71550 Federal Register / Vol. 75, No. 226 / Wednesday, November 24, 2010 / Rules and Regulations 

EPA-approved or conditionally 

approved are listed along with any 

limitations on their approval. Examples 

of EPA-approved documents and 

materials associated with the SIP 

include, but are not limited to: SIP 

Narratives; Particulate Matter Plans; 

Carbon Monoxide Plans; Ozone Plans; 

Maintenance plans; Vehicle Inspection 

and Maintenance (I/M) SIPs; Emissions 

Inventories; Monitoring Networks; State 

Statutes submitted for the purposes of 

demonstrating legal authority; Part D 

nonattainment area plans; Attainment 

demonstrations; Transportation control 

measures (TCMs); Committal measures; 

Contingency Measures; Non-regulatory 

and Non-TCM Control Measures; 15% 

Rate of Progress Plans; Emergency 

episode plans; and Visibility plans. As 

stated above, the ‘‘non-regulatory’’ 

documents are available for public 

inspection at the appropriate EPA 

Regional Office. 

V. Background 

A. Relationship of National Ambient Air 

Quality Standards (NAAQS) to SIPs 

EPA has established primary and 

secondary National Ambient Air Quality 

Standards (NAAQS) for six criteria 

pollutants, which are widespread 

common pollutants known to be 

harmful to human health and welfare. 

The criteria pollutants are: Carbon 

monoxide; lead; nitrogen oxides; ozone; 

particulate matter; and sulfur dioxide. 

See 40 CFR part 50 for a technical 

description of how the levels of these 

standards are measured and attained. 

State Implementation Plans provide for 

implementation, maintenance, and 

enforcement of the NAAQS in each 

State. Areas within each State that are 

designated nonattainment are subject to 

additional planning and control 

requirements. Accordingly, different 

regulations or programs in the SIP will 

apply to different areas. EPA lists the 

designation of each area at 40 CFR part 

81. 

B. What is a State Implementation Plan? 

The State Implementation Plan is a 

plan for each State that identifies how 

that State will attain and/or maintain 

the primary and secondary National 

Ambient Air Quality Standards 

(NAAQS) set forth in section 109 of the 

Clean Air Act and 40 Code of Federal 

Regulations 50.4 through 50.12 and 

which includes Federally-enforceable 

requirements. Each State is required to 

have a SIP which contains control 

measures and strategies which 

demonstrate how each area will attain 

and maintain the NAAQS. These plans 

are developed through a public process, 

formally adopted by the State, and 

submitted by the Governor’s designee to 

EPA. The Clean Air Act requires EPA to 

review each plan and any plan revisions 

and to approve the plan or plan 

revisions if consistent with the Clean 

Air Act. 

SIP requirements applicable to all 

areas are provided in section 110. Part 

D of title I of the Clean Air Act specifies 

additional requirements applicable to 

nonattainment areas. Section 110 and 

part D describe the elements of a SIP 

and include, among other things, 

emission inventories, a monitoring 

network, an air quality analysis, 

modeling, attainment demonstrations, 

enforcement mechanisms, and 

regulations which have been adopted by 

the State to attain or maintain NAAQS. 

EPA has adopted regulatory 

requirements which spell out the 

procedures for preparing, adopting and 

submitting SIPs and SIP revisions; these 

are codified in 40 CFR part 51. 

EPA’s action on each State’s SIP is 

promulgated in 40 CFR part 52. The first 

section in the subpart in 40 CFR part 52 

for each State is generally the 

‘‘Identification of plan’’ section which 

provides chronological development of 

the State SIP. Alternatively, if the state 

has undergone the new Incorporation by 

Reference formatting process (see 62 FR 

27968; May 22, 1997), the identification 

of plan section identifies the Statesubmitted rules and plan elements that 

have been Federally approved. The goal 

of the State-by-State SIP compilation is 

to identify those rules under the 

‘‘Identification of plan’’ section which 

are currently Federally-enforceable. In 

addition, some of the SIP compilations 

may include control strategies, such as 

transportation control measures, local 

ordinances, State statutes, and emission 

inventories. Some of the SIP 

compilations may not identify these 

other Federally-enforceable elements. 

The contents of a typical SIP fall into 

three categories: (1) State-adopted 

control measures which consist of either 

rules/regulations or source-specific 

requirements (e.g., orders and consent 

decrees); (2) State-submitted ‘‘nonregulatory’’ components (e.g., attainment 

plans, rate of progress plans, emission 

inventories, transportation control 

measures, statutes demonstrating legal 

authority, monitoring networks, etc.); 

and (3) additional requirements 

promulgated by EPA (in the absence of 

a commensurate State provision) to 

satisfy a mandatory section 110 or part 

D (Clean Air Act) requirement. 

C. What does it mean to be federallyenforceable? 

Enforcement of the state regulation 

before and after it is incorporated into 

the Federally-approved SIP is primarily 

a state responsibility. However, after the 

regulation is Federally approved, EPA is 

authorized to take enforcement action 

against violators. Citizens also have 

legal recourse to address violations as 

described in section 304 of the Clean 

Air Act. 

When States submit their most 

current State regulations for inclusion 

into Federally-enforceable SIPs, EPA 

begins its review as soon as possible. 

Until EPA approves a submittal by 

rulemaking action, State-submitted 

regulations will be State-enforceable 

only. Therefore, State-enforceable SIPs 

may exist that differ from Federallyenforceable SIPs. As EPA approves 

these State-submitted regulations, the 

regional offices will continue to update 

the SIP compilations to include these 

applicable requirements. 

Dated: November 17, 2010. 

Lisa P. Jackson, 

Administrator. 

[FR Doc. 2010–29640 Filed 11–23–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0130; FRL–8851–8] 

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

Ethylenediamine (NTHE); 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; CAS no. 102– 

60–3) when used as an inert ingredient 

stabilizer for formulation for pre- and 

post-harvest uses under 40 CFR 180.910 

and application to animals under 40 

CFR 180.930, at a maximum 

concentration of 20% by weight in 

pesticide formulations. The Joint Inerts 

Task Force (JITF), Cluster Support Team 

Number 15 (CST 15) EPA Company No. 

84947 submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting 

establishment of an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 


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establish a maximum permissible level 

for residues of NTHE. 

DATES: This regulation is effective 

November 24, 2010. Objections and 

requests for hearings must be received 

on or before January 24, 2011, 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: Lisa 

Austin, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7894; e-mail address: 

austin.lisa@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

www.gpoaccess.gov/ecfr. To access the 

harmonized test guidelines referenced 

in this document electronically, please 

go to http://www.epa.gov/ocspp and 

select ‘‘Test Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 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 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before January 24, 2011. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, 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. Petition for Exemption 

In the Federal Register of March 24, 

2010 (75 FR 14156) (FRL–8815–6), EPA 

issued a notice pursuant to section 408 

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

the filing of a pesticide petition (PP 

#0E7683) by The Joint Inerts Task Force 

(JITF), Cluster Support Team Number 15 

(CST 15) EPA Company No. 84947, c/o 

CropLife America, 1156 15th St., Suite 

400, Washington, DC 20005. The 

petition requested that 40 CFR 180.910 

and 40 CFR 180.930 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of NTHE (102–60–3) when used as an 

inert ingredient stabilizer for 

formulation in pesticide formulations 

applied to pre- and post-harvest uses 

and application to animals at a 

maximum concentration of 20% by 

weight in pesticide formulations. That 

notice referenced a summary of the 

petition prepared by the Joint Inerts 

Task Force (JITF), Cluster Support Team 

Number 15 (CST 15) EPA Company No. 

84947, the petitioner, which is available 

in the docket, http:// 

www.regulations.gov. The Agency 

received one comment in response to 

the notice of filing. The 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 section 408 of 

the Federal Food, Drug and Cosmetic 

Act (FFDCA) 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 the 

statute. 

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 


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acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

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

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue * * *.’’ 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

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

of FFDCA, and the factors specified in 

FFDCA section 408(c)(2)(B), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for NTHE including 

exposure resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with NTHE follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

validity, completeness, and reliability as 

well as the relationship of the results of 

the studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the adverse effects caused 

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

lowest-observed-adverse-effect-level 

(LOAEL) from the toxicity studies are 

discussed in this unit. 

The 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 1000 mg/kg/day (the highest dose 

tested). No developmental or 

reproductive effects were observed at 

doses of 100, 300, and 1000 mg/kg/day. 

There is no evidence of increased 

susceptibility to the offspring of rats 

following prenatal and post-natal 

exposure in the OPPTS Harmonized 

Guideline 870.3650 study. There were 

no offspring effects at any dose level up 

to the limit dose (1000 mg/kg/day). 

In addition, in a 90-day dietary study 

in rats (1956), where the 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 1000 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 indicates 

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 nondiabetic 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-observed 

adverse-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 Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 


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analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For 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 

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 

risk assessment is discussed in Unit 

IV.B. of the final rule published in the 

Federal Register of July 29, 2009 (74 FR 

37568) (FRL–8429–3). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to NTHE, EPA considered 

exposure under the proposed 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 

and that the concentration of inert 

ingredient in the scenarios leading to 

these highest of tolerances would be no 

higher than the concentration of the 

active ingredient. 

The Agency believes the assumptions 

used to estimate dietary exposures lead 

to an extremely conservative assessment 

of dietary risk due to a series of 

compounded conservatisms. First, 

assuming that the level of residue for an 

inert ingredient is equal to the level of 

residue for the active ingredient will 

overstate exposure. The concentrations 

of active ingredient in agricultural 

products are generally at least 50% of 

the product and often can be much 

higher. Further, pesticide products 

rarely have a single inert ingredient; 

rather there is generally a combination 

of different inert ingredients used which 

additionally reduces the concentration 

of any single inert ingredient in the 

pesticide product in 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. 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., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

A screening level residential exposure 

and risk assessment was completed for 


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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 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found NTHE 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 Web site 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 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 post-natal 

(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 point of 

departure 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 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 because of the neurotoxic 

effects seen in the OPPTS Harmonized 

Guideline 870.3650 reproductive/ 

developmental study and the absence of 

standard neurotoxicity and 

developmental studies. EPA considered 

the following factors in determining that 

a 10X FQPA SF should be retained: 

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 signetring 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 Safety 

Factor is appropriate. 

E. Aggregate Risks and Determination of 

Safety 

Determination of safety section. EPA 

determines whether acute and chronic 

dietary pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the acute PAD (aPAD) and chronic 

PAD (cPAD). For linear cancer risks, 

EPA calculates the lifetime probability 

of acquiring cancer given the estimated 

aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, NTHE is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to NTHE from 

food and water will utilize 84% of the 

cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

this unit, regarding residential use 

patterns, chronic residential exposure to 

residues of NTHE is not expected. 

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 currently used as an inert 

ingredient in pesticide products that are 

registered for uses that could result in 

short-term residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

NTHE. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 4,800 and 5,000 for adult males 

and females, respectively. Adult 


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Federal Register / Vol. 75, No. 226 / Wednesday, November 24, 2010 / Rules and Regulations 71555 

residential exposure includes high-end 

inhalation handler exposure from 

outdoor uses. EPA has concluded the 

combined short-term 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. Because 

EPA’s level of concern for NTHE is a 

MOE of 1,000 or below, these MOEs are 

not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

NTHE is currently used as an inert 

ingredient in pesticide products that are 

registered for uses that could result in 

intermediate-term residential exposure, 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to NTHE. 

Using the exposure assumptions 

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

the combined intermediate-term food, 

water, and residential exposures result 

in aggregate MOEs of 4,800 and 5,100, 

for adult males and females, 

respectively. EPA has concluded the 

combined intermediate-term 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. Because 

EPA’s level of concern for NTHE is a 

MOE of 1,000 or below, 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. 

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 NTHE 

residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

EPA is establishing a limitation on the 

amount of NTHE that may be used in 

pesticide formulations applied to 

growing crops and raw agricultural 

commodities. That limitation will be 

enforced through the pesticide 

registration process under the Federal 

Insecticide, Fungicide, and Rodenticide 

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

will not register any such pesticide for 

sale or distribution that contains greater 

than 20% of NTHE by weight in the 

pesticide formulation. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for NTHE. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 and 40 CFR 

180.930 for NTHE (102–60–3) when 

used as an inert ingredient (stabilizer for 

formulation) in pesticide formulations 

applied to pre- and post-harvest uses 

and application to animals at a 

maximum concentration of 20% by 

weight in pesticide formulations. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 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). 


jlentini on DSKJ8SOYB1PROD with RULES
71556 Federal Register / Vol. 75, No. 226 / Wednesday, November 24, 2010 / Rules and Regulations 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: November 16, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.910, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.910 Inert ingredients used pre-and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

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

(102–60–3).

Concentration in formulated end-use products not to 

exceed 20% by weight in pesticide formulations.

Stabilizer for formulation. 

*******

■ 3. In § 180.930, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

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

(102–60–3).

Concentration in formulated end-use products not to 

exceed 20% by weight in pesticide formulations.

Stabilizer for formulation. 

*******

[FR Doc. 2010–29647 Filed 11–23–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0061; FRL–8852–2] 

Polyoxyalkylated Glycerol Fatty Acid 

Esters; Tolerance Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of 

polyoxyalkylated glycerol fatty acid 

esters; the mono-, di-, or triglyceride 

mixtures of C8 through C22, primarily C8

through C18 saturated and unsaturated, 

fatty acids containing up to 15% water 

by weight reacted with a minimum of 

three moles of either ethylene oxide or 

propylene oxide, also known as 

polyoxyalkylated glycerol fatty acid 

esters, when used as an inert ingredient 

in a pesticide chemical formulation 

under 40 CFR 180.960. Croda Inc., 315 

Cherry Lane, Wilmington, DE 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 polyoxyalkylated 

glycerol fatty acid esters; the mono-, 

di-, or triglyceride mixtures of C8

through C22, primarily C8 through C18

saturated and unsaturated, fatty acids 

containing up to 15% water by weight 

reacted with a minimum of three moles 

of either ethylene oxide or propylene 

oxide, also known as polyoxyalkylated 

glycerol fatty acid esters, when used as 

an inert ingredient in a pesticide 

chemical formulation on food or feed 

commodities. 

DATES: This regulation is effective 

November 24, 2010. Objections and 

requests for hearings must be received 

on or before January 24, 2011, 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–2009–0661. 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: 


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