Federal Register / Vol. 77, No. 67 / Friday, April 6, 2012 / Rules and Regulations 20721 

Taking of Private Property 

This rule will not effect a taking of 

private property or otherwise have 

taking implications under Executive 

Order 12630, Governmental Actions and 

Interference with Constitutionally 

Protected Property Rights. 

Civil Justice Reform 

This rule meets applicable standards 

in sections 3(a) and 3(b)(2) of Executive 

Order 12988, Civil Justice Reform, to 

minimize litigation, eliminate 

ambiguity, and reduce burden. 

Protection of Children 

We have analyzed this rule under 

Executive Order 13045, Protection of 

Children from Environmental Health 

Risks and Safety Risks. This rule is not 

an economically significant rule and 

does not create an environmental risk to 

health or risk to safety that may 

disproportionately affect children. 

Indian Tribal Governments 

This rule does not have Tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have a substantial 

direct effect on one or more Indian 

Tribes, on the relationship between the 

Federal Government and Indian Tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes. 

Energy Effects 

We have analyzed this rule under 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use. We have 

determined that it is not a ‘‘significant 

energy action’’ under that order because 

it is not a ‘‘significant regulatory action’’ 

under Executive Order 12866 and is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. The Administrator of the Office 

of Information and Regulatory Affairs 

has not designated it as a significant 

energy action. Therefore, it does not 

require a Statement of Energy Effects 

under Executive Order 13211. 

Technical Standards 

The National Technology Transfer 

and Advancement Act (NTTAA) (15 

U.S.C. 272 note) directs agencies to use 

voluntary consensus standards in their 

regulatory activities unless the agency 

provides Congress, through the Office of 

Management and Budget, with an 

explanation of why using these 

standards would be inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedures; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This rule does not use technical 

standards. Therefore, we did not 

consider the use of voluntary consensus 

standards. 

Environment 

We have analyzed this rule under 

Department of Homeland Security 

Management Directive 023–01 and 

Commandant Instruction M16475.lD, 

which guide the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have concluded this action is one of a 

category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule is categorically 

excluded, under figure 2–1, paragraph 

(34)(g), of the Instruction. This rule 

involves establishing a temporary safety 

zone that will be enforced 12 hours per 

day for a total of 29 days. An 

environmental analysis checklist and a 

categorical exclusion determination are 

available in the docket where indicated 

under ADDRESSES. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1231; 46 U.S.C. 

Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 

33 CFR 1.05–1, 6.04–1, 6.04–6, 160.5; Pub. L. 

107–295, 116 Stat. 2064; Department of 

Homeland Security Delegation No. 0170.1. 

■ 2. Add a temporary § 165.T07–0037 to 

read as follows: 

§ 165.T07–0037 Safety Zone; Matlacha 

Bridge Construction, Matlacha Pass, 

Matlacha, FL. 

(a) Regulated Area. The following 

regulated area is a safety zone. All 

waters of Matlacha Pass within a 100 

yard radius of position 26°37′57.6′′ N, 

82°04′04.8′′ W. All coordinates are 

North American Datum 1983. 

(b) Definition. The term ‘‘designated 

representative’’ means Coast Guard 

Patrol Commanders, including Coast 

Guard coxswains, petty officers, and 

other officers operating Coast Guard 

vessels, and Federal, state, and local 

officers designated by or assisting the 

Captain of the Port St. Petersburg in the 

enforcement of the regulated area. 

(c) Regulations. (1) All persons and 

vessels are prohibited from entering, 

transiting through, anchoring in, or 

remaining within the regulated area 

unless authorized by the Captain of the 

Port St. Petersburg or a designated 

representative. 

(2) Persons and vessels desiring to 

enter, transit through, anchor in, or 

remain within the regulated area may 

contact the Captain of the Port St. 

Petersburg by telephone at 727–824– 

7524, or a designated representative via 

VHF radio on channel 16, to request 

authorization. If authorization to enter, 

transit through, anchor in, or remain 

within the regulated area is granted by 

the Captain of the Port St. Petersburg or 

a designated representative, all persons 

and vessels receiving such authorization 

must comply with the instructions of 

the Captain of the Port St. Petersburg or 

a designated representative. 

(3) The regulated area will only be 

enforced during the installation of the 

new bascule leaf requiring the 

placement of a barge within the main 

channel. 

(4) The Coast Guard will provide 

notice of the regulated area by Local 

Notice to Mariners, Broadcast Notice to 

Mariners, and on-scene designated 

representatives. 

(d) Effective Date and Enforcement 

Periods. This rule is effective from 

7 a.m. on March 12, 2012 through 

7 p.m. on April 10, 2012. This rule will 

be enforced daily from 7 a.m. until 

7 p.m. on March 12, 2012 through April 

10, 2012, during installation of the 

bascule leaf on the Matlacha Bridge. 

Dated: March 9, 2012. 

S.L. Dickinson, 

Captain, U.S. Coast Guard, Captain of the 

Port. 

[FR Doc. 2012–8311 Filed 4–5–12; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0604; FRL–9342–5] 

2-Ethyl-1-hexanol; Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 


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20722 Federal Register / Vol. 77, No. 67 / Friday, April 6, 2012 / Rules and Regulations 

SUMMARY: This regulation amends an 

exemption from the requirement of a 

tolerance for residues of 2-ethyl-1- 

hexanol (CAS no. 104–76–7) to increase 

the maximum use level for residues 

from 2.5% to 10% in final pesticide 

formulations, when used as an inert 

ingredient as a cosolvent, defoamer, 

solvent in pesticide formulations, inert 

ingredients used pre- and post-harvest, 

and inert ingredients applied to 

animals. Cognis submitted a petition to 

EPA under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting an 

amendment to the existing exemption 

for 2-ethyl-1-hexanol. 

DATES: This regulation is effective April 

6, 2012. Objections and requests for 

hearings must be received on or before 

June 5, 2012, 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–2011–0604. 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: 

Janet Whitehurst, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6129; email address: 

whitehurst.janet@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2011–0604 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 June 5, 2012. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0604, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

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 September 

7, 2011 (76 FR 55329) (FRL–8886–7), 

EPA issued a notice pursuant to FFDCA 

section 408, 21 U.S.C. 346a, announcing 

the filing of a pesticide petition (PP 

1E7893) by Cognis Corporation, c/o 

Lewis & Harrison LLC, 122 C St. NW., 

Suite 740, Washington, DC 20001. The 

petition requested that 40 CFR 180.910 

and 180.930 be amended by modifying 

an exemption from the requirement of a 

tolerance for residues of 2-ethyl-1- 

hexanol (CAS Reg. No. 104–76–7) to 

increase the maximum use level from 

2.5% to 20% in final pesticide 

formulations when used as an inert 

ingredient as a cosolvent, defoamer, 

solvent in pesticide formulations 

applied to agricultural growing crops or 

to raw agricultural commodities after 

harvest and direct application to 

animals. That notice referenced a 

summary of the petition prepared by 

Cognis Corporation, c/o Lewis & 

Harrison 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. 

Based upon review of the data 

supporting the petition, EPA has 

increased the maximum use limit for 2- 

ethyl-1-hexanol under 40 CFR 180.910 

and 180.930 to 10% and not 20% as 

requested by the petitioner due to 

aggregate risk concern. This limitation is 

based on the Agency’s risk assessment 

which can be found at http:// 

www.regulations.gov in the document 

‘‘Decision Document for Petition 

Number 1E7893:2-Ethylhexanol; Human 

Health Risk Asseessment and Ecological 


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Federal Register / Vol. 77, No. 67 / Friday, April 6, 2012 / Rules and Regulations 20723 

Effects Assessment for Proposed 

Exemption from Requirement of a 

Tolerance When Used as Inert 

Ingredients in Pesticide Formulations,’’ 

in docket ID number EPA–HQ–OPP– 

2011–0604. 

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 FFDCA section 

408(c)(2)(A), 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-ethyl-1-hexanol 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with 2-ethyl-1-hexanol 

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-ethyl-1-hexanol as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

are discussed in this unit. The available 

toxicity studies for 2-ethyl-1-hexanol are 

summarized in detail in the Decision 

Document for Petition Number 1E7893: 

‘‘2-Ethylhexanol; Human Health Risk 

Assessment and Ecological Effects 

Assessment for Proposed Exemption 

from the Requirement of a Tolerance 

When Used as Inert Ingredients in 

Pesticide Formulations.’’ 

The Agency has determined that 2- 

ethyl-1-hexanol is of low acute toxicity 

by the oral and dermal routes. Studies 

in rats and mice have LD50s ranging 

from 2,000 to 6,400 milligrams/kilogram 

(mg/kg) of body weight. 2-Ethyl-1- 

hexanol is moderately irritating to the 

skin and severely irritating to the eye. 

Eleven subacute and subchronic studies 

have been performed with 2-ethyl-1- 

hexanol. 

All the studies show that repeated 

exposure to 2-ethyl-1-hexanol has low 

potential for toxicity. The major target 

organ for 2-ethyl-1-hexanol is the liver 

with peroxisome proliferation as the 

major hepatic endpoint. The lowest 

NOAEL was observed in rats at 100 mg/ 

kg/day based on liver weights and liver 

peroxisomes at the LOAEL of 320 mg/ 

kg/day. No neurotoxic effects, even at 

high doses, were observed in the 

subchronic or chronic studies, so there 

is no reason to assume 2-ethyl-1- 

hexanol has neurotoxic potential. 

Numerous genotoxicity studies have 

been conducted with 2-ethyl-1-hexanol, 

including five Ames tests, an in vitro 

cell transformation assay, an 8- 

azaguanine resistance assay, a mouse 

micronucleus test, a mouse lymphoma 

assay, a Rec-assay, a CHO mutation 

assay, an unscheduled DNA synthesis 

assay, an in vivo dominant lethal assay 

and an in vivo chromosomal aberration 

assay. The results of all in vitro assays 

except the 8-azaguinine resistance assay 

were negative and all in vivo studies 

were negative as well. The genotoxicity 

data clearly indicate that 2-ethyl-1- 

hexanol is not mutagenic. 

Carcinogenicity studies in both rats 

and mice were conducted. In the mouse 

study, male and female mice were 

gavaged with 2-ethyl-1-hexanol at doses 

of 0, 50, 200 or 750 mg/kg/day for 18 

months. No substance-related changes 

were seen at 50 or 200 mg/kg/day. At 

750 mg/kg/day, reduced body weight 

gain related to decreased food 

consumption and increased mortality 

was noted. Treatment-related 

hematological changes were seen, and 

slight but not statistically significant 

increases were noted in focal 

hyperplasia of the epithelium of the 

forestomach. No statistically significant 

increases in tumor incidence were noted 

in mice. In the rat study, male and 

female rats were gavaged five days/week 

for 24 months at 0, 50, 150 or 500 mg/ 

kg/day. Dose-related reduced body 

weight gain was noted at 150 mg/kg/day 

and higher. Clinical findings included 

poor general condition, labored 

breathing, and piloerection. Increased 

mortality occurred in females at 500 mg/ 

kg/day. No increase in tumor incidence 

was noted. Based on the results of the 

rat and mice studies and lack of 

mutagenicity concerns, it can be 

reasonably concluded that 2-ethyl-1- 

hexanol is not likely to be carcinogenic. 

Developmental toxicity studies have 

been performed with 2-ethyl-1-hexanol; 

and a reproductive study has been 

performed using diethylhexyl adipate 

(DEHA) that readily metabolizes to 2- 

ethyl-1-hexanol in mammals. EPA 

concluded that none of the studies 


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20724 Federal Register / Vol. 77, No. 67 / Friday, April 6, 2012 / Rules and Regulations 

showed any developmental or 

reproductive toxicity associated with 2- 

ethyl-1-hexanol, even at high dose 

levels. 

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. 

Several subchronic, chronic/ 

carcinogenicity studies are available for 

2-ethyl-1-hexanol. No endpoint of 

concern for acute exposure was 

identified in the available database. The 

NOAEL, from the carcinogenicity study 

in rat was 50 mg/kg/day based on doserelated reduced body weights at the 

LOAEL of 450 mg/kg/day. The chronic 

RfD is 0.5 mg/kg/day using a 

hundredfold uncertainty factor (10X 

intraspecies and 10X interspecies 

variation). The population adjusted dose 

is equal to chronic RfD (0.5 mg/kg/day) 

since the FQPA factor is reduced from 

10X to 1X. This endpoint of concern 

was used for all exposure durations in 

order to be conservative in the risk 

assessment. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to 2-ethyl-1-hexanol EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from 2-ethyl1-hexanol in food as follows: The IDietary Exposure Evaluation Model 

(DEEM) is a highly conservative model 

with the assumption 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 between the active and 

inert ingredient (if any) and that the 

concentration of inert ingredient in the 

scenarios leading to these highest of 

tolerances would be no higher than the 

concentration of the active ingredient. 

The model assumes 100 percent crop 

treated (PCT) for all crops (every food 

eaten by a person each day has 

tolerance-level residues). 

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-ethyl-1- 

hexanol, a conservative drinking water 

concentration value of 100 parts per 

billion (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). 

There are no current residential uses 

known to the Agency and thus no 

residential exposures are expected. 

Therefore, a residential exposure 

assessment was not conducted. 

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-ethyl-1-hexanol 

to share a common mechanism of 

toxicity with any other substances, and 

2-ethyl-1-hexanol does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that 2-ethyl-1-hexanol does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www.epa.gov/pesticides/ 

cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There are several developmental 

toxicity studies available in mice and 

rats by the gavage route. One 

developmental toxicity study in rats via 

inhalation and a dermal developmental 

toxicity study in mice are also available. 

In one developmental toxicity study in 

mice via oral route, no developmental 

toxicity was observed at the highest 

dose of 1,525 mg/kg/day. In a separate 

developmental toxicity study in mice 

via oral route, no developmental effects 

were observed at doses up to 135 mg/ 

kg/day (the highest dose tested, HDT). 

In a rat developmental toxicity study via 

oral routes, the NOAEL for 

developmental and maternal toxicity 

was 800 mg/kg/day based on 

hydronephrosis and tail abnormalities 

seen at the LOAEL of 1,600 mg/kg/day 

above the limit dose of 1,000 mg/kg/day. 

No developmental toxicity was seen in 

rats (inhalation) and mice (dermal) at 

doses up to 850 mg/m3 and 2,520 mg/ 

kg/day, respectively. The available data 

on developmental toxicity studies with 

2-ethyl-1-hexanol clearly indicate no 

evidence of increased susceptibility for 

infants and children. No two generation 

reproduction study is available in the 

database for 2-ethyl-1-hexanol, however, 

no effects on sperm and other 

reproductive parameters were observed 

in rats at doses up to 1,080 mg/kg/day 

when fed on diets containing 

diethylhexyl adipate (DEHA). In 

mammals, DEHA is readily metabolized 

to 2-ethyl-1-hexanol. None of the 

studies showed any developmental or 

reproductive toxicity associated with 2- 


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Federal Register / Vol. 77, No. 67 / Friday, April 6, 2012 / Rules and Regulations 20725 

ethyl-1-hexanol, even at high dose 

levels. 

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 2-ethyl-1- 

hexanol includes several subchronic, 

chronic/carcinogenicity studies, 

mutagenicity studies, metabolism 

studies, and developmental studies. No 

two generation reproduction study is 

available in the database for 2- 

ethylhexanol, however, no effects on 

sperm and other reproductive 

parameters were observed in rats at 

doses up to 1,080 mg/kg/day when fed 

on diets containing diethylhexyl adipate 

(DEHA). In mammals, DEHA is readily 

metabolized to 2-ethylhexanol. 

ii. There is no indication that 2-ethyl1-hexanol is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional 

uncertainty factors (UFs) to account for 

neurotoxicity. No neurotoxicity studies 

are available in the database, however, 

no clinical signs of neurotoxicity were 

observed in the available subchronic 

and chronic studies. Therefore, the 

developmental neurotoxicity study is 

not necessary at this time. 

iii. No immunotoxicity study is 

available, however, there were no effects 

on the thymus or spleen indicated in the 

available database. Therefore, an 

immunotoxicity study is not required. 

iv. There is no evidence that 2-ethyl1-hexanol results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in the 2-generation reproduction study 

with a surrogate chemical. 

v. There are no residual uncertainties 

identified in the exposure databases. 

The food and drinking water assessment 

is not likely to underestimate exposure 

to any subpopulation, including those 

comprised of infants and children. The 

food exposure assessments are 

considered to be highly conservative as 

they are based on the use of the highest 

tolerance level from the surrogate 

pesticides for every food and 100% crop 

treated is assumed for all crops. EPA 

also made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to 2-ethyl-1-hexanol in drinking water. 

These assessments will not 

underestimate the exposure and risks 

posed by 2-ethyl-1-hexanol. 

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 population 

adjusted dose (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-ethyl-1-hexanol 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 2-ethyl-1- 

hexanol from food and water will utilize 

7.7% of the cPAD for U.S. population 

and 25% for children age 1 to 2 years, 

the population group receiving the 

greatest exposure. There are no 

residential uses for 2-ethyl-1-hexanol. 

Based on the explanation in this unit, 

regarding residential use patterns, 

chronic residential exposure to residues 

of 2-ethyl-1-hexanol is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). A short-term adverse 

effect was identified; however, 2-ethyl1-hexanol is not currently used as an 

inert ingredient in pesticide products 

that are registered for any use patterns 

that would result in short-term 

residential exposure. Short-term risk is 

assessed based on short-term residential 

exposure plus chronic dietary exposure. 

Because there is no short-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess short-term risk), 

no further assessment of short-term risk 

is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating short-term risk for 2-ethyl-1- 

hexanol. 

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). 

An intermediate-term adverse effect 

was identified; however, 2-ethyl-1- 

hexanol is not currently used as an inert 

ingredient in pesticide products that are 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 2- 

ethyl-1-hexanol. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies 

and lack of mutagenicity concerns, 2- 

ethyl-1-hexanol is not expected to pose 

a cancer risk to humans. 

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-ethyl-1- 

hexanol 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-ethyl-1- 

hexanol in or on any food commodities. 

EPA is establishing a limitation on the 

amount of 2-ethyl-1-hexanol 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 10% of 2-ethyl-1- 

hexanol in food use pesticide 

formulations. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nation Food and Agriculture 

Organization/World Health 


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20726 Federal Register / Vol. 77, No. 67 / Friday, April 6, 2012 / Rules and Regulations 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for 2-ethyl-1-hexanol. 

VI. Conclusions 

Therefore, the exemptions from the 

requirement of a tolerance for 2-ethyl-1- 

hexanol (CAS Reg. No. 104–76–7) at 40 

CFR 180.910 and 180.930 are amended 

to increase the maximum use level from 

2.5% to 10% in final pesticide 

formulations. 

VII. Statutory and Executive Order 

Reviews 

This final rule amends an exemption 

from the requirement for a tolerance 

under FFDCA section 408(d) 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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 

Governmentsx’’ (65 FR 67249, 

November 9, 2000) do not apply to this 

final rule. In addition, this final rule 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

(Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VIII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: March 27, 2012. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.910 revise the entry for 2- 

Ethyl-1-hexanol 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–Ethyl-1-hexanol (CAS Reg. No. 104–76–7) Not more than 10% of pesticide ....................... Solvent, adjuvant of surfactants.

*******

■ 3. In § 180.930 revise the entry for 2- 

Ethyl-1-hexanol to read as follows: 

§ 180.930 Inert Ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 


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Federal Register / Vol. 77, No. 67 / Friday, April 6, 2012 / Rules and Regulations 20727 

Inert ingredients Limits Uses 

*******

2-Ethyl-1-hexanol (CAS Reg. No. 104–76–7) .. Not more than 10% of pesticide ....................... Solvent adjuvant of surfactants. 

* * * * * * * 

[FR Doc. 2012–8195 Filed 4–5–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 65 

[Docket ID FEMA–2011–0002] 

Changes in Flood Elevation 

Determinations 

Correction 

In rule document 2011–33772 

appearing on pages 423–425 in the issue 

of Thursday, January 5, 2012 make the 

following correction: 

§ 65.4 [Corrected] 

On page 425, in the table, in the 

column ‘‘Chief executive officer of 

community’’, on the 10th line, ‘‘Mr. 

Robert Hyatt Davidson, County 

Manager’’ should read ‘‘Mr. Robert 

Hyatt, Davidson County Manager’’. 

[FR Doc. C1–2011–33772 Filed 4–5–12; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 65 

[Docket ID FEMA–2011–0002; Internal 

Agency Docket No. FEMA–B–1219] 

Changes in Flood Elevation 

Determinations 

Correction 

In rule document 2011–25157 

appearing on pages 60748–60751 in the 

issue of Friday, September 30, 2011, 

make the following corrections: 

§ 65.4 [Corrected] 

1. In the table appearing on page 

60750, in the column titled ‘‘Chief 

executive officer of the community’’, the 

eighth entry from the bottom of the 

page, ‘‘199 Town Center, Parkway 

Spring Hill, TN 37174’’ should read 

‘‘199 Town Center Parkway, Spring Hill, 

TN 37174’’. 

2. In the table appearing on page 

60750, the last entry in the column 

titled ‘‘Chief executive officer of the 

community’’, ‘‘301 West 2nd Street, 2nd 

Floor Austin, Texas 78701’’ should read 

‘‘301 West 2nd Street, 2nd Floor, 

Austin, Texas 78701’’. 

[FR Doc. C1–2011–25157 Filed 4–5–12; 8:45 am] 

BILLING CODE 1505–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

46 CFR Parts 2, 24, 30, 70, 90, 91, and 

188 

[Docket No. USCG–2011–0363] 

RIN 1625–AB71 

Seagoing Barges 

AGENCY: Coast Guard, DHS. 

ACTION: Direct final rule; withdrawal. 

SUMMARY: The Coast Guard is 

withdrawing its direct final rule 

published on December 14, 2011. The 

direct final rule notified the public of 

the Coast Guard’s intent to revise 

regulations for the inspection and 

certification of seagoing barges to align 

with the language of the applicable 

statutes. We are withdrawing that rule 

because we received two adverse 

comments. That rule will not become 

effective as scheduled. Instead, we plan 

to consider these issues in a notice of 

proposed rulemaking. 

DATES: The direct final rule published 

December 14, 2011, (76 FR 77712), is 

withdrawn on April 6, 2012. 

ADDRESSES: The docket for this 

withdrawn rulemaking is available for 

inspection or copying at the Docket 

Management Facility (M–30), U.S. 

Department of Transportation, West 

Building Ground Floor, Room W12–140, 

1200 New Jersey Avenue SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. You may also 

find this docket on the Internet by going 

to http://www.regulations.gov, inserting 

USCG–2011–0363 in the ‘‘Keyword’’ 

box, and then clicking ‘‘Search.’’ 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this notice, 

call or email Mr. Ken Smith, U.S. Coast 

Guard, telephone 202–372–1413, email 

Ken.A.Smith@uscg.mil. If you have 

questions on viewing material in the 

docket, call Renee V. Wright, Program 

Manager, Docket Operations, telephone 

202–366–9826. 

SUPPLEMENTARY INFORMATION: 

Background 

On December 14, 2011, we published 

a direct final rule entitled ‘‘Seagoing 

Barges’’ in the Federal Register (76 FR 

77712). That rule would have redefined 

‘‘seagoing barge’’ in 46 CFR parts 90 and 

91 and would have revised 46 CFR parts 

2, 24, 30, 70, 90, 91, and 188 to exempt 

specified seagoing barges from 

inspection and certification to align 

Coast Guard regulations with the 

language of the applicable statutes. 

In 1983, section 2101(32), Public Law 

98–89, 97 Stat. 500 (46 U.S.C. 2101) 

redefined ‘‘seagoing barge’’ as a non 

self-propelled vessel of at least 100 gross 

tons making voyages beyond the 

Boundary Line. Coast Guard regulations 

at 46 CFR 91.01–10(c) do not reflect the 

language change and instead refer to 

seagoing barges as vessels ‘‘on the high 

seas or ocean.’’ The withdrawn rule 

would have changed the language in 46 

CFR 91.01–10 from ‘‘on the high seas or 

ocean’’ to ‘‘beyond the Boundary Line’’ 

to reflect the language of Public Law 98– 

89. 

In 1993, Congress exempted from 

inspection seagoing barges that are 

unmanned and (1) not carrying 

hazardous material as cargo, or (2) 

carrying a flammable or combustible 

liquid, including oil, in bulk. (See Coast 

Guard Authorization Act of 1993, Pub. 

L. 103–206, 107 Stat. 2419 (46 U.S.C. 

3302(m).) Also in 1993, we stopped 

requiring the specified seagoing barges 

to be inspected in compliance with 

Public Law 103–206. However, we did 

not amend our regulations to reflect the 

exemption. That withdrawn rule would 

have changed the language concerning 

seagoing barges in 46 CFR 90.05–25, and 

46 CFR 91.01–10, and in the vessel 

inspection tables in 46 CFR parts 2, 24, 

30, 70, 90, and 188, to reflect the 

exemption created by Public Law 103– 

206. 


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