Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations 59901

Subpart P—Indiana for ‘‘2–2–1’’ and ‘‘2–2–4’’ to read as § 52.770 Identification of plan. follows: * * * * * ■ 2. In § 52.770 the table in paragraph (c) is amended by revising the entries (c) * * *

EPA-APPROVED INDIANA REGULATIONS

Indiana effec- Indiana citation Subject tive date EPA approval date Notes

******* 2–2–1 ...... Definitions ...... 03/16/2011 9/28/2011, [Insert page number where the docu- ment begins].

******* 2–2–4 ...... Air quality analysis; requirements 03/16/2011 9/28/2011, [Insert page number where the docu- ment begins].

*******

* * * * * ADDRESSES: EPA has established a affected entities may include, but are ■ 3. In § 52.773, paragraph (k) is docket for this action under docket not limited to: identification (ID) number EPA–HQ– • Crop production (NAICS code 111). removed. • [FR Doc. 2011–24790 Filed 9–27–11; 8:45 am] OPP–2010–0087. All documents in the Animal production (NAICS code docket are listed in the docket index 112). BILLING CODE 6560–50–P • available at http://www.regulations.gov. Food manufacturing (NAICS code 311). Although listed in the index, some • ENVIRONMENTAL PROTECTION information is not publicly available, Pesticide manufacturing (NAICS AGENCY e.g., Confidential Business Information code 32532). (CBI) or other information whose This listing is not intended to be 40 CFR Part 180 disclosure is restricted by statute. exhaustive, but rather provides a guide for readers regarding entities likely to be Certain other material, such as [EPA–HQ–OPP–2010–0087; FRL–8889–8] affected by this action. Other types of copyrighted material, is not placed on entities not listed in this unit could also the Internet and will be publicly Apopka Strain 97; be affected. The North American available only in hard copy form. Exemption From the Requirement of a Industrial Classification System Publicly available docket materials are Tolerance (NAICS) codes have been provided to available in the electronic docket at assist you and others in determining AGENCY: Environmental Protection http://www.regulations.gov, or, if only whether this action might apply to Agency (EPA). available in hard copy, at the Office of certain entities. If you have any ACTION: Final rule. Pesticide Programs (OPP) Regulatory questions regarding the applicability of Public Docket in Rm. S–4400, One this action to a particular entity, consult SUMMARY: This regulation establishes an Potomac Yard (South Bldg.), 2777 S. the person listed under FOR FURTHER exemption from the requirement of a Crystal Dr., Arlington, VA. The Docket INFORMATION CONTACT. tolerance for residues of Isaria Facility is open from 8:30 a.m. to 4 p.m., fumosorosea (formerly known as Monday through Friday, excluding legal B. How can I get electronic access to fumosoroseus) Apopka holidays. The Docket Facility telephone other related information? strain 97 in or on all food commodities number is (703) 305–5805. You may access a frequently updated when applied as an insecticide or electronic version of 40 CFR part 180 miticide and used in accordance with FOR FURTHER INFORMATION CONTACT: through the Government Printing good agricultural practices. Certis USA, Shanaz Bacchus, Biopesticides and Office’s e-CFR site at http:// LLC, submitted a petition to EPA under Pollution Prevention Division (7511P), ecfr.gpoaccess.gov/cgi/t/text/text- the Federal Food, Drug, and Cosmetic Office of Pesticide Programs, idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ Act (FFDCA) requesting an exemption Environmental Protection Agency, 1200 40tab_02.tpl. To access the harmonized from the requirement of a tolerance. Pennsylvania Ave., NW., Washington, test guidelines referenced in this This regulation eliminates the need to DC 20460–0001; telephone number: document electronically, please go to establish a maximum permissible level (703) 308–8097; e-mail address: [email protected]. http://www.epa.gov/ocspp and select for residues of Isaria fumosorosea ‘‘Test Methods and Guidelines.’’ Apopka strain 97 under the FFDCA. SUPPLEMENTARY INFORMATION: DATES: This regulation is effective C. How can I file an objection or hearing September 28, 2011. Objections and I. General Information request? requests for hearings must be received A. Does this action apply to me? Under FFDCA section 408(g), 21 on or before November 28, 2011, and U.S.C. 346a(g), any person may file an must be filed in accordance with the You may be potentially affected by objection to any aspect of this regulation instructions provided in 40 CFR part this action if you are an agricultural and may also request a hearing on those 178 (see also Unit I.C. of the producer, food manufacturer, or objections. You must file your objection SUPPLEMENTARY INFORMATION). pesticide manufacturer. Potentially or request a hearing on this regulation

VerDate Mar<15>2010 16:23 Sep 27, 2011 Jkt 223001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\FR\FM\28SER1.SGM 28SER1 emcdonald on DSK5VPTVN1PROD with RULES 59902 Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations

in accordance with the instructions Based upon review of the data A. Overview of Isaria fumosorosea provided in 40 CFR part 178. To ensure supporting the petition, EPA has Apopka Strain 97 proper receipt by EPA, you must modified the nomenclature of the active In 1986, Paecilomyces fumosoroseus identify docket ID number EPA–HQ– ingredient, which was recently Apopka strain 97, an entomopathogenic OPP–2010–0087 in the subject line on reclassified as Isaria fumosorosea (Refs. , was isolated from a mealy bug the first page of your submission. All 1, 2, and 3). The reason for this change in a greenhouse in Apopka, Florida. It objections and requests for a hearing is explained in Unit VII.C. Section was recently reclassified, however, as must be in writing, and must be 408(c)(2)(A)(i) of FFDCA allows EPA to Isaria fumosorosea Apopka strain 97 received by the Hearing Clerk on or establish an exemption from the (Refs. 1, 2, and 3). Because of this before November 28, 2011. Addresses requirement for a tolerance (the legal history, in this and other EPA for mail and hand delivery of objections limit for a pesticide chemical residue in documents it is variously referred to as and hearing requests are provided in 40 or on a food) only if EPA determines Isaria fumosorosea Apopka strain 97, CFR 178.25(b). that the exemption is ‘‘safe.’’ Section Paecilomyces fumosoroseus Apopka In addition to filing an objection or 408(c)(2)(A)(ii) of FFDCA defines ‘‘safe’’ strain 97, or PFR–97. The pure culture hearing request with the Hearing Clerk to mean that ‘‘there is a reasonable as described in 40 CFR part 178, please was identified in 1988 and deposited at certainty that no harm will result from the American Type Culture Collection submit a copy of the filing that does not aggregate exposure to the pesticide contain any CBI for inclusion in the (ATCC # 20874) in Manassas, Virginia. chemical residue, including all Conidia of the fungus attach to, and public docket. Information not marked anticipated dietary exposures and all confidential pursuant to 40 CFR part 2 penetrate, the cuticle of the host insect other exposures for which there is or mite where they germinate and grow. may be disclosed publicly by EPA reliable information.’’ This includes without prior notice. Submit a copy of This leads to pathogenesis and eventual exposure through drinking water and in death of the diseased insect or mite your non-CBI objection or hearing residential settings but does not include request, identified by docket ID number host. occupational exposure. Pursuant to Isaria fumosorosea Apopka strain 97 EPA–HQ–OPP–2010–0087, by one of section 408(c)(2)(B) of FFDCA, in the following methods: is the active ingredient in two microbial • establishing or maintaining in effect an pesticide products, which were Federal eRulemaking Portal: http:// exemption from the requirement of a www.regulations.gov. Follow the on-line registered under section 3 of the Federal tolerance, EPA must take into account Insecticide, Fungicide, and Rodenticide instructions for submitting comments. the factors set forth in section • Mail: OPP Regulatory Public Docket Act (FIFRA) on April 22, 1998 to 408(b)(2)(C) of FFDCA, which require (7502P), Environmental Protection Thermo Trilogy: EPA to give special consideration to TM Agency, 1200 Pennsylvania Ave., NW., 1. PFR–97 MUP (EPA Reg. No. exposure of infants and children to the Washington, DC 20460–0001. 70051–17); and • Delivery: OPP Regulatory Public pesticide chemical residue in 2. PFR–97TM 20% WDG (EPA Reg. No. Docket (7502P), Environmental establishing a tolerance exemption and 70051–19). Protection Agency, Rm. S–4400, One to ‘‘ensure that there is a reasonable Later, Thermo Trilogy changed its Potomac Yard (South Bldg.), 2777 S. certainty that no harm will result to name to Certis USA, LLC; Certis USA, Crystal Dr., Arlington, VA. Deliveries infants and children from aggregate LLC is both the petitioner and the are only accepted during the Docket exposure to the pesticide chemical current registrant of the aforementioned Facility’s normal hours of operation residue. * * *’’ Additionally, section products. Since the registration of these (8:30 a.m. to 4 p.m., Monday through 408(b)(2)(D) of FFDCA requires that EPA pesticide products in 1998, they have Friday, excluding legal holidays). consider ‘‘available information been labeled specifically for non-food Special arrangements should be made concerning the cumulative effects of [a applications in greenhouses and for deliveries of boxed information. The particular pesticide’s] * * * residues nurseries to control various insects and Docket Facility telephone number is and other substances that have a mites (e.g., whiteflies, aphids, thrips (703) 305–5805. common mechanism of toxicity.’’ and spider mites). EPA performs a number of analyses to After maintaining the registrations II. Background and Statutory Findings determine the risks from aggregate with non-food uses for 13 years, Certis In the Federal Register of March 10, exposure to pesticide residues. First, USA, LLC has now petitioned EPA to 2010 (75 FR 11171) (FRL–8810–8), EPA EPA determines the toxicity of establish an exemption from the issued a notice pursuant to section pesticides. Second, EPA examines requirement of a tolerance for residues 408(d)(3) of FFDCA, 21 U.S.C. exposure to the pesticide through food, of Isaria fumosorosea Apopka strain 97 346a(d)(3), announcing the filing of a drinking water, and through other in or on all food commodities. pesticide tolerance petition (PP 9F7665) exposures that occur as a result of Accordingly, EPA has reassessed the by Certis USA, LLC, 9145 Guilford Rd., pesticide use in residential settings. mammalian toxicology data that were Suite 175, Columbia, MD 21046. The III. Toxicological Profile submitted prior to 1998 to support the petition requested that 40 CFR part 180 initial applications for Isaria be amended by establishing an Consistent with section 408(b)(2)(D) fumosorosea Apopka strain 97 pesticide exemption from the requirement of a of FFDCA, EPA has reviewed the products. The overall conclusions from tolerance for residues of Paecilomyces available scientific data and other these data, along with Toxicity Category fumosoroseus (now recognized as Isaria relevant information in support of this classifications (as appropriate), are fumosorosea) Apopka strain 97. This action and considered its validity, described in Unit III.B., while more in- notice referenced a summary of the completeness, and reliability and the depth synopses of the study results can petition prepared by the petitioner, relationship of this information to be found in the 2011 Isaria fumosorosea Certis USA, LLC, which is available in human risk. EPA has also considered (formerly Paecilomyces fumosoroseus) the docket via http:// available information concerning the Apopka strain 97 Biopesticides www.regulations.gov. There were no variability of the sensitivities of major Registration Action Document (BRAD) comments received in response to the identifiable subgroups of consumers, and a 2011 data evaluation record notice of filing. including infants and children. provided as references in Unit IX. (Refs.

VerDate Mar<15>2010 16:23 Sep 27, 2011 Jkt 223001 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 E:\FR\FM\28SER1.SGM 28SER1 emcdonald on DSK5VPTVN1PROD with RULES Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations 59903

3 and 4). To learn more about the 4. Acute injection toxicity/ infectivity, and/or pathogenicity, as Toxicity Categories, please see 40 CFR pathogenicity (intraperitoneal)—rat exhibited in a toxicology test on rats 156.62. (Harmonized Guideline 885.3200; MRID presented in Unit III.B., supports the No. 431398–03). An acceptable acute establishment of a tolerance exemption B. Microbial Pesticide Toxicology Data injection toxicity/pathogenicity study for residues of Isaria fumosorosea Requirements demonstrated that single intraperitoneal Apopka strain 97 in or on all food All mammalian toxicology data doses of Isaria fumosorosea Apopka commodities when used in accordance requirements supporting the request for strain 97 suspensions, containing 1.6 × with good agricultural practices. an exemption from the requirement of a 107 conidia spores per animal, had no 1. Food exposure. For several reasons tolerance for residues of Isaria toxic or pathogenic effects. Moreover, described in this unit, exposure to this fumosorosea Apopka strain 97 in or on the spores were cleared from the body microbial active ingredient through food all food commodities have been fulfilled within two days (Toxicity Category IV). is expected to be minimal. When with studies evaluated by EPA as 5. Acute eye irritation—rabbit applied in accordance with good acceptable (i.e., data that are (Harmonized Guideline 870.2400; MRID agricultural practices, Isaria scientifically sound and useful for risk No. 431462–01). An acceptable acute fumosorosea Apopka strain 97, a well- assessment) or supplemental (i.e., data eye irritation study demonstrated that recognized pathogen of various insects that provide some information useful for Isaria fumosorosea Apopka strain 97 and mites, is unlikely to persist on risk assessment). produced slight eye irritation in rabbits. plants (Refs. 3 and 4). Any spores on 1. Acute oral toxicity/pathogenicity— A dose of 0.1 milliliter of diluted test plants due to pesticide application rat (Harmonized Guideline 885.3050; substance, containing ≥107 cfu, was would presumably decrease over time, Master Record Identification Number instilled in the eye, which was similar to other fungal entomopathogens (MRID No.) 431639–01). An acceptable examined 1 hour, 24 hours, 48 hours, 72 and microbial pest control agents, acute oral toxicity/pathogenicity study hours, 4 days, and 7 days after treatment because of constantly fluctuating demonstrated that Isaria fumosorosea (irritation symptoms reversed by day 4; environmental factors such as rainfall, Apopka strain 97 was not toxic, Toxicity Category IV). ultraviolet radiation, and temperature pathogenic, or infectious to test rodents. 6. Primary dermal irritation—rabbit (Refs. 2, 3, 4, 5, and 6). For instance, × 6 An oral dose of 1.7 10 colony-forming (Harmonized Guideline 870.2500; MRID using artificial sunlight, Fargues et al. units (cfu)/animal in a conidia spore No. 431462–02). An acceptable primary (1997) investigated the effects of solar suspension did not produce mortality or dermal irritation study demonstrated radiation on Paecilomyces abnormal clinical effects. No signs of that Isaria fumosorosea Apopka strain fumosoroseus Apopka strain 97 conidia fungal contamination were reported for 97 was slightly irritating to the skin of and found that both ultraviolet-B (280– the brain, mesenteric lymph nodes, rabbits (irritation symptoms reversed by 320 nm) and ultraviolet-A (320–400 nm) blood, kidney, spleen, liver, lung or 48 hours; Toxicity Category IV). light were most detrimental to the cecum, and no infectivity or 7. Dermal sensitization—guinea pig germinability, survival, and infectivity pathogenicity was recorded (Toxicity (Harmonized Guideline 870.2600; MRID of the conidia (Ref. 6). In addition to Category IV). No. 431462–03). A supplemental dermal certain environmental factors, washing, 2. Acute dermal toxicity—rabbit sensitization study demonstrated that peeling, and/or other processing of food (Harmonized Guideline 885.3100; MRID Isaria fumosorosea Apopka strain 97 treated with Isaria fumosorosea Apopka No. 432255–01). An acceptable acute was not a dermal sensitizer to guinea strain 97 should further remove, dilute, dermal toxicity test demonstrated that pigs when induced and challenged at and/or inactivate pesticidal residues on Isaria fumosorosea Apopka strain 97 3.0 × 107 ¥ 5.3 × 109 cfu. food (to the extent they exist), was not toxic to rabbits when applied 8. Hypersensitivity incidents particularly in light of the inability of dermally. Two grams of test substance (Harmonized Guideline 885.3400). No this microbe to survive in water or at applied to the skin of rabbits produced hypersensitivity incidents involving temperatures higher than 25° C (Refs. 3, a mild irritation at 72 hours post dosing, Isaria fumosorosea Apopka strain 97 4, and 5). In the remote likelihood that but dermal irritation was completely have been reported to EPA over the last this microbial pesticide is present in or reversed by day 7. There were no deaths 13 years, during which time the on food, the acute oral toxicity and and no evidence of systemic toxicity. associated pesticide products have been pathogenicity data demonstrated no The acute dermal median lethal dose both manufactured and used for non- toxicity, infectivity, and/or (LD50) (i.e., a statistically derived single food uses. pathogenicity is likely to occur with any dose that can be expected to cause death such exposure to Isaria fumosorosea in 50% of test animals) was greater than IV. Aggregate Exposure Apopka strain 97 (see additional 2,000 milligrams per kilogram (mg/kg) In examining aggregate exposure, discussion in Unit III.B.). (Toxicity Category III). section 408 of FFDCA directs EPA to 2. Drinking water exposure. The 3. Acute pulmonary toxicity/ consider available information potential for significant transfer of Isaria pathogenicity—rat (Harmonized concerning exposures from the pesticide fumosorosea Apopka strain 97 to Guideline 885.3150; MRID No. 431398– residue in food and all other non- drinking water is minimal to non- 02). An acceptable acute pulmonary occupational exposures, including existent, specifically given the three toxicity/pathogenicity study drinking water from ground water or bases elaborated upon in this unit. First, demonstrated that Isaria fumosorosea surface water and exposure through there are no aquatic use sites permitted Apopka strain 97 was not toxic, pesticide use in gardens, lawns, or for pesticide products containing Isaria pathogenic, or infectious when a single buildings (residential and other indoor fumosoroseus Apopka strain 97, so dose (106 conidia spores/animal) was uses). exposure to surface water is not intratrachaelly administered to rats. No anticipated. Second, Isaria fumosorosea deaths, signs of toxicity or infection, or A. Dietary Exposure Apopka strain 97 is not known as an colonization of the lungs were observed. Dietary exposure to this microbial aquatic microorganism; therefore, even Total clearance of the fungus was pesticide may occur (more likely if Isaria fumosorosea Apopka strain 97 attained by day eight after treatment through food than drinking water), but were to inadvertently come into contact (Toxicity Category IV). the lack of acute oral toxicity, with surface or ground waters, it is

VerDate Mar<15>2010 16:23 Sep 27, 2011 Jkt 223001 PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 E:\FR\FM\28SER1.SGM 28SER1 emcdonald on DSK5VPTVN1PROD with RULES 59904 Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations

unlikely to proliferate in water (Refs. 3 metabolite produced by other margin of exposure (safety) is necessary and 4). Finally, if Isaria fumosorosea substances that may be of toxicological to protect infants and children, and that Apopka strain 97 were to be transferred concern to human health. For the not adding any additional margin of to surface water intended for eventual purposes of this tolerance action, exposure (safety) will be safe for infants human consumption (e.g., through spray therefore, EPA has assumed that Isaria and children. drift or runoff) and also managed to fumosorosea Apopka strain 97 does not Moreover, based on the same data and persist, it would not survive the have a common mechanism of toxicity EPA analysis as previewed in this unit, conditions water is subjected to in with other substances. Following from the Agency is able to conclude that wastewater treatment systems or this, EPA concludes that no cumulative there is a reasonable certainty that no drinking water facilities, including high or incremental effects to humans, harm will result to the U. S. population, temperatures, chlorination, pH including infants and children, are including infants and children, from adjustments and/or filtration (Refs. 7 anticipated in connection with the use aggregate exposure to the residues of and 8). In the remote likelihood that this of Isaria fumosorosea Apopka strain 97 Isaria fumosorosea Apopka strain 97 microbial pesticide is present in when it is used in accordance with its when it is used—as labeled and in drinking water, the acute oral toxicity label directions and good agricultural accordance with good agricultural and pathogenicity data demonstrated no practices. For information regarding practices—as an insecticide or miticide. toxicity, infectivity and/or pathogenicity EPA’s efforts to determine which Such exposure includes all anticipated is likely to occur with any such chemicals have a common mechanism dietary exposures and all other exposure to Isaria fumosorosea Apopka of toxicity and to evaluate the exposures for which there is reliable strain 97 (see additional discussion in cumulative effects of such chemicals, information. EPA has arrived at this Unit III.B.). see EPA’s Web site at http:// conclusion because, considered www.epa.gov/pesticides/cumulative. B. Other Non-Occupational Exposure collectively, the data and information VI. Determination of Safety for United available on Isaria fumosorosea Apopka Non-occupational dermal and strain 97 do not demonstrate toxic, inhalation exposure to Isaria States (U.S.) Population, Infants and Children pathogenic, and/or infective potential to fumosorosea Apopka strain 97 is mammals, including infants and expected to be minimal to non-existent, In considering the establishment of a children. primarily because it will be applied to tolerance or tolerance exemption for a agricultural sites not in the proximity of pesticide chemical residue, FFDCA VII. Other Considerations residential areas where facilities with section 408(b)(2)(C) provides that EPA A. Analytical Enforcement Methodology sensitive subpopulations (e.g., schools, shall assess the available information nursing homes, and daycares) are most about consumption patterns among An analytical method is not required often situated. Even if non-occupational infants and children, special for enforcement purposes since EPA is dermal and inhalation exposure were to susceptibility of infants and children to establishing an exemption from the occur inadvertently (e.g., through spray pesticide chemical residues, and the requirement of a tolerance without any drift) or due to an eventual expansion of cumulative effects on infants and numerical limitation. use sites, such exposure would not be children of the residues and other B. International Residue Limits of concern since testing indicates that substances with a common mechanism Isaria fumosorosea Apopka strain 97 is of toxicity. In addition, FFDCA section In making its tolerance decisions, EPA not toxic, pathogenic, and/or infective 408(b)(2)(C) provides that EPA shall seeks to harmonize U.S. tolerances with (acute dermal toxicity and acute apply an additional tenfold (10X) international standards whenever pulmonary toxicity/pathogenicity); is margin of safety for infants and children possible, consistent with U.S. food only slightly irritating (primary dermal in the case of threshold effects to safety standards and agricultural irritation); and is not a sensitizer account for prenatal and postnatal practices. In this context, EPA considers (dermal sensitization) (see additional toxicity and the completeness of the the international maximum residue discussion in Unit III.B.). In addition, database on toxicity and exposure limits (MRLs) established by the Codex this active ingredient has been in use for unless EPA determines that a different Alimentarius Commission (Codex), as approximately 13 years without margin of safety will be safe for infants required by FFDCA section 408(b)(4). reported incidents. and children. This additional margin of The Codex Alimentarius is a joint U.N. safety is commonly referred to as the Food and Agriculture Organization/ V. Cumulative Effects From Substances Food Quality Protection Act Safety World Health Organization food With a Common Mechanism of Toxicity Factor. In applying this provision, EPA standards program, and it is recognized Section 408(b)(2)(D)(v) of FFDCA either retains the default value of 10X or as an international food safety requires that, when considering whether uses a different additional safety factor standards-setting organization in trade to establish, modify, or revoke a when reliable data available to EPA agreements to which the United States tolerance exemption, EPA consider support the choice of a different factor. is a party. EPA may establish a tolerance ‘‘available information concerning the Based on the acute toxicity and that is different from a Codex MRL; cumulative effects of [a particular pathogenicity data discussed in Unit however, FFDCA section 408(b)(4) pesticide’s] * * * residues and other III.B., as well as use of Isaria requires that EPA explain the reasons substances that have a common fumosorosea Apopka strain 97 as a for departing from the Codex level. mechanism of toxicity.’’ These microbial pesticide for approximately The Codex has not established a MRL considerations include the possible 13 years without reported adverse for Isaria fumosorosea Apopka strain cumulative effects of such residues on effects to humans, EPA concludes that 97. infants and children. EPA has not found there are no threshold effects of concern Isaria fumosorosea Apopka strain 97 to to infants, children, or adults when C. Revisions to Petitioned-for Tolerance share a common mechanism of toxicity Isaria fumosorosea Apopka strain 97 is Exemption to mammals with any other substances, used as labeled in accordance with good In the Federal Register of March 10, and Isaria fumosorosea Apopka strain agricultural practices. As a result, the 2010, EPA announced Certis USA, 97 does not appear to produce a toxic Agency concludes that no additional LLC’s filing of a pesticide petition that

VerDate Mar<15>2010 16:23 Sep 27, 2011 Jkt 223001 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 E:\FR\FM\28SER1.SGM 28SER1 emcdonald on DSK5VPTVN1PROD with RULES Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations 59905

proposed establishing an exemption Visible Radiation. Journal of Invertebrate Executive Order 13132, entitled from the requirement of a tolerance for Pathology 69:70–78. Federalism (64 FR 43255, August 10, residues of Paecilomyces fumosoroseus 7. U.S. EPA. 2004. Primer for Municipal 1999), and Executive Order 13175, Wastewater Treatment Systems. EPA Apopka strain 97. Data submitted to 832–R–04–001. Available from http:// entitled Consultation and Coordination EPA, as well as a review of current www.epa.gov/npdes/pubs/primer.pdf. with Indian Tribal Governments (65 FR literature, demonstrate that the 8. Centers for Disease Control and 67249, November 9, 2000), do not apply of the microorganism has Prevention. 2009. Drinking Water— to this final rule. In addition, this final changed. Paecilomyces fumosoroseus Water Treatment. Available from http:// rule does not impose any enforceable Apopka strain 97 is now classified as www.cdc.gov/healthywater/drinking/ duty or contain any unfunded mandate _ Isaria fumosorosea Apopka strain 97 public/water treatment.html. as described under Title II of the (Refs. 1, 2, and 3). X. Statutory and Executive Order Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104–4). VIII. Conclusions Reviews This action does not involve any This final rule establishes a tolerance EPA concludes that there is a technical standards that would require exemption under section 408(d) of reasonable certainty that no harm will EPA consideration of voluntary FFDCA in response to a petition result to the U.S. population, including consensus standards pursuant to section submitted to EPA. The Office of infants and children, from aggregate 12(d) of the National Technology Management and Budget (OMB) has exposure to residues of Isaria Transfer and Advancement Act of 1995 exempted these types of actions from fumosorosea Apopka strain 97. (NTTAA), Public Law 104–113, section review under Executive Order 12866, Therefore, an exemption from the 12(d) (15 U.S.C. 272 note). requirement of a tolerance is established entitled Regulatory Planning and for residues of Isaria fumosorosea Review (58 FR 51735, October 4, 1993). XI. Congressional Review Act (formerly Paecilomyces fumosoroseus) Because this final rule has been The Congressional Review Act, 5 Apopka strain 97 in or on all food exempted from review under Executive U.S.C. 801 et seq., generally provides Order 12866, this final rule is not commodities when applied as an that before a rule may take effect, the subject to Executive Order 13211, insecticide or miticide and used in agency promulgating the rule must entitled Actions Concerning Regulations accordance with good agricultural submit a rule report to each House of That Significantly Affect Energy Supply, practices. the Congress and to the Comptroller Distribution, or Use (66 FR 28355, May General of the United States. EPA will IX. References 22, 2001), or Executive Order 13045, submit a report containing this rule and entitled Protection of Children from 1. Agricultural Research Service Collection of other required information to the U.S. Environmental Health Risks and Safety Entomopathogenic Fungal (ARSEF) Senate, the U.S. House of Risks (62 FR 19885, April 23, 1997). Cultures. January 24, 2011. Isaria, plus Representatives, and the Comptroller Paecilomyces and Evlachovea USDA– This final rule does not contain any General of the United States prior to ARS Biological Integrated Pest information collections subject to OMB Management Research, Robert W. Holley approval under the Paperwork publication of this final rule in the Center for Agriculture and Health. 538 Reduction Act (PRA), 44 U.S.C. 3501 et Federal Register. This final rule is not Tower Road, Ithaca, New York 14853– seq., nor does it require any special a ‘‘major rule’’ as defined by 5 U.S.C. 2901. 804(2). 2. Zimmermann G. 2008. The considerations under Executive Order entomopathogenic fungi Isaria farinosa 12898, entitled Federal Actions to List of Subjects in 40 CFR Part 180 (formerly Paecilomyces farinosus) and Address Environmental Justice in Environmental protection, the Isaria fumosorosea species complex Minority Populations and Low-Income Administrative practice and procedure, (formerly Paecilomyces fumosoroseus): Populations (59 FR 7629, February 16, Agricultural commodities, Pesticides biology, ecology and use in biological 1994). Since tolerances and exemptions control. Biocontrol Science and and pests, Reporting and recordkeeping that are established on the basis of a requirements. Technology 18:865–901. petition under section 408(d) of FFDCA, 3. U.S. EPA. 2011. Isaria fumosorosea Dated: September 20, 2011. (formerly Paecilomyces fumosoroseus) such as the tolerance exemption in this Steven Bradbury, Apopka strain 97 Draft Biopesticides final rule, do not require the issuance of Registration Action Document (BRAD) a proposed rule, the requirements of the Director, Office of Pesticide Programs. dated August 10, 2011 (available as Regulatory Flexibility Act (RFA) (5 Therefore, 40 CFR chapter I is ‘‘Supporting & Related Material’’ within U.S.C. 601 et seq.) do not apply. amended as follows: docket ID number EPA–HQ–OPP–2010– This final rule directly regulates 0088 at http://www.regulations.gov). growers, food processors, food handlers, PART 180—[AMENDED] 4. U.S. EPA. 2011. Request for Exemption and food retailers, not States or tribes. ■ from the Requirement of a Tolerance. As a result, this action does not alter the 1. The authority citation for part 180 Data evaluation record prepared by I. continues to read as follows: Barsoum, Ph.D. (available as relationships or distribution of power ‘‘Supporting & Related Material’’ within and responsibilities established by Authority: 21 U.S.C. 321(q), 346a and 371. Congress in the preemption provisions docket ID number EPA–HQ–OPP–2010– ■ 2. Section 180.1306 is added to of section 408(n)(4) of FFDCA. As such, 0088 at http://www.regulations.gov). subpart D to read as follows: 5. U.S. EPA. 1996. Microbial Pesticide Test EPA has determined that this action will Guidelines—Background for Residue not have a substantial direct effect on § 180.1306 Isaria fumosorosea (formerly Analysis of Microbial Pest Control States or tribal governments, on the Paecilomyces fumosoroseus) Apopka Agents (OPPTS 885.2000). Available relationship between the national strain 97; exemption from the requirement from http://www.epa.gov/ocspp/pubs/ government and the States or tribal of a tolerance. frs/publications/Test_Guidelines/ series885.htm. governments, or on the distribution of An exemption from the requirement 6. Fargues J, Rougier M, Goujet R, Smits N, power and responsibilities among the of a tolerance is established for residues Coustere C, Itier B. 1997. Inactivation of various levels of government or between of Isaria fumosorosea (formerly Conidia of Paecilomyces fumosoroseus the Federal Government and Indian Paecilomyces fumosoroseus) Apopka by Near-Ultraviolet (UVB and UVA) and tribes. Thus, EPA has determined that strain 97 in or on all food commodities

VerDate Mar<15>2010 16:23 Sep 27, 2011 Jkt 223001 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 E:\FR\FM\28SER1.SGM 28SER1 emcdonald on DSK5VPTVN1PROD with RULES 59906 Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations

when applied as an insecticide or number: (703) 305–1243; e-mail as described in 40 CFR part 178, please miticide and used in accordance with address: [email protected]. submit a copy of the filing that does not good agricultural practices. SUPPLEMENTARY INFORMATION: contain any CBI for inclusion in the public docket. Information not marked [FR Doc. 2011–24990 Filed 9–27–11; 8:45 am] I. General Information BILLING CODE 6560–50–P confidential pursuant to 40 CFR part 2 A. Does this action apply to me? may be disclosed publicly by EPA without prior notice. Submit a copy of You may be potentially affected by your non-CBI objection or hearing ENVIRONMENTAL PROTECTION this action if you are an agricultural request, identified by docket ID number AGENCY producer, food manufacturer, or EPA–HQ–OPP–2010–0849, by one of pesticide manufacturer. Potentially 40 CFR Part 180 the following methods: affected entities may include, but are • Federal eRulemaking Portal: http:// [EPA–HQ–OPP–2010–0849; FRL–8889–1] not limited to those engaged in the www.regulations.gov. Follow the on-line following activities: instructions for submitting comments. Fluazifop-P-butyl; Pesticide Tolerances • Crop production (NAICS code 111). • Mail: Office of Pesticide Programs • Animal production (NAICS code AGENCY (OPP) Regulatory Public Docket (7502P), : Environmental Protection 112). Agency (EPA). • Food manufacturing (NAICS code Environmental Protection Agency, 1200 ACTION: Final rule. 311). Pennsylvania Ave., NW., Washington, • DC 20460–0001. Pesticide manufacturing (NAICS • SUMMARY: This regulation establishes code 32532). Delivery: OPP Regulatory Public and increases tolerances for residues of This listing is not intended to be Docket (7502P), Environmental fluazifop-P-butyl in or on cotton, gin exhaustive, but rather to provide a guide Protection Agency, Rm. S–4400, One byproducts; cotton, refined oil; and for readers regarding entities likely to be Potomac Yard (South Bldg.), 2777 S. cotton, undelinted seed. Syngenta Crop affected by this action. Other types of Crystal Dr., Arlington, VA. Deliveries Protection requested these tolerances entities not listed in this unit could also are only accepted during the Docket under the Federal Food, Drug, and be affected. The North American Facility’s normal hours of operation Cosmetic Act (FFDCA). Industrial Classification System (8:30 a.m. to 4 p.m., Monday through DATES: This regulation is effective (NAICS) codes have been provided to Friday, excluding legal holidays). September 28, 2011. Objections and assist you and others in determining Special arrangements should be made requests for hearings must be received whether this action might apply to for deliveries of boxed information. The on or before November 28, 2011, and certain entities. If you have any Docket Facility telephone number is must be filed in accordance with the questions regarding the applicability of (703) 305–5805. instructions provided in 40 CFR part this action to a particular entity, consult II. Summary of Petitioned-for Tolerance 178 (see also Unit I.C. of the the person listed under FOR FURTHER In the Federal Register of December SUPPLEMENTARY INFORMATION). INFORMATION CONTACT. 15, 2010 (75 FR 78240) (FRL–8853–1), ADDRESSES: EPA has established a B. How can I get electronic access to EPA issued a notice pursuant to section docket for this action under docket other related information? 408(d)(3) of FFDCA, 21 U.S.C. identification (ID) number EPA–HQ– You may access a frequently updated 346a(d)(3), announcing the filing of a OPP–2010–0849. All documents in the electronic version of EPA’s tolerance pesticide petition (PP 0F7768) by docket are listed in the docket index regulations at 40 CFR part 180 through Syngenta Crop Protection, P.O. Box available at http://www.regulations.gov. the Government Printing Office’s e-CFR 18300, Greensboro, NC 27419. The Although listed in the index, some site at http://ecfr.gpoaccess.gov/cgi/t/ petition requested that 40 CFR 180.411 information is not publicly available, text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ be amended by establishing tolerances e.g., Confidential Business Information Title40/40tab_02.tpl. for residues of the herbicide, fluazifop- (CBI) or other information whose P-butyl, butyl(R)-2-[4-[[5- disclosure is restricted by statute. C. How can I file an objection or hearing (trifluoromethyl)-2- Certain other material, such as request? pyridinyl]oxy]phenoxy]propanoate, and copyrighted material, is not placed on Under FFDCA section 408(g), 21 the free and conjugated forms of the the Internet and will be publicly U.S.C. 346a, any person may file an resolved isomer of fluazifop, (R)-2-[4- available only in hard copy form. objection to any aspect of this regulation [[5-(trifluoromethyl)-2- Publicly available docket materials are and may also request a hearing on those pyridinyl]oxy]phenoxy]propanoic acid, available in the electronic docket at objections. You must file your objection expressed as fluazifop, in or on cotton, http://www.regulations.gov, or, if only or request a hearing on this regulation undelinted seed at 0.9 ppm; and cotton, available in hard copy, at the OPP in accordance with the instructions gin byproducts at 0.8 ppm. That notice Regulatory Public Docket in Rm. S– provided in 40 CFR part 178. To ensure referenced a summary of the petition 4400, One Potomac Yard (South Bldg.), proper receipt by EPA, you must prepared by Syngenta Crop Protection, 2777 S. Crystal Dr., Arlington, VA. The identify docket ID number EPA–HQ– the registrant, which is available in the Docket Facility is open from 8:30 a.m. OPP–2010–0849 in the subject line on docket, http://www.regulations.gov. to 4 p.m., Monday through Friday, the first page of your submission. All There were no comments received in excluding legal holidays. The Docket objections and requests for a hearing response to the notice of filing. Facility telephone number is (703) 305– must be in writing, and must be Based upon review of the data 5805. received by the Hearing Clerk on or supporting the petition EPA has made FOR FURTHER INFORMATION CONTACT: before November 28, 2011. Addresses changes to the requested tolerances. Kathryn V. Montague, Registration for mail and hand delivery of objections First, EPA is raising the proposed Division (7505P), Office of Pesticide and hearing requests are provided in 40 cotton, gin byproducts tolerance from Programs, Environmental Protection CFR 178.25(b). 0.8 ppm to 1.5 ppm; second, raising the Agency, 1200 Pennsylvania Ave., NW., In addition to filing an objection or established cotton, refined oil tolerance Washington, DC 20460–0001; telephone hearing request with the Hearing Clerk from 0.2 ppm to 1.3 ppm; and finally,

VerDate Mar<15>2010 16:23 Sep 27, 2011 Jkt 223001 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 E:\FR\FM\28SER1.SGM 28SER1 emcdonald on DSK5VPTVN1PROD with RULES