Cumene Sulfonic Acid and Its Ammonium, Calcium, Magnesium, Potassium, Sodium and Zinc Salts; Exemption From the Requirement of a Tolerance, 27021-27027 [2017-12238]
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Federal Register / Vol. 82, No. 112 / Tuesday, June 13, 2017 / Rules and Regulations
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Approved by:
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[FR Doc. 2017–12114 Filed 6–12–17; 8:45 am]
BILLING CODE 1410–72–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2013–0467; FRL–9961–68]
Cumene Sulfonic Acid and Its
Ammonium, Calcium, Magnesium,
Potassium, Sodium and Zinc Salts;
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 cumene
sulfonic acid and its ammonium,
calcium, magnesium, potassium,
sodium and zinc salts when used as an
inert ingredient (surfactants, related
adjuvants of surfactants) in pesticide
formulations applied to growing crops
and to animals. Huntsman
Petrochemical LLC submitted a petition
to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), requesting
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SUMMARY:
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establishment of an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of cumene sulfonic acid and
its ammonium, calcium, magnesium,
potassium, sodium and zinc salts when
applied or used under these conditions.
DATES: This regulation is effective June
13, 2017. Objections and requests for
hearings must be received on or before
August 14, 2017, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2013–0467, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
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).
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27021
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
www.ecfr.gov/cgi-bin/textidx?&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–2013–0467 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 14, 2017. 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–
2013–0467, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
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IV. Aggregate Risk Assessment and
Determination of Safety
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 cumene sulfonic
acid and its ammonium, calcium,
magnesium, potassium, sodium and
zinc salts including exposure resulting
from the exemption established by this
action. EPA’s assessment of exposures
and risks associated with cumene
sulfonic acid and its ammonium,
calcium, magnesium, potassium,
sodium and zinc salts follows.
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
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.
II. Petition for Exemption
In the Federal Register of July 19,
2013 (78 FR 43115) (FRL–9392–9), EPA
issued a document pursuant to FFDCA
section 408, 21 U.S.C. 346a, announcing
the filing of a pesticide petition (PP IN–
10565) by Huntsman Corp., 8600
Gosling Rd., The Woodlands, TX 77381.
The petition requested that 40 CFR
180.920 and 180.930 be amended by
establishing an exemption from the
requirement of a tolerance for residues
of cumene sulfonic acid and its
ammonium, calcium, magnesium,
potassium, sodium and zinc salts (CAS
Reg. Nos. 15763–76–5, 16066–35–6,
164524–02–1, 28085–69–0, 28348–53–0,
28631–63–2, 32073–22–6, 37475–88–0,
37953–05–2, and 90959–88–9) when
used as an inert ingredient (surfactant,
related adjuvants of surfactants) in
pesticide formulations applied to
growing crops and to animals. That
document referenced a summary of the
petition prepared by Huntsman Corp.,
the petitioner, which is available in the
docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
III. Inert Ingredient Definition
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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.
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The toxicity of cumene sulfonic acid
and its ammonium, calcium,
magnesium, potassium, sodium and
zinc salts was considered in an October
2005 health assessment performed by
the Organization for Economic
Cooperation and Development (OECD)
in the Screening Information Data Set
(SIDS) Initial Assessment Profile (SIAP)
for the Hydrotropes Category.
The hydrotropes category covers
‘‘toluene sulfonic acid, sodium salt,’’
‘‘xylene sulfonic acid, sodium salt’’ and
‘‘cumene sulfonic acid, sodium salt.’’
This category also includes isomeric
forms (ortho, meta, and/or para) of the
respective sulfonic acid salts (sodium,
ammonium, calcium and potassium).
OECD notes that the hydrotropes
category may be initially considered as
three sub-groups: The methyl, dimethyl
and methylethyl benzene sulfonates, (or
the toluene, xylene and cumene
sulfonates). Although the counter ion
will also determine the physical and
chemical behavior of the compounds,
the chemical reactivity and
classification for this purpose is not
expected to be affected by the difference
in counter ion. The structures as well as
the physical/chemical and toxicological
properties of these chemical entities are
essentially the same. The three
subgroups are expected to be generally
comparable and predictable in their
chemical behavior (as such or in
solution) and that members from one
subgroup may be useful for
interpolations across to other subgroups
and to the hydrotropes category in
general. Therefore, on this basis, data on
other members of the hydrotrope
category can be used in a ‘read across’
fashion to determine the toxicity of
cumene sulfonic acid and its
ammonium, calcium, magnesium,
potassium, sodium and zinc salts
Cumene sulfonic acid and its salts
and the structurally related hydrotropes
are categorized as having low acute
toxicity via the oral, dermal, and
inhalation. They are not dermal irritants
or dermal sensitizers and are considered
slight eye irritants.
Several subchronic studies via the
oral route for hydrotropes are available
in the database. In two 14-day toxicity
studies in mice and rats with sodium
xylene sulfonate, no significant
treatment related toxicity was observed
at doses up to 4% in the diet
(approximately 4,000 mg/kg/day) in
mice. In rats, there were some
mortalities which were not observed in
a dose-related manner as well as losses
of body weight that were attributable to
palatability of the test article. These
effects were not considered as adverse
findings. In a repeat study in rats,
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mortality was not observed at doses up
to 4% in the diet. A 90-day subchronic
toxicity study conducted in Wistar rats
with doses of sodium xylene sulfonate
up to 5% in the diet. A decrease in
relative spleen weight in females, along
with some clinical chemistry and
hematology changes were observed at
the highest dose (3,454 mg/kg/day). In a
separate 90-day toxicity study in rats
and mice, no treatment related effects
were observed in mice and rats given
sodium xylene sulfonate in the diet at
2% (approximately 2,439 and 2,467 mg/
kg/day in mice and rats, respectively).
In a 90-day dietary toxicity study with
sodium cumene sulfonate in Wistar rats,
no evidence of systemic toxicity was
observed at doses up to 0.5% in the diet,
equivalent to 114 mg/kg/day (corrected
for purity of the test substance). Dermal
toxicity studies for 17 days and 90 days
duration were conducted in mice and
rats. No systemic toxicity was observed
in mice and rats exposed dermally to
sodium xylene sulfonate at doses up to
1,620 and 500 mg/kg/day in mice and
rats, respectively. The results of a 2-year
dermal toxicity study showed no
evidence of skin neoplasms or any other
neoplasms at doses up to 727 and 240
mg/kg/day in mice and rats,
respectively.
Hydrotropes were tested for their
mutagenic potential in various in vivo
and in vitro genotoxicity assays. Sodium
xylene sulfonate gave a negative
response in a mouse lymphoma assay,
the Ames assay, Sister Chromatid
Exchange assay, (positive at cytotoxic
concentrations only), a Chromosome
Aberration Test and three mouse
micronucleus assays. Calcium xylene
sulfonate and sodium cumene sulfonate
were negative for mutagenicity in the
Ames test. No evidence of tumors were
observed in mice and rats treated
dermally with sodium xylene sulfonate
for two years at doses of 0, 60, 120 and
240 mg/kg/day for rats and 0, 182, 364
and 727 mg/kg/day for mice.
No reproductive toxicity studies are
available for the hydrotropes, although
available oral and dermal toxicity
studies with various hydrotropes
included examination of reproductive
organs of both sexes. The OECD SIDS
assessment included reviews of a 91-day
oral rat feeding study with sodium
cumene sulfonate, a 90-day feeding
study with sodium xylene sulfonate
(mice and rats) and the 2-year dermal
studies with sodium xylene sulfonate
(in mice and rats) which included
examination of the reproductive organs
of both sexes. There was no evidence
from these studies to suggest that
hydrotropes would have an adverse
effect on reproductive organs by either
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the oral or dermal route. No
developmental toxicity studies in rats
and rabbits are available in the cumene
sulfonic acid and its salts. However, a
developmental study in rats is available
for a surrogate hydrotrope, calcium
xylene sulfonate. In this study the
NOAEL for maternal and fetal toxicity
was the highest dose tested, 3,000 mg/
kg/day (936 mg/kg/day, corrected for
purity of test material). Based on this
information, there is no evidence to
consider cumene sulfonic acid and its
salts as being developmental toxicants.
Specific information on the studies
received and the nature of the adverse
effects caused by cumene sulfonic acid
and its salts and the other members of
the hydrotrupes category as well as the
no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document,
‘‘Decision Document for Petition
Number 1E7936; sodium xylene
sulfonate Human Health Risk and
Ecological Effects Assessments for
Proposed Exemption from the
Requirement of a Tolerance When Used
as Inert Ingredients in Pesticide
Formulations.’’ at pp. 8–14 in docket ID
number EPA–HQ–OPP–2011–0951
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://
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27023
www.epa.gov/pesticides/factsheets/
riskassess.htm.
No endpoint of concern following a
single dose was identified in the
available database. The Agency
identified a NOAEL of 763 mg/kg/day
for systemic toxicity, which was
selected from an oral subchronic study.
Effects observed in this study were a
decrease in spleen weight in females
along with some clinical chemistry and
hematology changes at the LOAEL of
3,454 mg/kg/day. No adverse effects
were reported in males. This study was
used for chronic dietary exposure
assessment. An uncertainty factor of
100X is applied (10X for interspecies
extrapolation and 10X for intraspecies
variability). For several reasons, no
additional uncertainty factor is
necessary for the use of subchronic
study data for chronic exposure
assessment. First there was a wide dose
spread between the toxic effects seen at
the LOAEL of 3,454 mg/kg/day and the
NOAEL of 763 mg/kg/day. Second, the
changes observed in clinical chemistry
and hematological parameters were
small in magnitude and no effects on
organs were observed in the study.
Therefore, the changes observed were
not considered toxicologically
significant. Finally, the NOAEL in a
separate 90-day study in rats was 2,467
mg/kg/day indicating the lower NOAEL
value in the selected study is an artifact
of dose selection. Therefore, EPA
concluded that there is no need to retain
an additional uncertainty factor for use
of a short-term study for long-term
exposure assessment.
Based on the physicochemical data
and lack of systemic toxicity in the
available dermal toxicity studies, EPA
concluded that there is no need to
conduct quantitative dermal risk
exposure assessment.
No data are available on the
inhalation toxicity of cumene sulfonic
acid and its salts, however, as a solid
with an extremely low vapor pressure
and a particle size that is not in the
respirable range, the likelihood of
significant inhalation exposure to the
inert ingredient as a gas, vapor, or
aerosol is negligible.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to cumene sulfonic acid and
its salts, EPA considered exposure
under the proposed exemption from the
requirement of a tolerance for use as an
inert ingredient in pesticide
formulations applied to growing crops
and animals under the proposed
exemptions from the requirement of a
tolerance given at 40 CFR 180.920 and
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40 CFR 180.930. EPA assessed dietary
exposures from cumene sulfonic acid
and its salts in food as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide
chemical, if a toxicological study has
indicated the possibility of an effect of
concern occurring as a result of a oneday or single exposure. No such effects
were identified in the toxicological
studies for cumene sulfonic acid and its
salts, therefore, a quantitative acute
dietary exposure assessment is
unnecessary.
ii. Chronic exposure. The chronic
dietary exposure assessment for this
inert ingredient utilizes the Dietary
Exposure Evaluation Model Food
Commodity Intake Database (DEEM–
FCID), Version 3.16, which includes
food consumption information from the
U.S. Department of Agriculture’s
National Health and Nutrition
Examination Survey, ‘‘What We Eat In
America’’, (NHANES/WWEIA). This
dietary survey was conducted from 2003
to 2008. In the absence of actual residue
data, the inert ingredient evaluation is
based on a highly conservative model
which assumes that the residue level of
the inert ingredient would be no higher
than the highest established tolerance
for an active ingredient on a given
commodity. Implicit in this assumption
is that there would be similar rates of
degradation between the active and
inert ingredient (if any) 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 model assumes 100 percent crop
treated (PCT) for all crops and that every
food eaten by a person each day has
tolerance-level residues. A complete
description of the general approach
taken to assess inert ingredient risks in
the absence of residue data is contained
in the memorandum entitled ‘‘Alkyl
Amines Polyalkoxylates (Cluster 4):
Acute and Chronic Aggregate (Food and
Drinking Water) Dietary Exposure and
Risk Assessments for the Inerts.’’
(D361707, S. Piper, 2/25/09) and can be
found at https://www.regulations.gov in
docket ID number EPA–HQ–OPP–2008–
0738.
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 cumene
sulfonic acid and its salts, a
conservative drinking water
concentration value of 100 ppb based on
screening level modeling was used to
assess the contribution to drinking
water for the chronic dietary risk
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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 nonoccupational, non-dietary exposure
(e.g., textiles (clothing and diapers),
carpets, swimming pools, and hard
surface disinfection on walls, floors,
tables).
Cumene sulfonic acid and its salts
may be used as inert ingredient in
pesticide products that are registered for
specific uses that may result in indoor
or outdoor residential inhalation and
dermal exposures. A screening-level
residential exposure and risk
assessment was completed utilizing
conservative residential exposure
assumptions. The Agency assessed
short- and intermediate-term exposures
for residential handlers that would
result from low pressure handwand,
hose end sprayer and trigger sprayer for
outdoor scenarios of each pesticide
type, herbicide, insecticide and
fungicide and mopping, wiping and
aerosol sprays for indoor scenarios. The
Agency assessed post-application shortterm dermal exposure for children and
adults as well as short-term hand-tomouth exposure for children from
contact with treated lawns.
Cumene sulfonic acid and its salts
may also be used as a component of
personal care products. The OECD SIDS
assessment estimated highest human
exposures resulting from personal care
product use. These exposure estimates
ranged from 0.02–0.14 mg/kg/day for
shampoos and hair conditioners to
0.11–0.17 mg/kg/day for liquid face and
hand soaps. Exposure estimates for
cleaning product use and residuals on
clothing range from 0.01–0.08 mg/kg/
day. All exposure evaluations included
conservative (protective) input
assumptions (e.g., all modeled human
exposures are conservative due to the
use of a default assumption of 100%
absorption). However, the
physicochemical data and available
toxicological data suggest that dermal
absorption is likely to be minimal.
Based on the lack of concern for dermal
toxicity and the low estimates of
residential exposure via the oral, dermal
or inhalation routes of exposure, a
quantitative residential risk assessment
was not performed.
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
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pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found cumene sulfonic
acid and its salts to share a common
mechanism of toxicity with any other
substances, and cumene sulfonic acid
and its salts do not appear to produce
a toxic metabolite produced by other
substances. While there are other
chemicals belonging to the cumene
sulfonic acid and its salts class of
chemicals (i.e., the ‘‘hydrotropes’’
category) that may have a similar
toxicity profile, this does not necessarily
mean that all such chemicals share a
common mechanism of toxicity;
therefore, EPA has not assumed that
cumene sulfonic acid and its salts have
a common mechanism of toxicity with
other substances. In any event, EPA
believes that these chemicals will be
used as an alternative to cumene
sulfonic acid and its salts rather than in
conjunction with cumene sulfonic acid
and its salts and would not likely cooccur. Even if they did, the cPAD for
pesticidal uses occupies only 7% of the
cPAD for the general population and
any potential increase in exposure to
this class of chemicals will still be
below any levels of concern. 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.
There are no reproductive toxicity
studies reported for cumene sulfonic
acid and its salts. However, no effects
on reproductive organs were observed at
very high doses in number of studies
such as a 91-day oral rat feeding study
with sodium cumene sulfonate, the 90day feeding study with sodium xylene
sulfonate, and the 2-year dermal studies
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with sodium xylene sulfonate. Based on
the above evidence, EPA concluded that
cumene sulfonic acid and its salts are
not likely to be a reproductive toxicant.
This conclusion is in agreement with
the OECD conclusion that there is no
evidence to suggest that cumene
sulfonic acid and its salts would have
an adverse effect on reproductive
organs.
In a developmental toxicity study in
rats with calcium xylene sulfonate, no
maternal or developmental effects were
observed at doses of 3,000 mg/kg/day
(equal to 936 mg/kg/day corrected for
purity of test material).
There is no evidence of prenatal or
postnatal sensitivity as a result of
exposure to sodium xylene sulfonate.
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. Available studies included several
90-day toxicity studies via oral and
dermal routes, chronic studies,
mutagenicity battery, a developmental
study in rats and metabolism studies.
These studies provide an adequate
characterization of cumene sulfonic acid
and its salts toxicity.
ii. There is no indication that cumene
sulfonic acid and its salts is a
neurotoxic chemical and there is no
need for a developmental neurotoxicity
study or additional UFs to account for
neurotoxicity.
iii. No reproductive toxicity study or
developmental toxicity study are
available for cumene sulfonic acid and
its salts. However, the concern for
increased susceptibility of infants and
children exposure to cumene sulfonic
acid and its salts are low because no
effects on reproductive parameters were
observed in various oral toxicity studies
and the developmental toxicity in rats
for surrogate chemical show lack of
systemic toxicity at doses up to 936 mg/
kg/day (as discussed under Unit
IV.D.2.).
iv. No evidence of immunotoxicity
was observed in the database except
slightly decreased in spleen weight was
observed at the LOAEL of 3,454 mg/kg/
day. There are no concerns for
immunotoxicity and an immunotoxicity
study is not required because the slight
decreases in spleen weights were
observed at high doses without any
evidence of histopathological findings.
v. No additional uncertainty factor is
needed for the use of subchronic study
data for chronic exposure assessment.
The rational for this decision is
provided in Unit IV.B.
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vi. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100% CT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground water and surface water
modeling used to assess exposure to
sodium xylene sulfonate in drinking
water. EPA used similarly conservative
assumptions to assess post-application
exposure of children as well as
incidental oral exposure of toddlers.
These assessments will not
underestimate the exposure and risks
posed by cumene sulfonic acid and its
salts.
E. Aggregate Risks and Determination of
Safety
Determination of safety section. 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. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. No adverse effect resulting from
a single oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, cumene sulfonic
acid and its salts is 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 cumene
sulfonic acid and its salts from food and
water under the proposed uses will
utilize 7% of the cPAD for the U.S.
population and 26% of the cPAD for
children 1–2 years old, the population
subgroup receiving the greatest
exposure.
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 relative to residential exposure
was not identified. Short-term risk is
assessed based on short-term residential
exposure plus chronic dietary exposure.
Because there are no short-term
residential dermal exposure effects of
concern and chronic dietary exposure
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27025
has already been assessed under the
appropriately protective cPAD (which is
at least as protective as a POD that
would be 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 cumene
sulfonic acid and its salts.
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 relative
to residential exposure was not
identified. Intermediate-term risk is
assessed based on intermediate-term
residential exposure plus chronic
dietary exposure. Because there are no
adverse effects identified for
intermediate-term residential exposure
and chronic dietary exposure has
already been assessed under the
appropriately protective cPAD (which is
at least as protective as a POD that
would be used to assess intermediateterm risk), no further assessment of
intermediate-term risk is necessary, and
EPA relies on the chronic dietary risk
assessment for evaluating intermediateterm risk for cumene sulfonic acid and
its salts.
5. Aggregate cancer risk for U.S.
population. Based upon no evidence of
carcinogenicity in two adequate rodent
carcinogenicity studies via the dermal
route of exposure, negative response for
mutagenicity in a battery of genotoxicity
tests, and lack of any structural alerts for
carcinogenicity, cumene sulfonic acid
and its salts 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 residues of
cumene sulfonic acid and its
ammonium, calcium, magnesium,
potassium, sodium and zinc salts.
V. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is not establishing a numerical
tolerance for residues of cumene
sulfonic acid and its ammonium,
calcium, magnesium, potassium,
sodium and zinc salts.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under 40 CFR 180.920 and 180.930 for
cumene sulfonic acid and its
ammonium, calcium, magnesium,
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potassium, sodium and zinc salts (CAS
Reg. Nos. 15763–76–5, 16066–35–6,
164524–02–1, 28085–69–0, 28348–53–0,
28631–63–2, 32073–22–6, 37475–88–0,
37953–05–2, and 90959–88–9) when
used as an inert ingredient (surfactant,
related adjuvant of surfactant in
pesticide formulations applied to
growing crops and animals.
VII. Statutory and Executive Order
Reviews
This action establishes exemptions
from the requirement of a tolerance
under FFDCA section 408(d) in
response to a petition 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 action
has been exempted from review under
Executive Order 12866, this action 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 action 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 exemption 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 action 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 action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (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
(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: April 27, 2017.
Michael Goodis,
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, add alphabetically the
inert ingredient to the table to read as
follows:
■
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
*
*
*
*
*
Inert ingredients
Limits
Uses
*
*
*
*
Cumene sulfonic acid and its ammonium, calcium, magnesium, potassium, sodium
and zinc salts (CAS Reg. Nos. 15763–76–5, 16066–35–6, 164524–02–1, 28085–
69–0, 28348–53–0, 28631–63–2, 32073–22–6, 37475–88–0, 37953–05–2, and
90959–88–9).
*
........................
*
*
Surfactant, related adjuvant of surfactant.
*
*
*
3. In § 180.930, add alphabetically the
inert ingredient to the table to read as
follows:
■
*
*
*
*
§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
*
*
*
*
*
nlaroche on DSK30NT082PROD with RULES
Inert ingredients
Limits
Uses
*
*
*
*
Cumene sulfonic acid and its ammonium, calcium, magnesium, potassium, sodium
and zinc salts (CAS Reg. Nos. 15763–76–5, 16066–35–6, 164524–02–1, 28085–
69–0, 28348–53–0, 28631–63–2, 32073–22–6, 37475–88–0, 37953–05–2, and
90959–88–9).
*
........................
*
*
Surfactant, related adjuvant of surfactant.
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Federal Register / Vol. 82, No. 112 / Tuesday, June 13, 2017 / Rules and Regulations
Inert ingredients
*
*
*
[FR Doc. 2017–12238 Filed 6–12–17; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 648
[Docket No. 161118999–7280–02]
RIN 0648–XF409
Fisheries of the Northeastern United
States; Atlantic Sea Scallop Fishery;
Closure of the Elephant Trunk Flex
Access Area to General Category
Individual Fishing Quota Scallop
Vessels
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; closure.
AGENCY:
NMFS announces that the
Elephant Trunk Flex Scallop Access
Area will close to Limited Access
General Category Individual Fishing
Quota scallop vessels for the remainder
of the 2017 fishing year as of the
effective date below. After the effective
date, no vessel issued a Limited Access
General Category Individual Fishing
Quota permit may fish for, possess, or
land scallops from the Elephant Trunk
Flex Scallop Access Area. Regulations
require this action once it is projected
that 100 percent of trips allocated to the
Limited Access General Category
Individual Fishing Quota scallop vessels
for the Elephant Trunk Flex Scallop
Access Area will be taken.
DATES: Effective 0001 hr local time, June
12, 2017, through March 31, 2018.
FOR FURTHER INFORMATION CONTACT:
Shannah Jaburek, Fishery Management
Specialist, (978) 282–8456.
SUPPLEMENTARY INFORMATION: The reader
can find regulations governing fishing
activity in the Sea Scallop Access Areas
in 50 CFR 648.59 and 648.60. These
regulations authorize vessels issued a
nlaroche on DSK30NT082PROD with RULES
SUMMARY:
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Limits
Jkt 241001
*
*
valid Limited Access General Category
(LAGC) Individual Fishing Quota (IFQ)
scallop permit to fish in the Elephant
Trunk Flex Scallop Access Area under
specific conditions, including a total of
697 trips that may be taken by LAGC
IFQ vessels during the 2017 fishing
year. Section 648.59(g)(3)(iii) requires
the Elephant Trunk Flex Scallop Access
Area to be closed to LAGC IFQ
permitted vessels for the remainder of
the fishing year once the NMFS Greater
Atlantic Regional Administrator
determines that the allowed number of
trips for fishing year 2017 are projected
to be taken.
Based on trip declarations by LAGC
IFQ scallop vessels fishing in the
Elephant Trunk Flex Scallop Access
Area, and analysis of fishing effort,
NMFS projects that 697 trips will be
taken as of June 12, 2017. Therefore, in
accordance with § 648.59(g)(3)(iii),
NMFS is closing the Elephant Trunk
Flex Scallop Access Area to all LAGC
IFQ scallop vessels as of June 12, 2017.
No vessel issued an LAGC IFQ permit
may fish for, possess, or land scallops in
or from the Elephant Trunk Flex Scallop
Access Area after 0001 local time, June
12, 2017. Any LAGC IFQ vessel that has
declared into the Elephant Trunk Flex
Access Area scallop fishery, complied
with all trip notification and observer
requirements, and crossed the vessel
monitoring system demarcation line on
the way to the area before 0001, June 12,
2017, may complete its trip. This
closure is in effect for the remainder of
the 2017 scallop fishing year.
Classification
This action is required by 50 CFR part
648 and is exempt from review under
Executive Order 12866.
NMFS finds good cause pursuant to 5
U.S.C. 553(b)(B) to waive prior notice
and the opportunity for public comment
because it would be contrary to the
public interest and impracticable. The
Elephant Trunk Flex Access Area
opened for the 2017 fishing year on
March 23, 2017. The regulations at
§ 648.59(g)(3)(iii) require this closure to
ensure that LAGC IFQ scallop vessels do
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Uses
Sfmt 9990
*
*
not take more than their allocated
number of trips in the Elephant Trunk
Flex Scallop Access Area. The
projections of the date on which the
LAGC IFQ fleet will have taken all of its
allocated trips in an Access Area
become apparent only as trips into the
area occur on a real-time basis and as
activity trends begin to appear. As a
result, NMFS can only make an accurate
projection very close in time to when
the fleet has taken all of its trips. In
order to propose a closure for purposes
of receiving prior public comment,
NMFS would need to make a projection
based on very little information, which
would result in a closure too early or too
late. To allow LAGC IFQ scallop vessels
to continue to take trips in the Elephant
Trunk Flex Scallop Access Area during
the period necessary to publish and
receive comments on a proposed rule
would likely result in vessels taking
much more than the allowed number of
trips in the Elephant Trunk Flex Scallop
Access Area. Excessive trips and harvest
from the Elephant Trunk Flex Scallop
Access Area would result in excessive
fishing effort in the area, where effort
controls are critical, thereby
undermining conservation objectives of
the Atlantic Sea Scallop Fishery
Management Plan and requiring more
restrictive future management measures.
Also, the public had prior notice and
full opportunity to comment on this
closure process when we put these
provisions in place. Current regulations
prohibit LAGC IFQ scallop vessels from
fishing for, possessing, or landing
scallops from this area after the effective
date of this notification published in the
Federal Register. NMFS further finds,
pursuant to 5 U.S.C 553(d)(3), good
cause to waive the 30-day delayed
effectiveness period for the reasons
stated above.
Authority: 16 U.S.C. 1801 et seq.
Dated: June 8, 2017.
Margo B. Schulze-Haugen,
Acting Deputy Director, Office of Sustainable
Fisheries, National Marine Fisheries Service.
[FR Doc. 2017–12182 Filed 6–9–17; 8:45 am]
BILLING CODE 3510–22–P
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Agencies
[Federal Register Volume 82, Number 112 (Tuesday, June 13, 2017)]
[Rules and Regulations]
[Pages 27021-27027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12238]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2013-0467; FRL-9961-68]
Cumene Sulfonic Acid and Its Ammonium, Calcium, Magnesium,
Potassium, Sodium and Zinc Salts; 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 cumene sulfonic acid and its ammonium,
calcium, magnesium, potassium, sodium and zinc salts when used as an
inert ingredient (surfactants, related adjuvants of surfactants) in
pesticide formulations applied to growing crops and to animals.
Huntsman Petrochemical LLC 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 cumene sulfonic acid and its ammonium, calcium, magnesium,
potassium, sodium and zinc salts when applied or used under these
conditions.
DATES: This regulation is effective June 13, 2017. Objections and
requests for hearings must be received on or before August 14, 2017,
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-2013-0467, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_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-2013-0467 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 14, 2017. 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-2013-0467, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
[[Page 27022]]
II. Petition for Exemption
In the Federal Register of July 19, 2013 (78 FR 43115) (FRL-9392-
9), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-10565) by
Huntsman Corp., 8600 Gosling Rd., The Woodlands, TX 77381. The petition
requested that 40 CFR 180.920 and 180.930 be amended by establishing an
exemption from the requirement of a tolerance for residues of cumene
sulfonic acid and its ammonium, calcium, magnesium, potassium, sodium
and zinc salts (CAS Reg. Nos. 15763-76-5, 16066-35-6, 164524-02-1,
28085-69-0, 28348-53-0, 28631-63-2, 32073-22-6, 37475-88-0, 37953-05-2,
and 90959-88-9) when used as an inert ingredient (surfactant, related
adjuvants of surfactants) in pesticide formulations applied to growing
crops and to animals. That document referenced a summary of the
petition prepared by Huntsman Corp., the petitioner, which is available
in the docket, https://www.regulations.gov. There were no comments
received in response to the notice 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 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 cumene sulfonic acid and its
ammonium, calcium, magnesium, potassium, sodium and zinc salts
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with cumene
sulfonic acid and its ammonium, calcium, magnesium, potassium, sodium
and zinc salts 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.
The toxicity of cumene sulfonic acid and its ammonium, calcium,
magnesium, potassium, sodium and zinc salts was considered in an
October 2005 health assessment performed by the Organization for
Economic Cooperation and Development (OECD) in the Screening
Information Data Set (SIDS) Initial Assessment Profile (SIAP) for the
Hydrotropes Category.
The hydrotropes category covers ``toluene sulfonic acid, sodium
salt,'' ``xylene sulfonic acid, sodium salt'' and ``cumene sulfonic
acid, sodium salt.'' This category also includes isomeric forms (ortho,
meta, and/or para) of the respective sulfonic acid salts (sodium,
ammonium, calcium and potassium). OECD notes that the hydrotropes
category may be initially considered as three sub-groups: The methyl,
dimethyl and methylethyl benzene sulfonates, (or the toluene, xylene
and cumene sulfonates). Although the counter ion will also determine
the physical and chemical behavior of the compounds, the chemical
reactivity and classification for this purpose is not expected to be
affected by the difference in counter ion. The structures as well as
the physical/chemical and toxicological properties of these chemical
entities are essentially the same. The three subgroups are expected to
be generally comparable and predictable in their chemical behavior (as
such or in solution) and that members from one subgroup may be useful
for interpolations across to other subgroups and to the hydrotropes
category in general. Therefore, on this basis, data on other members of
the hydrotrope category can be used in a `read across' fashion to
determine the toxicity of cumene sulfonic acid and its ammonium,
calcium, magnesium, potassium, sodium and zinc salts
Cumene sulfonic acid and its salts and the structurally related
hydrotropes are categorized as having low acute toxicity via the oral,
dermal, and inhalation. They are not dermal irritants or dermal
sensitizers and are considered slight eye irritants.
Several subchronic studies via the oral route for hydrotropes are
available in the database. In two 14-day toxicity studies in mice and
rats with sodium xylene sulfonate, no significant treatment related
toxicity was observed at doses up to 4% in the diet (approximately
4,000 mg/kg/day) in mice. In rats, there were some mortalities which
were not observed in a dose-related manner as well as losses of body
weight that were attributable to palatability of the test article.
These effects were not considered as adverse findings. In a repeat
study in rats,
[[Page 27023]]
mortality was not observed at doses up to 4% in the diet. A 90-day
subchronic toxicity study conducted in Wistar rats with doses of sodium
xylene sulfonate up to 5% in the diet. A decrease in relative spleen
weight in females, along with some clinical chemistry and hematology
changes were observed at the highest dose (3,454 mg/kg/day). In a
separate 90-day toxicity study in rats and mice, no treatment related
effects were observed in mice and rats given sodium xylene sulfonate in
the diet at 2% (approximately 2,439 and 2,467 mg/kg/day in mice and
rats, respectively). In a 90-day dietary toxicity study with sodium
cumene sulfonate in Wistar rats, no evidence of systemic toxicity was
observed at doses up to 0.5% in the diet, equivalent to 114 mg/kg/day
(corrected for purity of the test substance). Dermal toxicity studies
for 17 days and 90 days duration were conducted in mice and rats. No
systemic toxicity was observed in mice and rats exposed dermally to
sodium xylene sulfonate at doses up to 1,620 and 500 mg/kg/day in mice
and rats, respectively. The results of a 2-year dermal toxicity study
showed no evidence of skin neoplasms or any other neoplasms at doses up
to 727 and 240 mg/kg/day in mice and rats, respectively.
Hydrotropes were tested for their mutagenic potential in various in
vivo and in vitro genotoxicity assays. Sodium xylene sulfonate gave a
negative response in a mouse lymphoma assay, the Ames assay, Sister
Chromatid Exchange assay, (positive at cytotoxic concentrations only),
a Chromosome Aberration Test and three mouse micronucleus assays.
Calcium xylene sulfonate and sodium cumene sulfonate were negative for
mutagenicity in the Ames test. No evidence of tumors were observed in
mice and rats treated dermally with sodium xylene sulfonate for two
years at doses of 0, 60, 120 and 240 mg/kg/day for rats and 0, 182, 364
and 727 mg/kg/day for mice.
No reproductive toxicity studies are available for the hydrotropes,
although available oral and dermal toxicity studies with various
hydrotropes included examination of reproductive organs of both sexes.
The OECD SIDS assessment included reviews of a 91-day oral rat feeding
study with sodium cumene sulfonate, a 90-day feeding study with sodium
xylene sulfonate (mice and rats) and the 2-year dermal studies with
sodium xylene sulfonate (in mice and rats) which included examination
of the reproductive organs of both sexes. There was no evidence from
these studies to suggest that hydrotropes would have an adverse effect
on reproductive organs by either the oral or dermal route. No
developmental toxicity studies in rats and rabbits are available in the
cumene sulfonic acid and its salts. However, a developmental study in
rats is available for a surrogate hydrotrope, calcium xylene sulfonate.
In this study the NOAEL for maternal and fetal toxicity was the highest
dose tested, 3,000 mg/kg/day (936 mg/kg/day, corrected for purity of
test material). Based on this information, there is no evidence to
consider cumene sulfonic acid and its salts as being developmental
toxicants.
Specific information on the studies received and the nature of the
adverse effects caused by cumene sulfonic acid and its salts and the
other members of the hydrotrupes category 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 document, ``Decision Document for Petition
Number 1E7936; sodium xylene sulfonate Human Health Risk and Ecological
Effects Assessments for Proposed Exemption from the Requirement of a
Tolerance When Used as Inert Ingredients in Pesticide Formulations.''
at pp. 8-14 in docket ID number EPA-HQ-OPP-2011-0951
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.
No endpoint of concern following a single dose was identified in
the available database. The Agency identified a NOAEL of 763 mg/kg/day
for systemic toxicity, which was selected from an oral subchronic
study. Effects observed in this study were a decrease in spleen weight
in females along with some clinical chemistry and hematology changes at
the LOAEL of 3,454 mg/kg/day. No adverse effects were reported in
males. This study was used for chronic dietary exposure assessment. An
uncertainty factor of 100X is applied (10X for interspecies
extrapolation and 10X for intraspecies variability). For several
reasons, no additional uncertainty factor is necessary for the use of
subchronic study data for chronic exposure assessment. First there was
a wide dose spread between the toxic effects seen at the LOAEL of 3,454
mg/kg/day and the NOAEL of 763 mg/kg/day. Second, the changes observed
in clinical chemistry and hematological parameters were small in
magnitude and no effects on organs were observed in the study.
Therefore, the changes observed were not considered toxicologically
significant. Finally, the NOAEL in a separate 90-day study in rats was
2,467 mg/kg/day indicating the lower NOAEL value in the selected study
is an artifact of dose selection. Therefore, EPA concluded that there
is no need to retain an additional uncertainty factor for use of a
short-term study for long-term exposure assessment.
Based on the physicochemical data and lack of systemic toxicity in
the available dermal toxicity studies, EPA concluded that there is no
need to conduct quantitative dermal risk exposure assessment.
No data are available on the inhalation toxicity of cumene sulfonic
acid and its salts, however, as a solid with an extremely low vapor
pressure and a particle size that is not in the respirable range, the
likelihood of significant inhalation exposure to the inert ingredient
as a gas, vapor, or aerosol is negligible.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cumene sulfonic acid and its salts, EPA considered exposure
under the proposed exemption from the requirement of a tolerance for
use as an inert ingredient in pesticide formulations applied to growing
crops and animals under the proposed exemptions from the requirement of
a tolerance given at 40 CFR 180.920 and
[[Page 27024]]
40 CFR 180.930. EPA assessed dietary exposures from cumene sulfonic
acid and its salts in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide chemical, if a
toxicological study has indicated the possibility of an effect of
concern occurring as a result of a one-day or single exposure. No such
effects were identified in the toxicological studies for cumene
sulfonic acid and its salts, therefore, a quantitative acute dietary
exposure assessment is unnecessary.
ii. Chronic exposure. The chronic dietary exposure assessment for
this inert ingredient utilizes the Dietary Exposure Evaluation Model
Food Commodity Intake Database (DEEM-FCID), Version 3.16, which
includes food consumption information from the U.S. Department of
Agriculture's National Health and Nutrition Examination Survey, ``What
We Eat In America'', (NHANES/WWEIA). This dietary survey was conducted
from 2003 to 2008. In the absence of actual residue data, the inert
ingredient evaluation is based on a highly conservative model which
assumes that the residue level of the inert ingredient would be no
higher than the highest established tolerance for an active ingredient
on a given commodity. Implicit in this assumption is that there would
be similar rates of degradation between the active and inert ingredient
(if any) 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 model assumes 100
percent crop treated (PCT) for all crops and that every food eaten by a
person each day has tolerance-level residues. A complete description of
the general approach taken to assess inert ingredient risks in the
absence of residue data is contained in the memorandum entitled ``Alkyl
Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food
and Drinking Water) Dietary Exposure and Risk Assessments for the
Inerts.'' (D361707, S. Piper, 2/25/09) and can be found at https://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.
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 cumene sulfonic acid
and its salts, a conservative drinking water concentration value of 100
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).
Cumene sulfonic acid and its salts may be used as inert ingredient
in pesticide products that are registered for specific uses that may
result in indoor or outdoor residential inhalation and dermal
exposures. A screening-level residential exposure and risk assessment
was completed utilizing conservative residential exposure assumptions.
The Agency assessed short- and intermediate-term exposures for
residential handlers that would result from low pressure handwand, hose
end sprayer and trigger sprayer for outdoor scenarios of each pesticide
type, herbicide, insecticide and fungicide and mopping, wiping and
aerosol sprays for indoor scenarios. The Agency assessed post-
application short-term dermal exposure for children and adults as well
as short-term hand-to-mouth exposure for children from contact with
treated lawns.
Cumene sulfonic acid and its salts may also be used as a component
of personal care products. The OECD SIDS assessment estimated highest
human exposures resulting from personal care product use. These
exposure estimates ranged from 0.02-0.14 mg/kg/day for shampoos and
hair conditioners to 0.11-0.17 mg/kg/day for liquid face and hand
soaps. Exposure estimates for cleaning product use and residuals on
clothing range from 0.01-0.08 mg/kg/day. All exposure evaluations
included conservative (protective) input assumptions (e.g., all modeled
human exposures are conservative due to the use of a default assumption
of 100% absorption). However, the physicochemical data and available
toxicological data suggest that dermal absorption is likely to be
minimal. Based on the lack of concern for dermal toxicity and the low
estimates of residential exposure via the oral, dermal or inhalation
routes of exposure, a quantitative residential risk assessment was not
performed.
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 cumene sulfonic acid and its salts to share a
common mechanism of toxicity with any other substances, and cumene
sulfonic acid and its salts do not appear to produce a toxic metabolite
produced by other substances. While there are other chemicals belonging
to the cumene sulfonic acid and its salts class of chemicals (i.e., the
``hydrotropes'' category) that may have a similar toxicity profile,
this does not necessarily mean that all such chemicals share a common
mechanism of toxicity; therefore, EPA has not assumed that cumene
sulfonic acid and its salts have a common mechanism of toxicity with
other substances. In any event, EPA believes that these chemicals will
be used as an alternative to cumene sulfonic acid and its salts rather
than in conjunction with cumene sulfonic acid and its salts and would
not likely co-occur. Even if they did, the cPAD for pesticidal uses
occupies only 7% of the cPAD for the general population and any
potential increase in exposure to this class of chemicals will still be
below any levels of concern. 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. There are no reproductive
toxicity studies reported for cumene sulfonic acid and its salts.
However, no effects on reproductive organs were observed at very high
doses in number of studies such as a 91-day oral rat feeding study with
sodium cumene sulfonate, the 90-day feeding study with sodium xylene
sulfonate, and the 2-year dermal studies
[[Page 27025]]
with sodium xylene sulfonate. Based on the above evidence, EPA
concluded that cumene sulfonic acid and its salts are not likely to be
a reproductive toxicant. This conclusion is in agreement with the OECD
conclusion that there is no evidence to suggest that cumene sulfonic
acid and its salts would have an adverse effect on reproductive organs.
In a developmental toxicity study in rats with calcium xylene
sulfonate, no maternal or developmental effects were observed at doses
of 3,000 mg/kg/day (equal to 936 mg/kg/day corrected for purity of test
material).
There is no evidence of prenatal or postnatal sensitivity as a
result of exposure to sodium xylene sulfonate.
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. Available studies included several 90-day toxicity studies via
oral and dermal routes, chronic studies, mutagenicity battery, a
developmental study in rats and metabolism studies. These studies
provide an adequate characterization of cumene sulfonic acid and its
salts toxicity.
ii. There is no indication that cumene sulfonic acid and its salts
is a neurotoxic chemical and there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
iii. No reproductive toxicity study or developmental toxicity study
are available for cumene sulfonic acid and its salts. However, the
concern for increased susceptibility of infants and children exposure
to cumene sulfonic acid and its salts are low because no effects on
reproductive parameters were observed in various oral toxicity studies
and the developmental toxicity in rats for surrogate chemical show lack
of systemic toxicity at doses up to 936 mg/kg/day (as discussed under
Unit IV.D.2.).
iv. No evidence of immunotoxicity was observed in the database
except slightly decreased in spleen weight was observed at the LOAEL of
3,454 mg/kg/day. There are no concerns for immunotoxicity and an
immunotoxicity study is not required because the slight decreases in
spleen weights were observed at high doses without any evidence of
histopathological findings.
v. No additional uncertainty factor is needed for the use of
subchronic study data for chronic exposure assessment. The rational for
this decision is provided in Unit IV.B.
vi. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground water and surface water modeling
used to assess exposure to sodium xylene sulfonate in drinking water.
EPA used similarly conservative assumptions to assess post-application
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by cumene sulfonic acid and its salts.
E. Aggregate Risks and Determination of Safety
Determination of safety section. 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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
cumene sulfonic acid and its salts is 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
cumene sulfonic acid and its salts from food and water under the
proposed uses will utilize 7% of the cPAD for the U.S. population and
26% of the cPAD for children 1-2 years old, the population subgroup
receiving the greatest exposure.
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 relative to residential exposure was not identified.
Short-term risk is assessed based on short-term residential exposure
plus chronic dietary exposure. Because there are no short-term
residential dermal exposure effects of concern and chronic dietary
exposure has already been assessed under the appropriately protective
cPAD (which is at least as protective as a POD that would be 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 cumene sulfonic acid and its salts.
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 relative to residential
exposure was not identified. Intermediate-term risk is assessed based
on intermediate-term residential exposure plus chronic dietary
exposure. Because there are no adverse effects identified for
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as a POD that would be 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 cumene sulfonic
acid and its salts.
5. Aggregate cancer risk for U.S. population. Based upon no
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies via the dermal route of exposure, negative response for
mutagenicity in a battery of genotoxicity tests, and lack of any
structural alerts for carcinogenicity, cumene sulfonic acid and its
salts 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 residues of cumene sulfonic acid and its ammonium, calcium,
magnesium, potassium, sodium and zinc salts.
V. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
cumene sulfonic acid and its ammonium, calcium, magnesium, potassium,
sodium and zinc salts.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 and 180.930 for cumene sulfonic acid
and its ammonium, calcium, magnesium,
[[Page 27026]]
potassium, sodium and zinc salts (CAS Reg. Nos. 15763-76-5, 16066-35-6,
164524-02-1, 28085-69-0, 28348-53-0, 28631-63-2, 32073-22-6, 37475-88-
0, 37953-05-2, and 90959-88-9) when used as an inert ingredient
(surfactant, related adjuvant of surfactant in pesticide formulations
applied to growing crops and animals.
VII. Statutory and Executive Order Reviews
This action establishes exemptions from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
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 action has been exempted from review
under Executive Order 12866, this action 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 action 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 exemption 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 action 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(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 (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: April 27, 2017.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
0
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. 180.920, add alphabetically the inert ingredient to the
table to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Cumene sulfonic acid and its .............. Surfactant, related
ammonium, calcium, magnesium, adjuvant of
potassium, sodium and zinc salts surfactant.
(CAS Reg. Nos. 15763-76-5, 16066-
35-6, 164524-02-1, 28085-69-0,
28348-53-0, 28631-63-2, 32073-22-
6, 37475-88-0, 37953-05-2, and
90959-88-9).
* * * * * * *
------------------------------------------------------------------------
0
3. In Sec. 180.930, add alphabetically the inert ingredient to the
table to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Cumene sulfonic acid and its .............. Surfactant, related
ammonium, calcium, magnesium, adjuvant of
potassium, sodium and zinc salts surfactant.
(CAS Reg. Nos. 15763-76-5, 16066-
35-6, 164524-02-1, 28085-69-0,
28348-53-0, 28631-63-2, 32073-22-
6, 37475-88-0, 37953-05-2, and
90959-88-9).
[[Page 27027]]
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2017-12238 Filed 6-12-17; 8:45 am]
BILLING CODE 6560-50-P