50884 Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Rules and Regulations 

proposed rule is not subject to any of 

these requirements. 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3511) 

This rule will not impose additional 

information collection requirements on 

the public. 

Executive Order 13132, ‘‘Federalism’’ 

We have examined the impact of the 

rule under Executive Order 13132, and 

it does not have policies that have 

federalism implications that would have 

substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Therefore, 

consultation with State and local 

officials is not required. 

List of Subjects in 32 CFR Part 199 

Claims, Dental health, Health care, 

Health insurance, Individuals with 

disabilities, Military personnel. 

■ Accordingly, 32 CFR part 199 is 

amended as follows: 

PART 199—CIVILIAN HEALTH AND 

MEDICAL PROGRAM OF THE 

UNIFORMED SERVICES (CHAMPUS) 

■ 1. The authority citation for part 199 

continues to read as follows: 

Authority: 5 U.S.C. 301; 10 U.S.C. chapter 

55. 

■ 2. Section 199.17 is amended by 

revising the second sentence of 

paragraph (a)(3), redesignating 

paragraph (v) as paragraph (w), and by 

adding a new paragraph (v) to read as 

follows: 

§ 199.17 TRICARE program 

* * * * * 

(a) * * * 

(3) * * * Its geographical 

applicability is to all 50 states (except as 

modified for the state of Alaska under 

paragraph (v) of this section) and the 

District of Columbia. * * * 

* * * * * 

(v) Administration of the TRICARE 

program in the state of Alaska. In view 

of the unique geographical and 

environmental characteristics impacting 

the delivery of health care in the state 

of Alaska, administration of the 

TRICARE program in the state of Alaska 

will not include financial underwriting 

of the delivery of health care by a 

TRICARE contractor. All other 

provisions of this section shall apply to 

administration of the TRICARE program 

in the state of Alaska as they apply to 

the other 49 states and the District of 

Columbia. 

* * * * * 

Dated: August 10, 2010. 

Patricia L. Toppings, 

OSD Federal Register Liaison Officer, 

Department of Defense. 

[FR Doc. 2010–20391 Filed 8–17–10; 8:45 am] 

BILLING CODE 5001–06–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Parts 3 and 165 

[Docket No. USCG–2010–0351] 

RIN 1625–ZA25 

Navigation and Navigable Waters; 

Technical, Organizational, and 

Conforming Amendments, Sector 

Columbia River; Correction 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule; correction. 

SUMMARY: The Coast Guard published in 

the Federal Register of August 11, 2010, 

a document concerning non-substantive 

changes to Title 33 Parts 3 and 165 of 

the Code of Federal Regulations. That 

publication contained several errors 

regarding the name of the Sector that 

was being disestablished and one being 

established in its place. In addition, 

there was an error in amendatory 

instruction 5. This document corrects 

these errors. 

DATES: This correction is effective 

August 18, 2010. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

e-mail Lt. Matthew Jones, Coast Guard; 

telephone 206–220–7110, e-mail 

Matthew.m.jones@uscg.mil. If you have 

questions on viewing the docket, call 

Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: In FR doc 

2010–19754 appearing on page 48564 in 

the issue of Wednesday, August 11, 

2010, the following corrections are 

made: 

1. In the document heading on page 

48564, correct the subject heading to 

read ‘‘Navigation and Navigable Waters; 

Technical, Organizational, and 

Conforming Amendments, Sector 

Columbia River.’’ 

2. On page 48564, in the first column, 

revise the summary section to read as 

follows: 

‘‘This rule makes non-substantive 

changes throughout our regulations. The 

purpose of this rule is to make 

conforming amendments and technical 

corrections to reflect the combination 

and renaming of Sector Portland and 

Group/Air Station Astoria to Sector 

Columbia River as part of the Coast 

Guard reorganization.’’ 

3. On page 48564, in the second 

column, revise the discussion of rule 

section to read as follows: 

‘‘This rule revises 33 CFR parts 3 and 

165 to reflect changes in Coast Guard 

internal organizational structure. Sector 

Portland and Group/Air Station Astoria 

have been disestablished and Sector 

Columbia River has been established in 

their place. The new Sector begins 

operations on August 23, 2010. This 

rule revises 33 CFR parts 3 and 165 to 

reflect the Sector Columbia River and 

Captain of the Port Zone name change 

in current regulations. This rule is a 

technical revision reflecting changes in 

agency procedure and organization, and 

does not indicate new authorities nor 

create any substantive requirements.’’ 

4. On page 48565, in the third 

column, revise amendatory instruction 

number 5 to read as follows: 

‘‘In § 165.1312(b), remove the phrase 

‘‘Coast Guard Captain of the Port, 

Portland’’ and add, in its place, the 

phrase ‘‘Captain of the Port Columbia 

River’’.’’ 

Dated: August 13, 2010. 

Steve Venckus, 

Chief, Office of Regulations and 

Administrative Law, United States Coast 

Guard. 

[FR Doc. 2010–20509 Filed 8–17–10; 8:45 am] 

BILLING CODE P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0601 and EPA–HQ– 

OPP–2008–0602; FRL–8836–3] 

2-(2’-hydroxy-3’, 5’-di-tert-amylphenyl) 

benzotriazole and Phenol, 2-(2Hbenzotriazole-2-yl)-6-dodecyl-4-methyl; 

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-(2’-hydroxy3’, 5’-di-tert-amylphenyl) benzotriazole 

(CAS Reg. No. 25973–55–1) and Phenol, 

2-(2H-benzotriazole-2-yl)-6-dodecyl-4- 

methyl; (CAS Reg. No. 23328–53–2) 

when used as a ultraviolet (UV) 


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Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Rules and Regulations 50885 

stabilizer at a maximum concentration 

of 0.6% in insecticide formulations 

applied pre-harvest to adzuki beans, 

canola, chickpeas, cotton, faba beans, 

field peas, lentils, linola, linseed, 

lucerne, lupins, mung beans, navy 

beans, pigeon peas, safflower, 

sunflower, and vetch under 40 CFR 

180.920. Ag-Chem Consulting on behalf 

of Caltex Inc. 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 2-(2’-hydroxy-3’, 5’-ditert-amylphenyl) benzotriazole and 

Phenol, 2-(2H-benzotriazole-2-yl)-6- 

dodecyl-4-methyl. 

DATES: This regulation is effective 

August 18, 2010. Objections and 

requests for hearings must be received 

on or before October 18, 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–2008–0601 and EPA–HQ–OPP– 

2008–0602. 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: 

Deirdre Sunderland, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 603–0851; e-mail address: 

sunderland.deirdre@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. 

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–2008–0601 and EPA–HQ–OPP– 

2008–0602 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 October 18, 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 numbers 

EPA– EPA–HQ–OPP–2008–0601 and 

EPA–HQ–OPP–2008–0602, 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 December 3, 

2008 (73 FR 73648) (FRL–8391–3), EPA 

issued a notice pursuant to section 408 

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

the filing of a pesticide petition (PP 

8E7362 and PP 8E7363) by, Ag-Chem 

Consulting, 12208 Quinque Lane, 

Clifton, VA 21024 on behalf of Caltex 

Inc., 2 Market Street, Sydney, Australia. 

The petition requested that 40 CFR 

180.920 be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of 2-(2’-hydroxy3’, 5’-di-tert-amylphenyl) benzotriazole 

(CAS Reg. No. 25973–55–1) and Phenol, 

2-(2H-benzotriazole-2-yl)-6-dodecyl-4- 

methyl; (CAS Reg. No. 23328–53–2) 

when used as an inert ingredient as an 

ultraviolet (UV) stabilizers at a 

maximum concentration of 0.6% in 

insecticide formulations applied to 

adzuki beans, canola, chickpeas, cotton, 

faba beans, field peas, lentils, linola, 

linseed, lucerne, lupins, mung beans, 

navy beans, pigeon peas, safflower, 

sunflower, and vetch. That notice 

referenced a summary of the petition 

prepared by Ag-Chem Consulting on 

behalf of Caltex Inc., the petitioner, 

which is available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 


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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 

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 2-(2’-hydroxy-3’, 

5’-di-tert-amylphenyl) benzotriazole and 

Phenol, 2-(2H-benzotriazole-2-yl)-6- 

dodecyl-4-methyl including exposure 

resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with 2-(2’-hydroxy-3’, 5’-ditert-amylphenyl) benzotriazole and 

Phenol, 2-(2H-benzotriazole-2-yl)-6- 

dodecyl-4-methyl 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 2-(2’-hydroxy-3’, 5’-di-tertamylphenyl) benzotriazole and Phenol, 

2-(2H-benzotriazole-2-yl)-6-dodecyl-4- 

methyl 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 petition provided evidence that 

Phenol, 2-(2H-benzotriazole-2-yl)-6- 

dodecyl-4-methyl is structurally and 

toxicologically similar to 2-(2’-hydroxy3’, 5’-di-tert-amylphenyl) benzotriazole. 

The Agency agrees that data on 2-(2’- 

hydroxy-3’, 5’-di-tert-amylphenyl) 

benzotriazole would represent a worst 

case scenario for Phenol, 2-(2Hbenzotriazole-2-yl)-6-dodecyl-4-methyl 

and has, therefore, been used when 

determining risk associated with the use 

of both of these chemicals. 

Acute studies with 2-(2’-hydroxy-3’, 

5’-di-tert-amylphenyl) benzotriazole 

revealed low acute toxicity with an oral 

LD50 >2325 mg/kg. Acute inhalation and 

dermal studies resulted in LC50 >1,420 

mg/m3 and LD50 >2,000 mg/kg, 

respectively for analog chemicals. Skin 

irritation studies with 2-(2’-hydroxy-5’- 

methylphenyl) benzotriazole (CAS Reg. 

No. 2440–22–4), an analog chemical, on 

rats and mice showed no local irritation 

and no systemic toxicity. 2-(2’-hydroxy5’-methylphenyl) benzotriazole was 

found to be slightly irritating to rabbit 

eyes. Skin sensitization studies with 2- 

(2’-hydroxy-5’-methylphenyl) 

benzotriazole in guinea pigs showed 

skin sensitization; however, studies 

conducted on humans showed no 

sensitization. 

A 90–day toxicity study in Wistar rats 

administered 2-(2’-hydroxy-3’, 5’-di-tertamylphenyl) benzotriazole through the 

diet. Thyroid, liver, kidney, spleen, and 

testes weights were increased in higher 

exposure groups. The primary target 

organ was the liver which showed 

microscopic changes and a greenishdrab discoloration at higher dose levels. 

Reproductive organs were not evaluated 

microscopically. Pigmentation was also 

seen in the proximal tubular cells of 

females. No mortality was observed. The 

no-observed-adverse-effect-level 

(NOAEL) of 20 mg/kg/day is based on 

liver and kidney effects seen at the 

lowest-observed-adverse-effect-level 

(LOAEL) of 40 mg/kg/day. 

In a 90–day dog study, Beagles were 

administered 2-(2’-hydroxy-3’, 5’-di-tertamylphenyl) benzotriazole via the diet. 

Animals in the high-dose group showed 

decreases in body weight and food 

consumption, and changes in blood 

chemistry. Males showed decreases in 

testes, prostate, and epididymal weights 

(≥120 mg/kg/day) and females showed 

deceases in uterus weight (≥60 mg/kg/ 

day). One male dog in the highest dose 

group died. Histopathologic effects were 

noted in the liver (the primary target 

organ), kidney, and testes (≥60 mg/kg/ 

day) groups along with atrophy of 

uterus, abnormal spermiogenesis, and 

atrophy of the prostate. Liver damage 

was observed in a few dogs. The NOAEL 

was 30 mg/kg/day based on body 

weight, liver, and kidney effects seen at 

the LOAEL of 60 mg/kg/day. 

Developmental studies have been 

conducted on two structurally similar 

chemicals. Rats and mice received the 

test substance containing 2-(2’-hydroxy5’-methylphenyl) benzotriazole (CAS 

Reg. No. 2440–22–4) on days 6–15 of 

gestation. No maternal toxicity was 

evident and the rates of implantation 

and embryotoxicity were not affected by 

treatment. No teratogenic effects were 

observed. The NOAEL for maternal and 

developmental toxicity was 1,000 mg/ 

kg/day (highest dose tested) in mice and 

rats. A second developmental rat study 

showed no maternal toxicity at any dose 

tested for 2-(2H- Benzotriazol-2-yl)-4,6- 


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bis(1-methyl-1-phenylethyl) phenol 

(CAS Reg. No. 70321–86–7). A 

significant reduction in fetal body 

weight and an increased delay of 

skeletal maturation was observed in the 

1,000 mg/kg/day dose group. However, 

there were no similar effects in the high 

dose group indicating that these effects 

may be ‘‘incidental’’. An omphalocele 

was seen in one fetus in the high dose 

group. The maternal toxicity NOAEL 

was 3,000 mg/kg/day (highest dose 

tested). A developmental toxicity 

NOAEL of 1,000 mg/kg/day was chosen 

based on the omphalocele seen at the 

LOAEL of 3,000 mg/kg/day. 

All genetic toxicity tests (in vitro and 

in vivo) conducted indicated that this 

group of chemicals are not mutagenic 

and will not undergo chromosomal 

aberrations. No evidence of 

carcinogenicity was observed in rats 

when 142 mg/kg/day of 2-(2’-hydroxy5’-methylphenyl) benzotriazole (CAS 

Reg. No. 2440–22–4) was administered 

in the diet for 104 weeks. Negative 

finding were also seen in rats and mice 

given up to 62 mg/kg/day for 24 months. 

No clinical signs of neurotoxicity were 

seen in any of the repeat dose studies. 

Therefore, 2-(2’-hydroxy-3’, 5’-di-tertamylphenyl) benzotriazole and Phenol, 

2-(2H-benzotriazole-2-yl)-6-dodecyl-4- 

methyl are not expected to be 

neurotoxic. 

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 nonthreshold 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. 

The point of departure for risk 

assessment for all durations and routes 

of exposure was from the 90–day 

toxicity study in rats. The NOAEL was 

20 mg/kg/day and the LOAEL was 40 

mg/kg/day based on increases in liver, 

kidney, spleen, and testes weights. 

Although the chronic point of departure 

was selected from a subchronic study, 

longer-term studies are available that 

shows the lack of toxicity even at higher 

doses (NOAEL higher than 60 mg/kg/ 

day in carcinogenicity studies on a 

structurally similar chemical). No 

additional uncertainty factor is needed 

for extrapolating from subchronic to 

chronic exposure. A 1,000 fold 

uncertainty factor was used for the 

chronic exposure (10X interspecies 

extrapolation, 10X for intraspecies 

variability and 10X FQPA factor for the 

lack of reproduction studies). The 

NOAEL of 20 mg/kg/day was used for 

all exposure duration via dermal and 

inhalation routes of exposure. The 

residential, occupational and aggregate 

level of concern (LOC) is for MOEs that 

are less than 1,000 and is based on 10X 

interspecies extrapolation, 10X for 

intraspecies variability and 10X FQPA 

factor for the lack of reproduction 

studies. Dermal absorption is estimated 

to be 10% based on SAR analysis. A 

100% inhalation is assumed. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to 2-(2’-hydroxy-3’, 5’-di-tertamylphenyl) benzotriazole and Phenol, 

2-(2H-benzotriazole-2-yl)-6-dodecyl-4- 

methyl, EPA considered exposure under 

the proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from 2-(2’- 

hydroxy-3’, 5’-di-tert-amylphenyl) 

benzotriazole and Phenol, 2-(2Hbenzotriazole-2-yl)-6-dodecyl-4-methyl 

in food as follows: 

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). 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. The Agency 

believes the assumptions used to 

estimate dietary exposures lead to an 

extremely conservative assessment of 

dietary risk. 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 case of 2-(2’-hydroxy-3’, 5’-ditert-amylphenyl) benzotriazole and 

Phenol, 2-(2H-benzotriazole-2-yl)-6- 

dodecyl-4-methyl, EPA made a specific 

adjustment to the dietary exposure 

assessment to account for the use 

limitations of the amount of 2-(2’- 

hydroxy-3’, 5’-di-tert-amylphenyl) 

benzotriazole and Phenol, 2-(2Hbenzotriazole-2-yl)-6-dodecyl-4-methyl 

that may be in formulations (no more 

than 0.6% by weight in pesticide 

products applied to adzuki beans, 

canola, chickpeas, cotton, faba beans, 

field peas, lentils, linola, linseed, 

lucerne, lupins, mung beans, navy 

beans, pigeon peas, safflower, 

sunflower, and vetch) and assumed that 

the 2-(2’-hydroxy-3’, 5’-di-tertamylphenyl) benzotriazole and Phenol, 

2-(2H-benzotriazole-2-yl)-6-dodecyl-4- 

methyl are present at the maximum 

limitation rather than at equal quantities 

with the active ingredient. 

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 2-(2’- 

hydroxy-3’, 5’-di-tert-amylphenyl) 

benzotriazole and Phenol, 2-(2Hbenzotriazole-2-yl)-6-dodecyl-4-methyl, 

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). 

Residential uses of these chemicals 

are extremely limited. However, in 

order to account for all of the current 

and unanticipated potential residential 

uses of these chemicals various 

exposure models were employed. The 


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Agency believes that the scenarios 

assessed represent highly conservative 

worse-case short and intermediate term 

exposures and risks to residential 

handlers and those experiencing postapplication exposure resulting from the 

use of indoor and outdoor pesticide 

product containing these inert 

ingredients in residential environments. 

Based on the use pattern the chronic 

exposure is not anticipated. Therefore, 

the risk from the chronic residential 

exposure was not assessed. 

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 2-(2’-hydroxy-3’, 

5’-di-tert-amylphenyl) benzotriazole and 

Phenol, 2-(2H-benzotriazole-2-yl)-6- 

dodecyl-4-methyl share a common 

mechanism of toxicity with any other 

substances, and 2-(2’-hydroxy-3’, 5’-ditert-amylphenyl) benzotriazole and 

Phenol, 2-(2H-benzotriazole-2-yl)-6- 

dodecyl-4-methyl do not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that 2-(2’-hydroxy-3’, 5’-di-tertamylphenyl) benzotriazole and Phenol, 

2-(2H-benzotriazole-2-yl)-6-dodecyl-4- 

methyl do not have a common 

mechanism of toxicity with other 

substances. For information regarding 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemicals, 

see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

Developmental studies have been 

conducted on two structurally similar 

chemicals. In one study, no maternal 

toxicity was evident and the rates of 

implantation and embryotoxicity were 

not affected by treatment. No teratogenic 

effects were observed; however, the 

study does not specify what 

developmental endpoints were 

examined. The NOAEL for maternal and 

developmental toxicity was 1,000 mg/ 

kg/day (highest dose tested). There was 

no evidence of increased susceptibility 

in this developmental toxicity study in 

rats and mice. 

In a second study, no maternal 

toxicity was observed at any dose tested. 

The maternal toxicity NOAEL was 3,000 

mg/kg/day. The developmental NOAEL 

was 1,000 mg/kg/day based on 

omphalocele seen in the one fetus in the 

high dose group (LOAEL 3,000 mg/kg/ 

day). The data suggest evidence of 

increased susceptibility in this 

developmental toxicity study in rats. 

However, there is a low concern for this 

susceptibility because this effect 

(omphalocele) was seen at a very high 

dose of 3,000 mg/kg/day and only in 

one fetus. In addition, the study did not 

provide historical controls that would 

assist in making determination whether 

this effect is treatment related or not. 

The dietary assessment includes 

estimates using highly conservative 

model assumptions. In addition, the 

drinking water assessment was 

conducted using the highly conservative 

value of 100 ppb. These model estimates 

are highly conservative so as to not 

under estimate the risk. 

3. Conclusion. EPA has determined 

that it does not have reliable data to 

vary from the default FQPA safety factor 

of 10X. EPA considered the following 

factors: 

i. The database for 2-(2’-hydroxy-3’, 

5’-di-tert-amylphenyl) benzotriazole and 

Phenol, 2-(2H-benzotriazole-2-yl)-6- 

dodecyl-4-methyl is incomplete. EPA 

lacks a 2–generation reproductive study 

or any study measuring reproductive 

performance parameters in male and 

female rats. EPA also does not have an 

immunotoxicity study. In a 90–day 

toxicity study in rats, slight increases in 

spleen weights without 

histopathological findings was observed 

at the highest dose tested (80 mg/kg/ 

day). There was no other evidence of 

immunotoxicity in the database. 

ii. No clinical signs of neurotoxicity 

were seen in any of the repeat dose 

studies. Therefore, 2-(2’-hydroxy-3’, 5’- 

di-tert-amylphenyl) benzotriazole and 

Phenol, 2-(2H-benzotriazole-2-yl)-6- 

dodecyl-4-methyl are not expected to be 

neurotoxic. 

iii. As discussed above, there is low 

concern for increased sensitivity in the 

young from exposure to 2-(2’-hydroxy3’, 5’-di-tert-amylphenyl) benzotriazole 

and Phenol, 2-(2H-benzotriazole-2-yl)-6- 

dodecyl-4-methyl. 

iv. The dietary assessment includes 

estimates using highly conservative 

model assumptions. In addition, the 

drinking water assessment was 

conducted using the highly conservative 

value of 100 ppb. Finally, the model 

estimates for residential exposure are 

highly conservative so as to not under 

estimate the risk. Of principal concern 

to EPA is the lack of a 2–generation 

reproductive study or any other study 

measuring reproductive performance 

parameters in male and female rats. 

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, 2-(2’-hydroxy-3’, 5’- 

di-tert-amylphenyl) benzotriazole and 

Phenol, 2-(2H-benzotriazole-2-yl)-6- 

dodecyl-4-methyl are not expected to 

pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure and the use limitation 

described previously in Unit C, the EPA 

has concluded that chronic exposure to 

2-(2’-hydroxy-3’, 5’-di-tert-amylphenyl) 


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benzotriazole and Phenol, 2-(2Hbenzotriazole-2-yl)-6-dodecyl-4-methyl 

from food and water will be 0.3% of the 

cPAD for US populations and 2.8 % for 

non-nursing infants, the population 

group receiving the greatest exposure. 

Based on its use pattern, chronic 

residential exposure is not anticipated. 

Therefore, chronic residential exposure 

to residues of 2-(2’-hydroxy-3’, 5’-ditert-amylphenyl) benzotriazole and 

Phenol, 2-(2H-benzotriazole-2-yl)-6- 

dodecyl-4-methyl were not assessed. 

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). 

2-(2’-hydroxy-3’, 5’-di-tertamylphenyl) benzotriazole and Phenol, 

2-(2H-benzotriazole-2-yl)-6-dodecyl-4- 

methyl could potentially be used as an 

inert ingredient in pesticide products 

that may be 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 2-(2’-hydroxy-3’, 5’-di-tertamylphenyl) benzotriazole and Phenol, 

2-(2H-benzotriazole-2-yl)-6-dodecyl-4- 

methyl. 

Using the exposure assumptions 

described in this unit for short-term 

exposures and the use limitation 

described previously in Unit C, EPA has 

concluded the combined short-term 

food, water, and residential exposures 

result in aggregate MOEs of 7,100 for 

adult males and females. Adult 

residential exposure combines high end 

dermal and inhalation handler exposure 

from liquids/trigger sprayer in home 

gardens 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 

10,000 for children. Children’s 

residential exposure includes total 

exposures associated with contact with 

treated lawns (dermal and hand-to 

mouth exposures). The EPA’s level of 

concern for 2-(2’-hydroxy-3’, 5’-di-tertamylphenyl) benzotriazole and Phenol, 

2-(2H-benzotriazole-2-yl)-6-dodecyl-4- 

methyl is for MOEs that are lower than 

1,000; therefore, 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). 

2-(2’-hydroxy-3’, 5’-di-tertamylphenyl) benzotriazole and Phenol, 

2-(2H-benzotriazole-2-yl)-6-dodecyl-4- 

methyl could potentially be used as 

inert ingredients in pesticide products 

that may be 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 2-(2’-hydroxy3’, 5’-di-tert-amylphenyl) benzotriazole 

and Phenol, 2-(2H-benzotriazole-2-yl)-6- 

dodecyl-4-methyl. 

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 55,000 for adult 

males and 54,000 for adult females. 

Adult residential exposure includes 

high end post application dermal 

exposure from contact with treated 

lawns. EPA has concluded the 

combined intermediate term aggregated 

food, water, and residential exposures 

result in an aggregate MOE of 16,000 for 

children. Children’s residential 

exposure includes total exposures 

associated with contact with treated 

lawns (dermal and hand-to-mouth 

exposures). The level of concern is for 

MOEs that are lower than 1,000; 

therefore, this MOE is not of concern. 

5. Aggregate cancer risk for U.S. 

population. 2-(2’-hydroxy-3’, 5’-di-tertamylphenyl) benzotriazole and Phenol, 

2-(2H-benzotriazole-2-yl)-6-dodecyl-4- 

methyl are not expected to be 

carcinogenic since there was no 

evidence of carcinogenicity in the 

available studies. 

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 2-(2’- 

hydroxy-3’, 5’-di-tert-amylphenyl) 

benzotriazole and Phenol, 2-(2Hbenzotriazole-2-yl)-6-dodecyl-4-methyl 

residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is not establishing a numerical 

tolerance for residues of 2-(2’-hydroxy3’, 5’-di-tert-amylphenyl) benzotriazole 

or Phenol, 2-(2H-benzotriazole-2-yl)-6- 

dodecyl-4-methyl in or on any food 

commodities. EPA is establishing a 

limitation on the amount of 2-(2’- 

hydroxy-3’, 5’-di-tert-amylphenyl) 

benzotriazole and Phenol, 2-(2Hbenzotriazole-2-yl)-6-dodecyl-4-methyl 

that may be used in pesticide 

formulations. 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 pesticide for sale or 

distribution that contains greater than 

0.6% of 2-(2’-hydroxy-3’, 5’-di-tertamylphenyl) benzotriazole or Phenol, 2- 

(2H-benzotriazole-2-yl)-6-dodecyl-4- 

methyl by weight in the pesticide 

formulation. 

B. International Residue Limits 

The Agency is not aware of any 

country requiring a tolerance for 2-(2’- 

hydroxy-3’, 5’-di-tert-amylphenyl) 

benzotriazole or Phenol, 2-(2Hbenzotriazole-2-yl)-6-dodecyl-4-methyl 

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 180.920 for 2-(2’-hydroxy3’, 5’-di-tert-amylphenyl) benzotriazole 

(CAS Reg. No. 25973–55–1) and Phenol, 

2-(2H-benzotriazole-2-yl)-6-dodecyl-4- 

methyl; (CAS Reg. No. 23328–53–2) 

when used as an inert ingredient [as an 

ultraviolet (UV) stabilizers at a 

maximum concentration of 0.6%] in 

insecticide formulations applied to 

adzuki beans, canola, chickpeas, cotton, 

faba beans, field peas, lentils, linola, 

linseed, lucerne, lupins, mung beans, 

navy beans, pigeon peas, safflower, 

sunflower, and vetch. 

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 


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50890 Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Rules and Regulations 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VIII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 9, 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 §180.920, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

2-(2’-hydroxy-3’,5’-di-tert-amylphenyl) benzotriazole (CAS Reg. No. 25973–55–1) maximum concentration of 

0.6% in insecticide formulations applied to 

adzuki beans, canola, 

chickpeas, cotton, faba 

beans, field peas, lentils, 

linola, linseed, lucerne, 

lupins, mung beans, navy 

beans, pigeon peas, safflower, sunflower, and 

vetch 

Ultraviolet (UV) stabilizer 

Phenol, 2-(2H-benzotriazole-2-yl)-6-dodecyl-4-methyl; (CAS Reg. No. 23328–53–2) maximum concentration of 

0.6% in insecticide formulations applied to 

adzuki beans, canola, 

chickpeas, cotton, faba 

beans, field peas, lentils, 

linola, linseed, lucerne, 

lupins, mung beans, navy 

beans, pigeon peas, safflower, sunflower, and 

vetch 

Ultraviolet (UV) stabilizer 


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* * * * * 

[FR Doc. 2010–20299 Filed 8–17–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0046; FRL–8836–4] 

N-alkyl (C8-C18) Primary Amines and 

Acetate Salts; Exemption from the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of N-alkyl (C8- 

C18) primary amines and acetate salts 

where the alkyl group is linear and may 

be saturated and/or unsaturated, herein 

referred to in this document as 

NAPAAS, when used as a surfactant 

and related adjuvants of surfactants for 

pre-harvest and post-harvest uses under 

40 CFR 180.910 and application to 

animals under 40 CFR 180.930 at a 

maximum concentration in formulated 

end-use products of 10% by weight in 

herbicide products, 4% by weight in 

insecticide products, and 4% by weight 

in fungicide products. The Joint Inerts 

Task Force (JITF), Cluster Support Team 

Number 25 submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting an 

establishment of an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of NAPAAS. 

DATES: This regulation is effective 

August 18, 2010. Objections and 

requests for hearings must be received 

on or before October 18, 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–2009–0046. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 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–2009–0046 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 October 18, 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–2009–0046, 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 February 4, 

2010, (75 FR 5793) (FRL–8807–5), EPA 

issued a notice pursuant to section 408 

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

the filing of a pesticide petition (PP 

9E7627) by The JITF, Cluster Support 

Team 25 (CST 25), c/o CropLife 


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