Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Rules and Regulations 57805 

Appendix C to Part 1191— 

Architectural Barriers Act: Scoping 

[Corrected] 

2. On page 26140, in the first column, 

adding a new instruction after 

amendment 3.p to read ‘‘In F233.2, 

revising the first, second, and third 

sentences;’’ 

3. On page 26140, in the first column, 

in amendment 3.t, the instruction 

‘‘Redesignating sections F233.3.2 

F233.3.3.1, F233.3.3.2, F233.3.4, 

F233.4.2, F233.4.3, F233.4.4, F233.4.4.1, 

F233.4.4.2, and F233.4.5 as F233.3.3, 

F233.3.4, F233.3.4.1, F233.3.4.2, 

F233.3.5, F233.4.3, F233.4.4, F233.4.5, 

F233.4.5.1, F233.4.5.2, and F233.4.6, 

respectively’’ is corrected to read 

‘‘Redesignating sections F233.3.2, 

F233.3.3, F233.3.3.1, F233.3.3.2, 

F233.3.4, F233.4.1.2, F233.4.2, F233.4.3, 

F233.4.4, F233.4.4.1, F233.4.4.2, and 

F233.4.5 as F233.3.3, F233.3.4, 

F233.3.4.1, F233.3.4.2, F233.3.5, 

F233.4.2, F233.4.3, F233.4.4, F233.4.5, 

F233.4.5.1, F233.4.5.2, and F233.4.6, 

respectively.’’ 

4. On page 26141, in the second 

column, first full paragraph, first line, 

replace ‘‘F223.3.4’’ with ‘‘F233.3.4’’. 

5. On p. 26142, in the second column, 

in amendment 4.f, the instruction ‘‘In 

606.4, adding a sentence at the end of 

the section;’’ is corrected to read, ‘‘In 

606.4, revising the heading to read 

‘‘Faucets and water spray units’’, and 

adding a sentence at the end of the 

section.’’ 

David M. Capozzi, 

Executive Director. 

[FR Doc. 2014–22984 Filed 9–25–14; 8:45 am] 

BILLING CODE 8150–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0517; FRL–9916–23] 

C9 Rich Aromatic Hydrocarbons, C10–11

Rich Aromatic Hydrocarbons, and 

C11–12 Rich Aromatic Hydrocarbons; 

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 C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons when used as 

inert ingredients (solvents) in pesticide 

formulations applied to animals. 

ExxonMobil Chemical Company 

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 C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons. 

DATES: This regulation is effective 

September 26, 2014. Objections and 

requests for hearings must be received 

on or before November 25, 2014, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0517, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http://

www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

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–2011–0517 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 November 25, 2014. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2011–0517, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 


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II. Petition for Exemption 

In the Federal Register of January 25, 

2006 (71 FR 4135) (FRL–7750–4) for C9

rich aromatic hydrocarbons, January 23, 

2006 (71 FR 3512) (FRL–7750–3) for 

C10–11 rich aromatic hydrocarbons, and 

February 1, 2006 (71 FR 5321) (FRL– 

7750–5) for C11–12 rich aromatic 

hydrocarbons, EPA issued notices 

pursuant to section 408 of FFDCA, 21 

U.S.C. 346a, announcing the filing of 

pesticide petitions (PP 4E6935, 4E6934, 

and 4E6937 respectively) by 

ExxonMobil Chemical Company, 13501 

Katy Freeway, Houston, TX 77079. The 

petitions requested that 40 CFR 180.930 

be amended by establishing exemptions 

from the requirement of a tolerance for 

residues of C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons when used as inert 

ingredients (solvents) in pesticide 

formulations applied to animals. Those 

documents referenced summaries of the 

petitions prepared by ExxonMobil 

Chemical Company. There were two 

comments received in response to the 

notices of filing. EPA’s response to these 

comments is discussed in Unit V.B of 

this document. 

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 C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons including exposure 

resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons 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. 

C9 rich aromatic hydrocarbons, C10–11

rich aromatic hydrocarbons, and C11–12

rich aromatic hydrocarbons are products 

of the petroleum distillation and 

refining process. These substances are 

various fractions of aromatic petroleum 

hydrocarbons with specific boiling 

point ranges and flash points. Each of 

the substances is comprised of a 

complex mixture of aromatic 

hydrocarbon molecules in the range of 

9 to 12 carbon atoms. Since C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons differ only in the 

proportions of the various hydrocarbon 

molecules within the C9 to C12 range, 

they have similar physicochemical and 

toxicological properties and have 

therefore been assessed together. 

C9 rich aromatic hydrocarbons, C10–11

rich aromatic hydrocarbons, and C11–12

rich aromatic hydrocarbons exhibit low 

acute toxicity by oral, inhalation and 

dermal routes (toxicity Category III or IV 

by all exposure routes). They are 

minimally irritating to eyes and skin 

and negative for dermal sensitization 

effects. Subchronic oral and inhalation 

toxicity studies indicate these 

substances to be relatively non-toxic. 

Reversible effects to the liver, thyroid, 

stomach, spleen, and urinary bladder 

were reported at mid and high doses in 

a subchronic oral toxicity study in rats. 

A developmental inhalation study in 

mice indicates no evidence of 

developmental effects or any adverse 

effects in maternal animals at dose 

levels below 715 milligrams/kilogram/

day (mg/kg/day). An oral developmental 

study in rats indicates maternal effects 

(decreased body weight gain and food 

consumption) at the mid-dose (150 mg/ 

kg/day) but no developmental effects at 

the highest dose tested (450 mg/kg/day). 

An inhalation reproduction study in rats 

indicates reduced body weight gain in 

parents and offspring at mid and high 

doses (715 and 2,145 mg/kg/day). Based 

on neurotoxicity studies, C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons are not expected 

to cause any nervous system damage. 

Due to their complex, multi-constituent 

nature, there are no substance-specific 

absorption, metabolism, distribution 

and excretion studies done specifically 

on C9 rich aromatic hydrocarbons, C10–11

rich aromatic hydrocarbons, and C11–12

rich aromatic hydrocarbons. However, 

sufficient metabolism data are available 

on other aromatic hydrocarbons to show 

that as a class they are typically well 

absorbed, widely distributed between 


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tissues, extensively metabolized and 

rapidly excreted. C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons are of low toxicological 

concern for developmental and 

reproductive effects and are not 

expected to be carcinogenic, based on 

the available toxicity data. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons as well as the noobserved-adverse-effect-level (NOAEL) 

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

can be found at http://

www.regulations.gov in the document 

‘‘Exemptions From the Requirement of a 

Tolerance for C9 Rich Aromatic 

Hydrocarbons, C10–11 Rich Aromatic 

Hydrocarbons, C11–12 Rich Aromatic 

Hydrocarbons,’’ at pp. 5–17 in docket ID 

number EPA–HQ–OPP–2006–0517. 

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 the NOAEL and the 

LOAEL are identified. Uncertainty/

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons used for human risk 

assessment is shown in Table 1 of this 

unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR C9 RICH AROMATIC HYDROCARBONS, C10–11 RICH

AROMATIC HYDROCARBONS, AND C11–12 RICH AROMATIC HYDROCARBONS FOR USE IN HUMAN RISK ASSESSMENT

Exposure/scenario 

Point of departure 

and uncertainty/

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary ..........................................

(All populations) ......................................

NOAEL = 150 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 1.5 

mg/kg/day.

aPAD = 1.5 mg/kg/

day. 

Prenatal Developmental 

Toxicity Study in Rats. 

LOAEL = 450 mg/kg/day based on decreased body weight 

gain and decreased food consumption. 

Chronic dietary .......................................

(All populations) ......................................

NOAEL = 150 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD= 1.5 

mg/kg/day.

cPAD = 1.5 mg/kg/ 

day. 

Prenatal Developmental 

Toxicity Study in Rats. 

LOAEL = 450 mg/kg/day based on decreased body weight 

gain and decreased food consumption. 

Inhalation, short-term ............................. NOAEL = 110 ppm 

(156 mg/kg/day).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 

100.

3-day inhalation neurotoxicity study in rats. 

LOAEL = 365 ppm based on low to moderate gait abnormalities. 

Cancer (Oral, dermal, inhalation) ........... Based on structure-activity relationship (SAR) analysis and structural alerts, not expected to be carcinogenic. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons, EPA considered exposure 

under the proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons in food as 

follows: 

i. Acute and Chronic Exposure. In 

conducting the acute and chronic 

dietary exposure assessment for C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons, EPA used food 

consumption information from the U.S. 

Department of Agriculture (USDA) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America (NHANES/WWEIA). This 

dietary survey was conducted from 2003 

to 2008. As to residue levels in food, no 

residue data were submitted for C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons. 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 ingredients. Upper-bound 

exposure estimates are based on the 

highest tolerance for a given commodity 

from a list of high-use insecticides, 

herbicides, and fungicides. A complete 

description of the general approach 

taken to assess inert ingredient risks in 

the absence of residue data can be found 

at http://www.regulations.gov in the 

document ‘‘Alkyl Amines 

Polyalkoxylates (Cluster 4): Acute and 

Chronic Aggregate (Food and Drinking 

Water) Dietary Exposure and Risk 


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57808 Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Rules and Regulations 

Assessments for the Inerts,’’ in docket 

ID number EPA–HQ–OPP–2008–0738. 

In the case of C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons, EPA made specific 

adjustments to the dietary exposure 

assessment to account for evaporative 

loss, which is an important 

consideration for compounds such as C9

rich aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons. 

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 C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons, 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). 

C9 rich aromatic hydrocarbons, C10–11

rich aromatic hydrocarbons, and C11–12

rich aromatic hydrocarbons are not 

currently used as inert ingredients in 

pesticide products that are registered for 

any use patterns that involve residential 

uses. The primary non-pesticidal uses of 

C9 rich aromatic hydrocarbons, C10–11

rich aromatic hydrocarbons, and C11–12

rich aromatic hydrocarbons are as 

gasoline additives. Residential 

exposures to these substances as a result 

of their use as gasoline additives could 

occur via inhalation during refueling 

and from potential transport of gasoline 

containing C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons into groundwater. There 

are no reliable data upon which to 

quantitatively assess such exposures to 

C9 rich aromatic hydrocarbons, C10–11

rich aromatic hydrocarbons, and C11–12

rich aromatic hydrocarbons specifically; 

however, modeled data for other 

gasoline additives suggest that 

inhalation exposures would be at levels 

of <5 micrograms/kilogram/day and that 

levels in groundwater would not exceed 

0.2–16 ppb. It is reasonable to assume 

that the potential inhalation exposure 

and levels in groundwater for C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons would not 

exceed these modeled levels for other 

gasoline additives, as C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons are used as gasoline 

additives at concentrations less than the 

gasoline additives for which modeled 

information are available. 

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 C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons to share a common 

mechanism of toxicity with any other 

substances, and C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons 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 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The available mammalian toxicology 

database for C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons is complete with respect 

to assessing increased susceptibility to 

infants and children. There were no 

adverse effects on the offspring of rats 

following prenatal and postnatal 

exposure in the developmental toxicity 

study at the highest dose tested of 450 

mg/kg/day. In a 3-generation inhalation 

toxicity study in rats, reproductive 

effects were seen only at dose levels 

above that at which parental effects 

were noted. 

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 C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons is complete, 

except for an immunotoxicity study. 

However, there is no evidence of 

immune system involvement in the 

available toxicity database for C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons. Therefore, EPA 

has determined that an additional 

uncertainty factor is not needed to 

account for the lack of this study. 

ii. There is no indication that C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons are neurotoxic 

chemicals, as there were no neurotoxic 

effects observed at the highest dose 

tested in a 90-day inhalation 

neurotoxicity study in rats with a C9

aromatic hydrocarbon material. Given 

the similar physicochemical and 

toxicological properties of the 

hydrocarbons assessed for this rule, EPA 

concludes that C10–11 and C11–12 rich 

aromatic hydrocarbons would 

demonstrate a similar lack of neurotoxic 

effects; therefore, there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons result in 

increased susceptibility in in utero rats 

in the prenatal developmental studies or 

in young rats in a 3-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 percent 

crop treated (PCT) and reasonable 


asabaliauskas on DSK5VPTVN1PROD with RULES
Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Rules and Regulations 57809 

worst-case expected residue levels. EPA 

made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to C9 rich aromatic hydrocarbons, C10–11

rich aromatic hydrocarbons, and C11–12

rich aromatic hydrocarbons in drinking 

water. Moreover, EPA used conservative 

assumptions about potential residential 

exposure from use of these 

hydrocarbons in gasoline. These 

assessments will not underestimate the 

exposure and risks posed by C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons will occupy 11% 

of the aPAD for children 1 to 2 years 

old, the population group receiving the 

greatest exposure. Therefore, C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons are 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 C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons from food and 

water will utilize 2.1% of the cPAD for 

children 1 to 2 years old, the population 

group receiving the greatest exposure. 

There are no residential pesticidal uses 

for C9 rich aromatic hydrocarbons, 

C10–11 rich aromatic hydrocarbons, and 

C11–12 rich aromatic hydrocarbons. Also, 

as noted in Unit IV.C.3., while gasoline 

containing C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons may result in some 

potential exposure via drinking water, 

such drinking water exposures are 

already addressed by the conservative 

assumptions for drinking water 

concentrations utilized in the chronic 

dietary exposure assessment. 

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. Short-term risk is 

assessed based on short-term residential 

exposure plus chronic dietary exposure. 

C9 rich aromatic hydrocarbons, C10–11

rich aromatic hydrocarbons, and C11–12

rich aromatic hydrocarbons are not 

contained in pesticide products 

registered for any specific use patterns 

that could result in in short-term 

residential exposure. However, potential 

short term residential exposures to C9

rich aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons may occur as a 

result of non-pesticide use as a gasoline 

additive. Using the exposure 

assumptions described in this unit for 

short-term exposures, EPA has 

concluded the combined short-term 

food, water, and residential exposure 

result in estimated worst-case MOEs 

exceeding 10,000 for adults and 

children. Because EPA’s level of 

concern for C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons is a MOE of 100 or below, 

these MOEs are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). An 

intermediate-term adverse effect was 

identified. Intermediate-term risk is 

assessed based on intermediate-term 

residential exposure plus chronic 

dietary exposure. C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons are not contained in 

pesticide products registered for any 

specific use patterns (nor are there any 

nonpestical uses) that could result in in 

intermediate short-term residential 

exposure. EPA considers the chronic 

risk assessment to cover intermediateterm risk. Based on the results of the 

chronic risk assessment, EPA concludes 

that there is not an intermediate-term 

risk. 

5. Aggregate cancer risk for U.S. 

population. The Agency has not 

identified any concerns for 

carcinogenicity relating to C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons; therefore, C9

rich aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons are 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 C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

B. Response to Comments 

One commenter opposed the 

authorization to sell any pesticide that 

leaves a residue on food. The Agency 

understands the commenter’s concerns 

and recognizes that some individuals 

believe that no residue of pesticides 

should be allowed. However, under the 

existing legal framework provided by 

section 408 of the FFDCA, EPA is 

authorized to establish pesticide 

tolerances or exemptions where persons 

seeking such tolerances or exemptions 

have demonstrated that the pesticide 

meets the safety standard imposed by 

the statute. 

A second commenter asserted that the 

subject chemical should not be allowed 

for use on food and that short-term tests 

(which, the commenter asserts, are the 

only tests EPA requires) are not 

sufficient to protect the public from 

harm. Although it is difficult to know 

exactly what the commenter means by 

‘‘short-term tests,’’ the Agency believes 

the comment to be inapplicable to the 

action at hand. Several repeat-dose 

testing studies are available for these 

hydrocarbons. The Agency has found 

that data acceptable for assessing the 

hazard of these aromatic hydrocarbons 

and concluded that these exemptions 

will be safe. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.930 for C9 rich 

aromatic hydrocarbons (CAS Reg. No. 

64742–95–6), C10–11 rich aromatic 

hydrocarbons (CAS Reg. No. 64742–94– 

5), and C11–12 rich aromatic 

hydrocarbons (CAS Reg. No. 64742–94– 

5) when used as an inert ingredient 

(solvent) in pesticide formulations 

applied to animals. 


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57810 Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Rules and Regulations 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes exemptions 

from the requirement of a tolerance 

under FFDCA section 408(d) in 

response to petitions 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 exemptions 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 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) (2 U.S.C. 1501 et seq.). 

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

VIII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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: September 17, 2014. 

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 § 180.930, add alphabetically the 

following inert ingredients in the table 

to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemption from the requirement of 

a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

C9 rich aromatic hydrocarbons (CAS Reg. No. 64742–95–6) ..................................................................................................... ............. Solvent. 

C10–11 rich aromatic hydrocarbons (CAS Reg. No. 64742–94–5) ............................................................................................... ............. Solvent. 

C11–12 rich aromatic hydrocarbons (CAS Reg. No. 64742–94–5) ............................................................................................... ............. Solvent. 

* * * * * * * 

[FR Doc. 2014–23018 Filed 9–25–14; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 69 

[WC Docket No. 05–25; RM–10593; FCC 

12–153] 

Special Access Proceeding; Effective 

Date for Data Collection 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: The Federal Communications 

Commission (Commission) has received 

approval for the information collection 

requirement contained in the Special 

Access Proceeding from the Office of 

Management and Budget (OMB) 

pursuant to the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3520). 

DATES: On December 11, 2012, the 

Commission adopted a Report and 

Order and Further Notice of Proposed 

Rulemaking (Report and Order) 

regarding the special access data 

collection and stated that the 

information collection would not go 

into effect until OMB approved the 

collection and the Commission 

published a notice in the Federal 

Register announcing the effective date 

of the collection. FCC 12–153, 78 FR 

2572 (Jan. 11, 2013). On August 15, 

2014, OMB approved the data collection 

requirement and assigned this new 

information collection OMB Control 

Number 3060–1197, as required by PRA. 

Accordingly, the information collection 

requirement contained in the Report 

and Order is effective September 26, 

2014. The Commission’s Wireline 

Competition Bureau (Bureau) will 


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