Proposed Rules. Notice of petition and request for comments; extension of comment period

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BILLING CODE 3410-10-M DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 1 [Docket No. APHIS-2006-0158] Animal Welfare; Petition for Rulemaking AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice of petition and request for comments; extension of comment period. SUMMARY: We are extending the comment period for our notice of petition and request for comments concerning the definition of *Class “B” licensee* in the Animal Welfare Act regulations.

This action will allow interested persons additional time to prepare and submit comments. DATES: We will consider all comments that we receive on or before July 9, 2007. ADDRESSES: You may submit comments by either of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov* , select “Animal and Plant Health Inspection Service” from the agency drop-down menu, then click “Submit.” In the Docket ID column, select APHIS-2006-0158 to submit or view public comments and to view supporting and related materials available electronically.

Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “User Tips” link. • *Postal Mail/Commercial Delivery:* Please send four copies of your comment (an original and three copies) to Docket No. APHIS-2006-0158, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No.

APHIS-2006-0158. *Reading Room:* You may read any comments that we receive on Docket No. APHIS-2006-0158 in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call

(202)690-2817 before coming. *Other Information:* Additional information about APHIS and its programs is available on the Internet at *http://www.aphis.usda.gov.* FOR FURTHER INFORMATION CONTACT: Dr. Jerry DePoyster, Senior Veterinary Medical Officer, Animal Care, APHIS, 4700 River Road Unit 84, Riverdale, MD 20737-1234;

(301)734-7586. SUPPLEMENTARY INFORMATION: On April 10, 2007, we published in the **Federal Register** (72 FR 17814, Docket No. APHIS-2006-0158) a notice of petition and request for comments. That document notified the public that the Animal and Plant Health Inspection Service had received a petition from The Hunte Corporation requesting that we replace the definition of *Class “B” licensee* in the Animal Welfare Act regulations with four new categories of licensees: Pet distributor, exhibitor animal distributor, laboratory animal distributor, and other distributor. Comments on the notice were required to be received on or before June 11, 2007. We are extending the comment period on Docket No. APHIS-2006-0158 for an additional 30 days. This action will allow interested persons additional time to prepare and submit comments. Authority: 7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7. Done in Washington, DC, this 17th day of May 2007. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E7-9901 Filed 5-22-07; 8:45 am] BILLING CODE 3410-34-P NUCLEAR REGULATORY COMMISSION 10 CFR Part 50 [Docket No. PRM-50-84] Mark Edward Leyse; Receipt of Petition for Rulemaking AGENCY: Nuclear Regulatory Commission. ACTION: Petition for rulemaking; notice of receipt. SUMMARY: The Nuclear Regulatory Commission

(NRC)has received and requests public comment on a petition for rulemaking dated March 15, 2007, filed by Mark Edward Leyse. The petition has been docketed by the NRC and has been assigned Docket No. PRM-50-84. The petitioner is requesting that the NRC amend the regulations that govern domestic licensing of production and utilization facilities to require that nuclear power facilities be operated to limit the thickness of crud (corrosion products) layers and/or the thickness of oxide layers on fuel rod cladding surfaces. The petitioner also requests that the requirements pertaining to Emergency Core Cooling System

(ECCS)evaluation models be amended to require that the steady-state temperature distribution and stored energy in reactor fuel at the onset of a postulated loss-of-coolant accident

(LOCA)be calculated by factoring in the role that the thermal resistance of crud and/or oxide layers on cladding plays in increasing the stored energy in the fuel. Lastly, the petitioner requests that the acceptance criteria for emergency core cooling systems for light-water nuclear power reactors be amended to stipulate a maximum allowable percentage of hydrogen content in cladding of fuel rods. DATES: Submit comments by August 6, 2007. Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except as to comments received on or before this date. ADDRESSES: You may submit comments by any one of the following methods. Please include the following number (PRM-50-84) in the subject line of your comments. Comments on petitions submitted in writing or in electronic form will be made available for public inspection. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including personal information such as social security numbers and birth dates in your submission. *Mail comments to:* Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555. Attention: Rulemaking and Adjudications staff. *E-mail comments to: SECY@nrc.gov.* If you do not receive a reply e-mail confirming that we have received your comments, contact us directly at

(301)415-1966. You may also submit comments via the NRC's rulemaking Web site at *http://ruleforum.llnl.gov* . Address comments about our rulemaking Web site to Carol Gallagher,

(301)415-5905; (e-mail *cag@nrc.gov* ). Comments can also be submitted via the Federal eRulemaking Portal *http:www.regulations.gov.* *Hand deliver comments to:* 11555 Rockville Pike, Rockville, Maryland, between 7:30 a.m. and 4:15 p.m. on Federal workdays. Publicly available documents related to this petition may be viewed electronically on the public computers located at the NRC Public Document Room (PDR), O1 F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland. The PDR reproduction contractor will copy documents for a fee. Selected documents, including comments, may be viewed and downloaded electronically via the NRC rulemaking Web site at *http://ruleforum.llnl.gov.* Publically available documents created or received at the NRC after November 1, 1999 are also available electronically at the NRC's Electronic Reading Room at *http://www.nrc.gov/reading-rm/adams.html* . From this site, the public can gain entry into the NRC's Agencywide Documents Access and Management System (ADAMS), which provides text and image files of NRC's public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC PDR Reference staff at 1-800-397-4209, 301-415-4737 or by e-mail to *pdr@nrc.gov* . For a copy of the petition, write to Michael T. Lesar, Chief, Rulemaking, Directives and Editing Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555. *Telephone:* 301-415-7163 or Toll-Free: 1-800-368-5642 or *E-mail: MTL@NRC.Gov.* SUPPLEMENTARY INFORMATION: Background The NRC has received a petition for rulemaking dated March 15, 2007, submitted by Mark Edward Leyse (petitioner). The petitioner requests that the NRC amend 10 CFR part 50, “Domestic Licensing of Production and Utilization Facilities.” Specifically, the petitioner requests that all holders of operating licenses for nuclear power plants be required to operate such plants at operating conditions ( *e.g.* , levels of power production, fuel cycle lengths, and light-water coolant chemistries) necessary to effectively limit the thickness of crud (corrosion products) layers and/or oxide layers on fuel rod cladding surfaces. The petitioner believes that new regulations are needed for reactor-operation parameters, uranium-oxide and mixed-oxide fuel and cladding, in order to ensure that cladding is free of unsafe thicknesses of crud and/or oxide, which in turn would help ensure that nuclear power plants operate in compliance with 10 CFR 50.46(b). 10 CFR 50.46(b) stipulates that the calculated peak cladding temperature

(PCT)must not exceed 2200°F in the event of a loss-of-coolant accident (LOCA). The petitioner also requests that 10 CFR part 50, Appendix K, “ECCS Evaluation Models” be amended to require that the steady-state temperature distribution and stored energy in the fuel at the onset of a postulated LOCA be calculated by factoring in the role that the thermal resistance of crud and/or oxide layers on cladding plays in increasing the stored energy in the fuel. Lastly, the petitioner requests that § 50.46 be amended to stipulate a maximum allowable percentage of hydrogen content in fuel cladding. The NRC has determined that the petition meets the threshold sufficiency requirements for a petition for rulemaking under 10 CFR 2.802. The petition has been docketed as PRM-50-84. The NRC is soliciting public comment on the petition for rulemaking. Discussion of the Petition The petitioner states that layers of crud and oxide on cladding surfaces of nuclear fuel rods could cause the temperature of fuel rods to increase up to 300 °F to 600 °F during power plant operations. The petitioner also states that during a LOCA, the thermal resistance of insulating layers of crud and oxide on cladding, and increased fuel temperatures will cause the PCT to be higher than if the cladding were clean. The petitioner believes that if a large break

(LB)LOCA occurred at a nuclear power plant that operated with heavy crud and oxide layers, there is a high probability that the PCT would exceed the 2200 °F limit in § 50.46(b)(1). The petitioner states that increased hydrogen content in cladding contributes to cladding embrittlement. The petitioner believes that § 50.46 should also be amended to specify a maximum allowable percentage of hydrogen in cladding. The petitioner states that in 2001, the Indian Point Unit 2 facility had a PCT of 2188 °F during a computer simulated LB LOCA. The petitioner believes that if heavy crud and oxide layers were present and included in the calculation, it is “highly probable” the calculated PCT would have exceeded the 2200 °F limit, perhaps by hundreds of degrees Fahrenheit. The petitioner states that if the 2200 °F limit was exceeded during actual operation, the cladding could lose its physical integrity and result in a core meltdown that would release radioactive material and contaminate the environment. The petitioner states that in 1995, the Three Mile Island Unit 1 facility (TMI-1) operated with crud deposits on the surface of fuel rods that raised the cladding temperature by 180 to 270 °F or greater over the typical operating temperature of 346 °C during Cycle 10. The petitioner believes that if an actual LB LOCA had occurred at TMI-1, the crud and oxide layers on the cladding would have caused the PCT to exceed 2200 °F. The petitioner states that because corrosion is not detected during plant operation, a significant length of time passes before corrosion progresses enough to perforate cladding and cause an increase in “offgas” activity meaning that heavily corroded fuel rods are often operated at full power for significant periods of time and could cause the cladding to fracture during the reflood period and lose structural integrity. The petitioner concludes that this could compromise the structural soundness and the ability to keep the core cooled and illustrates the impact that the thermal resistance of heavy layers of oxide and crud on cladding would have during a LOCA. The petitioner cites a September 30, 2003, Advisory Committee on Reactor Safeguards

(ACRS)meeting transcript stating that the thickness of crud deposited on the cladding during pressurized water reactor

(PWR)plant operation is often not known because “a great deal of PWR crud comes off the cladding during reactor shutdown.” The petitioner notes that crud deposits on cladding in PWRs have been measured at up to 125μm thick. The ACRS found that a crud layer with steam blanketing would have “extremely poor conductivity” and that crud is “difficult to characterize” because its thermal conductivities “depend on [its] morpholog[ies].” The petitioner also cites an Electric Power Research Institute

(EPRI)study to be completed in 2008 that will attempt “to determine the effect of tenacious crud on fuel surface heat transfer.” The petitioner notes that this study is for crud in a boiling water reactor

(BWR)but believes the results can also be applied to PWRs. The petitioner also notes that the EPRI study found that Zirconium dioxide (ZrO <sup>2</sup> ) has a low thermal conductivity and is used industrially as an insulating material. The petitioner cites an EPRI-sponsored study entitled, “Taming the Crud Problem: The Evolution,” presented at the Advances in Nuclear Fuel Management II Conference in October 2003 which states that: “Oxide can form, with or without the benefit of crud, in the presence of sustained cladding temperatures. Like crud, formation of an oxide layer inhibits heat transfer causing accelerated corrosion which can potentially lead to fuel failure.” The petitioner describes a fuel rod that failed at TMI-1 during Cycle 10 that may have had about a 200μm-thick layer of crud and oxide. The petitioner believes that if a LB LOCA occurred during this fuel cycle, the layer of crud and oxide would have inhibited effective heat transfer and likely caused the PCT to exceed 2200 °F, possibly causing a meltdown. The petitioner also reiterates that in 2001, the Indian Point Unit 2 facility had a PCT of 2188 °F in a computer simulated LB LOCA. The petitioner believes that if Indian Point Unit 2 had cladding conditions similar to those of TMI-1 Cycle 10, it is highly probable the PCT would also have been greater than 2200 °F. The petitioner states that TMI-1 is not the only PWR to experience crud-induced corrosion failures. In 1997, the Palo Verde Unit 2 and Seabrook facilities both had the same problem. The petitioner cites NUREG-1230, “Compendium of ECCS Research for Realistic LOCA Analysis” and states that the stored energy in the fuel increases because cladding encased in heavy amounts of crud and oxide cannot transfer heat efficiently to coolant during the blowdown phase of the event. The petitioner states that the increased stored energy caused by heavy crud and oxide layers on fuel cladding and the delay in the transfer of the heat to the coolant cause the cladding to be subjected to extremely high temperatures for much longer than if the cladding was clean (free of crud and oxidation) at the onset of the LOCA. The petitioner believes that this would result in more degradation of the fuel and embrittlement of cladding. The petitioner also states that when the cladding reacts with steam, an exothermic reaction occurs that generates additional heat on the cladding. The petitioner cites an ACRS meeting transcript from February 2, 2007, in which an NRC staff member explained that a basic LOCA transient calculation includes an oxidation limit and involves time and temperature. The petitioner also notes that NUREG-1230 states that embrittled cladding can fragment upon contact with emergency cooling water in a severe accident. The embrittlement is a function of temperature, time, the supply of steam and zircaloy, and can lead to the loss of effective cooling, making it relevant to fuel rod safety. The petitioner also notes that NUREG-1230 also states, “[the] amount of residual thermal energy [in the fuel rod] influences the *time* required to quench the reactor core with emergency cooling water [emphasis added].” The petitioner states that absorption of hydrogen would also contribute to a loss of cladding ductility during a LOCA along with cladding degradation and massive oxidation. He cites a failed fuel rod from the TMI-1, Cycle 10 event when hydrogen absorption caused hydrided material to break away from the outer portions of the cladding. The petitioner believes that the effects of increased stored energy due to a heavy crud layer in the fuel and the severity of cladding oxidation, embrittlement, and resulting fuel degradation during an actual event would be substantially greater than in an ECCS calculation based on clean cladding. The petitioner also states that little or no evidence exists that crud has ever been properly factored into PCT calculations for postulated LOCAs. He cites a June 17, 2003, Idaho National Engineering and Environmental Laboratory document that he believes stated that crud has not been applied to severe accident codes because it has not been demonstrated to be necessary and that users have not chosen to consider effects of crud. The petitioner also cites the 2002 annual report on ECCS evaluation from the Callaway facility that he believes proves that “little attention” was placed on effects of heavy crud on thermal resistance. The petitioner states that most cladding that experienced crud-induced corrosion failures recently at PWRs involved high-power, one-cycle fuel. He cites the TMI-1, Cycle 10 and Callaway, Cycle 6 events as examples and notes that the effects of crud can occur quickly. The cladding perforation at TMI-1 was detected only 121 days into the cycle. The petitioner states that the values of the stored energy in BOL fuel or fuel with burnups between 30 to 35 GWd/MTU are used to calculate PCTs during postulated LOCAs. The petitioner also believes it is significant that the stored energy of fuel sheathed in cladding with heavy crud and oxide layers is substantially higher than fuel of the same burnup rate sheathed in clean cladding that he states is used in PCT calculations performed for postulated LOCAs and during safety evaluations of the certification process of newer designs such as the Westinghouse AP 1000 reactor. The petitioner believes that the AP 1000 PCTs were not calculated for the maximum stored energy that fuel can reach during operation and that recent experiences with fuel at TMI-1, Palo Verde Unit 2, and Seabrook were not considered in PCT calculations performed during recent power “uprates” at other nuclear power facilities. The petitioner states that axial offset anomaly

(AOA)or crud-induced power shift

(CIPS)are phenomena caused by crud on cladding and can indicate how frequently crud affects nuclear power plant operation. The petitioner also states that AOA occurs in PWRs when crud deposits on cladding contain enough boron to reduce the rate of fission in the vicinity of the crud. He cites NRC Information Notice 97-85, “Effects of Crud Buildup and Boron Deposition on Power Distribution and Shutdown Margin” that describes how AOA causes power distribution shifts toward the bottom of the reactor core as a result of reduced fission in the upper reactor core. The petitioner states that although crud deposits must be at least 35μm thick for AOA to occur, it is possible that crud deposits thicker than 35μm do not cause AOA because not all crud deposits contain enough boron to cause this phenomenon. The petitioner also states that according to a 2002 Department of Energy report on nuclear energy plant optimization, the thickest layer of crud measured in a PWR was 125μm thick that caused AOA but not cladding perforation and that as of 2003, more than 30 fuel cycles in 16 PWRs had exhibited AOA. The petitioner also cites a 2006 EPRI report that acknowledged that crud has contributed to AOA at many power plants since the 1980s because fuel cycle operation and power up rates have increased appreciably and that excessive crud deposits create operational difficulties. According to a Westinghouse Electric Company official, AOAs are detectable and closely monitored to ensure that adequate shutdown margins can be maintained. Also, a plant can be operated at a lower power level if necessary. The petitioner cites the TMI-1, Cycle 10 event as an example that illustrates how low levels of boron can result in a slight AOA even though enough crud was present to induce fuel failure from corrosion. The petitioner states that if a heavy crud layer was detected during plant operation that did not cause an AOA, it is unlikely that the operation power level would be reduced because the thermal resistance of the crud and how it would raise the PCT during a LOCA would likely not be considered problematic. The petitioner describes what he believes was a crud-induced cladding corrosion failure of fuel in a BWR at the River Bend facility during Cycle 8 from 1998-99. The petitioner states that the fuel failure occurred when crud nearly bridged the gap between adjacent rods and believes it is significant that most of the failed rods were high-power, one-cycle rods (much like the recent corrosion-induced PWR fuel failures during the TMI-1 Cycle 10, Palo Verde Unit 2 Cycle 9, and Seabrook Cycle 5 events). The River Bend Cycle 8 fuel failure resulted from thick layers of crud, augmented with copper that accelerated the oxidation process to produce a local steam blanketing and high heat transfer resistance that created perforations in the fuel cladding according to the “Recent GE BWR Fuel Experience” report published in 2000 by the American Nuclear Society and the NRC inspection report pertaining to this event. The petitioner concludes that the combined effects of crud and oxide layers increased the cladding temperatures from around 560 °F to temperatures approaching 1200 °F. The petitioner states that if a LOCA had occurred during this event, the PCT could likely have exceeded the 2200 °F limit specified in § 50.46. The petitioner acknowledges that the NRC Licensee Event Report

(LER)50-458/99-016-00 states that the PCT was calculated to have been 1700 °F or less and demonstrates a substantial margin to the 2200 °F limit. However, the petitioner states that the LER ignores NRC guidelines for calculating the equivalent cladding reacted

(ECR)and believes that the PCT would have exceeded 1700 °F during a LB LOCA. The petitioner states that in 2000 when this LER was filed there was not much knowledge about values for the thermal conductivity of crud and how crud layers should be modeled in severe accident codes and believes this lack of knowledge still exists in 2007. The petitioner reiterates there is little or no evidence that crud has ever been properly factored into PCT calculations for simulated LOCAs at nuclear power plants. The petitioner states that essentially the same cladding condition occurred again at the River Bend facility between October 2001 to March 2003 during the Cycle 11 refueling event after a GE Nuclear Energy official had stated that heavy crud buildup during the Cycle 8 event was unique and had occurred only once in over 1000 reactor years of operation. He cites a paper presented at the 2004 International Meeting on LWR Fuel presented by the American Nuclear Society, “Fuel Failures During Cycle 11 at River Bend.” This paper stated that this fuel rod failure was caused by accelerated oxidation of the cladding resulting from unusually heavy deposits of tenacious crud that diminished heat transfer in local areas of the cladding surface. The petitioner notes that the failures occurred in high power, one-cycle rods where heavy crud and oxide layers were present. The petitioner believes that the PCT during a LB LOCA would have exceeded the 2200 °F limit specified in § 50.46 and means that the ECCS design basis for River Bend is non-conservative for calculating the PCT for a postulated LOCA when heavy crud and oxide layers exist on cladding. The petitioner disputes GE Nuclear Energy's conclusion that because the heavy crud deposits on fuel rods at the River Bend facility occurred at the lower elevations of the fuel assembly and the more limiting axial elevations during a postulated LOCA occur at the upper elevations of a fuel assembly where at River Bend the crud characteristics were normal, the heavy crud deposits would have no significant effect on the fuel response to a postulated LOCA. The petitioner states that the cladding surface temperatures during the River Bend events reached 1200 °F, far above the specified licensing basis of about 578 °F. The petitioner believes that the higher temperatures due to the heavy crud and oxide layers would result in less coolant flow than for clean cladding, would cause the cladding to be subjected to extremely high temperatures for a substantially longer duration than used in the licensing basis, and result in more fuel degradation. The petitioner also believes that the degradation of fuel and cladding would further obstruct reflood coolant flow, delay transfer of stored energy to the coolant during quench, and that during a LOCA there would already be severe cladding degradation, massive oxidation, and absorption of hydrogen that would contribute to a loss of cladding ductility. The petitioner has concluded that these factors mean that the River Bend facility operated in violation of § 50.46(b) during cycles 8 and 11 of refueling. The petitioner also states that the Browns Ferry facility operated from April 2001 to March 2003 with thick oxide layers at the upper elevations of the fuel rods and believes it is significant that the heavy crud and oxide layers that caused overheating and cladding perforations at TMI-1 during cycle 10 were located at upper elevations of fuel assemblies. The petitioner cites a 2004 paper, “An Integrated Approach to Maximizing Fuel Reliability” stating that a lack of understanding exists about the interplay of materials, fuel duty, and water chemistry variables and reports that crud or corrosion related fuel failures occurred at BWRs in six of the years between 1997 to 2004. The petitioner also cites an EPRI document, “2006 Portfolio 41.002 Fuel Reliability” which states that the fuel failure rate has increased in both BWRs and PWRs during the last couple of years due to extended and more aggressive fuel cycle operation. The petitioner states that although the nuclear industry observed that it appeared that nodular corrosion had been eliminated from BWR fuel cladding in 2000, by 2004 it had reemerged at several BWRs. The petitioner believes this is a result of increasing fuel duty by extending the length of fuel cycles and that problems with crud and oxide will continue unless the NRC implements regulations to ensure that BWRs and PWRs do not operate with high levels of crud and oxidation on cladding that cause violations of § 50.46(b). The petitioner states that Appendix K to 10 CFR part 50, “ECCS Evaluation Models” requires stored energy in nuclear fuel to be calculated to yield the highest PCT. The petitioner believes that Appendix K should require thermal conductivity of layers of crud and oxide to be factored into calculations of the stored energy in the fuel. The petitioner states that because a heavy crud layer would increase the quantity of stored energy in the fuel, the PCT would also increase above that of fuel with the same burnup sheathed in clean cladding. The petitioner also states that instructions specified in Appendix K for calculating the quantity of stored energy that contains heavy layers of crud and oxide are non-conservative. The petitioner notes that values of stored energy in BOL fuel or fuel with burnups between 30 to 35 Gwd/MTU are used to calculate PCTs during postulated LOCAs. However, the petitioner cites a January 2007 ACRS Subcommittee on Materials, Metallurgy, and Reactor Fuels during which a Westinghouse official cited data from LOCA calculations showing that single cycle fuel with burnups from zero to approximately 20 or 25 GWd/MTU yielded the highest PCTs. Westinghouse also stated that at burnups of about 30 GWd/MTU, there is approximately a ten percent reduction in achievable power, which yields PCTs approximately 100 °C lower than those of fresh fuel. The petitioner concludes it is significant that an ECCS design based on Appendix K requirements is non-conservative and hazardous for calculating the quantity of stored energy in one-cycle fuel that has heavy crud on the cladding. The petitioner states that an increase in hydrogen content in cladding contributes to cladding embrittlement. The petitioner cites an April 4, 2001, ACRS Reactor Fuels Subcommittee meeting during which an expert from Argonne National Laboratory stated that a reduction of ductility occurs when hydrogen levels reach about 600 to 700 parts-per-million

(ppm)in Zircaloy cladding. According to the petitioner, another expert from the Atomic Energy Research Institute stated that a threshold for a reduction of ductility in Zircaloy cladding occurs at even a lower hydrogen level of about 150 to 200 ppm. The petitioner also cites the TMI-1 Cycle 10 event that included massive hydrogen absorption in fuel cladding. The petitioner notes that hydrogen content in the cladding of a rod that did not fail measured 700 ppm at TMI-1 and that this level of hydrogen content in one-cycle cladding is similar to the 800 ppm level measured in fuel cladding at the H.B. Robinson, Unit 2 facility, a PWR. The petitioner states that some of the cladding at TMI-1 Cycle 10 contained levels of hydrogen that Argonne National Laboratory found would have caused a loss of cladding ductility in addition to the embrittlement resulting from excessive oxide levels. The Petitioner's Proposed Actions The petitioner states that new regulations are needed for reactor operation parameters, uranium-oxide and mixed-oxide fuel, and fuel cladding to ensure that cladding does not contain unsafe amounts of crud and oxide to help ensure that nuclear power plants operate in compliance with 10 CFR 50.46(b). The petitioner also states that nuclear power plant licensees should be required to factor the thermal resistance effects of crud and oxide layers on cladding into calculations of PCTs for postulated LOCAs at their facilities. Also, the NRC needs to consider effects of crud and oxide when reviewing power plant operations reports under 10 CFR 50.46, and before approving power uprates at existing facilities and new nuclear power plant designs, such as the recently certified Westinghouse AP1000 design. The petitioner requests that Appendix K to Part 50 be amended to require that the steady state temperature distribution and stored energy in the fuel at the onset of a postulated LOCA be calculated by factoring in the role that the thermal resistance of crud and oxide layers on cladding plays in increasing the stored energy in nuclear fuel. The petitioner also states that Appendix K should specify instructions to more accurately calculate the role that thermal resistance of crud and oxide layers on cladding plays in determining the stored energy in the fuel and the PCT during a postulated LOCA. Lastly, the petitioner requests that § 50.46 be amended to include a requirement that stipulates a maximum allowable percentage of hydrogen content in cladding because there is extensive evidence that excessive hydrogen levels and oxidation on cladding contributes to cladding embrittlement. The petitioner concludes that the requested amendments should also apply to any NRC-approved, best-estimate ECCS evaluations used instead of Appendix K calculations. The petitioner believes its requested amendments would ensure that nuclear power facilities prevent unsafe amounts of crud and oxide layers on cladding from occurring during operation to reduce risks to plant workers and the public, and help nuclear power facility operations to comply with 10 CFR 50.46(b). Dated at Rockville, Maryland, this 15th day of May 2007. For the Nuclear Regulatory Commission. Annette L. Vietti-Cook, Secretary of the Commission. [FR Doc. E7-9910 Filed 5-22-07; 8:45 am] BILLING CODE 7590-01-P FEDERAL TRADE COMMISSION 16 CFR Part 24 Guides for Select Leather and Imitation Leather Products AGENCY: Federal Trade Commission. ACTION: Request for public comments. SUMMARY: The Federal Trade Commission (“FTC” or “Commission”) is requesting public comments on its Guides for Select Leather and Imitation Leather Products (“Leather Guides”). The Commission is soliciting the comments as part of its systematic review of all current Commission regulations and guides. DATES: Written comments will be accepted until July 23, 2007. ADDRESSES: Interested parties are invited to submit written comments. Comments should refer to “Guides for Select Leather and Imitation Leather Products, Matter No. P078008” to facilitate the organization of comments. A comment filed in paper form should include this reference both in the text and on the envelope, and should be mailed or delivered to the following address: Federal Trade Commission/Office of the Secretary, Room H-135 (Annex L), 600 Pennsylvania Avenue, NW., Washington, DC 20580. Comments containing confidential material, however, must be filed in paper form, must be clearly labeled “Confidential,” and must comply with Commission Rule 4.9(c). 1 The FTC is requesting that any comment filed in paper form be sent by courier or overnight service, if possible, because postal mail in the Washington area and at the Commission is subject to delay due to heightened security precautions. Comments filed in electronic form must be submitted by accessing the following site: *https://secure.commentworks.com/ftc-leatherguides* , and following the instructions on the web-based form. 1 The comment must be accompanied by an explicit request for confidential treatment, including the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. The request will be granted or denied by the Commission's General Counsel, consistent with applicable law and the public interest. See Commission Rule 4.9(c), 16 CFR 4.9(c). The FTC Act and other laws the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives, whether filed in paper or electronic form. Comments received will be available to the public on the FTC Web site, to the extent practicable, at *http://www.ftc.gov* . As a matter of discretion, the FTC makes every effort to remove home contact information for individuals from the public comments it receives before placing those comments on the FTC Web site. More information, including routine uses permitted by the Privacy Act, may be found in the FTC's privacy policy at *http://www.ftc.gov/ftc/privacy.htm.* FOR FURTHER INFORMATION CONTACT: Susan E. Arthur,

(214)979-9370, Attorney, Southwest Region, Federal Trade Commission, 1999 Bryan Street, Suite 2150, Dallas, Texas 75201. SUPPLEMENTARY INFORMATION: I. Background The Commission's Leather Guides address misrepresentations regarding the composition and characteristics of specific leather and imitation leather products. The Guides apply to the manufacture, sale, distribution, marketing, or advertising of leather or simulated leather purses, luggage, wallets, footwear, and other similar products. Importantly, the Leather Guides state that disclosure of non-leather content should be made for material which has the appearance of leather but is not leather. The Leather Guides “are administrative interpretations of laws administered by the Commission for the guidance of the public in conducting its affairs in conformity with legal requirements. They provide the basis for voluntary and simultaneous abandonment of unlawful practices by members of industry.” 16 CFR 1.5. Conduct inconsistent with the Guides may result in corrective action by the Commission under applicable statutory provisions. The Commission adopted the Leather Guides in 1996, as part of its periodic review of its rules and guides. 2 The Leather Guides consolidated portions of the Guides for the Luggage and Related Products Industry (“Luggage Guides”), the Guides for Shoe Content Labeling and Advertising (“Shoe Content Guides”), and the Guides for the Ladies’ Handbag Industry (“Handbag Guides”). 3 The Leather Guides also included provisions previously contained in the Commission's Trade Regulation Rule Concerning Misbranding and Deception as to Leather Content of Waist Belts (“Waist Belt Rule”). 4 2 61 FR 51577 (October 3, 1996). 3 The Luggage Guides, the Shoe Content Guides, and the Handbag Guides were repealed in 1995. 60 FR 48027 (September 18, 1995). On the same day, the Commission requested public comment regarding proposed Leather Guides. 60 FR 48056 (September 18, 1995). 4 The Commission had previously repealed the Waist Belt Rule. 61 FR 25560 (May 22, 1966). The language of the Luggage Guides, the Shoe Content Guides, the Handbag Guides, and the Waist Belt Rule was updated and clarified in the Leather Guides, and unnecessary provisions were deleted. Further, the Leather Guides modified a number of provisions from the older Guides and the Waist Belt Rule. Among these modifications were an expansion of the scope of the Leather Guides to include misrepresentations in the marketing and advertising of industry products, the removal of the restriction that only top grain leather could be called “Leather” without qualification, and the inclusion of a requirement that manufacturers disclose the percentage of non-leather and leather material contained in bonded leather. II. Regulatory Review Program The Commission has determined, as part of its oversight responsibilities, to review all Commission rules and guides periodically. These reviews seek information about the costs and benefits of the Commission's rules and guides and their regulatory and economic impact. The information obtained assists the Commission in identifying rules and guides that warrant modification or rescission. Therefore, the Commission solicits comment on, among other things, the economic impact of and the continuing need for the Leather Guides; possible conflict between the Guides and state, local, federal, or international laws; and the effect of any technological, economic, environmental, or other industry changes on the Guides. III. Request for Comment The questions below are designed to assist the public and should not be construed as a limitation on the issues on which public comment may be submitted:

(1)Is there a continuing need for the Leather Guides as currently promulgated?

(2)Have the leather and imitation leather industries adopted the Leather Guides as part of their routine business practices? If so, how, and what effect, if any, does this have on the continuing need for the Guides?

(3)What benefits have the Leather Guides provided to purchasers of the products affected by the Guides?

(4)Are there costs imposed on purchasers when businesses follow the Leather Guides? If so, explain.

(5)How have the leather and imitation leather industries been affected by the Leather Guides' modifications to provisions previously contained in the Luggage Guides, the Shoe Content Guides, the Handbag Guides, and the Waist Belt Rule? How have those modifications affected purchasers?

(6)What burdens or costs, including costs of compliance, are imposed on businesses that follow the Leather Guides? In particular, what burdens or costs are imposed on small businesses that follow the Guides? Do the Guides provide benefits to businesses that follow them? If so, what benefits?

(7)What changes, if any, should be made to the Leather Guides to increase their benefits to purchasers? How would these changes affect any burdens or costs to businesses that follow the Leather Guides? How would these changes benefit purchasers?

(8)What changes, if any, should be made to the Leather Guides to reduce the burdens or costs to businesses that follow the Guides? How would these changes affect the benefits provided by the Guides?

(9)Do the Leather Guides overlap or conflict with other federal, state, or local laws or regulations? If so, explain. Do the Guides overlap or conflict with any foreign or international laws or regulations? If so, explain.

(10)Have consumer perceptions or preferences changed since the Leather Guides were issued, and, if so, do these changes warrant revising the Guides? If you believe that these changes warrant revisions, how should the Guides be revised?

(11)Since the Leather Guides were issued, what effects, if any, have changes in relevant technology, economic conditions, or environmental conditions had on the Guides? List of Subjects in 16 CFR Part 24 Advertising, Belts, Distribution, Footwear, Imitation leather products, Labeling, Ladies' handbags, Leather and leather products industry, Luggage and related products, Shoes, Trade practices, Waist belts. Authority: 15 U.S.C. 41-58. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. E7-9965 Filed 5-22-07; 8:45 am] BILLING CODE 6750-01-P SECURITIES AND EXCHANGE COMMISSION 17 CFR Part 240 [Release No. 34-55777; File No. S7-08-07] RIN 3235-AJ85 Amendments to Financial Responsibility Rules for Broker-Dealers AGENCY: Securities and Exchange Commission. ACTION: Proposed rule; extension of comment period. SUMMARY: The Securities and Exchange Commission is extending the comment period for a release proposing amendments to its net capital, customer protection, books and records, and notification rules for broker-dealers under the Securities Exchange Act of 1934 (“Exchange Act”), which was issued by the Commission on March 9, 2007 (Exchange Act Release No. 55431, 72 FR 12862 (Mar. 19, 2007)). The original comment period for Release No. 34-55431 is scheduled to end on May 18, 2007. The Commission is extending the time period in which to provide the Commission with comments on the proposed amendments described in Release No. 34-55431 for thirty-one days until Monday, June 18, 2007. This action will allow all interested persons additional time to analyze the issues and prepare their comments. DATES: Comments should be received on or before June 18, 2007. ADDRESSES: Comments may be submitted by any of the following methods: Electronic Comments • Use the Commission's Internet comment form ( *http://www.sec.gov/rules/proposed* ); or • Send an e-mail to *rule-comments@sec.gov* . Please include File Number S7-08-07 on the subject line; or • Use the Federal eRulemaking Portal ( *http://www.regulations.gov* ). Follow the instructions for submitting comments. Paper Comments • Send paper comments in triplicate to Nancy M. Morris, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090. All submissions should refer to File Number S7-08-07. This file number should be included on the subject line if e-mail is used. To help us process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site ( *http://www.sec.gov/rules/proposed* ). Comments will also be available for public inspection and copying in the Commission's Public Reference Room, 100 F Street, NE., Washington, DC 20549. All comments received will be posted without change; we do not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. FOR FURTHER INFORMATION CONTACT: Michael A. Macchiaroli, Associate Director, at

(202)551-5525; Thomas K. McGowan, Assistant Director, at

(202)551-5521; Randall Roy, Branch Chief, at

(202)551-5522; or Bonnie Gauch, Attorney,

(202)551-5524; Division of Market Regulation, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-6628. SUPPLEMENTARY INFORMATION: On March 9, 2007, the Commission requested comment on proposed amendments to the Commission's net capital, customer protection, books and records, and notification rules for broker-dealers under the Exchange Act. 1 Specifically, the proposed amendments are designed to address several emerging areas of concern regarding the financial requirements for broker-dealers. They also would update the financial responsibility rules and make certain technical amendments. The Commission originally requested that comments on this proposal be received by May 18, 2007. The Commission thus far has received few public comments and believes that extending the comment period would be appropriate in order to give the public additional time to thoroughly consider the matters addressed by the release. 2 Therefore, the Commission is extending the comment period for Release No. 34-55431 (Amendments to Financial Responsibility Rules for Broker-Dealers) for thirty-one days, to Monday, June 18, 2007. 3 1 *See* Exchange Act Release No. 55431, 72 FR 12862 (Mar. 19, 2007). 2 2 *See also* Letter from Gerard J. Quinn, Vice President and Associate General Counsel of SIFMA to Michael Macchiaroli, date May 4, 2007 (noting the importance of the issues discussed in the release and the complexity of the issues involved). 3 If the comment period was extended for thirty days, the due date would fall on a Sunday. Therefore, the Commission is extending the comment period for thirty-one days. Dated: May 17, 2007. By the Commission. Nancy M. Morris, Secretary. [FR Doc. E7-9833 Filed 5-22-07; 8:45 am] BILLING CODE 8010-01-P POSTAL SERVICE 39 CFR Part 111 New Address Quality Standards for First-Class Mail and Standard Mail AGENCY: Postal Service. ACTION: Proposed rule. SUMMARY: This proposed rule provides revisions to Mailing Standards of the United States Postal Service, Domestic Mail Manual

(DMM)that we will adopt no earlier than 18 months from the publication date of this notice. Move Update, the process for updating names and addresses, is currently required for mailers to obtain discounted rates for First-Class Mail. All address records used on pieces in discounted-rate mailings of First-Class Mail must be matched with customer-filed change-of-address orders received and maintained by the USPS using a USPS-approved method within 185 days of the date of mailing. Our proposal includes the following changes related to move update processing:

(1)Extending the Move Update requirement to all Standard Mail and

(2)reducing the window for move update processing of names and addresses used for mailings of discounted First-Class Mail from 185 days to 95 days prior to mailing. The revised timeframe would apply to all pieces in Standard Mail mailings. DATES: We must receive your comments on or before June 22, 2007. ADDRESSES: Mail or deliver written comments to the Office of Product Management—Addressing, National Customer Support Center, United States Postal Service, 6060 Primacy Parkway, Ste. 201, Memphis, TN 38188-0001. You may inspect and photocopy all written comments at USPS Headquarters Library, 475 L'Enfant Plaza, SW., 11th Floor N, Washington, DC 20260-1450 between 9 a.m. and 4 p.m., Monday through Friday. FOR FURTHER INFORMATION CONTACT: Charles B. Hunt, 901-681-4651; or Bert Olsen, 202-268-7276. SUPPLEMENTARY INFORMATION: The decisions mailers make about address quality directly affect their ability to reach valued customers. Over the years, the Postal Service has invested heavily to create an automated mailstream to help drive costs out of the delivery system. An efficient automated mailstream depends on accurate barcodes for success; but barcodes are only as accurate as the quality of the addressing information that is their foundation. The Postal Service is committed to working with the mailing industry to maintain a cost-efficient mailstream that provides timely delivery of the mail and ensures customer value. We work with customers to make sure databases are updated frequently and accurately to improve the overall accuracy of address information. If either the recipient has moved or the address is incorrect or missing an important addressing element then the mailpiece could become undeliverable-as-addressed

(UAA)mail—an unnecessary expense of time, effort, and money for both mailers and the Postal Service. Move Update is one of a number of ways to help mailers reach their customers in an efficient and cost-effective way. Approximately 44 million Americans change their addresses each year. Mailers who want to keep in touch with their customers and reach new customers have to make sure their mail is delivered. It's good business to update address lists frequently. The changes we are proposing to the Move Update standards are needed to improve the level of address quality for mailings entered at discounted First-Class Mail and Standard Mail rates and will result in higher-quality addressing on mailpieces and in timely delivery to intended recipients. We will provide a minimum 18-month implementation phase from the date of this notice to allow mailers of discounted First-Class Mail and Standard Mail sufficient time to make modifications necessary to comply with the proposed Move Update standards. Part A of this notice summarizes our proposal. Part B provides our proposed revisions to DMM standards. Part A

(1)Extend Move Update Requirement to Standard Mail We propose extending the Move Update standard, which currently applies only to discounted rate First-Class Mail, to Standard Mail. A key reason is that one of the conclusions of a independent study we commissioned in 2004 of the cost, volume, and characteristics of poorly addressed mail—what we call “Undeliverable-as-Addressed” mail or “UAA” mail—pointed out that mail entered as Standard Mail accounted for 62.8 percent of all UAA mail volume. Furthermore, the percent of Standard Mail that was UAA was higher than the percent for any other class of mail (Standard Mail was 6.4 percent, First-Class Mail was 3.4 percent, Periodicals was 2.2 percent, and Package Services was 3.0 percent). The majority of UAA Standard Mail is disposed of as waste—only a small percent of mail is endorsed for forwarding or return. In fact, in 2004, we disposed of approximately 6 billion Standard Mail mailpieces at a cost of almost $248 million. The cost of UAA Standard Mail is even greater to our customers, who must consider the wasted cost of producing those mailpieces destined for disposal. Furthermore, customers are impacted by the lost opportunities that UAA mail causes. When a Standard Mail mailpiece is discarded, the mailer's opportunity to connect with a potential customer is lost. This is where the greatest impact is felt from poor address quality. Given the significant cost impact of UAA Standard Mail to both the Postal Service and customers, we believe it is reasonable to implement the Move Update requirement for those using the discounted Standard Mail rates. Authorized Methods The following are authorized methods to meet the Move Update standard for Standard Mail: • NCOA Link TM processing. • FASTforward TM MLOCR processing (letter mail only). • Address Change Service (ACS), including the new OneCode ACS TM . • Ancillary service endorsements under DMM 507.1.5, except “Forwarding Service Requested.”

(2)Increase Frequency of Use of Move Update Processing Currently the DMM requires that addresses on all discounted-rate First-Class Mail be updated within 185 days before the mailing date using a USPS-approved method. We propose that this 185-day window be reduced to 95 days and linked to the previous proposal of expanding the Move Update requirement to Standard Mail. Approximately 14 percent of all Americans move every year. In 2006, families and individuals filed over 41 million change-of-address orders. In that same year, there were 2.3 million business filings. With such a dynamic environment, managing addresses affected by customer moves is challenging. On average, the monthly rate of deterioration of address currency, due to family and individual moves alone, is approximately 1.2 percent. In 6 months (the current Move Update requirement for discounted First-Class Mail), about 7.2 percent of addresses in your files have the potential to be inaccurate. To minimize this natural deterioration, we are proposing that Move Update processing be completed closer to the mailing date. By reducing the processing window from 185 days to 95 days prior to the mailing date, the natural deterioration of address currency can be expected to significantly decrease UAA volume and the costs associated with the redirection and rehandling (including disposal) of mail. Part B Although we are exempt from the notice and comment requirements of the Administrative Procedure Act [5 U.S.C. 553(b), (c)] regarding proposed rulemaking by 39 U.S.C. 410(a), we invite comments on the following proposed revisions to the Domestic Mail Manual, which is incorporated by reference in the Code of Federal Regulations. See 39 CFR 111. List of Subjects in 39 CFR Part 111 Administrative practice and procedure, Postal Service. Accordingly, 39 CFR part 111 is proposed to be amended as follows: PART 111—[AMENDED] 1. The authority citation for 39 CFR part 111 continues to read as follows: Authority: 5 U.S.C. 552(a); 39 U.S.C. 101, 401, 403, 404, 414, 3001-3011, 3201-3219, 3403-3406, 3621, 3626, 5001. 2. Revise the following sections of Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), as follows: 200 Discount Mail Letters and Cards 230 First-Class Mail 233 Rates and Eligibility 3.0 Basic Standards for First-Class Mail Letters 3.5 Move Update Standard 3.5.1 Basic Standards [Revise item a as follows:] a. Each address and associated occupant name used on the mailpieces in a mailing must be updated within 95 days before the mailing date, with one of the USPS-approved methods in 3.5.2. [Revise item c as follows:] c. The Move Update standard is met when an address used on a mailpiece in a mailing at any class of mail is updated with an approved method in 3.5.2, and the same address is used in a First-Class Mail mailing within 95 days after the address has been updated. 240 Standard Mail 243 Rates and Eligibility 3.0 Basic Standards for Standard Mail Letters [Add new item 3.9 as follows:] 3.9 Move Update Standard 3.9.1 Basic Standards The Move Update standard is a means of reducing the number of mailpieces in a mailing that require forwarding, return, or discard by the periodic matching of a mailer's address records with customer-filed change-of-address orders received and maintained by the USPS. For the purposes of this standard, “address” means a specific address associated with a specific occupant name. Addresses subject to the Move Update standard must meet these requirements: a. Each address and associated occupant name used on the mailpieces in a mailing must be updated within 95 days before the mailing date, with one of the USPS-approved methods in 3.9.2. b. Each individual address in the mailing is subject to the Move Update standard. c. The Move Update standard is met when an address used on a mailpiece in a mailing at any class of mail is updated with an approved method in 3.9.2, and the same address is used in a Standard Mail mailing within 95 days after the address has been updated. d. Except for mail bearing an alternative address format, addresses used on pieces claiming Standard Mail rates, regardless of any required surcharge, must meet the Move Update standard. 3.9.2 USPS-Approved Methods The following methods are authorized for meeting the Move Update standard: a. Address Change Service (ACS). b. National Change of Address Linkage System (NCOALink). c. FASTforward MLOCR processes if used each time before mail entry (for letter mail only). If a mailpiece that initially uses FASTforward MLOCR processing is rejected and then entered into a Direct View Encoding Desk

(DVED)operation (or similar system), the piece does not meet the Move Update standard. The name and address information on the piece must then be processed through a FASTforward RVE system to meet the Move Update standard. FASTforward RVE processes also meet the Move Update standard if used each time before mail entry. d. Ancillary service endorsements under 507.1.5.3, Standard Mail, except “Forwarding Service Requested.” 3.9.3 Mailer Certification The mailer's signature on the postage statement certifies that the Move Update standard has been met for each address in the corresponding mailing presented to the USPS. 300 Discount Mail Flats 330 First-Class Mail 333 Rates and Eligibility 3.0 Eligibility Standards for First-Class Mail Flats 3.5 Move Update Standard 3.5.1 Basic Standards [Revise item a as follows:] a. Each address and associated occupant name used on the mailpieces in a mailing must be updated within 95 days before the mailing date, with one of the USPS-approved methods in 3.5.2. [Revise item c as follows:] c. The Move Update standard is met when an address used on a mailpiece in a mailing at any class of mail is updated with an approved method in 3.5.2, and the same address is used in a First-Class Mail mailing within 95 days after the address has been updated. 340 Standard Mail 343 Rates and Eligibility 3.0 Basic Standards for Standard Mail Flats [Add new item 3.9 as follows:] 3.9 Move Update Standard 3.9.1 Basic Standards The Move Update standard is a means of reducing the number of mailpieces in a mailing that require forwarding, return, or discard by the periodic matching of a mailer's address records with customer-filed change-of-address orders received and maintained by the USPS. For the purposes of this standard, “address” means a specific address associated with a specific occupant name. Addresses subject to the Move Update standard must meet these requirements: a. Each address and associated occupant name used on the mailpieces in a mailing must be updated within 95 days before the mailing date, with one of the USPS-approved methods in 3.9.2. b. Each individual address in the mailing is subject to the Move Update standard. c. The Move Update standard is met when an address used on a mailpiece in a mailing at any class of mail is updated with an approved method in 3.9.2, and the same address is used in a Standard Mail mailing within 95 days after the address has been updated. d. Except for mail bearing an alternative address format, addresses used on pieces claiming Standard Mail rates, regardless of any required surcharge, must meet the Move Update standard. 3.9.2 USPS-Approved Methods The following methods are authorized for meeting the Move Update standard: a. Address Change Service (ACS). b. National Change of Address Linkage System (NCOALink). c. Ancillary service endorsements under 507.1.5.3, Standard Mail, except “Forwarding Service Requested.” 3.9.3 Mailer Certification The mailer's signature on the postage statement certifies that the Move Update standard has been met for each address in the corresponding mailing presented to the USPS. 400 Discount Mail Parcels 430 First-Class Mail 433 Rates and Eligibility 3.0 Basic Standards for First-Class Mail Parcels 3.5 Move Update Standard 3.5.1 Basic Standards [Revise item a as follows:] a. Each address and associated occupant name used on the mailpieces in a mailing must be updated within 95 days before the mailing date, with one of the USPS-approved methods in 3.6.2. [Revise item c as follows:] c. The Move Update standard is met when an address used on a mailpiece in a mailing at any class of mail is updated with an approved method in 3.6.2, and the same address is used in a First-Class Mail mailing within 95 days after the address has been updated. 440 Standard Mail 443 Rates and Eligibility 3.0 Basic Standards for Standard Mail Parcels [Add new item 3.9 as follows:] 3.9 Move Update Standard 3.9.1 Basic Standards The Move Update standard is a means of reducing the number of mailpieces in a mailing that require forwarding, return, or discard by the periodic matching of a mailer's address records with customer-filed change-of-address orders received and maintained by the USPS. For the purposes of this standard, “address” means a specific address associated with a specific occupant name. Addresses subject to the Move Update standard must meet these requirements: a. Each address and associated occupant name used on the mailpieces in a mailing must be updated within 95 days before the mailing date, with one of the USPS-approved methods in 3.9.2. b. Each individual address in the mailing is subject to the Move Update standard. c. The Move Update standard is met when an address used on a mailpiece in a mailing at any class of mail is updated with an approved method in 3.9.2, and the same address is used in a Standard Mail mailing within 95 days after the address has been updated. d. Except for mail bearing an alternative address format, addresses used on pieces claiming Standard Mail rates, regardless of any required surcharge, must meet the Move Update standard. 3.9.2 USPS-Approved Methods The following methods are authorized for meeting the Move Update standard: a. Address Change Service (ACS). b. National Change of Address Linkage System (NCOALink). c. Ancillary service endorsements under 507.1.5.3, Standard Mail, except “Forwarding Service Requested.” 3.9.3 Mailer Certification The mailer's signature on the postage statement certifies that the Move Update standard has been met for each address in the corresponding mailing presented to the USPS. We will publish an appropriate amendment to 39 CFR part 111 if our proposal is adopted. Neva Watson, Attorney, Legislative. [FR Doc. E7-9881 Filed 5-22-07; 8:45 am] BILLING CODE 7710-12-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 152, 156, 167, 168, 169, 172, and 174 [EPA-HQ-OPP-2006-1003; FRL-8132-1] RIN 2070-AJ32 Plant-Incorporated Protectants; Potential Revisions to Current Production Regulations; Extension of Comment Period AGENCY: Environmental Protection Agency (EPA). ACTION: Advance Notice of Proposed Rulemaking (ANPRM); extension of comment period. SUMMARY: EPA is extending the comment period for an ANPRM document concerning potential revisions to current production regulations for producers of plant-incorporated protectants

(PIPs)published in the **Federal Register** of April 4, 2007. This document extends the comment period for an additional 30 days. The comment period is extended because EPA received a request from the Association of American Pesticide Control Officials (AAPCO), the association representing State pesticide regulatory officials. The extended comment period will allow State regulators to consider the ANPRM at the State-FIFRA Issues Research and Evaluation Group (SFIREG) national meeting June 25-26, 2007, and submit comments representing the consensus of their membership. DATES: Comments must be received on or before July 13, 2007. ADDRESSES: Follow the detailed instructions provided under ADDRESSES in the ANPRM published in the **Federal Register** of April 4, 2007. FOR FURTHER INFORMATION CONTACT: Stephen Howie, Hazard Assessment Coordination and Policy Division, Office of Science Coordination and Policy, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(202)564-4146; fax number:

(202)564-8502; e-mail address: *howie.stephen@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? The Agency identified in the ANPRM those who may be potentially affected by that action. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How and to Whom Do I Submit Comments? To submit comments, or access the public docket, follow the detailed instructions provided in Unit I.B of the SUPPLEMENTARY INFORMATION of the April 4, 2007 ANPRM. II. What Action is EPA Taking? This document extends the comment period established in the ANPRM published in the **Federal Register** of April 4, 2007 (72 FR 16312) (FRL-8118-2). In that document, EPA stated that it is considering amendments to the current pesticide establishment and production regulations promulgated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and to other related FIFRA regulations as needed for producers of PIPs. EPA is extending the comment period, which expires on June 13, 2007, for an additional 30 days. The new comment period ends on July 13, 2007. The comment period is extended because EPA received a request from the AAPCO, the association representing State pesticide regulatory officials. The extended comment period will allow State regulators to consider the ANPRM at the State-FIFRA Issues Research and Evaluation Group (SFIREG) national meeting June 25-26, 2007, and submit comments representing the consensus of their membership. List of Subjects in 40 CFR Parts 152, 156, 167, 168, 169, 172, 174 Environmental protection, Pesticides and pests, Plant-incorporated protectants, Reporting and recordkeeping requirements. Dated: May 15, 2007. James B. Gulliford, Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances. [FR Doc. E7-9847 Filed 5-22-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0261; FRL-8130-8] Methamidophos, Oxydemeton-methyl, Profenofos, and Trichlorfon; Proposed Tolerance Actions AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to revoke certain tolerances for the insecticides methamidophos and oxydemeton-methyl. Also, EPA is proposing to modify certain tolerances for the insecticides methamidophos, oxydemeton-methyl, profenofos, and trichlorfon. In addition, EPA is proposing to establish new tolerances for the insecticides methamidophos and profenofos. The regulatory actions proposed in this document are in follow-up to the Agency's reregistration program under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and tolerance reassessment program under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q). DATES: Comments must be received on or before July 23, 2007. ADDRESSES: Submit your comments, identified by docket identification

(ID)number EPA-HQ-OPP-2007-0261, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line 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'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. *Instructions* : Direct your comments to docket ID number EPA-HQ-OPP-2007-0261. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The Federal regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket* : All documents in the docket are listed in the docket index available in regulations.gov. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. Although listed in the index, some information is not publicly available, e.g., 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 either 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 hours of operation of this Docket Facility are 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: Joseph Nevola, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460-0001; telephone number:

(703)308-8037; e-mail address: *nevola.joseph@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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in Unit II.A. 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. What Should I Consider as I Prepare My Comments for EPA? 1. *Submitting CBI* . Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. *Tips for preparing your comments* . When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, **Federal Register** date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations

(RED)and Report of the Food Quality Protection Act

(FQPA)Tolerance Reassessment Progress and Risk Management Decision

(TRED)for the active ingredient. REDs and TREDs recommend the implementation of certain tolerance actions, including modifications to reflect current use patterns, meet safety findings, and change commodity names and groupings in accordance with new EPA policy. Printed copies of many REDs and TREDs may be obtained from EPA's National Service Center for Environmental Publications (EPA/NSCEP), P.O. Box 42419, Cincinnati, OH 45242-2419, telephone: 1

(800)490-9198; fax: 1

(513)489-8695; internet at *http://www.epa.gov/ncepihom/* and from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone: 1

(800)553-6847 or

(703)605-6000; internet at *http://www.ntis.gov/* . Electronic copies of REDs and TREDs are available on the internet. The methamidophos, oxydemeton-methyl, and profenofos REDs and triclorfon TRED are found at *http://www.epa.gov/pesticides/reregistration/status.htm* . The selection of an individual tolerance level is based on crop field residue studies designed to produce the maximum residues under the existing or proposed product label. Generally, the level selected for a tolerance is a value slightly above the maximum residue found in such studies, provided that the tolerance is safe. The evaluation of whether a tolerance is safe is a separate inquiry. EPA recommends the raising of a tolerance when data show that:

(1)Lawful use (sometimes through a label change) may result in a higher residue level on the commodity.

(2)The tolerance remains safe, notwithstanding increased residue level allowed under the tolerance. In REDs, Chapter IV on “Risk management, Reregistration, and Tolerance reassessment” typically describes the regulatory position, FQPA assessment, cumulative safety determination, determination of safety for U.S. general population, and safety for infants and children. In particular, the human health risk assessment document which supports the RED describes risk exposure estimates and whether the Agency has concerns. In TREDs, the Agency discusses its evaluation of the dietary risk associated with the active ingredient and whether it can determine that there is a reasonable certainty (with appropriate mitigation) that no harm to any population subgroup will result from aggregate exposure. EPA also seeks to harmonize tolerances with international standards set by the Codex Alimentarius Commission, as described in Unit III. Explanations for proposed modifications in tolerances can be found in the RED and TRED document and in more detail in the Residue Chemistry Chapter document which supports the RED and TRED. Copies of the Residue Chemistry Chapter documents are found in the Administrative Record and paper copies for methamidophos, oxydemeton-methyl, profenofos, and trichlorfon are available in the public docket for this rule. Electronic copies are available through EPA's electronic public docket and comment system, regulations.gov at *http://www.regulations.gov/* . You may search for docket number EPA-HQ-OPP-2007-0261, then click on that docket number to view its contents. EPA has determined that the aggregate exposures and risks are not of concern for the above mentioned pesticide active ingredients based upon the data identified in the RED or TRED which lists the submitted studies that the Agency found acceptable. EPA has found that the tolerances that are proposed in this document to be modified, are safe; i.e., that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residues, in accordance with FFDCA section 408(b)(2)(C). (Note that changes to tolerance nomenclature do not constitute modifications of tolerances). These findings are discussed in detail in each RED or TRED. The references are available for inspection as described in this document under SUPPLEMENTARY INFORMATION . In addition, EPA is proposing to revoke certain specific tolerances because either they are no longer needed or are associated with food uses that are no longer registered under FIFRA. Those instances where registrations were canceled were because the registrant failed to pay the required maintenance fee and/or the registrant voluntarily requested cancellation of one or more registered uses of the pesticide. It is EPA's general practice to propose revocation of those tolerances for residues of pesticide active ingredients on crop uses for which there are no active registrations under FIFRA, unless any person, in comments on the proposal, indicates a need for the tolerance to cover residues in or on imported commodities or domestic commodities legally treated. 1. *Methamidophos* . Because methamidophos is a metabolite of acephate, EPA determined that residues of methamidophos resulting from the application of acephate should be included under the tolerance regulations for methamidophos as a pesticide. Therefore, EPA is proposing to recodify the tolerances for methamidophos from 40 CFR 180.315(a) into (a)(1) for permanent tolerances for residues of methamidophos (O,S-dimethyl phosphoramidothioate) in or on food commodities as a result of the application of the insecticide methamidophos and (a)(2) for residues of methamidophos (O,S-dimethyl phosphoramidothioate) in or on food commodities as a result of the application of the insecticide acephate. Currently, 40 CFR 180.3, the section on tolerances for related pesticide chemicals, contains a paragraph (d)(8) stating that where tolerances are established for residues of O,S-dimethyl phosphoramidothioate, resulting from the use of acephate (O,S-dimethyl acetylphos-phoramidothioate) and/or O,S-dimethylphosphoramidothioate on the same agricultural commodity, the total amount of O,S-dimethyl-phosphoramidothioate shall not yield more residue than that permitted by the higher of the two tolerances. However, with the proposed change to include tolerances for methamidophos that result from the application of acephate under the methamidophos tolerance regulations in 40 CFR 180.315(a)(2), there is no longer a need for the related pesticide chemical regulation under 40 CFR 180.3(d)(8); and therefore, EPA is proposing to remove existing paragraph (d)(8). With the exception of uses on cotton and potatoes, EPA canceled all methamidophos FIFRA section 3 registrations and, with the exception of uses on tomatoes, all section 24(c) regional registrations (62 FR 67071, December 23, 1997) (FRL-5764-2). Because there are no active registrations for uses of either methamidophos or acephate on broccoli, cabbage, cucumber, eggplant, and melon, the associated tolerances in 40 CFR 180.315 are no longer needed and should be revoked. Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.315 on broccoli, cabbage, cucumber, eggplant, and melon. Also, on July 31, 2002 (67 FR 49606)(FRL-7191-4), EPA published a final rule in the **Federal Register** in which it responded to the Canadian Horticultural Council's comment asking that certain tolerances in 40 CFR 180.315, including those on broccoli and cabbage, not be revoked. At that time, the Agency responded that it would not revoke the tolerances on broccoli and cabbage in 40 CFR 180.315, but would follow-up to see that data requirements were met should an interested party support those tolerances for import purposes. However, in the interim period, no interested party has declared an interest and committed in writing to do the required data to support the broccoli and cabbage tolerances for import purposes. However, because there are registered acephate uses on Brussels sprouts, cauliflower, celery, and head lettuce, EPA is proposing to recodify the tolerances for Brussels sprouts, cauliflower, and lettuce from 40 CFR 180.315(a) into (a)(2) and celery from

(b)into (a)(2). Also, in order to reflect active registered use of acephate on head lettuce, EPA is proposing in 40 CFR 180.315(a)(2) to revise “lettuce” to “lettuce, head.” In addition, because there is an existing tolerance for acephate use on cauliflower, which has been reassessed in the acephate RED at the same level, such that residues from metabolism to methamidophos are expected to be no greater than 0.5 parts per million (ppm), EPA is proposing to decrease the tolerance on cauliflower in 40 CFR 180.315(a)(2) from 1.0 to to 0.5 ppm. Also, this proposed level will harmonize with the Codex MRL of 0.5 mg/kg on cauliflower. At the time of the completion of the methamidophos IRED, a registrant submitted an import tolerance petition for peppers, strawberries, and squash. This petition has not been reviewed. Because there is an existing tolerance for acephate use on peppers, which in the acephate RED has been reassessed at the same level, such that residues from metabolism to methamidophos are expected to be no greater than 1.0 ppm, EPA is proposing to recodify the tolerance on pepper from 40 CFR 180.315(a) to (a)(2) at 1.0 ppm. Also, this proposed level will harmonize with the Codex MRL of 1.0 mg/kg on sweet peppers. Because there are registered methamidophos uses on potato, EPA is proposing to recodify the tolerance at 0.1 ppm on potato from 40 CFR 180.315(a) into (a)(1). There is a Codex MRL of 0.05 ppm on potato, but harmonization is not possible because of differences in agricultural practices. Based on available data that showed methamidophos residues as high as 0.191 ppm on cottonseed, EPA determined that the tolerance on cottonseed should be increased from 0.1 to 0.2 ppm. Therefore, the Agency is proposing to recodify the tolerance on cotton, undelinted seed from 40 CFR 180.315(a) to (a)(1) and increase the tolerance to 0.2 ppm. The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue. Also, this proposed level will harmonize with the Codex MRL of 0.2 mg/kg on cottonseed. Based on available data that showed methamidophos residues as high as 8.03 ppm on cotton gin byproducts, EPA determined that a tolerance on cotton gin byproducts should be established at 10.0 ppm. Therefore, the Agency is proposing to establish a tolerance on cotton, gin byproducts in 40 CFR 180.315(a)(1) at 10.0 ppm. Based on available data that showed methamidophos residues as high as 1.4 ppm on tomatoes, EPA determined that the tolerance on tomato should be increased from 1.0 to 2.0 ppm. Because there are only active FIFRA section 24(c) registrations for use of methamidophos on tomatoes and no active registrations for use of acephate on tomatoes, the Agency has determined that the tolerance should be recodified as a regional tolerance. Therefore, the Agency is proposing to recodify 40 CFR 180.315(b) as

(c)and the tolerance on tomato from 40 CFR 180.315(a) to (c), and increase the tolerance to 2.0 ppm. The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue. Also, EPA is proposing to revise the tolerance expression in newly recodified 40 CFR 180.315(c), as follows: Tolerances with regional registration, as defined in 40 CFR 180.1(m), are established for residues of methamidophos (O,S-dimethyl phosphoramidothioate) in or on the following food commodities as a result of the application of the insecticide methamidophos. In addition, EPA is proposing to revise 40 CFR 180.315 by adding separate paragraphs

(b)and (d), and reserving those sections for tolerances with section 18 emergency exemptions, and indirect or inadvertent residues, respectively. Because there are existing tolerances for use of acephate on dry and succulent beans and cranberries, which in the acephate RED have been reassessed at the same level, such that residues from metabolism to methamidophos are expected to be no greater than 1.0 ppm and 0.1 ppm, respectively, EPA is proposing to establish tolerances in 40 CFR 180.315(a)(2) for residues of methamidophos as a result from the application of acephate on bean, dry, seed at 1.0 ppm, bean, succulent at 1.0 ppm, and cranberry at 0.1 ppm. Because there is an existing tolerance for use of acephate on mint hay, which in the acephate RED has been reassessed to be increased from 15.0 to 27.0 ppm, such that residues from metabolism to methamidophos are expected to be increased from no greater than 1.0 to 2.0 ppm, EPA is proposing to establish a tolerance in 40 CFR 180.315(a)(2) for residues of methamidophos as a result from the application of acephate on mint, hay at 2.0 ppm and revise it to “peppermint, tops” and “spearmint, tops.” 2. *Oxydemeton-methyl* . Currently, the tolerances in 40 CFR 180.330 are expressed for residues of oxydemeton-methyl and its cholinesterase-inhibiting metabolites. Based on the Agency's determination that only residues of oxydemeton-methyl and its metabolite oxydemeton-methyl sulfone are of concern in plants, the tolerances in 40 CFR 180.330 should be recodified for plant commodities from 40 CFR 180.330(a) to (a)(1) and animal commodities from 40 CFR 180.330(a) to (a)(2). Therefore, EPA is proposing to recodify plant tolerances in 40 CFR 180.330(a)(1) and animal tolerances in 40 CFR 180.330(a)(2) and revise the tolerance expression in 40 CFR 180.330 as follows:

(a)*General* .

(2)Tolerances are established for the combined residues of the insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)-ethyl) O,O-dimethyl phosphorothioate) and its cholinesterase-inhibiting metabolites in or on the following food commodities. Because certain registered uses have product labels which prohibit harvest within one year of application, so that there is no reasonable expectation of residues on food commodities, the Agency considers them to be nonfood uses of oxydemeton-methyl. As a result, the tolerances in 40 CFR 180.330 for these nonfood uses are no longer needed and should be revoked for apple, apricot, grape, and plum, prune, fresh. Therefore, the Agency is proposing to revoke the tolerances in 40 CFR 180.330(a) on apple, grape, and plum, prune, fresh and in 40 CFR 180.330(c) on apricot. Because bean, lima, forage; clover, seed screenings; and sorghum milled fractions (except flour) are no longer considered by the Agency to be significant animal feed items, their tolerances in 40 CFR 180.330 are no longer needed and should be revoked. Therefore, the Agency is proposing to revoke the tolerances in 40 CFR 180.330 on bean, lima, forage; clover, seed screenings; and sorghum, milled fractions (except flour). In 1994, the technical registrant for oxydemeton-methyl

(ODM)agreed not to market ODM on snap beans, field corn, popcorn, pears, and turnips but retained them on registrations with the possibility of requesting to reinstate them on marketing labels after EPA's review of needed ODM data and completion of dietary and worker risk assessments. In a letter to the Agency dated February 4, 2004, the technical registrant requested to amend the registrations for both a technical and end-use registration and delete those uses. In the **Federal Register** of November 4, 2005 (70 FR 67167) (FRL-7744-7), EPA published a notice announcing the receipt of requests for amendments to delete uses in certain pesticide registrations, including deletion for ODM use on snap beans, field corn, popcorn, pears, and turnips concerning registrations for one technical and one end use product. That notice had an effective date of December 5, 2005 and allowed the registrant to sell or distribute product under the previously approved labelling for a period of 18 months after approval of the revision. There have been no end use marketing labels for ODM use on these commodities since September 18, 1995. However, there has been one active technical registration with these uses from 1995 through the December 5, 2005 effective date that amended its label. Nevertheless, despite the allowance by EPA that existing stocks for the technical and end use registrations could be sold or distributed by the registrant for 18 months, the Agency believes that no end users have used ODM on snap beans, field corn, popcorn, pears, and turnip commodities since 1995. Therefore, EPA believes that existing stocks of end use product was exhausted years ago and that such ODM treated-snap beans, field corn, popcorn, pears, and turnip commodities passed through channels of trade long ago and that sufficient time has passed. Consequently, EPA is proposing to revoke the tolerances in 40 CFR 180.330 on bean, snap, succulent; bean, snap, forage; corn, grain; pear; turnip; and turnip, greens; all on the date of publication of the final rule. Based on available data that showed combined oxydemeton-methyl residues of concern as high as 0.9 ppm in or on corn forage, EPA determined that the tolerance on corn forage should be decreased from 3.0 to 1.0 ppm. Therefore, the Agency is proposing in 40 CFR 180.330 to decrease the tolerance on corn, forage to 1.0 ppm and revise it to corn, sweet, forage. No tolerance on field corn forage is needed. Based on available data that showed combined oxydemeton-methyl residues of concern as high as 9.84 ppm in or on clover hay grown for seed, EPA determined that the tolerance on clover hay grown for seed should be decreased from 11.0 to 10.0 ppm. Therefore, the Agency is proposing in 40 CFR 180.330 to decrease the tolerance on clover, hay, grown for seed to 10.0 ppm and revise it to clover, hay. Based on available data that showed combined oxydemeton-methyl residues of concern as high as 0.15 ppm in or on lima beans, 0.2 ppm in or on melons, less than 0.1 ppm in or on pumpkins, and less than 0.05 ppm in or on walnuts, EPA determined that the tolerances on lima beans, cottonseed, melons, pumpkins, and walnuts should be decreased from 0.5 to 0.2 ppm, 0.1 to 0.02 ppm, 0.3 to 0.2 ppm, 0.3 to 0.2 ppm, and 0.3 to 0.05 ppm, respectively. Therefore, the Agency is proposing in 40 CFR 180.330 to decrease the tolerances on bean, lima to 0.2 ppm, cotton, undelinted seed to 0.02 ppm, melon to 0.2 ppm, pumpkin to 0.2 ppm, and walnut to 0.05 ppm. Based on available data that showed combined oxydemeton-methyl residues of concern as high as 1.22 ppm in or on cabbage, EPA determined that the tolerance on cabbage should be increased from 1.0 to 2.0 ppm. Therefore, the Agency is proposing in 40 CFR 180.330 to increase the tolerance on cabbage to 2.0 ppm. The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue. Also, because there is one active FIFRA section 24(c) registration for foliar use of oxydemeton-methyl on broccoli raab, EPA determined that data could be translated from cabbage and broccoli to broccoli raab, and therefore a tolerance should be established on broccoli raab at 2.0 ppm. Therefore, EPA is proposing to establish a regional tolerance on broccoli raab in 40 CFR 180.330(c) at 2.0 ppm and revise the tolerance expression in 40 CFR 180.330(c) as follows:

(c)Tolerances with regional registrations, as defined in 40 CFR 180.1(m), are established for the combined residues of the insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)-ethyl) O,O-dimethyl phosphorothioate) and its metabolite oxydemeton-methyl sulfone in or on the following food commodities. Based on a poultry metabolism study at the 6x feeding level that showed no residues of toxicological concern in poultry commodities and an earlier poultry metabolism study that showed residues were present in eggs and tissues, EPA determined that egg and poultry tolerances should be established at the limit of quantitation

(LOQ)of 0.01 ppm. Therefore, the Agency is proposing to establish tolerances in 40 CFR 180.330(a)(2) on egg; poultry, fat; poultry, meat; and poultry, meat byproducts at 0.01 ppm. Also, EPA is proposing to revise commodity terminology in 40 CFR 180.330 to conform to current Agency practice as follows: “alfalfa, green” to “alfalfa, forage;” “alfalfa, hay, grown for seed” to “alfalfa, hay;” “beet, sugar” to “beet, sugar, roots;” “corn, stover” to “corn, sweet, stover” (no tolerances are needed on field corn stover or popcorn stover) “mint, hay” to “peppermint, tops” and “spearmint, tops;” “onion, dry bulb” to “onion, bulb;” “orange, sweet” to “orange;” “sorghum, forage” to “sorghum, forage, forage” and “sorghum, grain, forage;” “sorghum, grain” to “sorghum, grain, grain.” There are no Codex MRLs for oxydemeton-methyl. 3. *Profenofos* . Currently, the tolerances in 40 CFR 180.404(a) are expressed for residues of profenofos and its metabolites converted to 4-bromo-2-chlorophenyl and calculated as profenofos. Based on the Agency's determination that only residues of profenofos *per se* are of toxicological concern, the tolerance expression in 40 CFR 180.404 should be revised to reflect that profenofos *per se* is the only regulated residue. Therefore, EPA is proposing to revise the tolerance expression in 40 CFR 180.404(a) as follows:

(a)*General* . Tolerances are established for residues of the insecticide profenofos (O-(4-bromo-2-chlorophenyl)-O-ethyl-S-propyl phosphorothioate) in or on the following food commodities. Based on available data that showed profenofos residues were as high as 1.1 ppm on cottonseed, EPA determined that the tolerance should be decreased from 3.0 to 2.0 ppm. Therefore, the Agency is proposing to decrease the tolerance in 40 CFR 180.404 on cotton, undelinted seed to 2.0 ppm. Also, this proposed level will harmonize with the Codex MRL of 2 mg/kg on cottonseed. Based on available data that showed profenofos residues as high as 53 ppm, EPA determined that a tolerance of 55.0 ppm should be established for cotton gin byproducts. Therefore, the Agency is proposing to establish a tolerance in 40 CFR 180.404 for the residues of profenofos on cotton, gin byproducts at 55.0 ppm. 4. *Trichlorfon* . There are no active registrations for the use of the insecticide trichlorfon for cattle commodities in the United States. However, trichlorfon is used as a dermal pour-on application for cattle for import purposes. Based on cattle metabolism data from dermal application of trichlorfon which showed residues of trichlorfon as high as 0.2 ppm in muscle and less than 0.5 ppm in fat, EPA determined that the tolerances on cattle meat and cattle fat should be increased from 0.1 ppm to 0.2 ppm and 0.1 to 0.5 ppm, respectively. Therefore, EPA is proposing in 40 CFR 180.198 to increase the tolerances on cattle, meat to 0.2 ppm and cattle, fat to 0.5 ppm. The Agency determined that the increased tolerances are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue. Dichlorvos is a degradate of trichlorfon. However, as stated in the 2006 Dichlorvos RED, non-detectable dichlorvos residues in livestock commodities are expected as a result of trichlorfon use, and dichlorvos was not a significant metabolite in the trichlorfon dermal metabolism data. Therefore, dietary

(food)exposure to dichlorvos residues resulting from use of trichlorfon is considered by the Agency to be negligible. Also, in 40 CFR 180.198, EPA is proposing to remove the “(N)” designation from all entries to conform to current Agency administrative practice, where the “(N)” designation means negligible residues. In addition, in order to conform to current Agency practice, EPA is proposing to revise 40 CFR 180.198 and establish subparts

(a)through (d), recodify general tolerances under 40 CFR 180.198(a) and reserve sections

(b)for tolerances with section 18 emergency exemptions,

(c)for regional registrations, and

(d)for indirect or inadvertent residues. There are no Codex MRLs for trichlorfon. B. What is the Agency's Authority for Taking this Action? A “tolerance” represents the maximum level for residues of pesticide chemicals legally allowed in or on raw agricultural commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a, as amended by the FQPA of 1996, Public Law 104-170, authorizes the establishment of tolerances, exemptions from tolerance requirements, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. Without a tolerance or exemption, food containing pesticide residues is considered to be unsafe and therefore “adulterated” under section 402(a) of the FFDCA, 21 U.S.C. 342(a). Such food may not be distributed in interstate commerce (21 U.S.C. 331(a)). For a food-use pesticide to be sold and distributed, the pesticide must not only have appropriate tolerances under the FFDCA, but also must be registered under FIFRA (7 U.S.C. 136 *et seq.* ). Food-use pesticides not registered in the United States must have tolerances in order for commodities treated with those pesticides to be imported into the United States. EPA is proposing these tolerance actions in follow-up to the tolerance recommendations made during the reregistration and tolerance reassessment processes (including follow-up on canceled or additional uses of pesticides). The safety finding determination under section 408 of the FFDCA standard is discussed in detail in each Post-FQPA RED and TRED for the active ingredient. REDs and TREDs recommend the implementation of certain tolerance actions, including modifications to reflect current use patterns, to meet safety findings, and change commodity names and groupings in accordance with new EPA policy. Printed and electronic copies of the REDs and TREDs are available as provided in Unit II.A. EPA has issued post-FQPA REDs for methamidophos, oxydemeton-methyl, and profenofos, and a TRED for trichlorfon, whose RED was completed prior to FQPA. REDs and TREDs contain the Agency's evaluation of the data base for these pesticides, including requirements for additional data on the active ingredients to confirm the potential human health and environmental risk assessments associated with current product uses, and in REDs state conditions under which these uses and products will be eligible for reregistration. The REDs and TREDs recommended the establishment, modification, and/or revocation of specific tolerances. RED and TRED recommendations such as establishing or modifying tolerances, and in some cases revoking tolerances, are the result of assessment under the FFDCA standard of “reasonable certainty of no harm.” However, tolerance revocations recommended in REDs and TREDs that are proposed in this document do not need such assessment when the tolerances are no longer necessary. EPA's general practice is to propose revocation of tolerances for residues of pesticide active ingredients on crops for which FIFRA registrations no longer exist and on which the pesticide may therefore no longer be used in the United States. EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Nonetheless, EPA will establish and maintain tolerances even when corresponding domestic uses are canceled if the tolerances, which EPA refers to as “import tolerances,” are necessary to allow importation into the United States of food containing such pesticide residues. However, where there are no imported commodities that require these import tolerances, the Agency believes it is appropriate to revoke tolerances for unregistered pesticides in order to prevent potential misuse. Furthermore, as a general matter, the Agency believes that retention of import tolerances not needed to cover any imported food may result in unnecessary restriction on trade of pesticides and foods. Under section 408 of the FFDCA, a tolerance may only be established or maintained if EPA determines that the tolerance is safe based on a number of factors, including an assessment of the aggregate exposure to the pesticide and an assessment of the cumulative effects of such pesticide and other substances that have a common mechanism of toxicity. In doing so, EPA must consider potential contributions to such exposure from all tolerances. If the cumulative risk is such that the tolerances in aggregate are not safe, then every one of these tolerances is potentially vulnerable to revocation. Furthermore, if unneeded tolerances are included in the aggregate and cumulative risk assessments, the estimated exposure to the pesticide would be inflated. Consequently, it may be more difficult for others to obtain needed tolerances or to register needed new uses. To avoid potential trade restrictions, the Agency is proposing to revoke tolerances for residues on crops uses for which FIFRA registrations no longer exist, unless someone expresses a need for such tolerances. Through this proposed rule, the Agency is inviting individuals who need these import tolerances to identify themselves and the tolerances that are needed to cover imported commodities. Parties interested in retention of the tolerances should be aware that additional data may be needed to support retention. These parties should be aware that, under FFDCA section 408(f), if the Agency determines that additional information is reasonably required to support the continuation of a tolerance, EPA may require that parties interested in maintaining the tolerances provide the necessary information. If the requisite information is not submitted, EPA may issue an order revoking the tolerance at issue. EPA has developed guidance concerning submissions for import tolerance support (65 FR 35069, June 1, 2000) (FRL-6559-3). This guidance will be made available to interested persons. Electronic copies are available on the internet at *http://www.epa.gov/* . On the Home Page select “Laws, Regulations, and Dockets,” then select Regulations and Proposed Rules and then look up the entry for this document under “ **Federal Register** —Environmental Documents.” You can also go directly to the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr/* . When EPA establishes tolerances for pesticide residues in or on raw agricultural commodities, consideration must be given to the possible residues of those chemicals in meat, milk, poultry, and/or eggs produced by animals that are fed agricultural products (for example, grain or hay) containing pesticides residues (40 CFR 180.6). When considering this possibility, EPA can conclude that: 1. Finite residues will exist in meat, milk, poultry, and/or eggs. 2. There is a reasonable expectation that finite residues will exist. 3. There is a reasonable expectation that finite residues will not exist. If there is no reasonable expectation of finite pesticide residues in or on meat, milk, poultry, or eggs, tolerances do not need to be established for these commodities (40 CFR 180.6(b) and (c)). EPA has evaluated certain specific meat, milk, poultry, and egg tolerances proposed for revocation in this rule and has concluded that there is no reasonable expectation of finite pesticide residues of concern in or on those commodities. C. When do These Actions Become Effective? EPA is proposing that the actions herein become effective on the date of publication of the final rule in the **Federal Register** , because their associated uses have been canceled for several years. The Agency believes that existing stocks of pesticide products labeled for the uses associated with the tolerances proposed for revocation have been completely exhausted and that treated commodities have had sufficient time for passage through the channels of trade. However, if EPA is presented with information that existing stocks would still be available and that information is verified, the Agency will consider extending the expiration date of the tolerance. If you have comments regarding existing stocks and whether the effective date allows sufficient time for treated commodities to clear the channels of trade, please submit comments as described under SUPPLEMENTARY INFORMATION . Any commodities listed in this proposal treated with the pesticides subject to this proposal, and in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by FQPA. Under this section, any residues of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the Food and Drug Administration that: 1. The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA, and 2. The residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from tolerance. Evidence to show that food was lawfully treated may include records that verify the dates when the pesticide was applied to such food. III. Are the Proposed Actions Consistent with International Obligations? The tolerance actions in this proposal are not discriminatory and are designed to ensure that both domestically produced and imported foods meet the food safety standards established by the FFDCA. The same food safety standards apply to domestically produced and imported foods. 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, as required by section 408(b)(4) of the FFDCA. 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, section 408(b)(4) of FFDCA requires that EPA explain the reasons for departing from the Codex level in a notice published for public comment. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual REDs and TREDs, and in the Residue Chemistry document which supports the RED and TRED, as mentioned in Unit II.A. Specific tolerance actions in this rule and how they compare to Codex MRLs (if any) are discussed in Unit II.A. IV. Statutory and Executive Order Reviews In this proposed rule, EPA is proposing to establish tolerances under FFDCA section 408(e), and also modify and revoke specific tolerances established under FFDCA section 408. The Office of Management and Budget

(OMB)has exempted these types of actions (e.g., establishment and modification of a tolerance and tolerance revocation for which extraordinary circumstances do not exist) from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this proposed rule has been exempted from review under Executive Order 12866 due to its lack of significance, this proposed rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001). This proposed rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq.* , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995

(UMRA)(Public Law 104-4). Nor does it require any special considerations as required by Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any other Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). 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). Pursuant to the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq.* ), the Agency previously assessed whether establishment of tolerances, exemptions from tolerances, raising of tolerance levels, expansion of exemptions, or revocations might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. These analyses for tolerance establishments and modifications, and for tolerance revocations were published on May 4, 1981 (46 FR 24950) and on December 17, 1997 (62 FR 66020), respectively, and were provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning the pesticides listed in this proposed rule, the Agency hereby certifies that this proposed action will not have a significant negative economic impact on a substantial number of small entities. In a memorandum dated May 25, 2001, EPA determined that eight conditions must all be satisfied in order for an import tolerance or tolerance exemption revocation to adversely affect a significant number of small entity importers, and that there is a negligible joint probability of all eight conditions holding simultaneously with respect to any particular revocation. (This Agency document is available in the docket of this proposed rule). Furthermore, for the pesticide named in this proposed rule, the Agency knows of no extraordinary circumstances that exist as to the present proposal that would change the EPA's previous analysis. Any comments about the Agency's determination should be submitted to the EPA along with comments on the proposal, and will be addressed prior to issuing a final rule. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This proposed rule directly regulates growers, food processors, food handlers and food retailers, not States. 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 the FFDCA. For these same reasons, the Agency has determined that this proposed rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This proposed rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this proposed rule. List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 16, 2007. Debra Edwards, Director, Office of Pesticide Programs. Therefore, it is proposed that 40 CFR chapter I be 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. §180.3 [Amended] 2. Section 180.3 is amended by removing paragraph (d)(8) and redesignationg paragraphs (d)(9) through (d)(14) as paragraphs (d)(8) through (d)(13). 3. Section 180.198 is revised to read as follows: §180.198 Trichlorfon; tolerances for residues.

(a)*General* . Tolerances are established for residues of the insecticide trichlorfon (dimethyl (2,2,2-trichloro-1-hydroxyethyl) phosphonate) in or on the following food commodities: Commodity Parts per million Cattle, fat 1 0.5 Cattle, meat 1 0.2 Cattle, meat byproducts 1 0.1 1 There are no U.S. registrations for cattle commodities as of June 24, 1999.

(b)*Section 18 emergency exemptions* . [Reserved]

(c)*Tolerances with regional registrations* . [Reserved]

(d)*Indirect or inadvertent residues* . [Reserved] 4. Section 180.315 is revised to read as follows: §180.315 Methamidophos; tolerances for residues.

(a)*General* .

(1)Tolerances are established for residues of methamidophos (O,S-dimethyl phosphoramidothioate) in or on the following food commodities as a result of the application of the insecticide methamidophos. Commodity Parts per million Cotton, gin byproducts 10.0 Cotton, undelinted seed 0.2 Potato 0.1

(2)Tolerances are established for residues of methamidophos (O,S-dimethyl phosphoramidothioate) in or on the following food commodities as a result of the application of the insecticide acephate. Commodity Parts per million Bean, dry, seed 1.0 Bean, succulent 1.0 Brussels sprouts 1.0 Cauliflower 0.5 Celery 1.0 Cranberry 0.1 Lettuce, head 1.0 Pepper 1.0 Peppermint, tops 2.0 Spearmint, tops 2.0

(b)*Section 18 emergency exemptions* . [Reserved]

(c)*Tolerances with regional registrations* . Tolerances with regional registration, as defined in 180.1(m), are established for residues of methamidophos (O,S-dimethyl phosphoramidothioate) in or on the following food commodities as a result of the application of the insecticide methamidophos. Commodity Parts per million Tomato 2.0

(d)*Indirect or inadvertent residues* . [Reserved] 5. Section 180.330 is revised to read as follows: §180.330 S-(2-(Ethylsulfinyl)ethyl) O,O-dimethyl phosphorothioate; tolerances for residues.

(a)*General* .

(1)Tolerances are established for the combined residues of the insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)-ethyl) O,O-dimethyl phosphorothioate) and its metabolite oxydemeton-methyl sulfone in or on the following food commodities: Commodity Parts per million Alfalfa, forage 5.0 Alfalfa, hay 11.0 Bean, lima 0.2 Beet, sugar, roots 0.3 Beet, sugar, tops 0.5 Broccoli 1.0 Brussels sprouts 1.0 Cabbage 2.0 Cauliflower 1.0 Clover, forage 5.0 Clover, hay 10.0 Corn, sweet, forage 1.0 Corn, sweet, kernel plus cob with husks removed 0.5 Corn, sweet, stover 3.0 Cotton, undelinted seed 0.02 Cucumber 1.0 Eggplant 1.0 Filbert 0.05 Grapefruit 1.0 Lemon 1.0 Lettuce, head 2.0 Melon 0.2 Onion, bulb 0.05 Orange 1.0 Pepper 0.75 Peppermint, tops 12.5 Pumpkin 0.2 Safflower, seed 1.0 Sorghum, forage, forage 2.0 Sorghum, grain, forage 2.0 Sorghum, grain, grain 0.75 Spearmint, tops 12.5 Squash, summer 1.0 Squash, winter 0.3 Strawberry 2.0 Walnut 0.05

(2)Tolerances are established for the combined residues of the insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)-ethyl) O,O-dimethyl phosphorothioate) and its cholinesterase-inhibiting metabolites in or on the following food commodities. Commodity Parts per million Cattle, fat 0.01 Cattle, meat 0.01 Cattle, meat byproducts 0.01 Egg 0.01 Goat, fat 0.01 Goat, meat 0.01 Goat, meat byproducts 0.01 Hog, fat 0.01 Hog, meat 0.01 Hog, meat byproducts 0.01 Horse, fat 0.01 Horse, meat 0.01 Horse, meat byproducts 0.01 Milk 0.01 Poultry, fat 0.01 Poultry, meat 0.01 Poultry, meat byproducts 0.01 Sheep, fat 0.01 Sheep, meat 0.01 Sheep, meat byproducts 0.01

(b)*Section 18 emergency exemptions* . [Reserved]

(c)*Tolerances with regional registrations* . Tolerances with regional registrations, as defined in 180.1(m), are established for the combined residues of the insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)-ethyl) O,O-dimethyl phosphorothioate) and its metabolite oxydemeton-methyl sulfone in or on the following food commodities: Commodity Parts per million Broccoli raab 2.0

(d)*Indirect or inadvertent residues* . [Reserved] 6. Section 180.404, paragraph

(a)is revised to read as follows: §180.404 Profenofos; tolerances for residues.

(a)*General* . Tolerances are established for residues of the insecticide profenofos (O-(4-bromo-2-chlorophenyl)-O-ethyl-S-propyl phosphorothioate) in or on the following food commodities: Commodity Parts per million Cattle, fat 0.05 Cattle, meat 0.05 Cattle, meat byproducts 0.05 Cotton, gin byproducts 55.0 Cotton, undelinted seed 2.0 Goat, fat 0.05 Goat, meat 0.05 Goat, meat byproducts 0.05 Horse, fat 0.05 Horse, meat 0.05 Horse, meat byproducts 0.05 Milk 0.01 Sheep, fat 0.05 Sheep, meat 0.05 Sheep, meat byproducts 0.05 FR Doc. 07-2561 Filed 5-22-07; 8:45 am BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0766; FRL-8126-1] [RIN 2070-AJ28] Pesticide Tolerance Crop Grouping Program; Proposed Expansion AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing revisions to its pesticide tolerance crop grouping regulations, which allow establishment of tolerances for multiple related crops, based on data from a representative set of crops. The present revision would create a new crop group for edible fungi (mushrooms), expand existing crop groups by adding new commodities, establish new crop subgroups, and revise the representative crops in some groups. Additionally, EPA is revising the generic crop group regulation to add a subsection explaining how the Agency will implement revisions to crop groups. EPA expects these revisions to promote greater use of crop groupings for tolerance-setting purposes and, in particular, will assist in retaining or making available pesticides for minor crop uses. This is the first in a series of planned crop group updates expected to be proposed over the next several years. DATES: Comments must be received on or before July 23, 2007. ADDRESSES: Submit your comments, identified by docket identification

(ID)number EPA-HQ-OPP-2006-0766, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line 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 Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket'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 telephone number is

(703)305-5805. *Instructions* : Direct your comments to docket ID number EPA-HQ-OPP-2006-0766. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The Federal regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket* : All documents in the docket are listed in the docket index. Although listed in the index, some information is not publicly available, e.g., 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 either 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 Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Ramè Cromwell, Field and External Affairs Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)308-9068; fax number:

(703)305-5884; e-mail address: *cromwell.rame@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. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. 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. What Should I Consider as I Prepare My Comments for EPA? 1. *Submitting CBI* . Do not submit this information to EPA through *www.regulations.gov* or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. *Tips for preparing your comments* . When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, **Federal Register** date, and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations

(CFR)part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. II. Background A. Tolerance-Setting Requirements and Petition from USDA IR-4 Program to Expand the Existing Crop Grouping System EPA is authorized to establish tolerances for pesticide chemical residues in food under section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 346a). EPA establishes tolerances for each pesticide based on the potential risks to human health posed by that pesticide. A tolerance is the maximum permissible residue level established for pesticides in raw agricultural produce and processed foods. Tolerances are observed carefully by growers, pesticide users, processors, and food marketers. Food that contains residues of a pesticide for which there is no tolerance is considered to be adulterated. The U.S. Food and Drug Administration and the U.S. Department of Agriculture together enforce the EPA's tolerance limits. Adulterated food is not permitted in commerce. To establish a tolerance, a petition is submitted to the Agency requesting the tolerance and furnishing information on the chemical identity and composition of the pesticide, its use pattern on the crop, toxicity data, and extensive residue data on the nature of the residue and the residue levels resulting from the proposed use pattern. The residue chemistry data requirements (40 CFR 158.240) have been identified as a limiting factor in making pesticide licensing and tolerance decisions for minor crops. This is particularly critical for low acreage minor crops where the expense and time investment for satisfying the residue chemistry requirements may preclude a registrant from petitioning the Agency for an individual crop tolerance for that use. A tolerance may be proposed for an individual commodity such as oranges or lemons, or for a group of related commodities in a crop group such as the citrus crop group. The crop grouping regulations (40 CFR 180.41) enables the establishment of tolerances for a group of crops based on residue data for certain crops that are representative of the group. The crop grouping concept leads to an estimate of maximum level of residue that could occur on any crop within the group. The minimum data required for a group tolerance consists of residue data for all representative commodities for a group. For example, for Crop Group 12 the stone fruits group, the representative commodities are sweet cherry or tart cherry; peach; and plum or fresh prune ( *Prunus domestica, Prunus* spp.). Crop group 12 includes the following commodities: Apricot; cherry; cherry, tart; nectarine; peach; plum; plum, chickasaw; plum, damsom; plum, Japanese; plumcot; prune (fresh). Once the group tolerance is established, the tolerance level applies to all agricultural commodities within the group. It is also possible to request a crop group tolerance with a particular member of the crop excluded. An example of exclusion to a crop group would be a tolerance for the Stone Fruit group 12, except peach. In this crop group residue data for cherry and plum are used to establish a group tolerance for the stone fruit group except peach. This proposed rule builds on a related crop grouping system initially established via regulation on December 6, 1962 (27 FR 12100). That initial crop grouping scheme has been subsequently replaced and improved upon on two separate occasions (June 29, 1983 (48 FR 29855) and May 17, 1995 (60 FR 26626)). The May 1995 amendments established the current crop grouping scheme and presented the crop groups in tables. Subgroups were also created for 8 of the 19 crop groups, new commodities were added to existing groups and some representative commodities were revised. This provided petitioners with more flexibility in obtaining supporting residue data. During the rulemaking process for the 1995 amendments, EPA received comments requesting the inclusion of additional crop groups in the crop grouping scheme for crops such as oil seed crops, subtropical fruits, and tropical fruits. Those proposed changes were determined to be beyond the scope of the 1995 rulemaking. Nonetheless, EPA welcomed the opportunity to evaluate additional crop group and subgroup proposals submitted by interested parties for future consideration. In 2002, a nation wide cooperative effort called the USDA Inter-regional Research Project No.4 (IR-4), along with the governments of Canada and Mexico held the first International Crop Grouping Symposium. One conclusion from the symposium was that EPA's crop group regulation should be updated to incorporate more than 500 “orphan crops” (both domestic and imported) which are not currently members of a crop group. The symposium also recommended that many of the existing crop groups in the crop group regulation be revised to facilitate harmonization of crop groups and simplification of commodity terminology for establishing Maximum Residue Levels

(MRLs)internationally. The full proceedings from this symposium are available at *http://www.ir4.rutgers.edu/Other/USDACropGroupingSymposium.pdf* . The International Crop Groupings Consulting Committee (ICGCC) was subsequently convened and is presently composed of over 180 crop, agrichemical and regulatory experts representing more than 40 countries, including the United States, Canada and the European Union

(EU)members. The goal of the ICGCC is to harmonize international crop groupings and to that end, involves NAFTA. At the request of IR-4, the ICGCC reviews proposals for revised or new crop groups and develops crop petitions to submit to the EPA. The review process is conducted by an ICGCC workgroup which validates the crop group, subgroup, and commodities (including adding or deleting commodities), and provides commodity information including cultural, nutritional, and medicinal information. The group makes MRL comparisons with Codex and EU crop classification and evaluates world production on relevant commodities. Within this process, growers and commodity experts provide valuable input on commodities and international members provide specific information on the commodities grown in their countries and regions which provides perspectives on harmonization approaches. The ICGCC prepares commodity monographs for each specific crop group as well as information tables for crop group comparison. The draft crop grouping petition is then examined by the workgroup and the final petition is submitted by USDA IR-4 to EPA for analysis. Today's proposal is based upon three petitions developed by the ICGCC workgroup and submitted to EPA by IR-4. These petitions and the monographs supporting them have been included in the docket for the proposed rule. EPA expects that a series of additional petitions seeking amendments and changes to the crop groupings regulations (40 CFR 180.41) will originate from the ICGCC workgroup over the next few years. EPA believes that this proposal is a burden-reducing regulation. It will provide for greater sharing of data by permitting the results from magnitude of residue field trial studies in one crop to be applied to other similar crops. The primary beneficiaries are minor crop producers and consumers. Minor crop producers will benefit because lower registration costs will encourage more products to be registered on minor crops, providing additional tools for pest control. Consumers are expected to benefit by having more affordable and abundant food products available. Secondary beneficiaries are pesticide registrants. Expanded markets for pesticide products will lead to increased sales. EPA's position is that data from representative crops will not underestimate the public exposure to pesticide residues through the consumption of treated crops. The IR-4 Project and EPA, which are publicly funded Federal government entities, will also more efficiently use some resources as a result of the rule. Revisions to the crop grouping scheme will result in no appreciable costs or negative impacts to consumers, minor crop producers, pesticide registrants, the environment, or human health. There is also a growing international need for harmonizing crop groupings as the benefits of work sharing become more apparent. B. International Considerations 1. *NAFTA partner involvement in this proposal* . EPA's Chemistry Science Advisory Council (ChemSAC), an internal Agency peer review committee, provided a detailed analysis for each proposed crop group to Canada's Pest Management Regulatory Agency (PMRA), IR-4, and the government of Mexico for their review and comment and invited these parties to participate in the ChemSac meeting to finalize the report. EPA scientists will present the amended crop grouping to PMRA's Science Management Committee

(SMC)for their evaluation. EPA will provide a “reviewer's guide” describing the crop grouping amendments and explaining how to express the changes to the crop group in the **Federal Register** to IR-4 and PMRA in support of implementation and to inform the regulatory community. 2. *Relationship of this proposal to Codex activities* . In 2004 and 2005, Canada and the U.S. Codex delegation discussed possible opportunities that a linkage of the USDA IR-4 crop group initiative with ongoing limited revisions of the Codex system of Classification of Foods and Animal Feeds could bring to harmonizing MRL recommendations. In December 2005, the NAFTA TWG executive agreed that the United States and Canada should work together to advance incorporation of U.S. and Canadian bilateral activities on crop groups into the CCPR Codex work. Involvement by NAFTA TWG member countries in the Codex process will facilitate the adoption of the ICGCC crop groups, thereby providing a mechanism for developing residue data using representative crops at the international level. Standardization of commodity terminology within the global context and the adoption of Codex MRLs representative of the ICGCC Crop Groups will greatly facilitate international guideline harmonization. As a result of these efforts, minor crop growers will have easier access to crop protection tools by an improved extrapolation from representative crops to other crops in the same crop group, while a broader harmonization will minimize impediments to trade. EPA believes that NAFTA partners will pursue such programmatic changes. PMRA will in parallel undertake to follow its procedures under the authority of Canada's Pest Control Products

(PCP)Act

(2002)to publish its regulatory directives. These regulatory documents will be used to update the Residue Chemistry Guidelines of each NAFTA member country. Once the new or updated crop groups become effective in the United States, Mexico will have them as a reference for the establishment of maximum residue limits in Mexico. III. Specific Proposed Revisions This section explains the proposed revisions to the crop group regulations. A. Phasing out Pre-existing Crop Groups Amending pre-existing crop groups may result in uncertainty as to the status of crop group tolerances established prior to such an amendment as well as confusion in distinguishing between groups established before and after the amendment. This problem is particularly acute when the amendment adds or removes commodities from the coverage of the crop group. To avoid potential confusion, EPA is proposing to amend the generic crop group regulations to include an explicit scheme for how revised crop groups will be organized in the regulations. In brief, EPA is proposing that, when a crop group is amended in a manner that expands or contracts its coverage of commodities, EPA will

(1)retain the pre-existing crop group in § 180.41;

(2)insert the revised crop group immediately after the pre-existing crop group in the CFR; and

(3)title the revised crop group in a way that clearly differentiates it from the pre-existing crop group. Under the proposed nomenclature the revised crop group will retain roughly the same name and number as the pre-existing group except that the number will be followed by a hyphen and the final two digits of the year it is established. For example, today EPA is proposing to revise Crop Group 3: Bulb Vegetables ( *Allium* spp.) Group. The revised group will be titled Crop Group 3-07: Bulb Vegetables Group. Dropping “( *Allium* spp.)” reflects the revised character of the group. Where additions to a crop group make the pre-existing crop group name misleading, EPA will amend the name as well as the number. For example, today EPA is proposing to revise Crop Group 13: Berries Group. The revised group will be titled Crop Group 13-07: Berries and Small Fruit Group. This change is necessary because of the addition of commodities to this group. Tolerances established for revised crop groups will include the new number (and new name, if applicable) so that it is apparent on the face of the tolerance regulation what commodities are covered. Similarly, it will be clear what tolerances for pre-existing crop groups are covered since these existing tolerance regulations use the pre-existing crop group names. Although EPA will initially retain pre-existing crop groups that have been superceded by revised crop groups, EPA will not establish new tolerances under the pre-existing groups. Further, EPA plans to eventually convert tolerances for any pre-existing crop groups to tolerances with the coverage of the revised crop group. This conversion will be effected both through the registration review process and in the course of preparing new risk assessments for a pesticide. To this end, EPA requests that petitioners for tolerances address this issue in their petitions. For example, assuming EPA adopts the amendment to Crop Group 3: Bulb Vegetables ( *Allium* spp.) Group, any tolerance petition for a pesticide that has a Group 3 tolerance should include a request that the Group 3 tolerance be amended to a Group 3-07 tolerance, since the representative commodities are equivalent. When all crop group tolerances for a superceded crop group have been revised or removed, EPA will remove the superceded group from § 180.41. B. Group 3-07: Bulb Vegetables Group EPA is proposing to revise the bulb vegetables crop group in the following manner. EPA will retain the pre-existing Crop Group 3 and title the revised group as Crop Group 3-07. 1. *Add commodities* . EPA proposes to amend the existing Crop Group 3 from 7 to 25 commodities. The existing crop group consists of the following seven commodities:

(1)Garlic ( *Allium sativum L. var.sativum* );

(2)Garlic, great-headed (elephant) ( *Allium ampeloprasm L. var ampleloprasum* );

(3)Leek ( *Alliumporrum L.* );

(4)Onion, dry bulb and green, ( *Allium cepa L. var. cepa* );

(5)Onion, Welsh, ( *Allium fistulosm* L.);

(6)Shallot, bulb ( *Allium cepa var. aggregatum* G. Don); and

(7)Shallot, fresh leaves ( *Allium cepa var.aggregatum* G. Don). The 18 commodities EPA proposes to add to the group are:

(1)Chive, fresh leaves ( *Allium schoenoprasum L* .);

(2)Chive, Chinese, fresh leaves ( *Allium tuberosum Rottler ex. Spreng* .);

(3)Daylily, bulb ( *Hemerocallis fulva L.* ) (L. var. fulva);

(4)Elegans hosta ( *Hosta Sieboldiana* *(Hook) Engl* );

(5)Fritillaria, bulb, ( *Fritillaria L. fritillary* );

(6)Fritillaria, leaves ( *Fritillaria L. fritillary* );

(7)Garlic, serpent, bulb, ( *Allium sativum var. ophioscorodon* );

(8)Kurrat ( *Allium kurrat Schweinf. ex. K. Kause* )

(9)Lady's leek ( *Allium cernuum* Roth);

(10)Lily, bulb ( *Lilium* spp. ( *Lilium Leichtlinii var maximowiczii, Lilium lancifolium* ));

(11)Onion, Beltsville bunching ( *Allium x proliferum* (Moench) Schrad. Ex. Willd);

(12)Onion, Chinese, bulb ( *Allium chinense* G. Don.);

(13)Onion, fresh ( *Allium fistulosum L. var. caespitosum Makino* );

(14)Onion, macrostem ( *Allium macrostemom* Bunge);

(15)Onion, pearl ( *Allium porrum var. sectivum* );

(16)Onion, potato, bulb ( *Allium cepa L. var. aggregatum* G. Don);

(17)Onion, tree, tops ( *Allium x proliferum* (Moench) Schrad. ex. Willd.); and

(18)Wild leek ( *Allium tricoccum* Aiton). Commodities are being added to this crop group for several reasons. EPA is now able to place many minor or specialty crops that were considered “orphan crops” into an appropriate crop group. The publication of the “Food and Feed Crops of the United States” includes over 690 crops and provides the necessary information. Additionally, increased demand for these minor fruits and vegetables by U.S. growers and consumers, particularly immigrants, drives the need for pest control tools and thus the need to group crops. Increasing the variety of available pest control tools for a crop enables U.S. growers to develop integrated pest management programs (IPM), which can minimize pest resistance for these high cash value alternative crops. 2. *Change the names of representative commodities* . EPA proposes to change the names of the representative commodities for the crop group by designating onion, bulb and onion, green as the representative commodities. The representative commodities for the group are currently listed as onion, green and onion dry bulb. This change merely adopts current commodity name designations. 3. *Create crop subgroups* . EPA proposes to add two crop subgroups to the revised crop group. The subgroups are: i. *Subgroup 3-07-A* . Bulb onion subgroup. *Representative crop* . Onion, bulb. Eleven commodities are included in this subgroup: Daylily, bulb; Fritillaria, bulb; Garlic, bulb; Garlic great-headed, bulb; Garlic, serpent, bulb; Lily, bulb; Onion, bulb; Onion, Chinese, bulb; Onion, pearl; Onion, potato, bulb; Shallot, bulb. ii. *Subgroup 3-07-B* . Green onion subgroup. *Representative crop* . Onion, green. Fifteen commodities are included in this subgroup: Chive, fresh leaves; Chive, Chinese, fresh leaves; Elegans hosta; Fritillaria, leaves; Kurrat; Lady's leek; Leek; Leek, wild; Onion, Beltsville bunching; Onion, fresh; Onion, green; Onion, macrostem; Onion, tree, tops; Onion, Welsh; Shallots, fresh leaves. Creation of subgroups provides flexibility in the establishment of crop group tolerances which can be important for international harmonization. EPA has determined that residue data on the designated representative crops will provide adequate information on residue levels in crops and subgroups. This determination is based on similarities in cultural practices, edible food portions (bulb vs. leaves), the fact that none of these crops are used as animal feed items, as well as existing data on residue levels in these crops. 4. *Change the format* . EPA proposes to convert the current narrative format of the existing group to tabular form. This format will make it easier to read and understand. 5. *Change the name* . EPA is proposing to drop the descriptor “( *Allium* spp.)” from the name because, commodities not in Allium spp. are now included in the group. C. Crop Group 13-07: Berry and Small Fruit Group EPA is proposing to revise and expand the berries crop group in the following manner. EPA will retain pre-existing Crop Group 13 and title the revised group as Crop Group 13-07. 1. *Add commodities* . Crop Group 13 currently contains the following 11 commodities:

(1)Blackberries ( *Rubus eubatus* );

(2)Blueberry, highbush;

(3)Blueberry, lowbush ( *Vaccinium* spp.);

(4)and

(5)Currant, black and red( *Ribes nigrum* L., *Ribes rubrum* L.);

(6)Elderberry ( *Sambucus* spp.);

(7)Gooseberry, ( *Ribes* spp.);

(8)Huckleberry, ( *Gaylussacia* spp.);

(9)Loganberry ( *Rubus loganobaccus* L.H. Bailey); and

(10)and

(11)Raspberry, black and red ( *Rubus cccidentalis* L., *Rubus strigosus* Michx., *Rubusidaeus* L.). EPA proposes to expand Crop group 13 by adding 36 commodities as follows:

(1)Amur River grape ( *Vitis amurensis* Rupr ( *Vitaceae* ));

(2)Aronia berry ( *Aronia* spp. ( *Rosaceae* ));

(3)Bayberry ( *Myrica* spp. ( *Myricaceae* ))

(4)Bearberry ( *Arctostaphylos uva-ursi* (L.) Spreng ( *Ericaceae* ));

(5)Bilberry ( *Vaccinium myrtillus* L. ( *Ericaceae* ));

(6)Buffalo Currant ( *Ribes aureum* Pursh. ( *Grossulariaceae* ));

(7)Buffaloberry ( *Shepherdia argentea* (Pursh) Nutt.( *Eleagnaceae* ));

(8)Che ( *Cudrania tricuspidata* Bur. ex Lavallee ( *Moraceae* ));

(9)Chilean guava ( *Myrtus ugni* Mol. ( *Myrtaceae* ));

(10)Chokecherry ( *Prunus virginiana* L. ( *Rosaceae)* );

(11)Cloudberry ( *Rubus chamaemorus* L. ( *Rosaceae* ));

(12)Cranberry ( *Vaccinium macrocarpon* Aiton ( *Ericaceae* ));

(13)European barberry ( *Berberis vulgaris* L. ( *Berberidaceae* ));

(14)Grape ( *Vitis* spp. ( *Vitaceae* ));

(15)Highbush cranberry, ( *Viburnum opulus* L. var. *Americanum* Aiton ( *Caprifoliaceae)* );

(16)Honeysuckle, edible ( *Lonicera caerula L. var. emphyllocalyx* Nakai ( *Caprifoliaceae* ));

(17)Jostaberry ( *Ribes x nidigrolaria* Rud. Bauer & A. Bauer. *Grossulariaceae* ( *Saxifragaceae* ));

(18)Juneberry (including Saskatoon Berry)( *Amelanchier* spp. ( *Rosaceae* ));

(19)Kiwifruit, fuzzy ( *Actinidia deliciosa* (A. Chev.) C.F. Liang & A.R. Ferguson ( *Actinidaceae* ));

(20)Kiwifruit, hardy ( *Actinidia arguta* (Siebold & Zucc.) Planch. Ex Miq ( *Actinidaceae* ));

(21)Lingonberry ( *Vaccinium vitis-idaea* L. ( *Ericaceae* ));

(22)Maypop ( *Passiflora incarnata* L. ( *Passifloraceae* ));

(23)Mountain Pepper Berries ( *Tasmannia lanceolata* (Poir.) A.C. Sm.( *Winteraceae* ));

(24)(Mulberry ( *Morus* spp. ( *Moraceae* ));

(25)Muntries ( *Kunzea pomifera* F. Muell. ( *Myrtaceae* ));

(26)(Native currant ( *Acrotriche depressa* R. Br. ( *Epacridaceae* ));

(27)Partridgeberry ( *Mitchella repens* L. ( *Rubiaceae* ));

(28)Phalsa ( *Grewia subinaequalis* DC. ( *Tiliaceae* ));

(29)Pincherry ( *Prunus pensylvanica* L. f. ( *Rosaceae* ));

(30)Riberry ( *Syzygium luehmannii (Myrtaceae)* );

(31)Salal ( *Gaultheria shallon* Pursh ( *Ericaceae* ));

(32)Schisandra berry ( *Schisandra chinensis* (Turcz.) Baill. ( *Schisandraceae* ));

(33)Sea buckthorn ( *Hippophae rhamnoides* L. ( *Eleagnaceae)* );

(34)Serviceberry ( *Sorbus* spp. ( *Rosaceae* ));

(35)Strawberry ( *Fragaria x ananassa* Duchesne, ( *Rosaceae* )) and

(36)Wild raspberry ( *Rubus muelleri* Lefevre ex P.J. Mull ( *Rosaceae* )). The proposed addition of crops to this crop group is based on reasons similar to those for expanding the bulb vegetable group. Additionally, newer varieties of specialty berries and small fruits have become available for grower and homeowner use that were not previously in this crop group. These commodities have similarities in cultural practices, edible food portions (mostly berries) and residue levels. 2. *Change the crop group name* . EPA proposes to change the name of “Crop Group 13: Berries Group” to “Crop Group 13-07: Berry and small fruit group.” This name change reflects the addition of the new commodities to the group. 3. *Revise the existing subgroups* . EPA is proposing that revised Crop Group 13-07 have two subgroups. Subgroup 13-07-A is similar to existing Subgroup 13-A except that wild raspberry has been added. Wild raspberry, like the other members of this subgroup, is a member of the genus “ *Rubus* spp.,”and the members of this genus have a similar fruit structure and are cultivated as shrubs. EPA proposes to revise the Bushberry subgroup 13-B by adding 9 additional commodities for a total of 16 as follows in the revised Bushberry subgroup 13-07-B:

(1)Aronia berry

(2)Blueberry, highbush, and cultivars and/or hybrids of these

(3)Blueberry, lowbush

(4)Buffalo currant

(5)Chilean guava

(6)Currrant, black and currant red

(7)Elderberry

(8)European barberry

(9)Gooseberry

(10)Highbush cranberry

(11)Honeysuckle, edible

(12)Huckleberry

(13)Jostaberry

(14)Native currant

(15)Salal

(16)Sea Buckthorn. The crops proposed to be added to this subgroup are all maintained as bushes and all have edible exposed berries. They are all similar in plant biology and cultural practices and are likely to have similar pest problems and the need for pest control products with similar use patterns. 4. *Create new subgroups* . EPA proposes to add six new subgroups to revised Crop Group 13-07 as follows: i. *Large shrub/tree berry subgroup 13-07-C* . ( *Representative commodities* . Elderberry or Mulberry) Bayberry; Buffaloberry; Che; Chokeberry; Elderberry; Juneberry; Mountain pepper berries; Mulberry; Phalsa; Pinchberry; Riberry; Serviceberry. ii. *Small fruit vine climbing subgroup 13-07-D* . ( *Representative commodities* . Grape and Fuzzy kiwifruit) Amur river grape; Gooseberry; Grape; Kiwifruit, fuzzy; Kiwifruit, hardy; Maypop; Schisandra berry. iii. *Small fruit vine climbing subgroup, except grape 13-07-E* . ( *Representative commodity* . Fuzzy kiwifruit) Amur river grape; Gooseberry; Kiwifruit, fuzzy; Kiwifruit, hardy; Maypop; Schisandra berry. iv. *Small fruit vine climbing subgroup except fuzzy kiwifruit, Grape 13-07-F.* ( *Representative commodity* . Grape) Amur river grape; Grape; Kiwifruit, hardy; Maypop; Schisandra berry. v. *Low growing berry subgroup 13-07-G* . ( *Reprensentative commodity* . Strawberry) Bearberry; Bilberry; Blueberry, lowbush; Cloudberry; Cranberry; Lingonberry; Muntries; Partridgeberry; Strawberry. vi. *Low growing berry subgroup, except strawberry 13-07-H* . ( *Representative commodity* . Cranberry) Bearberry; Bilberry; Blueberry, lowbush; Cloudberry; Cranberry; Ligonberry; Muntries; Partridgeberry. Creation of subgroups provides flexibility in the establishment of crop group tolerances which can be important for international harmonization. EPA has determined that residue data on the designated representative crops will provide adequate information on residue levels in crops and subgroups. This determination is based on similarities in cultural practices, edible food portions, geographical location, the fact that none of these crops are used as animal feed items, as well as existing data on residue levels in these crops. 5. *Revise the representative commodities* . EPA proposes to revise the representative crops for Crop Group 13-07 as follows: “Any one blackberry or any one raspberry; and blueberry” will be changed to “Any one blackberry or any one raspberry; highbush blueberry; elderberry or mulberry; grape; fuzzy kiwifruit; and strawberry.” As explained above, these commodities are representative of their respective subgroups and thus, in combination with other commodities, are representative of the entire group. D. New Crop Group 21: Edible Fungi Group EPA proposes to add a new crop group, entitled Edible Fungi, as Crop Group 21 and to include in this crop group 20 commodities in 12 fungi families.

(1)Blewitt ( *Lepista nuda* (Bull.:Fr.) Cooke ( *Tricholomataceae* ));

(2)Bunashimeji ( *Hypsizygus marmoreus (Agaricaceae)* );

(3)Chinese mushroom ( *Volvariella volvacea* (Bull.) Singer ( *Pluteaceae* ));

(4)Enoke ( *Flammulina velutipes* (Curt.) Singer ( *Tricholomataceae* ));

(5)Hime-Matsutake ( *Agaricus blazei* Murill ( *Agaricaceae* ));

(6)Hirmeola ( *Auricularia auricula (Auriculariaceae)* );

(7)Maitake ( *Grifola frondosa (Polyporaceae)* );

(8)Morel ( *Morchella* spp. ( *Morchellaceae* ));

(9)Nameko ( *Pholiota nameko, (Strophariaceae)* );

(10)Net Bearing (Dictyophora *Dictyophora indusiata (Phallaceae)* );

(11)Oyster Mushroom ( *Pleurotus ostreatus (Jacq.)* Kummer ( *Tricholomataceae* ));

(12)Pom Pom ( *Hericium erinaceus (Hydnaceae)* );

(13)Reishi Mushroom ( *Ganoderma lucidum (Leyss. Fr.)* Karst. ( *Ganodermataceae* ));

(14)Rodmans (Agaricus, *Agaricus bitorquis (Quel.) Saccardo (Agaricaceae)* );

(15)Shiitake mushroom ( *Lentinula edodes (Berk.) Pegl. (Polyporaceae)* );

(16)Shimeji ( *Tricholoma conglobatum* , ( *Tricholomataceae* ));

(17)Stropharia ( *Stropharia* spp. ( *Strophariaceae* ))

(18)Truffle *Tuber* spp. ( *Tuberaceae* );

(19)White button mushroom ( *Agaricus bisporus* (Lange) *Imbach (Agaricaceae* )) and

(20)White Jelly fungi ( *Tremella fuciformis (Tremellaceae* )). Edible Fungi Group 21 is proposed based on similarities in cultural edible food portions, residue levels, geographical locations, pest problems, the fact that none of these crops are used as animal feed items and for international harmonization purposes. All members of this crop group are either grown in indoor structures under very strict environmentally controlled conditions or cultivated outdoors as a crop. This new crop group will have no crop subgroup associated with it. The commodities grown in this proposed crop group are principally grown in other countries. This crop group will provide the opportunity for domestic growers to produce these high value minor crops that are in demand, particularly from immigrant populations in the United States. EPA proposes to define the representative commodities for the Edible Fungi Group 21 as: “White button mushrooms and any one oyster mushroom or any one Shiitake mushroom.” These proposed representative commodities were chosen based on their production and economic importance. The cultural practices, pest problems, and commercial production of the different edible fungi are also similar. Specialty mushrooms, which are expanding in the United States, will be represented by the oyster or shiitake mushroom. E. Technical Corrections EPA proposes that the misspelled commodity “Onion, Welch” in Crop Group 3 be corrected to “Onion, Welsh”. This correction will be made in pre-existing Crop Group 3. Additionally, EPA is proposing to list the commodities in pre-existing Crop Group 3 in tabular form. EPA proposes to revise the commodity definitions under 40 CFR 180.1(g) pertaining to onions and adding an entry for garlic to clarify these definitions. The proposed changes are: • Onion = Bulb onion, green onion, and garlic. • Onion, bulb = Bulb onion; garlic; great headed garlic; serpent garlic; Chinese onion; pearl onion; potato onion; and shallot, bulb. • Onion, green = Green onion; chive, fresh leaves; Chinese chive, fresh leaves; Kurrat; lady's leek; leek; wild leek; Beltsville bunching onion; fresh onion; tree onion, tops; welsh; and shallot, fresh leaves. • Garlic = Garlic, Great headed garlic, and serpent garlic. EPA proposes to revise the commodity definition in 40 CFR 180.1(g) for caneberries as follows: • Caneberry = *Rubus* spp. (including blackberry; *Rubus caesius* (youngberry); *Rubus loganbaccus* (loganberry); *Rubus idaeus* (red and black raspberries); and varieties and/or hybrids of these). This proposed amendment will correct the scientific names to the caneberry commodity definition and update the commodity terminology to conform to the “EPA Food and Feed Commodity Vocabulary” rules for commodity terminology. EPA proposes to establish a new commodity definition in 40 CFR 180.1(g) for raspberry as follows: Raspberry = *Rubus* spp. (including bababerry, black raspberry, blackcap, caneberry, framboise, frambueso, himbeere, keriberry, mayberry, red raspberry, thimbleberry, tulameen, yellow raspberry, and cultivars and/or hybrids of these). This proposed commodity definition for raspberry will further clarify the cultivars of raspberry covered in the Caneberry subgroup. EPA proposes to delete from § 180.41(b) the terms: Mushroom; grape; strawberry, and kiwifruit. These commodities were listed as not being in a crop group, but are now proposed to become crop group members. IV. Statutory and Executive Order Reviews A. Executive Order 12866 Under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993), the Office of Management and Budget

(OMB)has designated this proposed rule as a not-significant regulatory action under section 3(f) of the Executive Order. EPA prepared an analysis of the potential costs and benefits associated with this action. This analysis is contained in “Economic Analysis Proposed Expansion of Crop Grouping Program.” A copy of the analysis is available in the docket and is briefly summarized here. This is a burden-reducing regulation. Crop grouping has saved money by permitting the results of pesticide exposure studies for one to be applied to other, similar crops. The regulation exploits the above opportunity for saving money by expanding certain crop groups to include more crops. The primary beneficiaries of the regulation are minor crop producers and consumers. Specialty crop producers will benefit because lower registration costs will encourage more products to be registered on minor crops, providing additional tools pest control. Consumers will benefit by having a larger supply of imported and domestically produced specialty produce at potentially lower costs. Secondary beneficiaries are pesticide registrants, who benefit because expanded markets for pesticides products will lead to increased sales. The IR-4 Project and EPA, which are publicly funded Federal government entities, will also more efficiently use resources as a result of the rule. EPA will also benefit from broader operational efficiency gains, which result from fewer emergency pesticide use requests from specialty crop growers, the ability to conduct risk assessment based on crop grouping, greater ease of establishing import tolerances, greater capacity to assess risks of pesticides used on crops not grown in the United States, further harmonization of crop classification and nomenclature, harmonized commodity import and export standards and increased potential for resource sharing between EPA and other pesticide regulatory agencies. Revisions to the crop grouping program will result in no appreciable costs or negative impacts to consumers, specialty crop producers, pesticide registrants, the environment or human health. Benefits of the proposed rule can be shown through an example of the impact of the proposed changes to Crop Group 3. The proposed rule expands Crop Group 3, Bulb Vegetables from 7 to 25 crops, an increase of 18 from the original crop group. The addition of these crops would greatly increase the efficiency of IR-4 and EPA in registering pesticides on specialty crops. Assuming that the crops added to the crop group require only one field trial to be granted a stand-alone registration (grown on a regional basis and few acres), to accomplish the same result without expanding Crop Group 3 would require 18 field trials, at a cost of $5.4 million ($300,000 per field trial) and the administrative costs of both the IR-4 testing process and the EPA review process. In addition, specialty crop producers will potentially gain access to important pest control tools on 18 bulb vegetable crops, consumers will benefit from the potential for a cheaper, more abundant and varied supply of bulb vegetables, and pesticide registrants will potentially enjoy greater sales. B. Paperwork Reduction Act This action does not contain any new information collection requirements that would need approval by OMB under the provisions of the Paper Reduction Act (PRA), 44 U.S.C. 3501 *et seq.* However, the proposed rule is expected to reduce mandatory paperwork due to a reduction in required studies. The proposed rule will have the effect of reducing the number of residue chemistry studies because fewer representative crops would need to be tested under a crop grouping scheme, than it would otherwise be required. EPA is interested in your comments on the estimated reductions as presented in the Economic Analysis prepared for this proposed rule. Direct your comments to EPA using the public docket that has been established for this proposed rule as described in ADDRESSES . The Agency will consider and address comments received as it develops the final rule. C. Regulatory Flexibility Act Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 *et seq.* , the Agency hereby certifies that this rule will not have a significant adverse economic impact on a substantial number of small entities. This proposed rule does not have any direct adverse impacts on small businesses, small non-profit organizations, or small local governments. For purposes of assessing the impacts of today's rule on small entities, small entity is defined as:

(1)A small business according to the small business size standards established by the Small Business Administration (SBA);

(2)a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and

(3)a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives ‘‘which minimize any significant economic impact on of the proposed rule on small entities'' (5 U.S.C. sections 603 and 604). Thus, an agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden or otherwise has a positive economic effects on all of the small entities subject to the rule. This proposed action provides regulatory relief and regulatory flexibility because the new or expanded crop groups ease the process for pesticide manufacturers to obtain pesticide tolerances on greater numbers of crops and make it likely that pesticides will be more widely available to growers for use on crops, particularly specialty crops. D. Unfunded Mandates Reform Act Under Title II of the Unfunded Mandates Reform Act of 1995

(UMRA)(Public Law 104-4), EPA has determined that this action does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any 1 year. Accordingly, this rule is not subject to the requirements of sections 202, 203, 204, and 205 of UMRA. E. Executive Order 13132 Pursuant to Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), EPA has determined that this proposed rule does not have federalism implications, because it will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in the Order. Thus, Executive Order 13132 does not apply to this proposed rule. F. Executive Order 13175 As required by Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000), EPA has determined that this proposed rule does not have tribal implications because it will not have any affect on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in the Order. Thus, Executive Order 13175 does not apply to this proposed rule. G. Executive Order 13045 Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997) does not apply to this proposed rule because this action is not designated as an economically significant regulatory action as defined by Executive Order 12866 (see Unit IV.A.), nor does it establish an environmental standard, or otherwise have a disproportionate effect on children. H. Executive Order 13211 This proposed 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) because it is not designated as an regulatory action as defined by Executive Order 12866 (see Unit IV.A.), nor is it likely to have any adverse effect on the supply, distribution, or use of energy. I. National Technology Transfer and Advancement Act Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, and sampling procedures) that are developed or adopted by voluntary consensus standards bodies. This proposed rule does not impose any technical standards that would require EPA to consider any voluntary consensus standards. J. Executive Order 12898 Under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994), the Agency has not considered environmental justice-related issues because this proposed rule does not have an adverse impact on the environmental and health conditions in low-income and minority communities. List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedures, Pesticides and pests. Dated: May 10, 2007. James B. Gulliford, Assistant Administrator for Prevention, Pesticides and Toxic Substances. Therefore, it is proposed that 40 CFR chapter I be amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 would continue to read as follows: Authority: 21 U.S.C. 321(q), 346a, and 371. 2. In the table to § 180.1(g) by revising the entries for “Caneberries,” “Onions,” “Onions (dry bulb only),” and “Onions, green,” and by adding entries for “Garlic,” and “Raspberry” to read as follows: § 180.1 Definitions and interpretations.

(g)* * * A B * * * * * Caneberry *Rubus* spp. (including blackberry; *Rubus caesius* (youngberry) *Rubus loganbaccus* (loganberry); *Rubus idaeus* (red and black raspberries); and varities and/or hybrids of these. * * * * * Garlic Garlic, great headed garlic, and serpent garlic. * * * * * Onion Bulb onion, green onion, and garlic. Onion, bulb Bulb onion: garlic; great headed garlic; serpent garlic; Chinese onion; pearl onion; potato onion; and shallot, bulb. Onion, green Green onion; lady's leek; leek; wild leek; Beltsville bunching onion; fresh onion; tree onion, tops; Welsh, onion; and shallot, fresh leaves. * * * * * Raspberry *Rubus* spp. (including bababerry, black raspberry, blackcap, caneberry, framboise, frambueso, himbeere, keriberry, mayberry, red raspberry, thimbleberry, tulameen, yellow raspberry, and cultivars and /or hybrids of these). * * * * * 3. In § 180.40 by redesignating paragraph

(j)as paragraph

(k)and by adding new paragraph

(j)to read as follows: § 180.40 Tolerances for crop groups.

(j)When EPA amends a crop group in a manner that expands or contracts the commodities that are covered by the group, EPA will initially retain the pre-existing as well as the revised crop group in the CFR. The revised crop group will have the same number as the pre-existing crop group; however, the revised crop group number will be followed by a hyphen and the final two digits of the year in which it was established (e.g., if Crop Group 1 is amended in 2007, the revised group will be designated as Crop Group 1-07). If the pre-existing crop group had crop subgroups, these subgroups will be numbered in a similar fashion in the revised crop group. The name of the revised crop group will not be changed from the pre-existing crop group unless the revision so changes the composition of the crop group that the pre-existing name is no longer accurate. Once a revised crop group is established, EPA will no longer establish tolerances under the pre-existing crop group. At appropriate times, EPA will amend tolerances for crop groups that have been superseded by revised crop groups to conform the pre-existing crop group to the revised crop group. Once all of the tolerances for the pre-existing crop group have been updated, the pre-existing crop group will be removed from the CFR. 4. Section 180.41 is amended by removing the commodities: mushroom, grape, strawberry, and kiwifruit from paragraph (b); by revising paragraph (c)(3) and by redesignating paragraphs (c)(4) through (c)(19) as paragraphs (c)(5) through (c)(20), respectively, and by adding a new paragraph (c)(4) to read as follows: § 180.41 Crop group tables.

(c)* * *

(3)*Crop Group 3* . Bulb Vegetables ( *Allium* spp.) Group.

(i)*Representative commodities* . Onion, green; and onion, dry bulb.

(ii)*Commodities* . The following is a list of all the commodities in Crop Group 3. **Crop Group 3: Bulb Vegetable (Allium spp.) Group—Commodities** Garlic, bulb ( *Allium sativum* ) Garlic, great headed, (elephant) ( *Allium ampeloprasum* var. *ampeloprasum* ) Leek ( *Allium ampeloprasum* , *A. porrum, A. tricoccum* ) Onion, dry bulb and green ( *Allium cepa, A. fistulosum* ) Onion, Welsh, ( *Allium fistulosum* ) Shallot ( *Allium cepa* var. *cepa* )

(4)*Crop Group 3-07* . Bulb Vegetables Group.

(i)*Representative commodities* . Onion, bulb and onion, green.

(ii)*Table* . The following Table 1 lists all the commodities listed in Crop Group 3-07 and identifies the related crop subgroups. **Table 1.—Crop Group 3-07: Bulb Vegetable Group** Commodities Related crop subgroups Chive, fresh leaves *Allium schoenoprasum L* . 3-07-B Chive, Chinese, fresh leaves *Allium tuberosum* Rottler ex Spreng 3-07-B Daylily, bulb *Hemerocallis fulva* (L.) L. var. fulva 3-07-A Elegans hosta *Hosta Sieboldiana (Hook.) Engl* 3-07-B Fritillaria, bulb *Fritillaria L. fritillary* 3-07-A Fritillaria, leaves *Fritillaria L. fritillary* 3-07-B Garlic, bulb *Allium sativum* L. var. *sativum* ( *A. sativum* Common Garlic Group) 3-07-A Garlic, great headed, bulb *Allium ampeloprasum* L. var. *ampeloprasum* ( *A. ampeloprasum* Great-headed Garlic Group) 3-07-A Garlic, Serpent, bulb *Allium sativum* var. *ophioscorodon* (or *A. sativum* Ophioscorodon Group) 3-07-A Kurrat *Allium kurrat Schweinf. Ex. K. Krause* (or *A. ampeloprasum* Kurrat Group) 3-07-B Lady's leek *Allium cernuum* Roth 3-07-B Leek *Allium porrum* L. (syn: *A. ampeloprasum L.* var. *porrum* (L.) J. Gay) ( *A.ampeloprasum* Leek Group) 3-07-B Leek, wild *Allium tricoccum* Aiton 3-07-B Lily, bulb *Lilium* spp. ( *Lilium Leichtlinii* var *maximowiczii, Lilium lancifolium* ) 3-07-A Onion, Beltsville bunching *Allium x proliferum* (Moench) Schrad. (syn: *Allium fistulosum* L. x *A. cepa* L.) 3-07-B Onion, bulb *Allium cepa* L. var. *cepa* ( *A. cepa* Common Onion Group) 3-07-A Onion, Chinese, bulb *Allium chinense* G. Don. (syn: *A. bakeri* Regel) 3-07-A Onion, fresh *Allium fistulosum* L. var. *caespitosum* Makino 3-07-B Onion, green *Allium cepa* L. var *. cepa* ( *A. cepa* Common Onion Group) 3-07-B Onion, macrostem *Allium macrostemom* Bunge 3-07-B Onion, Pearl *Allium porrum* var. *sectivum* (or *A. ampeloprasum* Pearl Onion Group) 3-07-A Onion, potato, bulb *Allium cepa L.* var. *aggregatum* G. Don. ( *A. cepa* Aggregatum Group) 3-07-A Onion, tree, tops *Allium x proliferum* (Moench) Schrad. ex Willd. (syn: *A. cepa* var. *proliferum* (Moench) Regel; *A. cepa* L. var. *bulbiferum* L.H. Bailey; *A. cepa* L. var. *viviparum* (Metz.) Alef.) 3-07-B Onion, Welsh, tops *Allium fistulosum* L. 3-07-B Shallot, bulb *Allium cepa* var. *aggregatum* G. Don 3-07-A Shallot, fresh leaves *Allium cepa* var. *aggregatum* G. Don 3-07-B

(iii)*Table* . The following Table 2 identifies the crop subgroups for Crop Group 3-07, specifies the representative commodities for each subgroup and lists all the commodities included in each subgroup. **Table 2.—Crop Group 3-07: Subgroup Listing** Representative commodities Commodities **Crop subgroup 3-07-A** . Onion, bulb, subgroup Daylily, bulb; Fritillaria, bulb; Garlic, bulb; Garlic, great-headed, bulb; Garlic, Serpent, bulb; Lily, bulb; Onion, bulb; Onion, Chinese, bulb; Onion, Pearl; Onion, potato, bulb; Shallot, bulb. **Crop subgroup 3-07-B** . Onion, green, subgroup Chive, fresh leaves; Chive, Chinese, fresh leaves; Elegans hosta; Fritillaria, leaves; Kurrat; Lady's leek; Leek; Leek, wild; Onion, Beltsville bunching; Onion, fresh; Onion, green; Onion, macrostem; Onion, tree, tops; Welsh onion; Shallot, fresh leaves. 5. Section 180.41 is further amended by redesignating newly redesignated paragraphs (c)(15) through (c)(20) as paragraphs (c)(16) through (c)(21), respectively, and by adding a new paragraph (c)(15), and paragraph (c)(22) to read as follows: § 180.41 Crop group tables.

(c)* * *

(15)*Crop Group 13-07* . Berry and Small Fruit Crop Group.

(i)*Representative commodities* . Any one blackberry or any one raspberry; highbush blueberry; elderberry or mulberry; grape; kiwifruit, fuzzy; and strawberry.

(ii)*Table* . The following Table 1 lists all the commodities listed in Crop Group 13-07 and identifies the related crop subgroups. **Table 1.—Crop Group 13-07: Berry and Small Fruit Crop Group** Commodities Related crop subgroups Amur river grape ( *Vitis amurensis Rupr* ) 13-07-D 13-07-E 13-07-F Aronia berry ( *Aronia* spp.) 13-07-B Bayberry ( *Myrica* spp.) 13-07-C Bearberry ( *Arctostaphylos uva-ursi* ) 13-07-G 13-07-H Bilberry ( *Vaccinium myrtillus L* .) 13-07-G 13-07-H Blackberry ( *Rubus* spp.) (including Andean blackberry, arctic blackberry, bingleberry, black satin berry, boysenberry, brombeere, California blackberry, Chesterberry, Cherokee blackberry, Cheyenne blackberry, common blackberry, coryberry, darrowberry, dewberry, Dirksen thornless berry, evergreen blackberry, Himalayaberry, hullberry, lavacaberry, loganberry, lowberry, Lucretiaberry, mammoth blackberry, marionberry, mora, mures deronce, nectarberry, Northern dewberry, olallieberry, Oregon evergreen berry, phenomenalberry, rangeberry, ravenberry, rossberry, Shawnee blackberry, Southern dewberry, tayberry, youngberry, zarzamora, and cultivars and/or hybrids of these 13-07-A Blueberry, highbush ( *Vaccinium* spp.) 13-07-B Blueberry, lowbush ( *Vaccinium angustifolium* Aiton) 13-07-B Buffalo currant ( *Ribes aureum* Pursh) 13-07-B Buffaloberry ( *Shepherdia argentea* (Pursh) Nutt.) 13-07-C Che ( *Cudrania tricuspidata* Bur. Ex Lavallee 13-07-C Chilean guava ( *Myrtus ugni* Mol.) 13-07-B Chokecherry ( *Prunus virginiana* L.) 13-07-C Cloudberry ( *Rubus chamaemorus* L.) 13-07-G 13-07-H Cranberry ( *Vaccinium macrocarpon* Aiton) 13-07-G 13-07-H Currant, black ( *Ribes nigrum* L.) 13-07-B Currant, red ( *Ribes rubrum* L.) 13-07-B Elderberry ( *Sambucus* spp.) 13-07-B 13-07-C European barberry ( *Berberis vulgaris* L.) 13-07-B Gooseberry ( *Ribes* spp.) 13-07-B 13-07-D 13-07-E Grape ( *Vitis* spp.) 13-07-D 13-07-F Highbush cranberry ( *Viburnum opulus* L. var. *Americanum* Aiton) 13-07-B Honeysuckle, edible ( *Lonicera caerula L. var. emphyllocalyx* Nakai, *Lonicera carrula L var. edulis Turcz. Ex herder* ) 13-07-B Huckleberry ( *Gaylussacia* spp.) 13-07-B Jostaberry ( *Ribes x nidigrolaria* Rud. Bauer & A. Bauer) 13-07-B Juneberry, Saskatoon berry ( *Amelanchier* spp.) 13-07-B 13-07-C Kiwifruit, fuzzy ( *Actinidia deliciosa* A. Chev.) C.F. Liang & A.R. Ferguson) 13-07-D 13-07-E Kiwifruit, hardy ( *Actinidia arguta* (Siebold & Zucc.) Planch. Ex Miq) 13-07-D 13-07-E 13-07-F Lingonberry ( *Vaccinium vitis-idaea* L.) 13-07-B 13-07-G 13-07-H Maypop ( *Passiflora incarnata* L.) 13-07-E 13-07-F Mountain pepper berries ( *Tasmannia lanceolata* ) 13-07-C Mulberry *Morus* spp.) 13-07-C Muntries ( *Kunzea pomifera* ) 13-07-G 13-07-H Native currant ( *Acrotriche depressa* ) 13-07-B Partridgeberry ( *Mitchella repens* L.) 13-07-G 13-07-H Phalsa ( *Grewia subinaequalis* DC.) 13-07-C Pincherry ( *Prunus pensylvanica* L.f.) 13-07-C Raspberry, black and red ( *Rubus* spp.) 13-07-A Riberry ( *Syzygium luehmannii* ) 13-07-C Salal ( *Gaultheria shallon* Pursh) 13-07-B 13-07-C Schisandra berry ( *Schisandra chinensis* (Turcz.) Baill 13-07-D 13-07-E Sea buckthorn ( *Hippophae rhamnoides* L.) 13-07-B Serviceberry ( *Sorbus* spp.) 13-07-C Strawberry ( *Fragaria x ananassa* Duchesne) 13-07-G Wild raspberry ( *Rubus muelleri* Lefevre ex P.J. Mull) 13-07-A

(iii)*Table* . The following Table 2 identifies the crop subgroups for Crop Group 13-07, specifies the representative commodities for each subgroup and lists all the commodities included in each subgroup. **Table 2.—Crop Group 13-07: Subgroup Listing** Representative commodities Commodities Crop Subgroup 13-07-A. Caneberry subgroup. Blackberry; Raspberry, red and black; wild raspberry; loganberry; cultivars and/or hybrids of these. Crop Subgroup 13-07-B. Bushberry subgroup. Aronia, berry; blueberry, highbush, and cultivars and/or hybrids of these; blueberry, lowbush; currant, buffalo; Chilean,guava; currant, black; and currant, red; elderberry, European, barberry; gooseberry; cranberry, highbush; Honeysuckle, edible; Huckleberry; jostaberry; Juneberry: lingonberry; Native, currant; salal; Sea, buckthorn. Crop Subgroup 13-07-C. Large shrub/tree berry subgroup. Bayberry; Buffaloberry; che; chokecherry; elderberry; Juneberry; Mountain pepper, berries; mulberry; Phalsa; pincherry; riberry; salal; serviceberry. Crop Subgroup 13-07-D. Small fruit vine climbing subgroup. Amur river grape; gooseberry; grape; kiwifruit, fuzzy; kiwifruit, hardy; Maypop, Schisandra berry. Crop Subgroup 13-07-E. Small fruit vine climbing subgroup, except grape. Amur river grape; gooseberry; kiwifruit, fuzzy; kiwifruit, hardy; Maypop; schisandra berry. Crop Subgroup 13-07-F. Small fruit vine climbing subgroup except fuzzy kiwifruit. Amur river grape; grape, Kiwifruit, hardy; maypop; schisandra berry. Crop Subgroup 13-07-G. Lowgrowing berry subgroup. Bearberry; bilberry; blueberry,lowbush; cloudberry; cranberry; lingonberry; muntries; partridgeberry; strawberry Crop Subgroup 13-07-H. Lowgrowing berry subgroup, except strawberry. Bearberry; bilberry; blueberry, lowbush; cloudberry; cranberry; lingonberry; muntries; partridgeberry.

(22)*Crop Group 21* . Edible fungi Group.

(i)*Representative commodities* . White button mushroom and any one oyster mushroom or any Shiitake mushroom.

(ii)*Table* . The following is a list of all the commodities in Crop Group 21. There are no related subgroups. **Crop Group 21: Edible Fungi Group—Commodities** Blewitt, Lepista nuda ( *Tricholomataceae* ) Bunashimeji, Hypsizygus marrmoreus ( *Agaricaceae* ) Chinese mushroom, Volvariella volvacea (Bull.) Singer ( *Pluteaceae* ) Enoki, Flammulina velutipes (Curt.) Singer ( *Tricholomataceae* ) Hime-Matsutake, Agaricus blazei Murill ( *Agaricaeae* ) Hirmeola, Auricularia *auricular* ( *Auricularicaceae* ) Maitake, Grifola frondosa ( *Polyporaceae* ) Morel, Morchella spp. ( *Morchellaceae* ) Nameko, Pholiota nameko, ( *Strophariaceae* ) Net Bearing Dictyophora, Dictyophora indusiata ( *Phallaceae* ) Oyster mushroom, Pleurotus spp. ( *Tricholomataceae* ) Pom Pom, Hericium erinaceus ( *Hydnaceae* ) Reishi mushroom, Ganoderma lucidum (Leyss. Fr.) Karst. ( *Ganodermataceae* ) Rodman's agaricus, Agaricus bitorquis (Quel.) Saccardo ( *Agaricaceae* ) Shiitake mushroom, Lentinula edodes (Berk.) Pegl. ( *Polyporaceae* ) Shimeji, Tricholoma conglobatum, ( *Tricholomataceae* ) Stropharia, Stropharia spp. ( *Strophariaceae* ) Truffle, Tuber spp. ( *Tuberaceae* ) White button mushroom, Agaricus bisporous (Lange) Imbach ( *Agaricaceae* ) White Jelly Fungi, Tremella fuciformis ( *Tremellaceae* ) [FR Doc. E7-9595 Filed 5-22-07; 8:45 am] BILLING CODE 6560-50-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 438 and 447 [CMS-2279-P] RIN 0938-A095 Medicaid Program; Graduate Medical Education AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule would clarify that costs and payments associated with Graduate Medical Education programs are not expenditures for medical assistance that are federally reimbursable under the Medicaid program. DATES: *Comment date:* To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on June 22, 2007. ADDRESSES: In commenting, please refer to file code CMS-2279-P. Because of staff and resource limitations, we cannot accept comments by facsimile

(Fax)transmission. You may submit comments in one of four ways (no duplicates, please): 1. *Electronically.* You may submit electronic comments on specific issues in this regulation to *http://www.cms.hhs.gov/eRulemaking.* Click on the link “Submit electronic comments on CMS regulations with an open comment period.” (Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word.) 2. *By regular mail.* You may mail written comments (one original and two copies) to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2279-P, P.O. Box 8016, Baltimore, MD 21244-8016. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. *By express or overnight mail.* You may send written comments (one original and two copies) to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2279-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. *By hand or courier.* If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to one of the following addresses. If you intend to deliver your comments to the Baltimore address, please call telephone number

(410)786-7195 in advance to schedule your arrival with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 21244-1850. (Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Dianne Heffron,

(410)786-3247. SUPPLEMENTARY INFORMATION: *Submitting Comments:* We welcome comments from the public on all issues set forth in this rule to assist us in fully considering issues and developing policies. *Inspection of Public Comments:* All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: *http://www.cms.hhs.gov/eRulemaking.* Click on the link “Electronic Comments on CMS Regulations” on that Web site to view public comments. Comments received timely will be also available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951. I. Background Title XIX of the Social Security Act (the Act) authorizes Federal grants to States for Medicaid programs, operated by the State under an approved State plan, that provide medical assistance to needy individuals including low-income families, the elderly, and persons with disabilities. Under section 1903(a)(1) of the Act, federal grant funding, or federal financial participation (FFP), is available to States for a percentage of amounts “expended * * * for medical assistance under the State plan.” The care and services that may (or in some cases, must) be included within the scope of medical assistance under a Medicaid State plan are generally set forth in section 1905(a) of the Act. Included in this list, for example, in sections 1905(a)(1) and 1905(a)(2), are inpatient and outpatient hospital services. Graduate medical education

(GME)is not included in this list of care and services within the scope of medical assistance. Section 1902(a)(30) of the Act requires States to develop payment methodologies for services provided under the Medicaid State Plan that are consistent with economy, efficiency and quality of care. CMS has previously allowed States to include hospital GME activities as a component of the cost of Medicaid inpatient and outpatient hospital services. For the reasons we explain in more detail below, we do not believe that it is consistent with the Medicaid statute to pay for GME activities either as a component of hospital services or separately. GME is not a health service that is included in the authorized coverage package. Nor is GME recognized under the Medicaid statute as a component of the cost of Medicaid inpatient and outpatient hospital services. GME is not a health service (in contrast to the activities of disproportionate share hospitals). Therefore, we are proposing in this issuance to preclude FFP in State payments for GME. Inpatient Hospital Rates States are responsible for setting inpatient hospital rates. Section 1902(a)(13) of the Act requires States to develop rates for inpatient hospital services in a public process. Section 1902(a)(30)(A) of the Act further requires Medicaid service rates to be consistent with economy, efficiency, and quality of care. These provisions afford States a great deal of flexibility in determining their inpatient hospital rates. States may use various reimbursement systems including diagnosis-related groups (DRGs), per diem, case rates, cost or other payment methodologies as long as the methodologies meet the regulations at 42 CFR part 447 subpart C. An important limitation States must adhere to is the upper payment limit

(UPL)which describes a payment level above which FFP is not available. The UPL implements, in part, the statutory requirement for payment rates that are, “consistent with efficiency, economy, and quality of care” at section 1903(a)(30)(A) of the Act. The regulations at 42 CFR 447.272 and 447.321 define the UPL for hospital services. States must demonstrate that the rates they have developed to reimburse Medicaid hospital services do not, in the aggregate, and within three provider categories (government, non-State government, or private), exceed a reasonable estimate of what Medicare would have paid for the same services using Medicare payment principles. Unlike Medicaid, the Medicare program has very specific and detailed statutory requirements regarding payments for hospital services. The current payment system for hospitals segregates payments made to hospitals into two basic payments; operating costs and capital costs of inpatient hospital services. Prospective Hospital Payments can be supplemented by direct medical education

(DME)or indirect medical education

(IME)payments. The requirements are set forth in section 1886 of the Act. This section defines costs, details the cost reporting process, delineates a few categories of hospitals that are paid directly on the basis of reported costs and provides for the use of reported costs in the development of Medicare's prospective payment system for most hospitals. In particular, in section 1886(a)(4) of the Act, Medicare defines “operating costs of inpatient hospital services” as: * * * All routine operating costs, ancillary service operating costs, and special care unit operating costs with respect to inpatient hospital services as such costs are determined on an average per admission or per discharge basis (as determined by the Secretary), and includes the costs of all service for which payment may be made under this title that are provided by the hospital (or by an entity wholly owned or operated by the hospital) to the patient. * * * Such term does not include costs of approved educational activities. * * * Thus, Medicare expressly excludes costs associated with educational activities from the operating costs that can be included in the cost base used to develop the basic payment amounts under Medicare's prospective payment system for inpatient hospital services. Medicare and Graduate Medical Education With the creation in 1965 of the Medicare program, in anticipation of a need for additional physicians to treat a newly insured, aged-patient population, the costs associated with GME were included as reimbursable Medicare costs. The Office of the Inspector General

(OIG)issued a report in 1994 entitled *A Study of Graduate Medical Education Costs* describing the origins of Medicare policy regarding GME as based on a physician shortage in the U.S. that existed in the 1950s and 1960s. Physician training was viewed as a public good and, * * * Congress decided that Medicare should participate in educating physicians until communities shouldered the costs in some other fashion. Hence, it created Medicare GME funding for teaching hospitals. By the 1980s, the U.S. had a surplus of physicians and the alternative community sources for GME funding never materialized. The same OIG report indicated that there were attempts by the Congress and this agency to substantially limit or eliminate Medicare GME subsidies. Instead, the Medicare payment system for inpatient hospital services was completely altered in 1983, moving from cost reimbursement to a prospective payment system (PPS). The PPS included payments to hospitals for the costs of GME. The new system created two types of payments unique to teaching hospitals. The direct graduate medical education payment

(DGME)compensates teaching hospitals for the direct costs of their educational activities, as measured by the number of residents being trained and the historic cost of training residents. Additionally, qualifying teaching hospitals receive an indirect medical education

(IME)adjustment to their per discharge payment under the Medicare IPPS (inpatient prospective payment system) to account for additional costs (other than the direct costs of the training program) that teaching hospitals incur in treating Medicare patients. This additional payment reflects the costs of providing care at teaching hospitals generally due to the added costs of “learning by doing” treatment methods, and is in addition to the basic prospective payment for inpatient services based on “operating costs of inpatient hospital services''. Medicare recognizes direct costs of approved educational programs in sections 1886(h) and

(k)of the Act. Indirect medical education payments are provided for at section 1886(d)(5) of the Act. These sections address graduate medical education activities separate and apart from the other costs of providing inpatient hospital services. The statute provides specific instructions regarding which educational programs qualify a hospital for the additional GME payments and provides an explicit methodology to calculate the Medicare payment to an individual hospital for both its direct graduate medical education program and its indirect medical education payments. Regulations at 42 CFR part 412 describe the prospective payment system. Again, direct medical education costs are identified as excluded from the other Medicare inpatient hospital operating costs used to develop Medicare's prospective inpatient rates. Direct graduate medical education is specifically prohibited as part of the inpatient PPS rate at § 412.2(2)(e). Indirect medical education is separately identified as a payment adjustment based on a formula at § 412.105. The costs that the IME adjustment reimburses a qualifying hospital for are included as inpatient hospital operating costs on the Medicare cost report. IME is an adjustment to the IPPS discharge rate. The IPPS rate is an “average” rate based on the efficient provision of inpatient care at all hospitals. The IME adjustment is intended to compensate teaching hospitals for the additional costs they incur when providing hospital services versus non-teaching hospitals. *Medicaid and Graduate Medical Education Generally* In a 2003 state survey conducted by the Association of American Medical Colleges, 47 States and the District of Columbia reported using Medicaid funds to make GME payments under the Medicaid State Plan. Of these, 35 indicated that the payments were included in their per diem inpatient hospital rates, and 15 stated using supplemental or a combination of supplemental and per diem payments to make GME payments. This same report, *Medicaid Direct and Indirect Graduate Medical Education Payment: A 50 State Survey,* indicates that while States view these Medicaid GME payments as critical to State GME policy implementation, they generally do not track these payments. In large part, this inability to track Medicaid GME payments is due to the way in which these payments are made (which we discuss in more detail below). Basically, payments are made through increases in the rates paid for covered Medicaid services. This methodology assures Federal participation, but does not provide clear accountability. Funding intended by the States to support GME often becomes subsumed within MCO or hospital rates (including supplements to these rates) or inpatient disproportionate share hospital

(DSH)payments. As a result, it is difficult to quantify Medicaid GME payments or monitor and measure the effect of Medicaid payments on GME programs. *Medicaid State Plan Payments* As previously stated, Medicaid law does not dictate detailed payment requirements for covered hospital services. Rather, States are permitted flexibility, subject to a reasonable estimate of what Medicare would have paid for the services, to develop their own methods and standards to determine the price they will pay for Medicaid covered services. States are required to include such payment methodologies in their State plans, and thus must submit their payment methodologies to CMS for review and approval. Once approved, States receive FFP for the Medicaid payments they make under the approved methodology. Since there is no express authority in the Medicaid statute for payments to support GME programs, to receive FFP for such payments, the payments must be made under the guise of payments made for covered Medicaid services under the approved Medicaid State plan. Usually the payments are part of the inpatient hospital Medicaid rate structure. This is because the Medicaid inpatient UPL references Medicare payment principles as an integral part of the inpatient UPL calculation, and Medicare makes GME payments as a supplement to inpatient hospital service payment rates. States routinely make payments to hospitals up to the maximum level permitted under the UPL, using methodologies that have a base payment rate and provide for supplemental payments to selected types of hospitals. This is possible because the base reimbursement rates are, in the aggregate, below the UPL for the particular category of provider. This creates a “gap” beneath the UPL that allows States to make the supplemental payments for select providers. Some or all of these supplemental payments may be directed at hospitals which operate GME programs. There are limitations on the State's flexibility in designing their Medicaid programs and reimbursement under current regulations to provide funding for GME programs stemming from the absence of any direct authority to reimburse GME under Title XIX. Because this funding must be part of payment for medical services (either directly or included in comprehensive capitation rates paid to MCOs), this funding is not necessarily limited to teaching hospitals, linked to educational costs or measures, or coordinated with other sources of GME funding. Therefore, it is difficult for States to design Medicaid payments to correspond with the operation of GME programs in the State. This is particularly true in the case of GME programs that include significant training in non-hospital settings. As a result, there is generally no assurance that supplemental Medicaid payments for GME are actually effective in supporting these programs, or in furnishing any benefit to Medicaid program beneficiaries. Under the Medicaid program, beneficiaries receive a defined benefit package consisting of a variety of mandatory and optional services provided to qualifying recipients. The statute creates a Federal/State partnership to share in the cost of providing these health care services to low-income populations. The current program structure supports State definition of eligible populations, coverage options, and reimbursement for covered services for these eligible individuals. This structure does not accommodate the State medical training policy and goals. The Federal government is also limited by its statutory authority to only evaluate and monitor the efficiency and economy of Medicaid spending as it relates to rates paid for medical services and not for GME as no such authority to do so exists within current law. This rule proposes to clarify that CMS will not consider funding for GME as expenditures for a covered Medicaid service. We distinguish direct GME payments from indirect medical education

(IME)payments because IME payments (as defined under Medicare payment principles) represent an additional Medicare payment for health care services provided to Medicare beneficiaries in teaching hospitals. This rule would clarify that GME is outside the scope of medical assistance, and that GME funding is not an allowable component of payment methodologies included in a State's approved Medicaid State Plan or in any Medicaid managed care payment. This includes all payments under attachments 4.19-A and 4.19-B of a State's Medicaid State Plan. The rule would also provide that when calculating an inpatient UPL, States may not include additional payments Medicare makes to a hospital for direct educational costs as part of the reasonable estimate of Medicare payment. And the rule would provide that States may, as part of their UPL calculation, include Medicare payments for indirect medical education as these payments represent additional costs associated with providing services in teaching hospitals. CMS specifically seeks comments on the propriety of including Medicare IME adjustments as part of the UPL calculation. States may not make any educational payments under the Medicaid State Plan but are able to recognize, as part of the inpatient hospital rate structure, the additional Medicaid covered service costs that teaching hospitals incur when delivering Medicaid covered services. States that currently include GME payments as part of other services or administrative costs under the Medicaid State Plan must also cease claiming Federal funds for these educational program payments. II. Provisions of the Proposed Rule The provisions of this rule propose to clarify that, for purposes of Medicaid reimbursement eligible for FFP, GME is not an allowable cost or payment for medical assistance under the approved Medicaid State Plan. The provision would apply to all Medicaid providers and must be implemented in the first full State fiscal year following the effective date of the subsequent final rule. We are proposing to modify the regulations at 42 CFR part 447. Currently the general instructions regarding Medicaid State Plan requirements for payment methods for all Medicaid services are provided at § 447.201. We propose to add a new § 447.201(c) to indicate that GME cannot be included as part of any payment methodology in the Medicaid State Plan. We have included this clarification to address States that have included GME as part of their rate system for non-institutional services, institutional services, or as an administrative cost eligible for FFP. We propose also to modify §§ 447.257 and 447.304 to address that FFP is no longer available for any reimbursement that includes or specifically pays for GME. The current paragraph would be redesignated as paragraph

(a)and a new paragraph

(b)would be added providing that no FFP would be available for GME under the approved Medicaid State Plan. We propose to modify § 447.272(b)(1) and 447.321(b)(1) to indicate that the term “Medicare payment principles” must exclude any Medicare payments associated with direct GME when calculating the Medicaid UPL. We propose to modify § 438.6(c)(5) by removing paragraph

(v)that addresses the coordination of GME payments under the State plan with capitated rates paid to a Medicaid MCO. We propose to modify § 438.60 to provide that the limit on payment to other providers would not include an exception related to GME payments made to providers outside the capitation rate and under the Medicaid State Plan. III. Collection of Information Requirements This document does not impose any information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35). IV. Response to Comments Because of the large number of public comments we normally receive on **Federal Register** documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. V. Regulatory Impact Statement *A. Overall Impact* We have examined the impact of this rule as required by Executive Order 12866 (September 1993, Regulatory Flexibility Act

(RFA)(September 19, 1980, Pub. L. 96-534), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132. Executive Order 12866 (as amended by Executive Order 13258, which merely reassigns responsibility of duties, and Executive Order 13422) directs agencies to assess all costs and benefits of all available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis

(RIA)must be prepared for major rules with economically significant ($100 million or more in any 1 year). This rule would surpass the economic threshold and is considered a major rule. This rule is estimated to reduce Federal Medicaid outlays by $140 million in FY 2008, by $290 million in FY 2009, by $440 million in FY 2010, by $450 million in FY 2011, and by $460 million in FY 2012. The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6.5 million to $31.5 million in any 1 year. Individuals and States are not included in the definition of a small entity. We are not preparing an analysis for the RFA because the regulation would not have a direct impact on small entities. In this case, the regulation would directly affect payments the States receive from the Federal government, and the impact on health care facilities is a secondary impact. States may choose to continue to fund direct medical education programs using State-only funding; this rule simply eliminates the availability of Federal Medicaid funding for such direct education programs. Additionally, most hospitals that would qualify as small entities would likely be unaffected by this rule as they are unlikely to offer medical education programs. Generally, medical education programs are sponsored by large hospitals offering a variety of medical specialties and services. As we are uncertain of the impact on small entities, we specifically request public comment on the impact of small health care facilities. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this rule would not have a direct impact on the operations of a substantial number of small rural hospitals. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $120 million. This rule would not result in expenditures in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $120 million. This rule anticipates federal savings in excess of $120 million but does not require States to replace that federal funding with state funding. There is no federal mandate to fund GME programs with State funding. Funding GME is not a required activity or enforceable duty arising from participation in Medicaid, thus any reduction in federal funding will not decrease the funding available for required activities under the Medicaid program. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement or cost on State and local governments, preempts State law, or otherwise has Federalism implications. For purposes of Executive Order 13132, we find that this rule will not have a substantial effect on State or local government. While this regulation would eliminate the ability of States to claim Federal Medicaid funding for direct GME, it would not impose any requirement that States pay for such GME. The rule would simply recognize that GME is not authorized under the Medicaid statute as an element of medical assistance that is eligible for Federal Medicaid funding. B. Anticipated Effects Estimated Reduction in Federal Medicaid Outlays Resulting From the Graduate Medical Education Proposal Being Implemented by This Proposed Rule—Annual Expected Savings [Amounts in millions] Reduction in Federal Medicaid outlays in million dollars by fiscal year 2008 2009 2010 2011 2012 Graduate Medical Education Exclusion $140 $290 $440 $450 $460 Accounting Statement As required by OMB Circular A-4 (available at *http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf* ), in the table below, we have prepared an accounting statement showing the classification of the expenditures associated with the provision of this proposed rule. This table provides our best estimate of the reduction in Federal Medicaid outlays for the years 2008 through 2012 as result of the changes presented in this proposed rule. This rule only affects transfer payments between the Federal government and State governments. Direct Graduate Medical Education

(DGME)1. Effects on State Medicaid Programs Since Graduate Medical Education is not a Medicaid service authorized in Title XIX of the Act, States are not required to report GME costs on the form CMS-64-9. Instead, States that claim Federal funding for GME generally do so as a portion of their inpatient hospital rates, inpatient hospital supplemental payments, MCO payments or, in limited instances, as part of a supplemental, non-institutional provider payment. Because of the absence of a reporting obligation, the amount actually expended for Medicaid GME is not readily determinable. The Federal Government has no way to directly determine the number of States making GME payments, amounts States are spending or claiming as GME or the total number of hospitals receiving such payments. Any GME funding claimed would simply be reflected within total outlays related to a particular service category, such as inpatient hospital, on the form CMS 64.9. In addition, the impact of eliminating the Medicare DGME payment as part of a State's UPL calculation is difficult to determine because most states do not include their UPL methodology as part of their approved Medicaid State plan. States have the option of including this payment in their UPL calculation but it is not a requirement. Estimates of the impact of eliminating Direct Graduate Medical Education as an allowable program cost or payment were derived from data on State GME payments from a survey conducted by the National Conference of State Legislatures

(NCSL)and published in the Journal of Health Affairs in 2000. The NCSL GME estimates were trended forward by the Consumer Price Index to establish a project baseline of GME payments for FY 2008 through 2012. CMS also estimates an offset applied to these payments to account for behavioral changes, including the likelihood that States may replace a portion of their GME payments with other payments to hospitals to achieve a similar Federal spending level. The resulting net savings were calculated using an average Federal matching rate of 57 percent. CMS specifically seeks comment on the amount States pay and methods States use to pay for DME and IME in their Medicaid programs. States have several options to address medical education funding. One option is to replace funding provided as the Federal share of a Medicaid GME payment with State-only funding or private sector funding. States may increase other generally applicable taxes to provide funding for general medical education. States could also work through a better coordination of funding to more effectively leverage and coordinate all GME funding in a State, including Federal funding available through Area Health Education Centers (AHECs), Medicare funding, grant funding, and State funding to more effectively manage health education policy and outcomes. 2. Effects on Other Providers CMS currently cannot precisely estimate the total number of providers receiving Medicaid GME payments. States are not required to report this information nor are they required to make such payments to only teaching hospitals. The exclusion of the Medicare DGME payment when calculating a class of providers' applicable UPL could lower the ceiling for Medicaid payments available to a provider within that class but CMS cannot estimate the impact since States are not required to include the adjustment and CMS currently does not have information on how many currently do include it. However, States may pay providers up to the UPL, including the IME payment adjustment made by Medicare to compensate teaching hospitals for additional service delivery costs associated with providing care in teaching hospitals. Providers will continue to receive payments for covered Medicaid services, and hospitals that serve a disproportionate share of low-income patients will continue to be eligible for additional DSH payments. States may also provide State-only funding for direct educational costs thus alleviating any revenue loss associated with the Medicaid DGME exclusion. C. Alternatives Considered In developing this regulation, the following alternatives were considered. We considered the possibility of providing stronger review of State Plan reimbursement methodologies for graduate medical education. In addition, we considered developing standard parameters applicable to all Medicaid GME payments (for example, a requirement that payment should not exceed the unmet cost of the GME program, counting all GME revenue when determining unmet GME program cost). These alternatives would address our concern over the lack of oversight and accountability for Medicaid GME funding. They would also address concerns that federal payments for GME through three separate programs (Medicare, Medicaid, and AHECs) are not coordinated with overall program goals. In evaluating these alternatives, however, we were limited by the absence of any statutory authority in the Medicaid program to make GME payments. Absent such authority, we believe we are limited in our ability to regulate such payments because the payments have been made under some other category. In other words, because there is no direct statutory authority for GME payments under a Medicaid State Plan, there is little authority to regulate or oversee such payments if allowed. As discussed above, States make GME payments through provider rates paid to reimburse medical services delivered. The existing statute and regulations addressing these payments do not provide CMS with the regulatory authority to require payment methodologies identified as GME to detail specific program requirements or apply any minimum program parameters for their approval. In short, CMS lacks any express statutory authority to match Medicaid GME payments as program costs and therefore lacks clear regulatory authority to manage Federal participation in GME programs under current law. OMB—Statement of Accounts Annualized monetized transfers (in millions per year) Non-discounted $356 3% 351 7% 345 The savings reflect a reduction in payments from the federal government to the States. D. Conclusion For these reasons, we are not preparing an analysis for either the RFA or section 1102(b) of the Act because we have determined that this rule would not have a direct significant economic impact on a substantial number of small entities or a direct significant impact on the operations of a substantial number of small rural hospitals. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. List of Subjects 42 CFR Part 438 Grant programs—health, Medicaid, Reporting and recordkeeping requirements. 42 CFR Part 447 Accounting, Administrative practice and procedure, Drugs, Grant programs-health, Health facilities, Health professions, Medicaid, Reporting and recordkeeping requirements, Rural areas. For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as set forth below: PART 438—MANAGED CARE 1. The authority citation for part 438 continues to read as follows: Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302). Subpart A—General Provisions § 438.6 [Amended] 2. Section 438.6 is amended by removing paragraph (c)(5)(v). Subpart B—State Responsibilities 3. Section 438.60 is revised to read as follows: § 438.60 Limit on payment to other providers. The State agency must ensure that no payment is made to a provider other than the MCO, PIHP, or PAHP for services available under the contract between the State and the MCO, PIHP, or PAHP, except when these payments are provided for in title XIX of the Act or in 42 CFR. PART 447—PAYMENTS FOR SERVICES 4. The authority citation for part 447 continues to read as follows: Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302). Subpart B—Payment Methods: General Provisions 5. Section 447.201 is amended by adding a new paragraph

(c)to read as set forth below. § 447.201 State plan requirements.

(c)The plan must not include payments for graduate medical education to any provider or institution or include costs of graduate medical education as an allowable cost under any cost-based payment system (including costs or payments claimed as administrative costs). Subpart C—Payment for Inpatient Hospital and Long-Term Care Facility Services 6. Section 447.257 is amended by: A. Designating the existing paragraph as paragraph (a). B. Adding a new paragraph

(b)to read as follows: § 447.257 FFP: Conditions relating to institutional reimbursement.

(b)FFP is not available in expenditures for graduate medical education in hospitals and long-term care facilities. 7. Section 447.272 is amended by republishing the heading to paragraph

(b)and revising paragraph (b)(1) to read as follows: § 447.272 Inpatient services: Application of upper payment limits.

(b)*General rules.*

(1)“Upper payment limit” refers to a reasonable estimate of the amount that would be paid for the services furnished by the groups of facilities under Medicare payment principles in subchapter B of this chapter. For purposes of the Medicaid upper payment limit calculation, direct graduate medical education payments are not an allowable component of a Medicare payment and must be excluded from the calculation. Subpart F—Payment Methods for Other Institutional and Non-Institutional Services 8. Section 447.304 is amended by: A. Revising paragraph

(b)to read as follows: § 447.304 Adherence to upper limits; FFP.

(b)FFP is not available in expenditures for graduate medical education. 9. Section 447.321 is amended by republishing the heading to paragraph

(b)and revising paragraph (b)(1) to read as follows: § 447.321 Outpatient hospital and clinical services: Application of upper payment limits.

(b)*General rules.*

(1)“Upper payment limit” refers to a reasonable estimate of the amount that would be paid for the services furnished by the groups of facilities under Medicare payment principles in subchapter B of this chapter. For purposes of the Medicaid upper payment limit calculation, direct graduate medical education payments are not an allowable component of a Medicare payment and must be excluded from the calculation. (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program) Dated: May 11, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. Approved: May 17, 2007. Michael O. Leavitt, Secretary. [FR Doc. 07-2576 Filed 5-18-07; 4:38 pm]

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