Metarhizium anisopliae Strain F52; Exemption From the Requirement of a Tolerance, 26194-26198 [2011-11030]

Download as PDF 26194 Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Rules and Regulations jlentini on DSKJ8SOYB1PROD with RULES that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on July 5, 2011. This will incorporate these rules into the federally enforceable SIP. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. III. Statutory and Executive Order Reviews Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA’s role is to approve State choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action: • Is not a ‘‘significant regulatory action’’ subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993); • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.); • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.); • Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4); • Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999); • Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997); • Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); • Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because VerDate Mar<15>2010 16:12 May 05, 2011 Jkt 223001 application of those requirements would be inconsistent with the Clean Air Act; and • Does not provide EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994). In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the State, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law. The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action 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. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 5, 2011. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the Proposed Rules section of today’s Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)). PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Particulate matter, Reporting and recordkeeping requirements, Volatile organic compounds. Dated: March 31, 2011. Jared Blumenfeld, Regional Administrator, Region IX. Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows: PART 52—[AMENDED] 1. The authority citation for Part 52 continues to read as follows: ■ Authority: 42 U.S.C. 7401 et seq. Subpart F—California 2. Section 52.220 is amended by adding paragraph (c)(385) to read as follows: ■ § 52.220 Identification of plan. * * * * * (c) * * * (385) New and amended regulations for the following APCDs were submitted on February 28, 2011. (i) Incorporation by Reference. (A) Mendocino County Air Quality Management District. (1) Rule 130, ‘‘Definitions,’’ amended February 15, 2011. (B) Northern Sonoma County Air Pollution Control District. (1) Rule 130, ‘‘Definitions,’’ amended December 14, 2010. [FR Doc. 2011–11038 Filed 5–4–11; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2009–0194; FRL–8872–3] Metarhizium anisopliae Strain F52; 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 Metarhizium anisopliae strain F52 in or on all food commodities when applied as an insecticide, miticide, or ixodicide and used in accordance with good agricultural practices. Novozymes Biologicals, Inc. submitted a petition to SUMMARY: E:\FR\FM\06MYR1.SGM 06MYR1 Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Rules and Regulations EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Metarhizium anisopliae strain F52 under the FFDCA. DATES: This regulation is effective May 6, 2011. Objections and requests for hearings must be received on or before July 5, 2011, 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: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2009–0194. All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305–5805. FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–8097; e-mail address: bacchus.shanaz@epa.gov. SUPPLEMENTARY INFORMATION: jlentini on DSKJ8SOYB1PROD 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. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). VerDate Mar<15>2010 16:12 May 05, 2011 Jkt 223001 26195 • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. • Mail: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. B. How can I get electronic access to other related information? II. Background and Statutory Findings In the Federal Register of April 8, 2009 (74 FR 15969) (FRL–8407–6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 8F7508) by Novozymes Biologicals, Inc., 5400 Corporate Circle, Salem, VA 24153. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Metarhizium anisopliae strain F52. This notice referenced a summary of the petition prepared by the petitioner, Novozymes Biologicals, Inc., which is available in the docket, via http:// www.regulations.gov. There were no comments received in response to the notice of filing. Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is ‘‘safe.’’ Section 408(c)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA, which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance exemption and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate 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.gpoaccess.gov/ecfr. To access the harmonized test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ‘‘Test Methods and Guidelines.’’ C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2009–0194 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 July 5, 2011. 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 that does not contain any 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 a copy of your non-CBI objection or hearing request, identified by docket ID number EPA–HQ–OPP–2009–0194, by one of the following methods: • Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 E:\FR\FM\06MYR1.SGM 06MYR1 26196 Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Rules and Regulations exposure to the pesticide chemical residue. * * *’’ Additionally, section 408(b)(2)(D) of FFDCA requires that EPA consider ‘‘available information concerning the cumulative effects of [a particular pesticide’s] residues and other substances that have a common mechanism of toxicity.’’ EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. jlentini on DSKJ8SOYB1PROD with RULES III. Toxicological Profile Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and has considered its validity, completeness, and reliability and the relationship of this information 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. A. Overview of Metarhizium Anisopliae Strain F52 Metarhizium anisopliae strain F52 (called MetF52), a deuteromycetous and entomopathogenic fungus that is found worldwide, infects numerous insect (primarily Coleoptera of the families Elateridae and Curculionidae), mite, and tick species that are contacted by it. Once spores of Metarhizium anisopliae strain F52 attach to the surface of the target pest, they germinate, grow, penetrate the target pest’s exoskeleton, continue to grow in the target pest, and eventually cause death. Susceptible insects, mites, or ticks that come into contact with other insects, mites, or ticks that have been infected with Metarhizium anisopliae strain F52 also become infected with the fungus, thus continuing this microbe’s pesticidal effect. Given this distinct capability and efficiency in controlling various insects, mites, and ticks, Metarhizium anisopliae strain F52 is currently recognized as the active ingredient in several microbial pesticide products, which were conditionally registered under section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in June 2003 to Earth BioSciences, Inc. Since the registration of these pesticide products in 2003, they have been labeled specifically for nonfood applications in urban and suburban (residential) areas to control VerDate Mar<15>2010 16:12 May 05, 2011 Jkt 223001 various insects (e.g., thrips and root weevils), mites, and ticks. In 2006, the Metarhizium anisopliae strain F52containing registrations were transferred from Earth BioSciences, Inc. to Novozymes Biologicals, Inc. (TAE–001 Technical Bioinsecticide, EPA Reg. No. 70127–7; Taenure Granular Bioinsecticide, EPA Reg. No. 70127–8; Tick-EX G, EPA Reg. No. 70127–9; TickEX EC, EPA Reg. No. 70127–10). After maintaining the registrations with non-food uses for several years, Novozymes Biologicals, Inc. has now petitioned EPA to establish an exemption from the requirement of a tolerance for residues of Metarhizium anisopliae strain F52 in or on all food commodities. Accordingly, EPA has reevaluated an assessment of the mammalian toxicology data that were submitted prior to 2003 to support the initial applications for Metarhizium anisopliae strain F52 pesticide products. The overall conclusions from these data are described in Unit III.B., while more in-depth synopses of the study results can be found in a 2001 risk assessment, the 2003 Metarhizium anisopliae strain F52 Biopesticides Registration Action Document (BRAD), and the 2011 Addendum to the Metarhizium anisopliae strain F52 BRAD provided as references in Unit IX. (Refs. 1, 2, and 3). B. Microbial Pesticide Toxicology Data Requirements All mammalian toxicology data requirements supporting the request for an exemption from the requirement of a tolerance for residues of Metarhizium anisopliae strain F52 in or on all food commodities have been fulfilled with acceptable studies. 1. Acute oral toxicity and pathogenicity—rat (Harmonized Guideline 885.3050; Master Record Identification Number (MRID No.) 448447–09). An acceptable acute oral toxicity and pathogenicity study demonstrated that Metarhizium anisopliae strain F52 was not toxic and/ or pathogenic to rats when dosed at approximately 1.04 × 108 colonyforming units (cfu)/animal. 2. Acute dermal toxicity—rabbit (Harmonized Guideline 885.3100; MRID No. 448447–10). An acceptable acute dermal toxicity study demonstrated that Metarhizium anisopliae strain F52 was not toxic to rabbits when dosed at 3.63– 4.42 × 1010 cfu/animal (median lethal dose (LD50) > 2,000 milligrams per kilogram (mg/kg); Toxicity Category III). 3. Acute pulmonary toxicity and pathogenicity—rat (Harmonized Guideline 885.3150; MRID No. 448447– 11). An acceptable acute pulmonary PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 toxicity and pathogenicity study demonstrated that Metarhizium anisopliae strain F52 was not toxic and/ or pathogenic to rats when dosed intratracheally at approximately 1.17 × 108 cfu/animal. 4. Acute injection toxicity and pathogenicity—rat (Harmonized Guideline 885.3200; MRID No. 448447– 12). An acceptable acute injection toxicity and pathogenicity study demonstrated that Metarhizium anisopliae strain F52 was not toxic and/ or pathogenic to rats when dosed intraperitoneally at approximately 1 × 107 cfu/animal. 5. Acute eye irritation—rabbit (Harmonized Guideline 870.2400; MRID No. 448447–13). An acceptable acute eye irritation study demonstrated that Metarhizium anisopliae strain F52 was moderately irritating (i.e., the test substance caused corneal opacity, iritis, and conjunctival irritation with resolution by day 4) to rabbits when dosed at 6.3 × 108 cfu/eye/animal (Toxicity Category III). 6. Dermal sensitization—guinea pig (Harmonized Guideline 870.2600; MRID No. 448447–15). An acceptable dermal sensitization study demonstrated that Metarhizium anisopliae strain F52 was not a dermal sensitizer to guinea pigs when induced and challenged at 2.37 × 109 cfu. 7. Hypersensitivity incidents (Harmonized Guideline 885.3400; MRID No. 448447–14). No hypersensitivity incidents involving Metarhizium anisopliae strain F52 and occurring during fermentation, processing, formulation, research, or application have been reported to EPA. IV. Aggregate Exposure In examining aggregate exposure, section 408 of FFDCA directs 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). A. Dietary Exposure Dietary exposure to this microbial pesticide may occur (more likely through food than drinking water), but the lack of acute oral toxicity, infectivity, and/or pathogenicity, as exhibited in a toxicology test on rats presented in Unit III.B., supports the establishment of a tolerance exemption for residues of Metarhizium anisopliae strain F52. E:\FR\FM\06MYR1.SGM 06MYR1 jlentini on DSKJ8SOYB1PROD with RULES Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Rules and Regulations 1. Food. Exposure to this microbial active ingredient through food is expected to be minimal. When applied in accordance with good agricultural practices, Metarhizium anisopliae strain F52, a known pathogen of various insects, mites, and ticks, is unlikely to persist on plants. Any spores on plants due to pesticide application would presumably decrease over time, similar to other fungal entomopathogens and microbial pest control agents, because of environmental factors such as rainfall, ultraviolet radiation, and temperature (Refs. 4 and 5). For example, several studies, designed to evaluate the susceptibility of Metarhizium spores to sunlight, showed that ultraviolet radiation (UV–A and UV–B) quickly causes inactivation of these spores, both with and without the use of substances intended to act as sunscreens (Ref. 6). In the unlikely event that the applied fungus grew on the edible portions of treated crops, the results of the toxicology testing demonstrated that no toxicity, infectivity, and/or pathogenicity in treated animals occurred, even when dosed with high levels of Metarhizium anisopliae strain F52 by the oral route of exposure (see additional discussion in Unit III.B.). In conclusion, there are no concerns for Metarhizium anisopliae strain F52 exposure through food. 2. Drinking water exposure. Much like dietary exposure, drinking water exposure is expected to be negligible, albeit for slightly different reasons. Given the terrestrial use sites, the application methods with reduced chance for offsite movement of Metarhizium anisopliae strain F52 (e.g., soil incorporation), and low application rates, it is not likely that use of Metarhizium anisopliae strain F52 products, when good agricultural practices are followed, will result in significant increase in fungal spore exposure in drinking water. With regard to percolation through the soil, Zimmerman (2007) suggests that Metarhizium anisopliae is a typical soilborne fungus as it has mostly been isolated from the upper soil layer. Further, Zimmerman (2007) also goes on to describe field tests in which many sprayed Metarhizium anisopliae spores were found in upper layers of loamy soil and humus, thereby supporting the soil adhesion theory and the absence of significant spore percolation down to ground water. In the unlikely event of exposure to Metarhizium anisopliae strain F52 spores through drinking water, the results of the oral toxicology testing, as described in Unit III.B., demonstrated that no toxicity, VerDate Mar<15>2010 17:04 May 05, 2011 Jkt 223001 infectivity, and/or pathogenicity in treated animals occurred. As was concluded for food exposure, there are no concerns for Metarhizium anisopliae strain F52 exposure through drinking water. B. Other Non-Occupational Exposure Deuteromycetous fungi, such as Metarhizium anisopliae strain F52, are naturally occurring and found worldwide. As a pesticidal active ingredient, Metarhizium anisopliae strain F52 has historically been applied in residential areas. Because of the use patterns and low application rates, there will not likely be a significant increase in exposure over the background levels of Metarhizium anisopliae strain F52 in these residential areas. Furthermore, there is no evidence of any concern for inhalation or dermal toxicity at exposure levels several orders of magnitude higher than would be expected to be encountered by a typical residential end user (see Unit III.B.). Finally, given that this deuteromycetous fungi affects only certain species of insects, mites, and ticks, and that no recognized relationships exist between the Metarhizium genus and any pathogen of humans and animals, no adverse effects to humans from inhalation or dermal exposure to this widespread fungus have been reported or are anticipated. V. 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, EPA 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 Metarhizium anisopliae strain F52 to share a common mechanism of toxicity with any other substances, and Metarhizium anisopliae strain F52 does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that Metarhizium anisopliae strain F52 does not have a common mechanism of toxicity with other substances. Following from this, therefore, EPA concludes that there are no cumulative effects associated with Metarhizium anisopliae strain F52 that need to be considered. 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. PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 26197 VI. Determination of Safety for U.S. Population, Infants and Children FFDCA section 408(b)(2)(C) provides that EPA shall 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 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 unless EPA determines that a different margin of safety will be safe for infants and children. Margins of exposure (safety), which are often referred to as uncertainty factors, are incorporated into EPA risk assessments, either directly, or through the use of a margin of exposure analysis, or by using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk. Based on the acute toxicity and pathogenicity data discussed in Unit III.B., as well as use of Metarhizium anisopliae strain F52 as a microbial pesticide for approximately eight years without reported adverse effects to humans, 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 the residues of Metarhizium anisopliae strain F52. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. EPA has arrived at this conclusion because the data and information available on Metarhizium anisopliae strain F52 do not demonstrate toxic, pathogenic, and/or infective potential to mammals. Thus, there are no threshold effects of concern and, as a result, an additional margin of safety is not necessary. VII. Other Considerations A. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever E:\FR\FM\06MYR1.SGM 06MYR1 26198 Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Rules and Regulations possible, consistent with U.S. food safety standards and agricultural practices. In this context, EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/ World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for Metarhizium anisopliae strain F52. VIII. Conclusions 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 Metarhizium anisopliae strain F52. Therefore, an exemption is established for residues of Metarhizium anisopliae strain F52 in or on all food commodities when applied as an insecticide, miticide, or ixodicide and used in accordance with good agricultural practices. jlentini on DSKJ8SOYB1PROD with RULES IX. References 1. U.S. EPA. 2011. Addendum to Metarhizium anisopliae strain F52 Biopesticides Registration Action Document dated March 2011 (available as ‘‘Supporting & Related Materials’’ within docket ID number EPA–HQ– OPP–2010–0081 at http:// www.regulations.gov). 2. U.S. EPA. 2003. Metarhizium anisopliae strain F52 Biopesticides Registration Action Document. 3. U.S. EPA. 2001. Review of Toxicology Data for Metarhizium anisopliae F52 in Support of a Section Three Registration for Metarhizium anisopliae F52 from Taensa, Inc., Fairfield, CT. Memorandum from C.A. Wozniak, PhD and J.L. Kough, PhD to L. Cole dated December 11, 2001 (available as ‘‘Supporting & Related Materials’’ within docket ID number EPA–HQ–OPP–2010–0081 at http:// www.regulations.gov). 4. Jaronski ST. 2010. Ecological factors in the inundative use of fungal entomopathogens. Biocontrol 55:159– 185. 5. U.S. EPA. 1996. Microbial Pesticide Test Guidelines—Background for Residue Analysis of Microbial Pest Control Agents (OPPTS 885.2000). Available from: http://www.epa.gov/ocspp/pubs/ frs/publications/Test_Guidelines/ series885.htm. 6. Zimmermann G. 2007. Review of safety of the entomopathogenic fungus VerDate Mar<15>2010 16:12 May 05, 2011 Jkt 223001 Metarhizium anisopliae. Biocontrol Sci Techn 17(9):879–920. X. Statutory and Executive Order Reviews This final rule establishes a tolerance exemption under section 408(d) of FFDCA in response to a petition submitted to EPA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance 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 final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, EPA 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, EPA has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000), do not apply to this final rule. In addition, this final PO 00000 Frm 00022 Fmt 4700 Sfmt 9990 rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104–4). This action does not involve any technical standards that would require EPA consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). XI. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. 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 this final rule in the Federal Register. This final rule 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: April 28, 2011. Steven Bradbury, Director, 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. Section 180.1303 is added to subpart D to read as follows: ■ § 180.1303 Metarhizium anisopliae strain F52; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of Metarhizium anisopliae strain F52 in or on all food commodities when applied as an insecticide, miticide, or ixodicide and used in accordance with good agricultural practices. [FR Doc. 2011–11030 Filed 5–5–11; 8:45 am] BILLING CODE 6560–50–P E:\FR\FM\06MYR1.SGM 06MYR1

Agencies

[Federal Register Volume 76, Number 88 (Friday, May 6, 2011)]
[Rules and Regulations]
[Pages 26194-26198]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11030]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0194; FRL-8872-3]


Metarhizium anisopliae Strain F52; 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 Metarhizium anisopliae strain F52 in or 
on all food commodities when applied as an insecticide, miticide, or 
ixodicide and used in accordance with good agricultural practices. 
Novozymes Biologicals, Inc. submitted a petition to

[[Page 26195]]

EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting 
an exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of Metarhizium anisopliae strain F52 under the FFDCA.

DATES: This regulation is effective May 6, 2011. Objections and 
requests for hearings must be received on or before July 5, 2011, 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0194. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the Office of Pesticide Programs (OPP) Regulatory Public 
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal 
Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The Docket 
Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8097; e-mail 
address: bacchus.shanaz@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. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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.gpoaccess.gov/ecfr. To access the harmonized test guidelines 
referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

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

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2009-0194 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 
July 5, 2011. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2009-0194, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments.
     Mail: OPP Regulatory Public Docket (7502P), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of April 8, 2009 (74 FR 15969) (FRL-8407-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 8F7508) by Novozymes Biologicals, Inc., 5400 Corporate 
Circle, Salem, VA 24153. The petition requested that 40 CFR part 180 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of Metarhizium anisopliae strain F52. This 
notice referenced a summary of the petition prepared by the petitioner, 
Novozymes Biologicals, Inc., which is available in the docket, via 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings but does not include 
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C) of FFDCA, which require EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance exemption and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate

[[Page 26196]]

exposure to the pesticide chemical residue. * * *'' Additionally, 
section 408(b)(2)(D) of FFDCA requires that EPA consider ``available 
information concerning the cumulative effects of [a particular 
pesticide's] residues and other substances that have a common mechanism 
of toxicity.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and has considered its validity, completeness, and 
reliability and the relationship of this information 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.

A. Overview of Metarhizium Anisopliae Strain F52

    Metarhizium anisopliae strain F52 (called MetF52), a 
deuteromycetous and entomopathogenic fungus that is found worldwide, 
infects numerous insect (primarily Coleoptera of the families 
Elateridae and Curculionidae), mite, and tick species that are 
contacted by it. Once spores of Metarhizium anisopliae strain F52 
attach to the surface of the target pest, they germinate, grow, 
penetrate the target pest's exoskeleton, continue to grow in the target 
pest, and eventually cause death. Susceptible insects, mites, or ticks 
that come into contact with other insects, mites, or ticks that have 
been infected with Metarhizium anisopliae strain F52 also become 
infected with the fungus, thus continuing this microbe's pesticidal 
effect.
    Given this distinct capability and efficiency in controlling 
various insects, mites, and ticks, Metarhizium anisopliae strain F52 is 
currently recognized as the active ingredient in several microbial 
pesticide products, which were conditionally registered under section 3 
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in 
June 2003 to Earth BioSciences, Inc. Since the registration of these 
pesticide products in 2003, they have been labeled specifically for 
non-food applications in urban and suburban (residential) areas to 
control various insects (e.g., thrips and root weevils), mites, and 
ticks. In 2006, the Metarhizium anisopliae strain F52-containing 
registrations were transferred from Earth BioSciences, Inc. to 
Novozymes Biologicals, Inc. (TAE-001 Technical Bioinsecticide, EPA Reg. 
No. 70127-7; Taenure Granular Bioinsecticide, EPA Reg. No. 70127-8; 
Tick-EX G, EPA Reg. No. 70127-9; Tick-EX EC, EPA Reg. No. 70127-10).
    After maintaining the registrations with non-food uses for several 
years, Novozymes Biologicals, Inc. has now petitioned EPA to establish 
an exemption from the requirement of a tolerance for residues of 
Metarhizium anisopliae strain F52 in or on all food commodities. 
Accordingly, EPA has reevaluated an assessment of the mammalian 
toxicology data that were submitted prior to 2003 to support the 
initial applications for Metarhizium anisopliae strain F52 pesticide 
products. The overall conclusions from these data are described in Unit 
III.B., while more in-depth synopses of the study results can be found 
in a 2001 risk assessment, the 2003 Metarhizium anisopliae strain F52 
Biopesticides Registration Action Document (BRAD), and the 2011 
Addendum to the Metarhizium anisopliae strain F52 BRAD provided as 
references in Unit IX. (Refs. 1, 2, and 3).

B. Microbial Pesticide Toxicology Data Requirements

    All mammalian toxicology data requirements supporting the request 
for an exemption from the requirement of a tolerance for residues of 
Metarhizium anisopliae strain F52 in or on all food commodities have 
been fulfilled with acceptable studies.
    1. Acute oral toxicity and pathogenicity--rat (Harmonized Guideline 
885.3050; Master Record Identification Number (MRID No.) 448447-09). An 
acceptable acute oral toxicity and pathogenicity study demonstrated 
that Metarhizium anisopliae strain F52 was not toxic and/or pathogenic 
to rats when dosed at approximately 1.04 x 10\8\ colony-forming units 
(cfu)/animal.
    2. Acute dermal toxicity--rabbit (Harmonized Guideline 885.3100; 
MRID No. 448447-10). An acceptable acute dermal toxicity study 
demonstrated that Metarhizium anisopliae strain F52 was not toxic to 
rabbits when dosed at 3.63-4.42 x 10\10\ cfu/animal (median lethal dose 
(LD50) > 2,000 milligrams per kilogram (mg/kg); Toxicity 
Category III).
    3. Acute pulmonary toxicity and pathogenicity--rat (Harmonized 
Guideline 885.3150; MRID No. 448447-11). An acceptable acute pulmonary 
toxicity and pathogenicity study demonstrated that Metarhizium 
anisopliae strain F52 was not toxic and/or pathogenic to rats when 
dosed intratracheally at approximately 1.17 x 10\8\ cfu/animal.
    4. Acute injection toxicity and pathogenicity--rat (Harmonized 
Guideline 885.3200; MRID No. 448447-12). An acceptable acute injection 
toxicity and pathogenicity study demonstrated that Metarhizium 
anisopliae strain F52 was not toxic and/or pathogenic to rats when 
dosed intraperitoneally at approximately 1 x 10\7\ cfu/animal.
    5. Acute eye irritation--rabbit (Harmonized Guideline 870.2400; 
MRID No. 448447-13). An acceptable acute eye irritation study 
demonstrated that Metarhizium anisopliae strain F52 was moderately 
irritating (i.e., the test substance caused corneal opacity, iritis, 
and conjunctival irritation with resolution by day 4) to rabbits when 
dosed at 6.3 x 10\8\ cfu/eye/animal (Toxicity Category III).
    6. Dermal sensitization--guinea pig (Harmonized Guideline 870.2600; 
MRID No. 448447-15). An acceptable dermal sensitization study 
demonstrated that Metarhizium anisopliae strain F52 was not a dermal 
sensitizer to guinea pigs when induced and challenged at 2.37 x 10\9\ 
cfu.
    7. Hypersensitivity incidents (Harmonized Guideline 885.3400; MRID 
No. 448447-14). No hypersensitivity incidents involving Metarhizium 
anisopliae strain F52 and occurring during fermentation, processing, 
formulation, research, or application have been reported to EPA.

IV. Aggregate Exposure

    In examining aggregate exposure, section 408 of FFDCA directs 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).

A. Dietary Exposure

    Dietary exposure to this microbial pesticide may occur (more likely 
through food than drinking water), but the lack of acute oral toxicity, 
infectivity, and/or pathogenicity, as exhibited in a toxicology test on 
rats presented in Unit III.B., supports the establishment of a 
tolerance exemption for residues of Metarhizium anisopliae strain F52.

[[Page 26197]]

    1. Food. Exposure to this microbial active ingredient through food 
is expected to be minimal. When applied in accordance with good 
agricultural practices, Metarhizium anisopliae strain F52, a known 
pathogen of various insects, mites, and ticks, is unlikely to persist 
on plants. Any spores on plants due to pesticide application would 
presumably decrease over time, similar to other fungal entomopathogens 
and microbial pest control agents, because of environmental factors 
such as rainfall, ultraviolet radiation, and temperature (Refs. 4 and 
5). For example, several studies, designed to evaluate the 
susceptibility of Metarhizium spores to sunlight, showed that 
ultraviolet radiation (UV-A and UV-B) quickly causes inactivation of 
these spores, both with and without the use of substances intended to 
act as sunscreens (Ref. 6). In the unlikely event that the applied 
fungus grew on the edible portions of treated crops, the results of the 
toxicology testing demonstrated that no toxicity, infectivity, and/or 
pathogenicity in treated animals occurred, even when dosed with high 
levels of Metarhizium anisopliae strain F52 by the oral route of 
exposure (see additional discussion in Unit III.B.). In conclusion, 
there are no concerns for Metarhizium anisopliae strain F52 exposure 
through food.
    2. Drinking water exposure. Much like dietary exposure, drinking 
water exposure is expected to be negligible, albeit for slightly 
different reasons. Given the terrestrial use sites, the application 
methods with reduced chance for offsite movement of Metarhizium 
anisopliae strain F52 (e.g., soil incorporation), and low application 
rates, it is not likely that use of Metarhizium anisopliae strain F52 
products, when good agricultural practices are followed, will result in 
significant increase in fungal spore exposure in drinking water. With 
regard to percolation through the soil, Zimmerman (2007) suggests that 
Metarhizium anisopliae is a typical soil-borne fungus as it has mostly 
been isolated from the upper soil layer. Further, Zimmerman (2007) also 
goes on to describe field tests in which many sprayed Metarhizium 
anisopliae spores were found in upper layers of loamy soil and humus, 
thereby supporting the soil adhesion theory and the absence of 
significant spore percolation down to ground water. In the unlikely 
event of exposure to Metarhizium anisopliae strain F52 spores through 
drinking water, the results of the oral toxicology testing, as 
described in Unit III.B., demonstrated that no toxicity, infectivity, 
and/or pathogenicity in treated animals occurred. As was concluded for 
food exposure, there are no concerns for Metarhizium anisopliae strain 
F52 exposure through drinking water.

B. Other Non-Occupational Exposure

    Deuteromycetous fungi, such as Metarhizium anisopliae strain F52, 
are naturally occurring and found worldwide. As a pesticidal active 
ingredient, Metarhizium anisopliae strain F52 has historically been 
applied in residential areas. Because of the use patterns and low 
application rates, there will not likely be a significant increase in 
exposure over the background levels of Metarhizium anisopliae strain 
F52 in these residential areas. Furthermore, there is no evidence of 
any concern for inhalation or dermal toxicity at exposure levels 
several orders of magnitude higher than would be expected to be 
encountered by a typical residential end user (see Unit III.B.). 
Finally, given that this deuteromycetous fungi affects only certain 
species of insects, mites, and ticks, and that no recognized 
relationships exist between the Metarhizium genus and any pathogen of 
humans and animals, no adverse effects to humans from inhalation or 
dermal exposure to this widespread fungus have been reported or are 
anticipated.

V. 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, EPA 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 Metarhizium anisopliae strain F52 to share a 
common mechanism of toxicity with any other substances, and Metarhizium 
anisopliae strain F52 does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has assumed that Metarhizium anisopliae strain 
F52 does not have a common mechanism of toxicity with other substances. 
Following from this, therefore, EPA concludes that there are no 
cumulative effects associated with Metarhizium anisopliae strain F52 
that need to be considered. 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.

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

    FFDCA section 408(b)(2)(C) provides that EPA shall 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 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 unless EPA 
determines that a different margin of safety will be safe for infants 
and children. Margins of exposure (safety), which are often referred to 
as uncertainty factors, are incorporated into EPA risk assessments, 
either directly, or through the use of a margin of exposure analysis, 
or by using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk.
    Based on the acute toxicity and pathogenicity data discussed in 
Unit III.B., as well as use of Metarhizium anisopliae strain F52 as a 
microbial pesticide for approximately eight years without reported 
adverse effects to humans, 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 the residues of 
Metarhizium anisopliae strain F52. This includes all anticipated 
dietary exposures and all other exposures for which there is reliable 
information. EPA has arrived at this conclusion because the data and 
information available on Metarhizium anisopliae strain F52 do not 
demonstrate toxic, pathogenic, and/or infective potential to mammals. 
Thus, there are no threshold effects of concern and, as a result, an 
additional margin of safety is not necessary.

VII. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever

[[Page 26198]]

possible, consistent with U.S. food safety standards and agricultural 
practices. In this context, EPA considers the international maximum 
residue limits (MRLs) established by the Codex Alimentarius Commission 
(Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius 
is a joint U.N. Food and Agriculture Organization/World Health 
Organization food standards program, and it is recognized as an 
international food safety standards-setting organization in trade 
agreements to which the United States is a party. EPA may establish a 
tolerance that is different from a Codex MRL; however, FFDCA section 
408(b)(4) requires that EPA explain the reasons for departing from the 
Codex level.
    The Codex has not established a MRL for Metarhizium anisopliae 
strain F52.

VIII. Conclusions

    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 Metarhizium anisopliae strain 
F52. Therefore, an exemption is established for residues of Metarhizium 
anisopliae strain F52 in or on all food commodities when applied as an 
insecticide, miticide, or ixodicide and used in accordance with good 
agricultural practices.

IX. References

1. U.S. EPA. 2011. Addendum to Metarhizium anisopliae strain F52 
Biopesticides Registration Action Document dated March 2011 
(available as ``Supporting & Related Materials'' within docket ID 
number EPA-HQ-OPP-2010-0081 at http://www.regulations.gov).
2. U.S. EPA. 2003. Metarhizium anisopliae strain F52 Biopesticides 
Registration Action Document.
3. U.S. EPA. 2001. Review of Toxicology Data for Metarhizium 
anisopliae F52 in Support of a Section Three Registration for 
Metarhizium anisopliae F52 from Taensa, Inc., Fairfield, CT. 
Memorandum from C.A. Wozniak, PhD and J.L. Kough, PhD to L. Cole 
dated December 11, 2001 (available as ``Supporting & Related 
Materials'' within docket ID number EPA-HQ-OPP-2010-0081 at http://www.regulations.gov).
4. Jaronski ST. 2010. Ecological factors in the inundative use of 
fungal entomopathogens. Biocontrol 55:159-185.
5. U.S. EPA. 1996. Microbial Pesticide Test Guidelines--Background 
for Residue Analysis of Microbial Pest Control Agents (OPPTS 
885.2000). Available from: http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series885.htm.
6. Zimmermann G. 2007. Review of safety of the entomopathogenic 
fungus Metarhizium anisopliae. Biocontrol Sci Techn 17(9):879-920.

X. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption under section 
408(d) of FFDCA in response to a petition submitted to EPA. The Office 
of Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance 
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 final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes. As a result, this 
action does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, EPA 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, EPA has determined that 
Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999), and Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 9, 
2000), do not apply to this final rule. In addition, this final rule 
does not impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would 
require EPA consideration of voluntary consensus standards pursuant to 
section 12(d) of the National Technology Transfer and Advancement Act 
of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

XI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: April 28, 2011.
Steven Bradbury,
Director, 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. Section 180.1303 is added to subpart D to read as follows:


Sec.  180.1303  Metarhizium anisopliae strain F52; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Metarhizium anisopliae strain F52 in or on all food 
commodities when applied as an insecticide, miticide, or ixodicide and 
used in accordance with good agricultural practices.
[FR Doc. 2011-11030 Filed 5-5-11; 8:45 am]
BILLING CODE 6560-50-P