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[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Rules and Regulations]
[Pages 36356-36362]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15269]

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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.

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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 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:

[[Page 36357]]

     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

[[Page 36358]]

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 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 no-observed-adverse-effect-
level (NOAEL) and the lowest-observed-adverse-effect-level (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
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                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)......  NOAEL = 150 mg/kg/day..  Acute RfD = 1.5 mg/kg/   OCSPP Harmonized Test
                                       UFA = 10x..............   day.                     Guideline 870.3700
                                       UFH = 10x..............  aPAD = 1.5 mg/kg/day...   Prenatal Developmental
                                       FQPA SF = 1x...........                            Toxicity Study in Rats
                                                                                          Maternal LOAEL = 450
                                                                                          mg/kg/day based on
                                                                                          decreased body weight
                                                                                          gain and decreased
                                                                                          food consumption.

[[Page 36359]]

 
Chronic dietary (All populations)....  NOAEL= 150 mg/kg/day...  Chronic RfD = 1.5 mg/kg/ OCSPP Harmonized Test
                                       UFA = 10x..............   day.                     Guideline 870.3700
                                       UFH = 10x..............  cPAD = 1.5 mg/kg/day...   Prenatal Developmental
                                       FQPA SF = 1x...........                            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

[[Page 36360]]

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 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 nor 
are there any other non-pesticidal 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 
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 (10x) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10x, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. 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 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 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

[[Page 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 
intermediate-term 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-

[[Page 36362]]

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]

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.  180.910 the table is amended by adding alphabetically the 
following inert ingredients to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients                Limits               Uses
------------------------------------------------------------------------
 
                              * * * * * * *
C9 rich aromatic hydrocarbons      ..................  Solvent.
 (CAS 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. 2011-15269 Filed 6-21-11; 8:45 am]
BILLING CODE 6560-50-P
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