43076 Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Rules and Regulations 

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). 

X. 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 14, 2010. 

Steven Bradbury, 

Director, 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. Section 180.1298 is added to 

subpart D to read as follows: 

§ 180.1298 Trichoderma hamatum isolate 

382; exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Trichoderma hamatum isolate 382 in 

or on all food commodities when 

applied as a fungicide and used in 

accordance with good agricultural 

practices. 

[FR Doc. 2010–18076 Filed 7–22–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0138; FRL–8825–6] 

2-Propanol, 1,1′,1′′-nitrilotris-; 

Exemption from the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of 2-Propanol, 

1,1′,1′′-nitrilotris- (TIPA) (CAS No. 122– 

20–3) when used as an inert ingredient 

for use as a neutralizer on growing crops 

and raw agricultural commodities preand post-harvest. Dow AgroSciences, 

LLC submitted a petition to EPA under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), requesting establishment 

of an exemption from the requirement of 

a tolerance. This regulation eliminates 

the need to establish a maximum 

permissible level for residues of TIPA. 

DATES: This regulation is effective July 

23, 2010. Objections and requests for 

hearings must be received on or before 

September 21, 2010, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0138. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: Lisa 

Austin, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7894; e-mail address: 

austin.lisa@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR cite at 

http://www.gpoaccess.gov/ecfr. To 

access the harmonized test guidelines 

referenced in this document 

electronically, please go to http:// 

www.epa.gov/oppts and select ‘‘Test 

Methods and Guidelines.’’ 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. The EPA procedural 

regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0138 in the subject line on 

the first page of your submission. All 

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Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Rules and Regulations 43077 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before September 21, 2010. Addresses 

for mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2009–0138, 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 April 8, 

2009 (74 FR 15971) (FRL–8407–4), EPA 

issued a notice pursuant to section 408 

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

the filing of a pesticide petition (PP 

8E7504) by Dow AgroSciences, LLC, 

9330 Zionsville Rd, Indianapolis, IN, 

46268. The petition requested that 40 

CFR 180.910 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of TIPA (CAS No. 122–20–3) when used 

as an inert ingredient for use as a 

neutralizer in pesticide formulations 

applied to growing crops and raw 

agricultural commodities pre- and postharvest. That notice referenced a 

summary of the petition prepared by 

Dow AgroSciences, LLC, the petitioner, 

which is available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

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

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

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

of FFDCA, and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for TIPA including 

exposure resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with TIPA 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 TIPA 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. 

TIPA has low acute toxicity via the 

oral and dermal routes. It is moderately 

irritating to the skin and severely 

irritating to the eye. It is not a skin 

sensitizer. 

A subchronic study was available in 

the dog. Following subchronic exposure 

to TIPA to dogs via the diet, no 

treatment related effects were noted up 

to the highest dose tested (288 

milligrams/kilograms/day (mg/kg/day)). 

A developmental study was available 

for review (rat) on the surrogate 

chemical, diisopropanolamine (DIPA). 

In this study maternal and offspring 

toxicity were not observed at the highest 

dose tested (1,000 mg/kg/day). 

In a 1–generation reproduction 

toxicity study in rats with TIPA, no 

adverse clinical, histological, or 

reproductive effects were observed at 

the highest dose tested (M/F: 609/700 

mg/kg/day). 

Three mutagenicity studies (Ames 

test, mammalian gene mutation, and 

chromosome aberration) with TIPA 

were available for review. The results 

for these studies were negative. 

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TIPA is not expected to be 

carcinogenic since there were no 

triggers for carcinogenicity in the 

published study and a lack of systemic 

toxicity in the 1–generation 

reproduction study in rats as well as a 

negative response for mutagenicity. 

Also, TIPA is not listed as a carcinogen 

by ACGIH, IARC, NTP, or CA Prop 65. 

Metabolism studies demonstrated that 

TIPA was rapidly and extensively 

absorbed with a minimum of 83% oral 

absorption. Virtually the entire absorbed 

dose was rapidly excreted primarily as 

unchanged TIPA in the urine of treated 

rats. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors 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 TIPA used for human risk 

assessment is shown in the Table below. 

The 90–day toxicity study in the dog 

was selected for all exposure scenarios 

and durations for this risk assessment. 

The rationale for selecting this study is 

as follows. There was no toxicity 

observed at the highest dose (272 mg/ 

kg/day) tested in the 90–day dog study. 

Toxicity was not observed in the 1– 

generation reproduction toxicity study 

in the rat at 609 mg/kg/day, the highest 

dose tested. In a 14–day toxicity study 

via drinking water, the NOAEL was 

1,200 mg/kg/day. Although, the 30–day 

toxicity study via drinking water in the 

rat has a NOAEL of 140 mg/kg/day, 

there is no detail provided for 

microscopic findings in various organs. 

In addition, these findings were not 

reproduced in the 1–generation 

reproduction toxicity study in the rat. 

Therefore, less confidence was placed 

on the 30–day toxicity study in the rat. 

Finally, based on an EPA retrospective 

analysis, it was concluded that the 90– 

day toxicity and the 1–year toxicity 

studies in the dog are comparable. 

Therefore, based on the overall weight 

of evidence, the toxicity study in the 

dog provided a good basis for 

establishing the chronic reference dose 

(cRfD). 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TIPA FOR USE IN HUMAN RISK ASSESSMENT

Exposure/Scenario Point of Departure and Uncertainty/Safety Factors 

RfD, PAD, LOC for Risk Assessment Study and Toxicological Effects 

Acute dietary 

(Females 13–50 years of age) 

An acute endpoint was not identified in the database. 

Acute dietary 

(General population including infants and children) 

An acute endpoint was not identified in the database. 

Chronic dietary 

(All populations) 

NOAEL = 272 mg/kg/day UFA = 

10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 2.72 mg/kg/day 

cPAD = 2.72 mg/kg/day 

90–Day Oral Toxicity-Dog 

LOAEL = was not established. 

Incidental oral short-term 

(1 to 30 days) 

NOAEL = 272 mg/kg/day UFA = 

10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 90–Day Oral Toxicity-Dog 

LOAEL = was not established. 

Incidental oral intermediate-term 

(1 to 6 months) 

NOAEL = 272 mg/kg/day UFA = 

10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 90 Day Oral Toxicity-Dog 

LOAEL = was not established. 

Dermal short-term 

(1 to 30 days) 

Dermal (or oral) study 

NOAEL = 272 mg/kg/day 

(dermal absorption rate = 100% 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 90–Day Oral Toxicity-Dog 

LOAEL = was not established. 

Dermal intermediate-term 

(1 to 6 months) 

Dermal (or oral) study 

NOAEL = 272 mg/kg/day 

(dermal absorption rate = 100% 

when appropriate) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 90–Day Oral Toxicity-Dog 

LOAEL = was not established. 

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TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TIPA FOR USE IN HUMAN RISK ASSESSMENT— 

Continued 

Exposure/Scenario Point of Departure and Uncertainty/Safety Factors 

RfD, PAD, LOC for Risk Assessment Study and Toxicological Effects 

Inhalation short-term 

(1 to 30 days) 

Inhalation (or oral) study 

NOAEL = 272 mg/kg/day 

(inhalation absorption rate = 

100%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 90–Day Oral Toxicity-Dog 

LOAEL = was not established. 

Inhalation 

(1 to 6 months) 

Inhalation (or oral) study 

NOAEL = 272 mg/kg/day (inhalation absorption rate = 100% 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 90–Day Oral Toxicity-Dog 

LOAEL = was not established. 

Cancer 

(Oral, dermal, inhalation) 

Not likely to be carcinogenic based on no evidence of increased liver foci in rats and negative 

genotoxicity studies. 

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

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose. LOC = level of concern. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to TIPA, EPA considered 

exposure under the proposed exemption 

from the requirement of a tolerance. 

EPA assessed dietary exposures from 

TIPA in food as follows: 

i. Acute exposure. No adverse effects 

attributable to a single exposure of TIPA 

were seen in the toxicity databases. 

Therefore, an acute dietary risk 

assessment for TIPA is not necessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used food 

consumption information from the U.S. 

Department of Agriculture (USDA) 

[1994–1996 and 1998] Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, no residue data were submitted 

for TIPA. 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 levels of tolerances would 

be no higher than the concentration of 

the active ingredient. 

The Agency believes the assumptions 

used to estimate dietary exposures lead 

to an extremely conservative assessment 

of dietary risk due to a series of 

compounded conservatisms. First, 

assuming that the level of residue for an 

inert ingredient is equal to the level of 

residue for the active ingredient will 

overstate exposure. The concentrations 

of active ingredient in agricultural 

products are generally at least 50 

percent of the product and often can be 

much higher. Further, pesticide 

products rarely have a single inert 

ingredient; rather, there is generally a 

combination of different inert 

ingredients used which additionally 

reduces the concentration of any single 

inert ingredient in the pesticide product 

in relation to that of the active 

ingredient. 

Second, the conservatism of this 

methodology is compounded by EPA’s 

decision to assume that, for each 

commodity, the active ingredient which 

will serve as a guide to the potential 

level of inert ingredient residues is the 

active ingredient with the highest 

tolerance level. This assumption 

overstates residue values because it 

would be highly unlikely, given the 

high number of inert ingredients, that a 

single inert ingredient or class of 

ingredients would be present at the 

level of the active ingredient in the 

highest tolerance for every commodity. 

Finally, a third compounding 

conservatism is EPA’s assumption that 

all foods contain the inert ingredient at 

the highest tolerance level. In other 

words, EPA assumed 100 percent of all 

foods are treated with the inert 

ingredient at the rate and manner 

necessary to produce the highest residue 

legally possible for an active ingredient. 

In summary, EPA chose a very 

conservative method for estimating 

what level of inert residue could be on 

food, then used this methodology to 

choose the highest possible residue that 

could be found on food and assumed 

that all food contained this residue. No 

consideration was given to potential 

degradation between harvest and 

consumption even though monitoring 

data shows that tolerance level residues 

are typically one to two orders of 

magnitude higher than actual residues 

in food when distributed in commerce. 

Accordingly, although sufficient 

information to quantify actual residue 

levels in food is not available, the 

compounding of these conservative 

assumptions will lead to a significant 

exaggeration of actual exposures. EPA 

does not believe that this approach 

underestimates exposure in the absence 

of residue data. 

iii. Cancer. TIPA is not expected to be 

carcinogenic since there were no 

triggers for carcinogenicity in the 

published study and a lack of systemic 

toxicity in the 1–generation 

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reproduction study in rats as well as a 

negative response for mutagenicity. 

Since the Agency has not identified any 

concerns for carcinogenicity relating to 

TIPA, a cancer dietary exposure 

assessment was not performed. 

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 TIPA, a 

conservative drinking water 

concentration value of 100 parts per 

billion 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). 

TIPA may be used in inert ingredients 

in products that are registered for 

specific uses that may result in 

residential exposure. A screening level 

residential exposure and risk 

assessment was completed for products 

containing TIPA as inert ingredients. 

The TIPA inerts may be present in 

consumer personal (care) products and 

cosmetics (at concentrations up to 1%). 

The Agency selected representative 

scenarios, based on end-use product 

application methods and labeled 

application rates. The Agency 

conducted an assessment to represent 

worst-case residential exposure by 

assessing TIPA in pesticide 

formulations (outdoor scenarios) and 

TIPA in disinfectant-type uses (indoor 

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 TIPA to share a 

common mechanism of toxicity with 

any other substances, and TIPA does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that TIPA 

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 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. 

Fetal susceptibility was not observed in 

either the developmental study with 

DIPA or the one generation 

reproduction study with TIPA in the rat. 

There were no toxic effects observed in 

parents nor offspring in either study at 

the highest doses tested, 1,000 and 700 

mg/kg/day, respectively. A 

developmental toxicity study in rabbits 

is not available in the database. 

However, the concern for the lack of this 

study is low because no systemic 

toxicity was observed at the limit dose 

in the developmental and reproduction 

studies in rats (700 mg/kg/day). Also, 

other studies in the database such as the 

90–day toxicity study in the dog and the 

14–day toxicity study via drinking water 

in the rat do not show significant 

systemic toxicity. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for TIPA is 

adequate. 

ii. There is no indication that TIPA is 

a neurotoxic or immunotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that DIPA or 

TIPA result in increased susceptibility 

in in utero rats in the prenatal 

developmental studies or in young rats 

in the 1–generation reproduction study, 

respectively. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on the 

assumptions of 100% crop treated and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to TIPA in 

drinking water. EPA used similarly 

conservative assumptions to assess 

postapplication exposure of children as 

well as incidental oral exposure of 

toddlers. These assessments will not 

underestimate the exposure and risks 

posed by TIPA. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

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, TIPA 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 TIPA from food 

and water will utilize 22.9% of the 

cPAD for children 1 to 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 TIPA 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 

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Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Rules and Regulations 43081 

(considered to be a background 

exposure level). 

TIPA 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 

TIPA. 

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 679 for both adult males and 

females. Adult residential exposure 

combines high end dermal and 

inhalation handler exposure from 

indoor hand wiping with a high end 

post application dermal exposure from 

contact with treated lawns. EPA has 

concluded the combined short-term 

aggregated food, water, and residential 

exposures result in an aggregate MOE of 

337 for children. Children’s residential 

exposure includes total exposures 

associated with contact with treated 

lawns (dermal and hand-to-mouth 

exposures). Because EPA’s level of 

concern for TIPA is a MOE of 100 or 

below, these MOEs are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

TIPA 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 TIPA. 

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 1,114 for adult 

males and females. Adult residential 

exposure includes high end post 

application dermal exposure from 

contact with treated lawns. EPA has 

concluded the combined intermediateterm aggregated food, water, and 

residential exposures result in an 

aggregate MOE of 387 for children. 

Children’s residential exposure includes 

total exposures associated with contact 

with treated lawns (dermal and hand-tomouth exposures). Because EPA’s level 

of concern for TIPA is a MOE of 100 or 

below, these MOEs are not of concern. 

5. Aggregate cancer risk for U.S. 

population. TIPA is not expected to be 

carcinogenic since there were no 

triggers for carcinogenicity in the 

published study and a lack of systemic 

toxicity in the 1–generation 

reproduction study in rats as well as a 

negative response for mutagenicity. 

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 TIPA 

residues. 

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 2- 

Propanol, 1,1′,1′′-nitrilotris- nor have 

any CODEX Maximum Residue Levels 

(MRLs) been established for any food 

crops at this time. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 for TIPA (CAS 

No. 122–20–3) when used as an inert 

ingredient (used as a neutralizer) in 

pesticide formulations applied to 

growing crops and raw agricultural 

commodities pre- and post-harvest 

without limitation. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VIII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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43082 Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Rules and Regulations 

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 7, 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 the table in § 180.910, add 

alphabetically an entry for the following 

inert ingredient to read as follows: 

§ 180.910 Inert ingredients used pre-and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

2-Propanol, 1,1′,1′′-nitrilotris- (CAS No. 122–20–3) without limitation neutralizer 

*******

[FR Doc. 2010–18097 Filed 7–22–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–R03–SFUND–2010–0436; FRL–9177– 

8] 

National Oil and Hazardous 

Substances Pollution Contingency 

Plan; National Priorities List: Partial 

Deletion of the Letterkenny Army 

Depot Southeastern (SE) Area and 

Letterkenny Army Depot Property 

Disposal Office (PDO) Area Superfund 

Sites 

AGENCY: Environmental Protection 

Agency. 

ACTION: Direct final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) Region III is publishing a 

direct final Notice of Deletion of 

portions of the Letterkenny Army Depot 

Southeastern (SE) Area and Letterkenny 

Army Depot Property Disposal Office 

(PDO) Area (Sites), located in 

Chambersburg, PA, from the National 

Priorities List (NPL). The NPL, 

promulgated pursuant to section 105 of 

the Comprehensive Environmental 

Response, Compensation, and Liability 

Act (CERCLA) of 1980, as amended, is 

an appendix of the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (NCP). This direct 

final partial deletion is being published 

by EPA with the concurrence of the 

Commonwealth of Pennsylvania, 

through the Pennsylvania Department of 

Environmental Protection (PADEP), 

because EPA has determined that all 

appropriate response actions at these 

identified parcels under CERCLA, other 

than operation, maintenance, and fiveyear reviews, have been completed. 

However, this partial deletion does not 

preclude future actions under 

Superfund. 

This partial deletion pertains to the 

soil and groundwater of parcels 24, 27, 

28, 2–53, 2–53L, 2–54, 2–54L, 2–70, 2– 

70L, 3–89, 3–90, and 3–91. All other 

parcels within the site boundaries of 

Letterkenny Army Depot SE and PDO 

Areas will remain on the NPL and are 

not being considered for deletion as part 

of this action. 

DATES: This direct final partial deletion 

is effective September 21, 2010 unless 

EPA receives adverse comments by 

August 23, 2010. If adverse comments 

are received, EPA will publish a timely 

withdrawal of the direct final partial 

deletion in the Federal Register 

informing the public that the partial 

deletion will not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID no. EPA–R03– 

SFUND–2010–0436, by one of the 

following methods: 

• http://www.regulations.gov. Follow 

on-line instructions for submitting 

comments. 

• E-mail: hoover.gerald@epa.gov. 

• Fax: (215) 814–3025, Attn: Gerald 

Hoover. 

• Mail or Hand Delivery to: U.S. 

Environmental Protection Agency, 

Region III, Attn: Gerald Hoover (3HS11), 

1650 Arch Street, Philadelphia, PA 

19103–2029. Phone: (215) 814–2077. 

Business Hours: Mon. thru Fri.—9 a.m. 

to 4 p.m. 

Instructions: Direct your comments to 

Docket ID no. EPA–R03–SFUND–2010– 

0436. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through http:// 

www.regulations.gov or e-mail. The 

http://www.regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through http:// 

www.regulations.gov, your e-mail 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. 

Docket: All documents in the docket 

are listed in the http:// 

www.regulations.gov index. Although 

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in hard 

copy. Publicly available docket 

materials are available either 

electronically in http:// 

www.regulations.gov or at: 

U.S. EPA Region III, Library, 2nd Floor, 

1650 Arch Street, Philadelphia, PA, 

19103–2029. Phone: (215) 814–5254. 

Business Hours: Mon. thru Fri.—8 

a.m. to 5 p.m. 

Letterkenny Army Depot, Building 14, 

Chambersburg, PA 17201–4150. POC: 

Bryan Hoke. Phone: 717–267–9836. 

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