyl) ether when 

used as an inert ingredient in herbicide 

formulations only, for pre-harvest uses, 

and provided that uses in herbicide 

formulations intended for turf 

application are limited to no more than 

30% by weight in the final formulation. 

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 available mammalian toxicology 

database consists of one combined 

repeated dose toxicity study with the 

reproduction/developmental toxicity 

screening test in rats for the 

representative POE/POP mono(di-secbutylphenyl) ether, three subchronic 

oral toxicity studies (rats and dogs), and 

acute data on representative POE/POP 

mono(di-sec-butylphenyl) ether inerts. 

The POE/POP mono(di-secbutylphenyl) ether inert ingredients are 

not acutely toxic by the oral, dermal and 

inhalation routes of exposure and are 

slight to severe eye irritants and not a 

skin irritant. 

The OPPTS Harmonized Guideline 

870.3650 Combined Repeated Dose 

Toxicity Study with rats demonstrated 

that the representative POE/POP 

mono(di-sec-butylphenyl) ether had no 

effect on food consumption, body 

weight gain, and FOB parameters in 

males and females at any of the doses 

tested. Blood coagulation in male and 

female rats in the highest dose group as 

measured by prothrombin time, was 

significantly reduced. Microscopic 

effects observed included minimal or 

mild centrilobular hepatocellular 

hypertrophy which was seen in the liver 

of 4 of 5 male rats and 3 of 5 female rats 

in the 304 milligrams/kilogram/day 

(mg/kg/day) dose group. In the affected 

livers, centrilobular areas were more 

prominent due to enlarged 

(hypertrophied) hepatocytes with an 

increased amount of dense granular 

eosinophilic cytoplasm. As 

hepatocellular hypertrophy was not 

accompanied by inflammatory or 

degenerative changes, this finding was 

considered to be adaptive in nature, in 

response to metabolizing the test 

substance, and not adverse. An 

increased incidence of thyroid follicular 

epithelial hypertrophy and hyperplasia 

was observed in all male rats in the 304 

mg/kg/day dose group. This follicular 

change was characterized by increased 

size of follicular epithelial cells 

(hypertrophy) and, in some areas, there 

were increased amounts of small 

follicles and increased cells within the 

follicles (hyperplasia). Thyroid 


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Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 38947 

hormones were not measured in this 

study. It is possible that the thyroid 

changes were due to an indirect effect 

by increased metabolism of thyroid 

hormones by the liver. No treatment 

related effects were observed on litter 

sizes or on the early development of 

pups. 

In a 90–day oral toxicity study 

performed in rats (MRID 46610818), 

Polyglycol 26–2 was administered to 

male and female rats at dose levels of 0, 

5, 15, 50, 150, and 500 mg/kg/day. The 

no-observed-effect-level (NOAEL) was 

determined to be 50 mg/kg/day, and the 

lowest-observed-effect-level (LOAEL) 

was determined to be 150 mg/kg/day 

based up lesions in the liver and kidney 

of both sexes. 

In a 90–day Oral Toxicity Study 

performed in Beagle dogs (MRID 

46610819), Polyglycol 26–2 was 

administered orally at 0, 3, 10, 36, and 

92 mg/kg/day. No evidence of adverse 

effects was observed at any of the doses 

in this study. 

A similar study in Beagle dogs was 

carried out for Polyglycol 26–3 (MRID 

46610820). No adverse effects were 

noted at doses up to 100 mg/kg/day (the 

higest dose tested). The study was 

classified as Acceptable/non-guideline. 

There are no published metabolism 

studies for this series of surfactants. The 

mammalian metabolism pathway 

proposed in the petition is based on the 

polyalkoxylate metabolism of alkyl 

alchohols documented in publicly 

available literature. By analogy to the 

polyethoxylated surfactants, the 

significant metabolic pathway could be 

hydrolytic or oxidative removal of the 

polyalkoxylate chains to generate an 

isomeric mixture of di-sec butyl phenol 

and the polypropoxylate polyethoxylate 

alchohol that may be further oxidized. 

The proposed polypropoxylates and 

polyethoxylates, alchohols and 

carboxylic acids, should be rapidly 

excreted as conjugates. The liver, lungs 

and gastrointestinal tract are the most 

important sites for phenol metabolism 

with excretion proceeding rapidly 

through conjugation to generate phenyl 

glucuronide and phenyl sulfate. The disec butyl side chains may or may not be 

degraded but depending on their 

position on the phenol, because of steric 

hindrance, may slow down conjugation 

and conjugation of the phenolic 

polymeric component. 

There are no chronic toxicity studies 

available for POE/POP mono(di-secbutylphenyl) ether. The Agency used a 

qualitative structure activity 

relationship (SAR) database, DEREK 

Version 11, to determine if there were 

structural alerts suggestive of 

carcinogenicity. No structural alerts 

were identified. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by POE/POP mono(disec-butylphenyl) ether, as well as, the 

NOAEL and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

Polyoxyethylene Polyoxypropylene 

Mono(di-sec-Butylphenyl) Ether (JITF 

CST 20 Inert Ingredients). Human 

Health Risk Assessment to Support 

Proposed Exemption from the 

Requirement of a Tolerance When Used 

as Inert Ingredients in Pesticide 

Formulations at pp 9–14 and pp 42–47 

in docket ID number EPA–HQ–OPP– 

2008–0944. 

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 POE/POP mono(di-secbutylphenyl) ether used for human 

health risk assessment is shown in the 

following Table. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR POE/POP MONO(DI-SEC-BUTYLPHENYL) ETHER FOR

USE IN HUMAN HEALTH RISK ASSESSMENT

Exposure/Scenario Point of Departure and Uncertainty/Safety Factors 

RfD, PAD, LOC for 

Risk Assessment Study and Toxicological Effects 

Acute dietary (all populations) An effect attributable to a single exposure was not identified. 


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38948 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR POE/POP MONO(DI-SEC-BUTYLPHENYL) ETHER FOR

USE IN HUMAN HEALTH RISK ASSESSMENT—Continued 

Exposure/Scenario Point of Departure and Uncertainty/Safety Factors 

RfD, PAD, LOC for 

Risk Assessment Study and Toxicological Effects 

Chronic dietary (all populations) NOAEL= 82 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.82 

mg/kg/day 

cPAD = 0.82 mg/kg/ 

day 

Combined Repeated Dose Toxicity Study with 

the Reproduction/Developmental Toxicity 

Screening Test-Rat OPPTS Harmonized 

Guideline 870.3650 

Parental LOAEL = 304 mg/kg bw/day based 

on clinical signs in male and female rats 

(salivation), increased incidence of thyroid 

follicular epithelial hypertrophy and 

hyperplasia in male rats, reduction of prothrombin time in male and female rats, and 

reduction of activated partial thromboplastin 

time in female rats. 

Reproductive/Developmental LOAEL was not 

observed. 

Incidental Oral, Dermal, and Inhalation (Short-, Intermediate-, and Long-Term) NOAEL= 82 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

50% dermal absorption; inhalation 

toxicity is assumed to be equivalent to oral toxicity.

Residential LOC for 

MOE = 100.

Combined Repeated Dose Toxicity Study with 

the Reproduction/Developmental Toxicity 

Screening Test-Rat OPPTS Harmonized 

Guideline 870.3650 

Parental LOAEL = 304 mg/kg bw/day based 

on clinical signs in male and female rats, 

increased incidence of thyroid follicular 

epithelial hypertrophy and hyperplasia in 

male rats, reduction of prothrombin time in 

male and female rats, and reduction of activated partial thromboplastin time in female 

rats. 

Reproductive/ Developmental LOAEL was not 

observed. 

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

mono(di-sec-butylphenyl) ether is not expected to be carcinogenic. 

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect 

level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = 

potential variation in sensitivity among members of the human population (intraspecies). PAD = population adjusted dose (a=acute, c=chronic). 

FQPA SF = FQPA Safety Factor. RfD = reference dose. LOC = level of concern. 

C. Exposure Assessment 

Sufficient data were provided on the 

chemical identity of the POE/POP 

mono(di-sec-butylphenyl) ether inert 

ingredients; 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 generic cluster structures, the 

modeled physicochemical information, 

as well as the structure-activity 

relationship information. Additionally, 

information on other surfactants and 

chemicals of similar size and 

functionality was considered to 

determine the residues of concern for 

these inert ingredients. 

The registrant selected Polyglycol 26– 

2 (CAS RN 69029–39–6), a complex 

mixture of polyethoxylated/ 

polypropoxylated, POE/POP, ethers of a 

mixture of the three different isomeric 

di-sec-butyl phenols, for toxicity testing. 

The Agency has concluded that the 

cluster grouping was appropriate. Based 

on the chemical structure, it is likely 

that the parent compound will degrade 

in the environment to 2,4-di-sec-butyl 

phenol, and 2,6-di-sec-butyl phenol. 

The Agency considered the SAR 

analysis, and information in the 

literature, and concluded that the butylphenols are not likely to be more toxic 

than the parent compounds. 

Considering the high residue approach 

to the dietary risk assessment that 

basically assumes no degradation of the 

parent and 100% CT, and the fact that 

the two degradates are not likely to be 

more toxic than the parent, the parent 

compound risk assessment is protective 

of any potential toxicity effects of the 

butylphenols. Therefore, it is not 

necessary to assess the exposure to the 

butylphenols separately. 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to POE/POP mono(di-secbutylphenyl) ether, EPA considered 

exposure under the petitioned-for 

exemptions from the requirement of a 

tolerance. EPA assessed dietary 

exposures from POE/POP mono(di-secbutylphenyl) ether in food as follows: 

i. Acute exposure. No adverse effects 

attributable to a single exposure of POE/ 

POP mono(di-sec-butylphenyl) ether 

was seen in the toxicity databases. 

Therefore, acute dietary risk 

assessments for POE/POP mono(di-secbutylphenyl) ether is not necessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used food 

consumption information from the U.S. 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, no residue data were submitted 

for POE/POP mono(di-sec-butylphenyl) 

ether. In the absence of specific residue 

data, EPA has developed an approach 

which uses surrogate information to 

derive upper bound exposure estimates 

for the subject inert ingredient. Upper 

bound exposure estimates are based on 

the highest tolerance for a given 

commodity from a list of high-use 


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insecticides, herbicides, and fungicides. 

A complete description of the general 

approach taken to assess inert 

ingredient risks in the absence of 

residue data is contained in the 

memorandum entitled Alkyl Amines 

Polyalkoxylates (Cluster 4): Acute and 

Chronic Aggregate (Food and Drinking 

Water) Dietary Exposure and Risk 

Assessments for the Inerts. (D361707, S. 

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

http://www.regulations.gov in docket ID 

number EPA–HQ–OPP–2008–0738. 

In the dietary exposure assessment, 

the Agency assumed that the residue 

level of the inert ingredient would be no 

higher than the highest tolerance for a 

given commodity. Implicit in this 

assumption is that there would be 

similar rates of degradation (if any) 

between the active and inert ingredient 

and that the concentration of inert 

ingredient in the scenarios leading to 

these highest of tolerances would be no 

higher than the concentration of the 

active ingredient. 

The Agency believes the assumptions 

used to estimate dietary exposures lead 

to an extremely conservative assessment 

of dietary risk due to a series of 

compounded conservatisms. First, 

assuming that the level of residue for an 

inert ingredient is equal to the level of 

residue for the active ingredient will 

overstate exposure. The concentrations 

of active ingredient in agricultural 

products is generally at least 50% 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 

POE/POP mono(di-sec-butylphenyl) 

ether, EPA made a specific adjustment 

to the dietary exposure assessment to 

account for the use of these inerts in 

herbicide formulations only. The 

Agency identified the residue drivers 

(crop/tolerance combinations) in this 

assessment that constitute the majority 

of the dietary risk, and has replaced the 

residue value with the highest herbicide 

tolerances for those commodities. The 

risk drivers for the dietary assessment 

for which herbicide tolerances were 

used were the leafy vegetable (except 

brassica) crop group, pome fruits, and 

grapes. 

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 

summary, EPA chose a very 

conservative method for estimating 

what level of inert residue could be on 

food, then used this methodology to 

choose the highest possible residue that 

could be found on food and assumed 

that all food contained this residue. No 

consideration was given to potential 

degradation between harvest and 

consumption even though monitoring 

data shows that tolerance level residues 

are typically one to two orders of 

magnitude higher than actual residues 

in food when distributed in commerce. 

Accordingly, although sufficient 

information to quantify actual residue 

levels in food is not available, the 

compounding of these conservative 

assumptions will lead to a significant 

exaggeration of actual exposures. EPA 

does not believe that this approach 

underestimates exposure in the absence 

of residue data. 

iii. Cancer. The Agency used a 

qualitative structure activity 

relationship (SAR) database, DEREK11, 

to determine if there were structural 

alerts suggestive of carcinogenicity. No 

structural alerts for carcinogenicity were 

identified. POE/POP mono(di-secbutylphenyl) ether are not expected to 

be carcinogenic. Therefore, a cancer 

dietary exposure assessment is not 

necessary to assess cancer risk. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for POE/POP mono(di-sec-butylphenyl) 

ether. Tolerance level residues and/or 

100% CT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for POE/POP mono(di-sec-butylphenyl) 

ether in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of POE/POP 

mono(di-sec-butylphenyl) ether. Further 

information regarding EPA drinking 

water models used in the pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

A screening level drinking water 

analysis, based on the Pesticide Root 

Zone Model/Exposure Analysis 

Modeling System (PRZM/EXAMS) was 

performed to calculate the estimated 

drinking water concentrations (EDWCs) 

of POE/POP mono(di-sec-butylphenyl) 

ether. Modeling runs on four surrogate 

inert ingredients using a range of 

physical chemical properties that would 

bracket those of POE/POP mono(di-secbutylphenyl) ether were conducted. 

Modeled acute drinking water values 

ranged from 0.001 parts per billion 

(ppb) to 41 ppb. Modeled chronic 

drinking water values ranged from 

0.0002 ppb to 19 ppb. Further details of 

this drinking water analysis can be 

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

the document Polyoxyethylene 

Polyoxypropylene Mono(di-secButylphenyl) Ether (JITF CST 20 Inert 

Ingredients). Human Health Risk 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as Inert 

Ingredients in Pesticide Formulations at 

pp 15–16 and 50–52 in docket ID 

number EPA–HQ–OPP–2008–0944. 

For the purpose of the screening level 

dietary risk assessment to support this 

request for an exemption from the 

requirement of a tolerance for POE/POP 

mono(di-sec-butylphenyl) ether, a 

conservative drinking water 

concentration value of 100 ppb based on 

screening level modeling was used to 

assess the contribution to drinking 

water for chronic dietary risk 

assessments for the parent compounds 

and for the metabolites of concern. 

These values were directly entered into 

the dietary exposure model. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). POE/POP 

mono(di-sec-butylphenyl) ether may be 

used as inert ingredients in herbicide 

products that are registered for specific 

uses that may result in outdoor 

residential exposures. A screening level 

residential exposure and risk 

assessment was completed for herbicide 

products containing POE/POP mono(disec-butylphenyl) ether as inert 

ingredients. In this assessment, 

representative scenarios, based on enduse product application methods and 

labeled application rates, were selected. 

The POE/POP mono(di-sec-butylphenyl) 


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may be used as inert ingredients in 

pesticide formulations (herbicides) that 

are used around the home. The Agency 

did not identify any products intended 

for use on pets or home cleaning 

products that contain the POE/POP 

mono(di-sec-butylphenyl) ether inert 

ingredients. The Agency conducted an 

assessment to represent worst-case 

residential exposures to herbicides only 

by assessing POE/POP mono(di-secbutylphenyl) ether in herbicide 

formulations (Outdoor Scenarios). 

Further details of this residential 

exposure and risk analysis can be found 

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

memorandum entitled JITF Inert 

Ingredients. Residential and 

Occupational Exposure Assessment 

Algorithms and Assumptions Appendix 

for the Human Health Risk Assessments 

to Support Proposed Exemption from 

the Requirement of a Tolerance When 

Used as Inert Ingredients in Pesticide 

Formulations (D364751, 5/7/09, Lloyd/ 

LaMay in docket ID number EPA–HQ– 

OPP–2008–0710. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found POE/POP 

mono(di-sec-butylphenyl) ether to share 

a common mechanism of toxicity with 

any other substances, and the POE/POP 

mono(di-sec-butylphenyl) ether do not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that the 

POE/POP mono(di-sec-butylphenyl) 

ether do not have a common mechanism 

of toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(c) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The available mammalian toxicology 

database consists of one combined 

repeated dose toxicity study with the 

reproduction/developmental toxicity 

screening test in rats for alkyl phenolic 

glycol ether, three subchronic oral 

toxicity studies (rats and dogs), and 

acute data on the representative inerts. 

There was no evidence of increased 

susceptibility in the offspring because 

no developmental or reproductive 

toxicity was observed in the OPPTS 

Harmonized Guideline 870.3650 study. 

No treatment related effects were 

observed on litter sizes or on the early 

development of pups. 

3. Conclusion. EPA has determined 

that reliable data show that the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for POE/POP 

mono(di-sec-butylphenyl) ether is 

considered adequate for assessing the 

risks to infants and children (the 

available studies are described in Unit 

IV.D.2.). 

ii. No developmental or reproductive 

toxicity was observed in the OPPTS 

Harmonized Guideline 870.3650 

combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening test in rats following 

prenatal and postnatal exposure and 

there are no concerns for sensitivity of 

the offspring. 

iii. There was no evidence of 

neurotoxicity in the database. In 

addition, there is no indication that 

POE/POP mono(di-sec-butylphenyl) 

ether are neurotoxic chemicals and thus 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iv. The primary target organ toxicity 

observed in the database is thyroid 

toxicity, prothrombin time, and body 

weight effects. Thyroid effects are 

manifested following short duration 

exposure and only observed at 304 mg/ 

kg/day (the higest dose tested). The 

Agency has considerable knowledge and 

understanding of the mechanism of 

thyroid toxicity. The Agency concluded 

that any dose that prevents pertuvation 

of thyroid would be protective of 

chronic and cancer effects. Therefore, 

the Agency concluded that regulating at 

a NOAEL of 82 mg/kg/day with effects 

seen at 304 mg/kg/day with a 

hundredfold uncertainty factor 

(UFA=10X; UFh=10X) provides an 

adequate margin of protection and that 

an additional UF for extrapolation from 

subchronic toxicity study to a chronic 

exposure scenario is not needed. 

v. There are no residual uncertainties 

identified in the exposure databases. 

The food and drinking water assessment 

is not likely to underestimate exposure 

to any subpopulation, including those 

comprised of infants and children. The 

food exposure assessments are 

considered to be highly conservative as 

they are based on the use of the highest 

tolerance level from the surrogate 

pesticides for every food and 100% crop 

treated is assumed for all crops. EPA 

also made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to POE/POP mono(di-sec-butylphenyl) 

ether in drinking water. EPA used 

similarly conservative assumptions to 

assess post-application exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by POE/POP mono(di-secbutylphenyl) ether. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the acute populations adjusted dose 

(aPAD) and chronic population adjusted 

dose (cPAD). The aPAD and cPAD 

represent the highest safe exposures, 

taking into account all appropriate SFs. 

EPA calculates the aPAD and cPAD by 

dividing the POD by all applicable UFs. 

For linear cancer risks, EPA calculates 

the probability of additional cancer 

cases given the estimated aggregate 

exposure. Short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing the estimated aggregate food, 

water, and residential exposure to the 

POD to ensure that the MOE called for 

by the product of all applicable UFs is 

not exceeded. 

1. Acute risk. There was no hazard 

attributable to a single exposure seen in 

the toxicity database for POE/POP 

mono(di-sec-butylphenyl) ether. 

Therefore, the POE/POP mono(di-secbutylphenyl) ether are not expected to 

pose an acute risk. 

2. Chronic risk. A chronic aggregate 

risk assessment takes into account 

exposure estimates from chronic dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for chronic 

exposure (including limiting the uses of 

the POE/POP mono(di-sec-butylphenyl) 


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ether inert ingredients in agricultural 

products to use in herbicide 

formulations and using the maximum 

herbicide tolerances for key 

commodities), the chronic dietary 

exposure from food and water to POE/ 

POP mono(di-sec-butylphenyl) ether is 

14% of the cPAD for the U.S. 

population and 36% of the cPAD for 

children 1 to 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). 

POE/POP mono(di-sec-butylphenyl) 

ether are used as inert ingredients in 

pesticide products that are currently 

registered for uses that could result in 

short-term residential exposure and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to the 

POE/POP mono(di-sec-butylphenyl) 

ether. Using the exposure assumptions 

described in this unit, EPA has 

concluded that the combined short-term 

aggregated food, water, and residential 

exposures result in aggregate MOEs of 

110 for both adult males and females, 

respectively. Adult residential exposure 

combines high end outdoor dermal and 

inhalation handler exposure with a high 

end post application dermal exposure 

from contact with treated lawns. EPA 

has concluded the combined short-term 

aggregated food, water, and residential 

exposures result in an aggregate MOE of 

140 for children. Children’s residential 

exposure includes total exposures 

associated with contact with treated 

lawns (dermal and hand-to-mouth 

exposures). As the level of concern is for 

MOEs that are lower than 100, these 

MOEs are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

POE/POP mono(di-sec-butylphenyl) 

ether 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 POE/POP mono(di-sec-butylphenyl) 

ether. Using the exposure assumptions 

described in this unit, EPA has 

concluded that the combined 

intermediate-term aggregated food, 

water, and residential exposures result 

in aggregate MOEs of 470 and 490 for 

both adult males and females, 

respectively. Adult residential exposure 

includes high end post application 

dermal exposure from contact with 

treated lawns. EPA has concluded that 

the combined intermediate-term 

aggregated food, water, and residential 

exposures result in an aggregate MOE of 

190 for children. Children’s residential 

exposure includes total exposures 

associated with contact with treated 

lawns (dermal and hand-to-mouth 

exposures). As the level of concern is for 

MOEs that are lower than 100, these 

MOEs are not of concern. 

5. Aggregate cancer risk for U.S. 

population. The Agency has not 

identified any concerns for 

carcinogenicity relating to POE/POP 

mono(di-sec-butylphenyl) ether. 

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 

POE/POP mono(di-sec-butylphenyl) 

ether. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

B. International Residue Limits 

The Agency is not aware of any 

country requiring a tolerance for POE/ 

POP mono(di-sec-butylphenyl) ether nor 

have any CODEX Maximum Residue 

Levels been established for any food 

crops at this time. 

VI. Conclusion 

Therefore, an exemption from the 

requirement of a tolerance is established 

for residues of Polyoxyethylene 

polyoxypropylene mono(di-secbutylphenyl) ether when used as an 

inert ingredient in herbicide 

formulations only, for pre-harvest uses 

under 40 CFR 180.920 and used at no 

more than 30% by weight in herbicide 

formulations intended for application to 

turf. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the requirement of 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 exemption 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 


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38952 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 

(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 28, 2009. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.920, the table is amended 

by adding alphabetically the following 

inert ingredients: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

* * * * * * * 

Polyoxyethylene polyoxypropylene mono(di-secbutylphenyl) ether (CAS Reg. No. 69029–39–6) Limited to herbicide formulations only, and to 

no more than 30% by weight in herbicide 

formulations intended for application to turf 

Surfactants, related adjuvants of 

surfactants 

* * * * * * * 

[FR Doc. E9–18717 Filed 8–4–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0490; FRL–8428–5] 

Sodium and Ammonium 

Naphthalenesulfonate Formaldehyde 

Condensates; 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 the sodium and 

ammonium napthalenesulfonate 

formaldehyde condensates, herein 

referred to in this document as the 

SANFCs, when used as inert ingredients 

in pesticide formulations applied to 

growing corps under 40 CFR 180.920. 

The Joint Inerts Task Force (JITF), 

Cluster Support Team Number 11 and 

Akzo Nobel Surface Chemistry, LLC, 

submitted petitions 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 the SANFCs. 

DATES: This regulation is effective 

August 5, 2009. Objections and requests 

for hearings must be received on or 

before October 5, 2009, and must be 

filed in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0490. 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 


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