Sorbitan Monooleate Ethylene Oxide Adduct; Exemption From the Requirement of a Tolerance, 46260-46265 [2013-18188]

Download as PDF 46260 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations 4. Collection of Information This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). 5. Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism. 6. Protest Activities The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels. 7. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531–1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble. 8. Taking of Private Property This rule will not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. 9. Civil Justice Reform This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. ehiers on DSK2VPTVN1PROD with RULES 10. Protection of Children We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children. VerDate Mar<15>2010 14:07 Jul 30, 2013 Jkt 229001 11. Indian Tribal Governments This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. 12. Energy Effects This action is not a ‘‘significant energy action’’ under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. 13. Technical Standards This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. 14. Environment We have analyzed this rule under Department of Homeland Security Management Directive 023–01 and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321–4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves establishing a safety zone, requiring a permit wherein an analysis of the environmental impact of the regulations was performed. This rule is categorically excluded, under paragraph 34(h) of Figure 2–1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; Pub. L. 107–295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. Add § 165.T08–0410 to read as follows: ■ § 165.T08–0410 Safety Zone; Upper Mississippi River, Mile 662.8 to 663.9. (a) Location. The following area is a safety zone: All waters of the Upper Mississippi River, mile 662.8 to 663.9, extending the entire width of the waterway. (b) Effective Date. This rule is effective and enforceable on August 10, 2013. (c) Periods of Enforcement. This rule will be enforced during the following time period: From 8:30 p.m. until 10 p.m. for all waters from mile 662.8 to 663.9. The Captain of the Port Upper Mississippi River will inform the public of the enforcement periods via local notice to mariners and subsequent changes by broadcast notice to mariners. (d) Regulations. (1) In accordance with the general regulations in § 165.23 of this part, entry into this zone is prohibited unless authorized by the Captain of the Port Upper Mississippi River or a designated representative. (2) Persons or vessels requiring entry into or passage through the zone must request permission from the Captain of the Port Upper Mississippi River or a designated representative. The Captain of the Port Upper Mississippi River representative may be contacted at 314– 269–2332. (3) All persons and vessels shall comply with the instructions of the Captain of the Port Upper Mississippi River or their designated representative. Designated Captain of the Port representatives include United States Coast Guard commissioned, warrant, and petty officers. Dated: July 10, 2013. B.L. Black, Captain, U.S. Coast Guard, Captain of the Port Upper Mississippi River. [FR Doc. 2013–18342 Filed 7–30–13; 8:45 am] List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR Part 165 as follows: BILLING CODE 9110–04–P PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS Sorbitan Monooleate Ethylene Oxide Adduct; Exemption From the Requirement of a Tolerance 1. The authority citation for part 165 continues to read as follows: AGENCY: ■ Authority: 33 U.S.C., 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2012–0908; FRL–9389–8] Environmental Protection Agency (EPA). ACTION: Final rule. E:\FR\FM\31JYR1.SGM 31JYR1 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations This regulation establishes an exemption from the requirement of a tolerance for residues of sorbitan, mono9-octadecenoate, poly(oxy-1,2ethanediyl) derivs., (Z)- (CAS Reg. No 9005–65–6) (also known as ‘‘sorbitan monooleate ethylene oxide adduct’’ and as ‘‘polysorbate 80’’) when used as an inert ingredient in antimicrobial formulations for use on food-contact surfaces in public eating places, dairyprocessing equipment, and foodprocessing equipment and utensils. Exponent, on behalf of Ecolab, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of sorbitan monooleate ethylene oxide adduct. DATES: This regulation is effective July 31, 2013. Objections and requests for hearings must be received on or before September 30, 2013, 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–2012–0908, 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), EPA West 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: Lois Rossi, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: SUMMARY: ehiers on DSK2VPTVN1PROD with RULES 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 VerDate Mar<15>2010 14:07 Jul 30, 2013 Jkt 229001 Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office’s e-CFR site at https:// www.ecfr.gov/cgi-bin/text-idx?&c=ecfr& tpl=/ecfrbrowse/Title40/40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2012–0908 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before September 30, 2013. 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– 2012–0908, 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. PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 46261 • 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.htm. 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 February 15, 2013 (78 FR 11129) (FRL–9378–4), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN–10524) by Exponent, on behalf of Ecolab, Inc., 370 Wabasha St., 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 sorbitan monooleate ethylene oxide adduct when used as an inert ingredient in antimicrobial formulations applied to food-contact surfaces in public eating places, dairyprocessing equipment, and foodprocessing equipment and utensils. 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. 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 E:\FR\FM\31JYR1.SGM 31JYR1 46262 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations ehiers on DSK2VPTVN1PROD with RULES 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 sorbitan monooleate ethylene oxide adduct including exposure resulting from the exemption established by this action. EPA’s assessment of exposures and risks associated with sorbitan monooleate ethylene oxide adduct 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 VerDate Mar<15>2010 14:07 Jul 30, 2013 Jkt 229001 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 sorbitan monooleate ethylene oxide adduct as well as the no-observedadverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit. The acute oral toxicity of sorbitan monooleate ethylene oxide adduct is low; the LD50 was >25,000 mg/kg in the rat and mouse. Also, no systemic or adverse effects were observed in rats following a single oral dose of 22,000 mg/kg/day. Sorbitan monooleate ethylene oxide adduct did not cause eye irritation in rabbits. It was not a dermal sensitizer in guinea pigs. Acute dermal toxicity was not observed in rabbits exposed to sorbitan sesquioleate ethoxylate, a substance that is closely related to sorbitan monooleate ethylene oxide adduct. Sorbitan monooleate ethylene oxide adduct was administered via the diet to rats in a subchronic toxicity study. Systemic toxicity was not observed in rats following exposure to 2,500 mg/kg/ day of sorbitan monooleate ethylene oxide adduct in the diet for 13 weeks. In developmental and reproduction toxicity studies, rats and mice administered sorbitan monooleate ethylene oxide adduct at doses >10,000 mg/kg/day exhibited toxicity. These doses well exceed the limit dose of 1,000 mg/kg/day. Available mutagenicity studies included the rec-assay, reverse mutation assay, chromosome aberration test, a mouse micronucleus assay, and a dominant lethal test. Sorbitan monooleate ethylene oxide adduct was negative for inducing mutations and aberrations in all of the studies. Therefore, sorbitan monooleate ethylene oxide adduct is considered nonmutagenic. Evidence of carcinogenicity was not observed in mice. In rats, the incidence of adrenal medulla malignant and benign pheochromocytoma is 4% and 58%, respectively, in high dose males. The historical control ranges for malignant and total benign pheochromocytoma are 0–20% and 22– 48%, respectively. The incidence of total benign adrenal medulla pheochromocytoma (29/50, 58%) was marginally increased though not significantly in high dose (50,000 ppm) males only when compared to control male rats (21/50, 42%). Nevertheless, the Agency concluded that the concern for carcinogenicity is low based on the following: PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 1. The adrenal medulla pheochromocytomas were observed in only one sex and species at an extremely high dose, 2,500 mg/kg/day, which is in excess of 2.5 times the limit dose; 2. The increased incidence was observed in benign tumors, 3. The lack of mutagenicity of sorbitan monoleate ethylene oxide adduct; and 4. General low toxicity of the substance. Therefore, a cancer risk assessment was not conducted. Neurotoxicity parameters were evaluated in a reproduction toxicity study in rats with sorbitan monooleate ethylene oxide adduct. Evidence of neurotoxicity was not observed. Although no immunotoxicity studies were available for review, none of the submitted studies indicated any evidence of immunotoxicity. A metabolism study in rats showed that sorbitan monooleate ethylene oxide adduct administered orally is hydrolyzed, poorly absorbed, and excreted mainly in the feces. Bioaccumulation was not observed. B. Toxicological Points of Departure/ Levels of Concern The available toxicity studies indicate that sorbitan monooleate ethylene oxide adduct has very low toxicity. The toxicity database is consists of toxicity data on subchronic and chronic exposures; carcinogenicity, developmental, reproduction, mutagenicity and metabolism. Although a developmental study in rabbits and a dermal toxicity study are not available, there is no concern for the lack of these studies. There is no concern for the lack of a developmental study in rabbits because fetal susceptibility was not observed in the available developmental and reproduction studies in rats and mice. Also, toxicity was only observed at doses (>10,000 mg/kg/day) well above the limit dose. In regard to the sorbitan monooleate ethylene oxide adduct toxicity database, the lowest NOAEL (100 mg/kg/day) was observed in a developmental study in rats where 100 mg/kg/day was the only tested dose. However, the results in this study were considered unreliable because the effects were not reproducible in other studies conducted with the same species, at higher doses and longer exposure. In these remaining studies, toxicity was observed only at doses >2,500 mg/kg/day, well above the limit dose of 1,000 mg/kg/day. Therefore, since no endpoint of concern was identified for the acute and chronic dietary exposure assessment and short and intermediate dermal and inhalation exposure, a quantitative risk assessment E:\FR\FM\31JYR1.SGM 31JYR1 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations ehiers on DSK2VPTVN1PROD with RULES for sorbitan monooleate ethylene oxide adduct is not necessary. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to sorbitan monooleate ethylene oxide adduct, EPA considered exposure under the proposed exemption from the requirement of a tolerance (40 CFR 180.940(a)) and as an inert ingredient used in pesticide formulations applied to growing crops and animals under the existing exemptions from the requirement of a tolerance given at 40 CFR 180.910 and 180.930. EPA assessed dietary exposures from sorbitan monooleate ethylene oxide adduct in food as follows: Sorbitan monooleate ethylene oxide adducts are used as surfactants, related adjuvants of surfactants, emulsifiers, buffering agents, and corrosion inhibitors in a variety of residential pesticide products including yard, garden, and turf products, as well as in agricultural crop products, applied to growing crops, raw agricultural commodities after harvest, and/or to animals. Additionally, they are used extensively as emulsifiers, stabilizers and thickeners in food, cosmetics, personal care and medical products, and lubricants. For the general population, the majority of exposure to sorbitan monooleate ethylene oxide adduct occurs from the extensive use in consumer products and as FDAapproved direct and indirect food additives. Under this exemption from the requirement of a tolerance, residues of this chemical also may be found on food-contact surfaces, such as tableware and utensils, and in dairies and beverage- and food-processing plants. Because no hazard endpoint of concern was identified for the acute and chronic dietary assessment (food and drinking water), a quantitative dietary exposure risk assessment was not conducted. 2. Dietary exposure from drinking water. Sorbitan monooleate ethylene oxide adduct is not expected to be present in drinking water based on its physical/chemical properties. Further, a hazard endpoint of concern was not identified for the acute and chronic dietary assessment; therefore, a quantitative dietary exposure risk assessment was not conducted. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, VerDate Mar<15>2010 14:07 Jul 30, 2013 Jkt 229001 tables). In the case of sorbitan monooleate ethylene oxide adduct, the request is for use as an inert ingredient in antimicrobial formulations for use on food contact surfaces. Sorbitan monooleate ethylene oxide adduct may also be used in personal care products and in products that are registered for specific uses that may result in residential exposure. However, based on the lack of toxicity, a quantitative exposure assessment from ‘‘residential exposures’’ was not performed. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ EPA has not found sorbitan monooleate ethylene oxide adduct to share a common mechanism of toxicity with any other substances, and sorbitan monooleate ethylene oxide adduct does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that sorbitan monooleate ethylene oxide adduct does not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s Web site at 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. As part of its qualitative assessment, the Agency did not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children. The toxicity PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 46263 database contains several acute and subchronic, carcinogenicity, development toxicity, reproductive toxicity, and mutagenicity studies. The available toxicity studies indicate that sorbitan monooleate ethylene oxide adduct has very low toxicity. The lowest NOAEL (100 mg/kg/day) was observed in a developmental study where 100 mg/kg/day was the only tested dose. However, in the remaining studies where more than one dose was tested, toxicity was observed only at doses >2,500 mg/kg/day, well above the limit dose of 1,000 mg/kg/day. Further, fetal toxicity was only observed at doses >10,000 mg/kg/day. Although no neurotoxicity studies are available for sorbitan monooleate ethylene oxide adduct, EPA is not concerned for neurotoxic effects because neurotoxicity was not observed in a developmental study in rats where neurotoxic parameters were evaluated. Also, although no immunotoxicity studies are available for sorbitan monooleate ethylene oxide adduct, none of the submitted studies showed any indications of immunotoxicity. Thus, there is no residual uncertainty with regard to pre- and post-natal toxicity of sorbitan monooleate ethylene oxide adduct. 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 and no acute dietary endpoint was selected. Therefore, sorbitan monooleate ethylene oxide adduct is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that based on the lack of toxicity of sorbitan monooleate ethylene oxide adduct and since no chronic endpoint was identified, chronic risk is not expected. E:\FR\FM\31JYR1.SGM 31JYR1 46264 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations 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 no short-term adverse effect was identified, sorbitan monooleate ethylene oxide adduct is not expected to pose a short-term 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 no intermediate-term adverse effect was identified, sorbitan monooleate ethylene oxide adduct is not expected to pose an intermediate-term risk. 5. Aggregate cancer risk for U.S. population. Based on the discussion of the potential carcinogenicity of sorbitan monooleate ethylene oxide adduct in Unit IV.A., sorbitan monooleate ethylene oxide adduct is not expected to pose a cancer risk. 6. Determination of safety. Based on the lack of concern for hazard posed by sorbitan monooleate ethylene oxide adduct, 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 sorbitan monooleate ethylene oxide adduct. V. Other Considerations A. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. ehiers on DSK2VPTVN1PROD with RULES 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 VerDate Mar<15>2010 14:07 Jul 30, 2013 Jkt 229001 EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for sorbitan monooleate ethylene oxide adduct. VI. Conclusions Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.940(a) for sorbitan, mono-9-octadecenoate, poly(oxy-1,2ethanediyl) derivs., (Z)- (also known as sorbitan monooleate ethylene oxide adduct) (CAS Reg. No. 9005–65–6) when used as an inert ingredient (in antimicrobial formulations) applied to food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils. VII. Statutory and Executive Order Reviews This final rule 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 final rule has been exempted from review under Executive Order 12866, this final rule 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 final rule 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 to the requirement of a 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 final rule 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 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 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 final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (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 of 1995 (NTTAA) (15 U.S.C. 272 note). VIII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: July 22, 2013. Lois Rossi, 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, in paragraph (a), alphabetically add the following inert ingredient to the table to read as follows: ■ E:\FR\FM\31JYR1.SGM 31JYR1 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations § 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. * * * * Sorbitan, mono-9octadecenoate, poly(oxy-1,2ethanediyl) derivs., (Z)-. * * * 9005–65–6 * Limits None. * * 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: Menyon Adams, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 347–8496; email address: adams.menyon@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information * * * * * [FR Doc. 2013–18188 Filed 7–30–13; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2009–0917; FRL–9391–2] Complex Polymeric Polyhydroxy Acids; 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 Complex Polymeric Polyhydroxy Acids in or on all food commodities. This regulation eliminates the need to establish a maximum permissible level for residues of Complex Polymeric Polyhydroxy Acids (CPPA) under FFDCA. DATES: This regulation is effective July 31, 2013. Objections and requests for hearings must be received on or before September 30, 2013, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). SUMMARY: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2009–0917, 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), EPA West 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 ehiers on DSK2VPTVN1PROD with RULES ADDRESSES: VerDate Mar<15>2010 14:07 Jul 30, 2013 Jkt 229001 A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office’s e-CFR site at https:// www.ecfr.gov/cgi-bin/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–2009–0917 in the subject line on the first page of your submission. All PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 46265 objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before September 30, 2013. 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– 2009–0917, by one of the methods provided in 40 CFR 150.17(b). II. Background and Statutory Findings In the Federal Register of January 13, 2010 (75 FR 1775) (FRL–8805–6), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 9F7645) by James R. Yowell of Spring Trading Company (the Petitioner), on behalf of Floratine Biosciences Inc., 153 N. Main St., Suite 100, Collierville, TN 38017. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Complex Polymeric Polyhydroxy Acids. That document referenced a summary of the petition prepared by the Petitioner, which is available in the docket, https:// www.regulations.gov. No comments were received. 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 exemption is ‘‘safe.’’ Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a E:\FR\FM\31JYR1.SGM 31JYR1

Agencies

[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Rules and Regulations]
[Pages 46260-46265]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18188]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0908; FRL-9389-8]


Sorbitan Monooleate Ethylene Oxide Adduct; Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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[[Page 46261]]

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of sorbitan, mono-9-octadecenoate, 
poly(oxy-1,2-ethanediyl) derivs., (Z)- (CAS Reg. No 9005-65-6) (also 
known as ``sorbitan monooleate ethylene oxide adduct'' and as 
``polysorbate 80'') when used as an inert ingredient in antimicrobial 
formulations for use on food-contact surfaces in public eating places, 
dairy-processing equipment, and food-processing equipment and utensils. 
Exponent, on behalf of Ecolab, Inc. submitted a petition to EPA under 
the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the 
establishment of an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of sorbitan monooleate ethylene oxide adduct.

DATES: This regulation is effective July 31, 2013. Objections and 
requests for hearings must be received on or before September 30, 2013, 
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-2012-0908, 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), EPA West 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: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2012-0908 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
September 30, 2013. 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-2012-0908, 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.htm. 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 February 15, 2013 (78 FR 11129) (FRL-
9378-4), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-10524) by 
Exponent, on behalf of Ecolab, Inc., 370 Wabasha St., 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 sorbitan monooleate ethylene oxide adduct when used as an 
inert ingredient in antimicrobial formulations applied to food-contact 
surfaces in public eating places, dairy-processing equipment, and food-
processing equipment and utensils. 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.

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

[[Page 46262]]

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 sorbitan monooleate ethylene 
oxide adduct including exposure resulting from the exemption 
established by this action. EPA's assessment of exposures and risks 
associated with sorbitan monooleate ethylene oxide adduct 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 sorbitan monooleate ethylene oxide 
adduct 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 acute oral toxicity of sorbitan monooleate ethylene oxide 
adduct is low; the LD50 was >25,000 mg/kg in the rat and 
mouse. Also, no systemic or adverse effects were observed in rats 
following a single oral dose of 22,000 mg/kg/day. Sorbitan monooleate 
ethylene oxide adduct did not cause eye irritation in rabbits. It was 
not a dermal sensitizer in guinea pigs. Acute dermal toxicity was not 
observed in rabbits exposed to sorbitan sesquioleate ethoxylate, a 
substance that is closely related to sorbitan monooleate ethylene oxide 
adduct.
    Sorbitan monooleate ethylene oxide adduct was administered via the 
diet to rats in a subchronic toxicity study. Systemic toxicity was not 
observed in rats following exposure to 2,500 mg/kg/day of sorbitan 
monooleate ethylene oxide adduct in the diet for 13 weeks.
    In developmental and reproduction toxicity studies, rats and mice 
administered sorbitan monooleate ethylene oxide adduct at doses >10,000 
mg/kg/day exhibited toxicity. These doses well exceed the limit dose of 
1,000 mg/kg/day.
    Available mutagenicity studies included the rec-assay, reverse 
mutation assay, chromosome aberration test, a mouse micronucleus assay, 
and a dominant lethal test. Sorbitan monooleate ethylene oxide adduct 
was negative for inducing mutations and aberrations in all of the 
studies. Therefore, sorbitan monooleate ethylene oxide adduct is 
considered nonmutagenic.
    Evidence of carcinogenicity was not observed in mice. In rats, the 
incidence of adrenal medulla malignant and benign pheochromocytoma is 
4% and 58%, respectively, in high dose males. The historical control 
ranges for malignant and total benign pheochromocytoma are 0-20% and 
22-48%, respectively. The incidence of total benign adrenal medulla 
pheochromocytoma (29/50, 58%) was marginally increased though not 
significantly in high dose (50,000 ppm) males only when compared to 
control male rats (21/50, 42%). Nevertheless, the Agency concluded that 
the concern for carcinogenicity is low based on the following:
    1. The adrenal medulla pheochromocytomas were observed in only one 
sex and species at an extremely high dose, 2,500 mg/kg/day, which is in 
excess of 2.5 times the limit dose;
    2. The increased incidence was observed in benign tumors,
    3. The lack of mutagenicity of sorbitan monoleate ethylene oxide 
adduct; and
    4. General low toxicity of the substance. Therefore, a cancer risk 
assessment was not conducted.
    Neurotoxicity parameters were evaluated in a reproduction toxicity 
study in rats with sorbitan monooleate ethylene oxide adduct. Evidence 
of neurotoxicity was not observed.
    Although no immunotoxicity studies were available for review, none 
of the submitted studies indicated any evidence of immunotoxicity.
    A metabolism study in rats showed that sorbitan monooleate ethylene 
oxide adduct administered orally is hydrolyzed, poorly absorbed, and 
excreted mainly in the feces. Bioaccumulation was not observed.

B. Toxicological Points of Departure/Levels of Concern

    The available toxicity studies indicate that sorbitan monooleate 
ethylene oxide adduct has very low toxicity. The toxicity database is 
consists of toxicity data on subchronic and chronic exposures; 
carcinogenicity, developmental, reproduction, mutagenicity and 
metabolism. Although a developmental study in rabbits and a dermal 
toxicity study are not available, there is no concern for the lack of 
these studies. There is no concern for the lack of a developmental 
study in rabbits because fetal susceptibility was not observed in the 
available developmental and reproduction studies in rats and mice. 
Also, toxicity was only observed at doses (>10,000 mg/kg/day) well 
above the limit dose.
    In regard to the sorbitan monooleate ethylene oxide adduct toxicity 
database, the lowest NOAEL (100 mg/kg/day) was observed in a 
developmental study in rats where 100 mg/kg/day was the only tested 
dose. However, the results in this study were considered unreliable 
because the effects were not reproducible in other studies conducted 
with the same species, at higher doses and longer exposure. In these 
remaining studies, toxicity was observed only at doses >2,500 mg/kg/
day, well above the limit dose of 1,000 mg/kg/day. Therefore, since no 
endpoint of concern was identified for the acute and chronic dietary 
exposure assessment and short and intermediate dermal and inhalation 
exposure, a quantitative risk assessment

[[Page 46263]]

for sorbitan monooleate ethylene oxide adduct is not necessary.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to sorbitan monooleate ethylene oxide adduct, EPA considered 
exposure under the proposed exemption from the requirement of a 
tolerance (40 CFR 180.940(a)) and as an inert ingredient used in 
pesticide formulations applied to growing crops and animals under the 
existing exemptions from the requirement of a tolerance given at 40 CFR 
180.910 and 180.930. EPA assessed dietary exposures from sorbitan 
monooleate ethylene oxide adduct in food as follows:
    Sorbitan monooleate ethylene oxide adducts are used as surfactants, 
related adjuvants of surfactants, emulsifiers, buffering agents, and 
corrosion inhibitors in a variety of residential pesticide products 
including yard, garden, and turf products, as well as in agricultural 
crop products, applied to growing crops, raw agricultural commodities 
after harvest, and/or to animals. Additionally, they are used 
extensively as emulsifiers, stabilizers and thickeners in food, 
cosmetics, personal care and medical products, and lubricants.
    For the general population, the majority of exposure to sorbitan 
monooleate ethylene oxide adduct occurs from the extensive use in 
consumer products and as FDA-approved direct and indirect food 
additives. Under this exemption from the requirement of a tolerance, 
residues of this chemical also may be found on food-contact surfaces, 
such as tableware and utensils, and in dairies and beverage- and food-
processing plants. Because no hazard endpoint of concern was identified 
for the acute and chronic dietary assessment (food and drinking water), 
a quantitative dietary exposure risk assessment was not conducted.
    2. Dietary exposure from drinking water. Sorbitan monooleate 
ethylene oxide adduct is not expected to be present in drinking water 
based on its physical/chemical properties. Further, a hazard endpoint 
of concern was not identified for the acute and chronic dietary 
assessment; therefore, a quantitative dietary exposure risk assessment 
was not conducted.
    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). In the 
case of sorbitan monooleate ethylene oxide adduct, the request is for 
use as an inert ingredient in antimicrobial formulations for use on 
food contact surfaces. Sorbitan monooleate ethylene oxide adduct may 
also be used in personal care products and in products that are 
registered for specific uses that may result in residential exposure. 
However, based on the lack of toxicity, a quantitative exposure 
assessment from ``residential exposures'' was not performed.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found sorbitan monooleate ethylene oxide adduct to 
share a common mechanism of toxicity with any other substances, and 
sorbitan monooleate ethylene oxide adduct does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that sorbitan monooleate 
ethylene oxide adduct does not have a common mechanism of toxicity with 
other substances. For information regarding EPA's efforts to determine 
which chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at 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.
    As part of its qualitative assessment, the Agency did not use 
safety factors for assessing risk, and no additional safety factor is 
needed for assessing risk to infants and children. The toxicity 
database contains several acute and subchronic, carcinogenicity, 
development toxicity, reproductive toxicity, and mutagenicity studies. 
The available toxicity studies indicate that sorbitan monooleate 
ethylene oxide adduct has very low toxicity. The lowest NOAEL (100 mg/
kg/day) was observed in a developmental study where 100 mg/kg/day was 
the only tested dose. However, in the remaining studies where more than 
one dose was tested, toxicity was observed only at doses >2,500 mg/kg/
day, well above the limit dose of 1,000 mg/kg/day. Further, fetal 
toxicity was only observed at doses >10,000 mg/kg/day. Although no 
neurotoxicity studies are available for sorbitan monooleate ethylene 
oxide adduct, EPA is not concerned for neurotoxic effects because 
neurotoxicity was not observed in a developmental study in rats where 
neurotoxic parameters were evaluated. Also, although no immunotoxicity 
studies are available for sorbitan monooleate ethylene oxide adduct, 
none of the submitted studies showed any indications of immunotoxicity. 
Thus, there is no residual uncertainty with regard to pre- and post-
natal toxicity of sorbitan monooleate ethylene oxide adduct.

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 and no acute dietary endpoint was selected. Therefore, 
sorbitan monooleate ethylene oxide adduct is not expected to pose an 
acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that based on the lack of 
toxicity of sorbitan monooleate ethylene oxide adduct and since no 
chronic endpoint was identified, chronic risk is not expected.

[[Page 46264]]

    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 no 
short-term adverse effect was identified, sorbitan monooleate ethylene 
oxide adduct is not expected to pose a short-term 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 no intermediate-term adverse effect was identified, 
sorbitan monooleate ethylene oxide adduct is not expected to pose an 
intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Based on the 
discussion of the potential carcinogenicity of sorbitan monooleate 
ethylene oxide adduct in Unit IV.A., sorbitan monooleate ethylene oxide 
adduct is not expected to pose a cancer risk.
    6. Determination of safety. Based on the lack of concern for hazard 
posed by sorbitan monooleate ethylene oxide adduct, 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 
sorbitan monooleate ethylene oxide adduct.

V. Other Considerations

A. Analytical Enforcement Methodology

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

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 sorbitan monooleate 
ethylene oxide adduct.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.940(a) for sorbitan, mono-9-octadecenoate, 
poly(oxy-1,2-ethanediyl) derivs., (Z)- (also known as sorbitan 
monooleate ethylene oxide adduct) (CAS Reg. No. 9005-65-6) when used as 
an inert ingredient (in antimicrobial formulations) applied to food-
contact surfaces in public eating places, dairy-processing equipment, 
and food-processing equipment and utensils.

VII. Statutory and Executive Order Reviews

    This final rule 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 final rule has been exempted from review 
under Executive Order 12866, this final rule 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 final rule 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 to the 
requirement of a 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 final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: July 22, 2013.
Lois Rossi,
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, in paragraph (a), alphabetically add the following 
inert ingredient to the table to read as follows:

[[Page 46265]]

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

* * * * *
    (a) * * *

------------------------------------------------------------------------
                                          CAS Reg.
          Pesticide chemical                No.             Limits
------------------------------------------------------------------------
 
                                * * * * *
Sorbitan, mono-9-octadecenoate,           9005-65-6  None.
 poly(oxy-1,2-ethanediyl) derivs., (Z)-
 .
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-18188 Filed 7-30-13; 8:45 am]
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