Iron Oxide Yellow; Exemption From the Requirement of a Tolerance, 78928-78932 [2016-27191]

Download as PDF 78928 Federal Register / Vol. 81, No. 218 / Thursday, November 10, 2016 / Rules and Regulations Pennsylvania Ave. NW., Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: [FR Doc. 2016–27212 Filed 11–9–16; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY I. General Information 40 CFR Part 180 A. Does this action apply to me? [EPA–HQ–OPP–2016–0159; FRL–9953–21] Iron Oxide Yellow; 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 iron oxide yellow (CAS Reg. No. 20344–49–4) when used as an inert ingredient (colorant) in pesticide formulations intended for varroa mite control around bee hives at a maximum concentration not to exceed 0.15% by weight in the pesticide formulation. Technology Sciences Group, Inc. on behalf of Bayer HealthCare LLC submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of iron oxide yellow. DATES: This regulation is effective November 10, 2016. Objections and requests for hearings must be received on or before January 9, 2017, 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–2016–0159, 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 asabaliauskas on DSK3SPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 16:33 Nov 09, 2016 Jkt 241001 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– OPP–2016–0159 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 January 9, 2017. 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 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2016–0159, 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 April 25, 2016 (81 FR 24042) (FRL–9944–86), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN–10884) by Technology Sciences Group, Inc. (1150 18th Street NW., Suite 1000, Washington, DC 20036) on behalf of Bayer HealthCare LLC (Animal Health, P.O. Box 390, Shawnee Mission, KS 66201–0390). The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of iron oxide yellow (CAS Reg. No. 20344–49–4), when used as an inert ingredient (colorant) in pesticide formulations intended for varroa mite control around bee hives at a concentration not to exceed 0.15% by weight. That document referenced a summary of the petition prepared by Technology Sciences Group on behalf of Bayer HealthCare Inc., the petitioner, which is available in the docket, http:// www.regulations.gov. Comments were not received on 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; E:\FR\FM\10NOR1.SGM 10NOR1 Federal Register / Vol. 81, No. 218 / Thursday, November 10, 2016 / Rules and Regulations asabaliauskas on DSK3SPTVN1PROD with RULES 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 VerDate Sep<11>2014 16:33 Nov 09, 2016 Jkt 241001 support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for iron oxide yellow including exposure resulting from the exemption established by this action. EPA’s assessment of exposures and risks associated with iron oxide yellow 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 iron oxide yellow as well as the noobserved-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 in rats, mice and dogs is low for iron oxide yellow. In an eight-generation reproduction study with rats, iron oxide was administered in the feed at an estimated oral dose of 25 milligram (mg) iron/day. No signs of toxicity were evident, reproductive performance was not affected. Ten dogs were fed, from 1 to 9 years, diets containing iron oxide. Daily consumption was estimated to be 428 mg/dog. Two dogs experienced minor irregularities with stools, no other toxicological adverse effects were seen. Four dogs were injected (i.v.) weekly for 10 weeks until each dog had received a total of 0.5 to 1.0 g/kg. There were signs of retinitis pigmentosa however there were no negative effects in hepatic function tests and biopsies of the liver, spleen, pancreas and other organs. Hemochromatosis was not induced. Iron oxide yellow is poorly absorbed by mammalian systems after ingestion but data indicate it can be absorbed as iron after solubilization in the stomach and reduction to the ferrous form in the duodenum. Absorption of ingested iron in mammalian systems occurs primarily in the upper small intestine. Iron absorption is tightly regulated biologically such that individuals with low body iron stores absorb more iron while those with excess iron stores absorb less iron. Iron balance in the body is maintained by regulation of iron absorption in the upper small intestine because there are no specific mechanisms to eliminate excess iron. PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 78929 Iron is an essential element necessary for maintenance of mammalian metabolic systems. Iron intake varies depending on the source of iron, the foods consumed with the iron, the iron oxidation state and the iron needs of the body. For instance, iron from animal origin (heme-iron) is more readily absorbed than iron from vegetable origins (5–20% for meats; 1–10% from vegetable iron). The non-heme iron absorption depends on solubilization of plant-based or inorganic iron in the stomach prior to entry in the intestines. Non-heme iron from ferrous salts is more readily absorbed than iron from ionizable ferric salts, and iron from ferric oxides and hydroxides is the least readily absorbed. Non-heme iron is transported into the duodenal mucosal cells via a transmembrane metal transporter protein that is upregulated when body iron stores are low and down-regulated when body iron stores are high. This mechanism minimizes the likelihood of excess systemic exposure to iron. B. Toxicological Points of Departure/ Levels of Concern Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL are identified. Uncertainty/ safety factors 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 http:// www.epa.gov/pesticides/factsheets/ riskassess.htm. An acute effect was not found in the database therefore an acute dietary assessment is not necessary. A NOAEL has not been identified for risk assessment purposes. However, the acceptable daily intake (ADI) level E:\FR\FM\10NOR1.SGM 10NOR1 78930 Federal Register / Vol. 81, No. 218 / Thursday, November 10, 2016 / Rules and Regulations asabaliauskas on DSK3SPTVN1PROD with RULES identified by the World Health Organization Joint Expert Committee on Food and Agriculture is used as a safe exposure level for risk assessment purposes. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to iron oxide yellow, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from iron oxide yellow in food as follows: Dietary exposure (food and drinking water) to iron oxide yellow could occur following ingestion of honey with residues from treated beehives. Because no adverse effects attributable to a single exposure of iron oxide yellow are seen in the toxicity databases, an acute dietary risk assessment is not necessary. For the chronic dietary risk assessment, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM–FCIDTM, Version 3.16, and food consumption information from the U.S. Department of Agriculture’s (USDA’s) 2003–2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). One hundred percent crop treated was assumed, default processing factors, and tolerance-level residues for honey and use limitations of not more than 0.15% by weight in pesticide formulations. 2. Dietary exposure from drinking water. For the purpose of the screeninglevel dietary risk assessment to support this request for an exemption from the requirement of a tolerance for iron oxide yellow, 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). Iron oxide yellow might be used in inert ingredients in products that are registered for specific uses that may result in residential exposure, such as pesticides used in and around the home, personal (care) products, and cosmetics. The Agency conducted an assessment to represent worst-case residential dietary exposure from honey only. The Agency agrees with the World Health VerDate Sep<11>2014 16:33 Nov 09, 2016 Jkt 241001 Organization Joint Expert Committee on Food and Agriculture opinion that there was no need for additional human absorption studies. The WHO JEFCA committee concluded that it is unlikely that intake of iron oxides from all sources would exceed the Acceptable Daily Intake of 0–0.5 milligram/ kilogram/day (mg/kg/day). Thus the JEFCA committee did not prepare a toxicological monograph on the iron oxides. 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 iron oxide yellow to share a common mechanism of toxicity with any other substances, and iron oxide yellow does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that iron oxide yellow 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. Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. The toxicity database for iron oxide yellow contains an eight generation reproduction/developmental toxicity screening study with the rat. No signs of toxicity were evident and reproductive performance was not negatively affected. There is no indication of neurotoxicity or immunotoxicity in the available studies with dogs and rat therefore, there is no need to require neurotoxicity or immunotoxicity studies. Qualitative fetal susceptibility was observed in the 2-generation toxicity study in rats. However, concern for fetal effects are low since they only occurred in the presence of maternal toxicity and protecting against maternal toxicity will subsequently prevent fetal toxicity. In addition, the ADI of 0.5 mg/ kg/day, will be protective of fetal effects. In addition, the Agency used conservative exposure estimates, with 100 percent crop treated (PCT), tolerance-level residues, conservative drinking water modeling numbers, and a worst-case assessment of potential residential exposure for infants and children. D. Safety Factor for Infants and Children Section 408(b)(2)(c) of the FFDCA provides that EPA shall apply an additional 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 that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of iron oxide yellow, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. 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 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, iron oxide yellow 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 iron oxide yellow from food (honey) and water will utilize 0.0% of the ADI for children 1– PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 E. Aggregate Risks and Determination of Safety E:\FR\FM\10NOR1.SGM 10NOR1 asabaliauskas on DSK3SPTVN1PROD with RULES Federal Register / Vol. 81, No. 218 / Thursday, November 10, 2016 / Rules and Regulations 2 years old, the population group receiving the greatest exposure. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Iron oxide yellow may be used as an inert ingredient in pesticide products that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food (honey). Using the exposure assumptions described above, EPA has concluded that the combined short-term food, water, and residential exposure result in aggregate MOEs of 6,758 for both adult males and females respectively. As the level of concern is for MOEs that are lower than 100, this MOEs is not of concern. EPA has concluded the combined short-term food, water, and residential exposures result in an aggregate MOE of 4,347 for children. As the level of concern is for MOEs that are lower than 100, this MOEs is not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Iron oxide yellow may be used as an inert ingredient in pesticide products that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food (honey). Using the exposure assumptions described above, EPA has concluded that the combined short-term food, water, and residential exposure result in aggregate MOEs of 6,758 for both adult males and females respectively. As the level of concern is for MOEs that are lower than 100, this MOEs is not of concern. EPA has concluded the combined short-term food, water, and residential exposures result in an aggregate MOE of 4,347 for children. As the level of concern is for MOEs that are lower than 100, this MOEs is not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Iron oxide yellow may be used as inert ingredients in pesticide products that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food (honey) and water. Using the exposure VerDate Sep<11>2014 16:33 Nov 09, 2016 Jkt 241001 assumptions described above, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in aggregate MOEs of 6,758 for adult males and females. As the level of concern is for MOEs that are lower than 100, this MOE is not of concern. EPA has concluded the combined intermediate-term food, water, and residential exposures result in an aggregate MOE of 4,347 for children. As the level of concern is for MOEs that are lower than 100, this MOE is not of concern. 5. Aggregate cancer risk for U.S. population. Based on the data in the toxicological database iron oxide yellow is considered not expected to pose a cancer risk to humans. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to iron oxide yellow residues. V. Other Considerations A. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of iron oxide yellow in or on any food commodities. EPA is establishing a limitation on the amount of iron oxide yellow that may be used in pesticide formulations applied to growing crops and raw agricultural commodities after harvest. That limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will not register any pesticide formulation for use on growing crops or raw agricultural commodities after harvest for sale or distribution that exceed 0.15% of iron oxide yellow. VI. Conclusions Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 for iron oxide yellow (CAS Reg. No. 20344–49–4) when used as an inert ingredient (colorant) in pesticide products intended for varroa mite control around bee hives at a concentration not to exceed 0.15% by weight in the end-use product formulation. VII. Statutory and Executive Order Reviews This action establishes exemptions to the requirement for a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 78931 Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemptions 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 E:\FR\FM\10NOR1.SGM 10NOR1 78932 Federal Register / Vol. 81, No. 218 / Thursday, November 10, 2016 / Rules and Regulations 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). PART 180—[AMENDED] List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. ■ Dated: October 24, 2016. Daniel J. Rosenblatt, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: 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 inert ingredient ‘‘Iron oxide yellow (CAS Reg. No. 20344–49–4)’’ to the table to read as follows: ■ § 180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance. * * * * * Inert ingredients Limits Uses * * Iron oxide yellow (CAS Reg. No. 20344–49–4). * * Not to exceed 0.15% by weight of pesticide formulation. * * * Colorant in pesticide formulations for varroa mite control around bee hives * * * * * * * B. How can I get electronic access to other related information? [EPA–HQ–OPP–2015–0745; FRL–9954–04] 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. Trifloxystrobin; Pesticide Tolerances FOR FURTHER INFORMATION CONTACT: C. How can I file an objection or hearing request? [FR Doc. 2016–27191 Filed 11–9–16; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of trifloxystrobin in or on Cottonseed subgroup 20C; Cotton, gin byproducts; and amends the existing tolerance on Corn, field, forage. Bayer CropScience LP requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective November 10, 2016. Objections and requests for hearings must be received on or before January 9, 2017, 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–2015–0745, 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 asabaliauskas on DSK3SPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 16:33 Nov 09, 2016 Jkt 241001 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). PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 You may access a frequently updated electronic version of EPA’s tolerance regulations at 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. 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–2015–0745 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 January 9, 2017. 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 E:\FR\FM\10NOR1.SGM 10NOR1

Agencies

[Federal Register Volume 81, Number 218 (Thursday, November 10, 2016)]
[Rules and Regulations]
[Pages 78928-78932]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27191]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0159; FRL-9953-21]


Iron Oxide Yellow; 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 iron oxide yellow (CAS Reg. No. 20344-
49-4) when used as an inert ingredient (colorant) in pesticide 
formulations intended for varroa mite control around bee hives at a 
maximum concentration not to exceed 0.15% by weight in the pesticide 
formulation. Technology Sciences Group, Inc. on behalf of Bayer 
HealthCare LLC submitted a petition to EPA under the Federal Food, 
Drug, and Cosmetic Act (FFDCA), requesting the establishment of an 
exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of iron oxide yellow.

DATES: This regulation is effective November 10, 2016. Objections and 
requests for hearings must be received on or before January 9, 2017, 
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-2016-0159, 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-2016-0159 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 
January 9, 2017. 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-2016-0159, 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 April 25, 2016 (81 FR 24042) (FRL-9944-
86), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-10884) by 
Technology Sciences Group, Inc. (1150 18th Street NW., Suite 1000, 
Washington, DC 20036) on behalf of Bayer HealthCare LLC (Animal Health, 
P.O. Box 390, Shawnee Mission, KS 66201-0390). The petition requested 
that 40 CFR 180.910 be amended by establishing an exemption from the 
requirement of a tolerance for residues of iron oxide yellow (CAS Reg. 
No. 20344-49-4), when used as an inert ingredient (colorant) in 
pesticide formulations intended for varroa mite control around bee 
hives at a concentration not to exceed 0.15% by weight. That document 
referenced a summary of the petition prepared by Technology Sciences 
Group on behalf of Bayer HealthCare Inc., the petitioner, which is 
available in the docket, http://www.regulations.gov. Comments were not 
received on 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;

[[Page 78929]]

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 iron oxide yellow including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with iron oxide yellow 
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 iron oxide yellow 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 in rats, mice and dogs is low for iron 
oxide yellow. In an eight-generation reproduction study with rats, iron 
oxide was administered in the feed at an estimated oral dose of 25 
milligram (mg) iron/day. No signs of toxicity were evident, 
reproductive performance was not affected.
    Ten dogs were fed, from 1 to 9 years, diets containing iron oxide. 
Daily consumption was estimated to be 428 mg/dog. Two dogs experienced 
minor irregularities with stools, no other toxicological adverse 
effects were seen.
    Four dogs were injected (i.v.) weekly for 10 weeks until each dog 
had received a total of 0.5 to 1.0 g/kg. There were signs of retinitis 
pigmentosa however there were no negative effects in hepatic function 
tests and biopsies of the liver, spleen, pancreas and other organs. 
Hemochromatosis was not induced.
    Iron oxide yellow is poorly absorbed by mammalian systems after 
ingestion but data indicate it can be absorbed as iron after 
solubilization in the stomach and reduction to the ferrous form in the 
duodenum. Absorption of ingested iron in mammalian systems occurs 
primarily in the upper small intestine. Iron absorption is tightly 
regulated biologically such that individuals with low body iron stores 
absorb more iron while those with excess iron stores absorb less iron. 
Iron balance in the body is maintained by regulation of iron absorption 
in the upper small intestine because there are no specific mechanisms 
to eliminate excess iron.
    Iron is an essential element necessary for maintenance of mammalian 
metabolic systems. Iron intake varies depending on the source of iron, 
the foods consumed with the iron, the iron oxidation state and the iron 
needs of the body. For instance, iron from animal origin (heme-iron) is 
more readily absorbed than iron from vegetable origins (5-20% for 
meats; 1-10% from vegetable iron). The non-heme iron absorption depends 
on solubilization of plant-based or inorganic iron in the stomach prior 
to entry in the intestines. Non-heme iron from ferrous salts is more 
readily absorbed than iron from ionizable ferric salts, and iron from 
ferric oxides and hydroxides is the least readily absorbed. Non-heme 
iron is transported into the duodenal mucosal cells via a transmembrane 
metal transporter protein that is upregulated when body iron stores are 
low and down-regulated when body iron stores are high. This mechanism 
minimizes the likelihood of excess systemic exposure to iron.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which the NOAEL and the LOAEL are identified. 
Uncertainty/safety factors 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 http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    An acute effect was not found in the database therefore an acute 
dietary assessment is not necessary. A NOAEL has not been identified 
for risk assessment purposes. However, the acceptable daily intake 
(ADI) level

[[Page 78930]]

identified by the World Health Organization Joint Expert Committee on 
Food and Agriculture is used as a safe exposure level for risk 
assessment purposes.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to iron oxide yellow, EPA considered exposure under the 
proposed exemption from the requirement of a tolerance. EPA assessed 
dietary exposures from iron oxide yellow in food as follows:
    Dietary exposure (food and drinking water) to iron oxide yellow 
could occur following ingestion of honey with residues from treated 
beehives. Because no adverse effects attributable to a single exposure 
of iron oxide yellow are seen in the toxicity databases, an acute 
dietary risk assessment is not necessary. For the chronic dietary risk 
assessment, EPA used the Dietary Exposure Evaluation Model software 
with the Food Commodity Intake Database (DEEM-FCIDTM, 
Version 3.16, and food consumption information from the U.S. Department 
of Agriculture's (USDA's) 2003-2008 National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA). One hundred 
percent crop treated was assumed, default processing factors, and 
tolerance-level residues for honey and use limitations of not more than 
0.15% by weight in pesticide formulations.
    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 iron oxide yellow, 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). Iron 
oxide yellow might be used in inert ingredients in products that are 
registered for specific uses that may result in residential exposure, 
such as pesticides used in and around the home, personal (care) 
products, and cosmetics. The Agency conducted an assessment to 
represent worst-case residential dietary exposure from honey only. The 
Agency agrees with the World Health Organization Joint Expert Committee 
on Food and Agriculture opinion that there was no need for additional 
human absorption studies. The WHO JEFCA committee concluded that it is 
unlikely that intake of iron oxides from all sources would exceed the 
Acceptable Daily Intake of 0-0.5 milligram/kilogram/day (mg/kg/day). 
Thus the JEFCA committee did not prepare a toxicological monograph on 
the iron oxides.
    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 iron oxide yellow to share a common mechanism of 
toxicity with any other substances, and iron oxide yellow does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
iron oxide yellow 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

    Section 408(b)(2)(c) of the FFDCA provides that EPA shall apply an 
additional 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 that a different margin of safety will be safe for infants 
and children. Due to the expected low toxicity of iron oxide yellow, 
EPA has not used a safety factor analysis to assess the risk. For the 
same reasons the additional tenfold safety factor is unnecessary.
    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. The toxicity database for 
iron oxide yellow contains an eight generation reproduction/
developmental toxicity screening study with the rat. No signs of 
toxicity were evident and reproductive performance was not negatively 
affected. There is no indication of neurotoxicity or immunotoxicity in 
the available studies with dogs and rat therefore, there is no need to 
require neurotoxicity or immunotoxicity studies. Qualitative fetal 
susceptibility was observed in the 2-generation toxicity study in rats. 
However, concern for fetal effects are low since they only occurred in 
the presence of maternal toxicity and protecting against maternal 
toxicity will subsequently prevent fetal toxicity. In addition, the ADI 
of 0.5 mg/kg/day, will be protective of fetal effects. In addition, the 
Agency used conservative exposure estimates, with 100 percent crop 
treated (PCT), tolerance-level residues, conservative drinking water 
modeling numbers, and a worst-case assessment of potential residential 
exposure for infants and children.

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, 
iron oxide yellow 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 
iron oxide yellow from food (honey) and water will utilize 0.0% of the 
ADI for children 1-

[[Page 78931]]

2 years old, the population group receiving the greatest exposure.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Iron oxide yellow may be used as an inert ingredient in pesticide 
products that could result in short-term residential exposure and the 
Agency has determined that it is appropriate to aggregate chronic 
exposure through food (honey). Using the exposure assumptions described 
above, EPA has concluded that the combined short-term food, water, and 
residential exposure result in aggregate MOEs of 6,758 for both adult 
males and females respectively. As the level of concern is for MOEs 
that are lower than 100, this MOEs is not of concern.
    EPA has concluded the combined short-term food, water, and 
residential exposures result in an aggregate MOE of 4,347 for children. 
As the level of concern is for MOEs that are lower than 100, this MOEs 
is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Iron oxide yellow may be used as an inert ingredient in pesticide 
products that could result in short-term residential exposure and the 
Agency has determined that it is appropriate to aggregate chronic 
exposure through food (honey). Using the exposure assumptions described 
above, EPA has concluded that the combined short-term food, water, and 
residential exposure result in aggregate MOEs of 6,758 for both adult 
males and females respectively. As the level of concern is for MOEs 
that are lower than 100, this MOEs is not of concern.
    EPA has concluded the combined short-term food, water, and 
residential exposures result in an aggregate MOE of 4,347 for children. 
As the level of concern is for MOEs that are lower than 100, this MOEs 
is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Iron oxide yellow may be used as inert ingredients in pesticide 
products that could result in intermediate-term residential exposure 
and the Agency has determined that it is appropriate to aggregate 
chronic exposure through food (honey) and water. Using the exposure 
assumptions described above, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 6,758 for adult males and females. As the level of 
concern is for MOEs that are lower than 100, this MOE is not of 
concern. EPA has concluded the combined intermediate-term food, water, 
and residential exposures result in an aggregate MOE of 4,347 for 
children. As the level of concern is for MOEs that are lower than 100, 
this MOE is not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the data in 
the toxicological database iron oxide yellow is considered not expected 
to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to iron oxide yellow residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is not establishing a numerical tolerance for residues of 
iron oxide yellow in or on any food commodities. EPA is establishing a 
limitation on the amount of iron oxide yellow that may be used in 
pesticide formulations applied to growing crops and raw agricultural 
commodities after harvest. That limitation will be enforced through the 
pesticide registration process under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will 
not register any pesticide formulation for use on growing crops or raw 
agricultural commodities after harvest for sale or distribution that 
exceed 0.15% of iron oxide yellow.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 for iron oxide yellow (CAS Reg. No. 
20344-49-4) when used as an inert ingredient (colorant) in pesticide 
products intended for varroa mite control around bee hives at a 
concentration not to exceed 0.15% by weight in the end-use product 
formulation.

VII. Statutory and Executive Order Reviews

    This action establishes exemptions to the requirement for a 
tolerance under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993). Because this action has been exempted from review 
under Executive Order 12866, this action is not subject to Executive 
Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This action does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special 
considerations under Executive Order 12898, entitled ``Federal Actions 
to Address Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the exemptions 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

[[Page 78932]]

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: October 24, 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 inert ingredient ``Iron 
oxide yellow (CAS Reg. No. 20344-49-4)'' 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
------------------------------------------------------------------------
 
                              * * * * * * *
Iron oxide yellow (CAS Reg. No.   Not to exceed       Colorant in
 20344-49-4).                      0.15% by weight     pesticide
                                   of pesticide        formulations for
                                   formulation.        varroa mite
                                                       control around
                                                       bee hives
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2016-27191 Filed 11-9-16; 8:45 am]
 BILLING CODE 6560-50-P