C9, 36356-36362 [2011-15269]
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Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Rules and Regulations
the Agency has determined that this
action will not have a substantial direct
effect on States or Tribal governments,
on the relationship between the national
government and the States or Tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
Tribes. Thus, the Agency has
determined that Executive Order 13132,
entitled Federalism (64 FR 43255,
August 10, 1999) and Executive Order
13175, entitled Consultation and
Coordination with Indian Tribal
Governments (65 FR 67249, November
9, 2000) do not apply to this final rule.
In addition, this final rule does not
impose any enforceable duty or contain
any unfunded mandate as described
under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L.
104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VIII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Inert ingredients
*
Without limitation ................
*
*
*
[FR Doc. 2011–15266 Filed 6–21–11; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2011–0517; FRL–8876–2]
C9 Rich Aromatic Hydrocarbons,
C10–11 Rich Aromatic Hydrocarbons,
and C11–12 Rich Aromatic
Hydrocarbons; Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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
SUMMARY:
jlentini on DSK4TPTVN1PROD with RULES
Dated: June 10, 2011.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.920, the table is amended
by adding alphabetically the following
inert ingredient:
■
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
*
*
*
*
Limits
*
*
*
Diethylene Glycol MonoEthyl Ether (CAS Reg. No. 111–
90–0).
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
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*
Uses
*
*
Solvent, stabilizer and/or antifreeze.
*
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 https://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.
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*
*
*
*
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Kerry Leifer, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–8811; e-mail address:
leifer.kerry@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
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• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
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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.gpoaccess.gov/ecfr. To access the
harmonized test guidelines referenced
in this document electronically, please
go to https://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:
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• Federal eRulemaking Portal: https://
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, https://
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
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diatomaceous earth; thickeners such as
carrageenan and modified cellulose;
wetting, spreading, and dispersing
agents; propellants in aerosol
dispensers; microencapsulating agents;
and emulsifiers. The term ‘‘inert’’ is not
intended to imply nontoxicity; the
ingredient may or may not be
chemically active. Generally, EPA has
exempted inert ingredients from the
requirement of a tolerance based on the
low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and
Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue * * *.’’
EPA establishes exemptions from the
requirement of a tolerance only in those
cases where it can be clearly
demonstrated that the risks from
aggregate exposure to pesticide
chemical residues under reasonably
foreseeable circumstances will pose no
appreciable risks to human health. In
order to determine the risks from
aggregate exposure to pesticide inert
ingredients, the Agency considers the
toxicity of the inert in conjunction with
possible exposure to residues of the
inert ingredient through food, drinking
water, and through other exposures that
occur as a result of pesticide use in
residential settings. If EPA is able to
determine that a finite tolerance is not
necessary to ensure that there is a
reasonable certainty that no harm will
result from aggregate exposure to the
inert ingredient, an exemption from the
requirement of a tolerance may be
established.
Consistent with section 408(c)(2)(A)
of FFDCA, and the factors specified in
FFDCA section 408(c)(2)(B), EPA has
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reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for C9 rich aromatic
hydrocarbons, C10–11 rich aromatic
hydrocarbons, and C11–12 rich aromatic
hydrocarbons, including exposure
resulting from the exemption
established by this action. EPA’s
assessment of exposures and risks
associated with C9 rich aromatic
hydrocarbons, C10–11 rich aromatic
hydrocarbons, and C11–12 rich aromatic
hydrocarbons follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered their
validity, completeness, and reliability as
well as the relationship of the results of
the studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children.
C9 rich aromatic hydrocarbons, C10–11
rich aromatic hydrocarbons, and C11–12
rich aromatic hydrocarbons are products
of the petroleum distillation and
refining process. These substances are
various fractions of aromatic petroleum
hydrocarbons with specific boiling
point ranges and flash points. Each of
the substances is comprised of a
complex mixture of aromatic
hydrocarbon molecules in the range of
9 to 12 carbon atoms. Since C9 rich
aromatic hydrocarbons, C10–11 rich
aromatic hydrocarbons, and C11–12 rich
aromatic hydrocarbons differ only in the
proportions of the various hydrocarbon
molecules within the C9 to C12 range,
they have similar physicochemical and
toxicological properties and have
therefore been assessed together.
C9 rich aromatic hydrocarbons, C10–11
rich aromatic hydrocarbons, and C11–12
rich aromatic hydrocarbons exhibit low
acute toxicity by oral, inhalation and
dermal routes (toxicity Category III or IV
by all exposure routes). They are
minimally irritating to eyes and skin
and negative for dermal sensitization
effects. Subchronic oral and inhalation
toxicity studies indicate these
substances to be relatively non-toxic.
Reversible effects to the liver, thyroid,
stomach, spleen, and urinary bladder
were reported at mid and high doses in
a subchronic oral toxicity study in rats.
A developmental inhalation study in
mice indicates no evidence of
developmental effects or any adverse
effects in maternal animals at dose
levels below 715 milligrams/kilogram/
day (mg/kg/day). An oral developmental
study in rats indicates maternal effects
(decreased body weight gain and food
consumption) at the mid-dose (150 mg/
kg/day) but no developmental effects at
the highest dose tested (450 mg/kg/day).
An inhalation reproduction study in rats
indicates reduced body weight gain in
parents and offspring at mid and high
doses (715 and 2,145 mg/kg/day). Based
on neurotoxicity studies, C9 rich
aromatic hydrocarbons, C10–11 rich
aromatic hydrocarbons, and C11–12 rich
aromatic hydrocarbons are not expected
to cause any nervous system damage.
Due to their complex, multi-constituent
nature, there are no substance-specific
absorption, metabolism, distribution
and excretion studies done specifically
on C9 rich aromatic hydrocarbons, C10–11
rich aromatic hydrocarbons, and C11–12
rich aromatic hydrocarbons. However,
sufficient metabolism data are available
on other aromatic hydrocarbons to show
that as a class they are typically wellabsorbed, widely distributed between
tissues, extensively metabolized and
rapidly excreted. C9 rich aromatic
hydrocarbons, C10–11 rich aromatic
hydrocarbons, and C11–12 rich aromatic
hydrocarbons are of low toxicological
concern for developmental and
reproductive effects, based on the
available toxicity data, and are not
expected to be carcinogenic.
Specific information on the studies
received and the nature of the adverse
effects caused by C9 rich aromatic
hydrocarbons, C10–11 rich aromatic
hydrocarbons, and C11–12 rich aromatic
hydrocarbons as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at 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 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 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 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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Exposure/scenario
Point of departure and
uncertainty/safety factors
RfD, PAD, LOC for risk
assessment
Study and toxicological effects
Acute dietary (All populations) .......
NOAEL = 150 mg/kg/day .............
UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 1.5 mg/kg/day ..........
aPAD = 1.5 mg/kg/day
OCSPP Harmonized Test Guideline 870.3700 Prenatal Developmental Toxicity Study in Rats
Maternal LOAEL = 450 mg/kg/
day based on decreased body
weight gain and decreased food
consumption.
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36359
TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR C9, C10–11, AND C11–12 RICH AROMATIC
HYDROCARBONS FOR USE IN HUMAN RISK ASSESSMENT—Continued
Exposure/scenario
Point of departure and
uncertainty/safety factors
RfD, PAD, LOC for risk
assessment
Study and toxicological effects
Chronic dietary (All populations) ....
NOAEL= 150 mg/kg/day ...............
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD = 1.5 mg/kg/day .......
cPAD = 1.5 mg/kg/day
OCSPP Harmonized Test Guideline 870.3700 Prenatal Developmental Toxicity Study in Rats
Maternal LOAEL = 450 mg/kg/
day based on decreased body
weight gain and decreased food
consumption
Cancer (Oral, dermal, inhalation) ..
Based on structure-activity relationship (SAR) analysis and structural alerts, not expected to be carcinogenic.
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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 https://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
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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
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the highest tolerance level, i.e., EPA
assumed 100 percent of all foods are
treated with the inert ingredient at the
rate and manner necessary to produce
the highest residue legally possible for
an active ingredient. In summary, EPA
chose a very conservative method for
estimating what level of inert residue
could be on food, and then used this
methodology to choose the highest
possible residue that could be found on
food and assumed that all food
contained this residue. No consideration
was given to potential degradation
between harvest and consumption even
though monitoring data shows that
tolerance level residues are typically
one to two orders of magnitude higher
than actual residues in food when
distributed in commerce.
Accordingly, although sufficient
information to quantify actual residue
levels in food is not available, the
compounding of these conservative
assumptions will lead to a significant
exaggeration of actual exposures. EPA
does not believe that this approach
underestimates exposure in the absence
of residue data.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
for C9 rich aromatic hydrocarbons,
C10–11 rich aromatic hydrocarbons, and
C11–12 rich aromatic hydrocarbons, EPA
used food consumption information
from the U.S. Department of Agriculture
(USDA) 1994–1996 and 1998
Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII). As to
residue levels in food, no residue data
were submitted for C9 rich aromatic
hydrocarbons, C10–11 rich aromatic
hydrocarbons, and C11–12 rich aromatic
hydrocarbons. In the absence of specific
residue data, EPA has developed an
approach which uses surrogate
information to derive upper bound
chronic dietary exposure estimates for
the subject inert ingredient. This
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approach is as described in Unit IV.
C.1.i.
iii. Cancer. The Agency used a
qualitative structure activity
relationship (SAR) database, DEREK11,
to determine if there were structural
alerts suggestive of carcinogenicity. No
structural alerts for carcinogenicity were
identified. Therefore, a cancer dietary
exposure assessment is not necessary to
assess cancer risk.
2. Dietary exposure from drinking
water. For the purpose of the screening
level dietary risk assessment to support
this request for an exemption from the
requirement of a tolerance for C9 rich
aromatic hydrocarbons, C10–11 rich
aromatic hydrocarbons, and C11–12 rich
aromatic hydrocarbons, a conservative
drinking water concentration value of
100 parts per billion (ppb) based on
screening level modeling was used to
assess the contribution to drinking
water for the chronic dietary risk
assessments. These values were directly
entered into the dietary exposure model.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., textiles (clothing and diapers),
carpets, swimming pools, and hard
surface disinfection on walls, floors,
tables).
C9 rich aromatic hydrocarbons, C10–11
rich aromatic hydrocarbons, and C11–12
rich aromatic hydrocarbons are not
currently used as inert ingredients in
pesticide products that are registered for
any use patterns that involve residential
uses nor are there any other nonpesticidal residential uses for these inert
ingredients, thus no residential
exposures to C9 rich aromatic
hydrocarbons, C10–11 rich aromatic
hydrocarbons, and C11–12 rich aromatic
hydrocarbons are expected. The primary
non-pesticidal uses of C9 rich aromatic
hydrocarbons, C10–11 rich aromatic
hydrocarbons, and C11–12 rich aromatic
hydrocarbons are as gasoline additives.
Residential exposures to these
substances as a result of their use as
gasoline additives could occur via
inhalation during refueling and from
potential transport of gasoline
containing C9 rich aromatic
hydrocarbons, C10–11 rich aromatic
hydrocarbons, and C11–12 rich aromatic
hydrocarbons into groundwater. There
are no reliable data upon which to
quantitatively assess such exposures to
C9 rich aromatic hydrocarbons, C10–11
rich aromatic hydrocarbons, and C11–12
rich aromatic hydrocarbons; however,
modeled data for other gasoline
additives suggest that inhalation
exposures would be at levels of <5
micrograms/kilogram/day, and that
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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 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 (10×) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10×, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
The available mammalian toxicology
database for C9 rich aromatic
hydrocarbons, C10–11 rich aromatic
hydrocarbons, and C11–12 rich aromatic
hydrocarbons is complete with respect
to assessing increased susceptibility to
infants and children. There were no
adverse effects on the offspring of rats
following prenatal and postnatal
exposure in the OCSPP Harmonized
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Test Guideline 870.3700 oral
developmental toxicity study at the
highest dose tested of 450 mg/kg/day. In
a 3-generation inhalation toxicity study
in rats, reproductive effects were seen
only at dose levels above that at which
parental effects were noted.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1×. That decision is
based on the following findings:
i. The toxicity database for C9 rich
aromatic hydrocarbons, C10–11 rich
aromatic hydrocarbons, and C11–12 rich
aromatic hydrocarbons is largely
complete, missing only a developmental
neurotoxicity study and an
immunotoxicity study. EPA has
determined that an additional
uncertainty factor is not needed to
account for the lack of these studies for
the following reasons:
• There were no neurotoxic effects
observed at the highest dose tested in a
90-day inhalation neurotoxicity study in
rats with a C9 aromatic hydrocarbon
material. There is no evidence that C9
rich aromatic hydrocarbons, C10–11 rich
aromatic hydrocarbons, and C11–12 rich
aromatic hydrocarbons are neurotoxic
chemicals and there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity.
• There is no evidence that C9 rich
aromatic hydrocarbons, C10–11 rich
aromatic hydrocarbons, and C11–12 rich
aromatic hydrocarbons result in
increased susceptibility in in utero rats
in the prenatal developmental studies or
in young rats in a 3-generation
reproduction study.
• An immunotoxicity study is not
available; however, there is no evidence
of immune system involvement in the
available toxicity database for C9 rich
aromatic hydrocarbons, C10–11 rich
aromatic hydrocarbons, and C11–12 rich
aromatic hydrocarbons, therefore, there
is no need to add additional UFs to
account for the lack of an
immunotoxicity study.
ii. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100 percent
crop treated (PCT) and tolerance-level
residues. EPA made conservative
(protective) assumptions in the ground
and surface water modeling used to
assess exposure to C9 rich aromatic
hydrocarbons, C10–11 rich aromatic
hydrocarbons, and C11–12 rich aromatic
hydrocarbons in drinking water. These
assessments will not underestimate the
exposure and risks posed by C9 rich
aromatic hydrocarbons, C10–11 rich
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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
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short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level). A short-term adverse
effect was identified; however, C9 rich
aromatic hydrocarbons, C10–11 rich
aromatic hydrocarbons, and C11–12 rich
aromatic hydrocarbons are not currently
used as inert ingredients in pesticide
products that are registered for any use
patterns that would result in short-term
residential exposure. Short-term risk is
assessed based on short-term residential
exposure plus chronic dietary exposure.
Because there is no short-term
residential exposure and chronic dietary
exposure has already been assessed
under the appropriately protective
cPAD (which is at least as protective as
the POD used to assess short-term risk),
no further assessment of short-term risk
is necessary, and EPA relies on the
chronic dietary risk assessment for
evaluating short-term risk for C9 rich
aromatic hydrocarbons, C10–11 rich
aromatic hydrocarbons, and C11–12 rich
aromatic hydrocarbons. As noted in
Unit IV.C.3., there may be short-term
inhalation exposures to C9 rich aromatic
hydrocarbons, C10–11 rich aromatic
hydrocarbons, and C11–12 rich aromatic
hydrocarbons when these substance are
present as gasoline additives during
gasoline refueling, however those
exposures would be expected to be at
levels at least three orders of magnitude
below any level of concern and
therefore have not been included in a
quantitative short-term risk assessment.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level). An
intermediate-term adverse effect was
identified; however, C9 rich aromatic
hydrocarbons, C10–11 rich aromatic
hydrocarbons, and C11–12 rich aromatic
hydrocarbons are not currently used as
inert ingredients in pesticide products
that are registered for any use patterns
that would result in intermediate-term
residential exposure. Intermediate-term
risk is assessed based on intermediateterm residential exposure plus chronic
dietary exposure. Because there is no
intermediate-term residential exposure
and chronic dietary exposure has
already been assessed under the
appropriately protective cPAD (which is
at least as protective as the POD used to
assess intermediate-term risk), no
further assessment of intermediate-term
risk is necessary, and EPA relies on the
chronic dietary risk assessment for
evaluating intermediate-term risk for C9
rich aromatic hydrocarbons, C10–11 rich
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36361
aromatic hydrocarbons, and C11–12 rich
aromatic hydrocarbons.
5. Aggregate cancer risk for U.S.
population. The Agency has not
identified any concerns for
carcinogenicity relating to C9 rich
aromatic hydrocarbons, C10–11 rich
aromatic hydrocarbons, and C11–12 rich
aromatic hydrocarbons and C9 rich
aromatic hydrocarbons, C10–11 rich
aromatic hydrocarbons, and C11–12 rich
aromatic hydrocarbons are not expected
to pose a cancer risk to humans.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to C9 rich
aromatic hydrocarbons, C10–11 rich
aromatic hydrocarbons, and C11–12 rich
aromatic hydrocarbons residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is establishing an exemption
from the requirement of a tolerance
without any numerical limitation.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint U.N.
Food and Agriculture Organization/
World Health Organization food
standards program, and it is recognized
as an international food safety
standards-setting organization in trade
agreements to which the United States
is a party. EPA may establish a tolerance
that is different from a Codex MRL;
however, FFDCA section 408(b)(4)
requires that EPA explain the reasons
for departing from the Codex level.
The Codex has not established MRLs
for C9 rich aromatic hydrocarbons,
C10–11 rich aromatic hydrocarbons, and
C11–12 rich aromatic hydrocarbons.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under 40 CFR 180. 910 for residues of
C9 rich aromatic hydrocarbons (CAS
Reg. No. 64742–95–6), C10–11 rich
aromatic hydrocarbons (CAS Reg. No.
64742–94–5), and C11–12 rich aromatic
hydrocarbons (CAS Reg. No. 64742–94–
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5) when used as inert ingredients in
pesticide formulations applied to
growing crops or to raw agricultural
commodities after harvest.
VII. Statutory and Executive Order
Reviews
This final rule establishes exemptions
from tolerance under section 408(d) of
FFDCA in response to petitions
submitted to the Agency. The Office of
Management and Budget (OMB) has
exempted these types of actions from
review under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993).
Because this final rule has been
exempted from review under Executive
Order 12866, this final rule is not
subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the exemptions in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or Tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or Tribal governments,
on the relationship between the national
government and the States or Tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
Tribes. Thus, the Agency has
determined that Executive Order 13132,
entitled Federalism (64 FR 43255,
August 10, 1999) and Executive Order
13175, entitled Consultation and
Coordination with Indian Tribal
Governments (65 FR 67249, November
9, 2000) do not apply to this final rule.
In addition, this final rule does not
impose any enforceable duty or contain
any unfunded mandate as described
under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L.
104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VIII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: June 10, 2011.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.910 the table is amended
by adding alphabetically the following
inert ingredients to read as follows:
■
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
*
*
*
*
*
Inert ingredients
Limits
*
*
*
*
*
*
C9 rich aromatic hydrocarbons (CAS Reg. No. 64742–95–6) .............................................................................................
..................
*
Solvent.
*
*
*
*
*
*
C10–11 rich aromatic hydrocarbons (CAS Reg. No. 64742–94–5) .......................................................................................
..................
*
Solvent.
*
*
*
*
*
*
C11–12 rich aromatic hydrocarbons (CAS Reg. No. 64742–94–5) .......................................................................................
..................
*
Solvent.
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]]>Agencies
[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]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0517; FRL-8876-2]
C9 Rich Aromatic Hydrocarbons, C10-11 Rich Aromatic Hydrocarbons,
and C11-12 Rich Aromatic Hydrocarbons; Exemption From the Requirement
of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of C9 rich aromatic
hydrocarbons; C10-11 rich aromatic hydrocarbons; and
C11-12 rich aromatic hydrocarbons, when used as inert
ingredients in pesticide formulations applied to growing crops or to
raw agricultural commodities after harvest. ExxonMobil Chemical Company
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of C9 rich aromatic
hydrocarbons, C10-11 rich aromatic hydrocarbons, and
C11-12 rich aromatic hydrocarbons.
DATES: This regulation is effective June 22, 2011. Objections and
requests for hearings must be received on or before August 22, 2011,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2011-0517. All documents in the
docket are listed in the docket index available at https://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 https://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 https://www.gpoaccess.gov/ecfr. To access the harmonized test guidelines
referenced in this document electronically, please go to https://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: https://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, https://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 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 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 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 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
----------------------------------------------------------------------------------------------------------------
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 https://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 <5 micrograms/
kilogram/day, and that levels in groundwater would not exceed 0.2-16
ppb.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.
EPA has not found C9 rich aromatic hydrocarbons,
C10-11 rich aromatic hydrocarbons, and C11-12
rich aromatic hydrocarbons to share a common mechanism of toxicity with
any other substances, and C9 rich aromatic hydrocarbons,
C10-11 rich aromatic hydrocarbons, and C11-12
rich aromatic hydrocarbons does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that C9 rich
aromatic hydrocarbons, C10-11 rich aromatic hydrocarbons,
and C11-12 rich aromatic hydrocarbons do not have a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's Web site at 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 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
