[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Rules and Regulations]
[Pages 57805-57810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-23018]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0517; FRL-9916-23]
C9 Rich Aromatic Hydrocarbons, C10-11 Rich
Aromatic Hydrocarbons, and C11-12 Rich Aromatic
Hydrocarbons; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of C9 rich aromatic
hydrocarbons, C10-11 rich aromatic hydrocarbons, and
C11-12 rich aromatic hydrocarbons when used as inert
ingredients (solvents) in pesticide formulations applied to animals.
ExxonMobil Chemical Company submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment
of an exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of C9 rich aromatic hydrocarbons, C10-11
rich aromatic hydrocarbons, and C11-12 rich aromatic
hydrocarbons.
DATES: This regulation is effective September 26, 2014. Objections and
requests for hearings must be received on or before November 25, 2014,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0517, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0517 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
November 25, 2014. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2011-0517, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.
[[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 http://www.regulations.gov in the
document ``Exemptions From the Requirement of a Tolerance for C9 Rich
Aromatic Hydrocarbons, C10-11 Rich Aromatic Hydrocarbons, C11-12 Rich
Aromatic Hydrocarbons,'' at pp. 5-17 in docket ID number EPA-HQ-OPP-
2006-0517.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which the NOAEL and the LOAEL are identified.
Uncertainty/safety factors are used in conjunction with the POD to
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of
exposure (MOE). For non-threshold risks, the Agency assumes that any
amount of exposure will lead to some degree of risk. Thus, the Agency
estimates risk in terms of the probability of an occurrence of the
adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for C9 rich
aromatic hydrocarbons, C10-11 rich aromatic hydrocarbons,
and C11-12 rich aromatic hydrocarbons used for human risk
assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for C9 Rich Aromatic Hydrocarbons, C10 11 Rich Aromatic
Hydrocarbons, and C11 12 Rich Aromatic Hydrocarbons for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
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........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Based on structure-activity relationship (SAR) analysis and structural
alerts, not expected to be carcinogenic.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. PAD = population adjusted dose (a =
acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human
(interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to C9 rich aromatic hydrocarbons, C10-11
rich aromatic hydrocarbons, and C11-12 rich aromatic
hydrocarbons, EPA considered exposure under the proposed exemption from
the requirement of a tolerance. EPA assessed dietary exposures from
C9 rich aromatic hydrocarbons, C10-11 rich
aromatic hydrocarbons, and C11-12 rich aromatic hydrocarbons
in food as follows:
i. Acute and Chronic Exposure. In conducting the acute and chronic
dietary exposure assessment for C9 rich aromatic
hydrocarbons, C10-11 rich aromatic hydrocarbons, and
C11-12 rich aromatic hydrocarbons, EPA used food consumption
information from the U.S. Department of Agriculture (USDA) National
Health and Nutrition Examination Survey, What We Eat in America
(NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. As
to residue levels in food, no residue data were submitted for
C9 rich aromatic hydrocarbons, C10-11 rich
aromatic hydrocarbons, and C11-12 rich aromatic
hydrocarbons. In the absence of specific residue data, EPA has
developed an approach which uses surrogate information to derive upper
bound exposure estimates for the subject inert ingredients. Upper-bound
exposure estimates are based on the highest tolerance for a given
commodity from a list of high-use insecticides, herbicides, and
fungicides. A complete description of the general approach taken to
assess inert ingredient risks in the absence of residue data can be
found at http://www.regulations.gov in the document ``Alkyl Amines
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and
Drinking Water) Dietary Exposure and Risk
[[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 http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data available to EPA support the choice of
a different factor.
2. Prenatal and postnatal sensitivity. The available mammalian
toxicology database for C9 rich aromatic hydrocarbons,
C10-11 rich aromatic hydrocarbons, and C11-12
rich aromatic hydrocarbons is complete with respect to assessing
increased susceptibility to infants and children. There were no adverse
effects on the offspring of rats following prenatal and postnatal
exposure in the developmental toxicity study at the highest dose tested
of 450 mg/kg/day. In a 3-generation inhalation toxicity study in rats,
reproductive effects were seen only at dose levels above that at which
parental effects were noted.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for C9 rich aromatic
hydrocarbons, C10-11 rich aromatic hydrocarbons, and
C11-12 rich aromatic hydrocarbons is complete, except for an
immunotoxicity study. However, there is no evidence of immune system
involvement in the available toxicity database for C9 rich
aromatic hydrocarbons, C10-11 rich aromatic hydrocarbons,
and C11-12 rich aromatic hydrocarbons. Therefore, EPA has
determined that an additional uncertainty factor is not needed to
account for the lack of this study.
ii. There is no indication that C9 rich aromatic
hydrocarbons, C10-11 rich aromatic hydrocarbons, and
C11-12 rich aromatic hydrocarbons are neurotoxic chemicals,
as there were no neurotoxic effects observed at the highest dose tested
in a 90-day inhalation neurotoxicity study in rats with a C9
aromatic hydrocarbon material. Given the similar physicochemical and
toxicological properties of the hydrocarbons assessed for this rule,
EPA concludes that C10-11 and C11-12 rich
aromatic hydrocarbons would demonstrate a similar lack of neurotoxic
effects; therefore, there is no need for a developmental neurotoxicity
study or additional UFs to account for neurotoxicity.
iii. There is no evidence that C9 rich aromatic
hydrocarbons, C10-11 rich aromatic hydrocarbons, and
C11-12 rich aromatic hydrocarbons result in increased
susceptibility in in utero rats in the prenatal developmental studies
or in young rats in a 3-generation reproduction study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 percent crop treated (PCT) and reasonable
[[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