Environmental Protection Agency (EPA).
This regulation establishes a time-limited tolerance for residues of sulfur dioxide in or on fig. This action is associated with the utilization of a crisis exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on figs. This regulation establishes a maximum permissible level for residues of sulfur dioxide, including its metabolites and degradates (determined by measuring only sulfur dioxide (SO2)), in or on fig at 10 parts per million (ppm). This time-limited tolerance expires on December 31, 2014.
This regulation is effective September 14, 2011. Objections and requests for hearings must be received on or before November 14, 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).
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2011-0684. All documents in the docket are listed in the docket index available in http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the 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.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Libby Pemberton, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-9364; e-mail address: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
- Crop production (NAICS code 111).
- Animal production (NAICS code 112).
- Food manufacturing (NAICS code 311).
- Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://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 section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, 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-2011-0684 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 November 14, 2011. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0684, by one of the following methods:
- Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments.
- Mail: Office of Pesticide Programs (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
EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing a time-limited tolerance for residues of sulfur dioxide, including its metabolites and degradates (determined by measuring only sulfur dioxide (SO2)), at 10 ppm. This time-limited tolerance is effective until December 31, 2014.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under Start Printed Page 56645an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances to set binding precedents for the application of section 408 of FFDCA and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(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. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. * * *”
Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” EPA has established regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Sulfur Dioxide on Figs and FFDCA Tolerances
Excessive rain and humidity at flowering and early fruit development in the spring are critical factors in development of gray mold caused by Botrytis cinerea (B. cinerea) and these have been high in the areas where California figs are grown over the past two years. California estimated that gray mold could be responsible for a 24% yield loss; and there are no pre or post-harvest fungicides registered to control B. cinerea on fresh figs.
The Applicant asserts that an emergency condition exists in accordance with the criteria for approval of an emergency exemption, and has utilized a crisis exemption under FIFRA section 18 to allow the use of sulfur dioxide on figs for control of gray mold caused by B. cinerea in California. After having reviewed the submission, EPA concurs that an emergency condition exists.
As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of sulfur dioxide in or on fig. In doing so, EPA considered the safety standard in section 408(b)(2) of FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of FFDCA. Although these time-limited tolerances expire on December 31, 2014, under section 408(l)(5) of FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on figs after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this time-limited tolerance at the time of that application. EPA will take action to revoke this time-limited tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.
Because this time-limited tolerance is being approved under emergency conditions, EPA has not made any decisions about whether sulfur dioxide meets FIFRA's registration requirements for use on fig or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of sulfur dioxide by a State for special local needs under FIFRA section 24(c). Nor does this tolerance by itself serve as the authority for persons in any State other than California to use this pesticide on the applicable crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for sulfur dioxide, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(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 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. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. * * *”
Consistent with the factors specified in FFDCA section 408(b)(2)(D), 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 sulfite sensitive individuals, infants and children. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure expected as a result of this emergency exemption request and the time-limited tolerances for residues of sulfur dioxide, including its metabolites and degradates (determined by measuring only sulfur dioxide (SO2)), at 10 ppm. EPA's assessment of exposures and risks associated with establishing time-limited tolerances follows.
A. 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, and infants and children, as well as sulfite sensitive individuals.
Evaluations performed by the World Health Organization (WHO), the Start Printed Page 56646International Agency for Research on Cancer (IARC), and the Agency for Toxic Substances and Disease Registry (ATSDR) were relied upon for the safety finding for sulfur dioxide made in the May 2007 RED assessment on inorganic sulfites, which includes the chemicals sulfur dioxide and sodium metabisulfite (end-use inorganic sulfite products contain sulfur dioxide at 99.9 to 100%, and sodium metabisulfite at 37.5 to 98.5%. These assessments are based on peer-reviewed evaluations performed by the Cosmetic Ingredient Review (a program established in 1976 by the Cosmetic, Toiletry & Fragrance Association, now known as the Personal Care Products Council (PCPC), with the support of the U.S. Food and Drug Administration (FDA) and the Consumer Federation of America (CFA); the Organization for Economic Cooperation and Development-Screening Information Data Set and from other open literature sources. People may be exposed to small amounts of sulfur through the food supply. However, since sulfur does not cause any relevant toxic effects, no quantitative dietary risk assessment is needed. Short-term studies show that sulfur is of very low acute oral toxicity and does not irritate the skin (it has been placed in Toxicity Category IV, the least toxic category, for these effects). Sulfur dioxide (21 CFR 182.3862) is listed as Generally Recognized as Safe (GRAS) by the FDA as a preservative in certain foods. The Select Committee on GRAS Substances (a committee of qualified scientists contracted by FDA to review and evaluate the safety of GRAS substances) concluded that: “There is no evidence in the available information on sulfur dioxide that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when used at levels that are now current and in the manner now practiced.” This conclusion was based on the knowledge that orally administered sulfite is very rapidly oxidized to sulfate in all species studied. The metabolic removal of sulfite appears to be the critical defense mechanism. The WHO has emphasized the use of appropriate labeling for alerting individuals who cannot tolerate sulfites. After receiving and reviewing reports of adverse reactions in certain individuals following ingestion of sulfiting agents used as preservatives in food products, beverages, and fresh fruits and vegetables, the FDA require s ingredient labels to list sulfite concentrations in excess of 10 ppm. Several regulatory endpoints and standards for ambient air concentrations of sulfur dioxide have been established at the state, Federal and international levels. The endpoint selected by the Agency for the bystander inhalation risk assessment is 0.25 ppm sulfur dioxide, with one-hour exposure duration. The 0.25 ppm concentration is based on an ambient air quality standard set by the California Air Resources Board. This endpoint is deemed most applicable to this exposure scenario, as it is based on effects of concern for bystanders (such as bronchoconstriction, shortness of breath, wheezing, and chest tightness during physical activity in persons with asthma).
B. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to sulfur dioxide, EPA considered exposure under the time-limited tolerances established by this action, as well as all existing sulfur dioxide tolerances in 40 CFR 180.444. Exposures to sulfites when used as an active or inert pesticide ingredient are minimal because it is known to be readily biodegradable, quickly oxidized, and rapidly excreted from the body. In addition, sulfur dioxide (21 CFR 182.3862) is listed as GRAS by the FDA, with limitations, as a food preservative. As such, sulfites are found in many foods, primarily as a result of the GRAS preservative use. It is estimated that sulfite concentrations of >100 ppm may be found in dried fruits (excluding dark raisins and prunes), lemon and lime juices, wine, molasses, and sauerkraut juice. Dried potatoes, grape juice, wine vinegar, gravies, fruit topping, and maraschino cherries may contain between 50 and 100 ppm sulfur dioxide. Foods containing between 10 ppm and 50 ppm include pectin, fresh shrimp, corn syrup, sauerkraut, pickled foods, corn starch, hominy, frozen potatoes, maple syrup, imported jams and jellies, and fresh mushrooms (CIR 2003). Preliminary data developed by the Interregional Research Project No. 4 (IR-4) from the concluded experimental phase of a study now being conducted on figs was submitted with this exemption request. The design of the IR-4 study is sufficient in its scope having followed the protocol put forward for determining the magnitude of the residue on fresh figs from the use of sulfur dioxide. This study shows that following application made at a 10x exaggerated rate of 250 ppm sulfur dioxide/hour, samples analyzed from 1 hour up to 28 days after treatment were all found to have residue levels of sulfur dioxide below the limit of detection (LOD) of 10 ppm. In view of the data provided by IR-4, a linear extrapolation from the 10x exaggerated rate to a 1x application rate determined that a 1x rate is likely to result in residue levels of sulfur dioxide of 2.5 ppm or lower when following the use-pattern in this crisis exemption.
2. Drinking water exposure. Based on environmental fate information for sulfur dioxide and the requested post-harvest use pattern (in closed chambers), concentrations of concern are not expected in drinking water.
3. Inhalation exposure. Based on the Probabilistic Exposure and Risk Model for Fumigants, version 2.1.1 (PERFUM2) the requested use is expected to limit bystander exposure potential to sulfur dioxide concentrations at or below 0.25 ppm. This bystander exposure scenario is considered “worst-case,” in that it assumes the ventilation stack is at the edge of the treatment warehouse, and the warehouse is in close proximity to the fumigation facility property line.
4. Other non-occupational 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). Currently there are no residential uses for sulfur dioxide, as the use of inorganic sulfites is limited to postharvest fumigation of grapes. Environmental sources of sulfur dioxide exposure include the combustion of fossil fuels, smelting of sulfide ores, volcanic emissions, and other natural sources. Sulfur dioxide is also used to manufacture hydrosulfites, to bleach wood pulp and paper, to process, disinfect, and bleach food, for waste and water treatment, and in metal, ore, and oil refining (ATSDR 2004). Sufficient information is available from public sources to adequately characterize sulfur dioxide.
C. Safety Factor for Infants and Children
There is sufficient toxicological information for sulfur dioxide to address risks to infants and children. The available information indicates that there is no evidence of increased quantitative or qualitative susceptibility of the offspring after in utero or post-natal exposure. Based on the lack of significant toxicity in existing toxicological testing of sulfur dioxide and FDA's classification of sulfites as GRAS, EPA has not performed a quantative risk assessment for sulfur dioxide using safety factors. For the same reason, and given the absence of Start Printed Page 56647any evidence of pre- or post-natal sensitivity to sulfur dioxide, EPA concludes that there is reliable data to support not using an additional safety factor to protect infants and children.
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, the Agency 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 inorganic sulfites to share a common mechanism of toxicity with any other substances, and sulfur dioxide does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that sulfur dioxide does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
VI. Determination of Safety for U.S. Population, Infants and Children
The residue levels expected from this use on figs are relatively low when compared to concentrations of sulfites in many common foods and viewed as GRAS by the FDA. Given the low fig use rate, low expected residue levels, and relatively low consumption of figs, the safety finding made in the May 2007 RED assessment for the post-harvest use on grapes may be extended to include the proposed tolerance level of 10 ppm on figs. EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to sulfite sensitive individuals, infants and children, from aggregate exposure to residues of sulfur dioxide, including its metabolites and degradates.
VII. Other Considerations
A. Analytical Enforcement Methodology
For the determination of residues in food, the FDA has published a titrimetric method of analysis capable of providing a 10 ppm LOD. It is delineated in 21 CFR part 101 Appendix A and is based on the Association of Official Agricultural Chemists official method for sulfites. For this procedure, sulfur dioxide is steam distilled from the crop sample and trapped in hydrogen peroxide to produce sulfuric acid. The sulfuric acid is then titrated against aqueous sodium hydroxide and expressed as sulfur dioxide. The sulfur dioxide concentrations are converted to sulfite residues with molecular weight conversions. Adequate recovery data are available to support the use of this procedure as a tolerance enforcement method.
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. 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 sulfur dioxide in/on figs.
Therefore, a time-limited tolerance is established for residues of sulfur dioxide, including its metabolites and degradates, (determined by measuring only sulfur dioxide (SO2)), at 10 ppm. This tolerance is effective until December 31, 2014.
IX. Statutory and Executive Order Reviews
This final rule establishes tolerances under sections 408(e) and 408(l)(6) of FFDCA. 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, titled 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 in accordance with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances 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, nor does this action 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, the Agency 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, the Agency 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 Agency 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).
X. 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 Start Printed Page 56648publication 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).Start List of Subjects
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 2, 2011.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:Start Part
PART 180—[AMENDED]End Part Start Amendment Part
1. The authority citation for part 180 continues to read as follows:End Amendment Part Start Amendment Part
2. Section 180.444 is amended by:End Amendment Part Start Amendment Part
i. Designating the existing text as paragraph (a) and adding a heading; andEnd Amendment Part Start Amendment Part
ii. Adding paragraphs (b), (c) and (d).End Amendment Part
The amendments read as follows:
(a) General. * * *
(b) Section 18 emergency exemptions. Time-limited tolerances specified in the following table are established for residues of sulfur dioxide, including its metabolites and degradates in or on the specified agricultural commodities, resulting from use of the pesticide pursuant to FFIFRA section 18 emergency exemptions. Compliance with the tolerance levels specified below is to be determined by measuring only sulfur dioxide (SO2). The tolerances expire on the date specified in the table.
|Commodity||Parts per million||Expiration/revocation date|
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2011-23359 Filed 9-13-11; 8:45 am]
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