36356 Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Rules and Regulations 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or Tribal governments, 

on the relationship between the national 

government and the States or Tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VIII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 10, 2011. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.920, the table is amended 

by adding alphabetically the following 

inert ingredient: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Diethylene Glycol MonoEthyl Ether (CAS Reg. No. 111– 

90–0).

Without limitation ................ Solvent, stabilizer and/or antifreeze. 

* * * * * * * 

[FR Doc. 2011–15266 Filed 6–21–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0517; FRL–8876–2] 

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 in pesticide 

formulations applied to growing crops 

or to raw agricultural commodities after 

harvest. ExxonMobil Chemical 

Company submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons. 

DATES: This regulation is effective June 

22, 2011. Objections and requests for 

hearings must be received on or before 

August 22, 2011, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2011–0517. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Kerry Leifer, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8811; e-mail address: 

leifer.kerry@epa.gov. 

SUPPLEMENTARY INFORMATION: 

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: 


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• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

www.gpoaccess.gov/ecfr. To access the 

harmonized test guidelines referenced 

in this document electronically, please 

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

select ‘‘Test Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–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 August 22, 2011. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0517, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Exemption 

In the Federal Register of 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 5E6935, 5E6934, 

and 4E6937 respectively) by 

ExxonMobil Chemical Company, 13501 

Katy Freeway, Houston, TX 77079. The 

petitions requested that 40 CFR 180.910 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of 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 inert ingredients 

(solvents) in pesticide formulations 

applied to raw agricultural commodities 

and growing crops under 40 CFR 

180.910. Those notices referenced 

summaries of the petitions prepared by 

ExxonMobil, the petitioner, which is 

available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notices of filing. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

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

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue * * *.’’ 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

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

of FFDCA, and the factors specified in 

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


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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 wellabsorbed, widely distributed between 

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, based on the 

available toxicity data, and are not 

expected to be carcinogenic. 

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 no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for C9 rich aromatic 

hydrocarbons, C10-11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons used for human risk 

assessment is shown in the following 

Table. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR C9, C10–11, 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 

OCSPP Harmonized Test Guideline 870.3700 Prenatal Developmental Toxicity Study in Rats 

Maternal LOAEL = 450 mg/kg/ 

day based on decreased body 

weight gain and decreased food 

consumption. 


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TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR C9, C10–11, AND C11–12 RICH AROMATIC

HYDROCARBONS FOR USE IN HUMAN RISK ASSESSMENT—Continued 

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

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 

OCSPP Harmonized Test Guideline 870.3700 Prenatal Developmental Toxicity Study in Rats 

Maternal LOAEL = 450 mg/kg/ 

day based on decreased body 

weight gain and decreased food 

consumption 

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

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

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. LOC=level of concern. 

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 exposure. In conducting the 

acute 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) 

[1994–1996 and 1998] Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, no residue data were submitted 

for 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 

Assessments for the Inerts,’’ in docket 

ID number EPA–HQ–OPP–2008–0738. 

In the dietary exposure assessment, 

the Agency assumed that the residue 

level of the inert ingredient would be no 

higher than the highest tolerance for a 

given commodity. Implicit in this 

assumption is that there would be 

similar rates of degradation (if any) 

between the active and inert ingredient 

and that the concentration of inert 

ingredient in the scenarios leading to 

these highest of tolerances would be no 

higher than the concentration of the 

active ingredient. 

The Agency believes the assumptions 

used to estimate dietary exposures lead 

to an extremely conservative assessment 

of dietary risk due to a series of 

compounded conservatisms. First, 

assuming that the level of residue for an 

inert ingredient is equal to the level of 

residue for the active ingredient will 

overstate exposure. The concentrations 

of active ingredient in agricultural 

products are generally at least 50 

percent of the product and often can be 

much higher. Further, pesticide 

products rarely have a single inert 

ingredient; rather there is generally a 

combination of different inert 

ingredients used which additionally 

reduces the concentration of any single 

inert ingredient in the pesticide product 

relative to that of the active ingredient. 

Second, the conservatism of this 

methodology is compounded by EPA’s 

decision to assume that, for each 

commodity, the active ingredient which 

will serve as a guide to the potential 

level of inert ingredient residues is the 

active ingredient with the highest 

tolerance level. This assumption 

overstates residue values because it 

would be highly unlikely, given the 

high number of inert ingredients, that a 

single inert ingredient or class of 

ingredients would be present at the 

level of the active ingredient in the 

highest tolerance for every commodity. 

Finally, a third compounding 

conservatism is EPA’s assumption that 

all foods contain the inert ingredient at 

the highest tolerance level, i.e., EPA 

assumed 100 percent of all foods are 

treated with the inert ingredient at the 

rate and manner necessary to produce 

the highest residue legally possible for 

an active ingredient. In summary, EPA 

chose a very conservative method for 

estimating what level of inert residue 

could be on food, and then used this 

methodology to choose the highest 

possible residue that could be found on 

food and assumed that all food 

contained this residue. No consideration 

was given to potential degradation 

between harvest and consumption even 

though monitoring data shows that 

tolerance level residues are typically 

one to two orders of magnitude higher 

than actual residues in food when 

distributed in commerce. 

Accordingly, although sufficient 

information to quantify actual residue 

levels in food is not available, the 

compounding of these conservative 

assumptions will lead to a significant 

exaggeration of actual exposures. EPA 

does not believe that this approach 

underestimates exposure in the absence 

of residue data. 

ii. Chronic exposure. In conducting 

the 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) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, no residue data 

were submitted for 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 

chronic dietary exposure estimates for 

the subject inert ingredient. This 


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approach is as described in Unit IV. 

C.1.i. 

iii. Cancer. The Agency used a 

qualitative structure activity 

relationship (SAR) database, DEREK11, 

to determine if there were structural 

alerts suggestive of carcinogenicity. No 

structural alerts for carcinogenicity were 

identified. Therefore, a cancer dietary 

exposure assessment is not necessary to 

assess cancer risk. 

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. 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 nor are there any other nonpesticidal residential uses for these inert 

ingredients, thus no residential 

exposures to C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons are expected. 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; 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. 

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 do not have a common 

mechanism of toxicity with other 

substances. For information regarding 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemicals, 

see EPA’s 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 (10×) 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 10×, 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 OCSPP Harmonized 

Test Guideline 870.3700 oral 

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 1×. 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 largely 

complete, missing only a developmental 

neurotoxicity study and an 

immunotoxicity study. EPA has 

determined that an additional 

uncertainty factor is not needed to 

account for the lack of these studies for 

the following reasons: 

• 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. There is no evidence that C9

rich aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons are neurotoxic 

chemicals and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

• 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. 

• An immunotoxicity study is not 

available; 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, there 

is no need to add additional UFs to 

account for the lack of an 

immunotoxicity study. 

ii. 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 tolerance-level 

residues. 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. These 

assessments will not underestimate the 

exposure and risks posed by C9 rich 

aromatic hydrocarbons, C10–11 rich 


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Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Rules and Regulations 36361 

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 population 

adjusted dose (aPAD) and chronic 

population adjusted dose (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 

2.8% 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 0.6% of the cPAD for 

children (1 to 2 years old), the 

population group receiving the greatest 

exposure. There are no residential 

pesticide uses for C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons. As noted in Unit IV.C.3., 

non-pesticidal drinking water exposure 

to C9 rich aromatic hydrocarbons, C10–11

rich aromatic hydrocarbons, and C11–12

rich aromatic hydrocarbons may be 

possible from potential transport of 

gasoline containing C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons into groundwater; 

however, those potential exposures are 

addressed by the use of a conservative 

drinking water concentration value of 

100 ppb used to assess the contribution 

to drinking water for the chronic dietary 

risk assessments, therefore no further 

assessment of this potential exposure is 

needed. 

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, 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 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 C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons. As noted in 

Unit IV.C.3., there may be short-term 

inhalation exposures to C9 rich aromatic 

hydrocarbons, C10–11 rich aromatic 

hydrocarbons, and C11–12 rich aromatic 

hydrocarbons when these substance are 

present as gasoline additives during 

gasoline refueling, however those 

exposures would be expected to be at 

levels at least three orders of magnitude 

below any level of concern and 

therefore have not been included in a 

quantitative short-term risk assessment. 

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, 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 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 C9

rich aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons. 

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 and 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. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established MRLs 

for C9 rich aromatic hydrocarbons, 

C10–11 rich aromatic hydrocarbons, and 

C11–12 rich aromatic hydrocarbons. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180. 910 for residues of 

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– 


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36362 Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Rules and Regulations 

5) when used as inert ingredients in 

pesticide formulations applied to 

growing crops or to raw agricultural 

commodities after harvest. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes exemptions 

from tolerance under section 408(d) of 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or Tribal governments, 

on the relationship between the national 

government and the States or Tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VIII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 10, 2011. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.910 the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

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. 

*******


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