Aspergillus flavus AF36; Time Limited Exemption From the Requirement of a Tolerance, 1890-1894 [2016-00665]

Download as PDF 1890 Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Rules and Regulations § 52.1320 Subpart AA—Missouri 2. Section 52.1320(e) is amended by adding new entry (68) at the end of the table to read as follows: ■ * Identification of plan. * * (e) * * * * * EPA-APPROVED MISSOURI NONREGULATORY SIP PROVISIONS Name of nonregulatory SIP provision Applicable geographic or nonattainment area State submittal date * * * (68) Missouri Early Progress St. Louis ................................. Plan. * 8/26/13 [FR Doc. 2016–00428 Filed 1–13–16; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 52 and 70 [EPA–R07–OAR–2013–0765; FRL–9940–97– Region 7] Approval and Promulgation of Implementation Plans; State of Kansas; Annual Emissions Fee and Annual Emissions Inventory Environmental Protection Agency (EPA). ACTION: Direct final rule; technical amendment. AGENCY: mstockstill on DSK4VPTVN1PROD with RULES VerDate Sep<11>2014 16:27 Jan 13, 2016 Jkt 238001 paragraph (f) ‘‘The Kansas Department of Health and Environment submitted revisions to Kansas Administrative Record (KAR) 28–19–202 and 28–19– 517 on April 15, 2011; approval of section (c) effective March 28, 2014.’’ This technical amendment removes the erroneous part 52 approval of KAR 28–19–202 ‘‘Annual Emissions Fees’’ and recodifies the table. This action also revises paragraph (f) to read as follows: (f) ‘‘The Kansas Department of Health and Environment submitted revisions to Kansas Administrative Record (KAR) 28–19–202 and 28–19–517 on April 15, 2011; effective March 28, 2014.’’ Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds. Administrative practice and procedure, Air pollution control, Intergovernmental relations, Operating permits, Reporting and recordkeeping requirements. Dated: December 23, 2015. Becky Weber, Acting Regional Administrator, Region 7. Chapter I, title 40 of the Code of Federal Regulations is amended as follows: PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS 2. In § 52.870, paragraph(c) is amended by removing the table entry ‘‘K.A.R. 28–19–202.’’ ■ PART 70—STATE OPERATING PERMIT PROGRAMS 3. The authority citation for part 70 continues to read as follows: ■ Authority: 42 U.S.C. 7401 et seq. 4. Appendix A is amended by revising paragraph (f) under Kansas to read as follows: ■ Appendix A to Part 70—Approval Status of State and Local Operating Permits Programs * * * * * * * Kansas * * (f) The Kansas Department of Health and Environment submitted revisions to Kansas Administrative Record (KAR) 28–19–202 and 28–19–517 on April 15, 2011; effective March 28, 2014. * * * * * [FR Doc. 2016–00573 Filed 1–13–16; 8:45 am] 1. The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 et seq. Sfmt 4700 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2015–0538; FRL–9939–53] Aspergillus flavus AF36; Time Limited Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes a time-limited exemption from the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(a) requirement of a tolerance for residues of the pesticide Aspergillus flavus AF36 in or on dried figs resulting from use in accordance SUMMARY: ■ Fmt 4700 [Amended] BILLING CODE 6560–50–P 40 CFR Part 70 Frm 00030 § 52.870 * 40 CFR Part 52 PO 00000 Explanation * * * 1/14/16 [Insert Federal Reg- [EPA–R07–OAR–2015–0587; ister citation]. FRL–9941–01–Region 7]. List of Subjects The Environmental Protection Agency (EPA) inadvertently approved and codified this action under both part 52 (Approval and Promulgation of Implementation Plans) and part 70 (State Operating Permit Programs). This technical amendment removes the part 52 approval and codification and makes a clarification to part 70. DATES: This action is effective January 14, 2016. FOR FURTHER INFORMATION CONTACT: Lachala Kemp at (913) 551–7214, or by email at kemp.lachala@epa.gov. SUPPLEMENTARY INFORMATION: On January 27, 2014 (79 FR 4274), EPA published a direct final rule approving a SIP revision for Kansas that included revisions to K.A.R. 28–19–202 ‘‘Annual Emission Fees.’’ The rule revision amended KAR 28–19–202 ‘‘Annual Emissions Fees’’ to align the state’s reporting requirements with EPA’s reporting requirements, and was incorrectly approved and codified under part 52 and part 70. This rule also included revisions to the operating permits program, K.A.R 28–19–517 ‘‘Class I Operating Permits; Annual Emissions Inventory.’’ This part 70 appendix A revision added new SUMMARY: EPA approval date E:\FR\FM\14JAR1.SGM 14JAR1 Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Rules and Regulations with the terms of an emergency exemption issued under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This action is in response to the issuance of a crisis emergency exemption under FIFRA section 18 authorizing use of the pesticide on dried figs. The time-limited exemption from the requirement of a tolerance expires on December 31, 2017. DATES: This regulation is effective January 14, 2016. Objections and requests for hearings must be received on or before March 14, 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–2015–0538, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Susan T. Lewis, 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: mstockstill on DSK4VPTVN1PROD with RULES I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial 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). VerDate Sep<11>2014 16:27 Jan 13, 2016 Jkt 238001 B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office’s e-CFR site at https://www.ecfr. gov/cgi-bin/text-idx?&c=ecfr&tpl=/ ecfrbrowse/Title40/40tab_02.tpl. C. How can I file an objection or hearing request? Under section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 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–2015–0538 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 March 14, 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– 2015–0538, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https://www. epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets. PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 1891 II. Background and Statutory Findings EPA, on its own initiative, in accordance with FFDCA sections 408(e) and 408(l)(6), 21 U.S.C. 346a(e) and 346a(1)(6), is establishing a time-limited exemption from the requirement of a tolerance for residues of Aspergillus flavus AF36, in or on dried figs. This time-limited exemption from the requirement of a tolerance expires on December 31, 2017. Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances or exemptions from the requirement of a tolerance must be consistent with the safety standard in 408(b)(2) and (c)(2), respectively, and can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances or exemptions from the requirement of a tolerance to set binding precedents for the application of FFDCA section 408 and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party. Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement of a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is ‘‘safe.’’ Section 408(c)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. In evaluating the safety of an exemption, section 408(c)(2)(B) requires EPA to take into account the considerations set forth in 408(b)(2)(C) and (D). 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. . . .’’ E:\FR\FM\14JAR1.SGM 14JAR1 1892 Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that ‘‘emergency conditions exist which require such exemption.’’ EPA has established regulations governing such emergency exemptions in 40 CFR part 166. III. Emergency Exemption for Aspergillus flavus AF36 on Dried Figs and FFDCA Tolerances The California Department of Pesticide Regulation asserted that an emergency condition, brought on by an ongoing drought in California, existed in accordance with the criteria for approval of an emergency exemption, and utilized a crisis exemption under FIFRA section 18 to allow the use of Aspergillus flavus AF36 to reduce aflatoxin-producing fungi on dried figs in California. The California Department of Pesticide Regulation invoked the crisis exemption provision on June 15, 2015. After having reviewed the crisis exemption, EPA concurred on the emergency action in order to meet the emergency needs of fig growers in California. The crisis exemption program expired on July 31, 2015. As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of Aspergillus flavus AF36 in or on dried figs. In doing so, EPA considered the safety standard in FFDCA section 408(c)(2), and EPA decided that the necessary exemption from the requirement of a tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the crisis exemption in order to address an urgent, non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this exemption from the requirement of a tolerance without notice and opportunity for public comment as provided in FFDCA section 408(l)(6). This time-limited exemption from the requirement of a tolerance expires on December 31, 2017. EPA will take action to revoke the time-limited exemption from the requirement of a tolerance earlier if any experience with scientific data, or other relevant information on this pesticide indicates that the residues are not safe. Because this time-limited exemption from the requirement of a tolerance is being approved under emergency conditions, EPA has not made any decisions about whether Aspergillus flavus AF36 meets FIFRA’s registration requirements for use on dried figs or whether permanent tolerances or exemption from the requirement of a VerDate Sep<11>2014 16:27 Jan 13, 2016 Jkt 238001 tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this timelimited exemption from the requirement of a tolerance serves as a basis for registration of Aspergillus flavus AF36 by a State for special local needs under FIFRA section 24(c). Nor does this exemption from the requirement of a tolerance by itself serve as the authority for persons in any State other than California to use this pesticide on the applicable crop under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the crisis exemption for Aspergillus flavus AF36, contact the Agency’s Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT. IV. Toxicological Profile Consistent with the FFDCA section 408(b)(2)(D), the EPA reviewed the available scientific data and other relevant information for Aspergillus flavus AF36, and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. The EPA also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Aspergillus flavus refers to a diverse group of saprophytic soil fungi strains, which are ubiquitously distributed throughout the United States. This fungal group includes strains that produce aflatoxin (i.e., toxigenic strains) and strains that do not produce aflatoxins (i.e., atoxigenic strains). The toxigenic strains can cause aflatoxin contamination in seed, nut, and grain crops pre- and postharvest. In addition, toxigenic strains of several Aspergillus spp. can cause aspergillosis disease in humans (Ref. 1, 2). Aspergillus flavus AF36 is an atoxigenic strain registered as a microbial pesticide for use on cotton, corn, and pistachios. The AF36 strain is a soil colonizing fungus and displaces toxigenic strains through competition, thereby reducing aflatoxin levels on crops contaminated with toxigenic strains of Aspergillus spp. (Ref. 3). The toxicological profile of Aspergillus flavus were previously described in the Federal Register July 14, 2003 (68 FR 41535) (FRL–7311–6) and the data were used to establish the tolerance exemption for Aspergillus flavus AF36 in or on cotton (see the Federal Register of July 14, 2003), corn (see the Federal Register of March 23, 2011 (76 FR 16297) (FRL–8868–7)), and pistachio (see the Federal Register of March 9, 2012 (77 FR 14287) (FRL– PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 9341–5). The studies used to establish the tolerance exemptions in or on cotton, corn, and pistachio tested the toxicity/pathogenicity of Aspergillus flavus AF36 to rats through acute oral and pulmonary exposures and did not find any evidence of toxicity or infection (Ref. 1). Further, when exposed through intratracheal dosing, rats cleared Aspergillus flavus AF36 from their systems within 8 days. Moreover, rats exposed to Aspergillus flavus AF36 cleared the fungus from their body without compromising their immune system. After more than a decade of agricultural use in cotton and several years of use in corn and pistachio, there have not been any reports of hypersensitivity or other problems from workers exposed to Aspergillus flavus AF36. Therefore, based on the atoxigenic profile of Aspergillus flavus AF36, and previous toxicological evaluations to establish tolerance exemptions in or on cotton (see the Federal Register of July 14, 2003), corn (see the Federal Register of March 23, 2011), and pistachio (see the Federal Register of March 9, 2012), EPA concludes that there are no toxicological endpoints of concern for Aspergillus flavus AF36 and that there are no hazards associated with this particular isolate; therefore, any expected residues on food would be safe to consume. V. Aggregate Exposure In examining aggregate exposure, FFDCA section 408 directs the EPA to consider available information concerning exposures from the pesticide residue in food and all other nonoccupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). Food exposure: Aspergillus flavus AF36 will be applied as a single broadcast application to soil in California fig orchards from mid-June to mid-July 2015. The proposed method of application is by grain seed (wheatinfested Aspergillus flavus AF36 inoculum) applied to the orchard floor by ground. Grain seed inoculum is directed under the fig tree canopy where soil is wetted before and after the application. After application, Aspergillus flavus AF36 germinates using a grain carrier as a nutrient source and displaces aflatoxin-producing strains of Aspergillus flavus. Thus, the use of Aspergillus flavus AF36 in fig orchards should not increase the total Aspergillus flavus population in the environment (Ref. 1). Although, total Aspergillus flavus populations may E:\FR\FM\14JAR1.SGM 14JAR1 mstockstill on DSK4VPTVN1PROD with RULES Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Rules and Regulations increase immediately after applying Aspergillus flavus AF36, populations of Aspergillus flavus AF36 decline by spring of the year after application and there is no evidence of long term increases in populations of Aspergillus flavus resulting from application of Aspergillus flavus AF36. In addition, levels of natural Aspergillus flavus populations can fluctuate greatly over the course of a year (Ref. 1). Therefore, a temporary increase in Aspergillus flavus populations resulting from an application of Aspergillus flavus AF36 are not expected to produce effects that do not already occur from exposure to natural Aspergillus flavus populations. Drinking water exposure: Similar to previous drinking water exposures for cotton and corn uses (see Federal Register of July 14, 2003 and March 23, 2011) exposure to residues of Aspergillus flavus AF36 ensuing from application in fig orchards is possible as a result of consuming drinking water, but it is not likely to be greater than existing exposures to naturally occurring strains of Aspergillus flavus AF36. This time-limited exemption from the requirement of a tolerance will only allow for applications in California in an area where the climate is arid, which minimizes the potential for contamination of surface or ground water that may serve as a source of drinking water. Further, because Aspergillus flavus AF36 will only be applied as a granular formulation to terrestrial sites, offsite movement into water is not anticipated. If Aspergillus flavus AF36 residues should be present in drinking water, the results of a study assessing acute oral toxicity and pathogenicity found that no toxicity, pathogenicity, and/or infectivity is likely to occur from exposure to any level of Aspergillus flavus AF36 resulting from an application of Aspergillus flavus AF36 made in accordance with good agricultural practice. Other non-occupational exposure: Non-occupational dermal and inhalation exposure is expected to be minimal to non-existent for the use of Aspergillus flavus AF36 on figs. As previously described in the Federal Register of July 14, 2003, March 23, 2011, and March 9, 2012; Aspergillus flavus AF36 will be applied to agricultural sites and not in the proximity of schools, residential areas, nursing homes, or daycare facilities. Moreover, Aspergillus flavus AF36 will be applied in a granular form which will minimize drift and exposure. VerDate Sep<11>2014 16:27 Jan 13, 2016 Jkt 238001 VI. 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 EPA consider ‘‘available information concerning the cumulative effects of a particular pesticide’s . . . residues and other substances that have a common mechanism of toxicity.’’ The EPA has not found Aspergillus flavus AF36 to share a common mechanism of toxicity with any other substances, and Aspergillus flavus AF36 does not appear to produce a toxic metabolite produced by other substances. For the purposes of this exemption from the requirement of a tolerance action, therefore, the EPA has assumed that Aspergillus flavus AF36 does not have a common mechanism of toxicity with other substances since there is no indication of mammalian toxicity or pathogenicity resulting from exposure to Aspergillus flavus AF36. For information regarding the EPA’s efforts to determine chemicals that have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the EPA’s Web site at https://www.epa.gov/pesticides/ cumulative. VII. Determination of Safety for the U.S. Population, Infants and Children In considering the establishment of a time-limited exemption from the requirement of a tolerance for a pesticide chemical residue, FFDCA section 408(b)(2)(C) requires that EPA assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold (10X) margin of exposure (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 exposure (safety) will be safe for infants and children. This additional margin of exposure (safety) is commonly referred to as the Food Quality Protection Act Safety Factor. 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. PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 1893 In this instance, based on all the available information, EPA concludes that there are no effects of concern to infants, children, or adults when Aspergillus flavus AF36 is used in accordance with the crisis exemption. As a result, EPA concludes that no additional margin of exposure (safety) is necessary to protect infants and children. Moreover, based on the data and EPA analysis presented in this document, the Agency is able to conclude that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to the residues of Aspergillus flavus AF36 when it is used as an antifungal agent in accordance with the crisis exemption. Such exposure includes all anticipated dietary exposures and all other exposures for which there is reliable information. As discussed previously, there is reasonable certainty of no harm via dietary exposure from this fungus when used as an antifungal agent because the microorganism is non-toxic and nonpathogenic to animals and humans. EPA arrived at this conclusion based on the very low levels of mammalian toxicity for acute oral and pulmonary effects with no toxicity or infectivity at the doses tested (see Unit IV. of this document). VIII. Other Considerations Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. IX. Conclusion The EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Aspergillus flavus AF36. Therefore, a time-limited exemption from the requirement of a tolerance is established for residues of Aspergillus flavus AF36 in or on dried figs when used in accordance with the crisis exemption. This time-limited exemption from the requirement of a tolerance for residues of Aspergillus flavus AF36 in or on dried figs will expire and is revoked on December 31, 2017. X. References 1. U.S. EPA. 2015. Human Health and Environmental Assessment for the California Section 18 (Emergency Exemption) request for the use of AF36, an end use formulation containing the active ingredient, Aspergillus flavus E:\FR\FM\14JAR1.SGM 14JAR1 1894 Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES Strain AF36. Memorandum from G. Tomimatsu, Ph.D. and M. Djurickovic, M.S. to S. Borges. 2. Jensen, A.B., K. Aronstein, J.M. Flores, S. Vojvodic, M.A. Palacio and M. Spivak. 2013. Standard methods for fungal brood disease research. J. Apic. Res. 52 (1). 3. Ehrlich, K.C. 2014. Non-aflatoxigenic Aspergillus flavus to prevent aflatoxin contamination in crops: Advantages and limitations. Front. Micro. https://dx.doi. org/10.3389/fmicb.2014.00050. XI. Statutory and Executive Order Reviews This action establishes an exemption from the requirement of a tolerance under FFDCA sections 408(e) and 408(l)(6). 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 in accordance with FFDCA sections 408(e) and 408(l)(6), such as the exemption 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 VerDate Sep<11>2014 16:27 Jan 13, 2016 Jkt 238001 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). XII. 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: December 18, 2015. Susan Lewis, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.1206, add a new paragraph (d) to read as follows: ■ § 180.1206 Aspergillus flavus AF36; exemption from the requirement of a tolerance. * * * * * (d) Section 18 emergency exemptions. A time-limited exemption from the requirement of a tolerance is established for residues of Aspergillus flavus AF36, in or on dried figs, resulting from use of the pesticide pursuant to a FIFRA section 18 emergency exemption. This time-limited exemption from the requirement of a tolerance for residues PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 of Aspergillus flavus AF36 in or on dried figs will expire and is revoked on December 31, 2017. [FR Doc. 2016–00665 Filed 1–13–16; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 64 [Docket ID FEMA–2015–0001; Internal Agency Docket No. FEMA–8417] Suspension of Community Eligibility Federal Emergency Management Agency, DHS. ACTION: Final rule. AGENCY: This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA’s Community Status Book (CSB). The CSB is available at https:// www.fema.gov/fema/csb.shtm. DATES: The effective date of each community’s scheduled suspension is the third date (‘‘Susp.’’) listed in the third column of the following tables. FOR FURTHER INFORMATION CONTACT: If you want to determine whether a particular community was suspended on the suspension date or for further information, contact Patricia Suber, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646–4149. SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction SUMMARY: E:\FR\FM\14JAR1.SGM 14JAR1

Agencies

[Federal Register Volume 81, Number 9 (Thursday, January 14, 2016)]
[Rules and Regulations]
[Pages 1890-1894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00665]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0538; FRL-9939-53]


Aspergillus flavus AF36; Time Limited Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a time-limited exemption from the 
Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(a) requirement 
of a tolerance for residues of the pesticide Aspergillus flavus AF36 in 
or on dried figs resulting from use in accordance

[[Page 1891]]

with the terms of an emergency exemption issued under section 18 of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This 
action is in response to the issuance of a crisis emergency exemption 
under FIFRA section 18 authorizing use of the pesticide on dried figs. 
The time-limited exemption from the requirement of a tolerance expires 
on December 31, 2017.

DATES: This regulation is effective January 14, 2016. Objections and 
requests for hearings must be received on or before March 14, 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-2015-0538, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan T. Lewis, 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 https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 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-
2015-0538 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 March 14, 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-2015-0538, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6), 21 U.S.C. 346a(e) and 346a(1)(6), is establishing 
a time-limited exemption from the requirement of a tolerance for 
residues of Aspergillus flavus AF36, in or on dried figs. This time-
limited exemption from the requirement of a tolerance expires on 
December 31, 2017.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under FIFRA 
section 18. Such tolerances or exemptions from the requirement of a 
tolerance must be consistent with the safety standard in 408(b)(2) and 
(c)(2), respectively, and can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
FIFRA section 18 related time-limited tolerances or exemptions from the 
requirement of a tolerance to set binding precedents for the 
application of FFDCA section 408 and the safety standard to other 
tolerances and exemptions. Section 408(e) of FFDCA allows EPA to 
establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement of a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. In evaluating the safety of an exemption, 
section 408(c)(2)(B) requires EPA to take into account the 
considerations set forth in 408(b)(2)(C) and (D). 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. . . .''

[[Page 1892]]

    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Aspergillus flavus AF36 on Dried Figs and 
FFDCA Tolerances

    The California Department of Pesticide Regulation asserted that an 
emergency condition, brought on by an ongoing drought in California, 
existed in accordance with the criteria for approval of an emergency 
exemption, and utilized a crisis exemption under FIFRA section 18 to 
allow the use of Aspergillus flavus AF36 to reduce aflatoxin-producing 
fungi on dried figs in California. The California Department of 
Pesticide Regulation invoked the crisis exemption provision on June 15, 
2015. After having reviewed the crisis exemption, EPA concurred on the 
emergency action in order to meet the emergency needs of fig growers in 
California. The crisis exemption program expired on July 31, 2015.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of Aspergillus 
flavus AF36 in or on dried figs. In doing so, EPA considered the safety 
standard in FFDCA section 408(c)(2), and EPA decided that the necessary 
exemption from the requirement of a tolerance under FFDCA section 
408(l)(6) would be consistent with the safety standard and with FIFRA 
section 18. Consistent with the need to move quickly on the crisis 
exemption in order to address an urgent, non-routine situation and to 
ensure that the resulting food is safe and lawful, EPA is issuing this 
exemption from the requirement of a tolerance without notice and 
opportunity for public comment as provided in FFDCA section 408(l)(6). 
This time-limited exemption from the requirement of a tolerance expires 
on December 31, 2017. EPA will take action to revoke the time-limited 
exemption from the requirement of a tolerance earlier if any experience 
with scientific data, or other relevant information on this pesticide 
indicates that the residues are not safe.
    Because this time-limited exemption from the requirement of a 
tolerance is being approved under emergency conditions, EPA has not 
made any decisions about whether Aspergillus flavus AF36 meets FIFRA's 
registration requirements for use on dried figs or whether permanent 
tolerances or exemption from the requirement of a tolerance for this 
use would be appropriate. Under these circumstances, EPA does not 
believe that this time-limited exemption from the requirement of a 
tolerance serves as a basis for registration of Aspergillus flavus AF36 
by a State for special local needs under FIFRA section 24(c). Nor does 
this exemption from the requirement of a tolerance by itself serve as 
the authority for persons in any State other than California to use 
this pesticide on the applicable crop under FIFRA section 18 absent the 
issuance of an emergency exemption applicable within that State. For 
additional information regarding the crisis exemption for Aspergillus 
flavus AF36, contact the Agency's Registration Division at the address 
provided under FOR FURTHER INFORMATION CONTACT.

IV. Toxicological Profile

    Consistent with the FFDCA section 408(b)(2)(D), the EPA reviewed 
the available scientific data and other relevant information for 
Aspergillus flavus AF36, and considered its validity, completeness, and 
reliability, as well as the relationship of this information to human 
risk. The EPA also considered available information concerning the 
variability of the sensitivities of major identifiable subgroups of 
consumers, including infants and children.
    Aspergillus flavus refers to a diverse group of saprophytic soil 
fungi strains, which are ubiquitously distributed throughout the United 
States. This fungal group includes strains that produce aflatoxin 
(i.e., toxigenic strains) and strains that do not produce aflatoxins 
(i.e., atoxigenic strains). The toxigenic strains can cause aflatoxin 
contamination in seed, nut, and grain crops pre- and postharvest. In 
addition, toxigenic strains of several Aspergillus spp. can cause 
aspergillosis disease in humans (Ref. 1, 2).
    Aspergillus flavus AF36 is an atoxigenic strain registered as a 
microbial pesticide for use on cotton, corn, and pistachios. The AF36 
strain is a soil colonizing fungus and displaces toxigenic strains 
through competition, thereby reducing aflatoxin levels on crops 
contaminated with toxigenic strains of Aspergillus spp. (Ref. 3).
    The toxicological profile of Aspergillus flavus were previously 
described in the Federal Register July 14, 2003 (68 FR 41535) (FRL-
7311-6) and the data were used to establish the tolerance exemption for 
Aspergillus flavus AF36 in or on cotton (see the Federal Register of 
July 14, 2003), corn (see the Federal Register of March 23, 2011 (76 FR 
16297) (FRL-8868-7)), and pistachio (see the Federal Register of March 
9, 2012 (77 FR 14287) (FRL-9341-5). The studies used to establish the 
tolerance exemptions in or on cotton, corn, and pistachio tested the 
toxicity/pathogenicity of Aspergillus flavus AF36 to rats through acute 
oral and pulmonary exposures and did not find any evidence of toxicity 
or infection (Ref. 1). Further, when exposed through intratracheal 
dosing, rats cleared Aspergillus flavus AF36 from their systems within 
8 days. Moreover, rats exposed to Aspergillus flavus AF36 cleared the 
fungus from their body without compromising their immune system. After 
more than a decade of agricultural use in cotton and several years of 
use in corn and pistachio, there have not been any reports of 
hypersensitivity or other problems from workers exposed to Aspergillus 
flavus AF36. Therefore, based on the atoxigenic profile of Aspergillus 
flavus AF36, and previous toxicological evaluations to establish 
tolerance exemptions in or on cotton (see the Federal Register of July 
14, 2003), corn (see the Federal Register of March 23, 2011), and 
pistachio (see the Federal Register of March 9, 2012), EPA concludes 
that there are no toxicological endpoints of concern for Aspergillus 
flavus AF36 and that there are no hazards associated with this 
particular isolate; therefore, any expected residues on food would be 
safe to consume.

V. Aggregate Exposure

    In examining aggregate exposure, FFDCA section 408 directs the EPA 
to consider available information concerning exposures from the 
pesticide residue in food and all other non-occupational exposures, 
including drinking water from ground water or surface water and 
exposure through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses).
    Food exposure: Aspergillus flavus AF36 will be applied as a single 
broadcast application to soil in California fig orchards from mid-June 
to mid-July 2015. The proposed method of application is by grain seed 
(wheat-infested Aspergillus flavus AF36 inoculum) applied to the 
orchard floor by ground. Grain seed inoculum is directed under the fig 
tree canopy where soil is wetted before and after the application. 
After application, Aspergillus flavus AF36 germinates using a grain 
carrier as a nutrient source and displaces aflatoxin-producing strains 
of Aspergillus flavus. Thus, the use of Aspergillus flavus AF36 in fig 
orchards should not increase the total Aspergillus flavus population in 
the environment (Ref. 1). Although, total Aspergillus flavus 
populations may

[[Page 1893]]

increase immediately after applying Aspergillus flavus AF36, 
populations of Aspergillus flavus AF36 decline by spring of the year 
after application and there is no evidence of long term increases in 
populations of Aspergillus flavus resulting from application of 
Aspergillus flavus AF36. In addition, levels of natural Aspergillus 
flavus populations can fluctuate greatly over the course of a year 
(Ref. 1). Therefore, a temporary increase in Aspergillus flavus 
populations resulting from an application of Aspergillus flavus AF36 
are not expected to produce effects that do not already occur from 
exposure to natural Aspergillus flavus populations.
    Drinking water exposure: Similar to previous drinking water 
exposures for cotton and corn uses (see Federal Register of July 14, 
2003 and March 23, 2011) exposure to residues of Aspergillus flavus 
AF36 ensuing from application in fig orchards is possible as a result 
of consuming drinking water, but it is not likely to be greater than 
existing exposures to naturally occurring strains of Aspergillus flavus 
AF36. This time-limited exemption from the requirement of a tolerance 
will only allow for applications in California in an area where the 
climate is arid, which minimizes the potential for contamination of 
surface or ground water that may serve as a source of drinking water. 
Further, because Aspergillus flavus AF36 will only be applied as a 
granular formulation to terrestrial sites, offsite movement into water 
is not anticipated. If Aspergillus flavus AF36 residues should be 
present in drinking water, the results of a study assessing acute oral 
toxicity and pathogenicity found that no toxicity, pathogenicity, and/
or infectivity is likely to occur from exposure to any level of 
Aspergillus flavus AF36 resulting from an application of Aspergillus 
flavus AF36 made in accordance with good agricultural practice.
    Other non-occupational exposure: Non-occupational dermal and 
inhalation exposure is expected to be minimal to non-existent for the 
use of Aspergillus flavus AF36 on figs. As previously described in the 
Federal Register of July 14, 2003, March 23, 2011, and March 9, 2012; 
Aspergillus flavus AF36 will be applied to agricultural sites and not 
in the proximity of schools, residential areas, nursing homes, or 
daycare facilities. Moreover, Aspergillus flavus AF36 will be applied 
in a granular form which will minimize drift and exposure.

VI. 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 EPA consider 
``available information concerning the cumulative effects of a 
particular pesticide's . . . residues and other substances that have a 
common mechanism of toxicity.''
    The EPA has not found Aspergillus flavus AF36 to share a common 
mechanism of toxicity with any other substances, and Aspergillus flavus 
AF36 does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this exemption from the requirement of 
a tolerance action, therefore, the EPA has assumed that Aspergillus 
flavus AF36 does not have a common mechanism of toxicity with other 
substances since there is no indication of mammalian toxicity or 
pathogenicity resulting from exposure to Aspergillus flavus AF36. For 
information regarding the EPA's efforts to determine chemicals that 
have a common mechanism of toxicity and to evaluate the cumulative 
effects of such chemicals, see the EPA's Web site at https://www.epa.gov/pesticides/cumulative.

VII. Determination of Safety for the U.S. Population, Infants and 
Children

    In considering the establishment of a time-limited exemption from 
the requirement of a tolerance for a pesticide chemical residue, FFDCA 
section 408(b)(2)(C) requires that EPA assess the available information 
about consumption patterns among infants and children, special 
susceptibility of infants and children to pesticide chemical residues, 
and the cumulative effects on infants and children of the residues and 
other substances with a common mechanism of toxicity. In addition, 
FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional 
tenfold (10X) margin of exposure (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 exposure (safety) will 
be safe for infants and children. This additional margin of exposure 
(safety) is commonly referred to as the Food Quality Protection Act 
Safety Factor. 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.
    In this instance, based on all the available information, EPA 
concludes that there are no effects of concern to infants, children, or 
adults when Aspergillus flavus AF36 is used in accordance with the 
crisis exemption. As a result, EPA concludes that no additional margin 
of exposure (safety) is necessary to protect infants and children.
    Moreover, based on the data and EPA analysis presented in this 
document, the Agency is able to conclude that there is a reasonable 
certainty that no harm will result to the U.S. population, including 
infants and children, from aggregate exposure to the residues of 
Aspergillus flavus AF36 when it is used as an antifungal agent in 
accordance with the crisis exemption. Such exposure includes all 
anticipated dietary exposures and all other exposures for which there 
is reliable information. As discussed previously, there is reasonable 
certainty of no harm via dietary exposure from this fungus when used as 
an antifungal agent because the microorganism is non-toxic and non-
pathogenic to animals and humans. EPA arrived at this conclusion based 
on the very low levels of mammalian toxicity for acute oral and 
pulmonary effects with no toxicity or infectivity at the doses tested 
(see Unit IV. of this document).

VIII. Other Considerations

Analytical Enforcement Methodology

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

 IX. Conclusion

    The EPA concludes that there is a reasonable certainty that no harm 
will result to the U.S. population, including infants and children, 
from aggregate exposure to residues of Aspergillus flavus AF36. 
Therefore, a time-limited exemption from the requirement of a tolerance 
is established for residues of Aspergillus flavus AF36 in or on dried 
figs when used in accordance with the crisis exemption. This time-
limited exemption from the requirement of a tolerance for residues of 
Aspergillus flavus AF36 in or on dried figs will expire and is revoked 
on December 31, 2017.

X. References

1. U.S. EPA. 2015. Human Health and Environmental Assessment for the 
California Section 18 (Emergency Exemption) request for the use of 
AF36, an end use formulation containing the active ingredient, 
Aspergillus flavus

[[Page 1894]]

Strain AF36. Memorandum from G. Tomimatsu, Ph.D. and M. Djurickovic, 
M.S. to S. Borges.
2. Jensen, A.B., K. Aronstein, J.M. Flores, S. Vojvodic, M.A. 
Palacio and M. Spivak. 2013. Standard methods for fungal brood 
disease research. J. Apic. Res. 52 (1).
3. Ehrlich, K.C. 2014. Non-aflatoxigenic Aspergillus flavus to 
prevent aflatoxin contamination in crops: Advantages and 
limitations. Front. Micro. https://dx.doi.org/10.3389/fmicb.2014.00050.

XI. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a 
tolerance under FFDCA sections 408(e) and 408(l)(6). 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 in accordance 
with FFDCA sections 408(e) and 408(l)(6), such as the exemption 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).

XII. 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: December 18, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. In Sec.  180.1206, add a new paragraph (d) to read as follows:


Sec.  180.1206  Aspergillus flavus AF36; exemption from the requirement 
of a tolerance.

* * * * *
    (d) Section 18 emergency exemptions. A time-limited exemption from 
the requirement of a tolerance is established for residues of 
Aspergillus flavus AF36, in or on dried figs, resulting from use of the 
pesticide pursuant to a FIFRA section 18 emergency exemption. This 
time-limited exemption from the requirement of a tolerance for residues 
of Aspergillus flavus AF36 in or on dried figs will expire and is 
revoked on December 31, 2017.

[FR Doc. 2016-00665 Filed 1-13-16; 8:45 am]
BILLING CODE 6560-50-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.