Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Rules and Regulations 8731

need to determine and issue new under the criteria set forth in Executive PART 4022—BENEFITS PAYABLE IN interest assumptions promptly so that Order 12866. TERMINATED SINGLE-EMPLOYER the assumptions can reflect current Because no general notice of proposed PLANS market conditions as accurately as rulemaking is required for this possible. amendment, the Regulatory Flexibility ■ 1. The authority citation for part 4022 Because of the need to provide Act of 1980 does not apply. See 5 U.S.C. continues to read as follows: immediate guidance for the payment of 601(2). benefits under plans with valuation Authority: 29 U.S.C. 1302, 1322, 1322b, 1341(c)(3)(D), and 1344. dates during March 2012, PBGC finds List of Subjects in 29 CFR Part 4022 that good cause exists for making the Employee benefit plans, Pension ■ 2. In appendix B to part 4022, Rate Set assumptions set forth in this insurance, Pensions, Reporting and 221, as set forth below, is added to the amendment effective less than 30 days recordkeeping requirements. table. after publication. PBGC has determined that this action In consideration of the foregoing, 29 Appendix B to Part 4022—Lump Sum is not a ‘‘significant regulatory action’’ CFR part 4022 is amended as follows: Interest Rates for PBGC Payments

For plans with a valuation Immediate Deferred annuities Rate set date annuity rate (percent) (percent) On or after Before i1 i2 i3 n1 n2

******* 221 ...... 3–1–12 4–1–12 1.25 4.00 4.00 4.00 7 8

■ 3. In appendix C to part 4022, Rate Set Appendix C to Part 4022—Lump Sum 221, as set forth below, is added to the Interest Rates for Private-Sector table. Payments

For plans with a valuation Immediate Deferred annuities Rate set date annuity rate (percent) (percent) On or after Before i1 i2 i3 n1 n2

******* 221 ...... 3–1–12 4–1–12 1.25 4.00 4.00 4.00 7 8

Issued in Washington, DC, on this 8th day agricultural practices. Bio-ferm GmbH Internet and will be publicly available of February 2012. submitted a petition to EPA under the only in hard copy form. Publicly Laricke Blanchard, Federal Food, Drug, and Cosmetic Act available docket materials are available Deputy Director for Policy, Pension Benefit (FFDCA), requesting an exemption from in the electronic docket at http:// Guaranty Corporation. the requirement of a tolerance. This www.regulations.gov, or, if only [FR Doc. 2012–3540 Filed 2–14–12; 8:45 am] regulation eliminates the need to available in hard copy, at the OPP BILLING CODE 7709–01–P establish a maximum permissible level Regulatory Public Docket in Rm. S– for residues of Aureobasidium pullulans 4400, One Potomac Yard (South Bldg.), strains DSM 14940 and DSM 14941. 2777 S. Crystal Dr., Arlington, VA. The ENVIRONMENTAL PROTECTION DATES: This regulation is effective Docket Facility is open from 8:30 a.m. AGENCY February 15, 2012. Objections and to 4 p.m., Monday through Friday, requests for hearings must be received excluding legal holidays. The Docket 40 CFR Part 180 on or before April 16, 2012, and must Facility telephone number is (703) 305– be filed in accordance with the 5805. [EPA–HQ–OPP–2010–0099; FRL–9337–3] instructions provided in 40 CFR part FOR FURTHER INFORMATION CONTACT: 178 (see also Unit I.C. of the Aureobasidium pullulans Strains DSM Susanne Cerrelli, Biopesticides and SUPPLEMENTARY INFORMATION). 14940 and DSM 14941; Exemption Pollution Prevention Division (7511P), ADDRESSES: From the Requirement of a Tolerance EPA has established a Office of Pesticide Programs, docket for this action under docket Environmental Protection Agency, 1200 AGENCY: Environmental Protection identification (ID) number EPA–HQ– Pennsylvania Ave. NW., Washington, Agency (EPA). OPP–2010–0099. All documents in the DC 20460–0001; telephone number: ACTION: Final rule. docket are listed in the docket index (703) 308–8077; email address: available at http://www.regulations.gov. [email protected]. SUMMARY: This regulation establishes an Although listed in the index, some SUPPLEMENTARY INFORMATION: exemption from the requirement of a information is not publicly available, tolerance for residues of the e.g., Confidential Business Information I. General Information Aureobasidium pullulans strains DSM (CBI) or other information the disclosure A. Does this action apply to me? 14940 and DSM 14941 in or on all food of which is restricted by statute. Certain commodities when applied pre-harvest other material, such as copyrighted You may be potentially affected by and used in accordance with good material, is not made available via the this action if you are an agricultural

VerDate Mar<15>2010 16:38 Feb 14, 2012 Jkt 226001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\15FER1.SGM 15FER1 erowe on DSK2VPTVN1PROD with RULES 8732 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Rules and Regulations

producer, food manufacturer, or may be disclosed publicly by EPA the factors set forth in section pesticide manufacturer. Potentially without prior notice. Submit a copy of 408(b)(2)(C) of FFDCA, which require affected entities may include, but are your non-CBI objection or hearing EPA to give special consideration to not limited to: request, identified by docket ID number exposure of infants and children to the • Crop production (NAICS code 111). EPA–HQ–OPP–2010–0099, by one of pesticide chemical residue in • Animal production (NAICS code the following methods: establishing a tolerance and to ‘‘ensure 112). • Federal eRulemaking Portal: http:// that there is a reasonable certainty that • Food manufacturing (NAICS code www.regulations.gov. Follow the on-line no harm will result to infants and 311). instructions for submitting comments. children from aggregate exposure to the • Pesticide manufacturing (NAICS • Mail: Office of Pesticide Programs pesticide chemical residue. * * *’’ code 32532). (OPP) Regulatory Public Docket (7502P), Additionally, section 408(b)(2)(D) of This listing is not intended to be Environmental Protection Agency, 1200 FFDCA requires that the Agency exhaustive, but rather provides a guide Pennsylvania Ave. NW., Washington, consider ‘‘available information for readers regarding entities likely to be DC 20460–0001. concerning the cumulative effects of a affected by this action. Other types of • Delivery: OPP Regulatory Public particular pesticide’s residues’’ and entities not listed in this unit could also Docket (7502P), Environmental ‘‘other substances that have a common be affected. The North American Protection Agency, Rm. S–4400, One mechanism of toxicity.’’ Industrial Classification System Potomac Yard (South Bldg.), 2777 S. EPA performs a number of analyses to (NAICS) codes have been provided to Crystal Dr., Arlington, VA. Deliveries determine the risks from aggregate assist you and others in determining are only accepted during the Docket exposure to pesticide residues. First, whether this action might apply to Facility’s normal hours of operation EPA determines the toxicity of certain entities. If you have any (8:30 a.m. to 4 p.m., Monday through pesticides. Second, EPA examines questions regarding the applicability of Friday, excluding legal holidays). exposure to the pesticide through food, this action to a particular entity, consult Special arrangements should be made drinking water, and through other the person listed under FOR FURTHER for deliveries of boxed information. The exposures that occur as a result of INFORMATION CONTACT. Docket Facility telephone number is pesticide use in residential settings. (703) 305–5805. B. How can I get electronic access to III. Toxicological Profile II. Background and Statutory Findings other related information? Consistent with section 408(b)(2)(D) You may access a frequently updated In the Federal Register of March 10, of FFDCA, EPA has reviewed the electronic version of 40 CFR part 180 2010 (75 FR 11171) (FRL–8810–8), EPA available scientific data and other through the Government Printing issued a notice pursuant to section relevant information in support of this Office’s e-CFR site at http:// 408(d)(3) of FFDCA, 21 U.S.C. action and considered its validity, ecfr.gpoaccess.gov/cgi/t/text/text- 346a(d)(3), announcing the filing of a completeness, and reliability and the idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ pesticide tolerance petition (PP 9F7623) relationship of this information to 40tab_02.tpl. To access the harmonized by Bio-ferm GmbH, Konrad Lorenz Str. human risk. EPA has also considered test guidelines referenced in this 20, Tulln, 3430, Austria. The petition available information concerning the document electronically, please go to requested that 40 CFR part 180 be variability of the sensitivities of major http://www.epa.gov/ocspp and select amended by establishing an exemption identifiable subgroups of consumers, ‘‘Test Methods and Guidelines.’’ from the requirement of a tolerance for including infants and children. residues of Aureobasidium pullulans C. How can I file an objection or hearing strains DSM 14940 and DSM 14941. A. Overview of Aureobasidium request? This notice referenced a summary of the Pullulans Strains DSM 14940 and DSM Under FFDCA section 408(g), 21 petition prepared by the petitioner Bio- 14941 U.S.C. 346a, any person may file an ferm GmbH, which is available in the Aureobasidium pullulans is a ‘‘yeast- objection to any aspect of this regulation docket, http://www.regulations.gov. like’’ saprophytic fungus found in the and may also request a hearing on those There were no comments received in phyllosphere of many plants, and it has objections. You must file your objection response to the notice of filing. been isolated from soil and aquatic or request a hearing on this regulation Section 408(c)(2)(A)(i) of FFDCA environments (Refs. 1, 2, and 3). It is in accordance with the instructions allows EPA to establish an exemption commonly isolated from healthy grape provided in 40 CFR part 178. To ensure from the requirement for a tolerance (the (Refs. 4 and 5) and apple (Ref. 6) plants, proper receipt by EPA, you must legal limit for a pesticide chemical as well as other plants (Refs. 7, 8, 9, 10, identify docket ID number EPA–HQ– residue in or on a food) only if EPA and 11). Although associated with OPP–2010–0099 in the subject line on determines that the exemption is ‘‘safe.’’ disease in some plants, the fungus the first page of your submission. All Section 408(c)(2)(A)(ii) of FFDCA generally is recognized as a saprobe, objections and requests for a hearing defines ‘‘safe’’ to mean that ‘‘there is a since it derives its nourishment from must be in writing, and must be reasonable certainty that no harm will nonliving or decaying organic matter, received by the Hearing Clerk on or result from aggregate exposure to the and is only considered a weak pathogen before April 16, 2012. Addresses for pesticide chemical residue, including or parasite of certain plants (Refs. 2 and mail and hand delivery of objections all anticipated dietary exposures and all 12). It is a known antagonist of several and hearing requests are provided in 40 other exposures for which there is plant disease-causing organisms, and is CFR 178.25(b). reliable information.’’ This includes an important producer of enzymes for In addition to filing an objection or exposure through drinking water and in biotechnological and industrial hearing request with the Hearing Clerk residential settings, but does not include applications (Ref. 1). as described in 40 CFR part 178, please occupational exposure. Pursuant to Aureobasidium pullulans strains DSM submit a copy of the filing that does not section 408(c)(2)(B) of FFDCA, in 14940 and DSM 14941 were isolated contain any CBI for inclusion in the establishing or maintaining in effect an from apple leaves and classified by the public docket. Information not marked exemption from the requirement of a German Strain Collection for confidential pursuant to 40 CFR part 2 tolerance, EPA must take into account Microorganisms (DSMZ). Neither is a

VerDate Mar<15>2010 14:28 Feb 14, 2012 Jkt 226001 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\FR\FM\15FER1.SGM 15FER1 erowe on DSK2VPTVN1PROD with RULES Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Rules and Regulations 8733

mutant nor genetically modified strain human body temperature is 37 °C, and pathogenic in rat, when dosed at 0.8 × and they are not closely related to based on the results from these studies 108 cfu/animal. toxigenic human pathogens. As as discussed in this unit the Agency 3. Acute Injection Toxicity/ discussed in Pesticide Petition (PP) concluded that neither strain would be Pathogenicity (OCSPP Guideline 9F7623, product analysis data toxic, infective and/or pathogenic in 885.3200; MRID No. 47871807 and demonstrate that Aureobasidium humans. 47871808). In an acute subcutaneous pullulans strain DSM 14941 is closely 1. Acute Oral Toxicity/Pathogenicity toxicity/pathogenicity study (MRID related to strain DSM 14940. The two (Office of Chemical Safety and Pollution 47871807), male and female rats were strains share many similar genetic and Prevention (OCSPP) Guideline 885.3050; injected with Aureobasidium pullulans morphological characteristics. Bioferm Master Record Identification Number strain DSM 14940 (2.36 × 1010 cfu/g) GmbH has proposed to register two (MRID) No. 47899302. Twenty-four rats and DSM 14941 (1.5 × 1010 cfu/g). manufacturing-use pesticide products were administered a single dose of Interim sacrifices were made on days 3, (MPs): ‘‘Aureobasidium pullulans strain Aureobasidium pullulans strain DSM 7, and 14; the remaining animals were DSM 14941 Technical,’’ and 14941. Three animals of each sex were sacrificed at test end on day 21. There ‘‘Aureobasidium pullulans strain DSM sacrificed on days 3, 7, and 14; the were no deaths, and all animals 14940 Technical.’’ The active ingredient remaining animals were sacrificed at appeared normal throughout the study is 80% w/w (minimum of × 109 colony test end on day 21. Body tissues were except for edema or slight erythema at forming units/grams (unit of measure for examined for Aureobasidium pullulans. the injection site. Samples of the bacteria (cfu/g)) in each of the proposed All samples of feces, blood, brain, lung, following tissues were negative for technical products. liver, kidney, spleen, stomach, and Aureobasidium pullulans at all time Bio-ferm GmbH has proposed to intestine were negative. The lymph points: Feces, blood, brain, lung, liver, register two end-use products (EPs) nodes of one animal sacrificed on day kidney, spleen, stomach, and intestine. containing equal parts of 7 tested positive for the presence of Lymph node samples were negative Aureobasidium pullulans strains DSM Aureobasidium pullulans DSM 14941. except for one animal sacrificed on day 14940 and DSM 14941: ‘‘Blossom These findings show a pattern of 7. The study author suggested this was Protect’’ will be applied to pome fruit clearance with no Aureobasidium likely a post-mortem transmission. A only during the blossoming period to pullulans DSM 14941 detected by day pattern of clearance was observed in protect plants against bacterial fire 14. The results of this acceptable study this study, with no Aureobasidium blight, and ‘‘Botector’’ will be applied demonstrated that Aureobasidium pullulans DSM 14941 or 14940 detected preharvest to grapes, pome fruit, stone pullulans DSM 14941 was not toxic, by day 14. The results of this acceptable fruit, and strawberries to protect these infective, and/or pathogenic in rats, study demonstrated that Aureobasidium crops against fruit rot diseases caused when dosed at 4 × 108 cfu/animal. pullulans strains DSMZ 14940 and by Botrytis sp., Monilia sp., Penicillium 2. Acute Pulmonary Toxicity/ DSMZ 14941 were not toxic, infective, sp., Nectria sp., and Pezicula sp. Pathogenicity (OCSPP Guideline and/or pathogenic in rats, when dosed 885.3150; MRID No. 47899303). Male at 1.95 × 107 or 1.12 × 107cfu/animal, B. Microbial Pesticide Toxicology Data and female animals were exposed respectively. Requirements intratracheally with Aureobasidium In a second acute subcutaneous The Agency has determined that, for pullulans strain DSM 14941 Technical toxicity/pathogenicity study (MRID preharvest uses, all mammalian (4 × 108 cfu/g). Interim sacrifices were 47871808), male and female rats were toxicology data requirements submitted made 3 hours post-dose and on study injected with Aureobasidium pullulans to support the petition to exempt days 3, 7, and 14; the remaining animals strain DSM 14941 (1.1 × 109 cfu/g). residues of Aureobasidium pullulans were sacrificed at study end on day 21. Interim sacrifices were made on days 1 strains DSM 14940 and DSM 14941 There was no mortality, and, except on and 7; the remaining animals were from the requirement of a tolerance have the day of dosing when the entire test sacrificed at test end on day 21. There been fulfilled (Ref. 13). material group showed reduced motor were no deaths, and all animals The product analysis data activity and dyspnea, all animals appeared normal throughout the study demonstrated that Aureobasidium appeared normal throughout the study. except for severe edema or slight pullulans strain DSM 14941 is closely Tissue samples were evaluated for erythema at the injection site. Samples related to strain DSM 14940. Because Aureobasidium pullulans after sacrifice. of the following tissues were negative the strains are closely related, the The following tissues were negative for for Aureobasidium pullulans at all time Agency has determined that the findings Aureobasidium pullulans at all time points: Brain, lung, spleen, kidney, of the submitted acute toxicity/ points: Feces, brain, kidney, and lymph nodes, blood and urine. The skin pathogenicity studies conducted only intestine. Blood samples were negative was positive for Aureobasidium with strain DSM 14941 supported both except for one male on day 0; lung pullulans in three males and three strains, and those studies show no samples were negative except for two females from the test material group on evidence of toxicity, or pathogenicity at males and two females on day 0; liver day 1 and in two females of the same the doses tested. In addition, both samples were negative except for three group on day 7. The liver of one male strains were tested in an acute males on day 0; spleen samples were from the test material group was subcutaneous injection toxicity/ negative except for two males on day 0; positive on day 1. The cecum contents pathogenicity study in rats. The results lymph node samples were negative were positive in one male and one of this study indicated that both strains except for one animal on day 7, and female from the test material group on were not toxic, infective, and/or stomach samples were negative except day 1 and in two females from the same pathogenic to the test animals. These for two males on day 0. These findings group on day 7. These findings show a findings were supported by the results show a pattern of clearance with no pattern of clearance with no of a study of the influence of Aureobasidium pullulans DSM 14941 Aureobasidium pullulans DSM 14941 temperature on the growth of the two detected by day 14. The results of this detected by day 21. The results of this Aureobasidium pullulans strains, which acceptable study demonstrated that acceptable study demonstrated that showed that growth of both strains does Aureobasidium pullulans DSM 14941 Aureobasidium pullulans DSM 14941 not occur at or above 35 °C. Since was not toxic, infective, and/or was not toxic, infective, and/or

VerDate Mar<15>2010 14:28 Feb 14, 2012 Jkt 226001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\FR\FM\15FER1.SGM 15FER1 erowe on DSK2VPTVN1PROD with RULES 8734 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Rules and Regulations

pathogenic in rats, when dosed at 1.6 × 8. Acute Eye Irritation (OCSPP duplications for strain CBS 626.85 was 107 cfu/animal. Guideline 870.2400; MRID 47869618). In approximately five. Neither strain DSM 4. Acute Dermal Toxicity (OCSPP an eye irritation study, three rabbits 14940 or strain DSM 14941 was able to Guideline 870.1200; MRID 47869615). In were dosed with 0.1 mL (60–62 grams grow at 35 °C or 37 °C, while strain CBS an acute dermal toxicity study, the (g) of Blossom Protect (7 × 109 cfu/g A. 625.85 replicated (approximately) twice shaved skin of 10 rats was dosed with pullulans strain DSM 14940 and 7 × 109 at 35 °C and once at 37 °C. Based on the 2,000 milligram/kilogram (mg/kg) cfu/g A. pullulans strain DSM 14941). lack of growth of the DSM strains at 35 Blossom Protect (7 × 109 cfu/g each of One animal had a score of 1 for °C and above, and given human body strains DSM 14940 and DSM 14941) for conjunctival redness 1 hour after temperature is 37 °C, Aureobasidium 24 hours. One male exhibited application. There were no other pullulan strains DSM 14940 and DSM chromodacryorrhea from day 7 to day clinical signs, and all animals appeared 14941 are expected to be non- 14 and one female exhibited normal at 24 hours. Blossom protect was pathogenic in humans. This study was chromodacryorrhea from day 1 to day 2 considered to be virtually non-irritating. rated acceptable. of the study, but this was not considered This study was rated acceptable, and the 11. Hypersensitivity Incidents (OCSPP to be toxicologically significant because EP is classified as toxicity category IV. Guideline 885.3400; MRID No. this is a normal but rare response and 9. In vivo Micronucleus Assay (MRID 47945023). No hypersensitivity it did not result in mortality. All 47899304). Twenty mice (two groups of incidents, including immediate-type or animals appeared healthy at necropsy. five male and two groups of five female delayed-type reactions of humans and The lethal dose (LD50) was >2,000 mg/ mice) received single 2,000 mg/kg domestic animals during research, kg. This study was rated acceptable, and Aureobasidium pullulans strain DSM development, or testing of the end use product (EP) is classified as 14941 dissolved in water by oral gavage. Aureobasidium pullulans strains DSM toxicity category IV. There were no clinical signs observed in 14940 and DSM 14941 were reported by 5. Primary Dermal Irritation (OCSPP any of the test animals, which were the applicant. Any future Guideline 870.2500; MRID 47869619). In sacrificed 24 or 48 hours after receiving hypersensitivity incidents must be a dermal irritation study, the shaved the test material. The femoral bone reported per OCSPP Guideline skin of 3 rabbits was dosed with 0.5 g marrow was immediately harvested, and 885.3400. Blossom Protect (7 × 109 cfu/g the ratio of polychromatic erythrocytes IV. Aggregate Exposures Aureobasidium pullulans strain DSM to total erythrocytes (mature and 14940 and 7 × 109 cfu/g Aureobasidium immature) was determined, and 2,000 In examining aggregate exposure, pullulans strain DSM 14941) moistened immature erythrocytes/animal were section 408 of FFDCA directs EPA to with 1.0 milliliter (mL) deionized water scored for the presence of consider available information for 4 hours. All animals appeared micronucleated immature erythrocytes, concerning exposures from the pesticide normal throughout the study; thus, a sign of potential toxicity or damage to residue in food and all other non- Blossom Protect was considered to be genetic material in the cells. occupational exposures, including non-irritating. This study was rated Aureobasidium pullulans strain DSM drinking water from ground water or acceptable, and the EP is classified as 14941 did not produce a statistically surface water and exposure through toxicity category IV. significant increase in micronucleated pesticide use in gardens, lawns, or 6. Acute Oral Toxicity (OCSPP immature erythrocytes compared to the buildings (residential and other indoor Guideline 870.1100; MRID No. untreated control animals. The response uses). 47869614. In an acute oral toxicity of the positive control animals (treated A. Dietary Exposure study, six animals received a single with a known toxic substance, 2,000 mg/kg body weight (bw) dose of cyclophosphamide, by intraperitoneal Should this microbial pesticide be Blossom Protect 22% (2 × 1010 cfu/g) injection, at 10 mg/kg) was appropriate present on food, the acute toxicity, Aureobasidium pullulans strain DSM for comparison and did produce a infectivity, and pathogenicity data, as 14940, 22% (2 × 1010 cfu/g) statistically significant increase in well as the data demonstrating the lack Aureobasidium pullulans strain DSM micronucleated immature erythrocytes of growth at human body temperature 14941, 25% sucrose, 6% water. There compared to the untreated control submitted for Aureobasidium pullulans was no mortality, and all animals animals. This study was rated strains DSM 14940 and DSM 14941 appeared normal throughout the study. acceptable. demonstrated that no toxicity, The LD50 was >2,000 mg/kg. This study 10. Influence of Temperature on infectivity, and/or pathogenicity is was rated acceptable, and the EP is Reproduction (MRID 47871833). likely to occur with any exposure level classified as toxicity category III. Aureobasidium pullulans strain CBS resulting from application of these two 7. Acute Inhalation Toxicity (OCSPP 626.85 was isolated from the peritoneal proposed pesticide active ingredients in Guideline 870.1300; MRID 47869617). In dialysis fluid of a human in Australia. accordance with good agricultural an acute inhalation toxicity study, 10 The effects of temperature on the practices (see Unit III.B.). animals were exposed nose-only to a reproduction or growth of 1. Food. Naturally occurring 10% suspension of Blossom Protect (7 × Aureobasidium pullulans strains DSM Aureobasidium pullulans is likely to be 10 9 cfu/g A. pullulans strain DSM 14940 and, DSM 14941, in liquid present on fresh produce. According to 14940 and 7 × 109 cfu/g A. pullulans culture or on agar plates were examined Webb and Mundt (1978) (Ref. 11) strain DSM 14941) at 5.17 milligrams and compared against this positive Aureobasidium pullulans is ‘‘a major per liter (mg/L). The Mass Medium control, Aureobasidium pullulans strain resident on most green plants.’’ In a Aerodynamic Diameter (MMAD) was CBS 626.85, to observe the ability of study with several species of crop 4.2 mm. There were no deaths and all these strains to reproduce at human plants, they determined Aureobasidium animals appeared healthy throughout body temperature of 37 °C. All three pullulans to be among the most the study. Necropsy was unremarkable. strains grew well at 30 °C. At 33 °C, the abundant (71%–85%) of all fungi The lethal concentration (LC50) was number of replications (per 48 hours) of present on the plant surfaces. >5.17 mg/L. This study was rated the Aureobasidium pullulans strains Aureobasidium pullulans made up an acceptable, and the EP is classified as DSM 14940 and, DSM 14941 was less average of 77.1% of the mold species toxicity category IV. than one, while the number of isolated on green beans, and occurred at

VerDate Mar<15>2010 14:28 Feb 14, 2012 Jkt 226001 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 E:\FR\FM\15FER1.SGM 15FER1 erowe on DSK2VPTVN1PROD with RULES Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Rules and Regulations 8735

high levels (up to 2.7 × 104 cfu/ toxicity, infectivity, pathogenicity or III.B., EPA concludes that there is a centimeter2 (cm2) on certain fruits other adverse effects from non- reasonable certainty that no harm will (cucumbers and squash). Dietary occupational exposure are expected (see result to the U.S. population, including exposure to Aureobasidium pullulans Unit III.B.). infants and children, from aggregate strains DSM 14940 and DSM 14941, exposure to the residues of V. Cumulative Effects From Substances therefore, is possible from strawberries, With a Common Mechanism of Toxicity Aureobasidium pullulans strains DSM grapes, pome and stone fruits harvested 14940 and DSM 14941. This includes all naturally and from plants treated with Section 408(b)(2)(D)(v) of FFDCA anticipated dietary exposures and all these fungicidal active ingredients. The requires that, when considering whether other exposures for which there is submitted acute oral toxicity/ to establish, modify, or revoke a reliable information. EPA has arrived at pathogenicity studies indicated that if tolerance, the Agency consider this conclusion because the data and Aureobasidium pullulans strains DSM ‘‘available information’’ concerning the information available on Aureobasidium 14940 and DSM 14941 are ingested, no cumulative effects of a particular pullulans strains DSM 14940 and DSM toxic or pathogenic effects will result. In pesticide’s residues and ‘‘other 14941 do not demonstrate toxic, addition, Aureobasidium pullulans substances that have a common pathogenic, and/or infective potential to strains DSM 14940 and DSM 14941 do mechanism of toxicity.’’ mammals. Thus, there are no threshold not reproduce at the normal human The likelihood of adverse cumulative effects of concern and, as a result, the body temperature of 37 °C. Therefore, in effects occurring via a common Agency has concluded that an the event oral exposure should occur by mechanism of toxicity is minimal, based additional margin of safety for infants ingesting treated fruits, the Agency on the lack of toxicity/pathogenicity/ and children is unnecessary in this concludes that there is a reasonable infectivity potential of the active instance. Further, the need to consider certainty that no harm will result from ingredients when Aureobasidium consumption patterns, special pullulans strains DSM 14940 and DSM exposure to such residues. susceptibility, and cumulative effects 14941 are used in or on food 2. Drinking water exposure. Naturally does not arise when dealing with commodities and/or labeled for occurring Aureobasidium pullulans is pesticides with no demonstrated residential uses (see Unit III.B.). In ubiquitous and has been isolated from significant adverse effects. all types of water (Ref. 14). Exposure of addition, Aureobasidium pullulans humans to residues of pesticides strains DSM 14940 and DSM 14941 do VII. Other Considerations not appear to produce a toxic metabolite containing Aureobasidium pullulans A. Analytical Enforcement Methodology strains DSM 14940 and DSM 14941 in produced by other substances. For consumed drinking water is possible but information regarding EPA’s efforts to An analytical method is not required potential exposure through drinking determine which chemicals have a for enforcement purposes since the water is reduced, given the proposed common mechanism of toxicity and to Agency is establishing an exemption use patterns, use sites, and application evaluate the cumulative effects of such from the requirement of a tolerance methods for Aureobasidium pullulans chemicals, see EPA’s Web site at without any numerical limitation. strains DSM 14940 and DSM 14941, http://www.epa.gov/pesticides/ B. International Residue Limits which do not include direct application cumulative. to aquatic environments. In the event In making its tolerance decisions, EPA VI. Determination of Safety for U.S. seeks to harmonize U.S. tolerances with that Aureobasidium pullulans strains Population, Infants and Children DSM 14940 and DSM 14941 are international standards whenever transferred to surface water or ground FFDCA section 408(b)(2)(C) provides possible, consistent with U.S. food water intended for human consumption, that EPA shall assess the available safety standards and agricultural the fungi would not survive the high information about consumption patterns practices. EPA considers the temperatures, chlorination, pH among infants and children, special international maximum residue limits adjustments, and/or filtration water is susceptibility of infants and children to (MRLs) established by the Codex subjected to in a drinking water pesticide chemical residues, and the Alimentarius Commission (Codex), as treatment facility. Even if oral exposure cumulative effects on infants and required by FFDCA section 408(b)(4). should occur through consumed children of the residues and other The Codex Alimentarius is a joint U.N. drinking water, there is a reasonable substances with a common mechanism Food and Agriculture Organization/ certainty that no harm will result from of toxicity. In addition, FFDCA section World Health Organization food exposure to such residues, based upon 408(b)(2)(C) provides that EPA shall standards program, and it is recognized the lack of toxicity, infectivity, and/or apply an additional tenfold (10X) as an international food safety pathogenicity, as well as the inability of margin of safety for infants and children standards-setting organization in trade these fungal strains to grow at human in the case of threshold effects to agreements to which the United States body temperature, demonstrated in the account for prenatal and postnatal is a party. EPA may establish a tolerance previously described toxicological toxicity and the completeness of the that is different from a Codex MRL; studies (see Unit III.B.). database on toxicity and exposure however, FFDCA section 408(b)(4) unless EPA determines that a different requires that EPA explain the reasons B. Other Non-Occupational Exposure margin of safety will be safe for infants for departing from the Codex level. The use sites for these products and children. This additional margin of The Codex has not established a MRL include residential garden sites and safety is commonly referred to as the for Aureobasidium pullulans strains agricultural sites. Aureobasidium FQPA Safety Factor. In applying this DSM 14940 or DSM 14941. pullulans is naturally present in many provision, EPA either retains the default VIII. Conclusions habitats, and based on the data and value of 10X or uses a different other information submitted to satisfy additional safety factor when reliable EPA concludes that there is a data requirements for registration of the data available to EPA support the choice reasonable certainty that no harm will MPs and EPs containing the active of a different factor. result to the United States population, ingredients Aureobasidium pullulans Based on the acute toxicity and including infants and children, from strains DSM 14940 and DSM 14941, no pathogenicity data summarized in Unit aggregate exposure to residues of

VerDate Mar<15>2010 14:28 Feb 14, 2012 Jkt 226001 PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 E:\FR\FM\15FER1.SGM 15FER1 erowe on DSK2VPTVN1PROD with RULES 8736 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Rules and Regulations

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. Pasteuria nishizawae—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).

VerDate Mar<15>2010 14:28 Feb 14, 2012 Jkt 226001 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 E:\FR\FM\15FER1.SGM 15FER1 erowe on DSK2VPTVN1PROD with RULES