Secondary (CINF13/INF-CINF17/INF) Alkane Sulfonates; Exemption From the Requirement of a Tolerance, 19226-19231 [granule308]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 80, Number 69 (Friday, April 10, 2015)]
[Unknown Section]
[Pages 19226-19231]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: granule308]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA–HQ–OPP–2013–0756; FRL–9923–64]


Secondary (C13-C17) Alkane Sulfonates; 
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 two secondary alkane (C13-
C17) sulfonates (CAS Reg. Nos. 85711–69–9 and 
97489–15–1) when used as inert ingredients (surfactant) in 
pesticide formulations applied to growing crops at a maximum 
concentration not to exceed 40% by weight. Exponent, on behalf of 
Clariant Corporation, 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 secondary alkane (C13-C17) 
sulfonates.

DATES: This regulation is effective April 10, 2015. Objections and 
requests for hearings must be received on or before June 9, 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–2013–0756, 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: 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

[[Page 19227]]

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:
    &sbull; Crop production (NAICS code 111).
    &sbull; Animal production (NAICS code 112).
    &sbull; Food manufacturing (NAICS code 311).
    &sbull; 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 Publishing Office's e-CFR site at 
https://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 https://
www.epa.gov/ocspp and select “Test Methods and Guidelines.”

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA–HQ–OPP–2013–0756 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 June 9, 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–2013–0756, by one of the following 
methods:
    &sbull; 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.
    &sbull; Mail: OPP Docket, Environmental Protection Agency 
Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., 
Washington, DC 20460–0001.
    &sbull; 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 
&fnl;https://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of February 21, 2014 (79 FR 9870) 
(FRL–9904–98), EPA issued a document pursuant to FFDCA 
section 408, 21 U.S.C. 346a, announcing the filing of a pesticide 
petition (PP IN–10630) by Exponent, 1150 Connecticut Ave. NW., 
Washington, DC 20036 on behalf of Clariant Corporation, 4000 Monroe 
Rd., Charlotte, NC 28205. The petition requested that 40 CFR 180.920 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of two inert ingredients, collectively referred 
to as secondary alkane (C13-C17) sulfonates 
(SAS): Sulfonic acids, C13-17-sec-alkane, sodium 
salts (CAS Reg. No. 85711–69–9) and sulfonic acids, 
C14-17-sec-alkane, sodium salts (CAS Reg. No. 
97489–15–1) when used as surfactants in pesticide 
formulations applied to growing crops. That document referenced a 
summary of the petition prepared by Exponent, the petitioner, which is 
available in the docket, https://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA is 
limiting the tolerance exemption to pesticide formulations in which the 
maximum concentration of the secondary alkane sulfonates is 40% by 
weight. This limitation is based on the Agency's risk assessment which 
can be found at &fnl;https://www.regulations.gov in document 
“Secondary Alkane (C13-C17) Sulfonates 
(SAS); Human Health Risk Assessment and Ecological Effects Assessment 
to Support Proposed Exemption from the Requirement of a Tolerance When 
Used as an Inert Ingredient in Pre-harvest Pesticide Products Under 40 
CFR 180.920” in docket ID number 
EPA–HQ–OPP–2013–0756.

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

[[Page 19228]]

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 secondary alkane 
(C13-C17) sulfonates including exposure resulting 
from the exemption established by this action. EPA's assessment of 
exposures and risks associated with secondary alkane (C13-
C17) sulfonates 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 secondary alkane (C13-
C17) sulfonates (also referred to as SAS) 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.
    The Agency relied on data on CAS Reg. No. 85711–69–9 
(sulfonic acids (C13-C17 secondary alkane) to 
assess both inert ingredients. Bridging data in this manner is 
appropriate because CAS Reg. No. 97489–15–1 (sulfonic 
acids, C14-C17 secondary alkane) has an alkyl 
carbon chain length that falls within the carbon chain length range of 
CAS Reg. No. 85711–69–9 (sulfonic acids, C13-
C17 secondary alkane) and toxic effects attributable to the 
C14-C17 secondary alkane sulfonate would be 
observed in toxicity testing of the C13-C17 
secondary alkane sulfonate.
    The acute oral lethal dose (LD50) for SAS in rats is 
>500 milligram/kilogram (mg/kg). The acute dermal LD50 in 
mice is >200 mg/kg. Secondary alkane (C13-C17) 
sulfonate is not a dermal irritant based on primary skin irritation 
study in rabbits and it is not a dermal sensitizer in guinea pigs.
    A chronic toxicity study was conducted on SAS in rats and 
demonstrated a NOAEL of 4,000 parts per million (ppm) (equivalent to 
168 milligram/kilogram body weight/day (mg/kg bw/day) in males and 227 
mg/kg bw/day in females), and a LOAEL of 20,000 ppm (equivalent to 920 
mg/kg bw/day in males and 1,281 mg/kg bw/day in females) based on 
reduced body weight, body weight gain, and the clinical signs of 
reduced grooming in males and females.
    In a 2-generation reproduction study in rats dosed with SAS, there 
was no indication that offspring were more susceptible than the 
parental adults. The parental systemic LOAEL was 3,000 ppm (equivalent 
to 177 mg/kg bw/day in males and 181 mg/kg bw/day in females), based on 
decreased body weight gain during premating and on reduced organ 
weight. The parental NOAEL was 1,000 ppm (equivalent to 58.2 mg/kg bw/
day for males and 66 mg/kg bw/day for females). The offspring LOAEL was 
3,000 ppm (equivalent to 177 mg/kg bw/day) based on decreased pre- and 
post-implantation loss and decreased weight gain in offspring. The 
offspring NOAEL was 1,000 ppm (equivalent to 58.2 mg/kg bw/day).
    Secondary alkane (C13-C17) sulfonates were 
not mutagenic when tested in the in vitro mammalian cell gene mutation 
assay and in the Salmonella typhimurium reverse mutation assay.
    In a combined oral (dietary) chronic toxicity/carcinogenicity study 
of SAS in rats, there were no treatment-related neoplastic or non-
neoplastic microscopic findings observed up to 2.0% (equivalent to 805 
mg/kg bw/day in males and 1,032 mg/kg bw/day in females), the highest 
dose tested. A LOAEL was not identified. Although body weight of high-
dose males and females were lower by about 20% relative to controls 
throughout most of the study, decreased body weight was not viewed as 
an adverse effect since higher survival rates were observed in this 
group compared to controls.
    In a dermal carcinogenicity study of SAS in mice, no indication of 
increased incidence relative to controls of malignant neoplasms was 
observed. No LOAEL was demonstrated. The NOAEL was 1.0% (equivalent to 
0.6 mg/treatment), the highest concentration applied to the skin.
    Secondary alkane (C13-C17) sulfonates are 
rapidly absorbed and excreted in the urine and feces. Secondary alkane 
(C13-C17) sulfonates have a low potential for 
dermal absorption based on a dermal penetration study in rats.
    Although no immunotoxicity or neurotoxicity studies on SAS were 
available in the database, no evidence of immunotoxicity or 
neurotoxicity was observed in the submitted studies.

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 (UF) are used in conjunction with the POD to 
calculate a safe exposure level—generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)—and a 
safe margin of exposure (MOE). For non-threshold risks, the Agency 
assumes that any amount of exposure will lead to some degree of risk. 
Thus, the Agency estimates risk in terms of the probability of an 
occurrence of the adverse effect expected in a lifetime. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see https://
www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for secondary alkane 
(C13-C17) sulfonates used for human risk 
assessment is shown in Table 1 of this unit.
    The 2-generation reproductive toxicity study in rats was selected 
for oral, dietary, dermal, and inhalation exposure scenarios (all 
durations) for this risk assessment. The parental systemic NOAEL in 
this study was 1,000 ppm (equivalent to 58.2 mg/kg bw/day for males) 
based on reduced body weight gain during premating and on reduced organ 
weight seen at the LOAEL of 3,000 ppm (equivalent to 177 mg/kg bw/day). 
The rationale for selecting this study for the dietary, dermal, and 
inhalation exposure scenario is based on the fact that this study 
provided the lowest and most conservative toxicity endpoint and route-
specific studies are available.
    A default 100% inhalation absorption will be used for inhalation 
exposure scenarios. A 50% dermal absorption rate will be used for 
dermal exposure scenarios based on the toxicokinetic dermal absorption 
study.

[[Page 19229]]



 Table 1—Summary of Toxicological Doses and Endpoints for Secondary Alkane (C13-C17) Sulfonates 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
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 58.2 mg/kg    Chronic RfD = 0.582  Rat reproductive toxicity study.
                                    bw/day.               mg/kg bw/day.       LOAEL = 177 mg/kg bw/day based on
                                   UFA = 10x...........  cPAD = 0.58 mg/kg     decreased weight gain during
                                   UFH = 10x...........   bw/day.              premating and reduced organ
                                   FQPA SF = 1x........                        weight.
Cancer (Oral, dermal, inhalation)  Based on the lack of
                                    increased incidence
                                    of tumor formation
                                    compared to
                                    controls in
                                    multiple
                                    carcinogenicity
                                    studies and the
                                    lack of
                                    mutagenicity, SAS
                                    is considered not
                                    likely to be
                                    carcinogenic.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. 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 secondary alkane (C13-C17) 
sulfonates, EPA considered exposure under the proposed exemption from 
the requirement of a tolerance. EPA assessed dietary exposures from 
secondary alkane (C13-C17) sulfonates 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 1-day or single exposure. No such 
effects were identified in the toxicological studies for SAS; 
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, EPA, 
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.
    iii Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that SAS does not pose a cancer risk to humans. Therefore, a 
dietary exposure assessment for the purpose of assessing cancer risk is 
unnecessary.
    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 secondary alkane 
(C13-C17) sulfonates, 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).
    Based on the use pattern for pesticide products containing SAS as 
an inert ingredient, there are no residential uses and thus no 
residential exposures are expected.
    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 secondary alkane (C13-C17) 
sulfonates to share a common mechanism of toxicity with any other 
substances, and secondary alkane (C13-C17) 
sulfonates do not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has assumed that secondary alkane (C13-C17) 
sulfonates do not have a common mechanism of toxicity with other

[[Page 19230]]

substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at https://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. In a 2-generation 
reproduction toxicity study, there was no evidence of susceptibility of 
infants and children to SAS. In this study, the offspring and parental 
toxicity NOAEL was 1,000 ppm (equivalent to 58.2 mg/kg bw/day) based 
decreased pre- and post-implantation loss and decreased weight gain in 
offspring and decreased body weight gain during premating and on 
reduced organ weight in parental animals seen at the LOAEL was 3,000 
ppm (equivalent to 177 mg/kg bw/day).
    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 secondary alkane (C13-
C17) sulfonates includes a subchronic toxicity study, a 2-
generation reproduction study, chronic/carcinogenicity studies, several 
mutagenicity studies, and two toxicokinetic studies. The Agency 
concludes that for this ingredient, the results of these studies 
provide a reliable basis for assessing the range of potential effects 
to infants and children, such that the Agency has determined that no 
additional data are necessary at this time to evaluate effects to 
infants and children.
    ii. There is no indication that SAS is a neurotoxic chemical and 
there is no need for a developmental neurotoxicity study or additional 
UFs to account for neurotoxicity.
    iii. There is no evidence of increased susceptibility due to pre-or 
post-natal exposure to SAS in infants and children.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 percent crop treated (PCT) and tolerance-level residues. EPA 
made conservative (protective) assumptions utilizing a 100 ppb default 
value in the ground and surface water modeling used to assess exposure 
to secondary alkane (C13-C17) sulfonates in 
drinking water. These assessments will not underestimate the exposure 
and risks posed by secondary alkane (C13-C17) 
sulfonates.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. 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, therefore, an acute dietary exposure assessment was not 
conducted.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
SAS from food and water will utilize 97.1% of the cPAD for children 
1–2 years old, the population group receiving the greatest 
exposure.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-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/
intermediate-term adverse effect was identified; however, SAS is not 
used as inert ingredient in any pesticide product registered for any 
use patterns that would result in short-term or intermediate-term 
residential exposure. Because there is no short-term or intermediate-
term residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess 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 SAS.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two rodent carcinogenicity studies, 
secondary alkane (C13-C17) sulfonates are not 
expected to pose a cancer risk to humans.
    5. 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 secondary alkane (C13-C17) sulfonates 
residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Although EPA is establishing a limitation on the amount of SAS that 
may be used in pesticide formulations, an analytical enforcement 
methodology is not necessary for this exemption. The limitation will be 
enforced through the pesticide registration process under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et 
seq. EPA will not register any pesticide for sale or distribution for 
use on growing crops with concentrations of SAS exceeding 40% by weight 
of the formulation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nation Food 
and Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for secondary alkane 
(C13-C17) sulfonates.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established

[[Page 19231]]

under 40 CFR 180.920 for sulfonic acids, C13-17-
sec-alkane, sodium salts (CAS Reg. No. 85711–69–9) and 
sulfonic acids, C14-17-sec-alkane, sodium salts 
(CAS Reg. No. 97489–15–1) when used as inert ingredients 
(surfactant) in pesticide formulations applied to growing crops at not 
more than 40% by weight of the pesticide formulation.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption 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: March 10, 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 §&thnsp;180.920, add alphabetically the following inert 
ingredients to the table to read as follows:


§&thnsp;180.920  Inert ingredients used pre-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
       Inert ingredients                Limits                Uses
------------------------------------------------------------------------
 
*         *  &ems
p;      *     &em
sp;   *        &e
msp;*         *  
                      *
Sulfonic acids, C13-17-sec-     Not to exceed 40% by   Surfactant.
 alkane, sodium salts (CAS       weight in non-
 Reg. No.                        residential use
 85711–69–9).        pesticide
                                 formulation only.
Sulfonic acids, C14-17-sec-     Not to exceed 40% by   Surfactant.
 alkane, sodium salts (CAS       weight in non-
 Reg. No.                        residential
 97489–15–1).        pesticide
                                 formulation only.
 
*         *  &ems
p;      *     &em
sp;   *        &e
msp;*         *  
                      *
------------------------------------------------------------------------

[FR Doc. 2015–08218 Filed 4–9–15; 8:45 am]
 BILLING CODE 6560–50–P