37564 Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 

EPA-APPROVED IOWA NONREGULATORY PROVISIONS—Continued 

Name of nonregulatory SIP provision Applicable geographic or nonattainment area State submittal 

date 

EPA approval 

date Explanation 

(25) Letter Pertaining to NOX Rules 

and Analysis Which Certifies the 

Material Was Adopted by the 

State on October 17, 1990.

Statewide ...................................... 11/8/90 2/13/91, 56 FR 

5757.

(26) SO2 Plan ................................. Clinton .......................................... 3/13/91 11/1/91, 56 FR 

56158.

(27) Letter Withdrawing Variance 

Provisions.

Polk County .................................. 10/23/91 11/29/91, 56 FR 

60924.

Correction notice published 1/26/ 

93. 

(28) Letter Concerning Open Burning Exemptions.Statewide ...................................... 10/3/91 1/22/92, 57 FR 

2472.

(29) Compliance Sampling Manual Statewide ...................................... 1/5/93 5/12/93, 58 FR 

27939.

(30) Small Business Assistance 

Plan.

Statewide ...................................... 12/22/92 9/27/93, 58 FR 

50266.

(31) Voluntary Operating Permit 

Program.

Statewide ...................................... 12/8/94 

2/16/96 

2/27/96 

4/30/96, 61 FR 

18958.

(32) SO2 Plan ................................. Muscatine ..................................... 6/19/96 

5/21/97 

12/1/97, 62 FR 

63454.

(33) SO2 Maintenance Plan ............ Muscatine ..................................... 4/25/97 3/19/98, 63 FR 

13343.

(34) SO2 Control Plan ..................... Cedar Rapids ............................... 9/11/98 3/11/99, 64 FR 

12090.

(35) PM10 Control Plan ................... Buffalo, Iowa ................................ 10/1/98 3/18/99, 64 FR 

13346.

(36) CAA 110(a)(2)(D)(i) SIP— 

Interstate Transport.

Statewide ...................................... 11/22/06 3/8/07, 72 FR 

10380.

(37) SO2 Maintenance Plan for the 

Second 10-year Period.

Muscatine ..................................... 4/5/07 8/1/07; 72 FR 

41900.

(38) CAA 110(a)(1) and (2)— 

Ozone Infrastructure SIP.

Statewide ...................................... 6/15/07 3/04/08; 73 FR 

11554.

[FR Doc. E9–17929 Filed 7–28–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0130; FRL–8429–3] 

N,N,N′,N′′,-Tetrakis-(2-Hydroxypropyl) 

Ethylenediamine; 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,N,N′,N′′,- 

tetrakis-(2-hydroxypropyl) 

ethylenediamine (NTHE) when used as 

an inert ingredient for pre-harvest uses 

under 40 CFR 180.920 at a maximum of 

20% by weight in pesticide 

formulations. The Joint Inerts Task 

Force (JITF), Cluster Support Team 

Number 15 (CST 15), 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 NTHE. 

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–2009–0130. 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 


sroberts on DSKD5P82C1PROD with RULES
Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 37565 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gov/opptsfrs/home/ 

guidelin.htm. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0130 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–2009–0130, 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 9E7531) by JITF, 

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

St., 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 NTHE. That 

notice referenced a summary of the 

petition prepared by JITF, CST 15, the 

petitioner, which is available to the 

public in the docket, http:// 

www.regulations.gov. 

The Agency received only one 

comment in response to the notice of 

filing. One comment was received from 

a private citizen who opposed the 

authorization to sell any pesticide that 

leaves a residue on food. The Agency 

understands the commenter’s concerns 

and recognizes that some individuals 

believe that no residue of pesticides 

should be allowed. However, under the 

existing legal framework provided by 

FFDCA section 408, EPA is authorized 

to establish pesticide tolerances or 

exemptions where persons seeking such 

tolerances or exemptions have 

demonstrated that the pesticide meets 

the safety standard imposed by that 

statute. 

Based upon review of the data 

supporting the petition, EPA has 

modified the exemption requested by 

limiting NTHE to a maximum of 20% by 

weight in pesticide formulations. This 

limitation is based on the Agency’s risk 

assessment which can be found at 

http://www.regulations.gov in 

document, N,N,N′,N′′,-Tetrakis-(2- 

Hydroxypropyl) Ethylenediamine 

(NTHE - JITF CST 15 Inert Ingredient). 

Human Health Risk Assessment to 

Support Proposed Exemption from the 

Requirement of a Tolerance When Used 

as an Inert Ingredient in Pesticide 

Formulations in docket ID number 

EPA–HQ–OPP–2009–0130. 

This petition was submitted in 

response to a final rule published in the 

Federal Register issue 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 final 

rule published in the Federal Register 

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 


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37566 Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 

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 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 NTHE provided 

that the concentration of NTHE inerts is 

limited to no more than 20% by weight 

in pesticide formulations. 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 existing toxicology database for 

NTHE consists of one OPPTS 

Harmonized Guideline 870.3650 

(combined repeated dose toxicity study 

with the reproduction/developmental 

screening study in rats), a 90–day 

toxicity study in rats, and several 

studies in the scientific literature on 

acute oral toxicity and mutagenicity. 

The available toxicity data indicates 

that NTHE has low acute oral toxicity. 

NTHE was not mutagenic in an Ames 

Test. In the OPPTS Harmonized 

Guideline 870.3650 rat reproductive/ 

developmental toxicity screening study, 

there was no evidence of increased 

susceptibility. Parental toxicity 

manifested as microscopic brain lesions 

at 1,000 milligrams/kilograms/day (mg/ 

kg/day) (the highest dose tested). No 

developmental or reproductive effects 

were observed at doses of 100, 300, and 

1,000 mg/kg/day. There is no evidence 

of increased susceptibility to the 

offspring of rats following prenatal and 

postnatal exposure in the OPPTS 

Harmonized Guideline 870.3650 study. 

There were no offspring effects at any 

dose level up to the limit dose (1,000 

mg/kg/day). In addition, in a 90–day 

dietary study in rats (1956), where the 

no-observed-adverse-effect-level 

(NOAEL) was set at 600–900 mg/kg/day 

(1% in diet), based on body-weight gain 

effects at 3% and 5% in the diet and a 

slightly greater incidence of borderline 

abnormalities of the liver of 

questionable significance, there are no 

other repeat dose toxicity data available. 

The NOAEL from the OPPTS 

Harmonized Guideline 870.3650 study 

(300 mg/kg/day) is protective of any 

potential liver toxicity. 

However, there is suggestive evidence 

of adverse neurotoxic effects in the 

adult animal in the OPPTS Harmonized 

Guideline 870.3650 study at the limit 

dose of 1,000 mg/kg/day. These effects 

manifested as different sized vacuoles in 

the choroid plexus epithelial cells (some 

were signet-ring shaped) of the lateral 

ventricles of the brain in all high-dose 

parental male and female rats. None of 

the low- or mid-dose or control animals 

showed a similar change. 

Pharmacokinetics in rats indicate that, 

following oral dosing, NTHE is poorly 

absorbed and rapidly excreted in the 

urine, mainly unchanged (92%–96%). 

None of the hypothetical metabolites, 

such as keto- or N-dealkylated 

derivatives, were observed. The 

calculated bioavailability factor 

(F=0.018) revealed that less than 2% of 

the orally administered dose of NTHE is 

absorbed through the stomach and 

intestine. The half-life for elimination is 

82 minutes (in non-diabetic rats) as a 

first order process. 

There are no chronic toxicity studies 

available for NTHE. The Agency used a 

qualitative structure activity 

relationship (SAR) database, DEREK 11, 

to determine if there were structural 

alerts suggestive of carcinogenicity. No 

structural alerts were identified. In 

addition, there was little concern about 

any of the postulated metabolites having 

greater toxicity than the parent 

compounds. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by NTHE, 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 

N,N,N′,N′′,-Tetrakis-(2-Hydroxypropyl) 

Ethylenediamine (NTHE - JITF CST 15 

Inert Ingredient). Human Health Risk 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as an Inert 

Ingredient in Pesticide Formulations at 

pp. 7–11 and 31–34 in docket ID 

number EPA–HQ–OPP–2009–0130. 

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 NTHE used for human 

health risk assessment is shown in 

Table 1 of this unit. 


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

Exposure/Scenario POD 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. The brain lesions observed 

following repeat dosing at the limit dose would not be expected to occur following a single exposure. 

Chronic dietary 

(all populations) 

NOAEL= 300 mg/kg/day 

UFA = 10X 

UFH = 10X 

FQPA SF = 10X 

Chronic RfD = 3 

mg/kg/day 

cPAD = 3 mg/kg/ 

day 

OPPTS Harmonized Guideline 870.3650 

reproduction/developmental screen in 

rats 

LOAEL = 1,000 mg/kg/day, based on microscopic lesions (vacuoles in choroid 

plexus epithelial cells of the lateral ventricles) of the brain in all high-dose animals (both sexes). 

Short-Term (1–30 days) Incidental Oral and 

Inhalation 

NOAEL= 300 mg/kg/day 

UFA = 10X 

UFH = 10X 

FQPA SF = 10X 

Inhalation hazard assumed to 

be equivalent to oral hazard 

Residential LOC 

for MOE = 

1,000 

OPPTS Harmonized Guideline 870.3650 

reproduction/developmental screen in 

rats 

LOAEL = 1,000 mg/kg/day, based on microscopic lesions (vacuoles in choroid 

plexus epithelial cells of the lateral ventricles) of the brain in all high-dose animals (both sexes). 

Intermediate- and Long-Term (1–6 months 

and >6 months) Incidental Oral and Inhalation 

Oral NOAEL = 300 mg/kg/day 

UFA = 10X 

UFH = 10X 

FQPA SF = 10X 

Inhalation hazard assumed to 

be equivalent to oral hazard 

Residential LOC 

for MOE = 

1,000 

OPPTS Harmonized Guideline 870.3650 

reproduction/developmental screen in 

rats 

LOAEL = 1,000 mg/kg/day, based on microscopic lesions (vacuoles in choroid 

plexus epithelial cells of the lateral ventricles) of the brain in all high-dose animals (both sexes). 

Cancer 

(oral, dermal, inhalation) 

Classification: No animal toxicity data available for an assessment. Based on SAR analysis, 

NTHE 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-effectlevel. 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 = Food Quality Protection Act of 1996 Safety Factor. RfD = reference dose. MOE = margin of exposure. LOC = level of concern. SAR 

= structure activity relationship. 

C. Exposure Assessment 

Limited information is available on 

the metabolism and environmental 

degradation of this compound. The 

Agency has considered the chemical 

structure, the submitted 

physicochemical data, as well as SAR 

information, to determine the residues 

of concern for this inert ingredient. 

A rat metabolism study showed little 

absorption, with most of the parent 

compound excreted unchanged in the 

urine. Although data on plant 

metabolism and environmental 

degradation are not available, any 

postulated metabolites as a result of dealkylation are likely to be highly water 

soluble (like the parent) and are not 

likely to be more toxic than the parent 

compound. Therefore, a risk assessment 

based on the toxicity data for the parent 

compound is not likely to underestimate 

risk. 

Available data indicate that oral 

absorption of NTHE is low, and dermal 

absorption is expected to be very low. 

Low dermal absorption is expected 

based on its physicochemical 

properties. Therefore, it is concluded 

that quantification of dermal risk is not 

necessary for NTHE. 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to NTHE, EPA considered 

exposure under the petitioned-for 

exemption from the requirement of a 

tolerance. EPA assessed dietary 

exposures from NTHE in food as 

follows: 

i. Acute exposure. No adverse effects 

attributable to a single exposure of 

NTHE was seen in the toxicity 

databases; therefore, an acute exposure 

assessment for NTHE is not necessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, 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 NTHE. In the 

absence of specific residue data, EPA 

has developed an approach which uses 

surrogate information to derive upper 

bound exposure estimates for the 

subject inert ingredient. Upper bound 

exposure estimates are based on the 

highest tolerance for a given commodity 

from a list of high-use insecticides, 

herbicides, and fungicides. A complete 

description of the general approach 

taken to assess inert ingredient risks in 

the absence of residue data 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 


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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 

NTHE, EPA made a specific adjustment 

to the dietary exposure assessment to 

account for the use limitations of the 

amount of NTHE that may be in 

formulations (no more than 20% by 

weight in pesticide formulations) and 

assumed that NTHE is present at the 

maximum limitation rather than at 

equal quantities with the active 

ingredient. This remains a very 

conservative assumption because 

surfactants are generally used at levels 

far below this percentage. 

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 SAR database, DEREK11, to 

determine if there were structural alerts 

suggestive of carcinogenicity. No 

structural alerts for carcinogenicity were 

identified. NTHE is 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 NTHE. Tolerance level residues and/ 

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 NTHE in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of NTHE. 

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 NTHE. Modeling runs on four 

surrogate inert ingredients using a range 

of physical chemical properties that 

would bracket those of NTHE were 

conducted. Modeled acute drinking 

water values ranged from 0.001 part 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 

N,N,N′,N′′,-Tetrakis-(2-Hydroxypropyl) 

Ethylenediamine (NTHE - JITF CST 15 

Inert Ingredient). Human Health Risk 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as an Inert 

Ingredient in Pesticide Formulations at 

pp. 11–12 and 36–38 in docket ID 

number EPA–HQ–OPP–2009–0130. 

For the purpose of the screening level 

dietary risk assessment to support this 

request for an exemption from the 

requirement of a tolerance for NTHE, a 

conservative drinking water 

concentration value of 100 ppb based on 

screening level modeling was used to 

assess the contribution to drinking 

water for the chronic dietary risk 

assessments for parent compound. 

These values were directly entered into 

the dietary exposure model. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

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

indoor pest control, termiticides, and 

flea and tick control on pets). NTHE 

may be used as inert ingredients in 

pesticide products that are registered for 

specific uses that may result in outdoor 

residential exposures. 

A screening level residential exposure 

and risk assessment was completed for 

products containing NTHE as an inert 

ingredient. In this assessment, 

representative scenarios, based on enduse product application methods and 

labeled application rates, were selected. 

The Agency did not identify any 

products intended for use on pets or 

home cleaning products that contain 

NTHE. For each of the use scenarios, the 

Agency assessed residential handler 

(applicator) inhalation exposure for 

outdoor 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. Similarly, residential post 

application oral exposure assessments 

were also performed utilizing high end 

outdoor exposure 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 


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cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found to share a common 

mechanism of toxicity with any other 

substances, and NTHE does not appear 

to produce a toxic metabolite produced 

by other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that NTHE does 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 existing toxicology database for 

NTHE consists of one OPPTS 

Harmonized Guideline 870.3650 

combined repeated dose toxicity study 

with the reproduction/developmental 

screening study in rats, and several 

studies in the scientific literature on 

acute oral toxicity and mutagenicity. 

In the case of NTHE, there was no 

increased susceptibility to the offspring 

of rats following pre and postnatal (PND 

0–4) exposure in the OPPTS 

Harmonized Guideline 870.3650 study 

(gavage dosing of males for 28 days, 

females for 46 days). There were no 

offspring effects at any dose level up to 

the limit dose (1,000 mg/kg/day) where 

maternal/paternal toxicity was 

manifested as microscopic lesions in the 

brain at 1,000 mg/kg/day. Although the 

parental NOAEL selected as the POD for 

the chronic dietary, incidental oral, and 

inhalation risk assessments is protective 

of the adult animal, the particular 

findings in the parental animals lead to 

uncertainties for the offspring. There is 

a concern for neurodevelopment since 

this is not addressed in the OPPTS 

Harmonized Guideline 870.3650 

reproduction/developmental screening 

study. 

3. Conclusion. Despite the fact that no 

quantitative or qualitative increased 

susceptibility to offspring was seen in 

the OPPTS Harmonized Guideline 

870.3650 combined repeated dose 

toxicity study and the conservative 

exposure assessment, EPA has 

determined that the FQPA SF cannot be 

reduced. A 10X FQPA SF is retained for 

the following reason: 

In the OPPTS Harmonized Guideline 

870.3650 study in rats there is some 

evidence of neurotoxicity in the adult 

animals in the OPPTS Harmonized 

Guideline 870.3650 reproductive/ 

developmental study, which occurred 

only at the highest-dose tested of 1,000 

mg/kg/day. The vacuoles in the choroid 

plexus epithelial cells of the lateral 

ventricles of the brain were of different 

size, and some of the epithelial cells 

were signet-ring shaped. None of the 

other dose groups (100 and 300 mg/kg/ 

day) showed a similar change. These 

results indicate a potential concern for 

effects on neurodevelopment at high 

doses following repeat exposure. Given 

that neither neurotoxicity nor standard 

developmental toxicity studies are 

available on NTHE, retention of the 

FQPA SF is appropriate. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest-safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk.There was no hazard 

attributable to a single exposure seen in 

the toxicity database for NTHE. 

Therefore, NTHE is 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 20% by weight in pesticide 

formulations, the chronic dietary 

exposure from food and water to NTHE 

is 26% of the cPAD for the U.S. 

population and 84% of the cPAD for 

children 1–2 years old, the most highly 

exposed population subgroup. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

NTHE is used as an inert ingredient 

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 

NTHE. 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 

4,800 and 5,000 for adult males and 

females, respectively. Adult residential 

exposure includes high-end inhalation 

handler exposure from outdoor uses. 

EPA has concluded the combined shortterm aggregated food, water, and 

residential exposures result in an 

aggregate MOE of 1,100 for children. 

Children’s residential exposure includes 

incidental oral exposure from treated 

turf. As the LOC is for MOEs that are 

lower than 1,000, 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). 

NTHE is 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 NTHE. Using 

the exposure assumptions described in 

this unit, EPA has concluded that the 

combined intermediate-term aggregated 

exposures result in aggregate MOEs of 

4,800 and 5,100, for adult males and 

females, respectively. EPA has 

concluded the combined intermediateterm aggregated food, water, and 

residential exposures result in an 

aggregate MOE of 1,200 for children. 

Children’s residential exposure includes 

incidental oral exposure from treated 

turf. As the LOC is for MOEs that are 

lower than 1,000, 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 NTHE. 


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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 

NTHE. 

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 NTHE 

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 N,N,N′,N′′,-tetrakis-(2- 

hydroxypropyl) ethylenediamine when 

used as an inert ingredient for preharvest uses under 40 CFR 180.920 at a 

maximum of 20% by weight in pesticide 

formulations. 

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 21, 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 §180.920, the table is amended 

by adding alphabetically the following 

inert ingredient to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

* * * * * 

N,N,N′,N′′,-tetrakis-(2-hydroxypropyl) ethylenediamine 

(CAS Reg. No. 102–60–3).

Concentration in formulated end-use 

products not to exceed 20% by weight 

in pesticide formulations.

Stabilizer for formulation 

* * * * * 


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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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