Bacteriophage of Clavibacter Michiganensis Subspecies Michiganensis; Exemption From the Requirement of a Tolerance, 66187-66192 [2011-27042]

Download as PDF Federal Register / Vol. 76, No. 207 / Wednesday, October 26, 2011 / Rules and Regulations more flexible staffing may be the most rational option. Authority: 39 U.S.C. 101, 401, 403, 404, 410, 1001. II. Explanation of Changes From Proposed Rule ■ The final rule includes the following additional changes to the proposed rule. Paragraph 241.1(a) has been revised to clarify that the operation or staffing of a Post Office by non-postmaster personnel must be at the direction of the postmaster, and that it may include times when the postmaster is not physically present. While the proposed rule referred to whether a Post Office was ‘‘operated or managed’’ by nonpostmaster personnel, the phrase ‘‘operated or staffed’’ better reflects the intended meaning that a postmaster would continue to manage operations at the Post Office, albeit possibly without personally operating or staffing it on a continuous basis. A sentence is added to paragraph 241.3(a)(1)(ii) (redesignated as 241.3(a)(1)(iii)) to clarify that these regulations will no longer apply to discontinuance actions pending as of December 1, 2011, that pertain to the conversion of a Post Office to another type of USPS-operated facility. The definition of ‘‘consolidation’’ in paragraph 241.3(a)(2)(iv) is revised to restrict the term’s definition to instances where a Postal Service-operated retail facility is replaced with a contractoroperated retail facility that reports to a Postal Service-operated retail facility. Consistent with the proposed rule, the term no longer encompasses situations where a Post Office is replaced with a Classified Station or Classified Branch. Paragraph 241.3(b)(4) is revised to indicate the possibility that a consolidated facility’s name, or a similar name, can be used by the succeeding facility, rather than suggesting an expectation that the former name will be maintained, thereby allowing for the range of contract- and service-specific circumstances that can affect such a determination. The Postal Service hereby adopts the following changes to 39 CFR part 241. § 241.1 erowe on DSK2VPTVN1PROD with RULES Organization and functions (government agencies), Postal Service. Accordingly, 39 CFR part 241 is amended as follows: PART 241—RETAIL ORGANIZATION AND ADMINISTRATION: ESTABLISHMENT, CLASSIFICATION, AND DISCONTINUANCE 1. The authority citation for 39 CFR part 241 continues to read as follows: ■ VerDate Mar<15>2010 15:10 Oct 25, 2011 Jkt 226001 (a) Establishment. Post Offices are established and maintained at locations deemed necessary to ensure that regular and effective postal services are available to all customers within specified geographic boundaries. A Post Office may be operated or staffed by a postmaster or by another type of postal employee at the direction of the postmaster, including when the postmaster is not physically present. * * * * * ■ 3. In § 241.3: ■ a. Paragraph (a)(1)(i)(B) is revised; ■ b. Paragraph (a)(1)(ii) is redesignated as paragraph (a)(1)(iii), and new paragraph (a)(1)(ii) is added; ■ c. Newly redesignated paragraph (a)(1)(iii) is revised; ■ d. Paragraph (a)(2)(iv) is revised; ■ e. Paragraph (b)(2)(i) is revised; ■ f. Paragraph (b)(4) is revised; and ■ g. Paragraph (c)(2) is revised. The revisions and additions read as follows: (iv) ‘‘Consolidation’’ means an action that converts a Postal Service-operated retail facility into a contractor-operated retail facility. The resulting contractoroperated retail facility reports to a Postal Service-operated retail facility. * * * * * (b) * * * (2) * * * (i) In a consolidation, the ZIP Code for the replacement contractor-operated retail facility is the ZIP Code originally assigned to the discontinued facility. * * * * * (4) Name of facility established by consolidation. If a USPS-operated retail facility is consolidated by establishing in its place a contractor-operated facility, the replacement unit can be given the same name of the facility that is replaced, if appropriate in light of the nature of the contract and level of service provided. (c) * * * (2) Consolidation. The proposed action may include a consolidation of USPS-operated retail facilities. A consolidation arises when a USPSoperated retail facility is replaced with a contractor-operated retail facility. * * * * * § 241.3 Discontinuance of USPS-operated retail facilities. Stanley F. Mires, Attorney, Legal Policy and Legislative Advice. (a) * * * (1) * * * (i) * * * (B) Combine a USPS-operated Post Office, station, or branch with another USPS-operated retail facility, or (ii) The conversion of a Post Office into, or the replacement of a Post Office with, another type of USPS-operated retail facility is not a discontinuance action subject to this section. A change in the staffing of a Post Office such that it is staffed only part-time by a postmaster, or not staffed at all by a postmaster, but rather by another type of USPS employee, is not a discontinuance action subject to this section. (iii) The regulations in this section are mandatory only with respect to discontinuance actions for which initial feasibility studies have been initiated on or after July 14, 2011. Unless otherwise provided by responsible personnel, the rules under § 241.3 as in effect prior to July 14, 2011 shall apply to discontinuance actions for which initial feasibility studies have been initiated prior to July 14, 2011. Discontinuance actions pending as of December 1, 2011, that pertain to the conversion of a Post Office to another type of USPS-operated facility are no longer subject to these regulations. (2) * * * [FR Doc. 2011–27641 Filed 10–25–11; 8:45 am] 2. In § 241.1, paragraph (a) is revised to read as follows: List of Subjects in 39 CFR Part 241 66187 PO 00000 Post offices. Frm 00019 Fmt 4700 Sfmt 4700 BILLING CODE 7710–12–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2009–0538; FRL–8891–3] Bacteriophage of Clavibacter Michiganensis Subspecies Michiganensis; Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes an exemption from the requirement of a tolerance for residues of lytic bacteriophage of Clavibacter michiganensis subspecies michiganensis produced in Clavibacter michiganensis subspecies michiganensis in or on tomato when applied as a bactericide in accordance with good agricultural practices. On behalf of OmniLytics, Inc., Interregional Research Project Number 4 (IR–4) submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA) requesting an exemption from SUMMARY: E:\FR\FM\26OCR1.SGM 26OCR1 66188 Federal Register / Vol. 76, No. 207 / Wednesday, October 26, 2011 / Rules and Regulations the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of lytic bacteriophage of Clavibacter michiganensis subspecies michiganensis produced in Clavibacter michiganensis subspecies michiganensis under the FFDCA. DATES: This regulation is effective October 26, 2011. Objections and requests for hearings must be received on or before December 27, 2011, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2009–0538. All documents in the docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at https://www.regulations.gov, or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305–5805. FOR FURTHER INFORMATION CONTACT: Denise Greenway, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–8263; e-mail address: greenway.denise@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information erowe on DSK2VPTVN1PROD with RULES A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). VerDate Mar<15>2010 15:10 Oct 25, 2011 Jkt 226001 • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office’s e-CFR site at https:// ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2009–0538 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 27, 2011. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA–HQOPP–2009–0538, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. II. Background and Statutory Findings In the Federal Register of September 23, 2009 (74 FR 48556) (FRL–8434–7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 9E7552) by IR–4, Rutgers University, 500 College Rd. East, Suite 201W, Princeton, NJ 08540 (on behalf of OmniLytics, Inc., 9100 South 500 West, Sandy, UT 84070). The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of bacteriophage of Clavibacter michiganensis subspecies michiganensis. This notice referenced a summary of the petition prepared by the petitioner, IR–4, which is available in the docket via https:// www.regulations.gov. There were no comments received in response to the notice of filing. Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is ‘‘safe.’’ Section 408(c)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA, which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance exemption and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate E:\FR\FM\26OCR1.SGM 26OCR1 Federal Register / Vol. 76, No. 207 / Wednesday, October 26, 2011 / Rules and Regulations exposure to the pesticide chemical residue. * * *’’ Additionally, section 408(b)(2)(D) of FFDCA requires that EPA consider ‘‘available information concerning the cumulative effects of [a particular pesticide’s] * * * residues and other substances that have a common mechanism of toxicity.’’ EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. erowe on DSK2VPTVN1PROD with RULES III. Toxicological Profile Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. A. Bacteriophage Overview Bacteriophage, the most abundant group of biological entities on the planet, are naturally occurring viruses that are found in soil and water and in association with plants and animals, including humans (Refs. 1 through 8). Bacteriophage are obligate parasites of bacteria, which means they attach to, infect, and reproduce in bacteria, and are host-specific for bacteria, with specific bacteriophage attacking only one bacterial species and most frequently only one strain within a bacterial species (Refs. 9 through 11). As such, bacteriophage do not attack other beneficial bacteria. In addition, there is no evidence for bacteriophage infecting any other life form, including humans, except bacteria (Refs. 7, 12, and 13). Humans and other animals commonly consume bacteriophage as they are abundantly found in water, on plant surfaces, and in foods such as ground beef, pork sausage, chicken, oysters, cheese, mushrooms, and broccoli (Refs. 3, 4, and 14 through 19). In addition, bacteriophage are common commensals of the human gut and likely play an important role in regulating populations of various bacteria in the gastrointestinal tract (Ref. 7). As cited in public literature, bacteriophage have been used for more than 80 years as therapeutic agents with no ill effects and are active against bacteria that cause VerDate Mar<15>2010 15:10 Oct 25, 2011 Jkt 226001 many infections and human diseases (Refs. 7, 20, and 21). Since 2005, bacteriophage have also been used in a pesticide product (Agriphage; EPA Reg. No. 67986–1), without reported incidents, to control particular bacterial diseases (Xanthomonas campestris pv. vesicatoria and Pseduomonas syringae pv. tomato) of tomato and pepper. In conjunction with registration of the aforementioned pesticide product, EPA established an exemption from the requirement of a tolerance for residues of bacteriophage of Xanthomonas campestris pv. vesicatoria and ´ Pseudomonas syringae pv. tomato in or on tomato and pepper (see the Federal Register of December 28, 2005 (70 FR 76704) (FRL–7753–6)). Much like the previously registered bacteriophage, OmniLytics, Inc. is proposing that bacteriophage of Clavibacter michiganensis subspecies michiganensis be applied as a pesticide for a very limited use-to control bacterial canker disease on tomato. B. Microbial Pesticide Toxicology Data Requirements All mammalian toxicology data requirements supporting the request for an exemption from the requirement of a tolerance for residues of bacteriophage of Clavibacter michiganensis subspecies michiganensis in or on tomato have been fulfilled with submission of valid studies from the public literature (Refs. 22 and 23). As mentioned in Unit III.A., bacteriophage are viruses that only infect specific bacteria, a basic fact supported by both information presented in public literature and the absence of reported adverse effects to humans even with commonplace exposure to bacteriophage. Literature submitted established that bacteriophage have been used historically and through modern times in lieu of or to assist the action of antibiotics. Clinical uses encompass all manner of administration from injection/intravenous and surgical wound applications to topical and ingestible preparations. There have been no reports of adverse effects from such administrations and in other similar cases using controlled scientific studies. Also submitted were literature citations showing that bacteriophage are common and abundant in soils, are in a wide range of plant materials, and are generally present in high numbers in the environment (e.g., up to 1010 plaqueforming units (PFU) per liter may be found in non-polluted waters). Yet again, no adverse effects to humans have been reported with these types of PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 66189 potential exposure. Moreover, bacteriophage presence reported in foods and feeds ranges from 101 to 105 PFU/100 grams (g) of meat and up to 107 PFU/100 g of cheese without any known harmful effects after consumption of such materials. Finally, the petitioner noted that, during an extensive history of bacteriophage laboratory and pesticidal usage, adverse reports in the literature have not been documented and episodes of hypersensitivity have not occurred. Because bacteriophage are obligate bacterial parasites and are not known to infect humans, the only human health risk associated with use of bacteriophage of Clavibacter michiganensis subspecies michiganensis as a bactericide is potential for acquisition and production of microbial toxins. This acquisition occurs through lysogeny, which is when bacteriophage integrate into the genome of toxigenic bacterial host strains and pick up and transmit those genetic traits to other bacteria that otherwise would not produce toxic substances. Therefore, bacteriophage of Clavibacter michiganensis subspecies michiganensis that meet the following two conditions do not present this risk issue: 1. Bacteriophage produced in Clavibacter michiganensis subspecies michiganensis, which has been sequenced and determined to be an atoxigenic host bacteria, and 2. Bacteriophage possessing the capability to lyse host bacteria, i.e., completely destroy host cells during the viral production process, which precludes genetic transfer of possible toxins to other bacteria (Ref. 22). IV. Aggregate Exposure In examining aggregate exposure, section 408 of FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other nonoccupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). A. Dietary Exposure 1. Food exposure. Published literature submitted by the petitioner, as well as other publicly available literature, indicate that bacteriophage are commonly associated with food and are therefore regularly consumed by humans. According to Ackermann (1997), these viruses have been found in association with ‘‘buds, leaves, root nodules (leguminous plants), roots, E:\FR\FM\26OCR1.SGM 26OCR1 erowe on DSK2VPTVN1PROD with RULES 66190 Federal Register / Vol. 76, No. 207 / Wednesday, October 26, 2011 / Rules and Regulations rotting fruit, seeds, stems, and straw; crown gall tumors * * * healthy or diseased alfalfa, barley, beans, broccoli, Brussels sprouts, buckwheat, clover, cotton, cucumber, lucerne, mulberry, oats, peas, peach trees, radish, rutabaga, ryegrass, rye, timothy, tobacco, tomatoes, [and] wheat’’ (Ref. 14). Moreover, bacteriophage have been isolated from a wide range of food products, including ground beef, pork sausage, chicken, farmed freshwater fish, common carp, marine fish, oil sardines, raw skim milk, and cheese (Refs. 15, 16, and 24 through 27). In fact, several studies have suggested that 100% of the ground beef and chicken meat sold at retail stores contain various levels of bacteriophage. For instance, bacteriophage were recovered from 100% of examined fresh chicken and pork sausage samples and from 33% of delicatessen meat samples analyzed; the levels ranged from 3.3 × 1010 to 4.4 × 1010 PFU/100 g of fresh chicken, up to 3.5 × 1010 PFU/100 g of fresh pork, and up to 2.7 × 1010 PFU/100 g of roast turkey breast samples (Ref 16). Other studies similarly showed the widespread occurrence of bacteriophage in certain foods: a. 38 bacteriophage-host systems were isolated from 22 of 45 refrigerated products (Ref 27); b. Bacteriophage infecting fire blight pathogen (Erwinia amylovora) were isolated from apple, pear, and raspberry tissues and from soil samples collected at sites displaying fire blight symptoms (Ref 5); and c. Shellfish, which filter large quantities of seawater, concentrated both bacteria and bacteriophage (Ref 6). Because lytic bacteriophage of Clavibacter michiganensis subspecies michiganensis produced in Clavibacter michiganensis subspecies michiganensis are intended to be applied to tomatoes, it is likely that dietary exposure will occur; however, no adverse effects are expected to occur. Despite constant and direct food exposure to bacteriophage (examples provided in the preceding paragraph and in Unit III.), no adverse effects to humans have been reported in publicly available literature. Indeed, no such effects are expected given that bacteriophage, including the one at issue in this action, are not capable of infecting eukaryotic cells and are host specific, attacking only bacteria. 2. Drinking water exposure. Published literature submitted by the petitioner, as well as other publicly available literature, indicate that, much like food, bacteriophage are commonly associated with water and are therefore regularly consumed by humans. According to VerDate Mar<15>2010 15:10 Oct 25, 2011 Jkt 226001 Demuth et al. (1993), ‘‘Bacteriophage * * * have been isolated from all types of bacteria and from virtually any aquatic or terrestrial habitat where bacteria can exist. However, only in the last few years has it been recognized that viruses (phage) are extremely abundant in ocean and fresh water and may exceed the concentration of bacteria by up to 100-fold’’ (Ref. 3). Other studies showed that bacteriophage of Erwinia carotovora and Erwinia ananas were isolated from certain freshwater lakes in Florida and Texas (Ref. 4) and that coliphage were present in some samples of drinking water (Ref 28). When lytic bacteriophage of Clavibacter michiganensis subspecies michiganensis produced in Clavibacter michiganensis subspecies michiganensis are applied to tomato as a bactericide in accordance with good agricultural practices, exposure of humans to residues of these bacteriophage in consumed drinking water may occur. Although lytic bacteriophage of Clavibacter michiganensis subspecies michiganensis produced in Clavibacter michiganensis subspecies michiganensis are not expected to reach surface water because the proposed use patterns do not include direct application to aquatic sites, it is possible that this microbial pest control agent could make it into ground water. Nonetheless, if oral exposure to lytic bacteriophage of Clavibacter michiganensis subspecies michiganensis produced in Clavibacter michiganensis subspecies michiganensis occurs through consumed drinking water (e.g., due to surface water contamination by microbial pesticide spray drift or runoff or contact with ground water), for the many reasons enumerated in Unit III. and Unit IV.A.1., EPA concludes there is reasonable certainty that this type of drinking water exposure, or any level of drinking water exposure for that matter, will not result in harm to humans. B. Other Non-Occupational Exposure Dermal and inhalation nonoccupational exposures to lytic bacteriophage of Clavibacter michiganensis subspecies michiganensis produced in Clavibacter michiganensis subspecies michiganensis are not expected as all proposed pesticide applications will take place in distinct agricultural settings. Even if dermal and inhalation non-occupational exposures were to occur inadvertently (e.g., through spray drift) or due to an eventual expansion of use sites, such exposures would not be PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 of concern given the information presented in Unit III. and Unit IV.A. V. Cumulative Effects From Substances With a Common Mechanism of Toxicity Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance exemption, EPA consider ‘‘available information concerning the cumulative effects of [a particular pesticide’s] * * * residues and other substances that have a common mechanism of toxicity.’’ EPA has not found lytic bacteriophage of Clavibacter michiganensis subspecies michiganensis produced in Clavibacter michiganensis subspecies michiganensis to share a common mechanism of toxicity with any other substances, and lytic bacteriophage of Clavibacter michiganensis subspecies michiganensis produced in Clavibacter michiganensis subspecies michiganensis do not appear to produce a toxic metabolite against the target pest. For the purposes of this tolerance action, therefore, EPA has assumed that lytic bacteriophage of Clavibacter michiganensis subspecies michiganensis produced in Clavibacter michiganensis subspecies michiganensis do not have a common mechanism of toxicity with other substances. Therefore, section 408(b)(2)(D)(v) of the FFDCA does not apply. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s Web site at https://www.epa.gov/pesticides/ cumulative. VI. Determination of Safety for United States (U.S.) Population, Infants and Children FFDCA section 408(b)(2)(C) provides that EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold (10×) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor. In E:\FR\FM\26OCR1.SGM 26OCR1 Federal Register / Vol. 76, No. 207 / Wednesday, October 26, 2011 / Rules and Regulations applying this provision, EPA either retains the default value of 10× or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. As previously discussed in Unit III. and Unit IV., humans, including infants and children, have been exposed to bacteriophage through food and water, where they are commonly found, and through decades of therapeutic use with no known or reported adverse effects. Based on this, as well as all the other reasons enumerated repeatedly in this unit, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to the residues of lytic bacteriophage of Clavibacter michiganensis subspecies michiganensis produced in Clavibacter michiganensis subspecies michiganensis. Such exposure includes all anticipated dietary exposures and all other exposures for which there is reliable information. EPA has arrived at this conclusion because, considered collectively, the public literature available on bacteriophage, including the one at issue in this action, do not demonstrate toxic, pathogenic, and/or infective potential to mammals. Thus, there are no threshold effects of concern and, as a result, an additional margin of safety is not necessary. VII. Other Considerations A. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes for the reasons stated above and because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation. erowe on DSK2VPTVN1PROD with RULES B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. In this context, EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/ World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) VerDate Mar<15>2010 15:10 Oct 25, 2011 Jkt 226001 requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for lytic bacteriophage of Clavibacter michiganensis subspecies michiganensis produced in Clavibacter michiganensis subspecies michiganensis. C. Revisions to Requested Exemption In its petition, the petitioner requested generally that the Agency issue an exemption from the requirement of a tolerance for residues of bacteriophage of Clavibacter michiganensis subspecies michiganensis in or on tomato. The petitioner’s supporting materials indicated that the actual pesticide that would be used would be safe because the bacteriophage were lytic and produced in Clavibacter michiganensis subspecies michiganensis. The Agency believes both that these two conditions are necessary to make the safety finding and the petitioner was only requesting a narrow exemption; therefore, the Agency is modifying the tolerance exemption regulatory text to include such criteria. VIII. Conclusions EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of lytic bacteriophage of Clavibacter michiganensis subspecies michiganensis produced in Clavibacter michiganensis subspecies michiganensis. Therefore, an exemption from the requirement of a tolerance is established for residues of lytic bacteriophage of Clavibacter michiganensis subspecies michiganensis produced in Clavibacter michiganensis subspecies michiganensis in or on tomato when applied as a bactericide in accordance with good agricultural practices. IX. References 1. Keel C, Ucurum Z, Michaux P, Adrian M, Haas D. 2002. Deleterious impact of a virulent bacteriophage on survival and biocontrol activity of Pseudomonas fluorescens strain CHAO in natural soil. Molecular Plant-Microbe Interactions 15:567–576. 2. Liew KW, Alvarez AM. 1981. Biological and morphological characterization of Xanthomonas campestris bacteriophages. Phytopatholoy 71:269–273. 3. Demuth J, Neve H, Witzel K–P. 1993. Direct electron microscopy study on the morphological diversity of bacteriophage populations in Lake Plussse. Applied and Environmental Microbiology 59:3378–3384. PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 66191 4. Eayre CG, Bartz JA, Concelmo DE. 1995. Bacteriophages of Erwinia carotovora and Erwinia ananas isolated from freshwater lakes. Plant Disease 79:801– 804. 5. Schnabel EL, Jones AL. 2001. Isolation and characterization of five Erwinia amylovora bacteriophages and assessment of phage resistance in strains of Erwinia amylovora. Applied and Environmental Microbiology 67:59–64. 6. Denis FA. 1975. Contamination of shellfish with strains of Pseudomonas aeruginosa and specific bacteriophages. Canadian Journal of Microbiology 21:1055–1057. 7. Merril CR, Scholl D, Adhya SL. 2003. The prospect for bacteriophage therapy in Western medicine. Nature 2:489–497. 8. Rohwer F. 2003. Global phage diversity. Cell 113:1–2. 9. Stocker BAD. 1955. Bacteriophage and bacterial classification. Journal of General Microbiology 12:375–381. 10. Duckworth DH, Gulig PA. 2002. Bacteriophage: potential treatment for bacterial infections. Biodrugs 16:57–62. 11. Summers WC. 2001. Bacteriophage therapy. Annual Review of Microbiology 55:437–451. 12. Lorch A. 1999. Bacteriophage: an alternative to antibiotics? Biotechnology and Development Monitor 39:14–17. 13. Petricciani JC, Hsu TC, Stock AD, Turner JH, Wenger SL, Elisberg BL. 1978. Bacteriophages, vaccines, and people: an assessment of risk. Proceedings of the Society for Experimental Biology and Medicine. 58:378–382. 14. Ackermann H–W. 1997. Bacteriophage ecology. Pp. 335–339 in: ‘‘Progress in Microbial Ecology (Proceedings of Seventh International Symposium on Microbial Ecology)’’. Martins MT, Sato ¨ MIZ, Tiedje JM, Hagler LCN, Dobereiner J, Sanchez PS, eds. Brazilian Society for Microbiology. 15. Kennedy JE Jr, Wei CI, Oblinger JL. 1986. Methodology for enumeration of coliphages in foods. Applied and Environmental Microbiology 51:956–962. 16. Kennedy JE Jr, Oblinger JL, Bitton G. 1984. Recovery of coliphages from chicken, pork sausage and delicatessen meats. Journal of Food Protection 47:623–626. 17. DePaola A, Motes ML, Chan AM, Suttle CA. 1998. Phages infecting Vibrio vulnificus are abundant and diverse in oysters (Crassostrea virginica) collected from the Gulf of Mexico. Applied and Environmental Microbiology 64:346–351. 18. Quiberoni A, Tremblay D, Ackermann H– W, Moineau S, Reinheimer JA. 2006. Diversity of Streptococcus thermophilus phages in a large-production cheese factory in Argentina. Journal of Dairy Science 89:3791–3799. 19. Guillaumes J, Houdeau G, Germain R, Olivier JM. 1988. Improvement of the biocontrol of Pseudomonas tolaasii using bacteriophages associated with an antagonistic bacterium. Bulletin OEPP 18:77–82. 20. Radetsky P. 1996. The good virus. Discover 17:50–58. 21. Chanishvili N, Chanishvili T, Tediashvili M, Barrow PA. 2001. Phages and their E:\FR\FM\26OCR1.SGM 26OCR1 66192 Federal Register / Vol. 76, No. 207 / Wednesday, October 26, 2011 / Rules and Regulations application against drug-resistant bacteria. Journal of Chemical Technology and Biotechnology 76:689–699. 22. U.S. EPA. 2011. Bacteriophage of Clavibacter michiganensis subsp. michiganensis—AgriPhage CMM. Memorandum from J.V. Gagliardi, Ph.D. to A. Gross dated June 30, 2011. 23. U.S. EPA. 2011. Bacteriophage of Clavibacter michiganensis subspecies michiganensis Biopesticides Registration Action Document dated August 25, 2011 (available as ‘‘Supporting & Related Material’’ with docket ID number EPA– HQ–OPP2009–0539 at https://www. regulations.gov). 24. Atterbury RJ, Connerton PL, Dodd CER, Rees CED, Connerton IF. 2003. Isolation and characterization of Campylobacter bacteriophages from retail poultry. Applied and Environmental Microbiology 69:4511–4518. 25. Gautier M, Rouault A, Sommer P, Briandet R. 1995. Occurrence of Propionibacterium freudenreichii bacteriophages in swiss cheese. Applied and Environmental Microbiology 61:2572–2576. 26. Greer GG. 2005. Bacteriophage control of foodborne bacteria. Journal of Food Protection 68:1102–1111. 27. Whitman PA, Marshall RT. 1971. Isolation of psychrophilic bacteriophagehost systems from refrigerated food products. Applied Microbiology 22:220–223. 28. El-Abagy MM, Dutka BJ, Kamel M. 1988. Incidence of coliphage in potable water supplies. Applied and Environmental Microbiology 54:1632–1633. erowe on DSK2VPTVN1PROD with RULES X. Statutory and Executive Order Reviews This final rule establishes a tolerance exemption under section 408(d) of FFDCA in response to a petition submitted to EPA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income VerDate Mar<15>2010 15:10 Oct 25, 2011 Jkt 226001 Populations (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, EPA has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, EPA has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000), do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104–4). This action does not involve any technical standards that would require EPA consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). XI. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: September 30, 2011. Steven Bradbury, Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.1307 is added to subpart D to read as follows: ■ § 180.1307 Bacteriophage of Clavibacter michiganensis subspecies michiganensis; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of lytic bacteriophage of Clavibacter michiganensis subspecies michiganensis produced in Clavibacter michiganensis subspecies michiganensis in or on tomato when applied as a bactericide in accordance with good agricultural practices. [FR Doc. 2011–27042 Filed 10–25–11; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 101119575–1554–02] RIN 0648–BA46 Fisheries of the Northeastern United States; Monkfish; Framework Adjustment 7 National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Final rule. AGENCY: This final rule implements measures that were approved in Framework Adjustment 7 to the Monkfish Fishery Management Plan. The New England Fishery Management Council and Mid-Atlantic Fishery Management Council developed Framework Adjustment 7 to adjust the annual catch target for the Northern Fishery Management Area to be consistent with the most recent SUMMARY: E:\FR\FM\26OCR1.SGM 26OCR1

Agencies

[Federal Register Volume 76, Number 207 (Wednesday, October 26, 2011)]
[Rules and Regulations]
[Pages 66187-66192]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27042]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0538; FRL-8891-3]


Bacteriophage of Clavibacter Michiganensis Subspecies 
Michiganensis; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of lytic bacteriophage of Clavibacter 
michiganensis subspecies michiganensis produced in Clavibacter 
michiganensis subspecies michiganensis in or on tomato when applied as 
a bactericide in accordance with good agricultural practices. On behalf 
of OmniLytics, Inc., Interregional Research Project Number 4 (IR-4) 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA) requesting an exemption from

[[Page 66188]]

the requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of lytic 
bacteriophage of Clavibacter michiganensis subspecies michiganensis 
produced in Clavibacter michiganensis subspecies michiganensis under 
the FFDCA.

DATES: This regulation is effective October 26, 2011. Objections and 
requests for hearings must be received on or before December 27, 2011, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0538. All documents in the 
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at https://www.regulations.gov, or, if only available in hard 
copy, at the Office of Pesticide Programs (OPP) Regulatory Public 
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal 
Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The Docket 
Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Denise Greenway, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8263; e-mail 
address: greenway.denise@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at https://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2009-0538 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
December 27, 2011. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQOPP-2009-0538, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: OPP Regulatory Public Docket (7502P), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of September 23, 2009 (74 FR 48556) (FRL-
8434-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 9E7552) by IR-4, Rutgers University, 500 College Rd. East, 
Suite 201W, Princeton, NJ 08540 (on behalf of OmniLytics, Inc., 9100 
South 500 West, Sandy, UT 84070). The petition requested that 40 CFR 
part 180 be amended by establishing an exemption from the requirement 
of a tolerance for residues of bacteriophage of Clavibacter 
michiganensis subspecies michiganensis. This notice referenced a 
summary of the petition prepared by the petitioner, IR-4, which is 
available in the docket via https://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings but does not include 
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C) of FFDCA, which require EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance exemption and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate

[[Page 66189]]

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

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness, and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children.

A. Bacteriophage Overview

    Bacteriophage, the most abundant group of biological entities on 
the planet, are naturally occurring viruses that are found in soil and 
water and in association with plants and animals, including humans 
(Refs. 1 through 8). Bacteriophage are obligate parasites of bacteria, 
which means they attach to, infect, and reproduce in bacteria, and are 
host-specific for bacteria, with specific bacteriophage attacking only 
one bacterial species and most frequently only one strain within a 
bacterial species (Refs. 9 through 11). As such, bacteriophage do not 
attack other beneficial bacteria. In addition, there is no evidence for 
bacteriophage infecting any other life form, including humans, except 
bacteria (Refs. 7, 12, and 13). Humans and other animals commonly 
consume bacteriophage as they are abundantly found in water, on plant 
surfaces, and in foods such as ground beef, pork sausage, chicken, 
oysters, cheese, mushrooms, and broccoli (Refs. 3, 4, and 14 through 
19). In addition, bacteriophage are common commensals of the human gut 
and likely play an important role in regulating populations of various 
bacteria in the gastrointestinal tract (Ref. 7). As cited in public 
literature, bacteriophage have been used for more than 80 years as 
therapeutic agents with no ill effects and are active against bacteria 
that cause many infections and human diseases (Refs. 7, 20, and 21).
    Since 2005, bacteriophage have also been used in a pesticide 
product (Agriphage; EPA Reg. No. 67986-1), without reported incidents, 
to control particular bacterial diseases (Xanthomonas campestris pv. 
vesicatoria and Pseduomonas syringae pv. tomato) of tomato and pepper. 
In conjunction with registration of the aforementioned pesticide 
product, EPA established an exemption from the requirement of a 
tolerance for residues of bacteriophage of Xanthomonas campestris pv. 
vesicatoria and Pseud[oacute]monas syringae pv. tomato in or on tomato 
and pepper (see the Federal Register of December 28, 2005 (70 FR 76704) 
(FRL-7753-6)). Much like the previously registered bacteriophage, 
OmniLytics, Inc. is proposing that bacteriophage of Clavibacter 
michiganensis subspecies michiganensis be applied as a pesticide for a 
very limited use-to control bacterial canker disease on tomato.

B. Microbial Pesticide Toxicology Data Requirements

    All mammalian toxicology data requirements supporting the request 
for an exemption from the requirement of a tolerance for residues of 
bacteriophage of Clavibacter michiganensis subspecies michiganensis in 
or on tomato have been fulfilled with submission of valid studies from 
the public literature (Refs. 22 and 23).
    As mentioned in Unit III.A., bacteriophage are viruses that only 
infect specific bacteria, a basic fact supported by both information 
presented in public literature and the absence of reported adverse 
effects to humans even with commonplace exposure to bacteriophage. 
Literature submitted established that bacteriophage have been used 
historically and through modern times in lieu of or to assist the 
action of antibiotics. Clinical uses encompass all manner of 
administration from injection/intravenous and surgical wound 
applications to topical and ingestible preparations. There have been no 
reports of adverse effects from such administrations and in other 
similar cases using controlled scientific studies. Also submitted were 
literature citations showing that bacteriophage are common and abundant 
in soils, are in a wide range of plant materials, and are generally 
present in high numbers in the environment (e.g., up to 1010 plaque-
forming units (PFU) per liter may be found in non-polluted waters). Yet 
again, no adverse effects to humans have been reported with these types 
of potential exposure. Moreover, bacteriophage presence reported in 
foods and feeds ranges from 101 to 105 PFU/100 grams (g) of meat and up 
to 107 PFU/100 g of cheese without any known harmful effects after 
consumption of such materials. Finally, the petitioner noted that, 
during an extensive history of bacteriophage laboratory and pesticidal 
usage, adverse reports in the literature have not been documented and 
episodes of hypersensitivity have not occurred.
    Because bacteriophage are obligate bacterial parasites and are not 
known to infect humans, the only human health risk associated with use 
of bacteriophage of Clavibacter michiganensis subspecies michiganensis 
as a bactericide is potential for acquisition and production of 
microbial toxins. This acquisition occurs through lysogeny, which is 
when bacteriophage integrate into the genome of toxigenic bacterial 
host strains and pick up and transmit those genetic traits to other 
bacteria that otherwise would not produce toxic substances. Therefore, 
bacteriophage of Clavibacter michiganensis subspecies michiganensis 
that meet the following two conditions do not present this risk issue:
    1. Bacteriophage produced in Clavibacter michiganensis subspecies 
michiganensis, which has been sequenced and determined to be an 
atoxigenic host bacteria, and
    2. Bacteriophage possessing the capability to lyse host bacteria, 
i.e., completely destroy host cells during the viral production 
process, which precludes genetic transfer of possible toxins to other 
bacteria (Ref. 22).

IV. Aggregate Exposure

    In examining aggregate exposure, section 408 of FFDCA directs EPA 
to consider available information concerning exposures from the 
pesticide residue in food and all other non-occupational exposures, 
including drinking water from ground water or surface water and 
exposure through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses).

A. Dietary Exposure

    1. Food exposure. Published literature submitted by the petitioner, 
as well as other publicly available literature, indicate that 
bacteriophage are commonly associated with food and are therefore 
regularly consumed by humans. According to Ackermann (1997), these 
viruses have been found in association with ``buds, leaves, root 
nodules (leguminous plants), roots,

[[Page 66190]]

rotting fruit, seeds, stems, and straw; crown gall tumors * * * healthy 
or diseased alfalfa, barley, beans, broccoli, Brussels sprouts, 
buckwheat, clover, cotton, cucumber, lucerne, mulberry, oats, peas, 
peach trees, radish, rutabaga, ryegrass, rye, timothy, tobacco, 
tomatoes, [and] wheat'' (Ref. 14). Moreover, bacteriophage have been 
isolated from a wide range of food products, including ground beef, 
pork sausage, chicken, farmed freshwater fish, common carp, marine 
fish, oil sardines, raw skim milk, and cheese (Refs. 15, 16, and 24 
through 27). In fact, several studies have suggested that 100% of the 
ground beef and chicken meat sold at retail stores contain various 
levels of bacteriophage. For instance, bacteriophage were recovered 
from 100% of examined fresh chicken and pork sausage samples and from 
33% of delicatessen meat samples analyzed; the levels ranged from 3.3 x 
1010 to 4.4 x 1010 PFU/100 g of fresh chicken, up to 3.5 x 1010 PFU/100 
g of fresh pork, and up to 2.7 x 1010 PFU/100 g of roast turkey breast 
samples (Ref 16). Other studies similarly showed the widespread 
occurrence of bacteriophage in certain foods:
    a. 38 bacteriophage-host systems were isolated from 22 of 45 
refrigerated products (Ref 27);
    b. Bacteriophage infecting fire blight pathogen (Erwinia amylovora) 
were isolated from apple, pear, and raspberry tissues and from soil 
samples collected at sites displaying fire blight symptoms (Ref 5); and
    c. Shellfish, which filter large quantities of seawater, 
concentrated both bacteria and bacteriophage (Ref 6).
    Because lytic bacteriophage of Clavibacter michiganensis subspecies 
michiganensis produced in Clavibacter michiganensis subspecies 
michiganensis are intended to be applied to tomatoes, it is likely that 
dietary exposure will occur; however, no adverse effects are expected 
to occur. Despite constant and direct food exposure to bacteriophage 
(examples provided in the preceding paragraph and in Unit III.), no 
adverse effects to humans have been reported in publicly available 
literature. Indeed, no such effects are expected given that 
bacteriophage, including the one at issue in this action, are not 
capable of infecting eukaryotic cells and are host specific, attacking 
only bacteria.
    2. Drinking water exposure. Published literature submitted by the 
petitioner, as well as other publicly available literature, indicate 
that, much like food, bacteriophage are commonly associated with water 
and are therefore regularly consumed by humans. According to Demuth et 
al. (1993), ``Bacteriophage * * * have been isolated from all types of 
bacteria and from virtually any aquatic or terrestrial habitat where 
bacteria can exist. However, only in the last few years has it been 
recognized that viruses (phage) are extremely abundant in ocean and 
fresh water and may exceed the concentration of bacteria by up to 100-
fold'' (Ref. 3). Other studies showed that bacteriophage of Erwinia 
carotovora and Erwinia ananas were isolated from certain freshwater 
lakes in Florida and Texas (Ref. 4) and that coliphage were present in 
some samples of drinking water (Ref 28).
    When lytic bacteriophage of Clavibacter michiganensis subspecies 
michiganensis produced in Clavibacter michiganensis subspecies 
michiganensis are applied to tomato as a bactericide in accordance with 
good agricultural practices, exposure of humans to residues of these 
bacteriophage in consumed drinking water may occur. Although lytic 
bacteriophage of Clavibacter michiganensis subspecies michiganensis 
produced in Clavibacter michiganensis subspecies michiganensis are not 
expected to reach surface water because the proposed use patterns do 
not include direct application to aquatic sites, it is possible that 
this microbial pest control agent could make it into ground water. 
Nonetheless, if oral exposure to lytic bacteriophage of Clavibacter 
michiganensis subspecies michiganensis produced in Clavibacter 
michiganensis subspecies michiganensis occurs through consumed drinking 
water (e.g., due to surface water contamination by microbial pesticide 
spray drift or runoff or contact with ground water), for the many 
reasons enumerated in Unit III. and Unit IV.A.1., EPA concludes there 
is reasonable certainty that this type of drinking water exposure, or 
any level of drinking water exposure for that matter, will not result 
in harm to humans.

B. Other Non-Occupational Exposure

    Dermal and inhalation non-occupational exposures to lytic 
bacteriophage of Clavibacter michiganensis subspecies michiganensis 
produced in Clavibacter michiganensis subspecies michiganensis are not 
expected as all proposed pesticide applications will take place in 
distinct agricultural settings. Even if dermal and inhalation non-
occupational exposures were to occur inadvertently (e.g., through spray 
drift) or due to an eventual expansion of use sites, such exposures 
would not be of concern given the information presented in Unit III. 
and Unit IV.A.

V. Cumulative Effects From Substances With a Common Mechanism of 
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance exemption, EPA 
consider ``available information concerning the cumulative effects of 
[a particular pesticide's] * * * residues and other substances that 
have a common mechanism of toxicity.''
    EPA has not found lytic bacteriophage of Clavibacter michiganensis 
subspecies michiganensis produced in Clavibacter michiganensis 
subspecies michiganensis to share a common mechanism of toxicity with 
any other substances, and lytic bacteriophage of Clavibacter 
michiganensis subspecies michiganensis produced in Clavibacter 
michiganensis subspecies michiganensis do not appear to produce a toxic 
metabolite against the target pest. For the purposes of this tolerance 
action, therefore, EPA has assumed that lytic bacteriophage of 
Clavibacter michiganensis subspecies michiganensis produced in 
Clavibacter michiganensis subspecies michiganensis do not have a common 
mechanism of toxicity with other substances. Therefore, section 
408(b)(2)(D)(v) of the FFDCA does not apply. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
EPA's Web site at https://www.epa.gov/pesticides/cumulative.

VI. Determination of Safety for United States (U.S.) Population, 
Infants and Children

    FFDCA section 408(b)(2)(C) provides that EPA shall assess the 
available information about consumption patterns among infants and 
children, special susceptibility of infants and children to pesticide 
chemical residues, and the cumulative effects on infants and children 
of the residues and other substances with a common mechanism of 
toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA 
shall apply an additional tenfold (10x) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines that a different margin of safety 
will be safe for infants and children. This additional margin of safety 
is commonly referred to as the Food Quality Protection Act Safety 
Factor. In

[[Page 66191]]

applying this provision, EPA either retains the default value of 10x or 
uses a different additional safety factor when reliable data available 
to EPA support the choice of a different factor.
    As previously discussed in Unit III. and Unit IV., humans, 
including infants and children, have been exposed to bacteriophage 
through food and water, where they are commonly found, and through 
decades of therapeutic use with no known or reported adverse effects. 
Based on this, as well as all the other reasons enumerated repeatedly 
in this unit, EPA concludes that there is a reasonable certainty that 
no harm will result to the U.S. population, including infants and 
children, from aggregate exposure to the residues of lytic 
bacteriophage of Clavibacter michiganensis subspecies michiganensis 
produced in Clavibacter michiganensis subspecies michiganensis. Such 
exposure includes all anticipated dietary exposures and all other 
exposures for which there is reliable information. EPA has arrived at 
this conclusion because, considered collectively, the public literature 
available on bacteriophage, including the one at issue in this action, 
do not demonstrate toxic, pathogenic, and/or infective potential to 
mammals. Thus, there are no threshold effects of concern and, as a 
result, an additional margin of safety is not necessary.

VII. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

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

C. Revisions to Requested Exemption

    In its petition, the petitioner requested generally that the Agency 
issue an exemption from the requirement of a tolerance for residues of 
bacteriophage of Clavibacter michiganensis subspecies michiganensis in 
or on tomato. The petitioner's supporting materials indicated that the 
actual pesticide that would be used would be safe because the 
bacteriophage were lytic and produced in Clavibacter michiganensis 
subspecies michiganensis. The Agency believes both that these two 
conditions are necessary to make the safety finding and the petitioner 
was only requesting a narrow exemption; therefore, the Agency is 
modifying the tolerance exemption regulatory text to include such 
criteria.

VIII. Conclusions

    EPA concludes that there is a reasonable certainty that no harm 
will result to the U.S. population, including infants and children, 
from aggregate exposure to residues of lytic bacteriophage of 
Clavibacter michiganensis subspecies michiganensis produced in 
Clavibacter michiganensis subspecies michiganensis. Therefore, an 
exemption from the requirement of a tolerance is established for 
residues of lytic bacteriophage of Clavibacter michiganensis subspecies 
michiganensis produced in Clavibacter michiganensis subspecies 
michiganensis in or on tomato when applied as a bactericide in 
accordance with good agricultural practices.

IX. References

1. Keel C, Ucurum Z, Michaux P, Adrian M, Haas D. 2002. Deleterious 
impact of a virulent bacteriophage on survival and biocontrol 
activity of Pseudomonas fluorescens strain CHAO in natural soil. 
Molecular Plant-Microbe Interactions 15:567-576.
2. Liew KW, Alvarez AM. 1981. Biological and morphological 
characterization of Xanthomonas campestris bacteriophages. 
Phytopatholoy 71:269-273.
3. Demuth J, Neve H, Witzel K-P. 1993. Direct electron microscopy 
study on the morphological diversity of bacteriophage populations in 
Lake Plussse. Applied and Environmental Microbiology 59:3378-3384.
4. Eayre CG, Bartz JA, Concelmo DE. 1995. Bacteriophages of Erwinia 
carotovora and Erwinia ananas isolated from freshwater lakes. Plant 
Disease 79:801-804.
5. Schnabel EL, Jones AL. 2001. Isolation and characterization of 
five Erwinia amylovora bacteriophages and assessment of phage 
resistance in strains of Erwinia amylovora. Applied and 
Environmental Microbiology 67:59-64.
6. Denis FA. 1975. Contamination of shellfish with strains of 
Pseudomonas aeruginosa and specific bacteriophages. Canadian Journal 
of Microbiology 21:1055-1057.
7. Merril CR, Scholl D, Adhya SL. 2003. The prospect for 
bacteriophage therapy in Western medicine. Nature 2:489-497.
8. Rohwer F. 2003. Global phage diversity. Cell 113:1-2.
9. Stocker BAD. 1955. Bacteriophage and bacterial classification. 
Journal of General Microbiology 12:375-381.
10. Duckworth DH, Gulig PA. 2002. Bacteriophage: potential treatment 
for bacterial infections. Biodrugs 16:57-62.
11. Summers WC. 2001. Bacteriophage therapy. Annual Review of 
Microbiology 55:437-451.
12. Lorch A. 1999. Bacteriophage: an alternative to antibiotics? 
Biotechnology and Development Monitor 39:14-17.
13. Petricciani JC, Hsu TC, Stock AD, Turner JH, Wenger SL, Elisberg 
BL. 1978. Bacteriophages, vaccines, and people: an assessment of 
risk. Proceedings of the Society for Experimental Biology and 
Medicine. 58:378-382.
14. Ackermann H-W. 1997. Bacteriophage ecology. Pp. 335-339 in: 
``Progress in Microbial Ecology (Proceedings of Seventh 
International Symposium on Microbial Ecology)''. Martins MT, Sato 
MIZ, Tiedje JM, Hagler LCN, D[ouml]bereiner J, Sanchez PS, eds. 
Brazilian Society for Microbiology.
15. Kennedy JE Jr, Wei CI, Oblinger JL. 1986. Methodology for 
enumeration of coliphages in foods. Applied and Environmental 
Microbiology 51:956-962.
16. Kennedy JE Jr, Oblinger JL, Bitton G. 1984. Recovery of 
coliphages from chicken, pork sausage and delicatessen meats. 
Journal of Food Protection 47:623-626.
17. DePaola A, Motes ML, Chan AM, Suttle CA. 1998. Phages infecting 
Vibrio vulnificus are abundant and diverse in oysters (Crassostrea 
virginica) collected from the Gulf of Mexico. Applied and 
Environmental Microbiology 64:346-351.
18. Quiberoni A, Tremblay D, Ackermann H-W, Moineau S, Reinheimer 
JA. 2006. Diversity of Streptococcus thermophilus phages in a large-
production cheese factory in Argentina. Journal of Dairy Science 
89:3791-3799.
19. Guillaumes J, Houdeau G, Germain R, Olivier JM. 1988. 
Improvement of the biocontrol of Pseudomonas tolaasii using 
bacteriophages associated with an antagonistic bacterium. Bulletin 
OEPP 18:77-82.
20. Radetsky P. 1996. The good virus. Discover 17:50-58.
21. Chanishvili N, Chanishvili T, Tediashvili M, Barrow PA. 2001. 
Phages and their

[[Page 66192]]

application against drug-resistant bacteria. Journal of Chemical 
Technology and Biotechnology 76:689-699.
22. U.S. EPA. 2011. Bacteriophage of Clavibacter michiganensis 
subsp. michiganensis--AgriPhage CMM. Memorandum from J.V. Gagliardi, 
Ph.D. to A. Gross dated June 30, 2011.
23. U.S. EPA. 2011. Bacteriophage of Clavibacter michiganensis 
subspecies michiganensis Biopesticides Registration Action Document 
dated August 25, 2011 (available as ``Supporting & Related 
Material'' with docket ID number EPA-HQ-OPP2009-0539 at https://www.regulations.gov).
24. Atterbury RJ, Connerton PL, Dodd CER, Rees CED, Connerton IF. 
2003. Isolation and characterization of Campylobacter bacteriophages 
from retail poultry. Applied and Environmental Microbiology 69:4511-
4518.
25. Gautier M, Rouault A, Sommer P, Briandet R. 1995. Occurrence of 
Propionibacterium freudenreichii bacteriophages in swiss cheese. 
Applied and Environmental Microbiology 61:2572-2576.
26. Greer GG. 2005. Bacteriophage control of foodborne bacteria. 
Journal of Food Protection 68:1102-1111.
27. Whitman PA, Marshall RT. 1971. Isolation of psychrophilic 
bacteriophagehost systems from refrigerated food products. Applied 
Microbiology 22:220-223.
28. El-Abagy MM, Dutka BJ, Kamel M. 1988. Incidence of coliphage in 
potable water supplies. Applied and Environmental Microbiology 
54:1632-1633.

X. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption under section 
408(d) of FFDCA in response to a petition submitted to EPA. The Office 
of Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance 
exemption in this final rule, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes. As a result, this 
action does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, EPA has determined that this 
action will not have a substantial direct effect on States or tribal 
governments, on the relationship between the national government and 
the States or tribal governments, or on the distribution of power and 
responsibilities among the various levels of government or between the 
Federal Government and Indian tribes. Thus, EPA has determined that 
Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999), and Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 9, 
2000), do not apply to this final rule. In addition, this final rule 
does not impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would 
require EPA consideration of voluntary consensus standards pursuant to 
section 12(d) of the National Technology Transfer and Advancement Act 
of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

XI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: September 30, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.1307 is added to subpart D to read as follows:


Sec.  180.1307  Bacteriophage of Clavibacter michiganensis subspecies 
michiganensis; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of lytic bacteriophage of Clavibacter michiganensis subspecies 
michiganensis produced in Clavibacter michiganensis subspecies 
michiganensis in or on tomato when applied as a bactericide in 
accordance with good agricultural practices.

[FR Doc. 2011-27042 Filed 10-25-11; 8:45 am]
BILLING CODE 6560-50-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.