Animal and Plant Health Inspection Service
Forest Service
Committee for Purchase From People Who Are Blind or Severely Disabled
International Trade Administration
National Oceanic and Atmospheric Administration
Army Department
Federal Energy Regulatory Commission
Western Area Power Administration
Presidential Documents
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Food and Drug Administration
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Employment and Training Administration
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Surface Transportation Board
Comptroller of the Currency
Monetary Offices
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
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Animal and Plant Health Inspection Service, USDA.
Affirmation of interim rule as final rule.
We are adopting as a final rule, without change, an interim rule that amended the Oriental fruit fly regulations by removing the Santa Ana area of Orange County, CA, from the list of quarantined areas and removing restrictions on the interstate movement of regulated articles from that area. That action was necessary to remove restrictions that were no longer necessary to prevent the spread of the Oriental fruit fly into noninfested areas of the United States. The Santa Ana area of Orange County, CA, was the last remaining area in California quarantined for Oriental fruit fly. Therefore, as a result of that action, there are no longer any areas in the continental United States quarantined for the Oriental fruit fly.
Effective on October 26, 2007, we are adopting as a final rule the interim rule published at 72 FR 40061-40062 on July 23, 2007.
Mr. Wayne D. Burnett, Domestic Coordinator, Fruit Fly Exclusion and Detection Programs, APHIS, 4700 River Road Unit 137, Riverdale, MD 20737-1234; (301) 734-6553.
The Oriental fruit fly,
The Oriental fruit fly regulations, contained in 7 CFR 301.93 through 301.93-10 (referred to below as the regulations), restrict the interstate movement of regulated articles from quarantined areas to prevent the spread of the Oriental fruit fly to noninfested areas of the United States. The regulations also designate soil and a large number of fruits, nuts, vegetables, and berries as regulated articles.
In an interim rule
Comments on the interim rule were required to be received on or before January 16, 2007. We did not receive any comments.
In a second interim rule
Comments on the interim rule were required to be received on or before March 23, 2007. We received one comment by that date, from a private citizen. The commenter alluded to fruit fly eradication efforts that had occurred in the 1980s, but did not address the interim rule.
Finally, in a third interim rule
Comments on the interim rule were required to be received on or before September 21, 2007. We did not receive any comments. Therefore, for the reasons given in the interim rule, we are adopting the July 2007 interim rule as a final rule.
This action also affirms the information contained in the interim rule concerning Executive Order 12866 and the Regulatory Flexibility Act, Executive Orders 12372 and 12988, and the Paperwork Reduction Act.
Further, for this action, the Office of Management and Budget has waived its review under Executive Order 12866.
Agricultural commodities, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Transportation.
Nuclear Regulatory Commission.
Direct final rule: confirmation of effective date.
The Nuclear Regulatory Commission (NRC) is confirming the effective date of October 30, 2007, for the direct final rule that was published in the
Documents related to this rulemaking, including any comments received, may be examined at the NRC Public Document Room, located at One White Flint North, 11555 Rockville Pike, Rockville, MD 20852.
Jayne M. McCausland, Office of Federal and State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-6219, e-mail
On August 16, 2007 (72 FR 45880), the NRC published a direct final rule amending its regulations at 10 CFR 72.214 to revise the TN-68 cask system listing within the “List of Approved Spent Fuel Storage Casks” to include Amendment No. 1 to CoC No. 1027. This amendment modifies the CoC by revising several fuel parameters that include increasing fuel burnup to 60 gigawatts-day/metric ton of uranium, increasing total cask decay heat to 30 kilowatts, increasing maximum average fuel enrichment to 4.7 weight percent uranium-235, and decreasing minimum fuel assembly cooling time to 7 years. Amendment No. 1 will also add up to eight damaged fuel assemblies as authorized contents of the cask and reduce the cask spacing on the storage pad. In the direct final rule, NRC stated that if no significant adverse comments were received, the direct final rule would become final on October 30, 2007. The NRC did not receive any comments on the direct final rule. Therefore, this rule will become effective as scheduled.
For the Nuclear Regulatory Commission.
Federal Aviation Administration, DOT.
Final Rule.
This amendment supersedes an existing airworthiness directive (AD) for the specified Bell Helicopter Textron, Inc. (Bell) Helicopters. That AD currently requires inspecting each affected tail rotor blade (blade) forward tip weight retention block (tip block) and the aft tip closure (tip closure) for adhesive bond voids, and removing any blade with an excessive void from service. That AD also requires modifying certain blades by installing shear pins and tip closure rivets. This amendment contains the same requirements but expands the applicability to include other part and serial-numbered blades. This AD also clarifies the requirement to re-identify the modified blade by adding “FM” after the part number and also requires dynamically balancing the tail rotor. The existing AD was prompted by five occurrences of missing tip blocks or tip closures resulting in minor to substantial damage. This amendment was prompted by the determination that the AD should apply to other affected part and serial-numbered blades. The actions specified by this AD are intended to prevent loss of a tip block or tip closure, loss of a blade and subsequent loss of control of the helicopter.
Effective November 30, 2007.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of November 30, 2007.
You may get the service information identified in this AD from Bell Helicopter Textron, Inc., P.O. Box 482, Fort Worth, Texas 76101, telephone (817) 280-3391, fax (817) 280-6466.
Michael Kohner, Aviation Safety Engineer, FAA, Rotorcraft Directorate, Rotorcraft Certification Office, Fort Worth, Texas 76193-0170, telephone (817) 222-5447, fax (817) 222-5783.
A proposal to amend 14 CFR part 39 by superseding AD 2002-09-04, Amendment 30-12737 (67 FR 22349, May 3, 2002), for the specified Bell model helicopters was published in the
Since issuing AD 2002-09-04, Bell issued further revisions to Alert Service Bullet (ASB) Nos. 205-00-80, 205B-00-
The previously described unsafe condition is likely to exist or develop on other helicopters of these same type designs. Therefore, this AD supersedes AD 2002-09-04 to expand the applicability for the blade part and serial number. This AD also clarifies the requirement to re-identify the modified blade by adding “FM” after the part number and also requires dynamically balancing the tail rotor. Because blades, S/N with a prefix of “A” or “AFS” and a number 11926, 13351, 13367, 13393, 13400, 13402, 13515, 13540, 13568, 13595 to 13602, 13619, and subsequent, will be modified before delivery, we are excluding them from the applicability of this AD.
Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were received on the proposal or the FAA's determination of the cost to the public. The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.
The FAA estimates that this AD will affect 281 helicopters of U.S. registry. The required actions will take about 3 work hours per helicopters to inspect certain blades, install the shear pins and tip closure rivets, reidentify the modified blades, and dynamically balance the blade assembly at an average labor rate of $80 per work hour. Required supplies will cost about $35 per helicopter. Based on these figures, we estimate the total cost impact of the AD on U.S. operators to be $77,275.
We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect 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.
For the reason discussed above, I certify that the regulation:
1. Is not a “significant regulatory action” under Executive Order 12833;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared an economic evaluation of the estimated costs to comply with this AD. See the AD docket to examine the economic evaluation.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
Model 205A, 205A-1, 205B, 212, 412, 412CF, and 412EP helicopters with a tail rotor blade (blade), part number 212-010-750-009 through -129, all serial numbers except serial numbers with a prefix of “A” or “AFS” and the number 11926, 13351, 13367, 13393, 13400, 13402, 13515, 13540, 13568, 13595 through 13602, 13619, and subsequent assigned numbers, installed, certificated in any category.
Within 100 hours time-in-service, unless accomplished previously.
To prevent loss of the forward tip weight retention block (tip block) or aft tip closure (tip closure), loss of the blade, and subsequent loss of control of the helicopter, accomplish the following:
(a) Inspect the tip block and tip closure for voids. Remove from service any blade with a void in excess of that allowed by the Component Repair and Overhaul Manual limitations.
(b) Inspect the tip block attachment countersink screws in four locations to determine if the head of each countersunk screw is flush with the surface of the abrasion strip. The locations of these four screws are depicted on Figure 1 of Bell Helicopter Textron, Inc. Alert Service Bulletins 205-00-80, 205B-00-34, 212-00-111, 412-00-106, and 412CF-00-13, all Revision D, all dated March 18, 2005 (ASB). If any of these screws are set below the surface of the abrasion strip or are covered with filler material, install shear pins by following the Accomplishment Instructions, Part A, Shear Pin Installation paragraphs, of the ASB appropriate for your model helicopter.
(c) Install the aft tip closure rivets, re-identify the modified blade by adding an “FM,” and dynamically balance the tail rotor hum assembly by following the Accomplishment Instructions, Part B, Aft Tip Closure Rivet Installation paragraphs, of the ASB appropriate for your model helicopter.
(d) To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Contact the Manager, Rotorcraft Certification Office, Rotorcraft Directorate, FAA, ATTN: Michael Kohner, Aviation Safety Engineer, Fort Worth, Texas 76193-0170, telephone (817) 222-5447, fax (817) 222-5783, for information about previously approved alternative methods of compliance.
(e) Inspecting certain screws to determine if they are flush with the surface of the abrasion strip, modifying blades by installing shear pins or aft tip closure rivets as necessary, and re-identifying the modified blade shall be done by following Bell Helicopter Textron, Inc. Alert Service Bulletins 205-00-80, 205B-00-34, 212-00-111, 412-00-106, and 412CF-00-13, all Revision D, all dated March 18, 2005. The Director of the Federal Register approved this incorporation by reference under 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be
(f) This amendment becomes effective November 30, 2007.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule; request for comments.
We are adopting a new airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) provided by the aviation authority for the United Kingdom to identify and correct an unsafe condition on an aviation product. The MCAI states the following:
This action is necessary following the discovery of IP Compressor Rotor stage 2-3 interstage spacer cracking on an in-service Trent 700 engine. Stress analysis of the damaged rotor has shown a possible threat to the rotor integrity, the cracking therefore presents a potential unsafe condition. The cause of the cracking is currently under investigation.
This AD becomes effective November 13, 2007.
The Director of the Federal Register approved the incorporation by reference of RR service bulletins (SBs) RB.211-72-AE753, Revision 1, dated May 24, 2005, and RB.211-72-AF197, dated December 20, 2006, listed in the AD as of November 13, 2007.
You may send comments by any of the following methods:
•
•
•
•
You may examine the AD docket on the Internet at
Christopher Spinney, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 16 New England Executive Park, Burlington, MA 01803; e-mail:
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2007-0136, dated May 14, 2007, to correct an unsafe condition for the specified products. The EASA AD states:
This Airworthiness Directive requires inspections for cracks in the stage 2-3 interstage spacer of the IP Compressor Rotor during shop visit.
This action is necessary following the discovery of IP Compressor Rotor stage 2-3 interstage spacer cracking on an in-service Trent 700 engine. Stress analysis of the damaged rotor has shown a possible threat to the rotor integrity, the cracking therefore presents a potential unsafe condition. The cause of the cracking is currently under investigation.
Rolls-Royce plc has issued Service Bulletins RB.211-72-AE753, Revision 1, dated May 24, 2005, and RB.211-72-AF197, dated December 20, 2006. The actions described in that service information are intended to correct the unsafe condition identified in the EASA AD.
This product has been approved by the aviation authority of the United Kingdom, and is approved for operation in the United States. Pursuant to our bilateral agreement with the United Kingdom, they have notified us of the unsafe condition described in the EASA AD and service information referenced above. We are issuing this AD because we evaluated all the information provided by the EASA and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design. We are issuing this AD to detect cracks in the stage 2-3 interstage spacer of the IP Compressor Rotor. Cracking of the stage 2-3 interstage spacer could result in an uncontained engine failure and damage to the airplane. This AD requires inspecting the stage 2-3 interstage spacer using an eddy current inspection process at every shop visit. You must use the service information described previously to perform the actions required by this AD.
Although no airplanes that are registered in the United States use these engines, the possibility exists that the engines could be used on airplanes that are registered in the United States in the future. The unsafe condition described previously is likely to exist or develop on other RR RB211 Trent 768-60, 772-60, 772B-60, and 772C-60 turbofan engines of the same type design. Therefore, we determined that notice and opportunity for public comment before issuing this AD are unnecessary and that good cause exists for making this amendment effective in fewer than 30 days.
This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect 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.
For the reasons discussed above, I certify this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a) This airworthiness directive (AD) becomes effective November 13, 2007.
(b) None.
(c) This AD applies to Rolls-Royce plc RB211 Trent 768-60, 772-60, 772B-60, and 772C-60 turbofan engines. These engines are installed on, but not limited to, Airbus A330 series airplanes.
(d) This action is necessary following the discovery of IP Compressor Rotor stage 2-3 interstage spacer cracking on an in-service Trent 700 engine. Stress analysis of the damaged rotor has shown a possible threat to the rotor integrity, the cracking therefore presents a potential unsafe condition. The cause of the cracking is currently under investigation.
We are issuing this AD to detect cracks in the stage 2-3 interstage spacer of the IP Compressor Rotor. Cracking of the stage 2-3 interstage spacer could result in an uncontained engine failure and damage to the airplane.
(e) Inspect the IP compressor drum stage 2-3 interstage spacer for cracking at every shop visit as follows:
(1) If the IP Compressor rotor is not removed from the IP Compressor Casing, inspect the IP compressor drum stage 2-3 interstage spacer by borescope in accordance with Rolls-Royce RB211 Propulsion System Alert Non Modification Service Bulletin RB211-72-AE753 revision 1, section 3 Accomplishment Instructions (paragraphs F and G are applicable in revision 1).
(2) If the IP Compressor rotor is removed from the IP Compressor Casing inspect the IP compressor drum stage 2-3 interstage spacer by Eddy Current Inspection in accordance with Rolls-Royce RB211 propulsion System Alert Non Modification Service Bulletin RB211-72-AF197 initial issue, section 3 accomplishment Instructions.
(3) IP compressor drums on which cracking is identified by the above means must be rejected from service.
(f) None.
(g)
(h) Refer to EASA Airworthiness Directive 2007-0136, dated May 14, 2007, for related information.
(i) Contact Christopher Spinney, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; e-mail:
(j) You must use the service information specified in Table 1 of this AD to do the actions required by this AD, unless the AD specifies otherwise.
(1) The Director of the Federal Register approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) For service information identified in this AD, contact Rolls-Royce plc, P.O. Box 31, DERBY, DE24 8BJ, UK, telephone: 44 (0) 1332 242424; fax: 44 (0) 1332 249936.
(3) You may review copies at the FAA, New England Region, 12 New England Executive Park, Burlington, MA 01803; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
This rule modifies Class D airspace at Castle Airport, Atwater, CA. This action lowers the ceiling of the Atwater, Castle Class D airspace to below 2.000 feet mean sea level (MSL), changes the southern boundary of the airspace and add an extension to the north. FAA is taking this action to provide controlled airspace for the safety of aircraft executing Standard Instrument Approach Procedures (SIAPs) and other Instrument Flight Rules (IFR) operations at Castle Airport. Except for editorial changes, this rule is the same as the Notice of Proposed Rule Making.
Larry Tonish, System Support Specialists, Federal Aviation Administration, Western Service Area, 1601 Lind Avenue, SW., Renton, WA 98057; telephone (425) 917-6766.
On May 29, 2007, the FAA proposed to amend Title 14 Code of the Federal Regulations part 71 (14 CFR part 71) to modify Class D airspace at Castle Airport, Atwater, CA (72 FR 29455). The proposal was the result of an informal meeting on April 26, 2007 with representatives from FAA, local and aviation communities at Atwater, CA. At that meeting, the participants discussed various airspace alternatives designed to accommodate IFR and Visual Flight Rules (VFR) operations in and out of nearby Merced Airport located 6 miles to the south of Castle Airport. The FAA, local and aviation communities agreed on an alternative that would reduce the ceiling of Class D airspace, modify the southern border, and add an extension on the north side of the Class D for safety of aircraft executing SIAP's and other IFR operations at Castle Airport. Class D airspace will be effective during specified dates and times established in advance by a Notice to Airmen. The effective date and time will, thereafter, be published in the Airport/Facility Directory.
Interested parties were invited to participate in this rule making proceeding by submitting written comments on the proposal to the FAA. Eight comments were received, 5 positive and 3 negative. Of the three negative comments, one commenter suggested no change. The no change proposal was discussed at the April 26, 2007 meeting, considered by the FAA and was not adopted because there were no landmarks to identify the common Class D boundary with Merced Airport. The remaining two commenters recommended that the Castle Class D airspace be truncated along Highway 99. This recommendation was also considered by the FAA and not adopted because it would not allow sufficient airspace to conduct terminal operations at Castle Airport.
This amendment to 14 CFR part 71 modifies Class D airspace at Castle Airport, Atwater, CA. An Airport Traffic Control Tower (ATCT) is being established at Castle Airport, Atwater, CA, which will meet criteria for Class D airspace. Class D airspace areas are published in Paragraph 5000 of FAA Order 7400.9R, dated August 15, 2007, and effective September 15, 2007, which is incorporated by reference in 14 CFR 71.1. The Class D airspace designations listed in this document would be published subsequently in the Order.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. The FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would provide for the safety of aircraft operations at Castle airport.
Airspace, Incorporation by reference, Navigation (air).
49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface to but not including 2,000 feet MSL beginning at lat. 37°20′22″ N., long. 120°38′49″ W., and extending clockwise around the 4.5-nautical mile radius of the Castle Airport to lat. 37°20′02″ N., long. 120°29′39″ W., thence to the point of beginning; and within 1.9 miles each side of the El Nido VORTAC 320° radial from the 4.5-nautical mile radius to 17.6 miles from the El Nido VORTAC. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective dates and times will thereafter be continuously published in the Airport/Facility Directory.
Consumer Product Safety Commission.
Final amendments.
The Commission is amending the flammability standards for carpets and rugs to remove the reference to Eli Lilly Company Product No. 1588 in Catalog No. 79, December 1, 1969, as the standard ignition source and provide a technical specification defining the ignition source. The specification for the standard ignition source is a timed burning tablet, consisting of essentially pure methenamine, with a nominal heat of combustion value of 7180 calories/gram, a mass of 150 mg +/−5 mg, flat, and a nominal diameter of 6 mm. The amendment has an immediate effective date.
The amendment is effective October 26, 2007.
Patricia K. Adair, Project Manager, Directorate for Engineering Sciences, Consumer Product Safety Commission, Washington, DC 20207; telephone (301) 504-7536.
The standards for surface flammability of carpets and rugs appear at 16 CFR parts 1630 and 1631. They were codified and published in 1975, 40 FR 59931 and 59935 (December 30, 1975). The standards were originally issued in 1970 by the Department of Commerce under the authority of the Flammable Fabrics Act (FFA). Subpart A of 16 CFR parts 1630 and 1631 set forth the standards. Subpart B contains the implementing regulations of the standards. Subpart C contains alternative washing procedures for hide carpets and rugs and wool flotaki carpets and rugs. Subpart D of 16 CFR part 1630 contains the staff interpretations and policies.
16 CFR parts 1630 and 1631 establish minimum acceptance criteria for the surface flammability of carpets and rugs when exposed to a standard small source of ignition, a burning methenamine tablet, under prescribed conditions (the “pill test”). These standards reduce the risks of death, personal injury, and property damage associated with fires that result from the surface ignition of carpets and rugs.
Both standards require a timed burning tablet as the standard ignition source for flammability performance testing. The standards define the ignition source at 1630.1(f) and 1631.1(f) as a methenamine tablet, weighing approximately 0.149 grams (2.30 grains), sold as Product No. 1588 in Catalog No. 79, December 1, 1969 by the Eli Lilly Company, or an equal tablet.
In April 2002, Commission staff learned that the Eli Lilly Company was no longer producing the methenamine tablets specified in the carpet and rug standards. Although the standards allow for the use of “an equal” methenamine tablet and give parameters for chemical composition and weight of the tablet, they do not provide any guidance on determining whether tablets from alternative sources are “equal” to those manufactured by the Eli Lilly Company. In July 2003, CPSC staff met with representatives of the Carpet and Rug Institute (CRI) to discuss evaluation of alternative methenamine tablets for use in 16 CFR part 1630 and Part 1631. CRI members were experiencing differing test results using the old Eli Lilly tablets and currently available tablets. CRI members had begun to study the various characteristics of the current tablets. In one case, about 50% of one manufacturer's tablets were found broken in the bottle, with others breaking later. This problem was attributed to the tablets having a domed top. The problem has since been corrected with a flat tablet.
CRI urged the Commission to specify clearly the characteristics of the “equal” tablets that should be used for determining compliance to the carpet and rug standards. In an effort to make such a determination, the Commission staff conducted a comparison study to evaluate the weight, chemical composition, and combustion characteristics of presently available brands of methenamine tablets relative to each other and those produced by the Eli Lilly Company. The outcome of the study indicated that tablets consisting of essentially pure methenamine, having a heat of combustion value of approximately 7180 calories/gram and weighing approximately 0.149 grams may be considered equivalent to the tablets produced by the Eli Lilly Company and referenced in the regulation.
On July 29, 2004, the Commission's Office of Compliance issued a letter to industry in response to inquiries received by the CPSC staff regarding the equivalency of methenamine tablets formerly manufactured by the Eli Lilly Company and similar tablets currently produced by other manufacturers. The letter stated that the Commission staff determined that tablets consisting of essentially pure methenamine and weighing approximately 0.149 grams may be considered equivalent to the tablets formerly produced by the Eli Lilly Company. Therefore, tablets meeting these criteria may be used for purposes of determining conformance with the carpet and rug standards.
As mentioned above, the Eli Lilly Company is no longer producing the methenamine tablets specified in the carpet and rug standards. The standards allow for the use of “an equal” methenamine tablet and give parameters for chemical composition and weight of the tablet, but they do not provide any guidance on determining whether tablets from the alternative sources are “equal” to those manufactured by the Eli Lilly Company. The Commission staff conducted a comparison study to evaluate the weight, chemical composition, and combustion characteristics of presently available brands of methenamine tablets relative to each other and those produced by the Eli Lilly Company. The outcome of the Commission's comparative study
On November 13, 2006, the Commission issued a
On January 12, 2007, the Commission issued a
The carpet and rug flammability standards were issued under section 4 of the FFA (15 U.S.C. 1193), which authorizes the issuance or amendment of flammability standards to protect the public against unreasonable risks of fire leading to death, personal injury, or significant property damage. As required by section 4(b) of the FFA, both standards are based on findings that they are needed to adequately protect the public against the unreasonable risk of the occurrence of fire leading to death, personal injury, or significant property damage.
Section 4(j)(1) of the Flammable Fabrics Act requires the Commission to prepare a final regulatory analysis before issuing a final rule. The regulatory analysis must contain a description of the potential benefits and costs of the regulation, a description of any alternatives to the final regulation, and a summary of any significant issues raised by the comments submitted during the public comment period. The Commission must also find that the benefits expected from the rule bear a reasonable relationship to its costs and that the rule imposes the least burdensome requirement which prevents or adequately reduces the risk of injury for which the regulation is being promulgated. 15 U.S.C. 1193(j)(2).
Since 2002, when production of the previous methenamine tablet was discontinued by its manufacturer, producers and importers of carpets and rugs that comply with the standards have been performing tests with “equivalent” methenamine tablets. The technical amendment will, therefore, maintain current industry practice. The technical amendment to redefine the methenamine tablet will have no significant impact on expected benefits or costs of the flammability standards for carpets and rugs.
The Commission received two comments on the proposed rule. The American Fiber Manufacturers Associated supported the technical amendment as proposed. The Permanent Mission of India to the World Trade Organization objected to flammability as a mandatory requirement and recommended that compliance with the standards be voluntary to avoid potential trade restrictions on woolen rugs. The Commission notes that the standards have been in effect since 1970; the amendment only provides a generic specification for the ignition source and will not alter the overall scope of the standards. Thus, the amendment will have no impact on U.S. or international trade.
The Commission staff is aware of one U.S. voluntary standard regarding the type of ignition source to be used in testing the flammability of carpets and rugs. This standard, ASTM D2859-04, “Standard Test Method for Ignition Characteristics of Finished Textile Floor Covering Materials,” describes the use of the Eli Lilly Tablet as satisfactory. It also states that “normal variation in the weight of the different tablets will not affect the test results.”
There is an existing international voluntary standard developed by the International Organization for Standardization in 1982 (ISO 6925), that describes a tablet test for the flammability of textile floor coverings. The prescribed tablets are of “hexamethylenetetramine, flat, having a mass of 150mg (plus or minus 5mg) and a diameter of 6mm.” The allowable variance is about 3.3%. The mass expressed in ISO 6925 is essentially equivalent to that specified in the U.S. Standards under the FFA. While the ISO standard did not identify the Eli Lilly tablet, it noted that the tablets were commercially available. Thus, the ISO-specified tablet is equivalent to the Eli Lilly tablet in its specifications.
Canada's 1973 mandatory standard for carpets and textile floor coverings under the Hazardous Products Act, CGSB 4-GP-2, also specifies in its appendix the Eli Lilly tablet as the ignition source. It notes that “normal variation in weight * * * will not affect the test results.”
Section 4(b) of the FFA (15 U.S.C. 1193(b)) provides that an amendment of a flammability standard shall become effective one year from the date it is promulgated, unless the Commission finds for good cause that an earlier or later effective date is in the public interest, and publishes that finding. Because manufacturers are already using “equal” methenamine tablets as allowed by the current standards, the Commission finds that an immediate effective date upon publication of the amendments is appropriate.
In accordance with section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 605(b)), in the proposed rule, the Commission preliminarily certified that these amendments to the carpet and rug flammability standards would not have a significant economic impact on a substantial number of small entities, including small businesses. 71 FR 66,145. No information available to the Commission since the issuance of the proposed rule warrants changing this preliminary certification. The amendments keep current industry practices and procedures in place. No additional actions will be required of small entities. Based on available information, there will be little or no effect on small producers of carpets and rugs, since the standards already require that all carpets and rugs meet the criteria of the tests, and, given the equivalence of the test tablets, the results of the tests should be the same. Accordingly, the Commission certifies that this final rule will not have a significant economic impact on a substantial number of small entities.
The amendments fall within the categories of Commission actions described at 16 CFR 1021.5(c) that have little or no potential for affecting the human environment. The amendments are not expected to have a significant
Executive Order 12988, Civil Justice Reform, (February 5, 1996), requires that the Commission specify the preemptive effect, if any, to be given each new regulation. This technical amendment does not alter the preemptive effect of the underlying regulation.
Carpets, Consumer protection, Flammable materials, Floor coverings, Labeling, Records, Rugs, Textiles, Warranties.
Sec. 4, 67 Stat. 112, as amended, 81 Stat. 569-570; 15 U.S.C. 1193.
(f)
(a) * * *
(3)
Sec. 4, 67 Stat. 112, as amended, 81 Stat. 569-570; 15 U.S.C. 1193.
(f)
(a) * * *
(3)
1. “Briefing Package: Technical Amendment to the Flammability Standards for Carpets and Rugs, 16 CFR part 1630 and 16 CFR part 1631,” U.S. Consumer Product Safety Commission, October 3, 2006.
2. Technical Amendment to the Flammability Standards for Carpets and Rugs; Proposed Amendments, 71 FR 66145 (November 13, 2006).
3. Proposed Technical Amendment to the Flammability Standards for Carpets and Rugs; Notice of Opportunity for Oral Comment, 72 FR 1472 (January 12, 2007).
Commodity Futures Trading Commission.
Final rule.
The Commodity Futures Trading Commission (Commission) is amending Commission Regulation 18.05 in two respects: to make it explicit that persons holding or controlling reportable positions on a designated contract market (DCM) or derivatives transaction execution facility (DTEF) must retain books and records and make available to the Commission upon request any pertinent information with respect to all other positions and transactions in the commodity in which the trader has a reportable position, including positions held or controlled or transactions executed on all reporting markets, over-the-counter (OTC) and/or pursuant to Sections 2(d), 2(g) or 2(h)(1)-(2) of the Commodity Exchange Act (Act) or Part 35 of the Commission's regulations, on exempt commercial markets operating pursuant to Sections 2(h)(3)-(5) of the Act (ECMs), on exempt boards of trade operating pursuant to Section 5d of the Act (EBOTs), and on foreign boards of trade (FBOTs); and to make the regulation clearer and more complete with respect to hedging activity. The amendments will enhance the Commission's ability to deter and prevent price manipulation or any other disruptions to the integrity of the regulated futures markets, help to ensure the avoidance of systemic risk, and clarify the meaning of the regulation.
Duane C. Andresen, Special Counsel, Division of Market Oversight, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street, NW., Washington, DC 20581. Telephone 202-418-5492; e-mail
Section 3(b) of the Act
It is the purpose of this chapter to serve the public interests described in subsection (a) of this section through a system of effective self-regulation of trading facilities, clearing systems, market participants and market professionals under the oversight of the Commission. To foster these public interests, it is further the purpose of this chapter to deter and prevent price manipulation or any other disruptions to market integrity; to ensure the financial integrity of all transactions subject to this chapter and the avoidance of systemic risk; to protect all market participants from fraudulent or other abusive sales practices and misuses of
It shall be unlawful for any person to make any contract for the purchase or sale of any commodity for future delivery on or subject to the rules of any contract market or derivatives transaction execution facility—
(1) if such person shall directly or indirectly make such contracts with respect to any commodity or any future of such commodity during any one day in an amount equal to or in excess of such amount as shall be fixed from time to time by the Commission, and
(2) if such person shall directly or indirectly have or obtain a long or short position in any commodity or any future of such commodity equal to or in excess of such amount as shall be fixed from time to time by the Commission, unless such person files or causes to be filed with the properly designated officer of the Commission such reports regarding any transactions or positions described in clauses (1) and (2) hereof as the Commission may by rule or regulation require and unless, in accordance with rules and regulations of the Commission, such person shall keep books and records of all such transactions and positions and transactions and positions in any such commodity traded on or subject to the rules of any other board of trade, and of cash or spot transactions in, and inventories and purchase and sale commitments of such commodity. Such books and records shall show complete details concerning all such transactions, positions, inventories, and commitments, including the names and addresses of all persons having any interest therein, and shall be open at all times to inspection by any representative of the Commission or the Department of Justice. For the purposes of this section, the futures and cash or spot transactions and positions of any person shall include such transactions and positions of any persons directly or indirectly controlled by such person.
(1) Transactions and positions in the exchange-traded commodity;
(2) Transactions and positions in any such commodity traded on or subject to the rules of any other board of trade; and
(3) Cash or spot transactions in, and inventories and purchase and sale commitments of such commodity.
Such books and records must be open at all times for inspection by any representative of the Commission or the Department of Justice.
Section 8a(5) of the Act
(1) For reports specified in parts 17, 18 and § 19.00(a)(2) and (a)(3) of this chapter any open contract position that at the close of the market on any business day equals or exceeds the quantity specified in § 15.03 of this part in either:
(i) Any one future of any commodity on any one reporting market, excluding future contracts against which notices of delivery have been stopped by a trader or issued by the clearing organization of a reporting market; or
(ii) Long or short put or call options that exercise into the same future of any commodity, or long or short put or call options for options on physicals that have identical expirations and exercise into the same physical, on any one reporting market.
(2) For the purposes of reports specified in § 19.00(a)(1) of this chapter, any combined futures and futures-equivalent option open contract position as defined in part 150 of this chapter in any one month or in all months combined, either net long or net short in any commodity on any one reporting market, excluding futures positions against which notices of delivery have been stopped by a trader or issued by the clearing organization of a reporting market, which at the close of the market on the last business day of the week exceeds the net quantity limit in spot, single or in all-months fixed in § 150.2 of this chapter for the particular commodity and reporting market.
The LTRS, which requires that clearing members, futures commission merchants (FCM) and foreign brokers file daily reports with the Commission, enables the Commission to assess an individual trader's activities and potential market power and to enforce the Commission or DCM-set limits on speculative positions.
Every trader who holds or controls a reportable futures or option position shall keep books and records showing all details concerning all positions and transactions for future delivery in the commodity on all reporting markets, all positions and transactions in the commodity option, and all positions and transactions in the cash commodity, its products and byproducts and, in addition, commercial activities that the trader hedges in the commodity underlying the futures contract in which the trader is reportable, and shall upon request furnish to the Commission any pertinent information concerning such positions, transactions or activities.
(1) All positions and transactions for future delivery in the commodity on all reporting markets;
(2) All positions and transactions in the commodity option;
(3) All positions and transactions in the cash commodity, its products and byproducts; and
(4) Commercial activities that the trader hedges in the commodity underlying the futures contract in which the trader is reportable.
The regulation requires reportable traders to maintain books and records of futures positions and transactions in the commodity in which they are reportable and all positions and transactions in the cash commodity and its products and byproducts * * *. [T]he Commission wishes to underscore its view that the book and recordkeeping requirements and inspection provision contained therein are essential to accomplish the purposes of the Act and within the Commission's authority to adopt pursuant to section[s] 4i and 8a(5) of the Act. These requirements have always applied to the traders who hold or control a reportable position, and have not been restricted in any way. “Reporting Requirements for Contract Markets, Futures Commission Merchants, Members of Exchanges and Large Traders,” 46 FR 59960, 59963 (December 8, 1981) (footnote omitted).
A reportable trader is required to furnish to the Commission, upon request, any pertinent information concerning these positions, transactions or activities.
In order to enhance its ability to detect and prevent manipulation of regulated markets and products and to ensure the avoidance of systemic risk, as well as to clarify the meaning of the regulation and bring it up to date, the Commission published in the
1. To make it explicit that persons holding or controlling reportable positions on a reporting market must retain books and records and make available to the Commission upon request pertinent information with respect to all non-reporting transactions,
2. To make the regulation clearer and more complete with respect to hedging activity.
The proposal recognized that there is a close relationship among transactions conducted on reporting markets and non-reporting transactions and that it is sometimes necessary to determine all transactions and positions in the commodity in which the trader is reportable in order to more effectively detect and prevent manipulation of regulated markets and products and to ensure the avoidance of systemic risk.
The proposal noted that while Regulation 18.05 explicitly requires that a trader holding reportable positions keep books and records and provide to the Commission, upon request, pertinent information with respect to positions and transactions in the underlying commodity on DCMs and DTEFs, it does not explicitly do so with respect to positions and transactions in virtually identical contracts executed on ECMs, EBOTs or FBOTs or in the same commodity executed OTC and/or pursuant to Sections 2(d), 2(g) or 2(h)(1)-(2) of the Act or Part 35 of the Commission's regulations. The Commission noted that information concerning non-reporting transactions is important to its ability to conduct effective market surveillance of the DCM and DTEF contracts. Thus, if a trader is reportable because of futures or option positions in a contract on a DCM or DTEF, the trader's books and records with respect to non-reporting positions and transactions in the same commodity are relevant to effective surveillance and supervision of the DCM or DTEF contract in which the trader is reportable.
The proposal noted that the Act provides ample authority to require keeping books and records and providing pertinent information concerning non-reporting transactions. Section 4i explicitly encompasses non-reporting transactions on “any other board of trade” (such as FBOTs, ECMs operating pursuant to Sections 2(h)(3)-(5) of the Act, and EBOTs operating pursuant to Section 5d of the Act) and in the form of cash or spot transactions, inventories, and purchase and sale commitments. Further, Section 3(b) of the Act declares that the purpose of the Act is to, among other things, deter and prevent price manipulation or any other disruptions to market integrity and to ensure the avoidance of systemic risk. Section 8a(5) of the Act authorizes the Commission to promulgate such regulations as, in its judgment, are reasonably necessary to accomplish any of the purposes of the Act. As noted in the proposal, amending Regulation 18.05 to clearly require that reportable traders keep books and records showing all details concerning non-reporting transactions in the reportable commodity is a reasonably necessary means of accomplishing the purposes of Section 3(b) of the Act.
The proposal also noted that although non-reporting transactions themselves generally are not subject to most regulatory provisions of the Act, the futures or option transactions executed and maintained on a DCM or DTEF that result in a reportable position are subject to such provisions and, pursuant to Section 3(a) of the Act, are affected with a national public interest. It is the purpose of the Act pursuant to Section 3(b) that the Commission deter and prevent price manipulation of all commodities traded on these regulated markets. The proposal stated that to accomplish this purpose, it is necessary that the Commission have the ability to review all activities in commodities traded on these markets, regardless of where the transactions are executed. By taking a position on a regulated market, a trader agrees to abide by the rules of the market and the Commission, including prohibitions against manipulation. To enhance its ability to detect and deter manipulation and other threats to market integrity, the Commission requires persons holding reportable positions to maintain books and records of transactions that could impact the regulated market and related cash market, including non-reporting transactions.
Finally, the proposal noted that staff has interpreted Regulation 18.05 to include position and transaction data for non-reporting transactions and has received such information in response to requests made pursuant to the Regulation. Thus, consistent with the Act and Commission practice, the Commission proposed to amend Regulation 18.05 to make explicit that a trader with a reportable position must keep books and records showing all details concerning all non-reporting transactions in the same commodity and provide pertinent information to the Commission upon request.
The proposal also noted that there are two issues that arise in connection with the Regulation 18.05 requirement that traders keep books and records showing all details concerning “commercial activities that the trader hedges in the commodity underlying the futures contract in which the trader is reportable.” First, the phrase has led to some confusion. Originally inserted into the paragraph as “commercial activities that the trader hedges in the futures commodity in which the trader is reportable,” its purpose was to require that, “in addition to books and records of positions or transactions in a cash commodity, a reportable trader must also maintain records of commercial activities which the trader hedges.”
The Commission therefore proposed to amend the regulation to revert to the original approach and include hedges in the option contract in which the trader is reportable. By modifying the phrase to read “commercial activities that the trader hedges in the futures or option contract in which the trader is reportable,” Regulation 18.05 captures information with respect to hedges in other than the cash commodity, its products or byproducts (i.e., a trader with a reportable position in gold futures or options that is a hedge of a cash position in silver would be required to comply with the Regulation 18.05 requirements with respect to the silver position).
The Commission received six comment letters on its proposal. Commenters included the American Public Gas Association (APGA), the Industrial Energy Consumers of America (IECA), the International Swaps and Derivatives Association, Inc. (ISDA), the Managed Funds Association (MFA), the New York Public Service Commission (NYPSC), and the New York Mercantile Exchange (NYMEX). Most of the commenters generally endorsed the proposal and/or its underlying purpose, but felt that additional steps are necessary to resolve the underlying matters that the proposal is intended to address. Two commenters raised concerns regarding the recordkeeping and reporting aspects of the proposal.
The APGA commented that it strongly supports the proposed amendment but is concerned about the economic links between NYMEX and OTC contracts and believes that further steps are necessary for the Commission to carry out surveillance of the natural gas markets. It expressed concern that the LTRS does not routinely reach traders' large OTC positions and noted that it has petitioned Congress to provide the Commission with authority for a LTRS with respect to trading in financial contracts in natural gas. Further, the APGA commented that reliance on special call authority leaves open the potential for manipulation or other disruptive behavior with little risk of detection until after damage to the market has been done.
The IECA commented that it supports the proposal but noted that requiring companies to keep books and records does not prevent market manipulation and that preemptive monitoring of entities with large positions that cover both futures and OTC markets is necessary. Further, such entities should be required to report daily to the Commission. The IECA also recommended that the Commission support the establishment of an advisory panel on energy markets with consumer participation thereon.
The NYPSC noted that it supports the proposed rule and its underlying purpose and that given the increases in natural gas prices over the past several years, the relevant government entities must take all available steps to prevent market manipulation and ensure the integrity of the natural gas markets. The NYPSC maintained that it is essential to evaluate exposure on both NYMEX and the InterContinental Exchange (ICE), an ECM, and stated that the Commission's inability to directly regulate traders that use ICE exclusively creates a serious loophole in effective regulatory oversight of the financial markets. Concerned that traders will avoid regulatory oversight by trading exclusively on ICE, the NYPSC recommended that the Commission should monitor the migration of traders that currently utilize NYMEX to ICE as the exclusive means of trading natural gas contracts.
The ISDA and the MFA voiced support for the proposal but raised concerns about the proposal's recordkeeping and reporting obligations. The ISDA stated its view that the proposal does not create additional recordkeeping or reporting obligations and requested clarification with respect to the scope of Regulation 1.35(a), which contains recordkeeping and reporting language similar to that in proposed Regulation 18.05. Further, the ISDA requested clarification that the records required to be retained under proposed Regulation 18.05 are subject to Regulation 1.31 retention requirements and consist of accurate records of positions and actual transaction documentation created in the ordinary course of business. The MFA requested that the Commission confirm that the current system of books and records maintained by traders in the normal course of business and in the format created in the normal course of business would meet the proposal's recordkeeping and retention requirements.
The NYMEX voiced support for the intention underlying the proposal but commented that the purpose of the proposal can be met only by imposing identical requirements on linked trading facilities meeting specified criteria. NYMEX posited that the proposal, if implemented, would create an incentive for market participants to do all their trading at unregulated or non-transparent venues or to trade at a level below the reportable level on the regulated exchange. Further, NYMEX commented that the proposal was limited in effectiveness because of the anticipated infrequent use of the special call procedure; would impose a cost on the regulated exchanges because of the shift in trading activity; and would have adverse public policy consequences. NYMEX recommended that the Commission defer the amendments to Regulation 18.05 in favor of a more comprehensive legislative approach that would result in the implementation of reporting requirements on organized trading facilities that have triggered specified criteria.
The Commission has carefully considered the comments submitted and has decided, for reasons cited herein and in the proposal, to amend the regulation as proposed. As previously stated, staff has interpreted Regulation 18.05 to include position and transaction data for non-reporting transactions and has received such information in response to requests made pursuant to the Regulation. Thus, the proposal to amend Regulation 18.05 merely makes explicit what has been implicit.
NYMEX's comment that the proposal would lead market participants to move their trading activity to unregulated or non-transparent venues, or trade at a level below the reportable level on the regulated exchange in order to avoid the consequences of holding reportable positions, is highly speculative and, in the Commission's estimation, unlikely. As previously discussed, the amendments to Regulation 18.05 clarify existing authority and, accordingly, any “disincentive” for traders to trade on a regulated market already exists, with or without the amendments. In addition, the Commission sees little merit in following NYMEX's suggestion to defer in favor of a legislative approach. The Commission can control neither the timing nor the terms of legislation addressing reporting obligations on currently non-reporting markets, or even whether such legislation is enacted in the first instance. Should legislation in this area be enacted which expands the Commission's jurisdiction with respect to transactions that are currently non-reportable, further amendments to the regulation could be considered.
With respect to the comments regarding the proposal's recordkeeping and reporting obligations, the Commission confirms that the amendments should not change current recordkeeping or reporting obligations, assuming that traders are currently keeping complete transaction records. Records required to be retained under Regulation 18.05 consist of accurate records of positions and actual transaction documentation created in the ordinary course of business. Thus, books and records that currently should be maintained by traders in the normal course of business and in the format created in the normal course of business would meet the regulation's recordkeeping requirements. Such records are subject to the Regulation 1.31 retention requirements. Finally,
Section 15(a) of the Act requires the Commission to consider the costs and benefits of its action before issuing a new regulation or order under the Act. By its terms, Section 15(a) does not require the Commission to quantify the costs and benefits of a new regulation or to determine whether the benefits of the regulation outweigh its costs. Rather, Section 15(a) simply requires the Commission to “consider the costs and benefits” of its action.
Section 15(a) further specifies that the costs and benefits of the rule or order shall be evaluated in light of five broad areas of market and public concern: (1) Protection of market participants and the public; (2) efficiency, competitiveness, and financial integrity of futures markets; (3) price discovery; (4) sound risk management practices; and (5) other public interest considerations. The Commission may, in its discretion, give greater weight to any one of the five enumerated areas of concern and may, in its discretion, determine that, notwithstanding its costs, a particular rule or order is necessary or appropriate to protect the public interest or to effectuate any of the provisions or to accomplish any of the purposes of the Act.
The Commission's proposal contained an analysis of its consideration of these costs and benefits and solicited public comment thereon. As previously noted, NYMEX commented that the proposal, by adding another incentive for market participants to shift their trading activity from regulated and transparent venues to unregulated and non-transparent venues, would impose a cost on the regulated exchanges and would have adverse public policy consequences. NYMEX also questioned the extent of the benefits to be obtained from the proposal in light of the acknowledgement that special calls for information would continue to be made on an infrequent basis.
The Commission believes, as it stated in the discussion of NYMEX's comments above, that attempting to discern what impact amended Regulation 18.05 will have on potential large traders, or what costs to the regulated exchanges would be associated with any shift in trading activity, is highly speculative. Because the amendments clarify existing authority, any “disincentive” for traders to trade on a regulated market already exists, with or without the amendments. Additionally, the Commission finds no merit in the contention that the extent of the benefits to be obtained from the amendments are questionable in light of the acknowledgement that special calls for information would continue to be made on an infrequent basis. The Commission is confident that such special calls will be made when deemed necessary and that the information provided in response to such special calls will assist the Commission in meeting its regulatory responsibilities.
After consideration of the costs and benefits and the public comments received thereon, the Commission has determined to adopt the amendments to Regulation 18.05 set forth below.
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601
The Paperwork Reduction Act (PRA)
The Commission submitted the proposed rule amendments and their associated information collection requirements to the Office of Management and Budget (OMB) for its review. No comments were received in response to the Commission's invitation in the notice of proposed rulemaking to comment on the information which would be required by the proposed rule amendments.
Commodity futures, Reporting and recordkeeping requirements.
7 U.S.C. 2, 4, 5, 6a, 6c, 6f, 6g, 6i, 6k, 6m, 6n, 12a and 19; 5 U.S.C. 552 and 552(b), unless otherwise noted.
(a) Every trader who holds or controls a reportable futures or option position shall keep books and records showing all details concerning all positions and transactions in the commodity:
(1) On all reporting markets;
(2) Over the counter and/or pursuant to Sections 2(d), 2(g) or 2(h)(1)-(2) of the Act or Part 35 of this chapter;
(3) On exempt commercial markets operating pursuant to Sections 2(h)(3)-(5) of the Act;
(4) On exempt boards of trade operating pursuant to Section 5d of the Act; and
(5) On foreign boards of trade.
(b) Every such trader shall also keep books and records showing all details concerning all positions and transactions in the cash commodity, its products and byproducts, and all commercial activities that the trader hedges in the futures or option contract in which the trader is reportable.
(c) The trader shall upon request furnish to the Commission any pertinent information concerning such positions, transactions, or activities in a form acceptable to the Commission.
United States Mint, Treasury.
Final rule.
The United States Mint is adopting a new rule establishing procedures under which the United States Mint will implement and execute the provisions of 31 U.S.C. 333(c), which authorizes the Secretary of the Treasury to assess a civil penalty against any person who has misused the words, titles, abbreviations, initials, symbols, emblems, seals, or badges of the United States Mint.
James Adler, Senior Attorney, United States Mint, at (202) 354-7286.
The United States Mint is adopting today the new regulation set forth below under 31 CFR part 92.
Section 333(c) of title 31, United States Code, authorizes the Secretary of the Treasury to assess a civil penalty against any person who has misused the words, titles, abbreviations, initials, symbols, emblems, seals, or badges of the Department of the Treasury, including those of the United States Mint. The Secretary of the Treasury has delegated to the Director of the United States Mint the authority to enforce the civil penalty provisions of 31 U.S.C. 333(c) with respect to the misuse of United States Mint words, titles, abbreviations, initials, symbols, seals, trademarks, and badges, and with respect to the misuse of Department of the Treasury words, titles, abbreviations, initials, symbols, seals, trademarks, and badges when in connection with activities related to United States Mint operations and programs. This rule establishes procedures that the United States Mint will follow to carry out that authority and to ensure that those assessed a civil penalty under 31 U.S.C. 333(c) are accorded due process. These procedures are based on the procedures of the Department of the Treasury at 31 CFR part 27.
This final rule is based on the notice of proposed rulemaking published Wednesday, January 12, 2005 (the “NPRM”) (70 FR 2081). The NPRM sought public comment on the proposed rule.
The comment period for the NPRM ended on February 18, 2005. The United States Mint received 17 comments from members of the public, businesses and trade associations. The Federal Trade Commission also submitted a staff comment.
Eight of the comments were from members of the public. Seven of the eight expressed support for the United States Mint's proposed regulation. One of these comments objected to the use of names by companies that “attempt to confuse the public into the belief that the product is being sold and promoted by the U.S. Mint.” Another expressed the opinion, “You should come down as hard as possible on these companies.” A third stated, “I strongly recommend the proposal maintained be adopted that would prevent firms from cashing in on U.S. Mint.” A fourth asserted that it is “about time the U.S. Mint played hardball and protected its products. Use of Mint products to make money by misleading new collectors gives a black eye to collecting.” The eighth submission enclosed a newspaper article on the proposed regulation without comment.
Substantive comments from the public included a request that the United States Mint not “limit penalties to audience size” and a suggestion that “civil penalties must include a clause for full restitution for those customers who purchased the items that were marketed in violation of the statute.”
As to the comment on restitution, we note that the proposed regulation would have permitted the imposition of a “civil monetary penalty and/or civil or equitable remedy.” Upon further examination of 31 U.S.C. 333(c) and the statute's legislative history, however, we have determined that the term “civil penalty” in this regulation should refer only to a monetary penalty payable to the Treasury. Accordingly, the final regulation will permit an assessing official to impose a civil monetary penalty on a person “who violates the provisions of paragraph (a) of this section.” The phrase “civil penalty” is defined in the regulation to mean “(1) A civil monetary penalty.” Consistent with our view of the underlying statutory authority, therefore, the final regulation will not permit the United States Mint to order restitution as a remedy. This, of course, is in no way intended to limit any relief to which a person who is injured by the misleading use of United States Mint names or symbols may be entitled in private litigation or through an enforcement action by another Federal or state agency.
With regard to the comment that the United States Mint not “limit penalties to audience size,” the proposed regulation's operative clause with regard to the amount of penalty imposed for a violation reads as follows:
(c)
In reviewing the public comments on civil penalties, and the role of the examining official in recommending civil penalties to the assessing official, we concluded that the proposed rule did not make it clear that the Initial Notice of Assessment would include a proposed civil monetary penalty. We have clarified the provisions of § 92.15 to provide that the Initial Notice of Assessment will include a statement of the proposed penalty.
Six of the comments that the United States Mint received were from small businesses involved in the coin business. Each of these commenters expressed concern over the proposed regulation, with several expressing direct opposition. Two expressed general support for the regulation.
The United States Mint acknowledges the perception of several commenters that the proposed regulation may not be fairly enforced because the United States Mint sells United States coinage and, under the regulation, would have the power to take action against private businesses whose advertisements and solicitations misuse the names, symbols
Several commenters expressed concern about the role of the United States Mint's Director as the decision maker under the regulation. One commenter raised the issue of whether the United States Mint's Director can be considered an impartial decision maker. Another commenter alleged that the regulations were unfair in that they gave the United States Mint, a competitor in the marketing of legal tender coinage, discretion to assess civil penalties against its own competitors. This, it stated, “creat[ed] a situation that is intrinsically unfair and open to abuse.”
We note, however, that there is no inherent conflict of interest in having the United States Mint policing the improper use of the United States Mint's and the Treasury Department's names and symbols. The owner of intellectual property has the responsibility of protecting that property from improper use; this doctrine is codified and well recognized in the body of Federal intellectual property law. Additionally, no United States Mint or Treasury Department official who could have a role in the execution of the regulation has any official duty that inherently conflicts with the interests that the regulation is designed to protect. The authority of a Government agency to assess fines, in accordance with the authority and procedures established under law, naturally requires officials of that agency to act fairly, impartially, and judiciously. Every United States Mint and Treasury Department official—like all Government officials—has a duty to avoid conflicts of interest, act impartially, not give preferential treatment, protect and conserve public property, and adhere to the law. 5 CFR 2635.101. These duties are not inconsistent with these officials' fiduciary responsibility to protect public funds. Although it is true that the United States Mint generates revenues through the sale of numismatic items, the United States Mint is a Federal agency—not a commercial enterprise. By law, any amount in the United States Mint Public Enterprise Fund that is determined to be in excess of the amount required by the Fund, including the proceeds of fines assessed under the regulation, shall be transferred to the Treasury for deposit as miscellaneous receipts. See 31 U.S.C. 5136. Accordingly, fines paid under the regulation are not analogous to profit generated by a private company; they do not accrue to the benefit of either the United States Mint or its officials but, rather, to the General Treasury.
One commenter stated, “These regulations will be enforced by government officials who have an economic interest in the results of the enforcement proceedings.” Contrary to the comment, neither the examining official nor the assessing official will have any economic interest in the results of enforcement proceedings under this subpart. Employee compensation for all United States Mint employees is not based upon the United States Mint's coin sales or revenue. The United States Mint has performance awards and incentives that do affect compensation; however, these are based on criteria relating to the United States Mint's efficiency of operations and reductions in overhead and other costs. Civil penalties assessed under this regulation affect none of these criteria.
Several commenters expressed the concern that the United States Mint would use its enforcement ability under the regulation in an unfair manner. One stated, “The regulation gives the Mint too much power to unfairly pick and choose the competitors it wishes to punish.” Another stated, “We are concerned about the Mint's path on trying to eliminate competition with regulations and unfair enforcement actions.” The United States Mint, in proposing and enacting these regulations, does not seek to “eliminate competition” but, rather, seeks to reduce consumer confusion and deceptive practices. Under Federal law, the United States Mint is the only entity permitted to produce United States coinage. As a Government monopoly, the United States Mint does not have competition in producing legal tender coinage for the United States. The purpose of the proposed rule, therefore, is not to eliminate competition but, instead, to protect consumers, collectors and the public from the improper use of Treasury and United States Mint names and symbols.
This protection is necessary because third parties increasingly have engaged in marketing practices that have the potential to mislead consumers by using the United States Mint's and Treasury Department's name and symbols with products not produced by either the United States Mint or the Treasury Department. More specifically, the United States Mint is aware of advertisements that have used the United States Mint's name and symbols in marketing tokens and medals not produced by the United States Mint. These tokens and medals are designed to resemble the designs of United States legal tender coinage despite the fact that tokens and medals have no status as legal tender in the United States. The United States Mint is also aware that other parties have acquired coinage and numismatic items produced by the United States Mint, have altered them (usually by plating and coloring them), and then have advertised the resulting items for sale as products of the United States Mint. We view these practices as being deceptive because, in both instances, the use of the United States Mint's and the Treasury Department's names and symbols in these contexts conveys the false impression that the advertisement, product or activity is endorsed, sponsored or affiliated with the United States Mint or the Treasury Department. The goal of the United States Mint in enacting these regulations is simply to prevent the deceptive misuse of the Treasury Department's and the United States Mint's names and symbols by third parties.
Two commenters also expressed concern over the provision in the proposed regulations that disclaimers will not be considered when determining whether an advertisement is misusing a United States Mint or Treasury Department name or symbol. One commented, “If a company has an advertisement for the sale of U.S. Mint coins, but clearly states that it is not affiliated, endorsed or authorized by the U.S. Mint, the regulation states that the disclaimers will be ignored. This makes no sense.”
Similarly, the Federal Trade Commission's staff comment, in part, addressed the proposed rule's treatment of disclaimers of affiliation and indicated, “The proposed rule's treatment of disclaimers of affiliation in this process may raise some potential legal and policy issues.” The comment then set forth the FTC's approach to reviewing advertising claims.
We note, however, that the statute upon which the regulation is based specifically addresses disclaimers. It states the following:
(b) Treatment of Disclaimers.
Any determination of whether a person has violated the provisions of subsection (a) shall be made without regard to any use of a disclaimer of affiliation with the United States Government or any particular agency or instrumentality thereof.
Given the clear requirement in 31 U.S.C. 333(b) that a determination of a violation be made without regard to any use of a disclaimer of affiliation, this
We believe, however, that it is appropriate to consider the use of a disclaimer as a factor in determining the amount of any civil penalty that the Assessing Official imposes under the regulation. If the disclaimer is clear and prominent and is likely to be noticed by a consumer and is not contradicted or confused by any claims made in the materials found to be in violation of 31 U.S.C. 333, then the Examining Official may propose, and the Assessing Official may assess, a civil penalty in an amount lower than that which would otherwise be appropriate, including, where warranted, a penalty in a nominal amount.
The remaining comments were submitted by two trade associations. The Magazine Publishers of America, while supporting the proposed rule, indicated its concern “that the proposed rule may inadvertently impose liability on publishers and other media that, through no fault of their own, disseminate false advertisements.” The Magazine Publishers of America requested that an exception be included in the final rule “to exempt the media from fines * * * associated with false advertising.” The Magazine Publishers of America also cited several Federal statutes, court decisions and state statutes in which media publishers were not held responsible for the content of advertisements from parties who purchased advertising space in their publications.
After considering these comments, we concur that publishers of newspapers, magazines, and other broadcasters of media, who merely sell advertising space to third parties should not be held responsible for ensuring compliance with the rule proposed by the United States Mint. The rule focuses on the person who “uses” the operable words, letters, symbols, or emblems in connection with, or as part of, an advertisement, solicitation, business activity, or product; the rule does not focus on a party who makes space available to the using person. Accordingly, we believe that the rule could not be applied to assess a penalty against a publisher or broadcaster that merely sells space and has no responsibility for the substantive content of an advertisement. However, we do not believe that amending the rule to excuse publishers or broadcasters from liability under all possible circumstances is appropriate. Rather, in each case, the examining and assessing officials will look to the extent of the publisher's or broadcaster's participation in the preparation of the challenged advertisement, solicitation, or business activity, and whether the publisher or broadcaster knew or should have known during that preparation process that the advertisement, solicitation, or business activity included improper uses of names, emblems, or symbols covered by 31 U.S.C. 333 and the rule. Finally, we note that the same definition of “person” has appeared at 31 CFR 27.2(f) (the Treasury Department regulation implementing 31 U.S.C. 333) since 1997 with no reported action against any publisher or broadcaster.
The other trade association submitting comments was the Industry Council for Tangible Assets (ICTA), a trade association for rare coin and precious metals dealers. In summary, the ICTA believes the proposed regulations: (1) “exceed the mandate of 31 U.S.C. 333 by adding ‘trademark' to the scope of the regulation”; (2) “[are] overly broad and will deny due process to those who directly compete with the Mint”; (3) “raise serious concerns about violations of commercial free speech protected by the first amendment”; and (4) “are flawed in their failure to allow for a reasonable period to cure alleged violations.” The ICTA comments also indicate that “existing law provides the Mint with adequate remedies for perceived problems and there are more appropriate regulations that could be proposed to accomplish the goals of the Mint.” The Professional Numismatics Guild sent a letter expressing its support for the comments made by the ICTA.
The ICTA asserts that the United States Mint has “exceeded the mandate of 31 U.S.C. 333 by adding ‘trademark' to the scope of the regulation.” It also asserts that United States Mint's definition of the phrase “symbol” under the regulation “facially appears to go beyond the scope of 31 U.S.C. 333(c)” as it includes “a trademark, designation of origin, or mark of identification.” ITCA Comment at 13.
An examination of the statute, 31 U.S.C. 333, shows that the word “symbol” occurs in two places in subsection (a) although the statute does not define the term. The statute uses the term “symbol” in section (a) stating the following:
No person may use, in connection with, or as a part of, any advertisement, solicitation, business activity or product, whether alone or with other words, letters,
It is well-established that words in a statute are to be given their common, ordinary meaning.
The United States Mint, however, has decided to modify slightly the definition of the word “symbol” in the final rule for clarity. Hence, “symbol” is now defined as “any design or graphic used by the United States Mint or the Treasury Department to represent themselves or their products.” It further clarifies that a “design or graphic may include (1) a trademark, designation of origin, or mark of identification, or (2) a stylized depiction comprising letters, words, or numbers.”
The ICTA, secondly, asserts that the proposed rule “[is] overly broad and will deny due process to those who directly compete with the Mint.” After
The ITCA commented that the proposed regulation “threaten[s] the freedom of commercial speech under the First Amendment.” In particular, the ITCA indicated that “the regulations fail the Supreme Court's
The ICTA asserted that the proposed regulations “are flawed in their failure to allow for a reasonable period to cure alleged violations.” However, the statute does not provide for, nor does it require the agency to afford to an offending party, a cure period. Indeed, we note that another part of the statute (31 U.S.C. 333(d)) provides for criminal penalties for precisely the same offenses over which the agency would exercise civil penalty authority. Although a notice of assessment naturally would put an alleged offending party on notice that it immediately should consider steps to cure the alleged misuse, the inherent purpose for the statute is to allow the agency to penalize the offending party for the misuse. In light of this concern, however, the United States Mint has modified the final regulation slightly so that it expressly requires the examining and assessing officials to consider the repeated nature of the misuse in determining whether, and to what extent, a penalty should be imposed against an offending party.
Some of the commenters pointed out that if the Government seeks to infringe upon a citizen's liberty, it “always has the obligation of providing a neutral decision-maker—one who is not inherently biased against the individual or who has personal interest in the outcome.”
In general, “[t]he mere fact that an administrative or adjudicative body derives a financial benefit from fines or penalties that it imposes is not in general a violation of due process * * *.”
We do not believe the regulation raises issues of impartiality. First, the Director of the United States Mint has no personal or official economic interest in the results of any enforcement action under this regulation. Pursuant to the United States Mint Public Enterprise Fund (PEF) statute, 31 U.S.C. 5136, all receipts from fines assessed under the regulation would be deposited in the PEF and the Secretary of the Treasury would transfer these amounts, along with regular United States Mint seigniorage and profits, to the General Fund as miscellaneous receipts. As miscellaneous receipts in the Treasury—the drawing of funds from which are subject to appropriation by Congress—neither the Secretary of the Treasury, nor the Director of the Mint could be subject to “possible temptation * * * when [their] executive responsibilities * * * may make [them] partisan to maintain the high level of contribution” from the assessment process provided for under the regulation.
Upon additional review and consideration of the provisions outlined in the interim rule, the agency has removed from the regulation sections 92.16(d)(3) & (4), which provide for agency counsel review. We also made conforming changes to section 92.17(a). The agency determined that these steps in the examination and assessment process are best addressed through internal procedures.
We also have made minor clarifying changes throughout the final rule.
This final rule is not a significant regulatory action for the purposes of Executive Order 12866. While a proposed rule was published for public comment, the rule establishes agency practice and procedure, and prior notice and the opportunity for public comment were not required pursuant to 5 U.S.C. 553(b)(A) (or any other law). For this reason, a Regulatory Flexibility Act analysis is not required.
The final rule does not require new “collection of information” requirements within the meaning of the Paperwork Reduction Act of 1995. The only information collected would be that provided voluntarily by persons sent Initial Notices of Assessment under the regulation.
The format of the final rule is generally consistent with the format of the rule proposed in the NPRM.
Administrative practice and procedure, Advertising, Consumer protection, Currency, Penalties, Seals and insignia, Signs and symbols, Trademarks.
5 U.S.C. 301, 31 U.S.C. 321 and 333.
(a) The procedures in this subpart implement the provisions of 31 U.S.C. 333(c), which authorize the Secretary of the Treasury to assess a civil penalty against any person who has misused the words, titles, abbreviations, initials, symbols, emblems, seals, or badges of the United States Mint in violation of 31 U.S.C. 333(a).
(b) The procedures in this subpart do not apply to the extent that the Secretary of the Treasury, the Director of the United States Mint, or their authorized designees have specifically granted to the person express permission, in writing, to manufacture, produce, sell, possess, or use the words, titles, abbreviations, initials, symbols, emblems, seals, or badges in a contract, agreement, license, letter, memorandum, or similar document.
(c) The procedures in this subpart are limited to actions initiated by the United States Mint to enforce the provisions of 31 U.S.C. 333. The procedures herein do not affect the provisions of 31 CFR Part 27. Therefore, this subpart shall not be construed as the exclusive means for the Secretary of the Treasury to enforce 31 U.S.C. 333 insofar as a covered misuse affects the United States Mint.
(a)
(b)
(1) An employee of the Treasury Department in the grade of GS-15 or higher; and
(2) Capable of examining the matter without actual or apparent conflict of interest.
(c)
(d)
(e)
(1) The date that the misuse occurred;
(2) The date that the misuse had the effect of conveying the false impression that the activity was associated with or approved, endorsed, sponsored or authorized by the United States Mint or its officers or employees; or
(3) If the violation is a continuing one, the date on which the misuse of the words, titles, abbreviations, initials, symbols, emblems, seals, or badges protected by 31 U.S.C. 333 or the procedures in this subpart last occurred.
(f)
(g)
(h)
(i)
(1) A trademark, designation of origin, or mark of identification, or
(2) A stylized depiction comprising letters, words, or numbers.
(a)
(1) That person uses in connection with, or as a part of, any advertisement, solicitation, business activity, or product, whether alone or with other words, letters, symbols, or emblems—
(i) The words “Department of the Treasury,” “United States Mint,” or “U.S. Mint”;
(ii) The titles “Secretary of the Treasury,” “Treasurer of the United States,” “Director of the United States Mint,” or “Director of the U.S. Mint”;
(iii) The abbreviations or initials of any entity or title referred to in paragraph (a)(1)(i) or (a)(1)(ii) of this section;
(iv) Any symbol, emblem, seal, or badge of an entity referred to in paragraph (a)(1)(i) of this section (including the design of any envelope, stationery, or identification card used by such an entity); or
(v) Any colorable imitation of any such words, titles, abbreviations, initials, symbols, emblems, seals, or badges; and
(2) That person's use is in a manner that could reasonably be interpreted or construed as conveying the false impression that such advertisement, solicitation, business activity, or product is in any manner approved, endorsed, sponsored, authorized by, or associated with the United States Mint, or any officer, or employee thereof.
(b)
(c)
(d)
(2) The assessing official may commence a civil action to recover or enforce any civil penalty imposed in a Final Notice of Assessment issued pursuant to § 92.17 at any time before the end of the two-year period beginning on the date of the Final Notice of Assessment. If judicial review of the Final Notice of Assessment is sought, the two-year period begins to run from the date that a final and unappealable court order is issued.
(e)
(a) When an employee of the United States Mint learns of or discovers a potential violation of 31 U.S.C. 333 or this subpart, he or she will refer the matter, with all available evidence, to the assessing official.
(b) The assessing official will consider relevant factors when determining whether to initiate an action to impose a civil penalty under the procedures in this subpart. Those factors may include, but are not limited to, the following:
(1) The scope of the misuse;
(2) The purpose and/or nature of the misuse;
(3) The extent of the harm caused by the misuse;
(4) The circumstances of the misuse;
(5) The commercial benefit intended to be derived from the misuse; and
(6) The repeated nature of the misuse.
(c) If the assessing official decides to initiate an action to impose a civil penalty under the procedures in this subpart, he or she will, in writing:
(1) Appoint an examining official; and
(2) Delegate to the examining official the authority to prepare, sign, and serve an Initial Notice of Assessment on behalf of the assessing official.
The examining official shall review all immediately available evidence on the matter; determine a proposed civil penalty based on the factors listed under § 92.16(d)(2)(iii); and prepare and serve an Initial Notice of Assessment by United States mail or other means upon the person believed to be in violation of § 92.13 and otherwise subject to a civil penalty. The notice shall provide the name and telephone number of the examining official, who can provide information concerning the notice and the procedures in this subpart. The notice shall include the following:
(a) A specific reference to the provisions of § 92.13 violated;
(b) A concise statement of the facts that support the conclusion that such a violation occurred;
(c) The amount of the civil penalty proposed and the maximum amount of the potential civil penalty that the assessing official could impose;
(d) A notice informing the person alleged to be in violation of § 92.13 that he or she:
(1) May, within 30 days of the date of the notice, pay the proposed civil penalty, thereby waiving the right to make a written response under § 92.16 and to seek judicial review under § 92.18:
(i) By electronic funds transfer (EFT) in accordance with instructions provided by the examining official in the Initial Notice of Assessment; or
(ii) By means other than EFT only with the written approval of the assessing official;
(2) May make a written response in accordance with § 92.16 within 30 days of the date of the notice addressing, as appropriate:
(i) Why a civil penalty should not be imposed; and
(ii) Why a civil penalty should be in a lesser amount than proposed.
(3) May be represented by an attorney or other representative, provided that a designation of representative signed by the person alleged to be in violation is received by the examining official; and
(4) May request, within 20 days of the date of the notice, a copy of or opportunity to review any documents and/or other evidence that the United States Mint compiled and relied on in determining to issue the notice (the assessing official reserves the right to assert privileges available under law and may decline to disclose certain documents and/or other evidence protected by such privileges; however, any documents or other evidence withheld from disclosure shall be expunged from the record and shall not be considered by the examining and assessing officials in arriving at their respective recommendations and decisions); and
(e) An advisement of the following:
(1) If no written response is received within the time allowed in § 92.16(b), a Final Notice of Assessment may be issued without a presentation by the person;
(2) If a written response has been made and the examining official deems it necessary, the examining official may request, orally or in writing, additional information from the respondent;
(3) A Final Notice of Assessment may be issued in accordance with § 92.17 requiring that the proposed civil penalty be paid;
(4) A Final Notice of Assessment is subject to judicial review in accordance with 5 U.S.C. 701
(5) All submissions sent in response to the Initial Notice of Assessment must be transmitted to the address specified in the notice and include the name, address, and telephone number of the respondent.
(a)
(i) A reference to and specific identification of the Initial Notice of Assessment involved;
(ii) The full name of the person against whom the Initial Notice of Assessment has been made;
(iii) If the respondent is not a natural person, the name and title of the officer authorized to act on behalf of the respondent; and
(iv) If a representative of the person named in the Initial Notice of Assessment is filing the written response, a copy of the duly executed designation as representative.
(2) The written response must admit or deny each violation of § 92.13 set forth in the Initial Notice of Assessment. Any violation not specifically denied will be presumed to be admitted. Where a violation is denied, the respondent shall specifically set forth the legal or factual basis upon which the allegation is denied. If the basis of the written response is that the respondent is not the person responsible for the alleged violation, the written response must set forth sufficient information to allow the examining and assessing officials to determine the truth of such an assertion. The written response should include any and all documents and other information that the respondent believes
(b)
(2) If a request for documents or other evidence is made pursuant to § 92.15(d)(4), the written response must be submitted not later than 20 days after the date of the United States Mint's response to the request.
(3)(i) In computing the number of days allowed for filing a written response under this paragraph, the first day counted is the day after the date of the Initial Notice of Assessment is issued. If the last date on which the response is required to be filed by this paragraph is a Saturday, Sunday or Federal holiday, the response will be due on the next business day after that date.
(ii) If a response is transmitted by United States mail, it will be deemed timely filed if postmarked on or before the due date.
(4) The examining official may extend the period for making a written response under paragraphs (b)(1) and (b)(2) of this section for up to ten days for good cause shown. Requests for extensions beyond ten days must be approved by the assessing official and must be based on good cause shown. Generally, failure to obtain representation in a timely manner will not be considered good cause.
(c)
(d)
(1) In fully considering the matter, the examining official will not consider any evidence introduced into the record by the United States Mint after the date of the Initial Notice of Assessment unless and until the respondent has been notified that such additional evidence will be considered, and has had an opportunity to request, review and comment on such evidence.
(2) The examining official will prepare a concise report, addressed to the assessing official, which will contain the following:
(i) The entire administrative record on the matter, including all information provided in or with a written response timely filed by the respondent and any additional information provided pursuant to § 92.15(e)(2), as well as all evidence upon which the Initial Notice of Assessment was based, and any additional evidence as provided for in § 92.16(d)(1).
(ii) A finding, based on the preponderance of the evidence, as to each alleged violation specified in the Initial Notice of Assessment;
(iii) For each violation that the examining official determines to have occurred, a recommendation as to the appropriate amount of a civil penalty to be imposed which, upon additional consideration of the evidence, may be the same as, more than, or less than the amount initially proposed by the examining official pursuant to § 92.15. In making this recommendation, the examining official will consider all relevant factors including, but not limited to, the following:
(A) The scope of the misuse;
(B) The purpose and/or nature of the misuse;
(C) The extent of the harm caused by the misuse;
(D) The circumstances of the misuse;
(E) The commercial benefit intended to be derived from the misuse; and
(F) The repeated nature of the misuse.
(iv) If the examining official determines that a violation has occurred, a proposed Final Notice of Assessment that incorporates his or her findings and recommendations.
(v) Any additional information or considerations that the assessing officer should consider in a decision whether to issue a Final Notice of Assessment under § 92.17.
(a) In making a final determination whether to impose a penalty, the assessing official shall take into consideration the entire report prepared by the examining official. Although the assessing official should accord appropriate weight to the findings and recommendations of the examining official, the assessing official is not bound by them. The assessing official may approve, disapprove, modify, or substitute any or all of the examining official's findings and recommendations if, in his or her judgment, the evidence in the record supports such a decision. The assessing official will determine whether:
(1) The facts warrant a conclusion that no violation has occurred; or
(2)(i) The facts warrant a conclusion that one or more violations have occurred; and
(ii) The facts and violations found justify the conclusion that a civil penalty should be imposed.
(b) If the assessing official determines that no violation has occurred, the official shall promptly send a letter indicating that determination to the person served with an Initial Notice of Assessment and to any designated representative of such person.
(c) If the assessing official determines that a violation has occurred:
(1) The assessing official shall issue a Final Notice of Assessment to the person served with an Initial Notice of Assessment and to any designated representative of such person.
(2) The assessing official may, in his or her discretion:
(i) Impose a civil penalty;
(ii) Not impose a civil penalty; or
(iii) Impose a civil penalty and suspend the payment of all or some of the civil penalty, conditioned on the violator's future compliance with 31 U.S.C. 333.
(3) If a civil penalty is imposed under § 92.17(c)(2)(i) or (iii), the assessing official shall determine the appropriate amount of the penalty in accordance with 31 U.S.C. 333(c)(2). In determining the amount of a civil penalty, the assessing official will consider relevant factors including, but not limited to, the following:
(i) The scope of the misuse;
(ii) The purpose and/or nature of the misuse;
(iii) The extent of the harm caused by the misuse;
(iv) The circumstances of the misuse;
(v) The commercial benefit intended to be derived from the misuse; and
(vi) The repeated nature of the misuse.
(4) The Final Notice of Assessment shall:
(i) Include the following:
(A) A specific reference to each provision of § 92.13 found to have been violated;
(B) A concise statement of the facts supporting a conclusion that each violation has occurred;
(C) An analysis of how the facts and each violation justifies the conclusion that a civil penalty should be imposed; and
(D) The amount of each civil penalty imposed and a statement as to how the
(ii) Inform the person of the following:
(A) Payment of a civil penalty imposed by the Final Notice of Assessment must be made within 30 days of the date of the notice;
(B) Payment of a civil penalty imposed by the Final Notice of Assessment shall be paid by EFT in accordance with instructions provided in the notice, unless the assessing official has given written approval to have payment made by other means;
(C) If payment of a civil penalty imposed by the Final Notice of Assessment has been suspended on the condition that the person comply in the future with 31 U.S.C. 333 and this subpart, the failure by the person to so comply will make the civil penalty payable on demand;
(D) If a civil penalty is not paid within 30 days of the date of the Final Notice of Assessment (or on demand under paragraph (c)(3)(ii)(D) of this section), a civil action to collect the penalty or enforce compliance may be commenced at any time within two years of the date of the Final Notice of Assessment; and
(E) Any civil penalty imposed by the Final Notice of Assessment may be subject to judicial review in accordance with 5 U.S.C. 701
A Final Notice of Assessment issued under the procedures in this subpart may be subject to judicial review pursuant to 5 U.S.C. 701
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary Safety Zone on the Morgan City-Port Allen Alternate Route, from Mile Marker 0.5 to Mile Marker 1.0, bank to bank. This Safety Zone is needed to protect divers, vessels, and tows from destruction, loss, or injury from salvage operations to remove a crane from beneath the Long-Allen Fixed Bridge, and to facilitate compliance with a court approved Consent Judgment whereby the crane must be removed prior to December 1, 2007.
This rule is effective from 6 a.m. on October 29, 2007 until 6 p.m. on November 11, 2007.
Documents indicated in this preamble as being available in the docket are part of COTP Morgan City-07-018 and are available for inspection or copying at Marine Safety Unit Morgan City, 800 David Drive, Morgan City, Louisiana, 70380 between 8 a.m. and 4 p.m., Monday through Friday, except Federal holidays.
Lieutenant Commander (LCDR) Rick Paciorka, Marine Safety Unit Morgan City, at (985) 380-5320.
We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM, and under 5 U.S.C. 553(d)(3), good cause exists for making this rule effective less than 30 days after publication in the
Due to an allision with the Long-Allen fixed bridge, a crane was lost from a barge into the Morgan City-Port Allen Alternate Route. Salvage operations will be conducted in the vicinity of the Long-Allen Fixed bridge to recover the crane. The Morgan City-Port Allen Alternate Route will be closed to marine traffic during salvage operations. This Safety Zone is needed to protect divers, vessels, and tows from destruction, loss or injury from the dangers associated with the salvage operations, and to facilitate compliance with a court approved Consent Judgment whereby the salvage operation must be concluded by 1 December 2007.
The Coast Guard is establishing a temporary Safety Zone on the Morgan City-Port Allen Alternate Route, from Mile Marker 0.5 to Mile Marker 1.0, bank to bank. The temporary Safety Zone will continue in effect until the salvage operations are complete. Vessels and tows may not enter this zone while salvage operations are taking place. This rule is effective from 6 a.m. on October 29, 2007 until 6 p.m. on November 11, 2007.
This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.
This rule will only be in effect for a 14 day period of time and notifications to the marine community will be made through broadcast notice to mariners. The impacts on routine navigation are expected to be moderate to great. Vessels may continue to transit through alternate routes to their destinations.
Under the Regulatory Flexibility Act (5 U.S.C. 601—612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities.
The Coast Guard certifies under 5 U.S.C. 605 (b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit through the Safety Zone from 6 a.m. CDT on October 29, 2007 until 6 p.m. CST on November 11, 2007. This Safety Zone will not have a significant economic impact on a substantial number of small entities because this rule will be in effect for a 14 day period of time. Additionally, vessels may continue to transit through alternate routes to their destinations.
If you are a small business entity and are significantly affected by this regulation, please contact LCDR Rick Paciorka, Marine Safety Unit Morgan City, at (985) 380-5320.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so they could better evaluate its effects on them and participate in the rulemaking process.
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.
This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, 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.
We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that Order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation because this rule is not expected to result in any significant adverse environmental impact as described in NEPA.
Under figure 2-1, paragraph (34)(g), of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule.
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) Vessels requiring entry into or passage through the Safety Zone must
(3) All persons and vessels shall comply with the instructions of the Captain of the Port Morgan City and designated on-scene U.S. Coast Guard patrol personnel. On-scene U.S. Coast Guard patrol personnel include commissioned, warrant, and petty officers of the U.S. Coast Guard.
Environmental Protection Agency (EPA).
Direct final rule.
EPA is approving a request submitted by the Michigan Department of Environmental Quality (MDEQ) on February 13, 2007, to revise the Michigan State Implementation Plan (SIP). The state has requested approval of two rules in two areas of Part 6, Emission Limitations and Prohibitions-Existing Sources of Volatile Organic Compound (VOC) Emissions by adding R 336.1660, Standards for VOC Emissions from Consumer Products, by adopting by reference the Ozone Transport Commission's Model Rule with some modifications, and adding R 336.1661, Definitions for Consumer Products, to define VOC.
This direct final rule will be effective December 26, 2007, unless EPA receives adverse comments by November 26, 2007. If adverse comments are received, EPA will publish a timely withdrawal of the direct final rule in the
Submit your comments, identified by Docket ID No. EPA-R05-OAR-2007-0192, by one of the following methods:
1.
2.
3.
4.
5.
Douglas Aburano, Environmental Engineer, Criteria Pollutant Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 353-6960,
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:
MDEQ submitted the requested rule revisions on February 13, 2007.
MDEQ held hearings on July 10, 2006 and August 17, 2006, and did not receive any adverse comments.
The State has requested the following revisions in Part 6, Emission Limitations and Prohibitions—Existing Sources of VOC Emissions: (1) Changes to R 336.1660, Standards for VOC Emissions from Consumer Products; and (2) changes to R 336.1661, Definitions for Consumer Products. The revisions are described in more detail below.
MDEQ is requesting the addition of Part 6, R 336.1660, in which the state has adopted by reference the provisions in the Ozone Transport Commission's “Model Rule for Consumer Products,” dated March 6, 2001, with some modifications. The modifications are related to implementation dates that are updated from the Model Rule and include several other minor changes.
The rules limit the VOC content of consumer products, including personal care products, household products, automotive after-market products, adhesives and sealants, insecticides, coatings and related products (except architectural and maintenance coatings), and other miscellaneous products. The rules require that no person shall sell, supply, offer for sale, or manufacture for sale, in the state of Michigan, any of the affected consumer products (mostly aerosols and sprays), unless the VOC content limits specified in the Table of Standards of the rules are adhered to. Additionally, the rule has several other related requirements.
MDEQ is requesting the addition of Part 6, R 336.1661, in order to define VOC. R 336.1661 contains definitions used exclusively in R 336.1660.
We are approving revisions to the Michigan SIP in two portions of Part 6: (1) To add R 336.1660, Standards for VOC Emissions from Consumer Products, in which Michigan has adopted by reference the Ozone Transport Commission's Model Rule with some modifications, and (2) to add R 336.1661, Definitions for Consumer Products, to define VOC. Michigan has adopted the Model Rule by reference with two exceptions. Michigan did not adopt the sections that address violations and severability. It was not necessary for Michigan to adopt these two specific sections of the Model Rule as there are Michigan specific rules that already address these issues. Michigan Act 348, which is approved into the Michigan SIP, addresses violations. Section 324.9122 of Michigan Act 451 provides for severability of the State's rules.
We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of this
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and, therefore, is not subject to review by the Office of Management and Budget.
Because it is not a “significant regulatory action” under Executive Order 12866 or a “significant energy action,” this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001).
This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, 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 by Executive Order 13175 (59 FR 22951, November 9, 2000).
This action also does not have Federalism implications because it does 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 Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act.
This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal Standard.
In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the state to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.
This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 26, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
(c) * * *
Environmental Protection Agency (EPA).
Direct final rule.
The EPA is approving Michigan's June 29, 2007, request to revise recordkeeping and reporting requirements for abnormal conditions, start-up, shutdown, and malfunction of a source, process, or process equipment. The revised rule contains more specific and complete recordkeeping and reporting requirements than are currently approved into the Michigan State Implementation Plan (SIP). In the proposed rules section of this
This direct final rule will be effective December 26, 2007, unless EPA receives adverse comments by November 26, 2007. If adverse comments are received, EPA will publish a timely withdrawal of the direct final rule in the
Submit your comments, identified by Docket ID No. EPA-R05-OAR-2007-0631, by one of the following methods:
1.
2.
3.
4.
5.
Kathleen D'Agostino, Environmental Engineer, Criteria Pollutant Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-1767,
In the following, whenever “we,” “us,” or “our” are used, we mean the United States Environmental Protection Agency.
On June 29, 2007, the Michigan Department of Environmental Quality (MDEQ) submitted a revision to the Michigan SIP. The submittal revises recordkeeping and reporting requirements for abnormal conditions, start-up, shutdown, and malfunction of a source, process, or process equipment contained in R 336.1912 of the Michigan Administrative Code. The revised rule contains more specific and complete recordkeeping and reporting requirements than are currently approved into the SIP.
The rule requires the owner or operator of a source to:
1. Operate in a manner consistent with good air pollution control practices for minimizing emissions during periods of abnormal conditions, start-up, shutdown, and malfunctions;
2. Provide notice of an abnormal condition, start-up, shutdown, or malfunction that results in the emission of a hazardous air pollutant or toxic air contaminant in excess of an emission standard which continues for more than one hour;
3. Provide notice and a written report of an abnormal condition, start-up, shutdown, or malfunction that results in emissions of any air contaminant continuing for more than two hours in excess of a standard or limitation;
4. Certify the truth, accuracy, and completeness of written reports; and
5. Incorporate into a preventative maintenance and malfunction abatement plan actions taken to correct and to prevent a reoccurrence of an abnormal condition or malfunction.
Notices, which can be by any reasonable means, including electronic, telephonic, or oral communication, are required to be submitted to the MDEQ no later than two business days after the start-up or shutdown or after discovery of the abnormal conditions or malfunction. Written reports are required to be submitted to the MDEQ within ten days after the start-up or shutdown occurred, within ten days after the abnormal conditions or malfunction has been corrected, or within thirty days of discovery of the abnormal conditions or malfunction, whichever is first.
Written reports must include the time and date, probable causes and duration of the abnormal conditions, start-up, shutdown, or malfunction; identification of the source, process, or process equipment involved; the type and, where possible, quantity or magnitude of the excess emissions; and information describing the measures taken and air pollution control practices followed to minimize emissions. For abnormal conditions and malfunctions, the report must also include a summary of the actions taken to correct and to prevent a reoccurrence of the abnormal conditions or malfunction and the time taken to correct the malfunction.
EPA is approving R 336.1912 as a revision to the Michigan SIP. We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of this
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and
Because it is not a “significant regulatory action” under Executive Order 12866 or a “significant energy action,” this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001).
This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, 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 by Executive Order 13175 (59 FR 22951, November 9, 2000).
This action also does not have Federalism implications because it does 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 Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act.
This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal Standard.
In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the state to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.
This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 26, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
(c) * * *
Environmental Protection Agency (EPA).
Notice of partial deletion of sites from the Otis Air National Guard Base/Camp Edwards Superfund Site from the National Priorities List.
EPA New England Region (EPA) announces the deletion of 61 source area sites on the Otis Air National Guard Base/Camp Edwards Superfund Site from the National Priorities List (NPL). All 61 source area sites as listed in Table 1 were originally proposed for deletion (72 FR 41976) August 1, 2007, and encompass a total acreage of 482.1 acres. A source area site is defined by: soil; structures, if present; and does not include any contaminated groundwater plume that may be below the site. Otis Air National Guard Base/Camp Edwards is a Federal Facility Superfund Site known locally as the Massachusetts Military Reservation (MMR), so this notice will use MMR as the abbreviation to describe the entire Superfund Site. The United States Air Force is the lead agency at the MMR Superfund Site.
This partial deletion pertains to only the surface area of sites investigated (and in some cases cleaned-up) for soil contamination, and does not pertain to any of the 12 groundwater plumes associated with MMR Superfund Site. All other sites (including all contaminated groundwater plumes on the Site) not included in this notice will remain on the NPL. In the northern half of the MMR, there are source area sites and groundwater plumes associated with an investigation and cleanup program known as the Impact Area Groundwater Study Program which is being conducted under the authority of Safe Drinking Water Act Administrative Orders. These sites and groundwater plumes are not the subject of this partial deletion.
This partial deletion of the 61 source area sites on MMR is effective on October 26, 2007.
Bob Lim, Remedial Project Manager, U.S. Environmental Protection Agency, One Congress Street, Suite 1100 (HBT), Boston, Massachusetts 02114-2023, (617) 918-1392, Fax (617) 918-1291, e-mail:
Otis Air National Guard Base/Camp Edwards is a Federal Facility Superfund Site known locally as the Massachusetts Military Reservation (MMR), so this notice will use MMR as the abbreviation to describe the entire Superfund Site. MMR is located in portions of the towns of Bourne, Falmouth, Mashpee, and Sandwich.
This partial deletion pertains to the soil and, if present, structures at 61 sites ranging in size from half an acre to 80.7 acres. The total proposed area is 482.1 acres. Table 1 identifies structures as being present with an asterisk next to the site name. There would be 19 source area sites remaining. Even though some of the sites appear to be above contaminated groundwater plumes, this partial deletion does not include any plumes of contaminated groundwater because data shows that the sites are not related to the plumes. Currently eleven groundwater pump and treat cleanup remedies will continue operating until cleanup goals are met. In the northern half of MMR, there is a separate, ongoing investigation and cleanup program known as the Impact Area Groundwater Study Program (IAGWSP). These sites and groundwater plumes are not the subject of this Notice of Intent for Partial Deletion.
On August 1, 2007, EPA published a Notice of Intent for Partial Deletion in the
EPA identifies sites that appear to present a significant risk to public health, welfare, or the environment and maintains the NPL as the list of those sites. Any site deleted from the NPL remains eligible for Fund-financed actions in the unlikely event that conditions at the site warrant such action. Section 300.425(e)(3) of the NCP states that Fund-financed actions may be taken at sites deleted from the NPL. Deletion of a site from the NPL does not affect responsible party liability or impede Agency efforts to recover costs associated with response efforts. This partial deletion does not alter the status of all the remaining sites and groundwater plumes of the MMR Site which are not proposed for partial deletion and remain on the NPL.
Environmental protection, Air pollution control, Chemicals, Hazardous substances, Hazardous waste, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water supply.
33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O. 12777, 56 FR 54757, 3 CFR 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR 1987 Comp., p. 193.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule; correcting amendment.
On March 30, 2007, we published a final rule entitled “Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers to Perform Organ Transplants.” The effective date was June 28, 2007. This correcting amendment corrects a technical error identified in the March 30, 2007 final rule.
Jeannie Miller, (410) 786-3164.
FR Doc. 07-1435 of March 30, 2007 (72 FR 15198) contained a technical error that this rule serves to identify and correct. In amending subpart E of part 482, we inadvertently omitted existing §§ 482.60, 482.61, 482.62, and 482.66. Our intention was to retain these sections, which address psychiatric hospitals and “swing-bed” hospitals, without change.
In amending subpart E of part 482, we inadvertently omitted existing §§ 482.60, 482.61, 482.62, and 482.66. Our intention was to retain these sections, which address psychiatric hospitals and “swing-bed” hospitals, without change.
We ordinarily publish a notice of proposed rulemaking in the
We find for good cause that it is unnecessary to undertake notice and comment rulemaking because this final rule merely provides technical corrections to the regulations. We are not making any changes to our existing regulations, but reinstating provisions that have previously been approved and were unintentionally omitted from the final rule that appeared in the March 30, 2007
Further, we believe a delayed effective date is unnecessary because this correcting amendment merely reinstates provisions already approved and in effect. Therefore, we find good cause to waive notice and comment procedures, as well as the 30-day delay in effective date.
Grant programs—health, Hospitals, Medicare, Reporting and recordkeeping requirements.
Secs. 1102, 1871 and 1881 of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr), unless otherwise noted.
Psychiatric hospital must—
(a) Be primarily engaged in providing, by or under the supervision of a doctor of medicine or osteopathy, psychiatric services for the diagnosis and treatment of mentally ill persons;
(b) Meet the conditions of participation specified in §§ 482.1 through 482.23 and §§ 482.25 through 482.57;
(c) Maintain clinical records on all patients, including records sufficient to permit CMS to determine the degree and intensity of treatment furnished to Medicare beneficiaries, as specified in § 482.61; and
(d) Meet the staffing requirements specified in § 482.62.
The medical records maintained by a psychiatric hospital must permit determination of the degree and intensity of the treatment provided to individuals who are furnished services in the institution.
(a)
(1) The identification data must include the patient's legal status.
(2) A provisional or admitting diagnosis must be made on every patient at the time of admission, and must include the diagnoses of intercurrent diseases as well as the psychiatric diagnoses.
(3) The reasons for admission must be clearly documented as stated by the patient and/or others significantly involved.
(4) The social service records, including reports of interviews with patients, family members, and others, must provide an assessment of home plans and family attitudes, and community resource contacts as well as a social history.
(5) When indicated, a complete neurological examination must be recorded at the time of the admission physical examination.
(b)
(1) Be completed within 60 hours of admission;
(2) Include a medical history;
(3) Contain a record of mental status;
(4) Note the onset of illness and the circumstances leading to admission;
(5) Describe attitudes and behavior;
(6) Estimate intellectual functioning, memory functioning, and orientation; and
(7) Include an inventory of the patient's assets in descriptive, not interpretative, fashion.
(c)
The written plan must include—
(i) A substantiated diagnosis;
(ii) Short-term and long-range goals;
(iii) The specific treatment modalities utilized;
(iv) The responsibilities of each member of the treatment team; and
(v) Adequate documentation to justify the diagnosis and the treatment and rehabilitation activities carried out.
(2) The treatment received by the patient must be documented in such a way to assure that all active therapeutic efforts are included.
(d)
(e)
The hospital must have adequate numbers of qualified professional and supportive staff to evaluate patients, formulate written, individualized comprehensive treatment plans, provide active treatment measures, and engage in discharge planning.
(a)
(1) Evaluate patients;
(2) Formulate written individualized, comprehensive treatment plans;
(3) Provide active treatment measures; and
(4) Engage in discharge planning.
(b)
(1) The clinical director, service chief, or equivalent must meet the training and experience requirements for examination by the American Board of Psychiatry and Neurology or the American Osteopathic Board of Neurology and Psychiatry.
(2) The director must monitor and evaluate the quality and appropriateness of services and treatment provided by the medical staff.
(c)
(d)
(1) The director of psychiatric nursing services must be a registered nurse who has a master's degree in psychiatric or mental health nursing, or its equivalent from a school of nursing accredited by the National League for Nursing, or be qualified by education and experience in the care of the mentally ill. The director must demonstrate competence to participate in interdisciplinary formulation of individual treatment plans; to give skilled nursing care and therapy; and to direct, monitor, and evaluate the nursing care furnished.
(2) The staffing pattern must insure the availability of a registered professional nurse 24 hours each day. There must be adequate numbers of registered nurses, licensed practical nurses, and mental health workers to provide the nursing care necessary under each patient's active treatment program.
(e)
(f)
(1) The director of the social work department or service must have a master's degree from an accredited school of social work or must be qualified by education and experience in the social services needs of the mentally ill. If the director does not hold a masters degree in social work, at least one staff member must have this qualification.
(2) Social service staff responsibilities must include, but are not limited to, participating in discharge planning, arranging for follow-up care, and developing mechanisms for exchange of appropriate, information with sources outside the hospital.
(g)
(1) The program must be appropriate to the needs and interests of patients and be directed toward restoring and maintaining optimal levels of physical and psychosocial functioning.
(2) The number of qualified therapists, support personnel, and consultants must be adequate to provide comprehensive therapeutic activities consistent with each patient's active treatment program.
A hospital that has a Medicare provider agreement must meet the following requirements in order to be granted an approval from CMS to provide post-hospital extended care services, as specified in § 409.30 of this chapter, and be reimbursed as a swing-bed hospital, as specified in § 413.114 of this chapter:
(a)
(1) The facility has fewer than 100 hospital beds, excluding beds for newborns and beds in intensive care type inpatient units (for eligibility of hospitals with distinct parts electing the optional reimbursement method, see § 413.24(d)(5) of this chapter).
(2) The hospital is located in a rural area. This includes all areas not delineated as “urbanized” areas by the Census Bureau, based on the most recent census.
(3) The hospital does not have in effect a 24-hour nursing waiver granted under § 488.54(c) of this chapter.
(4) The hospital has not had a swing-bed approval terminated within the two years previous to application.
(b)
(1) Resident rights (§ 483.10 (b)(3), (b)(4), (b)(5), (b)(6), (d), (e), (h), (i), (j)(1)(vii), (j)(1)(viii), (l), and (m)).
(2) Admission, transfer, and discharge rights (§ 483.12 (a)(1), (a)(2), (a)(3), (a)(4), (a)(5), (a)(6), and (a)(7)).
(3) Resident behavior and facility practices (§ 483.13).
(4) Patient activities (§ 483.15(f)).
(5) Social services (§ 483.15(g)).
(6) Discharge planning (§ 483.20(e)).
(7) Specialized rehabilitative services (§ 483.45).
(8) Dental services (§ 483.55).
Animal and Plant Health Inspection Service, USDA.
Proposed rule; reopening of comment period.
We are reopening the comment period for our proposed rule that would amend the regulations on importing nursery stock by providing a new option for the postentry quarantine growing period for articles of
We will consider all comments that we receive on or before November 26, 2007.
You may submit comments by either of the following methods:
•
•
Dr. Arnold T. Tschanz, Senior Import Specialist, Commodity Import Analysis and Operations, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737-1236; (301) 734-5306.
On August 8, 2007, we published in the
Comments on the proposed rule were required to be received on or before October 9, 2007. We are reopening the comment period on Docket No. 03-002-4 until November 26, 2007. This action will allow interested persons additional time to prepare and submit comments. We will also consider all comments received between October 9, 2007, and the date of this notice.
7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Cessna Aircraft Company (Cessna) Models 525, 525A, and 525B airplanes. This proposed AD would require you to inspect the lower wing skin structure, forward wing spar, lower fuselage skin, fairings, and the external fairing frames for corrosion; repair any damage found; apply a corrosion inhibitive sealant to the fuselage fairings before reinstalling; and disable the cockpit mounted pilot relief tube. This proposed AD results from leaking of the cockpit mounted pilot relief tube, which caused corrosion of the airplane structure. We are proposing this AD to detect and correct any damage from corrosion of the airplane structure. Corrosion of the airplane structure could cause structural degradation and lead to structural failure of the airplane with consequent loss of control.
We must receive comments on this proposed AD by December 26, 2007.
Use one of the following addresses to comment on this proposed AD:
•
•
•
•
For service information identified in this proposed AD, contact Cessna Aircraft Company, Citation Marketing Division, P.O. 7706, Wichita, Kansas 67277; telephone: 1-800-835-4090; fax: 1-800-517-8500.
T.N. Baktha, Aerospace Engineer, 1801 Airport Road, Room 100, Wichita, Kansas 67209; telephone: (316) 946-4155; fax: (316) 946-4107.
We invite you to send any written relevant data, views, or arguments regarding this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
Cessna reported wing skin corrosion in a Model 525 and belly skin corrosion in several Model 525A airplanes. Cessna received information on more than 18 cases of significant corrosion. Cessna also received information on 42 cases of some corrosion on Models 525, 525A, and 525B airplanes. Corrosive fluids leaked after use of the cockpit mounted pilot relief tube and caused corrosion of the fuselage skins, fairings, fairing support structure, and wing structure.
This condition, if not corrected, could result in structural degradation and lead to structural failure of the airplane with consequent loss of control.
We have reviewed the following Cessna service information for this AD:
• Service Bulletin SB525-53-20, dated April 30, 2007;
• Service Bulletin SB525A-53-01, dated April 30, 2007;
• Service Bulletin SB525B-53-01, dated April 30, 2007;
• Alert Service Letter ASL525-53-04, Revision 2, dated August 19, 2007;
• Alert Service Letter ASL525A-53-05, Revision 2, dated July 25, 2007; and
• Alert Service Letter ASL525B-53-02, Revision 2, dated July 25, 2007.
The service information describes procedures for the following actions:
• Inspecting the lower wing skin structure, forward wing spars, lower fuselage skin, fairings, and external fairing frames for corrosion;
• Repairing corrosion by blending within specified limits or by contacting the manufacturer to obtain an FAA-approved repair scheme if corrosion damage can not be repaired within the limits specified;
• Doing a surface eddy current inspection or a dye-penetrant inspection on the repaired blended areas for cracks, and contacting the manufacturer to obtain an FAA-approved repair scheme if cracks are found;
• Applying a corrosion inhibitive sealant to the fuselage fairings before reinstalling; and
• Disabling the cockpit mounted relief tube.
We are proposing this AD because we evaluated all information and determined the unsafe condition described previously is likely to exist or develop on other products of the same type design. This proposed AD would require you to inspect the lower wing skin structure, forward wing spar, lower fuselage skin, fairings, and the external fairing frames for corrosion; repair any damage found; apply a corrosion inhibitive sealant to the fuselage fairings before reinstalling; and disable the cockpit mounted pilot relief tube.
We estimate that this proposed AD would affect 261 airplanes in the U.S. registry.
We estimate the following costs to do the proposed inspection:
We have no way of determining the number of airplanes that may need repair or further inspection based on the results of the proposed inspection, or the costs associated with such repair or inspection.
We estimate the following costs to do the proposed disabling of the cockpit mounted pilot relief tube:
Cessna will provide warranty credit to the extent specified in Cessna Citation Service Bulletin SB525-53-20, dated April 30, 2007; Service Bulletin SB525A-53-01, dated April 30, 2007; Service Bulletin SB525B-53-01, dated April 30, 2007; Alert Service Letter ASL525-53-04, Revision 2, dated August 19, 2007; Alert Service Letter ASL525A-53-05, Revision 2, dated July 25, 2007; and Alert Service Letter ASL525B-53-02, Revision 2, dated July 25, 2007.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that
We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect 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.
For the reasons discussed above, I certify that the proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
You may examine the AD docket that contains the proposed AD, the regulatory evaluation, any comments received, and other information on the Internet at
Air transportation, Aircraft, Aviation safety, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by adding the following new AD:
(a) We must receive comments on this airworthiness directive (AD) action by December 26, 2007.
(b) None.
(c) This AD applies to the following airplane models and serial numbers that have a cockpit mounted pilot relief tube installed and are certificated in any category:
(d) This AD results from leaking of the pilot relief tube, which caused corrosion of the airplane structure. We are issuing this AD to detect and correct any damage from corrosion on the airplane structure. Corrosion of the airplane structure could cause structural degradation and lead to structural failure of the airplane with consequent loss of control.
(e) To address this problem, you must do the following, unless already done:
(f) The Manager, Wichita Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: T.N. Baktha, Wichita ACO, Aerospace Engineer, 1801 Airport Road, Room 100, Wichita, Kansas 67209; telephone: (316) 946-4155; fax: (316) 946-4107. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
(g) To get copies of the service information referenced in this AD, contact Cessna Aircraft Company, Citation Marketing Division, P.O. 7706, Wichita, Kansas 67277; telephone: 1-800-835-4090; fax: 1-800-517-8500. To view the AD docket, go to U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, or on the Internet at
Environmental Protection Agency (EPA).
Proposed rule.
The EPA is proposing to approve, as part of the Michigan State Implementation Plan (SIP), Michigan's June 29, 2007, request to revise recordkeeping and reporting requirements for abnormal conditions, start-up, shutdown, and malfunction of a source, process, or process equipment. The revised rule contains more specific and complete recordkeeping and reporting requirements than are currently approved into the SIP.
Comments must be received on or before November 26, 2007.
Submit your comments, identified by Docket ID No. EPA-R05-OAR-2007-0631, by one of the following methods:
1.
2.
3.
4.
5.
Please see the direct final rule which is located in the Rules section of this
Kathleen D'Agostino, Environmental Engineer, Criteria Pollutant Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-1767,
In the Final Rules section of this
Environmental Protection Agency (EPA).
Proposed rule.
EPA is approving a request submitted by the Michigan Department of Environmental Quality (MDEQ) on February 13, 2007, to revise the Michigan State Implementation Plan (SIP). The state has requested approval of two rules in two areas of Part 6, Emission Limitations and Prohibitions—Existing Sources of Volatile Organic Compound (VOC) Emissions by adding R 336.1660, Standards for VOC Emissions from Consumer Products, by adopting by reference the Ozone Transport Commission's Model Rule with some modifications and R 336.1661, Definitions for Consumer Products, to define VOC.
Comments must be received on or before November 26, 2007.
Submit your comments, identified by Docket ID No. EPA-R05-OAR-2007-0192, by one of the following methods:
1.
2.
3.
4.
5.
Please see the direct final rule which is located in the Rules section of this
Douglas Aburano, Environmental Engineer, Criteria Pollutant Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 353-6960,
In the Final Rules section of this
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Advanced notice of proposed rulemaking; request for comments.
NMFS announces that it is considering, and is seeking public comment on proposed rulemaking to control future access to the South Atlantic for-hire fishery. If a management regime is developed and implemented under the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), the control date would limit the number of participants in the fishery. This announcement is intended, in part, to promote awareness of the potential eligibility criteria for future access so as to discourage speculative entry into the fishery while the South Atlantic Fishery Management Council (Council) and NMFS consider whether and how access to the for-hire fishery should be controlled.
Written comments must be received on or before 5 p.m., local time, November 26, 2007.
You may submit comments, identified by 0648-AW03, by any one of the following methods:
• Electronic Submissions: Submit all electronic public comments via the Federal eRulemaking Portal
• Fax: Attn: Kate Michie 727-824-5308.
• Mail: Kate Michie, NMFS Southeast Regional Office, Sustainable Fisheries Division, 263 13th Avenue South, St. Petersburg, FL 33701.
Instructions: All comments received are a part of the public record and will generally be posted to
NMFS will accept anonymous comments. Attachments to electronic comments will be accepted in Microsoft Word, Excel, WordPerfect, or Adobe PDF file formats only.
Kim Iverson, Public Information Officer, South Atlantic Fishery Management Council; toll free 1-866-SAFMC-10 or 843-571-4366;
At the June 2007 Council meeting, the Council recommended a control date of March 8, 2007, applicable to persons who are contemplating entering any for-hire fishery (charter and headboats) in the exclusive economic zone (EEZ) of the South Atlantic region. The Council requested that this control date be published in the
Establishment of the control date responds to the Council's concerns that for-hire fisheries are expanding quite rapidly and the perception that many of
Control dates are intended to discourage speculative entry into a fishery, as new entrants entering the fishery after the control date are forewarned that they are not guaranteed future participation in the fishery.
Establishment of this control date does not commit the Council or NMFS to any particular management regime or criteria for entry into the for-hire fishery. Fishermen are not guaranteed future participation in the fishery regardless of their level of participation before or after the control date. The Council may recommend a different control date or it may recommend a management regime that does not involve a control date. Other criteria, such as documentation of landings or fishing effort, may be used to determine eligibility for participation in a limited access fishery. The Council and/or NMFS also may choose to take no further action to control entry or access to the fisheries, in which case the control date may be rescinded. Any action by the Council will be taken pursuant to the requirements for fishery management plan and amendment development established under the Magnuson-Stevens Act.
This notification also gives the public notice that interested participants should locate and preserve records that substantiate and verify their participation in any for-hire fishery in the South Atlantic EEZ.
16 U.S.C. 1801
Office of the Chief Economist, USDA.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), this notice announces that the Department of Agriculture, Office of the Chief Economist, is hereby requesting an extension of a currently approved information collection, Guidelines for Designating Biobased Products for Federal Procurement.
Comments received by December 26, 2007 will be considered.
Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
All responses to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record.
The Committee is making a revision to the Procurement List Proposed Additions published on June 15, 2007 (72 FR 33200). The proposed NPA for the Maintenance Record Holder NSN 8105-00-190-9824 has changed from Bestwork Industries for the Blind, Inc., Runnemede, NJ, to Raleigh Lions Clinic for the Blind, Inc., Raleigh, NC.
The Procurement List Proposed Additions notice citing Bestwork Industries for the Blind, Inc., Runnemede, NJ, is no longer under consideration.
Proposed Additions to and Deletions from the Procurement List.
The Committee is proposing to add to the Procurement List products to be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and to delete products and a service previously furnished by such agencies.
Committee for Purchase From People Who Are Blind or Severely Disabled, Jefferson Plaza 2, Suite 10800, 1421 Jefferson Davis Highway, Arlington, Virginia 22202-3259.
This notice is published pursuant to 41 U.S.C. 47(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice for each product will be required to procure the products listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. If approved, the action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the products to the Government.
2. If approved, the action will result in authorizing small entities to furnish the products to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the products proposed for addition to the Procurement List.
Comments on this certification are invited. Commenters should identify the statement(s) underlying the certification on which they are providing additional information.
The following products are proposed for addition to the Procurement List for production by the nonprofit agencies listed:
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. If approved, the action may result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. If approved, the action may result in authorizing small entities to furnish the products and service to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the products and service proposed for deletion from the Procurement List.
Comments on this certification are invited. Commenters should identify the statement(s) underlying the certification on which they are providing additional information.
The following products and service are proposed for deletion from the Procurement List:
Committee for Purchase from People Who Are Blind or Severely Disabled.
Addition to the Procurement List.
This action adds to the Procurement List a service to be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled, Jefferson Plaza 2, Suite 10800, 1421 Jefferson Davis Highway, Arlington, Virginia 22202-3259.
Kimberly M. Zeich, Telephone: (703) 603-7740, Fax: (703) 603-0655, or e-mail
On August 31, 2007, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice (72 FR 50323) of proposed additions to the Procurement List.
After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the service and impact of the addition on the current or most recent contractors, the Committee has determined that the service listed below is suitable for procurement by the Federal Government under 41 U.S.C. 46-48c and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the service to the Government.
2. The action will result in authorizing small entities to furnish the service to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the service proposed for addition to the Procurement List.
Accordingly, the following service is added to the Procurement List:
This action does not affect current contracts awarded prior to the effective date of this addition or options that may be exercised under those contracts.
In the document appearing on page 56984, FR Doc E7-19717, Procurement List Additions and Deletions, on October 5, 2007, the Committee published the following product and NSNs (Long Format Replacement Pages—FCCL 7510-00-NSH-0257; 7510-01-537-1400) with coverage as A-List for the total Government requirement as specified by the General Services Administration.
This notice corrects the coverage for the above mentioned product and NSNs to B-List for the Broad Government requirement as specified by the General Services Administration.
Import Administration, International Trade Administration, Department of Commerce.
On March 2, 2007, in response to a request from an interested party, the Department of Commerce initiated a changed-circumstances review of the antidumping duty order on ball bearings and parts thereof from France. On March 9, 2007, the Department self-initiated changed-circumstances reviews of the antidumping duty orders on ball bearings and parts thereof from Italy and the United Kingdom. We are now rescinding the changed-circumstances reviews for France and Italy because we have initiated administrative reviews covering the firms in question and intend to address any considerations arising from the changed-circumstances reviews on the orders on ball bearings and parts thereof from France and Italy in the context of the 2006/2007 administrative review of these orders.
October 26, 2007.
Kristin Case or Edythe Artman, AD/CVD Operations, Office 5, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230; telephone (202) 482-3174 or (202) 482-3931, respectively.
The Department of Commerce (the Department) published antidumping duty orders on ball bearings and parts thereof (ball bearings) from France, Italy, and the United Kingdom on May 15, 1989. See
On August 11, 2000, the Department revoked the antidumping duty order on ball bearings from Italy with respect to those produced by Somecat S.p.A. (SNFA Italy)
On January 9, 2007, SKF France S.A. and SKF Aerospace France S.A.S. (collectively SKF France) and SNFA France notified the Department of a change of ownership in SNFA France and requested the initiation of a changed-circumstances review of the order on ball bearings from France. In a separate filing on the same date, SKF Industries S.p.A. (SKF Italy) and SNFA Italy notified the Department of a change in ownership of SNFA Italy. On January 26, 2007, SKF UK Ltd. (SKF UK) and SNFA UK filed such a notification with respect to SNFA UK. Each notification stated that AB SKF, the parent SKF company, had purchased all outstanding shares of the SNFA companies through its subsidiary, SKF Holding France S.A., on July 4, 2006.
We initiated a changed-circumstances review pursuant to the request by SKF France and SNFA France on March 2, 2007. See
On June 29, 2007, we initiated administrative reviews of the orders on ball bearings from France, Italy, and the United Kingdom for the period from May 1, 2006, through April 30, 2007. See
The products covered by these orders are ball bearings and parts thereof. These products include all bearings that employ balls as the rolling element. Imports of these products are classified under the following categories: antifriction balls, ball bearings with integral shafts, ball bearings (including radial ball bearings) and parts thereof, and housed or mounted ball bearing units and parts thereof.
Imports of these products are classified under the following
As a result of recent changes to the Harmonized Tariff Schedule, effective February 2, 2007, the subject merchandise is also classifiable under the following additional HTS item numbers: 8708.30.5090, 8708.40.7500, 8708.50.7900, 8708.50.8900, 8708.50.9150, 8708.50.9900, 8708.80.6590, 8708.94.75, 8708.95.2000, 8708.99.5500, 8708.99.68, and 8708.99.8180.
Although the HTSUS item numbers above are provided for convenience and customs purposes, written descriptions of the scope of these orders remain dispositive.
For a listing of scope determinations which pertain to the orders, see the Scope Determination Memorandum from the Antifriction Bearings Team to Laurie Parkhill, dated May 29, 2007, which is on file in the Central Records Unit (CRU) of the main Commerce building, room B-099, in the General Issues record (A-100-001) for the 2005-2006 reviews.
The mergers of the SKF/SNFA entities in France, Italy, and the United Kingdom occurred in July 2006, during the period under review in the 2006/2007 administrative reviews of the orders on ball bearings from those countries. Because SKF France and SKF Italy have been selected as respondents for individual examination in those reviews, we will be examining the impact of the mergers with respect to the sales that they, or their subsidiaries, made to the United States during the period of review and the effect that these mergers have had on the operations and management of the relevant firms for the purposes of determining, among other things, whether the SKF companies should be collapsed with their SNFA counterparts. Thus, we intend to address any considerations arising from the changed-circumstances reviews on ball bearings from France and Italy in the context of the administrative reviews for SKF France and SKF Italy. Accordingly, we are rescinding the changed-circumstances reviews with respect to the antidumping duty orders on ball bearings and parts thereof from France and Italy.
We will incorporate the records of the rescinded reviews into the records of the appropriate administrative reviews.
Import Administration, International Trade Administration, Department of Commerce.
Victoria Cho at (202) 482-5075, AD/CVD Operations, Office 3, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Ave., NW., Washington, DC 20230.
On September 29, 2006, the U.S. Department of Commerce (“Department”) published a notice of initiation of the administrative review of the antidumping duty order on corrosion-resistant carbon steel flat products from Korea, covering the period August 1, 2005 to July 31, 2006.
Section 751(a)(3)(A) of the Tariff Act of 1930, as amended (“the Act”), requires the Department to issue final results within 120 days after the date on which the preliminary results are published. However, if it is not practicable to complete the review within that time period, section 751(a)(3)(A) of the Act allows the Department to extend the time limit for the final results to a maximum of 180 days.
We determine that it is not practicable to complete the final results of this review within the original time limit. Several technical issues arose which require the collection and analyses of certain additional information after the preliminary results. Therefore, to allow sufficient time to collect and analyze the additional information, and to conduct the briefing process, the Department is fully extending the final results. The final results are now due not later than March 10, 2008, the next business day after 180 days from publication of the preliminary results. The amended schedule for interested parties to submit case briefs, written comments, and/or hearing is not later than Monday, January 14, 2008. Rebuttal briefs are limited to issues raised in such briefs or comments and may be filed no later than five days after the time limit for filing the case briefs or comments.
This extension is in accordance with section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(2).
Import Administration, International Trade Administration, Department of Commerce.
October 26, 2007.
Kate Johnson (Brazil) at (202) 482-4929, David Goldberger (Ecuador) at (202) 482-4136, Elizabeth Eastwood (India) at (202) 482-3874, Irina Itkin (Thailand) at (202) 482-0656, and Irene Gorelik (Vietnam) at (202) 482-6905, AD/CVD Operations, Offices 2 and 9, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230.
On April 6, 2007, the Department of Commerce (the Department) published notices of initiation of the administrative reviews of the antidumping duty orders on certain frozen warmwater shrimp from Brazil, Ecuador, India, and Thailand, and the Socialist Republic of Vietnam (Vietnam), covering the period February 1, 2006, through January 31, 2007.
In July 2007, after issuing quantity and value questionnaires and receiving responses, the Department selected mandatory respondents in each of the above-mentioned administrative reviews.
In August and September 2007, the Department rescinded the Brazil, Ecuador, and Thailand administrative reviews with respect to certain companies.
Section 751(a)(3)(A) of the Tariff Act of 1930, as amended (the Act), requires the Department to make a preliminary determination in an administrative review within 245 days after the last day of the anniversary month of an order or finding for which a review is requested. Consistent with section 751(a)(3)(A) of the Act, the Department may extend the 245-day period to 365 days if it is not practicable to complete the review within a 245-day period. The deadline for the preliminary results of these reviews is currently October 31, 2007.
The Department determines that completion of the preliminary results of these administrative reviews within the statutory time period is not practicable.
This notice is published pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(2).
Import Administration, International Trade Administration, Department of Commerce.
October 26, 2007.
Mike Heaney (Brazil), AD/CVD Operations, Office 7, Erin Begnal (the People's Republic of China) AD/CVD Operations, Office 9, Stephen Bailey (Thailand), AD/CVD Operations, Office 7, Douglas Kirby (the United Arab Emirates), AD/CVD Operations, Office 6, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230; telephone: (202) 482-4475, (202) 482-1442, (202) 482-0193, and (202) 482-3782, respectively.
On September 28, 2007, the Department of Commerce (the Department) received petitions on imports of PET Film from Brazil, the People's Republic of China (PRC), Thailand, and the United Arab Emirates (UAE) (petitions) filed in proper form by Dupont Teijin Films, Mitsubishi Polyester Film Inc., SKC Inc., and Toray Plastics (America) Inc., (collectively, petitioners).
In accordance with section 732(b) of the Tariff Act of 1930, as amended (the Act), petitioners allege that imports of PET Film from Brazil, the PRC, Thailand, and the UAE are being, or are likely to be, sold in the United States at less than fair value, within the meaning of section 731 of the Act, and that such imports materially injure, or threaten material injury to, an industry in the United States.
The Department finds that petitioners filed these petitions on behalf of the domestic industry because petitioners are an interested party as defined in section 771(9)(C) of the Act, and petitioners have demonstrated sufficient industry support with respect to the
The products covered by these investigations are all gauges of raw, pre-treated, or primed PET Film, whether extruded or co-extruded. Excluded are metallized films and other finished films that have had at least one of their surfaces modified by the application of a performance-enhancing resinous or inorganic layer more than 0.00001 inches thick. Also excluded is Roller transport cleaning film which has at least one of its surfaces modified by application of 0.5 micrometers of SBR latex. Tracing and drafting film is also excluded. PET Film is classifiable under subheading 3920.62.00.90 of the Harmonized Tariff Schedule of the United States (HTSUS). While HTSUS subheadings are provided for convenience and Customs purposes, our written description of the scope of these investigations is dispositive.
Section 732(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 732(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers who support the petition account for (i) at least 25 percent of the total production of the domestic like product and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 732(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers accounting for more than 50 percent of the total production of the domestic like product, the Department shall (i) poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A) or (ii) determine industry support using a statistically valid sampling method if there is a large number of producers in the industry.
Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs the Department to look to producers who produce the domestic like product. The International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both the Department and the ITC must apply the same statutory definition regarding the domestic like product (section 771(10) of the Act), they do so for different purposes and pursuant to a separate and distinct authority. In addition, the Department's determination is subject to limitations of time and information because the Department determines industry support at the time of initiation. Although this may result in different definitions of the domestic like product, such differences do not render the decision of either agency contrary to law.
Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like-product analysis begins is “the article subject to an investigation,”
With regard to the domestic like product, petitioners do not offer a definition of domestic like product distinct from the scope of the investigations. Based on our analysis of the information submitted on the record, we have determined that PET Film constitutes a single domestic like product and we have analyzed industry support in terms of that domestic like product. For a discussion of the domestic like-product analysis in these cases,
In determining whether petitioners have standing (
Our review of the data provided in these petitions, supplemental submissions, and other information readily available to the Department indicates that petitioners have established industry support. First, these petitions established support from domestic producers accounting for more than 50 percent of the total production of the domestic like product and, as such, the Department is not required to take further action in order to evaluate industry support (
The Department finds that petitioners filed these petitions on behalf of the domestic industry in accordance with section 732(c)(4)(A) of the Act. Petitioners are an interested party as defined in section 771(9)(C) of the Act and have demonstrated sufficient industry support in favor of the initiation of the antidumping duty investigations.
Petitioners allege that the U.S. industry producing the domestic like product is being materially injured by reason of the imports of the subject merchandise sold at less than normal value. While the imports from the UAE do not meet the statutory requirement for cumulation on a volume basis, in its analysis for threat, petitioners allege that imports from the UAE will imminently account for more than three percent of all imports of the subject merchandise by volume and, therefore, they are not negligible. In addition, petitioners have demonstrated that imports from the UAE for the first half of 2007 do meet the statutory requirement for cumulation on a volume basis.
For Brazil, Thailand, and the UAE, in accordance with section 351.204(b) of the Department's regulations, because these petitions were filed on September 28, 2007, the anticipated period of investigation (POI) is July 1, 2006 through June 30, 2007. For the PRC, the anticipated POI is January 1, 2007, through June 30, 2007.
The following is a description of the allegations of sales at less than fair value upon which the Department has based its decision to initiate investigations with respect to Brazil, the PRC, Thailand, and the UAE. The sources of data for the deductions and adjustments relating to U.S. price and normal value are discussed in greater detail in the
Petitioners state that Brazilian producer Terphane Ltda.'s U.S. affiliate, Terphane Inc., was the importer of record for PET Film imports from Brazil during the POI. Petitioners calculated constructed export price (CEP) using information regarding a representative sale of 48-gauge packaging film made through Terphane Inc. to an unaffiliated customer in the United States. Petitioners deducted from U.S. price a mark-up based on the expenses and profit rate of a U.S. importer of PET Film. We adjusted petitioners' mark-up value to exclude certain expenses covered in separate deductions (
Petitioners based normal value on a sale of 48-gauge packaging film by Terphane Ltda. to one of its home market customers in Brazil during the POI. Petitioners deducted credit and packing expenses. Petitioners calculated credit using the standard thirty-day period between shipment and payment dates for PET Film sales consistent with other countries subject to these petitions, and used average prime rates available for Brazil for the POI. Petitioners maintain packing costs in Brazil and the United States are equivalent and therefore based packing expenses on those of one petitioning firm.
Petitioners also allege Terphane Ltda.'s home market sale is below its cost of production. Petitioners therefore calculated constructed value for 48-gauge packaging film, basing Terphane Ltda.'s cost of production on that of a U.S. producer's experience during the POI, adjusted for known differences between the United States and Brazil.
For U.S. price, petitioners relied on price information of a representative sale of Chinese PET Film sold by a U.S. distributor to a U.S. customer in early 2007, based on the experience of a salesperson at one of the petitioning firms.
Because the Department considers the PRC to be a non-market-economy country (NME), petitioners constructed normal value based on the factors-of-
Petitioners assert that India is the appropriate surrogate country for valuing the factors of production for the PRC because India is: (1) a significant producer of identical merchandise; and (2) at a level of economic development comparable to that of the PRC.
Petitioners provided dumping-margin calculations using the Department's NME methodology as required by 19 CFR 351.202(b)(7)(i)(C) and 19 CFR 351.408. Petitioners calculated normal value for the U.S. price discussed above based on U.S. industry experience for producing PET Film, which they state is consistent with standard PET Film production methodology. Petitioners also state that Chinese producers use substantially the same material inputs and production processes as U.S. producers.
For the normal-value calculations, pursuant to section 773(c)(4) of the Act, petitioners used surrogate values from a variety of sources, including the
For PTA and MEG, the main raw materials in the production of PET Film, petitioners provided surrogate values based on the
For the normal-value calculations, petitioners derived the figures for factory overhead, selling, general, and administrative expenses, and profit from the financial ratios of three large Indian producers of PET Film: Flex Industries, Garware Polyester Limited, and Polyplex Corporation. The financial statements that petitioners provided covered the period of April 2005 to March 2006. Additionally, petitioners calculated a simple average of the three companies' financial ratios for purposes of the petition.
In 2005, the Department modified the process by which exporters and producers may obtain separate-rate status in NME investigations. The Department's practice is discussed further in
For U.S. price, petitioners relied on a representative sale of Thai PET Film sold to a U.S. customer during the proposed POI.
For normal value, petitioners submitted price information for a home market sale obtained by an employee of a Thai PET Film reseller.
Petitioners calculated constructed value for 48-gauge packaging film. With exception of FOH, SG&A expense, interest expense and profit rates, which were based on PTL's experience, petitioners calculated constructed value using PTL's cost of production using the experience of a U.S. producer of PET Film, adjusted for known differences between costs in Thailand and the United States. We recalculated petitioners' price-to-CV margin calculation to include an amount for packing.
Petitioners calculated both a CEP and an export price (EP). Petitioners based CEP on a sale made by Flex UAE's U.S. affiliate, Flex America, to an unaffiliated customer during the proposed POI. The PET Film at issue is 92-gauge packaging film which, Petitioners explain, is a common and representative type of PET Film sold in the U.S. market and was sold on a “Delivered, Duty Paid” basis with 30 day payment terms. Petitioners deducted a distributor mark-up (based on Flex America's financial statements), international freight, U.S. Duty, U.S. inland freight, and U.S. credit. We have adjusted the CEP price by recalculating the claimed distributor mark-up submitted by petitioners to eliminate line items which are being deducted separately from U.S. price (
Petitioners calculated EP on the POI weighted-average AUV customs value for PET Film imports from the UAE into the U.S. for subheading number 3920.62.00.90 of the Harmonized Tariff Schedule of the United States (HTS) based on Customs Value data collected from the USITC.
For normal value, petitioners submitted price information for a home market sale which took place during the POI. However, complete information with respect to certain home market expense(s) were not reasonably available to the petitioners. As such, adequate home market prices were not reasonably available to petitioners; therefore, we have relied on petitioners' information for constructed value to calculate normal value.
Petitioners calculated COM (except direct materials and fixed overhead) and packing expenses based on a U.S. producer's cost experience adjusted for known differences to manufacture PET Film in the UAE, using publicly-available data.
Petitioners valued raw materials using the per pound value of purchased polyester chips divided by the production quantity reported in FY 2006 financial statements of Flex UAE, a PET Film producer in the UAE. These were the most recent statement available.
Petitioners determined energy costs using the cost experience of a U.S. PET Film producer to manufacture one pound of PET Film, adjusted by the ratio of energy costs in UAE to that in the United States. Petitioners obtained the annual UAE energy costs for 2004 from the Industrial/Commercial rate published by the UAE's Regulation and Supervision Bureau and the annual U.S. energy costs for 2004 from the International Energy Agency publication, Energy Prices and Taxes for 2006.
To calculate labor, fixed overhead, SG&A expense, interest expense and profit, petitioners relied on the financial statements of Flex UAE for the fiscal year end December 31, 2006. We recalculated petitioners' price-to-CV margin calculation to include an amount for packing.
In prior NME investigations, it has been the Department's practice to request quantity and value information from all known exporters identified in the PRC Petition.
The Department will calculate combination rates for certain respondents that are eligible for a separate rate in this investigation, pursuant to 19 CFR 351.107(b)(1). The
Based on the data provided by petitioners, there is reason to believe that imports of PET Film from Brazil, Thailand, the UAE, and the PRC are being, or are likely to be, sold in the United States at less than fair value. Based on comparisons of export price/constructed export price to normal value that we revised as discussed above and calculated in accordance with section 773(c) of the Act, these are the estimated dumping margins for PET Film: 1) the estimated dumping margins for Brazil range from 13.08 percent (price-to-price) to 44.36 percent (price to CV); 2) the estimated dumping margin for the PRC is 76.72 percent; 3) the estimated dumping margin for Thailand is 80.24 percent (price-to-CV); and 4) the UAE's estimated dumping margins range from 35.44 percent (EP-to-CV) to 73.23 percent (CEP-to-CV).
Based upon the examination of the petitions on PET Film from Brazil, the PRC, Thailand, and the UAE and other information reasonably available to the Department, the Department finds that these petitions meet the requirements of section 732 of the Act. Therefore, we are initiating antidumping duty investigations to determine whether imports of PET Film from Brazil, the PRC, Thailand, and the UAE are being, or are likely to be, sold in the United States at less than fair value. In accordance with section 733(b)(1)(A) of the Act, unless postponed, we will make our preliminary determinations no later than 140 days after the date of this initiation.
Petitioners have provided information demonstrating reasonable grounds to believe or suspect that sales of PET Film in Brazil were made at prices below the fully absorbed cost of production (COP), within the meaning of section 773(b) of the Act, and requested that the Department conduct a sales-below-costs investigation. We note that because petitioners were unable to provide adequate home market prices for Thailand or the UAE, we are not initiating country-wide cost investigations for those countries at this time. According to 19 CFR 351.301(d)(2)(i)(A), petitioners are not precluded from filing a cost allegation once the information becomes available.
An allegation of sales below COP need not be specific to individual exporters or producers.
As described in the section below on “Cost of Production and Constructed Value,” the Department calculated a country-specific COP for a certain gauge of PET Film for Brazil. Based upon a comparison of the prices of the foreign-like product in the home market to the calculated COP of the product, we find reasonable grounds to believe or suspect that sales of the foreign like product were made below the COP, within the meaning of section 773(b)(2)(A)(i) of the Act. Accordingly, the Department is initiating a country-wide cost investigation with regard to Brazil. We note, however, that if we determine that the Brazilian home market is not viable, our initiation of a country-wide cost investigation with respect to sales in the home market will be rendered moot.
Pursuant to section 773(a)(4) of the Act, COP consists of the cost of manufacturing (“COM”); selling, general and administrative (SG&A) expenses; financial expenses; and packing.
Pursuant to section 773(a)(4) of the Act, petitioners calculated a single CV as the basis for normal value (NV). Petitioners calculated CV using the COM; SG&A expenses; financial expenses. Petitioners then added the average profit rate based on the most recent financial statements of a PET Film producer.
Petitioners calculated COM and packing based on a U.S. producer's cost experience, adjusted for known differences (
Petitioners determined labor costs using the labor cost experience of a U.S. PET Film producer to manufacture one pound of PET Film, adjusted by the ratio of labor costs in Brazil to those of the United States. Petitioners obtained the annual Brazilian and U.S. labor costs from the Department's “Expected Wage Calculation: 2003,” found at
Petitioners determined energy costs using the cost experience of a U.S. PET Film producer to manufacture one pound of PET Film, adjusted by the ratio of energy costs in Brazil to that of the United States. Petitioners obtained the annual Brazilian and U.S. energy costs from the International Energy Agency publication, Energy Prices and Taxes for 2004.
Petitioners determined the fixed overhead costs (exclusive of energy and labor) using the cost experience of a U.S. PET Film producer to manufacture one pound of PET Film. Petitioners' stated this was reasonable because the one producer of PET Film in Brazil does not publish its financial statements.
To calculate SG&A expense, interest expense and profit, petitioners relied on the financial statements of Braskem Ltda. for the fiscal year ended December 31, 2005, the most recent financial statements available.
We recalculated fixed overhead costs based on the financial statements of Braskem Ltda. for the fiscal year ended December 31, 2005, as this best reflects the cost experience in Brazil.
In accordance with section 732(b)(3)(A) of the Act, a copy of the public version of these petitions have been provided to the representatives of the Governments of Brazil, the PRC, Thailand, and the UAE. We will attempt to provide a copy of the public version of the petitions to the foreign producers/exporters named in the petitions.
We have notified the ITC of our initiation, as required by section 732(d) of the Act.
The ITC will preliminarily determine, no later than November 12, 2007, whether there is a reasonable indication that imports of PET Film from Brazil, the PRC, Thailand, and the UAE materially injure, or threaten material injury to, a U.S. industry. A negative ITC determination covering all classes or kinds of merchandise covered by the petitions would result in the investigations being terminated. Otherwise, these investigations will proceed according to statutory and regulatory time limits.
This notice is issued and published pursuant to section 777(i) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
The Department of Commerce (“the Department”) has received a request for a new shipper review of the antidumping duty order on Stainless Steel Bar (“SSB”) from Germany published on March 7, 2002 (67 FR 10382). In accordance with section 751(a)(2)(B) of the Tariff Act of 1930, as amended (“the Act”), and 19 CFR 351.214(d), we are initiating an antidumping new shipper review of Flanschenwerk Bebitz GmbH (“Flanschenwerk”).
October 26, 2007.
Brandon Farlander or Damian Felton, AD/CVD Operations, Office 1, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230; telephone: (202) 482-0182 or (202) 482-0133, respectively.
The Department received a timely request from Flanschenwerk, in accordance with 19 CFR 351.214(c), for a new shipper review of the antidumping duty order on SSB from Germany, which has a September semiannual anniversary month.
Pursuant to section 751(a)(2)(B)(i)(I) of the Act and 19 CFR 351.214(b)(2)(i), Flanschenwerk, an exporter and producer of the subject merchandise, certified that it did not export subject merchandise to the United States during the period of investigation (“POI”) (October 1, 1999, through September 30, 2000). Pursuant to section 751(a)(2)(B)(i)(II) of the Act and 19 CFR 351.214(b)(2)(iii)(A), Flanschenwerk also certified that since the initiation of the investigation it has not been affiliated with any exporter or producer who exported the subject merchandise to the United States during the POI, including those not individually examined during the investigation. Pursuant to 19 CFR 351.214(b)(2)(iv), Flanschenwerk also submitted documentation establishing the date on which its SSB was first shipped for export to the United States, the volume of that shipment, and the date of the first sale to an unaffiliated customer in the United States.
The Department conducted a query of the U.S. Customs and Border Protection (“CBP”) database to confirm that Flanschenwerk's shipment of subject merchandise had entered the United States for consumption and has been suspended for antidumping duties. The Department also corroborated Flanschenwerk's assertion that it made no subsequent shipments to the United States by reviewing CBP data.
For the purposes of this order, the term “stainless steel bar” includes articles of stainless steel in straight lengths that have been either hot-rolled, forged, turned, cold-drawn, cold-rolled or otherwise cold-finished, or ground, having a uniform solid cross section along their whole length in the shape of circles, segments of circles, ovals, rectangles (including squares), triangles, hexagons, octagons, or other convex polygons. SSB includes cold-finished stainless steel bars that are turned or ground in straight lengths, whether produced from hot-rolled bar or from
Except as specified above, the term does not include stainless steel semi-finished products, cut length flat-rolled products (
The SSB subject to this order is currently classifiable under subheadings 7222.11.00.05, 7222.11.00.50, 7222.19.00.05, 7222.19.00.50, 7222.20.00.05, 7222.20.00.45, 7222.20.00.75, and 7222.30.00.00 of the
Based on the information on the record and in accordance with section 751(a)(2)(B) of the Act and 19 CFR 351.214(d)(1), we have determined that Flanschenwerk has met the statutory and regulatory requirements for the initiation of a new shipper review. Thus, we are initiating a new shipper review of the antidumping duty order on SSB from Germany (produced and exported) by Flanschenwerk. Because we are initiating this new shipper review in the month immediately following the semiannual anniversary month, this review covers the period from March 1, 2007, through August 31, 2007, in accordance with 19 CFR 351.214(g)(1)(i)(B). We intend to issue the preliminary results of this review no later than 180 days after the date on which this review is initiated, and the final results within 90 days after the date on which we issue the preliminary results.
On August 17, 2006, the Pension Protection Act of 2006 (“H.R. 4”) was signed into law. Section 1632 of H.R. 4 temporarily suspends the authority of the Department to instruct CBP to collect a bond or other security in lieu of a cash deposit in new shipper reviews. Therefore, the posting of a bond under section 751(a)(B)(iii) of the Act in lieu of a cash deposit is not available in this case. Importers of SSB manufactured and exported by Flanschenwerk must continue to post cash deposits of estimated antidum ping duties on each entry of subject merchandise (
Interested parties may submit applications for disclosure under administrative protective order in accordance with 19 CFR 351.305 and 351.306.
This initiation and notice are in accordance with section 751(a)(2)(B) of the Act, 19 CFR 351.214(d) and 19 CFR 351.221(c)(1)(i).
Import Administration, International Trade Administration, Department of Commerce.
October 26, 2007.
The Department of Commerce (the Department) is conducting a new-shipper review of the antidumping duty order on stainless steel wire rods (wire rods) from India manufactured and exported by Sunflag Iron & Steel Co., Ltd. (Sunflag). The period of review (POR) is December 1, 2005, through November 30, 2006. We preliminarily determine to apply adverse facts available to Sunflag's U.S. sales. We invite interested parties to comment on these preliminary results. Parties who submit argument in this proceeding are requested to submit with the argument (1) a statement of the issue and (2) a brief summary of the argument.
Catherine Cartsos or Minoo Hatten, AD/CVD Operations, Office 5, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230; telephone: (202) 482-1757 and (202) 482-1690, respectively.
On December 1, 1993, the Department published the antidumping duty order on stainless steel wire rods from India. See
The merchandise under review is stainless steel wire rods which are hot-rolled or hot-rolled annealed and/or pickled rounds, squares, octagons, hexagons or other shapes, in coils. Wire rods are made of alloy steels containing, by weight, 1.2 percent or less of carbon and 10.5 percent or more of chromium, with or without other elements. These products are only manufactured by hot-rolling and are normally sold in coiled
The wire rods subject to this order are currently classifiable under subheadings 7221.00.0005, 7221.00.0015, 7221.00.0030, 7221.00.0045, and 7221.00.0075 of the
Consistent with our practice, we investigated whether the two U.S. transactions reported by Sunflag during the POR were
Section 776(a)(2) of the Act provides that, if an interested party or any other person (A) withholds information that has been requested by the administering authority, (B) fails to provide such information by the deadlines for the submission of the information or in the form and manner requested, subject to subsections (c)(1) and (e) of section 782, (C) significantly impedes a proceeding under this title, or (D) provides such information but the information cannot be verified as provided in section 782(i), the administering authority shall, subject to section 782(d), use the facts otherwise available in reaching the applicable determination.
Section 782(d) of the Act provides that, if the Department determines that a response to a request for information does not comply with the request, the Department shall promptly inform the person submitting the response of the nature of the deficiency and shall, to the extent practicable, provide that person with an opportunity to remedy or explain the deficiency in light of the time limits established for the completion of the administrative review. Section 782(e) of the Act states that the Department shall not decline to consider information determined to be “deficient” under section 782(d) if all of the following requirements are met: (1) the information is submitted by the established deadline; (2) the information can be verified; (3) the information is not so incomplete that it cannot serve as a reliable basis for reaching the applicable determination; (4) the interested party has demonstrated that it acted to the best of its ability; and (5) the information can be used without undue difficulties.
Moreover, section 776(b) of the Act provides that, if the Department finds that an interested party has failed to cooperate by not acting to the best of its ability to comply with a request for information, the Department may use an inference adverse to the interests of that party in selecting from among the facts otherwise available. In addition, the Statement of Administrative Action accompanying the Uruguay Round Agreements Act, H.R. Doc. 103- 316, Vol. 1, at 870 (1994) (SAA), establishes that the Department may employ an adverse inference “to ensure that the party does not obtain a more favorable result by failing to cooperate to the best of its ability than if it had cooperated fully.” It also instructs the Department to consider, in employing adverse inferences, “the extent to which a party may benefit from its own lack of cooperation.”
We preliminarily determine that Sunflag's questionnaire response of May 11, 2007, and supplemental questionnaire responses of June 26, 2007, and July 14, 2007, cannot serve as the basis for calculating a margin for Sunflag because we are unable to depend on the accuracy and reliability of the information in those responses. In our questionnaire we describe the form and manner in which the respondent should report its sales data. Specifically, we state,
As discussed in detail in the October 19, 2007, Memorandum entitled “2005/2006 New-Shipper Review of Stainless Steel Wire Rods from India - Decision to Apply Adverse Facts Available and the Selection of an Appropriate Rate for the Preliminary Results of Review” (AFA Memorandum), we found at verification that Sunflag did not report its sales in the home market as instructed. We found that, for its home-market database, Sunflag reported each invoice as a single observation even in those instances where the invoice contained multiple sales of different products (
Also at verification we found discrepancies with certain variables Sunflag reported in the home-market and U.S. databases. We have insufficient information on the record to correct all of the discrepancies related to these variables. Moreover, Sunflag did not report most home-market expenses (four types of discounts, inland freight, commissions, indirect selling expenses, and variable cost of manufacturing in the home market) on a per-unit basis, as we requested in our questionnaire but, instead, reported them based on the total invoice quantity. In addition, because in its home-market database Sunflag reported each invoice as a single aggregated observation even in those instances where the invoice contained multiple sales of different products, the information it reported in most of the expense fields is inaccurate. For a detailed discussion with respect to these deficiencies see AFA Memorandum and memorandum from Catherine Cartsos and Edythe Artman to File entitled “Verification of the Sales Response of Sunflag Iron & Steel Co., Ltd., in the Antidumping New-Shipper Review of Stainless Steel Wire Rod from India,” dated October 19, 2007 (Verification Report). Therefore, Sunflag failed to provide information in the form and manner requested in the Department's original questionnaire.
A further flaw in Sunflag's information concerns our finding at the verification of the discrepancy between
In addition to finding that Sunflag misreported and neglected to report home-market sales, Sunflag provided additional information that could not be verified. During the verification the Department officials found that Sunflag's reported sales data contained pervasive errors and much of the data remained substantially unverified due to Sunflag's lack of preparedness. Even though Sunflag officials received our Verification Agenda, which outlined in detail the steps we would follow at verification, more than a week in advance of the verification, they were not well prepared. Therefore, we experienced constant and serious delays while at verification. Because of these delays, it was impossible to verify all of the information we had identified as subject to our examination in the Verification Agenda. See section 776(a)(2)(D) of the Act.
Sunflag significantly impeded the new-shipper review by not providing accurate and necessary information contained in its records. See section 776(a)(2)(C) of the Act. Also, the Department can decline to consider information Sunflag submitted because, as demonstrated above, sections 782(e)(2) and (3) of the Act are not met. Accordingly, pursuant to sections 776(a)(2) of the Act, the use of total facts available for Sunflag is justified.
Section 776(b) of the Act provides that, if the Department finds that an interested party has failed to cooperate by not acting to the best of its ability to comply with a request for information, the Department may use an inference adverse to the interests of that party in selecting from among the facts otherwise available. See,
Sunflag had the documents necessary to report complete and correct information in the necessary and requested manner and format. Because it did not do so, we find that Sunflag did not act to the best of its ability in reporting necessary and accurate information and presenting its data in the requested manner that would enable us to calculate a margin. Therefore, we find it appropriate to use an inference that is adverse to Sunflag's interest in selecting from among the facts otherwise available. By doing so, we ensure that Sunflag will not obtain a more favorable rate by failing to cooperate.
Section 776(b) of the Act states that an adverse inference may include reliance on information derived from the petition. See also 19 CFR 351.308(c). We have preliminarily assigned Sunflag, as facts otherwise available with an adverse inference, the petition margin rate of 48.80 percent. While this is the highest margin in the history of the proceeding, it is also the all-others rate and, therefore, the rate currently applicable to entries of merchandise from Sunflag. Any rate lower than 48.80 percent would give Sunflag a more favorable rate despite its failure to cooperate to the best of its ability.
Section 776(c) of the Act requires that the Department corroborate, to the extent practicable, secondary information from independent sources that are reasonably at its disposal. Secondary information is defined as “information derived from the petition that gave rise to the investigation or review, the final determination concerning the subject merchandise, or any previous review under section 751 concerning the subject merchandise.” See SAA at 870. The SAA clarifies that “corroborate” means that the Department will satisfy itself that the secondary information to be used has probative value. See SAA at 870. The Department will examine, to the extent practicable, the reliability and relevance of the information. The SAA emphasizes, however, that the Department need not prove that the selected facts available are the best alternative information. See SAA at 869. The SAA also states that independent sources used to corroborate such evidence may include, for example, published price lists, official import statistics and customs data, and information obtained from interested parties during the particular investigation. See SAA at 870. See also19 CFR 351.308(d).
With respect to the reliability aspect of the corroboration, we will consider information reasonably at our disposal to determine whether a margin continues to be reliable and whether there are circumstances that would render data used as facts available unreliable. The 48.80 percent all-others rate from the investigation is the average of the rates applied to each original respondent in the investigation. In the investigation, the Department applied the highest rate among the margins in the petition to each respondent based upon a determination by the Department to use the best information available. See
The normal value the petitioner used in the petition was based on an actual home-market price quote from an Indian producer of stainless steel wire rods. The price quote for normal value in the petition was contemporaneous with the U.S. price quote in the petition as the basis for export price.
We determined that, because the home-market and U.S. price quotation reflected commercial practices of the particular industry during the period of investigation, the information was relevant to mandatory respondents which refused to participate in the investigation. No information has been presented in the current review that calls into question the reliability of this information nor has this rate been judicially invalidated. Further, the 48.80 percent rate was most recently corroborated and applied as an adverse facts-available rate to a respondent in the 2001-2002 review of this order. See
To assess the relevance of the petition margin for purposes of this review, in accordance with section 776(c) of the Act we examined the key elements of the calculations of export price and normal value upon which the petitioners based their margins for the petition, to the extent practicable. See
In the current new-shipper review we were able to corroborate the U.S. price in the petition, which was used as the basis of the 48.80 percent rate, by comparing this price to information from a respondent in the concurrent administrative review covering the same POR, Mukand Limited (Mukand). Mukand's reported U.S. price is significantly lower than the U.S. price in the petition, thus corroborating the petition U.S. price. See Memorandum from the analyst to the file entitled, “Placement of Mukand's Home-Market and U.S. Data on the Record,” dated October 19, 2007 (Mukand Data Memo).
In the current new-shipper review, in order to corroborate normal value, we looked again at information from Mukand's response for the concurrent administrative review covering the same POR. We find that the home-market prices in Mukand's March 15, 2007, questionnaire response are similar to, and in many instances much higher than, the price provided as normal value in the 1992 petition, which contributed to the all-others rate of 48.80 percent. See Mukand Data Memo.
For these reasons, the Department considers the normal value to be corroborated. Furthermore, because the 48.80 percent rate is also the all-others rate for this order, Sunflag's shipments have entered the United States at this rate such that the 48.80 percent rate is relevant to the current POR.
Finally, this is a new-shipper review; hence, as the first review of Sunflag, there are no probative alternatives specific to the company. Accordingly, by using information that was applied in the less-than-fair-value investigation (LTFV), corroborated in the 2001-2002 review of this order, and preliminarily determined to be relevant to Sunflag in this review, we have corroborated the adverse facts-available rate “to the extent practicable.” See section 776(c) of the Act, 19 CFR 351.308(d).
As a result of this review, we preliminarily determine that a dumping margin of 48.80 percent for Sunflag exists for the period December 1, 2005, through November 30, 2006.
We will disclose the documents resulting from our analysis to parties in this review within five days of the date of publication of this notice. Any interested party may request a hearing within 30 days of the publication of this notice in the
Interested parties are invited to comment on the preliminary results of this review. The Department will consider case briefs filed by interested parties within 30 days after the date of publication of this notice in the
We intend to issue the final results of this new-shipper review, including the results of our analysis of issues raised in the written comments, within 90 days after the date on which the preliminary results are issued.
The Department shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries. Because we are relying on total adverse facts available to establish Sunflag's dumping margin, we preliminarily determine to instruct CBP to apply a dumping margin of 48.80 percent to all entries of subject merchandise during the POR that were produced or exported by Sunflag. The Department will issue instructions to CBP 15 days after the publication of the final results of review.
The following cash-deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this new-shipper review, as provided by section 751(a)(1) of the Act: (1) the cash-deposit rate for Sunflag will be the rate established in the final results of this new-shipper review; (2) for previously investigated or reviewed companies not listed above, the cash-deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or the LTFV investigation but the manufacturer is, the cash-deposit rate will be the rate established for the most recent period for the manufacturer of the subject merchandise; and (4) the cash-deposit rate for all other manufacturers or exporters will continue to be the “all others” rate of 48.80 percent, which is the “all others” rate established in the LTFV investigation. See
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duites occurred and the subsequent assessment of double antidumping duties.
We are issuing and publishing this notice in accordance with sections 751(a)(2)(B) and 777(i)(1) of the Act and 19 CFR 351.214.
Import Administration, International Trade Administration, Department of Commerce.
On July 30, 2007, the Department of Commerce (“Department”) issued its preliminary results in the changed circumstances review of the antidumping duty order on wooden bedroom furniture (“WBF”) from the People's Republic of China (“PRC”).
October 26, 2007.
Juanita H. Chen or Robert A. Bolling, AD/CVD Operations, Office 8, Import Administration, International Trade Administration, U.S. Department of Commerce, 14
On January 18, 2007, in response to a joint request by Tradewinds Furniture Ltd. and Tradewinds Intl (collectively, “Tradewinds”), the Department initiated a changed circumstances review to determine whether Tradewinds Furniture Ltd. and Tradewinds Intl are successors-in-interest to Nanhai Jiantai and Fortune Glory, respectively.
The product covered by the order is wooden bedroom furniture. Wooden bedroom furniture is generally, but not exclusively, designed, manufactured, and offered for sale in coordinated groups, or bedrooms, in which all of the individual pieces are of approximately the same style and approximately the same material and/or finish. The subject merchandise is made substantially of wood products, including both solid wood and also engineered wood products made from wood particles, fibers, or other wooden materials such as plywood, oriented strand board, particle board, and fiberboard, with or without wood veneers, wood overlays, or laminates, with or without non-wood components or trim such as metal, marble, leather, glass, plastic, or other resins, and whether or not assembled, completed, or finished.
The subject merchandise includes the following items: (1) wooden beds such as loft beds, bunk beds, and other beds; (2) wooden headboards for beds (whether stand-alone or attached to side rails), wooden footboards for beds, wooden side rails for beds, and wooden canopies for beds; (3) night tables, night stands, dressers, commodes, bureaus, mule chests, gentlemen's chests, bachelor's chests, lingerie chests, wardrobes, vanities, chessers, chifforobes, and wardrobe-type cabinets; (4) dressers with framed glass mirrors that are attached to, incorporated in, sit on, or hang over the dresser; (5) chests-on-chests
The scope of the order excludes the following items: (1) seats, chairs, benches, couches, sofas, sofa beds, stools, and other seating furniture; (2) mattresses, mattress supports (including box springs), infant cribs, water beds, and futon frames; (3) office furniture, such as desks, stand-up desks, computer cabinets, filing cabinets, credenzas, and bookcases; (4) dining room or kitchen furniture such as dining tables, chairs, servers, sideboards, buffets, corner cabinets, china cabinets, and china hutches; (5) other non-bedroom furniture, such as television cabinets, cocktail tables, end tables, occasional tables, wall systems, book cases, and entertainment systems; (6) bedroom furniture made primarily of wicker, cane, osier, bamboo or rattan; (7) side rails for beds made of metal if sold separately from the headboard and footboard; (8) bedroom furniture in which bentwood parts predominate
Imports of subject merchandise are classified under subheading 9403.50.9040 of the HTSUS as “wooden . . . beds” and under subheading 9403.50.9080 of the HTSUS as “other . . . wooden furniture of a kind used in the bedroom.” In addition, wooden headboards for beds, wooden footboards for beds, wooden side rails for beds, and wooden canopies for beds may also be entered under subheading 9403.50.9040 of the HTSUS as “parts of wood” and framed glass mirrors may also be entered under subheading 7009.92.5000 of the HTSUS as “glass mirrors . . . framed.” This order covers all wooden bedroom furniture meeting the above description, regardless of tariff classification. Although the HTSUS subheadings are provided for convenience and customs purposes, our written description of the scope of this proceeding is dispositive.
As noted in the
Due to their proprietary nature, all issues raised in the post-preliminary comments by parties in this review (
Tradewinds concurs with the Department's preliminary findings with respect to the successorship of Tradewinds Furniture Ltd. Moreover, there has been no information submitted to the record that indicates the Department should change its finding with regards to Tradewinds Furniture Ltd. As a result, for the reasons stated in the
Therefore, we will instruct U.S. Customs and Border Protection to apply the cash deposit rate established for Nanhai Jiantai to all entries of merchandise exported by Tradewinds Furniture Ltd. The cash deposit determination from this changed circumstances review will apply to all entries of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this changed circumstances review.
While Tradewinds asserts that its submitted documentation supports a finding that Tradewinds Intl is the successor-in-interest to Fortune Glory, and should be legally entitled to the Fortune Glory rate, we find that Tradewinds failed to provide sufficient evidence indicating that Tradewinds Intl is “essentially the same” as Fortune Glory for a successor-in-interest finding. Contrary to Tradewinds' argument, while we noted in our
As a result, we continue to find that Tradewinds Intl is not the successor-in-interest to Fortune Glory at this time and, therefore, should not be given the same antidumping duty treatment as Fortune Glory.
This notice is issued and published in accordance with sections 751(b)(1) and 777(i)(1) of the Tariff Act of 1930, as amended, and 19 C.F.R. 351.216.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
In accordance with the Marine Mammal Protection Act, NMFS hereby issues a permit for a period of 3 years to authorize the incidental, but not intentional, taking of three stocks of endangered marine mammals by the California/Oregon (CA/OR) drift gillnet fishery. The three stocks are: fin whale, California/Oregon/Washington (CA/OR/WA) stock; humpback whale, Eastern North Pacific (ENP) stock; and sperm whale, CA/OR/WA stock. This authorization is based in part on a determination that this incidental take will have a negligible impact on the affected marine mammal stocks.
This permit is effective for a 3-year period beginning October 26, 2007.
Copies of the reference materials may be obtained from Protected Resources Division, NMFS, Southwest Region, 501 West Ocean Blvd., Suite 4200, Long Beach, CA 90802-4213. Attention: Christina Fahy.
Monica DeAngelis, NMFS, Southwest Region, Protected Resources Division, (562) 980-3232 or Christina Fahy, (562) 980-4023.
Pursuant to the Marine Mammal Protection Act (MMPA) (16 U.S.C. 1361,
MMPA section 101(a)(5)(E) requires NMFS to allow the taking of marine mammals from species or stocks listed as threatened or endangered under the Endangered Species Act (ESA) (16 U.S.C. 1531
MMPA section 101(a)(5)(E)(ii) requires NMFS to publish a list of the fisheries for which the necessary determinations have been made for the taking of threatened or endangered marine mammals incidental to the fisheries' operations. This list of fisheries currently contains the three fisheries that are the subject of this notice and identified in Table 1. The MMPA also requires NMFS, upon such determinations, to issue a permit to those fisheries in which vessels are required to be registered (Category I and II fisheries).
The 2007 List of Fisheries indicates that two Category III fisheries (CA lobster, prawn, shrimp, rock crab, fish pot and CA/OR/WA crab pot) have a history of taking humpback whales. NMFS is currently in the process of characterizing the trap and pot fisheries off the west coast of the United States and assessing the impact, based on the available information, to determine if reclassifying these fisheries is warranted. As provided by the MMPA, the taking of this stock of humpback whales would be authorized, if it were to occur and the owner or master of the vessel reported the take, as required by MMPA section 118(e). MMPA section 101(a)(5)(E)(ii) states that (1) permits are not required for Category III fisheries because participants are not required to register their vessels and (2) that after an appropriate negligible impact determination is completed, taking threatened or endangered marine mammals would not be a violation, so long as any injury or mortality is reported in accordance with MMPA section 118.
Among the requirements of MMPA section 101(a)(5)(E) to issue a permit to take ESA-listed marine mammals incidental to commercial fishing, NMFS must determine whether the incidental taking from commercial fisheries would have a negligible impact on the affected stock or stocks of threatened or endangered marine mammals. Negligible impact determinations are required only in MMPA section 101(a)(5), and they are used in the procedures to authorize the take of small numbers of any stock of marine mammals incidental to activities other than commercial fishing (termed the “Small Take Program”) and to permit the take of threatened or endangered marine mammals incidental to commercial fishing operations. That is, within the MMPA's provisions for the Small Take Program, NMFS must determine if the taking (by harassment, injury, and mortality) incidental to specified activities will have a negligible impact on the affected stocks of marine mammals (MMPA sections 101(a)(5)(A)(I) and 101(A)(5)(D)(i)(I)). For permitting the take of threatened or endangered marine mammals incidental to fishing operations, NMFS must determine if mortality and serious injury incidental to commercial fisheries will have a negligible impact on the affected species or stocks of
NMFS has implemented these programs through regulations and has relied upon qualitative and quantitative approaches to determine the levels of taking that would result in a negligible impact to affected stocks of marine mammals. The quantitative approach is more appropriate for serious injury and mortality than for non-lethal takes because mortality and serious injury are considered removals from the population and can be evaluated by well-documented models of population dynamics.
The MMPA does not define “negligible impact.” There is, however, a reference to negligible impact in the House of Representatives committee report for the MMPA Amendments of 1981. That report states, “'negligible' is intended to mean an impact which is able to be disregarded. In this regard, the committee notes that Webster's Dictionary defines the term 'negligible' to mean 'so small or unimportant or of so little consequence as to warrant little or no attention.'” (House of Representatives, Report 97-228, September 16, 1981). NMFS defined negligible impact in regulations for the Small Take Program (50 CFR 216.103) as “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.” This qualitative definition indicates that detectable population-level effects are important features in negligible impact determinations.
This qualitative definition of negligible impact was the standard NMFS used to implement the Small Take Program from its inception in 1981 through 1994, when additional amendments to the MMPA required a more quantitative approach for assessing what level of removals from a population stock of marine mammals could be considered a negligible impact. It remains the only formal definition of negligible impact for implementing the MMPA, and its use was expanded in 1995 (see 50 CFR 229.2) to include determinations related to incidental taking from commercial fishing.
The MMPA Amendments of 1994 were enacted primarily to establish a regime to govern the taking of marine mammals incidental to commercial fishing operations, including MMPA section 101(a)(5)(E). These amendments were based in large part on a legislative proposal NMFS submitted to Congress in 1992. This legislative proposal was, in turn, based in large part on recommended guidelines, required by MMPA section 114, from the Marine Mammal Commission (Commission) in early 1990 (Recommended Guidelines to Govern the Incidental Taking of Marine Mammals in the Course of Commercial Fishing Operations after October 1993, transmitted to NMFS on July 12, 1990). In these guidelines, the Commission recommended, among five other characteristics of a mechanism to govern the take of threatened and endangered marine mammals incidental to fishing, “ the authorized level of take would have a negligible effect on population size and recovery time...” The Commission provided initial quantitative guidance on negligible effect on population size and recovery time as the following: “an effect that (a) will not cause or contribute to a further decline in distribution or size lasting more than twelve months; and/or (b) will not cause greater than a 10-percent increase in the best available estimate of the time it will take the affected species or population to recover to its maximum net productivity level.”
The first of the Commission's quantitative approaches is more appropriate for an activity that would have a relatively short duration relative to the life expectancy of the affected stocks of marine mammals and, in the case of commercial fishing, for the remote likelihood of serious injury or mortality by a Category III fishery. Where incidental mortality or serious injury may occur on a more regular basis, as expected for interactions with Category I or II commercial fisheries, the delay-in-recovery standard would be more appropriate.
NMFS has consistently used the Commission's delay-in-recovery guideline in distinguishing negligible from non-negligible impact. To apply this criterion, however, NMFS had to estimate what annual levels of removal would cause no more than a 10 percent delay in time to recovery. Such an effort was initiated at a NMFS-convened workshop (June 1994) to develop guidelines for preparing marine mammal stock assessment reports. Among the many items considered at that workshop, participants agreed that recovery factors (RF) used in the calculation of Potential Biological Removal (PBR) for each stock of marine mammals should compensate for uncertainty and possible unknown estimation errors. In discussing the RF for stocks of endangered species of marine mammals, participants noted that a RF of 0.1 would preserve 90 percent of net annual production for recovery of the stock, limiting the proportion of net annual production of the stock available for authorization of mortality or serious injury incidental to human-caused mortality. Participants also stated that reserving such a high proportion of net annual production of endangered species was appropriate to “ allow stocks to recover at near maximum rates, and to minimize the probability that naturally occurring stochastic mortality would result in extinction of the stock.” (Barlow
In applying the negligible impact criterion to determinations made initially under the MMPA Amendments of 1994, NMFS understood that total human-caused mortality and serious injury limited to a level no greater than a PBR calculated with RF of 0.1 would be negligible; however, MMPA section 101(a)(5)(E) required a determination related to the impact of mortality and serious injury incidental to commercial fishing rather than incidental to all human activities. Accordingly, NMFS proposed to use, and subsequently used, 10 percent of any stock's PBR as the upper limit of mortality and serious injury incidental to commercial fishing in making the first negligible impact determinations (60 FR 31666, June 16, 1995 (proposed) and 65 FR 45399, August 31, 1995 (interim)). A rationale supporting this approach was that a negligible (or insignificant) level of fishery-related mortality and serious injury should be only a small portion of the maximum level of mortality and serious injury a stock could sustain. NMFS noted that the threshold value was a starting point; that is, the criterion should not be used rigidly but should produce the first estimate, which, in turn, could be modified on a case-by-case basis according to existing information. Although 10 percent of PBR was used in 1995 in issuing permits to fisheries under MMPA section 101(a)(5)(E), NMFS later became concerned that 10 percent of PBR may result in a much smaller number than the 10 percent-delay criterion would require (Wade and Angliss, 1997).
Later, Wade (1998) summarized the robustness trials conducted in support of the PBR approach for marine mammal conservation, including an aspect that was missing from simulations conducted for the NMFS-convened workshop in 1994: exploring the maximum level of annual removals from a population that would result in no more than a 10-percent delay in the time a population would need for recovery to its Maximum Net Productivity Level (MNPL). Wade (1998) found that an upper limit of annual removals equal to the value of a PBR calculation with a RF of 0.15 would allow 95 percent of simulations to equilibrate at or above MNPL, which was an initial step in quantifying the maximum number of annual removals resulting in a negligible impact. However, in some applications the negligible impact standard must also address a performance criterion for marine mammal stocks that are not necessarily depleted. Wade (1998), therefore, reported that an upper limit of annual mortality limited to a value equal to a PBR calculation with a RF of 0.1 would allow 95 percent of simulations to equilibrate within 95 percent of the carrying capacity of the affected stock of marine mammals.
Wade's (1998) performance testing included removals to the threshold level for a period of 100 years and evaluated the robustness of each case over a range of bias or uncertainty in productivity rates, abundance estimation, and mortality estimation. Thus, the limits are appropriate for use on long-term average removals and do not indicate that a short-term level of removal exceeding the threshold would delay time to recovery by more than 10 percent.
In 1998, NMFS published a notice (63 FR 71894, December 30, 1998) advising the public that NMFS was extending the 3-year permit issued to fisheries in 1995 to authorize the taking of threatened or endangered marine mammals. This notice also informed the public that NMFS considered the 6-month extension of the permit an opportunity to review existing criteria for the issuance of permits and to address issues that have arisen since the permits were first issued. NMFS solicited public comments to develop alternatives to 10 percent of PBR as a criterion for determining negligible impact; however, none were received.
Having received no comments upon which to develop alternatives for determining negligible impact, NMFS published a notice proposing to issue permits under MMPA section 101(a)(5)(E) in 1999 (64 FR 28800, May 27, 1999). The notice contained a statement that NMFS, through internal deliberation, had adopted the following criteria for making negligible impact determinations for such permits:
(1) The threshold for initial determination will remain at 0.1 PBR. If total human-related serious injuries and mortalities are less than 0.1 PBR, all fisheries may be permitted.
(2) If total human-related serious injuries and mortalities are greater than PBR, and fisheries-related mortality is less than 0.1 PBR, individual fisheries may be permitted if management measures are being taken to address non-fisheries-related serious injuries and mortalities. When fisheries-related serious injury and mortality is less than 10 percent of the total, the appropriate management action is to address components that account for the major portion of the total.
(3) If total fisheries-related serious injuries and mortalities are greater than 0.1 PBR and less than PBR and the population is stable or increasing, fisheries may be permitted subject to individual review and certainty of data. Although the PBR level has been set up as a conservative standard that will allow recovery of a stock, there are reasons for individually reviewing fisheries if serious injuries and mortalities are above the threshold level. First, increases in permitted serious injuries and mortalities should be carefully considered. Second, as serious injuries and mortalities approach the PBR level, uncertainties in elements such as population size, reproductive rates, and fisheries-related mortalities become more important.
(4) If the population abundance of a stock is declining, the threshold level of 0.1 PBR will continue to be used. If a population is declining despite limitations on human-related serious injuries and mortalities below the PBR level, a more conservative criterion is warranted.
(5) If total fisheries-related serious injuries and mortalities are greater than PBR, permits may not be issued.
Criterion 1 is the starting point for analyses. If this criterion is satisfied, the analysis would be concluded. The remaining criteria describe alternatives under certain conditions, such as fishery mortality below the negligible threshold but other human-caused mortality above the threshold, or fishery and other human-caused mortality between the negligible threshold and PBR for a stock that is increasing or stable. If criterion 1 is not satisfied, NMFS may use one of the other criteria, as appropriate.
In 2000, NMFS issued a permit to the CA/OR drift gillnet fishery to authorize the taking of threatened and endangered marine mammals incidental to its operation (65 FR 64670, October 30, 2000). For that permit, as for the current permit, NMFS used the criteria adopted in 1999 to distinguish between negligible and non-negligible impact on affected stocks of marine mammals.
Observer data, stranding records, and marine mammal reporting forms indicate the CA/OR drift gillnet fishery is the only Category I or II commercial fishery that takes the CA/OR/WA stocks of fin and sperm whales, and the ENP stock of humpback whales. However, based on stranding records, pot fisheries that operate in California (currently listed as Category III fisheries), may also take humpback whales.
On July 28, 2006 (71 FR 42809), NMFS proposed the issuance of a permit under MMPA section 101(a)(5)(E), for a period of 3 years, to authorize the incidental, but not intentional, taking of three stocks of threatened or endangered marine mammals (CA/OR/WA stocks of fin and sperm whales and the ENP stock of humpback whales) by the CA/OR drift gillnet fishery. That notice summarized documentation that: (1) a recovery plan has been developed or is being developed for the affected stocks, and (2) where required under section 118 of the MMPA, a monitoring program has been established, vessels engaged in such fisheries are registered, and a take reduction plan has been, or is being, developed.
The proposed permit indicated that recovery plans had been developed (humpback whales) or were being developed (fin and sperm whales). These recovery plans are available on the internet at the following address:
Vessels active in the fishery are registered under the MMPA each year, and an observer program has been in place in the CA/OR drift gillnet fishery since 1990 (see Description of the Fishery; Carretta
In 2005, NMFS received an application for an Exempted Fishing Permit (EFP) for drift gillnet fishing from the Federation of Independent Seafood Harvesters to reopen the area closed in 2001 (described below) to drift gillnet fishing. The Pacific Fishery Management Council (PFMC) reviewed the EFP and facilitated the development of the permit conditions. These included: drift gillnet EFP fishing effort in the closure area would be limited to no more than 300 sets, and 100 percent observer coverage would be required, and up to 30 vessels would be eligible to participate. The permit included limits on the number of protected species that could be incidentally entangled in the drift gillnet EFP fishery. The PFMC recommended that NMFS issue the 2006 permit, and NMFS formally began review of the EFP, which included consultation under the ESA, to consider the impacts on ESA-listed species. The proposed 2006 EFP recommended by the PFMC for issuance was not issued. However, the PFMC recommended at their April 2007 meeting that NMFS issue this EFP in 2007 with the same terms and conditions as originally recommended for the 2006 application. On June 5, 2007, in a letter from NMFS to the PFMC, NMFS determined that it would not issue the permit for the proposed 2007 drift gillnet EFP, due to the potential for leatherback sea turtle mortalities that would result if the EFP were approved. If NMFS considers the issuance of a DGN EFP during the three years of this 101(a)(5)(E) permit, taking of listed marine mammal stocks considered under this permit would be covered under the existing analysis. The data analyzed in the negligible impact determination for this permit included years prior to 2001 when the currently closed area (requested to be opened under the EFP in 2006 and 2007) was open to fishing. Therefore, any taking of these stocks of marine mammals incidental to fishing under a similarly issued EFP (if it is granted) would be authorized by this permit. All drift gillnet fishing under an EFP would be subject to applicable requirements under the HMS FMP and would have to comply with the POCTRP. In addition, any proposed EFP application would be subjected to thorough review and analysis of impacts, in order to satisfy all mandated requirements under the ESA and the National Environmental Policy Act (NEPA).
The CA/OR drift gillnet fishery operates primarily outside of state waters to about 150 nm offshore ranging from the U.S. Mexico border in the south to northward of the Columbia River, depending on sea surface temperature conditions. The 2007 List of Fisheries (72 FR 14466, March 28, 2007) estimated that there were 85 vessels in the fishery. This estimate of the number of vessels in the fishery is a historical reference based upon the number of vessels that indicated intent to participate in the fishery and may not be an accurate estimate of the number of vessels actively engaged in fishing in any given year. The drift gillnet fishery is a limited entry program, managed with gear, seasons, and area closures. In 2005, there were 90 fishing permits issued, and 42 vessels actively fished under their permit (Pacific Fishery Management Council 2006). More detailed information on the operation of this fishery is included in Appendix 2 of the final negligible impact determination associated with this permit.
Under California State regulations, the fishery is restricted to waters outside 200 nm from February 1 through April 30, and outside 75 nm from May 1 through August 14; the fishery is allowed to fish inside 75 nm from August 15 though January 31. In the portion of the U.S. EEZ off the Oregon coast, the fishery is closed throughout the year east of a line approximating 1000 fathoms. Because of these restrictions, vessels are not active during February, March, and April, and very little fishing effort occurs during the months of May, June, and July because CA/OR drift gillnet vessels targeting swordfish tend to set on warm ocean water temperature breaks, which do not appear along the California coast until late summer.
The fishery has been conducted under state and/or Federal regulations since MMPA section 118 was enacted. When the List of Fisheries under MMPA section 118 was first began, the CA/OR drift gillnet fishery was state-regulated. As a result, when NMFS promulgated regulations implementing the POCTRP (62 FR 51805, October 3, 1997), there were no other Federal actions associated with the fishery. For initial implementation of the take reduction plan, NMFS completed a consultation under ESA section 7 in September, 1997 (no jeopardy determination) and completed an Environmental Assessment under NEPA in August 1997. The regulatory requirements in the POCTRP included the use of extenders so that the upper part of the gillnet was 36 ft (10.9 m) below the surface and the use of acoustic warning devices (pingers) on nets.
As part of reasonable and prudent alternatives contained in a 2000 ESA consultation on the drift gillnet fishery, in 2001, a seasonal (15 August-15 November) area closure was implemented in the drift gillnet fishery north of Point Conception, to protect leatherback turtles that feed in the area and were observed entangled in previous fishing seasons. Additional seasonal/area closures in southern California have been established in the drift gillnet fishery to protect loggerhead turtles during declared or predicted El Nino years.
On February 4, 2004, NMFS partially approved the HMS FMP prepared by the PFMC. This FMP includes commercial fisheries using various gear types to target highly migratory species; however, only the drift gillnet fishery has a history of taking threatened or endangered marine mammals. Implementing regulations for the approved portions of the FMP were published on April 7, 2004 (69 FR 18444). The preamble to these regulations noted that an Environmental Impact Statement (EIS) had been prepared and filed with the Environmental Protection Agency and that a formal consultation under the ESA had been completed. These documents analyzed the effects of the fishery on the human environment and on threatened or endangered species.
The HMS FMP includes a permit requirement for vessels or vessel owners. Participants in the CA/OR drift gillnet fishery are also required to have a valid permit issued annually by the California Department of Fish and Game or Oregon Department of Fish and Wildlife, as applicable, depending upon where fishing occurs and landings are made. In accordance with MMPA section 118(c), only those vessels in the CA/OR drift gillnet fishery that have registered for a Marine Mammal Authorization Program (MMAP) are authorized to take marine mammals incidental to their fishing operations. Vessels holding this permit must comply with the POCTRP and implementing regulations.
NMFS has evaluated the best available information for the three stocks listed as threatened or endangered under the ESA addressed by this permit and has determined (using data from 1998 through 2005 and computing a yearly average), on a stock-by-stock basis, whether the mortality and serious injury incidental to the CA/OR drift gillnet fishery is having a negligible impact on such stocks (NMFS 2006). Based on this assessment, using the 1999 criteria (see History of Applying Negligible Impact in Fisheries) for the three stocks of marine mammals addressed by this permit, NMFS concludes that the estimated mortality and serious injury incidental to commercial fishing will have a negligible impact on these stocks of fin, humpback, and sperm whales. A stock-by-stock summary of the negligible impact determination follows.
The annual average serious injury and mortality to the CA/OR/WA stock of fin whales from all human-caused sources, including commercial fisheries (0.63 animals) plus ship strikes (0.88 animals), is 1.51 animals, which is 10 percent of this stock's PBR. Although criterion 1 states the threshold is less than rather than equal to 10 percent of PBR, there are circumstances that prompt NMFS to determine that this minor deviation from the guidelines is reasonable. The abundance of this stock is increasing, the PBR calculation uses a recovery factor of 0.1, and the serious injury and mortality is far below a level that would cause more than a 10 percent delay in recovery. During the past 16 years, only one fin whale has been observed taken by the CA/OR drift gillnet fishery (1999; which is after the implementation of the POCTRP and prior to the 2001 closure off California and Oregon), indicating that the likelihood that a fin whale would be taken in the CA/OR drift gillnet fishery is very low. NMFS estimates that total human-caused mortality and serious injury of fin whales will be less than 10 percent of the PBR of this stock. Therefore, mortality and serious injury of fin whales incidental to commercial fishing will have a negligible impact on the CA/OR/WA stock of fin whales under criterion 1.
The annual average serious injury and mortality to the ENP stock of humpback whales from all human-caused sources, including commercial fisheries (1.5 animals) plus ship strikes (0.25 animals), is 1.75 animals, which is 76.1 percent of this stock's PBR (above the 0.1 PBR threshold, but below PBR). Although several humpback whales were entangled in recent years in crab pot gear and in unknown pot/net fisheries in California, the total fisheries-related serious injury and mortality is less than this stock's PBR. Since the beginning of the NMFS observer program in 1990, no mortalities or serious injuries of humpback whales have been attributed to the CA/OR drift gillnet fishery. No other Category I or II commercial fisheries have a history of causing mortality and serious injury of this stock. In addition, after the implementation of the POCTRP, overall cetacean entanglement rates in the drift gillnet fishery dropped considerably. Finally, the population for this stock is considered to be increasing by 6-7 percent per year (Carretta
The annual average serious injury and mortality to the CA/OR/WA stock of sperm whales from commercial fisheries ( 0.75 animals) plus ship strikes (0.38 animals), is 1.13 animals, which is 62.5 percent of this stock's PBR (above the 0.1 PBR threshold, but below PBR). The minimum population estimate for this stock is considered to be variable, with no obvious trend (Carretta
A permit is hereby issued to the CA/OR drift gillnet fishery authorizing the non-lethal taking of individuals from the CA/OR/WA stock of fin whales, the ENP stock of humpback whales, and the CA/OR/WA stock of sperm whales for a 3-year period. If NMFS determines at a later date that incidental mortality and serious injury from commercial fishing is having more than a negligible impact on these stocks, NMFS may use its emergency authority under MMPA section 118 to protect the affected stock or stocks and may modify the permit issued herein. In accordance with the MMPA, participants in Category III fisheries included in Table I are also authorized to take marine mammals from these three stocks of marine mammals so long as such taking is reported in accordance with MMPA section 118(d).
NMFS received six comment letters concerning the proposal for issuance of the 101(a)(5)(E) permit under the MMPA. All of these letters were in opposition to the issuance this permit. Two commenters expressed opposition to the issuance of a permit but did not explain the basis for their opposition. Therefore, these comments are not included the following summary of comments and responses.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that Dr. Kathryn A. Ono, Department of Biological Sciences, University of New England, Biddeford, ME, has applied in due form for a permit to conduct research on marine mammals.
Written, telefaxed, or e-mail comments must be received on or before November 26, 2007.
The application and related documents are available for review upon written request or by appointment in the following office(s):
Permits, Conservation and Education Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301)713-2289; fax (301)427-2521; and
Northeast Region, NMFS, One Blackburn Drive, Gloucester, MA 01930-2298; phone (978)281-9300; fax (978)281-9394.
Written comments or requests for a public hearing on this application should be mailed to the Chief, Permits, Conservation and Education Division, F/PR1, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910. Those individuals requesting a hearing should set forth the specific reasons why a hearing on this particular request would be appropriate.
Comments may also be submitted by facsimile at (301)427-2521, provided the facsimile is confirmed by hard copy submitted by mail and postmarked no later than the closing date of the comment period.
Comments may also be submitted by e-mail. The mailbox address for providing e-mail comments is
Tammy Adams or Jaclyn Daly, (301)713-2289.
The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361
The applicant requests a 5-year permit to examine expanding populations of the Western North Atlantic stocks of harbor seals (
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application for implementation of regulations and a letter of authorization; request for comments and information.
NMFS has received a request from the U.S. Navy (Navy) for implementation of regulations and an authorization for the taking of marine mammals incidental to conducting a Full Ship Shock Trial (FSST) of the MESA VERDE (LPD-19) in the offshore waters of the Atlantic Ocean off Mayport, FL. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is announcing our receipt of the Navy's request for the development and implementation of regulations governing the incidental taking of marine mammals and inviting information, suggestions, and comments on the Navy's application and request.
Comments and information must be received no later than November 26, 2007.
Comments on the application should be addressed to Michael Payne, Chief, Permits, Conservation and Education Division, Office of Protected Resources, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910-3225. The mailbox address for providing email comments is
A copy of the Navy's application may be obtained by writing to the address specified above (See
Ken Hollingshead, Office of Protected Resources, NMFS, (301) 713-2289, ext. 128.
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for incidental takings will be granted if NMFS finds that the taking will have a negligible impact on the affected species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for certain subsistence uses, and if the permissible methods of taking and the requirements pertaining to the mitigation, monitoring and reporting of such taking are set forth.
NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.
With respect to military readiness activities, the MMPA defines “harassment” as:
(i) any act that injures or has the significant potential to injure a marine mammal or marine mammal stock in the wild [Level A Harassment]; or (ii) any act that disturbs or is likely to disturb a marine mammal or marine mammal stock in the wild by causing disruption of natural behavioral patterns, including, but not limited to, migration, surfacing, nursing, breeding, feeding, or sheltering, to a point where such behavioral patterns are abandoned or significantly altered [Level B Harassment].
On June 25, 2007, NMFS received an application from the Navy requesting implementation of regulations and authorization for the taking of marine mammals incidental to its conducting an FSST during a four-week period in the spring/summer of 2008 utilizing the MESA VERDE (LPD 19), a new amphibious transport dock ship. The shock trial of the MESA VERDE would consist of up to four underwater detonations of a nominal 4,536 kilogram (10,000 lb) charge at a rate of one detonation per week. The purpose of the proposed action is to generate data to assess the survivability of SAN ANTONIO Class amphibious transport dock ships. An entire manned ship must undergo an at-sea shock trial to obtain survivability data that are not obtainable through computer modeling and component testing on machines or surrogates. Navy ship design, crew training, and survivability lessons learned during previous shock trials, and total ship survivability trials, have proven their value by increasing a ship's ability to survive battle damage.
Each new class of surface ships must undergo realistic survivability testing to assess the survivability of the hull and the ship's systems, and to evaluate the ship's capability to protect the crew from an underwater explosion. The Navy has developed the shock trial to meet its obligation to perform realistic survivability testing. A shock trial consists of a series of underwater detonations that propagate a shock wave through the ship's hull under deliberate and controlled conditions. The effects of the shock wave on the ship's hull, equipment, and personnel safety features are then evaluated. This information would be used by the Navy to validate or improve the survivability of the SAN ANTONIO Class, thereby reducing the risk of injury to the crew, and damage to or loss of a ship. The proposed shock trial qualifies as a military readiness activity as defined in Section 315(f) of Public Law 107-314; 16 U.S.C. 703 note.
A summary of the marine mammal species found in the Mayport, FL, area is presented here. For more detail on marine mammal abundance, density and the methods used to obtain this information, reviewers are requested to refer to either the Navy application or the Navy DEIS (see
Potential impacts on several marine mammal species known to occur in the area offshore of Mayport, FL from shock testing include both lethal and non-lethal injury, as well as harassment. Death or injury may occur as a result of the explosive blast, and injury may occur as a result of non-injurious physiological responses to the explosion-generated shockwave and its acoustic signature. The Navy believes it is very unlikely that injury will occur from exposure to the chemical by-products released into the surface waters, and no permanent alteration of marine mammal habitat would occur. While the Navy does not anticipate any lethal takes would result from these detonations due to mitigation and monitoring measures that are proposed to be undertaken by the Navy, marine mammal density-based calculations indicate that the Mayport site has the potential to result in up to 1 mortality, 2 Level A harassments (injuries), and 282 takings by Level B (behavioral) harassment.
The Navy's proposed action includes mitigation that would minimize risk to marine mammals and sea turtles. The Navy proposes to (1) through pre-detonation aerial surveys, select a test area within the chosen site location with the lowest number of marine mammals and sea turtles; (2) monitor the area visually (aerial and shipboard monitoring) before each test and postpone detonation if any marine mammal is detected within a range that has a potential to cause injury; and (3) monitor the area after each test to locate any injured animals. If post-detonation monitoring shows that marine mammals were killed or injured as a result of the test, testing would be halted until procedures for subsequent detonations could be reviewed and changed as necessary. NMFS may propose and require additional mitigation through its rulemaking and Endangered Species Act (ESA) consultation.
The Navy has released a Draft Environmental Impact Statement (Draft EIS) for the MESA VERDE FSST to the public. This document is available for viewing and downloading at
The Navy will be consulting with NMFS under section 7 of the ESA on this action. This consultation will be concluded prior to a determination on issuance regulations and an MMPA authorization to the Navy for this action.
Interested persons may submit information, suggestions, and comments concerning the Navy's request (see
National Marine Fisheries Service (NMFS), National Oceanic and
Notice of public meetings.
The Mid-Atlantic Fishery Management Council's (Council) Summer Flounder Monitoring Committee, Scup Monitoring Committee, Black Sea Bass Monitoring Committee, and the Mid-Atlantic Fishery Council's and the Atlantic States Marine Fisheries Commission's Summer Flounder, Scup, and Black Sea Bass Advisors will hold public meetings.
The meetings will be held on Thursday, November 15, 2007 beginning at 10 a.m. with the Monitoring Committees. The Advisory Panels will begin meeting at 2 p.m. See
The meetings will be held at the Renaissance Philadelphia Airport, 500 Stevens Drive, Philadelphia, PA 19113, telephone: (610) 521-5900.
Daniel T. Furlong, Executive Director, Mid-Atlantic Fishery Management Council; telephone: (302) 674-2331, extension 19.
The purpose of these meetings is to recommend the 2008 recreational management measures for the summer flounder, scup, and black sea bass fisheries.
Although non-emergency issues not contained in this agenda may come before these groups for discussion, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
The meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to M. Jan Saunders, (302) 674-2331 extension 18, at the Council Office at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
This document provides notice of the type-approval of the Faria WatchDog 750VMS for use in the Northwestern Hawaiian Islands Marine National Monument.
To obtain copies of the list of NOAA-approved Vessel Monitoring Systems (VMS) Mobile Transceiver Unit and VMS Mobile Communications Service Providers, or to obtain information regarding the status of VMS systems being evaluated by NOAA, write to the VMS Support Center, NOAA Fisheries Service, Office for Law Enforcement (OLE), 8484 Georgia Avenue, Suite 415, Silver Spring, MD 20910; or call toll free 888-219-9228.
For questions regarding the status of VMS evaluations contact Jonathan Pinkerton, National VMS Program Manager by phone: 301-427-2300 or by fax: 301-427-2055.
The WatchDog 750VMS manufactured and sold by Faria WatchDog, Inc. has satisfied the requirements for type-approval for use in the Northwestern Hawaiian Islands Marine National Monument.
The transceiver consists of an integrated dual mode GPS/GSM/GPRS/Iridium Satellite Communicator mounted in the wheelhouse or on a console and antennas mounted atop the vessel. The MTU also includes a 7 inch color touch screen display that enables vessel operators to send and receive e-mail and electronic forms. The unit is pre-configured and tested for NOAA Fisheries Service VMS operations. Authorized dealers who are listed at
Automatic GPS position reporting starts after transceiver installation and power activation onboard the vessel. The unit is a car radio sized transceiver powered by any 9 to 16 VDC power supply. The unit can be factory configured for automatic reduced position transmissions when the vessel is stationary (i.e., in port) which allows for port stays in a reduced power state and without the need for unit shut down. The unit restarts normal position transmission automatically when the vessel goes to sea.
The unit has an omni-directional Iridium, GPS, and GSM/GPRS antennas, providing operation from 5 degrees above or below the horizon anywhere on earth. The GSM/GPRS capability gives the system the additional ability to communicate through the AT&T wireless network where available. Iridium only units are permitted for use in the Northwestern Hawaiian Islands Marine National Monument.
A configuration option is available to automatically send daily status reports to a private e-mail address. A 2 inch user interface is included with this system that displays if the MTU is operating properly and can send emergency notification messages to up to four e-mail addresses and/or telephone numbers. A complete list of options is available from the VMS provider.
A vessel owner may purchase the Faria Watchdog 750VMS and the Iridium/GSM communications service by contacting a Faria Watchdog Inc., authorized reseller. Reseller information can be found on the internet at
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of vessel monitoring systems; type-approval.
This document provides notice of vessel monitoring systems (VMS) approved by NOAA for use by vessels participating in the Pacific Coast Groundfish Fishery, Open Access Sector and sets forth relevant features of the VMS.
To obtain copies of the list of NOAA-approved VMS mobile transmitting units and NOAA-approved VMS communications service providers, please contact the VMS Support Center at phone 888-219-9228, fax 301-427-0049, or write to NOAA Fisheries Office for Law Enforcement (OLE), VMS Support Center, 8484 Georgia Avenue, Suite 415, Silver Spring, MD 20910. For more addresses regarding approved VMS, see the
The public may acquire this notice, installation/activation checklists, and relevant updates by calling the VMS support center, phone 888-219-9228, fax 301-427-0049. For questions regarding the status of VMS provider evaluations, contact Jonathan Pinkerton, National VMS Program Manager, phone 301-427-2300; fax 301-427-0049. For questions regarding the Pacific Coast Groundfish Fishery, Open Access Sector VMS requirement, contact Joe Albert, Northwest Divisional VMS Program Manager, phone 206-526-6135.
The Boatracs satellite communications VMS transmitting units that meet the minimum technical requirements for the Pacific Coast Groundfish Fishery, Open Access Sector is the BOATRACS - FMTC/G. The address for the Boatracs distributor dealer contact is provided under the heading “VMS Provider Address”.
The FMTC/G is an integrated GPS two-way satellite communications system, consisting of two major hardware components, the Mobile Communication Transceiver (MCT) and the Enhanced Display Unit (EDU). The MCT contains the antenna and integrated GPS which communicates with the satellite and contains the operating circuitry and memory. The EDU is a shock and splash resistant display and key board unit consisting of, a liquid crystal display, keyboard, with adjustable contrast, brightness, and audible alerts. A back light illuminates the display for night view. The EDU has message waiting, no signal, and audible message received indicators.
The Mobile Communications Transceiver is 6.7 inches high, 11.4 inches wide and weighs 11 pounds. The base of the unit is 6.595 inches in diameter. The MCT draws approximately 2.3 amps of current from the power supply while transmitting and 1.2 amps when vessel is idle.
The Enhanced Display Unit is a hardened and splash proof keyboard display unit with a 15-line X 40-character screen that allows for both text and graphics. It is 12.72 inches wide, 9.3 inches long, 2.21 inches in depth, and weighs 3 pounds and is holster mounted in the cabin.
A vessel owner may purchase this system by contacting the entity identified in this notice under the heading “VMS Provider Address”. The owner should identify himself or herself as a vessel owner issued a permit to operate in the Pacific Coast Groundfish Fishery, Open Access Sector, so the transceiver set can be properly configured.
The Faria WatchDog 750VMS with VTERM Features: The transceiver consists of an integrated dual model GPS/GSM/GPRS/Iridium Satellite Communicator mounted in the wheelhouse and antennas mounted atop the vessel. The Faria VTERM is a touch screen display provides the capability to process electronic forms, declarations, and send e-mail. A configuration option is available to automatically send daily status reports to a private e-mail address and position reports to a secure web site where the data is provided on a map and in tabular form. A 2-inch user interface is also included with this system that displays if the MTU is operating properly and can send emergency notification messages to up to four e-mail addresses and/or telephone numbers. The unit is pre-configured and tested for NMFS VMS (non-GMDSS) operations. Authorized dealers who are listed at
Automatic GPS position reporting starts after transceiver installation and power activation onboard the vessel. The unit is a car radio sized transceiver powered by any 9 to 16 VDC power supply. It is factory configured for automatic reduced position transmissions when the vessel is stationary (i.e., in port) which allows for port stays in a reduced power state and without the need for unit shut down. The unit restarts normal position transmission automatically when the vessel goes to sea.
The Faria WatchDog 750VMS has an omni-directional Iridium, GPS, and GSM/GPRS antennas, providing operation from +/− 5 degrees above or below the horizon anywhere on earth. The GSM/GPRS capability gives the system the additional ability to communicate through the Cingular wireless network where available.
A vessel owner may purchase this system by contacting the entity identified in this notice under the heading “VMS Provider Address”. The owner should identify himself or herself as a vessel owner issued a permit to operate in the Pacific Coast Groundfish Fishery, Open Access Sector, so the transceiver set can be properly configured.
The Thrane & Thrane Sailor Gold VMS(TT-3026D)have been found to meet the minimum technical requirements for vessels issued permits to operate in the Pacific Coast Groundfish Fishery, Open Access Sector. The address for the Thrane & Thrane distributor contact is provided in this notice under the heading VMS Provider Addresses.
The TT-3026D Gold VMS both feature an integrated GPS/Inmarsat-C unit. The unit is factory pre-configured for NMFS VMS operations (non-Global Maritime Distress & Safety System (non-GMDSS). The Thrane and Thrane Gold VMS includes a marine grade monitor with keyboard and integrated mouse. Satellite commissioning services are provided by Thrane & Thrane personnel.
Automatic GPS position reporting starts after transceiver installation and power activation onboard the vessel. The unit is an integrated transceiver/antenna/GPS design using a floating 10 to 32 VDC power supply. The unit is
The TT-3026D provides operation down to +/-15 degree angles. The unit has the capability of two-way communications to send electronic forms and to receive e-mail and other messages. A configuration option is available to automatically send position reports to a private address, such as a fleet management company.
To use the TT-3026D the vessel owner will need to establish an Inmarsat-C system use contract with an approved Inmarsat-C communications service provider. The owner will be required to complete the Inmarsat-C Registration for Service Activation for Maritime Mobile Earth Station. The owner should consult with Thrane & Thrane when completing this form.
Thrane & Thrane personnel will perform the following services before shipment: (1) configure the transceiver according to OLE specifications for vessels issued permits to operate in the Pacific Coast Groundfish Fishery, Open Access Sector; (2) download the predetermined NMFS position reporting and broadcast command identification numbers into the unit; (3) test the unit to ensure operation when installation has been completed on the vessel; and (4) forward the Inmarsat service provider and the transceiver identifying information to OLE.
A vessel owner may purchase this system by contacting the entity identified in this notice under the heading “VMS Provider Address”. The owner should identify himself or herself as a vessel owner issued a permit to operate in the Pacific Coast Groundfish Fishery, Open Access Sector, so the transceiver set can be properly configured.
OLE has approved the below-listed communications service providers: Faria GSM/Iridium, Stratos Global, and VIZADA satellite communications services for the Pacific Coast Groundfish Fishery, Open Access Sector.
Qualcomm Enterprise Services delivers integrated wireless applications and services to businesses around the world. We enable enterprises to operate at peak performance and improve the quality of life for customers in their value chain. Mobile workforce, enterprise management, and machine-to-machine communications are some of the key applications being mobilized by enterprises today.
Vessel owners wishing to use Qualcomm services will need to purchase a Boatracs FMTC/G transceiver. Information regarding configuration, installation, and service activation procedures for the transceiver can be obtained from Boatracs. The contact information for Boatracs is located under the heading of VMS provider addresses.
The Faria Watchdog GSM/Iridium Service is a dual mode GSM/GPRS and Iridium platform to ensure that connections are highly reliable, near real time and cost effective. The primary channel is the GSM/GPRS and the secondary channel is Iridium.
The owner must confirm the operation and communications service to ensure that position reports are automatically sent to and received by OLE before leaving on a fishing trip under VMS. OLE does not regard the fishing vessel as being in compliance until position reports are automatically received. For confirmation purposes, contact the VMS support center, phone 888-219-9228, fax 301-427-0049.
It is recommended, for vendor warranty and customer service purposes, that the vessel owner keep for his or her records and that Stratos Global or VIZADA have on record the following identifying information: (a) Signed and dated receipts and contracts; (b) transceiver serial number; (c) VIZADA or Stratos Global customer number, user name and password; (d) e-mail address of transceiver; (e) Inmarsat identification number; (f) owner name; (g) vessel name; (h) vessel documentation or registration number; and (i) mobile earth station license (FCC license).
OLE will provide an installation and activation checklist which the vessel owner must follow. The vessel owner must sign a statement on the checklist certifying compliance with the installation procedures and return the checklist to OLE. Installation can be performed by an electronics specialist, and the installation cost is paid by the owner.
The owner must confirm the operation and communications service to ensure that position reports are automatically sent to and received by OLE before leaving on a fishing trip under VMS. OLE does not regard the fishing vessel as being in compliance until position reports are automatically received. For confirmation purposes, contact the VMS support center, phone 888-219-9228, fax 301-427-0049.
Stratos Global is a provider Vessel Monitoring Services to the fishing industry. By installing an approved OLE Imarsat-C transceiver on the vessel, fishermen can send and receive E-mail, to and from land, transceiver automatically sends vessel position reports to OLE, and is fully compliant with the International Coast Guard Search and Rescue Centers. Stratos Global Vessel Monitoring System Services are being sold through Thrane and Thrane Inc. For the Thrane and Thrane and Stratos Global addresses, look under the heading “VMS Provider Address”.
Inmarsat-C is a store-and-forward data messaging service. Inmarsat C allows users to send and receive information virtually anywhere in the world, on land, at sea, and in the air. Inmarsat-C supports a wide variety of applications including Internet e-mail, position and weather reporting, a free daily news service, and remote equipment monitoring and control. Mariners can use Inmarsat-C free of charge to send critical safety at sea messages as part of the U.S. Coast Guard's Automated Mutual-Assistance Vessel Rescue system and of the NOAA Shipboard Environmental Acquisition System programs. VIZADA Vessel Monitoring System Services is being sold through Thrane & Thrane, Inc. For the Thrane & Thrane and VIZADA addresses, look under the heading “VMS Provider Address”.
VIZADA and Stratos Global Features offered through Thrane & Thrane: Customer Service supports the security and privacy of vessel accounts and messages with the following: (a) password authentication for vessel owners or agents and for OLE to prevent unauthorized changes or inquiries; and (b) separation of private messages from OLE messages. (OLE requires VMS-related position reports, only.) Billing is separated between accounts for the vessel owner and the OLE. VMS position reports and vessel-initiated messaging are paid for by the vessel owner. Messaging initiated from OLE operations center is paid for by NOAA.
Thrane & Thrane provides customer service for VIZADA and Stratos Global users to support and establish two-way transmission of transceiver unit configuration commands between the transceiver and land-based control
The vessel owner can configure automatic position reports to be sent to a private address, such as to a fleet management company. The vessel can send and receive private e-mail and other messages when the transceiver has such an input device as a laptop or personal computer attached.
Vessel owners wishing to use Stratos Global or VIZADA services will need to purchase an Inmarsat-C transceiver approved for the fishery. The owner will need to complete an Inmarsat-C system use contract with Stratos Global or VIZADA, including a mobile earth station license (FCC requirement). The transceiver will need to be commissioned with Inmarsat according to Stratos Global's or VIZADA instructions. The owner should refer to and follow the configuration, installation, and service activation procedures for the specific transceiver purchased.
Boatracs corporate offices address is 9155 Brown Deer Rd, Suite 8, San Diego, CA 92121. Telephone numbers are toll free (877) 468-8722 and direct dialed (858) 458-8100. The primary point of contact is Debbie Foste, Manager of Fisheries, e-mail
Faria Watchdog Inc., authorized reseller. Reseller information can be found on the internet website at
For Thrane & Thrane Sailor 3026D Gold VMS, Stratos Global or VIZADA information contact Lauri Paul, Marine Products, Thrane & Thrane, Inc., 509 Viking Drive, Suite K, L & M, Virginia Beach, VA 23452; voice: 757-753-9450 or 757-463-9557; fax: 757-463-9581, e-mail:
Commodity Futures Trading Commission.
Notice.
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
Comments must be submitted on or before November 26, 2007.
David Van Wagner, Commodity Futures Trading Commission, Division of Market Oversight, 202-418-5481, fax 202-418-5527, E-mail
As agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the CFTC's regulations were published on December 30, 1981. See 46 FR 63035 (Dec. 30, 1981). The
Send comments regarding the burden estimated or any other aspect of the information collection, including suggestions for reducing the burden, to the addresses listed below. Please refer to OMB Control No. 3038-0059 in any correspondence.
David Van Wagner, Chief Counsel, Division of Market Oversight, U.S. Commodity Futures Trading Commission, 1155 21st Street, NW., Washington, DC 20581, and Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for CFTC, 725 17th Street, Washington, DC 20503.
Department of Defense.
Notice.
Pursuant to Section 10(a), Public Law 92-463, as amended, notice is hereby given of a forthcoming meeting of the Defense Department Advisory Committee on Women in the Services (DACOWITS). The purpose of the Committee meeting is to do the second review of the 2007 report and work on the findings and recommendations. The meeting is open to the public, subject to the availability of space.
Interested persons may submit a written statement for consideration by the Defense Department Advisory Committee on Women in the Services. Individuals submitting a written statement must submit their statement to the Point of Contact listed below at the address detailed below, NLT 5 p.m., 12 November 2007. If a written statement is not received by 12 November 2007 prior to the meeting, which is the subject of this notice, then it may not be provided to or considered by the Defense Department Advisory Committee on Women in the Services until its next open meeting. The Designated Federal Officer will review all timely submissions with the Defense Department Advisory Committee on Women in the Services Chairperson and ensure they are provided to the members of the Defense Department Advisory Committee on Women in the Services. If members of the public are interested in making an oral statement, a written statement must be submitted as above. After reviewing the written comments, the Chairperson and the Designated Federal Officer will determine who of the requesting persons will be able to make an oral presentation of their issue during an open portion of this meeting or at a future meeting. Determination of who will be making an oral presentation will depend on time available and if the topics are relevant to the Committee's activities. Two minutes will be allotted to persons desiring to make an oral presentation. Oral presentations by members of the public will be permitted only on Thursday, 15 November from 4:30 p.m. to 5 p.m. before the full Committee. Number of oral presentations to be made will depend on the number of requests received from members of the public.
15 November 2007, 8:30 a.m.-5 p.m., 16 November 2007, 8:30 a.m.-5 p.m.
MSgt Robert Bowling, USAF, DACOWITS, 4000 Defense Pentagon, Room 2C548A, Washington, DC 20301-4000.
Meeting agenda.
Welcome & Administrative Remarks.
Review second draft of the report.
Work on findings and recommendations.
Discuss topics for next year.
Public Forum.
Welcome & Administrative Remarks.
Review second draft of the report.
Work on findings and recommendations.
Exact order may vary.
Department of the Army, DoD
Notice of availability (NOA).
The Department of the Army announces the availability of the FEIS which evaluates the potential environmental and socioeconomic impacts associated with the BRAC and Transformation Actions at Fort Benning, Georgia.
The waiting period for the FEIS will end 30 days after publication of an NOA in the
To obtain a copy of the FEIS contact Mr. John Brent, Fort Benning Directorate of Public Works, Environmental Management Division, Bldg #6 (Meloy Hall), Room 310, Fort Benning, GA 31905; e-mails to
Ms. Monica Manganaro at (706) 545-3438, Fort Benning Public Affairs Office or Mr. Brandon Cockrell at (706) 545-3210.
The FEIS covers the construction activities, personnel increases, and training activities associated with the BRAC Commission recommendations, the Global Defense Posture Realignment (GDPR) overseas restationing actions, Army Modular Force (AMF) initiatives, and other discretionary stationing activities at Fort Benning, Georgia.
As a result of BRAC recommendations, Fort Benning will be receiving personnel, equipment, and missions from various realignment and closure actions within the Department of Defense. To implement the BRAC Commission recommended initiatives, the Army will provide the necessary facilities/buildings and infrastructure to support the changes. Permanent facilities will be constructed to house the Armor Center and School as well as several other unit relocations. Fort Benning also proposes to implement other transformation actions as the Army undergoes restructuring to meet the demands of the 21st century. The AMF initiative involves the Army's transition from a division-centric design to a standard brigade organization. The reshaping of the military force structure also includes provision for the return of units currently based overseas to United States installations as part of the GDPR. Finally, discretionary stationing actions (activations, inactivations, realignments, and relocations) are proposed, which contribute to and are interrelated with the transformation process.
Following an examination of all implementation alternatives, those alternatives found not to be viable were dropped from further analysis in the Fort Benning FEIS. Alternatives carried forward are: (1) Transformation Alternative A, which entails cantonment area development, construction of small- and large-caliber weapons ranges, heavy maneuver areas and corridors, a driver's training course, off-road driver's training area, and a vehicle recovery area to support the training range requirements; (2) Transformation Alternative B (the Army's Preferred Alternative), which is similar to Transformation Alternative A, with cantonment, maneuver and range projects, but with additional development of new tank training areas in the Good Hope area in the southern part of Fort Benning; and (3) the No Action Alternative, under which Fort Benning missions would continue as they were being performed in November 2005, when the BRAC Commission recommendations became law. The No Action Alternative provides the environmental baseline conditions for comparison to the impacts associated with the action alternatives.
Environmental consequences of two action alternatives (Alternative A and the Preferred Alternative), as well as the No Action Alternative, were evaluated for 13 resources. Under Alternative A, approximately 10,700 acres would be disturbed by Transformation activities; under the Preferred Alternative, approximately 19,100 acres would be disturbed. With the Preferred Alternative, there could potentially be land use compatibility issues for lands adjacent to the proposed Good Hope Maneuver Area. Changes would occur to aesthetic and visual resources, but impacts would not be significant. In terms of socioeconomics, development would take place and personnel growth would result in economic gains under both action alternatives, although the majority of the regional population increase is due to non-Army, private sector decisions; housing would be required; and if the local market could not support this increase in needs, there could be minor short-term effects. The Army and the local community are planning and coordinating to accommodate the increased student population. One available funding source for additional school construction is the Qualified Public Educational Facility (QPEF) Bond Program. On-post traffic congestion both during the construction period and operational phase is anticipated as well as traffic buildup at the main gate during peak hours; however, these would not be to such an extent to be significant with implementation of mitigation measures. Air quality would experience short-term construction emissions increases but would not significantly affect regional air quality in the long term. Noise would increase both on and off post, increasing the potential for annoyance in adjacent communities, but would not be significant with implementation of existing complaint processes. Utilities, safety, cultural resources, and hazardous and toxic materials and waste would not be significantly impacted by the proposed action. However, soils, water resources (including wetlands and state designated impaired streams), special status species (particularly, a population of relict trillium and the Rd-cockaded woodpecker), and Unique Ecological Areas could experience significant impacts under either action alternative. Cumulative impacts are expected to be the same for both action alternatives and would add significant impacts for socioeconomics given the anticipated additional Army and private growth in the area.
Fort Benning proposes to mitigate significant negative effects through a variety of strategies, including avoiding sensitive cultural resource sites, and preparation of an operational noise plan among others. Implementing applicable road improvements on post could minimize significant impacts to increased traffic. Through formal consultation with U.S. Fish and Wildlife Service, plans to minimize the effects on federally listed species will also be implemented, as specified in a biological assessment and opinion.
A Record of Decision will be signed at the end of the 30-day waiting period.
An electronic version of the FEIS can be viewed or downloaded from the following Web site:
Department of Energy.
Notice of opening meeting.
This notice announces a meeting of the Advanced Scientific Computing Advisory Committee (ASCAC). Federal Advisory Committee Act (Public Law 92-463, 86 Stat. 770) requires that public notice of these meetings be announced in the
Tuesday, November 6, 2007, 9 a.m. to 5:30 p.m.; Wednesday, November 7, 2007, 9 a.m. to 11:45 a.m.
Hilton Gaithersburg, 620 Perry Parkway, Gaithersburg, MD 20877.
Melea Baker, Office of Advanced Scientific Computing Research; SC-21/Germantown Building; U.S. Department of Energy; 1000 Independence Avenue, SW.; Washington, DC 20585-1290; Telephone (301) 903-7486, (E-mail:
Take notice that on October 12, 2007, Acacia Natural Gas Corporation (Acacia) filed a petition for rate approval for NGPA section 311 maximum interruptible transportation rates equal to 12.23 cents per MMBtu, pursuant to section 284.123(b)(2) of the Commission's regulations, with a proposed effective date of January 1, 2008.
Any person desiring to participate in this rate proceeding must file a motion to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the date as indicated below. Anyone filing an intervention or protest must serve a copy of that document on the Applicant. Anyone filing an intervention or protest on or before the intervention or protest date need not serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on October 3, 2007, pursuant to the Federal Energy Regulatory Commission's September 17, 2007, letter order, Ameren Illinois Transmission Company (Ameren Transco) filed a certificate of concurrence Ameren Transco designating the Joint Ownership Agreement, accepted as Rate Schedule No. 1.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on October 15, 2007, Tim D. Brown filed an application for approval to hold interlocking positions, pursuant to section 45.8 of the Commission's regulation, 18 CFR 45.8 (2007).
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant and all the parties in this proceeding.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on October 12, 2007, Entergy Gulf States, Inc., on behalf of Gulf States Louisiana, L.L.C. and Entergy Texas, Inc., filed a petition for declaratory order regarding payment of dividends from paid-in capital.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on October 9, 2007, and supplemented on October 19, 2007, Midcontinent Express Pipeline LLC (Midcontinent), 747 East 22nd Street, Lombard, Illinois 60148, filed an abbreviated application pursuant to section 7(c) of the Natural Gas Act (NGA) and Part 157 of the Commission's regulations, for a certificate of public convenience and necessity to construct and operate a new 502-mile natural gas pipeline system from southeastern
Midcontinent requests: (1) Authorization to construct a new natural gas pipeline system consisting of 502 miles of primarily 30-inch to 42-inch diameter pipeline, a booster compressor station (9,470 hp), and 4 mainline compressor stations (102,250 hp), which will originate in southeastern Oklahoma, continue through Texas, Louisiana, Mississippi, and terminate in western Alabama; (2) authorization to lease up to 800,000 Dth/d in the Enogex Inc. intrastate system in Oklahoma to be connected at the origin of the Midcontinent system; (3) approval of Midcontinent's pro forma tariff and proposed recourse rates; and (4) issuance of a blanket construction certificate pursuant to Subpart F of Part 157 and a blanket transportation certificate pursuant to Subpart G of Part 284. On October 9, 2007, Enogex Inc. filed a related application, in Docket No. CP08-9-000, seeking a limited-jurisdiction certificate authorizing Enogex to lease up to 800,000 Dth/d of its intrastate pipeline capacity to Midcontinent.
Midcontinent proposes phased in-service dates and recourse rates. Midcontinent has committed to lease 275,334 Dth/d of capacity on the Enogex system but requests authority to increase the lease capacity up to 800,000 Dth/d at any time during the first 5 years after the project's in-service date. Midcontinent also requests that it be allowed up to 5 years after the project's in-service date in which to construct 2 of the requested mainline compressor stations. The project will have two zones. Without the 2 delayed-construction compressor stations, Zone 1 will have a capacity of 1,400,000 Dth/d and Zone 2 capacity will be 1,000,000 Dth/d. Construction of the final 2 compressor stations will provide an additional 100,000 Dth/d of capacity in Zone 1 and an additional 200,000 Dth/d in Zone 2. Estimated initial project cost is $1.28 billion without the final 2 compressor stations, rising to $1.34 billion with the final 2 compressor stations. Midcontinent requests a preliminary determination on non-environmental issues by March 2008, and a final order by July 2008, in order to commence construction by August 1, 2008. Midcontinent anticipates placing some pipeline facilities in-service on October 31, 2008, with all of the proposed facilities, except the final 2 compressor stations, going into service on February 28, 2009.
Any questions regarding the application are to be directed to Bruce H. Newsome, Vice President, Regulatory, Midcontinent Express Pipeline LLC, 747 East 22nd Street, Lombard, Illinois 60148-5072, telephone: (630) 691-3526 or e-mail:
On February 22, 2007, the Commission staff granted Midcontinent's request to utilize the National Environmental Policy Act (NEPA) Pre-Filing Process and assigned Docket No. PF07-4-000 to staff activities involving the project. Now, as of the filing of this application on October 9, 2007, the NEPA Pre-Filing Process for this project has ended. From this time forward, this proceeding will be conducted in Docket No. CP08-6-000, as noted in the caption of this notice.
Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding, or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
Take notice that on September 13, 2007, the Deputy Secretary, U.S. Department of Energy, pursuant to the authority vested in the Deputy Secretary by the Department of Energy's Delegation Order Nos. 00-001.00C and 00-037.00, and by sections 302(a) and 301(b) of the Department of Energy Organization Act (Pub. L. 95091), submitted for confirmation and approval on a final basis, Rate Schedules SOCO-1-C, SOCO-2-C, SOCO-3-C, SOCO-4-C, ALA-1-L, MISS-1-L, Duke-1-C, Duke-2-C, Duke-3-C, Duke-4-C, Santee-1-C, Santee-2-C, Santee-3-C, Santee-4-C, SCE&G-1-C, SCE&G-2-C, SCE&G-3-C, SCE&G-4-C, Pump-1-A, Pump-2, Replacement-1, and Regulation-1, effective October 1, 2007 and ending September 30, 2012.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on October 15, 2007, Southeastern Power Administration (Southeastern) filed an appeal of the September 25, 2007 decision of the North American Electric Reliability Corporation (NERC) to include Southeastern Power Administration on the NERC compliance registry within the SERC Reliability Corporation for the function of transmission operator and resource planner. Southeastern states that it has the responsibility to market the electric power generated at reservoir projects owned and operated by the U.S. Army Corps of Engineers in the southeast and neither owns or operates a generation or transmission system. Southeastern asks the Commission to reverse the NERC's decision to register Southeastern as a transmission operator and resource planner.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on October 5, 2007, Southern Natural Gas Company (Southern), P.O. Box 2563, Birmingham, Alabama 35202-2563, filed an application in Docket No. CP08-5-000 pursuant to section 7 of the Natural Gas Act (NGA), for approval to abandon and lease certain pipeline and appurtenant facilities and authorization to construct, install and operate a new compressor unit on its Cypress Pipeline and related appurtenant facilities. Magnolia Enterprise Holdings, Inc. (MEHI), Ten Peachtree Place, Location 1466, Atlanta, Georgia 30309, filed a request in the same application pursuant to section 7 of the NGA, for authorization to acquire certain pipeline, measurement and compression facilities and to lease those facilities back to Southern, all as more fully set forth in the application which is on file with the Commission and open to public inspection.
It is stated that pursuant to the terms of a Purchase and Sale Agreement between Southern and AGL Resources, Inc., MEHI's parent company, Southern requests authorization to abandon by sale to MEHI an undivided interest of the following:
Twin 30 Pipelines extending from Southern's interconnection with Elba Island to Port Wentworth, Georgia in Chatham
It is stated that upon closing of the sale of the facilities, MEHI and Southern request authorization for MEHI to lease to Southern the facilities, including the compression facilities to be constructed, and AGLC's Brunswick Pipeline that it proposes to sell to MEHI so that Southern may operate and maintain the facilities as part of its interstate gas pipeline system under the terms of Southern's tariff. In addition, it is stated that MEHI requests pregranted abandonment authority to sell the AGLC Brunswick Pipeline back to AGLC upon termination of the lease.
This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Any initial questions regarding Southern's proposal in this application should be directed to Patricia S. Francis, Senior Counsel, Southern Natural Gas Company, P.O. Box 2563, Birmingham, Alabama 35202-2563, or call (205) 325-7696. Any initial questions regarding EMHI's proposal in this application should be directed to Shannon Omia Pierce, Senior Regulatory Counsel, AGL Resources, Inc., Ten Peachtree Place, 15th floor, Atlanta, Georgia 30309, or call (404) 584-3394.
Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.
There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceeding for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 14 copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.
However, a person does not have to intervene to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.
Persons who wish to comment only on the environmental review of this project, should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commentors will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commentors will not be required to serve copies of filed documents on all other parties. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the applicant. However, the non-party commentors will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the commission's final order.
The Commission strongly encourages electronic filings of comments, protests, and interventions via the Internet in lieu of paper; see 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link.
Take notice that on September 17, 2007, the Deputy Secretary, U.S. Department of Energy, pursuant to the authority vested on the Deputy Secretary by the Department of Energy's Delegation Order Nos. 00-001.00C and 00-037.00, and by sections 301(b), 302(a), 402(e), 641, 642, 643 and 644 of the Department of Energy Organization Act (Pub. L. 95091), submitted for confirmation and approval on a final basis, the annual power rate increase for the sale of power and energy by the Southwestern Power Administration from the Sam Rayburn Dam to the Sam Rayburn Dam Electric Cooperative, Inc., under Contract No. DE-PM-75-92SW00215, effective October 1, 2007 and ending September 30, 2012.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on October 16, 2007, Trunkline Gas Company LLC (Trunkline), P. O. Box 4967, Houston, Texas 77210-4967, filed in Docket No. CP08-10-000 a prior notice request pursuant to sections 157.205(b), 157.208(c), and 157.212 of the Commission's regulations under the Natural Gas Act (NGA), and Trunkline's blanket certificate issued in Docket No. CP83-84-000 on October 1, 1983.
Specifically, Trunkline proposes design and construct two 24-inch tap assemblies, valves, overpressure protection equipment, a remote terminal unit and approximately 400 feet of 24-inch pipe to receive LNG from Creole Trail LNG, L.P. LNG import terminal by way of the Cheniere Pipeline facilities.
Any questions regarding this application should be directed to Stephen T. Veatch, Regulatory Affairs, Trunkline Gas Company, LLC, 5444 Westheimer Road, Houston, TX, 77056, or call (713)989-2024 or (713)989-7660.
Any person or the Commission's Staff may, within 60 days after the issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and, pursuant to section 157.205 of the Commission's Regulations under the Natural Gas Act (NGA) (18 CFR 157.205) a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for protest. If a protest is filed and not withdrawn within 30 days after the time allowed for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA.
The Commission strongly encourages electronic filings of comments, protests, and interventions via the Internet in lieu of paper. See 18 CFR 385.2001(a) (1) (iii) and the instructions on the Commission's Web site (
Take notice that on October 22, 2007, the Southern California Generation Coalition (SCGC) filed a formal complaint against Southern California Gas Company (SoCalGas) pursuant to section 5 of the Natural Gas Act (NGA), 15 U.S.C. 171d, and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206. SCGC alleges that SoCalGas has received California Public Utilities Commission (CPUC) approval to charge and, absent Commission intervention, will charge and intrastate fee for access to its intrastate pipeline system in violation of the Supremacy Clause of the United States Constitution, the NGA, the Commission's rules and regulations and under the NGA, and Commission precedent.
SCGC certifies that copies of the complaint were served on counsel for SoCalGas as listed in the CPUC proceeding because SoCalGas is not listed on the Commission's list of Corporate Officials.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
Take notice that the Commission received the following PURPA 210(m)(3) filings:
Take notice that the Commission received the following electric reliability filings:
Any person desiring to intervene or to protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. It is not necessary to separately intervene again in a subdocket related to a compliance filing if you have previously intervened in the same docket. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. In reference to filings initiating a new proceeding, interventions or protests submitted on or before the comment deadline need not be served on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St., NE., Washington, DC 20426.
The filings in the above proceedings are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed dockets(s). For assistance with any FERC Online service, please e-mail
The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of its staff will conduct two public meetings on the draft environmental impact statement (DEIS) for the Yadkin Hydroelectric Project and the Yadkin-Pee Dee River Hydroelectric Project. The times and locations of these meetings are as follows:
The purpose of these meetings is to solicit comments on the DEIS prepared for the relicensing applications of the Yadkin and Yadkin-Pee Dee River Projects. The DEIS was issued and publicly noticed on September 28, 2007, and is available for review on the Commission's Web site at
The Yadkin Project is located on the Yadkin River in Davidson, Davie, Montgomery, Rowan, and Stanly Counties, North Carolina. The Yadkin-Pee Dee River Project is located on the Yadkin and Pee Dee Rivers in Anson, Montgomery, Richmond, and Stanly Counties, North Carolina. There are no federal lands affected by these projects.
These meetings are open to the public. All local, state, and federal agencies, Indian Tribes, and other interested parties are invited to participate. Transcripts of the meetings will be prepared.
The deadline for filing comments on the DEIS is December 8, 2007. Comments should be filed with: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. Comments should reference either Project No. 2197-073 (Yadkin Project) or Project No. 2206-030 (Yadkin-Pee Dee River Project). Comments may be filed electronically via the Internet in lieu of paper. The Commission strongly encourages electronic filings. See 18 CFR 385.2001(a)(1)(iii) and instructions on the Commission's Web site at
For further information, contact Stephen Bowler at (202) 502-6861 or
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
All documents (original and eight copies) should be filed with: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. Comments, protests, and interventions may be filed electronically via the Internet in lieu of paper; see 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link. The Commission strongly encourages electronic filings. Please include the project number (P-12842-000) on any comments or motions filed.
The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person in the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k.
l.
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n.
o.
p.
q.
r.
Comments, protests and interventions may be filed electronically via the Internet in lieu of paper. See 18 CFR 385.2001 (a)(1)(iii) and the instructions on the Commission's Web site under “e-filing” link. The Commission strongly encourages electronic filing.
s.
t.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
All documents (original and eight copies) should be filed with: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. Comments, protests, and interventions may be filed electronically via the Internet in lieu of paper; see 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link. The Commission strongly encourages electronic filings. Please include the project number (P-12843-000) on any comments or motions filed.
The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person in the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k.
l.
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n.
o.
p.
q.
r.
Comments, protests and interventions may be filed electronically via the Internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under “e-filing” link. The Commission strongly encourages electronic filing.
s.
t.
Take notice that the following hydroelectric applications have been filed with the Commission and are available for public inspection:
a.
b.
Free Flow Power Corporation, filed the application for Project No. 12829-000 on July 23, 2007.
FFP Project 8, LLC filed the application for Project No.12852-000 on July 25, 2007.
c. Name of the project is Greenville Bend Project. The project would be located on the Mississippi River in Orleans and Jefferson Counties, Louisiana. The project would use no dam or impoundment.
d.
e.
f.
g.
All documents (original and eight copies) should be filed with: Secretary, Federal Energy Regulatory Commission,
The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person in the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
h.
i. The filings are available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
j. Competing Preliminary Permit—Anyone desiring to file a competing application for preliminary permit for a proposed project must submit the competing application itself, or a notice of intent to file such an application, to the Commission on or before the specified comment date for the particular application (see 18 CFR 4.36). Submission of a timely notice of intent allows an interested person to file the competing preliminary permit application no later than 30 days after the specified comment date for the particular application. A competing preliminary permit application must conform with 18 CFR 4.30 and 4.36.
k. Competing Development Application—Any qualified development applicant desiring to file a competing development application must submit to the Commission, on or before a specified comment date for the particular application, either a competing development application or a notice of intent to file such an application. Submission of a timely notice of intent to file a development application allows an interested person to file the competing application no later than 120 days after the specified comment date for the particular application. A competing license application must conform with 18 CFR 4.30 and 4.36.
l. Notice of Intent—A notice of intent must specify the exact name, business address, and telephone number of the prospective applicant, and must include an unequivocal statement of intent to submit, if such an application may be filed, either a preliminary permit application or a development application (specify which type of application). A notice of intent must be served on the applicant(s) named in this public notice.
m. Proposed Scope of Studies under Permit—A preliminary permit, if issued, does not authorize construction. The term of the proposed preliminary permit would be 36 months. The work proposed under the preliminary permit would include economic analysis, preparation of preliminary engineering plans, and a study of environmental impacts. Based on the results of these studies, the Applicant would decide whether to proceed with the preparation of a development application to construct and operate the project.
n. Comments, Protests, or Motions to Intervene—Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
o. Filing and Service of Responsive Documents—Any filings must bear in all capital letters the title “COMMENTS”, “NOTICE OF INTENT TO FILE COMPETING APPLICATION”, “COMPETING APPLICATION”, “PROTEST”, and “MOTION TO INTERVENE”, as applicable, and the Project Number of the particular application to which the filing refers. Any of the above-named documents must be filed by providing the original and the number of copies provided by the Commission's regulations to: The Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. An additional copy must be sent to Director, Division of Hydropower Administration and Compliance, Federal Energy Regulatory Commission, at the above-mentioned address. A copy of any notice of intent, competing application or motion to intervene must also be served upon each representative of the Applicant specified in the particular application.
p. Agency Comments—Federal, state, and local agencies are invited to file comments on the described application. A copy of the application may be obtained by agencies directly from the Applicant. If an agency does not file comments within the time specified for filing comments, it will be presumed to have no comments. One copy of an agency's comments must also be sent to the Applicant's representatives.
Take notice that the Commission will convene a technical conference in the above-referenced proceeding on Thursday, November 15, 2007, at 10 a.m. (EDT), in a room to be designated at the offices of the Federal Energy Regulatory Commission, 888 First Street, NE., Washington DC 20426.
The Commission's September 27, 2007 Order
Commission Staff and parties will have the opportunity to discuss all of the issues raised by CIG's proposals to modify its fuel and LUF mechanism and to adjust its cash-out price calculations. Specifically, CIG should be prepared to address all the concerns raised in the protests, and if necessary, to provide additional technical, engineering and operational support for its proposals. Any party proposing alternatives to CIG's proposals should also be prepared to similarly support its position.
FERC conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations please send an e-mail to
All interested persons are permitted to attend. For further information please contact Debbie-Anne Reese at (202) 502-8758 or e-mail
Western Area Power Administration, DOE.
Notice of availability and public hearing.
Western Area Power Administration (Western) announces the availability of the Supplemental Draft Big Stone II Power Plant and Transmission Project (Project) Environmental Impact Statement (Supplemental Draft EIS) for public review and comment. The U.S. Department of Agriculture Rural Utilities Service (RUS) and U.S. Department of Defense, U.S. Army Corps of Engineers (USACE), are participating as cooperating agencies in the EIS process. The Supplemental Draft EIS addresses the environmental impacts of a different back-up water supply plan that uses groundwater instead of surface water along with associated cooling alternatives for the proposed Big Stone II power plant's back-up water supply. The National Environmental Policy Act (NEPA) requires Western to make the Supplemental Draft EIS available to interested members of the public, groups, and Federal, State, local, and tribal agencies for review and comment to assure they have an opportunity to provide input to the Federal decision making process. Comments on the Supplemental Draft EIS may be provided in writing or at the hearing scheduled during the review period.
Western invites the public to comment on the Supplemental Draft EIS during the 45-day public review and comment period, which begins on October 26, 2007, and ends on Monday, December 10, 2007.
Western will hold one public hearing on November 13, 2007, at 7 p.m., at the Milbank Chamber of Commerce in Milbank, South Dakota.
The hearing will be held at the Milbank Chamber of Commerce, 1001 E. 4th Ave., Milbank, South Dakota.
Written comments on the Supplemental Draft EIS should be mailed, faxed, or e-mailed to: Ms. Nancy Werdel, NEPA Document Manager, Big Stone II EIS, A7400, Western Area Power Administration, P.O. Box 281213, Lakewood, CO 80228-8213, fax (720) 962-7263 or 7269, e-mail
For further information or to request a copy or summary of the Supplemental Draft EIS, please write Ms. Nancy Werdel, NEPA Document Manager, Big Stone II EIS, A7400, Western Area Power Administration, P.O. Box 281213, Lakewood, CO 80228-8213, fax (720) 962-7263 or 7269, e-mail
For general information on DOE's NEPA review process, please contact: Carol M. Borgstrom, Director, Office of NEPA Policy and Compliance, GC-20, U.S. Department of Energy, Washington, DC 20585, (202) 586-4600 or (800) 472-2756.
In May 2006, Western Area Power Administration (Western) issued the Big Stone II Power Plant and Transmission Project Draft Environmental Impact Statement (Draft EIS). The Draft EIS described the details of the Proposed Action to construct a nominal 600-megawatt (MW), coal-fired, baseload electric generating facility and associated transmission line and substation upgrades, known as the Big Stone II Project (proposed Project). The primary source of water for the existing plant and the proposed Big Stone II plant would be withdrawals from Big Stone Lake. The proposed Project described in the Draft EIS included construction of a 450-acre surface water pond as the source of back-up water. The 450-acre surface water pond would have been filled with water from Big Stone Lake during normal operating conditions and used in the event of a drought or operational constraints, when sufficient quantities of water could not be pumped from Big Stone Lake. The Rural Utilities Service (RUS) and the U.S. Army Corps of Engineers (USACE) are participating as cooperating agencies in the EIS process.
The purpose of the Supplemental Draft EIS is to present and analyze the environmental impacts of using groundwater instead of surface water for the proposed Big Stone II power plant's back-up water supply along with different cooling alternatives. Changes to the proposed Project are based on comments received on the Draft EIS concerning wetland impacts from construction of the 450-acre water storage pond and additional construction costs associated with the pond.
The Council on Environmental Quality NEPA regulations (40 CFR 1502.9) and DOE NEPA regulations (10 CFR 1021.314) require that a supplement to a draft environmental impact statement be prepared if there are substantial changes to the Proposed Action or significant new circumstances or information relevant to environmental concerns, and contribute to the impacts of the Proposed Action. Western determined that the use of groundwater as the back-up water supply would significantly change the environmental impacts of the proposed Project as presented in the Draft EIS and required the preparation of a Supplemental Draft EIS.
The Supplemental Draft EIS considers two cooling technology alternatives with groundwater as the back-up water supply. Groundwater would be produced from the Veblen Aquifer. Both alternatives would use surface water from Big Stone Lake as the primary water source. Alternative 2 (wet cooling with groundwater back-up water supply), the Revised Proposed Action, retains the original wet cooling system technology identified in the Draft EIS but uses groundwater supply as its back-up water supply. Alternative 3 (wet/dry
The Supplemental Draft EIS evaluates the environmental impacts of the proposed Project on air quality, water resources (groundwater, floodplains, surface water), geology, minerals, paleontological resources, soils, biological resources (vegetation, wildlife, fisheries, special status species, wetland/riparian areas), cultural and historical resources, land use (land use planning, public facilities, recreation, agricultural practices and prime and unique farmland), infrastructure, public health, waste management, visual resources, noise, social and economic values, environmental justice, and cumulative impacts.
Western maintains a mailing list of those interested in the Big Stone II Project EIS. Copies of the complete Supplemental Draft EIS or the Executive Summary have been distributed to all persons and groups on the mailing list that requested a copy. A distribution has been made to various libraries in the proposed Project area.
Oral comments on the Supplemental Draft EIS will be accepted only during the public hearing scheduled for the date and location provided above. Those wishing to make oral comments may do so at the scheduled public hearing. Speakers will be asked to register at the door prior to the beginning of the hearing. Speakers are encouraged to provide a written version of their oral comments for the record. Each speaker will be allowed 5 minutes to present comments unless more time is requested and available. Comments will be recorded by a court reporter at the hearing and will become part of the public hearing record. Western will conduct an open house information session 2 hours prior to the public hearing to field questions and provide information to the public.
Copies of the Supplemental Draft EIS are available for public review at the offices and public libraries listed below:
The Draft EIS is also available at DOE Reading Rooms at the following addresses:
U.S. Department of Energy, Forrestal Building, Reading Room 1E-190, 1000 Independence Avenue, SW., Washington, DC 20585; Western Area Power Administration, Corporate Services Office, 12155 West Alameda Parkway, Lakewood, Colorado 80228; and Western Area Power Administration, Upper Great Plains Customer Service Region, South Dakota Maintenance Office, 200 4th Street, SW., Huron, South Dakota 57350.
Western will consider all written comments postmarked or received during the public comment period in preparing the Final EIS. Decisions by each of the involved Federal agencies will be made after considering comments on the Draft, Supplemental Draft, and Final EIS. The decisions to be made by Western, RUS, and USACE regarding the proposed Big Stone II Power Plant and Transmission Project will be issued following the Final EIS in the form of separate records of decision for each agency.
Environmental Protection Agency (EPA).
Notice.
The EPA Science Advisory Board (SAB) Staff Office is seeking public nominations of additional experts in the formation of the Asbestos Expert Panel in the areas of biostatistics, statistical modeling, epidemiology, meta-analysis, Bayesian analysis and toxicology of inhaled particles. Previous nominations of individuals for this asbestos panel need not be re-submitted, as they will still be considered.
New nominations should be submitted by November 16, 2007.
Members of the public who wish to obtain further information regarding this announcement may contact Ms. Vivian Turner, Designated Federal Officer, by telephone: (202) 343-9697 or e-mail at:
EPA's Office of Solid Waste and Emergency Response (OSWER) requested the Science Advisory Board (SAB) provide technical advice on the proposed methodology to estimate cancer potency from inhalation exposure to asbestos. In 71 FR 48926-48927, the SAB announced the formation of an Asbestos Expert Panel and solicited nominations for members to that Panel. In response to that
The Science Advisory Board Staff Office is now seeking additional nominations for nationally and internationally recognized non-EPA scientists who have expert knowledge in
The SAB is a chartered Federal Advisory Committee, established by 42 U.S.C. 4365, to provide independent scientific and technical advice, consultation, and recommendations to the EPA Administrator on the technical bases for EPA policies and actions. The SAB expert panel will provide technical advice to EPA through the chartered SAB. The SAB Asbestos Panel will comply with the provisions of the Federal Advisory Committee Act (FACA) and all appropriate SAB procedural policies.
The process for forming an SAB panel is described in the
For the SAB, a balanced panel is characterized by inclusion of nominees who possess the necessary domains of knowledge, the relevant scientific perspectives (which, among other factors, can be influenced by work history and affiliation), and the collective breadth of experience to adequately address the charge. Public responses to the Short List will be considered in the selection of the panel members, along with information provided by nominees and information independently gathered by SAB Staff (e.g., financial disclosure information and computer searches to evaluate a nominee's prior involvement with the topic under review). Specific criteria to be used in evaluating Short List nominees include: (a) Scientific and/or technical expertise, knowledge, and experience (primary factors); (b) absence of financial conflicts of interest; (c) scientific credibility and impartiality; (d) availability and willingness to serve; and (e) ability to work constructively and effectively on committees.
Availability of EPA comments prepared pursuant to the Environmental Review Process (ERP), under section 309 of the Clean Air Act and section 102(2)(c) of the National Environmental Policy Act as amended. Requests for copies of EPA comments can be directed to the Office of Federal Activities at 202-564-7167.
An explanation of the ratings assigned to draft environmental impact statements (EISs) was published in FR dated April 6, 2007 (72 FR 17156).
Environmental Protection Agency (EPA).
Notice of settlements.
Under Section 122(h) of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), the United States Environmental Protection Agency has entered into three separate settlements for reimbursement of past response costs concerning the B&B Manufacturing Superfund Site located in Mobile, Mobile County, Alabama.
The Agency will consider public comments on the settlements until November 26, 2007. The Agency will consider all comments received and may modify or withdraw its consent to the settlements if comments received disclose facts or considerations which indicate that the settlements are inappropriate, improper, or inadequate.
Copies of the settlements are available from Ms. Paula V. Batchelor. Submit your comments, identified by Docket ID No. EPA-RO4-SFUND-2007-1052 or Site name B&B Manufacturing Superfund Site by one of the following methods:
•
•
•
Written comments may be submitted to Ms. Batchelor within 30 calendar days of the date of this publication.
Paula V. Batchelor at 404/562-8887.
Department of Health and Human Services, Office of the Secretary.
Notice.
The Office for Human Research Protections (OHRP) is requesting written comments on a proposed amendment to item 5 of the categories of research that may be reviewed by the institutional review board (IRB) through an expedited review procedure, last published in the
In addition, OHRP is requesting comments on the entire expedited review list that was last published in the
As part of its charge to provide expert advice and recommendations to the Secretary of Health and Human Services (the Secretary) and the Assistant Secretary for Health on issues and topics pertaining to or associated with the protection of human research subjects, the Secretary's Advisory Committee on Human Research Protections (SACHRP), through its Subcommittee on Subpart A, considered whether the current expedited review categories should be modified. On March 14, 2007, SACHRP submitted recommendations regarding expedited review to the Secretary, and on June 18, 2007, the Secretary sent a letter to the SACHRP chairperson, stating that HHS would give serious consideration to these recommendations. In regard to the current expedited review categories, SACHRP recommended that expedited review category 7 should be revised as described in Section V below. Therefore, in addition to requesting comments on the entire expedited review list that was published in the
As required under 21 CFR 56.110(a), FDA also will publish in the
Submit written or electronic comments by December 26, 2007.
Submit written comments to EXPEDITED REVIEW, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may be sent via e-mail to
Mr. Glen Drew, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 1-866-447-4777 or by e-mail to:
The Department of Health and Human Services (HHS) human subjects protection regulations at 45 CFR 46.110 permit expedited review procedures for certain kinds of human subjects research that have been found by an IRB to involve no more than minimal risk to research subjects, or for minor changes in previously IRB-approved research during the period (of one year or less) for which approval is authorized. An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB, in
The HHS regulations at 45 CFR 46.110 also give the Secretary the authority to amend and republish the list of research categories that may be reviewed by the IRB through an expedited review procedure, after consultation with other departments and agencies. This same section of the HHS regulations also requires that an amended expedited review list be published by the Secretary in the
As required by HHS regulations at 45 CFR 46.110, this proposed amendment of expedited review category 5 was developed after consulting with the other Federal departments and agencies that have promulgated the Federal Policy for the Protection of Human Subjects.
The first expedited review list was published by the Secretary in 1981 (46 FR 8392). On November 10, 1997, OPRR, now OHRP, and FDA published identical proposed revisions to the 1981 expedited review list (published for OPRR at 62 FR 60607). The category of research in question, expedited review category 5, was addressed in the proposed categories 4 and 5 in the November 10, 1997
(4) Research involving existing identifiable data, documents, records, or biological specimens (including pathological or diagnostic specimens) where these materials, in their entirety, have been collected prior to the research, for a purpose other than the proposed research.
(5) Research involving solely (a) prospectively collected identifiable residual or discarded specimens, or (b) prospectively collected identifiable data, documents, or records, where (a) or (b) has been generated for nonresearch purposes.
In addition, a chart included in OPRR's and FDA's November 10, 1997
The comments received on OPRR's and FDA's November 10, 1997
(5) Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
The preamble of the OPRR November 9, 1998
Categories four (4) and five (5) on the proposed list have been combined into one new category five (5) on the 1998 list. This new section is added in response to comments that raised questions about the relationship of proposed categories four (4) and five (5) to exempt research and about separating out existing and prospectively collected materials. The term “nonresearch purposes” was maintained in new category five (5) to describe the origins of the research material * * *
Similarly, the FDA November 9, 1998
Categories four and five on the proposed list have been combined into one new category, category five, addressing research involving materials collected or which will be collected solely for nonresearch purposes. This new category five was formed in response to comments that raised questions about why the two categories separated out existing and prospectively collected materials. The term “nonresearch purposes” was maintained in new category five to describe the origins of the research materials.
The description of expedited review category 5 and the preamble language as published in the November 9, 1998 OPRR and FDA
As evidence of this confusion, in their 1999 report,
NBAC finds that there is no need to distinguish between collections originally created for clinical purposes and those created for research purposes. In both cases, research on the collected materials should be eligible for expedited review if the research presents no more than a minimal risk to the study subjects.
As a result of this finding, NBAC recommended that “OPRR should revise its guidance to make clear that all minimal-risk research involving human biological materials—regardless of how they were collected—should be eligible for expedited IRB review.” In response to NBAC's 1999 report, HHS convened a multi-agency Working Group to analyze the appropriateness, feasibility, and practical implications of implementing NBAC's recommendations and to develop a set of proposed HHS activities to enhance the protection of human subjects in research involving human biological materials. In regard to the NBAC recommendation above, the HHS Working Group stated:
The Working Group concurs with Recommendation 2 and agrees with NBAC that, for purposes of determining eligibility for expedited IRB review, it is not necessary to draw a distinction between samples originally collected for clinical purposes and those obtained for research purposes. The Working Group also agrees with NBAC's observation that current guidance regarding the types of research that IRBs may review through expedited procedures (63 FR 60364 [HHS] and 60353 [FDA], November 9, 1998) appears to exclude research utilizing existing specimens previously collected for research purposes. It is the understanding of the Working Group that this apparent exclusion is not intentional but rather resulted from a copy editing oversight * * *
After reviewing OPRR's and FDA's 1997 and 1998
OHRP notes that neither OPRR's nor FDA's November 10, 1997
For the reasons described in Section IV, OHRP is proposing to revise expedited review category 5 as set forth below.
Remove (5) in its entirety, and add, in its place:
(5) Research involving materials (data, documents, records, or specimens) that
(a) have previously been collected for nonresearch purposes;
(b) have previously been collected for research purposes, provided the materials were not collected for the currently proposed research; or
(c) will be collected solely for nonresearch purposes.
Some research under section (a) or (b) of this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.
OHRP is also requesting comments on the entire expedited review list that was last published in the
(1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
(b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
(2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
(a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
(b) from other adults and children,
(3) Prospective collection of biological specimens for research purposes by noninvasive means.
(4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
(5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
(6) Collection of data from voice, video, digital, or image recordings made for research purposes.
(7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
(8) Continuing review of research previously approved by the convened IRB as follows:
(a) Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
(b) where no subjects have been enrolled and no additional risks have been identified; or
(c) where the remaining research activities are limited to data analysis.
(9) Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
In addition to requesting comments on all of the expedited review categories listed above, OHRP specifically requests comments on a recommendation by SACHRP to revise expedited review category 7 as follows:
Research (a) on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, affective states, interpersonal relationships, identity, language, communication, cultural beliefs or practices, and social behavior); or (b) employing methods commonly used in social, behavioral, epidemiologic, health services and educational research (including, but not limited to, survey, interview, oral history, participant observation, ethnographic, focus group, program evaluation, human factors evaluation, or quality assurance methods). (Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following meeting on updating the NIOSH publication “Occupational Exposure Sampling Strategies Manual”.
The document can be found at
Instructions are provided for submitting comments.
The meeting has several scheduled presentations and panels that will include time for questions and answers. In addition, two breakout sessions will be held to solicit discussion and input on specific occupational exposure issues.
Presentations, questions, and oral comments given at the meeting will be recorded and included in the docket. Written comments will also be accepted at the meeting. Written comments may also be submitted to Diane Miller, Robert A. Taft Laboratories, 4676 Columbia Parkway, MS C-34, Cincinnati, Ohio 45226, telephone 513/533-8611. All material submitted to the Agency should reference docket number NIOSH-091 and must be submitted by November 30, 2007 to be considered by the Agency. All electronic comments should be formatted as Microsoft Word. Please make reference to docket number NIOSH-091.
NIOSH seeks to obtain materials, including published and unpublished reports and research findings, relevant to the current practice, limitations, and needs for development of occupational exposure assessment practices and policies.
NIOSH will use this information to assess the needs and scientific basis for revisions to its guidance and recommendations in occupational exposure assessment.
All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226.
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the Agency's function; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
1.
2.
(1) Reviewing the actions of individuals or entities providing services or furnishing items under Medicaid; conducting audits of claims submitted for payment; identifying overpayments; and educating providers and others on payment integrity and quality of care; and
(2) Providing effective support and assistance to States to combat Medicaid fraud, waste, and abuse.
To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web Site address at
To be assured consideration, comments and recommendations for the proposed information collections must be received by the OMB desk officer at the address below, no later than 5 p.m. on November 26, 2007:
Centers for Medicare & Medicaid Services, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS) is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
1.
CMS requires that MA and PDP organizations submit a completed formulary and PBP as part of the annual bidding process. During this process, organizations prepare their proposed plan benefit packages for the upcoming contract year and submit them to CMS for review and approval. Based on operational changes and policy clarifications to the Medicare program and continued input and feedback by the industry, CMS has made the necessary changes to the plan benefit package submission.
2.
To obtain copies of the supporting statement and any related forms for the proposed paperwork collections
To be assured consideration, comments and recommendations for the proposed information collections must be received at the address below, no later than 5 p.m. on December 26, 2007:
Centers for Medicare and Medicaid Services, HHS.
Proposed notice.
This proposed notice with comment period acknowledges the receipt of a deeming application from the Community Health Accreditation Program for continued recognition as a national accrediting organization for home health agencies that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on November 26, 2007.
In commenting, please refer to file code CMS-2276-PN. 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.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
4.
(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
Cindy Melanson, (410) 786-0310. Patricia Chmielewski, (410) 786-6899.
Comments received timely will also be 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.
Under the Medicare program, eligible beneficiaries may receive covered services from a home health agency (HHA) provided certain requirements are met. Sections 1861(m) and (o), and 1891 of the Social Security Act (the Act) establish distinct criteria for facilities seeking designation as an HHA. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488. The regulations at 42 CFR part 484 specify the conditions that an HHA must meet in order to participate in the Medicare program, the scope of covered services and the conditions for Medicare payment for Home Health Care.
Generally, in order to enter into a provider agreement with the Medicare program, an HHA must first be certified by a State survey agency as complying
Section 1865(b)(1) of the Act provides that, if a provider entity demonstrates through accreditation by an approved national accrediting organization that all applicable Medicare conditions are met or exceeded, we will deem those provider entities as having met the requirements. Accreditation by an accrediting organization is voluntary and is not required for Medicare participation.
If an accrediting organization is recognized by the Secretary as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program would be deemed to meet the Medicare conditions. A national accrediting organization applying for deeming authority under part 488, subpart A must provide us with reasonable assurance that the accrediting organization requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the reapproval of accrediting organizations are set forth at §§ 488.4 and 488.8(d)(3). The regulations at § 488.8(d)(3) require accrediting organizations to reapply for continued deeming authority every six years or sooner as determined by us.
Community Health Accreditation Program's (CHAP's) term of approval as a recognized accreditation program for HHA's expires March 31, 2008.
Section 1865(b)(2) of the Act and our regulations at § 488.8(a) require that our findings concerning review and reapproval of a national accrediting organization's requirements consider, among other factors, the applying accrediting organization's requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities found not in compliance with the conditions or requirements; and ability to provide us with the necessary data for validation.
Section 1865(b)(3)(A) of the Act further requires that we publish, within 60 days of receipt of an organization's complete application, a notice identifying the national accrediting body making the request, describing the nature of the request, and providing at least a 30-day public comment period. We have 210 days from the receipt of a complete application to publish notice of approval or denial of the application.
The purpose of this proposed notice is to inform the public of CHAP's request for continued deeming authority for HHAs. This notice also solicits public comment on whether CHAP's requirements meet or exceed the Medicare conditions for participation for HHAs.
CHAP submitted all the necessary materials to enable us to make a determination concerning its request for reapproval as a deeming organization for HHAs. This application was determined to be complete on September 3, 2007. Under section 1865(b)(2) of the Act and our regulations at § 488.8 (Federal review of accrediting organizations), our review and evaluation of CHAP will be conducted in accordance with, but not necessarily limited to, the following factors:
• The equivalency of CHAP's standards for an HHA as compared with CMS' HHA conditions of participation.
• CHAP's survey process to determine the following:
Because of the large number of public comments we normally receive on
Upon completion of our evaluation, including evaluation of comments received as a result of this notice, we will publish a final notice in the
This document does not impose 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).
In accordance with the provisions of Executive Order 12866, the Office of Management and Budget did not review this proposed notice.
In accordance with Executive Order 13132, we have determined that this proposed notice would not have a significant effect on the rights of States, local or tribal governments.
Section 1865 of the Social Security Act (42 U.S.C. 1395bb).
Centers for Medicare and Medicaid Services, HHS.
Proposed notice.
This proposed notice with comment period acknowledges the receipt of a deeming application from The Joint Commission for continued recognition as a national accrediting organization for home health agencies that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on November 26, 2007.
In commenting, please refer to file code CMS-2277-PN. 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.
2.
Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2277-PN, P.O. Box 8010, Baltimore, MD 21244-8010.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2277-PN, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4.
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
Cindy Melanson, (410) 786-0310. Patricia Chmielewski, (410) 786-6899.
Comments received timely will also be 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.
Under the Medicare program, eligible beneficiaries may receive covered services from a home health agency (HHA) provided certain requirements are met. Sections 1861(m) and (o), and 1891 of the Social Security Act (the Act) establish distinct criteria for facilities seeking designation as an HHA. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488. The regulations at 42 CFR part 484 specify the conditions that an HHA must meet in order to participate in the Medicare program, the scope of covered services and the conditions for Medicare payment for home health care.
Generally, in order to enter into a provider agreement with the Medicare program, an HHA must first be certified by a State survey agency as complying with the conditions or requirements set forth in part 484 of our regulations. Thereafter, the HHA is subject to regular surveys by a State survey agency to determine whether it continues to meet these requirements. There is an alternative, however, to surveys by State agencies.
Section 1865(b)(1) of the Act provides that, if a provider entity demonstrates through accreditation by an approved national accrediting organization that all applicable Medicare conditions are met or exceeded, we will deem those provider entities as having met the requirements. Accreditation by an accrediting organization is voluntary and is not required for Medicare participation.
If an accrediting organization is recognized by the Secretary as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program would be deemed to meet the Medicare conditions. A national accrediting organization applying for deeming authority under part 488, subpart A must provide us with reasonable assurance that the accrediting organization requires the accredited provider entities to meet requirements that are at least as
The Joint Commission's term of approval as a recognized accreditation program for HHAs expires March 31, 2008.
Section 1865(b)(2) of the Act and our regulations at § 488.8(a) require that our findings concerning review and reapproval of a national accrediting organization's requirements consider, among other factors, the applying accrediting organization's requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities found not in compliance with the conditions or requirements; and ability to provide us with the necessary data for validation.
Section 1865(b)(3)(A) of the Act further requires that we publish, within 60 days of receipt of an organization's complete application, a notice identifying the national accrediting body making the request, describing the nature of the request, and providing at least a 30-day public comment period. We have 210 days from the receipt of a complete application to publish notice of approval or denial of the application.
The purpose of this proposed notice is to inform the public of The Joint Commission's request for continued deeming authority for HHAs. This notice also solicits public comment on whether The Joint Commission's requirements meet or exceed the Medicare conditions for participation for HHAs.
The Joint Commission submitted all the necessary materials to enable us to make a determination concerning its request for reapproval as a deeming organization for HHAs. This application was determined to be complete on September 3, 2007. Under section 1865(b)(2) of the Act and our regulations at § 488.8 (Federal review of accrediting organizations), our review and evaluation of The Joint Commission will be conducted in accordance with, but not necessarily limited to, the following factors:
• The equivalency of The Joint Commission standards for an HHA as compared with CMS' HHA conditions of participation.
• The Joint Commission's survey process to determine the following:
Because of the large number of public comments we normally receive on
Upon completion of our evaluation, including evaluation of comments received as a result of this notice, we will publish a final notice in the
This document does not impose 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).
In accordance with the provisions of Executive Order 12866, the Office of Management and Budget did not review this proposed notice.
In accordance with Executive Order 13132, we have determined that this proposed notice would not have a significant effect on the rights of States, local or tribal governments.
Section 1865 of the Social Security Act (42 U.S.C. 1395bb).
Centers for Medicare & Medicaid Services (CMS), HHS.
Final notice.
This final notice announces the approval of the American Diabetes Association (ADA) as a national accreditation organization for the purpose of determining that an entity meets the necessary quality standards to furnish outpatient diabetes self-management training services under Part B of the Medicare program.
Joan A. Brooks, (410) 786-5526.
To participate in the Medicare program, diabetes self-management training (DSMT) programs must meet conditions for coverage specified in our regulations at 42 CFR part 410, subpart H. One requirement is that entities must satisfy required quality standards. Currently, one way of satisfying the quality standards under § 410.145 is to be approved by an approved accrediting body. The regulations pertaining to the application procedures for national accreditation organizations for DSMT are at § 410.142. After we approve and recognize the accreditation organization, it may accredit an entity to meet one of the sets of quality standards described in § 410.144.
In evaluating an application from an accrediting organization, we consider the following factors under section 1865(b)(2) of the Social Security Act (the Act):
• Accreditation requirements.
• Survey procedures.
• Ability to provide adequate resources for conducting required surveys and to supply information for use in enforcement activities.
• Monitoring procedures.
• Ability to provide us with the necessary data for validation.
We are required by § 410.142(d) to publish a proposed notice in the
We received a complete application from the American Diabetes Association (ADA) on March 3, 2007. On May 25, 2007, we published a proposed notice in the
• Entities' failure to meet the required number of participants for group training;
• Entities' failure to meet the requirement for both a registered dietician (RD) and a registered nurse (RN) on the training team; and
• Entities' failure to bill correctly.
Recent revisions made to the National Standards for Diabetes Self-Management Education Programs (NSDSMEP) include: 1) a reduction in the number of participants required for group training (from 15 to 10); and 2) a change in the instructional requirements that DSMT programs must meet. Previously, a DSMT entity was required to have both a RD and a RN conduct training. The recent revisions to the NSDSMEP changed this requirement. An entity may now have either a RD or a RN conduct training. This revision should help to alleviate some of the administrative burdens faced by entities when administering the DSMT benefit. Additionally, we have revised Chapter 18 of the CMS Claims Processing Manual, and Chapter 15 of the CMS Benefits Policy Manual to clarify the instructions for filing specific claims. Our findings indicate that the ADA continues to use one of the sets of quality standards described in § 410.144. It also continues to meet the CMS criteria as “a nonprofit organization with demonstrated experience in representing the interests of individuals with diabetes” to accredit entities to furnish training as specified in § 410.142(a).
The ADA began its Education Recognition Program (ERP) in 1986. At that time they formally recognized diabetes self-management education programs that meet the NSDSMEP. These standards, created by the National Diabetes Advisory Board (NDAB), were designed to promote quality diabetes self-management education nationwide for every person with diabetes.
A Task Force consisting of the ADA, the American Association of Diabetes Educators, the American Dietetic Association, the Veteran's Health Service, the National Certification Board for Diabetes Educators, the Centers for Disease Control and Prevention, the Department of Veterans Affairs, the Diabetes Research and Training Centers, the Indian Health Service, and the National Certification Board for Diabetes Educators was convened on March 31, 2006 and again on September 19, 2006 as part of the update process. The revised standards were approved on March 25, 2007 and was published in the June 2007 issue of Diabetes Care, Volume 30, Number 6. The task force reviewed the standards for their appropriateness, relevancy, scientific basis, specificity, and ability to be implemented in multiple settings. The current NSDSMEP standards (7th Edition) were effectuated in June 2007 and reflect the changing approaches in diabetes training and education.
We reviewed ADA's materials and the findings presented by the Iowa Foundation for Medicare Care (IFMC, Contract #GS-35F-5831 H/HHDM 500-2006-0015IG), which was under contract with CMS to validate ADA's accreditation policies. IFMC surveyed a sample of ADA's accredited facilities. Based on these reviews, we have determined that the ADA's deeming authority has been exercised in compliance with § 410.142. Therefore, ADA's continued recognition as a national accrediting organization is approved and is effective for 6 years, beginning October 27, 2007.
Sections 1865 of the Social Security Act (42 U.S.C. 1395bb).
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.
Kelly Buchanan, DFO, (410) 786-6132, or e-mail
In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces the quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Secretary is mandated by section 1868(a)(1) of the Social Security Act (the Act) to appoint a Practicing Physicians Advisory Council based on nominations submitted by medical organizations representing physicians. The Council meets quarterly to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary. To the extent feasible and consistent with statutory deadlines, the Council's consultation must occur before
The Council consists of 15 physicians, including the Chair. Members of the Council include both participating and nonparticipating physicians, and physicians practicing in rural and underserved urban areas. At least 11 members of the Council must be physicians as described in section 1861(r)(1) of the Act; that is, State-licensed doctors of medicine or osteopathy. The remaining 4 members may include dentists, podiatrists, optometrists, and chiropractors. Members serve for overlapping 4-year terms.
Section 1868(a)(2) of the Act provides that the Council meet quarterly to discuss certain proposed changes in regulations and manual issuances that relate to physicians' services, identified by the Secretary. Section 1868(a)(3) of the Act provides for payment of expenses and per diem for Council members in the same manner as members of other advisory committees appointed by the Secretary. In addition to making these payments, the Department of Health and Human Services and CMS provide management and support services to the Council. The Secretary will appoint new members to the Council from among those candidates determined to have the expertise required to meet specific agency needs in a manner to ensure appropriate balance of the Council's membership.
The Council held its first meeting on May 11, 1992. The current members are: Anthony Senagore, M.D., Chairperson; Jose Azocar, M.D.; M. Leroy Sprang, M.D.; Karen S. Williams, M.D.; Peter Grimm, D.O.; Jonathon E. Siff, M.D., MBA; John E. Arradondo, M.D., MPH; Helena Wachslicht Rodbard, M.D.; Vincent J. Bufalino, M.D.; Tye J. Ouzounian, M.D.; Geraldine O'Shea, D.O.; Arthur D. Snow, Jr., M.D.; Gregory J. Przybylski, M.D.; Jeffrey A. Ross, DPM, M.D.; and Roger L. Jordan, O.D.
The meeting will commence with the Council's Executive Director providing a status report, and the CMS responses to the recommendations made by the Council at the August 27, 2007 meeting, as well as prior meeting recommendations. Additionally, an update will be provided on the Physician Regulatory Issues Team. In accordance with the Council charter, we are requesting assistance with the following agenda topics:
• Stark Update.
• Overview of Medicare Demonstration Projects.
• Physician Fee Schedule Final Rule.
• Outpatient Prospective Payment System (OPPS)/Ambulatory Surgical Center (ASC) Final Rule.
• 9th Scope of Work/Quality Improvement Organization (QIO) Program.
For additional information and clarification on these topics, contact the DFO as provided in the
The meeting is open to the public, but attendance is limited to the space available. Persons wishing to attend this meeting must register by contacting the DFO at the address listed in the
Since this meeting will be held in a Federal Government Building, the Hubert H. Humphrey Building, Federal security measures are applicable. In planning your arrival time, we recommend allowing additional time to clear security. To gain access to the building, participants will be required to show a government-issued photo identification (for example, driver's license or passport), and must be listed on an approved security list before persons are permitted entrance. Persons not registered in advance will not be permitted into the Hubert H. Humphrey Building and will not be permitted to attend the Council meeting.
All persons entering the building must pass through a metal detector. In addition, all items brought to the Hubert H. Humphrey Building, whether personal or for the purpose of presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for the purpose of presentation.
Individuals requiring sign language interpretation or other special accommodation must contact the DFO via the contact information specified in the
(Section 1868 of the Social Security Act (42 U.S.C. 1395ee) and section 10(a) of Pub. L. 92-463 (5 U.S.C. App. 2, section 10(a)).)
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix 2, section 10(a) (Pub. L. 92-463), this notice announces a meeting of the Panel on December 4, 2007. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.
Lynne Johnson, (410) 786-0090. Please refer to the CMS Advisory Committees' Information Line (1-877-449-5659 toll free)/(410-786-9379 local) or the Internet (
Section 9(a)(2) of the Federal Advisory Committee Act authorizes the Secretary to establish an advisory panel if the Secretary determines that the panel is “in the public interest in connection with the performance of duties imposed * * * by law.” Such duties are imposed by section 1804 of the Social Security Act (the Act), requiring the Secretary to provide informational materials to Medicare beneficiaries about the Medicare program, and section 1851(d) of the Act, requiring the Secretary to provide for “activities * * * to broadly disseminate information to medicare beneficiaries * * * on the coverage options provided under [Medicare Advantage] in order to promote an active, informed selection among such options.”
The Advisory Panel is also authorized by 1114(f) of the Social Security Act, 42 U.S.C. 1311(f), and section 222 of the Public Health Service Act, 42 U.S.C. 217a. The Secretary signed the charter establishing this Panel on January 21, 1999 (64 FR 7899) and approved the renewal of the charter on November 14, 2006. The establishment of the charter and the renewal of the charter were announced in the February 17, 1999
The goals of the Panel are as follows:
• To develop and implement a national Medicare education program that describes the options for selecting a health plan under Medicare.
• To enhance the Federal government's effectiveness in informing the Medicare consumer, including the appropriate use of public-private partnerships.
• To expand outreach to vulnerable and underserved communities, including racial and ethnic minorities, in the context of a national Medicare education program.
• To assemble an information base of best practices for helping consumers evaluate health plan options and build a community infrastructure for information, counseling, and assistance.
The current members of the Panel are: Anita B. Boles, Independent Consultant, Health Communications; Gwendolyn T. Bronson, SHINE/SHIP Counselor, Massachusetts SHINE Program; Dr. Yanira Cruz, President and Chief Executive Officer, National Hispanic Council on Aging; Clayton Fong, President and Chief Executive Officer, National Asian Pacific Center on Aging; Nan Kirsten-Forte, Executive Vice President, Consumer Services, WebMD; Dr. Jessie C. Gruman, President and Chief Executive Officer, Center for the Advancement of Health; Dr. David Lansky, Director, Health Program, Markle Foundation; Dr. Daniel Lyons, Senior Vice President, Government Programs, Independence Blue Cross; Dr. Frank B. McArdle, Manager, Hewitt Research Office, Hewitt Associates; Traci McClellan, J.D., Executive Director, National Indian Council on Aging; Dr. Keith Mueller, Professor and
The agenda for the December 4, 2007 meeting will include the following:
• Recap of the previous (September 20, 2007) meeting.
• Medicare Enrollment, Outreach, Education, and Partnering Activities Update.
• Public Comment.
• Listening Session with CMS Leadership.
• Next Steps.
Individuals or organizations that wish to make a 5-minute oral presentation on an agenda topic should submit a written copy of the oral presentation to Lynne Johnson at the address listed in the
Individuals requiring sign language interpretation or other special accommodations should contact Ms. Johnson at the address listed in the
Sec. 222 of the Public Health Service Act (42 U.S.C. 217a) and sec. 10(a) of Pub. L. 92-463 (5 U.S.C. App. 2, sec. 10(a) and 41 CFR 102-3).
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that it intends to continue to exercise enforcement discretion to ensure the continued availability of exocrine pancreatic insufficiency drug products after April 28, 2008. FDA intends to exercise its enforcement discretion with respect to unapproved pancreatic enzyme drug products until April 28, 2010, if the manufacturers have investigational new drug applications (INDs) on active status on or before April 28, 2008, and have submitted new drug applications (NDAs) on or before April 28, 2009. FDA is granting this extension to ensure the availability of exocrine pancreatic insufficiency drug products during the additional time needed by manufacturers to obtain marketing approval.
The period during which FDA intends to exercise its enforcement discretion against unapproved pancreatic insufficiency drug products is extended to April 28, 2010, if the manufacturer has an active IND on or before April 28, 2008, and has submitted an NDA on or before April 28, 2009.
Mary Catchings, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.
In the
Pancreatic extract drug products have been marketed in the United States for many years. Marketing of some versions of these products predates the 1938 passage of the Federal Food, Drug, and Cosmetic Act (the act). Over the years, other pancreatic extract drug products have entered the market. Various dosage forms of pancreatic enzyme drug products are currently marketed as prescription drug products: Uncoated tablets, powders, capsules, enteric-coated tablets, and encapsulated enteric-coated microspheres.
Some pancreatic extract drug products were marketed over-the-counter (OTC). As part of the OTC drug review, FDA evaluated the safety and effectiveness of drug products used to treat exocrine pancreatic insufficiency. FDA's review of data and information on pancreatic extract drug products found significant variations in bioavailability among the various dosage forms and among products from different manufacturers of the same dosage form. Available data have shown that the formulation, dosage, and manufacturing process of pancreatic enzyme drug products have a critical effect on the safe and effective use of these drugs. FDA concluded that preclearance of each product to standardize enzyme bioactivity would be necessary. FDA also determined that continuous physician monitoring of patients is a collateral measure necessary to the safe and effective use of pancreatic enzyme drug products, requiring that these products be available by prescription only and that the products be approved through the new drug approval process to standardize enzyme activity (56 FR 32282, July 15, 1991; 60 FR 20162, April 24, 1995).
The 2004 notice reiterated FDA's determination that all pancreatic extract drug products are new drugs under section 201(p) of the act (21 U.S.C. 321(p)), requiring approved NDAs under section 505 of the act (21 U.S.C. 355) and 21 CFR part 314. The document stated that FDA expects to receive only NDAs, including applications submitted under section 505(b)(2) of the act, for these products. To assist manufacturers of pancreatic extract drug products in preparing and submitting documentation to meet NDA requirements for the drug products, FDA announced the availability of a draft guidance for industry entitled “Exocrine Pancreatic Insufficiency Drug Products—Submitting NDAs” in the
FDA stated in the 2004 notice that pancreatic extract drug products are used to treat exocrine pancreatic insufficiency, a condition in which symptoms are due to deficient secretion of pancreatic enzymes (i.e., lipase, protease, amylase) essential for normal digestion and absorption, and no alternative drug is relied upon by the medical community to treat the lack of lipase, protease, and amylase caused by exocrine pancreatic insufficiency. The severity of the conditions varies from patient to patient as does the dosage requirement of pancreatic enzyme replacement therapy needed to relieve the symptoms of pancreatic insufficiency.
Pancreatic enzyme therapy is a daily requirement for patients with exocrine pancreatic insufficiency and is needed for survival for many of these patients (e.g., cystic fibrosis patients). The appropriate daily dose of pancreatic enzymes must be individualized and adjusted when clinically indicated. To meet the needs of patients requiring pancreatic enzyme replacement therapy, drug products with varying dosage forms, enzyme content, and activity need to remain available for patient use. Only one product, Cotazym, sponsored by Organon, Inc., is the subject of an approved NDA and that product is not currently being marketed.
The 2004 notice advised that FDA intended to exercise its enforcement discretion until April 28, 2008, as to unapproved pancreatic enzyme drug products that were marketed on or before April 28, 2004. FDA determined that pancreatic enzyme drug products are medically necessary and, accordingly, FDA intended to exercise its enforcement discretion so that pancreatic extract drug products would remain available during the period necessary for manufacturers to conduct the required studies, prepare applications, and have the applications approved.
This provision for the exercise of enforcement discretion applied only to pancreatic enzyme products marketed on or before the publication of the April 28, 2004,
In response to the 2004 notice, a number of manufacturers of pancreatic extract drug products have indicated that they need an extension of time to obtain approved applications. The manufacturers contend that additional time is needed because of numerous problems encountered during the drug development process, predominantly manufacturing issues, and difficulty conducting all of the required studies needed for NDA filing and approval.
The agency has carefully considered the requests and concludes that additional time is justified to ensure the continued availability of pancreatic extract drug products after April 28, 2008. As these pancreatic extract drugs are naturally-derived products of porcine origin, manufacturers must conform with currently accepted standards for protein therapeutic products. The justification for this extension is based upon chemistry, manufacturing, and control issues that previously have not been well-understood and have been found to be particularly challenging for these enzyme preparations derived from porcine pancreas. These issues include the following:
• Control and evaluation of variability of pancreatic source materials used in drug substance manufacture;
• Measurement of viral loads, viral inactivation, and resultant risk assessment and mitigation strategies as described in International Conference on Harmonisation guidance Q5A;
• Development and implementation of validated purity and identity drug substance and product release and stability testing methodologies for the very complex protein mixtures derived from porcine pancreas;
• Required modification and validation of the traditional lipase potency assay methodology based upon recent scientific studies; and
• Maintenance and confirmation of drug product stability without the use of overages to increase the dating period.
By this notice, FDA is extending the period during which it intends to exercise its enforcement discretion as to certain unapproved pancreatic enzyme products until April 28, 2010.
This extension of the period during which FDA intends to exercise its enforcement discretion applies to any manufacturer of pancreatic extract drug products marketed on or before publication of the 2004 notice, if the manufacturer has an active IND for its pancreatic extract product on or before April 28, 2008, has submitted an NDA on or before April 28, 2009, and is pursuing approval of its application with due diligence as determined by FDA. In determining the due diligence of an applicant, FDA will examine the facts and circumstances of the applicant's actions during the drug development and review period to determine whether the applicant exhibited the degree of attention, continuous directed effort, and timeliness as may reasonably be expected from, and are ordinarily exercised by, an applicant during this period. FDA will take into consideration whether the applicant is conducting its clinical trials in a manner and at a rate sufficient for NDA submission on or before April 28, 2009, the adequacy and completeness of any required or necessary documents submitted by the applicant to FDA, the speed and thoroughness with which the applicant responds to any FDA requests for information or notifications of deficiencies, and any other relevant evidence of whether the applicant is making a genuine effort to meet the deadlines set out in this notice and obtain FDA approval for its products.
FDA believes that establishing certain milestones will ensure that manufacturers are actively pursuing an NDA approval. Under those circumstances, extending the period of enforcement discretion as described in this notice will provide sufficient time for manufacturers to obtain approval of NDAs. Therefore, the agency does not anticipate that any further extensions will be needed. The agency, however, does not intend to exercise its enforcement discretion as described in this notice if the following conditions exist: (1) A person manufacturing or shipping an unapproved product covered by this notice is violating other provisions of the act or (2) there is significant new information related to a safety risk associated with a specific product covered by this notice.
FDA intends to take regulatory action, including but not limited to initiating seizure, injunction, or other judicial or administrative proceedings, against manufacturers that are marketing unapproved pancreatic insufficiency drug products and are not actively pursuing approval. Actively pursuing approval means that the manufacturer has an active IND on or before April 28, 2008, and has submitted an NDA on or
This notice is issued under sections 502 and 505 of the act (21 U.S.C. 352) and under authority delegated to the Assistant Commissioner for Policy.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Impact-Resistant Lenses: Questions and Answers.” This draft guidance document answers manufacturer, importer, and consumer questions on impact-resistant lenses, including questions on test procedures, lens testing apparatus, record maintenance, and exemptions to testing.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by January 24, 2008.
Submit written requests for single copies of the guidance document entitled “Impact-Resistant Lenses: Questions and Answers” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the
Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to either
John Stigi, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3150.
Eyeglasses and sunglasses are medical devices and are subject to device regulations, including § 801.410 (21 CFR 801.410). This draft guidance document revises the original guidance document entitled “Impact-Resistant Lenses: Questions and Answers” (FDA 87-4002), issued September 1987. This draft guidance document also contains detailed and updated discussions of the following: (1) Lens blanks; (2) semi-finished, finished, and plano lenses; and (3) import entry inspections.
To reduce the number of eye injuries, eyeglasses and sunglasses must be fitted with impact-resistant lenses capable of withstanding the impact test described under § 801.410(d)(2). This draft guidance answers questions for manufacturers, importers, and testing laboratories on such topics as test procedures, lens testing apparatus, record maintenance, and exemptions to testing.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on impact-resistant lenses. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive “Impact-Resistant Lenses: Questions and Answers,” you may either send an e-mail request to
CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts,
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 801.109 have been approved under OMB Control No. 0910-0485; the collections of information in 21 CFR 807.87 have been approved under OMB Control No. 0910-0120; and the collections of information in 21 CFR part 820 have been approved under OMB Control No. 0910-0073.
Interested persons may submit to the Division of Dockets Management (see
National Institutes of Health, Public Health Service, HHS.
Notice.
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.
The electrospinning process is a simple, economical means to produce biomaterial matrices or scaffolds of ultra-fine fibers derived from a variety of biodegradable polymers (Li WJ,
1. W-J Li
2. W-J Li
3. CK Kuo
4. W-J Li
U.S. Provisional Application No. 60/690,998 filed 15 Jun 2005 (HHS Reference No. E-116-2005/0-US-01).
PCT Application No. PCT/US2006/0237477 filed 15 Jun 2006 (HHS Reference No. E-116-2005/0-PCT-02).
Degeneration of the intervertebral disc (IVD) is a common and significant source of morbidity in our society. Approximately 8 of 10 adults at some point in their life will experience an episode of significant low back pain, with the majority improving without any formal treatment. However, for the subject requiring surgical management current interventions focus on fusion of the involved IVD levels, which eliminates pain but does not attempt to restore disc function. Approximately 200,000 spinal fusions were performed in the United States in 2002 to treat pain associated with lumbar disc degeneration. Spinal fusion however is thought to significantly alter the biomechanics of the disc and lead to further degeneration, or adjacent segment disease. Therefore, in the past decade there has been mounting interest in the concept of IVD replacement. The replacement of the IVD holds tremendous potential as an alternative to spinal fusion for the treatment of degenerative disc disease by offering a safer alternative to current spinal fusion practices.
At the present time, several disc replacement implants are at different stages of preclinical and clinical testing. These disc replacement technologies are designed to address flexion, extension, and lateral bending motions; however, they do little to address compressive forces and their longevity is limited due to their inability to biointegrate. Therefore, a cell-based tissue engineering approach offers the most promising alternative to replace the degenerated IVD. Current treatment for injuries that penetrate subchondral bone include subchondral drilling, periosteal tissue grafting, osteochondral allografting, chondrogenic cell and transplantation; but are limited due to suboptimal integration with host tissues.
The present invention claims tissue engineered intervertebral discs comprising a nanofibrous polymer hydrogel amalgam having cells dispersed therein, methods of fabricating tissue engineered intervertebral discs by culturing a mixture of stem cells or intervertebral disc cells and a electrospun nanofibrous polymer hydrogel amalgam in a suitable bioreactor, and methods of treatment comprising implantation of tissue engineered intervertebral disc into a subject.
U.S. Provisional Application No. 60/847,839 filed 27 Sep 2006 (HHS Reference No. E-309-2006/0-US-01).
U.S. Provisional Application No. 60/848,284 filed 28 Sep 2006 (HHS Reference No. E-309-2006/1-US-01).
The device is small in size, and of conventional culture plate format.
Provides the ability to grow larger biologic samples than microfluidic systems, while utilizing smaller medium volumes than conventional bioreactors. The bioreactor culture chamber is adapted to contain sample volumes on a milliliter scale (10 [mu]L to 1 mL, with a preferred size of 100 [mu]L), significantly larger than chamber volumes in microfluidic systems (on the order of 1 [mu]L). Typical microfluidic systems are designed to culture cells and not larger tissue samples.
The integrated medium reservoirs and bioreactor chamber design provide for, (1) concentration of biofactors produced by the biologic sample, and (2) the use of smaller amounts of exogenous biofactor supplements in the culture medium. The local medium volume (within the vicinity of the sample) is less than twice the sample volume. The total medium volume utilized is small, preferably 2 ml, significantly smaller than conventional bioreactors (typically using 500-1000 mL).
Provides for real-time monitoring of sample growth and function in response to stimuli via an optical port and embedded sensors. The optical port provides for microscopy and spectroscopy measurements using transmitted, reflected, or emitted (e.g., fluorescent, chemiluminescent) light. The embedded sensors provide for measurement of culture fluid pressure and sample pH, oxygen tension, and temperature.
Capable of providing external stimulation to the biologic sample, including mechanical forces (e.g. fluid shear, hydrostatic pressure, matrix compression, microgravity via clinorotation), electrical fields (e.g., AC currents), and biofactors (e.g., growth factors, cytokines) while monitoring their effect in real-time via the embedded sensors, optical port, and medium sampling port.
Monitoring of biologic sample response to external stimulation can be performed non-invasively and non-destructively through the embedded sensors, optical port, and medium sampling port. Testing of tissue mechanical and electrical properties (e.g., stiffness, permeability, loss modulus via stress or creep test, electrical impedance) can be performed over time without removing the sample from the bioreactor device.
The bioreactor sample chamber can be constructed with multiple levels fed via separate perfusion circuits, facilitating the growth and production of multiphasic tissues.
U.S. Provisional Application No. 60/701,186 filed 20 Jul 2005 (HHS Reference No. E-042-2005/0-US-01).
PCT Application No. PCT/US2006/028417 filed 20 Jul 2006, which published as WO 2007/012071 on 25 Jan 2007 (HHS Reference No. E-042-2005/0-PCT-02).
National Institutes of Health, Public Health Service, HHS.
Notice.
These technologies relate to compositions and methods useful in treating autoimmune diseases generally, and Multiple Sclerosis specifically.
Scientists at the NIH have discovered a method for the treatment or prevention of autoimmune diseases, allergic or atopic disorders, and graft rejections. This method selectively induces apoptosis of disease causing T lymphocytes, while sparing the majority of T-cells. Cell death is achieved by the cyclical administration of disease specific antigens and IL-2.
Further, the NIH scientists have developed compositions and methods for clinical assessment, diagnosis and treatment of Multiple Sclerosis (MS). The compositions are molecules related to the human proteolipid protein (PLP), and the 21.5 kDA fetal isoform of human myelin basic protein (MBP), including nucleic acids and polypeptides. The polypeptides can be used to assay T-cells for responsiveness to MBP and PLP epitopes. They are further useful as therapeutic agents for treating MS by inducing T-cell apoptosis. The inventors have demonstrated that treatment with MP4, a protein chimera of MBP, and a modified form of PLP, termed PLP4, prevented clinical symptoms of MS in both rodent and non-human primates. They have also completed primate toxicity tests demonstrating the compounds are non-toxic.
Novel application of these methods described in these technologies include:
Infusion of autoimmune disease antigen peptides reduces the severity of allergic diseases.
Pre-immunization prior to engraftment with foreign tissues prolongs graft survival time.
With molecular identification of allergy-evoking antigens, it will be possible to immunize in cycle with IL-4 to induce apoptosis of T cells involved in allergic disorders.
It is envisioned that autoimmune diseases such as multiple sclerosis, rheumatic fever, lupus and others can be treated using IL-2 and the relevant peptide to cause apoptosis of the T cells responsible for the disease.
The fact that interleukin-2 and 4 participates in the death of a subpopulation of T lymphocytes cells capable of causing diseases while leaving the majority of T lymphocyte cells substantially unaffected enhances the therapeutic value of these inventions.
The use of a novel therapeutic agent, i.e., MP4, in the treatment of MS.
Autoimmune diseases result from a dysfunction of the immune system in which the body attacks its own organs, tissues and cells. More than 80 clinically distinct autoimmune diseases have been identified, including: type-1 diabetes (300,000-500,000 cases in the U.S.); systemic lupus erythematosus (240,000 cases in the U.S.); multiple sclerosis (250,000 to 350,000); rheumatoid arthritis (2.1 million cases in the U.S.); inflammatory bowel diseases, including both Crohn's disease and ulcerative colitis (800,000 in the U.S.); hemolytic anemia; Graves' disease; scleroderma; psoriasis (2% to 4% of the U.S. population); Sjörgen's syndrome, Immune Thrombocytopenic Purpura (ITP). Collectively, autoimmune diseases afflict 14-22 million Americans or 5% to 8% of the United States population.
Treatment of autoimmune diseases generally involves suppressing the immune system, and depending on the particular disease, different treatments are used. To demonstrate the diversity among these treatments consider the following: immunosuppressants such as azathioprine, chlorambucil, cyclophosphamide, cyclosporine or methostrexate are among the category of therapeutic agents employed in treating some autoimmune diseases. Corticosteroids such as prednisone are also used for both their immunosuppressive effect and anti-inflammatory activities. Tumor Necrosis Factor Antagonists, such as Etanercept and Infliximab are also used in treating some autoimmune disorders. Finally, Platelet transfusion and Plasmapheresis are used to treat a few autoimmune disorders.
MS is an autoimmune disease affecting the central nervous system, characterized by disseminated patches of demyelination in the brain and spinal cord, resulting in multiple and varied neurologic symptoms and signs, usually with remissions and exacerbations. The currently approved drugs for MS are different recombinant forms of interferons and are primarily used for the treatment of RRMS. Antegren, which blocks cellular adhesion, is currently in the pipeline and will be useful in treating SPMS patients.
There is a current theoretical patient population of approx 368,000 patients with MS in the U.S. and approx. 450,000 in Western Europe. Considering an estimated yearly growth rate of this market of 0.9%, this number will increase to approximately 390,000 by 2010 and approximately 400,000 by 2013 in the U.S. alone.
The total U.S. sales in 2003 for the top MS drugs, i.e., Rebif, Avonex, Betaseron, and Copaxone, was about $1.7 billion. However, within a six-month period, 6-10% of the patients have to discontinue interferon therapy. These patients are likely to switch to new therapies as they become available. Thus, this is the patient population that will benefit from the compositions discovered at the NIH, i.e., MP4 therapy.
This technology consists of the following patents and patent applications:
1. U.S. Patent No. 6,083,503, entitled “Interleukin-2 stimulated T lymphocyte cell death for the treatment of autoimmune diseases, allergic responses, and graft rejection” (E-137-1991/0-US-03);
2. U.S. Patent No. 5,989,546, entitled “Interleukin-2 stimulated T lymphocyte cell death for the treatment of allergic responses” (E-137-1991/0-US-04);
3. U.S. Patent No. 5,935,575, entitled “Interleukin-4 stimulated T lymphocyte cell death for the treatment of allergic disorders” (E-151-1992/0-US-11);
4. U.S. Patent Application No. 08/431,644 entitled “Modified Myelin Basic Protein Molecules” (E-033-1996/0-US-01); and
5. U.S. Patent Application No. 08/482,114 entitled “Modified Proteolipid Protein Molecules” (E-128-1996/1-US-01).
There will be a teleconference where the principal investigator will explain this technology. Licensing and collaborative research opportunities will also be discussed. If you are interested in participating in this teleconference please call or e-mail Mojdeh Bahar; (301) 435-2950;
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice is hereby given of a change in the meeting of the Training and Career Development Subcommittee, November 14, 2007, 9 a.m. to November 16, 2007, 5 p.m., Double Tree Hotel & Executive Meeting Center, 8120 Wisconsin Ave., Bethesda, MD 20814 which was published in the
The date of the meeting was changed to November 13-16, 2007. The meeting is closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C. as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Interagency Autism Coordinating Committee.
The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should inform the Contact Person listed below in advance of the meeting.
Any member of the public interested in presenting oral comments to the committee may notify the Contact Person listed on this notice at least 10 days in advance of the meeting. Interested individuals and representatives of organizations may submit a letter of intent, a brief description of the organization represented, and a short description of the oral presentation. Only one representative of an organization may be allowed to present oral comments and if accepted by the committee, presentations may be limited to five minutes. Both printed and electronic copies are requested for the record. In addition, any interested person may file written comments with the committee by forwarding their statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, all guests and vehicles are screened upon entry into the underground parking garage at the Ronald Reagan Building. Please allow extra time for this process.
A registration form and information about the meeting is available on this IACC Web site:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Office of the Secretary, Department of Homeland Security.
Notice of determination.
The Secretary of Homeland Security has determined, pursuant to law, that it is necessary to waive certain laws, regulations and other legal requirements in order to ensure the expeditious construction of physical barriers and roads in the vicinity of the international land border of the United States in Arizona.
This Notice is effective on October 26, 2007.
In section 102(a) of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996, Public Law 104-208, Div. C, 110 Stat. 3009-546, 3009-554 (Sept. 30, 1996) (IIRIRA) (8 U.S.C. 1103 note (2000)), Congress provided that the Attorney General shall take such actions as may be necessary to install additional physical barriers and roads (including the removal of obstacles to detection of illegal entrants) in the vicinity of the United States border to deter illegal crossings in areas of high illegal entry into the United States. Pursuant to sections 1511 and 1517 of the Homeland Security Act of 2002, Public Law 107-296, 116 Stat. 2135, 2309, 2311 (Nov. 25, 2002) (HSA) (6 U.S.C. 551, 557), the authorities of the Attorney General contained in section 102 of the IIRIRA were transferred to me. In section 102(c) of the IIRIRA, as amended by section 102 of the REAL ID Act of 2005, Public Law 109-13, Div. B, 119 Stat. 231, 302, 306 (May 11, 2005) (REAL ID Act) (8 U.S.C. 1103 note), Congress granted to me the authority to waive all legal requirements that I, in my sole discretion, determine necessary to ensure the expeditious construction of barriers and roads under section 102 of IIRIRA.
I determine that the area in the vicinity of the United States border from approximately 4.75 miles west of the Naco, Arizona Port of Entry to the western boundary of the San Pedro Riparian National Conservation Area (SPRNCA) in southeastern Arizona including the lands covered by the Temporary Restraining Order (TRO) signed by Judge Ellen S. Huvelle on October 10, 2007, in the case of
Transportation Security Administration; United States Coast Guard; DHS.
Notice.
The Department of Homeland Security (DHS) through the Transportation Security Administration (TSA) issues this notice of the dates for the beginning of the initial enrollment for the Transportation Worker Identification Credential (TWIC) for the Port of Corpus Christi, in Corpus Christi, TX.
TWIC enrollment in Corpus Christi, TX will begin on November 1, 2007.
You may view published documents and comments concerning the TWIC Final Rule, identified by the docket numbers of this notice, using any one of the following methods.
(1) Searching the Federal Docket Management System (FDMS) web page at
(2) Accessing the Government Printing Office's Web page at
(3) Visiting TSA's Security Regulations Web page at
James Orgill, TSA-19, Transportation Security Administration, 601 South 12th Street, Arlington, VA 22202-4220. Transportation Threat Assessment and Credentialing (TTAC), TWIC Program, (571) 227-4545 e-mail:
The Department of Homeland Security (DHS), through the United States Coast Guard and the Transportation Security Administration (TSA), issued a joint final rule (72 FR 3492; January 25, 2007) pursuant to the Maritime Transportation Security Act (MTSA), Pub. L. 107-295, 116 Stat. 2064 (November 25, 2002), and the Security and Accountability for Every Port Act of 2006 (SAFE Port Act), Pub. L. 109-347 (October 13, 2006). This rule requires all credentialed merchant mariners and individuals with unescorted access to secure areas of a regulated facility or vessel to obtain a TWIC. In this final rule, on page 3510, TSA and Coast Guard stated that a phased enrollment approach based upon risk assessment and cost/benefit would be used to implement the program nationwide, and that TSA would publish a notice in the
This notice provides the start date for TWIC initial enrollment at the Port of Corpus Christi, TX only. Enrollment in this port will begin on November 1, 2007. The Coast Guard will publish a separate notice in the
To obtain information on the pre-enrollment and enrollment process, and enrollment locations, visit TSA's TWIC Web site at
U.S. Customs and Border Protection, Department of Homeland Security (DHS).
Notice of Federal Advisory Committee meeting.
The Departmental Advisory Committee on Commercial Operations of U.S. Customs and Border Protection and Related Homeland Security Functions (popularly known as “COAC”) will meet on November 16, 2007 in Washington, DC. The meeting will be open to the public.
COAC will meet Friday, November 16th from 9 a.m. to 1 p.m. Please note that the meeting may close early if the committee has completed its business.
The meeting will be held at the Ronald Reagan Building in the Rotunda Ballroom, 1300 Pennsylvania Avenue, NW., Washington, DC 20004. Written material and comments should reach the contact person listed below by November 9th. Requests to have a copy of your material distributed to each member of the committee prior to the meeting should reach the contact person at the address below by November 9, 2007. Comments must be identified by USCBP-2007-0089 and may be submitted by one of the following methods:
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Ms. Wanda Tate, Office of International Affairs and Trade Relations, U.S. Customs and Border Protection, Department of Homeland Security, 1300 Pennsylvania Ave., NW., Room 8.5C, Washington, DC 20229;
Pursuant to the Federal Advisory Committee Act (5 U.S.C., app.), DHS hereby announces the meeting of the Departmental Advisory Committee on Commercial Operations of U.S. Customs and Border Protection and Related Homeland Security Functions (COAC). COAC is tasked with providing advice to the Secretary of Homeland Security, the Secretary of the Treasury, and the Commissioner of U.S. Customs and Border Protection (CBP) on matters pertaining to the commercial operations of CBP and related functions within DHS or the Department of the Treasury.
The fourth meeting of the tenth term of COAC will be held at the date, time and location specified above. A tentative agenda for the meeting is set forth below.
This meeting is open to the public. Please note that the meeting may close early if all business is finished.
Participation in COAC deliberations is limited to committee members, Department of Homeland Security officials, and persons invited to attend the meeting for special presentations.
All visitors to the Ronald Reagan building will have to go through a security checkpoint to be admitted to the building. Since seating is limited, all persons attending this meeting should provide notice, preferably by close of business Tuesday, November 13, 2007, to Ms. Wanda Tate, Office of Trade Relations, U.S. Customs and Border Protection, Department of Homeland Security, Washington, DC 20229, telephone 202-344-1440; facsimile 202-344-2064.
For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact Ms. Wanda Tate as soon as possible.
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice.
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless.
Kathy Ezzell, Department of Housing and Urban Development, 451 Seventh Street SW., Room 7262, Washington, DC 20410; telephone (202) 708-1234; TTY number for the hearing- and speech-impaired (202) 708-2565 (these telephone numbers are not toll-free), or call the toll-free Title V information line at 800-927-7588.
In accordance with 24 CFR part 581 and section 501 of the Stewart B. McKinney Homeless Assistance Act (42 U.S.C. 11411), as amended, HUD is publishing this Notice to identify Federal buildings and other real property that HUD has reviewed for suitability for use to assist the homeless. The properties were reviewed using information provided to HUD by Federal landholding agencies regarding unutilized and underutilized buildings and real property controlled by such agencies or by GSA regarding its inventory of excess or surplus Federal property. This Notice is also published in order to comply with the December 12, 1988 Court Order in
Properties reviewed are listed in this Notice according to the following categories: Suitable/available, suitable/unavailable, suitable/to be excess, and unsuitable. The properties listed in the three suitable categories have been reviewed by the landholding agencies, and each agency has transmitted to HUD: (1) Its intention to make the property available for use to assist the homeless, (2) its intention to declare the property excess to the agency's needs, or (3) a statement of the reasons that the property cannot be declared excess or made available for use as facilities to assist the homeless.
Properties listed as suitable/available will be available exclusively for homeless use for a period of 60 days from the date of this Notice. Where property is described as for “off-site use only” recipients of the property will be required to relocate the building to their own site at their own expense. Homeless assistance providers interested in any such property should send a written expression of interest to HHS, addressed to John Hicks, Division of Property Management, Program Support Center, HHS, Room 5B-17, 5600 Fishers Lane, Rockville, MD 20857; (301) 443-2265. (This is not a toll-free number.) HHS will mail to the interested provider an application packet, which will include instructions for completing the application. In order to maximize the opportunity to utilize a suitable property, providers should submit their written expressions of interest as soon as possible. For complete details concerning the processing of applications, the reader is encouraged to refer to the interim rule governing this program, 24 CFR part 581.
For properties listed as suitable/to be excess, that property may, if subsequently accepted as excess by GSA, be made available for use by the homeless in accordance with applicable law, subject to screening for other Federal use. At the appropriate time, HUD will publish the property in a Notice showing it as either suitable/available or suitable/unavailable.
For properties listed as suitable/unavailable, the landholding agency has decided that the property cannot be declared excess or made available for use to assist the homeless, and the property will not be available.
Properties listed as unsuitable will not be made available for any other purpose for 20 days from the date of this Notice. Homeless assistance providers interested in a review by HUD of the determination of unsuitability should call the toll free information line at 1-800-927-7588 for detailed instructions or write a letter to Mark Johnston at the address listed at the beginning of this Notice. Included in the request for review should be the property address (including zip code), the date of publication in the
For more information regarding particular properties identified in this Notice (
U.S. Geological Survey (USGS), Interior.
Notice of an extension of an information collection (1028-0056).
To comply with the Paperwork Reduction Act of 1995 (PRA), we are notifying the pubic that we have submitted to OMB an information collection request (ICR) to renew approval of the paperwork requirements for “North American Reporting Center for Amphibian Malformations (NARCAM) Voluntary Observation Submission Form.” This notice also provides the public a second opportunity to comment on the paperwork burden of this form. The form is available online at
Submit written comments by November 26, 2007.
Please submit comments on this information collection directly to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs, Attention: Desk Office for the Department of the Interior via OMB e-mail: (
Please also submit a copy of your comments to the Department of the Interior, USGS, via:
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• Mail or hand-carry comments to the Department of the Interior; USGS Clearance Officer, U.S. Geological Survey, 807 National Center, Reston, VA 20192. Please reference Information Collection 1028-0056 in your comments.
Lisa Zolly at (703) 648-4277. Copies of the full Information Collection Request and the forms can be obtained at no cost at
We will protect information considered proprietary under the Freedom of Information Act (5 U.S.C. 552) and its implementing regulations (43 CFR part 2), and under regulations at 30 CFR 250.197, “Data and information to be made available to the public or for limited inspection.” Responses are voluntary. No questions of a “sensitive” nature are asked. We intend to release data collected on the NARCAM online form only in a format that is not reporter-specific; no information that would identify an individual reporter will be released to the public.
To comply with the public consultation process, on August 22, 2007, we published a
Bureau of Land Management, Interior.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, the Bureau of Land Management (BLM) has submitted a request for an extension of an approved information collection to the Office of Management and Budget (OMB) for approval.
The OMB is required to respond to this request within 60 days but may respond after 30 days. Submit your comments to OMB at the address below by November 26, 2007 to receive maximum consideration.
Send comments to the OMB, Interior Department Desk Officer (1004-0168), at OMB-OIRA via e-mail
You may contact Ted Hudson to obtain copies and explanatory material on this information collection at (202) 452-5042. Persons who use a telecommunication device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) on 1-800-877-8330, 24 hours a day, seven days a week, to contact Mr. Hudson.
On June 9, 2006, the BLM published a notice in the
We are soliciting comments on the following:
(a) Whether the collection of information is necessary for the proper functioning of the agency, including whether the information will have practical utility;
(b) The accuracy of our estimates of the information collection burden, including the validity of the methodology and assumptions we use;
(c) Ways to enhance the quality, utility, and clarity of the information collected; and
(d) Ways to minimize the information collection burden on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
(1) Act of August 28, 1937 (43 U.S.C. 1181a & b); and
(2) The Federal Land Policy and Management Act of 1976 (43 U.S.C. 1762).
The BLM uses this information to approve use of BLM roads for access to timber on the O. and C. lands, and to determine the amount of charges for such use.
Bureau of Land Management, Interior.
Notice of availability.
In accordance with the National Environmental Policy Act of 1969 (NEPA, 42 U.S.C. 4321
A 90-day public comment period will begin the date the Environmental Protection Agency publishes their Notice of Availability in the
The DRMP/DEIS will be posted on the Internet at:
Web site:
Comments, including names and addresses of respondents, will be available for public review at the Anasazi Heritage Center, 27501 Hwy 184, Dolores, CO 81323. Before including your address, phone number, e-mail address, or other personal identifying information in your comment, be advised that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold from public review your personal identifying information, we cannot guarantee that we will be able to do so. Copies of the DRMP/DEIS are also available during regular business hours at the following locations:
Heather Musclow, Monument Planner, Canyons of the Ancients National Monument, 27501 Highway 184, Dolores, CO 81323; Phone: (970) 882-5632.
To have your name added to the Canyons of the Ancients Resource Management Plan mailing list or to view and download the DRMP/DEIS in portable document format (PDF) go to the project Web site:
The planning area is located in Southwest Colorado in Dolores and Montezuma counties. The plan will provide a framework to guide subsequent management decisions on approximately 164,000 acres managed by the BLM. Within the Monument boundary, there are approximately 400 acres of National Park Service lands (Hovenweep National Monument) and 18,000 acres of private inholdings. The Canyons of the Ancients National Monument is currently being managing under the BLM 1985 San Juan/San Miguel RMP and the Interim Guidance provided after the Monument was established.
• San Juan/San Miguel Resource Management Plan.
The current RMP was approved in 1985 and has been amended five times. The Wilderness Study Areas (WSA) within the Monument are being managed under interim guidance provided by the Interim Management Policy and Guidance for Lands under Wilderness Review until such time that Congress makes a final wilderness decision. The DRMP/DEIS discusses how those lands would be managed if Congress released them from wilderness study.
The Canyons of the Ancients National Monument has worked extensively with the community, interested and affected publics, Native American tribes, and cooperating agencies in the development of the DRMP/DEIS. The Monument has conducted a broad community-based public input process. Cooperating agencies include The Colorado State Historical Society and the United States Fish and Wildlife Service. Five alternatives are analyzed in the DRMP/DEIS.
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Section 202(c)(3) of FLPMA requires the DRMP/DEIS to examine the designation of Areas of Critical Environmental Concern (ACEC) on BLM lands. The Monument was an Anasazi ACEC prior to being designated a Monument. The ACEC designation has continued but is considered of little value since the Monument designation provides protection of the same outstanding characteristics. Therefore, the Anasazi ACEC designation is proposed to be dropped in this plan. The Values and Limitations to protect the natural and cultural resources of the Monument are consistent with the previous ACEC. The McElmo Research Natural Area (RNA) would continue its ACEC designation with four units proposed located immediately north of, and adjacent to, McElmo Canyon:
• McElmo Unit (existing RNA, 427 acres),
• McElmo Expansion Unit (2,738 acres),
• Cannonball Mesa Unit (2,797 acres), and
• Sand Canyon Unit (1,864 acres).
All of the RNA units have the same values and use limitations.
Potential ACEC acres vary by alternative as shown in the table below.
Major issues considered in the DRMP/DEIS include:
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Bureau of Land Management, Interior.
Notice of availability.
In accordance with the National Environmental Policy Act of 1969 (NEPA, 42 U.S.C. 4321
To ensure that they will be considered, BLM must receive written comments on the DRMP/DEIS within 90 days following the date the Environmental Protection Agency publishes its notice of availability in the
Address written comments to: RMP Comments, Richfield Field Office, Bureau of Land Management (BLM), 150 East 900 North, Richfield, Utah 84701. Comments may also be faxed to the Field Office at 435-896-1550, or submitted electronically by e-mail:
For further information, or to have your name added to the Richfield RMP mailing list, visit the RMP Web site:
The DRMP/DEIS addresses public lands and resources managed by the Richfield Field Office in Garfield, Piute, Sanpete, Sevier, and Wayne Counties, Utah. These lands and resources are currently managed under six old land use plans: Cedar-Beaver-Garfield-Antimony RMP (1986), Forest Management Framework Plan (MFP) (1982), Henry Mountains MFP (1982), Mountain Valley MFP (1981), Parker Mountain MFP (1983), and San Rafael RMP (1991). The planning area includes approximately 2.1 million acres of BLM-administered surface lands and additional Federally-owned minerals under Federal, state, and private lands in the area. Decisions in the Richfield RMP will only apply to BLM-administered public lands and Federally-owned minerals. The DRMP/DEIS proposes and analyzes five alternatives for future management of the public lands and resources in the planning area. Alternative B is BLM's proposed action and the preferred alternative. Major issues considered in the DRMP/DEIS include oil and gas leasing, mining, range and livestock management, access and transportation, recreation and off-highway vehicle management, special status species, special designations (including Areas of Critical Environmental Concern [ACECs] and wild and scenic rivers), and lands with wilderness characteristics, among others. When completed, the new RMP will replace management decisions in the existing land use plans. As required by law, the DRMP/DEIS considers the designation and protection of ACECs. ACEC values and resource use limitations vary by ACEC, and the ACECs themselves vary by alternative. See table below.
The application of the Federal coal unsuitability criteria to the Henry Mountains and Emery Coal Fields is included in Appendix 8 of the DRMP/DEIS. As required by 43 CFR 3461.2-1(a)(2), the public is invited to comment on the results of the application of the criteria and the application process used. The criteria are listed under 43 CFR 3461.5. Additionally, the BLM will conduct a public hearing on coal leasing potential in the DRMP/DEIS before it is finalized, if such a hearing is requested by any person who may be adversely affected by adoption of the proposed plan.
DOI Bureau of Land Management (BLM), Lead Agency; USDA Forest Service (FS), Co-lead Agency; and the State of Idaho, Idaho Department of Environmental Quality, Cooperating Agency.
Notice of Availability of the Final Environmental Impact Statement for the Smoky Canyon Mine, Panels F and G Mine Expansion Project.
In accordance with the National Environmental Policy Act of 1969 (NEPA, 42 U.S.C. 4321
The FEIS is now available for public review. The BLM Record of Decision will be released no sooner than 30 days after publication of a Notice of Availability of the FEIS in the
Copies of the FEIS have been sent to affected Federal, State, and local Government agencies and to interested parties. The FEIS will be available in limited quantities at the Bureau of Land Management, Pocatello Field Office, 4350 Cliffs Drive, Pocatello, Idaho 83204, phone (208) 478-6340 and the Caribou-Targhee National Forest, Soda Springs Ranger District, 410 E. Hooper Avenue, Soda Springs, Idaho 83276, phone (208) 547-4356. It will also be available on the BLM Web site at:
Bill Stout, Bureau of Land Management, phone (208) 478-6340; or Jeff Jones, Caribou-Targhee National Forest, phone (208) 236-7572.
The FEIS was prepared to provide decision makers and the public with a complete and objective evaluation of significant environmental impacts, beneficial and adverse, resulting from the proposed action and from all reasonable alternatives.
The proposed extension of on-going mining operations, into Panels F and G, lies within the Caribou-Targhee National Forest in Southeast Idaho, on lands administered by the FS associated with two Federal phosphate leases held by the J.R. Simplot Company (the lessee, hereinafter referred to as the proponent) and are administered by the BLM under authority of the Mineral Leasing Act of 1920. Mining, to recover phosphate ore, and reclamation would take place over an estimated 16-year period. The environmental impacts of the proponent's Proposed Action, six mining alternatives, one no-mining alternative, and eight transportation alternatives are analyzed in the FEIS.
The BLM Idaho State Director, or delegated official, will consult with the Caribou-Targhee National Forest Supervisor regarding surface management and mitigation on leased lands within the Caribou-Targhee National Forest and will make a decision regarding approval of the proposed Mine & Reclamation Plan and several proposed lease modifications. The FS will also make a decision whether to authorize off-lease facilities such as roads and power lines.
The proposed Mine & Reclamation Plan was submitted by the proponent in April 2003. The plan consists of the development of two open mine pits (Panel F, to be located on Federal Phosphate Lease I-27512, and Panel G,
The proposed Panel F pit would extend off of the existing lease. The proponent has applied for a lease modification to enlarge Federal Phosphate Lease I-27512 to accommodate those operations. The application includes two tracts, the North Lease Modification and the South Lease Modification, both for the purpose of ore recovery. Subsequent to preparation of the DEIS, the proponent has also applied for a lease modification to Federal Phosphate Lease I-01441 to accommodate 18 acres of off-lease external overburden fill at Panel G. The environmental impacts of mining off of the existing leases, within the lease modification areas, are analyzed in the FEIS.
Many of these proposed activities would occur within Forest Service Inventoried Roadless Areas. Inventoried Roadless Areas are managed according to local land use plans and Forest Service roadless management regulations, such as the Roadless Area Conservation Rule (RACR). The Agency Preferred Alternative identified in the FEIS may be modified in the Record of Decision to comply with laws and regulations applicable at that time.
The agency Preferred Alternative would approve mining both leases described as Panel F and Panel G. To accommodate the proposed off-lease mining, BLM would approve the lease modifications to I-27512 (Panel F). As described in Mining Alternative D, BLM would require construction of a Store and Release cover system to reduce the infiltration of water through seleniferous backfill and external seleniferous overburden fills. The FS would require power line placement on poles along the haul road corridor, as described in Mining Alternative E. The transportation route between Panel F and the existing mine would be constructed according to the Proposed Action. The agency Preferred Transportation Alternative to access Panel G is the Proposed Action, Panel G West Haul/Access Road. The environmentally preferable transportation alternative would be Alternative 2, the East Haul/Access Road. The Alternative 2 road alignment crosses a portion of private land. Implementation of this alternative is contingent upon the proponent's ability to secure an easement across the private land. Access to Panel G is not required for several years. During that time, if Simplot and the private land holder were to come to a mutual agreement that would provide Simplot an easement, the East Haul/Access Road would replace the Panel G West Haul/Access Road.
Issues were identified for the proposed mining of Panels F and G by the agencies and by the public during the scoping process. They include potential effects on: ground water, surface water, geology and minerals, air quality and noise, soils, vegetation, wetlands, wildlife, fisheries and aquatic life, livestock grazing, recreation, Inventoried Roadless Areas, socio-economics, visual resources, cultural resources, and Tribal Treaty Resources. Alternatives to the proposed action were developed to address these issues.
Mining alternatives include mining without one or both lease modifications to Panel F, no external seleniferous overburden fills, no external overburden fills at all, construction of an infiltration-reducing cover over seleniferous material, constructing the power line only within proposed disturbance, and using generators in Panel G instead of a power line. The transportation alternatives include one variation on the haul road between Panel F and the existing mine, two variations of a haul road from Panel G located east of the project area, a more direct haul road from Panel G to Panel F, a variation of the proposed West Haul Road, and using a conveyor system to transport ore from Panel G to the existing mill. Two variations of the conveyor alternative are assessed with alternate routes for moving personnel and equipment between Panel G and the existing mine.
Bureau of Land Management, Interior.
Notice of public meeting.
The Powder River Regional Coal Team (RCT) has scheduled a public meeting for December 6, 2007, to review current and proposed activities in the Powder River Coal Region and to review pending coal lease applications (LBA).
The RCT meeting will begin at 9 a.m. MST on December 6, 2007. The meeting is open to the public.
The meeting will be held at the Wyoming Oil and Gas Conservation Commission, 2211 King Boulevard, Casper, Wyoming.
Robert Janssen, Regional Coal Coordinator, BLM Wyoming State Office, Division of Minerals and Lands, 5353 Yellowstone Road, Cheyenne, Wyoming 82009: telephone 307-775-6206 or Rebecca Spurgin, Regional Coal Coordinator, BLM Montana State Office, Division of Resources, 5001 Southgate Drive, Billings, Montana 59101: telephone 406-896-5080.
The purpose of the meeting is to discuss pending coal lease by applications (LBA's) in the Powder River Basin as well as other Federal coal related actions in the region. Specific coal lease applications and other matters for the RCT to consider include:
1. The Porcupine LBA, a lease application filed by BTU Western Resources on September 27, 2006, which is adjacent to the North Antelope-Rochelle mine. This application was reviewed by the RCT at a public meeting on January 18, 2007. At that time, approximately 5,116 acres and 598 million tons of Federal coal were included in the application. The applicant now wishes to amend this application. More details will be presented at the meeting. The RCT needs to consider the BLM processing schedule for the Porcupine LBA.
2. The BLM is doing a coal review study in the Powder River Basin. The results of this study will be used in the preparation of coal related NEPA documents in the Powder River coal region. The RCT will be updated on the progress and results of this study.
3. Update on U.S. Geological Survey coal inventory work.
4. Update on BLM land use planning efforts in the Powder River Basin of Wyoming and Montana.
5. Other Coal Lease Applications and issues that may arise prior to the meeting.
The RCT may generate recommendation(s) for any or all of these topics and other topics that may arise prior to the meeting date.
The meeting will serve as a forum for public discussion on Federal coal management issues of concern in the Powder River Basin region. Any party interested in providing comments or data related to the above pending applications, or any party proposing other issues to be considered by the RCT, may either do so in writing to the State Director (922), BLM Wyoming State Office, 5353 Yellowstone Road, Cheyenne, WY 82009, no later than November 21, 2007, or by addressing the RCT with his/her concerns at the meeting on December 6, 2007.
The draft agenda for the meeting follows:
1. Introduction of RCT Members and guests.
2. Approval of the Minutes of the January 18, 2007 Regional Coal Team meeting held in Casper, Wyoming.
3. Coal activity since the last RCT meeting.
4. Industry Presentations on Lease Applications: BTU Western Resources, Modification of the Porcupine LBA.
5. BLM presentation on Powder River Basin coal review study.
6. U.S. Geological Survey presentation on Coal Inventory.
7. BLM land use planning efforts.
8. Other pending coal actions and other discussion items that may arise.
9. Discussion of the next meeting.
10. Adjourn.
Pursuant to § 102(2)(C) of the National Environmental Policy Act of 1969 (Pub. L. 91-190, as amended), and the Council on Environmental Quality Regulations (40 CFR part 1500-1508), the National Park Service, Department of the Interior, has prepared a Draft Comprehensive Management Plan and programmatic Environmental Impact Statement identifying and evaluating two alternatives to current administration and management of the Ala Kahakai National Historic Trail. These alternatives respond to the National Trails System Act (16 U.S.C. 1241-1251), NPS planning requirements, and the issues identified during public scoping. They address trail administration and management, cultural and natural resource protection, and use of the trail by local residents, Native Hawaiians, and the visiting public.
When approved, the comprehensive management plan will guide, for approximately 15 years, the National Park Service in administering, preserving, protecting, developing, managing, and maintaining the 175-mile trail which includes portions of the ancient and historic ala loa (long trail; coastal trail around the island). The EIS compares baseline conditions of a “no action” alternative with potential impacts and two “action” alternatives and, where appropriate, suggests mitigation measures to reduce the intensity of the potential effect or to avoid the potential effect. Three other preliminary alternatives were considered but rejected because they did not achieve the objectives of the plan or were infeasible. An “environmentally preferred” alternative is also identified.
The purposes of the Ala Kahakai NHT, derived from the legislative history, the Feasibility Study, and the public scoping phase completed in 2003, are to:
• Preserve, protect, reestablish as necessary, and maintain a substantial portion of the ancient ala loa and associated resources and values, along with linking trails on or parallel to the shoreline on Hawaii Island, and
• Provide for a high quality experience, enjoyment, and education (guided by Native Hawaiian protocol and etiquette) while protecting the trail's natural and cultural heritage and respecting private and community interest.
Federal ownership of the Ala Kahakai NHT is limited to the trail alignment within the four national parks it links: Pu'ukohola Heiau National Historic Site, Kaloko-Honokohau National Historical Park (NHP), Pu'uhonua o Honaunau NHP, and Hawaii Volcanoes National Park. Approximately 17% of the NHT is within the boundaries of these national parks. With trail authorization, these trail segments become federally protected components of the NHT, in compliance with § 3(a)(3) of the National Trails System Act.
The National Trails System Act, as amended, requires the preparation of a comprehensive management plan (CMP) for each new trail in the system. The CMP is intended to provide direction for natural and cultural resource preservation, education, and trail user experience of the Ala Kahakai NHT over the next 15 years. It considers the trail in its entirety. It identifies the necessity of community partnerships to protect trail resources and provide appropriate trail user services. As a partnership endeavor, the success of this plan is not solely determined by the NPS; rather its success rests with the will and preservation of other local government agencies, communities, organizations, neighborhood associations, and individuals who have the capacity and desire to implement actions within this plan.
Between July 2003 and March 2004, the planning team developed five preliminary alternatives for future management based on information gained from the scoping process: No Action, Single Ala Kahakai Trail alternative, Ahupua'a Trail Systems alternative, Historic Trail Clusters alternative, and Public Lands alternative. The NPS provided a booklet to the public describing these alternatives and inviting comment. In addition, the NPS conducted nine public meetings between April 17 and June 19, 2004, to gather comments on the alternatives. The comment period for the draft alternatives closed on June 25, 2004. Subsequently the planning team prepared a draft alternatives document that eliminated alternative E because it was favored in public meetings only as a step to completing the entire trail. Eventually, alternative D was eliminated for the same reason.
In December 2006, to ensure that issues were properly stated and addressed, an internal review draft of this document was sent to the four national parks on Hawaii Island, other National Park Service reviewers, and reviewers in Hawaii who have been involved in the study process and have knowledge of the Ala Kahakai NHT. These reviewers' comments were incorporated into the public review draft.
Written comments on the Draft EIS/CMP should be addressed to Superintendent, Ala Kahakai NHT, 73-4786 Kanalani Street, #14, Kailua-Kona, HI 96740. Questions at this time regarding the comprehensive management plan and EIS planning process or inquiries about public meetings should be addressed to the superintendent either by mail or by telephone at (805) 326-6012. The document will be sent directly to those who have requested it, and will also be available at the park headquarters and local libraries, or electronically at
National Park Service, Department of the Interior.
Notice of Availability of the Record of Decision for the Final General Management Plan/Environmental Impact Statement, Flight 93 National Memorial.
Pursuant to Sec. 102(2)(C) of the National Environmental Policy Act of 1969, Pub. L. 91-190, 83 Stat. 852, 853, codified as amended at 42 U.S.C. 4332(2)(C), the National Park Service announces the availability of the Record of Decision for the Final General Management Plan and Environmental Impact Statement (Final GMP/EIS) for the Flight 93 National Memorial in Pennsylvania. On July 23, 2007, the Regional Director, Northeast Region, approved the Record of Decision for the project, selecting Alternative 2—Preferred Design Alternative, which was described on pages II-14 to II-23 of the Final GMP/EIS and announced to the public in a Notice of Availability published in the
The selected alternative and one other alternative, Alternative 1—No Action, were analyzed in the Draft and Final Environmental Impact Statements. Each alternative was evaluated as to how it would guide the development and future management of the national memorial over the next 15 to 20 years with regard to the following issues: (1) The types of management actions required for the development, protection and preservation of park resources; (2) The types and general intensities of development (including the memorial features, visitor facilities, transportation and access requirements) associated with the public enjoyment and use of the area, including general locations, timing of implementation and anticipated costs; (3) Visitor carrying capacities and implementation commitments for major aspects of the memorial; and (4) Potential modifications to the external boundaries of the park, if any, and the reasons for the proposed changes. The full range of foreseeable environmental consequences was assessed and disclosed for historic and cultural resources, natural resources, land use, transportation, socioeconomic impacts, visual and aesthetic impacts, energy requirements, and public health and safety.
The NPS has selected Alternative 2 because it best fulfills the goals of the Flight 93 National Memorial's Missions Statement, as well as the purpose and intent of the Flight 93 National Memorial Act. The selected alternative commemorates the actions of the passengers and crew by creating a designed memorial landscape, which blends with the contour of the land and enhances the physical features of the site. It protects the final resting places of the passengers and crew and places special attention on providing an appropriate setting for the memorial. A new visitor facility will provide for interpretive exhibits, public education and outreach, and visitor services. The public will have a broader range of opportunities to learn about the deeds of the passengers and crew members and the events that occurred on September 11, 2001. The selected alternative also provides a venue for visitors to get closer to the crash site while removing parking and other visitor support facilities from the views around the crash site. Under the selected alternative, visitor traffic will be contained within the site and removed from the neighboring villages to create safer roadway conditions and significantly improve conditions for residents living along these routes. The selected alternative will not result in the impairment of resources and values. The construction costs to build the memorial features and the related infrastructure would be shared through a partnership involving the public, the Commonwealth of Pennsylvania, and the federal government.
The Record of Decision includes a statement of the decision made, synopses of other alternatives considered, the basis for the decision, a finding of no impairment of park resources and values, and an overview of public involvement in the decision-making process. This decision is the result of a public planning process that began with publication of a Notice of Intent in the
The Record of Decision for the Final GMP/EIS for the Flight 93 National Memorial is available online at
Joanne Hanley, Superintendent, National Parks of Western Pennsylvania, National Park Service, 109 W. Main St., Suite 104, Somerset, PA 15501, phone (814) 443-4557,
The
On January 14, 2005, the Secretary of the Interior approved a boundary recommendation for the memorial presented by the Flight 93 Advisory commission. The details of the boundary were published in the
Four partner organizations (the Partners) participated in the planning of a permanent memorial for Flight 93: (1) The Flight 93 Advisory Commission, (2) the Families of Flight 93, a nonprofit organization, (3) the Flight 93 Memorial Task Force, and (4) the National Park Service, the Federal agency responsible for compliance with the National Environmental Policy Act of 1969 (Pub. L. 91-190, as amended). On September 11, 2004, the Partners opened a two-stage international design competition to solicit a broad range of concepts for the design of the new memorial. During Stage 1 of the competition, five top designs were selected by a jury of professionals, family members and local leaders after extensive public exhibit of the designs. A Stage 2 design jury selected the final design that best achieved the mission of the new memorial. The selected design was announced to the public on September 7, 2005, and is the basis of the preferred alternative in the Draft and Final GMP/EIS. After public announcement of the final design, the National Park Service received comments criticizing the design's principal landscape feature, a curved allée or pathway lined with red maple trees, comparing it to an Islamic crescent symbol. The design was refined and again presented to the public in November 2005. The design refinements were generally well-received by the public; however, a sector of the public continued to assert that the design contained Islamic symbolism. In response, the partners met with religious scholars, design professionals, and other family members and toured the site with the principal critic of the design. At the conclusion of these activities and consultations, it was determined that the perceptions of religious symbolism in the design had been adequately addressed by the architect and that the details of the design do not affect the Final GMP/EIS. The NPS, along with the other Partners, were satisfied that the design properly honors the passengers and crew and that the refinements showed the architects' sensitivity and responsiveness to public comments.
National Park Service, U.S. Department of the Interior.
Notice.
Notice is hereby given in accordance with the Federal Advisory Committee Act (5 U.S.C. Appendix (1988)), that the Preservation Technology and Training Board (Board) of the National Center for Preservation Technology and Training (NCPTT), National Park Service will meet on Friday and Saturday, November, 2-3, 2007, in San Juan, Puerto Rico.
The Board was established by Congress to provide leadership, policy advice, and professional oversight to the National Park Service's NCPTT in compliance with Section 404 of the National Historic Preservation Act of 1966, as amended, (16 U.S.C. 470x-2(e)).
The meeting will run from 9 a.m. to 5 p.m. on November 2 and from 9 a.m. to 12 p.m. on November 3.
The Board's meeting agenda will include: review and comment on NCPTT FY2007 accomplishments and operational priorities for FY2008; FY2007 and FY2008 NCPTT budget and initiatives; proposed Wingspread Conference on Sustainability in Preservation; revitalization of the Friends group, and Board workgroup reports.
The Board meeting is open to the public. Facilities and space for accommodating members of the public are limited, however, and persons will be accommodated on a first come, first served basis. Any member of the public may file a written statement concerning any of the matters to be discussed by the Board.
Minutes of the meeting will be available for public inspection no later than 90 days after the meeting at the office of the Executive Director, National Center for Preservation Technology and Training, National Park Service, U.S. Department of the Interior, 645 University Parkway, Natchitoches, LA 71457—telephone (318) 356-7444.
An exceptional set of circumstances in the approval and transmission of this notice has resulted in the publication of the notice less than 15 days before the date of the meeting. The National Park Service has made extraordinary efforts to provide notification to all Board members and to the public. The meeting is being co-located with the Association for Preservation Technology (APT) meeting, and it would cause an undue burden on the Board members to reschedule the meeting.
Mr. Kirk A. Cordell, Executive Director, National Center for Preservation Technology and Training, National Park Service, U.S. Department of the Interior, 645 University Parkway, Natchitoches, LA 71457—telephone (318) 356-7444. In addition to U.S. Mail or commercial delivery, written comments may be sent by fax to Mr. Cordell at (318) 356-9119.
National Park Service, Interior.
Proposed exchange of federally-owned lands for privately-owned lands in Lake Clark National Park and Preserve. The federally-owned lands are located in the Kenai Peninsula Borough, Alaska. The private lands are located in the Lake and Peninsula Borough, Alaska.
We must receive written comments on the proposed exchange by December 10, 2007.
Detailed information concerning this exchange is available from the Superintendent, Lake Clark National Park and Preserve, 240 W. 5th Avenue, Anchorage, Alaska 99501.
The following described federally-owned land has been determined to be suitable for disposal by exchange. The authority for this exchange is section 1302(h) of the Alaska National Interest Lands Conservation Act (ANILCA) of December 2, 1980, 16 U.S.C. 3192(h). The federal land which is proposed for disposal is within the boundary of the Lake Clark National Park and Preserve. It is located approximately 2 miles southwesterly of the mouth of Silver Salmon Creek and contains approximately 4.55 acres. The land has been surveyed for cultural resources and endangered and threatened species. These reports are available upon request from the Superintendent, Lake Clark National Park and Preserve at the address set forth above. Title to the above land will be conveyed in fee simple with covenants and restrictions that prohibit for-profit selling of services, industrial uses and commercial development. The covenants also limit development and occupancy of the parcel and require that future development be visually compatible with surrounding park and preserve lands. Conveyance of the land by the United States will be done by patent.
In exchange for the land identified above the United States of America will acquire U.S. Survey 8481, Alaska, a 79.98-acre parcel on the southern shore of Lake Clark at Sucker Bay, approximately 16.5 miles southwesterly of the village of Port Alsworth, and approximately 7.5 miles northwesterly of Nondalton in fee simple with no reservations. The value of the properties exchanged shall be determined by a current fair market value appraisal. If the appraised value of the Sucker Bay parcel is greater than the appraised value of the Silver Salmon Creek parcel, the parties will complete the exchange, subject to approval of title to the Sucker Bay parcel by the Department of the Interior, Regional Solicitor. An environmental assessment of the proposed action was completed in January 2007 and a Finding of No Significant Impact approved on March 26, 2007.
For a period of 45 calendar days from the date of this notice, interested parties may submit comments to the above address. Comments will be evaluated and this action may be modified or vacated accordingly. In the absence of any action to modify or vacate, this realty action will become the final determination of the Department of the Interior.
Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Bureau of Reclamation, Interior.
Notice of a public meeting and announcement of subsequent meetings to be held.
The Bureau of Reclamation is holding a meeting to inform the public about the
November 7, 2007, 1:30 p.m. to 6 p.m.
Hyatt Regency Albuquerque, 330 Tijeras, Albuquerque, New Mexico, 87102.
Debbie Byers at (303) 445-2790.
The
Although you may register the day of the workshop beginning at 12 p.m., we highly encourage you to register prior to the date of the meeting online at
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) (Order No. 9) issued by the presiding administrative law judge (“ALJ”) granting complainants” motion to substitute parties in the above-captioned investigation.
Eric Frahm, Office of the General Counsel, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone (202) 205-3107. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at
The Commission instituted this investigation on April 27, 2007, based on a complaint filed by InterDigital Communications Corp. of King of Prussia, Pennsylvania and InterDigital Technology Corp. of Wilmington, Delaware (collectively, “InterDigital”). 72 FR. 21049 (April 27, 2007). The complaint, as amended and supplemented, alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain 3G wideband code division multiple access (WCDMA) handsets and components thereof by reason of infringement of claims 1, 2, 7-10, 14, 15, 21, 22, 24, 30-32, 34, 35, 46, 47, 49, 59, and 60 of U.S. Patent No. 7,117,004; claims 7 and 10 of U.S. Patent No. 6,674,791; claims 1-4 of U.S. Patent No. 6,693,579; and claims 1, 3, and 6-12 of U.S. Patent No. 7,190,966. The complaint further alleges the existence of a domestic industry as required by section 337(a)(2). The notice of investigation named Samsung Electronics Co., Ltd. of Seoul, Korea; Samsung Electronics America, Inc. of Ridgefield Park, New Jersey; and Samsung Telecommunications America LLC of Richardson, Texas (collectively, “Samsung”) as respondents.
On September 12, 2007, InterDigital filed a motion to substitute parties. Specifically, InterDigital moved to substitute one of the co-complainants, InterDigital Communications Corporation, with InterDigital Communications, LLC. InterDigital stated in its motion that the substitution will not substantively affect the investigation, and the Commission investigative attorney made no objection. Likewise, Samsung made no objection, subject to certain conditions.
On September 27, 2007, the ALJ granted InterDigital's motion to substitute parties, without conditions. No petitions for review were filed. The Commission has determined not to review the ALJ's ID.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in section 210.42 of the Commission's Rules of Practice and Procedure (19 CFR 210.42).
By order of the Commission.
The Department of Labor (DOL) hereby announces the submission of the following public information collection requests (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35). A copy of each ICR, with applicable supporting documentation; including among other things a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained from the RegInfo.gov Web site at
Interested parties are encouraged to send comments to the Office of Information and Regulatory Affairs, Attn: John Kraemer, OMB Desk Officer for the Occupational Safety and Health Administration (OSHA), Office of Management and Budget, Room 10235, Washington, DC 20503, Telephone: 202-395-7316 / Fax: 202-395-6974 (these are not toll-free numbers), E-mail:
The OMB is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
The Department of Labor (DOL) hereby announces the submission the following public information collection requests (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35). A copy of each ICR, with applicable supporting documentation; including among other things a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained from the RegInfo.gov Web site at
Interested parties are encouraged to send comments to the Office of Information and Regulatory Affairs, Attn: Carolyn Lovett, OMB Desk Officer for the Employment Standards Administration (ESA), Office of Management and Budget, Room 10235, Washington, DC 20503, Telephone: 202-395-7316/Fax: 202-395-6974 (these are not toll-free numbers), E-mail:
The OMB is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Employee Benefits Security Administration, Labor.
Notice of proposed exemptions.
This document contains notices of pendency before the Department of Labor (the Department) of proposed exemptions from certain of the prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974 (ERISA or the Act) and/or the Internal Revenue Code of 1986 (the Code).
All interested persons are invited to submit written comments or requests for a hearing on the pending exemptions, unless otherwise stated in the Notice of Proposed Exemption, within 45 days from the date of publication of this
All written comments and requests for a hearing (at least three copies) should be sent to the Employee Benefits Security Administration (EBSA), Office of Exemption Determinations, Room N-5700, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210.
Notice of the proposed exemptions will be provided to all interested persons in the manner agreed upon by the applicant and the Department within 15 days of the date of publication in the
The proposed exemptions were requested in applications filed pursuant to section 408(a) of the Act and/or section 4975(c)(2) of the Code, and in accordance with procedures set forth in 29 CFR Part 2570, Subpart B (55 FR 32836, 32847, August 10, 1990). Effective December 31, 1978, section 102 of Reorganization Plan No. 4 of 1978, 5 U.S.C. App. 1 (1996), transferred the authority of the Secretary of the Treasury to issue exemptions of the type requested to the Secretary of Labor. Therefore, these notices of proposed exemption are issued solely by the Department.
The applications contain representations with regard to the proposed exemptions which are summarized below. Interested persons are referred to the applications on file with the Department for a complete statement of the facts and representations.
The Department is considering granting an exemption under the authority of section 408(a) of the Act and section 4975(c)(2) of the Code and in accordance with the procedures set forth in 29 CFR Part 2570, Subpart B (55 FR 32836, 32847, August 10, 1990). If the exemption is granted, the restrictions of sections 406(a), 406(b)(1) and (b)(2) of the Act and the sanctions resulting from the application of section 4975 of the Code, by reason of section 4975(c)(1)(A) through (E) of the Code, will not apply to the proposed sale of certain shares of common stock (the Stock) issued by Alden Enterprises, Inc. (Alden), an unrelated party, by the individually directed account in the Plan (the Account) of Jayaprakash K. Kamath, M.D. (Dr. Kamath), to Geetha J. Kamath, M.D., (Mrs. Kamath), Dr. Kamath's spouse and a party in interest with respect to the Plan.
This proposed exemption is subject to the following conditions:
(a) The sale of the Stock by the Account to Mrs. Kamath is a one-time transaction for cash.
(b) The Stock is sold to Mrs. Kamath for a price that reflects the fair market value of the Stock, as determined by a qualified, independent appraiser (the Appraiser).
(c) The closing of the sale (the Closing Date) occurs at a time that is mutually agreed upon by Mrs. Kamath and the Plan trustees (the Trustees) within 30 days of the Department's approval of the final exemption.
(d) As of the Closing Date, the Appraiser reviews the assumptions previously made in determining the appraised value of the Stock to see whether there has been a 3% or more increase (Material Increase) in the fair market value of the Stock between December 31, 2006 (the Appraisal Date) and the Closing Date.
(e) If the Appraiser determines that there has been no Material Increase in the fair market value of the Stock on the Closing Date, the Appraiser issues a letter to the parties to the sale to such effect and the sale price of the Stock remains at the value determined on the Appraisal Date.
(f) If the Appraiser determines that there has been a Material Increase in the fair market value of the Stock, he advises the parties to the transaction, in writing, as to the increased value as of the Closing Date. Then, the sale price for the Stock is revised to reflect the increased value and the amount of such increase is paid to the Trustees by Mrs. Kamath following the receipt of the updated appraisal report from the Appraiser setting forth the increased value of the Stock.
(g) The sale proceeds from the transaction are credited to Dr. Kamath's Account simultaneously with the transfer of the Stock's title to Mrs. Kamath.
(h) The Account is not responsible for paying any fees, commissions, or other costs or expenses associated with the sale of the Stock.
(i) The terms and conditions of the Stock sale remain at least as favorable to the Account as the terms and conditions obtainable under similar circumstances negotiated at arm's length with an unrelated party.
1. Dr. Kamath is a gastroenterologist and oncologist and a 50% owner of Gastroenterology and Oncology Associates, P.A. (the Employer), the sponsor of the Plan. The Employer is a Florida corporation, which is located in St. Petersburg, Florida. The Employer is also owned 50% by Mrs. Kamath.
2. The Plan is a profit-sharing plan that was established by the Employer and provides for participant-directed investments. Dr. and Mrs. Kamath are the Plan Trustees. In addition, Dr. Kamath serves as the Plan Administrator. As of December 31, 2006, which is the most recent date Plan information is available, the Plan had 42 participants, one of whom included Dr. Kamath. Also as of December 31, 2006, the Plan had net assets available for benefits totaling $3,312,699. Of those assets, approximately $2,058,927 was held in Dr. Kamath's Account in the Plan.
3. Among the assets allocated to Dr. Kamath's Account are 42.84 shares of common stock, which constitute 14% of the issued and outstanding shares of Alden, a closely-held Florida corporation. Alden's primary business is the ownership and operation of a resort hotel on Florida's Gulf Coast. The property underlying the Stock consists of a 4.84 acre tract of land improved with 10 buildings that comprise the 142-unit beachfront hotel known as the “Alden Beach Resort.” The property is located at 5900 Gulf Boulevard, in the city of St. Pete Beach, Pinellas County, Florida.
None of the other shareholders of Alden are related to the Kamaths or the Employer. In addition, neither the Kamaths nor members of their family are officers or directors of Alden.
4. The Account acquired the Stock from Margaret Bradford, a retired, former Alden employee and an unrelated party, on September 15, 1983, for a cash purchase price of $150,000. The purchase price paid by the Account for the Stock was negotiated by the Trustees and Ms. Bradford. During its ownership of the Stock, the Account received $706,860 in dividends from 1983 until 2006. In addition, the Alden Beach Resort was refinanced in 1990, and the proceeds were distributed to the shareholders. The Account received $433,860 from the refinancing. The Account incurred no expenses or administrative costs in connection with its ownership of the Stock. As a result of the acquisition and holding of the Stock, the Account has experienced a
5. An administrative exemption is requested from the Department to allow Dr. Kamath's Account to sell the Stock to Mrs. Kamath. Following the sale, Mrs. Kamath proposes to transfer the Stock to a revocable trust for estate planning purposes. The sale price for the Stock will be based upon its independently appraised fair market value. The consideration for the Stock will be paid by Mrs. Kamath in cash. The Account will pay no fees or commissions in connection with the transaction.
6. The value of the Stock on December 31, 2006 was $899,640, according to a January 2, 2007 appraisal report that was prepared by Mr. James W. Brockardt, CBA, a qualified, independent appraiser. The Appraiser, who is the President of Brockardt Consulting Group, LLC, an independent appraisal firm located in Pennington, New Jersey, has worked in the area of securities valuation since 1975. The Appraiser represents that he is completely independent of the parties involved in the transaction and has no present or prospective interest in the Stock.
The Appraiser initially valued the Stock under both the Cost Approach and the Income Approach to valuation. Then, he determined a “freely traded value” based upon weighting 75% to the Cost Approach, and 25% to the Income Approach. This value was next discounted by 35% for lack of marketability. As a result of the calculation, the Appraiser determined that the Stock had an aggregate fair market value, on a minority interest basis, of $6,428,398, or a per share value, on a minority interest basis, of $21,000. Thus, the 42.84 shares of Stock held by Dr. Kamath's Account have a total fair market value of $899,640. In addition, the Stock represents approximately 25.74% of the Account's assets.
7. The proposed transaction is contingent upon the Department's issuance of a final exemption, on or before December 31, 2007, authorizing such transaction in accordance with an Agreement for Sale of Stock (the Stock Sale Agreement), to be entered into between Mrs. Kamath and the Trustees. In this regard, the Stock Sale Agreement provides that if the Department grants a final exemption approving the transaction, the closing of the transaction will occur within 30 days of such approval.
As of the Closing Date, the Appraiser will review the assumptions he previously made in determining the appraised value of the Stock to see whether there has been a 3% or more increase (i.e., a Material Increase) in the fair market value of the Stock between the Appraisal Date (i.e., December 31, 2006) and the Closing Date. If the Appraiser determines that there has been no Material Increase in the fair market value of the Stock on the Closing Date, he will issue a letter to Mrs. Kamath and the Trustees informing them that the sale price of the Stock will be the value determined on the Appraisal Date. On the other hand, if the Appraiser determines that there has been a Material Increase in the fair market value of the Stock, he will advise the parties to the transaction, in writing, as to the increased value as of the Closing Date. Then, the sale price for the Stock will be revised to reflect the increased value and the amount of such increase will be paid by Mrs. Kamath to the Trustees following the receipt of the updated appraisal report from the Appraiser. Mrs. Kamath will pay the Trustees for the Stock either in cash or by wire transfer.
If the Department does not grant a final exemption authorizing the proposed transaction by December 31, 2007, the transaction will be automatically rescinded and it will become null and void.
8. The Trustees represent that the transaction is in the best interest of the Account because the sale ensures that the Account will have greater liquidity and diversification since its assets will be invested in either marketable securities or assets that are traded on an established market. This will enable Dr. Kamath's interest to be rolled over to his individual retirement account upon his retirement. Also, given the lack of operating or financial control of a minority shareholder, such as the Account, the Trustees state that it would be difficult, if not impossible, to sell the Stock. Further, the Trustees explain that the transaction will enable Alden to make a Subchapter S corporation election.
9. It is represented that the transaction is protective of the Account because the fair market value of the property underlying the Stock will be updated on the Closing Date by the Appraiser. Further, the Account has not been required, nor will it be required, to pay any fees, commissions or other expenses or costs in connection with the subject transaction.
10. In summary, it is represented that the proposed transaction will satisfy the statutory requirements for an exemption under section 408(a) of the Act because:
(a) The sale of the Stock by the Account to Mrs. Kamath will be a one-time transaction for cash.
(b) The Stock will be sold to Mrs. Kamath for a price that reflects the fair market value of the Stock, as determined by the Appraiser on the Closing Date.
(c) The Closing Date of the transaction will occur at a time that is mutually agreed upon by Mrs. Kamath and the Trustees within 30 days of the Department's approval of the final exemption.
(d) The Appraiser will determine whether there has been a Material Increase in the fair market value of the Stock between the Appraisal Date and the Closing Date, and if so, he will make appropriate adjustments to the sale price in an updated appraisal report.
(e) Dr. Kamath's Account will not be responsible for paying any fees, commissions, or other costs or expenses associated with the sale of the Stock.
(f) The terms and conditions of the Stock sale will remain at least as favorable to the Account as the terms and conditions obtainable under similar circumstances negotiated at arm's length with an unrelated party.
Because Dr. Kamath is the only participant in the Plan, it has been determined that there is no need to distribute the notice of proposed exemption to interested persons. Accordingly, comments and requests for a public hearing are due within thirty (30) days after the publication of the notice of proposed exemption in the
Ms. Jan D. Broady of the Department, telephone (202) 693-8556. (This is not a toll-free number.)
The Department is considering granting an exemption under the authority of section 408(a) of the Act (or ERISA) and section 4975(c)(2) of the Code and in accordance with the procedures set forth in 29 CFR part 2570, subpart B (55 FR 32836, 32847, August 10, 1990).
If the exemption is granted, the restrictions of section 406(a)(1)(A) and (D) of the Act and the sanctions
(A) The acquisition, from an offshore corporation (the Offshore Corporation) of certain non-voting equity securities (Shares), which represent interests in the economic value of the Offshore Corporation by an ERISA-covered client plan (the Client Plan), where the Offshore Corporation is a party in interest with respect to the Client Plan, due to the ownership of all of the voting equity shares (Manager Shares) of the Offshore Corporation by Wellington Global Administrator, Ltd. (Wellington Global Administrator), a subsidiary of Wellington Management, which is (or may become) a fiduciary and a service provider with respect to the Client Plan; and
(B) The redemption of the Client Plan's Shares by the Offshore Corporation either in cash or in kind.
This proposed exemption is conditioned upon adherence to the material facts and representations described herein and upon satisfaction of the following conditions, which apply both retroactively and prospectively, unless otherwise excepted:
(a) All decisions to acquire or redeem Shares have been made or are made on behalf of the Client Plan by an authorized fiduciary, which is independent of Wellington and the applicable Offshore Corporation.
(b) At the time of acquisition of Shares from an Offshore Corporation, each Client Plan either had or has assets at least equal to $100 million.
(1) In the case of a master trust that holds assets of multiple related Client Plans maintained by a single employer or a controlled group of employers, as defined in section 407(d)(7) of the Act, this requirement is satisfied if the master trust has aggregate assets at least equal to $100 million (assuming the fiduciary responsible for making the investment decision is the Client Plan sponsor or an affiliate of the Client Plan sponsor).
(2) In the case of a pooled fund (e.g., a group trust) whose assets are “plan assets” subject to the Act, this requirement is satisfied as long as either (i) the pooled fund has at least $100 million in aggregate assets and the fiduciary making the investment decision is unrelated to Wellington and manages at least $200 million in assets (exclusive of the aggregate assets invested in the Offshore Corporations); or (ii) at least 50 percent of the units of beneficial interest in the pooled fund are held by Client Plans, each of which has total net assets of at least $100 million.
(c) Wellington has not provided and does not provide investment advice (within the meaning of 29 CFR 2510.3-21(c)), nor is it a fiduciary with respect to any Client Plan's investment in an Offshore Fund.
(d) All acquisitions and redemptions of Shares by a Client Plan have been made or are made for fair market value, determined as follows:
(1) Equity securities have been valued or are valued at their last sale price or official closing price on the market on which such securities primarily trade using sources independent of Wellington and the issuer. If no sales occurred on such day, equity securities are valued at the last reported independent “bid” price or, if sold short, at the last reported independent “asked” price.
(2) Fixed income securities have been valued or are valued on either the basis of “firm quotes” obtained at the time of the acquisition or redemption of Shares from U.S.-registered or foreign broker-dealers, which are registered and subject to the laws of their respective jurisdiction, which quotes reflect the share volume involved in the transaction, or on the basis of prices provided by independent pricing services that determine valuations based on market transactions for comparable securities and various relationships between such securities that are generally recognized by institutional traders.
(3) Options have been valued or are valued at the mean between the current independent “bid” price and the current independent “asked” price or, where such prices are not available are valued at their fair value in accordance with Fair Value Pricing Practices by Wellington Management's pricing committee, which utilizes a set of defined rules and an independent review process.
(4) If current market quotations are not readily available for any investments, such investments have been valued or will be valued at their fair value by Wellington Management's pricing committee in accordance with Fair Value Pricing Practices.
(e) A Client Plan's Shares have been redeemed or may be redeemed, in whole or in part, without the payment of any redemption fee or other penalty, on a pre-specified, periodic (not longer than semi-annual) basis, upon no more than 45 days' advance notice, except for a one-year lock-up period imposed on new investors.
(f) Redemptions of Shares in an Offshore Corporation by a Client Plan have been made or are made in cash unless:
(1) A Client Plan consents to such in kind redemption; or
(2) Wellington requires that such redemption be made in kind on a pro rata basis to protect the best interests of the Offshore Fund and the remaining investors, including other Client Plan investors.
(g) In advance of the initial investment by a Client Plan in an Offshore Corporation's Shares, the independent fiduciary of a Client Plan has received or receives—
(1) A copy of the proposed exemption and the final exemption. (This disclosure provision applies to the prospective exemptive relief described herein.)
(2) An offering memorandum describing the relevant Offshore Fund(s), as well as the relevant investment objectives, fees and expenses and redemption and valuation procedures; and
(3) All reasonably available relevant information as such independent fiduciary may request.
(h) On an ongoing basis, Wellington has provided or provides a Client Plan with the following information:
(1) Unaudited performance reports at the end of each month;
(2) Audited annual financial statements and access to a protected internet site; and
(3) Client services group assistance for any investor inquiries.
(i) No commission or sales charge has been assessed or is assessed against the Client Plan in connection with its acquisition of an Offshore Corporation's Shares.
(j) Not more than 10% of the assets of the Client Plan has been invested or is invested, in the aggregate, in Shares of all Offshore Corporations (determined at the time of any acquisition of such Shares) and not more than 5% of the assets of the Client Plan has been indirectly invested or is invested, in the aggregate, in any one offshore fund (the Offshore Fund), a separate collective investment vehicle underlying an Offshore Corporation, (also determined at the time of any acquisition of an interest in such Offshore Fund by such Client Plan).
(k) For prospective transactions only, each Offshore Corporation, each Offshore Fund, Wellington Management Investment, Inc. (Wellington
(1) Has agreed to submit to the jurisdiction of the federal and state courts located in the Commonwealth of Massachusetts;
(2) Has agreed to appoint an agent for service of process in the United States, which may be an affiliate (the Process Agent);
(3) Has consented to service of process on the Process Agent; and
(4) Has agreed that any enforcement by a Plan of its rights pursuant to this exemption will, at the option of the Plan, occur exclusively in the United States courts.
(l) For prospective transactions only, Wellington maintains in the United States for a period of six years from the date of the covered transactions, such records as are necessary to enable the persons described in paragraph (m) of this Section II to determine whether the conditions of this exemption were met, except that:
(1) If the records necessary to enable the persons described in paragraph (m) to determine whether the conditions of the exemption have been met are lost or destroyed, due to circumstances beyond the control of Wellington, then no prohibited transaction will be considered to have occurred solely on the basis of the unavailability of those records; and
(2) No party in interest other than Wellington shall be subject to the civil penalty that may be assessed under section 502(i) of the Act or to the taxes imposed by section 4975(a) and (b) of the Code if the records have not been maintained or are not available for examination as required by paragraph (m) below.
(m)(1) Except as provided in paragraph (m)(2) of this Section II and notwithstanding the provisions of subsections (a)(2) and (b) of section 504 of the Act, the records referred to above in paragraph (l) of this Section II are unconditionally available for examination during normal business hours at their customary location to the following persons or an authorized representative thereof:
(i) Any duly authorized employee or representative of the Department or the Internal Revenue Service (the Service);
(ii) Any fiduciary of a Client Plan; or
(iii) Any participant or beneficiary of a Client Plan or any duly authorized employee or representative of such participant or beneficiary.
(2) None of the persons described above in paragraphs (ii) and (iii) of this paragraph (m)(1)(ii) and (iii) of this Section II shall be authorized to examine trade secrets of Wellington, or any commercial or financial information, which is privileged or confidential.
(a) The term “Wellington” means Wellington Management Company, LLP and its subsidiaries.
(b) An “affiliate” of Wellington means—
(1) Any person directly or indirectly through one or more intermediaries, controlling, controlled by, or under common control with the person;
(2) Any officer, director, employee, relative, or partner in any such person; and
(3) Any corporation or partnership of which such person is an officer, director, partner, or employee.
(c) The term “control” means the power to exercise a controlling influence over the management or policies of a person other than an individual.
(d) The term “Offshore Corporation” means —
(1) WMIB;
(2) Any future expansion of WMIB that includes an additional class of securities or an additional Offshore Fund that is organized as a Bermuda limited partnership, which corresponds to the new WMIB class that is established by Wellington pursuant to the WMIB structure, and conforms to the same conditions, rules and regulations described in this exemption;
(3) Archipelago; or
(4) Any future “fund of funds” investment vehicle that is formed by Wellington under Bermuda law and is set up in substantially the same manner as Archipelago, with the same management structure, and conforms to the same conditions, rules and regulations described in this exemption.
(e) The term “Offshore Fund” means a collective investment vehicle that is organized as a Bermuda limited partnership, which corresponds to each class of WMIB securities. Each Offshore Fund invests primarily in publicly-traded securities, although up to 15% of each Offshore Fund may be invested in securities that are not readily marketable.
(f) The term “U.S. broker-dealer” means a broker-dealer registered in the United States under the Securities Exchange Act of 1934 (the 1934 Act) or exempted from registration under section 15(a)(1) of the 1934 Act as a dealer in exempted government securities (as defined in section 3(a)(12) of the 1934 Act).
(g) The term “foreign broker-dealer” means a broker that has, as of the last day of its most recent fiscal year, equity capital that is the equivalent of not less than $200 million and is registered and regulated, under the relevant securities laws of a governmental entity of a country other than the United States, where such regulation and oversight by the governmental entities is comparable to regulatory regimes within the United States.
(h) “Manager Shares” refer to the equity securities of an Offshore Corporation that have voting rights and control the election of the Board of Directors of an Offshore Corporation. Manager Shares do not participate in the economic performance of the Offshore Corporation and are owned 100% by Wellington Global Administrator.
(i) “Shares” refer to the equity securities of an Offshore Corporation that do not have voting rights. Such shares represent substantially all of the economic value of the Offshore Corporation and are or will be directly linked either (i) by class to a corresponding Offshore Fund (in the case of WMIB) or (ii) to a mix of various WMIB classes (in the case of Archipelago or any other fund of funds entity).
1. Wellington, or the applicant (the Applicant), is a Massachusetts limited liability partnership that is a federally registered investment adviser and a financial services organization. Wellington manages the assets of many individual and institutional clients. As of September 30, 2006, Wellington had over $544 billion in assets under management, including the assets of many ERISA-covered employee benefit plans.
2. Wellington currently sponsors two offshore, open-end limited liability investment companies (i.e., the Offshore Corporations)—Wellington Management Investors (Bermuda), Ltd. (WMIB) and Archipelago Holdings, Ltd. (Archipelago). Each Offshore Corporation was formed under the laws
Wellington Management Investment, a Delaware corporation, which is wholly owned by Wellington Management, does not have any contractual relationship with, or provide any services to, the Offshore Corporations or the Offshore Funds. Wellington Management Investment holds a 0.025% interest in Wellington Global Holdings, a 0.1% interest in Wellington Global Administrator and a 0.1% interest in Wellington Hedge Management. The remaining interests in each such entity are directly held by Wellington Management, so that all three entities are nearly 100% owned by Wellington Management.
Wellington Global Holdings serves as the investment general partner of each WMIB Offshore Fund and, in such capacity, has hired Wellington Management as the investment sub-adviser of each WMIB Offshore Fund. Wellington Global Holdings also serves as the investment manager of Archipelago. Wellington Global Administrator serves as the administrative general partner of each WMIB Offshore Fund and also as the administrative manager of Archipelago. Wellington Hedge Management serves as the general partner of the Wellington-sponsored domestic “onshore” hedge funds, but has no responsibility or relationship with respect to the Offshore Corporations or the Offshore Funds.
In the future, WMIB may be expanded by Wellington to include additional classes of equity interests and additional Offshore Funds, corresponding in each case to the new WMIB class of equity interest. The future classes of equity interests and Offshore Funds will be established pursuant to the WMIB structure.
3. Archipelago is a “fund of funds” in that all of its assets are invested in a mix of the WMIB classes and, as a result, indirectly in a mix of the Offshore Funds and other funds associated with those particular classes
4. The Applicant explains that a Client Plan may choose to invest in Archipelago, rather than directly in the various classes of WMIB shares, because the amount it is investing may be too small to enable it to achieve the degree of diversification it desires among the various Offshore Funds. In particular, the WMIB classes typically require a minimum investment of $1-$3 million per class. For a relatively small investment (Archipelago's minimum investment is approximately $1 million), Archipelago represents an opportunity for greater diversification according to the Applicant.
Wellington represents that it may in the future establish additional Offshore Corporations that are substantially similar to Archipelago. However, these future “fund of funds” investment vehicles will invest in a different mix of WMIB classes than Archipelago.
5. The Applicant explains that within the universe of hedge funds, WMIB and Archipelago are not considered highly leveraged, nor will any future Offshore Corporations be highly leveraged. The Applicant states that many other hedge funds are more highly leveraged than WMIB and Archipelago. The Applicant bases this opinion on the SEC's Staff Report, “Implications of the Growth of Hedge Funds” (September 2003), which noted that, if a leverage ratio is defined as the ratio of total absolute dollars invested to total dollars of equity, a leverage ratio of greater than 2 to 1 is considered “high” while a ratio of less than or equal to 2 to 1 is considered “low.” When applying this criterion to the Offshore Funds, the Applicant states that historically, in most instances, total leverage exposure of each Offshore Fund has been substantially less than 2 to 1, and is consistent with the SEC's view that the leverage ratio is low.
Further, each Offshore Corporation margins its long securities only through its prime broker, which is subject to the terms of Regulation T issued by the Board of Governors of the Federal Reserve System pursuant to the Securities Exchange Act of 1934. The Offshore Corporations are limited to 100% leverage with respect to long securities,
In addition, the Applicant states that “100% leverage” with respect to its long securities” means that the Offshore Fund could utilize $100 of its own capital to purchase long securities and an additional $100 of borrowed funds to purchase long securities yielding a total long security position of $200 of which 50% would be attributable to debt and 50% would be attributable to the investment of its own equity. This would be analogous to an investment in real estate in which a property is bought for $200 with a mortgage of $100 with the remaining $100 being derived from the investor's own capital.
Moreover, the Applicant explains that since a Plan is likely to invest a small percentage of its assets in any particular Offshore Fund it may well be completely prudent and appropriate for some plan assets to be invested in an Offshore Fund that
Moreover, the Applicant states that the Offshore Corporations are designed to provide absolute returns rather than to outperform a designated market.
6. Each Offshore Corporation has (or will have) two broad classes of equity securities—Manager Shares and Shares. Manager Shares are voting shares and hence control the election of the Board of Directors of an Offshore Corporation, but do not participate in the economic performance of the Offshore Corporation. Manager Shares are owned 100% by Wellington Global Administrator. Shares are non-voting but represent substantially all of the economic value of the Offshore Corporation and are or will be directly linked either (a) by class to a corresponding Offshore Fund (in the case of WMIB) or (b) to a mix of various WMIB classes (in the case of Archipelago or any other fund of funds entity). Shares are presently owned by numerous investors, primarily unrelated non-U.S. individuals and institutions and unrelated U.S. non-taxable investors, but not by any Client Plans.
In order to comply with National Association of Securities Dealers (NASD) rules (the “new issues rules”) relating to the allocation of certain initial public offerings (IPOs), each Offshore Corporation offers three sub-classes of Shares: A Shares, which participate fully in initial public offering (IPO) allocations; C Shares, which participate only to a limited extent (i.e., only to the extent permitted by the applicable NASD rules) in IPO allocations; and E Shares, which do not participate to any extent in IPO allocations. In all other respects, these three sub-classes are identical. These NASD rules only impact investors that are professional money managers or broker-dealers as well as certain of their respective affiliates and related persons. All other investors would be required to invest in A Shares.
Client Plans that are not “restricted” (as defined in NASD Rule 2790
In addition, each Share sub-class is further divided into a different series in order to account for different loss carryforwards associated with specific Shares held by investors depending upon their holding periods with respect to such Shares. According to the Applicant, the separate accounting and the resultant separate series are needed in order to reflect the correct incentive allocation amounts with respect to each investor. In this regard, the incentive allocation payable to Wellington Global Holdings, as the investment general partner, at the Offshore Fund level incorporates a “high-water mark”
7. Each Offshore Corporation is exempt from registration under the Investment Company Act of 1940 (the 1940 Act) by reason of Section 3(c)(7) of the 1940 Act (i.e., all U.S. investors in the Offshore Corporation must be “qualified purchasers”). In addition, the assets of each Offshore Corporation are not currently, and are not expected to be, “plan assets” subject to the Act because the aggregate interests of each class of equity securities issued by the Offshore Corporation that are held by “benefit plan investors” are currently, and are expected to be, less than 25% of the aggregate outstanding interests of such class (determined in accordance with the plan assets regulation).
8. As an investment adviser registered under the Investment Advisers Act of 1940, Wellington Management is subject to the jurisdiction of the SEC. In this respect, the Applicant states that Wellington Management is subject to regulatory review and oversight by the SEC, which review encompasses all of Wellington Management's client relationships, including its relationships with the Offshore Corporations and the Offshore Funds. The sub-advisory agreement pursuant to which Wellington Management manages the assets of each Offshore Fund provides that such agreement is subject to the laws of Massachusetts (to the extent not preempted by applicable U.S. federal law). As a resident of Massachusetts, Wellington Management is subject to the jurisdiction of the state and federal courts in Massachusetts. Moreover, each Offshore Corporation, each Offshore Fund, Wellington Global Holdings and Wellington Global Administrator, will consent to the jurisdiction of such courts, and will appoint Wellington Management as its agent for service of process.
9. Wellington's compensation is paid exclusively at the Offshore Fund-level. Thus, Wellington will receive no duplicate fees from a Client Plan. In this
Wellington believes its compensation with respect to these entities is reasonable, within the meaning of section 408(b)(2) of the Act and the regulations promulgated thereunder, and consistent with (and in many cases lower than) the levels of compensation charged by other managers of comparable entities. In addition, Wellington states that the reasonableness of its compensation is further evidenced by the fact that substantially all of the investors in these entities are independent of Wellington and all investors have made their decisions to invest in such entities after full disclosure of the level of compensation to be charged.
10. The Applicant believes that certain of its clients may desire to invest in one or more Offshore Corporations. In particular, U.S. tax-exempt investors, including Client Plans, frequently invest in offshore funds structured as corporations (for U.S. tax purposes) in order to minimize the amount of unrelated business taxable income they incur as a result of certain investment strategies and activities. In effect, the Applicant states that the introduction of the Offshore Corporation shields the Client Plan from any unrelated business taxable income, thereby enhancing the after-tax investment return of the Client Plan. Because an investment in an Offshore Corporation would allow Client Plans to invest in these investment strategies and activities on the most tax efficient basis, the Applicant believes that it is in the best interest of Client Plans and their participants and beneficiaries, and also consistent with the requirements of section 408(a) of the Act, for the Department to grant an administrative exemption for the past and future acquisition and redemption of an Offshore Corporation's non-voting Shares by a Client Plan.
11. Accordingly, the Applicant requests an administrative exemption from the Department that would permit a Client Plan to acquire Shares from an Offshore Corporation. The exemption would also allow the Client Plan to redeem Shares from an Offshore Corporation, either in cash or in kind. An administrative exemption is required because Wellington Management is (or may become) a party in interest with respect to a Client Plan, as a fiduciary and a service provider under section 3(14)(A) and (B) of the Act. Wellington Management would also be considered a party in interest with respect to a Client Plan under section 3(14)(H) of Act because it owns directly 10% or more of Wellington Global Administrator, a service provider to a Client Plan. In this respect, Wellington Management owns more than 99% of the common stock of Wellington Global Administrator and indirectly, more than 99% of Manager Shares.
In addition, Wellington Global Administrator is a party in interest with respect to a Client Plan under section 3(14)(H) of the Act inasmuch as it is a 10% or more shareholder of an Offshore Corporation due to its ownership of 100% of Manager Shares.
Further, an Offshore Corporation would be considered a party in interest with respect to a Client Plan because under section 3(14)(G) of the Act, it is a corporation in which 50% of the combined voting power of all stock entitled to vote is owned directly by Wellington Global Administrator, a service provider, and indirectly by Wellington Management, a fiduciary and a service provider.
Therefore in the absence of an administrative exemption, the acquisition or redemption by a Client Plan of Shares from an Offshore Corporation would constitute a prohibited purchase and sale transaction between the Client Plan and a party in interest in violation of section 406(a)(1)(A) and (D) of the Act.
Because all decisions with respect to a Client Plan's acquisition or redemption of Shares would be (or have been made) by independent fiduciaries of Client Plans which are unrelated to Wellington, no exemption from section 406(b) of the Act is being requested by the Applicant.
If granted, the exemption would provide retroactive relief, effective from January 1, 2001 until December 31, 2003 for transactions involving two Client Plans that formerly invested in the Offshore Corporations. The exemption would also provide prospective relief that would be effective on the date the grant notice is published in the
The Applicant is aware that the prospective transactions described herein may be covered by the statutory exemption for service providers under section 408(b)(17) of the Act. Section 408(b)(17) of the Act requires that, in connection with transactions entered into pursuant to this statutory exemption, that a plan receive no less nor pay no more than “adequate consideration.” For purposes of the statutory exemption, the term “adequate consideration” means,
• In the case of a security for which there is a generally recognized market—
○ The price of the security prevailing on a national securities exchange which is registered under section 6 of the Securities Exchange Act of 1934, taking into account factors such as the size of the transaction and marketability of the security, or
○ If the security is not traded on a national securities exchange, a price not less favorable to the plan than the offering price for the security established by the current bid and asked prices quoted by persons independent of the issuer and of the party in interest, taking into account factors such as the size of the transaction and marketability of the security, and
• In the case of an asset other than a security for which there is a generally recognized market, the fair market value of the asset as determined in good faith by a fiduciary or fiduciaries in accordance with regulations prescribed by the Secretary of Labor.
The Applicant is concerned about the requirement in section 408(b)(17) that the plan “receives no less, nor pays no more, than adequate consideration.” In this context, the Applicant explains that this provision means fair market value as determined in good faith by the relevant plan fiduciary in accordance with regulations prescribed by the Department. In the absence of such regulations, the Applicant states that the determination of what constitutes adequate consideration is unclear, particularly if the underlying assets of an Offshore Fund are invested in securities and other investments that are not publicly-traded. But for this concern, the Applicant states that the statutory relief provided under section 408(b)(17) of the Act would be adequate for prospective transactions.
12. The Applicant requests retroactive exemptive relief with respect to the
The Lahey Plan invested $6 million in Archipelago on July 1, 2003 to acquire Class A Shares. Based upon an available Form 5500, the Lahey Plan had total assets of approximately $150 million as of September 30, 2003. Thus, the Lahey Plan's investment in Archipelago represented approximately 4% of that Client Plan's assets. During its ownership of the Class A Shares, Archipelago made no interim distributions to the Lahey Plan. On December 31, 2003, the Lahey Plan redeemed its interest in Archipelago in cash. The Lahey Plan received $6,712,168.
It is represented that Wellington did not provide investment advice (within the meaning of 29 CFR 2510.3-21(c)), nor was it a fiduciary, with respect to either the Lahey Plan's or the NCR Plan's investments in the Class A Shares. Rather, in each case, the decision to acquire Class A Shares was made by an authorized fiduciary of the Client Plan who was independent of Wellington. Neither the independent fiduciary of the Client Plan nor Wellington had any knowledge that such acquisition would give rise to a prohibited transaction under section 406(a) of the Act. This was because the parties were not aware that Wellington Management's 95% indirect ownership of Manager Shares in WMIB and Archipelago resulted in either Offshore Corporation becoming a party in interest with respect to the applicable Client Plan. When the prohibited transaction concern was identified, the Applicant states that each Client Plan redeemed its interest in the Offshore Corporation in December 2003, within a reasonable period of time after such discovery. In the case of the Lahey Plan, the redemption was made entirely in cash, while the NCR Plan requested, and was given, a redemption that was partially in cash and partially in kind. The NCR Plan was permitted to receive an in-kind redemption in part because it intended to reinvest its redemption proceeds in a parallel domestic fund, also managed by Wellington.
During their investment in the Offshore Corporations, both the Lahey Plan and the NCR Plan were provided with the opportunity to access, among other things, monthly unaudited performance reports and audited annual financial statements. Both the Lahey Plan and the NCR Plan were also able to access this information online or through paper mailings that were initially given to the sponsor of the NCR Plan. In addition, during the entire duration of their respective investments, both Client Plans had telephone access to the Wellington's Hedge Fund Group for assistance with any questions they may have had.
Neither the NCR Plan nor the Lahey Plan paid any sales or redemption fees or commissions in connection with their subscription and redemption of Class A Shares. Like all other investors, the Client Plans did indirectly bear the management fee and incentive allocation borne by the underlying partnerships to which their respective Class A Shares related.
13. With respect to the determination of fair market value for purposes of the redemption transactions relating to the NCR Plan and the Lahey Plan, the Applicant states that to the extent that any of the assets of an Offshore Fund consisted of publicly-traded securities or other assets for which independent market prices were available, the public market prices or independent pricing sources were utilized. The Applicant further states that to the extent that any of the assets of an Offshore Fund were not capable of being valued in this manner, Wellington Management's pricing committee, which is comprised of senior Wellington investment professionals, determined the fair value of such assets pursuant to its Fair Value Pricing Practices.
In making its fair value pricing determination, the Applicant represents that it utilizes a set of defined decision rules, which involve varying degrees of objectivity, an independent review process, and a continuing review of securities in fair value status. The valuation process is operated in a consistent manner over time as well as among investor accounts.
14. Given that (a) there was no awareness of the technical prohibited transaction concern involved, (b) the investment decision was made by an independent fiduciary on the same terms as all other investors in the Offshore Corporation after receipt of an offering memorandum describing the details of the investment, (c) each of these two Client Plans had, at the time of investment, aggregate assets in excess of $100 million, (d) each Client Plan redeemed its entire interest in the Offshore Corporation within a reasonable period of time after the prohibited transaction concern was discovered, and (e) neither Client Plan incurred a loss on account of its investment in the Offshore Corporation, the Applicant believes that a retroactive exemption covering the acquisition and redemption of interests in the Offshore Corporations by these two Client Plans is appropriate. For these Client Plans, the exemption would be effective
15. The Applicant represents that the following safeguards for the prospective exemption will be in place:
• All decisions to acquire or redeem Shares will be made or are made on behalf of the Client Plan by an independent fiduciary.
• The Client Plan, either individually or through a pooled investment vehicle such as a master trust or a pooled fund, will have assets at least equal to $100 million. For example: (a) In the case of a master trust that holds assets of multiple related Client Plans maintained by a single employer or a controlled group of employers, as defined by section 407(d)(7) of the Act, this requirement will be satisfied if the master trust has aggregate assets at least equal to $100 million (assuming the fiduciary responsible for making the investment decision is the Client Plan sponsor or an affiliate of the Client Plan sponsor); or (b) in the case of a pooled fund (e.g., a group trust) whose assets are “plan assets” subject to the Act, this requirement will be satisfied as long as either (1) the pooled fund has at least $100 million in aggregate assets and the fiduciary making the investment decision is unrelated to Wellington and manages at least $200 million in assets (exclusive of the aggregate assets invested in the Offshore Corporations); or (2) at least 50 percent of the units of beneficial interest in the pooled fund are held by Client Plans, each of which has total net assets of at least $100 million.
• Wellington will not provide investment advice (within the meaning of 29 CFR 2510.3-21(c)), nor is it a fiduciary with respect to any Client Plan investment in an Offshore Fund.
• All acquisitions and redemptions of Shares by a Client Plan will be for fair market value, determined as follows: (a) equity securities will be valued at their last sale price or official closing price on the market on which such securities primarily trade using sources independent of Wellington and the issuer. If no sales occurred on such day, equity securities are valued at the last reported independent “bid” price or, if sold short, at the last reported independent “asked” price; (b) fixed income securities will be valued either on the basis of “firm quotes” obtained at the time of the acquisition or redemption of Shares from U.S.-registered or foreign broker-dealers, which are registered and subject to the laws of their respective jurisdiction, which quotes reflect the share volume involved in the transaction, or on the basis of prices provided by independent pricing services that determine valuations based on market transactions for comparable securities and various relationships between such securities that are generally recognized by institutional traders; (c) options will be valued at the mean between the current independent “bid” price and the current independent “asked” price or, where such prices are not available are valued at their fair value in accordance with Fair Value Pricing Practices by Wellington Management's pricing committee, which utilizes a set of defined rules and an independent review process; or (d) if current market quotations are not readily available for any investments, such investments will be valued at their fair value by Wellington Management's pricing committee, in accordance with Fair Value Pricing Practices.
• A Client Plan's Shares will be redeemed, in whole or in part, without the payment of any redemption fee or other penalty, on a pre-specified, periodic (not longer than semi-annual) basis, upon no more than 45 days' advance notice, except for a one-year lock-up period imposed on new investors. (If the Applicant extends the lock-up period to existing investors, such investors would receive advance notice and have an opportunity to withdraw from the affected Offshore Fund without penalty before the change become effective.)
• Redemptions of Shares in an Offshore Corporation by a Client Plan will be made in cash unless: (a) A Client Plan consents to such in kind redemption; or (b) Wellington requires that such redemption be made in kind on a pro rata basis to protect the best interests of the Offshore Fund and the remaining investors, including other Client Plan investors. (Each Offshore Corporation may redeem Shares in kind if deemed by the Board of Directors to be in the best interests of the Offshore Corporation. There is no threshold over which redemptions are automatically funded in kind, nor is there any minimum amount of redemption below which the redemption cannot be made in kind.)
• In advance of the initial investment by a Client Plan in an Offshore Corporation's Shares, the relevant independent fiduciary will receive: (a) A copy of the proposed and final exemption for prospective relief described herein; (b) an offering memorandum describing the relevant Offshore Fund(s), as well as the relevant investment objectives, fees and expenses and redemption and valuation procedures; and (c) all reasonably available relevant information as such independent fiduciary may request.
• On an ongoing basis, Wellington will provide a Client Plan with the following information: (a) Unaudited performance reports at the end of each month; (b) audited annual financial statements and access to a protected internet site; and (c) client services group assistance for any investor inquiries.
• No commission or sales charge will be assessed against the Client Plan in connection with its acquisition of an Offshore Corporation's Shares.
• Not more than 10% of the assets of the Client Plan will be invested, in the aggregate, in non-voting Shares of all Offshore Corporations (determined at the time of any acquisition of the Shares) and not more than 5% of the assets of the Client Plan will be invested, in the aggregate, in any one Offshore Fund (determined at the time of any acquisition of an interest in such Offshore Fund by such Client Plan).
• Each Offshore Corporation, each Offshore Fund, Wellington Management Investment, Wellington Global Holdings, Wellington Hedge Management, and Wellington Global Administrator will consent to the jurisdiction of the federal and state courts located in the Commonwealth of Massachusetts and has appointed Wellington Management as its agent for service of process.
• Wellington will maintain in the United States for a period of six years from the date of the covered transactions, such records as are necessary to enable any duly authorized employee or representative of the Department or the Service, any fiduciary of a Client Plan, or any participant or beneficiary of a Client Plan to determine whether the conditions of this exemption have been or are met.
16. In summary, the Applicant represents that the transactions have satisfied or will satisfy the statutory criteria for an exemption under section 408(a) of the Act because:
(a) All decisions to acquire or redeem such Shares have been or will be made on behalf of the Client Plan by an authorized fiduciary who is independent of Wellington and the applicable Offshore Corporation;
(b) At the time of acquisition of Shares from an Offshore Corporation, each Client Plan has had or will have assets at least equal to $100 million either individually or through a pooled arrangement.
(c) Wellington has not provided or will not provide investment advice (within the meaning of 29 CFR 2510.3-21(c)), nor is it a fiduciary with respect
(d) A Client Plan's Shares have been redeemed or will be redeemed, in whole or in part, without the payment of any redemption fee or other penalty, on a pre-specified, periodic (not longer than semi-annual) basis, upon no more than 45 days' advance notice, except for a one-year lock-up period imposed on new investors.
(e) All acquisitions and redemptions of Shares by a Client Plan have been made or will be made for fair market value or have been valued or will be valued by Wellington Management's pricing committee, which utilizes a set of defined rules and an independent review process, all in accordance with Fair Value Pricing Practices.
(f) Redemptions of interests in an Offshore Corporation by a Client Plan have been made or will be made in kind or cash unless: (1) A Client Plan consents to such in kind redemption; or (2) Wellington requires that such redemption be made in kind to protect the best interests of the Offshore Fund and the remaining investors, including other Client Plan investors.
(g) In advance of the initial investment by a Client Plan in an Offshore Corporation's Shares, the relevant independent fiduciary has received or will receive: (1) A copy of the proposed exemption and the final exemption (This disclosure provision applies to the prospective exemptive relief described herein.); (2) an offering memorandum describing the relevant Offshore Fund(s), as well as the relevant investment objectives, fees and expenses and redemption and valuation procedures; and (3) all reasonably available relevant information as such independent fiduciary may request.
(h) On an ongoing basis, Wellington has provided or will provide the independent fiduciary of a Client Plan with the following information: (1) Unaudited performance reports at the end of each month; (2) audited annual financial statements and access to a protected internet site; and (3) client services group assistance for any investor inquiries.
(i) No commission or sales charge has been assessed or will be assessed against the Client Plan in connection with its acquisition of an Offshore Corporation's Shares.
(j) Not more than 10% of the assets of the Client Plan has been invested or will be invested, in the aggregate, in non-voting Shares of all Offshore Corporations (determined at the time of any acquisition of such Shares) and not more than 5% of the assets of the Client Plan has been indirectly invested or will be invested, in the aggregate, in any one Offshore Fund (determined at the time of any acquisition of an interest in such Offshore Fund by such Client Plan).
(k) For prospective transactions only, each Offshore Corporation, each Offshore Fund, Wellington Management Investment, Wellington Global Holdings, Wellington Hedge Management, and Wellington Global Administrator will consent to the jurisdiction of the federal and state courts located in the Commonwealth of Massachusetts and has appointed Wellington Management as its agent for service of process.
(l) For prospective transactions only, Wellington will maintain in the United States for a period of six years from the date of the covered transactions, such records as are necessary to enable such persons as any duly authorized employee or representative of the Department or the Service, any fiduciary of a Client Plan, or any participant or beneficiary of a Client Plan, to determine whether the conditions of this exemption will be met.
17. The Department notes that the general standards of fiduciary conduct under the Act would apply to the transactions permitted herein, and that the satisfaction of the conditions of this exemption should not be viewed as an endorsement, by the Department, of investments in the Offshore Corporations by Wellington's Client Plans. Therefore, the Department believes that it would be helpful to provide general information regarding its views on the responsibilities of an independent fiduciary of a Client Plan in connection with such plan's investment in an Offshore Corporation.
As noted in the Department's Interpretive Bulletin, 29 CFR 2509.94-3(d) (59 FR 66736, December 28, 1994), apart from consideration of the prohibited transaction provisions, a Client Plan's independent fiduciary must determine that such plan's investment in an Offshore Corporation is consistent with the general standards of fiduciary conduct under section 404 of the Act. In this regard, section 404(a)(1)(A) and (B) of the Act requires that fiduciaries discharge their duties to a plan solely in the interests of the participants and beneficiaries, for the exclusive purpose of providing benefits to participants and beneficiaries and defraying reasonable administrative expenses, and with the care, skill, prudence, and diligence under the circumstances then prevailing that a prudent person acting in a like capacity and familiar with such matters would use in the conduct of an enterprise of a like character and with like aims. In addition, section 404(a)(1)(C) of the Act requires that fiduciaries diversify plan investments so as to minimize the risk of large losses, unless under the circumstances it is clearly prudent not to do so.
Accordingly, the independent fiduciary of a Client Plan must act “prudently,” “solely in the interest” of the Client Plan's participants and beneficiaries, and with a view to the need to diversify such plan assets when deciding whether to invest plan assets in Shares of an Offshore Corporation. If such investment is not “prudent,” or not “solely in the interest” of the participants and beneficiaries of the plan or would result in an improper lack of diversification of plan assets, the responsible fiduciary or fiduciaries of the plan would be liable for any losses resulting from such a breach of fiduciary responsibility.
The Department further emphasizes that it expects the independent fiduciary to fully understand the benefits and risks associated with the Client Plan's investment in an Offshore Corporation, following disclosure to such fiduciary of all relevant information, including the fees that are paid to Wellington. Further, such plan fiduciary must be capable, either directly or indirectly through the use of hired professional experts, of monitoring the investment, including any changes in the performance of the investment. Thus, in considering a Client Plan's investment in an Offshore Corporation, an independent fiduciary should take into account its ability to provide adequate oversight of the particular investment.
Ms. Jan D. Broady of the Department, telephone number (202) 693-8556. (This is not a toll-free number.)
The Department is considering granting an exemption under the authority of section 408(a) of the Act and 4975(c)(2) of the Code, and in accordance with the procedures set forth in 29 CFR part 2570 subpart B (55 FR 32836, 32847, August 10, 1990). If the proposed exemption is granted, the restrictions in sections 406(a)(1)(A) through (D) and 406(b)(1) and (b)(2) of the Act, and the sanctions resulting from the application of section 4975 of the Code, by reason of section
(A) The Plan pays no sales commissions, redemption fees, or other similar fees in connection with the Redemption (other than customary transfer charges paid to parties other than GEAM and any affiliates thereof (GEAM Affiliates));
(B) The assets transferred to the Plan pursuant to the Redemption consist entirely of cash and Transferable Securities, as such term is defined in Section II, below;
(C) With certain exceptions described below, the Plan receives in any Redemption its pro rata portion of the securities that, when added to the cash received, is equal in value to the number of Shares redeemed, as determined in a single valuation performed in the same manner and as of 4 p.m. (local time for the New York Stock Exchange) on the same day, in accordance with Rule 2a-4 under the Investment Company Act of 1940, as amended (the 1940 Act), and the then-existing procedures established by the Board of Trustees of the Mutual Fund (using sources independent of GEAM and GEAM Affiliates). Notwithstanding the foregoing, Transferable Securities that are odd lot securities, fractional shares, and accruals on such securities may be distributed in cash;
(D) Neither GEAM, nor any affiliate thereof, receives any direct or indirect compensation, or any fees, including any fees payable pursuant to Rule 12b-1 under the 1940 Act, in connection with any Redemption of the Shares;
(E) Prior to a Redemption, GEAM provides in writing to an independent fiduciary, as such term is defined in Section II (Independent Fiduciary), a full and detailed written disclosure of information regarding the Redemption;
(F) Prior to a Redemption, the Independent Fiduciary provides written authorization for such Redemption to GEAM, such authorization being terminable at any time prior to the date of Redemption without penalty to the Plan;
(G) Before authorizing a Redemption, based on the disclosures provided by GEAM to the Independent Fiduciary, the Independent Fiduciary determines that the terms of the Redemption are fair to the Plan, and comparable to, and no less favorable than, terms obtainable at arm's length between unaffiliated parties, and that the Redemption is in the best interests of the Plan and its participants and beneficiaries;
(H) Not later than thirty (30) business days after the completion of a Redemption, the Mutual Fund will provide to the Independent Fiduciary a written confirmation regarding such Redemption containing:
(i) The total number of Shares of the Mutual Fund and the percentage held by the Plan immediately before the Redemption (and the related per Share net asset value and the total dollar value of the Shares held);
(ii) The identity (and related aggregate dollar value) of each security provided to the Plan pursuant to the Redemption, including each security valued in accordance with Rule 2a-4 under the 1940 Act and the then-existing procedures established by the Board of Trustees of the Mutual Fund (using sources independent of GEAM and GEAM Affiliates);
(iii) The current market price of each security received by the Plan pursuant to the Redemption; and
(iv) The identity of each pricing service or market-maker consulted in determining the value of such securities;
(I) The value of the securities received by the Plan for each redeemed Share, when added to the cash received, equals the net asset value of such Share at the time of the transaction, and such value equals the value that would have been received by any other investor for shares of the same class of the Mutual Fund at that time;
(J) Subsequent to a Redemption, within 180 days of the date of such Redemption, the Independent Fiduciary performs a post-transaction review that will include, among other things, testing a sampling of material aspects of the Redemption deemed in its judgment to be representative, including pricing;
(K) Each of the Plan's dealings with the Mutual Funds, the investment advisers to the Mutual Funds, the principal underwriter for the Mutual Funds, or any affiliated person thereof, are on a basis no less favorable to the Plan than dealings between the Mutual Funds and other shareholders holding shares of the same class as the Shares;
(L) GEAM will maintain, or cause to be maintained, for a period of six years from the date of any covered transaction such records as are necessary to enable the persons described in paragraph (M) below to determine whether the conditions of this exemption, if granted, have been met, except that (i) this recordkeeping condition shall not be violated if, due to circumstances beyond the control of GEAM, the records are lost or destroyed prior to the end of the six year period, (ii) no party in interest with respect to the Plan other than GEAM shall be subject to the civil penalty that may be assessed under section 502(i) of the Act or to the taxes imposed by section 4975(a) and (b) of the Code, if such records are not maintained or are not available for examination as required by paragraph (M) below;
(M)(1) Except as provided in subparagraph (2) of this paragraph (M), and notwithstanding any provisions of section 504(a)(2) and (b) of the Act, the records referred to in paragraph (L) above are unconditionally available at their customary locations for examination during normal business hours by (i) any duly authorized employee or representative of the Department of Labor, the Internal Revenue Service, or the Securities and Exchange Commission (SEC), (ii) any fiduciary of the Plan or any duly authorized representative of such fiduciary, (iii) any participant, beneficiary, or union employee covered by the Plan or duly authorized representative of such participant, beneficiary, or union employee, (iv) any employer whose employees are covered by Plan and any employee organization whose members are covered by such Plan.
(2) None of the persons described in paragraphs (M)(1)(ii), (iii) and (iv) shall be authorized to examine trade secrets of GEAM or the Mutual Funds, or commercial or financial information that is privileged or confidential; and
(3) Should GEAM or the Mutual Funds refuse to disclose information on the basis that such information is exempt from disclosure pursuant to paragraph (2) above, GEAM shall, by the close of the thirtieth (30th) day following the request, provide a written notice advising that person of the reasons for the refusal and that the Department may request such information.
(A) The term “affiliate” means:
(1) Any person (including a corporation or partnership) directly or indirectly through one or more intermediaries, controlling, controlled by, or under common control with the person;
(2) Any officer, director, employee, relative, or partner in any such person; and
(3) Any corporation or partnership of which such person is an officer, director, partner, or employee.
(B) The term “control” means the power to exercise a controlling influence over the management or policies of a person other than an individual.
(C) The term “net asset value” means the amount for purposes of pricing all purchases and sales calculated by dividing the value of all securities, determined by a method as set forth in the Mutual Fund's prospectus and statement of additional information, and other assets belonging to the Mutual Fund, less the liabilities charged to each such Mutual Fund, by the number of outstanding shares.
(D) The term “Independent Fiduciary” means a fiduciary who is: (i) Independent of and unrelated to GEAM and its affiliates, and (ii) appointed to act on behalf of the Plan with respect to the in-kind transfer of assets from one or more Mutual Funds to, or for the benefit of, the Plan. For purposes of this proposed exemption, a fiduciary will not be deemed to be independent of and unrelated to GEAM if: (i) Such fiduciary directly or indirectly controls, is controlled by, or is under common control with GEAM, (ii) such fiduciary directly or indirectly receives any compensation or other consideration in connection with any transaction described in this proposed exemption (except that an independent fiduciary may receive compensation from GEAM in connection with the transactions contemplated herein if the amount or payment of such compensation is not contingent upon or in any way affected by the independent fiduciary's ultimate decision), and (iii) an amount equal to more than two percent (2%) of such fiduciary's gross income, for federal income tax purposes, in its prior tax year, will be paid to such fiduciary by GEAM and its affiliates in such fiduciary's current tax year.
(E) The term “Transferable Securities” means securities that are traded on public securities markets or for which quoted bid and asked prices are available from persons independent of GEAM and would not include the following types of securities or assets: (a) Securities that would have to be registered under the Securities Act of 1933, as amended; (b) securities issued by entities in countries that restrict the holdings of securities by non-nationals, including investment vehicles such as the Mutual Funds, or otherwise limit the ability to transfer the security other than through a local securities exchange transaction; and (c) certain portfolio assets (such as forward currency contracts, futures and option contracts, swap transactions, and repurchase agreements) that, although they may be liquid and marketable, involve the assumption of contractual obligations, require special trading facilities, or may be traded only with the counterparty to the transactions in order to effect a change in beneficial ownership.
(F) The term “relative” means a “relative” as such term is defined in section 3(15) of the Act (or a “member of the family,” as such term is defined in section 4975(e)(6) of the Code), or a brother, sister, or a spouse of a brother or a sister.
1. GE Asset Management Incorporated (i.e., GEAM) is a direct, wholly-owned subsidiary of the General Electric Company (i.e., GE). GEAM serves as investment adviser to the GE Funds, an open-end management investment company registered under the 1940 Act that consists of a number of series (the Retail Funds). The Retail Funds generally offer four classes of shares: A, B, C, and Y. Class Y shares are held by various institutional investors. Investors in Class Y shares of the Retail Funds do not pay sales commissions or redemption fees in connection with the purchase or redemption of such shares, nor do they pay any 12b-1 or similar fees with respect to the distribution of such shares. Individual account plans maintained by GE and its affiliates (i.e., the Plans), subject to the Act and the Code, were, in the past, invested in Class Y shares of certain Retail Funds.
2. GEAM also serves as investment adviser to GE Institutional Funds, an open-end management investment company registered under the 1940 Act that consists of a number of portfolios (the Institutional Funds). The Institutional Funds are designed primarily for institutional investors, such as corporations, foundations, endowments, and trusts, as well as charitable, religious, and educational institutions. Shares of the Institutional Funds are currently offered in two classes: the Investment Class (Class I) and Service Class. Purchasers of Class I shares do not pay any sales charges (including front-end, contingent deferred, or asset-based sales charges), nor do they pay shareholder service and distribution fees in connection with their investments in the Institutional Funds.
The applicant represents that certain Institutional Funds have the same investment objectives, investment strategies, and portfolio managers as corresponding Retail Funds, and therefore have substantially identical portfolio holdings as those corresponding Retail Funds.
3. Historically, the investor qualification requirements established by the Institutional Funds precluded the Plans from investing in them. As a result of recent changes to those investor eligibility requirements, however, the Plans may now invest in Class I shares of the Institutional Funds.
To facilitate investments by the Plans in the Institutional Funds, the Retail Funds and the Institutional Funds determined to permit simultaneous in-kind Redemption and in-kind purchase transactions where possible, and such transactions were effected in March 2006. The applicant represents that this approach benefited the Plans, as well as other shareholders of the Retail Funds and the Institutional Funds, by avoiding the significant brokerage costs that would have been incurred—if portfolio securities of the Retail Funds were sold to realize cash to pay redemption proceeds that were then used to acquire similar portfolio securities in corresponding Institutional Funds. The process of effecting the March 2006 Redemptions began with the commencement of a blackout period applicable to the relevant Plans upon the close of the New York Stock Exchange on March 15, and was completed when the blackout was lifted at 2:30 p.m., Eastern Time, on March 20.
4. With respect to prohibited transaction issues under the Act and the Code, the applicant has requested this exemption to cover the in-kind Redemptions effected in March 2006. Prior to March 2006, the applicant had discussions with the Department, through outside counsel, about obtaining individual retroactive relief for the contemplated Redemptions, modeled on similar prior individual exemptions. The applicant notes that PTE 77-3 provides an exemption for the sale of shares of a mutual fund by an employee benefit plan covering employees of the investment adviser for the mutual fund and its affiliates, subject to certain conditions. However, in several published exemptions, in which the Department has granted individual relief for the in-kind redemption of shares by plans of the investment advisers of mutual funds—
The applicant requests retroactive relief for the March 2006 Redemptions and for any other in-kind Redemptions involving the Mutual Funds that are effected prior to the date that an exemption, if granted, is published in the
The applicant is not requesting relief for the in-kind acquisitions of Institutional Funds shares effected in March 2006 (and, it is represented, in the future would be effected) in accordance with PTE 77-3, in reliance on Advisory Opinion 98-06A (July 30, 1998).
5. The applicant represent that, with respect to issues raised under the 1940 Act by the aforementioned transactions, the Retail Funds effected the March 2006 in-kind Redemptions in reliance upon the no-action relief granted by the SEC to Signature Financial Group, Inc. (pub. avail. Dec. 28, 1999) (the Signature Letter).
The Signature Letter does not address the marketability of the securities distributed in kind. The range of securities distributed pursuant to this “safe harbor” may therefore be broader than the range of securities covered by SEC Rule 17a-7, 17 CFR 270.17a-7. In granting past exemptive relief with respect to in-kind transactions involving mutual funds, the Department has required that the securities being distributed in-kind fall within Rule 17a-7. One of the requirements of Rule 17a-7 is that the securities are those for which “market quotations are readily available.” SEC Rule 17a-7(a). Under this exemption request, exemptive relief also would be limited to in-kind distribution of securities for which market quotations are readily available. In addition, the Signature Letter requires pro rata distributions for any in-kind redemptions.
According to the applicant, the March 2006 Redemptions were effected pursuant to certain procedures adopted by the Board of Trustees of the Retail Funds, and the in-kind acquisitions were effected pursuant to corresponding procedures adopted by the Board of Trustees of the Institutional Funds. (The same persons serve as members of the Boards of both the Retail Funds and the Institutional Funds.) The securities and cash received by a Plan in an in-kind Redemption from a Retail Fund pursuant to such procedures were used only for the simultaneous purchase of shares of the corresponding Institutional Fund. Any in-kind Redemptions (and simultaneous in-kind acquisitions) occurring in the future would be effected pursuant to the same procedures (the Procedures).
6. Under the Procedures, each in-kind Redemption was effected at the current net asset value per Share of the relevant Retail Fund and was effected simultaneously with the in-kind acquisition of shares of the corresponding Institutional Fund. Pursuant to each in-kind Redemption, subject to the exceptions noted below, a Plan received a pro rata portion of securities of the Retail Fund that was equal in value to the number of Retail Fund Shares redeemed, as determined in a single valuation performed as of 4 p.m. Eastern Time (local time for the closing of the New York Stock Exchange) on the same day, in the same manner as such securities would be valued for purposes of computing the Retail Fund's net asset value per share in accordance with Rule 2a-4 under the 1940 Act and the procedures established by the Board of Trustees of the Retail Funds (using sources independent of GEAM and affiliates of GEAM).
Securities for which quotations are readily available on a national securities exchange are valued at the last quoted sales price, or if there is no reported sale, the security is valued at the last quoted bid price. Certain fixed income securities are valued by a dealer or by a pricing service based upon a computerized matrix system, which considers market transactions and dealer supplied valuations. Valuations for municipal bonds are based on prices obtained from a qualified municipal bond pricing service, which prices are based on the mean of the bid and ask prices of the secondary market. The value of the securities received by the Plan, as determined by the Retail Fund for purposes of an in-kind Redemption, is the same value of such securities that is used in determining the number of Institutional Fund shares purchased by such Plan as a result of the in-kind
7. Furthermore, under the Procedures, securities received by a Plan pursuant to an in-kind Redemption are limited to securities that are traded on public securities markets or for which quoted bid and asked prices are available from persons independent of GEAM (
In addition, under the Procedures, a Plan receives from the relevant Retail Fund (and deposits to the corresponding Institutional Fund) cash for the portion of the Retail Fund's assets represented by cash equivalents (such as certificates of deposit, commercial paper, and repurchase agreements). A Plan receives from the relevant Retail Fund (and deposits to the corresponding Institutional Fund) cash for other securities and assets that are not readily distributable (including securities and assets of the types described in (a), (b) and (c) of the preceding paragraph, receivables, and prepaid expenses) net of a pro rata portion of all liabilities (including accounts payable), and for those portfolio securities not amounting to round lots (e.g., 100 shares) (or would not amount to round lots if included in the in-kind Redemption and purchase) or fractional shares and accruals on these securities.
The applicant represents that the March Redemptions also satisfied the remaining conditions set forth in Section I not addressed above. Thus, for example, neither GEAM nor a GEAM Affiliate, received any fees (including any fees pursuant to Rule 12b-1 under the 1940 Act) in connection with any in-kind Redemption.
8. Further, the applicant retained U.S. Trust Company, N.A. (U.S. Trust), a national bank, to act as the Independent Fiduciary on behalf of the Plans with regard to the March 2006 Redemptions. It is represented that U.S. Trust is independent of, and unrelated to, GEAM and GEAM Affiliates and is qualified to perform the functions of the Independent Fiduciary. U.S. Trust has acknowledged that it is a fiduciary to the Plans, as defined in section 3(21) of the Act, and has represented that it understands and accepts the duties, responsibilities, and liabilities in acting as a fiduciary under the Act for the Plan, pursuant to the terms of an engagement letter, dated December 20, 2005, by and between GEAM and U.S. Trust.
As a condition of the proposed exemption, prior to any in-kind Redemption with respect to a Plan, GEAM and the Plan must provide the Independent Fiduciary with (or cause the Independent Fiduciary to be provided with) information necessary for the Independent Fiduciary to determine the fairness of the proposed in-kind Redemption. Before authorizing any in-kind Redemption, the Independent Fiduciary must determine, based on the information provided, that the terms of the in-kind Redemption are fair to the participants of the Plan and are comparable to, and no less favorable than, terms obtainable at arm's length between unaffiliated parties, and that the in-kind Redemption is in the best interests of the Plan and its participants and beneficiaries. If the Independent Fiduciary makes that determination, the Independent Fiduciary provides written authorization for such in-kind Redemption to GEAM. However, that authorization is terminable at any time prior to the date of the in-kind Redemption, without penalty to the Plan.
U.S. Trust also conducted a post-transaction review, summarized in a letter dated September 5, 2006, within 180 days of the date of the March 2006 Redemptions. The post-transaction review confirmed that the transfer was carried out in accordance with the required criteria and procedures, by testing a sampling of certain material aspects of the redemption transactions.
In the Pre-Trade analysis performed by GEAM, the costs to redeem in cash and repurchase all of the securities from the Funds to the corresponding GE Institutional Funds were estimated to be $435,612.34 combined for commissions, spread, taxes and fees. By completing the redemption and reinvestment in kind rather than in cash these costs were avoided. The Plans were immediately reinvested after the in kind redemption; therefore, potential opportunity costs associated with reinvestment risk were eliminated. If the Plans had received cash instead of their pro rata portion of the assets in each of the Funds, they would have been forced to incur their pro rata portion of the sell side transactions costs, and they would have had to incur all of the buy side transactions costs when they reinvested the proceeds. Furthermore, there may have been a time lag from the date of the redemption request to the time the Plans had fully redeployed the proceeds. This time lag would have imposed an opportunity cost by not being invested in securities that would have had the potential to match the Plans [sic] stated objectives.
With respect to any future Redemptions, as a condition of the proposed exemption, the Independent Fiduciary will also perform such a post-transaction review within 180 days of the date of the Redemption.
9. In summary, the applicant represents that the Redemptions have satisfied, and will satisfy, the statutory criteria for an exemption under section 408(a) of the Act for the following reasons:
(A) The Plan pays no sales commissions, redemption fees, or other similar fees in connection with the Redemption (other than customary transfer charges paid to parties other than GEAM and GEAM Affiliates);
(B) The assets transferred to the Plan pursuant to the Redemption consist entirely of cash and Transferable Securities;
(C) With certain exceptions described below, the Plan receives in any Redemption its pro rata portion of the securities that, when added to the cash received, is equal in value to the number of Shares redeemed, as determined in a single valuation performed in the same manner and as of 4 p.m. (local time for the New York Stock Exchange) on the same day, in accordance with Rule 2a-4 under the 1940 Act, and the then-existing procedures established by the Board of Trustees of the Mutual Fund (using sources independent of GEAM and GEAM Affiliates). Notwithstanding the foregoing, Transferable Securities that are odd lot securities, fractional shares, and accruals on such securities may be distributed in cash;
(D) Neither GEAM, nor any GEAM Affiliate, receives any direct or indirect
(E) Prior to a Redemption, GEAM provides in writing to an Independent Fiduciary a full and detailed written disclosure of information regarding the Redemption;
(F) Prior to a Redemption, the Independent Fiduciary provides written authorization for such Redemption to GEAM, such authorization being terminable at any time prior to the date of Redemption without penalty to the Plan;
(G) Before authorizing a Redemption, based on the disclosures provided by GEAM to the Independent Fiduciary, the Independent Fiduciary determines that the terms of the Redemption are fair to the Plan, and comparable to, and no less favorable than, terms obtainable at arm's length between unaffiliated parties, and that the Redemption is in the best interests of the Plan and its participants and beneficiaries;
(H) Not later than thirty (30) business days after the completion of a Redemption, the Mutual Fund will provide to the Independent Fiduciary a written confirmation regarding such Redemption containing:
(i) The total number of Shares of the Mutual Fund and the percentage held by the Plan immediately before the Redemption (and the related per Share net asset value and the total dollar value of the Shares held);
(ii) The identity (and related aggregate dollar value) of each security provided to the Plan pursuant to the Redemption, including each security valued in accordance with Rule 2a-4 under the 1940 Act and the then-existing procedures established by the Board of Trustees of the Mutual Fund (using sources independent of GEAM and GEAM Affiliates);
(iii) The current market price of each security received by the Plan pursuant to the Redemption; and
(iv) The identity of each pricing service or market-maker consulted in determining the value of such securities;
(I) The value of the securities received by the Plan for each redeemed Share, when added to the cash received, equals the net asset value of such Share at the time of the transaction, and such value equals the value that would have been received by any other investor for shares of the same class of the Mutual Fund at that time;
(J) Subsequent to a Redemption, within 180 days of the date of such Redemption, the Independent Fiduciary performs a post-transaction review that will include, among other things, testing a sampling of material aspects of the Redemption deemed in its judgment to be representative, including pricing;
(K) Each of the Plan's dealings with the Mutual Funds, the investment advisers to the Mutual Funds, the principal underwriter for the Mutual Funds, or any affiliated person thereof, are on a basis no less favorable to the Plan than dealings between the Mutual Funds and other shareholders holding shares of the same class as the Shares.
Ms. Karin Weng of the Department, telephone (202) 693-8557. (This is not a toll-free number.)
The Department is considering granting an exemption under the authority of section 4975(c)(2) of the Code and in accordance with the procedures set forth in 29 CFR Part 2570, Subpart B (55 FR 32836, 32847, August 10, 1990).
If the exemption is granted, the sanctions resulting from the application of section 4975 of the Code, by reason of section 4975(c)(1)(A) through (E) of the Code, shall not apply to the past sale, on March 28, 2006, by the William T. Smith IRA (the IRA) of certain bonds (the Bonds) to Middleburg, a disqualified person with respect to the IRA.
This proposed exemption is conditioned upon adherence to the material facts and representations described herein and upon satisfaction of the following conditions:
(a) The sale was a one-time transaction for cash;
(b) The sale price for the Bonds was based on the Bonds' face value;
(c) The Bonds' face value was in excess of bids for the Bonds solicited from independent brokers and in excess of the price for the Bonds quoted by an independent valuation service for the date of the sale;
(d) Neither the IRA nor Mr. William T. Smith, the owner of the IRA, paid any fees, commissions, or other costs or expenses associated with the sale;
(e) The IRA received its portion of income and all interest accrued on the Bonds through the date of the sale;
(f) The terms and conditions of the sale were at least as favorable to the IRA as those obtainable in an arm's length transaction with an unrelated party; and
(g) Within 30 days of the publication of the grant notice in the
1. The plan to which the proposed exemption applies is an individual retirement account described under section 408(a) of the Code. The IRA is a “traditional IRA” in that the custodian, rather than the IRA account holder, makes the investment decisions for such plan. Mr. William T. Smith is the IRA account holder. As of February 28, 2006, the IRA had total assets having a fair market value of $578,193.89.
Middleburg,
2. On June 28, 2005, Middleburg purchased 200 Federal Home Loan Bank (FHLB) bonds having a combined face value of $200,000.00.
3. In February 2006, Mr. Smith decided to move his IRA to another custodian. As a result, he requested that Middleburg liquidate all of his IRA holdings in order to transfer cash to the new custodian. While attempting to liquidate the Bonds held by the IRA, Middleburg discovered that the issue would trade only in $100,000.00 blocks. Middleburg represents that the salesman neglected to mention this limitation when the Bonds were first purchased. As a result, this limitation made the Bonds held in the IRA illiquid.
4. In order to satisfy Mr. Smith's request, Middleburg decided that it needed to make a market for the Bonds held in the IRA. To ensure that the transaction would occur on terms that were at least as favorable as an arm's length sale to a third party, Middleburg represents that it solicited bids as if it had $100,000.00 worth of the Bonds to sell. The bids from various independent dealers ranged from $99.50 to $99.80 per $100.00 of Bond value, or $99,500 to $99,800, respectively. In addition, Middleburg advertised the Bonds all day on March 28, 2006.
5. Middleburg decided that it would buy the Bonds held by the IRA at their full face value of $100 per $100 of Bond value, which exceeded the fair market value at the time. In this regard, the Bond's fair market value, as quoted by Bloomberg Fair Value Service on March 28, 2006, the trade date, was $99.87 per $100 of Bond value or $24,968 for the Bonds. Thus, Middleburg paid the IRA $25,000.00, plus accrued interest of $3.47, or a total purchase price of $25,003.47 for the Bonds. Middleburg did not charge the IRA any fees or commissions in connection with the transaction. Because the IRA sustained a loss as a result of the sale, Middleburg will pay the IRA $196.53 within 30 days of the publication of the grant notice in the
6. In summary, Middleburg represents that the subject transaction satisfied or will satisfy the statutory criteria for an exemption under section 4975(c)(2) of the Code for the following reasons: (a) The sale was a one-time transaction for cash; (b) the sale price for the Bonds was based on the Bonds' face value; (c) the Bonds' face value was in excess of bids for the Bonds solicited from independent brokers and in excess of the price for the Bonds quoted by an independent valuation service for the date of the sale; (d) the IRA paid no fees, commissions, or other costs or expenses associated with the sale; (e) the IRA received its portion of income and all interest accrued on the Bonds through the date of the sale; (f) the terms and conditions of the sale were at least as favorable to the IRA as those obtainable in an arm's length transaction with an unrelated party; and (g) within 30 days of the publication of the grant notice in the
Because Mr. Smith is the only participant in the IRA, it has been determined that there is no need to distribute the notice of proposed exemption to interested persons. Therefore, comments and requests for a hearing must be received by the Department within 30 days of the date of publication of the proposed exemption in the
Ms. Blessed Chuksorji of the Department, telephone number (202) 693-8567. (This is not a toll-free number.)
The Department is considering granting an exemption under the authority of section 408(a) of the Act (or ERISA) and section 4975(c)(2) of the Code, and in accordance with the procedures set forth in 29 CFR part 2570, subpart B (55 FR 32836, 32847, August 10, 1990.)
If the proposed exemption is granted, the restrictions of sections 406(a)(1)(D) and 406(b) of ERISA and the sanctions resulting from the application of section 4975 of the Code, including the loss of exemption of an IRA pursuant to section 408(e)(2)(A) of the Code, by reason of section 4975(c)(1)(D), (E) and (F) of the Code, shall not apply to the receipt of services at reduced or no cost by an individual for whose benefit an IRA or, if self-employed, a Keogh Plan, is established or maintained, or by members of his or her family, from Citigroup pursuant to an arrangement in which the account value of, or the fees incurred for services provided to, the IRA or Keogh Plan is taken into account for purposes of determining eligibility to receive such services, provided that each condition of Section II of this exemption is satisfied.
(a) The IRA or Keogh Plan whose account value, or whose fees paid, are taken into account for purposes of determining eligibility to receive services under the arrangement must be established and maintained for the exclusive benefit of the participant covered under the IRA or Keogh Plan, his or her spouse or their beneficiaries.
(b) The services offered under the arrangement must be of a type that a qualified affiliate could offer consistent with all applicable federal and state banking laws and all applicable federal and state laws regulating broker-dealers.
(c) The services offered under the arrangement must be provided by a qualified affiliate in the ordinary course of its business as a bank or a broker-dealer to customers who qualify for reduced or no cost services, but do not maintain IRAs or Keogh Plans with a qualified affiliate.
(d) For the purpose of determining eligibility to receive services, the arrangement satisfies:
(i) Eligibility requirements based on the account value of the IRA or Keogh Plan are as favorable as any such requirement based on the value of any other type of account which the qualified affiliate includes to determine eligibility; and/or
(ii) Eligibility requirements based on the amount of fees incurred by the IRA or Keogh Plan, are as favorable as any requirements based on the amount of fees incurred by any other type of account which the qualified affiliate includes to determine eligibility.
(e) The combined total of all fees for the provision of services to the IRA or Keogh Plan is not in excess of reasonable compensation within the meaning of section 408(b)(2) of ERISA and section 4975(d)(2) of the Code.
(f) The investment performance of the investments made by the IRAs and/or Keogh Plans is no less favorable than the investment performance of identical investments that could have been made at the same time by a customer of Citigroup who is not eligible for (or who does not receive) reduced or no cost services.
(g) The services offered under the arrangement to the IRA or Keogh Plan customer must be the same as are offered to non-IRA or non-Keogh Plan customers of qualified affiliates with
The following definitions apply to this exemption:
(a) The term “bank” means a bank described in section 408(n) of the Code.
(b) The term “broker-dealer” means a broker-dealer registered under the Securities Exchange Act of 1934, as amended.
(c) The term “IRA” means an individual retirement account described in Code section 408(a), an individual retirement annuity described in Code section 408(b) or a Coverdell education savings account described in section 530 of the Code. For purposes of this exemption, the term IRA shall not include an IRA which is an employee benefit plan covered by Title I of ERISA, except for a Simplified Employee Pension (SEP) described in section 408(k) of the Code or a Simple Retirement Account described in section 408(p) of the Code which provides participants with the unrestricted authority to transfer their balances to IRAs or Simple Retirement Accounts sponsored by different financial institutions.
(d) The term “Keogh Plan” means a pension, profit-sharing, or stock bonus plan qualified under Code section 401(a) and exempt from taxation under Code section 501(a) under which some or all of the participants are employees described in section 401(c) of the Code. For purposes of this exemption, the term Keogh Plan shall not include a Keogh Plan which is an employee benefit plan covered by Title I of ERISA.
(e) The term “account value” means investments in cash or securities held in the account for which market quotations are readily available. For purposes of this exemption, the term cash shall include savings accounts that are insured by a federal deposit insurance agency and constitute deposits as that term is defined in 29 CFR 2550.408b-4(c)(3). The term account value shall not include investments that are offered by Citigroup (or a qualified affiliate) exclusively to IRAs and Keogh Plans.
(f) The term “qualified affiliate” means any person directly or indirectly controlling, controlled by, or under common control with Citigroup Inc. that is a bank or broker-dealer.
(g) The term “members of his or her family” refers to beneficiaries of the individual for whose benefit the IRA or Keogh Plan is established or maintained, who would be members of the family as that term is defined in Code section 4975(e)(6), or a brother, a sister, or a spouse of a brother or sister.
(h) The term “service” includes incidental products of a de minimis value which are directly related to the provision of services covered by the exemption.
(i) The term “fees” means commissions and other fees received by a broker-dealer from the IRA or Keogh Plan for the provision of services, including, but not limited to, brokerage commissions, investments management fees, investments advisory fees, custodial fees and administrative fees.
(j) The term “Citigroup” means Citigroup Inc. and any person directly or indirectly controlling, controlled by, or under common control with Citigroup Inc.
(k) The term “control” means the power to exercise a controlling influence over the management or policies of a person other than an individual.
1. Citigroup, Inc. is a holding company whose businesses provide a broad range of financial services to consumer and corporate customers around the world. As of September 30, 2006, Citigroup and its subsidiaries had total consolidated assets of approximately $1.75 trillion. Citigroup's consumer and corporate banking business is a global franchise encompassing, among other things, branch and electronic banking, consumer lending services, investment services, and credit and debit card services. Citigroup also provides securities trading, research and brokerage services to consumer and corporate customers, primarily through its Smith Barney business. Smith Barney, a division of a subsidiary of Citigroup Inc., is a retail brokerage firm with more than 12,500 financial advisors who serve approximately 7.1 million client accounts, representing approximately $1.3 trillion in assets, and are located in approximately 600 offices across the United States. In the ordinary course of its business, Citigroup provides a range of financial services to IRAs and pension, profit sharing and stock bonus plans qualified under section 401(a) of the Code under which some or all of the participants are employees described in section 401(c) of the Code.
2. PTE 93-33 as amended (64 FR 11044, March 8, 1999), provides relief from the restrictions of sections 406(a)(1)(D) and 406(b) of ERISA and the sanctions resulting from the application of sections 4975(a) and (b), 4975(c)(3) and 408(e)(2) of the Code by reason of section 4975(c)(1)(D), (E) and (F) of the Code, and permits the receipt of services at reduced or no cost by an individual for whose benefit an IRA or Keogh Plan is established or maintained or by members of his or her family, from a bank pursuant to an arrangement in which the account balance of the IRA or Keogh Plan is taken into account for purposes of determining eligibility to receive such services, provided the conditions of the exemption are met. PTE 93-33 permitted banks to offer its customers only those services that may be offered by banks under applicable federal and state banking laws.
PTE 97-11 as amended, (67 FR 76425, December 12, 2002) permits the receipt of services at reduced or no cost by an individual for whose benefit an IRA or Keogh Plan is established or maintained or by members of his or her family, from a broker-dealer registered under the Securities Exchange Act of 1934 pursuant to an arrangement in which the account value of, or the fees incurred for services provided to, the IRA or Keogh Plan is/are taken into account for purposes of determining eligibility to receive such services, provided that certain conditions are met. Under PTE 97-11 relief is provided from the restrictions of sections 406(a)(1)(D) and 406(b) of ERISA and the sanctions resulting from the application of sections 4975(a) and (b), 4975(c)(3) and 408(e)(2) of the Code by reason of section 4975(c)(1)(D), (E) and (F) of the Code. PTE 97-11 limits the services that may be offered by broker-dealers under a relationship brokerage program to those services that the broker-dealer itself may offer consistent with federal and state laws regulating broker-dealers.
The applicant requests an exemption to permit both account balances of an IRA or Keogh Plan or fees incurred by the IRA or Keogh Plan with respect to a qualified affiliate that serves as trustee or custodian, to be taken into account by Citigroup in determining eligibility to receive reduced or no cost services that are provided by its qualified affiliates.
3. The applicant represents that the proposed exemption is necessary and appropriate because federal and state banking and securities laws have undergone changes since PTEs 93-33 and 97-11 were granted. In general, banks and broker-dealers are now permitted to offer services to its customers that integrate banking and broker-dealer type services. These services were traditionally provided either by a bank to its customers or by a broker-dealer to its customers. Specifically, PTEs 93-33 and PTE 97-11 were granted by the Department prior to the enactment of the Gramm-Leach-Bliley Act of 1999 (the “GLBA”). According to the applicant, the GLBA altered the U.S. legal and regulatory framework governing the operations of U.S. bank holding companies such as Citigroup, the corporate parent of Citibank, N.A. (“Citibank”) and Citigroup Global Capital Markets Inc. (“CGMI”), the broker-dealer within which Smith Barney operates as a business division. The applicant represents that the GLBA permits bank holding companies that qualify as “financial holding companies” (“FHCs”)—including Citigroup—to affiliate broadly with various types of financial services firms, including full-service U.S. broker-dealers. Further, the enactment of the GLBA has greatly facilitated both financial services integration in the United States and the growth of bank-affiliated securities operations.
According to the applicant, a second significant U.S. regulatory development occurred in 1995 when the U.S. Federal Reserve Board (the FRB) adopted a rule regarding inter-affiliate combined balance discount service programs offered to individual customers of banks and bank affiliates.
In the context of the regulatory developments described above, the applicant states that Citigroup's decision to offer discount services as described in its application reflects the important changes in Citigroup's business model that have occurred since PTEs 93-33 and 97-11 were granted by the Department. The applicant states that in 1998, Citigroup was created through the acquisition of Citicorp, Citibank's corporate parent, by Travelers Group, to form Citigroup. As part of this transaction, Citibank became affiliated with Smith Barney (formerly, Salomon Smith Barney), which operates a significant retail securities brokerage business.
4. The transactions covered by the proposed exemption are the receipt of services at reduced or no cost by an individual for whose benefit an IRA or, if self-employed, a Keogh Plan account, is established or maintained, or by members of his or her family, from Citigroup, pursuant to an arrangement in which the account balance of, or fees paid by, the IRA or Keogh Plan account is taken into account for purposes of determining eligibility to receive the reduced or no cost services. The proposed exemption does not apply to IRAs or Keogh Plans that are covered by Title I of ERISA except for a Simplified Employee Pension (SEP) described in section 408(k) of the Code or a Simple Retirement Account described in section 408(p) of the Code which provides participants with the unrestricted authority to transfer their balances to IRAs or Simple Retirement Accounts sponsored by different financial institutions. The IRA or Keogh Plan account must be established or maintained for the exclusive benefit of the participant covered by the IRA or Keogh Plan, or his family members. The services must be of a type that either a bank or broker-Dealer could offer consistent with all federal and state laws applicable to their businesses. Citigroup provides such services to its customers, including customers who do not maintain IRAs or Keogh Plans with Citigroup, in the regular course of Citigroup's business. The account balance or fee level required for the receipt of reduced or no cost services is equal to the lowest level required for any other type of account which is used to determine eligibility to receive reduced or no cost services. The investment performance of the IRA or Keogh Plan account's investments is no less favorable than the investment performance of identical investments that could have been made at the same time by a customer who is not eligible for (or who does not receive) reduced or no cost services.
5. As part of its reduced or no cost service program, the applicant contemplates providing such services as: Reductions or waivers of fees for services such as checking, ATM, investment advisory and account opening or maintenance fees, preferred lending rates, premium interest crediting rates, credit or debit cards providing services such as enhanced mileage accumulation and reward points features and the provision of investment information and seminars that are available on an invitation-only basis. In this regard, the applicant offers the following example of a reduced or no cost service program:
An individual client of Citigroup is a beneficial owner of an IRA with assets of $250,000 and with respect to which Smith Barney is custodian. Un-invested cash in the IRA is swept into a bank deposit program (“BDP”) on a daily basis, pursuant to the client's instruction. Assume that the client also maintains a Smith Barney Financial Management Account (“FMA Account”), a securities brokerage account, with an asset balance of $200,000, as well as personal savings and checking accounts, with an aggregate asset balance of $100,000, at Citibank. Without the proposed exemption, the client is not eligible for “Reserved” status in regard to the relationship with his Smith Barney custodied accounts (FMA Account
If the proposed exemption is granted, Citigroup would be permitted to aggregate the client's accounts (in accordance with the conditions of the exemption), and the combined asset balance in excess of $500,000 would result in an elimination of the $100 and $40 annual fees. In addition, the BDP investments would be eligible for a higher interest rate, equal to 3.51% Annual Percentage Yield as of June 13, 2007. Further, as part of a Reserved relationship, Smith Barney would waive the following fees (among others) in the client's FMA Account: ATM fees, shipping costs for lost or stolen cards, fees for transferring securities, safekeeping fees for physically holding securities, Fed wire fees, fees charged for bounced checks, fees charged to stop payment on a check, and check reorder fees.
6. In summary, the Applicant represents that the transactions will satisfy the statutory criteria for an exemption under section 408(a) of the Act and section 4975(c)(2) since, among other things:
(a) The IRA or Keogh Plan whose account value, or whose fees paid, are taken into account for purposes of determining eligibility to receive services under the arrangement will be established and maintained for the exclusive benefit of the participant covered under the IRA or Keogh Plan, his or her spouse or their beneficiaries.
(b) The services offered under the arrangement will be of a type that a qualified affiliate could offer consistent with all applicable federal and state banking laws and all applicable federal and state laws regulating broker-dealers.
(c) The services offered under the arrangement will be provided by a qualified affiliate in the ordinary course of its business as a bank or a broker-dealer to customers who qualify for reduced or no cost services, but do not maintain IRAs or Keogh Plans with a qualified affiliate.
(d) For the purpose of determining eligibility to receive services, the arrangement will satisfy:
(i) Eligibility requirements based on the account value of the IRA or Keogh Plan are as favorable as such requirements based on the value of any other type of account which the qualified affiliate includes to determine eligibility; and/or
(ii) Eligibility requirements based on the amount of fees incurred by the IRA or Keogh Plan, are as favorable as any requirements based on the amount of fees incurred by any other type of account which the qualified affiliate includes to determine eligibility.
(e) The combined total of all fees for the provision of services to the IRA or Keogh Plan will not be in excess of reasonable compensation within the meaning of section 408(b)(2) of ERISA and section 4975(d)(2) of the Code.
(f) The investment performance of the investments made by the IRAs and/or Keogh Plans will be no less favorable than the investment performance of identical investments that could have been made at the same time by a customer of Citigroup who is not eligible for (or who does not receive) reduced or no cost services.
(g) The services offered under the arrangement to the IRA or Keogh Plan customer will be the same as are offered to non-IRA or non-Keogh Plan customers of qualified affiliates with account values of the same amount or the same amount of fees generated.
The Applicant represents that because those potentially interested persons cannot all be identified at the time this proposed exemption is published in the
Allison Padams-Lavigne, U.S. Department of Labor, telephone (202) 693-8564. (This is not a toll-free number.)
The attention of interested persons is directed to the following:
(1) The fact that a transaction is the subject of an exemption under section 408(a) of the Act and/or section 4975(c)(2) of the Code does not relieve a fiduciary or other party in interest or disqualified person from certain other provisions of the Act and/or the Code, including any prohibited transaction provisions to which the exemption does not apply and the general fiduciary responsibility provisions of section 404 of the Act, which, among other things, require a fiduciary to discharge his duties respecting the plan solely in the interest of the participants and beneficiaries of the plan and in a prudent fashion in accordance with section 404(a)(1)(b) of the Act; nor does it affect the requirement of section 401(a) of the Code that the plan must operate for the exclusive benefit of the employees of the employer maintaining the plan and their beneficiaries;
(2) Before an exemption may be granted under section 408(a) of the Act and/or section 4975(c)(2) of the Code, the Department must find that the exemption is administratively feasible, in the interests of the plan and of its participants and beneficiaries, and protective of the rights of participants and beneficiaries of the plan;
(3) The proposed exemptions, if granted, will be supplemental to, and not in derogation of, any other provisions of the Act and/or the Code, including statutory or administrative exemptions and transitional rules. Furthermore, the fact that a transaction is subject to an administrative or statutory exemption is not dispositive of whether the transaction is in fact a prohibited transaction; and
(4) The proposed exemptions, if granted, will be subject to the express condition that the material facts and representations contained in each application are true and complete, and that each application accurately describes all material terms of the transaction which is the subject of the exemption.
In accordance with section 223 of the Trade Act of 1974 (19 U.S.C. 2273), and section 246 of the Trade Act of 1074 (26 U.S.C. 2813), as amended, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance on October 27, 2006,
At the request of the State agency, the Department reviewed the certification for workers of the subject firm. The workers were engaged in the production (assemble, test, etc.) of flash memory test systems.
New information shows that when Benchmark Electronics, Inc., Loveland Division, closed in November 2006, a customer, Verigy US Development, retained the on-site leased workers from Volt Services Group to complete their outstanding orders of flash memory test systems.
Accordingly, the Department is amending the certification to include on-site leased workers who were retained by Verigy US Development.
The intent of the Department's certification is to include all workers of Benchmark Electronics, Inc., Loveland Division who were adversely affected by increased customer imports.
The amended notice applicable to TA-W-60,023 is hereby issued as follows:
“All workers of Benchmark Electronics, Inc., Loveland Division, including on-site leased workers from Volt Services Group who were retained by Verigy US Development, Loveland, Colorado, who became totally or partially separated from employment on or after September 6, 2005, through October 27, 2008, are eligible to apply for adjustment assistance under Section 223 of the Trade Act of 1974, and are also eligible to apply for alternative trade adjustment assistance under Section 246 of the Trade Act of 1974.”
In accordance with Section 223 of the Trade Act of 1974 (19 U.S.C. 2273), and Section 246 of the Trade Act of 1974 (26 U.S.C. 2813), as amended, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance on October 11, 2007, applicable to workers of Fujitsu Ten Corporation of America, Rushville Indiana Operations, including on-site leased workers of Personnel Management, Inc., Rushville, Indiana. The notice will be published soon in the
At the request of the State agency, the Department reviewed the certification for workers of the subject firm. The workers are engaged in the production of automotive electronic controls.
The review of the investigation record shows that the Department inadvertently excluded from the certification on-site leased workers from Penmack.
Accordingly, the Department is amending this certification to include on-site leased workers from Penmack. The workers of Penmack at the Rushville site are sufficiently under the control of Fujitsu Corporation of America to be considered leased workers.
The amended notice applicable to TA-W-62,073 is hereby issued as follows:
“All workers of Fujitsu Ten Corporation of America, Rushville Indiana Operations, including on-site leased workers of Personnel Management, Inc. and Penmack, Rushville, Indiana, who became totally or partially separated from employment on or after August 28, 2006, through October 11, 2009, are eligible to apply for adjustment assistance under Section 223 of the Trade Act of 1974, and are also eligible to apply for alternative trade adjustment assistance under Section 246 of the Trade Act of 1974.”
In accordance with Section 223 of the Trade Act of 1974, as amended (19 U.S.C. 2273) the Department of Labor herein presents summaries of determinations regarding eligibility to apply for trade adjustment assistance for workers (TA-W) number and alternative trade adjustment assistance (ATAA) by (TA-W) number issued during the period of
In order for an affirmative determination to be made for workers of a primary firm and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of Section 222(a) of the Act must be met.
I. Section (a)(2)(A) all of the following must be satisfied:
A. A significant number or proportion of the workers in such workers' firm, or an appropriate subdivision of the firm, have become totally or partially separated, or are threatened to become totally or partially separated;
B. the sales or production, or both, of such firm or subdivision have decreased absolutely; and
C. increased imports of articles like or directly competitive with articles produced by such firm or subdivision have contributed importantly to such workers' separation or threat of separation and to the decline in sales or production of such firm or subdivision; or
II. Section (a)(2)(B) both of the following must be satisfied:
A. A significant number or proportion of the workers in such workers' firm, or an appropriate subdivision of the firm, have become totally or partially separated, or are threatened to become totally or partially separated;
B. there has been a shift in production by such workers' firm or subdivision to a foreign country of articles like or directly competitive with articles which are produced by such firm or subdivision; and
C. One of the following must be satisfied:
1. The country to which the workers' firm has shifted production of the articles is a party to a free trade agreement with the United States;
2. the country to which the workers' firm has shifted production of the articles to a beneficiary country under the Andean Trade Preference Act, African Growth and Opportunity Act, or the Caribbean Basin Economic Recovery Act; or
3. there has been or is likely to be an increase in imports of articles that are like or directly competitive with articles which are or were produced by such firm or subdivision.
Also, in order for an affirmative determination to be made for secondarily affected workers of a firm and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of Section 222(b) of the Act must be met.
(1) Significant number or proportion of the workers in the workers' firm or an appropriate subdivision of the firm have become totally or partially separated, or are threatened to become totally or partially separated;
(2) the workers' firm (or subdivision) is a supplier or downstream producer to a firm (or subdivision) that employed a group of workers who received a certification of eligibility to apply for trade adjustment assistance benefits and such supply or production is related to the article that was the basis for such certification; and
(3) either—
(A) The workers' firm is a supplier and the component parts it supplied for the firm (or subdivision) described in paragraph (2) accounted for at least 20 percent of the production or sales of the workers' firm; or
(B) a loss or business by the workers' firm with the firm (or subdivision) described in paragraph (2) contributed importantly to the workers' separation or threat of separation.
In order for the Division of Trade Adjustment Assistance to issue a certification of eligibility to apply for Alternative Trade Adjustment Assistance (ATAA) for older workers, the group eligibility requirements of Section 246(a)(3)(A)(ii) of the Trade Act must be met.
1. Whether a significant number of workers in the workers' firm are 50 years of age or older.
2. Whether the workers in the workers' firm possess skills that are not easily transferable.
3. The competitive conditions within the workers' industry (i.e., conditions within the industry are adverse).
The following certifications have been issued. The date following the company name and location of each determination references the impact date for all workers of such determination.
The following certifications have been issued. The requirements of Section 222(a)(2)(A) (increased imports) of the Trade Act have been met.
The following certifications have been issued. The requirements of Section 222(a)(2)(B) (shift in production) of the Trade Act have been met.
The following certifications have been issued. The requirements of Section 222(b) (supplier to a firm whose workers are certified eligible to apply for TAA) of the Trade Act have been met.
The following certifications have been issued. The requirements of Section 222(b) (downstream producer for a firm whose workers are certified eligible to apply for TAA based on increased imports from or a shift in production to Mexico or Canada) of the Trade Act have been met.
The following certifications have been issued. The date following the company name and location of each determination references the impact date for all workers of such determination.
The following certifications have been issued. The requirements of Section 222(a)(2)(A) (increased imports) and Section 246(a)(3)(A)(ii) of the Trade Act have been met.
The following certifications have been issued. The requirements of Section 222(a)(2)(B) (shift in production) and Section 246(a)(3)(A)(ii) of the Trade Act have been met.
The following certifications have been issued. The requirements of Section 222(b) (supplier to a firm whose workers are certified eligible to apply for TAA) and Section 246(a)(3)(A)(ii) of the Trade Act have been met.
The following certifications have been issued. The requirements of Section
In the following cases, it has been determined that the requirements of 246(a)(3)(A)(ii) have not been met for the reasons specified.
The Department has determined that criterion (1) of Section 246 has not been met. The firm does not have a significant number of workers 50 years of age or older.
The Department has determined that criterion (2) of Section 246 has not been met. Workers at the firm possess skills that are easily transferable.
The Department has determined that criterion (3) of Section 246 has not been met. Competition conditions within the workers' industry are not adverse.
In the following cases, the investigation revealed that the eligibility criteria for worker adjustment assistance have not been met for the reasons specified.
Because the workers of the firm are not eligible to apply for TAA, the workers cannot be certified eligible for ATAA.
The investigation revealed that criteria (a)(2)(A)(I.A.) and (a)(2)(B)(II.A.) (employment decline) have not been met.
The investigation revealed that criteria (a)(2)(A)(I.B.) (Sales or production, or both, did not decline) and (a)(2)(B)(II.B.) (shift in production to a foreign country) have not been met.
The investigation revealed that criteria (a)(2)(A)(I.C.) (increased imports) and (a)(2)(B)(II.B.) (shift in production to a foreign country) have not been met.
The workers' firm does not produce an article as required for certification under Section 222 of the Trade Act of 1974.
The investigation revealed that criteria of Section 222(b)(2) has not been met. The workers' firm (or subdivision) is not a supplier to or a downstream producer for a firm whose workers were certified eligible to apply for TAA.
I hereby certify that the aforementioned determinations were issued during the period of
Pursuant to Section 221 of the Trade Act of 1974, as amended, an investigation was initiated on October 9, 2007 in response to a petition filed by a company official on behalf of workers of Lamplight Farms, Menomonee Falls, Wisconsin.
The petitioner has requested that the petition be withdrawn. Consequently, the investigation has been terminated.
Pursuant to Section 221 of the Trade Act of 1974, as amended, an investigation was initiated on October 4, 2007 in response to a petition filed by a company official on behalf of workers of Manpower Incorporated, Spring Lake, Michigan.
All workers of the subject firm are covered by a certification of eligibility to apply for worker adjustment assistance and alternative trade adjustment assistance under petition number TA-W-61,530 (amended), that does not expire until August 23, 2009.
Consequently, further investigation in this case would serve no purpose and the investigation under this petition has been terminated.
By application dated September 17, 2007, the petitioner requested administrative reconsideration of the Department's negative determination regarding eligibility to apply for Trade Adjustment Assistance (TAA), applicable to workers and former workers of the subject firm. The denial notice was signed on September 7, 2007 and published in the
Pursuant to 29 CFR 90.18(c) reconsideration may be granted under the following circumstances:
(1) If it appears on the basis of facts not previously considered that the determination complained of was erroneous;
(2) if it appears that the determination complained of was based on a mistake in the determination of facts not previously considered; or
(3) if in the opinion of the Certifying Officer, a misinterpretation of facts or of the law justified reconsideration of the decision.
The petition for the workers of Molon Motor and Coil Corporation, El Paso, Texas engaged in production of vacuum cleaner motors was denied because the “contributed importantly” group eligibility requirement of Section 222 of the Trade Act of 1974, as amended, was not met. The “contributed importantly” test is generally demonstrated through a
The petitioner attached a letter from the subject firm's customer indicating that this customer “discontinued use of the Molon motors in favor of an Asian sourced motor” and that this customer “was the sole customer using the motors produced” at the subject firm.
The Department contacted the sole customer of the subject firm for further clarification. The customer confirmed that even though his firm is a U.S. based company, the production facility for which the vacuum cleaner motors were purchased is located in Mexico. The customer stated that all vacuum cleaner motors purchased from the subject firm were shipped directly to the Mexican facility and thus were exports. This facility in Mexico is now purchasing vacuum cleaner motors from Asia and there was no increase in imports of vacuum cleaner motors into the United States by this customer. Therefore, the loss of business at the subject firm is attributed to a loss in export sales.
After review of the application and investigative findings, I conclude that there has been no error or misinterpretation of the law or of the facts which would justify reconsideration of the Department of Labor's prior decision. Accordingly, the application is denied.
In accordance with Section 223 of the Trade Act of 1974 (19 U.S.C. 2273), and Section 246 of the Trade Act of 1974 (26 U.S.C. 2813), as amended, the Department of Labor issued a Certification of Eligibility To Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance on June 15, 2007, applicable to workers of National Braid Manufacturing Co., Long Island City, New York. The notice was published in the
At the request of the State agency, the Department reviewed the certification for workers of the subject firm. The workers were engaged in the production of trimmings for textiles.
New information shows that the correct name of the subject firm should read National Braid Manufacturing Co., also known as Long Island City Trim. Workers separated from employment at the subject firm had their wages reported under a separate unemployment insurance (UI) tax accounts for National Braid Manufacturing Co., also known as Long Island City Trim.
Accordingly, the Department is amending this certification to correctly identify the name of the subject firm.
The intent of the Department's certification is to include all workers of National Braid Manufacturing Co., Long Island City, New York, who were adversely affected by increased company imports of trimmings for textiles.
The amended notice applicable to TA-W-61,555 is hereby issued as follows:
“All workers of National Braid Manufacturing Co., also known as Long Island City Trim, Long Island City, New York, who became totally or partially separated from employment on or after May 15, 2006, through June 15, 2009, are eligible to apply for adjustment assistance under Section 223 of the Trade Act of 1974, and are also eligible to apply for alternative trade adjustment assistance under Section 246 of the Trade Act of 1974.”
National Science Foundation.
Notice of permit applications received under the Antarctic Conservation Act.
Notice is hereby given that the National Science Foundation (NSF) has received a waste management permit application for operation of a remote field support and emergency provisions helicopter flight seeing for the Motor Vessel,
Interested parties are invited to submit written data, comments, or views with respect to this permit application by November 26, 2007. Permit applications may be inspected by interested parties at the Permit Office, address below.
Comments should be addressed to Permit Office, Room 755, Office of Polar Programs, National Science Foundation, 4201 Wilson Boulevard, Arlington, Virginia 22230.
Dr. Polly A. Penhale, Environmental Officer, at the above address or (703) 292-8030.
NSF's Antarctic Waste Regulation, 45 CFR part 671, requires all U.S. citizens and entities to obtain a permit for the use or release of a designated pollutant in Antarctica, and for the release of waste in Antarctica. NSF has received a permit application under this Regulation for a team of eight traveling with the
Application for the permit is made by: Jon S. Bowermaster, OCEANS 8 Productions, Box 730, Stone Ridge, NY 12484.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463 as amended), the National Science Foundation announces the following meeting:
Hilton Arlington Hotel, 950 North Stafford Street, Arlington, Virginia.
Science and Technology Policy Institute (STPI), 1899 Pennsylvania Ave, NW., Washington, DC.
Office of Science and Technology Policy (OSTP), Old Executive Office Building, Washington, DC.
1 p.m.-4 p.m. Hilton Arlington Hotel. Open—Overview and history of Federally Funded Research and Development Center (FFRDC); Briefings and Panel Discussions.
4:30 p.m.-5:30 p.m. Hilton Arlington, Hotel. Closed—Review of contract.
8 a.m.-9 p.m. Hilton Arlington Hotel. Open—Briefings and Panel Discussions with Deputy Director, NSF.
9:30 a.m.-12n Science and Technology Policy Institute. Open—Presentations and briefing by STPI.
12n-2 p.m. Science and Technology Policy Institute. Closed—Review and evaluation of the use and need for the Institute.
2:30 p.m.-4:30 p.m. Office of Science and Technology Policy. Closed—Briefings and discussions with OSTP representatives.
8 a.m.-1:30 p.m. Hilton Arlington Hotel. Closed—Meetings with NSF representatives and other government clients. Review and prepare report.
Alaska Industrial X-Ray, Inc., (AIX or Licensee) is the holder of NRC License No. 50-16084-01 issued by the Nuclear Regulatory Commission (NRC or Commission) pursuant to 10 CFR Part 34. The license authorizes the Licensee to conduct industrial radiography at temporary job sites anywhere in the United States where the NRC maintains jurisdiction for regulating licensed material. The license was issued on October 24, 1990, was most recently renewed on March 13, 2001, and is due to expire on March 31, 2011.
On June 4, 2007, the NRC's Office of Investigation (OI) initiated an investigation into AIX's activities at a facility, not owned by AIX, located in Anchorage, Alaska. This off-site facility is owned by an AIX client, and AIX has been performing radiography at that location since the 1990s. Based on information obtained during the investigation, serious concerns were identified concerning the AIX senior managers' oversight of licensed activities and AIX's ability to protect the public health and safety. Specifically, AIX radiographers, including the company Radiation Safety Officer, knowingly conducted radiography activities without the two individuals required by 10 CFR 34.41(a) (sometimes called the 2-person rule). This occurred on numerous instances over a period of up to three years and presented unnecessary risk to the public health and safety.
In the 1990s, AIX constructed a facility that was referred to as a “vault” at its client's facility. AIX applied to the NRC to have the “vault” approved as a Permanent Radiographic Installation as described in 10 CFR 34.33. Radiography conducted in an authorized permanent radiographic installation could be conducted with a single radiographer; otherwise, 10 CFR 34.41(a) requires, in part, that at least two qualified individuals be present during radiography. However, the NRC never approved the “vault” as a Permanent Radiographic Installation because of serious deficiencies in the design and requested further information from AIX. One of the design deficiencies was that the “vault” had very little shielding on most of the front of the vault; the shielding consisted of a lead-lined steel frame gate that was only about 3
The investigation revealed that on numerous occasions over a period of up to three years, AIX would send two qualified individuals to the off-site facility to perform radiography, and that AIX would commence radiography in compliance with 10 CFR 34.41(a).
The NRC notes that enforcement action was taken against AIX on April 25, 2001 (EA-01-015) for a willful failure to follow 10 CFR 34.41(a), while conducting radiography at the same off-site facility. During an OI investigation in 2000, a radiographer admitted he did not always follow the 2-person rule on limited occasions at this same “vault” that AIX had constructed. At the time of the predecisional enforcement conference, AIX was trying to get the “vault” approved as a Permanent Radiographic Installation. The company president and the company radiation safety officer attended the predecisional enforcement conference with AIX on March 13, 2001. A central issue was that the “vault” was not approved as a permanent radiographic installation, and so the radiographer's actions were in violation of 10 CFR 34.41(a). The NRC's April 25, 2001, letter also made this point, and a Notice of Violation was issued to AIX for the violation of 10 CFR 34.41(a). AIX's corrective actions were provided by letters dated February 25, 2001, and March 12, 2001.
The NRC is continuing its review of the information obtained through the investigation. However, based on the information gathered thus far, the NRC has serious concerns about the potential safety consequences inherent in not complying with regulatory requirements during radiography activities. Such activities are among the most risk-significant activities conducted by material licensees and, in the absence of appropriate controls, may lead to significant radiation exposures to individuals. The deficiencies in the design of the “vault” raised numerous questions and did not meet NRC requirements for designation as a Permanent Radiographic Installation. As such, the NRC is concerned that a member of the public could unknowingly be exposed as a result of AIX's failures to follow the 2-person rule. In addition, the NRC has found that AIX radiographers, including the radiation safety officer, have violated 10 CFR 34.41(a) on numerous instances for a period of up to three years, and that the company president, who at a minimum suspected violations were occurring, did not take appropriate actions to stop them. In addition, the NRC had previously issued an escalated enforcement action to AIX for a willful violation of the same regulation at the same location. This conduct undermines the trust the NRC had placed in AIX's senior officials.
Consequently, in light of the above, I lack the requisite reasonable assurance that the Licensee's current operations can be conducted under License No. 50-16084-01 in compliance with the Commission's requirements and that the health and safety of the public, including the Licensee's employees, will be protected. Therefore, the public, health, safety and interest require that License No. 50-16084-01 be suspended in part and that licensed material be placed in locked, safe storage, pending further review of the information in this case. Furthermore, pursuant to 10 CFR 2.202, I find that the significance of the violation and conduct described above is such that the public health, safety and interest require that this Order be immediately effective.
Accordingly, pursuant to Sections 81, 161b, 161i, 182 and 186 of the Atomic Energy Act of 1954, as amended, and the Commission's regulations in 10 CFR 2.202 and 10 CFR part 34,
A. The authority to perform radiographic operations under License No. 50-16084-01 is hereby suspended pending further notice by the NRC. The Licensee shall cease all radiographic operations and return all byproduct material possessed under this license to locked, safe storage at the Licensee's facilities. All other requirements of the License and applicable Commission requirements, including those in 10 CFR part 20 remain in effect.
B. Within 24 hours following issuance of this Order, the Licensee shall contact Mr. Leonard Wert, Director, Division of Nuclear Materials Safety, NRC Region IV, or his designee, through the NRC Operations Center at telephone number (301) 816-5100, and advise him of the current location, physical status, and storage arrangements of licensed material. A written response documenting this information shall be submitted, under oath or affirmation, to the Regional Administrator, U.S. NRC Region IV, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011 within seven days of the date of this Order.
C. If the Licensee removes licensed material from locked storage, the Licensee shall notify NRC Region IV no less than 48 hours before removal of the licensed material. This notice shall be provided to Mr. Leonard Wert, Director, Division of Nuclear Materials Safety, or his designee, at telephone number (817) 860-8106.
D. The Licensee shall not receive any NRC-licensed material while this Order is in effect.
E. All records related to licensed activities shall be maintained in their current form and must not be altered in any way.
F. Within 60 days of the date of this Order, the Licensee shall provide, in writing, specific actions that are acceptable to the NRC and that provide adequate assurance by independent means that the Licensee, if it conducts radiography activities, will comply with NRC regulations.
The Regional Administrator, Region IV, may, in writing, relax or rescind this order upon demonstration by the Licensee of good cause.
In accordance with 10 CFR 2.202, the Licensee must, and any other person adversely affected by this Order may, submit an answer to this Order within 20 days of its issuance. In addition, the Licensee and any other person adversely affected by this Order may request a hearing on this Order within 20 days of its issuance. Where good cause is
A request for a hearing must be filed in accordance with the NRC E-Filing rule, which the NRC promulgated in August, 2007, 72 FR 49,139 (Aug. 28, 2007). The E-Filing process requires participants to submit and serve documents over the Internet or, in some cases, to mail copies on electronic optical storage media. Participants may not submit paper copies of their filings unless they seek a waiver in accordance with the procedures described below.
To comply with the procedural requirements associated with E-Filing, at least five (5) days prior to the filing deadline the requestor must contact the Office of the Secretary by e-mail at
Once a requestor has obtained a digital ID certificate, had a docket created, and downloaded the EIE viewer, it can then submit a request for a hearing through EIE. Submissions should be in Portable Document Format (PDF) in accordance with NRC guidance available on the NRC public Web site at
A person filing electronically may seek assistance through the “Contact Us” link located on the NRC Web site at
Participants who believe that they have good cause for not submitting documents electronically must file a motion, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by (1) first class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville, Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service.
Documents submitted in adjudicatory proceedings will appear in NRC's electronic hearing docket which is available to the public at
If a person other than the Licensee requests a hearing, that person shall set forth with particularity the manner in which his interest is adversely affected by this Order and shall address the criteria set forth in 10 CFR 2.309(d).
If a hearing is requested by a Licensee or a person whose interest is adversely affected, the Commission will issue an Order designating the time and place of any hearings. If a hearing is held, the issue to be considered at such hearing shall be whether this Order should be sustained. Pursuant to 10 CFR 2.202(c)(2)(i), the Licensee, or any other person adversely affected by this Order, may, in addition to demanding a hearing, at the time the answer is filed or sooner, move the presiding officer to set aside the immediate effectiveness of the Order on the ground that the Order, including the need for immediate effectiveness, is not based on adequate evidence but on mere suspicion, unfounded allegations, or error. In the absence of any request for hearing, or written approval of an extension of time in which to request a hearing, the provisions specified in Section IV above shall be final 20 days from the date of this Order without further order or proceedings. If an extension of time for requesting a hearing has been approved, the provisions specified in Section IV shall be final when the extension expires if a hearing request has not been received.
For the Nuclear Regulatory Commission.
The U.S. Nuclear Regulatory Commission (NRC or the Commission) is considering an application for the renewal of Operating License Nos. DPR-66 and NPF-73, which authorize FirstEnergy Nuclear Operating Company (FENOC), to operate Beaver Valley Power Station, Units 1 and 2, respectively, at 2900 megawatts thermal for each unit. The renewed licenses would authorize the applicant to operate Beaver Valley Power Station, Units 1 and 2, for an additional 20 years beyond the period specified in the current licenses. The current operating licenses for Beaver Valley Power Station, Units 1 and 2, expire on January 29, 2016, and May 27, 2026, respectively.
FENOC submitted the application dated August 27, 2007, pursuant to Title 10 of the
The Commission's staff has determined that FENOC has submitted sufficient information in accordance with 10 CFR 54.19, 54.21, 54.22, 54.23, 51.45, and 51.53(c) to enable the staff to undertake a review of the application, and the application is therefore acceptable for docketing. The current Docket Nos. 50-334 and 50-412 for Operating License Nos. DPR-66 and NPF-73, respectively, will be retained. The determination to accept the license renewal application for docketing does not constitute a determination that a renewed license should be issued, and does not preclude the NRC staff from requesting additional information as the review proceeds.
Before issuance of each requested renewed license, the NRC will have made the findings required by the Atomic Energy Act of 1954 (the Act), as amended, and the Commission's rules and regulations. In accordance with 10 CFR 54.29, the NRC may issue a renewed license on the basis of its review if it finds that actions have been identified and have been or will be taken with respect to: (1) Managing the effects of aging during the period of extended operation on the functionality of structures and components that have been identified as requiring aging management review; and (2) time-limited aging analyses that have been identified as requiring review, such that there is reasonable assurance that the activities authorized by the renewed license will continue to be conducted in accordance with the current licensing basis (CLB), and that any changes made to the plant's CLB comply with the Act and the Commission's regulations.
Additionally, in accordance with 10 CFR 51.95(c), the NRC will prepare an environmental impact statement that is a supplement to the Commission's NUREG-1437, “Generic Environmental Impact Statement for License Renewal of Nuclear Power Plants,” dated May 1996. In considering the LRA, the Commission must find that the applicable requirements of Subpart A of 10 CFR part 51 have been satisfied. Pursuant to 10 CFR 51.26, and as part of the environmental scoping process, the staff intends to hold a public scoping meeting. Detailed information regarding the environmental scoping meeting will be the subject of a separate
Within 60 days after the date of publication of this
As required by 10 CFR 2.309, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding, taking into consideration the limited scope of matters that may be considered pursuant to 10 CFR parts 51 and 54. The petition must specifically explain the reasons why intervention should be permitted with particular reference to the following factors: (1) The nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (2) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (3) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The petition must also set forth the specific contentions which the petitioner/requestor seeks to have litigated in the proceeding.
Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the requestor/petitioner shall provide a brief explanation of the bases of each contention and a concise statement of the alleged facts or the expert opinion that supports the contention on which the requestor/petitioner intends to rely in proving the contention at the hearing. The requestor/petitioner must also provide references to those specific sources and documents of which the requestor/petitioner is aware and on which the requestor/petitioner intends to rely to establish those facts or expert opinion. The requestor/petitioner must provide sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact.
The Commission requests that each contention be given a separate numeric or alpha designation within one of the following groups: (1) Technical (primarily related to safety concerns); (2) environmental; or (3) miscellaneous.
As specified in 10 CFR 2.309, if two or more requestors/petitioners seek to co-sponsor a contention or propose substantially the same contention, the requestors/petitioners will be required to jointly designate a representative who shall have the authority to act for the requestors/petitioners with respect to that contention.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing. A request for hearing or a petition for leave to intervene must be filed in accordance with the NRC E-Filing rule, which the NRC promulgated in August 2007, 72 FR 49, 139 (August 28, 2007). The E-filing process requires participants to submit and serve documents over the internet or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek a waiver in accordance with the procedures described below.
To comply with the procedural requirements of E-Filing, at least five (5) days prior to the filing deadline, the petitioner/requestor must contact the Office of the Secretary by e-mail at
Once a requestor/petitioner has obtained a digital ID certificate, had a docket created, and downloaded the EIE viewer, it can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format (PDF) in accordance with NRC guidance available on the NRC public Web site at
A person filing electronically may seek assistance through the “Contact Us” link located on the NRC Web site at
Participants who believe that they have a good cause for not submitting documents electronically must file a motion, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudication Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail or expedited delivery service upon depositing the document with the provider of the service.
Non-timely requests and/or petitions and contentions will not be entertained absent a determination by the Commission, the presiding officer, or the Atomic Safety and Licensing Board Panel that the petition and/or request should be granted and/or the contentions should be admitted based on a balancing of the factors specified in 10 CFR 2.309(c)(1)(i)-(viii). To be timely, filings must be submitted no later than 11:59 p.m. Eastern Time on the due date.
Documents submitted in adjudicatory proceedings will appear in NRC's electronic hearing docket which is available to the public at
Detailed information about the license renewal process can be found under the Nuclear Reactors icon at
The NRC staff has verified that a copy of the LRA is also available to local residents near Beaver Valley Power Station, Units 1 and 2, at the Beaver Area Memorial Library, 100 College Avenue, Beaver, Pennsylvania 15009, and the Beaver County Library System, 1 Campus Drive, Monaca, Pennsylvania 15061.
For the Nuclear Regulatory Commission.
The ACRS Subcommittee on ESBWR will hold a meeting on November 15, 2007, Room T-2B3, 11545 Rockville Pike, Rockville, Maryland.
The entire meeting will be open to public attendance, with the exception of a portion that may be closed to discuss unclassified safeguards and proprietary information pursuant to 5 U.S.C. 552b(c)(3) and (4).
The agenda for the subject meeting shall be as follows:
The Subcommittee will review and discuss the Draft Safety Evaluation with Open Items for several chapters of the ESBWR Design Certification and make a recommendation to the full Committee. The Subcommittee will hear presentations by and hold discussions with representatives of the NRC staff, GE-Hitachi Nuclear Energy Americas LLC, and other interested persons regarding this matter. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Officer, Mr. Charles G. Hammer (telephone 301/415-7363) five days prior to the meeting, if possible, so that appropriate arrangements can be made. Electronic recordings will be permitted only during those portions of the meeting that are open to the public. Detailed procedures for the conduct of and participation in ACRS meetings were published in the
Further information regarding this meeting can be obtained by contacting the Designated Federal Officer between 6:45 a.m. and 3:30 p.m. (ET). Persons planning to attend this meeting are urged to contact the above named individual at least two working days prior to the meeting to be advised of any potential changes to the agenda.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Railroad Retirement Board (RRB) is forwarding an Information Collection Request (ICR) to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB) to request a revision to a currently approved collection of information: 3220-0022, Application and Claim for Unemployment Benefits and Employment Service consisting of Form(s) UI-1 and UI-1 (Internet), Application for Unemployment Benefits and Employment Service, and UI-3 and UI-3 (Internet), Claim for Unemployment Benefits. Our ICR describes the information we seek to collect from the public. Review and approval by OIRA ensures that we impose appropriate paperwork burdens.
The RRB invites comments on the proposed collection of information to determine (1) the practical utility of the collection; (2) the accuracy of the estimated burden of the collection; (3) ways to enhance the quality, utility and clarity of the information that is the subject of collection; and (4) ways to minimize the burden of collections on respondents, including the use of automated collection techniques or other forms of information technology. Comments to RRB or OIRA must contain the OMB control number of the ICR. For proper consideration of your comments, it is best if RRB and OIRA receive them within 30 days of publication date.
Section 2 of the Railroad Unemployment Insurance Act (RUIA), provides unemployment benefits for qualified railroad employees. These benefits are generally payable for each day of unemployment in excess of four during a registration period (normally a period of 14 days).
Section 12 of the RUIA provides that the RRB establish, maintain and operate free employment facilities directed toward the reemployment of railroad employees. The procedures for applying for the unemployment benefits and employment service and for registering and claiming the benefits are prescribed in 20 CFR part 325.
Form UI-1 (or its Internet equivalent, Form UI-1 (Internet)),
Completion of Forms UI-1, UI-1(Internet), UI-3 and UI-3 (Internet) is required to obtain or retain benefits. The number of responses required of each claimant varies, depending on their period of unemployment.
Comments regarding the information collection should be sent to Ronald J. Hodapp, Railroad Retirement Board, 844 North Rush Street, Chicago, Illinois 60611-2092 or
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
FINRA is proposing to amend NASD Rule 3210 (Short Sale Delivery Requirements) in light of the amendments to Rule 203 of Regulation SHO under the Act.
Below is the text of the proposed rule change. Proposed new language is
(a) If a participant of a registered clearing agency has a fail to deliver position at a registered clearing agency in a non-reporting threshold security for 13 consecutive settlement days, the participant shall immediately thereafter close out the fail to deliver position by purchasing securities of like kind and quantity.
[(b) The provisions of this rule shall not apply to the amount of the fail to deliver position that the participant of a registered clearing agency had at a registered clearing agency on the settlement day immediately preceding the day that the security became a non-reporting threshold security; provided, however, that if the fail to deliver position at the clearing agency is subsequently reduced below the fail to deliver position on the settlement day immediately preceding the day that the security became a non-reporting threshold security, then the fail to deliver position excepted by this paragraph (b) shall be the lesser amount.]
(1) The term “market maker” has the same meaning as in section 3(a)(38) of the Exchange Act.
(2) The term “non-reporting threshold security” means any equity security of an issuer that is not registered pursuant to section 12 of the Exchange Act and for which the issuer is not required to file reports pursuant to section 15(d) of the Exchange Act:
(A) For which there is an aggregate fail to deliver position for five consecutive settlement days at a registered clearing agency of 10,000 shares or more and for which on each settlement day during the five consecutive settlement day period, the reported last sale during normal market hours for the security on that settlement day that would value the aggregate fail to deliver position at $50,000 or more, provided that if there is no reported last sale on a particular settlement day, then the price used to value the position on such settlement day would be the previously reported last sale; and
(B) Is included on a list published by NASD.
A Security shall cease to be a non-reporting threshold security if the aggregate fail to deliver position at a registered clearing agency does not meet or exceed either of the threshold tests specified in paragraph
(3) The term “participant” means a participant as defined in section 3(a)(24) of the Exchange Act, that is an NASD member.
(4) The term “registered clearing agency” means a clearing agency, as defined in section 3(a)(23)(A) of the Exchange Act, that is registered with the Commission pursuant to section 17A of the Exchange Act.
(5) The term “settlement day” means any business day on which deliveries of securities and payments of money may be made through the facilities of a registered clearing agency.
(a) Where to File
A member seeking exemptive relief as permitted under Rules 1021, 1050, 1070, 2210, 2315, 2320, 2340, 2520, 2710, 2720, 2790, 2810, 2850, 2851, 2860, Interpretive Material 2860-1, 3010(b)(2), 3020, 3150,
(b) through (c) No change.
In its filing with the Commission, FINRA included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. FINRA has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
On August 7, 2007, the SEC adopted certain amendments to Regulation SHO under the Act.
The purpose of this proposed rule change is to make conforming changes to NASD Rule 3210 to reflect the amendments to Rule 203 of Regulation SHO by eliminating the grandfather provision from Rule 3210 and extending the close-out requirement for fails to deliver resulting from sales of non-reporting threshold securities pursuant to SEC Rule 144.
NASD Rule 3210 (Short Sale Delivery Requirements) applies delivery requirements to non-reporting threshold securities that are substantially similar to the Regulation SHO delivery requirements, which apply only to reporting securities.
Given the SEC's recent amendments to the Regulation SHO close-out requirement, FINRA is proposing to amend Rule 3210 to make conforming amendments to its mandatory close-out requirement to eliminate the grandfathering provision and extend the close-out requirement for SEC Rule 144 restricted securities. Specifically, consistent with the SEC's amendments to Rule 203(b)(3)(i) of Regulation SHO, FINRA is proposing (1) to require that any previously grandfathered fail to deliver position in a non-reporting security that is on the Rule 3210 threshold list on the October 15, 2007 operative date of the proposed rule change be closed out within 35 settlement days of such date; (2) that if the fail to deliver position has persisted for 35 consecutive settlement days from the October 15, 2007 operative date of the proposed rule change, the proposal would prohibit a participant and any broker-dealer for which it clears transactions, including market makers, from accepting any short sale orders or effecting further short sales in the particular non-reporting threshold security without borrowing, or entering
Likewise, in light of the SEC's recent amendments to provide additional time to close-out fails to deliver resulting from sales of threshold securities pursuant to SEC Rule 144, FINRA is proposing to amend Rule 3210 to make conforming amendments to its close-out requirement. Specifically, consistent with the SEC's amendments to Rule 203 of Regulation SHO, FINRA is proposing to amend Rule 3210 to extend the close-out requirement from 13 to 35 consecutive settlement days for fails to deliver resulting from sales of non-reporting threshold securities pursuant to SEC Rule 144. Also consistent with the SEC's amendments to the Regulation SHO close-out requirement, FINRA is proposing to apply the pre-borrow requirement in amended Rule 3210(b) to these fails to deliver. Therefore, if the fail to deliver position persists for 35 consecutive settlement days, a participant of a registered clearing agency and any broker-dealer for which it clears transactions, including market makers, would be prohibited from effecting further short sales in the particular non-reporting threshold security without borrowing, or entering into a bona-fide arrangement to borrow, the security until the participant closes out the entire fail to deliver position by purchasing securities of like kind and quantity.
FINRA believes that making conforming changes to Rule 3210 to maintain consistency with the Regulation SHO delivery requirements is appropriate. Further, as noted in the proposing and adopting releases relating to the amendments to Rule 203 of Regulation SHO, the SEC indicated that, if the proposed amendments to Regulation SHO were adopted, the SEC anticipated that Rule 3210 would be similarly amended.
Lastly, as part of the rule change (SR-NASD-2004-044) proposing Rule 3210, the SEC approved paragraph (g) of Rule 3210, which permits FINRA to grant exemptive relief from the Rule 3210 short sale delivery requirements pursuant to the Rule 9600 Series. As part of another rule change, FINRA inadvertently deleted the reference to Rule 3210 in the list of rules in Rule 9610(a) for which exemptive relief may be available.
As noted above, FINRA has filed the proposed rule change for immediate effectiveness. FINRA proposes to make the proposed rule change operative on October 15, 2007, to coincide with the operative date of the amendments to Rule 203 of Regulation SHO.
FINRA believes that the proposed rule change is consistent with the provisions of section 15A(b)(6) of the Act,
FINRA does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily abrogate such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• 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 SR-FINRA-2007-013 and should be submitted on or before November 16, 2007.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Nasdaq proposes to establish fees for a new real-time surveillance alert and report module to assist Nasdaq member firms with their Regulation NMS (“Reg NMS”) compliance. The text of the proposed rule change is available at http://www.nasdaq.complinet.com, the Exchange, and the Commission's Public Reference Room.
In its filing with the Commission, Nasdaq included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. Nasdaq has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
Nasdaq proposes to establish a new service called Nasdaq Regulation Reconnaissance Service (“Reg Recon”) to assist Nasdaq members in their efforts to comply with applicable regulatory requirements. Specifically, Reg Recon will provide Nasdaq members with individualized real-time surveillance alerts of possible violations of Reg NMS under the Act. Members will also have access to download those surveillance alerts for use as part of their policies and procedures to ensure compliance with Reg NMS obligations. Reg Recon is intended as only one source of assistance for Nasdaq member firms with their Reg NMS compliance and does not purport in any way to ensure or guarantee Reg NMS compliance. Specifically, Reg Recon will be available as an add-on to the Nasdaq Workstation and Weblink ACT 2.0.
Section 12(f) of the Act
Reg Recon will assist Nasdaq members in two ways. First, it will assist members with compliance with Rule 611 of Reg NMS by providing real-time alerts that are trade reported by the member to the FINRA/Nasdaq TRF and represent potential trade-throughs. Nasdaq will generate these alerts by reading the UQDF data feed and comparing it to the prices of trades reported to the TRF. When that comparison reveals that a potential trade-through has occurred, the Reg Recon functionality will send the member a real-time surveillance alert. Nasdaq expects that firms will use these alerts as part of their compliance procedures to verify that the TRF trade was properly executed and trade reported.
Second, Reg Recon will provide subscribers with Nasdaq Self Help Declarations/Revocations messages (“Notices”). These Notices will alert participants that Nasdaq is experiencing communications issues with a particular market center. It is intended to cause members to perform an independent review of their communications with that market center and assess their trading obligations with respect to that market. Nasdaq has stated that these Notices are not intended to relieve firms of their obligations to conduct independent self-help analysis and to adopt policies and procedures designed to achieve compliance with those obligations.
Both real-time surveillance alerts and the Notices will be available to download each day to allow firms to review their TRF trade reporting activities. The product also provides reports that give users the ability to generate and download reports to view all of their potential TRF trade-throughs and sort by exempt versus non-exempt, intermarket sweep order (“ISO”) versus non-ISO, and Nasdaq Self Help Declarations/Revocations. Additionally,
The fee for this product will be a $1,000/market maker participant identifier/month subscription fee, which Nasdaq believes fairly reflects the value of this product. Use of the Reg Recon Service is voluntary and available only to Nasdaq member firms and the subscription fees will be imposed on all purchasers equally. The proposed fees will cover the costs associated with establishing the service, responding to customer requests, configuring Nasdaq's systems, programming to user specifications, and administering the service, among other things. Large firms' order management systems are offering this product at a much higher price, but they have the ability to charge a significant amount more than Nasdaq since firms potentially will need to route to other market centers to comply with the rule and the order management system will have all order information for every market center, not just the TRF data.
The Service is responsive to the requests of market participants seeking to augment their order management systems' solutions, as well as provide a back-up to those solutions, and for smaller firms with less sophisticated trading systems/environments. Nasdaq believes that the product is reasonably priced in light of the amount of quote data that must be processed coupled with the support required to assist firms in understanding the product and, in turn, Reg NMS.
Nasdaq believes that the proposed rule change is consistent with the provisions of Section 6 of the Act,
Nasdaq does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not:
(i) Significantly affect the protection of investors or the public interest;
(ii) impose any significant burden on competition; and
(iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, if consistent with the protection of investors and public interest, it has become effective pursuant to Section 19(b)(3)(A) of the Act
Normally, a proposed rule change filed under Rule 19b-4(f)(6) may not become operative prior to 30 days after the date of filing. However, Rule 19b-4(f)(6)(iii)
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily abrogate such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Nancy M. Morris, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to amend its listing fees for structured products included in its Listed Company Manual (“Manual”). The Exchange seeks to clarify when certain existing fees will apply to specific structured products and also proposes to create a new fee section (Section 902.09) that will apply a new lower fee schedule to securities listed pursuant to Sections 703.15 (Foreign Currency Warrants and Currency Index Warrants), 703.17 (Stock Index Warrants Listing Standards), and 703.22 (Equity Index-Linked Securities, Commodity-Linked Securities and Currency-Linked Securities and Currency-Linked Securities). Except as described below, the proposed revisions would apply retroactively as of October 3, 2007. The text of the proposed rule change is available at the Commission's Public Reference Room, at the Exchange, and at
In its filing with the Commission, the Exchange included statements concerning the purpose of, and basis for, the proposed rule change, and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend its listing fees for structured products. The Exchange seeks to clarify when certain existing fees will apply to specific structured products and also proposes to create a new fee section (Section 902.09) that will apply a new lower fee schedule to securities listed pursuant to Sections 703.15 (Foreign Currency Warrants and Currency Index Warrants), 703.17 (Stock Index Warrants Listing Standards) and 703.22 (Equity Index-Linked Securities, Commodity-Linked Securities and Currency-Linked Securities) of the Manual. The listing and annual fees set forth in Section 902.05 of the Manual relate to long-term structured products (
Section 902.06 of the Manual sets forth the listing fees for certain securities with a term of less than seven years, including, but not limited to, warrants representing equity securities, index warrants, foreign currency warrants, contingent value rights and structured products. The Exchange proposes to revise Section 902.06 to exclude from its coverage those securities that will be subject to the fees set forth in new Section 902.09. The Exchange proposes to adopt new Section 902.09 to establish a new fee schedule for fees related to securities listed pursuant to Sections 703.15 (Foreign Currency Warrants and Currency Index Warrants), 703.17 (Stock Index Warrants Listing Standards) and 703.22 (Equity Index-Linked Securities, Commodity-Linked Securities and Currency-Linked Securities) of the Manual. The listing fees applicable to securities subject to Section 902.09 Manual are as follows:
These fees will apply each time an issuer lists a security of one of the classes specified in Section 902.09 of the Manual and also to subsequent listings of additional shares of the same security. The Exchange will treat each series of the security as a separate issue.
In addition, the following annual fees will apply to securities subject to Section 902.09:
These Annual Fees will be billed in January for the forthcoming year.
The proposed $2,500 fee for certain changes that involve modifications to Exchange records is applicable under the proposed fee schedule. This fee is consistent with the provisions of Sections 902.05 and 902.06 of the Manual.
The Exchange also proposes to amend Section 902.08 (Listing Fees for Debt Securities) of the Manual to reflect that the Automated Bond System is now “NYSE Bonds.”
Finally, the Exchange currently applies the fee schedules set forth in Section 902.05 and 902.06 of the Manual to securities listed pursuant to Sections 703.15, 703.17 and 703.22 of the Manual. However, Sections 902.05 and 902.06 of the Manual do not identify Sections 703.15, 703.17 and 703.22 as securities to which the fees would apply. As a result, the Exchange requests permission to apply retroactively for the period from June 7, 2006 to October 2, 2007 the fee schedules set forth in Sections 902.05 and 902.06 of the Manual to all securities previously listed pursuant to Sections 703.15, 703.17 and 703.22 of the Manual. Beginning October 3, 2007, all securities listed pursuant to Sections 703.15, 703.17 and 703.22 of the Manual would be subject to the fee schedule set forth in Section 902.09 of the Manual.
The Exchange believes that the proposal is consistent with Section 6(b) of the Act
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange has neither solicited nor received written comments on the proposed rule change.
Within 35 days of the date of publication of this notice in the
(A) By order approve such proposed rule change, or
(B) Institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Nancy M. Morris, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The proposed rule change would allow OCC to clear and settle options on exchange traded fund (“ETF”) shares generally known as “Leveraged ETF Shares.”
In its filing with the Commission, OCC included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. OCC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to accommodate the introduction of options on ETF shares that represent interests in entities making a broad array of investments in order to provide investment returns that are equivalent to (a) a multiple of the percentage return of a specific stock index (“Multiple Fund Shares” or “Index Multiple ETFs”) or (b) a multiple of the inverse percentage return of a specific stock index (“Inverse Fund Shares” or “Index Inverse ETFs”) (Multiple Fund Shares, Index Multiple ETFs, Inverse Fund Shares, and Index Inverse ETFs are collectively “Leveraged ETF Shares”).
Currently, the definition of “fund share” in Article I, Section 1 of OCC's By-Laws lists the various underlying investments that may be made by the ETF issuing the fund share. In order to avoid creating an ever-lengthening list of possible investments that may prove to be non-exhaustive, OCC proposes to amend the definition of “fund share” to state that the term means “a publicly traded security (as defined in Section 3(a)(10) of the Securities Exchange Act of 1934, as amended) that represents an interest in a trust, investment company, commodity pool, or similar entity holding and/or trading in one or more investments.”
The proposed rule change is consistent with the requirements of Section 17A of the Act because it (1) promotes the prompt and accurate clearance and settlement of transactions in options on Leveraged ETF Shares by applying the same basic rules and procedures to such options as are applied to options on other equity interests, (2) fosters cooperation and coordination with persons engaged in the clearance and settlement of securities transactions, (3) removes impediments to and perfects the mechanism of a national system for the prompt and accurate clearance and settlement of securities transactions, and (4) protects investors and the public interest. The proposed rule change is not inconsistent with the rules of OCC, including any rule proposed to be amended.
OCC does not believe that the proposed rule change would impose any burden on competition.
Written comments were not and are not intended to be solicited with respect to the proposed rule change, and none have been received.
Section 17A(b)(3)(F) of the Act requires, among other things, that the rules of a clearing agency be designed to promote the prompt and accurate clearance and settlement of securities transactions.
OCC has requested that the Commission approve the proposed rule prior to the thirtieth day after publication of the notice of the filing. The Commission finds good cause for approving the proposed rule change prior to the thirtieth day after the publication of notice because such approval will allow Amex to commence trading of options on Leveraged ETF Shares without any unnecessary delay.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Nancy M. Morris, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
On the basis of the foregoing, the Commission finds that the proposed rule change is consistent with the requirements of the Act and in particular Section 17A of the Act and the rules and regulations thereunder.
For the Commission by the Division of Market Regulation, pursuant to delegated authority.
Federal Aviation Administration (FAA), DOT.
Notice of petition for exemption received.
This notice contains a summary of a petition seeking relief from specified requirements of 14 CFR. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number involved and must be received on or before November 15, 2007.
You may send comments identified by Docket Number FAA-2007-0007 using any of the following methods:
•
•
•
•
Tyneka Thomas (202) 267-7626 or Frances Shaver (202) 267-9681, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), DOT.
Notice of petitions for exemption received.
This notice contains a summary of certain petitions seeking relief from specified requirements of 14 CFR. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of any petition or its final disposition.
Comments on petitions received must identify the petition docket number involved and must be received on or before November 15, 2007.
You may send comments identified by Docket Number FAA-2007-29267 using any of the following methods:
•
•
•
•
•
We will post all comments we receive, without change, to
Tyneka Thomas (202) 267-7626 or Frances Shaver (202) 267-9681, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), DOT.
Notice of petition for exemption received.
This notice contains a summary of a petition seeking relief from specified requirements of 14 CFR. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number involved and must be received on or before November 15, 2007.
You may send comments identified by Docket Number FAA-2007-28292 using any of the following methods:
•
•
•
•
Madeleine Kolb, Transport Airplane Directorate, FAA at 425-227-1134.
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), DOT.
Notice of meeting.
The FAA is issuing this notice to advise the public of a meeting of the Executive Committee of the Aviation Rulemaking Advisory Committee.
The meeting will be on December 5, 2007, at 10 a.m.
The meeting will take place at the Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591, 10th Floor, MacCracken Room.
Gerri Robinson, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591, telephone (202) 267-9678; fax (202) 267-5075; e-mail
Under section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), we are giving notice of a meeting of the Executive Committee of the Aviation Rulemaking Advisory Committee taking place on December 5, 2007, at the Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591. The agenda includes:
• ISO Feedback.
• Report out from the Aviation Maintenance Technician Schools Curriculum and Operating Requirements Working Group to the Executive Committee.
• Issue Area Status Reports from Assistant Chairs.
• Future of ARAC.
• Continuous Improvement of FAA Rulemaking Process.
• Remarks from other EXCOM members.
The public must arrange by November 26 to present oral statements at the meeting. The public may present written statements to the executive committee by providing 25 copies to the Executive Director, or by bringing the copies to the meeting.
If you are in need of assistance or require a reasonable accommodation for this meeting, please contact the person listed under the heading
Surface Transportation Board, DOT.
Notice of OMB Approval of Information Collection.
Pursuant to the Paperwork Reduction Act, 44 U.S.C. 3501
This collection, which is codified at 49 CFR 1243.3, has been assigned OMB Control No. 2140-0014. Unless renewed, OMB approval expires on October 31, 2010. The display of a currently valid OMB control number for this collection is required by law. Under the PRA and 5 CFR 1320.8, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection displays a currently valid OMB control number.
Surface Transportation Board, DOT.
Notice of public hearing.
The Surface Transportation Board will hold a public hearing beginning at 10 a.m. on Tuesday, December 4, 2007, at its offices in Washington, DC. The purpose of the hearing will be to allow current parties of record to comment on the proposed methodology to be employed in determining the railroad industry's estimated cost of capital and the record developed in this proceeding. Parties of record wishing to speak at the hearing should notify the Board in writing.
The public hearing will take place on Tuesday, December 4, 2007. Any party of record wishing to speak at the hearing should file with the Board a written notice of intent to participate, and should identify the party, the proposed speaker, the time requested, and the topic(s) to be covered, as soon as possible but no later than November 20, 2007. Each speaker should also file with the Board his/her written testimony by November 27, 2007.
All notices of intent to participate and testimony may be submitted either via the Board's e-filing format or in the traditional paper format. Any person using e-filing should attach a document and otherwise comply with the Board's “
Timothy Strafford, (202) 245-0356. [Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at: (800) 877-8339.]
Each year the Surface Transportation Board (Board) determines the railroad industry's cost of capital. The Board then uses this cost of capital figure for a variety of regulatory purposes. It is used to evaluate the adequacy of individual railroads' revenues each year. It is also employed in maximum rate cases, feeder line applications, rail line abandonments, and trackage rights cases.
The Board calculates the cost of capital as the weighted average of the cost of debt and the cost of equity, with the weights determined by the capital structure (the fraction of capital from debt or equity on a market-value basis) of the railroad industry. While the cost of debt is observable and readily available, the cost of equity (the expected return that equity investors require) can only be estimated. How best to calculate the cost of equity is the subject of a vast amount of literature covering the fields of finance, economics, and regulation. In each case, however, because the cost of equity cannot be directly observed, estimating the cost of equity requires adopting a financial model and making a variety of simplifying assumptions. The Board currently uses a Discounted Cash Flow (DCF) methodology to calculate the cost of equity, which in turn is used to calculate the cost of capital.
By advance notice of proposed rulemaking served on September 20, 2006, the Board sought comments on the appropriate methodology to be employed in determining the cost of equity component of the cost of capital. On February 15, 2007, the Board held a hearing on the Board's cost-of-capital calculation, and how this evidence should be submitted and analyzed in future proceedings. On August 14, 2007, the Board proposed to move from a DCF method to a Capital Asset Pricing Model (CAPM) method in determining the estimated cost of capital. Generally, CAPM first determines the return an investor would receive on a risk-free investment. An estimate of the risk premium associated with the particular investment is then developed. Once the risk premium is quantified, its value is added to the risk-free investment rate to obtain an estimate of the cost of equity.
In the August 14, 2007 decision, the Board invited comments on the proposed methodology. A number of parties have commented on the importance of this proceeding and the Association of American Railroads
This action will not significantly affect either the quality of the human environment or the conservation of energy resources.
West Texas and Lubbock Railway Company (WTLC),
The transaction is expected to be consummated on or after November 10, 2007.
WTLC certifies that its projected annual revenues as a result of this transaction would not exceed $5 million and would not result in the creation of a Class II or Class I rail carrier.
If the verified notice contains false or misleading information, the exemption is void
An original and 10 copies of all pleadings, referring to STB Finance Docket No. 35079, must be filed with the Surface Transportation Board, 395 E Street, SW., Washington, DC 20423-0001. In addition, a copy of each pleading must be served on John D. Heffner, John D. Heffner, PLLC, 1750 K Street, NW., Suite 350, Washington, DC 20006.
Board decisions and notices are available on our Web site at
By the Board, David M. Konschnik, Director, Office of Proceedings.
In order to comply with the mandate of section 999(a)(3) of the Internal Revenue Code of 1986, the Department of the Treasury is publishing a current list of countries which require or may require participation in, or cooperation with, an international boycott (within the meaning of section 999(b)(3) of the Internal Revenue Code of 1986).
On the bais of the best information currently available to the Department of the Treasury, the following countries require or may require participation in, or cooperation with, an international boycott (within the meaning of section 999(b)(3) of the Internal Revenue Code of 1986).
Kuwait, Lebanon, Libya, Qatar, Saudi Arabia, Syria, United Arab Emirates, Yemen, Republic of.
Iraq is not included in this list, but its status with respect to future lists remains under review by the Department of the Treasury.
Office of the Comptroller of the Currency (OCC), Treasury.
Notice and request for comment.
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment concerning an information collection titled, “Examination Questionnaire.” The OCC also gives notice that it has sent the information collection to OMB for review and approval.
Comments must be submitted by November 26, 2007.
Communications Division, Office of the Comptroller of the Currency, Public Information Room, Mailstop 1-5, Attention: 1557-0199, 250 E Street, SW., Washington, DC 20219. In addition, comments may be sent by fax to (202) 874-4448, or by electronic mail to
Additionally, you should send a copy of your comments to OCC Desk Officer, 1557-0199, by mail to U.S. Office of Management and Budget, 725 17th Street, NW., #10235, Washington, DC 20503, or by fax to (202) 395-6974.
You may request additional information or a copy of the collection from Mary Gottlieb, (202) 874-5090, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 250 E Street, SW., Washington, DC 20219.
The OCC is proposing to extend the approval for the following information collection:
(a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information has practical utility;
(b) The accuracy of the agency's estimate of the burden of the collection of information;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.
Office of the Comptroller of the Currency (OCC), Treasury.
Notice and request for comment.
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment concerning its information collection titled, “Assessment of Fees—12 CFR 8.”
You should submit written comments by December 26, 2007.
Communications Division, Office of the Comptroller of the Currency, Public Information Room, Mail Stop 1-5, Attention: 1557-0223, 250 E Street, SW., Washington, DC 20219. In addition, comments may be sent by fax to (202) 874-4448, or by electronic mail to
Additionally, you should send a copy of your comments to OCC Desk Officer, 1557-0223, by mail to U.S. Office of Management and Budget, 725 17th Street, NW., #10235, Washington, DC 20503, or by fax to (202) 395-6974.
You can request additional information or a copy of the collection from Mary Gottlieb, (202) 874-5090, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 250 E Street, SW., Washington, DC 20219.
The OCC is proposing to extend OMB approval of the following information collection:
Comments submitted in response to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on:
(a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information has practical utility;
(b) The accuracy of the agency's estimate of the burden of the collection of information;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.
Environmental Protection Agency (EPA).
Final rule.
EPA is updating its data requirements in part 158 of Title 40 in the Code of Federal Regulations for the registration of conventional pesticide products. As scientific understanding of potential hazards posed by pesticides has evolved, some data requirements have been imposed on a case-by-case basis but not codified since 1984. Besides providing the regulated community with clearer and more transparent information, the updated data requirements will enhance the development of health and environmental data to conduct scientifically sound chemical hazard/risk assessments to protect human health and the environment. In a companion final rule also being promulgated today, EPA is making technical changes arising from this final rule.
This final rule is effective on December 26, 2007.
EPA has established a docket for this action under Docket identification number EPA-HQ-OPP-2004-0387. All documents in the docket are listed on the regulations.gov web site. Although listed in the index, some information is not publicly available, i.e., 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 electronically through www.regulations.gov or in hard copy at the Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Room S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA 22202. This Docket is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305-5805.
For information on the data requirements for ecological effects and environmental fate, contact: Ann Stavola, Field and External Affairs Division (FEAD), Office of Pesticide Programs (OPP) (7506P), Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number: (703) 305-5354; fax number: (703) 305-5884; e-mail address:
You may be potentially affected by this action if you are a producer or registrant of a pesticide product, including agricultural, residential, and industrial, but not including antimicrobial pesticides, biochemical pesticides, or microbial pesticides.
This action may also affect any person or company who might petition the Agency for new tolerances, hold a pesticide registration with existing tolerances, or any person or company who is interested in obtaining or retaining a tolerance in the absence of a registration, that is, an import tolerance. This latter group may include pesticide manufacturers or formulators, importers of food, grower groups, or any person or company who seeks a tolerance. Potentially affected entities may include, but are not limited to:
Chemical Producers (NAICS 32532), e.g., pesticide manufacturers or formulators of pesticide products, importers or any person or company who seeks to register a pesticide or to obtain a tolerance for a pesticide.
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) code has 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.C. If you have any questions regarding the applicability of this action to a particular entity, consult the persons listed under
The Agency is updating and revising its data requirements for the registration of conventional pesticide products. The data requirements for the registration of antimicrobial products, product performance, and biochemical and microbial pesticides are not being revised in this action. EPA issued a proposed rule addressing data requirements for biochemical and microbial pesticides on March 8, 2006 (71 FR 12072). Antimicrobial data requirements have been moved to new part 161.
As scientific understanding of potential hazards posed by pesticides has evolved, some data requirements have been imposed on a case-by-case basis but not codified since 1984. By codifying the data requirements that have been applied on a case-by-case basis, the Agency believes the pesticide industry and other partners in the regulated community will be better prepared for the pesticide registration process.
This rule is issued under the authority of FIFRA sections 3, 4, 5, 12, and 25; and FFDCA section 408.
In current part 158, the data requirements cover both conventional and antimicrobial pesticides. Biochemical and microbial pesticides are set apart at § 158.690 and § 158.740. EPA proposed to limit the applicability of revised part 158 to conventional chemicals in anticipation of additional revisions tailored to biochemical, microbial, and antimicrobial pesticides. EPA received no key comments concerning the proposed limited applicability of part 158, and accordingly, EPA is adopting its proposed scope. Elsewhere in today's
If EPA were to maintain the proposed rule's exclusive application to conventional pesticides, the result would be that there would be no data requirements established by regulation for antimicrobial pesticides. Applicants would have to rely solely on consultations with EPA to determine the data requirements for their antimicrobial products without the benefit of regulatory data requirements. However, EPA has decided to preserve the current data requirements to provide regulatory coverage for antimicrobial
Part 161 is intended to be transitional and will be revoked upon the effective date of a replacement regulation tailored to antimicrobial pesticide data requirements. EPA recognizes that current data requirements of this transitional part are not optimal for registrants of antimicrobial pesticides. Because the 1984 data requirements were developed primarily to address agricultural chemicals, it has been difficult for antimicrobial registrants to discern data requirements that apply to antimicrobial products. This difficulty will not be corrected in simply transferring the current requirements to a new location. As a result, applicants should continue to routinely consult with the Agency to interpret the requirements of new part 161 as they apply to antimicrobial products. EPA supports and encourages the consultation process for all applicants, as the data requirements are highly dependent on pesticide type and use pattern. EPA is fully committed to the development of tailored data requirements for antimicrobial pesticides and expects to issue a proposed rule by the end of 2008.
EPA published an NPRM on March 11, 2005 (70 FR 12275), proposing to update and revise its data requirements for the registration of conventional pesticide products in 40 CFR part 158. The data requirements identify the types of information that EPA needs to: determine that a pesticide product can be registered; issue a tolerance or tolerance exemption for pesticide residues in food; or allow the experimental use of the pesticide. The proposed rule was intended to: improve the scientific basis for pesticide decisions; update the requirements last codified in 1984; and reorganize part 158 to improve usability. These efforts will help protect human health and the environment by providing an up-to-date scientific framework for identifying and assessing the risks of conventional pesticides for use in the United States. The closing date of the 90-day comment period for the NPRM was June 9, 2005. The comment period was extended to September 7, 2005, to allow stakeholders additional time to assess the impact of the proposed revisions on their particular situations and prepare their comments (40 FR 33414). One hundred seven public comments were filed in Docket ID OPP-2004-0387. For a detailed response to comments, refer to Docket ID OPP-2004-0387. In addition, EPA convened a 2-day public workshop in Arlington, Virginia, to explain the provisions of the NPRM on May 3-4, 2005. There were 126 attendees at the public workshop.
EPA's proposed rule structured the subparts of part 158 to match the original sequence of guidelines. A number of commenters found this structure confusing, and one commenter submitted an alternative structure, which was considered along with other alternative structures. EPA agrees with commenters that the current relatively random structure is not ideal for the average registrant who is seeking to determine the data requirements that apply to his product. Accordingly, in the final rule, EPA is restructuring the subparts to be more user-friendly.
EPA reasons that the users most in need of clarity are the infrequent, follow-on applicants, whose actual data requirements are in many cases limited to end-use product data of various types. In general, larger pesticide companies that routinely submit complex new chemical/new use applications and petitions for tolerance are responsible for the bulk of toxicology, residue chemistry, ecological effects and environmental fate data developed using the pure active ingredient (PAI), technical grade of active ingredient (TGAI) or the typical end-use product (TEP). In the case of exposure data, a variety of industry task forces, again primarily comprising large companies, are developing surrogate databases, so that newly generated data may not be necessary for many exposure scenarios.
In all these cases, FIFRA sec. 3(c)(1)(F) and its regulations in part 152 provide for the use of data developed by others, either under the formulators' exemption of section 3(c)(2)(D), or with appropriate permission or compensation offers. These provisions were put in place specifically to obviate the need for duplicate data development while protecting the rights of data submitters. Thus, smaller follow-on or me-too registrants often are required to generate only product-specific chemistry data, acute toxicity data, and efficacy data (generally designated in part 158 tables with End Use Product (EP) as the test substance). These applicants will benefit by the restructured part 158 so that they don't have to search for applicable data requirements by sifting through voluminous data requirements that may be satisfied by formulators' exemption, citation or offer-to-pay procedures.
EPA believes that major registrants will not be disrupted by a restructuring of the subparts because they are familiar with the data requirements, and, in any case, should be able to easily find the data requirement applicable to their product or petition in the current structure. Accordingly, EPA has restructured the subparts to place those data requirements applicable to the bulk of applications (new end-use products and me-too products) towards the beginning of part 158.
The resulting order does not correspond to the previous guidelines issued in 1982
The structure of part 158 in the final rule proceeds from product chemistry to efficacy to hazard/toxicity requirements of all types (human health, ecological toxicity) then exposure data requirements of all types (pre- and post-application human exposures, exposure to residues in food), and environmental fate, which overlap human exposure through drinking water, and ecological exposure, and spray drift. EPA has reserved subparts among these various segments for future additions on the same topic. EPA has also consolidated subparts addressing the same topics: plant protection data requirements (proposed as subpart J) have been incorporated into new subpart G (ecological effects data requirements) as have terrestrial and aquatic nontarget organisms data requirements (proposed as subpart E).
Finally, EPA intends that freestanding data requirements subparts such as biochemical pesticides, microbial pesticides, and antimicrobial pesticides be located at the end of the series. Product performance requirements, which span all categories of pesticides, would at present remain a separate subpart near the beginning of the series. In the proposed rule, EPA had reserved subpart P for Pesticide Management and Disposal but has removed the topic from the final rule while reserving subpart P. At present, EPA has no plans to develop data requirements specific to disposal. If EPA does so in the future, it will
EPA has placed data requirements for experimental use permits in subpart C of part 158. EPA eliminated the current use of brackets in each discipline to indicate which data requirements applied to an experimental use permit (see Unit VII.).
The final structure of part 158 is as follows:
EPA proposed revising subpart A by adding new material, deleting some portions, and revising the portions that were retained or relocated. The new material included definitions for “applicant” and “registration,” with references to definitions in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA) that apply to part 158. Deletions from subpart A include: timing of the imposition of data requirements; flexibility of the data requirements; consultation with the Agency; agricultural versus non-agricultural pesticides; and biochemical and microbial pesticides.
EPA proposed deleting the section on minor uses but based on the comments and subsequent review, the Agency has in the final rule retained portions of the minor use section with an introductory paragraph. The section on the formulators' exemption was updated and relocated to 40 CFR part 152, subpart E.
EPA proposed minor revisions to § 158.32, describing how data are to be formatted for submission to EPA. Commenters supported revising Pesticide Registration (PR) Notice 86-5 to clarify provisions and avoid rejection of data for formatting reasons; one commenter also suggested integrating formatting guidance from PR 86-5 with § 158.32 in the final rule. The Agency has begun the process of updating the guidance in PR Notice 86-5 to further clarify the submission process. The improved guidance, together with consultation with the Agency, should help reduce the formatting conflicts. EPA will provide the public an opportunity to comment on the proposed revisions to PR 86-5. Since the details of the revisions are still underway, EPA has not changed the final rule.
EPA proposed a number of minor revisions to § 158.33 concerning requirements for identification of and Agency treatment of confidential business information (CBI) under FIFRA sec. 10. These revisions were intended to clarify the provisions governing the Agency's ability to release information, and to bring the regulations in line with a court decision (District Court for the District of Columbia in
EPA received four comments concerning these proposed revisions, all from industry trade organizations. In general, the commenters disputed the Agency's positions or interpretations of the status of certain types of information as non-confidential (and therefore eligible for disclosure). One commenter misunderstood the provisions of FIFRA sec. 10 and based his comments upon an erroneous conception. EPA disagrees with all commenters and made no revisions in the final rule. EPA intends to abide by the Court decision which supports the Agency's interpretation of FIFRA sec. 10. EPA has responded to all comments in its Response to Comments document in the docket for this rule.
There were no comments on the confidentiality claims for plant-incorporated protectant information or on releasing information to state and foreign governments with consent.
EPA proposed to revise the flagging requirements by updating and clarifying the criteria by:
• Reducing the number of study criteria from 11 to 7 by combining certain studies under one criterion;
• Combining reproductive, prenatal developmental toxicity and developmental neurotoxicity under one criterion to reflect the focus on infants and children.
Commenters requested clarification on the criteria and suggested the revisions would increase the burden to registrants. All of the listed flagging criteria need not apply to a toxicology study. If any of the criteria listed are applicable to the study, then the corresponding criterion number is to be included in the flagging statement submitted with the study. In the proposed rule, the Agency acknowledged that the revisions could flag more studies but this was expected because of the new types of toxicity studies to further protect infants and children. EPA made no revisions to the flagging requirements in the final rule. EPA has responded to comments in its Response to Comments document in the docket for this rule.
EPA proposed reformatting the waiver process while retaining the provisions. Several commenters expressed their concerns about clarity, timelines and organization of information for waiver requests and made several suggestions. EPA refined data requirements and test notes to help the registrant determine if a waiver request is in order. Applicants are encouraged to discuss the waiver with the Agency before developing and submitting supporting data, information, or other materials. The Agency is committed to timely decisions and notification of the applicant. Organizational changes that were proposed will be retained for the final rule. EPA has responded to comments in its Response to Comments document in the docket for this rule.
EPA proposed to remove or revise provisions in part 158 that directly or indirectly arise from the statutory formulators' exemption of FIFRA sec. 3(c)(2)(D). First, EPA proposed to remove language in § 158.50 pertaining to the statutory formulators' exemption. Second, EPA proposed removing the asterisks denoting the application of the formulators' exemption to product chemistry and toxicology data requirements.
A number of commenters objected to the removal of formulators' exemption language, and others were confused by the removal of the asterisks. It is clear that commenters are confused by the distinction between the array of data that the Agency must have to determine whether a pesticide may be registered (the data requirements of part 158), and the means by which those data requirements are satisfied (the data citation and compensation provisions of part 152, subpart E, including the
The primary purpose of part 158 is to specify the data requirements pertaining to a pesticide product. Part 158 was never intended to serve the broader purpose of specifying the various means by which an individual applicant can legally satisfy the data requirements: that is the purpose of the data compensation provisions of part 152. Part 152 explains all of the means of satisfying a data requirement specified in part 158, including submitting new data, citing existing data, citing to public literature, obtaining a waiver, or claiming eligibility for the formulators' exemption. EPA believes that it should reinforce this distinction by removing from part 158 what is actually incomplete information about the formulators' exemption.
Eligibility for the formulators' exemption is not a function of a data requirement. Rather, eligibility depends on the purchase of a registered product for incorporation into another product. The 1984 regulations erred in attempting to apply the formulators' exemption to specific product chemistry and acute toxicology requirements by means of the asterisk notation. First, the manner in which the asterisks were displayed was such that it was not clear precisely when the formulators' exemption did and did not excuse an applicant from the requirement to submit data. Further, it was unclear because it potentially conveyed the notion that the data requirement need not be satisfied. The fact that certain data need not be submitted or cited by an applicant eligible for the formulators' exemption does not mean that those data are not necessary to support the registration of the product, merely that the data requirement has been satisfied by another means. Usually the requirement has been satisfied by submission of data by the producer of the registered TGAI or manufacturing use product (MP) that the applicant purchases.
Additionally, maintaining information on the formulators' exemption in two locations in the Code of Federal Regulations is administratively cumbersome. As one commenter noted, the statute has been revised since both of these regulations were issued, and neither § 152.85 nor § 158.50 is accurate or complete. For this reason, EPA believes it is important to consolidate the formulators' exemption language in a single location.
All commenters correctly pointed out that although EPA indicated in the preamble that the formulators' exemption text of § 158.50 was to be relocated to part 152, no proposed regulatory language was included. EPA agrees that it did not include in the proposal the actual regulatory text that would be incorporated into part 152. In a companion final rule making technical changes, and which is published elsewhere in this issue of the
Although EPA believes that the formulators'exemption should properly be located in part 152 together with other provisions concerning submission or citation of data, the Agency recognizes the value of referring to the provisions of part 152 in part 158. Accordingly, EPA has revised § 158.70(a), by including a new paragraph (1) which explains that the provisions of part 158 should be read in conjunction with those of part 152, subpart E.
EPA proposed to delete material in § 158.60 concerning minor uses. Minor use policies in existence in 1984 and information in anticipation of reregistration needs for data were included in original part 158. The information is by no means complete concerning EPA policies on minor uses, which have since expanded by statute. Nonetheless, several commenters wanted EPA to retain the information in paragraphs (a)(2) and (3). EPA has in the final rule retained paragraphs (a)(2) and (3), but has removed the remaining material and renumbered those paragraphs. The paragraphs being deleted have been superseded (the definition in paragraph (a)), are guidance only (paragraphs (a)(1) and (b)), or are covered by regulations elsewhere (paragraph (a)(4)).
The weight-of-evidence approach is referenced in part 158 under several disciplines. The approach requires a critical analysis of the entire body of available data for consistency and biological plausibility. Some considerations in this approach are listed below:
•
•
•
•
In the case of the developmental neurotoxicity (DNT) study, such a weight of the evidence approach is used when evaluating:
1. Treatment-related neurological effects in adult animal studies, such as:
• Clinical signs of neurotoxicity
• Neuropathology
• Functional or behavioral effects
2. Treatment-related neurological effects in developing animals, following pre- and/or postnatal exposure, such as:
• Nervous system malformations or neuropathy
• Brain weight changes in offspring
• Functional or behavioral changes in the offspring
3. Causative association between exposures and adverse neurological effects in human epidemiological studies
4. A mechanism that is associated with adverse effects on the development of the nervous system, such as:
• SAR relationship to known neurotoxicants
• Altered neuroreceptor or neurotransmitter responses
A compound could be subject to a DNT requirement under a variety of circumstances using these criteria in a weight of evidence approach that considers dose response, logical pattern of effects, data quality, biological plausibility, consistency of observations in the broader toxicological database, likeness of the case to structural analogues, and mode of action understanding. For example, the following scenarios for 3 different chemicals (chemicals A, B, and C) describe findings that could lead to the conclusion that a DNT study is needed. Chemical A is found to result in
However, a single effect would not necessarily always trigger a DNT. For example, a small decrease in brain weight at the highest dose tested in one adult animal study but no indications of neurotoxicity, including the lack of corresponding decreases in brain weight in other adequate toxicity studies, would not necessarily trigger a DNT. Similarly, a decreased response to stimuli at doses that result in significant body weight loss and poor health of the animal may not provide a weight-of-evidence basis for triggering the DNT.
EPA proposed subdividing the current nine major use patterns to 15 major use patterns to fully address nonagricultural uses. Commenters asked for definitions of the proposed major use patterns and the phrases “major use pattern,” and “pesticide use site groups.” One commenter suggested adding a new major use pattern in addition to the ones proposed by EPA. Commenters also identified inconsistencies in major use patterns between the preamble and the regulatory text. EPA believed that the resulting use patterns from the subdivision of existing major use patterns were fairly self-explanatory and believed that adding the suggested terrestrial nonfood non-crop uses might create too fine a distinction and add to the already existing confusion. However, the Agency does appreciate the commenters' assistance in locating inconsistencies between the regulatory text and the preamble and believes the inconsistencies have been corrected.
One major use pattern in the proposed rule, Indoor medical, has been eliminated from the final rule. It is a use pattern primarily applied to antimicrobial products, not conventional pesticides, and will be considered for subpart W when proposed for comment. There were several variations of aquatic nonfood use patterns that commenters found confusing. The definition of the aquatic nonfood residential category was questioned by several commenters who assumed it referred to indoor tropical fish aquaria or koi fish ponds in yards. A survey of labels associated with this use category produced only a handful of products. Therefore EPA has consolidated the various aquatic nonfood use patterns into one aquatic nonfood use pattern, thus reducing the number of aquatic nonfood patterns to one. The elimination of Indoor medical and several aquatic nonfood use patterns reduced the final number of major use patterns. Thus, the final number of major use pattern for conventional pesticides will be 12, rather than the 15 in the proposed rule. The final 12 use patterns are: terrestrial food crop; terrestrial feed crop; terrestrial nonfood crop; aquatic food; aquatic nonfood; greenhouse food crop; greenhouse nonfood crop; forestry; residential outdoor; residential indoor; indoor food; and indoor nonfood.
In addition, not all the general use patterns will appear in the data table for each discipline. Some of the use patterns have been collapsed under a larger major use pattern for ease of use. For example, the major use patterns in the Toxicology Data Requirements table consist of Food and Nonfood. The discussion in § 158.500(b) explains that the general use patterns of terrestrial food crop, terrestrial feed crop, aquatic food, greenhouse food crop, and indoor food have been placed under the major use pattern Food. The Nonfood use patterns include products classified under terrestrial nonfood crop, aquatic nonfood, greenhouse nonfood crop, forestry, residential outdoor and indoor, and indoor nonfood. Therefore only two major use patterns appear in the data requirement table for Toxicology. Similar adjustments have been made to other disciplines as appropriate.
EPA proposed updating the current Appendix A, a compendium of pesticide use sites associated with major use patterns to assist registrants in determining which data requirements might apply to their products. EPA also proposed removing the updated Appendix A from 40 CFR part 158 and placing it on the OPP website and titled as
EPA is continuing its longstanding system of identifying test substances in the tables as follows: Technical grade of the active ingredient (TGAI); manufacturing-use product (MP); pure active ingredient (PAI); pure active ingredient, radiolabeled (PAIRA); end-use product (EP); and typical end-use product (TEP).
Some commenters were confused by the explanations of R and CR in the proposed rule and requested tighter definitions and clarification of the test notes since the latter provided insufficient guidance. In the proposed rule, EPA requested comment on its R/CR designation, and received no suggestions for alternative means of presenting the data requirements. As described in the preamble to the proposed rule, the R/CR terminology is a general presentation of the likelihood that a data requirement will apply. The use of R does not necessarily indicate that a study is always required, but that it is more likely to be required than not. The use of CR means a study is less likely to be required. However, both R and CR designations must be read in the context of the accompanying test notes to provide context for the R/CR in the table. An applicant may assume that a data requirement with R will typically
EPA requested comment on a way to identify data requirements for EUPs to replace the current bracketing system within each data table. A commenter suggested that EPA should separate out the data requirements applicable to experimental use permits, which have been expressed since 1984 by simply bracketing a registration data requirement in the tables. Other commenters misunderstood the bracketing, assuming that bracketed data requirements were somehow conditional in nature. EPA agrees that the bracket system diminishes the visibility of the EUP data requirements and leaves them scattered throughout the registration data requirements, and has therefore separated out and consolidated them. At the same time, EPA has updated the test notes to reflect those in the subparts on registration data requirements.
Because an experimental use permit is intended to precede a full registration, EPA has elected to place those data requirements early in the part 158 organizational structure. An alternative location for EUP data requirements would have been to locate them in part 172, thereby consolidating all EUP requirements in one place. However, examination of part 172 yielded no logical location for the data requirements except at the very end. Accordingly EPA has placed EUP requirements in subpart C of part 158, preferring to keep all data requirements pertaining to conventional pesticides in one place for ease of use. Where test notes for registration requirements have been revised based on comments to the proposed rule, in separating out EUP requirements, EPA has also revised those same test notes as they apply to EUPs.
EPA proposed a few changes in product chemistry requirements and it received a number of comments on elements of the data requirements that EPA had not proposed changing. They include:
• certified limits
• preliminary analysis
• submittal of samples
• definition of TGAI vs. MP
• statement of formula
• grouping of products to reduce or consolidate product chemistry requirements
• data on pesticide degradates
These comments are outside the scope of the proposal and may be considered for future revisions of part 158. Accordingly, EPA has not revised the final rule.
EPA has transferred the contents of the product performance section (current § 158.640) essentially unchanged into the revised part 158. The regulatory text of the product performance section is reprinted in this final rule for clarity and completeness.
1.
Fifteen commenters submitted a variety of comments on this data requirement. All comments are addressed in the detailed Response to Comments document in the docket. Key comments are discussed in this unit.
Two commenters requested clarification of when this testing would be required and one commenter compared the U.S. requirement with that of the European Union (EU). Three commenters strongly supported including immunotoxicity testing in the toxicology data requirements for all pesticides. Six commenters opposed the codification of this data requirement on several bases and offered alternatives: divergence in immunological structure and response between species that gives animal studies limited predictive power for immunogenicity in humans; using data from other toxicity studies as a trigger for immunotoxicity studies; and changing from R to CR. EPA disagrees with these comments because data and analysis have shown that functional immunotoxicity testing, particularly when considered in conjunction with data already required by EPA on immunotoxic endpoints, is likely to increase EPA's ability to identify pesticides with immunotoxic effects. Additionally, functional immunotoxicity testing allows for better characterization of the possible effects of an immunotoxicant.
Three commenters had detailed technical questions about the test guideline which were not appropriate for discussion in part 158 since the latter concerns only data requirements. Their comments and suggestions were forwarded to the appropriate scientists for review and consideration in the context of guideline revision. While EPA agrees that the testing protocol may need further refinement, discussions on alternative testing paradigms will continue through the various scientific venues (e.g., International Life Sciences Institute/Health and Environmental Sciences Institute (ILSI/HESI) cooperative effort) as well as through future consultation with stakeholders on the development and validation of this test guideline.
EPA recognizes that there are a range of opinions on the necessity of an across-the-board requirement for functional immunotoxicity testing. However, EPA's judgment, as supported by the recommendations of the NRC and FIFRA SAP, is that there is value-added from requiring functional immunotoxicity testing for all pesticides. Therefore in the final rule, EPA retains a requirement for immunotoxicity testing on all food and nonfood pesticides on the TGAI. EPA has responded to comments in its Response to Comments document in the docket for this rule.
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Several commenters questioned requiring a 90-day study for nonfood uses when exposures rarely exceed 45 days. EPA considers the 21- to 28-day dermal study insufficient for nonfood use assessment because higher tiered oral studies (i.e., chronic or carcinogenicity studies) are not usually required for nonfood use pesticides. While 45-day exposures are common, EPA believes that they are not the maximum duration. For example, professional applicators may be subjected to repeated exposures during the 3 months of peak summer infestations. Since for many pesticides there is increased toxicity with increased exposure, professional applicators may not be adequately protected with 45-day studies. Existing regulations provide flexibility to implement alternative studies, on a case-by-case basis, as appropriate. Registrants should consult with the Agency if there is any question regarding the appropriate duration of the study. The highest level of hazard evaluation available for a nonfood use pesticide is satisfied through a subchronic toxicity test, i.e., a 90-day repeated exposure to the nonfood pesticide. Therefore, the final rule will require the 90-day dermal toxicity study for nonfood uses.
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One commenter questioned whether the results of standard tests in developing animals were sufficient to trigger a DNT test and whether the inhibition of cholinesterase activity (ChEI) would be the most sensitive effect for organophosphorus and N-methyl carbamate pesticides. The Agency has completed review of 20 DNT studies conducted with organophosphorus pesticides. In 13 out of 20 studies, ChEI was measured in the pups; cholinesterase was the most sensitive endpoint in those 13. Only a limited number of DNT studies are available for carbamates, and the endpoint for only one chemical was used to assess acute dietary risk.
Two commenters suggested amending the 2-generation reproduction study to include findings of thyroid effects, thus providing another criterion for DNT testing. Although such a criterion was included in the proposed weight-of-evidence approach, experience gained with the study resulted in the removal of this criterion. Instead, when thyroid effects of concern are observed, the Agency may require a more specific special study. In the final rule, EPA continues to encourage registrants to conduct DNT studies in combination with a 2-generation reproduction study when addressing the DNT requirement.
Ten commenters asked for clarification of Test Note 27 to indicate whether the listed effects were part of the approach and not individual triggers. EPA has revised this Test Note to eliminate the impression that the items in the list were individual triggers and referred commenters to its published Risk Assessment Guidelines for a more detailed explanation of the terms used in the test note. Due to an addition of a test note, Test Note 27 in the proposed rule was re-numbered to Test Note 28 in the final rule.
Therefore, the Agency is conditionally requiring the DNT study in the rat for food and nonfood pesticides. All available toxicology data for the pesticide will contribute to the weight-of-evidence determination of the need for a DNT study. The criteria for the weight-of-evidence determination are listed in Test Note 28 and include neurological effects from adult animal studies as well as neurobehavioral effects after pre- and post-natal exposure of the pesticide to young animals.
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The FIFRA SAP reviewed the Agency's retrospective analysis of the toxicity studies and encouraged the Agency to continue its analysis with a larger database. The FIFRA SAP made the following recommendations:
i. Increase the robustness of data analysis by including dog study datasets that were not used for the RfD determination.
ii. Conduct an analysis more representative of a prospective comparison through delineating the 13-week No Observed Adverse Effect Levels (NOAELs) and Lowest Observed Adverse Effect Levels (LOAELs)
iii. Consider data analysis for separate classes of pesticides.
iv. Include additional background information on RfD that provides better perspectives for reviewing the Agency position paper.
v. Revise the title of the Agency position paper to reflect the purpose of the data analysis.
The FIFRA SAP said in its report that “if the results of the analysis continue to indicate little added value from the 1-year dog studies, the Agency could move toward eliminating them on a stronger basis.”
In response, EPA conducted a more extensive analysis of dog toxicity studies on 110 chemicals representing over 50 different classes of pesticides [Ref. 12]. EPA concluded from this analysis that extending a dog toxicity study beyond a 13-week duration does not provide additional essential toxicity information; eliminating the 1-year dog toxicity study does not compromise the data needed for the determination of chronic RfDs and margins of exposure (MOE). Thus, reliance on the required chronic rodent studies, 2-generation rat reproductive study, and the 13-week dog toxicity study provides an adequate basis for chronic RfD derivation in pesticide risk assessment.
EPA acknowledges that there may be situations where a longer duration dog toxicity study may be warranted when a pesticide chemical is highly bioaccumulating (e.g. builds up in body fat) and is eliminated so slowly that it does not achieve steady state or sufficient tissue concentrations to elicit an effect during a 90-day study. EPA anticipates that this situation will be infrequent since current pesticides are not usually designed to be highly persistent and bioaccumulating. If such a chemical is encountered, EPA would require the appropriate Tier II metabolism and pharmacokinetic studies to more precisely evaluate bioavailability, half life, and steady state to determine if a longer duration dog toxicity study is needed. The circumstances that might lead to a request for the 1-year dog study are identified in Test Note 36.
In the proposed rule published March 2005, EPA discussed the work underway on alternative testing paradigms by the International Life Sciences Institute (ILSI)/Health and Environmental Sciences Institute (HESI). EPA is in conceptual agreement with the ILSI/HESI philosophy of moving toxicology testing away from a rigid guideline-based screening approach and towards a more knowledge-based approach. The ILSI/HESI approach was published in a series of papers in the January 2006 issue of
Eleven commenters addressed the ILSI/HESI testing paradigm, all supporting its development and early adoption. One commenter suggested that EPA update the proposed rule with the ILSI/HESI study findings and reissue a revised proposed rule for comment. In a similar vein, another suggested incorporating a timetable into the final rule for modifying subpart F (Toxicology). Another commenter believed a number of the concepts developed in by ILSI/HESI were ripe for incorporation into pesticide testing requirements at this time. This same commenter suggested not finalizing the proposed rule until there was an opportunity to consider and incorporate the important concepts developed by Agricultural Chemical Safety Assessment (ACSA). EPA believes that incorporating the concepts into the final rule is premature since EPA has not had the opportunity to determine if the new testing paradigm will meet its risk assessment needs. EPA believes that delaying the remaining proposed changes which comprise the bulk of the proposal would be a disservice to the regulated community. In a differing view, a commenter was concerned about the lack of public interest representatives in ILSI-EPA discussions and recommended that EPA terminate its collaborative working relationship with ILSI and industry trade groups. Since the Agency is interested in more efficient risk assessment paradigms, it will continue to work with all stakeholders in investigating efforts in that direction and welcomes the participation of any public interest representatives in the discussions.
EPA is committed to moving towards a more efficient and refined testing/risk assessment paradigm. Given the Agency's experience with regulating pesticides over the last 30 years, the Agency is interested in improving certain aspects of the testing process. In particular, EPA is more attuned to risk assessment needs (i.e., an integrated approach) that avoids requesting data not used in risk assessment and that reduces and refines the use of laboratory animals.
In the proposed rule, EPA discussed the relevance and importance of the ILSI/HESI project, Agricultural Chemical Safety Assessment (ACSA): a Tiered Approach. This project, with the participation of EPA scientists, represents a pursuit of a more efficient and accurate tiered testing of pesticide chemicals. A series of reports authored by ILSI/HESI was published in a special edition of the
ACSA represents the first comprehensive effort to scientifically redesign the toxicology animal-testing framework for agricultural chemicals. The ACSA proposal is consistent with EPA's direction and goals to develop a more efficient and reliable testing paradigm. Under the ACSA scheme, some studies would be eliminated while endpoint coverage would be increased in redesigned studies based on responses observed in a core set of toxicity tests. The value of the scheme is that animals are more fully utilized and the need for some tests can be eliminated if the core set of tests or existing knowledge does not indicate a concern. Decisions on next steps must be made throughout the course of the study as a thorough evaluation of all available information, including data on the pharmacokinetics and mode of action of the pesticide (if such data exist), could lead to different conclusions regarding the appropriate way to approach testing.
For example, in the case of the developmental neurotoxicity study, for some chemicals, it might be concluded that adequate testing of the developing nervous system would be best accomplished with a standard developmental neurotoxicity study. Refinements to the guideline study could include, for example, changes to the route and/or duration of exposure (e.g., initiation of dosing to maternal animals prior to gestation day 6, or direct gavage administration to pups during lactation), the evaluation of appropriate biomarkers of exposure or effect, the use of more targeted functional, behavioral, or cognitive testing in offspring, or the histopathological and/or morphometric evaluation of particular regions of the central or peripheral nervous system that are known to be affected by either the chemical or chemical class. For other chemicals, the information in the toxicological database could lead to the conclusion that an alternative test should be performed instead of a guideline developmental neurotoxicity study. Alternative chemical-specific methods could be identified as a preferred option.
EPA has multiple activities underway to address the remaining science and policy issues associated with the ACSA proposal. One essential step towards
Another critical step is gaining scientific consensus on the triggers (i.e., the points at which a concern is indicated and a higher level of testing is needed). The retrospective analyses will also be used to refine or confirm the ACSA proposed triggers for test decisions. Once the analysis is complete, EPA will be able to complete draft guidance on testing. The analyses and guidance are planned to be subject to SAP review and public comment in 2008.
Another essential step is testing how the ACSA scheme works in practice. There are plans to conduct several case studies using the ACSA tiered testing proposal. From these case studies, EPA will be able to assess the laboratory testing feasibility of such a complex study and to evaluate the ability of the approach and its parameters to characterize known toxicants and address risk assessment needs. Based on early scientific reviews, EPA scientists are already working on improvement of the ACSA tiered testing approach.
EPA will consider the results of the SAP review of the retrospective analyses and draft guidance, issues raised by stakeholders, and the case studies, in determining what revisions to current data requirements and testing guidelines may be appropriate. As the science issues are adequately vetted and crucial questions resolved, EPA will promulgate the appropriate regulatory changes on a timely basis. In the meantime, the existing regulations provide flexibility to implement any updated, new or novel testing schemes, on a case-by-case basis, as appropriate, until the changes are codified. Case-by-case determinations would be made in consultations with the Agency without the necessity of the waiver process.
It should be noted that ACSA is only one proposal that EPA will consider in improving the risk assessment process of environmental chemicals. Other relevant activities to consider include the National Academy of Sciences (NAS) recommendations on Toxicity Testing and Assessment of Environmental Agents expected in 2007 (Project ID BEST-U-03-08-A at
Before considering regulatory changes to reflect the results of EPA's consideration of ACSA, NAS, and other recommendations, the Agency will develop scientific position papers on the new approach and recommendations for internal and external review. Internal review includes review by the FIFRA SAP and opportunities for public comment. External peer review as well as acceptability by other national and international regulatory authorities are crucial before implementation of any new testing paradigm and data requirements. Harmonization with the data requirements of these same authorities is also an important factor. International regulations currently require studies that were omitted in ACSA; this would pose significant problems for registrants if a harmonized approach is not adopted world-wide.
Lastly, EPA is committed to review part 158 data requirements frequently to incorporate new science that has been fully documented and peer reviewed.
EPA received comments in several areas that were common to all science disciplines under this subpart.
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Based on these comments, in the final rule the Agency is no longer specifying the red-winged blackbird as the only acceptable passerine species for an additional avian acute oral toxicity study. However, the passerine acute oral study is still required, in addition to one with either the upland gamebird or the waterfowl. More than one tested species allows for consideration of interspecies sensitivity, and testing of a passerine addresses concerns that broad, untested avian taxa may be more sensitive than previously required mallards and bobwhites (Refs. 8 and 9).
EPA will consider studies using alternative species, as long as the alternative species meet the Agency's needs. EPA also intends to revise the avian acute oral toxicity guideline to include a passerine species, with the red-winged blackbird listed as among the preferred species. The Agency will revisit the issue of an acceptable species list with this goal in mind. Testing protocols may list other acceptable species upon reconsideration of this issue.
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One commenter advocated the development of reproduction tests with passerine species. Their interest was based on the fact that the current species used in this test, the mallard and the bobwhite, are precocial species (birds that are born covered with feathers, able to see and leave the nest soon after hatching) and passerine birds are altricial (birds that are born naked and blind and depend on their parents for food). The Agency believes that addressing the potential differences in reproduction between passerines and other birds is scientifically appropriate. However, at this time, no protocols have been made available to the Agency for such testing. Given the challenges testing labs are faced with for existing reproduction tests, protocols for passerines are not likely to be developed in the near future. Thus, the Agency is not expanding avian reproduction testing to passerine species at this time.
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The Agency evaluates the need for wild mammal toxicity on a case-by-case basis. The results of effects testing or fate testing alone are not the causal factor in such a determination. There may be case-specific information that would trigger the need for additional testing. This might include lines of information that suggest that available toxicity data provide unsuitable surrogacy for a particular nontarget species. Accordingly, the Agency has not revised the final rule.
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The Agency will consider any peer-reviewed reptile testing protocols for
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EPA received five comments regarding the data requirement for simulated or actual field testing with terrestrial animals. One comment stated that the information provided in the test note for this data requirement was nebulous and asked for clarification. Three comments stated that additional testing, particularly with wild species in the natural environment, should only be conducted when refined risk assessments indicate a potential concern. The fifth comment supported the continued requirement of the study.
The Agency evaluates the need for field testing on a case-by-case basis. Field studies have traditionally been performed to address uncertainties in risk assessments, especially those risk assessments predicting environmental effects of concern. However, setting a conditional requirement that triggers such studies only when risk assessment tools predict adverse effects ignores the possibility that lines of information may conversely point out inadequacies of the existing tool to provide adequate protection. To this end, the Agency has retained the existing field testing data requirements in part 158.
One of the commenters proposed a change to the test note for the terrestrial field study (test note 6 in the final rule). Their rationale was that a refined risk assessment should be the basis for requiring this higher tier study. A refined assessment may indicate that field data are needed to resolve uncertainties in the risk assessment. If so, then the field test is required. The Agency agrees with the comment and changed test note 6.
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A significant number of the comments the Agency received concerned the confusion in the data table regarding the use patterns that would need to be supported by TEP and the conditions that would trigger TEP testing with birds. Two commenters stated that TEP testing of birds should only be triggered when the risk from the TGAI is high, and birds are expected to encounter the intact end-use formulation in the field or expected to use the formulation itself as a food source. In contrast, a commenter recommended TEP testing for all products with potential aquatic or terrestrial nontarget exposure.
The Agency evaluates the need for testing of TEPs on a case-by-case basis. In such evaluations, the Agency relies on available lines of evidence such as published literature, adverse effects information submitted under FIFRA sec. 6(a)(2), European regulatory testing, and confidential statements of formula. The potential for nontarget organism exposure to TEP would naturally be a consideration as well. In light of the number of comments received on this issue, and past experience that shows TEP testing has only been required for granular formulations or other special situations, the conditional requirement has been removed from the data requirements and does not appear in the final rule. It will remain consistent with past policy and be required on a case-by-case basis.
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Two criteria, the soil-binding ability and persistence of the pesticide, were the focus of many comments. The criteria, as listed in the proposal, are the soil partition coefficient (Kd) value
The Agency's justification for selecting Kd
EPA received a comment that questioned the appropriateness of using the Kd value as a trigger for sediment testing. They suggested that the trigger should be based on the results of the aquatic transformation studies, particularly the mass balance results and the half-lives in sediments. Their method indicated that pesticides with Kd values lower than 50 L/kg, our proposed value, could also bind to sediment.
Agency scientists re-analyzed the value for the Kd criterion with United States Geological Survey (USGS) data (Ref. 13) and found that Kd values for pesticides commonly detected in sediments can range as low as 1.6 and as high as 2,095. This analysis provided EPA with an important new perspective on Kd values, and the Agency considered lowering the value of the criterion. However, EPA decided not to change the Kd value from that in the proposed rule based on science and policy considerations. First, the Kd value, which indicates binding potential of the pesticide (unadjusted for dependency upon organic carbon) is not the primary factor in determining the need for sediment testing (i.e., persistence, toxicity and exposure are the main factors). More importantly, the Agency believes that such a change warrants input from the scientific community along with broader public input on the Kd trigger. The Agency
The criteria for persistence is determined by using the aerobic aquatic metabolism data and the aerobic soil metabolism data. The anaerobic soil metabolism data are not used for this purpose. Commenters questioned the half-life value of
It appears from the above comments that the commenters misunderstand the purpose of the persistence trigger. Refer to Test Notes 21 and 22. EPA affirms that the intent of the triggers for the acute and chronic sediment tests are not to determine length of test. They were designed to determine if the sediment compartment should be considered for testing. Once that determination is made, then problem formulation will determine the specifics of the data required. The Agency strongly advises that the registrant consult with EPA concerning type of study and test organism selection. The Kd trigger is the same for either the acute or chronic sediment test. It is the persistence (i.e. half-life) that drives the decision regarding which study to require. For example, if the soil or aquatic aerobic/anaerobic half-lives are less than 10 days (Agency policy is to use the most conservative value, unless evidence is provided to support the use of an alternative value), then the Agency would accept the 10 day (acute) sediment study, unless there are clear reproductive issues
Two commenters proposed that a value of log Kow
One commenter wanted EPA to specify in the test notes when freshwater or marine organisms must be tested for sediment toxicity. Sediment toxicity data are required for marine/estuarine test species if the product is intended for direct application to the estuarine or marine environments, or the product is expected to enter this environment in significant concentrations, either by runoff or erosion, because of its expected use or mobility pattern. The test notes are amended to clarify when marine organism testing is required.
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With regard to greenhouse and indoor uses, the Agency requires the testing of one fish species to adequately assess the hazards to fish. If the LC
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The Agency affirms that chronic studies are required to support registration of an end-use pesticide product that is applied directly to water or is expected to be transported to water from the intended use site. This condition applies to estuarine as well as freshwater environments. These study requirements reflect the uncertainty that surrounds pesticide exposure and their potential for impact to aquatic organisms. Since exposure is a major driving parameter in assessing acute and/or chronic risk, this factor must be defined and addressed. The test notes for these studies list the details.
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The commenters stated that proposed test notes 13 and 15 were inconsistent with regard to the preferred estuarine fish species in the test note. As discussed in the Generic Issues unit (Unit XI.A.), the test notes in the final rule no longer indicate the names of preferred test species as they are fully discussed in the appropriate guidelines.
The comment regarding TEP with estuarine organisms is similar to that for TEP testing with freshwater organisms discussed in Unit XI.B.2.vii., except that the commenter recommended estuarine organisms should only be tested with the TEP if testing with the TGAI indicated that estuarine organisms are more sensitive than freshwater organisms, or if the freshwater organism tests demonstrate that the TEP is more toxic than the TGAI. The Agency response to the comment on TEP testing is addressed in Unit XI.B.2.vii.
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EPA proposed to change the conditions under which the accumulation in fish and accumulation in aquatic organisms would be required. EPA received eight comments regarding the fish and nontarget organism accumulation studies. Three of the commenters suggested that this data requirement be placed in proposed subpart E (now subpart G), Terrestrial and Aquatic Nontarget Organism Data Requirements, and not proposed subpart N. There were two comments stating that test note 10 was well written, and
The Agency agrees with the comments, and has moved the two studies under proposed subpart N, Accumulation in Fish and Accumulation in Aquatic Nontarget Organisms to subpart G, under the data requirements for aquatic organisms - bioavailability, biomagnification and toxicity. Therefore, all the ecological and fate requirements related to bioaccumulation are located solely in subpart G. We also agree with the comment that the language of Test Note 10 (Accumulation in Fish) in the proposed environmental fate data table is appropriate for the Accumulation in aquatic nontarget organisms data requirement in subpart G. Test note 10, “Not required when the octanol/water partition coefficients of the pesticide and its major degradates are less than 1,000; or there are no potential exposures to fish and other nontarget aquatic organisms; or the hydrolytic half-life is less than 5 days at pH 5, 7, and 9.” was moved to subpart G and renumbered as test note 19. This test note replaces test note 21 in proposed subpart E (now subpart G).
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The Agency requires TEP testing of freshwater and estuarine organisms for all outdoor uses. As the environments of the estuarine and freshwater organisms are different, how the chemical ingredients that comprise a formulated product will react in the different aquatic systems cannot be readily predicted. Therefore, the responses of each group of organisms are independent of each other, necessitating testing of both freshwater and estuarine organisms with the TEP in addition to the TGAI, if the triggers in the test note 9 are met.
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EPA proposed to expand Tier I and Tier II seedling emergence, vegetative vigor and aquatic plant growth studies to include terrestrial food and feed crops, aquatic food crops, forestry and residential outdoor uses. The conditional requirements for Tier III phytotoxicity terrestrial and aquatic field studies were also expanded with the addition of the same use patterns. The use patterns were expanded beyond terrestrial and aquatic nonfood uses and forestry uses in order to capture scenarios which may be impacted by drift and runoff from pesticide applications in neighboring areas.
Two comments requested explanations for including outdoor residential uses and indoor uses among those requiring plant testing. Outdoor residential use patterns are now included among the sites requiring plant testing because data indicate that herbicide uses on sites such as turf can harm nontarget plants through runoff. Turf is classified as an outdoor residential terrestrial use, and therefore requires nontarget plant testing. The Agency acknowledges that including indoor uses among those requiring aquatic plant growth testing in Table 3 in the proposed rule was an error as EPA did not intend to propose such a requirement. Plant testing is not required for indoor uses. Additionally, testing for aquatic nonfood residential use, also included by error in Table 3, has been eliminated in the final rule.
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The Agency received one comment regarding an apparent error in the placement of test note 3 for the Tier I and Tier II seedling emergence studies. EPA acknowledges that test note 3 was inaccurately placed next to the seedling emergence studies. This has been
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Another commenter referred to the findings of the FIFRA SAP in 2001 when it convened to discuss the proposed NAFTA (North America Fair Trade Act) Nontarget Plant Toxicity Tests. [Ref. 4] The FIFRA SAP indicated that progression from Tier I to Tier II should be based on a statistically significant effect
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The Agency also proposed to include additional use patterns and exposure scenarios under the data requirement for the honey bee acute contact toxicity study. Previously, the requirement was limited to outdoor use patterns when the crop may be in bloom and thereby attractive to honey bees. The change addresses not only blooming but also pollen-shedding and nectar-producing parts of nontarget plants that may be attractive to honey bees and may be in or near the site of a pesticide application. The criteria for requiring the honey bee residue study was corrected from an LD
There were several comments pertaining to the field study requirement for pollinators concerning the criteria that the requirement could be based on data from arthropods other than bees. These commenters asked for clarification to confirm that the data pertain solely to terrestrial and not aquatic arthropods. The test note for the pollinator field study was modified to clarify this point. Another comment concerned the designation of the acute contact toxicity study as R for the aquatic uses, citing several application scenarios or formulation types, such as direct application to water or granular formulations, that would reduce exposure to honey bees. The Agency agrees with the comment and changed the requirement for aquatic uses to CR.
A commenter recommended that EPA rely on surrogate data from other agencies such as the Occupational Safety and Health Administration's (OSHA) permissible exposure limits that are regulatory limits on the amount of concentration of hazardous substances in the air. Other commenters indicated that exposure data were available from several reliable sources besides the Pesticide Handlers Exposure Database and the Outdoor Residential Exposure Task Force mentioned in the proposed rule. These commenters identified other task forces that have generated exposure data—Indoor Residential Exposure Task Force, the Agricultural Handlers Exposure Task Force, and the Agricultural Reentry Task Force.
The Agency assumes that the commenter is referring to Permissible Exposure Limits (PELs) when he speaks of “OSHA workplace exposure limits.” The Agency does consider regulatory levels set by other authorities during risk assessment, including OSHA PELs; however, EPA and OSHA have different legislative mandates. OSHA does not have the authority under FIFRA to regulate pesticide exposures and therefore does not set PELs for chemicals used solely for pesticides.
The Agency has a long history of relying on surrogate exposure data and databases. To estimate occupational and residential exposures, the Agency uses databases containing large numbers of measured values of dermal and inhalation exposure for pesticide workers. Using these measured data from one study/scenario as surrogate or generic data for another study/scenario is appropriate since it is generally believed for pesticides of low volatility that the physical parameters of the handling and application process (e.g. the type of formulations, the method of application, and the type of clothing), not the chemical properties of the pesticide, control the amount of dermal and inhalation exposure. In contrast, OSHA evaluates exposures on a site-specific basis by collecting samples on workers and does not rely on surrogate databases.
However, for certain types of pesticide formulations or use scenarios, there is no exposure data, and therefore, it is not possible to perform an occupational/residential risk assessment. This is particularly one of the types of situations in which the Agency would require chemical-specific exposure data.
Some commenters questioned the currency of several guidelines in the context of dermal exposure and inhalation exposure data requirements. EPA will consider the comments as its scientists work to revise/update the guidelines. The Agency has reviewed and accepted many studies that are not conducted in accordance with current guidelines, but which serve its needs and provide suitable information for risk assessment purposes. In addition, some guidelines have not been finalized but are available in draft form. Notwithstanding such flexibility, EPA intends to finalize these test draft guidelines by the end of 2008.
EPA made no revisions in the final rule. EPA received other comments on this topic and has responded in its Response to Comments document in the docket for this rule.
EPA proposed changing several existing post-application data requirements from CR to R, expanding the use sites that those data requirements cover to include residential uses sites, and codifying certain data that had been previously sought on a case-by-case basis. Currently, EPA frequently conducts post-application exposure assessments, particularly with regard to residential
Commenters also identified test guidelines that still exist only in draft form and are absent from the list of OPPTS harmonized guidelines. EPA agrees that these test guidelines need to be finalized and intends to finalize them by the end of 2008.
EPA made no revisions in the final rule. EPA received other comments on this topic and has responded to comments in its Response to Comments document in the docket for this rule.
EPA has transferred the contents of the spray drift section (current § 158.440) essentially unchanged into subpart L of part 158. The regulatory text of the spray drift sections is reprinted in this final rule for clarity and completeness.
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EPA received two comments on the test note for the photodegradation in water data requirement which provided values for the electronic absorption spectra for the pesticide at which the study is not required. One comment asked for more specific guidance regarding the absorbance of the hydrolysis mixture, and the other comment asked for clarification about the structural identities of the hydrolysis products. EPA believes the test note is clear, but the commenters detailed concerns that could be addressed on an individual basis.
EPA proposed to change the designation of the requirement for the photodegradation on soil study from conditionally required (CR) to required (R) for terrestrial food crop and forestry uses patterns. The Agency received one comment about this photodegradation requirement that questioned the proposed change in classification as stated in the proposed rule. EPA is codifying a long-standing practice of requiring this study for terrestrial and forestry use patterns. The test note explaining that the study is not required when the chemical is to be applied only by soil injection or is incorporated in the soil has been retained.
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EPA has continued to require the anaerobic soil study as needed, notwithstanding its inadvertent omission from the CFR, but has also upon occasion accepted the anaerobic aquatic study in lieu of the anaerobic soil study. However, with the harmonization of the OPP environmental fate guidelines with those of the OECD and with PMRA under NAFTA agreements, and with the technical correction and clarification of the requirements in this rule, this practice of substituting the anaerobic aquatic study is no longer appropriate. In the harmonized guidelines, the two studies use different test media and redox conditions, so the results of these two studies will not necessarily be comparable. Continuing to use the anaerobic aquatic study when the Agency requires the anaerobic soil study will not fully address Agency risk assessment needs.
The commenters were also concerned about the expansion of the anaerobic aquatic metabolism requirement to include all terrestrial use patterns, such that the applicants would be required to conduct two anaerobic studies. This added requirement, in their estimate, would have a significant impact, doubling the time of the anaerobic system requirement. With this rule EPA now requires both anaerobic studies for terrestrial uses where the pesticide is likely to move from the site of application to nearby aquatic systems. Since the degradation or dissipation rates and pathways of pesticides in aquatic systems can be different from those of terrestrial systems, soil metabolism studies alone may not be adequate to cover these terrestrial use patterns.
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EPA acknowledges that some pesticides, based on their environmental fate profile and uses, may require both the aquatic and the terrestrial field dissipation studies, but we estimated that the frequency of this occurring is low. The Agency expanded the terrestrial field dissipation data requirement to gain a better understanding of the patterns of a pesticide's fate and transport when applied to crops that grow in both flooded and dry conditions in one growing season. This decision was endorsed by the FIFRA SAP in 1994. The data provided by the aquatic field study for terrestrial applications will provide data necessary to understand the fate of a terrestrially applied pesticide that has a high potential to enter aquatic environments. Data from these studies can reduce potential overestimation of exposure and risk and can confirm assumptions of low levels of toxic degradates. The test note for the aquatic study is based on harmonized language with PMRA under NAFTA, and provides the details that must be considered to determine if an aquatic (sediment) dissipation study is necessary for a terrestrial use.
One commenter recommended that to be consistent with the terrestrial field dissipation data requirement, the Agency should state that aquatic food crops, like rice and cranberry uses, which are managed to have a dry-land period for production, now must be conducted under the Terrestrial Field Dissipation (TFD) requirement. EPA agrees with this comment and has amended the test note for this study. The TFD guideline is available on the websites of EPA and PMRA.
EPA changed the requirement for the forestry dissipation study from required to conditionally required for pesticides used in forests. The Agency received five comments expressing the concern that with this change it is no longer clear what conditions of pesticide use in forestry would trigger this requirement. The Agency made the change because these studies are very difficult to conduct and very difficult to interpret. The trend over the past few years has been to rely on the terrestrial field dissipation studies for forestry uses. If this terrestrial dissipation study cannot assess all of the major routes of dissipation, the forestry study will be required.
The Agency did not propose any changes in the requirement for a field dissipation study for combination and tank mixes. Three comments identified the test note for this study as vague and with no useful information. They suggested that the test note be revised to clarify when this data requirement is needed, and the relevance of this data. EPA took their recommendation and rewrote this test note to clarify that this study may be triggered if there is specific evidence that the presence of one pesticide can affect the dissipation characteristics of another pesticide when applied simultaneously or serially.
vii.
The Agency agrees with the comments, and moved the two studies under proposed subpart N, Accumulation in Fish and Accumulation in Aquatic Nontarget Organisms to subpart G, under the data requirement for aquatic organisms - bioavailability, biomagnification and toxicity. Therefore, all the ecological and fate requirements related to bioaccumulation are located solely in subpart G. We also agree with the comment that the language of Note 10 (Accumulation in Fish) in the proposed environmental fate data table is appropriate for the Accumulation in aquatic nontarget organisms data requirement in subpart G. Test note 10, “Not required when the octanol/water partition coefficients of the pesticide and its major degradates are less than 1,000; or there are no potential exposures to fish and other nontarget aquatic organisms; or the hydrolytic half-life is less than 5 days at pH 5, 7, and 9.” was moved to subpart G and renumbered as test note 19. This test note replaces draft test note 21 in proposed subpart E (now G).
viii.
In addition to these use patterns, one commenter recommended that the ground water monitoring data requirement be conditionally required (CR) for residential outdoor uses. We agree that there may be certain cases where a ground water monitoring study would be needed to inform a risk management decision for residential outdoor use pesticides. In the final rule, EPA made this study CR, but we expect that the need for this study is likely to be rare.
ix.
EPA proposed codifying the residue chemistry data requirements that have arisen since the 1984 regulations were issued and clarifying and simplifying the 1984 data requirements. EPA has responded to comments in its Response to Comments document in the docket for this rule.
Some commenters viewed the proposed residential outdoor use pattern as an expansion of requirements for home garden uses and believed such uses do not fall under the scope of the FFDCA. EPA did not intend to expand the data requirement for residential uses; the current practice is to require data based on residential use only if the corresponding agricultural use on that crop is not approved or if the residential use is likely to have higher residues based on increased application rates or shorter preharvest intervals. EPA agrees that FFDCA does not apply to commodities that are not introduced into interstate commerce and tolerances are not established for residues on home garden crops. EPA does assess under FIFRA whether any adverse effects (e.g. dietary risks) could occur.
Some commenters requested a definition of indoor food use. EPA considers indoor food uses to be primarily pesticide treatment in food areas of food handling establishments (FHEs). FHEs include food servicing, food manufacturing, and food processing. Crack, crevice and space treatments are examples of application areas where pests hide or through which they enter a building. The FHE uses described above fall under the auspices of FFDCA and generally require residue data and tolerances (or exemptions from tolerances) for residues of conventional pesticides in food.
1.
2.
3.
4.
5.
A commenter felt that it would be appropriate to address radiovalidation under both the Nature of the Residue and the Analytical Method entries. While EPA views radiovalidation as an element of the Analytical method requirement, EPA believes the issue may be addressed in either the metabolism study report or the method validation report. Radiovalidation would not be necessary when the extraction procedures in the method and metabolism studies are identical or very similar and the metabolism study was deemed acceptable in terms of the levels of residues extracted and characterized/identified.
6.
7.
A commenter questioned the necessity of conducting separate feeding studies for separate metabolites. Only when the chemical structure of the plant metabolite raises concerns over potential bioconcentration and/or increased toxicity would EPA require additional animal studies dosing with the plant metabolite. The study is rarely requested, but EPA prefers to maintain the proposed test substance and footnote to alert applicants to the possibility of such data.
8.
This final rule does not apply to the data requirements for the registration of: biochemical pesticide products; microbial pesticide products; or antimicrobial pesticide products. EPA proposed to limit the applicability of revised part 158 to conventional pesticides in anticipation of additional revisions tailored to biochemical, microbial, and antimicrobial pesticides. Elsewhere in today's
EPA has transferred the contents of the sections that were not addressed in the proposal essentially unchanged into the revised part 158, i.e., spray drift (subpart L) and product performance (subpart E). The regulatory text of the sections for which no changes were proposed is reprinted in this final rule for clarity and completeness.
The preamble to the proposed rule discussed the Agency's extensive consultation and harmonization efforts with Canada and the OECD. Both the Pest Management Regulatory Agency (PMRA) and the EU submitted comments in response to the Agency's proposed rule. Both provided extensive comparisons of data requirements between the United States and their respective requirements. The PMRA stated that, in virtually every scientific discipline, the requirements exhibit a high degree of harmonization with the Canadian requirements. The EU, whose comments were based on their draft data requirements, noted that the U.S. requirements are not completely compatible with the corresponding EU data requirements. Nonetheless, the data requirements of the United States and the EU are comparable in many cases, with some exceptions. Both PMRA and the EU highlighted areas where continued collaboration toward development of a common testing strategy would be useful. EPA will continue to work with Canada and the EU through the OECD to harmonize data requirements, testing protocols and methodologies, and to promote work-sharing opportunities.
EPA received 53 comments, primarily from individuals, supporting its proposal to eliminate the 1-year dog study from the core toxicology data requirements and urging increased minimization of animal testing,
The Agency is committed to avoiding unnecessary animal testing while taking into consideration principles of sound science and the requirements of FIFRA to protect humans and the environment. For example, chemicals with a demonstrated pH indicating a strongly acidic or alkaline substance need not be tested in animals to screen for eye or skin corrosivity potential. EPA will consider data from a validated
EPA is working closely with 15 other U.S. agencies to advance the validation and adoption of alternative test methods through the Federal Interagency Coordinating Committee on Validation of Alternative Methods (ICCVAM) (http://iccvam.niehs.nih.gov), established by the National Institute of Environmental Health Sciences. ICCVAM works towards:
1. Encouraging the reduction of the number of animals used in testing, where possible.
2. Seeking opportunities to replace test methods requiring animals with alternative test methods when validated acceptable alternative methods are available.
3. Optimizing animal use by test method refinement.
ICCVAM, together with the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), convenes independent peer review panels, as appropriate, to evaluate the validation status of proposed test methods and coordinates expert panel meetings or workshops for validation or test method-related activities. ICCVAM has developed guidelines for the nomination and submission of new, revised, and alternative test methods (http://iccvam.niehs.nih.gov/SuppDocs/submission.htm).
The Agency has also co-sponsored a number of major workshops to advance alternative test method activities. EPA, ICCVAM, and NICEATM collaborated in the development of performance standard concepts for validated alternative tests (May 2004 NIH Publication No. 04-4510 [Ref. 6]. Recently, at the request of EPA, ICCVAM/NICEATM coordinated the review of four
The Agency also recognizes the need for timely periodic review, revision and/or supplementation, as applicable, of its test guidelines. As new tests and test batteries are validated, the Agency can present them to the FIFRA SAP to review their applicability in meeting regulatory needs. EPA can seek comment from the SAP on test guideline or other test method-related issues, depending on the circumstances. As other appropriate alternative or
Finally, the Agency is committed to a more hypothesis-based testing paradigm by advancing
EPA is committed to revise part 158 data requirements to incorporate new science. In the meantime, the existing regulations provide flexibility to implement any updated, new or novel testing schemes, on a case-by-case basis, as appropriate, until the changes are codified.
EPA received comments from four California water treatment authorities and two California cities' environmental agencies. The comments centered on their strong recommendations that FIFRA data requirements meet the needs of the Clean Water Act (CWA) regulatory program and should consider urban water quality issues. California water-treatment authorities questioned the adequacy of the Agency's assessment of risks with regard to water quality considerations including: use of aquatic toxicity data, surface water quality studies, and urban uses of pesticides, particularly when these uses result in pesticide residues in receiving waters from storm sewers or sewage treatment plants.
The goal of the 158 data requirements is to require the registrants to submit scientifically sound data, conducted according to recommended guidelines to enable the scientists in the Pesticide Program to conduct ecological risk assessments on a national scale. EPA believes the 158 data requirements are sufficient to conduct high quality risk assessments. EPA's evaluation and registration of pesticides under FIFRA take into account impacts on the aquatic environment. Also, under FIFRA, EPA has the authority to impose a specific restriction on the use of a pesticide in a particular geographic location. Such a restriction will appear in or be referenced on the labeling of all products distributed anywhere in the United States, but will affect the use of the pesticide only when it occurs within the identified geographic area. Although EPA has not routinely imposed labeling restrictions on pesticides to prevent degradation of high quality water, it could do so. As part of its reregistration and registration review programs, EPA's Pesticide and Water Offices are working more closely together to identify sites where water quality standards are not being met as a result of the presence of unacceptable levels of pesticide residues, and the Pesticide Office considers those issues in its reviews. OPP provides State and Tribal pesticide lead agencies with water quality grant funds in order to develop and carry out management programs to protect ground and surface water resources from pesticide risks.
Incidental to its proposed data requirements for conventional pesticides, EPA discussed the possibility of future data and information needs to develop and/or refine risk assessments for endangered species. EPA did not propose any data requirements specific to endangered species, but described its current level of information and data usage. EPA requested comment on the value and
EPA appreciates the response it received from commenters on these topics, primarily from industry task forces and associations. As endangered species data requirements were not proposed, EPA has not responded to the comments as part of this final rule, but will consider them in the context of its ongoing risk assessments. If EPA finds that it needs to amend part 158 to normalize endangered species data requirements, it will consider these comments in the development of a future proposed rule.
After the effective date, the data requirements in this final rule will apply to all new registrations of conventional pesticides. The Agency does not intend to apply these requirements retroactively to all existing pesticide registrations, but the Agency may find it necessary to call in some data on certain existing registrations, as warranted by emerging risks of concern on particular pesticides or as a result of possible programmatic changes and priorities on existing pesticides. FIFRA sec. 3(c)(2) provides EPA broad authority, before and after registration, to require scientific testing and submission of the resulting data to the Agency by registrants and applicants of pesticide products. Although the data requirements in part 158 are imposed primarily as a part of initial registration, EPA is authorized under FIFRA sec. 3(c)(2)(B) to require a registrant to develop and submit additional data necessary to maintain a registration. This post-registration data call-in authority recognizes that the scientific underpinnings of risk assessment change, and is another means by which EPA may keep data for use in risk assessment current with evolving science.
EPA will consider as part of its review of a pending application whether and how to apply these updated data requirements. EPA expects that few changes will be needed, as these updated requirements reflect current practice.
Some commenters believed the revised data requirements in 40 CFR part 158 had to be finalized before registration review could be implemented. While the part 158 data requirements and registration review are related, they are not inextricably linked but rather proceed along parallel tracks. The Agency makes case-by-case data determinations as standard program practice so the registration review program now being implemented can operate effectively in the absence of updated data requirements. The updated data requirements in this final rule will provide applicants with more clarity and transparency in the information presented in part 158.
The Agency established an official docket for this rulemaking under Docket ID No. OPP-2004-0387. All of the documents that have been included in that docket are available at http://www.fdms.gov. The following is a list of the documents that are specifically referenced in this final rule. Not all docket materials are available electronically but all publicly available docket materials are available through the Docket facility described under
1. Barton, H.A., Pastoor, T.P., Baetcke, K., Chambers, J.E., Diliberto, J., Doerrer, N.G.,Driver, J.H., Hastings, C.E., Iyengar, S., Krieger, R., Stahl, B., and Timchalk, C. The acquisition and application of absorption, distribution, metabolism, and excretion (ADME) data in agricultural chemical safety assessments. January 2006.
2. Carmichael, N.G., Barton, H.A., Boobis, A.R., Cooper, R.L., Dellarco, V.L., Doerrer, N.G., Fenner-Crisp, P.A., Doe, J.E., Lamb, J.C., and Pastoor, T.P. Agricultural chemical safety assessment: a multi-sector approach to the modernization of human safety requirements. January 2006.
3. Cooper, R.L., Lamb, J.C., Barlow, S.M., Bentley, K., Brady, A.M., Doerrer, N.G., Eisenbrandt, D.L., Fenner-Crisp, P.A., Hines, R.N., Irvine, L., Kimmel, C.A., Koeter, H., Li, A.A., Makris, S.L., Sheets, L., Speijers, G.J.A., and Whitby, K. A tiered approach to life stages testing for agricultural chemical safety assessment. January 2006.
4. Davy, M., Petrie, R., Smrchek, J., Kuchnicki, T., and Francois, D. Proposal to Update Nontarget Plant Toxicity Testing under NAFTA: Scientific Advisory Panel Briefing. Washington, DC: Office of Prevention, Pesticides, and Toxic Substances, U.S. Environmental Protection Agency and Health Canada - Pest Management Regulatory Agency. June 27-29, 2001.
5. Doe, J.E., Boobis, A.R., Blacker, A., Dellarco, V.L., Doerrer, N.G., Franklin, C., Goodman, J.I., Kronenberg, J.M., Lewis, R., McConnell, E.E., Mercier, T., Moretto, A., Nolan, C., Padilla, S., Phang, W., Solecki, R., Tilbury, L., van Ravenswaay, B., and Wolf, D.C. A tiered approach to systemic toxicity testing for agricultural chemical safety assessment. January 2006.
6. Interagency Coordinating Committee on the Validation of Alternative Methods and the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods. Recommended Performance Standards for
7. Kennedy, J.M. and Talbert, R.E. Comparative persistence of dinitroaniline-type herbicides on the soil surface. 1977.
8. Mineau, P., Baril, A., Collins, B.T., Duffe, J., Joerman, G. and Luttik, R. Pesticide acute toxicity reference values for birds. 2001.
9. Schafer, E.W. and Brunton, R.B. Indicator bird species for toxicity determinations: is the technique usable in test method development? 1979. Vertebrate Pest Control and Management Materials (American Society for Testing and Materials Special Technical Publication 680), pp. 157-168.
10. U.S. Environmental Protection Agency. A Comparison of the Results of Studies on Pesticides from 1- or 2-Year Dog Studies with Dog Studies of Shorter Duration; a set of scientific issues being considered by the EPA, May 5 and 6, 2005, FIFRA Scientific Advisory Panel Meeting, held at the Holiday Inn-Rosslyn at Key Bridge, Arlington, Virginia. Washington, DC: U.S. Environmental Protection Agency. May 2005.
11. U.S. Environmental Protection Agency. Economic Analysis of the Change in the Data Requirements Rule for Conventional Pesticides. Washington, DC: Biological and Economic Analysis Division, Office of Pesticide Programs, U.S. Environmental Protection Agency. November 7, 2006.
12. U.S. Environmental Protection Agency. Length of Dog Toxicity Study(ies) that is Appropriate for Chronic RfD Determinations of Pesticide Chemicals. Washington, DC: Health Effects Division, Office of Pesticide Programs, U.S. Environmental Protection Agency. March 20, 2006.
13. U.S. Geological Survey. Pesticides in stream sediment and aquatic biota: current understanding of distribution
14. Letter from Dr. Maurice Zeeman, U.S. National Coordinator, OECD Test Guidelines Program, to Dr. Eisaku Toda, Environment, Health, and Safety Division, OECD/Environment Directorate, regarding the U.S. comments received in response to requested review of the proposed OECD Test Guideline 223: Avian Acute Oral Toxicity Test. March 24, 2003.
In accordance with FIFRA sec. 25(a), a draft of this final rule was submitted to the FIFRA SAP, the Secretary of Agriculture and appropriate Congressional Committees. The FIFRA SAP waived its review of this final rule because the significant scientific issues involved have already been reviewed by the SAP and additional review isn't necessary.
Under Executive Order 12866, entitled
In addition, EPA prepared an analysis of the potential costs and benefits associated with this action, entitled “Economic Analysis of the Changes in the Data Requirements Rule for Conventional Pesticides” [Ref. 11]. A copy of the analysis is available in the docket for this action.
This final rule is similar to the proposed rule except that some data requirements will no longer be required. As such, the estimated annual cost of this final rule will be less than the estimated annual cost of the proposed rule. The estimated costs for the data requirements that will no longer be required are:
1.
2.
• Scheduled Controlled Operant Behavior,
• Peripheral Nerve Function,
• Neurophysiology: Sensory Evoked Potentials.
In addition, some of the test notes associated with the Ecological Effects data requirements have been revised. These revisions will slightly reduce the percent of time these data requirements may be imposed, resulting in a slight reduction of the cost of the rule. However, these costs were not re-estimated because of the expected minimal impact. As a result of these changes, the estimated annual incremental cost of the final rule is expected to be about $33.6 million for the industry. The elimination of the toxicity tests as described above reduces the estimated cost of the rule by almost $17 million.
This cost reduction also applies to the high-cost option (require data 100% of the time). The low-cost option (codification of current practice) is the same in the proposed and final rule. It is no longer the lowest cost option under the final rule because current practice retains the data requirements that were eliminated in the final rule. Since the expected overall impact of this final rule on businesses is expected to be small, the Agency believes that the effect on the availability of pesticides to users is not likely a deleterious one. On balance, the Agency believes that the cost of the rule is justified by the benefits from the enhanced protection of human health and the environment.
The information collection activities related to the submission of data to EPA in order to register a conventional pesticide product are already approved by OMB under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. This action does not impose any new information collection burden. The information collection activities are already approved by OMB under the following existing ICRs:
1. The activities associated with the establishment of a tolerance are currently approved under OMB Control No. 2070-0024 (EPA ICR No. 0597);
2. The activities associated with the application for a new or amended registration of a pesticide are currently approved under OMB Control No. 2070-0060 (EPA ICR No. 0277);
3. The activities associated with the generation of data for reregistration are currently approved under OMB Control No. 2070- 0107 (EPA ICR No. 1504); and
4. The activities associated with the generation of data for experimental use permits are currently approved under OMB Control No. 2070-0040 (EPA ICR No. 0276).
Copies of these OMB-approved Information Collection Request (ICR) may be obtained from Susan Auby, Collection Strategies Division; U.S. Environmental Protection Agency (2822T); 1200 Pennsylvania Ave., NW, Washington, DC 20460 or by calling (202) 566-1672.
Under the PRA, “burden” means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number, or is otherwise required to submit the specific information by a statute. The OMB control numbers for EPA's regulations codified in Title 40 of the Code of Federal Regulations, after appearing in the preamble of the final rule, are further displayed either by publication in the
For the ICR activity contained in this final rule, in addition to displaying the applicable OMB control number in this Unit, the Agency is amending the table in 40 CFR 9.1 to list the OMB control number assigned to the collection activities in this rulemaking. Due to the technical nature of the table, EPA finds that further notice and comment about amending the table is unnecessary. As a result, EPA finds that there is good
Pursuant to section 605(b) of the Regulatory Flexibility (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. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) a small business engaged in the manufacture of pesticide and other agricultural chemicals with 500 employees or fewer as defined by NAIC code 325320; (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. EPA has determined that this final rule does not impact any small governmental jurisdictions or any small not-for-profit enterprise because these entities are rarely pesticide applicants or registrants. The small entities directly regulated by this final rule are small manufacturers of pesticides and other agricultural chemicals.
Since the expected incremental cost of the final rule is about $33.6 million, which is about 33% less (almost 17 million less) than what was estimated for the proposed rule, the potential impacts on small businesses in the final rule would be less than what was estimated for the proposed rule. The small business impacts for the final rule were not re-estimated since they were not significant under the proposed rule and will therefore be even less significant under the final rule.
Based on the Economic Analysis for the proposed rule, of the 61 firms that might be impacted by this final rule, EPA had estimated that 2.4% are likely to experience a cost increase of 1% or more of gross sales. A cost increase of 3% or more of gross sales is expected to be experienced by 1.6% of the potentially impacted small firms.
Although this final rule will not have a significant economic impact on a substantial number of small entities, EPA nonetheless has tried to reduce the impact of this rule on small entities. EPA believes that the users most in need of clarity are the infrequent, generally small applicants, whose data requirements are in many cases limited to enduse product data of various types. Smaller follow-on or me-too registrants are often required to generate only product-specific chemistry data, acute toxicity data, and efficacy data. These applicants will benefit by the restructured part 158 so they don't have to search for applicable data requirements by sifting through voluminous data requirements that may be satisfied by the formulators' exemption, citation, or offer-to-pay procedures. EPA has restructured the subparts to place the data requirements applicable to the bulk of applications (new end-use and me-too products) towards the beginning of part 158 to make the regulation more user-friendly.
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 or tribal governments, in the aggregate, or on the private sector in any 1 year. The annual costs associated with this action are estimated to total about $33.6 million to applicants and registrants. These costs represent the incremental costs due to the additional or modified data requirements contained in this action. Since State, local, and tribal governments are rarely pesticide applicants or registrants, this rule is not expected to affect small governments. Thus, today's rule is not subject to the requirements of sections 202 and 205 of the UMRA.
Under Executive Order 13132, entitled
In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and State and local governments, EPA specifically solicited comment on the proposed rule from State and local officials. EPA did not receive comments on federalism. EPA did receive comments on substantive parts of the rule from State governments and these are addressed elsewhere.
Under Executive Order 13175, entitled
Executive Order 13045, entitled
This rule is not subject to Executive Order 13211, entitled
As noted in the proposed rule, Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note)
This rulemaking involves environmental monitoring or measurement. Consistent with the Agency's Performance Based Measurement System (PBMS), EPA has decided not to require the use of specific, prescribed analytic methods. Rather, the rule will allow the use of any methods that meets the prescribed performance criteria. The PBMS approach is intended to be more flexible and cost-effective for the regulated community; it is also intended to encourage innovation in analytical technology and improved data quality. EPA is not precluding the use of any method, whether it constitutes a voluntary consensus standard or not, as long as it meets the performance criteria specified.
This rule does not have an adverse impact on the environmental and health conditions in low-income and minority communities. Therefore, under Executive Order 12898, entitled
The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to the publication of the rule in the
Reporting and recordkeeping requirements.
Environmental protection, Confidential business information, Pesticides and pests, Reporting and recordkeeping requirements.
7 U.S.C. 135 et seq., 136 136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601 2671; 21 U.S.C. 331j, 346a, 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971 1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g 1, 300g 2, 300g 3, 300g 4, 300g 5, 300g 6, 300j 1, 300j 2, 300j 3, 300j 4, 300j 9, 1857 et seq., 6901 6992k, 7401 7671q, 7542, 9601 9657, 11023, 11048.
7 U.S.C. 136 - 136y; 21 U.S.C. 346a.
(a)
(b)
(2) This part establishes general policies and procedures associated with the submission of data in support of a pesticide regulatory action.
(3) This part does not include study protocols, methodology, or standards for conducting or reporting test results; nor does this part describe how the Agency uses or evaluates the data and information in its risk assessment and risk management decisions, or the regulatory determinations that may be based upon the data.
(c)
(2)
(3)
(4)
All terms defined in sec. 2 of the Federal Insecticide, Fungicide, and Rodenticide Act apply to this part and are used with the meaning given in the Act. Applicable terms from the Federal Food, Drug, and Cosmetic Act also apply to this part. Individual subparts may contain definitions that pertain solely to that subpart. The following additional terms apply to this part:
(1) An application for registration or amended registration of a pesticide product under FIFRA sec. 3 or 24.
(2) A submission of data required in conjunction with reregistration of a currently registered product under FIFRA sec. 4.
(3) An application for an experimental use permit under FIFRA sec. 5.
(4) A submission of data in response to a notice issued by EPA under FIFRA sec. 3(c)(2)(B).
(5) A petition to establish or modify a tolerance or an exemption from the requirement of a tolerance for a pesticide chemical residue under FFDCA sec. 408.
(a) The requirements of this part apply to the following submissions:
(1) An application for new or amended registration under FIFRA sec. 3 or 24.
(2) An application for experimental use permit under FIFRA sec. 5.
(3) A submission of data or information to support the continuation of a registration under FIFRA sec. 3, 4, or 24.
(4) A petition to establish, modify or revoke a tolerance or exemption from a tolerance under FFDCA sec. 408.
(b) The information specified in this part must be furnished with each submission described in paragraph (a) of this section if it has not been submitted previously, or if any previous submission is not accurate or complete.
(a) FIFRA provides EPA flexibility to require, or not require, data and information for the purposes of making regulatory judgments for pesticide products. EPA has the authority to establish or modify data needs for individual pesticide chemicals. The actual data required may be modified on an individual basis to fully characterize the use and properties, characteristics, or effects of specific pesticide products under review. The Agency encourages each applicant to consult with EPA to discuss the data requirements particular to its product prior to and during the registration process.
(b) The Agency cautions applicants that the data routinely required in this part may not be sufficient to permit EPA to evaluate the potential of the product to cause unreasonable adverse effects to man or the environment. EPA may require the submission of additional data or information beyond that specified in this part if such data or information are needed to appropriately evaluate a pesticide product.
(c) This part will be updated as needed to reflect evolving program needs and advances in science.
(a)
(2) The requirements of this section do not apply to administrative materials accompanying a data submission, including forms, labeling, and correspondence.
(b)
(1) Identity of the submitter.
(2) The transmittal date.
(3) Identification of the regulatory action with which the submission is associated,
(4) A list of the individual documents included in the submission.
(c)
(1) A title page including the following information:
(i) The title of the study, including identification of the substance(s) tested and the test name or data requirement addressed.
(ii) The author(s) of the study.
(iii) The date the study was completed.
(iv) If the study was performed in a laboratory, the name and address of the laboratory, project numbers or other identifying codes.
(v) If the study is a commentary on or supplement to another previously
(vi) If the study is a reprint of a published document, all relevant facts of publication, such as the journal title, volume, issue, inclusive page numbers, and date of publication.
(2) The appropriate statement(s) regarding any data confidentiality claims as described in § 158.33.
(3) A statement of compliance or non-compliance with respect to Good Laboratory Practice Standards as required by 40 CFR 160.12, if applicable.
(4) A complete and accurate English translation must be included for any information that is not in English.
(5) A flagging statement as prescribed by § 158.34, if applicable.
(a)
(1)
(2)
(b)
(2) FFDCA sec. 408(i) protects confidential information submitted in connection with an application for a tolerance or exemption to the same extent as FIFRA sec. 10. References in this section to FIFRA sec. 10 are deemed to apply equally to information submitted pursuant to FFDCA sec. 408, pursuant to the authority in sec. 408(i).
(c)
(2)
(i)
No claim of confidentiality, on any basis whatsoever, is made for any information contained in this document. I acknowledge that information not designated as within the scope of FIFRA sec. 10(d)(1)(A), (B), or (C) and which pertains to a registered or previously registered pesticide is not entitled to confidential treatment and may be released to the public, subject to the provisions regarding disclosure to multinational entities under FIFRA sec. 10(g).
(ii)
Information claimed as confidential has been removed to a confidential attachment.
(3)
(ii) All information in the confidential attachment that consists of (or whose disclosure would in turn disclose) manufacturing or quality control processes must be individually identified in the confidential attachment as a claim for information within the scope of FIFRA sec. 10(d)(1)(A).
(iii) All information in the confidential attachment that consists of (or whose disclosure would in turn disclose) the details of any methods for testing, detecting, or measuring the quantity of any deliberately added inert ingredient of a pesticide, must be individually identified in the confidential attachment as a claim for information within the scope of FIFRA sec. 10(d)(1)(B).
(iv) All information in the confidential attachment that consists of (or whose disclosure would in turn disclose) the identity or percentage quantity of any deliberately added inert ingredient of a pesticide must be individually identified in the confidential attachment as a claim for information within the scope of FIFRA sec. 10(d)(1)(C).
(v) Information in the confidential attachment that is designated in accordance with paragraphs (c)(3)(ii) - (iv) of this section must be on a separate page from information that is not so designated.
(4)
I authorize the Environmental Protection Agency to release any information contained in this document to State or foreign governments, without relinquishing proprietary rights or any confidentiality claims asserted above.
(ii) Information designated as releasable to state or foreign governments in accordance with this section may be released to such a government without further notice to the submitter. EPA will inform the State or foreign government of any of the confidentiality claims associated with the information.
(d)
(2) Information that is not entitled to be protected as confidential in accordance with FIFRA sec. 10(b), this section and with EPA confidentiality regulations at 40 CFR part 2, subpart B, may be released to the public without the affirmation of non-multinational status provided under FIFRA sec. 10(g), provided that the information does not contain or consist of any complete unpublished report submitted to EPA, or excerpts or restatements of any such report which reveal the full methodology and complete results of the study, test, or experiment, and all explanatory information necessary to understand the methodology or interpret the results.
(a) Any applicant who submits a study of a type listed in paragraph (b) of this section must submit with the study a statement in accordance with paragraph (c) of this section.
(b) The following table indicates the study types and the criteria to be applied to each. Column 1 lists the study types by name. Column 2 lists the associated Pesticide Assessment Guideline number. Column 3 lists the criteria applicable to each type of study. Column 4 lists the reporting code to be included in the statement specified in paragraph (c) of this section when any criterion is met or exceeded.
(c)
(1) Study does not meet or exceed criteria.
I have applied the criteria of 40 CFR 158.34 for flagging studies for potential adverse effects to the results of the attached study. This study neither meets nor exceeds any of the applicable criteria.
(2) Study meets or exceeds criteria.
I have applied the criteria of 40 CFR 158.34 for flagging studies for potential adverse effects to the results of the attached study. This study meets or exceeds the criteria numbered [insert all applicable reporting codes].
(a) The data requirements specified in this part as applicable to a category of products will not always be appropriate for every product in that category. Some products may have unusual physical, chemical, or biological properties or atypical use patterns which would make particular data requirements inappropriate, either because it would not be possible to generate the required data or because the data would not be useful in the Agency's evaluation of the risks or benefits of the product. The Agency will waive data requirements it finds are inappropriate, but will ensure that sufficient data are available to make the determinations required by the applicable statutory standards.
(b)(1) Applicants are encouraged to discuss a data waiver request with the Agency before developing and submitting supporting data, information, or other materials.
(2) All waiver requests must be submitted to the Agency in writing. The request must clearly identify the data requirement(s) for which a waiver is sought along with an explanation and supporting rationale why the applicant
(c) The Agency will review each waiver request and subsequently inform the applicant in writing of its decision. If the decision could apply to more than the requested product, the Agency, in its discretion, may choose to send a notice to all registrants or publish a notice in the
FIFRA sec. 2(ll) defines the term “minor use”and FIFRA provides a number of statutory provisions concerning minor uses. In addition, EPA has established policies with respect to minor uses of pesticides, including, but not limited to, the following:
(a) A new data requirement pertinent to both an unregistered minor use and a registered major use will not be applied to a minor use applicant until it is applied to the major use registration.
(b) EPA will accept appropriate and adequate extrapolations and regional data to support establishment of individual minor use tolerances.
(a)
(1) The provisions in this part 158 should be read in conjunction with the provisions in § 152.85 to claim eligibility for the formulators' exemption.
(2) [Reserved]
(b)
(c)
(d)
(2)
(e)
The data routinely required by this part may not be sufficient to permit EPA to evaluate every pesticide product. If the information required under this part is not sufficient to evaluate the potential of the product to cause unreasonable adverse effects on man or the environment, additional data requirements will be imposed. However, EPA expects that the information required by this part will be adequate in most cases for an assessment of the properties and effects of the pesticide.
(a)
(b)
(a)
(1) Terrestrial food crop use.
(2) Terrestrial feed crop use.
(3) Terrestrial nonfood crop use.
(4) Aquatic food crop use.
(5) Aquatic nonfood use.
(6) Greenhouse food crop use.
(7) Greenhouse nonfood crop use.
(8) Forestry use.
(9) Residential outdoor use.
(10) Residential indoor use.
(11) Indoor food use.
(12) Indoor nonfood use.
(b)
(c) Applicants unsure of the correct use pattern for their particular product should consult the Agency.
The tables in this part use the descriptors R (required), CR (conditionally required), and NR (not required) as a general indication of the applicability of a data requirement. In all cases, the test notes referred to in the table must be consulted to determine the actual applicability of the data requirement.
(a) EPA requires data designated as “required”(R) for products with a given use pattern in order to evaluate the risks or benefits of a product having that use pattern under any conditions established by the test notes.
(b) Data designated as “conditionally required” (CR) for products with a given use pattern are required by EPA to evaluate the risks or benefits of a product having that use pattern if the product meets the conditions specified in the notes accompanying the requirement. The determination of whether the data must be submitted is based on the product's use pattern, physical or chemical properties, expected exposure of nontarget organisms, and/or results of previous testing (for example, tier testing). Applicants must evaluate each applicable test note for the conditions and criteria to be considered in determining whether conditionally required data must be submitted.
(c) Data not required for the Agency's assessment of the risks and benefits of a particular use pattern are designated “not required” (NR) in data tables.
As with current practice, the actual data and studies required may be modified on an individual basis to fully characterize the use and properties of specific pesticide products under review. While EPA is attempting to assist the applicant in this subpart, it is important to emphasize that it is the applicant's obligation under FIFRA to demonstrate that an individual product meets the standard under FIFRA and/or FFDCA. Accordingly, applicants are encouraged to consult with the Agency on the appropriate data requirements as set forth here as they relate to their specific product prior to and during the registration process.
(a)
(2) Key to table notations. R = required data; CR = conditionally required data; NR = Not required; MP = manufacturing-use product; EP = end-use product; TEP = typical end-use product; TGAI = technical grade of the active ingredient; PAI = pure active ingredient; PAIRA = pure active ingredient, radiolabeled; Choice = choice of several test substances depending on studies required.
(b)
(1) Refer to the applicable subpart(s) of this part. These subparts describe the data requirements including data tables for each subject area.
(2) Select the general use pattern(s) that best cover the use pattern(s) specified on the pesticide product label as explained in § 158.100. All applicable use patterns must be included.
(3) Proceed down the appropriate general use pattern column in the table and note which tests are required (R), conditionally required (CR), or not required (NR). Required and conditionally required studies are described in § 158.110.
(4) Review the notes for each requirement to determine its applicability to the specific product proposed for registration.
(5)(i) Proceed down the Test substance columns and determine the appropriate test substance needed for that study. If the data are intended to support a manufacturing-use product, use the MP column. If the data are intended to support an end-use product, use the EP column.
(ii) The test substances columns specify which substance is to be used for testing. Applicants should note that the substance that must be used when performing the study may or may not be the product itself. For example, the data from a certain study may be required to support the registration of an end-use product, but the test substance column may state that the particular test shall be performed using the technical grade of the active ingredient(s) in the end-use product.
(iii) Manufacturing-use products (MP) and end-use products (EP) containing a single active ingredient and no intentionally added inert ingredients are considered identical in composition to each other, and to the technical grade of the active ingredient (TGAI) from which they were derived. Therefore, the data from a test conducted using any one of these as the test substance is also suitable to meet the requirement (if any) for the same test to be conducted using either of the other substances.
(6) Refer to the Pesticide Assessment Guideline reference number for each study located in the first column. See § 158.70(c) for information pertaining to the guidelines and how to obtain copies.
(a)
(b)
(i) To support the conclusions expressed in the statement of formula;
(ii) To compare to the composition of materials used in required testing under this part; and
(iii) To determine whether a product is “identical or substantially similar”to another product, a determination that involves the comparison of product composition.
(2)
(3)
(i) To confirm or provide supportive information on the identity and composition of the product;
(ii) To assess the hazards of the ingredient or product; and
(iii) To trigger or evaluate certain other studies required by this part.
(c)
(d)
(1)
(2)
(3)
(4)
(5)
(i) To detect, with sensitive assay methods, the capacity of a chemical to alter genetic material in cells.
(ii) To determine the relevance of these mutagenic changes to mammals.
(iii) When mutagenic potential is demonstrated, to incorporate these findings in the assessment of heritable effects, carcinogenicity, and, possibly, other health effects.
(6)
(e)
(2)
(3)
(f)
(g)
(h)
(2)
(3)
(4)
(5)
(i)
(2) Information on the chemical identity and composition of the pesticide product, the amounts, frequency and time of the pesticide application, and results of tests on the amount of residues remaining on or in the treated food or feed, are needed to support a finding as to the magnitude and identity of residues which result in food or animal feed as a consequence of a proposed pesticide usage.
(3) Residue chemistry data are also needed to support the adequacy of one or more methods for the enforcement of the tolerance, and to support practicable methods for removing residues that exceed any proposed tolerance.
(4)
Sections 158.200 through 158.270 describe how to use these tables to determine the experimental use permit data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed at the end of each table. Refer to 40 CFR part 172 for further information on experimental use permits.
All product chemistry data, as described in § 158.310, must be submitted to support a request for an experimental use permit.
All product performance data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit.
(a)
(2) Data are also required for forestry and residential outdoor uses.
(b)
(c)
(d)
1. The Agency has waived the requirement to submit efficacy data unless the pesticide product bears a claim to control pest microorganisms that pose a threat to human health and whose presence cannot readily be observed by the user including, but not limited to, microorganisms infectious to man in any area of the inanimate environment, or a claim to control vertebrates (such as rodents, birds, bats, canids, and skunks) that may directly or indirectly transmit diseases to humans. However each registrant must ensure through testing that his product is efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency reserves the right to require, on a case-by-case basis, submission of efficacy data for any pesticide product registered or proposed for registration.
2. [Reserved]
All toxicology data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit.
(a)
(2) Nonfood use patterns include products classified under the general use patterns of terrestrial nonfood crop use, aquatic nonfood crop use, aquatic nonfood outdoor use, greenhouse nonfood crop use, forestry use, residential outdoor use, indoor nonfood use, and indoor residential use.
(b)
(c)
(d)
1. Not required if test material is a gas or a highly volatile liquid.
2. Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
3. Required if the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or particulate).
4. Required if repeated dermal exposure is likely to occur under conditions of use.
5. Required if the test material is an organophosphorus substance, which includes uncharged organophosphorus esters, thioesters, or anhydrides of organophosphoric, organophosphonic, or organophosphoramidic acids, or of related phosphorothioic, phosponothioic, or phosphorothioamidic acids, or is structurally related to other substances that may cause the delayed neurotoxicity sometimes seen in this class of chemicals.
6. These studies are seldom required to support EUPs. They may be required if the dietary exposure for these EUPs occupies a large part, e.g., greater than 50%, of the reference dose.
7. The oral route, by oral intubation, is preferred unless the chemical or physical properties of the test substance or the pattern of exposure suggests a more appropriate route of exposure.
8. May be combined with the 2-generation reproduction study in rodents by utilizing a second mating of the parental animals in either generation.
9. At a minimum, an initial battery of mutagenicity tests with possible confirmatory testing is required. Other relevant mutagenicity tests that may have been performed, plus a complete reference list must also be submitted.
10. Choice of assay using either:
i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, maximizing assay conditions for small colony expression or detection;
ii. Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) gene locus, accompanied by an appropriate
iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene locus.
11. The micronucleus rodent bone marrow assay is preferred; however, rodent bone marrow assays using metaphase analysis (aberrations) are acceptable.
All data for terrestrial nontarget organisms and aquatic nontarget organisms as described in § 158.243 must be submitted to support a request for an experimental use permit. No data for nontarget plant protection must be submitted to support a request for an experimental use permit.
All terrestrial and aquatic nontarget organism data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit.
(a)
(2) Data are also required for the general use patterns of forestry and residential outdoor use.
(b)
(c)
(d)
1. Data using the TGAI are required to support all outdoor end-use product uses including, but not limited to, turf. Data are generally not required to support end-use products in the form of a gas, a highly volatile liquid, a highly reactive solid, or a highly corrosive material.
2. For greenhouse and indoor end-use products, data using the TGAI are required to support manufacturing-use products to be reformulated into these same end-use products or to support end-use products when there is no registered manufacturing-
3. Data are required on one passerine species and either one waterfowl species or one upland game bird species for terrestrial, aquatic, forestry, and residential outdoor uses. Data are preferred on waterfowl or upland game bird species for indoor and greenhouse uses.
4. Data are required on waterfowl and upland game bird species.
5. Data are required on one coldwater fish and one warmwater fish for terrestrial, aquatic, forestry, and residential outdoor uses. For indoor and greenhouse uses, testing with only one of either fish species is required.
6. EP or TEP testing is required for any product which meets any of the following conditions:
i. The end-use pesticide will be introduced directly into an aquatic environment (e.g., aquatic herbicides and mosquito larvicides) when used as directed.
ii. The maximum expected environmental concentration (MEEC) or the estimated environmental concentration (EEC) in the aquatic environment is
iii. An ingredient in the end-use formulation other than the active ingredient is expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms.
7. Data are required on one freshwater aquatic invertebrate species.
8. Data are generally not required for outdoor residential uses, other than turf, unless data indicate that pesticide residues from the proposed use(s) can potentially enter waterways.
9. Data are required on one freshwater fish species. If the test species is different from the two species used for the freshwater fish acute toxicity tests, a 96 hour LC
10. Not required when:
i. The octanol/water partition coefficients of the pesticide and its major degradates are
ii. There are no potential exposures to fish and other nontarget aquatic organisms; or
iii. The hydrolytic half-life is
11. The freshwater fish test species for the TEP testing is the most sensitive of the species tested with the TGAI. A freshwater invertebrate must also be tested with the EP or TEP using the same species tested with the TGAI.
No data for applicator exposure and post-application exposure must be submitted to support a request for an experimental use permit.
All environmental fate data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit.
(a)
(2) Data are also required for the general use patterns of forestry use and residential outdoor use.
(b)
(c)
(d)
1. Study is required for indoor uses in cases where environmental exposure is likely to occur. Such sites include, but are not limited to, agricultural premises, in or around farm buildings, barnyards, and beehives.
2. Required for aquatic uses for aquatic sites that are intermittently dry. Such sites include, but are not limited to cranberry bogs and rice paddies.
3. Adsorption and desorption using a batch equilibrium method is preferred. However, in some cases, for example, where the pesticide degrades rapidly, soil column leaching with unaged or aged columns may be more appropriate to fully characterize the potential mobility of the parent compound and major transformation products.
All residue chemistry data, as described in § 158.1410, are required for an experimental use permit for which a temporary tolerance under FFDCA
The following terms are defined for the purposes of this subpart:
(1) Includes directions for use of the product (as distributed or sold, or after combination by the user with other substances) for controlling pests or defoliating, desiccating or regulating growth of plants, or as a nitrogen stabilizer, and
(2) does not state that the product may be used to manufacture or formulate other pesticide products.
(1) The process of mixing, blending, or dilution of one or more active ingredients with one or more other active or inert ingredients, without an intended chemical reaction, to obtain a manufacturing-use product or an end-use product, or
(2) The repackaging of any registered product.
(1) Any impurity present in the technical grade of active ingredient; and
(2) Any impurity which forms in the pesticide product through reactions between the active ingredient and any other component of the product or packaging of the product.
(1) Contains any active ingredient derived from a source that is not an EPA-registered product; or
(2) Contains any active ingredient that was produced or acquired in a manner that does not permit its inspection by the Agency under FIFRA sec. 9(a) prior to its use in the process.
(1) Which contains no inert ingredient, other than one used for purification of the active ingredient; and
(2) Which is produced on a commercial or pilot plant production scale (whether or not it is ever held for sale).
(a)
(b)
(c)
(d)
(e)
(f)
1. Data must be provided in accordance with § 158.320.
2. Data must be provided in accordance with § 158.325.
3. Data must be provided in accordance with § 158.330.
4. Data must be provided in accordance with § 158.335.
5. Data must be provided in accordance with § 158.340.
6. Data must be provided in accordance with § 158.345.
7. Data must be provided in accordance with § 158.350.
8. Data must be provided in accordance with § 158.355.
9. If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI.
10. Data are required if the product is produced by an integrated system.
11. Basic manufacturers are required to provide the Agency with a sample of each TGAI used to formulate a product produced by an integrated system when the new TGAI is first used as a formulating ingredient in products registered under FIFRA. A sample of the active ingredient (PAI) suitable for use as an analytical standard is also required at this time. Samples of end-use products produced by an integrated system must be submitted on a case-by-case basis.
12. Data on the stability to metals and metal ions are required only if the TGAI is
13. Required when the product contains an oxidizing or reducing agent.
14. Required when the product contains combustible liquids.
15. Required when the product is potentially explosive.
16. Required when the product is an emulsifiable liquid and is to be diluted with petroleum solvent.
17. Required when the EP is a liquid and is to be used around electrical equipment.
18. Required when the test substance is soluble or dispersible in water.
19. Required when the product is a liquid.
20. Required when the TGAI is solid at room temperature.
21. Required when the TGAI is liquid at room temperature.
22. Required when the test substance contains an acid or base functionality (organic or inorganic) or an alcoholic functionality (organic).
23. Required for water insoluble test substances (
24. Required if technical chemical is organic and non-polar.
25. Not required for salts.
26. Data on stability of the MP and TGAI to storage at normal temperatures are required. Data on the stability of the TGAI to high temperatures are required if the TGAI is expected to be subjected to temperatures
Information on the composition of the pesticide product must be furnished. The information required by paragraphs (a), (b), and (f) of this section must be provided for each product. In addition, if the product is produced by an integrated system, the information on impurities required by paragraphs (c) and (d) of this section must be provided.
(a)
(1) If the source of any active ingredient in the product is an EPA-registered product:
(i) The chemical and common name (if any) of the active ingredient, as listed on the source product.
(ii) The nominal concentration of the active ingredient in the product, based upon the nominal concentration of active ingredient in the source product.
(iii) Upper and lower certified limits of the active ingredient in the product, in accordance with § 158.350.
(2) If the source of any active ingredient in the product is not an EPA-registered product:
(i) The chemical name according to Chemical Abstracts Society (CAS) nomenclature, the CAS Registry Number, and any common names.
(ii) The molecular, structural, and empirical formulae and the molecular weight or weight range.
(iii) The nominal concentration.
(iv) Upper and lower certified limits of the active ingredient in accordance with § 158.350.
(v) The purpose of the ingredient in the formulation.
(b)
(1) The chemical name of the ingredient according to Chemical Abstracts Society nomenclature, the CAS Registry Number, and any common names (if known). If the chemical identity or chemical composition of an ingredient is not known to the applicant because it is proprietary or trade secret information, the applicant must ensure that the supplier or producer of the ingredient submits to the Agency (or has on file with the Agency) information on the identity or chemical composition of the ingredient. Generally, it is not required that an applicant know the identity of each ingredient in a mixture that he uses in his product. However, in certain circumstances, the Agency may require that the applicant know the identity of a specific ingredient in such a mixture. If the Agency requires specific knowledge of an ingredient, it will notify the applicant in writing.
(2) The nominal concentration.
(3) Upper and lower certified limits in accordance with § 158.350.
(4) The purpose of the ingredient in the formulation.
(c)
(1) Identification of the ingredient as an impurity.
(2) The chemical name of the impurity.
(3) The nominal concentration of the impurity in the product.
(4) A certified upper limit, in accordance with § 158.350.
(d)
(1) Identification of the ingredient as an impurity.
(2) The chemical name of the impurity.
(3) The nominal concentration of the impurity in the final product.
(e)
(f)
The following information must be submitted on the materials used to produce the product:
(a)
(i) The name of the EPA-registered product.
(ii) The EPA registration number of that product.
(2) For each inert ingredient:
(i) Each brand name, trade name, common name, or other commercial designation of the ingredient.
(ii) All information that the applicant knows (or that is reasonably available to him) concerning the composition (and, if requested by the Agency, chemical and physical properties) of the ingredient, including a copy of technical specifications, data sheets, or other documents describing the ingredient.
(iii) If requested by the Agency, the name and address of the producer of the ingredient or, if that information is not known to the applicant, the name and address of the supplier of the ingredient.
(b)
(2) The following information concerning each active ingredient that is not derived from an EPA-registered product:
(i) The name and address of the producer of the ingredient (if different from the applicant).
(ii) Information about each starting material used to produce the active ingredient, as follows:
(A) Each brand name, trade name, or other commercial designation of the starting material.
(B) The name and address of the person who produces the starting material or, if that information is not known to the applicant, the name and address of each person who supplies the starting material.
(C) All information that the applicant knows (or that is reasonably available to
(3) The information required by paragraph (a)(2) of this section concerning each inert ingredient.
(c)
If the product is produced by an integrated system, the applicant must submit information on the production (reaction) processes used to produce the active ingredients in the product. The applicant must also submit information about the formulation process, in accordance with § 158.335.
(a) Information must be submitted for the current production process for each active ingredient that is not derived from an EPA-registered product. If the production process is not continuous (a single reaction process from starting materials to active ingredient), but is accomplished in stages or by different producers, the information must be provided for each such production process.
(b) The following information must be provided for each process resulting in a separately isolated substance:
(1) The name and address of the producer who uses the process, if not the same as the applicant.
(2) A general characterization of the process (
(3) A flow chart of the chemical equations of each intended reaction occurring at each step of the process, and of the duration of each step and of the entire process.
(4) The identity of the materials used to produce the product, their relative amounts, and the order in which they are added.
(5) A description of the equipment used that may influence the composition of the substance produced.
(6) A description of the conditions (
(7) A description of any purification procedures (including procedures to recover or recycle starting materials, intermediates or the substance produced).
(8) A description of the procedures used to assure consistent composition of the substance produced,
The applicant must provide information on the formulation process of the product (unless the product consists solely of a technical grade of active ingredient) as required by the following sections:
(a) Section 158.330(b)(2), pertaining to characterization of the process.
(b) Section 158.330(b)(4), pertaining to ingredients used in the process.
(c) Section 158.330(b)(5), pertaining to process equipment.
(d) Section 158.330(b)(6), pertaining to the conditions of the process.
(e) Section 158.330(b)(8), pertaining to quality control measures.
The applicant must provide a discussion of the impurities that may be present in the product, and why they may be present. The discussion should be based on established chemical theory and on what the applicant knows about the starting materials, technical grade of active ingredient, inert ingredients, and production or formulation process. If the applicant has reason to believe that an impurity that EPA would consider toxicologically significant may be present, the discussion must include an expanded discussion of the possible formation of the impurity and the amounts at which it might be present. The impurities which must also be discussed are the following, as applicable:
(a)
(2) Each other impurity which the registrant or applicant has reason to believe may be present in his product at any time before use at a level
(i) The composition (or composition range) of each starting material used to produce his product.
(ii) The impurities which the applicant knows are present (or believes are likely to be present) in the starting materials, and the known or presumed level (or range of levels) of these impurities.
(iii) The intended reactions and side reactions which may occur in the production of the product, and the relative amounts of byproduct impurities produced by such reactions.
(iv) The possible degradation of the ingredients in the product after its production but prior to its use.
(v) Post-production reactions between the ingredients in the product.
(vi) The possible migration of components of packaging materials into the pesticide.
(vii) The possible carryover of contaminants from use of production equipment previously used to produce other products or substances.
(viii) The process control, purification and quality control measures used to produce the product.
(b)
(1) The possible carryover of impurities present in any registered product which serves as the source of any of the product's active ingredients. The identity and level of impurities in the registered source need not be discussed or quantified unless known to the formulator.
(2) The possible carryover of impurities present in the inert ingredients in the product.
(3) Possible reactions occurring during the formulation of the product between any of its active ingredients, between the active ingredients and inert ingredients, or between the active ingredient and the production equipment.
(4) Post-production reactions between any of the product's active ingredients and any other component of the product or its packaging.
(5) Possible migration of packaging materials into the product.
(6) Possible contaminants resulting from earlier use of equipment to produce other products.
(c)
(1) From other possible chemical reactions.
(2) Involving other ingredients.
(3) At additional points in the production or formulation process.
(a) If the product is produced by an integrated system, the applicant must
(b) Based on the preliminary analysis, a statement of the composition of the technical grade of the active ingredient must be provided. If the technical grade of the active ingredient cannot be isolated, a statement of the composition of the practical equivalent of the technical grade of the active ingredient must be submitted.
The applicant must propose certified limits for the ingredients in the product. Certified limits become legally binding limits upon approval of the application. Certified limits will apply to the product from the date of production to date of use. If the product label bears a statement prohibiting use after a certain date, the certified limits will apply only until that date.
(a)
(1) An upper and lower limit for each active ingredient.
(2) An upper and lower limit for each inert ingredient.
(3) If the product is a technical grade of active ingredient or is produced by an integrated system, an upper limit for each impurity of toxicological significance associated with the active ingredient and found to be present in any sample of the product.
(4) On a case-by-case basis, certified limits for other ingredients or impurities as specified by EPA.
(b)
(2) Table of standard certified limits.
(c)
(2) If certified limits are required for impurities, the applicants must propose a certified limit. The standard certified limits may not be used for such substances.
(3) Certified limits should:
(i) Be based on a consideration of the variability of the concentration of the ingredient in the product when good manufacturing practices and normal quality control procedures are used.
(ii) Allow for all sources of variability likely to be encountered in the production process.
(iii) Take into account the stability of the ingredient in the product and the possible formation of impurities between production and sale or distribution.
(4) The applicant may include an explanation of the basis of his proposed certified limits, including how the certified limits were arrived at (
(d)
(1) More precise limits.
(2) More thorough explanation of how the certified limits were determined.
(3) A narrower range between the upper and lower certified limits than that proposed.
(e)
I hereby certify that, for purposes of FIFRA sec. 12(a)(1)(C), the description of the composition of [
An analytical method suitable for enforcement purposes must be provided for each active ingredient in the product and for each other ingredient or impurity that the Agency determines to be toxicologically significant.
(a)
(b)
(c)
(d)
(e)
1. The Agency has waived the requirement to submit product performance data unless the pesticide product bears a claim to control pest microorganisms that pose a threat to human health and whose presence cannot readily be observed by the user including, but not limited to, microorganisms infectious to man in any area of the inanimate environment, or a claim to control vertebrates (such as rodents, birds, bats, canids, and skunks) that may directly or indirectly transmit diseases to humans. However each registrant must ensure through testing that his product is efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency reserves the right to require, on a case-by-case basis, submission of product performance data for any pesticide product registered or proposed for registration.
2. [Reserved]
(a)
(b)
(2) Nonfood use patterns include products classified under the general use patterns of terrestrial nonfood crop use, aquatic nonfood use, greenhouse nonfood crop use, forestry use, residential outdoor use, and indoor nonfood use.
(c)
(d)
(e)
1. Not required if test material is a gas or a highly volatile liquid.
2. Diluted EP testing is required to support the end product registration if results using the EP meet the criteria for restricted use classification under § 152.170(b) or special review consideration under § 154.7(a)(1).
3. Not required if the test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
4. Required if the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or particulate).
5. Required if repeated dermal exposure is likely to occur under conditions of use.
6. Required if the test material is an organophosphorus substance, which includes uncharged organophosphorus esters; thioesters or anhydrides of organophosphoric, organophosphonic, or organophosphoramidic acids; or of related phosphorothioic, phosponothioic, or phosphorothioamidic acids; or is structurally related to other substances that may cause the delayed neurotoxicity sometimes seen in this class of chemicals.
7. As determined by the Agency, additional measurements may also be required, such as cholinesterase activity for certain pesticides, e.g., organophosphates and some carbamates. The route of exposure must correspond with the primary route of exposure.
8. Required for nonfood use pesticides if oral exposure could occur.
9. The 90-day study is required in the rat for hazard characterization (possibly endpoint selection) and dose-setting for the chronic/carcinogenicity study. It is not required in the mouse, but the Agency would strongly encourage the registrant to conduct a 90-day range finding for the purposes of dose selection for the mouse carcinogenicity study to achieve adequate dosing and an acceptable study. The registrant is also encouraged to consult with the Agency on the results of the 90-day mouse study prior to conducting the carcinogenicity study.
10. Required for agricultural uses or if repeated human dermal exposure may occur. Not required if an acceptable 90-day dermal toxicity study is performed and submitted.
11. EP testing is required if the product, or any component of it, may increase dermal absorption of the active ingredient(s) as determined by testing using the TGAI, or increase toxic or pharmacologic effects.
12. Required for food uses if either of the following criteria is met:
(i) The use pattern is such that the dermal route would be the primary route of exposure; or
(ii) The active ingredient is known or expected to be metabolized differently by the dermal route of exposure than by the oral route, and a metabolite is the toxic moiety.
13. Required if there is the likelihood of significant repeated inhalation exposure to the pesticide as a gas, vapor, or aerosol.
14. Based on estimates of the magnitude and duration of human exposure, studies of shorter duration, e.g., 21- or 28-days, may be sufficient to satisfy this requirement. Registrants should consult with the Agency to determine whether studies of shorter duration would meet this requirement.
15. Required if results of acute neurotoxicity study indicate significant statistical or biological effects, or if other available data indicate the potential for this type of delayed neurotoxicity, as determined by the Agency.
16. All 90-day subchronic studies in rats can be designed to simultaneously fulfill the requirements of the 90-day neurotoxicity study using separate groups of animals for testing. Although the subchronic guidelines include the measurement of neurological endpoints, they do not meet the requirement of the 90-day neurotoxicity study.
17. Required if either of the following are met:
(i) The use of the pesticide is likely to result in repeated human exposure over a considerable portion of the human lifespan, as determined by the Agency;
(ii) The use requires a tolerance or an exemption from the requirement of a tolerance.
18. Based on the results of the acute and subchronic neurotoxicity studies, or other available data, a combined chronic toxicity and neurotoxicity study may be required.
19. Studies which are designed to simultaneously fulfill the requirements of both the chronic oral and carcinogenicity studies (i.e., a combined study) may be conducted. Minimum acceptable study durations are:
(i) Chronic rodent feeding study (food use) - 24 months.
(ii) Chronic rodent feeding study (nonfood use) - 12 months.
(iii) Mouse carcinogenicity study - 18 months.
(iv) Rat carcinogenicity study - 24 months.
20. Required if any of the following, as determined by the Agency, are met:
(i) The use of the pesticide is likely to result in significant human exposure over a considerable portion of the human life span which is significant in terms of either frequency, duration, or magnitude of exposure;
(ii) The use requires a tolerance or an exemption from the requirement of a tolerance; or
(iii) The active ingredient, metabolite, degradate, or impurity (a) is structurally related to a recognized carcinogen, (b) causes mutagenic effects as demonstrated by
21. If this study is modified or waived, a subchronic 90-day oral study conducted in the same species may be required.
22. Testing in two species is required for all uses.
23. The oral route, by oral intubation, is preferred unless the chemical or physical properties of the test substance or the pattern of exposure suggests a more appropriate route of exposure.
24. Additional testing by other routes may be required if the pesticide is determined to be a prenatal developmental toxicant after oral dosing.
25. May be combined with the 2-generation reproduction study in rodents by utilizing a second mating of the parental animals in either generation.
26. Required to support products intended for food uses and to support products intended for nonfood uses if use of the product is likely to result in significant human exposure over a portion of the human life span in terms of frequency, magnitude or duration of exposure.
27. An information-based approach to testing is preferred, which utilizes the best available knowledge on the chemical (hazard, pharmacokinetic, or mechanistic data) to determine whether a standard guideline study, an enhanced guideline study, or an alternative study should be conducted to assess potential hazard to the developing animal, or in some cases to support a waiver for such testing. Registrants should submit any alternative proposed testing protocols and supporting scientific rationale to the Agency prior to study initiation.
28. Study required using a weight-of-evidence approach considering:
(i) The pesticide causes treatment-related neurological effects in adult animal studies (i.e., clinical signs of neurotoxicity, neuropathology, functional or behavioral effects).
(ii) The pesticide causes treatment-related neurological effects in developing animals, following pre- and postnatal exposure (i.e. nervous system malformations or neuropathy, brain weight changes in offspring, functional or behavioral changes in the offspring).
(iii) The pesticide elicits a causative association between exposures and adverse neurological effects in human epidemiological studies.
(iv) The pesticide evokes a mechanism that is associated with adverse effects on the development of the nervous system (e.g., SAR relationship to known neurotoxicants, altered neuroreceptor or neurotransmitter responses).
29. The use of a combined study that utilizes the 2-generation reproduction study in rodents as a basic protocol for the addition of other endpoints or functional assessments in the immature animal is encouraged.
30. At a minimum, an initial battery of mutagenicity tests with possible confirmatory testing is required. Other relevant mutagenicity tests that may have been performed, plus a complete reference list must also be submitted.
31. Choice of assay using either:
(i) Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, maximizing assay conditions for small colony expression or detection;
(ii) Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) gene locus, accompanied by an appropriate
(iii) CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene locus.
32. The micronucleus rodent bone marrow assay is preferred; however, rodent bone marrow assays using metaphase analysis (aberrations) are acceptable.
33. Required when chronic or carcinogenicity studies are required. May be required if significant adverse effects are seen in available toxicology studies and these effects can be further elucidated by metabolism studies.
34. May be required if the product's use will result in exposure to domestic animals through, but not limited to, direct application.
35. A risk assessment assuming that dermal absorption is equal to oral absorption must be
36. A 1-year non-rodent study (i.e., 1-year dog study) would be required if the Agency finds that a pesticide chemical is highly bioaccumulating and is eliminated so slowly that it does not achieve steady state or sufficient tissue concentrations to elicit an effect during a 90-day study. EPA would require the appropriate tier II metabolism and pharmacokinetic studies to evaluate more precisely bioavailability, half-life, and steady state to determine if a longer duration dog toxicity study is needed.
For nonfood use pesticides only, applicants have two options for generating and submitting required toxicology (§ 158.500) and human exposure (§ 158.1020, § 158.1070, and § 158.1410) studies. Applicants are to select one of the following:
(a) Acute, subchronic, chronic, and other toxicological studies on the active ingredient must be submitted together. The specific makeup of the set of toxicology study requirements is based on the anticipated exposure to the pesticide as determined by the Agency. If hazards are identified based upon review of these studies, specific exposure data will be required to evaluate risk.
(b) Certain toxicological and exposure studies must be submitted simultaneously with the toxicology data submitted in a tiered system. Exposure data must be submitted along with first tier toxicology data. The requirement for additional second and third level toxicology testing will be determined by the Agency based on the results of the first tiered studies.
(1) The required first-tier toxicology studies consist of:
(i) Battery of acute studies.
(ii) A subchronic 90-day dermal study or a subchronic 90-day inhalation study.
(iii) An acute and subchronic neurotoxicity screening battery in the rat.
(iv) Prenatal developmental toxicity studies in both the rat and rabbit.
(v) Reproduction and fertility studies in rats.
(vi) Battery of mutagenicity studies.
(vii) Immunotoxicity study.
(2) The conditionally required second-tier studies include:
(i) Subchronic 90-day feeding studies in both the rodent and nonrodent.
(ii) Dermal penetration study.
(3) The conditionally required third-tier studies include:
(i) Chronic feeding studies in the rodent.
(ii) Carcinogenicity.
(iii) Metabolism study.
(iv) Additional mutagenicity testing.
(a)
(b)
(2) Data are also required for the general use patterns of forestry and residential outdoor use.
(3) In general, for all outdoor end-uses, including turf, the following studies are required: Two avian oral LD
(c)
(d)
(e)
1. Data using the TGAI are required to support all outdoor end-use product uses including, but not limited to turf. Data are generally not required to support end-use products in the form of a gas, a highly volatile liquid, a highly reactive solid, or a highly corrosive material.
2. For greenhouse and indoor end-use products, data using the TGAI are required to support manufacturing-use products to be reformulated into these same end-use products or to support end-use products when there is no registered manufacturing-use product. Avian acute oral data are not required for liquid formulations for greenhouse and indoor uses. The study is not required if there is no potential for environmental exposure.
3. Data are required on one passerine species and either one waterfowl species or one upland game bird species for terrestrial, aquatic, forestry, and residential outdoor uses. Data are preferred on waterfowl or upland game bird species for indoor and greenhouse uses.
4. Data are required on waterfowl and upland game bird species.
5. Tests are required based on the results of lower tier toxicology studies, such as the acute and subacute testing, intended use pattern, and environmental fate characteristics that indicate potential exposure.
6. Higher tier testing may be required for a specific use pattern when a refined risk assessment indicates a concern based on laboratory toxicity endpoints and refined exposure assessments.
7. Environmental chemistry methods used to generate data associated with this study must include results of a successful confirmatory method trial by an independent laboratory. Test standards and procedures for independent laboratory validation are available as addenda to the guideline for this test requirement.
8. Data are required on one coldwater fish and one warmwater fish for terrestrial, aquatic, forestry, and residential outdoor uses. For indoor and greenhouse uses, testing with only one of either fish species is required.
9. EP or TEP testing is required for any product which meets any of the following conditions:
i. The end-use pesticide will be introduced directly into an aquatic environment (e.g., aquatic herbicides and mosquito larvicides) when used as directed.
ii. The maximum expected environmental concentration (MEEC) or the estimated environmental concentration (EEC) in the aquatic environment is
iii. An ingredient in the end-use formulation other than the active ingredient is expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms.
10. Data are required on one freshwater aquatic invertebrate species.
11. Data are required on one estuarine/marine mollusk, one estuarine/marine invertebrate and one estuarine/marine fish species.
12. Data are generally not required for outdoor residential uses, other than turf, unless data indicate that pesticide residues from the proposed use(s) can potentially enter waterways.
13. Data are required on one freshwater fish species. If the test species is different from the two species used for the freshwater fish acute toxicity tests, a 96-hour LC
14. Data are required on one estuarine/marine invertebrate species.
15. Data are required on estuarine/marine species if the product meets any of the following conditions:
i. Intended for direct application to the estuarine or marine environment.
ii. Expected to enter this environment in significant concentrations because of its expected use or mobility patterns.
iii. If the acute LC
iv. If the estimated environmental concentration (EEC) in water is
A. Studies of other organisms indicate the reproductive physiology of fish and/or invertebrates may be affected.
B. Physicochemical properties indicate bioaccumulation of the pesticide.
C. The pesticide is persistent in water (e.g., half-life in water
16. Data are required on one estuarine/marine fish species.
17. Data are required on estuarine/marine species if the product is intended for direct application to the estuarine or marine environment, or the product is expected to enter this environment in significant concentrations because of its expected use or mobility patterns.
18. Data are required on freshwater species if the end-use product is intended to be applied directly to water, or is expected to be transported to water from the intended use site, and when any of the following conditions apply:
i. If the estimated environmental concentration (EEC) is
ii. If studies of other organisms indicate that the reproductive physiology of fish may be affected.
19. Not required when:
i. The octanol/water partition coefficients of the pesticide and its major degradates are
ii. There are no potential exposures to fish and other nontarget aquatic organisms; or
iii. The hydrolytic half-life is
20. Data are required based on the results of lower tier studies such as acute and chronic aquatic organism testing, intended use pattern, and environmental fate characteristics that indicate significant potential exposure.
21. Data are required if:
i. The half-life of the pesticide in the sediment is
A. The soil partition coefficient (Kd) is
B. The log Kow is
C. The Koc
ii. Registrants must consult with the Agency on appropriate test protocols prior to designing the study.
22. Data are required if:
i. The estimated environmental concentration (EEC) in sediment is
ii. The half-life of the pesticide in the sediment is
A. The soil partition coefficient (Kd) is
B. The log Kow is
C. The Koc
iii. Registrants must consult with the Agency on appropriate test protocols prior to designing the study.
23. Sediment testing with estuarine/marine test species is required if the product is intended for direct application to the estuarine or marine environment or the product is expected to enter this environment in concentrations which the Agency believes to be significant, either by runoff or erosion, because of its expected use or mobility pattern.
24. Data are required only when the formulation contains one or more active ingredients having an acute LD
25. Required if any of the following conditions are met:
i. Data from other sources (Experimental Use Permit program, university research, registrant submittals, etc.) indicate potential adverse effects on colonies, especially effects other than acute mortality (reproductive, behavioral, etc.);
ii. Data from residual toxicity studies indicate extended residual toxicity.
iii. Data derived from studies with terrestrial arthropods other than bees indicate potential chronic, reproductive or behavioral effects.
26. The freshwater fish test species for the TEP testing is the most sensitive of the species tested with the TGAI. Freshwater invertebrate and acute estuarine and marine organisms must also be tested with the EP or TEP using the same species tested with the TGAI.
(a)
(b)
(2) Data are also required for the general use patterns of forestry use and residential outdoor use.
(c)
(d)
(e)
1. Not required for contained pesticide treatments such as bait boxes and pheromone traps unless adverse effects reports are received by the Agency.
2. Not required for known phytotoxicants.
3. Generally not required for granular formulations. May be requested on a case-by-case basis.
4. Required for known phytotoxicants such as herbicides, desiccants and defoliants.
5. Required if a tested terrestrial species exhibits a 25 percent or greater detrimental effect in the Tier I study. When Tier II testing is required, the test species should be the species that showed detrimental effects in the Tier I testing.
6. Required if the tested aquatic species exhibits a 50 percent or greater detrimental effect in the Tier I study. When Tier II testing is required, the test species should be the species that showed detrimental effects in the tier I testing.
7. Not required for aquatic residential uses.
8. Environmental chemistry methods used to generate data must include the results of a successful confirmatory method trial by an independent laboratory.
9. Tests are required on a case-by-case basis based on the results of lower tier phytotoxicity studies, adverse incident reports, intended use pattern, and environmental fate characteristics that indicate potential exposure.
10. Registrants must consult with the Agency on appropriate test protocols prior to designing the study.
(a) If EPA determines that industrial standards, such as the workplace standards set by the Occupational Safety and Health Administration (OSHA), provide adequate protection from risk under FIFRA for a particular pesticide use pattern, exposure data may not be required for that use pattern. Applicants should consult with the Agency on appropriate testing prior to the initiation of studies.
(b) The Agency may accept surrogate exposure data estimations from other sources to satisfy applicator exposure data requirements if the data meet the basic quality assurance, quality control, good laboratory practice, and other scientific requirements set by EPA. In order to be acceptable, the Agency must find that the surrogate exposure data estimations have adequate information to address applicator exposure data requirements and contain adequate replicates of acceptable quality data to reflect the specific use prescribed on the label and the applicator activity of concern, including formulation type, application methods and rates, type of activity, and other pertinent information. The Agency will consider using such surrogate data for evaluating human exposure on a case-by-case basis.
Applicator exposure data described in paragraph (d) of this section are required based on toxicity and exposure criteria. Data are required if a product meets, as determined by the Agency, at least one of the toxicity criteria in paragraph (a) of this section and either or both of the exposure criteria in paragraph (b) of this section.
(a)
(2) Scientifically sound epidemiological or poisoning incident data indicate that adverse health effects may have resulted from handling of the pesticide.
(b)
(2) Respiratory exposure may occur during the prescribed use.
(a)
(b)
(2) Residential use patterns include residential outdoor use and residential indoor use. These use patterns are limited to nonoccupational,
(c)
(d)
(e)
1. Protocols must be submitted for approval prior to the initiation of the study. Details for developing protocols are available from the Agency.
2. Biological monitoring data may be submitted in addition to, or in lieu of, dermal and inhalation exposure data, provided the human pharmacokinetics of the pesticide and/or metabolite/analog compounds (i.e., whichever method is selected as an indicator of body burden or internal dose) allow for the back calculation to actual dose.
3. Data are required if the product is applied outdoors.
4. Data are required if the product is applied indoors.
5. Data reporting and calculations are required when handler exposure data are submitted.
(a) If EPA determines that industrial standards, such as the workplace standards set by the Occupational Safety and Health Administration, provide adequate protection for a particular pesticide use pattern, post-application exposure data may not be required for that use pattern. Applicants should consult with the Agency on appropriate testing before the initiation of studies.
(b) The Agency may accept surrogate exposure data from other sources to satisfy post-application exposure data requirements if the data meet the basic quality assurance, quality control, good laboratory practice, and other scientific needs of EPA. In order to be acceptable, among other things, the Agency must find that the surrogate exposure data have adequate information to address post-application exposure data requirements and contain adequate replicates of acceptable quality data to reflect the specific use prescribed on the label and the post-application activity of concern, including formulation type, application methods and rates, type of activity, and other pertinent information. The Agency will consider using such surrogate data for evaluating human exposure on a case-by-case basis.
Exposure data described in § 158.1070(d) are required based upon toxicity and exposure criteria. Data are required if a product meets, as determined by the Agency, either or both of the toxicity criteria in paragraph (a) of this section and either or both of the exposure criteria in paragraph (b) of this section.
(a)
(2) Scientifically sound epidemiological or poisoning incident data indicate that adverse health effects may have resulted from post-application exposure to the pesticide.
(b)
(1)
(ii) Residential human post-application exposure to pesticide residues on plants or in soil could occur. Such uses may include turf grass, fruits, vegetables, and ornamentals grown at sites, including, but not limited to, homes, parks, and recreation areas.
(2)
(ii) Residential human post-application exposure to pesticide residues could occur following the application of the pesticide to indoor spaces or surfaces at residential sites, such as, but not limited to homes, daycare centers, hospitals, schools, and other public buildings.
(a)
(b)
(2) Residential use patterns include residential outdoor use and indoor residential use. These use patterns are limited to nonoccupational,
(c)
(d)
(e)
1. Protocols must be submitted for approval prior to the initiation of the study. Details for developing protocols are available from the Agency.
2. Bridging applicable residue dissipation data to dermal exposure data is required.
3. Turf grass transferable residue dissipation data are required when pesticides are applied to turf grass. Dislodgeable foliar residue dissipation data are required when pesticides are applied to the foliage of plants other than turf grass.
4. Data are required for occupational sites if (i) there are uses on turf grass or other plant foliage, and (ii) the human activity data indicate that workers are likely to have post-application dermal contact with treated foliage while participating in typical activities.
5. Data are required for residential sites if there are uses on turf grass or other plant foliage.
6. Data are required for occupational sites, if (i) there are outdoor or greenhouse uses to or around soil or other planting media, and (ii) the human activity data indicate that workers are likely to have post-application dermal contact with treated soil or planting media while participating in typical activities.
7. Data are required for residential sites if the pesticide is applied to or around soil or other planting media both outdoors and indoors,
8. Data are required for occupational sites if the pesticide is applied to or around on non-plant surfaces,
9. Data are required for residential sites if the pesticide is applied to or around non-plant surfaces,
10. Data are required for occupational sites if the human activity data indicate that workers are likely to have post-application exposures while participating in typical activities.
11. Data are required for residential sites if post-application exposures are likely.
12. Biological monitoring data may be submitted in addition to, or in lieu of, dermal and inhalation exposure data provided the human pharmocokinetics of the pesticide and/or metabolite/analog compounds (
13. Data are required when passive dosimetry techniques are not applicable for a particular exposure scenario, such as a swimmer exposure to pesticides.
14. Data reporting and calculations are required when any post-application exposure monitoring data are submitted.
15. The selection of a sampling method will depend on the nondietary pathway(s) of interest. Data must be generated to consider all potential pathways of nondietary ingestion exposure that are applicable (
(a)
(b)
(c)
(d)
(e)
1. This study is required when aerial applications (rotary and fixed winged) and mist blower or other methods of ground application are proposed and it is estimated that the detrimental effect level of those nontarget organisms expected to be present would be exceeded. The nontarget organisms include humans, domestic animals, fish and wildlife, and nontarget plants.
2. [Reserved]
(a)
(b)
(2) Data are also required for the general use patterns of forestry use and residential outdoor use.
(c)
(d)
(e)
1. Study is required for indoor uses in cases where environmental exposure is likely to occur. Such sites include, but are not limited to, agricultural premises, in or around farm buildings, barnyards, and beehives.
2. Not required when the electronic absorption spectra, measured at pHs 5, 7, and 9, of the chemical and its hydrolytic products, if any, show no absorption or tailing between 290 and 800 nm.
3. Not required when the chemical is to be applied only by soil injection or is incorporated in the soil.
4. Requirement based on use patterns and other pertinent factors including, but not limited to, the Henry's Law Constant of the chemical. In view of methodological difficulties with the study of photodegradation in air, prior consultation with the Agency regarding the protocol is recommended before the test is performed.
5. Required for aquatic food and nonfood crop uses for aquatic sites that are intermittently dry. Such sites include, but are not limited to, cranberry bogs and rice paddies.
6. Adsorption and desorption using a batch equilibrium method is preferred. However in some cases, for example, where the pesticide degrades rapidly, soil column leaching with unaged or aged columns may be more appropriate to fully characterize the potential mobility of the parent compound and major transformation products.
7. Environmental chemistry methods used to generate data associated with this study must include results of a successful confirmatory method trial by an independent laboratory. Test standards and procedures for independent laboratory validation are available as addenda to the guideline for this test requirement.
8. Requirement for terrestrial uses is based on potential for aquatic exposure and if pesticide residues have the potential for persistence, mobility, nontarget aquatic toxicity or bioaccumulation. Not required for aquatic residential uses. Field testing under the terrestrial field dissipation requirement may be more appropriate for some aquatic food crops, such as rice and cranberry uses, that are managed to have a dry-land period for production. The registrant is encouraged to consult with the Agency on protocols.
9. Agency approval of a protocol is necessary prior to initiation of the study.
10. This study may be triggered if there is specific evidence that the presence of one pesticide can affect the dissipation characteristics of another pesticide when applied simultaneously or serially.
11. Required if the weight-of-evidence indicates that the pesticide and/or its degradates is likely to leach to ground water, taking into account other factors such as the toxicity of the chemicals(s), available monitoring data, and the vulnerability of ground water resources in the pesticide use area.
12. If the terrestrial dissipation study cannot assess all of the major routes of dissipation, the forestry study will be required.
The following terms are defined for the purposes of this subpart:
(a)
(b)
(2) Data may be required for nonfood uses if pesticide residues may occur in food or feed as a result of the use. Data requirements for these nonfood uses will be determined on a case-by-case basis. For example, most products used in or near kitchens require residue data for risk assessment purposes even though tolerances may not be necessary in all cases.
(c)
(d)
(e)
1. Required if indoor use could result in pesticide residues in or on food or feed.
2. Material safety data sheets must accompany standards as specified by OSHA in 29 CFR 1910.1200.
3. Required for residential outdoor uses on food crops if the corresponding agricultural use is not approved or the residential use is expected to produce higher residues based on the label directions.
4. Required for indoor uses where the pesticide is applied directly to food, in order to determine metabolites and/or degradates. Not required when only indirect contact with food would occur (
5. Data for fish are required for all pesticides applied directly to water inhabited, or which will be inhabited, by fish that may be caught or harvested for human consumption.
6. Required when a pesticide is to be applied directly to livestock, to livestock premises, to livestock drinking water, or to crops used for livestock feed. If results from the plant metabolism study show differing metabolites in plants from those found in animals, an additional livestock metabolism study involving dosing with the plant metabolite(s) may also be required.
7. Required when the Agency determines that it is reasonably foreseeable that a food or feed crop could be subsequently planted on the site of pesticide application after harvest or failure of the treated crop. Typically not required for pesticide uses in permanent food crops (e.g., various tree crops, vines) or semi-permanent crops (e.g., asparagus, pineapples).
8. A residue analytical method suitable for enforcement purposes is required whenever a numeric tolerance (including temporary and time-limited tolerances) is proposed.
9. New analytical methods to be used for enforcement purposes must include results from an independent laboratory validation.
10. A residue method, storage stability data, and crop field trials are required for the nonfood crop tobacco (green, freshly harvested). Depending on the level of residues found on the green tobacco, additional data may be required on cured/dried tobacco and pyrolysis products.
11. Data are required to determine whether FDA/USDA multiresidue methodology would detect and identify the pesticides and any metabolites.
12. Data are required for any magnitude of the residue study unless analytical samples are stored frozen for 30 days or less, and the active ingredient is not known to be volatile or labile.
13. Studies using single serving samples of a raw agricultural commodity may be needed for acutely toxic pesticides and/or their metabolites. These residue studies must be conducted using a statistical design accepted by the Agency.
14. Required for indoor uses which are direct postharvest treatments of raw agricultural commodities (
15. Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance higher than that of the raw agricultural commodity.
16. Required when the pesticide use is a direct application to livestock.
17. Data are required if pesticide residues are present in or on livestock feed items or intentionally added to drinking water. These studies, however, may not be required in cases where the livestock metabolism studies indicate negligible transfer of the pesticide's residues of concern to tissues, milk, and eggs at the maximum expected exposure level for the animals.
18. If results from the plant metabolism study show differing metabolites in plants from those found in animals, an additional livestock feeding study involving dosing with the plant metabolite(s) may also be required.
19. Data are required whenever a pesticide may be applied directly to water, unless it can be demonstrated that the treated water would not be available for human or livestock consumption.
20. Data are required when a pesticide is to be applied directly to water that could be used for irrigation or to irrigation facilities such as irrigation ditches.
21. Data are required whenever a pesticide may be used in a food handling or feed handling establishment.
22. Required when residues at the tolerance level may result in a risk of concern. These data may include washing, cooking, processing or degradation studies as well as market basket surveys for a more precise residue determination.
23. Typically required if pesticide residues of concern greater than 0.01 ppm are found
24. Crop field trials are required to establish tolerances on rotational crops when quantifiable residues of concern are observed in the field rotational crops study.
25. Not required for an exemption from a tolerance provided that dietary exposure estimates are not needed due to low toxicity or that theoretical estimates of exposure are adequate to assess dietary risk.
26. Not required for an exemption from a tolerance.
Environmental Protection Agency (EPA).
Final Rule.
This is the final rule for Biochemical and Microbial Pesticide Data Requirements. The Agency published a proposed rule on March 8, 2006, on the data requirements to support registration of biochemical and microbial pesticides and proposed to update definitions for both biochemical and microbial pesticides. The Agency received comments from 20 commenters, representing State and Federal agencies, industry, and private consultants.
This rule is effective on December 26, 2007.
EPA has established a docket for this action under Docket identification number EPA-HQ-OPP-2004-0415. All documents in the docket are listed on the regulations.gov web site. Although listed in the index, some information is not publicly available, i.e., 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 electronically through www.regulations.gov or in hard copy at the Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Room S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA 22202. This Docket is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305-5805 .
Candace Brassard or Nathanael Martin, U.S. Environmental Protection Agency (7506P), 1200 Pennsylvania Ave., NW., Washington, DC 20460, telephone: 703-305-6598 or 703-305-6475, e-mail:
You may be potentially affected by this action if you are a producer or registrant of a biochemical or microbial pesticide product. This action may also affect any person or company that might petition the Agency for new tolerances for biochemical or microbial pesticides, or hold a pesticide registration with existing tolerances, any person or company interested in obtaining or retaining a tolerance in the absence of a registration. Potentially affected entities may include, but are not limited to:
• Crop Production (NAICS code 111).
• Animal Production (NAICS code 112).
• Food Manufacturing and Processing (NAICS code 311).
• Chemical Producers (NAICS code 32532), e.g., pesticide manufacturers or formulators of pesticide products, importers, or any person or company that seeks to register a pesticide or obtain a tolerance for a pesticide.
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. If you have any questions regarding the applicability of this action to a particular entity, consult the persons listed under
All documents in the docket are listed in the docket index at
EPA published a notice of proposed rulemaking in the
In response to comments, EPA is modifying some aspects of the rule relating to types of products being tested, i.e., technical grade active ingredient (TGAI) versus typical end-product (TEP), modifying some test notes where appropriate, adding or deleting some data requirements, and modifying the definition of a microbial pesticide.
The final rule updates the definitions of a biochemical pesticide and a microbial pesticide to more accurately describe these categories of pesticides, and to make a conforming change to the definition of microbial pesticide in 40 CFR 172.43. The rule also informs the public how the Agency will assist applicants in determining what data are appropriate to support registration of a biochemical or microbial pesticide. EPA encourages applicants to request pre-submission meetings to discuss these data issues. The final rule also provides for assistance to applicants, in some narrow circumstances, in preparation of an applicant's data waiver.
As an ancillary matter, this final rule is making certain technical changes necessitated by EPA's decision to create new part 161 to contain data requirements specific to antimicrobial pesticides. New part 161 is discussed fully in the final rule for conventional pesticides published elsewhere in this issue of the
This final rule is one in a series of proposed and final rules to update and clarify pesticide data requirements.
On March 8, 2006, the Agency published a notice of proposed rulemaking for Biochemical and Microbial Pesticide Data Requirements (71 FR 12072). The Agency received submissions from 20 commenters. This final rule describes briefly the background of the final rule and responds to key issues raised by commenters.
EPA is responsible for registration of the following categories of pesticides: biochemicals, microbials, plant-incorporated protectants, conventional pesticides, and antimicrobial pesticides. These pesticides, although regulated under the same statutory standards under FIFRA and FFDCA, pose different levels of risk and exposure that lead to significant differences in data needs. EPA has embarked on a series of rulemakings intended to update data requirements for the various types of pesticides. This final rule is the second and builds on the previous update for conventional chemicals.
Elsewhere in this issue of the
EPA proposed to also upgrade the structure of part 158, assigning biochemical data requirements to subpart L and microbial pesticide data requirements to subpart M of part 158. As a result of the comments on the proposed rule for conventional pesticides, EPA has restructured part 158. Biochemical pesticide data requirements will now be under subpart U and microbial pesticide data requirements will be under subpart V.
As described in the final rule on Conventional Pesticides published elsewhere in this issue of the
Many of the revisions are intended to improve the usefulness of part 158 data tables by better identifying the specific data requirements that could apply to a particular pesticide application. As with the original design of part 158 in 1984, given the variety in pesticide chemistry, exposure, and hazard, these revisions are intended to retain a fair amount of flexibility in their application, while improving clarity and transparency to the regulated community.
As with conventional pesticides, the R/CR terminology is a general presentation of the likelihood that a data requirement will apply. The use of R does not necessarily indicate that a study is always required, but that it is more likely to be required than not. The use of CR means a study is less likely to be required. However, both R and CR designations must be read in the context of the accompanying test notes to the table. An applicant may assume that a data requirement with R will typically be required all the time. The test notes accompanying that R designation may provide supplementary information or identify some condition(s) when the study is not required. A CR designation will generally include more extensive test notes describing the limited conditionality of the requirement. The final rule continues this longstanding practice. EPA revised some of the test notes to clarify the conditions under which the data would be required.
This document is the final rule for the Biochemical and Microbial Pesticide Data Requirements. This document also finalizes definitions of both a biochemical and microbial pesticide. The Agency issued a Notice of Proposed Rulemaking on Biochemical and Microbial Pesticide Data Requirements, 71 FR 12072; March 8, 2006. This notice was an update of the biochemical and microbial pesticide data requirements to support the registration of biochemical and microbial pesticides originally promulgated in 1984.
In the preamble to the proposed rule, the Agency discussed a process for consultations with applicants. The public responses were in favor of the Agency recognizing that applicants often needed assistance in determining what information or data are appropriate to support registration of a biochemical or microbial pesticide.
EPA encourages applicants to seek pre-submission meetings to discuss the appropriate data or information to support their product and the opportunity for requesting data waivers. During the pre-submission meeting, EPA may be aware that certain data requirements are already satisfied by available data or information. Sources of existing data include public literature and/or studies submitted by another registrant, which may be cited by the applicant in accordance with relevant data compensation procedures. EPA may also be aware of sound scientific rationales that render certain testing unnecessary. Ultimately, the applicant may submit an application based on the discussion with EPA, along with a signed copy of the minutes (which have been concurred on by the Agency) of the pre-submission meeting listing each data requirement and the reason why EPA and the company believe a waiver is appropriate.
In addition, the Agency is offering a post-submission process. Even after submission of an application for registration, EPA may find that either of these scenarios may exist (i.e., basis for citing to other data or information, or waiver of a data requirement). Again, EPA may discuss these issues with the applicant and the applicant may choose to amend its application by citing to other data/information or requesting a waiver.
This pre-submission and post-submission process for ensuring that the data requirements are either satisfied or waived is specific to the review of biochemical and microbial registration applications, due primarily to the specific nature and circumstances unique to these pesticides (e.g., information already known to the Agency) and thus the Agency does not anticipate this process being widely applicable to other types of pesticides, such as conventional or antimicrobial pesticides.
EPA notes that in providing this assistance during the pre-submission and post-submission process, it will only consider readily accessible information, such as information found in Agency databases, and will not search for applicable information, data, or literature. Further, although this process is intended to help applicants in supporting their applications, EPA does not encourage applicants to rely on this process to fill informational data gaps; doing so may be at the expense of timely review or may ultimately result in rejection of an application or petition.
Finally, providing assistance in this manner does not effectively allow applicants to circumvent the data requirements or the requirement to submit a request for waiver of a data requirement. The applicant must at all times submit the waiver request; EPA is simply providing assistance in identifying what requirements are likely to be waived for a particular product or, in some narrow circumstances, assistance in the preparation of the waiver request. Because we are using the pre-and post-submission process to assist applicants in filing their own waiver requests, we are not amending the existing waiver provisions at 40 CFR 158.45.
EPA requested comment on whether the Agency should coordinate with USDA for reviewing microbial pesticides prior to registration. The Agency was prompted by USDA's need for coordination when an Animal and Plant Health Inspection Service (APHIS) movement permit under 7 CFR part 340 is needed. USDA suggested that registrants be required to submit a copy of the applicable APHIS permits as part of the registration application to EPA. After discussing this issue with USDA, EPA is developing a process for coordinating the review of these applications with USDA to avoid delays.
With respect to some of the environmental fate data requirements, the Agency is providing two sets of guideline numbers where needed; the first guideline numbers are those currently used by the Agency. The second guideline numbers, which are in parentheses, are the draft guidelines that have completed peer review and will be published as EPA final guidelines in the near future. Guideline numbers are provided in part 158 as information/guidance to applicants, and both guideline numbers are provided for each data requirement in this rule as an interim measure until the draft guidelines are finalized. In general, draft guidelines do not represent official Agency position until finalized. In either case, an applicant is not compelled to use the cited guidelines, but may choose to use an alternative methodology that will provide the information needed to complete the risk assessment. In such cases, applicants are encouraged to consult with EPA beforehand. Applicants may also consult with EPA about using an alternative methodology in draft guideline that has completed peer review.
As with the existing guidelines, draft guidelines are developed through a rigorous scientific process, including public comment and extensive peer review by the Scientific Advisory Panel, and many have been harmonized internationally. As such, they represent the Agency's recommended approach to developing data that will generally be likely to satisfy the Agency's data needs for risk assessment, and an applicant choosing to use the Agency guidelines may have greater confidence that the resulting data will adequately address our needs. This may also be the case for the draft guidelines referenced in parentheses in this rule. Once finalized, the Agency would correct the guideline references as appropriate.
The Agency did receive comments that applied to both biochemical and microbial pesticide data requirements. These issues are discussed as follows:
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EPA did not propose to change the existing data requirements and neither the existing data table nor the proposed regulating text would require the applicant to submit data comparing product efficacy. The Agency agrees with the commenter that there should not have been a distinction between biochemical and conventional pesticides in their efficacy, but that the efficacy varies between all pesticides and their products, and with respect to public health claims, the label should reflect the efficacy of the product.
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In addition, after reviewing the comments submitted, the Agency decided to discontinue specific species designation for all non-target organisms. The test notes in the final rule only indicate upland game, waterfowl, or passerine species for avian concerns and coldwater and warmwater fish for fish concerns.
In summary, passerine species data are still conditionally required in the final rule for both biochemical and microbial pesticides. The individual test notes indicate when these data would be appropriate. With respect to developing test data over 5 years, EPA will consider such protocol concerns when it revises its test guidelines. The Agency is finalizing the proposed addition of the passerine species.
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As for the specific example of immunotoxicity, these data are currently required and are being submitted to support existing registrations and is currently required in 40 CFR 158.690. EPA has been requiring or applicants have been submitting immunotoxicity data based on specific conditions, consistent with the 880.3550 guideline in more recent years, so the Agency classified this as a newly codified data requirement as a Tier II and Tier III data requirement.
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A biochemical pesticide is a pesticide that:
(1) Is a naturally-occurring substance or structurally similar and functionally identical to a naturally-occurring substance;
(2) Has a history of exposure to humans and the environment demonstrating minimal toxicity, or in the case of a synthetically derived biochemical pesticide, is equivalent to a naturally-occurring substance that has such a history; and
(3) Has a non-toxic mode of action to the target pest(s).
As explained in the proposed rule, EPA proposed to clarify the “naturally-occurring” clause of the prior definition by adding a criterion that the pesticide have a history of exposure demonstrating minimal toxicity. EPA believes that if a pesticide is present in the environment in sufficient quantities, there would be a good chance that any innate toxicity would already have been recognized due to observed effects on humans or representative non-target organisms. A pesticide that meets this, as well as other specified criteria, is more appropriate for the tiering data structure that EPA uses for biochemicals than a pesticide that does not have such history of exposure or a pesticide that has a history of exposure in which such exposure has revealed toxicity concerns.
The tiering structure can be beneficial if data submitted to satisfy the early tiers allow EPA to determine that the pesticide does not cause unreasonable adverse effects on the environment. This determination at the early tiered stage can reduce the total amount of data generated to satisfy registration as compared to pesticides that do not meet the biochemical definition.
If the pesticide is naturally occurring but otherwise does not clearly meet the biochemical definition, EPA is not likely to use the biochemical pesticides tiering structure for testing; instead, EPA would likely apply the data requirements for conventional pesticides for an adequate assessment of the risks from the proposed use of such a pesticide. However, note that in some limited cases, EPA may assess a pesticide under the biochemical pesticide tiering structure even though the pesticide is not a biochemical pesticide. Specifically, EPA added paragraph (c) to 40 CFR 158.2000 to allow some limited use of the biochemical tiering structure for pesticides not clearly meeting the biochemical definition but for which only minimal additional data would be necessary. Please refer to the preamble of the proposed rule for further explanation.
EPA also proposed that to meet the definition of “biochemical” the pesticide must have a non-toxic mode of action to the target pest. EPA proposed this criterion to conform to the original intent for defining biochemical, that the term describes a pesticide that is “not the result of target organism
In addition, most of these commenters believed that the proposed definition, which included the language “Has a history of exposure ... demonstrating minimal toxicity” and “Has a non-toxic mode of action to the target pest(s),” would also make the criteria for defining a biochemical more restrictive, possibly disallowing insect pheromones, juvenile growth hormones, and most plant and animal extracts to be classified as biochemical pesticides. One commenter indicated that the definition should include both natural occurrence and non-toxic mode of action as part of the definition for low risk.
One commenter generally supported the new definition but suggested that EPA also consider setting some limits to exposure since some naturally-occurring substances may be much more toxic if their use patterns result in high exposure levels. Another commenter expressed a concern that saponins would not be considered as biochemical pesticides under the proposed definition.
The Agency would like to clarify that the provision that a biochemical pesticide is a naturally-occurring substance as well as a compound that is structurally-similar and functionally identical to a naturally-occurring substance, also applies to pheromones. The pheromone definition in today's rule has been modified to make this explicit. In addition, the straight chain lepidopteran pheromone definition will be slightly corrected to correspond with the internationally-recognized definition as used in the tolerance exemption at § 180.1153. The word “double” is added to “three bonds” to read as “three double bonds”. The Agency is also replacing “designated by” with “consisting of” in order to make the definition more transparent. The revised definition will read: “ A straight chain lepidopteran pheromone is a lepidopteran pheromone consisting of an unbranched aliphatic chain (between 9 and 18 carbons) ending in an alcohol, aldehyde, or acetate functional group and containing up to three double bonds in the aliphatic backbone.”
EPA does not believe that the recommended inclusion of a “mitigating mode of action” is needed. First, the Agency interprets the phrase “non-toxic mode of action” to include such pest control mechanisms as attraction, repellency (including irritants), growth regulation/development changes, induction of systemic acquired resistance, and physical modes of action such as desiccation, coatings, or smothering, e.g., by naturally-occurring oils. The Agency recognizes that physical modes of action, e.g. suffocation, may be lethal to the target pest, but since they do not involve toxic chemical/poison-induced effects in the context of this program, they are considered to be a non-toxic mode of action. This is how EPA has interpreted “unique modes of action” as used in the prior definition. EPA notes that the Biochemical Classification Committee (consisting of EPA scientists) was formed in 1995 and has been responsible for determining whether a proposed pesticide is eligible to be evaluated as a biochemical pesticide and has consistently applied this interpretation of the existing definition. EPA proposed to include the phrase “non-toxic mode of action” instead of the phrase “unique modes of action” because EPA believes the former and proposed phrase better/more accurately describes our historical approach for defining “biochemical pesticides,” and intended no change in the scope of the term historically applied. In addition, to the fact that the proposed phrase captures commenter's concern, commenters did not adequately define the word “mitigate” as it would apply to pesticidal modes of action. Thus, EPA believes using a reference to mitigating mode of action is unnecessary and may only add confusion in implementation.
Finally, for practical reasons, EPA does not believe that setting a limit based on the amount of existing exposure as compared to that contemplated by the proposed use pattern is necessary as recommended by the commenter. Implementation of this concept would be very difficult since the classification of the product would depend on the uses proposed with the initial application, which often change subsequent to the risk assessment process. It would be impractical to have to reclassify an active ingredient from a biochemical pesticide to a chemical pesticide based on use patterns. In practice, EPA will initially classify a pesticide as a biochemical pesticide, but will apply additional data requirements, up to and including those for conventional pesticides, to adequately assess the risk. In no case will an initial determination of biochemical status preclude the Agency from requiring data not specifically included in subpart U if necessary.
Another commenter stated the belief that saponins (naturally-occurring glycosides within plants) should be considered biochemical pesticides and that the new definition precludes such a finding. The Agency believes not all saponins would necessarily be registered as biochemical pesticides. Each one has to be evaluated carefully. This illustrates the importance of having sufficient exposure of naturally occurring chemicals to determine if any unreasonable toxicity is observed. Some saponins are known to be poisonous to people if swallowed, and some saponins can cause severe dermal irritation, and others may not be absorbed at low levels in the diet. Many saponins are
As noted in Unit II, 20 commenters responded to the proposal. The following sections are responses to comments raised:
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Specifically, particle size is generally expressed as mean mass aerodynamic diameter (MMAD), which is a practical way to account for the different possible shapes such as fibers, clumps, etc. The particle size distribution is used as a set of criteria to determine respirability for purposes of establishing the need and/or the acceptability of inhalation toxicity studies (acute and, if the main route of exposure is inhalation, subchronic toxicity studies), and again, these data can also be used for spray drift evaluation.
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The final rule conditionally requires the data to be submitted when the use of the biochemical pesticide could result in exposure levels that might exceed those historically encountered, and if so, other additional information would be necessary (e.g., directions for use, application rates, or other exposure information) to determine potential risks.
Thus, in general, when the use of any biochemical pesticide can be expected to exceed historical exposure to humans or the environment, the Agency would require exposure information to assure minimal risk associated with that use. Although it is true that insect repellents are typically applied at levels that can be expected to exceed those historically encountered, many other pesticide use patterns may also result in exposure levels exceeding these historically encountered use patterns. Again, these data requirements are not limited to insect repellents.
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Microbial pesticide means a microorganism intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant, that:
i. Is a eucaryotic microorganism including, but not limited to, protozoa, algae, and fungi.
ii. Is a procaryotic microorganism, including, but not limited to bacteria.
iii. Is an autonomous replicating microscopic element, including, but not limited to, viruses.
EPA proposed this revision to 40 CFR 158.65 to better conform to the description of the class of non-exempt biological control agents in 152.20(a)(3), and to use a structure for defining microbial pesticide similar to that at 40 CFR 172.43. EPA explained that the proposed revisions are not intended to change, and in EPA's view does not change, the scope of the previous regulatory definitions and descriptions of microbial pesticides at §§ 158.65, 152.20(a)(3), or § 172.43. EPA also proposed changes to § 172.43 so that the definition would conform to the newly proposed definition of microbial pesticide, but did not intend to change the scope of that provision. These revisions are intended to include all microorganisms as microbial pesticides based on the currently accepted taxonomic nomenclature as of the date of publication of this rule.
EPA also proposed to refine the current regulatory text relating to the need to separately register new species or isolates and to separate that provision from the definition section to avoid confusion on the definition of microbial pesticide.
In the preamble to the proposed rule, EPA noted that microorganisms are known to produce many chemical pesticidal substances. These pesticidal substances, when distributed or sold independently of the microorganism, are considered to be biochemical pesticides, conventional chemical pesticides, or antimicrobial pesticides, depending on the mode of action and the use. The microorganism would then usually be considered part of the manufacturing process. For example, streptomycin, an antibiotic produced by a bacterium,
See Unit VIII.A. of the preamble to the proposed rule (71 FR 12072, March 8, 2006) for a more complete discussion of the changes proposed for the definition of microbial pesticide.
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In response to the comment concerning nematodes, EPA will offer some general guidance on nematodes here. Nematodes have been identified as a macroscopic biocontrol organism that is exempt from regulation in accordance with § 152.20(a) on the basis that another Federal regulatory agency is adequately regulating them. However, EPA is aware that the insecticidal activity of some commercially marketed nematodes is due to insecticidal microorganisms that live in a symbiotic relationship inside the nematode gut, (e.g.,
EPA carefully considered the comment raising the issue of whether an isolate occasionally could be evaluated to satisfy a subset of data requirements at a higher taxonomic level than strain level and whether an isolate might sometimes be included as part of a very similar strain. EPA believes the proposed microbial pesticide definition applicability provision is sufficiently flexible to ensure adequate consideration and data on new isolates, while allowing use of existing data to support registration if similar to an existing strain that is already registered. The wording of the provision relating to applicability of the microbial data requirements reads, “each new isolate of a microbial pesticide is treated as a new strain and must be registered independently of any similar registered microbial pesticide strain and supported by data required in this subpart.” This wording does not preclude the possibility of using data from another isolate to support the assessment if it can be shown that the two isolates are sufficiently closely related. In this way it ensures that each isolate will be independently considered for registration purposes. The differences in taxonomy between different microorganism classifications, particularly for baculoviruses, would make any attempt to further clarify this provision very complex and potentially confusing as the systematic nomenclature of these organisms change over time. The Agency intends to use its best scientific judgment in each instance to determine if one isolate is sufficiently closely related to another isolate to allow sharing of data or waiving of data requirements.
The definition of a microbial pesticide has been revised as follows:
(1) “Microbial agent” replaces “microorganism;”
(2) “Eubacteria and Archaebacteria” replaces bacteria; and lastly,
(3) “parasitically” replaces “autonomous”.
A number of issues were identified that were focused on the guidelines, i.e., number of applications, maximum dosing of pesticides during testing, etc. These issues are outside the scope of this rule and EPA will consider them in the context of guideline development.
The following issues were identified for specific data requirements for microbial pesticides. The Agency responds to these comments in this preamble. When appropriate, the Agency has revised the regulatory text.
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The Agency is not requiring pathogenicity/toxicity data for viral agents based on the difficulty of establishing the clearance endpoint for viruses. In these tests, the individual organ macerates must be tested for infectivity by a bioassay in the target pest. The Agency finds that the results from the cell culture assays are more sensitive and present a greater potential for the virus to express infectivity and cytopathic effects. The final rule is the same as the proposed rule for this data requirement.
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EPA evaluates potential effects on immunocompromised people as part of the assessment process of a microbial pesticide, considering its relationship to known human pathogens, the test data, and the potential exposure from its use.
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Definitive environmental expression studies are very difficult to perform for naturally-occurring microorganisms that can increase in numbers in the
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In promulgating its final rule on conventional pesticides, EPA segregated the Experimental Use Permit (EUP) data requirements into a separate subpart C. This was done in response to comments suggesting this change for clarity and to avoid confusion about the purpose of the brackets. For consistency and ease of use, EPA has adopted this new format for biochemical and microbial pesticides. Accordingly, the brackets have been removed from the product chemistry, residue, toxicology, non-target organism, and environmental fate data tables.
The new data requirements for experimental use permits are listed in § 158.2080 for biochemical pesticides and § 158.2170 for microbial pesticides.
After the effective date, the data requirements in this final rule will apply to all new registrations of biochemical pesticides and microbial pesticides. The Agency does not intend to apply these requirements retroactively to all existing pesticide registrations but the Agency may find it necessary to call in some data on certain existing registrations, as warranted by emerging risks of concern on particular pesticides or as a result of possible programmatic changes and priorities on existing pesticides.
FIFRA sec. 3(c)(2) provides EPA broad authority, before and after registration, to require scientific testing and submission of the resulting data to the Agency by registrants and applicants of pesticide products. Although the data requirements in part 158 are imposed primarily as a part of initial registration, EPA is authorized under FIFRA sec. 3(c)(2)(B) to require a registrant to develop and submit additional data to maintain a registration. This post-registration data call-in authority recognizes that the scientific underpinnings of risk assessment change, and is another means by which EPA may keep data for use in risk assessment current with evolving science.
EPA will consider as part of its review of a pending application whether and how to apply these updated data requirements. EPA expects that few changes will be needed, as these updated requirements reflect current practice.
The following is a listing of the documents that are specifically referenced in this final rule. These documents and other supporting materials are included in the docket established for this rulemaking under docket ID No. EPA-HQ-OPP-2004-0415 at
1. Dearfield, K.L., Cimino, M.C., McCarroll, N.E., et al. “Genotoxicity risk assessment: a proposed classification strategy.”
2. December 3, 1990 EPA memo: Schneider to Hutton.
3. Gagliardi, J.V., Buyer, J.S. Angle, J.S. and Russek-Cohen, E. 2001a. Structural and functional analysis of whole-soil microbial communities for risk and efficacy testing following microbial inoculation of wheat roots in diverse soils. Soil Biol. Biochem. 33:25-40.
4. Gagliardi J.V., Angle J.S., Germida J.J., Wyndham R.C., Chanway C.P., Watson R.J., Greer C.W., McIntyre T, Yu H.H., Levin M.A., Russek-Cohen E, Rosolen S, Nairn J, Seib A, Martin-Heller T, Wisse G. 2001b. Intact soil-core microcosms compared with multi-site field releases for prerelease testing of microbes in diverse soils and climates.
5. U.S. EPA, 2006. “Economic Analysis of the Final Data Requirements For Biochemical And Microbial Pesticides Rule.” FEAD/OPP/U.S. EPA, Washington, D.C.
6. U.S. EPA, 2002. “Supporting Statement for an Information Collection Request: Tolerance Petitions for Pesticides on Food/Feed Crops and New Inert Ingredients.” OMB Control No. 2070-0024, EPA ICR No. 0597. OPP/U.S. EPA, Washington, D.C.
7. U.S. EPA, 2002. “Supporting Statement for an Information Collection Request: Application for New or Amended Pesticide Registration.” OMB Control No. 2070-0060, EPA ICR No. 0277. OPP/U.S. EPA, Washington, D.C.
8. U.S. EPA, 2001. “Supporting Statement for an Information Collection Request:” Data Generation for Reregistration; Phase 4 and 5 Reregistration.” OMB Control No. 2070-0107, EPA ICR No. 1504. OPP/U.S. EPA, Washington, D.C.
9. U.S. EPA, 2001. “Supporting Statement for an Information Collection Request: Data Call-Ins for the Special Review and Registration Review Programs.” OMB Control No. 2070-0057, EPA ICR No. 0057. OPP/U.S. EPA, Washington, D.C.
10. U.S. EPA, 2004. “Supporting Statement for an Information Collection Request: Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting.” OMB Control No. 2070-0142, EPA ICR No. 1693, Washington, D.C.
In accordance with FIFRA sec. 25(a), the Agency submitted a draft of this final rule to the FIFRA Scientific Advisory Panel (SAP), the Secretary of Agriculture, and the Committee on Agriculture in the House of Representatives, and the Committee on Agriculture, Nutrition, and Forestry in the United States Senate.
The FIFRA SAP waived its review of this final rule because the significant scientific issues involved have already been reviewed by the SAP and additional review is unnecessary.
Under Executive Order 12866, entitled
In addition, EPA has prepared an analysis of the potential costs and benefits associated with this action, entitled
For the proposed rule, EPA estimated that the total annual impact to the pesticide industry is a regulatory compliance cost reduction of $3.04 million per year, with an estimated average cost reduction of $60,000 per firm, per year. During the public comment period for the proposed rule, no comments were received on the economic analysis. The majority of the comments on the proposed rule focused on definitional issues; none of the clarifications made in this final rule affect the Agency's estimate on the total annual impact to the pesticide industry. Accordingly, no substantive changes have been made to the Economic Analysis for this rulemaking.
As such, the likely impact of this final rule on businesses overall is expected to be mostly beneficial. EPA believes that the final rule would have no effect on the availability of pesticides to users. On balance, the Agency believes that cost savings resulting from the final changes to the data requirements presented in this final rule can be realized without compromising the protection of human health and the environment.
This final rule does not contain any new information collection requirements that require additional approval by OMB under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. Under the PRA, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number, or is otherwise required to submit the specific information by a statute. The OMB control numbers for EPA's regulations codified in Title 40 of the CFR, after appearing in the preamble of the final rule, are further displayed either by publication in the
Under the PRA, “burden” means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to: review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.
The information collection requirements (i.e., the paperwork collection activities) related to the submission of data necessary to register a pesticide product are already approved by OMB under several existing information collection requests (ICR). Specifically, the activities that would generate a paperwork burden under this rule are covered by the following ICRs:
• The activities associated with the establishment of a tolerance are currently approved under OMB Control No. 2070-0024 (EPA ICR No. 0597) (Ref. 5).
• The activities associated with the application for a new or amended registration of a pesticide are currently approved under OMB Control No. 2070-0060 (EPA ICR No. 0277) (Ref. 6).
• The activities associated with the generation of data for reregistration are currently approved under OMB Control No. 2070-0107 (EPA ICR No. 1504) (Ref. 7).
• The activities associated with the generation of data for special review or registration review are currently approved under OMB Control No. 2070-0057 (EPA ICR No. 0922) (Ref. 8).
• The activities associated with notification of genetically modified microbial pesticides are currently approved under OMB Control No. 2070-0142 (EPA ICR No. 1693) (Ref. 9).
These existing ICRs cover the paperwork activities contained in this rule because these activities already occur as part of existing program activities. These program activities are an integral part of the Agency pesticide program, and the corresponding ICRs are regularly renewed as required under the PRA, such that these OMB Control Nos. are maintained valid.
Based on these existing approvals, the Agency estimates that the total average annual public reporting burden currently approved by OMB for these various activities ranges from 8 hours to approximately 3,000 hours per respondent, depending on the activity and other factors surrounding the particular pesticide product. Additional information about this estimate is provided in the Economic Analysis for this rulemaking.
Pursuant to section 605(b) of the
Under the RFA, small entities include small businesses, small not-for-profit organizations, and small governmental jurisdictions. For purposes of assessing the impacts of today's rule on small entities, small entity is defined in accordance with the RFA as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; (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.
Based on the industry profile that EPA prepared using historical pesticide registration data as part of the Economic Analysis prepared for this rulemaking, EPA has determined that this rule is not expected to impact any small not-for-profit organizations or small governmental jurisdictions. The
EPA then used historical data to estimate the impacts of the rule on these small businesses. Of 51 firms with biochemical or microbial registration actions between 1997 to 2004, financial data for determining company size was available for 40 firms, with 23 of those firms classified as small businesses. According to the analysis, all of these small entities would realize a reduction in costs based on the rule changes compared to the current part 158 data requirements. Given these estimated impacts on small businesses, EPA concluded that the revisions in this rule may benefit and would not likely have a significant adverse economic impact on a substantial number of small entities.
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 one year. As described in Unit XI.A., the total annual impact to the pesticide industry is estimated to be a regulatory compliance cost reduction of about $3.04 million per year.
In addition, since State, local, and tribal governments are rarely pesticide applicants or registrants, the final rule is not expected to significantly or uniquely affect small governments. Accordingly, this action is not subject to the requirements of sections 202 and 205 of UMRA.
Pursuant to Executive Order 13132, entitled
As required by Executive Order 13175, entitled
Executive Order 13045, entitled
This rule is not subject to Executive Order 13211, entitled
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, sampling procedures, etc.) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.
This regulation proposes the types of data to be required to support a biochemical or microbial pesticide registration but does not propose to require specific methods or standards to generate those data. Therefore, this regulation does not impose any technical standards that would require Agency consideration of voluntary consensus standards. EPA is not precluding the use of any method, whether it constitutes a voluntary consensus standard or not, as long as it meets the performance criteria specified. The Agency invited comment on its conclusion regarding the applicability of voluntary consensus standards to this rulemaking effort and did not receive any comments on this point.
This rule does not have an adverse impact on the environmental and health conditions in low-income and minority communities. Therefore, under Executive Order 12898, entitled
The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the Agency promulgating the rule must
Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
7 U.S.C. 136-136y; 21 U.S.C. 346a.
This subpart applies to all biochemical pesticides as defined in paragraphs (a), (b), and (c) of this section.
(a)
(1) A
(i) Is a naturally-occurring substance or structurally-similar and functionally identical to a naturally-occurring substance;
(ii) Has a history of exposure to humans and the environment demonstrating minimal toxicity, or in the case of a synthetically-derived biochemical pesticides, is equivalent to a naturally-occurring substance that has such a history; and
(iii) Has a non-toxic mode of action to the target pest(s).
(2) A
(i) An
(ii) A
(iii) A
(b)
(1) Semiochemicals (insect pheromones and kairomones),
(2) Natural plant and insect regulators,
(3) Naturally-occurring repellents and attractants, and
(4) Enzymes.
(c)
(a) Sections 158.2030 through 158.2070 identify the data requirements that are required to support registration of biochemical pesticides. Sections 158.2080 through 158.2084 identify the data requirements that are required to support Experimental Use Permits (EUPs). Variations in the test conditions are identified within the test notes. Definitions that apply to all biochemical data requirements can be found in § 158.2000.
(b) Each data table includes “use patterns” under which the individual data are required, with variations including food and nonfood uses for terrestrial and aquatic applications, greenhouse, indoor, forestry, and residential outdoor applications under certain circumstances.
(c) The categories for each data requirement are “R”, which stands for required, and “CR” which stands for conditionally required. Generally, “R” indicates that the data are more likely required than for those data requirements with “CR.” However, in each case, the regulatory text preceding the data table and the test notes following the data table must be used to determine whether the data requirement must be satisfied.
(d) Each table identifies the test substance that is required to be tested to satisfy the data requirement. Test substances may include: technical grade active ingredient (TGAI), manufacturing-use product (MP), end-use product (EP), typical end-use
(e) The data requirements are organized into a tier-testing system with specified additional studies at higher tiers being required if warranted by adverse effects observed in lower tier studies. The lower tier studies are a subset of those required for conventional pesticides, and the studies overall are generally selected from those required for conventional pesticides.
(f) Two sets of guideline numbers are provided for some of the environmental fate data requirements. For ease of understanding, the current guidelines will be used as an interim measure until the new guidelines (in parentheses) are finalized.
(a)
(2) Definitions in § 158.300 apply to data requirements in this section.
(b)
(c)
(d)
(e)
1. Data must be provided in accordance with § 158.320.
2. If the MP and EP are produced by an integrated formulation system (non-registered source), these data are also required on TGAI.
3. Data must be provided in accordance with §§ 158.325, 158.330, and § 158.335.
4. Data must be provided in accordance with § 158.340.
5. Data must be provided in accordance with § 158.345. Also, required to support the registration of each manufacturing-use product (including registered TGAIs) and end-use products produced by an integrated formulation system. Data on other end-use products would be required on a case-by-case basis.
6. Data must be provided in accordance with § 158.350.
7. Data must be provided in accordance with § 158.355.
8. If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI. EP testing may also be appropriate.
9. Required if the product contains combustible liquids.
10. Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents.
11. Required if the test substance is soluble or dispersible in water.
12. Required if the product is a liquid.
13. Required when the technical chemical is a solid at room temperature.
14. Required when the technical chemical is a liquid at room temperature.
15. Required for water insoluble test substances (
16. Required for organic chemicals unless they dissociate in water or are partially or completely soluble in water.
17. Data on the stability to metals and metal ions is required only if the active ingredient is expected to come in contact with either material during storage.
18. True density or specific density are required for all test substances. Data on bulk density is required for MPs or EPs that are solid at room temperature.
19. Not required for salts.
(a)
(b)
(2) Data are conditionally required for nonfood uses if pesticide residues may occur in food or feed as a result of the use. Data requirements for these nonfood uses would be determined on a case-by-case basis. For example, most products used in or near kitchens require residue data for risk assessment purposes even though tolerances may not be necessary in all cases.
(c)
(d)
(e)
1. Residue chemistry data requirements apply to biochemical pesticide products when Tier II or Tier III toxicology data are required, as specified for biochemical agents in the biochemical human health assessment data requirements, §158.2050.
2. The same chemical identity data are required for biochemical product chemistry data requirements, §158.2030, with an emphasis on impurities.
3. Required information includes crops to be treated, rate of application, number and timing of applications, preharvest intervals, and relevant restrictions.
4. Required for residential outdoor uses on food crops if the corresponding agricultural use is not approved or the residential use is expected to produce higher residues based on the label directions .
5. Required unless it is an arthropod pheromone applied at a rate less than or equal to 150 grams active ingredient per acre.
6. Required for indoor uses where the pesticide is applied directly to food, in order to determine metabolites and/or degradates. Not required when only indirect contact with food would occur (e.g., crack and crevice treatments).
7. Required when a pesticide is to be applied directly to livestock, to livestock premises, to livestock drinking water, or to crops used for livestock feed.
8. If results from the plant metabolism study show differing metabolites in plants from those found in animals, an additional livestock metabolism study involving dosing with the plant metabolite(s) may also be required.
9. A residue analytical method suitable for enforcement of tolerances is required whenever a numeric tolerance (including temporary and time-limited tolerances) is proposed.
10. Required if indoor use could result in pesticide residues in or on food or feed.
11. Data are required to determine whether FDA/USDA multiresidue methodology would detect and identify the pesticides and any metabolites.
12. Data are required whenever a pesticide may be applied directly to water, unless it can be demonstrated that the treated water would not be available for human or livestock consumption.
13. Data on fish are required for all pesticides applied directly to water inhabited, or which will be inhabited by fish that may be caught or harvested for human consumption .
14. Data are required when a pesticide is to be applied directly to water that could be used for irrigation or to irrigation facilities such as irrigation ditches.
15. Data are required whenever a pesticide may be used in food/feed handling establishments.
16. Data on the nature and level of residue in processed food/feed are required when detectible residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance higher than that of the raw agricultural commodity.
17. Required when residues at the tolerance level may result in risk of concern. These data may include washing, cooking, processing, or degradation studies as well as market basket surveys for a more precise residue determination.
18. The proposed tolerance must reflect the maximum residue likely to occur in crops, in meat, milk, poultry, or eggs.
19. Required when a residue analytical method is required.
(a)
(2) The data in this section are not required for straight chain lepidopteran pheromones when applied up to a maximum use rate of 150 grams active ingredient/acre/year.
(b)
(2) Nonfood use patterns include products classified under the general use patterns of terrestrial nonfood crop use; aquatic nonfood residential use; aquatic nonfood outdoor use; aquatic nonfood industrial use; greenhouse nonfood crop use; forestry use; residential outdoor use; residential indoor use; indoor food use; indoor nonfood use; indoor medical use.
(c)
(d)
(e)
1. Required unless the test material is a gas or highly volatile (vapor pressure
2. Required unless the test material is corrosive to skin or has pH
3. Required when the pesticide, under conditions of use, would result in respirable material (e.g., gas, volatile substance or aerosol/particulate), unless it is a straight chain lepidopteran pheromone.
4. Required if repeated contact with human skin is likely to occur under conditions of use.
5. Hypersensitivity incidents must be reported as adverse effects data.
6. Required for non-food uses that are likely to result in repeated oral exposure to humans.
7. Required to support uses involving purposeful application to the human skin or which would result in comparable prolonged human exposure to the product (e.g., insect repellents) and if any of the following criteria are met:
i. Data from a 90-day oral study are not required.
ii. The active ingredient is known or expected to be metabolized differently by the dermal route of exposure than by the oral route and the metabolite is of toxicological concern.
iii. The use pattern is such that the dermal route would be the primary route of exposure.
8. Required if there is a likelihood of significant levels of repeated inhalation exposure to the pesticide as a gas, vapor, or aerosol.
9. Required if the use of the product under widespread and commonly recognized practice may reasonably be expected to result in significant exposure to female humans (e.g., occupational exposure or repeated application of insect repellents directly to the skin). Tier II data is required on a different test species from Tier I data when
10. Required to support nonfood uses if either:
i. The use is likely to result in significant human exposure; or
ii. The active ingredient (or its metabolites) is structurally related to a known mutagen or belongs to any chemical class of compounds containing a known mutagen. Additional mutagenicity tests that may have been performed plus a complete reference list must also be submitted. Subsequent testing may be required based on the available evidence.
11. Choice of assay using either:
i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, maximizing assay conditions for small colony expression or detection;
ii. Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) gene locus, accompanied by an appropriate
iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene locus.
12. Required if there are effects on hematology, clinical chemistry, lymphoid organ weights, and histopathology are observed in the 90-day studies.
13. The micronucleus rodent bone marrow assay is preferred; however, rodent bone marrow assays using metaphase analysis (aberrations) are acceptable.
14. Required if adverse effects are observed in the Tier II immunotoxicity study. The protocol for evaluating adverse effects to the immune response should be developed after evaluating the effects noted in the immunotoxicity study.
15. These data are required when the data used for the human health assessment indicates that the biochemical may pose a potential hazard to the applicator/user.
16. Required if there is evidence of:
i. Endocrinological effects from the subchronic toxicity studies.
ii. Developmental effects in the prenatal developmental toxicity study(s), or
iii. Genotoxicity to mammals based on results from the mutagenicity tests.
17. Required if the potential for adverse chronic effects is indicated based on any of the following:
i. The subchronic effect level established in the following Tier I studies: 90-day oral toxicity study, 90-day dermal toxicity study, or 90-day inhalation toxicity study.
ii. The pesticide use pattern (e.g., rate, frequency, and site of application).
iii. The frequency and level of repeated human exposure that is expected.
18. Required if the product meets either of the following criteria:
i. The active ingredient (or any of its metabolites, degradation products, or impurities) produce(s) in Tier I subchronic studies a morphologic effect (e.g., hyperplasia or metaplasia) in any organ that potentially could lead to neoplastic change.
ii. Adverse cellular effects suggesting carcinogenic potential are observed in Tier II immunotoxicity and Tier III immune response study or in Tier II mammalian mutagenicity assays.
In addition, a 90-day range finding study in both rats and mice is required to determine the dose levels if carcinogenicity studies are required. If the mouse carcinogenicity study is not required, the 90-day mouse subchronic study is likewise not required.
19. Required if results from lower tiered mutation or reproductive studies indicate there is potential for chromosomal aberration to occur.
20. May be required if the product's use will result in exposure to domestic animals through, but not limited to, direct application or consumption of treated feed.
(a)
(2) The data in this section are not required for arthropod pheromones when applied at up to a maximum use rate of 150 grams active ingredient/acre/year except when the product is expected to be available to avian species (i.e., granular formulation).
(b)
(c)
(d)
(e)
1. Required for the EP when any end-use formulation may contain other ingredients that may be toxic to nontarget organisms or to support arthropod pheromones that would be available to avian wildlife, (e.g., a granular product).
2. Tests for pesticides intended solely for indoor application would be required on a case-by-case basis, depending on use pattern, physical/chemical properties, production volume, and other pertinent factors.
3. Not required for any use groups if the pesticide is highly volatile (estimated volatility
4. Preferred test species are Upland game, waterfowl, or passerine for avian acute oral toxicity studies; Upland game and waterfowl for avian dietary studies; and coldwater fish species for acute freshwater fish studies.
5. Required for the EP when the end-use formulation may contain other ingredients that may be toxic to nontarget organisms.
6. Required on a case-by-case basis when results from Tier I studies indicate adverse effects.
7. Required when results of any one or more of the nontarget organism studies in Tier I indicate potential adverse effects on nontarget organisms and the pesticide is to be applied on land. In view of methdological difficulties with the study of photodegradation in air, prior consultation with the Agency regarding the protocol is recommended before the test is performed.
8. Required when results of any one or more of the nontarget organism studies in Tier I indicate potential adverse effects on nontarget organisms and the pesticide is to be applied in a passive dispenser.
9. Required to support registration of known phytotoxicants, i.e. herbicides, desiccants, defoliants, and plant growth regulators.
10. Required if environmental fate characteristics indicate that the estimated environmental concentration of the pesticide in the aquatic environment is
11. Required if either of the following criteria are met:
i. Environmental fate characteristics indicate that the estimated concentration of the pesticide in the terrestrial environment is
ii. The pesticide or any of its metabolites or degradation products are stable in the environment to the extent that potentially toxic amounts may persist in the avian or mammalian feed.
12. Required when results of Tier I nontarget organism studies indicate potential adverse effects on nontarget insects and results of Tier II tests indicate exposure of nontarget insects. Additional insect species may have to be tested if necessary to address issues raised by use patterns and potential exposure of important nontarget insect species, (e.g., threatened or endangered species).
13. Required if the product is expected to be transported from the site of application by air, soil, or water. The extent of movement would be determined by the results of the Tier II environmental fate studies.
14. Required depending on pesticide mode of action, method and timing of application, and results of any available efficacy data. Typically the honeybee acute toxicity guideline (guideline 850.3020) satisfies this requirement, however, additional nontarget insect species may have to be tested if necessary to address issues raised by use patterns and potential exposure of important nontarget insect species, (e.g., endangered species.)
Product performance data must be developed for all biochemical
(a) Sections 158.2081 through 158.2084 describe the experimental use permit (EUP) data requirements for biochemical pesticides. Variations in the test conditions are identified within the test notes. Definitions that apply to all biochemical data requirements can be found in § 158.2000.
(b) For general information on the data requirement tables, see § 158.2010(b)-(f).
(a)
(2) Depending on the results of the required product chemistry studies, appropriate use restrictions, labeling requirements, or special packaging requirements may be imposed.
(b)
(c)
(d)
(e)
1. Data must be provided in accordance with § 158.320.
2. If the MP and EP are produced by an integrated formulation system (non-registered source), these data are also required on TGAI.
3. Data must be provided in accordance with § 158.325, § 158.330, and § 158.335.
4. Data must be provided in accordance with § 158.340.
5. Data must be provided in accordance with § 158.345. Also, required to support the registration of each manufacturing-use product (including registered TGAIs) and end-use products produced by an integrated formulation system. Data on other end-use products would be required on a case-by-case basis. For pesticides in the production stage, a preliminary product analytical method and data would suffice to support an experimental use permit.
6. Data must be provided in accordance with § 158.350.
7. Data must be provided in accordance with § 158.355.
8. If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI. EP testing may also be appropriate.
9. Required if the product contains combustible liquids.
10. Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents.
11. Required if the test substance is soluble or dispersible in water.
12. Required if the product is a liquid.
13. Required when the technical chemical is a solid at room temperature.
14. Required when the technical chemical is a liquid at room temperature.
15. Required for water insoluble test substances (
16. Required for organic chemicals unless they dissociate in water or are partially or completely soluble in water.
17. Data on the stability to metals and metal ions is required only if the active ingredient is expected to come in contact with either material during storage.
18. True density or specific density are required for all test substances. Data on bulk density is required for MPs or EPs that are solid at room temperature.
19. Not required for salts.
(a)
(b)
(2) Data are conditionally required for nonfood uses if pesticide residues may occur in food or feed as a result of the use. Data requirements for these nonfood uses would be determined on a case-by-case basis. For example, most products used in or near kitchens require residue data for risk assessment purposes even though tolerances may not be necessary in all cases.
(c)
(d)
(e)
1. Residue chemistry data requirements apply to biochemical pesticide products when Tier II or Tier III toxicology data are required, as specified for biochemical agents in the biochemical human health assessment data requirements, §158.2050.
2. The same chemical identity data are required for biochemical product chemistry data requirements,§158.2030 with an emphasis on impurities.
3. Required information includes crops to be treated, rate of application, number and timing of applications, preharvest intervals, and relevant restrictions.
4. Required for residential outdoor uses on food crops if the corresponding agricultural use is not approved or the residential use is expected to produce higher residues based on the label directions.
5. Required unless it is an arthropod pheromone applied at a rate less than or equal to 150 grams active ingredient per acre.
6. Required for indoor uses where the pesticide is applied directly to food, in order to determine metabolites and/or degradates. Not required when only indirect contact with food would occur (e.g., crack and crevice treatments).
7. Required when a pesticide is to be applied directly to livestock, to livestock premises, to livestock drinking water, or to crops used for livestock feed. If results from the plant metabolism study show differing metabolites in plants form those found in animals, an additional livestock metabolism study involving dosing with the plant metabolite(s) may also be required.
8. Livestock feeding studies are required whenever a pesticide residue is present in livestock feed or when direct application to livestock uses occurs.
9. Required if indoor use could result in pesticide residues in or on food or feed.
10. Data are required to determine whether FDA/USDA multiresidue methodology would detect and identify the pesticides and any metabolites.
11. Data are required whenever a pesticide may be applied directly to water, unless it can be demonstrated that the treated water would not be available for human or livestock consumption.
12. Data on fish are required for all pesticides applied directly to water inhabited, or which will be inhabited, by fish that may be caught or harvested for human consumption.
13. Data are required when a pesticide is to be applied directly to water that could be used for irrigation or to irrigation facilities such as irrigation ditches.
14. Data are required whenever a pesticide may be used in food/feed handling establishments.
15. Data on the nature and level of residue in processed food/feed are required when detectible residues could potentially concentrate on processing thus requiring the
16 Anticipated residue data are required when the assumption of tolerance level residues would result in predicted exposure at an unsafe level of exposure. Data, using single serving samples of a raw agricultural commodity, on the level or residue in food as consumed would be used to obtain a more precise estimate of potential dietary exposure. These data may also include washing, cooking, processing or degradation studies as well as market basket surveys for a more precise residue determination.
17. The proposed tolerance must reflect the maximum residue likely to occur in crops, in meat, milk, poultry, or eggs.
18. Required when a residue analytical method is required.
(a)
(2) The data in this section are not required for straight chain lepidopteran pheromones when applied up to a maximum use rate of 150 grams active ingredient/acre/year.
(b)
(2) Nonfood use patterns include products classified under the general use patterns of terrestrial nonfood crop use; aquatic nonfood residential use; aquatic nonfood outdoor use; aquatic nonfood industrial use; greenhouse nonfood crop use; forestry use; residential outdoor use; residential indoor use; indoor food use; indoor nonfood use; indoor medical use.
(c)
(d)
(e)
1. Required unless the test material is a gas or highly volatile (vapor pressure
2. Required unless the test material is corrosive to skin or has pH
3. Required when the pesticide, under conditions of use, would result in respirable material (e.g., gas, volatile substance or aerosol/particulate), unless it is a straight chain lepidopteran pheromone.
4. Hypersensitivity incidents must be reported as adverse effects data.
5. Required if the use of the product under widespread and commonly recognized practice may reasonably be expected to result in significant exposure to female humans (e.g., occupational exposure or repeated application of insect repellents directly to the skin). Tier II data is required on a different test species from Tier I data when developmental effects are observed in the first study and information on species-to-species extrapolation is needed.
6. Required to support nonfood uses if either:
i. The use is likely to result in significant human exposure; or
ii. The active ingredient (or its metabolites) is structurally related to a known mutagen or belongs to any chemical class of compounds containing a known mutagen.
Additional mutagenicity tests that may have been performed plus a complete reference list must also be submitted. Subsequent testing may be required based on the available evidence.
7. Choice of assay using either:
i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, maximizing assay conditions for small colony expression or detection;
ii. Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) gene locus, accompanied by an appropriate
iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene locus.
(a)
(2) The data in this section are not required for arthropod pheromones when applied at up to a maximum use rate of 150 grams active ingredient/acre/year except when the product is expected to be available to avian species (i.e., granular formulation).
(b)
(c)
(d)
(e)
1. Required for the EP when any end-use formulation may contain other ingredients that may be toxic to nontarget organisms or to support arthropod pheromones that would be available to avian wildlife, (e.g., a granular product).
2. Not required for any use groups if the pesticide is highly volatile (estimated volatility
3. Preferred test species are: upland game, waterfowl, or passerine for avian acute oral toxicity studies; upland game or waterfowl for avian dietary studies; and coldwater fish for acute freshwater fish studies.
4. Required for the EP when the end-use formulation may contain other ingredients that may be toxic to nontarget organisms.
(a) This subpart applies to all living or dead microbial pesticides as described in paragraphs (b) and (c) of this section.
(b)
(1) Is a eucaryotic microorganism including, but not limited to, protozoa, algae, and fungi;
(2) Is a procaryotic microorganism, including, but not limited to, Eubacteria and Archaebacteria; or
(3) Is a parasitically replicating microscopic element, including, but not limited to, viruses.
(c)
(2) Each new isolate of a microbial pesticide is treated as a new strain and must be registered independently of any similar registered microbial pesticide strain and supported by data required in this subpart.
(3) Genetically modified microbial pesticides may be subject to additional data or information requirements on a case-by-case basis depending on the particular microbial agent and/or its parental strains, the proposed pesticide use pattern, and the manner and extent to which the organism has been genetically modified.
(4) Pest control organisms such as insect predators, nematodes, and macroscopic parasites are exempt from the requirements of FIFRA as authorized by section 25(b) of FIFRA and specified in § 152.20 (a) of this chapter.
(a) For all microbial pesticides. (1) The following § 158.2120 through § 158.2150 identify the data requirements that are required to support registration of microbial pesticides. The variations in the test conditions are identified within the test notes.
(2) Each data table includes “use patterns” under which the individual data are required, with variations including all use patterns, food and nonfood uses for terrestrial and aquatic applications, greenhouse, indoor, forestry, and residential outdoor applications under certain circumstances.
(3) The categories for each data requirement are “R,” which stands for required, and “CR” which stands for conditionally required. If a bracket appears around the “R” or “CR,” the data are required for both the registration and experimental use permit requests. Generally, “R” indicates that the data are more likely required than for those data requirements with “CR.” However, in each case, the regulatory text preceding the data table and the test notes following the data table must be used to determine whether the data requirement must be satisfied.
(4) Each table identifies the test substance that is required to be tested to satisfy the data requirement. Test substances may include: technical grade active ingredient (TGAI), manufacturing-use product (MP), end-use product (EP), typical end-use product (TEP), residue of concern, and pure active ingredient (PAI) or all of the above (All). Commas between the test substances (i.e., TGAI, EP) indicate that data may be required on the TGAI or EP or both depending on the conditions set forth in the test note. Data requirements which list two test substances (i.e., TGAI and EP) indicate that both are required to be tested. Data requirements that list only MP as the test substance apply to products containing solely the technical grade of the active ingredient and manufacturing-use products to which other ingredients have been intentionally added. Data requirements listing the EP as the test substance apply to any EP with an ingredient in the end-use formulation other than the active ingredient that is expected to enhance the toxicity of the product.
(b) Additional data requirements for genetically modified microbial pesticides. Additional requirements for genetically modified microbial pesticides may include but are not limited to: genetic engineering techniques used; the identity of the inserted or deleted gene segment (base sequence data or enzyme restriction map of the gene); information on the control region of the gene in question; a description of the “new” traits or characteristics that are intended to be expressed; tests to evaluate genetic stability and exchange; and selected Tier II environmental expression and toxicology tests.
(a)
(b)
(c)
(d)
1. Required to support registration of each manufacturing-use product and end-use product. This analysis must be conducted at the point in the production process after which there would be no potential for microbial contamination or microbial regrowth. For full registration, generally an analysis of samples is a compilation of batches, over a period of time, depending on the frequency of manufacturing.
2. Only required for emulsifiable liquid forms of microbial pesticides.
3. Required when microbial pesticides are packaged in metal, plastic, or paper containers.
4. Only required for liquid forms of microbial pesticides.
(a)
(b)
(c)
(d)
1. Required when the results of testing:
i. Indicate the potential to cause adverse human health effects or the product characterization indicates the microbial pesticide has a significant potential to produce a mammalian toxin; and
ii. The use pattern is such that residues may be present in or on food or feed crops.
(a)
(b)
(c)
(d)
1. The acute oral toxicity/pathogenicity study is required to support the TGAI. However, it can be combined with the unit dose portion of the acute oral toxicity study, with an EP or MP test material to fulfill the requirement for the TGAI and the MP or EP in a single study, if the new protocol is designed to address the endpoints of concern.
2. Data not required for products whose active ingredient is a virus. For test materials whose size or consistency may prevent use of an intravenous injection, the intraperitoneal injection procedure may be employed.
3. Hypersensitivity incidents, including immediate type and delayed-type reactions of humans or domestic animals, occur during the testing or production of the TGAI, MP, or EP, or are otherwise known to the applicant must be reported if they occur.
4. Data must be submitted only for products whose active ingredient is a virus.
5. The 870 series studies for the MP and EP are intended to provide data on the acute toxicity of the product. Waivers for any or all of these studies may be granted when the applicant can demonstrate that the combination of inert ingredients is not likely to pose any significant human health risks. Where appropriate, the limit dose approach to testing is recommended.
6. Required when the product consists of, or under conditions of use would result in, an inhalable material (e.g., gas, volatile substances, or aerosol particulate).
7. Data required when significant toxicity, in the absence of pathogenicity and significant infectivity, is observed in acute oral, injection, or pulmonary studies (Tier I). Route(s) of exposure correspond to route(s) where toxicity was observed in Tier I studies. The toxic component of the TGAI is to be tested.
8. Data required when significant infectivity and/or unusual persistence is observed in the absence of pathogenicity or toxicity in Tier I studies. Routes of exposure (oral and/or pulmonary) correspond to routes in Tier I studies where adverse effects were noted. Data may also be required to evaluate adverse effects due to microbial contaminants or to toxic byproducts.
9. Data are required when one or more of the following criteria are met:
i. Significant infectivity of the microbial pest control agent (MPCA) was observed in test animals in the Tier II subchronic study and in which no significant signs of toxicity or pathogenicity were observed.
ii. The microbial pesticide is a virus which can persist or replicate in mammalian cell culture lines.
iii. The microbial pesticide is not amenable to thorough taxonomic classification, and is related to organisms known to be parasitic for mammalian cells.
iv. The microbial pesticide preparation is not well purified, and may contain contaminants which are parasitic for mammals.
10. Data may be required for products known to contain or suspected to contain carcinogenic viruses or for microbial components that are identified as having significant toxicity in Tier II testing.
11. Data may be required for products known to contain or suspected to contain viruses that can interact in an adverse manner with components of the mammalian immune system.
12. An analysis of human infectivity/pathogenicity potential using scientific literature, genomic analysis, and/or actual specific cell culture/animal data may be required for products known to contain or suspected of containing intracellular parasites of mammalian cells for products that exhibit pathogenic characteristics in Tier I and/or Tier II, for products which are closely related to known human pathogens based on the product analysis data, or for known human pathogens that have been “disarmed” or rendered non-pathogenic for humans.
13. Test standards may have to be modified depending on the characteristics of the microorganism. Requirements may vary for these studies depending on the active ingredient being tested. Consultation with the Agency is advised before performing these Tier III studies.
(a)
(b)
(c)
(d)
(e)
1. Tests for pesticides intended solely for indoor application would be required on a case-by-case basis, depending on use pattern, production volume, and other pertinent factors.
2. The preferred species for the avian oral study is either the upland game or waterfowl. The preferred species for the avian inhalation toxicity/pathogenicity study and the avian chronic toxicity/pathogenicity study is the upland game. There is also the option to test the passerine if there is a concern. The coldwater fish is preferred for freshwater fish testing. However, two species (coldwater and warmwater fish species are the preferred species) must be tested for uses involving direct freshwater exposure. Freshwater invertebrate testing is also required.
3. Data required when the nature of the microbial pesticide and/or its toxins indicates potential pathogenicity to birds.
4. Required on a case-by-case basis if results of tests required by § 158.2140 are inadequate or inappropriate for assessment of hazards to wild mammals.
5. Required when there will be significant exposure to aquatic organisms (fish and invertebrates).
6. Required if the product is intended for direct application into the estuarine or marine environment or expected to enter this environment in significant concentrations because of expected use or mobility pattern.
7. Required if the microbial pesticide is taxonomically related to a known plant pathogen.
8. Data are not required unless an active microbial ingredient controls the target insect pest by a mechanism of infectivity; i.e. may create an epizootic condition in nontarget insects.
9. Required if toxic or pathogenic effects are observed in one or more of the following tests for microbial pesticides:
i. Avian acute oral or avian inhalation studies.
ii. Wild mammal studies.
iii. Nontarget plant studies (terrestrial).
iv. Honey bee studies.
v. Nontarget insect studies.
10. Required when toxic or pathogenic effects are observed in any of the following Tier I tests for microbial pest control agents:
i. Freshwater fish studies.
ii. Freshwater invertebrate studies.
iii. Nontarget plant studies (aquatic).
11. Required if product is applied on land or in fresh water or marine/estuarine environments and toxic or pathogenic effects are observed in any of the following Tier I tests for microbial pesticides:
i. Estuarine and marine animal toxicity and pathogenicity.
ii. Plant studies - estuarine or marine species.
12. An appropriate dose-response toxicity test is required when toxic effects on nontarget terrestrial wildlife or aquatic organisms (including plants) are reported in one or more Tier I tests and results of Tier II tests indicate exposure of the microbial agent to the affected nontarget terrestrial wildlife or aquatic organisms. The protocols for these tests may have to be modified in accordance with results from the nontarget organism and environmental expression studies.
13. Required when one or more of the following are present:
i. Pathogenic effects are observed in Tier I avian studies.
ii. Tier II environmental expression testing indicate that long-term exposure of terrestrial animals is likely.
14. Required when product is intended for use in water or expected to be transported to water from the intended use site, and when pathogenicity or infectivity was observed in Tier I aquatic studies.
15. Required if, after an analysis of the microbial pesticide's ability to survive and multiply in the environment and what ecological habitat it would occupy, the intended use patterns, and the results of previous nontarget organisms and environmental expression tests, it is determined that use of the microbial agent may result in adverse effects on the nontarget organisms in aquatic environments. Testing is to determine if applications of the microbial pest control would be expected to disrupt the balance of populations in the target ecosystem.
16. Tier IV studies may be conducted as a condition of registration as post-registration monitoring if the potential for unreasonable adverse effects appears to be minimal during that period of use due to implementation of mitigation measures.
17. Required when both of the following conditions occur:
i. Pathogenic effects observed at actual or expected field residue exposure levels are reported in Tier III; and
ii. The Agency determines that quarantine methods would not prevent the microbial pesticide from contaminating areas adjacent to the test area.
18. Short term simulated or actual field studies are required when it is determined that the product is likely to cause adverse short-term or acute effects, based on consideration of available laboratory data, use patterns, and exposure rates.
19. Data from a long-term simulated field test (e.g., where reproduction and growth of confined populations are observed) and/or an actual field test (e.g., where reproduction and growth of natural populations are observed) are required if laboratory data indicate that adverse long-term, cumulative, or life-cycle effects may result from intended use.
20. Since test standards would be developed on a case-by-case basis, consultation with the Agency and development of a protocol is advised before performing these Tier IV studies.
Product performance data must be developed for all microbial pesticides. However, the Agency has waived all requirements to submit efficacy data unless the pesticide product bears a claim to control public health pests, such as pest microorganisms infectious to man in any area of the inanimate environment or a claim to control vertebrates (including but not limited to: rodents, birds, bats, canids, and skunks) or invertebrates (including but not limited to: mosquitoes and ticks) that may directly or indirectly transmit diseases to humans. However, each registrant must ensure through testing that his products are efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency reserves the right to require, on a case-by-case basis, submission of efficacy data for any pesticide product registered or proposed for registration.
(a) For all microbial pesticides. (1) The following § 158.2171 through § 158.2174 identify the data requirements that are required to support experimental use permits for microbial pesticides. The variations in the test conditions are identified within the test notes.
(2) For general information on the data requirement tables, see § 158.2110(a)(2)-(4).
(b) Additional data requirements for genetically modified microbial pesticides. Additional requirements for genetically modified microbial pesticides may include but are not limited to: genetic engineering techniques used; the identity of the inserted or deleted gene segment (base sequence data or enzyme restriction map of the gene); information on the control region of the gene in question; a description of the “new” traits or characteristics that are intended to be expressed; tests to evaluate genetic stability and exchange; and selected Tier II environmental expression and toxicology tests.
(a)
(b)
(c)
(d)
1. If an experimental use permit is being sought, and if the pesticide is not already under full-scale production, a schematic diagram and/or description of the manufacturing process suffices.
2. If an experimental use permit is being sought, and if the product is not already under full-scale production, a discussion of unintentional ingredients is required to be submitted to the extent this information is available.
3. Required to support registration of each manufacturing-use product and end-use product. This analysis must be conducted at the point in the production process after which there would be no potential for microbial contamination or microbial regrowth. For pesticides in the production stage, a preliminary product analytical method and data would suffice to support an experimental use permit. For full registration, generally an analysis of samples is a compilation of batches, over a period of time, depending on the frequency of manufacturing.
4. Only required for emulsifiable liquid forms of microbial pesticides.
5. Required when microbial pesticides are packaged in metal, plastic, or paper containers.
6. Only required for liquid forms of microbial pesticides.
(a)
(b)
(c)
(d)
1. Required when the results of testing:
i. Indicate the potential to cause adverse human health effects or the product characterization indicates the microbial pesticide has a significant potential to produce a mammalian toxin; and
ii. The use pattern is such that residues may be present in or on food or feed crops.
(a)
(b)
(c)
(d)
1. The acute oral toxicity/pathogenicity study is required to support the TGAI. However, it can be combined with the unit dose portion of the acute oral toxicity study, with an EP or MP test material to fulfill the requirement for the TGAI and the MP or EP in a single study, if the new protocol is designed to address the endpoints of concern.
2. Data not required for products whose active ingredient is a virus. For test materials whose size or consistency may prevent use of an intravenous injection, the intraperitoneal injection procedure may be employed.
3. Hypersensitivity incidents, including immediate type and delayed type reactions of humans or domestic animals occur during the testing or production of the TGAI, MP, or EP, or are otherwise known to the applicant must be reported if they occur.
4. Data must be submitted only for products whose active ingredient is a virus.
5. The 870 series studies for the MP and EP are intended to provide data on the acute toxicity of the product. Waivers for any or all of these studies may be granted when the applicant can demonstrate that the combination of inert ingredients is not likely to pose any significant human health risks. Where appropriate, the limit dose approach to testing is recommended.
6. Required when the product consists of, or under conditions of use that would result in an inhalable material (e.g., gas, volatile substances, or aerosol particulate).
(a)
(b)
(c)
(d)
(e)
1. Tests for pesticides intended solely for indoor application would be required on a case-by-case basis, depending on use pattern, production volume, and other pertinent factors. Tests to support EUP's are based on the application timing and acreage.
2. The preferred species for the avian oral study is either the upland game or waterfowl. The preferred species for the avian inhalation toxicity/pathogenicity study and the avian chronic toxicity/pathogenicity study is the upland game. There is also the option to test a passerine species if there is a concern. The coldwater fish is preferred for freshwater fish testing. However, two species (coldwater and warmwater fish are the preferred species) must be tested for uses involving direct freshwater exposure. Freshwater invertebrates are preferred for invertebrate testing.
3. Required when there will be significant exposure to aquatic organisms (fish and invertebrates).
4. Required if the microbial pesticide is taxonomically related to a known plant pathogen.
5. Data are not required unless an active microbial ingredient controls the target insect pest by a mechanism of infectivity; i.e. may create an epizootic condition in nontarget insects.
Environmental Protection Agency (EPA).
Final rule.
This document makes technical changes and revises cross references in the Code of Federal Regulations (CFR) to reflect changes in pesticide data requirements being promulgated elsewhere in today's
This final rule is effective December 26, 2007.
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2004-0387. To access the electronic docket, go to
Jean Frane, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-5944; fax number: (703) 305-5884; e-mail address:
You may be potentially affected by this action if you are a producer or registrant of a pesticide product. This action may also affect any person or company who might petition the Agency for new tolerances, hold a pesticide registration with existing tolerances, or any person or company
• Pesticide Producers (NAICS code 32532), e.g., pesticide manufacturers or formulators of pesticide products, importers or any person or company who seeks to register a pesticide or to obtain a tolerance for a pesticide.
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) code has 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 persons listed under
In the
This final rule makes certain technical changes and corrects cross-references elsewhere in pesticide regulations to conform to new parts 161 and 158. By issuing a separate technical changes rule, EPA intends that the promulgation of the substantive revisions for conventional, biochemical and microbial pesticide data requirements will be straightforward without confusing technical changes. The key changes are:
1.
2.
Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), provides that, when an Agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the Agency may issue a final rule without providing notice and an opportunity for public comment. EPA has determined that it is unnecessary to make today's rule final without prior proposal and opportunity for comment, because EPA is simply making corrections to cross-references for accuracy. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B).
This rule makes technical changes and cross-reference corrections in the EPA regulations governing pesticides. The amendments are administrative in nature and, for the most part, amend the CFR so that it is consistent with regulations concerning data requirements being promulgated elsewhere in this issue of the
Accordingly, these amendments are not subject to review under Executive Order 12866, entitled
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
The Congressional Review Act, 5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Pesticides and pests, Reporting and recordkeeping requirements.
Environmental protection, Labeling, Pesticides and pests, Reporting and recordkeeping requirements.
Environmental protection, Pesticides and pests, Reporting and recordkeeping requirements.
Environmental protection, Laboratories, Pesticides and pests, Reporting and recordkeeping requirements.
Environmental protection, Administrative practice and procedure, Advertising, Exports, Labeling, Pesticides and pests, Reporting and recordkeeping requirements.
Environmental protection, Intergovernmental relations, Labeling, Pesticides and pests, Reporting and recordkeeping requirements, Research.
7 U.S.C. 136-136y. Subpart U is also issued under 31 U.S.C. 9701.
(a) * * *
(3) The following biological control agents are not exempt from FIFRA requirements:
(i) A eucaryotic microorganism including, but not limited to, protozoa, algae and fungi;
(ii) A procaryotic microorganism including, but not limited to, Eubacteria and Archaebacteria; or
(iii) A parasitically-replicating microscopic element, including, but not limited to, viruses.
(b) * * *
(4) The analytical method required under § 158.355 of this chapter must be suitable for use on both the basic formulation and the alternate formulation.
(c)
(f) * * *
(2) An applicant must furnish any data specified in part 158 or part 161 of this chapter, as applicable, of this chapter which are required by the Agency to determine that the product meets the registration standards of FIFRA sec. 3(c)(5) or (7). Each study must comply with:
(i) Section 158.32 of this chapter, with respect to format of data submission.
(ii) Section 158.33 of this chapter, with respect to studies for which a claim of trade secret or confidential business information is made.
(iii) Section 158.34 of this chapter, with respect to flagging for potential adverse effects.
(iv) Section 160.12 of this chapter, with respect to a statement whether studies were conducted in accordance with Good Laboratory Practices of part 160.
(a)
(b)
(2) The data to which the formulators' exemption applies usually will concern the safety of one or more of the product's active ingredients, specifically, those active ingredients which are contained in the purchased product. In general, data for which the required test substance is the technical grade of the active ingredient, the pure active ingredient, the radiolabeled pure active ingredient, or a typical end-use product are eligible for the formulators' exemption.
(3) The formulators' exemption generally does not apply to data on the applicant's product itself, including the
(c)
(1) The application indicates that the ingredient's presence in the product is attributable solely to the purchase from another person of an identified, registered product containing that ingredient and the use of the purchased product in formulating the product; and
(2) The purchased product is a registered manufacturing-use product whose label does not prohibit its use for making an end-use product labeled for any use for which the applicant's product will be labeled; or
(3) The purchased product is a registered end-use product labeled for each use for which the applicant's product will be labeled.
(d)
(i) Identification of the applicant, and of the product by EPA registration number or file symbol.
(ii) Identification of each ingredient in the pesticide that is eligible for the formulators' exemption, and the EPA registration number of the product that is the source of that ingredient.
(iii) A statement that the listed ingredients meet the requirements for the formulators' exemption.
(iv) A statement that the applicant has submitted (either previously or with the current application) a complete, accurate and current Confidential Statement of Formula.
(v) The name, title and signature of the applicant or his authorized representative and the date of signature.
(2) An applicant for amended registration is not required to submit a new formulators' exemption statement, if the current statement in Agency files is complete and accurate.
(e)
(a) * * *
(2) If a Registration Standard has not been issued, or if an issued Registration Standard does not cover all data requirements for products containing the active ingredient in question, the applicant must list the applicable requirements as prescribed by 40 CFR part 158 or part 161, as applicable. All required (R) studies, and any studies that could be conditionally required (CR) based upon composition, use pattern, or the results of required studies, are to be listed. The applicant may demonstrate via the data gap procedures in § 152.96 that a conditional requirement need not be satisfied by the submission or citation of data at the time of application.
(a) * * *
(2) * * *
(iii) For each such active ingredient, the type(s) of study he has previously submitted (corresponding to Guidelines reference numbers given in tables in 40 CFR part 158 or part 161, as applicable), the date of submission, and the EPA registration number, file symbol, or other identifying reference for which it was submitted.
The applicant is responsible for the accuracy and completeness of all information submitted in connection with the application. The Agency will review each application to determine whether it is complete. An application is incomplete if any pertinent item specified in § 152.50 has not been submitted, or has been incorrectly submitted (for example, data required by part 158, or part 161 of this chapter, as applicable, and not submitted in accordance with the requirements for format, claims of confidential business information, or flagging).
(d) The Agency has determined that the composition of the product is such as to warrant the proposed efficacy claims for it, if efficacy data are required to be submitted by part 158 or part 161, as applicable, of this chapter for the product.
(b)
7 U.S.C. 136-136y.
7 U.S.C. 136-136y.
(a) * * *
(2) A study which indicates that the pesticide may not perform in accordance with one or more claims made by the registrant regarding uses intended for control of microorganisms tha may pose a risk to human health, including any of the public health antimicrobials identified in part 161 of this chapter.
7 U.S.C. 136a, 136c, 136d, 136f, 136j, 136v, 136w; 21 U.S.C. 346a, 348, 371, Reorganization Plan No. 3 of 1970.
7 U.S.C. 136-136y.
(b) * * *
(3) * * *
(ii) An exporter who is also the manufacturer of a U.S. registered pesticide may add new uses to the label of that product for export purposes, without triggering the requirements of section 17(a)(2), as long as the new uses are within the same general use patterns as those for the registered product. The general pesticide use patterns are: terrestrial food crop and terrestrial non-food crop; greenhouse food crop and greenhouse nonfood crop; aquatic food crop and aquatic nonfood crop' indoor use' and forestry use. Adding new uses to the label which change the use pattern, such as changes from nonfood to food use, outdoor to indoor use, or terrestrial to aquatic use, render the product unregistered and subject to the requirements of section 17 for unregistered products. If the new use added to the label is a food or feed use, a tolerance must already be established for the use of that pesticide in or on that commodity.
7 U.S.C. 136c, 136w. Section 172.4 is also issued under 31 U.S.C. 9701.
(1) Is a eucaryotic microorganism including, but not limited to, protozoa, algae and fungi;
(2) Is a procaryotic microorganism, including, but not limited to, Eubacteria and Archaebacteria; or
(3) Is a parasitically replicating microscopic element, including, but not limited to, viruses.