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Aureobasidium pullulans strains DSM 5. Fleet, G.H. 2003. Yeast interactions and Dated: January 30, 2012. 14940 and DSM 14941. Therefore, an wine flavor. Int. J. Food Microbiol., 86: Steven Bradbury, exemption from the requirement of a 11–22. Director, Office of Pesticide Programs. tolerance is established for residues of 6. Granado, J., B. Thurig, E. Kieffer, L. Petrini, Aureobasidium pullulans strains DSM A. Fliessbach, L. Tamm, F.P. Weibel, Therefore, 40 CFR chapter I is 14940 and DSM 14941 in or on all food G.S. Wyss. 2008. Culturable fungi of amended as follows: stored ‘Golden Delicious’ apple fruits: a commodities when applied as a PART 180—[AMENDED] preharvest fungicide and used in one-season comparison study of organic and integrated production systems in accordance with good agricultural ■ Switzerland. Microb. Ecol., 56: 720–732. 1. The authority citation for part 180 practices. 7. Gao, X.-X., H. Zhou, D.-Y. Xu, C.-H. Yu, continues to read as follows: IX. Statutory and Executive Order Y.-Q. Chen, L.-H. Qu. 2005. High Authority: 21 U.S.C. 321(q), 346a and 371. Reviews diversity of endophytic fungi from the pharmaceutical plant, Heterosmilax ■ 2. Section 180.1312 is added to This final rule establishes a tolerance japonica Kunth revealed by cultivation- subpart D to read as follows: under section 408(d) of FFDCA in independent approach. FEMS Microbiol. § 180.1312 Aureobasidium pullulans response to a petition submitted to the Letters, 249: 255–266. strains DSM 14940 and DSM 14941; Agency. The Office of Management and 8. Osono, T. 2008. Endophytic and epiphytic Budget (OMB) has exempted these types exemption from the requirement of a phyllosphere fungi of Camellia japonica: tolerance. of actions from review under Executive seasonal and leaf age-dependent Order 12866, entitled Regulatory variations. Mycologia, 100: 387–391. An exemption from the requirement Planning and Review (58 FR 51735, 9. Slavikova, E., R. Vadkertiova, and D. of a tolerance is established for residues October 4, 1993). Because this final rule Vranova. 2007. Yeasts colonizing the leaf of the microbial pesticides, has been exempted from review under surfaces. J. Basic Microbiol. 47: 344–350. Aureobasidium pullulans strains DSM Executive Order 12866, this final rule is 10. Suryanarayanan, T.S., S.K. Wittlinger, 14940 and DSM 14941 in or on all food not subject to Executive Order 13211, and S.H. Faeth. 2005. Endophytic fungi commodities when applied preharvest entitled Actions Concerning Regulations associated with cacti in Arizona. Mycol. and used in accordance with good That Significantly Affect Energy Supply, Res. 109: 635–639. agricultural practices. Distribution, or Use (66 FR 28355, May 11. Webb, T.A. and J.O. Mundt. 1978. Molds [FR Doc. 2012–3585 Filed 2–14–12; 8:45 am] on vegetables at the time of harvest. 22, 2001) or Executive Order 13045, BILLING CODE 6560–50–P entitled Protection of Children from Appl. Environ. Microbiol., 35: 655–658. Environmental Health Risks and Safety 12. Kockova-Kratochvilova, A., M. Cernakova, and E. Slavikova. 1980. Risks (62 FR 19885, April 23, 1997). ENVIRONMENTAL PROTECTION Morphological changes during the life AGENCY This final rule does not contain any cycle of Aureobasidium pullulans (de information collections subject to OMB Bary) Arnaud. Folia Microbiologica, 25. 40 CFR Part 180 approval under the Paperwork 13. U.S. EPA. December 2011. DRAFT Reduction Act (PRA), 44 U.S.C. 3501 et Biopesticides Registration Action [EPA–HQ–OPP–2010–0807; FRL–9337–2] seq., nor does it require any special Document of Aureobasidium pullulans considerations under Executive Order strains DSM 14940 and 14941. —Pn1; Exemption 12898, entitled Federal Actions to 14. Slavikova, E. and R. Vadkertiova. 1997. From the Requirement of a Tolerance Address Environmental Justice in Seasonal occurrence of yeasts and yeast Minority Populations and Low-Income like organisms in the river Danube. AGENCY: Environmental Protection Populations (59 FR 7629, February 16, Antonie van Leeuwenhoek 72: 77–80, Agency (EPA). 1997. 1994). ACTION: Final rule. Since tolerances and exemptions that XI. Congressional Review Act are established on the basis of a petition SUMMARY: This regulation establishes an under section 408(d) of FFDCA, such as The Congressional Review Act, 5 exemption from the requirement of a the tolerance in this final rule, do not U.S.C. 801 et seq., generally provides tolerance for residues of Pasteuria require the issuance of a proposed rule, that before a rule may take effect, the nishizawae—Pn1 in or on all food the requirements of the Regulatory agency promulgating the rule must commodities when applied as a Flexibility Act (RFA) (5 U.S.C. 601 et submit a rule report to each House of nematicide and used in accordance with seq.) do not apply. the Congress and to the Comptroller good agricultural practices. Pasteuria General of the United States. EPA will Bioscience, Inc. submitted a petition to X. References submit a report containing this rule and EPA under the Federal Food, Drug, and 1. Chi, Z., F. Wang, Z. Chi, L. Yue, G. Liu, other required information to the U.S. Cosmetic Act (FFDCA), requesting an T. Zhang. 2009. Bioproducts from Senate, the U.S. House of exemption from the requirement of a ureobasidium pullulans, a Representatives, and the Comptroller tolerance. This regulation eliminates the biotechnologically important yeast. General of the United States prior to need to establish a maximum Appl. Microbiol. Biotechnol., 82: 793– publication of this final rule in the permissible level for residues of 804. Pasteuria nishizawae—Pn1 under the 2. Cooke, W.B. 1959. An ecological life Federal Register. This final rule is not history of Aureobasidium pullulans (De a ‘‘major rule’’ as defined by 5 U.S.C. FFDCA. Bary) Arnaud. Mycopathologia, 12: 1–45. 804(2). DATES: This regulation is effective 3. Slepecky, R.A. and W.T. Starmer. 2009. List of Subjects in 40 CFR Part 180 February 15, 2012. Objections and Phenotypic plasticity in fungi: a review requests for hearings must be received with observations on Aureobasidium Environmental protection, on or before April 16, 2012, and must pullulans. Mycologia 101: 823–832. 4. Fleet, G.H. 2002. The yeast ecology of wine Administrative practice and procedure, be filed in accordance with the grapes. Pp. 1–17 in Biodiversity and Agricultural commodities, Pesticides instructions provided in 40 CFR part Biotechnol. Of Wine Yeasts (Ciani, M., and pests, Reporting and recordkeeping 178 (see also Unit I.C. of the ed.). Research Signpost, Kerala, India. requirements. SUPPLEMENTARY INFORMATION).

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ADDRESSES: EPA has established a B. How can I get electronic access to II. Background and Statutory Findings docket for this action under docket other related information? identification (ID) number EPA–HQ– In the Federal Register of February 4, You may access a frequently updated 2011 (76 FR 6465) (FRL–8858–7), EPA OPP–2010–0807. All documents in the electronic version of 40 CFR part 180 docket are listed in the docket index issued a notice pursuant to section through the Government Printing 408(d)(3) of FFDCA, 21 U.S.C. available at http://www.regulations.gov. Office’s e-CFR site at http:// Although listed in the index, some 346a(d)(3), announcing the filing of a ecfr.gpoaccess.gov/cgi/t/text/text- pesticide tolerance petition (PP 0F7749) information is not publicly available, idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ e.g., Confidential Business Information by Pasteuria Bioscience, Inc., 12085 40tab_02.tpl. To access the harmonized (CBI) or other information whose Research Dr., Suite 185, Alachua, FL test guidelines referenced in this disclosure is restricted by statute. 32615. The petition requested that 40 document electronically, please go to Certain other material, such as CFR part 180 be amended by http://www.epa.gov/ocspp and select copyrighted material, is not placed on establishing an exemption from the ‘‘Test Methods and Guidelines.’’ the Internet and will be publicly requirement of a tolerance for residues available only in hard copy form. C. How can I file an objection or hearing of Pasteuria nishizawae—Pn1. This Publicly available docket materials are request? notice referenced a summary of the petition prepared by the petitioner, available in the electronic docket at Under FFDCA section 408(g), 21 http://www.regulations.gov, or, if only Pasteuria Bioscience, Inc., which is U.S.C. 346a(g), any person may file an available in the docket via http:// available in hard copy, at the Office of objection to any aspect of this regulation Pesticide Programs (OPP) Regulatory www.regulations.gov. Comments were and may also request a hearing on those received on the notice of filing. EPA’s Public Docket in Rm. S–4400, One objections. You must file your objection Potomac Yard (South Bldg.), 2777 S. response to these comments is or request a hearing on this regulation discussed in Unit VII.C. Crystal Dr., Arlington, VA. The Docket in accordance with the instructions Facility is open from 8:30 a.m. to 4 p.m., provided in 40 CFR part 178. To ensure Section 408(c)(2)(A)(i) of FFDCA Monday through Friday, excluding legal proper receipt by EPA, you must allows EPA to establish an exemption holidays. The Docket Facility telephone identify docket ID number EPA–HQ– from the requirement for a tolerance (the number is (703) 305–5805. OPP–2010–0807 in the subject line on legal limit for a pesticide chemical FOR FURTHER INFORMATION CONTACT: the first page of your submission. All residue in or on a food) only if EPA Jeannine Kausch, Biopesticides and objections and requests for a hearing determines that the exemption is ‘‘safe.’’ Pollution Prevention Division (7511P), must be in writing, and must be Section 408(c)(2)(A)(ii) of FFDCA Office of Pesticide Programs, received by the Hearing Clerk on or defines ‘‘safe’’ to mean that ‘‘there is a Environmental Protection Agency, 1200 before April 16, 2012. Addresses for reasonable certainty that no harm will Pennsylvania Ave. NW., Washington, mail and hand delivery of objections result from aggregate exposure to the DC 20460–0001; telephone number: and hearing requests are provided in 40 pesticide chemical residue, including (703) 347–8920; email address: CFR 178.25(b). all anticipated dietary exposures and all [email protected]. In addition to filing an objection or other exposures for which there is SUPPLEMENTARY INFORMATION: hearing request with the Hearing Clerk reliable information.’’ This includes as described in 40 CFR part 178, please exposure through drinking water and in I. General Information submit a copy of the filing that does not residential settings but does not include A. Does this action apply to me? contain any CBI for inclusion in the occupational exposure. Pursuant to public docket. Information not marked section 408(c)(2)(B) of FFDCA, in You may be potentially affected by establishing or maintaining in effect an this action if you are an agricultural confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA exemption from the requirement of a producer, food manufacturer, or tolerance, EPA must take into account pesticide manufacturer. Potentially without prior notice. Submit a copy of your non-CBI objection or hearing the factors set forth in section affected entities may include, but are 408(b)(2)(C) of FFDCA, which require not limited to: request, identified by docket ID number • EPA–HQ–OPP–2010–0807, by one of EPA to give special consideration to Crop production (NAICS code 111). exposure of infants and children to the • Animal production (NAICS code the following methods: pesticide chemical residue in 112). • Federal eRulemaking Portal: http:// • Food manufacturing (NAICS code www.regulations.gov. Follow the on-line establishing a tolerance exemption and 311). instructions for submitting comments. to ‘‘ensure that there is a reasonable • Pesticide manufacturing (NAICS • Mail: OPP Regulatory Public Docket certainty that no harm will result to code 32532). (7502P), Environmental Protection infants and children from aggregate This listing is not intended to be Agency, 1200 Pennsylvania Ave. NW., exposure to the pesticide chemical exhaustive, but rather provides a guide Washington, DC 20460–0001. residue. * * *’’ Additionally, section for readers regarding entities likely to be • Delivery: OPP Regulatory Public 408(b)(2)(D) of FFDCA requires that EPA affected by this action. Other types of Docket (7502P), Environmental consider ‘‘available information entities not listed in this unit could also Protection Agency, Rm. S–4400, One concerning the cumulative effects of [a be affected. The North American Potomac Yard (South Bldg.), 2777 S. particular pesticide’s] * * * residues Industrial Classification System Crystal Dr., Arlington, VA. Deliveries and other substances that have a (NAICS) codes have been provided to are only accepted during the Docket common mechanism of toxicity.’’ assist you and others in determining Facility’s normal hours of operation EPA performs a number of analyses to whether this action might apply to (8:30 a.m. to 4 p.m., Monday through determine the risks from aggregate certain entities. If you have any Friday, excluding legal holidays). exposure to pesticide residues. First, questions regarding the applicability of Special arrangements should be made EPA determines the toxicity of this action to a particular entity, consult for deliveries of boxed information. The pesticides. Second, EPA examines the person listed under FOR FURTHER Docket Facility telephone number is exposure to the pesticide through food, INFORMATION CONTACT. (703) 305–5805. drinking water, and through other

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exposures that occur as a result of through parasitism that ultimately pathogenic to laboratory rats when pesticide use in residential settings. results in the death of infected females: administered by oral gavage in a single 1. Endospores attach to the cuticle of dose of 1.6 × 109 spores per animal. III. Toxicological Profile a juvenile soybean cyst Although clearance and infectivity were Consistent with section 408(b)(2)(D) female. not measured, EPA believes these of FFDCA, EPA has reviewed the 2. Once a soybean cyst nematode endpoints are not a concern given available scientific data and other female invades soybean roots, Pasteuria Pasteuria nishizawae—Pn1’s well- relevant information in support of this nishizawae—Pn1 produces a germ tube established host specificity for the action and considered its validity, that penetrates the body of the soybean cyst nematode (Refs. 1 and 2). completeness, and reliability and the nematode. 2. Acute pulmonary toxicity/ relationship of this information to 3. Primary and secondary pathogenicity—rat (Harmonized human risk. EPA has also considered microcolonies of Pasteuria Guideline 885.3150; MRID No. 481517– available information concerning the nishizawae—Pn1 develop and 10). A supplemental acute pulmonary variability of the sensitivities of major proliferate within the body of the toxicity/pathogenicity study identifiable subgroups of consumers, nematode, causing its death (Ref. 2). demonstrated that Pasteuria In light of the demonstrated including infants and children. nishizawae—Pn1 was not toxic and/or nematicidal capabilities and host pathogenic to laboratory rats when A. Overview of Pasteuria nishizawae— specificity of Pasteuria nishizawae— administered by intratracheal Pn1 Pn1, Pasteuria Bioscience, Inc. has instillation in a single dose of 1.6 × 108 proposed to register pesticide products spores per animal. Although clearance Pasteuria, a genus of , that could be applied to soybean or its includes several species that have and infectivity were not measured, EPA seed to control the soybean cyst believes these endpoints are not a shown potential in controlling plant- nematode. parasitic that attack and concern given Pasteuria nishizawae— cause significant damage to many B. Microbial Pesticide Toxicology Data Pn1’s well-established host specificity agricultural crops (see, e.g., the Federal Requirements for the soybean cyst nematode (Refs. 1 Register of December 28, 1994 (59 FR and 2). All applicable mammalian toxicology 3. Acute injection toxicity/ 66740) (FRL–4923–4) and June 30, 2010 data requirements supporting the pathogenicity (intravenous)—rat (75 FR 37734) (FRL–8831–9) for final request for an exemption from the (Harmonized Guideline 885.3200; MRID rules that established tolerance requirement of a tolerance for residues No. 481517–11). A supplemental acute exemptions for residues of the of Pasteuria nishizawae—Pn1 in or on injection toxicity/pathogenicity study nematicides, Pasteuria penetrans (40 all food commodities have been fulfilled demonstrated that Pasteuria CFR 180.1135) and Pasteuria usgae (40 with data submitted by the petitioner. nishizawae—Pn1 was not toxic and/or CFR 180.1290), respectively). These The results of the acute dermal toxicity pathogenic to laboratory rats when gram-positive, mycelial, endospore- and primary dermal irritation tests administered intravenously in a single forming bacteria are mostly obligate revealed no toxicity or irritation dose of 1.0 × 109 spores per animal. parasites (i.e., organisms that depend on attributed to Pasteuria nishizawae— Although clearance and infectivity were particular hosts to complete their own Pn1, and these studies received a not measured, EPA believes these life cycle) of plant-parasitic nematodes, Toxicity Category IV classification (see endpoints are not a concern given although one Pasteuria species— 40 CFR 156.62). Moreover, acute oral, Pasteuria nishizawae—Pn1’s well- —is known to pulmonary, and injection toxicity/ established host specificity for the parasitize species, which are pathogenicity tests indicated that soybean cyst nematode (Refs. 1 and 2). tiny often called ‘‘water Pasteuria nishizawae—Pn1 was not 4. Hypersensitivity incidents fleas’’ due to their flea-like size and toxic and/or pathogenic via the tested (Harmonized Guideline 885.3400; MRID appearance (Refs. 1 and 2). Pasteuria routes of exposure. Although infectivity No. 481517–12). The petitioner reported species are ubiquitous in most and clearance were not evaluated in any that no hypersensitivity incidents, environments and are found in of the acute toxicity/pathogenicity tests, including immediate-type or delayed- nematodes in at least 80 countries on 5 EPA believes that these endpoints are type reactions of humans and domestic continents, as well as on islands in the not a concern given the host specificity animals, occurred during research, Atlantic, Pacific, and Indian Oceans of Pasteuria nishizawae for the soybean development, or testing of Pasteuria (Ref. 2). Higher population densities cyst nematode (Refs. 1 and 2). Finally, nishizawae—Pn1. often occur in areas where there is an the petitioner has reported that no 5. Acute dermal toxicity—rabbit ample supply of nematode hosts (e.g., hypersensitivity incidents occurred (Harmonized Guideline 870.1200; MRID where crops susceptible to nematodes during development and testing of this No. 481517–14). An acceptable acute are cultivated) (Refs. 3, 4, and 5). bacterium. The overall conclusions from dermal toxicity study demonstrated that Pasteuria nishizawae—Pn1 was all toxicological information submitted a test substance containing Pasteuria specifically isolated from an Illinois by the petitioner are briefly described in nishizawae—Pn1 was not toxic to soybean field in the mid-2000s (Ref. 1). this unit, while more in-depth synopses rabbits when dosed at 2,000 milligrams Although endospores of Pasteuria of some study results can be found in per kilogram (mg/kg) for 24 hours. The nishizawae have been observed to attach the associated Biopesticides Registration dermal median lethal dose, which is a to the cuticle of 3 nematodes of the Action Document provided as a statistically derived single dose that can genus and 1 nematode of the reference in Unit IX. (Ref. 6). be expected to cause death in 50% of genus Globodera, it is known only to 1. Acute oral toxicity/pathogenicity— test animals, was greater than 2,000 mg/ infect and complete its life cycle within rat (Harmonized Guideline 885.3050; kg for male and female rats combined the female soybean cyst nematode Master Record Identification Number (Toxicity Category IV). (Heterodera glycines) (Ref. 2). In the (MRID No.) 481517–09). A supplemental 6. Primary dermal irritation—rabbit following manner, Pasteuria acute oral toxicity/pathogenicity study (Harmonized Guideline 870.2500; MRID nishizawae—Pn1 exerts a pesticidal demonstrated that Pasteuria No. 481517–16). An acceptable primary effect on the soybean cyst nematode nishizawae—Pn1 was not toxic and/or dermal irritation study demonstrated

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that a test substance containing runoff. Furthermore, ground water is not No mechanism of toxicity in Pasteuria nishizawae—Pn1 was expected to have significant exposure to mammals has been identified for essentially non-irritating to the skin of Pasteuria nishizawae—Pn1 since, like Pasteuria nishizawae—Pn1, and rabbits (Toxicity Category IV). other microorganisms, this microbial Pasteuria nishizawae—Pn1 does not pesticide would likely be filtered out by appear to produce a toxic metabolite IV. Aggregate Exposure the particulate nature of many soil types against the target pest. For the purposes In examining aggregate exposure, (Refs. 10, 11, and 12). If Pasteuria of this tolerance action, EPA has section 408 of FFDCA directs EPA to nishizawae—Pn1 were to be transferred assumed that Pasteuria nishizawae— consider available information to surface or ground waters (e.g., Pn1 does not have a common concerning exposures from the pesticide through spray drift or runoff) that are mechanism of toxicity with other residue in food and all other non- intended for eventual human substances. Therefore, section occupational exposures, including consumption and directed to 408(b)(2)(D)(v) of FFDCA does not drinking water from ground water or wastewater treatment systems or apply. For information regarding EPA’s surface water and exposure through drinking water facilities, it may not efforts to determine which chemicals pesticide use in gardens, lawns, or survive some of the conditions water is have a common mechanism of toxicity buildings (residential and other indoor subjected to in such systems or and to evaluate the cumulative effects of uses). facilities, including chlorination, pH such chemicals, see EPA’s Web site at A. Dietary Exposure adjustments, and filtration (Refs. 13 and http://www.epa.gov/pesticides/ 14). In the remote likelihood that cumulative. 1. Food exposure. Dietary exposure to Pasteuria nishizawae—Pn1 is present in Pasteuria nishizawae—Pn1, a naturally VI. Determination of Safety for U.S. drinking water (e.g., water not subject to occurring soil bacterium (Refs. 7, 8, and Population, Infants and Children 9), is anticipated to be negligible. For certain conditions in treatment systems optimal control of the target pest and facilities), its specificity for the FFDCA section 408(b)(2)(C) provides (soybean cyst nematode), Pasteuria soybean cyst nematode and available that, in considering the establishment of nishizawae—Pn1 is applied in a manner data indicate no toxicity, pathogenicity, a tolerance or tolerance exemption for a that facilitates spore movement into or and/or infectivity is likely to occur with pesticide chemical residue, EPA shall spore placement near the root zone of any drinking water exposure that results assess the available information about potentially affected plants. This requires from pesticide applications made in consumption patterns among infants that end users take certain actions, accordance with good agricultural and children, special susceptibility of depending on the treatment type, that practices (see additional discussion in infants and children to pesticide would inevitably minimize the amount Unit III.). chemical residues, and the cumulative effects on infants and children of the of Pasteuria nishizawae—Pn1 residues B. Other Non-Occupational Exposure on above-ground commodities. That is, residues and other substances with a although Pasteuria nishizawae—Pn1 Given Pasteuria nishizawae’s natural common mechanism of toxicity. In can be applied to soil, plants, or seeds, presence in soil (Refs. 7, 8, and 9), non- addition, FFDCA section 408(b)(2)(C) some seeds are incorporated into the occupational exposure to the bacterium provides that EPA shall apply an soil immediately after treatment (at- is likely already occurring. Additional additional tenfold (10X) margin of safety planting, hopper box, planter box, or exposure to Pasteuria nishizawae—Pn1 for infants and children in the case of slurry box seed treatments), and due to pesticidal applications is not threshold effects to account for prenatal pesticide applications made to plants or expected because all proposed pesticide and postnatal toxicity and the the soil are always followed by end-use products are labeled for use in completeness of the database on toxicity irrigation to incorporate Pasteuria distinct agricultural settings. Even if and exposure unless EPA determines nishizawae—Pn1 into the soil. In non-occupational exposures were to that a different margin of safety will be instances where food commodities occur (e.g., eventual expansion of use safe for infants and children. This develop underground or where treated sites), such exposures would not exceed additional margin of safety is commonly seed is diverted for food or feed EPA’s level of concern in light of referred to as the Food Quality purposes or to process into oil, exposure Pasteuria nishizawae—Pn1’s specificity Protection Act Safety Factor. In to Pasteuria nishizawae—Pn1 is a more for the soybean cyst nematode and test applying this provision, EPA either likely scenario. Regardless of the results that indicated Pasteuria retains the default value of 10X or uses situation, should Pasteuria nishizawae—Pn1 is not toxic (acute a different additional safety factor when nishizawae—Pn1 be present on food, its dermal toxicity and acute pulmonary reliable data available to EPA support specificity for the soybean cyst toxicity/pathogenicity), is essentially the choice of a different factor. nematode and available data indicate no non-irritating (primary dermal Based on the acute toxicity and toxicity, pathogenicity, and/or irritation), and is not pathogenic (acute pathogenicity data discussed in Unit infectivity is likely to occur with any pulmonary toxicity/pathogenicity) (see III.B., as well as Pasteuria nishizawae— dietary exposure that results from additional discussion in Unit III.). Pn1’s host specificity for the soybean pesticide applications made in V. Cumulative Effects From Substances cyst nematode, EPA concludes that accordance with good agricultural With a Common Mechanism of Toxicity there are no threshold effects of concern practices (see additional discussion in to infants, children, or adults when Unit III.). Section 408(b)(2)(D)(v) of FFDCA Pasteuria nishizawae—Pn1 is used as 2. Drinking water exposure. Exposure requires that, when considering whether labeled in accordance with good to residues of Pasteuria nishizawae— to establish, modify, or revoke a agricultural practices. As a result, EPA Pn1 in consumed drinking water is tolerance exemption, EPA consider concludes that no additional margin of possible but not likely. The proposed ‘‘available information concerning the exposure (safety) is necessary to protect use patterns for Pasteuria nishizawae— cumulative effects of [a particular infants and children and that not adding Pn1 are soil directed, soil incorporated, pesticide’s] * * * residues and other any additional margin of exposure and/or seed directed, thereby limiting substances that have a common (safety) will be safe for infants and contact with surface water by drift and mechanism of toxicity.’’ children.

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Moreover, based on the same data and chemicals combine. Another commenter nomenclature in the future. Second, EPA analysis as presented in this unit, (EPA–HQ–OPP–2010–0905–0003) also EPA is changing ‘‘in or on all raw the Agency is able to conclude that expressed opposition to granting agricultural crops’’ to ‘‘in or on all food there is a reasonable certainty that no tolerances and tolerance exemptions for commodities’’ to align with the harm will result to the U.S. population, several chemicals, including Pasteuria terminology the Agency currently uses including infants and children, from nishizawae—Pn1, that were described when establishing tolerance exemptions aggregate exposure to the residues of in the Federal Register of February 4, for residues of other like active Pasteuria nishizawae—Pn1 when it is 2011. This commenter stated that the ingredients. food supply must be rigorously tested, used as labeled and in accordance with VIII. Conclusions good agricultural practices as a that studies submitted by the chemical nematicide. Such exposure includes all industry must be subjected to EPA concludes that there is a anticipated dietary exposures and all independent peer review, and that only reasonable certainty that no harm will other exposures for which there is long-term studies can provide data on result to the U.S. population, including reliable information. EPA has arrived at the health impact of exposure to the infants and children, from aggregate this conclusion because, considered chemicals in the February 4, 2011 notice exposure to residues of Pasteuria collectively, the data and information of filing. nishizawae—Pn1. Therefore, an available on Pasteuria nishizawae—Pn1 Data provided by the petitioner exemption from the requirement of a do not demonstrate toxic, pathogenic, demonstrated that Pasteuria tolerance is established for residues of and/or infective potential to mammals, nishizawae—Pn1 is not toxic and/or Pasteuria nishizawae—Pn1. including infants and children. pathogenic at the doses administered IX. References orally, intratracheally, intravenously, VII. Other Considerations and dermally to rats or rabbits (see Unit 1. U.S. EPA. 2011a. Pasteuria nishizawae strain PN1. Memorandum from J.V. A. Analytical Enforcement Methodology III.B.). Although infectivity and clearance were not evaluated in any of Gagliardi, Ph.D. and J.L. Kough, Ph.D. to An analytical method is not required J. Kausch dated August 16, 2011. these studies, EPA believes that these 2. U.S. EPA. 2011b. Environmental Risk for enforcement purposes for the endpoints are not a concern given reasons stated in this document and Assessment of Pasteuria nishizawae Pn1 Pasteuria nishizawae—Pn1’s well- (PC 016455) for a Section 3 Registration because EPA is establishing an established host specificity for the of the Technical Product (EPA File exemption from the requirement of a soybean cyst nematode (Refs. 1 and 2). Symbol 85004–A) and Two End Use tolerance without any numerical Moreover, since no mechanism of Products (EPA File Symbols 85004–T limitation. toxicity in mammals has been identified and 85004–O) for Control of the Soybean for Pasteuria nishizawae—Pn1, and Cyst Nematode in Soybeans. B. International Residue Limits Memorandum from S. Borges and G. Pasteuria nishizawae—Pn1 does not Tomimatsu, Ph.D. to J. Kausch dated In making its tolerance decisions, EPA appear to produce a toxic metabolite seeks to harmonize U.S. tolerances with September 15, 2011 (available as against the target pest, EPA has assumed ‘‘Supporting & Related Material’’ within international standards whenever that Pasteuria nishizawae—Pn1 does docket ID number EPA–HQ–OPP–2010– possible, consistent with U.S. food not have a common mechanism of 0806). safety standards and agricultural toxicity with other substances. After 3. Cetintas R, Dickson DW. 2004. Persistence practices. In this context, EPA considers conducting a comprehensive assessment and suppressiveness of Pasteuria the international maximum residue of the data and information submitted penetrans to Meloidogyne arenaria Race 1. Journal of Nematology 36:540–549. limits (MRLs) established by the Codex by the petitioner, EPA has concluded Alimentarius Commission (Codex), as 4. Tain B, Yang J, Zhang K–Q. 2007. Bacteria there is a reasonable certainty that no used in the biological control of plant- required by FFDCA section 408(b)(4). harm will result to the U.S. population, parasitic nematodes: Populations, The Codex Alimentarius is a joint U.N. including infants and children, from mechanisms of action, and future Food and Agriculture Organization/ aggregate exposure to residues of prospects. FEMS Microbiology Ecology World Health Organization food Pasteuria nishizawae—Pn1. Thus, 61:197–213. standards program, and it is recognized under the standard in FFDCA section 5. Noel GR. 2008. IPM of soybean cyst as an international food safety 408(c)(2), a tolerance exemption is nematode in the USA. In: Integrated standards-setting organization in trade Management and Biocontrol of Vegetable appropriate. and Grain Crops Nematodes. Eds. A. agreements to which the United States Cianio and K.G. Mukerji. Springer. Pages is a party. EPA may establish a tolerance D. Revisions to Requested Tolerance Exemption 119–126. that is different from a Codex MRL; 6. U.S. EPA. 2011c. Draft Pasteuria however, FFDCA section 408(b)(4) Two modifications have been made to nishizawae—Pn1 Biopesticides requires that EPA explain the reasons the requested tolerance exemption. Registration Action Document dated for departing from the Codex level. First, since Pasteuria Bioscience, Inc. December 21, 2011 (available as The Codex has not established a MRL already created a unique isolate ‘‘Supporting & Related Material’’ within for Pasteuria nishizawae—Pn1. identifier (i.e., Pn1) for Pasteuria docket ID number EPA–HQ–OPP–2010– nishizawae, inclusion of the American 0806). C. Response to Comments 7. Atibalentja N, Jakstys BP, Noel GR. 2004. Type Culture Collection accession Life cycle, ultrastructure, and host Two comments were submitted. An number (i.e., SD–5833) within this specificity of the North American isolate anonymous commenter (EPA–HQ–OPP– microbial pesticide’s taxonomic name of Pasteuria that parasitizes the soybean 2010–0012–0019) generally expressed was unnecessary. Use of just Pasteuria cyst nematode, Heterodera glycines. opposition to EPA granting tolerance nishizawae—Pn1 throughout this Journal of Nematology 36:171–180. exemptions to several petitioners, document, particularly in the tolerance 8. Noel GR, Atibalentja N, Domier LL. 2005. including Pasteuria Bioscience, Inc. exemption expression, is now consistent Emended description of Pasteuria nishizawae. International Journal of Specifically, this commenter mentioned with the representation of this active Systematic and Evolutionary concern with the prevalence of many ingredient in other associated regulatory Microbiology 55:1681–1685. toxic chemicals in the environment and documents and should assist in 9. Sayre RM, Wergin WP, Schmidt JM, Starr lack of information regarding how such preventing confusion regarding its MP. 1991. Pasteuria nishizawae sp. nov.,

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a mycelial and endospore-forming and food retailers, not States or tribes. PART 180—[AMENDED] bacterium parasitic on cyst nematode of As a result, this action does not alter the genera Heterodera and Globodera. relationships or distribution of power ■ 1. The authority citation for part 180 Research in Microbiology 14:551–564. and responsibilities established by continues to read as follows: 10. Pang L, McLeod M, Aislabie J, Sˇ imu˚ nek J, Close M, Hector R. 2008. Modeling Congress in the preemption provisions Authority: 21 U.S.C. 321(q), 346a and 371. of section 408(n)(4) of FFDCA. As such, transport of microbes in ten undisturbed ■ 2. Section 180.1311 is added to soils under effluent irrigation. Vadose EPA has determined that this action will Zone Journal 7:97–111. not have a substantial direct effect on subpart D to read as follows: 11. Aislabie J, Smith JJ, Fraser R, McLeod M. States or tribal governments, on the § 180.1311 Pasteuria nishizawae—Pn1; 2001. Leaching of bacterial indicators of relationship between the national exemption from the requirement of a faecal contamination through four New government and the States or tribal tolerance. Zealand soils. Australian Journal of Soil governments, or on the distribution of An exemption from the requirement Research 39:1397–1406. power and responsibilities among the 12. DeFelice K, Wollenhaupt N, Buchholz D. of a tolerance is established for residues 1993. Aquifers and Soil Filter Effect. various levels of government or between of Pasteuria nishizawae—Pn1 in or on Available from http:// the Federal Government and Indian all food commodities when applied as a extension.missouri.edu/p/WQ24. tribes. Thus, EPA has determined that nematicide and used in accordance with 13. Centers for Disease Control and Executive Order 13132, entitled good agricultural practices. Prevention. 2009. Drinking Water— Federalism (64 FR 43255, August 10, [FR Doc. 2012–3586 Filed 2–14–12; 8:45 am] Water Treatment. Available from http:// 1999), and Executive Order 13175, www.cdc.gov/healthywater/drinking/ entitled Consultation and Coordination BILLING CODE 6560–50–P _ public/water treatment.html. with Indian Tribal Governments (65 FR 14. U.S. EPA. 2004. Primer for Municipal 67249, November 9, 2000), do not apply Wastewater Treatment Systems. EPA ENVIRONMENTAL PROTECTION 832–R–04–001. Available from http:// to this final rule. In addition, this final AGENCY www.epa.gov/npdes/pubs/primer.pdf. rule does not impose any enforceable duty or contain any unfunded mandate 40 CFR Part 180 X. Statutory and Executive Order as described under Title II of the Reviews Unfunded Mandates Reform Act of 1995 [EPA–HQ–OPP–2011–0783; FRL–9332–9] This final rule establishes a tolerance (UMRA) (Pub. L. 104–4). Spirotetramat; Pesticide Tolerances for exemption under section 408(d) of This action does not involve any Emergency Exemptions FFDCA in response to a petition technical standards that would require submitted to EPA. The Office of EPA consideration of voluntary AGENCY: Environmental Protection Management and Budget (OMB) has consensus standards pursuant to section Agency (EPA). exempted these types of actions from 12(d) of the National Technology ACTION: Final rule. review under Executive Order 12866, Transfer and Advancement Act of 1995 SUMMARY: This regulation establishes entitled Regulatory Planning and (NTTAA), Public Law 104–113, section time-limited tolerances for residues of Review (58 FR 51735, October 4, 1993). 12(d) (15 U.S.C. 272 note). Because this final rule has been spirotetramat in or on onion, dry bulb exempted from review under Executive XI. Congressional Review Act under section 408(l)(6) of the Federal Order 12866, this final rule is not Food, Drug, and Cosmetic Act (FFDCA), The Congressional Review Act, 5 21 U.S.C. 346a(l)(6). This action is in subject to Executive Order 13211, U.S.C. 801 et seq., generally provides entitled Actions Concerning Regulations response to EPA’s granting of an that before a rule may take effect, the emergency exemption under section 18 That Significantly Affect Energy Supply, agency promulgating the rule must Distribution, or Use (66 FR 28355, May of the Federal Insecticide, Fungicide, submit a rule report to each House of and Rodenticide Act (FIFRA) 22, 2001), or Executive Order 13045, the Congress and to the Comptroller entitled Protection of Children from authorizing use of the pesticide on dry General of the United States. EPA will bulb onions. This regulation establishes Environmental Health Risks and Safety submit a report containing this rule and Risks (62 FR 19885, April 23, 1997). a maximum permissible level for other required information to the U.S. residues of spirotetramat in or on these This final rule does not contain any Senate, the U.S. House of information collections subject to OMB commodities. The time-limited Representatives, and the Comptroller tolerances expire on December 31, 2014. approval under the Paperwork General of the United States prior to Reduction Act (PRA), 44 U.S.C. 3501 et DATES: This regulation is effective publication of this final rule in the February 15, 2012. Objections and seq., nor does it require any special Federal Register. This final rule is not considerations under Executive Order requests for hearings must be received a ‘‘major rule’’ as defined by 5 U.S.C. on or before April 16, 2012, and must 12898, entitled Federal Actions to 804(2). Address Environmental Justice in be filed in accordance with the Minority Populations and Low-Income List of Subjects in 40 CFR Part 180 instructions provided in 40 CFR part Populations (59 FR 7629, February 16, 178 (see also Unit I.C. of the 1994). Environmental protection, SUPPLEMENTARY INFORMATION. Since tolerances and exemptions that Administrative practice and procedure, ADDRESSES: EPA has established a are established on the basis of a petition Agricultural commodities, Pesticides docket for this action under docket under section 408(d) of FFDCA, such as and pests, Reporting and recordkeeping identification (ID) number EPA–HQ– the tolerance exemption in this final requirements. OPP–2011–0783. All documents in the rule, do not require the issuance of a Dated: February 1, 2012. docket are listed in the docket index proposed rule, the requirements of the Steven Bradbury, available in http://www.regulations.gov. Regulatory Flexibility Act (RFA) (5 Director, Office of Pesticide Programs. Although listed in the index, some U.S.C. 601 et seq.) do not apply. information is not publicly available, This final rule directly regulates Therefore, 40 CFR chapter I is e.g., Confidential Business Information growers, food processors, food handlers, amended as follows: (CBI) or other information whose

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