Sodium Bisulfate; Exemption From the Requirement of a Tolerance, 32662-32666 [2014-13229]

Download as PDF 32662 Federal Register / Vol. 79, No. 109 / Friday, June 6, 2014 / Rules and Regulations (2) The veteran was receiving serviceconnected disability compensation on the date of death; (3) The veteran would have been receiving service-connected disability compensation on the date of death, but for the receipt of military retired pay or non-service-connected disability pension; or (4) The Secretary determines the veteran is eligible for a burial allowance under § 3.1708. (c) Amount payable. The amount payable under this section will not exceed the cost of transporting the remains to the national cemetery closest to the veteran’s last place of residence in which burial space is available, and is subject to the limitations set forth in paragraph (d) of this section. (d) Reimbursable transportation expenses. (1) VA will reimburse reasonable transportation expenses, including but not limited to the costs of shipment via common carrier (i.e., procuring permits for shipment, a shipping case, sealing of the shipping case, and applicable Federal taxes) and costs of transporting the remains to the place of burial. (2) A reasonable transportation expense is an expense that is usual and customary in the context of burial transportation, with a corresponding charge that is the usual and customary charge made to the general public for the same or similar services. (Authority: 38 U.S.C. 2303, 2308) Burial Benefits: Other § 3.1710 Escheat (payment of burial benefits to an estate with no heirs). VA will not pay burial benefits if the payment would escheat (that is, would be turned over to the State because there are no heirs to the estate of the person to whom such benefits would be paid). (Authority: 38 U.S.C. 501(a)) mstockstill on DSK4VPTVN1PROD with RULES § 3.1711 Effect of contributions by government, public, or private organizations. (a) Contributions by government or employer. With respect to claims for a plot or interment allowance under § 3.1707, if VA has evidence that the U.S., a State, any agency or political subdivision of the U.S. or of a State, or the employer of the deceased veteran has paid or contributed payment to the veteran’s plot or interment expenses, VA will pay the claimant up to the lesser of: (1) The allowable statutory amount; or (2) The amount of the total plot or interment expenses minus the amount of expenses paid by any or all of the organizations described in this paragraph (a). VerDate Mar<15>2010 13:35 Jun 05, 2014 Jkt 232001 (b) Burial expenses paid by other agencies of the U.S. (1) Burial allowance when Federal law or regulation also provides for payment. VA cannot pay the non-service-connected burial allowance when any Federal law or regulation also specifically provides for the payment of the deceased veteran’s burial, funeral, or transportation expenses. However, VA will pay the non-service-connected burial allowance when a Federal law or regulation allows the payment of burial expenses using funds due, or accrued to the credit of, the deceased veteran (such as Social Security benefits), but the law or regulation does not specifically require such payment. In such cases, VA will pay the maximum amount specified in 38 U.S.C. 2302. (2) Payment by military service department. VA will not pay or will recoup the non-service-connected burial allowance for deaths occurring during active service or for other deaths for which the service department pays the burial, funeral, or transportation expenses. (3) When a veteran dies while hospitalized. When a veteran dies while hospitalized at the expense of the U.S. government (including, but not limited to, death in a VA facility) and benefits would be otherwise payable under 10 U.S.C. 1482 and a provision of this subpart B, only one of these benefits is payable. VA will attempt to locate a relative of the veteran or another person entitled to reimbursement under § 3.1702(b) and will ask that person to elect between these benefits. (Authority: 38 U.S.C. 2302, 2303(b)) § 3.1712 Effect of forfeiture on payment of burial benefits. (a) Forfeiture for fraud. VA will pay burial benefits, if otherwise in order, based on a deceased veteran who forfeited his or her right to receive benefits due to fraud under § 3.901, Fraud. However, VA will not pay burial benefits to a claimant who participated in fraudulent activity that resulted in forfeiture under § 3.901. (b) Forfeiture for treasonable acts or for subversive activity. VA will not pay burial benefits based on a period of service commencing before the date of commission of the offense if either the veteran or the claimant has forfeited the right to all benefits except insurance payments under § 3.902, Forfeiture for treasonable acts, or § 3.903, Forfeiture for subversive activities, because of a treasonable act or subversive activities, unless the offense was pardoned by the President of the U.S. (Authority: 38 U.S.C. 6103, 6104, 6105) PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 Cross Reference: § 3.1(aa), for the definition of ‘‘fraud.’’ § 3.1713 1958. Eligibility based on status before When any person dies who had a status under any law in effect on December 31, 1957, that afforded entitlement to burial benefits, burial benefits will be paid, if otherwise in order, even though such status does not meet the service requirements of 38 U.S.C. chapter 23. (Authority: 38 U.S.C. 2305) [FR Doc. 2014–13230 Filed 6–5–14; 8:45 am] BILLING CODE 8320–01–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2012–0922; FRL–9910–50] Sodium Bisulfate; 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 sodium bisulfate when used as an inert ingredient in antimicrobial formulations on food contact surfaces in public eating places, dairy processing equipment and food processing equipment and utensils at no more than 2,000 ppm in final formulation. Exponent on behalf of Ecolab, Inc. 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 sodium bisulfate. DATES: This regulation is effective June 6, 2014. Objections and requests for hearings must be received on or before August 5, 2014, 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–2012–0922, 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 ADDRESSES: E:\FR\FM\06JNR1.SGM 06JNR1 Federal Register / Vol. 79, No. 109 / Friday, June 6, 2014 / Rules and Regulations 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/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. mstockstill on DSK4VPTVN1PROD with RULES 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–2012–0922 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 5, 2014. Addresses for VerDate Mar<15>2010 13:35 Jun 05, 2014 Jkt 232001 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– 2012–0922, 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 January 16, 2013 (78 FR 3377) (FRL–9375–4), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN– 10526) 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 sodium bisulfate (CAS Reg. No. 7681–38–1) when used as an inert ingredient in antimicrobial pesticide formulations applied to food contact surfaces in public eating places, dairy processing equipment and food processing equipment and utensils at no more than 2,000 ppm in final formulation. That document referenced a summary of the petition prepared by Exponent, 1150 Connecticut Ave. NW., Suite 1100, Washington, DC 20036, the petitioner, which is available in the docket, https://www.regulations.gov. 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 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 32663 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 E:\FR\FM\06JNR1.SGM 06JNR1 32664 Federal Register / Vol. 79, No. 109 / Friday, June 6, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES 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 sodium bisulfate including exposure resulting from the exemption established by this action. EPA’s assessment of exposures and risks associated with sodium bisulfate 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 sodium bisulfate as well as the noobserved-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies are discussed in this unit. The acute oral toxicity of sodium bisulfate is low. The acute oral LD50 in male rats was 2,800 mg/kg. It was minimally irritating to the rabbit’s skin and mildly irritating to the eyes. An acute inhalation study was available with sodium sulfate. Inhalation toxicity was not observed at 0.01 mg/l (the only dose tested). No dermal toxicity or dermal sanitization studies were available in the database. Due to the lack of data for sodium bisulfate, both human metabolic processes and toxicity data for sodium sulfate were used for the risk characterization. Both sodium bisulfate and sodium sulfate readily undergo hydrolysis and dissociate to sodium ions and sulfate ions in the body. Sodium sulfate was administered to male Sprague-Dawley rats at a dietary concentration of 0.84% (approximately 320–400 mg/kg/day) for 27 and 44 weeks. There was no mortality, tumors, body weight change or significant changes in food and/or water consumption. The NOAEL was ∼320– 400 mg/kg/day. In another study, male Sprague-dawley rats were given in diet 0.0, 0.125, 0.250, 0.5, 1 and 2% sodium sulfate (approximately 0, 125, 250, 500, 1,000 and 2,000 mg/kg/day) for 4 weeks. VerDate Mar<15>2010 13:35 Jun 05, 2014 Jkt 232001 No changes in food and water consumption, body weight gain, food conversion efficiency, urine production or diarrhea. Blood hemoglobin, white blood count, serum alkaline phosphatase, inorganic phosphate and gross organ pathology were also unaffected. The NOAEL was 2,000 mg/ kg/day (highest dose tested). A LOAEL was not observed in this study. Sodium sulfate showed no mutagenic effect in the Ames test using various strains of S. typhimurium (TA1535, TA1537, TA100, TA98) both with and without S9 activation. No carcinogenicity studies were available in the database. The National Toxicology Program (NTP), International Agency for Research on Cancer (IARC), and Occupational Safety & Health Administration (OSHA) have not listed sodium bisulfate as a carcinogen. A DEREK analysis was performed on sodium bisulfate and no structural alerts were detected. EPA concluded that sodium bisulfate is unlikely to pose a carcinogenic risk to humans based on lack of mutagenicity concerns for sodium sulfate, lack of any structural alerts for carcinogenicity, lack of any systemic toxicity at doses up to 2,800 mg/kg/day, and its metabolism to form a sulfate which is natural constituent present in the body. Sodium sulfate was included in a test of a method for rapid assessment of teratogenicity. Pregnant ICR/SIM mice were given a saturated aqueous solution of sodium sulfate orally by gavage to deliver a dose of 2,800 mg/kg/day on days 8–12 of gestation. No maternal deaths occurred and the average maternal weight gain during the treatment period was not significantly different from that of water-treated controls. Twenty-four litters were delivered alive, and none were resorbed. The mean numbers of neonates delivered alive and dead in each litter and the survival of neonates on day 3 were not statistically significantly different from those of controls. Only body weight on day 1 was statistically significantly greater than that of controls. The maternal and developmental NOAEL = 2,800 mg/kg bw, the only dose tested. No immunotoxicity, neurotoxicity or reproductive toxicity studies were available in the database. Sodium bisulfate mammalian metabolism is essentially that of the sodium cation and sulfate anion. As previously noted, when sodium bisulfate is added to food products containing water or after ingestion of sodium bisulfate it ionizes to sodium ions, hydrogen ions and sulfate ions. Following ingestion, sulfate anions are PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 predominantly not absorbed from the gastrointestinal tract and are excreted unchanged in urine. However, the sulfate anion is a normal constituent in the body, predominantly resulting from the body’s metabolism of sulfurcontaining food sources such as foods containing the essential amino acids cysteine and methionine. Sulfate anions are vital components in a number of human biosynthetic pathways such as cartilage production and the formation of pancreatic digestive enzymes. Additionally, the sulfate anion is also an important conjugate in the Phase II conjugation/elimination of oxidized (OH) aromatic ring metabolites and for hydroxyl steroid hormones, such as estrogen, where it acts as a transport agent to target organ tissue receptors. B. Toxicological Points of Departure/ Levels of Concern Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/ safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https:// www.epa.gov/pesticides/factsheets/ riskassess.htm. There was no hazard identified in repeat dose developmental studies at the limit dose of 2,800 mg/kg/day of sodium sulfate to either parental animals or their offspring. No effects were seen in two subchronic oral toxicity up to approximately 2,000 mg/ kg/day of sodium sulfate. Based on the metabolism of sodium bisulfate to sulfate and sodium ions, both of which are essential components in the human E:\FR\FM\06JNR1.SGM 06JNR1 Federal Register / Vol. 79, No. 109 / Friday, June 6, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES metabolic processes, there is a lack of toxicological concern. Thus, due to its low potential hazard and lack of hazard endpoint, the Agency has determined that a quantitative risk assessment using safety factors applied to a point of departure protective of an identified hazard endpoint is not appropriate. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to sodium bisulfate, EPA considered exposure under the proposed exemption from the requirement of a tolerance (40 CFR 180.940(a)) such as food in contact with sanitized counters in public eating places, utensils, dairy processing equipment and food processing equipment as well as other uses which may result in dietary exposure. However, because no hazard was identified for the acute and chronic dietary assessment (food and drinking water), or for the short-, intermediate-, and long-term residential assessments, no quantitative aggregate exposure assessments were performed. 2. Dietary exposure from drinking water. Residues of sodium bisuflate from uses in food contact sanitizing solutions, utensil, dairy processing equipment and food processing equipment may enter drinking water. However, because no hazard was identified for the acute and chronic dietary assessment, or for the short-, intermediate-, and long-term residential assessments as listed in this unit, no quantitative aggregate exposure assessments were performed. 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, tables). Residential (dermal and inhalation) exposure from food contact surface sanitizing solutions for public eating places, dairy-processing equipment, food-processing equipment and utensils are possible. Since an endpoint for risk assessment was not identified, a quantitative residential exposure assessment for sodium bisulfate was not conducted. 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 VerDate Mar<15>2010 13:35 Jun 05, 2014 Jkt 232001 substances that have a common mechanism of toxicity.’’ EPA has not found sodium bisulfate to share a common mechanism of toxicity with any other substances, and sodium bisulfate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that sodium bisulfate 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 The toxicity database for sodium bisulfate is adequate for assessment of risks to infants and children and the potential exposure is adequately characterized given the low toxicity of the chemical and formation of sulfate ion. No hazard was identified and there is no residual uncertainty regarding prenatal and/or postnatal toxicity. No acute or subchronic neurotoxicity studies are available, but there were no clinical signs of neurotoxicity or any systemic toxicity observed in the available database at doses up to 2,800 mg/kg/day. No developmental, reproductive, or teratogenic effects were seen in the available studies at doses up to and including 2,800 mg/kg/day. Based on this information, there is no concern at this time for increased sensitivity to infants and children to sodium bisulfate when used as an inert ingredient in pesticide formulations for food contact surface sanitizing applications and a safety factor analysis has not been used to assess risk. For the same reason, EPA has determined that an additional safety factor is not needed to protect the safety of infants and children. E. Aggregate Risks and Determination of Safety Taking into consideration all available information on sodium bisulfate, EPA has determined that there is a reasonable certainty that no harm to any population subgroup, including infants and children, will result from aggregate exposure to sodium bisulfate under reasonable foreseeable circumstances. Therefore, the establishment of an exemption from tolerance under 40 CFR 180.940(a) for residues of sodium bisulfate when used as an inert ingredient in pesticide formulations applied to food contact surface sanitizing solutions for public eating PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 32665 places, dairy processing equipment, food processing equipment and utensils at no more than 2,000 ppm in formulation, is safe under FFDCA section 408. 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 sodium bisulfate in or on any food commodities. EPA is establishing a limitation on the amount of sodium bisulfate that may be used in pesticide formulations. The limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will not register any pesticide for sale or distribution that contains greater than 2,000 ppm of sodium bisulfate in the pesticide formulation. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nation Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for sodium bisulfate. VI. Conclusions Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.940(a) for sodium bisulfate (CAS Reg. No. 7681–38–1) when used as an inert ingredient in antimicrobial pesticide formulations applied to food contact surface sanitizing solutions for public eating places, dairy processing equipment, food processing equipment and utensils at no more than 2,000 ppm in formulation. E:\FR\FM\06JNR1.SGM 06JNR1 32666 Federal Register / Vol. 79, No. 109 / Friday, June 6, 2014 / Rules and Regulations VII. Statutory and Executive Order Reviews This final rule 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 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 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. Pesticide chemical * mstockstill on DSK4VPTVN1PROD with RULES [EPA–HQ–OPP–2013–0654 and EPA–HQ– OPP–2013–0655; FRL–9910–38] Flutriafol; Pesticide Tolerances Environmental Protection Agency (EPA). AGENCY: Final rule. 13:35 Jun 05, 2014 Jkt 232001 * This regulation is effective June 6, 2014. Objections and requests for hearings must be received on or before August 5, 2014, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). DATES: PO 00000 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: June 2, 2014. 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 the table in paragraph (a), alphabetically add the following inert ingredient to read as follows: ■ § 180.940 Tolerance exemptions for active and inert ingredients for use in antimicrobial formulations (Food-contact surface sanitizing solutions). * * * (a) * * * * This regulation establishes, amends, and removes tolerances for residues of flutriafol in or on multiple commodities which are identified and discussed later in this document. Cheminova A/S c/o Cheminova, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). 40 CFR Part 180 List of Subjects in 40 CFR Part 180 * * * * * * When ready for use, the end-use concentration is not to exceed 2,000 ppm. SUMMARY: ENVIRONMENTAL PROTECTION AGENCY 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). Limits * BILLING CODE 6560–50–P VerDate Mar<15>2010 Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will * 7681–38–1 [FR Doc. 2014–13229 Filed 6–5–14; 8:45 am] ACTION: VIII. Congressional Review Act CAS Reg. No. * * Sodium bisulfate ........................................ * 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). Frm 00034 Fmt 4700 Sfmt 4700 * * The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2013–0654 and EPA–HQ–OPP–2013–0655, 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 ADDRESSES: E:\FR\FM\06JNR1.SGM 06JNR1

Agencies

[Federal Register Volume 79, Number 109 (Friday, June 6, 2014)]
[Rules and Regulations]
[Pages 32662-32666]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13229]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0922; FRL-9910-50]


Sodium Bisulfate; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of sodium bisulfate when used as an inert 
ingredient in antimicrobial formulations on food contact surfaces in 
public eating places, dairy processing equipment and food processing 
equipment and utensils at no more than 2,000 ppm in final formulation. 
Exponent on behalf of Ecolab, Inc. 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 sodium bisulfate.

DATES: This regulation is effective June 6, 2014. Objections and 
requests for hearings must be received on or before August 5, 2014, 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-2012-0922, 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

[[Page 32663]]

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-2012-0922 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
August 5, 2014. 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-2012-0922, 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 January 16, 2013 (78 FR 3377) (FRL-9375-
4), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-10526) 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 sodium 
bisulfate (CAS Reg. No. 7681-38-1) when used as an inert ingredient in 
antimicrobial pesticide formulations applied to food contact surfaces 
in public eating places, dairy processing equipment and food processing 
equipment and utensils at no more than 2,000 ppm in final formulation. 
That document referenced a summary of the petition prepared by 
Exponent, 1150 Connecticut Ave. NW., Suite 1100, Washington, DC 20036, 
the petitioner, which is available in the docket, https://www.regulations.gov.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue. . . .''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will

[[Page 32664]]

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 sodium bisulfate including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with sodium bisulfate 
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 sodium bisulfate 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 sodium bisulfate is low. The acute oral 
LD50 in male rats was 2,800 mg/kg. It was minimally 
irritating to the rabbit's skin and mildly irritating to the eyes. An 
acute inhalation study was available with sodium sulfate. Inhalation 
toxicity was not observed at 0.01 mg/l (the only dose tested). No 
dermal toxicity or dermal sanitization studies were available in the 
database.
    Due to the lack of data for sodium bisulfate, both human metabolic 
processes and toxicity data for sodium sulfate were used for the risk 
characterization. Both sodium bisulfate and sodium sulfate readily 
undergo hydrolysis and dissociate to sodium ions and sulfate ions in 
the body.
    Sodium sulfate was administered to male Sprague-Dawley rats at a 
dietary concentration of 0.84% (approximately 320-400 mg/kg/day) for 27 
and 44 weeks. There was no mortality, tumors, body weight change or 
significant changes in food and/or water consumption. The NOAEL was 
~320-400 mg/kg/day. In another study, male Sprague-dawley rats were 
given in diet 0.0, 0.125, 0.250, 0.5, 1 and 2% sodium sulfate 
(approximately 0, 125, 250, 500, 1,000 and 2,000 mg/kg/day) for 4 
weeks. No changes in food and water consumption, body weight gain, food 
conversion efficiency, urine production or diarrhea. Blood hemoglobin, 
white blood count, serum alkaline phosphatase, inorganic phosphate and 
gross organ pathology were also unaffected. The NOAEL was 2,000 mg/kg/
day (highest dose tested). A LOAEL was not observed in this study.
    Sodium sulfate showed no mutagenic effect in the Ames test using 
various strains of S. typhimurium (TA1535, TA1537, TA100, TA98) both 
with and without S9 activation.
    No carcinogenicity studies were available in the database. The 
National Toxicology Program (NTP), International Agency for Research on 
Cancer (IARC), and Occupational Safety & Health Administration (OSHA) 
have not listed sodium bisulfate as a carcinogen. A DEREK analysis was 
performed on sodium bisulfate and no structural alerts were detected. 
EPA concluded that sodium bisulfate is unlikely to pose a carcinogenic 
risk to humans based on lack of mutagenicity concerns for sodium 
sulfate, lack of any structural alerts for carcinogenicity, lack of any 
systemic toxicity at doses up to 2,800 mg/kg/day, and its metabolism to 
form a sulfate which is natural constituent present in the body.
    Sodium sulfate was included in a test of a method for rapid 
assessment of teratogenicity. Pregnant ICR/SIM mice were given a 
saturated aqueous solution of sodium sulfate orally by gavage to 
deliver a dose of 2,800 mg/kg/day on days 8-12 of gestation. No 
maternal deaths occurred and the average maternal weight gain during 
the treatment period was not significantly different from that of 
water-treated controls. Twenty-four litters were delivered alive, and 
none were resorbed. The mean numbers of neonates delivered alive and 
dead in each litter and the survival of neonates on day 3 were not 
statistically significantly different from those of controls. Only body 
weight on day 1 was statistically significantly greater than that of 
controls. The maternal and developmental NOAEL = 2,800 mg/kg bw, the 
only dose tested.
    No immunotoxicity, neurotoxicity or reproductive toxicity studies 
were available in the database.
    Sodium bisulfate mammalian metabolism is essentially that of the 
sodium cation and sulfate anion. As previously noted, when sodium 
bisulfate is added to food products containing water or after ingestion 
of sodium bisulfate it ionizes to sodium ions, hydrogen ions and 
sulfate ions. Following ingestion, sulfate anions are predominantly not 
absorbed from the gastrointestinal tract and are excreted unchanged in 
urine. However, the sulfate anion is a normal constituent in the body, 
predominantly resulting from the body's metabolism of sulfur-containing 
food sources such as foods containing the essential amino acids 
cysteine and methionine. Sulfate anions are vital components in a 
number of human biosynthetic pathways such as cartilage production and 
the formation of pancreatic digestive enzymes. Additionally, the 
sulfate anion is also an important conjugate in the Phase II 
conjugation/elimination of oxidized (OH) aromatic ring metabolites and 
for hydroxyl steroid hormones, such as estrogen, where it acts as a 
transport agent to target organ tissue receptors.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    There was no hazard identified in repeat dose developmental studies 
at the limit dose of 2,800 mg/kg/day of sodium sulfate to either 
parental animals or their offspring. No effects were seen in two 
subchronic oral toxicity up to approximately 2,000 mg/kg/day of sodium 
sulfate. Based on the metabolism of sodium bisulfate to sulfate and 
sodium ions, both of which are essential components in the human

[[Page 32665]]

metabolic processes, there is a lack of toxicological concern. Thus, 
due to its low potential hazard and lack of hazard endpoint, the Agency 
has determined that a quantitative risk assessment using safety factors 
applied to a point of departure protective of an identified hazard 
endpoint is not appropriate.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to sodium bisulfate, EPA considered exposure under the 
proposed exemption from the requirement of a tolerance (40 CFR 
180.940(a)) such as food in contact with sanitized counters in public 
eating places, utensils, dairy processing equipment and food processing 
equipment as well as other uses which may result in dietary exposure.
    However, because no hazard was identified for the acute and chronic 
dietary assessment (food and drinking water), or for the short-, 
intermediate-, and long-term residential assessments, no quantitative 
aggregate exposure assessments were performed.
    2. Dietary exposure from drinking water. Residues of sodium 
bisuflate from uses in food contact sanitizing solutions, utensil, 
dairy processing equipment and food processing equipment may enter 
drinking water. However, because no hazard was identified for the acute 
and chronic dietary assessment, or for the short-, intermediate-, and 
long-term residential assessments as listed in this unit, no 
quantitative aggregate exposure assessments were performed.
    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).
    Residential (dermal and inhalation) exposure from food contact 
surface sanitizing solutions for public eating places, dairy-processing 
equipment, food-processing equipment and utensils are possible. Since 
an endpoint for risk assessment was not identified, a quantitative 
residential exposure assessment for sodium bisulfate was not conducted.
    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 sodium bisulfate to share a common mechanism of 
toxicity with any other substances, and sodium bisulfate does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
sodium bisulfate 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

    The toxicity database for sodium bisulfate is adequate for 
assessment of risks to infants and children and the potential exposure 
is adequately characterized given the low toxicity of the chemical and 
formation of sulfate ion. No hazard was identified and there is no 
residual uncertainty regarding prenatal and/or postnatal toxicity. No 
acute or subchronic neurotoxicity studies are available, but there were 
no clinical signs of neurotoxicity or any systemic toxicity observed in 
the available database at doses up to 2,800 mg/kg/day. No 
developmental, reproductive, or teratogenic effects were seen in the 
available studies at doses up to and including 2,800 mg/kg/day.
    Based on this information, there is no concern at this time for 
increased sensitivity to infants and children to sodium bisulfate when 
used as an inert ingredient in pesticide formulations for food contact 
surface sanitizing applications and a safety factor analysis has not 
been used to assess risk. For the same reason, EPA has determined that 
an additional safety factor is not needed to protect the safety of 
infants and children.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on sodium 
bisulfate, EPA has determined that there is a reasonable certainty that 
no harm to any population subgroup, including infants and children, 
will result from aggregate exposure to sodium bisulfate under 
reasonable foreseeable circumstances. Therefore, the establishment of 
an exemption from tolerance under 40 CFR 180.940(a) for residues of 
sodium bisulfate when used as an inert ingredient in pesticide 
formulations applied to food contact surface sanitizing solutions for 
public eating places, dairy processing equipment, food processing 
equipment and utensils at no more than 2,000 ppm in formulation, is 
safe under FFDCA section 408.

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 
sodium bisulfate in or on any food commodities. EPA is establishing a 
limitation on the amount of sodium bisulfate that may be used in 
pesticide formulations. The limitation will be enforced through the 
pesticide registration process under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will 
not register any pesticide for sale or distribution that contains 
greater than 2,000 ppm of sodium bisulfate in the pesticide 
formulation.

B. International Residue Limits

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

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.940(a) for sodium bisulfate (CAS Reg. No. 
7681-38-1) when used as an inert ingredient in antimicrobial pesticide 
formulations applied to food contact surface sanitizing solutions for 
public eating places, dairy processing equipment, food processing 
equipment and utensils at no more than 2,000 ppm in formulation.

[[Page 32666]]

VII. Statutory and Executive Order Reviews

    This final rule 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 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 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: June 2, 2014.
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 the table in paragraph (a), alphabetically add 
the following inert ingredient 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
------------------------------------------------------------------------
 
                              * * * * * * *
Sodium bisulfate...............       7681-38-1  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 2,000
                                                  ppm.
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2014-13229 Filed 6-5-14; 8:45 am]
BILLING CODE 6560-50-P
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