9-Octadecenoic Acid (9Z, 11589-11594 [2015-04396]

Download as PDF Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Rules and Regulations * * * * * [FR Doc. 2015–04277 Filed 3–3–15; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2013–0601; FRL–9922–29] 9-Octadecenoic Acid (9Z)-, Sulfonated, Oxidized and its Potassium and Sodium Salts; Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes an exemption from the requirement of a tolerance for residues of 9-octadecenoic acid (9Z)-, sulfonated, oxidized; 9octadecenoic acid (9Z)-, sulfonated, oxidized, potassium salts; and 9octadecenoic acid (9Z)-, sulfonated, oxidized, sodium salts, when used as an inert ingredient in antimicrobial pesticide formulations used on food contact surfaces in public eating places, dairy processing equipment and food processing equipment and utensils at a maximum end-use concentration not to exceed 250 parts per million (ppm). Ecolab 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 9-octadecenoic acid (9Z)-, sulfonated, oxidized and its potassium and sodium salts. DATES: This regulation is effective March 4, 2015. Objections and requests for hearings must be received on or before May 4, 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–2013–0601, 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 ebenthall on DSK5SPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 23:09 Mar 03, 2015 Jkt 235001 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, Director, 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 Publishing Office’s e-CFR site at https:// www.ecfr.gov/cgi-bin/textidx?&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–2013–0601 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 May 4, 2015. Addresses for mail and hand delivery of objections and PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 11589 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– 2013–0601, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets. II. Petition for Exemption In the Federal Register of September 12, 2013 (78 FR 56185) (FRL–9399–7), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN–10549) by Ecolab, Inc. 370 N. Wabasha Street, St. Paul, MN 55102. The petition requested that 40 CFR 180.940(a) be amended by establishing an exemption from the requirement of a tolerance for residues of 9-octadecenoic acid (9Z)-, sulfonated, oxidized (CAS Reg. No. 1315321–93–7); 9-octadecenoic acid (9Z)-, sulfonated, oxidized, potassium salts (CAS Reg. No. 1315321–94–8); and 9-octadecenoic acid (9Z)-, sulfonated, oxidized, sodium salts, (CAS No. 1315321–95–9) when used as an inert ingredient in antimicrobial pesticide formulations used on food contact surfaces in public eating places, dairy processing equipment, and food processing equipment and utensils at a maximum end-use concentration not to exceed 250 ppm. That document referenced a summary of the petition prepared by Ecolab Inc, the petitioner, which is available in the docket, https:// www.regulations.gov. There were no E:\FR\FM\04MRR1.SGM 04MRR1 11590 Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Rules and Regulations comments received in response to the notice of filing. ebenthall on DSK5SPTVN1PROD with RULES 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 VerDate Sep<11>2014 22:23 Mar 03, 2015 Jkt 235001 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 9-octadecenoic acid (9Z)-, sulfonated, oxidized and its potassium and sodium salts including exposure resulting from the exemption established by this action. EPA’s assessment of exposures and risks associated with 9-octadecenoic acid (9Z)-, sulfonated, oxidized and its potassium and sodium 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 9-octadecenoic acid (9Z)-, sulfonated, oxidized and its potassium and sodium salt (also referred to as peroxy sulfonated oleic acid (PSOA)) as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies discussed in this unit. Peroxy sulfonated oleic acid is acutely toxic via the oral route and is highly corrosive via the dermal and inhalation routes of exposure. In a 28-day oral toxicity study (OECD Guideline 407), rats were administered PSOA via gavage at dose levels of 15 milligrams/ kilogram/day (mg/kg/day) and 50 mg/ kg/day. No observable adverse effects were seen at either dose level but since no systemic effects were observed, the dosing was considered by the Agency to not be adequate. In a developmental toxicity (OECD Guideline 414) study with PSOA, the parental NOAEL for systemic effects was 50 mg/kg bw/day, the highest dose tested. The NOAEL for embryotoxic, fetotoxic and developmental effects was PO 00000 Frm 00056 Fmt 4700 Sfmt 4700 also 50 mg/kg bw/day, the highest dose tested. The dosing in the 28-day gavage study and the developmental toxicity studies was considered inadequate because animals were not challenged at higher doses. The applicant suggested that the higher doses were not utilized because of the corrosive nature of the chemical. Since there was no evidence of corrosivity in the study, a 14-day oral toxicity study was conducted at dose levels of 100 mg/kg/day, 300 mg/kg/day and 1,000 mg/kg/day. The study results confirmed that higher doses would have been corrosive. In a series of genotoxicity studies PSOA is negative for inducing mutations in bacterial and mammalian cells, with and without metabolic activation. In the in vitro chromosome aberration study using human lymphocytes, PSOA was positive with and without metabolic activation. However, the in vivo micronucleus assay in rats was negative. A neurotoxicity study was not conducted with PSOA. However, detailed functional observations were made among the parameters measured in the 28-day subchronic oral feeding study. There were no PSOA related changes in any of the parameters measured, including functional observations battery (FOB). No evidence of neurotoxicity was observed. An immunotoxicity study was not conducted with PSOA. However, minimal hemorrhage in the thymus was observed after the recovery period in the 14-day oral toxicity study with rats. Since, this effect is a common background lesion it is not considered indicative of potential immunotoxicity. There are no known chronic toxicity studies with PSOA and no available PSOA mammalian metabolism 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 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 E:\FR\FM\04MRR1.SGM 04MRR1 Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Rules and Regulations 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 11591 complete description of the risk assessment process, see https:// www.epa.gov/pesticides/factsheets/ riskassess.htm. TABLE 1—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR 9-OCTADECENOIC ACID (9Z)-, SULFONATED, OXIDIZED AND ITS POTASSIUM AND SODIUM SALT FOR USE IN HUMAN RISK ASSESSMENT Dose used in risk assessment, interspecies and intraspecies and any traditional UF Exposure/scenario Acute dietary (all populations) ....... Chronic dietary (all populations) .... Cancer (Oral, dermal, inhalation) .. Special FQPA SF and LOC for risk assessment Study and toxicological effects An endpoint attributable to a single dose exposure has not been identified. NOAEL= 50 mg/kg/day ................. UFA = 10X UFH= 10X Chronic RfD = 0.5 mg/kg/day NA ................................................. FQPA SF = 1X ............................. cPAD = chronic RfD/Special NA ................................................. 14-day and 28-day rat oral toxicity study in rats. LOAEL = 300 mg/kg/day based on gastrointestinal irritation. NA. 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). ebenthall on DSK5SPTVN1PROD with RULES C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to PSOA, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from peroxy sulfonated oleic acids in food as follows: In the absence of actual dietary exposure data resulting from this use, EPA has utilized a conservative, healthprotective method of estimating dietary intake that is based upon conservative assumptions related to the amount of residues that can be transferred to foods as a result of the proposed use of 9octadecenoic acid (9Z)-, sulfonated, oxidized and its potassium and sodium salts in food contact sanitizing pesticide products. This same methodology has been utilized by EPA in estimating dietary exposures to antimicrobial pesticides used in food-handling settings. A complete description of the approach used to assess dietary exposures resulting from food contact sanitizing solution uses of nitric acid can be found at https:// www.regulations.gov in document ‘‘Peroxy Sulfonated Oleic Acids; Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide Formulations,’’ pp. 14–15 in docket ID number EPA– HQ–OPP–2013–0601. EPA assessed dietary exposures from 9-octadecenoic acid (9Z)-, sulfonated, oxidized and its potassium and sodium salts in food as follows: VerDate Sep<11>2014 22:23 Mar 03, 2015 Jkt 235001 i. Acute exposure. No adverse effects attributable to a single exposure of PSOA were seen in the toxicity databases. Therefore, an acute dietary exposure assessment for 9-octadecenoic acid (9Z)-, sulfonated, oxidized and its potassium and sodium salts is not necessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment, the Agency believes the assumptions used to estimate chronic dietary exposures lead to an extremely conservative assessment of chronic dietary risk due to a series of compounded conservative assumptions. First, when a surface is treated with a disinfectant, a quantity of the disinfectant remains on the surface (residual solution). In the absence of any other data, EPA has used an estimated worst-case concentration of 1 mg of residual solution per square centimeter (cm) of treated surface area for this quantity. Second, the conservatism of this methodology is compounded by EPA’s decision to assume a worst case scenario that all food that an individual consumers will come into contact with 4,000 cm2 of sanitized non-porous food contact surfaces. This contact area represents all the surface area from silverware, china, and glass used by a person who regularly eats three meals per day at an institutional or public facility. Third, EPA assumes that 100% of the material present on food contact surfaces will migrate to food. 2. Dietary exposure from drinking water. Due to the proposed use pattern, the Agency believes PSOA will not enter surface water or ground water as PO 00000 Frm 00057 Fmt 4700 Sfmt 4700 a result of the proposed use. Therefore a dietary exposure assessment for drinking water is not necessary. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure. Peroxy sulfonated oleic acids are not used as an inert ingredient in pesticide products that are registered for specific uses that may result in both indoor and outdoor residential exposures. Therefore, a residential exposure and risk assessment was not conducted for PSOA. 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 peroxy sulfonated oleic acids to share a common mechanism of toxicity with any other substances, and peroxy sulfonated oleic acids do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that peroxy sulfonated oleic acids do not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such E:\FR\FM\04MRR1.SGM 04MRR1 11592 Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Rules and Regulations ebenthall on DSK5SPTVN1PROD with RULES chemicals, see EPA’s Web site at https:// www.epa.gov/pesticides/cumulative. assessment will not underestimate the exposure and risks posed by PSOA. 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 is no concern for fetal susceptibility. There were no treatment related effects observed in a developmental toxicity study in rats up to the maximum dose tested (50 mg/kg/ day). Based on the corrosive nature of PSOA toxicity testing at doses greater than 100 mg/kg/day results in local effects (i.e., severe gastrointestinal irritation) with other observed systemic effects being secondary to the irritation effects. Therefore, based on the available data, there are no concerns for residual uncertainties concerning prenatal and postnatal toxicity. 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 NOAEL used for risk assessment is based on the corrosive effects of PSOA which occur at dose levels below which any systemic toxicity is observed and is therefore protective of potential developmental and reproductive effects. ii. There is no indication that PSOA 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 indication that PSOA is an immunotoxic chemical and there is no need for additional UFs to account for immunotoxicity. iv. There is no evidence that PSOA results in increased susceptibility in in utero rodents. v. There are no residual uncertainties identified in the exposure databases. EPA made conservative (healthprotective) assumptions regarding dietary exposure to PSOA. This E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 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, peroxy sulfonated oleic acids are not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to peroxy sulfonated oleic acids from food and water will utilize 18% of the cPAD for children 1–2 years old, the population group receiving the highest exposure. There are no residential uses for peroxy sulfonated oleic acids. Based on the explanation in Unit IIIC.3 residential use patterns, chronic residential exposure to residues of peroxy sulfonated oleic acids is not expected. 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). Because there are no residential uses, short-term residential exposures are not likely to occur, and no short-term adverse effect was identified therefore peroxy sulfonated oleic acids are not expected to pose a short-term aggregate risk. 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). Because there are no residential uses, intermediate-term residential exposures are not likely to occur, and peroxy VerDate Sep<11>2014 22:23 Mar 03, 2015 Jkt 235001 PO 00000 Frm 00058 Fmt 4700 Sfmt 4700 sulfonated oleic acids are not expected to pose an intermediate-term aggregate risk. 5. Aggregate cancer risk for U.S. population. Based upon negative response for mutagenicity in a battery of genotoxicity tests, and lack of any structural alerts for carcinogenicity, peroxy sulfonated oleic acids 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 peroxy sulfonated oleic acids residues. V. Other Considerations A. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of peroxy sulfonated oleic acids of in or on any food commodities. EPA is establishing a limitation on the amount of peroxy sulfonated oleic acids that may be used in pesticide formulations. That 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 which the final end use concentration of peroxy sulfonated oleic acids in antimicrobial food contact surface sanitizing solutions would exceed 250 ppm. 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 peroxy sulfonated oleic acids. E:\FR\FM\04MRR1.SGM 04MRR1 11593 Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Rules and Regulations VI. Conclusions Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.940(a) for residues of 9-octadecenoic acid (9Z)-, sulfonated, oxidized (CAS Reg. No. 1315321–93–7); 9-octadecenoic acid (9Z)-, sulfonated, oxidized, potassium salts (CAS Reg. No. 1315321–94–8); and 9-octadecenoic acid (9Z)-, sulfonated, oxidized, sodium salts, (CAS No. 1315321–95–9) when used as an inert ingredient in antimicrobial pesticide formulations used on food contact surfaces in public eating places, dairy processing equipment and food processing equipment and utensils at a maximum end-use concentration not to exceed 250 ppm. VII. Statutory and Executive Order Reviews This action establishes 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 tolerance 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 Pesticide chemical * 1315321–93–7 9-Octadecenoic acid (9Z)-, sulfonated, oxidized, potassium salts. 9-Octadecenoic acid (9Z)-, sulfonated, oxidized, sodium salts. ebenthall on DSK5SPTVN1PROD with RULES VerDate Sep<11>2014 * 22:23 Mar 03, 2015 1315321–94–8 1315321–95–9 * Jkt 235001 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: February 25, 2015. Susan Lewis, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.940(a), alphabetically add the following inert ingredients to the table in paragraph (a) to read as follows: ■ § 180.940 Tolerance exemptions for active and inert ingredients for use in antimicrobial formulations (Food-contact surface sanitizing solutions). * * * (a) * * * CAS Reg. No. * * 9-Octadecenoic acid (9Z)-, sulfonated, oxidized * 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). PO 00000 * Limits * * * * When ready for use, the end-use concentration is not to exceed 250 ppm. When ready for use, the end-use concentration is not to exceed 250 ppm. When ready for use, the end-use concentration is not to exceed 250 ppm. * Frm 00059 * Fmt 4700 * Sfmt 4700 E:\FR\FM\04MRR1.SGM * 04MRR1 * 11594 * * Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Rules and Regulations * * will accept comments via email. Please send them to PRA@fcc.gov. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@ fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418–0530 (voice), (202) 418–0432 (TTY). * [FR Doc. 2015–04396 Filed 3–3–15; 8:45 am] BILLING CODE 6560–50–P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 64 [WC Docket No. 13–39; FCC 13–135] Rural Call Completion Recordkeeping and Reporting Requirements Federal Communications Commission. ACTION: Final rule; announcement of effective date. AGENCY: In this document, the Federal Communications Commission (Commission) announces that the Office of Management and Budget (OMB) has approved, for a period of three years, the information collection associated with the Commission’s Report and Order (Order) WC Docket No. 13–39, FCC 13– 135. This document is consistent with the Order, which stated that the Commission would publish a document in the Federal Register announcing OMB approval and the effective date of the requirements. DATES: 47 CFR 64.2103, 64.2105, 64.2107, and the information collection in paragraph 67 of this Report and Order, which contains information collection requirements published at 78 FR 76218, December 17, 2013 are effective on March 4, 2015. FOR FURTHER INFORMATION CONTACT: Randy Clarke, Acting Division Chief, Wireline Competition Bureau, at (202) 418–1587. SUPPLEMENTARY INFORMATION: This document announces that, on January 29, 2015, OMB approved, for a period of three years, the information collection requirements contained in the Commission’s Order, FCC 13–135, published at 78 FR 76218, December 17, 2013. The OMB Control Number is 3060–1186. The Commission publishes this document as an announcement of the effective date of paragraphs 66 and 67, of document WC Docket No. 13–39, FCC 13–135. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Nicole Ongele, Federal Communications Commission, Room 1–620, 445 12th Street SW., Washington, DC 20554, or via email at: Nicole.Ongele@fcc.gov. Please include the OMB Control Number, 3060–1186, in your correspondence. The Commission also ebenthall on DSK5SPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 22:23 Mar 03, 2015 Jkt 235001 Synopsis As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received OMB approval on January 29, 2015, for the information collection requirements contained in 64.2103, 64.2105, and 64.2107 of the Commission’s Rules and the information collection in paragraph 67 of the Order. Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060–1186. The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104–13, October 1, 1995, and 44 U.S.C. 3507. The total annual reporting burdens and costs for the respondents are as follows: OMB Control Number: 3060–1186. OMB Approval Date: January 29, 2015. OMB Expiration Date: January 31, 2018. Title: Rural Call Completion Recordkeeping and Reporting Requirements. Form Number: FCC Form 480. Respondents: Businesses or other forprofit entities. Number of Respondents and Responses: 225 respondents; 940 responses. Estimated Time per Response: 12.5 hours (per quarter). Frequency of Response: Quarterly and one-time reporting requirements and recordkeeping requirement. Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 151, 154(i), 201(b), 202(a), 218, 220(a), 251(a), 403. Total Annual Burden: 11,280 hours. Total Annual Cost: $793,750. Privacy Impact Assessment: No impact (s). Nature and Extent of Confidentiality: An assurance of confidentiality is not PO 00000 Frm 00060 Fmt 4700 Sfmt 4700 offered because this information collection does not require the collection of personally identifiable information from individuals. If the FCC requests that respondents submit information which respondents believe is confidential, respondents may request confidential treatment of such information pursuant to Section 0.459 of the FCC’s rules, 47 CFR 0.459. Needs and Uses: On October 28, 2013, the Wireline Competition Bureau (Bureau) of the Federal Communications Commission adopted a Report and Order (Order), in WC Docket No. 13–39; FCC 13–135, 78 FR 76218, Rural Call Completion. Under the rules adopted by the Order, submission of Form 480 is mandatory for a ‘‘covered provider’’ as defined in 47 CFR 64.2101(c). A covered provider failing to file Form 480 in a timely fashion may be subject to penalties under the Communications Act, including sections 502 and 503(b). In the Order the Commission improves its ability to monitor problems with completing calls to rural areas, and enforce restrictions against blocking, choking, reducing, or restricting calls. The Order applies the new rules to ‘‘covered providers,’’ meaning providers of long-distance voice service that make the initial long-distance call path choice for more than 100,000 domestic retail subscriber lines, counting the total of all business and residential fixed subscriber lines and mobile phones and aggregated over all of the providers’ affiliates. In most cases, this is the calling party’s long-distance provider. Covered providers include LECs, interexchange carriers (IXCs), commercial mobile radio service (CMRS) providers, and VoIP service providers. These rules do not apply to intermediate providers. Covered providers must file quarterly reports and retain the call detail records for at least six calendar months. Long-distance voice service providers that have more than 100,000 domestic retail subscriber lines but that, for reasons set forth in paragraph 67 of the Order, are not required to file quarterly reports are required to file a one-time letter in WC Docket No. 13–39 explaining that they do not make the initial long-distance call path choice for more than 100,000 long-distance voice service subscriber lines and identifying the long-distance provider or providers to which they hand off their end-user customers’ calls. The Order also allows qualifying providers to certify that they meet the conditions for a Safe Harbor that would reduce reporting and retention obligations. In addition, the Commission has delegated to the E:\FR\FM\04MRR1.SGM 04MRR1

Agencies

[Federal Register Volume 80, Number 42 (Wednesday, March 4, 2015)]
[Rules and Regulations]
[Pages 11589-11594]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-04396]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0601; FRL-9922-29]


9-Octadecenoic Acid (9Z)-, Sulfonated, Oxidized and its Potassium 
and Sodium 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 9-octadecenoic acid (9Z)-, sulfonated, 
oxidized; 9-octadecenoic acid (9Z)-, sulfonated, oxidized, potassium 
salts; and 9-octadecenoic acid (9Z)-, sulfonated, oxidized, sodium 
salts, when used as an inert ingredient in antimicrobial pesticide 
formulations used on food contact surfaces in public eating places, 
dairy processing equipment and food processing equipment and utensils 
at a maximum end-use concentration not to exceed 250 parts per million 
(ppm). Ecolab 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 9-octadecenoic 
acid (9Z)-, sulfonated, oxidized and its potassium and sodium salts.

DATES: This regulation is effective March 4, 2015. Objections and 
requests for hearings must be received on or before May 4, 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-2013-0601, 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, Director, 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 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-2013-0601 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 
May 4, 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-2013-0601, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of September 12, 2013 (78 FR 56185) (FRL-
9399-7), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-10549) by 
Ecolab, Inc. 370 N. Wabasha Street, St. Paul, MN 55102. The petition 
requested that 40 CFR 180.940(a) be amended by establishing an 
exemption from the requirement of a tolerance for residues of 9-
octadecenoic acid (9Z)-, sulfonated, oxidized (CAS Reg. No. 1315321-93-
7); 9-octadecenoic acid (9Z)-, sulfonated, oxidized, potassium salts 
(CAS Reg. No. 1315321-94-8); and 9-octadecenoic acid (9Z)-, sulfonated, 
oxidized, sodium salts, (CAS No. 1315321-95-9) when used as an inert 
ingredient in antimicrobial pesticide formulations used on food contact 
surfaces in public eating places, dairy processing equipment, and food 
processing equipment and utensils at a maximum end-use concentration 
not to exceed 250 ppm. That document referenced a summary of the 
petition prepared by Ecolab Inc, the petitioner, which is available in 
the docket, https://www.regulations.gov. There were no

[[Page 11590]]

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 9-octadecenoic acid (9Z)-, 
sulfonated, oxidized and its potassium and sodium salts including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with 9-octadecenoic acid 
(9Z)-, sulfonated, oxidized and its potassium and sodium 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 9-octadecenoic acid (9Z)-, sulfonated, 
oxidized and its potassium and sodium salt (also referred to as peroxy 
sulfonated oleic acid (PSOA)) as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies discussed in this unit.
    Peroxy sulfonated oleic acid is acutely toxic via the oral route 
and is highly corrosive via the dermal and inhalation routes of 
exposure. In a 28-day oral toxicity study (OECD Guideline 407), rats 
were administered PSOA via gavage at dose levels of 15 milligrams/
kilogram/day (mg/kg/day) and 50 mg/kg/day. No observable adverse 
effects were seen at either dose level but since no systemic effects 
were observed, the dosing was considered by the Agency to not be 
adequate.
    In a developmental toxicity (OECD Guideline 414) study with PSOA, 
the parental NOAEL for systemic effects was 50 mg/kg bw/day, the 
highest dose tested. The NOAEL for embryotoxic, fetotoxic and 
developmental effects was also 50 mg/kg bw/day, the highest dose 
tested.
    The dosing in the 28-day gavage study and the developmental 
toxicity studies was considered inadequate because animals were not 
challenged at higher doses. The applicant suggested that the higher 
doses were not utilized because of the corrosive nature of the 
chemical. Since there was no evidence of corrosivity in the study, a 
14-day oral toxicity study was conducted at dose levels of 100 mg/kg/
day, 300 mg/kg/day and 1,000 mg/kg/day. The study results confirmed 
that higher doses would have been corrosive.
    In a series of genotoxicity studies PSOA is negative for inducing 
mutations in bacterial and mammalian cells, with and without metabolic 
activation. In the in vitro chromosome aberration study using human 
lymphocytes, PSOA was positive with and without metabolic activation. 
However, the in vivo micronucleus assay in rats was negative.
    A neurotoxicity study was not conducted with PSOA. However, 
detailed functional observations were made among the parameters 
measured in the 28-day subchronic oral feeding study. There were no 
PSOA related changes in any of the parameters measured, including 
functional observations battery (FOB). No evidence of neurotoxicity was 
observed. An immunotoxicity study was not conducted with PSOA. However, 
minimal hemorrhage in the thymus was observed after the recovery period 
in the 14-day oral toxicity study with rats. Since, this effect is a 
common background lesion it is not considered indicative of potential 
immunotoxicity. There are no known chronic toxicity studies with PSOA 
and no available PSOA mammalian metabolism 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 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

[[Page 11591]]

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.

Table 1--Summary of Toxicological Dose and Endpoints for 9-Octadecenoic Acid (9Z)-, Sulfonated, Oxidized and Its
                           Potassium and Sodium Salt for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose used in risk
                                             assessment,
          Exposure/scenario                interspecies and     Special FQPA SF and LOC  Study and toxicological
                                         intraspecies and any     for risk assessment            effects
                                            traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations)......       An endpoint attributable to a single dose exposure has not been
                                                                       identified.
                                      --------------------------------------------------------------------------
Chronic dietary (all populations)....  NOAEL= 50 mg/kg/day....  FQPA SF = 1X...........  14-day and 28-day rat
                                       UFA = 10X..............  cPAD = chronic RfD/       oral toxicity study in
                                       UFH= 10X...............   Special.                 rats.
                                       Chronic RfD = 0.5 mg/kg/                          LOAEL = 300 mg/kg/day
                                        day.                                              based on
                                                                                          gastrointestinal
                                                                                          irritation.
Cancer (Oral, dermal, inhalation)....  NA.....................  NA.....................  NA.
----------------------------------------------------------------------------------------------------------------
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 PSOA, EPA considered exposure under the proposed exemption 
from the requirement of a tolerance. EPA assessed dietary exposures 
from peroxy sulfonated oleic acids in food as follows:
    In the absence of actual dietary exposure data resulting from this 
use, EPA has utilized a conservative, health-protective method of 
estimating dietary intake that is based upon conservative assumptions 
related to the amount of residues that can be transferred to foods as a 
result of the proposed use of 9-octadecenoic acid (9Z)-, sulfonated, 
oxidized and its potassium and sodium salts in food contact sanitizing 
pesticide products. This same methodology has been utilized by EPA in 
estimating dietary exposures to antimicrobial pesticides used in food-
handling settings. A complete description of the approach used to 
assess dietary exposures resulting from food contact sanitizing 
solution uses of nitric acid can be found at https://www.regulations.gov 
in document ``Peroxy Sulfonated Oleic Acids; Human Health Risk 
Assessment and Ecological Effects Assessment to Support Proposed 
Exemption from the Requirement of a Tolerance When Used as Inert 
Ingredients in Pesticide Formulations,'' pp. 14-15 in docket ID number 
EPA-HQ-OPP-2013-0601. EPA assessed dietary exposures from 9-
octadecenoic acid (9Z)-, sulfonated, oxidized and its potassium and 
sodium salts in food as follows:
    i. Acute exposure. No adverse effects attributable to a single 
exposure of PSOA were seen in the toxicity databases. Therefore, an 
acute dietary exposure assessment for 9-octadecenoic acid (9Z)-, 
sulfonated, oxidized and its potassium and sodium salts is not 
necessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, the Agency believes the assumptions used to estimate 
chronic dietary exposures lead to an extremely conservative assessment 
of chronic dietary risk due to a series of compounded conservative 
assumptions. First, when a surface is treated with a disinfectant, a 
quantity of the disinfectant remains on the surface (residual 
solution). In the absence of any other data, EPA has used an estimated 
worst-case concentration of 1 mg of residual solution per square 
centimeter (cm) of treated surface area for this quantity. Second, the 
conservatism of this methodology is compounded by EPA's decision to 
assume a worst case scenario that all food that an individual consumers 
will come into contact with 4,000 cm\2\ of sanitized non-porous food 
contact surfaces. This contact area represents all the surface area 
from silverware, china, and glass used by a person who regularly eats 
three meals per day at an institutional or public facility. Third, EPA 
assumes that 100% of the material present on food contact surfaces will 
migrate to food.
    2. Dietary exposure from drinking water. Due to the proposed use 
pattern, the Agency believes PSOA will not enter surface water or 
ground water as a result of the proposed use. Therefore a dietary 
exposure assessment for drinking water is not necessary.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure. Peroxy sulfonated oleic acids are not used as an inert 
ingredient in pesticide products that are registered for specific uses 
that may result in both indoor and outdoor residential exposures. 
Therefore, a residential exposure and risk assessment was not conducted 
for PSOA.
    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 peroxy sulfonated oleic acids to share a common 
mechanism of toxicity with any other substances, and peroxy sulfonated 
oleic acids do not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has assumed that peroxy sulfonated oleic acids do not have a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such

[[Page 11592]]

chemicals, see EPA's Web site at https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is no concern for 
fetal susceptibility. There were no treatment related effects observed 
in a developmental toxicity study in rats up to the maximum dose tested 
(50 mg/kg/day). Based on the corrosive nature of PSOA toxicity testing 
at doses greater than 100 mg/kg/day results in local effects (i.e., 
severe gastrointestinal irritation) with other observed systemic 
effects being secondary to the irritation effects. Therefore, based on 
the available data, there are no concerns for residual uncertainties 
concerning prenatal and postnatal toxicity.
    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 NOAEL used for risk assessment is based on the corrosive 
effects of PSOA which occur at dose levels below which any systemic 
toxicity is observed and is therefore protective of potential 
developmental and reproductive effects.
    ii. There is no indication that PSOA 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 indication that PSOA is an immunotoxic chemical 
and there is no need for additional UFs to account for immunotoxicity.
    iv. There is no evidence that PSOA results in increased 
susceptibility in in utero rodents.
    v. There are no residual uncertainties identified in the exposure 
databases. EPA made conservative (health-protective) assumptions 
regarding dietary exposure to PSOA. This assessment will not 
underestimate the exposure and risks posed by PSOA.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the acute PAD (aPAD) 
and chronic PAD (cPAD). The aPAD and cPAD represent the highest safe 
exposures, taking into account all appropriate SFs. EPA calculates the 
aPAD and cPAD by dividing the POD by all applicable UFs. For linear 
cancer risks, EPA calculates the probability of additional cancer cases 
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 POD to ensure that the MOE 
called for by the product of all applicable UFs is not exceeded.
    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, 
peroxy sulfonated oleic acids are not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
peroxy sulfonated oleic acids from food and water will utilize 18% of 
the cPAD for children 1-2 years old, the population group receiving the 
highest exposure. There are no residential uses for peroxy sulfonated 
oleic acids. Based on the explanation in Unit IIIC.3 residential use 
patterns, chronic residential exposure to residues of peroxy sulfonated 
oleic acids is not expected.
    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). Because there 
are no residential uses, short-term residential exposures are not 
likely to occur, and no short-term adverse effect was identified 
therefore peroxy sulfonated oleic acids are not expected to pose a 
short-term aggregate risk.
    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). Because there are no residential uses, intermediate-term 
residential exposures are not likely to occur, and peroxy sulfonated 
oleic acids are not expected to pose an intermediate-term aggregate 
risk.
    5. Aggregate cancer risk for U.S. population. Based upon negative 
response for mutagenicity in a battery of genotoxicity tests, and lack 
of any structural alerts for carcinogenicity, peroxy sulfonated oleic 
acids 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 peroxy sulfonated oleic acids residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is not establishing a numerical tolerance for residues of 
peroxy sulfonated oleic acids of in or on any food commodities. EPA is 
establishing a limitation on the amount of peroxy sulfonated oleic 
acids that may be used in pesticide formulations. That 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 which the final end use concentration of peroxy 
sulfonated oleic acids in antimicrobial food contact surface sanitizing 
solutions would exceed 250 ppm.

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 peroxy sulfonated oleic 
acids.

[[Page 11593]]

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.940(a) for residues of 9-octadecenoic acid 
(9Z)-, sulfonated, oxidized (CAS Reg. No. 1315321-93-7); 9-octadecenoic 
acid (9Z)-, sulfonated, oxidized, potassium salts (CAS Reg. No. 
1315321-94-8); and 9-octadecenoic acid (9Z)-, sulfonated, oxidized, 
sodium salts, (CAS No. 1315321-95-9) when used as an inert ingredient 
in antimicrobial pesticide formulations used on food contact surfaces 
in public eating places, dairy processing equipment and food processing 
equipment and utensils at a maximum end-use concentration not to exceed 
250 ppm.

VII. Statutory and Executive Order Reviews

    This action establishes 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 tolerance 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: February 25, 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.  180.940(a), alphabetically add the following inert 
ingredients to the table in paragraph (a) to read as follows:


Sec.  180.940  Tolerance exemptions for active and inert ingredients 
for use in antimicrobial formulations (Food-contact surface sanitizing 
solutions).

* * * * *
    (a) * * *

------------------------------------------------------------------------
       Pesticide chemical            CAS Reg. No.           Limits
------------------------------------------------------------------------
 
                              * * * * * * *
9-Octadecenoic acid (9Z)-,             1315321-93-7  When ready for use,
 sulfonated, oxidized.                                the end-use
                                                      concentration is
                                                      not to exceed 250
                                                      ppm.
9-Octadecenoic acid (9Z)-,             1315321-94-8  When ready for use,
 sulfonated, oxidized, potassium                      the end-use
 salts.                                               concentration is
                                                      not to exceed 250
                                                      ppm.
9-Octadecenoic acid (9Z)-,             1315321-95-9  When ready for use,
 sulfonated, oxidized, sodium                         the end-use
 salts.                                               concentration is
                                                      not to exceed 250
                                                      ppm.
 
                              * * * * * * *
------------------------------------------------------------------------


[[Page 11594]]

* * * * *
[FR Doc. 2015-04396 Filed 3-3-15; 8:45 am]
BILLING CODE 6560-50-P
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