
[Federal Register Volume 80, Number 145 (Wednesday, July 29, 2015)]
[Rules and Regulations]
[Pages 45079-45085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18610]



[[Page 45079]]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0325; FRL-9930-22]


Ethanesulfonic Acid, 2-hydroxy and the Corresponding Ammonium, 
Sodium, Potassium, Calcium, Magnesium, 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 ethanesulfonic acid, 2-hydroxy- (CAS 
Reg. No. 107-36-8); ethanesulfonic acid, 2-hydroxy-, ammonium salt (CAS 
Reg. No. 57267-78-4); ethanesulfonic acid, 2-hydroxy-, sodium salt (CAS 
Reg. No. 1562-00-1); ethanesulfonic acid, 2-hydroxy-, potassium salt 
(CAS Reg. No. 1561-99-5); ethanesulfonic acid, 2-hydroxy-, calcium salt 
(CAS Reg. No. 10550-47-7); ethanesulfonic acid, 2-hydroxy-, magnesium 
salt (CAS Reg. No. 17345-56-1), and ethanesulfonic acid, 2-hydroxy-, 
zinc salt (CAS Reg. No. 129756-32-7) when used as inert ingredients 
(chelator, sequestrant and conditioning agent) in pesticide 
formulations applied to growing crops and raw agricultural commodities 
after harvest and applied to animals. Technology Sciences Group Inc. 
(1150 18th St. NW., Suite 1000 Washington, DC 20036) on behalf of 
Huntsman Corporation (8600 Gosling Rd., The Woodlands, TX 77381) 
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 ethanesulfonic 
acid, 2-hydroxy- and its corresponding ammonium, sodium, potassium, 
calcium, magnesium, and zinc salts.

DATES: This regulation is effective July 29, 2015. Objections and 
requests for hearings must be received on or before September 28, 2015, 
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-2014-0325, 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: Susan Lewis, 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. To access the OCSPP test guidelines referenced in this 
document electronically, please go to http://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.''

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2014-0325 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 
September 28, 2015. 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-2014-0325, 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.

II. Petition for Exemption

    In the Federal Register of August 1, 2014 (79 FR 44729) (FRL-9911-
67), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-10684) by 
Technology Sciences Group Inc. (1150 18th St. NW., Suite 1000, 
Washington, DC 20036) on behalf of Huntsman Corporation (8600 Gosling 
Rd., The Woodlands, TX 77381). The petition requested that 40 CFR 
180.910 and 40 CFR 180.930 be amended by establishing an exemption from 
the requirement of a tolerance for residues of ethanesulfonic acid, 2-
hydroxy- (CAS Reg. No. 107-36-8); ethanesulfonic acid, 2-hydroxy-, 
ammonium salt (CAS Reg. No. 57267-78-4); ethanesulfonic acid, 2-
hydroxy-, sodium salt (CAS Reg. No. 1562-00-1);

[[Page 45080]]

ethanesulfonic acid, 2-hydroxy-, potassium salt (CAS Reg. No. 1561-99-
5); ethanesulfonic acid, 2-hydroxy-, calcium salt (CAS Reg. No. 10550-
47-7); ethanesulfonic acid, 2-hydroxy-, magnesium salt (CAS Reg. No. 
17345-56-1), and ethanesulfonic acid, 2-hydroxy-, zinc salt (CAS Reg. 
No. 129756-32-7) when used as inert ingredients (chelator, sequestrant, 
and conditioning agent) in pesticide formulations applied to growing 
crops and raw agricultural commodities after harvest and applied to 
animals in accordance with 40 CFR 180.910 and 180.930, respectively. 
That document referenced a summary of the petition prepared by 
Technology Sciences Group Inc., 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 ethanesulfonic acid, 2-hydroxy 
and the corresponding ammonium, sodium, potassium, calcium, magnesium, 
and zinc salts (also referred to as isethionic acid and its salts) 
including exposure resulting from the exemption established by this 
action. EPA's assessment of exposures and risks associated with 
isethionic acid and its 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. Specific information on the studies received and the nature 
of the adverse effects caused by isethionic acid and its salts as well 
as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies are 
discussed in this unit.
    Isethionate salts are expected to metabolize and dissociate into 
isethionic acid in the body. Therefore, toxicity for each of the 
isethionate salt forms are expected to have equal toxicity and share 
similar physical and chemical characteristics. Studies on isethionic 
acid or any one of its salt can be considered relevant for the entire 
group.
    The acute oral toxicity of isethionic acid ammonium salt is low. 
The acute oral lethal dose (LD)50 in rats were > 1,000 
milligram/kilogram/body weight (mg/kg-bw). The acute dermal toxicity in 
rats was > 1,000 mg/kg-bw. Ammonium isethionate is a minimal eye 
irritant based on a primary eye irritation study in rabbits. Ammonium 
isethionate is not dermally irritating based on a primary skin 
irritation study in rabbits. Ammonium isethionate has an acute 
inhalation lethal concentration (LC)50 > 6.295 milligram/
liter (mg/L) and is not a dermal sensitizer.
    In a 90-day oral toxicity study on rats via gavage with sodium 
isethionate, decreased mean corpuscular hemoglobin concentration, 
increased mean absolute and relative reticulocyte counts, increased 
spleen weights and microscopic changes in the liver, bile duct, and 
spleen were observed at 1,000 milligram/kilogram/day (mg/kg/day) 
(LOAEL). Effects showed complete reversal after exposure was 
discontinued. The NOAEL for sodium isethionate was identified in this 
study as 200 mg/kg/day.
    In an OSCPP Harmonized Test Guideline 870.3650 combined repeated 
dose toxicity study with the reproduction/developmental toxicity 
screening test, ammonium isethionate was administered to rats by 
gavage. The parental systemic LOAEL for ammonium isethionate is 500 mg/
kg/day based on absolute and relative kidney weights and relative 
adrenal weights, and the parental systemic NOAEL is 250 mg/kg/day. The 
reproductive/developmental LOAEL for ammonium isethionate in rats was 
not identified, and the reproductive/developmental NOAEL is greater 
than or equal to 500 mg/kg/day.
    Ammonium isethionate was negative for mutagenicity or chromosomal 
aberrations in a battery of tests of genotoxicity including a reverse 
gene mutation assay in bacteria, an in vitro mammalian cell gene 
mutation test using mouse lymphoma cells and an in vitro mammalian cell 
micronucleus test.
    The OncoLogicTM structure-activity model was used to 
evaluate the likelihood that isethionic acid and its salts may cause 
cancer. Structure-activity modeling using Oncologic

[[Page 45081]]

indicates that isethionic acid does not contain structural alerts of 
potential concern for carcinogenicity. Based on the negative results 
for genotoxicity as well as the structure-activity model for 
carcinogenicity there is a low concern for isethionic acid and its 
salts as potential carcinogens.
    No neurotoxicity studies were available in the database for 
isethionic acid and its salts. However, a functional observational 
battery (FOB) and locomotor activity patterns were evaluated in the 
combined reproduction/developmental toxicity screening test and 90-day 
oral toxicity study. No alterations in the FOB or locomotor activity 
patterns were observed.
    No Immunotoxicity studies on isethionic acid and its salts were 
available in the database. Increased spleen weights and microscopic 
changes in the spleen were observed in the 90-day toxicity study in 
rats; however, the chronic reference dose (cRfD) is based on this study 
and is protective of these effects.
    No metabolism studies were available in the database for isethionic 
acid and its salts.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which the NOAEL and the LOAEL are identified. 
Uncertainty/safety factors are used in conjunction with the POD to 
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of 
exposure (MOE). For non-threshold risks, the Agency assumes that any 
amount of exposure will lead to some degree of risk. Thus, the Agency 
estimates risk in terms of the probability of an occurrence of the 
adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for isethionic acid and 
its salts used for human risk assessment is shown in Table 1 of this 
unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Isethionic Acid and Its Salts for Use in Human Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50          An acute effect was not found in the database therefore an acute dietary
 years of age).                                             assessment is not necessary.
                                  ------------------------------------------------------------------------------
Acute dietary (General population     An acute effect was not found in the database therefore an acute dietary
 including infants and children).                           assessment is not necessary.
                                  ------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 200 mg/kg/    Chronic RfD = 200    90-day oral toxicity-rat LOAEL =
                                    day.                  mg/kg/day.           1,000 mg/kg/day based on
                                   UFA = 10x...........  cPAD = 2.0 mg/kg/     decreased body weight, changes in
                                   UFH = 10x...........   day.                 hematology parameters, increased
                                   FQPA SF = 1x........                        spleen weights, macroscopic
                                                                               changes in the liver and
                                                                               microscopic changes in the liver,
                                                                               bile duct and spleen.
Incidental oral short-term (1 to   NOAEL = 200 mg/kg/    LOC for MOE = 100..  90-day oral toxicity-rat LOAEL =
 30 days).                          day.                                       1,000 mg/kg/day based on
                                   UFA = 10x...........                        decreased body weight, changes in
                                   UFH = 10x...........                        hematology parameters, increased
                                   FQPA SF = 1x........                        spleen weights, macroscopic
                                                                               changes in the liver and
                                                                               microscopic changes in the liver,
                                                                               bile duct and spleen.
Incidental oral intermediate-term  NOAEL = 200 mg/kg/    LOC for MOE = 100..  90-day oral toxicity-rat LOAEL =
 (1 to 6 months).                   day.                                       1,000 mg/kg/day based on
                                   UFA = 10x...........                        decreased body weight, changes in
                                   UFH = 10x...........                        hematology parameters, increased
                                   FQPA SF = 1x........                        spleen weights, macroscopic
                                                                               changes in the liver and
                                                                               microscopic changes in the liver,
                                                                               bile duct and spleen.
Dermal short-term (1 to 30 days).  Dermal (or oral)      LOC for MOE = 100..  90-day oral toxicity-rat LOAEL =
                                    study NOAEL = 200                          1,000 mg/kg/day based on
                                    mg/kg/day (dermal                          decreased body weight, changes in
                                    absorption rate =                          hematology parameters, increased
                                    100%.                                      spleen weights, macroscopic
                                   UFA = 10x...........                        changes in the liver and
                                   UFH = 10x...........                        microscopic changes in the liver,
                                   FQPA SF = 1x........                        bile duct and spleen.
Dermal intermediate-term (1 to 6   Dermal (or oral)      LOC for MOE = 100..  90-day oral toxicity-rat LOAEL =
 months).                           study NOAEL = 200                          1,000 mg/kg/day based on
                                    mg/kg/day (dermal                          decreased body weight, changes in
                                    absorption rate =                          hematology parameters, increased
                                    100%.                                      spleen weights, macroscopic
                                   UFA = 10x...........                        changes in the liver and
                                   UFH = 10x...........                        microscopic changes in the liver,
                                   FQPA SF = 1x........                        bile duct and spleen.

[[Page 45082]]

 
Inhalation short-term (1 to 30     Inhalation (or oral)  LOC for MOE = 100..  90-day oral toxicity-rat LOAEL =
 days).                             study NOAEL = 200                          1,000 mg/kg/day based on
                                    mg/kg/day                                  decreased body weight, changes in
                                    (inhalation                                hematology parameters, increased
                                    absorption rate =                          spleen weights, macroscopic
                                    100%).                                     changes in the liver and
                                   UFA = 10x...........                        microscopic changes in the liver,
                                   UFH = 10x...........                        bile duct and spleen.
                                   FQPA SF = 1x........
Inhalation (1 to 6 months).......  Inhalation (or oral)  LOC for MOE = 100..  90-day oral toxicity-rat LOAEL =
                                    study NOAEL = 200                          1,000 mg/kg/day based on
                                    mg/kg/day                                  decreased body weight, changes in
                                    (inhalation                                hematology parameters, increased
                                    absorption rate =                          spleen weights, macroscopic
                                    100%).                                     changes in the liver and
                                   UFA = 10x...........                        microscopic changes in the liver,
                                   UFH = 10x...........                        bile duct and spleen.
                                   FQPA SF = 1x........
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)       Based on structural activity analysis, lack of effects suggestive of
                                      potential carcinogenicity in subchronic studies and negative results for
                                     genotoxicity in bacterial and mammalian cell assays, there is a low concern
                                     for the salts of isethionate and isethionic acid as potential carcinogens.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to isethionic acid and its salts, EPA considered exposure 
under the proposed exemption from the requirement of a tolerance. EPA 
assessed dietary exposures from isethionic acid and its salts in food 
as follows:
    An acute dietary risk assessment was not conducted because no 
endpoint of concern following a single exposure was identified in the 
available studies. A chronic dietary exposure assessment was completed 
and performed using the Dietary Exposure Evaluation Model DEEM-
FCID\TM\, 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 that 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 isethionic acid and 
its salts, a conservative drinking water concentration value of 100 
parts per billion (ppb) based on screening level modeling was used to 
assess the contribution to drinking water for the chronic dietary risk 
assessments for parent compound. These values were directly entered 
into the dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables).
    Isethionic acid and its salts may be used as inert ingredients 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 dermal and inhalation 
exposures for residential handlers that would result from low pressure 
hand wand, hose end sprayer and trigger sprayer for each pesticide 
type, herbicide, insecticide, and fungicide. The Agency assessed post-
application short-term dermal exposure for children short-term hand-to-
mouth and dermal exposure for children and adults from contact with 
treated lawns.
    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 isethionic acid and its salts to share a common 
mechanism

[[Page 45083]]

of toxicity with any other substances, and isethionic acid and its 
salts does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has assumed that isethionic acid and its salts does not have a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act (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. Fetal susceptibility was not 
observed in the combined developmental/reproduction toxicity screening 
test in rats. Neither offspring nor reproduction toxicity was observed 
in this study at dose levels up to 500 mg/kg/day in rats, the highest 
dose tested.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1x. That decision is based on the following 
findings:
    i. The toxicity database for isethionic acid and its salts contains 
the following acceptable studies: Subchronic, reproduction/
developmental screening study, and a mutagenicity study. The database 
is considered to be adequate to assess prenatal and postnatal toxicity.
    ii. There is no indication that isethionic acid and its salts are 
neurotoxic chemicals and there is no need for a developmental 
neurotoxicity study or additional uncertainty factors (UF) to account 
for neurotoxicity.
    iii. There is no indication that isethionic acid and its salts are 
immunotoxic chemicals. Although increased spleen weights and 
microscopic changes in the spleen were observed in the 90-day toxicity 
study in rats those effects were due to red blood cell destruction and 
therefore not considered an immuno toxic effect. In any event, the cRfD 
is based on this study and is protective of these effects. Therefore, 
there is no need for an Immunotoxicity study or additional UFs to 
account for Immunotoxicity.
    iv. There is no evidence that isethionic acid and its salts result 
in increased susceptibility for infants and children.
    v. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to isethionic acid and its salts in drinking water. 
EPA used similarly conservative assumptions to assess postapplication 
exposure of children as well as incidental oral exposure of toddlers. 
These assessments will not underestimate the exposure and risks posed 
by isethionic acid and its salts.

E. Aggregate Risks and Determination of Safety

    1. 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.
    2. 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, 
isethionic acid and its salts is not expected to pose an acute risk.
    3. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
isethionic acid and its salts from food and water will utilize 9.5% of 
the cPAD for the U.S. population and 35.3% of the cPAD for children 1-2 
yrs. old, the population group receiving the greatest exposure.
    4. 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). Isethionic 
acid and its salts may be used as an inert ingredient in pesticide 
products that are registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to isethionic acid and its salts.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 187 for adults 
and 123 for children. Because EPA's level of concern for isethionic 
acid and its salts are MOEs of 100 or below, these MOEs are not of 
concern.
    5. 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). Isethionic acid and its salts are currently used as an inert 
ingredient in pesticide products that are registered for uses that 
could result in intermediate-term residential exposure. The endpoint of 
concern selected for short- and intermediate-term exposure assessment 
is the same NOAEL, therefore intermediate term exposure is not expected 
to exceed short term aggregate exposure and therefore there are no 
concerns for intermediate-term aggregate exposure.
    6. Aggregate cancer risk for U.S. population. The Agency has not 
identified any concerns for carcinogenicity relating to isethionic acid 
and its salts; therefore, a cancer dietary exposure assessment was not 
performed and an aggregate risk and aggregate cancer risk assessment is 
not a concern.
    7. 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 isethionic acid and its salt residues.

V. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

VI. Conclusions

    Therefore, exemptions from the requirement of a tolerance are

[[Page 45084]]

established under 40 CFR 180.910 and 40 CFR 180.930 for ethanesulfonic 
acid, 2-hydroxy- (CAS Reg. No. 107-36-8); ethanesulfonic acid, 2-
hydroxy-, ammonium salt (CAS Reg. No. 57267-78-4); ethanesulfonic acid, 
2-hydroxy-, sodium salt (CAS Reg. No. 1562-00-1); ethanesulfonic acid, 
2-hydroxy-, potassium salt (CAS Reg. No. 1561-99-5); ethanesulfonic 
acid, 2-hydroxy-, calcium salt (CAS Reg. No. 10550-47-7); 
ethanesulfonic acid, 2-hydroxy-, magnesium salt (CAS Reg. No. 17345-56-
1), and ethanesulfonic acid, 2-hydroxy-, zinc salt (CAS Reg. No. 
129756-32-7) when used as inert ingredients (chelators, sequestrants, 
and conditioning agents) in pesticide formulations applied to growing 
crops and raw agricultural commodities after harvest and applied to 
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 exemptions in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This 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: July 21, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.910, add alphabetically the inert ingredients to the 
table to read as follows:


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

* * * * *

------------------------------------------------------------------------
      Inert ingredients              Limits                 Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy- (CAS Reg. No. 107-                         sequestrant, or
 36-8).                                              conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, ammonium salts                            sequestrant, or
 (CAS Reg. No. 57267-78-4).                          conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, calcium salts                             sequestrant, or
 (CAS Reg. No. 10550-47-7).                          conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, magnesium salts                           sequestrant, or
 (CAS Reg. No. 17345-56-1).                          conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, potassium salts                           sequestrant, or
 (CAS Reg. No. 1561-99-5).                           conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, sodium salts (CAS                         sequestrant, or
 Reg. No. 1562-00-1).                                conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, zinc salts (CAS                           sequestrant, or
 Reg. No. 129756-32-7).                              conditioning agent.
 
                              * * * * * * *
------------------------------------------------------------------------


[[Page 45085]]


0
3. In Sec.  180.930, add alphabetically the inert ingredients 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
------------------------------------------------------------------------
 
                              * * * * * * *
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy- (CAS Reg. No. 107-                         sequestrant, or
 36-8).                                              conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, ammonium salts                            sequestrant, or
 (CAS Reg. No. 57267-78-4).                          conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, calcium salts                             sequestrant, or
 (CAS Reg. No. 10550-47-7).                          conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, magnesium salts                           sequestrant, or
 (CAS Reg. No. 17345-56-1).                          conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, potassium salts                           sequestrant, or
 (CAS Reg. No. 1561-99-5).                           conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, sodium salts (CAS                         sequestrant, or
 Reg. No. 1562-00-1).                                conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, zinc salts (CAS                           sequestrant, or
 Reg. No. 129756-32-7).                              conditioning agent.
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2015-18610 Filed 7-28-15; 8:45 am]
 BILLING CODE 6560-50-P


