Document ID: EPA-HQ-OPP-2013-0467-0004
Agency: epa
Document Type: Rule
Title: Tolerance Exemptions: Cumene Sulfonic Acid and Its Ammonium, Calcium, Magnesium, Potassium, Sodium and Zinc Salts
Posted Date: 2017-06-13T04:00Z

[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]

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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.

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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 http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 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 http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-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: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

[[Page 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, http://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 http://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 http://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 http://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 http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. 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]]

 
 
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[FR Doc. 2017-12238 Filed 6-12-17; 8:45 am]
 BILLING CODE 6560-50-P