C9, 57805-57810 [2014-23018]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Rules and Regulations]
[Pages 57805-57810]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23018]


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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.

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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 https://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 https://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 https://
www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab02.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: https://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 https://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

[[Page 57806]]

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

[[Page 57807]]

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 no-observed-adverse-effect-
level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from 
the toxicity studies can be found at https://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 https://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
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary....................  NOAEL = 150 mg/kg/    Acute RfD = 1.5 mg/  Prenatal Developmental
(All populations)................   day.                  kg/day.             Toxicity Study in Rats.
                                   UFA = 10x...........  aPAD = 1.5 mg/kg/    LOAEL = 450 mg/kg/day based on
                                   UFH = 10x...........   day..                decreased body weight gain and
                                   FQPA SF = 1x........                        decreased food consumption.
Chronic dietary..................  NOAEL = 150 mg/kg/    Chronic RfD= 1.5 mg/ Prenatal Developmental
(All populations)................   day.                  kg/day.             Toxicity Study in Rats.
                                   UFA = 10x...........  cPAD = 1.5 mg/kg/    LOAEL = 450 mg/kg/day based on
                                   UFH = 10x...........   day..                decreased body weight gain and
                                   FQPA SF = 1x........                        decreased food consumption.
Inhalation, short-term...........  NOAEL = 110 ppm (156  LOC for MOE = 100..  3-day inhalation neurotoxicity
                                    mg/kg/day).                                study in rats.
                                   UFA = 10x...........                       LOAEL = 365 ppm based on low to
                                   UFH = 10x...........                        moderate gait abnormalities.
                                   FQPA SF = 1x........
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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 https://www.regulations.gov in the document ``Alkyl Amines 
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and 
Drinking Water) Dietary Exposure and Risk

[[Page 57808]]

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 non-occupational, 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 https://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

[[Page 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 intermediate-term 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.

[[Page 57810]]

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]

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. In Sec.  180.930, add alphabetically the following inert ingredients 
in the table to read as follows:


Sec.  180.930  Inert ingredients applied to animals; exemption from the 
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
         Inert ingredients                 Limits             Uses
------------------------------------------------------------------------
 
                              * * * * * * *
C9 rich aromatic hydrocarbons (CAS   .................  Solvent.
 Reg. No. 64742-95-6).
C10	11 rich aromatic hydrocarbons    .................  Solvent.
 (CAS Reg. No. 64742-94-5).
C11	12 rich aromatic hydrocarbons    .................  Solvent.
 (CAS Reg. No. 64742-94-5).
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2014-23018 Filed 9-25-14; 8:45 am]
BILLING CODE 6560-50-P