Ammonium Persulfate; Exemption From the Requirement of a Tolerance, 63710-63714 [2016-22366]

Download as PDF 63710 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations 2. Add § 180.1338 to subpart D to read as follows: ■ § 180.1338 Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G; temporary exemptions from the requirement of a tolerance. Temporary exemptions from the requirement of a tolerance are established for residues of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G in or on the food and feed commodities of corn, field; corn, pop; and corn, sweet when used in accordance with the terms of Experimental Use Permit No. 91163– EUP–1. These temporary exemptions from the requirement of a tolerance expire on June 30, 2020. [FR Doc. 2016–22357 Filed 9–15–16; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY I. General Information 40 CFR Part 180 [EPA–HQ–OPP–2013–0237; FRL–9951–08] Ammonium Persulfate; 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 ammonium persulfate (CAS Reg. No.7727–54–0) when used as an inert ingredient (preservative) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest, etc.) at a concentration not to exceed 0.05% by weight. Exponent, Inc., on behalf of Becker Underwood, 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 ammonium persulfate under the approved conditions. DATES: This regulation is effective September 16, 2016. Objections and requests for hearings must be received on or before November 15, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2013–0237, is available at http://www.regulations.gov or at the Office of Pesticide Programs Lhorne on DSK30JT082PROD with RULES SUMMARY: VerDate Sep<11>2014 13:04 Sep 15, 2016 Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: Jkt 238001 A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office’s e-CFR site at http:// www.ecfr.gov/cgi-bin/textidx?&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– PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 OPP–2013–0237 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 November 15, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2013–0237, by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/ dockets. II. Petition for Exemption In the Federal Register of June 5, 2013 (78 FR 33785) (FRL–9386–2), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 2E8096) by Exponent, Inc., 1150 Connecticut Ave., Suite 1100, Washington, DC 20036, on behalf of Becker Underwood, Inc., 801 Dayton Avenue, Ames, IA 50010. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of ammonium persulfate (CAS Reg. No. 7727–54–0) when used as an inert ingredient (preservative) in pesticide formulations applied to growing crops or raw agricultural commodities after harvest at a concentration not to exceed 0.05% by weight in pesticide formulations. That document referenced a summary of the petition prepared by Exponent, Inc., the E:\FR\FM\16SER1.SGM 16SER1 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. Lhorne on DSK30JT082PROD with RULES III. Inert Ingredient Definition Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term ‘‘inert’’ is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients. IV. Aggregate Risk Assessment and Determination of Safety Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .’’ EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the VerDate Sep<11>2014 13:04 Sep 15, 2016 Jkt 238001 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 ammonium persulfate including exposure resulting from the exemption established by this action. EPA’s assessment of exposures and risks associated with ammonium persulfate 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 ammonium persulfate as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies The acute oral and dermal rat lethal dose (LD)50s are 495 milligram/kilogram body weight (mg/kg bw) and >2,000 mg/ kg bw, respectively. The inhalation lethal concentration (LC)50 for ammonium persulfate in rats is >2,950 mg/cubic meter (m3). It is irritating to the eyes but not the skin. It is not a dermal sensitizer. Several subchronic studies were available for review for the sodium, potassium and ammonium salts of persulfate. In a 28 day oral (diet) toxicity study in rats, toxicity was manifested as decreased relative adrenal weight at 600 parts per million (ppm) (82 mg/kg/day). The NOAEL was 300 ppm; equal to 41 mg/kg/day. In a 3 months oral (diet) toxicity study in dogs, toxicity was not observed at doses up to 333 mg/kg/day, the highest dose tested. In a toxicity study in rats, ammonium persulfate was administered PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 63711 via inhalation for 13 weeks then allowed a 6-week recovery period. Toxicity was manifested as rales, increased respiratory rate, inflammation of the trachea and bronchi/bronchioles, decreased body weight, and increased lung weight at 25 mg/m3. The NOAEL was 10.3 mg/m3. The reproductive and developmental toxicity of ammonium persulfate has been tested in rats. Parental, offspring and reproduction toxicity was not observed at doses up to 250 mg/kg/day, the highest dose tested. Available mutagenicity and genotoxicity studies included the Ames test, gene mutation and chromosomal aberration assays. Ammonium persulfate produced negative results in all of these studies. Oral and inhalation studies of the carcinogenic and promoting potential of ammonium persulfate do not exist; however, the carcinogenic and promoting potential of ammonium persulfate was tested in a non-guideline study via the dermal route of exposure. In a tumor promotion study, mice were treated dermally with ammonium persulfate biweekly for 51 weeks. In another study, mice were treated topically with a solution of 200 mg/ milliliter (mL) ammonium persulfate for 51 weeks. The incidence of tumors did not increase in either study. Neurotoxicity and immunotoxicity studies were not available for review. However, evidence of neurotoxicity and immunotoxicity of ammonium persulfate was not observed in the submitted studies. B. Toxicological Points of Departure/ Levels of Concern Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which 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 E:\FR\FM\16SER1.SGM 16SER1 63712 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations Lhorne on DSK30JT082PROD with RULES degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http:// www.epa.gov/pesticides/factsheets/ riskassess.htm. There was no hazard attributable to a single exposure seen in the toxicity database for ammonium persulfate. Therefore, ammonium persulfate is not expected to pose an acute risk. The NOAEL for ammonium persulfate was established at 300 ppm; equal to 41 mg/kg/day based on the 28-day repeat dose oral toxicity study in rats based on decreased relative adrenal weight at 600 ppm (82 mg/kg/day). The chronic risk assessment for ammonium persulfate is based on this endpoint and the chronic reference dose (cRfD) is 0.41 mg/kg/day. The additional Food Quality Protection Act (FQPA) uncertainty factor of 3X is applied for use of short-term study for a long-term risk assessment. EPA concluded that the uncertainty factor of 3X is adequate because the end point selected for the risk assessment is very conservative since no effects on absolute adrenal weight was observed; relative weight could be due to slight decrease in body weight; no other systemic toxicity was seen at this dose level and there were no systemic toxicity observed in a 90-day toxicity study in dogs which considered as long term study. Since the FQPA safety factor (SF) has been reduced to 3X, the cPAD is 0.14 mg/kg/day. The NOAEL for inhalation exposure has been established as 10.3 mg/m3 (3 mg/kg/day) based on reversible rales and respiratory rate increases in rats. For dermal exposures, the NOAEL for ammonium persulfate is based on the chronic oral NOAEL with an assumption of 100% dermal adsorption. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to ammonium persulfate, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from ammonium persulfate in food as follows: An acute dietary risk assessment was not conducted because no endpoint of concern following a single exposure was identified in the available studies. A chronic dietary exposure assessment was completed and performed using the Dietary Exposure Evaluation Model DEEM–FCIDTM, Version 3.16.which VerDate Sep<11>2014 13:04 Sep 15, 2016 Jkt 238001 includes food consumption information from the U.S. Department of Agriculture’s National Health and Nutrition Examination Survey, ‘‘What We Eat In America’’, (NHANES/ WWEIA). This dietary survey was conducted from 2003 to 2008. In the absence of actual residue data, the inert ingredient evaluation is based on a highly conservative model that assumes that the residue level of the inert ingredient would be no higher than the highest established tolerance for an active ingredient on a given commodity. Implicit in this assumption is that there would be similar rates of degradation between the active and inert ingredient (if any) and that the concentration of inert ingredient in the scenarios leading to these highest of tolerances would be no higher than the concentration of the active ingredient. The model assumes 100 percent crop treated (PCT) for all crops and that every food eaten by a person each day has tolerance-level residues. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled ‘‘Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts’’ (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA–HQ–OPP–2008–0738. 2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for ammonium persulfate, a conservative drinking water concentration value of 100 parts per billion (ppb) based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables). While there are no current or proposed residential uses for ammonium persulfate, it is possible that ammonium persulfate may be used as an inert ingredient in pesticide products for which short-term and intermediateterm residential exposures may result. In the absence of specific residential exposure scenarios, risk estimates for residential exposures to ammonium PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 persulfate can be modeled based on occupational exposure assessments. Occupational exposure assessments for ammonium persulfate for occupational mixer/loader/applicator exposure and occupational post-application exposure for comparable use scenarios (e.g., low pressure handwand turf application) with only baseline personal protective equipment result in MOEs of 10,000 or greater (i.e., exposures are not of concern). Given the larger treatment areas and higher concentrations used in these occupational use pesticide products than would be seen in residential uses, MOEs for residential use scenarios would exceed 1,000 or more and therefore there are no concerns for residential exposures to ammonium sulfate. 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 ammonium persulfate to share a common mechanism of toxicity with any other substances, and ammonium persulfate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that ammonium persulfate does not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s Web site at http:// www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA SF. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. E:\FR\FM\16SER1.SGM 16SER1 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations Lhorne on DSK30JT082PROD with RULES 2. Prenatal and postnatal sensitivity. There is no evidence of increased susceptibility of infants and children following exposure to ammonium persulfate. In the reproductive and developmental toxicity study of ammonium persulfate in rats, parental, offspring and reproduction toxicity was not observed at doses up to 250 mg/kg/ day, the highest dose tested. 3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 3X. That decision is based on the following findings: i. The toxicity database for ammonium persulfate is partially complete. The additional uncertainty FQPA factor of 3X is applied for use of short-term study for long term risk assessment. ii. There is no indication that ammonium persulfate is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that ammonium persulfate results in increased susceptibility in rats in utero or in young in the reproductive and developmental screening study. iv. There is no evidence of any triggers for immunotoxicity in the available database, therefore there is no need for an immunotoxicity study at this time or an additional UF factor to account for lack of an immunotoxicity study. v. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to ammonium persulfate in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by ammonium persulfate. 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 VerDate Sep<11>2014 13:04 Sep 15, 2016 Jkt 238001 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, ammonium persulfate 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 chronic exposure to ammonium persulfate from food and water will utilize <1% of the cPAD for children 1– 2 years old, the population group receiving the greatest exposure. 3. Short- and Intermediate-term risk. A short- & intermediate-term adverse effect was identified for ammonium persulfate. Short- and intermediate-term risk is assessed based on short- and intermediate-term residential exposure plus chronic dietary exposure. While there are no current or proposed residential uses for ammonium persulfate, it is possible that ammonium persulfate may be used as an inert ingredient in pesticide products for which short- and intermediate-term residential exposures may result. Margins of exposure (MOEs) for shortand intermediate-term residential use scenarios have been calculated and exceed 10,000 or more and therefore, since the level of concern is for MOEs of 300 or less, there are no concerns for residential exposures to ammonium persulfate. 4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of mutagenicity and lack of evidence of tumors in the tumor promoting studies via dermal route, and lack of carcinogenicity for sulfates and ammonia (break down products), ammonium persulfate is not expected to pose a cancer risk to humans. 5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to ammonium persulfate residues. V. Other Considerations A. Analytical Enforcement Methodology Although EPA is establishing a limitation on the amount of ammonium persulfate that may be used in pesticide formulations, an analytical enforcement methodology is not necessary for this exemption from the requirement of PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 63713 tolerance. The limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will not register any pesticide for sale or distribution for use on growing crops with concentrations of ammonium persulfate exceeding 0.05% by weight of the formulation. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations 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 ammonium persulfate. VI. Conclusions Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 for ammonium persulfate (CAS Reg. No. 7727–54–0) when used as an inert ingredient (preservative) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest at a concentration not to exceed 0.05% by weight. VII. Statutory and Executive Order Reviews This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of E:\FR\FM\16SER1.SGM 16SER1 63714 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). VIII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Inert ingredients Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: September 1, 2016. Daniel J. Rosenblatt, Acting 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 § 180.910, add alphabetically the following inert ingredient to the table to read as follows: ■ § 180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance. * * * * [FR Doc. 2016–22366 Filed 9–15–16; 8:45 am] BILLING CODE 6560–50–P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 90 [PS Docket Nos. 12–94, 06–229, 06–150; FCC 16–117] Implementing Public Safety Broadband Provisions of the Middle Class Tax Relief and Job Creation Act of 2012 Federal Communications Commission. ACTION: Final rule. AGENCY: Lhorne on DSK30JT082PROD with RULES List of Subjects in 40 CFR Part 180 Limits * * * * Ammonium persulfate (CAS Reg.No. 7727–54–0) ...................................................... 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). In this document, the Federal Communications Commission (Commission) addresses the 758–769/ 788–799 MHz band, which the Commission licensed to the First Responder Network Authority (FirstNet) on a nationwide basis pursuant to the SUMMARY: VerDate Sep<11>2014 13:04 Sep 15, 2016 Jkt 238001 * 0.05% Frm 00040 Fmt 4700 * Preservative * provisions of the Middle Class Tax Relief and Job Creation Act of 2012. We provide a mechanism to facilitate the relocation of the public safety narrowband incumbents currently operating on FirstNet’s spectrum. We also affirmatively decline at this time to impose specific build-out requirements on FirstNet as a condition of renewal of its license. DATES: Effective October 17, 2016. FOR FURTHER INFORMATION CONTACT: Roberto Mussenden, Policy and Licensing Division, Public Safety and Homeland Security Bureau, (202) 418– 1428. SUPPLEMENTARY INFORMATION: This is a summary of the Commission’s Report and Order in PS Docket No. 12–94, FCC 16–117, adopted on August 24, 2016 and released on August 25, 2016. The document is available for download at http://fjallfoss.fcc.gov/edocs_public/. The complete text of this document is also available for inspection and copying during normal business hours PO 00000 Uses Sfmt 4700 * * * in the FCC Reference Information Center, Portals II, 445 12th Street SW., Room CY–A257, Washington, DC 20554. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to FCC504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202– 418–0530 (voice), 202–418–0432 (TTY). 1. In 2013, the Commission’s Notice of Proposed Rulemaking (NPRM) sought comment on implementation of certain provisions of the Public Safety Spectrum Act, including how to relocate narrowband incumbents operating on the spectrum licensed to FirstNet, and how to address FirstNet’s renewal expectations, including whether FirstNet should be subject to Commission-initiated build-out requirements. 2. In the Report and Order, the Commission permits narrowband incumbents to remain on FirstNet’s licensed spectrum until August 31, E:\FR\FM\16SER1.SGM 16SER1

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[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)]
[Rules and Regulations]
[Pages 63710-63714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22366]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0237; FRL-9951-08]


Ammonium Persulfate; 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 ammonium persulfate (CAS Reg. No.7727-
54-0) when used as an inert ingredient (preservative) in pesticide 
formulations applied to growing crops and raw agricultural commodities 
after harvest, etc.) at a concentration not to exceed 0.05% by weight. 
Exponent, Inc., on behalf of Becker Underwood, 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 ammonium persulfate under the 
approved conditions.

DATES: This regulation is effective September 16, 2016. Objections and 
requests for hearings must be received on or before November 15, 2016, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2013-0237, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2013-0237 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 
November 15, 2016. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2013-0237, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of June 5, 2013 (78 FR 33785) (FRL-9386-2), 
EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, 
announcing the filing of a pesticide petition (PP 2E8096) by Exponent, 
Inc., 1150 Connecticut Ave., Suite 1100, Washington, DC 20036, on 
behalf of Becker Underwood, Inc., 801 Dayton Avenue, Ames, IA 50010. 
The petition requested that 40 CFR 180.910 be amended by establishing 
an exemption from the requirement of a tolerance for residues of 
ammonium persulfate (CAS Reg. No. 7727-54-0) when used as an inert 
ingredient (preservative) in pesticide formulations applied to growing 
crops or raw agricultural commodities after harvest at a concentration 
not to exceed 0.05% by weight in pesticide formulations. That document 
referenced a summary of the petition prepared by Exponent, Inc., the

[[Page 63711]]

petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

III. Inert Ingredient Definition

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

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue . . . .''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for ammonium persulfate including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with ammonium persulfate 
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 ammonium persulfate as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies
    The acute oral and dermal rat lethal dose (LD)50s are 
495 milligram/kilogram body weight (mg/kg bw) and >2,000 mg/kg bw, 
respectively. The inhalation lethal concentration (LC)50 for 
ammonium persulfate in rats is >2,950 mg/cubic meter (m\3\). It is 
irritating to the eyes but not the skin. It is not a dermal sensitizer.
    Several subchronic studies were available for review for the 
sodium, potassium and ammonium salts of persulfate. In a 28 day oral 
(diet) toxicity study in rats, toxicity was manifested as decreased 
relative adrenal weight at 600 parts per million (ppm) (82 mg/kg/day). 
The NOAEL was 300 ppm; equal to 41 mg/kg/day. In a 3 months oral (diet) 
toxicity study in dogs, toxicity was not observed at doses up to 333 
mg/kg/day, the highest dose tested. In a toxicity study in rats, 
ammonium persulfate was administered via inhalation for 13 weeks then 
allowed a 6-week recovery period. Toxicity was manifested as rales, 
increased respiratory rate, inflammation of the trachea and bronchi/
bronchioles, decreased body weight, and increased lung weight at 25 mg/
m\3\. The NOAEL was 10.3 mg/m\3\.
    The reproductive and developmental toxicity of ammonium persulfate 
has been tested in rats. Parental, offspring and reproduction toxicity 
was not observed at doses up to 250 mg/kg/day, the highest dose tested.
    Available mutagenicity and genotoxicity studies included the Ames 
test, gene mutation and chromosomal aberration assays. Ammonium 
persulfate produced negative results in all of these studies.
    Oral and inhalation studies of the carcinogenic and promoting 
potential of ammonium persulfate do not exist; however, the 
carcinogenic and promoting potential of ammonium persulfate was tested 
in a non-guideline study via the dermal route of exposure. In a tumor 
promotion study, mice were treated dermally with ammonium persulfate 
biweekly for 51 weeks. In another study, mice were treated topically 
with a solution of 200 mg/milliliter (mL) ammonium persulfate for 51 
weeks. The incidence of tumors did not increase in either study.
    Neurotoxicity and immunotoxicity studies were not available for 
review. However, evidence of neurotoxicity and immunotoxicity of 
ammonium persulfate was not observed in the submitted studies.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which 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

[[Page 63712]]

degree of risk. Thus, the Agency estimates risk in terms of the 
probability of an occurrence of the adverse effect expected in a 
lifetime. For more information on the general principles EPA uses in 
risk characterization and a complete description of the risk assessment 
process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    There was no hazard attributable to a single exposure seen in the 
toxicity database for ammonium persulfate. Therefore, ammonium 
persulfate is not expected to pose an acute risk.
    The NOAEL for ammonium persulfate was established at 300 ppm; equal 
to 41 mg/kg/day based on the 28-day repeat dose oral toxicity study in 
rats based on decreased relative adrenal weight at 600 ppm (82 mg/kg/
day). The chronic risk assessment for ammonium persulfate is based on 
this endpoint and the chronic reference dose (cRfD) is 0.41 mg/kg/day. 
The additional Food Quality Protection Act (FQPA) uncertainty factor of 
3X is applied for use of short-term study for a long-term risk 
assessment. EPA concluded that the uncertainty factor of 3X is adequate 
because the end point selected for the risk assessment is very 
conservative since no effects on absolute adrenal weight was observed; 
relative weight could be due to slight decrease in body weight; no 
other systemic toxicity was seen at this dose level and there were no 
systemic toxicity observed in a 90-day toxicity study in dogs which 
considered as long term study. Since the FQPA safety factor (SF) has 
been reduced to 3X, the cPAD is 0.14 mg/kg/day. The NOAEL for 
inhalation exposure has been established as 10.3 mg/m\3\ (3 mg/kg/day) 
based on reversible rales and respiratory rate increases in rats. For 
dermal exposures, the NOAEL for ammonium persulfate is based on the 
chronic oral NOAEL with an assumption of 100% dermal adsorption.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to ammonium persulfate, EPA considered exposure under the 
proposed exemption from the requirement of a tolerance. EPA assessed 
dietary exposures from ammonium persulfate in food as follows:
    An acute dietary risk assessment was not conducted because no 
endpoint of concern following a single exposure was identified in the 
available studies. A chronic dietary exposure assessment was completed 
and performed using the Dietary Exposure Evaluation Model DEEM-
FCID\TM\, Version 3.16.which includes food consumption information from 
the U.S. Department of Agriculture's National Health and Nutrition 
Examination Survey, ``What We Eat In America'', (NHANES/WWEIA). This 
dietary survey was conducted from 2003 to 2008. In the absence of 
actual residue data, the inert ingredient evaluation is based on a 
highly conservative model that assumes that the residue level of the 
inert ingredient would be no higher than the highest established 
tolerance for an active ingredient on a given commodity. Implicit in 
this assumption is that there would be similar rates of degradation 
between the active and inert ingredient (if any) and that the 
concentration of inert ingredient in the scenarios leading to these 
highest of tolerances would be no higher than the concentration of the 
active ingredient. The model assumes 100 percent crop treated (PCT) for 
all crops and that every food eaten by a person each day has tolerance-
level residues. A complete description of the general approach taken to 
assess inert ingredient risks in the absence of residue data is 
contained in the memorandum entitled ``Alkyl Amines Polyalkoxylates 
(Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) 
Dietary Exposure and Risk Assessments for the Inerts'' (D361707, S. 
Piper, 2/25/09) and can be found at http://www.regulations.gov in 
docket ID number EPA-HQ-OPP-2008-0738.
    2. Dietary exposure from drinking water. For the purpose of the 
screening level dietary risk assessment to support this request for an 
exemption from the requirement of a tolerance for ammonium persulfate, 
a conservative drinking water concentration value of 100 parts per 
billion (ppb) based on screening level modeling was used to assess the 
contribution to drinking water for the chronic dietary risk assessments 
for parent compound. These values were directly entered into the 
dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables).
    While there are no current or proposed residential uses for 
ammonium persulfate, it is possible that ammonium persulfate may be 
used as an inert ingredient in pesticide products for which short-term 
and intermediate-term residential exposures may result. In the absence 
of specific residential exposure scenarios, risk estimates for 
residential exposures to ammonium persulfate can be modeled based on 
occupational exposure assessments. Occupational exposure assessments 
for ammonium persulfate for occupational mixer/loader/applicator 
exposure and occupational post-application exposure for comparable use 
scenarios (e.g., low pressure handwand turf application) with only 
baseline personal protective equipment result in MOEs of 10,000 or 
greater (i.e., exposures are not of concern). Given the larger 
treatment areas and higher concentrations used in these occupational 
use pesticide products than would be seen in residential uses, MOEs for 
residential use scenarios would exceed 1,000 or more and therefore 
there are no concerns for residential exposures to ammonium sulfate.
    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 ammonium persulfate to share a common mechanism 
of toxicity with any other substances, and ammonium persulfate does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
ammonium persulfate does not have a common mechanism of toxicity with 
other substances. For information regarding EPA's efforts to determine 
which chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA SF. In 
applying this provision, EPA either retains the default value of 10X, 
or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.

[[Page 63713]]

    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of infants and children following exposure to 
ammonium persulfate. In the reproductive and developmental toxicity 
study of ammonium persulfate in rats, parental, offspring and 
reproduction toxicity was not observed at doses up to 250 mg/kg/day, 
the highest dose tested.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 3X. That decision is based on the following 
findings:
    i. The toxicity database for ammonium persulfate is partially 
complete. The additional uncertainty FQPA factor of 3X is applied for 
use of short-term study for long term risk assessment.
    ii. There is no indication that ammonium persulfate is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that ammonium persulfate results in 
increased susceptibility in rats in utero or in young in the 
reproductive and developmental screening study.
    iv. There is no evidence of any triggers for immunotoxicity in the 
available database, therefore there is no need for an immunotoxicity 
study at this time or an additional UF factor to account for lack of an 
immunotoxicity study.
    v. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to ammonium persulfate in drinking water. EPA used 
similarly conservative assumptions to assess postapplication exposure 
of children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
ammonium persulfate.

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, 
ammonium persulfate 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 chronic exposure to 
ammonium persulfate from food and water will utilize <1% of the cPAD 
for children 1-2 years old, the population group receiving the greatest 
exposure.
    3. Short- and Intermediate-term risk. A short- & intermediate-term 
adverse effect was identified for ammonium persulfate. Short- and 
intermediate-term risk is assessed based on short- and intermediate-
term residential exposure plus chronic dietary exposure. While there 
are no current or proposed residential uses for ammonium persulfate, it 
is possible that ammonium persulfate may be used as an inert ingredient 
in pesticide products for which short- and intermediate-term 
residential exposures may result. Margins of exposure (MOEs) for short- 
and intermediate-term residential use scenarios have been calculated 
and exceed 10,000 or more and therefore, since the level of concern is 
for MOEs of 300 or less, there are no concerns for residential 
exposures to ammonium persulfate.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of mutagenicity and lack of evidence of tumors in the tumor 
promoting studies via dermal route, and lack of carcinogenicity for 
sulfates and ammonia (break down products), ammonium persulfate is not 
expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to ammonium persulfate residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Although EPA is establishing a limitation on the amount of ammonium 
persulfate that may be used in pesticide formulations, an analytical 
enforcement methodology is not necessary for this exemption from the 
requirement of tolerance. The limitation will be enforced through the 
pesticide registration process under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will 
not register any pesticide for sale or distribution for use on growing 
crops with concentrations of ammonium persulfate exceeding 0.05% by 
weight of the formulation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
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 ammonium persulfate.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 for ammonium persulfate (CAS Reg. No. 
7727-54-0) when used as an inert ingredient (preservative) in pesticide 
formulations applied to growing crops and raw agricultural commodities 
after harvest at a concentration not to exceed 0.05% by weight.

VII. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of

[[Page 63714]]

Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This action does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special 
considerations under Executive Order 12898, entitled ``Federal Actions 
to Address Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: September 1, 2016.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

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


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

------------------------------------------------------------------------
         Inert ingredients              Limits              Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Ammonium persulfate (CAS Reg.No.             0.05%  Preservative
 7727-54-0).
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2016-22366 Filed 9-15-16; 8:45 am]
 BILLING CODE 6560-50-P